Physical Therapy- Journal of the APTA, Volume 90, Issue 6 (June 2010)

June 2010  Volume 90  Number 6

Research Reports 843

Clinical Prediction Rules for Musculoskeletal Conditions

921

Physical Performance Measures in Elderly African Americans

860

Graded Activity and Graded Exposure for Low Back Pain

928

Responsiveness of Shoulder Computerized Adaptive Test Measures

880

Balance Exercise Program for Patients With Total Knee Arthroplasty

Case Reports

895

Home Program of Hip Abductor Exercises

905

Impact of Work-Related Pain on Therapists

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939

Constrained Physical Therapist Practice

953

Implementation of Measurement Instruments

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at PT 2010 Reserve These Dates and Times for PTJ Sessions at PT 2010 The 2009 Rothstein Debate: “Should Physical Therapists Be Physician Extenders?” Thursday, June 17

9:30–11:00 am

Moderator: Anthony Delitto, PT, PhD, FAPTA, Pittsburgh, PA; debaters to be announced

PTJ Breakfast—Essentials of Writing and Reviewing Research Reports Friday, June 18

8:00–9:30 am

Be more effective and time-efficient by focusing on the essential elements of high-quality papers! International, consensus-based checklists for different research designs can make your life easier. Also covered: PTJ’s checklists for different types of case reports. Bring questions. PTJ’s Editorial Board can help—regardless of which journals you publish in or review for. Eat, learn, advance.

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Physical Therapy Journal of the American Physical Therapy Association

Editorial Office Managing Editor / Associate Director of Publications: Jan P. Reynolds, [email protected] PTJ Online Editor / Assistant Managing Editor: Steven Glaros Associate Editor: Stephen Brooks, ELS Production Manager: Liz Haberkorn

Editor in Chief

Rebecca L. Craik, PT, PhD, FAPTA, Philadelphia, PA [email protected]

Deputy Editor in Chief

Daniel L. Riddle, PT, PhD, FAPTA, Richmond, VA

Editor in Chief Emeritus

Jules M. Rothstein, PT, PhD, FAPTA (1947–2005)

Steering Committee

Permissions / Reprint Coordinator: Michele Tillson

Anthony Delitto, PT, PhD, FAPTA (Chair), Pittsburgh, PA; J. Haxby Abbott, PhD, MScPT, DipGrad, FNZCP, Dunedin, New Zealand; Joanell Bohmert, PT, MS, Mahtomedi, MN; Alan M. Jette, PT, PhD, FAPTA, Boston, MA; Charles Magistro, PT, FAPTA, Claremont, CA; Ruth B. Purtilo, PT, PhD, FAPTA, Boston, MA; Julie Whitman, PT, DSc, OCS, Westminster, CO

Advertising Manager: Julie Hilgenberg

Editorial Board

Manuscripts Coordinator: Karen Darley

Director of Publications: Lois Douthitt

APTA Executive Staff Vice President for Communications: Felicity Feather Clancy Chief Financial Officer: Rob Batarla Chief Executive Officer: John D. Barnes

Advertising Sales Ad Marketing Group, Inc 2200 Wilson Blvd, Suite 102-333 Arlington, VA 22201 703/243-9046, ext 102

Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, Malvern, Victoria, Australia; W. Todd Cade, PT, PhD, St. Louis, MO; James Carey, PT, PhD, Minneapolis, MN; John Childs, PT, PhD, Schertz, TX; Charles Ciccone, PT, PhD, FAPTA (Continuing Education), Ithaca, NY; Joshua Cleland, PT, DPT, PhD, OCS, FAAOMPT, Concord, NH; Janice J. Eng, PT/OT, PhD, Vancouver, BC, Canada; James C. (Cole) Galloway, PT, PhD, Newark, DE; Steven Z. George, PT, PhD, Gainesville, FL; Kathleen Gill-Body, PT, DPT, NCS, Boston, MA; Paul J.M. Helders, PT, PhD, PCS, Utrecht, The Netherlands; Maura D. Iversen, PT, ScD, MPH, Boston, MA; Diane U. Jette, PT, DSc, Burlington, VT; Christopher Maher, PT, PhD, Lidcombe, NSW, Australia; Christopher J. Main, PhD, FBPsS, Keele, United Kingdom; Kathleen Kline Mangione, PT, PhD, GCS, Philadelphia, PA; Patricia Ohtake, PT, PhD, Buffalo, NY; Carolynn Patten, PT, PhD, Gainesville, FL; Linda Resnik, PT, PhD, OCS, Providence, RI; Kathleen Sluka, PT, PhD, Iowa City, IA; Patty Solomon, PT, PhD, Hamilton, Ont, Canada

Statistical Consultants

President / Advertising Account Manager: Jane Dees Richardson

Steven E. Hanna, PhD, Hamilton, Ont, Canada; John E. Hewett, PhD, Columbia, MO; Hang Lee, PhD, Boston, MA; Xiangrong Kong, PhD, Baltimore, MD; Paul Stratford, PT, MSc, Hamilton, Ont, Canada; Samuel Wu, PhD, Gainesville, FL

Board of Directors

Committee on Health Policy and Ethics

President: R. Scott Ward, PT, PhD Vice President: Paul A. Rockar Jr, PT, DPT, MS

Linda Resnik, PT, PhD, OCS (Chair), Providence, RI; Janet Freburger, PT, PhD, Chapel Hill, NC; Alan Jette, PT, PhD, FAPTA, Boston, MA; Michael Johnson, PT, PhD, OCS, Philadelphia, PA; Justin Moore, PT, DPT, Alexandria, VA; Ruth Purtilo, PT, PhD, FAPTA, Boston, MA

Secretary: Babette S. Sanders, PT, MS Treasurer: Connie D. Hauser, PT, DPT, ATC Speaker of the House: Shawne E. Soper, PT, DPT, MBA Vice Speaker of the House: Laurita M. Hack, PT, DPT, MBA, PhD, FAPTA Directors: Sharon L. Dunn, PT, PhD, OCS; Kevin L. Hulsey, PT, DPT, MA; Dianne V. Jewell, PT, DPT, PhD, CCS, FAACVPR; Aimee B. Klein, PT, DPT, DSc, OCS; Kathleen K. Mairella, PT, DPT, MA; Stephen C.F. McDavitt, PT, DPT, MS, FAAOMPT; Lisa K. Saladin, PT, PhD; Mary C. Sinnott, PT, DPT, MEd; Nicole L. Stout, PT, MPT, CLT-LANA

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Linking Evidence And Practice Advisory Group

Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, Malvern, Victoria, Australia (Co-Chair); Diane U. Jette, PT, DSc, Burlington, VT (Co-Chair); W. Todd Cade, PT, PhD, St. Louis, MO; Christopher Maher, PT, PhD, Lidcombe, NSW, Australia; Kathleen Kline Mangione, PT, PhD, GCS, Philadelphia, PA; David Scalzitti, PT, DPT, PhD, Alexandria, VA

June 2010

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Subscriptions

Physical Therapy (PTJ) (ISSN 00319023) is published monthly by the American Physical Therapy Association (APTA), 1111 North Fairfax Street, Alexandria, VA 22314-1488, at an annual subscription rate of $12 for members, included in dues. Nonmember rates are as follows: Individual (inside USA)— $99; individual (outside USA)—$119 surface mail, $179 air mail. Institutional (inside USA)—$129; institutional (outside USA)—$149 surface mail, $209 air mail. Periodical postage is paid at Alexandria, VA, and at additional mailing offices. Postmaster: Send address changes to Physical Therapy, 1111 North Fairfax Street, Alexandria, VA 22314-1488. Single copies: $15 USA, $15 outside USA; with the exception of January 2001: $50 USA, $70 outside USA. All orders payable in US currency. No replacements for nonreceipt after a 3-month period has elapsed. Canada Post International Publications Mail Product Sales Agreement No. 0055832.

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Mission Statement

Physical Therapy (PTJ) engages and inspires an international readership on topics related to physical therapy. As the leading international journal for research in physical therapy and related fields, PTJ publishes innovative and highly relevant content for both clinicians and scientists and uses a variety of interactive approaches to communicate that content, with the expressed purpose of improving patient care.

Readers are invited to submit manuscripts to PTJ. PTJ’s content—including editorials, commentaries, letters, and book reviews—represents the opinions of the authors and should not be attributed to PTJ or its Editorial Board. Content does not reflect the official policy of APTA or the institution with which the author is affiliated, unless expressly stated.

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LINKING EVIDENCE AND PRACTICE Exercise for Osteoarthritis of the Knee Chung-Wei Christine Lin, Deborah Taylor, Sita M.A. Bierma-Zeinstra, Christopher G. Maher highlights the findings and application of Cochrane reviews and other evidence pertinent to the practice of physical therapy. The Cochrane Library is a respected source of reliable evidence related to health care. Cochrane systematic reviews explore the evidence for and against the effectiveness and appropriateness of interventions— medications, surgery, education, nutrition, exercise—and the evidence for and against the use of diagnostic tests for specific conditions. Cochrane reviews are designed to facilitate the decisions of clinicians, patients, and others in health care by providing a careful review and interpretation of research studies published in the scientific literature.1 Each article in this new PTJ series will summarize a Cochrane review or other scientific evidence resource on a single topic and will present clinical scenarios based on real patients to illustrate how the results of the review can be used to directly inform clinical decisions. This article focuses on a patient with moderate osteoarthritis in both knees. Can exercise help this patient?

O

steoarthritis (OA) is a joint disorder characterized by progressive degeneration of the articular cartilage, resulting in a loss of joint space and loss of marginal and central new bone formation. Structural abnormalities of all tissues in the joint—including the cartilage, subchondral bone, synovium, capsule, and ligaments—also may be present.2 Pain and functional limitation are the main complaints in people with symptomatic OA. Worldwide, OA is one of the leading causes of disability, particularly in the elderly population,3,4 and is most prevalent at the hip and knee. Osteoarthritis can be managed conservatively, and, in more severe cases, by joint replacement surgery. However, international guidelines recommend conservative treatments as first-line care for people with OA.5–8 These treatments include medications, exercise, education, and weight loss. Exercise is used to address specific problems experienced by people with knee OA. These problems include reduced joint range of motion, lower-limb muscle strength,9 and aerobic fitness10 at the level of body function and activity limitation11 and reduced quality of life12,13 at a global level of health. Fransen and McConnell14 conducted a Cochrane systematic review to evaluate the benefits of exercise for knee OA on 2 outcomes: pain and physical function (Tab. 1).

Find Case #1 at http:// ptjournal.apta.org/cgi/content/ full/90/1/9.

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Take-Home Message Thirty-two randomized or quasirandomized controlled trials comparing land-based exercises with a nonexercise intervention were included in this Cochrane review,14 and the pooled results showed a small benefit for exercise in reducing pain and improving physical function. Because studies in the review varied widely in the mode, content, and dosage of exercises provided, it was not possible to suggest an optimal exercise strategy. Most studies, however, provided an exercise program consisting of strengthening exercises with or without range of motion or aerobic exercises. An indirect comparison of the different modes of exercise showed that lower-limb muscle strengthening, aerobic exercise, or a combination of both seemed to be equally effective for both pain and physical function.14,15 The Cochrane review had some limitations. Only studies published in English were included, and only data collected at the end of the treatment period were extracted; therefore, only short-term effects were presented. Randomized controlled trials published since the 2008 Cochrane review found similar posttreatment benefits in support of exercise.16–19 In the studies that provided longerterm results (3 months or more), there was some indication that the benefits of exercise persisted.17,19 However, a systematic review investigating the long-term benefits of exercise showed that exercise did not have a significant effect

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Case #2 Exercise for Osteoarthritis of the Knee Table 1.

Exercise for Osteoarthritis of the Knee: Cochrane Review Results14 ➢ 32 randomized and quasi-randomized controlled trials were included, providing data on 3,616 participants for pain and 3,719 participants for selfreported physical function. ➢ Participants in the studies fulfilled the American College of Rheumatology diagnostic criteria for knee osteoarthritis or had self-reported knee pain and were recruited from the community, general practice clinics, or rheumatology, orthopedic, or physical therapy outpatient clinics. ➢ Studies compared land-based exercise with any nonexercise intervention (most commonly, no treatment/waiting list or education sessions). Exercise programs varied widely in the mode of delivery (eg, individual vs group), content, and dosage. Twenty studies included strengthening exercises, and 9 studies included aerobic exercises in the exercise program. ➢ Only data from the most immediate assessment after the treatment period were reported. Overall, exercise had a small benefit in reducing pain and improving physical function. Pain

There was a small and statistically significant benefit toward exercise (standardized mean differencea=0.40, 95% confidence interval=0.30−0.50). The most common measure for pain was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (15 studies), followed by the visual analog scale (9 studies).

Self-reported physical function

There was a small and statistically significant benefit toward exercise (standardized mean differencea=0.37, 95% confidence interval=0.25−0.49). The most common measure for physical function was the WOMAC subscale for physical function (17 studies).

➢ In general, mode of delivery, content, and dosage of exercises did not influence outcomes, except that a higher number of contact sessions between clinicians and patients increased the size of the treatment effect. ➢ Studies with more rigorous trial design (eg, blinded outcome assessment, larger sample size) produced smaller, though still statistically significant, treatment effects. a The standardized mean difference is the difference in mean outcome between groups divided by the standard deviation of the outcome.23 As a guide, a standardized mean difference of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect.24

on pain or physical function after 6 months, except when booster sessions were implemented.20

Case #2: Exercise for Osteoarthritis of the Knee Can exercise help this patient? Mr S is a 55-year-old man with a 3-year history of progressively increasing bilateral knee pain, left worse than right. During the

past 3 months, he was in a sedentary job, his weight increased by more than 10 kg, and his symptoms increased significantly. Mr S reported left knee pain as being 6 out of 10 on the visual analog scale (Tab. 2), and he was using a walking stick to walk any distance. He had minimal symptoms at night, stiffness that resolved after about 15 minutes in the morning, and symptoms that worsened as the day went on. His pain was

Table 2.

Mr S’s Progress Before and After an Exercise Program, Contrasted With the Minimal Clinically Important Difference of Each Scalea Minimal Clinically Important Difference Pain (visual analog scale, /10)

a b

6

3

>1.521

Walking on flat surface

5

8

Walking on hills

4

7

Sitting

6

9

Mr S had moderate osteoarthritis in the left knee. A higher score denotes better physical function.

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After Exercise

222

Worst pain Self-reported physical function (Patient-Specific Functional Scale, /10)b

Before Exercise

exacerbated by walking more than 15 minutes or on hills and by long periods of sitting. Mr S found relief by using a walking stick, moving his knees when sitting, and taking regular doses of a nonsteroidal anti-inflammatory drug and paracetamol. Mr S’s radiographic films showed a decreased medial knee joint height with osteophyte formation. Overall, his presentation was consistent with moderate knee OA. Mr S was working full time, sitting at a desk for most of the day, and reported that he was managing his daily activities (eg, shopping, gardening) with slight difficulty. On the Patient-Specific Functional Scale21 (/10), where a score of 0 was “unable to perform activity” and 10 was “able to perform activity at the same level as before,” he identified 3 activities that he had difficulties with: walking on a flat surface, walking on hills, and sitting (Tab. 2). Mr S had no limitations in knee range of motion; however, there was pain at end-range flexion on the June 2010

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Case #2 Exercise for Osteoarthritis of the Knee left. Knee extension was slightly weaker on the left. He also had calf and hamstring muscle tightness that was worse on the left than on the right. How did the results of the Cochrane systematic review apply to Mr S? Exercise is recommended as part of the first-line care for OA, and results of the Cochrane review support the use of exercise. Mr S himself stated that he had no regular exercise routine, and his goal was to be shown an appropriate exercise regimen that would help him improve his ability to walk and decrease his pain. Mr S started on an exercise program that included quadriceps and gluteal muscle strengthening exercises and calf and hamstring muscle stretches. The dose for the strengthening and stretching exercises was established based on examination findings, and the exercises were progressed to more challenging functional exercises with increased

©2010, Fotosearch, LLC. All rights reserved.

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resistance as he improved. These exercises included sit-to-stand exercises, step exercises with emphasis on good lower-limb alignment, and resisted gluteus medius muscle exercises in a standing position with a blue Thera-Band.* After 4 weeks, he was able to commence a progressively paced walking program, starting with 20 minutes on alternate days. If there was no increase in his symptoms, Mr S was instructed to increase the walk by 5 minutes at a time until he was comfortably managing 45 minutes. He also had borrowed a stationary bicycle and was encouraged to use it for up to 20 minutes 3 times a week. In conjunction, at his first treatment, Mr S was given education on OA and the importance of self-management strategies (exercise, pacing, and weight loss). How well do the outcomes of the intervention provided to Mr S match those suggested in the systematic review? After 8 weeks of strengthening, stretching, and progressive walking and bicycle exercises, Mr S reported a decrease in his pain. His physical function improved. The decrease in pain on the visual analog scale and improvement in physical function on the Patient-Specific Functional Scale were greater than the minimal clinically important difference for each scale21,22 (Tab. 2). Mr S reported that he was now able to walk for almost an hour before needing to rest and rarely needed to use his walking stick.

* The Hygenic Corporation. 1245 Home Ave, Akron, OH 44310.

Can you apply the results of the Cochrane systematic review to your own patients? The findings of the Cochrane review apply well to Mr S. He had specific deficits that could be addressed with exercise, he was keen for an exercise program to improve his deteriorating condition, and he subsequently benefited from the program. As a person who is middle aged and has moderate symptoms compounded by lifestyle factors (eg, sedentary lifestyle, increasing weight), Mr S is not atypical of the patients with OA seen by physical therapists. Therefore, benefits from exercise can be expected from most patients who follow an exercise program. The Cochrane review shows that variations in the delivery, content, and dosage do not influence outcomes, except that a higher number of contact sessions leads to greater effects, meaning that physical therapists can adapt the exercises to the individual patient (eg, home vs gym-based programs, strengthening exercises vs aerobic exercises vs tai chi). What can be advised based on the results of this systematic review? Patients with knee OA often experience pain and problems in activities involving the lower limb (eg, walking) or prolonged positioning (eg, sitting), as well as stiffness after a night’s sleep. Exercise can target these specific deficits. Knee OA also is a potentially deteriorating condition without a curative treatment. Therefore, patients with knee OA are likely to benefit from exercise in managing this long-term condition. It is the physical therapist’s role to prescribe appropriate exercises to suit a patient’s goals, lifestyle, and overall health condition and ensure that the exercise program is pro-

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Case #2 Exercise for Osteoarthritis of the Knee gressive and challenging in order to deliver benefits. The benefits of exercise are contingent on a patient’s adherence to the exercise program. Evidence to date shows that, although exercise has short-term benefits in reducing pain and improving physical function, these benefits may not persist in the long term without adherence to the exercise program. Therefore, strategies to increase long-term adherence to exercise, such as adding in booster sessions, may be necessary to maximize the benefits of exercise for people with knee OA. C.-W.C. Lin, PT, PhD, is Research Fellow, Musculoskeletal Division, The George Institute for International Health and Sydney Medical School, The University of Sydney, PO Box M201, Missenden Rd, Sydney, New South Wales 2050, Australia. D. Taylor, PT, BAppSc(Phty), is Senior Musculoskeletal Physiotherapist, Physiotherapy Department, Royal North Shore Hospital, Pacific Highway, St Leonards, New South Wales 2065, Australia. S.M.A. Bierma-Zeinstra, PhD, is Associate Professor, Department of General Practice, Erasmus MC University Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. C.G. Maher, PT, PhD, is Director, Musculoskeletal Division, The George Institute for International Health and Professor, Sydney Medical School, The University of Sydney, PO Box M201, Missenden Rd, Sydney, New South Wales 2050, Australia. Address all correspondence to Dr Maher at: cmaher@ george.org.au.

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Dr Lin and Dr Maher are funded by the National Health and Medical Research Council, Australia. DOI: 10.2522/ptj.20100084

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References

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The Cochrane Library. Available at: http://www3.interscience.wiley.com/ cgi-bin/mrwhome/106568753/HOME. Accessed December 8, 2009. Felson DT, Lawrence RC, Dieppe PA, et al. Osteoarthritis: new insights, part 1: the disease and its risk factors. Ann Intern Med. 2000;133:635–646.

Guccione AA, Felson DT, Anderson JJ, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham study. Am J Public Health. 1994;84:351–358. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81:646–656. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–162. Jordan KM, Arden NK, Doherty M, et al. EULAR Recommendations 2003: an evidence-based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003;62:1145–1155. Conaghan PG, Dickson J, Grant RL. Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ. 2008;336:502–503. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000;43:1905–1915. Fransen M, Crosbie J, Edmonds J. Isometric muscle force measurement for clinicians treating patients with osteoarthritis of the knee. Arthritis Rheum. 2003;49:29–35. Philbin EF, Groff GD, Ries MD, Miller TE. Cardiovascular fitness and health in patients with end-stage osteoarthritis. Arthritis Rheum. 1995;38:799–805. Fautrel B, Hilliquin P, Rozenberg S, et al. Impact of osteoarthritis: results of a nationwide survey of 10,000 patients consulting for OA. Joint Bone Spine. 2005;72:235–240. Fitzgerald JD, Orav EJ, Lee TH, et al. Patient quality of life during the 12 months following joint replacement surgery. Arthritis Rheum. 2004;51:100– 109. Salaffi F, Carotti M, Stancati A, Grassi W. Health-related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res. 2005;17:255–263. Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008;4:CD004376. Roddy E, Zhang W, Doherty M. Aerobic walking or strengthening exercise for osteoarthritis of the knee? A systematic review. Ann Rheum Dis. 2005;64:544– 548.

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16 Jan M-H, Lin C-H, Lin Y-F, et al. Effects of weight-bearing versus nonweightbearing exercise on function, walking speed, and position sense in participants with knee osteoarthritis: a randomized controlled trial. Arch Phys Med Rehabil. 2009;90:897–904. 17 Jenkinson CM, Doherty M, Avery AJ, et al. Effects of dietary intervention and quadriceps strengthening exercises on pain and function in overweight people with knee pain: randomised controlled trial. BMJ. 2009;339:b3170. 18 Lim B-W, Hinman RS, Wrigley TV, et al. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008;59:943–951. 19 Wang C, Schmid CH, Hibberd PL, et al. Tai chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009;61:1545– 1553. 20 Pisters MF, Veenhof C, van Meeteren NL, et al. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007;57:1245– 1253. 21 Chatman AB, Hyams SP, Neel JM, et al. The Patient-Specific Functional Scale: measurement properties in patients with knee dysfunction. Phys Ther. 1997;77:820–829. 22 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005;64:29–33. 23 Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions, Version 5.0.2 [updated September 2009]. The Cochrane Collaboration. 2009. Available at: www. cochrane-handbook.org. 24 Cohen J. Statistical Power Analysis in the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Associates Inc; 1988.

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Research Report Critical Appraisal of Clinical Prediction Rules That Aim to Optimize Treatment Selection for Musculoskeletal Conditions Tasha R. Stanton, Mark J. Hancock, Christopher G. Maher, Bart W. Koes

Background. Clinical prediction rules (CPRs) for treatment selection in musculoskeletal conditions have become increasingly popular.

Purpose. The purposes of this review are: (1) to critically appraise studies evaluating CPRs and (2) to consider the clinical utility and stage of development of each CPR.

Data Sources. Pertinent databases were searched up to April 2009. Studies aiming to develop or evaluate a CPR for treatment response in musculoskeletal conditions were included. Two independent reviewers assessed eligibility and extracted methodological data, stage of development, and effect size information.

Study Selection/Data Extraction and Synthesis. Eighteen studies, evaluating 15 separate CPRs, were included. Fourteen CPRs were at the derivation stage, and all CPRs had been evaluated using a single-arm trial design, thus it is not possible to determine whether the CPRs identify prognosis (regardless of treatment) or specifically response to treatment. The CPR at the validation stage investigated spinal manipulative therapy (SMT) for low back pain and had been evaluated in 2 separate well-conducted randomized controlled trials. The first trial demonstrated a clinically meaningful effect of the SMT CPR; the additional effect from SMT in patients “positive-on-the-rule” was 15 Oswestry disability units at week 1 and 9 units at week 4. The second trial showed that the CPR did not generalize to a different clinical setting, including a modified treatment.

T.R. Stanton, BScPT, MScRS, is a PhD candidate, Musculoskeletal Division, The George Institute for International Health, University of Sydney, PO Box M201, Missenden Road, Sydney, New South Wales, Australia 2111. Address all correspondence to Ms Stanton at: [email protected]. M.J. Hancock, BAppSc, PhD, is Lecturer, University of Sydney. C.G. Maher, BAppSc, PhD, is Director, Musculoskeletal Division, The George Institute for International Health, University of Sydney. B.W. Koes, MSc, PhD, is Professor, Erasmus Medical Centre, Rotterdam, the Netherlands. [Stanton TR, Hancock MJ, Maher CG, Koes BW. Critical appraisal of clinical prediction rules that aim to optimize treatment selection for musculoskeletal conditions. Phys Ther. 2010;90:843– 854.] © 2010 American Physical Therapy Association

Limitations. Due to differences in methods of reporting and journal publication restraints (eg, word count restrictions), some quality assessment items may have been completed in the included studies, but not captured in this review.

Conclusions. There is, at present, little evidence that CPRs can be used to predict effects of treatment for musculoskeletal conditions. The principal problem is that most studies use designs that cannot differentiate between predictors of response to treatment and general predictors of outcome. Only 1 CPR has been evaluated within an RCT designed to predict response to treatment. Validation of these rules is imperative to allow clinical application.

Post a Rapid Response to this article at: ptjournal.apta.org June 2010

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Clinical Prediction Rules for Musculoskeletal Conditions

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any treatments for musculoskeletal disorders have shown small effects when tested in randomized controlled trials (RCTs).1–5 One possible reason for these small effects is that trials include heterogeneous groups of patients,6 some of whom respond to the treatment and some of whom do not.7 Identifying patients who respond best to certain treatments has been spotlighted as a research priority.8,9 As a result, there has been increased interest and research activity regarding characteristics of patients who respond best to certain interventions. Identifying patients who respond best to treatment can be done using a single patient characteristic10 –13; however, a combination or cluster of patient characteristics may be more informative than single features. With a clinical prediction rule (CPR), various components of the patient’s history, physical examination, and basic laboratory results are combined to determine the diagnosis, prognosis, or likely response to treatment of that individual.14 The development of a CPR involves the following stages: derivation (analyzing a data set to establish a rule with predictive power), narrow validation (evaluating the rule in a similar clinical setting and population), broad

Available With This Article at ptjournal.apta.org • eAppendix 1: Database Search Strategies • eAppendix 2: Populations in Which Clinical Prediction Rules Have Been Tested • The Bottom Line Podcast • Audio Abstracts Podcast

validation (evaluating the rule in multiple clinical settings), and impact analysis (determining whether the rule changes clinicians’ behavior, improves patient outcomes, or reduces costs).14 It is suggested that CPRs undergo full validation before being recommended for clinical practice.14,15 The recent surge in research activity in the area of CPRs to select treatment for musculoskeletal conditions provides the rationale for a systematic review to locate, appraise, and synthesize the primary studies. At present, 2 systematic reviews16,17 exist, but both have limitations. The review by Beneciuk et al16 focused on intervention studies but judged quality using a scale18 designed for prognosis studies. The review by May and Rosedale17 included intervention, prognosis, diagnosis, and construct validity and judged the quality of these very different study designs with the same scale. These methods produced a counterintuitive result where 2 RCTs, the optimal design for assessing treatment effect modification,19,20 both received lower scores than a study with a single-arm design, which cannot measure treatment effect modification. The 2 existing reviews also do not provide a clear understanding of the clinical utility of each CPR. Issues such as the stage of development of each CPR, the components of the CPR, and the specific treatment outcome the rules aim to predict were not considered. Consequently, the purposes of this article are: (1) to give a comprehensive summary of existing CPRs and (2) to critically appraise the research evaluating CPRs used to select treatment for musculoskeletal conditions in primary care.

This article was published ahead of print on April 22, 2010, at ptjournal.apta.org.

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Method Data Sources and Searches Potential studies were identified via a literature search of the following databases: MEDLINE, EMBASE, CINAHL, AMED, PubMed, and PEDro (up to April 1, 2009). PubMed was searched (in addition to MEDLINE) to include articles currently published electronically, but not yet available in MEDLINE or PreMEDLINE. The following key words were used: “clinical prediction rule” or “clinical prediction tool” or “prediction tool” or “clinical decision rule” or “clinical decision tool’ or “decision tool” or “decision model” combined with musculoskeletal disorders and pain terminology. See eAppendix 1 (available at ptjournal. apta.org) for full search strategies for all databases. Study Selection The following eligibility criteria were applied to each study to determine inclusion status: • The study was published in a peerreviewed journal. • An explicit aim of the study was to develop or evaluate a CPR. • The CPR aims to assist treatment selection for patients with musculoskeletal conditions seen in primary care. We considered primary care to be a clinical setting, such as a general practice, physical therapy, or chiropractic clinic, where no referral is required. • The criteria in the CPR must be easily obtained in primary care (eg, patient history, assessment findings, simple laboratory results). These criteria do not include invasive procedures such as nerve blocks. • The CPR comprises ⬎1 criterion.

One author (T.R.S.) examined the titles, key words, and abstracts of the results from the electronic database search and excluded clearly ineligible studies. Full reports of the reJune 2010

Clinical Prediction Rules for Musculoskeletal Conditions maining records were independently assessed for inclusion by 2 authors drawn from a panel of 3 authors (T.R.S., C.G.M., and B.W.K.). Any disagreements were resolved through consensus or, if not possible, through consultation with all authors. Citation tracking of included studies identified 2 additional references. Data Extraction and Quality Assessment The following data were extracted: • General information on the CPR: the musculoskeletal condition for which the CPR was created, the target treatments, the components of the rule, the scoring schema (and weighting, if applicable), whether the rationale for predictors was described, the number of studies available, and the stage in the process of development of the rule (derivation, validation [narrow/ broad], or impact analysis stage).14 • Derivation studies: the sample, number of candidate variables tested, what constitutes “positive on the rule” (eg, 4 out of 5 predictors present or not applicable), whether analyses were specified a priori, effect size information (eg, positive likelihood ratios, significance of the interaction test), whether the outcome measure was dichotomized or continuous, the definition of successful outcome if dichotomized (eg, 50% reduction in disability), the length of follow-up, the proportion of sample meeting the rule, the number of participants not meeting the study inclusion criteria, and whether an internal validity investigation was completed (eg, bootstrapping, split-half, jackknife). • Validation studies: in addition to the information for derivation studies, we extracted the study design (single arm or controlled), the type of validation (eg, narrow, broad), and, in RCTs only, whether an interaction test was performed, whether

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the sample size was calculated for the interaction, and the methodological quality (PEDro score)21 of the articles.

The search results are shown in the Figure. Assessment of methodological quality items for all included studies is presented in Table 1.

Data Synthesis and Analysis Statistical pooling of the results of included studies was not completed, as the purpose of this study was to summarize and evaluate the CPRs currently published. Due to the lack of a validated quality assessment scale for CPRs that assist in treatment selection, quality was assessed using previous recommendations on methodological issues for treatment CPRs.14,15,19,20,22–24 Using 7 methodological quality assessment items taken from the literature (Tab. 1), all included studies were evaluated, and criteria were scored as “present,” “absent,” “unclear,” or “not applicable.”

The general characteristics of the CPRs are shown in Table 2 (the sample populations are shown in eAppendix 2, available at ptjournal. apta.org). The musculoskeletal conditions and number of CPRs developed were: low back pain (LBP)— 4 rules25,30,31,33; neck pain— 4 rules27,36,38,42; patellofemoral pain— 4 rules34,35,37,39; knee osteoarthritis (OA)—1 rule29; ankle sprain—1 rule41; and lateral epicondylalgia—1 rule.40 The CPRs were developed to inform selection of: manipulative and manual therapy—9 rules27,29 –31,34,38,40 – 42; exercise— 4 rules33,36,40,41; traction—2 rules25,36; taping—1 rule35; and orthoses—2 rules.37,39 Of the 15 CPRs included, only 1 was at the validation stage of development,26,28,30,32 with all others at a derivation level.25,27,29,31,33– 42

Results The search retrieved 574 records with 18 studies, representing 15 separate CPRs considered eligible.25– 42

The Bottom Line What do we already know about the topic? Clinical prediction rules (CPRs) that aim to select the most effective treatment for an individual patient are becoming increasingly common. It is recommended that CPRs are not applied clinically until they are validated.

What new information does this study offer? This study found that, currently, there is little evidence that published CPRs can be used to predict effects of treatment for musculoskeletal conditions. Most studies use designs that cannot differentiate between predictors of response to treatment and predictors of outcome regardless of treatment.

If you’re a patient, what might these findings mean for you? You and your clinician should base treatment decisions on evidence of what helps most patients with a similar condition (eg, evidence from a well-conducted clinical trial).

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Clinical Prediction Rules for Musculoskeletal Conditions Table 1. Methodological Quality Assessment Items Met by Each Included Studya Study

Designb

Rationalec

Sample Sized

Analysise

Interaction Testf

Powered for Interactiong

Internal Validityh

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Derivation-level studies Cai et al,25 2009 Cleland et

al,27

2007

Currier et al,29 2007 Flynn et

al,30

X

X

X

X

X

X

X

Fritz et al,31 2005

X

X

⻫

X

X

X

X

Hicks et al,33 2005

X

X

X

X

X

X

X

Iverson et al,34 2008

X

X

X

X

X

X

X

2006

X

X

X

X

X

X

X

Raney et al,36 2009

X

X

?

X

X

X

X

Lesher et

Sutlive et

2002

al,35

al,37

2004

Thiel et al,42 2008

X

X

X

X

X

X

X

X

X

⻫

X

X

X

X

Tseng et al,38 2006

X

X

?

X

X

X

X

Vicenzino et al,40 2008

X

X

X

X

X

X

X

Vicenzino et al,39 2008

X

X

?

X

X

X

X

Whitman et al,41 2009

X

X

X

X

X

X

X

⻫

X

n/a

X

⻫

⻫

X

Validation-level studies Childs et al,26 2004 Cleland et

al,28

2006

Hancock et al,32 2008

X

X

n/a

X

X

X

X

⻫

X

n/a

⻫

⻫

X

X

⻫ ⫽ present, X ⫽ absent, ? ⫽ unclear, n/a ⫽ not applicable. Appropriate study design used (a controlled study design is recommended to assess treatment effect modification). Rationale provided for predictors (predictors with no logical rationale may represent spurious findings). d Appropriate sample size (at least 10 outcome events per candidate variable recommended). e Analysis specified a priori. f Interaction test performed in controlled studies to determine predictors. g Sample size powered for the interaction test. h Internal validity investigation completed (techniques such as boot-strapping, split-half, and jackknife should be performed to ensure internal validity). a

b c

Table 3 provides information on the characteristics of the derivation studies. All 14 CPRs at a derivation level had been generated from data from single-arm studies or from data from 1 arm of an RCT.39,40 Outcomes typically were measured in the short term (eg, after a single treatment session); only 2 studies included a follow-up of greater than 3 weeks.33,39 No study provided a rationale for the candidate variables considered for inclusion in the CPR, and in 33% (5/15) of the studies, it was unclear how many total candidate variables were used in the analysis.35–37,39,42 Counterintuitively, 1 CPR reported the same 4 variables to 846

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predict both improvement and worsening of neck symptoms with cervical manipulation.42 All studies reported positive findings (found predictors significantly related to outcome). Table 4 presents characteristics specific to the validation studies. Three validation studies were performed,26,28,32 all in respect to the same CPR on manipulation for LBP.30 Two of these studies, 1 single-arm trial28 and 1 RCT,26 looked at narrow validation (same patient population and treatment), and the third validation study, an RCT,32 investigated the broad validation of this CPR (dif-

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ferent sample patient population and modified treatment). Only 1 study specified the analyses a priori,32 and only 1 of the 2 RCTs calculated the sample size for the interaction between rule status and treatment effect.26 Clinically important effect sizes were found in the RCT validation study of spinal manipulative therapy for LBP.26 The additional effect from spinal manipulative therapy in patients who were positive on the rule was 15 Oswestry disability units at week 1 and 9 Oswestry disability units at week 4.26 The second RCT validation study (in which sample size was not calculated for the interaction) did not find a significant June 2010

Clinical Prediction Rules for Musculoskeletal Conditions effect of rule status (positive or negative) on response to treatment (manipulation versus placebo).32 The 2 validation RCTs both used longer, more clinically relevant maximum follow-up times of 12 weeks32 and 6 months.26

Discussion We found that all derivation-level CPRs used single-arm study designs to derive predictors, raising doubts about the veracity of current CPRs. In total, 15 CPRs to aid selection of a range of treatments for musculoskeletal conditions were found. However, only 1 CPR for selecting spinal manipulation for LBP30 had reached the validation stage of CPR development, with the CPR predicting response to treatment in a narrow validation study but not treatment effects in a broad validation study.26,28,32 Although single-arm study designs can be a preliminary step in developing prediction rules by identifying potential candidate variables, they are not able to differentiate between predictors of response to treatment and predictors of outcome regardless of treatment. These studies do not include a control group, so they cannot provide information on treatment effects or on factors that modify treatment effects. The predictive factors identified in these studies, therefore, have a higher risk of being merely nonspecific predictors of outcome or prognostic factors. Neither of the 2 previous systematic reviews16,17 on this topic discussed this issue of use of a singlearm trial design at the derivation level. One review stated that “most of the derivation studies were of high quality,”17(p40) a claim we would argue is potentially misleading, considering no derivation studies used a study design that allows specific identification of treatment effect modifiers.

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Figure. Flow chart describing the results of the literature search. CPR⫽clinical prediction rule.

One potential justification for using prognostic factors identified in single-arm trials to develop a treatment CPR is that the prognostics factors also may be treatment effect modifiers. Although this can happen,30 there are cases where it does not.43 There also are examples where the same clinical feature predicts poor prognosis yet predicts a good response to treatment.44 This uncertain relationship makes it essential to carefully interpret the results of studies reporting a treatment CPR from single-arm trials. Although these studies are hypothesis generating, variables identified in single-arm trial designs run a greater risk of not being significant in a subsequent controlled study. Moreover, for

some CPR candidate variables, there are many existing data sets from RCTs that would provide a better evaluation of the variable as an effect modifier than a single-arm study. For example, 5 of the CPRs included age as a variable,25,33,36,39,40 and as age is almost always measured in RCTs, a more robust evaluation of age as a treatment effect modifier would be possible from secondary analysis of individual trials or from the pooled data from several trials using a metaregression approach. Having said that, to properly develop a CPR, an RCT designed specifically for the purpose of CPR development, with appropriate sample size and a priori analysis, is necessary.22

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Clinical Prediction Rules for Musculoskeletal Conditions Table 2. General Characteristics of the Clinical Prediction Rulea Clinical Prediction Rule (Original Study)

Musculoskeletal Condition/ Treatment

Cai et al,25 2009

LBP/mechanical traction

Cleland et al,27 2007

Features of Rule 1. 2. 3. 4.

FABQW score ⬍21 Absence of neurological deficit Age ⬎30 y Noninvolvement in manual work

What Constitutes “Positive on the Rule”?

Stage of Development

4 of 4 variables

Derivation

Neck pain/thoracic 1. Symptoms ⬍30 d spine manipulation 2. No symptoms distal to the shoulder 3. Looking up does not aggravate symptoms 4. FABQPA score ⬍12 5. Diminished upper thoracic spine kyphosis 6. Cervical extension range of motion ⬍30°

ⱖ3 out of 6 variables Weighting of variables using relative size of the ␤ coefficients

Derivation

Currier et al,29 2007

Painful knee osteoarthritis/hip mobilization

1. Pain with ipsilateral hip distraction 2. Ipsilateral knee passive flexion ⬍122° 3. Ipsilateral hip passive medial (internal) rotation ⬍17° 4. Pain or paresthesia in ipsilateral hip or groin 5. Ipsilateral anterior thigh pain

Any 2 of the 5 variables

Derivation

Flynn et al,30 2002 (original 5-item rule)

LBP/lumbar spine manipulation

1. Duration of symptoms ⬍16 d 2. At least one hip with ⬎35° medial rotation 3. Lumbar hypomobility with spring test ⱖ1 level 4. No symptoms distal to the knee 5. FABQW score ⬍19

ⱖ4 out of 5 variables

Fritz et al,31 2005 (2-item Flynn rule)

LBP/lumbar spine manipulation

1. Duration of symptoms ⬍16 d 2. No symptoms distal to the knee

2 out of 2 variables

Derivation

Hicks et al,33 2005

LBP/stabilization exercise

1. 2. 3. 4.

ⱖ3 out of 4 variables

Derivation

Iverson et al,34 2008

Patellofemoral pain/ lumbopelvic manipulation

1. Side-to-side difference in hip medial rotation ⬎14° 2. Ankle dorsiflexion (knee flexed) ⬎16° 3. Navicular drop ⬎3 mm 4. No self-reported stiffness with sitting ⬎20 min 5. Squatting reported as most painful activity

Presence of hip medial rotation asymmetry ⱖ14° or, if hip medial rotation asymmetry not present, ⱖ3 out of 5 predictors

Derivation

Lesher et al,35 2006

Patellofemoral pain syndrome/patellar taping

1. Positive patellar tilt test 2. Tibial varum ⬎5°

Either 1 of 2 variables

Derivation

Raney et al,36 2009

Nonspecific neck pain/cervical traction and exercise

1. Peripheralization with lower cervical spine (C4–C7) mobility testing 2. Positive shoulder abduction test 3. Age ⱖ55 y 4. Positive upper-limb tension test A 5. Positive neck distraction test

ⱖ3 out of 5 variables or ⱖ4 out of 5 variables

Derivation

Sutlive et al,37 2004

Patellofemoral pain syndrome/foot orthosis use and modified activity

1. Forefoot valgus alignment ⱖ2° 2. Great toe extension of ⱕ78° 3. Navicular drop ⱕ3 mm

Any 1 of 3 variables No combination of variables led to positive likelihood ratio ⬎2.0

Derivation

Positive prone instability test Aberrant movements present Average straight leg raise ⬎91° Age ⬍40 y

Derivation, narrow validation (Childs et al,26 2004; Cleland et al,28 2006); broad validation (Hancock et al,32 2008)

(Continued)

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Clinical Prediction Rules for Musculoskeletal Conditions Table 2. Continued Clinical Prediction Rule (Original Study) Thiel et al,42 2008

Musculoskeletal Condition/ Treatment Patients receiving a cervical spine manipulation seen by chiropractors/ cervical manipulation

Features of Rule Improving: 1. Neck pain 2. Shoulder, arm pain 3. Reduced neck, shoulder, arm movement, stiffness 4. Headache 5. Upper, mid back pain 6. ⱕ1 presenting symptom

What Constitutes “Positive on the Rule”?

Stage of Development

Improvement: any 4 variables Worsening: any 4 of 6 variables Global improvement: not able to be used

Derivation

ⱖ3 out of 6 variables or ⱖ4 out of 6 variables

Derivation

Not given

Derivation

Worsening: 1. Neck pain 2. Shoulder, arm pain 3. Headache 4. Numbness, tingling in upper limbs 5. Upper, mid back pain 6. Fainting, dizziness, light-headedness Tseng et al,38 2006

Neck pain (radiculopathy, disk herniation, myofascial pain syndrome, and cervicogenic headache)/cervical manipulation

1. Neck Disability Index initial score ⬍11.50 2. Having bilateral involvement 3. Not performing sedentary work ⬎5 h/d 4. Feeling better while moving the neck 5. Without feeling worse while extending the neck 6. Diagnosis of spondylosis without radiculopathy

Vicenzino et al,39 2008

Patellofemoral pain/ foot orthoses

1. 2. 3. 4.

Vicenzino et al,40 2008

Lateral epicondylalgia/ manual therapy and exercise

1. Age ⬍49 y 2. Affected limb pain-free grip ⬎112 N 3. Unaffected limb pain-free grip ⬍336 N

ⱖ3 out of 4 variables

Derivation

Whitman et al,41 2009

Ankle sprain/manual therapy and general mobility

1. 2. 3. 4.

3 out of 4 variables, not 4 out of 4 variables

Derivation

Age ⬎25 y Height ⬍165 cm Worst pain (VAS) ⬍53.25 mm Midfoot width difference from WB to NWB ⬎10.96 mm

Symptoms worse when standing Symptoms worse in evening Navicular drop ⱖ5.0 mm Distal tibial fibular joint hypomobility

a LBP⫽low back pain, FABQW⫽Fear-Avoidance Beliefs Questionnaire–Work Subscale, FABQPA⫽Fear-Avoidance Beliefs Questionnaire–Physical Activity Subscale, VAS⫽visual analog scale, WB⫽weight bearing, NWB⫽non–weight bearing.

Two derivation studies used data from RCTs to develop CPRs but ignored data from the control group.39,40 This approach effectively results in a single-arm study that has the same risks as mentioned above. The genesis of 1 CPR40 for management of lateral epicondylalgia was particularly unusual because it was preceded by a meta-regression study45 based upon pooled data from 2 RCTs46,47 (n⫽383). The conclusion of the meta-regression study was “patient characteristics play only a small role in predicting treatment outJune 2010

comes,”45(p1601) with only baseline pain intensity predicting response to physical therapy treatment. Inexplicably, the CPR derivation study40 considered only data from the physical therapy arm of 1 RCT (n⫽64) and created a CPR that did not include baseline pain. It seems erroneous to revert to a weaker single-arm design to develop a CPR, and the pitfalls of this approach were well illustrated when the one treatment effect modifier identified in the metaregression study was not identified in the single-arm design study.

In contrast to previous reviews in this area, we examined the proportion of patients suitable for rule application and the proportion that were rule positive, as these factors are important to the generalizability and clinical importance of the CPR. The proportion of potential participants excluded from the studies ranged from 20% to 71%,26 –29,32,41 suggesting that some rules have limited application. For example, in a CPR on hip mobilization for painful knee OA, only 35% of patients seeking care for their OA met the inclu-

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Clinical Prediction Rules for Musculoskeletal Conditions Table 3. Methodological Characteristics of Derivation Studies Evaluating Clinical Prediction Rulesa Clinical Prediction Rule (Original Study)

No. of Variables Tested

Predictive Abilityb

Definition of Successful Outcome

Length of Follow-up

Percentage of Sample Meeting the Rule

No. of Participants Ineligible at Baseline

Cai et al,25 2009

44

4 LR⫹⫽9.4 (3.1–28.0) ⱖ3 LR⫹⫽3.0 (2.0–4.5) ⱖ2 LR⫹⫽1.8 (1.5–2.2) ⱖ1 LR⫹⫽1.1 (0.99–1.2)

⬎50% reduction in Oswestry Maximum: score 9d Success ratec⫽19% (25/129)

13/129 (10%)

Not reported

Cleland et al,27 2007d

34

ⱖ5 ⱖ4 ⱖ3 ⱖ2 ⱖ1

Score of ⫹5 or greater on the ⫺7 to ⫹7 global rating of change scale Success rate⫽54% (42/78)

2–8 d

ⱖ3⫽37/78 (47%)

25/105 (24%)

2 LR⫹⫽12.9 (0.8–205.6) 1 LR⫹⫽5.1 (1.8–14.6) More than 2 variables did not improve the LR⫹ (no participants were positive on ⬎3 variables)

30% reduction in pain (NRS) during 2 functional tasks or global rating of change score of ⫹3 or greater on a ⫺7 to ⫹7 scale Success rate⫽68% (41/60)

2d

Unclear

110/170 (65%)

5 LR⫹⫽infinite ⱖ4 LR⫹⫽24.4 (4.6–139.4) ⱖ3 LR⫹⫽2.6 (1.8–4.2) ⱖ2 LR⫹⫽1.2 (1.1–1.4) ⱖ1 LR⫹⫽1.0 (1.0–1.2)

50% reduction in Oswestry score Success rate⫽45% (32/71)

2–8 d

4⫽15/71 (21%)

Not reported

LR⫹⫽infinite LR⫹⫽12 (2.3–70.8) LR⫹⫽5.5 (2.7–12.0) LR⫹⫽2.09 (1.5–2.5) LR⫹⫽1.2 (1.1–1.2)

Weighted: 3.5 points out of a total of 10 points; LR⫹⫽5.9 (2.6–13.0) Currier et al,29 2007d

ⱖ73

Flynn et al,30 2002 (original 5-item rule)

61

Fritz et al,31 2005 (2-item Flynn rule)e

2

Both criteria present; LR⫹⫽7.2 (3.2–16.1)

50% reduction in Oswestry score Success rate⫽45% (63/141)

2–8 d

41/141⫽29%

Not applicable

Hicks et al,33 2005

43

ⱖ3 LR⫹⫽4.0 (1.6–10.0) ⱖ2 LR⫹⫽1.9 (1.2–2.9) ⱖ1 LR⫹⫽1.3 (1.0–1.6)

50% reduction in Oswestry score Success rate⫽33% (18/54)

8 wk

Not reported

Not reported

Iverson et al,34 2008

39

5 LR⫹⫽infinite ⱖ4 LR⫹⫽infinite ⱖ3 LR⫹⫽18.4 (3.6–105.3) ⱖ2 LR⫹⫽2.1 (1.3–2.9) ⱖ1 LR⫹⫽1.1 (0.9–1.3)

50% reduction in pain (NRS) during 3 functional tasks or global rating of change score of ⫹4 or greater on a ⫺7 to ⫹7 scale Success rate⫽45% (22/49)

Immediate (after the treatment session)

5⫽2/49 (4%) 4⫽5/49 (10%) 3⫽9/49 (18%) 2⫽16/49 (33%) 1⫽11/49 (2%) 0⫽6/49 (12%) ⱖ3⫽16/49 (33%)

Not reported

Lesher et al,35 2006

31 (unclear)

Either 1 of 2 variables; LR⫹⫽4.4 (1.3–12.3)

ⱖ50% reduction in mean pain (NRS) during 3 functional tasks or global rating of change score of ⫹4 or higher on a ⫺7 to ⫹7 scale Success rate⫽52% (26/50)

Immediate Positive patellar tilt Not reported (after the test⫽17/50 treatment (34%) session) Tibial varum ⬎5°⫽10 (unclear)/ 50 (20%) or 15 (unclear)/50 (30%)

Raney et al,37 2009d

Unclear

ⱖ4 ⱖ3 ⱖ2 ⱖ1

LR⫹⫽23.1 (2.5–227.9) LR⫹⫽4.8 (2.2–11.4) LR⫹⫽1.4 (1.1–2.0) LR⫹⫽1.2 (0.97–1.4)

Global rating of change score of ⫹6 or greater on a ⫺7 to ⫹7 scale Success rate⫽44% (30/68)

3 wk

5⫽0 4⫽9/68 (13%) 3⫽15/68 (22%)

Not reported

Sutlive et al,37 2004

37 (unclear)

Forefoot alignment ⱖ2° of valgus; LR⫹⫽4.0 (0.7–21.9) Great toe extension ⱕ78°; LR⫹⫽4.0 (0.7–21.9) Navicular drop test; LR⫹⫽2.3 (1.3–4.3)

ⱖ50% improvement in pain on visual analog scale Success rate⫽60% (27/45)

3 wk

Not reported

Not reported

(Continued)

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Clinical Prediction Rules for Musculoskeletal Conditions Table 3. Continued Clinical Prediction Rule (Original Study)

No. of Variables Tested

Thiel et al,42 2008

ⱖ22

Predictive Abilityb Immediately improving: 5 LR⫹⫽0.75 (0.65–0.86) 4 LR⫹⫽6.3 (5.2–7.5) 3 LR⫹⫽4.3 (3.9–4.7) 2 LR⫹⫽2.6 (2.5–2.8) 1 LR⫹⫽1.5 (1.5–1.6) Immediately worsening: 6 LR⫹⫽1.0 (0.67–1.6) 5 LR⫹⫽3.2 (1.9–5.2) 4 LR⫹⫽3.6 (2.9–4.3) 3 LR⫹⫽2.4 (2.1–2.7) 2 LR⫹⫽1.4 (1.3–1.6) 1 LR⫹⫽1.0 (0.9–1.1) Global improvement: 2 LR⫹⫽0.94 (0.9–0.98) 1 LR⫹⫽1.0 (1.0–1.1)

Tseng et al,38 2006

Vicenzino et al,40 2008d,e

ⱖ18

12

ⱖ5 ⱖ4 ⱖ3 ⱖ2 ⱖ1

LR⫹⫽infinite LR⫹⫽5.3 (1.7–16.5) LR⫹⫽1.9 (1.0–3.7) LR⫹⫽0.2 (0.08–0.49) LR⫹⫽0.07 (0.01–0.5)

MWMT: 1 LR⫹⫽1.8 (1.1–3.0) 2 LR⫹⫽3.7 (1.0–13.6) 3 LR⫹⫽infinite Wait and see: 1 LR⫹⫽1.0 (0.08–13.6) 2 LR⫹⫽3.1 (0.42–23.0) 3 LR⫹⫽1.2 (0.29–5.0)

Vicenzino et al,39 2008e

Unclear

Whitman et al,41 2009d

45

Percentage of Sample Meeting the Rule

No. of Participants Ineligible at Baseline

Definition of Successful Outcome

Length of Follow-up

“Immediate improvement” vs “no immediate improvement” “Immediate worsening” vs “no immediate worsening” At 7 days, global improvement was measured: “much better and a noticeable chance that has made a real difference” vs “no global improvement” Success rate⫽70% (20,083/ 28,807 treatment consultations)

Immediate (after treatment session) and 7 d following

Not reported

Not reported

ⱖ50% reduction in pain (NRS) or global rating of change score of ⫹4 or higher on a ⫺7 to ⫹7 scale or satisfaction with treatment rated as “very satisfied” (5-point scale) Success rate⫽60% (60/100)

Immediate (after the treatment session)

6⫽0 5⫽4/100 (4%) 4⫽27/100 (27%) 3⫽35/100 (35%)

Not reported

Score of 0, 1, or 2 on a 0 (“completely recovered”) to 5 (“much worse”) global perceived effect Success rate⫽79% (49/62)

3 wk

MWMT: 3⫽4/62 (6%) 2⫽34/62 (55%) 1⫽57/62 (92%) 0⫽5/62 (8%)

Not reported

Wait and see: 3⫽2/57 (4%) 2⫽30/57 (53%) 1⫽14/57 (25%) 0⫽7/57 (12%)

4⫽unable to calculate, no patients met 4 ⱖ3 LR⫹⫽8.8 (1.2–66.9) ⱖ2 LR⫹⫽2.2 (1.1–4.2) ⱖ1 LR⫹⫽1.6 (1.2–2.1)

Patients reporting “marked improvement” on a 5point global improvement scale Success rate⫽40% (17/42)

12 wk

ⱖ3⫽7/42 (17%)

Not reported

4 3 2 1

Global rating of change score of ⫹5 or greater on a ⫺7 to ⫹7 scale Success rate⫽75% (64/85)

2–8 d

3⫽19/85 (22%)

85/125 (68%)

LR⫹⫽0.43 (0.11–1.8) LR⫹⫽5.9 (1.1–41.6) LR⫹⫽1.2 (0.67–2.0) LR⫹⫽0.33 (0.11–1.0)

a Outcome measures of improvement/success of treatment were dichotomized for all studies. LR⫹⫽positive likelihood ratio, Oswestry score⫽modified Oswestry Disability Questionnaire score, MWMT⫽mobilization with movement treatment arm, NRS⫽numerical rating scale. b Predictive ability is expressed as the likelihood of a positive outcome for each score on the clinical prediction rule. Values in parentheses are 95% confidence intervals. c Success rate was defined as the % of participants considered to have a successful intervention based on the definition of a successful outcome. d Cutoff for success determined a priori. e Post hoc analysis of one arm of a randomized controlled trial.

sion criteria of the study.29 Similarly, of those patients who do enter the study, if only a very small proportion of patients, or almost everyone, meets the rule, the rule will have limited usefulness in clinical pracJune 2010

tice. In the studies included in this review, the number of patients from the sample who were positive on the rule ranged from 10% to 47%.25,27,29 –31,33–39,41 Generally, these proportions seem to be in the

range of clinical importance, although Cai and colleagues’ CPR, in which only 10% of the patients met the rule for mechanical traction for LBP,25 is perhaps of questionable impact.

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Clinical Prediction Rules for Musculoskeletal Conditions Table 4. Methodological Characteristics of Validation Studies Evaluating Clinical Prediction Rulesa

Clinical Prediction Rule (Original Study)

Interaction Test/Sample Size Calculated for the Interaction

Effect Size SMT ⫻ rule status (Oswestry score): 1 wk: 15 unitse 4 wk: 9 unitse 6 mo: 3 unitse

Definition of Successful Outcome

Length of Follow-up

Childs et al,26 2004b,c,d PEDro score: 8/10

Yes/yes

Cleland et al,28 2006b,d,f

Not applicable 11 of the 12 achieved 50% reduction 1 wk a successful in Oswestry outcome score (dichotomized)

Hancock et al,32 2008c,d,g,h PEDro score: 9/10

Yes/no

50% reduction 1 wk, 4 wk, 6 mo in Oswestry score (dichotomized)

Pain (NRS) SMT ⫻ rule status: Disability (RMQ) 1 wk: NRS⫽0.31,i i (continuous) RMQ⫽1.77 2 wk: NRS⫽0.11,i RMQ⫽2.38i 4 wk: NRS⫽⫺0.22,i RMQ⫽1.08i 12 wk: NRS⫽0.051,i RMQ⫽2.31i

Percentage of Sample Meeting the Rule

No. of Participants Ineligible for the Study

ⱖ4/5⫽24/131 (18%)

386/543 (71%)

Not applicable (meeting the rule was part of inclusion criteria)

1, 2, 4, and 12 wk Unable to tell

3/15 (20%)

80/320 (25%)

a

All studies evaluated Flynn and colleagues’ original 5-item rule.30 Oswestry score⫽modified Oswestry Disability Questionnaire score, SMT⫽spinal manipulation therapy, NRS⫽numerical rating scale, RMQ⫽Roland-Morris Disability Questionnaire. b Narrow validation. c Randomized controlled trial. d Cutoff for success determined a priori. e Significant at P⬍.05. f Single-arm trial. g Broad validation. h Main analysis determined a priori. i Significant at Pⱖ.05.

Related to the proportion of patients to whom the rule is applicable is the possibility of spectrum bias in the reviewed studies. Spectrum bias can occur when a study draws preferentially from a limited portion of the patient spectrum.48 Although the purpose of a CPR is to identify a limited portion of the spectrum of patients who will respond to a certain treatment, starting with a baseline group that is limited in spectrum decreases the generalizability of the CPR. Many CPR studies have recruited a specific group of patients (eg, army recruits), and although not a point of criticism, this approach requires attention and supports the importance of broad validation studies. Similar to previous reviews, we found that short-term follow-ups 852

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commonly were used when determining “success” with a treatment (eg, immediately after treatment, 2– 8 days following treatment), meaning that what is predicted in many of the CPRs is of questionable importance. Only 2 derivation studies had a follow-up greater than 3 weeks posttreatment.33,39 Furthermore, very few studies clearly reported the candidate variables (and the number of candidate variables) entered into their analysis. Only one study32 was based upon a registered trial with a published protocol. This makes it difficult to judge the potential for type I error within a study, as we are unsure whether the authors failed to report nonsignificant predictors. With regard to the last issue, we note that there was only 1 negative study32 among the 18 studies we located. Last, the risk of response

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bias is more of concern in single-arm studies compared with RCTs, as patients are not blinded to the treatment received or expected outcome. None of the included studies presented a rationale for why the variables included in the CPR would be expected to predict response to treatment. Several authors have warned about spurious treatment effect modifiers and the need to be mindful of this issue when no logical rationale for a predictor exists.14,15,23 The chance of spurious findings is classically illustrated by a study finding that subgrouping patients based on astrological birth sign predicted response to aspirin therapy following a myocardial infarction.49 Accordingly, the CPR must make clinical sense.14,15 For example, absence of nerve root signs predicted a better June 2010

Clinical Prediction Rules for Musculoskeletal Conditions response to mechanical traction for LBP,25 which is directly opposite to what clinical lore advocates.50 Furthermore, because in many studies25,27,29,30,33,41 a large number of predictor variables were used in the analyses (eg, ⱖ73 potential predictors),29 the likelihood that some variables will be significant by chance alone (type I error) is greatly increased.22 No studies tested the internal validity of their analysis using techniques such as bootstrapping. Although in some CPRs the predictor variables demonstrated face validity, 1 CPR found quite counterintuitive results. In a CPR by Thiel and Bolton42 looking for predictors of response to manipulation in patients with neck symptoms, the presence of 4 symptoms (neck pain, shoulder/ arm pain, headache, and upper/ mid back pain) were predictors of improvement (versus staying the same) and worsening (versus staying the same). This pattern of results does not make sense and is perhaps an artifact of the way the analysis was set up. It may have been more informative to set up the analysis to predict improvement (versus staying the same or deteriorating). To date, only 1 CPR on manipulation as a treatment for LBP30 has undergone validation testing. Of the studies that did perform validation analyses, only 1 study was powered for the interaction.26 It is recommended that CPR studies have a sample large enough to detect differences between the interaction of the rule status (positive or negative on the rule) and the treatment given (treatment or placebo/alternate treatment).22,23 If a validation study is not powered for this interaction, it may not find statistically significant differences between those positive and negative on the CPR when these differences truly exist. The remaining RCT validation study was not powered for the interaction32; however, it exhibJune 2010

ited tight confidence intervals, suggesting that it was not underpowered. Interestingly, this manipulation CPR demonstrated narrow validation26 but not broad validation. Failure of broad validation of this CPR could have occurred for numerous reasons. First, the broad validation RCT used a treatment different from that of the original CPR study (provided mainly mobilization treatment for LBP instead of manipulation only). Alternatively, the possibility of spectrum bias influencing results cannot be ignored. Hancock et al32 studied a population of patients with LBP in community primary care, whereas Childs et al26 studied a population of primarily army recruits. The paucity of validation studies for other CPRs and the absence of impact analysis investigations are likely related to the recent use of CPRs to determine response to treatment. However, based on the number of derivation studies this review found, it appears researchers are creating new rules but not validating the existing ones.

Conclusion In contrast to previous systematic reviews, we found that all of the CPRs included in this study were derived using single-arm study designs. The results of these studies must be interpreted with caution, as these CPRs run a greater risk of identifying prognostic factors rather than factors that modify the effect of a treatment. Other important limitations of many of the included studies are use of short-term outcomes only, arguably trivial findings, and limited rule application potential. Only 1 CPR on spinal manipulation for LBP underwent validation in a controlled trial and can be considered for clinical application (and only in a population similar to that tested).

cluding review of manuscript before submission). Ms Stanton, Dr Hancock, and Dr Maher provided writing. Ms Stanton and Dr Maher provided data collection. Data from this article were presented at the Australian Physiotherapy Conference (Musculoskeletal Physiotherapy Association Conference); October 1, 2009; Sydney, New South Wales, Australia. Ms Stanton is supported by the University of Sydney International Research Scholarship for funding of her PhD candidacy. Professor Maher is supported by Australia’s National Health and Medical Research Council for funding of his research fellowship. This article was received July 14, 2009, and was accepted February 24, 2010. DOI: 10.2522/ptj.20090233

References 1 Hancock MJ, Maher CG, Latimer J, et al. Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial. Lancet. 2007;370: 1638 –1643. 2 Lund H, Weile U, Christensen R, et al. A randomized controlled trial of aquatic and land-based exercise in patients with knee osteoarthritis. J Rehabil Med. 2008;40: 137–144. 3 Skillgate E, Vingard E, Alfredsson L. Naprapathic manual therapy or evidence-based care for back and neck pain: a randomized, controlled trial. Clin J Pain. 2007;23: 431– 439. 4 Staples MP, Forbes A, Ptasznik R, et al. A randomized controlled trial of extracorporeal shock wave therapy for lateral epicondylitis (tennis elbow). J Rheumatol. 2008; 35:2038 –2046. 5 Veenhof C, Koke AJ, Dekker J, et al. Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: a randomized clinical trial. Arthritis Rheum. 2006;55:925–934. 6 Delitto A. Research in low back pain: time to stop seeking the elusive “magic bullet.” Phys Ther. 2005;85:206 –208. 7 Kent P, Keating J. Do primary-care clinicians think that nonspecific low back pain is one condition? Spine (Phila Pa 1976). 2004;29:1022–1031. 8 Borkan JM, Cherkin DC. An agenda for primary care research on low back pain. Spine (Phila Pa 1976). 1996;21: 2880 –2884. 9 Borkan JM, Koes B, Reis S, Cherkin DC. A report from the Second International Forum for Primary Care Research on Low Back Pain: reexamining priorities. Spine (Phila Pa 1976). 1998;23:1992–1996.

All authors provided concept/idea/research design, data analysis, and consultation (in-

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Clinical Prediction Rules for Musculoskeletal Conditions 10 Baldwin ML, Butler RJ, Johnson WG, Cote P. Self-reported severity measures as predictors of return-to-work outcomes in occupational back pain. J Occup Rehabil. 2007;17:683–700. 11 Fishbain DA, Lewis JE, Cutler R, et al. Does smoking status affect multidisciplinary pain facility treatment outcome? Pain Med. 2008;9:1081–1090. 12 Ritter MA, Wing JT, Berend ME, et al. The clinical effect of gender on outcome of total knee arthroplasty. J Arthroplasty. 2008;23:331–336. 13 Schmidt I, Rechter L, Hansen VK, et al. Prognosis of subacute low back pain patients according to pain response. Eur Spine J. 2008;17:57– 63. 14 McGinn TG, Guyatt GH, Wyer PC, et al; Evidence-Based Medicine Working Group. Users’ guides to the medical literature, XXII: how to use articles about clinical decision rules. JAMA. 2000;284:79 – 84. 15 Laupacis A, Sekar N, Stiell IG. Clinical prediction rules: a review and suggested modifications of methodological standards. JAMA. 1997;277:488 – 494. 16 Beneciuk JM, Bishop MD, George SZ. Clinical prediction rules for physical therapy interventions: a systematic review. Phys Ther. 2009;89:114 –124. 17 May S, Rosedale R. Prescriptive clinical prediction rules in back pain research: a systematic review. J Man Manip Ther. 2009;17:36 – 45. 18 Kuijpers T, van der Windt DA, van der Heijden GJ, Bouter LM. Systematic review of prognostic cohort studies on shoulder disorders. Pain. 2004;109:420 – 431. 19 Beattie P, Nelson R. Clinical prediction rules: what are they and what do they tell us? Aust J Physiother. 2006;52:157–163. 20 Hancock MJ, Herbert RD, Maher CG. A guide to interpretation of studies investigating subgroups of responders to physical therapy interventions. Phys Ther. 2009;89:698 –704. 21 Maher CG, Sherrington C, Herbert RD, et al. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003;83:713–721. 22 Klebanoff MA. Subgroup analysis in obstetrics clinical trials. Am J Obstet Gynecol. 2007;197:119 –122. 23 Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002;21:2917–2930. 24 Toll DB, Janssen KJ, Vergouwe Y, Moons KG. Validation, updating, and impact of clinical prediction rules: a review. J Clin Epidemiol. 2008;61:1085–1094. 25 Cai C, Pua YH, Lim KC. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with mechanical lumbar traction. Eur Spine J. 2009;18:554 –561.

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26 Childs J, Fritz J, Flynn T, et al. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004;141:920 –928. 27 Cleland JA, Childs JD, Fritz JM, et al. Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther. 2007;87:9 –23. 28 Cleland JA, Fritz JM, Whitman JM, et al. The use of a lumbar spine manipulation technique by physical therapists in patients who satisfy a clinical prediction rule: a case series. J Orthop Sports Phys Ther. 2006;36:209 –214. 29 Currier L, Froehlich P, Carow S, et al. Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization. Phys Ther. 2007;87:1106 –1119. 30 Flynn T, Fritz J, Whitman J, et al. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine (Phila Pa 1976). 2002; 27:2835–2843. 31 Fritz JM, Childs JD, Flynn TW. Pragmatic application of a clinical prediction rule in primary care to identify patients with low back pain with a good prognosis following a brief spinal manipulation intervention. BMC Fam Pract. 2005;6:29. 32 Hancock MJ, Maher CG, Latimer J, et al. Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial. Eur Spine J. 2008;17:936 –943. 33 Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005;86:1753–1762. 34 Iverson CA, Sutlive TG, Crowell MS, et al. Lumbopelvic manipulation for the treatment of patients with patellofemoral pain syndrome: development of a clinical prediction rule. J Orthop Sports Phys Ther. 2008;38:297–309; discussion 309 –212. 35 Lesher J, Sutlive T, Miller G, et al. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006; 36:854 – 866. 36 Raney NH, Petersen EJ, Smith TA, et al. Development of a clinical prediction rule to identify patients with neck pain likely to benefit from cervical traction and exercise. Eur Spine J. 2009 Jan 4 [Epub ahead of print]. 37 Sutlive TG, Mitchell SD, Maxfield SN, et al. Identification of individuals with patellofemoral pain whose symptoms improved after a combined program of foot orthosis use and modified activity: a preliminary investigation. Phys Ther. 2004; 84:49 – 61.

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38 Tseng Y, Wang WT, Chen W, et al. Predictors for the immediate responders to cervical manipulation in patients with neck pain. Man Ther. 2006;11:306 –315. 39 Vicenzino B, Collins N, Cleland J, McPoil T. A clinical prediction rule for identifying patients with patellofemoral pain who are likely to benefit from foot orthoses: a preliminary determination. Br J Sports Med. 2008 Dec 3 [Epub ahead of print]. 40 Vicenzino B, Smith D, Cleland J, Bisset L. Development of a clinical prediction rule to identify initial responders to mobilisation with movement and exercise for lateral epicondylalgia. 2008 Oct 1 [Epub ahead of print]. 41 Whitman JM, Cleland JA, Mintken P, et al. Predicting short-term response to thrust and nonthrust manipulation and exercise in patients post inversion ankle sprain. J Orthop Sports Phys Ther. 2009; 39:188 –200. 42 Thiel HW, Bolton JE. Predictors for immediate and global responses to chiropractic manipulation of the cervical spine. J Manipulative Physiol Ther. 2008;31: 172–183. 43 Underwood MR, Morton V, Farrin A, UK BEAM Trial Team. Do baseline characteristics predict response to treatment for low back pain: secondary analysis of the UK BEAM dataset [ISRCTN32683578]. Rheumatology (Oxford). 2007;46:1297–1302. 44 Behrendt CE, Gehan EA. Treatmentsubgroup interaction: an example from a published, phase II clinical trial. Contemp Clin Trials. 2009;30:279 –281. 45 Bisset L, Smidt N, Van der Windt DA, et al. Conservative treatments for tennis elbow do subgroups of patients respond differently? Rheumatology (Oxford). 2007;46: 1601–1605. 46 Bisset L, Beller E, Jull G, et al. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ. 2006; 333:939. 47 Smidt N, van der Windt DA, Assendelft WJ, et al. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002;359:657– 662. 48 Mulherin SA, Miller WC. Spectrum bias or spectrum effect: subgroup variation in diagnostic test evaluation. Ann Intern Med. 2002;137:598 – 602. 49 ISIS-2 Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988;332:349 –360. 50 Delitto A, Erhard RE, Bowling RW. A treatment-based classification approach to low back syndrome: identifying and staging patients for conservative management. Phys Ther. 1995;75:470 – 489.

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Invited Commentary I enjoyed reading the article by Stanton et al,1 and I believe it is timely and well written. I have been a strong advocate for the development of clinical prediction rules (CPRs) for treatment selection in physical therapist practice, as I believe that, ultimately, they can improve the precision of our clinical decision making. Perhaps it is a good time for us to revisit our approach to developing and validating CPRs, and this study raises some important issues for us to consider as we move forward. Three particular issues that I would like to address in this commentary are: (1) the experimental design for developing CPRs, (2) when it is necessary to have a CPR, and (3) the proliferation of single-group CPR derivation studies in our literature without follow-up validation. The main purpose of a CPR is to inform the clinician under what circumstances, based on items from the patient’s clinical history and examination, a particular treatment may be an effective option. In essence, we are trying to match the right patients with the right treatments. From an experimental design point of view, Stanton et al are correct in stating that we are really trying to identify modifiers of treatment effect, or what some may term “treatment moderators,” when we develop CPRs. Treatment moderators specify for whom or under what conditions the treatment is likely to work.2 There is an excellent article by Kraemer et al2 that describes important theoretical and experimental design issues for identifying treatment moderators. According to Kraemer et al, when an investigator examines the association of baseline variables with treatment response using a single group, it really is not possible to distinguish whether any associated vari-

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ables are moderators of treatment response, nonspecific predictors of treatment outcome, or even correlates of change in response due to artifact (eg, statistical regression to the mean). In order to really identify a treatment moderator, a control or comparison group would be needed so that a moderator variable ⫻ treatment group interaction could be examined, thus confirming whether the variable is really a moderator of treatment outcome.2 This approach is directly in line with the recommendations provided by Stanton et al. It would appear that we have 2 options to consider in developing CPRs. One option is to use a 2-stage process, where a single-arm trial is done first to identify an algorithm of responsiveness (which has been considered the CPR development stage) and then follow up with a second study, which is a randomized clinical trial (RCT) comparing the target treatment with a control or comparison group while performing secondary analyses to examine whether the CPR developed in the first study really does moderate treatment outcome. The second option would be to forgo the single-arm study and derive the CPR directly from an RCT that would be designed specifically to test whether candidate variables moderated the treatment outcome effect, by powering the study to identify candidate variable ⫻ treatment interactions. Stanton and colleagues prefer this second approach. My opinion is that there are advantages and disadvantages to both approaches and researchers may select one approach over the other after the advantages and disadvantages are weighed in the context of a number of factors such as the level of knowledge on

likely candidate variables or resources available to conduct larger randomized trials. If the investigator has a fairly good idea of what the likely candidate variables would be to moderate treatment outcome and has the resources (adequate source of participants, adequate amount of funding) to conduct an RCT that could be powered for subanalyses to examine the candidate moderator variable ⫻ treatment group interactions, then it would seem best to develop the CPR starting with an RCT. Two clear advantages would be: (1) only one study would be needed to develop and provide some preliminary validity for the CPR, and (2) it would be possible to directly determine whether the candidate variables were indeed moderators of treatment outcome, and we could be fairly confident that the CPR developed from these moderator variables would be likely to hold up under subsequent validation studies. One potential disadvantage of this approach is that if there were a fairly large number of candidate variables to assess and it was somewhat uncertain whether they would pass as moderators of treatment outcome, it would be necessary to explore each variable, which may require a very large sample size for adequate power to detect the significant interactions. If the resources in terms of adequate sample source and funding to conduct such a study were not available, then the ability to identify true moderators would be limited, thus limiting the ability to successfully develop the CPR. It might be better to select the 2-step approach in developing the CSR in the case where there is not enough knowledge to limit the number of

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Clinical Prediction Rules for Musculoskeletal Conditions candidate variables to a few variables that we are reasonably certain would be likely moderators of treatment outcome and limited resources would preclude conducting an RCT that would be large enough to include all the candidate variables in subanalyses for examining their potential as treatment moderators. By first examining which variables from the larger group of candidate variables are likely to be predictors of treatment outcome, it may be possible to narrow the field of candidate variables so that hypotheses for testing treatment moderators in the subsequent RCT may be more precise and the required resources to conduct the RCT may be more manageable. Stanton et al have explained that a serious potential risk of this approach is that predictors of treatment outcome are not always moderators of treatment outcome and it is possible that the variables identified in the first step may not be validated in the second step as treatment moderators. I agree with this point, but I believe there are steps that can be taken to minimize this risk. The success of the 2-step process for developing the CPR is largely dependent on how well the initial singlearm observational study is conducted. Stanton et al have addressed many of the factors that need to be considered in designing the initial observational study in order to increase the probability of success. The sample size in the single-arm study should be consistent with the number of variables that will be explored so that there are enough observations per candidate variable to ensure a reliable result. Sound theoretical rationale (biomechanical, biological, psychological plausibility) for including candidate variables in the analysis should be provided so that the risk of identifying spurious variables is minimized or eliminated. The length of the follow-up periods 856

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to determine whether the outcome of treatment is successful should be long enough to be relevant to the patient population under examination (ie, follow-up periods for people with acute injury may not be the same as follow-up periods for people with chronic conditions such as arthritis). I share a similar frustration with Stanton et al that many of the current single-group CPR derivation studies have not met these requirements. We do not know at this point whether the variables identified in these studies are true treatment moderators, because the subsequent RCTs have not been reported. The increasing development of larger patient databases in health care systems, where the data collection procedures for these databases are standardized, may improve the quality of preliminary single-arm observational studies to develop hypotheses to test candidate treatment moderators in a subsequent RCT. One may still argue that when looking at large numbers of candidate variables, there is always a chance that spurious variables will be identified as significant predictors. However, if faced with the “risk” of having a spurious variable identified versus an underpowered study that is likely to not identify an important predictor variable, I would take the former because I am confident that the validation process will ultimately identify the spurious variable. Regardless of the approach an investigator selects to pursue development of a CPR, ultimately an RCT with subanalyses to test for the rule status ⫻ treatment interaction must be performed to qualify that a CPR has indeed been developed. Although the results of a single-arm derivation study may begin to inform clinicians of factors that might improve their decision making for a given treatment approach, it should be recognized that the CPR is really not a CPR until the RCT confirming

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treatment effect moderation has been completed. There is one small point of disagreement I have with Stanton et al in their discussion of validation of CPRs. They use a previous study3 from their group as an example of a “broad” validation study for the CPR for spinal manipulation developed by Flynn et al4 and “narrowly” validated by Childs et al.5 They conclude that the validation of the CPR was not reproduced in this broader validation study. They acknowledge that a possible explanation was that the intervention used in the broader validation study was modified from that used in the original CPR. The original CPR was specifically for high-thrust manipulation. In the broader validation study, 97% of the participants received a low-thrust manipulation,3 or what some people may consider a mobilization intervention. In my opinion, this “modification” of intervention is a serious design flaw of that study, and I do not accept the notion that this study was indeed a broad validation study of this CPR. If we put it in the context of treatment dosage, it would not be surprising to find that a CPR designed for a high-dose treatment does not work when it is applied for a low-dosed or underdosed treatment because, in effect, they are probably no longer the same treatment. If we are going to critically review the study designs used to validate CPRs, then perhaps we should be as critical of our own work as we are of other investigators. The second issue I would like to address has to do with whether we really need a CPR in certain circumstances. Fritz suggested, “Prediction rules have the greatest potential to favorably impact physical therapy care when they are developed for clinical conditions that are by nature heterogeneous, with several viable yet discrete treatment approaches, June 2010

Clinical Prediction Rules for Musculoskeletal Conditions and some degree of risk associated with an incorrect choice. In these circumstances, clinical decision making is complex, uncertain, and most likely to benefit from tools such as CPRs.”6(p160) Stanton et al suggest that when the proportion of patients who are appropriate for application of the CPR is low in the population, then we should question whether the CPR really has much impact or relevance. This logic would preclude almost any approach to studying target disorders of low prevalence. I do not necessarily disagree with this point in some instances, but we also should consider that at times there may be patient groups that are of disproportionately low prevalence in our clinic populations but also are challenging where treatment decision making is concerned. A CPR that could guide effective treatment decision making for these patients could still be very relevant, despite the fact that the prevalence in the population is low. Another instance where I believe we should really question whether a CPR is needed is when we start with a pretest or pretreatment probability of success that is already pretty high. For example, there are 2 studies on the development of a CPR for treatment selection that reported pretreatment probabilities of success on the order of 61%7 and 75%.8 Acknowledging that in both studies application of the CPR improved posttreatment probability of success (89%7 and 95%8), I would argue that the pretreatment probabilities of success alone would induce me to try these treatment approaches without even considering use of the CPR derived in these studies. If you give me a treatment approach where the probability of success is likely to be greater than 60% and the probability of doing harm is low, I would not need a CPR to guide my decision to try the treatment approach.

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The final issue I would like to address is the point by Stanton et al that physical therapist researchers appear to be inundating our literature with new single-group CPR derivation studies without validating existing ones. I agree that this is a concern. Without advancing to the validation step, we are really no better off than if all of our evidencebased decisions were made based on case reports or case series. I think I have made it clear that I agree with Stanton et al that using randomized trial designs at the derivation stage would be the preferred way to go. On the other hand, I can see that CPRs that are derived from singlegroup studies could eventually become validated, provided that they ultimately confirm a real rule status ⫻ treatment interaction in sound randomized trials. I urge my colleagues who have already developed CPRs to go the extra step and complete the validation process. I also have some suggestions for our journals that will review and publish future studies concerning CPR development and validation to consider: (1) limit the publication of CPR derivation studies to those that examine the moderator variable ⫻ treatment interaction in randomized trials using a control or comparison group, or (2) for those studies using a singlegroup design to derive a CPR, delay publication until at least a narrow validation study also has been performed, or (3) if it is believed that even the single-arm observational study has important information to disseminate, then publish it, not as the derivation of a CPR, but rather as a report on predictors of outcome that need further exploration as treatment moderators that could be used to develop a CPR. I see the present situation of the proliferation of CPR derivation studies as similar to the proliferation of reliability studies in the 1980s and early 1990s. Currently, PTJ is unlikely to publish a

study concerning the reliability of a measurement unless there also is information concerning measurement validity and clinical utility. I believe my second suggestion where CPRs are concerned would parallel this philosophy. I believe in the pursuit of developing and validating CPRs to enhance our treatment decision making in physical therapy, and I commend all of my colleagues who have dedicated themselves to this pursuit. I want to thank Stanton et al for their thoughtprovoking and timely report on the state of the science in this area, and I thank the Editorial Board for giving me the privilege to participate in the dialogue on this exciting and important topic. G.K. Fitzgerald, PT, PhD, FAPTA, is Associate Professor, Department of Physical Therapy, Associate Professor, Clinical and Translational Science Institute, and Director, Physical Therapy Clinical and Translational Research Center, University of Pittsburgh, 6035 Forbes Tower, Pittsburgh, PA 15260. Address all correspondence to Dr Fitzgerald at: [email protected]. DOI: 10.2522/ptj.20090233.ic

References 1 Stanton TR, Hancock MJ, Maher CG, Koes BW. Critical appraisal of clinical prediction rules that aim to optimize treatment selection for musculoskeletal conditions. Phys Ther. 2010;90:843– 854. 2 Kraemer HC, Wilson TG, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59: 877– 883. 3 Hancock MJ, Maher CG, Latimer J, et al. Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial. Eur Spine J. 2008;17:936 –943. 4 Flynn T, Fritz J, Whitman J, et al. A clinical prediction rule for classifying patients with low back pain who demonstrate shortterm improvement with spinal manipulation. Spine (Phila Pa 1976). 2002;27: 2835–2843. 5 Childs J, Fritz J, Flynn T, et al. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004;141:920 –928.

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8 Whitman JM, Cleland JA, Mintken P, et al. Predicting short-term response to thrust and nonthrust manipulation and exercise in patients post inversion ankle sprain. J Orthop Sports Phys Ther. 2009;39:188 –200.

Tasha R. Stanton, Mark J. Hancock, Christopher G. Maher, Bart W. Koes

We would like to thank Fitzgerald for his thoughtful and generous commentary1 on our work.2 We believe the recent dialogue on this topic in the physical therapy community is very valuable and a sign of the maturity of the profession. We have only a few points that we would like to add. We agree with Fitzgerald on the key point that a randomized controlled trial (RCT) with appropriate analysis “must be performed to qualify that a CPR [clinical prediction rule] has indeed been developed.” In selecting the potential predictors for investigation in the RCT, we agree that a well-conducted singlearm study may be useful, along with selecting predictors based on a strong theoretical rationale or clinical experience. One note of caution relates to the suggestion by Fitzgerald that using a single-arm trial rather than an underpowered RCT is less likely to miss important predictors. We would argue that single-arm trials may be even more likely to miss true predictors of response to the intervention. As single-arm studies are designed to identify predictors of good prognosis regardless of treatment, a factor associated with a poor prognosis but a good response to treatment will likely not be identified in a single-arm trial. Therefore, singlearm trials can easily miss important predictors of response to treatment. We believe secondary analysis of the thousands of existing RCTs may provide as good, if not better, information than single-arm trials to help in selecting the best predictors for analysis in a prospective, adequately powered RCT. Secondary analyses of

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7 Mintken PE, Cleland JA, Carpenter KJ, et al. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010;90:26 – 42.

existing RCTs also are cheaper and easier to do than performing singlearm trials, which are still expensive to perform. The language regarding stages of development of CPRs is well defined in the literature.3 This language, however, was developed for studies of diagnosis and prognosis. In the physical therapy literature investigating responders to treatment, this language has been modified, resulting in much confusion. Over recent years in the physical therapy literature, a singlearm study has been considered a derivation study, with the following RCT considered a validation study. As mentioned above, we agree strongly with Fitzgerald’s emphasis that an RCT must be performed “to qualify that a CPR has indeed been developed [our emphasis].” Therefore, we do not consider that the first RCT is, in any way, a “validation” study, as referred to in the literature on development of CPRs. The single-arm study is simply a method to generate hypotheses of potential predictors in the same way as a theoretical rationale or clinical experience may be used. Because we do not know what the potential predictors arising from a single-arm study actually are (nonspecific predictors of outcome, treatment effect modifier, or error?), a CPR for a specific intervention cannot exist until we have confirmed that these potential predictors are, in fact, treatment effect modifiers, which is accomplished by performing an RCT and analyzing the predictor variable ⫻ treatment group interaction. Therefore, we argue that the initial RCT following a single-arm study con-

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firms only that a CPR exists; it does not validate a CPR, and it should be considered a derivation study according to the original literature on CPR development. A second RCT would be the true validation study. This point has been recommended in recent articles.4,5 We have previously responded to comments about the study by Hancock et al6 mentioned by Fitzgerald and will only briefly comment here. If, as mentioned above, we consider the study by Childs et al7 a derivation study (first RCT on this CPR8), then Hancock and colleagues’ study6 is the first attempt at validation. We were interested in whether the rule would generalize to a different setting including a modified treatment. This is not an unreasonable question, as evidenced by the fact that the same researchers also recently published an RCT to investigate the CPR in patients receiving different treatments (alternative manipulation and mobilization).9 To refer to the study by Hancock et al6 as flawed is, in our opinion, a misunderstanding of the aim and interpretation of the study. The study demonstrated the CPR does not generalize to this new setting including a modified treatment but says nothing about whether it will generalize in a new sample of patients if the identical manipulation is used. We await a second appropriately designed RCT to answer that question. Last, we would like to extend Fitzgerald’s call to researchers to test CPRs using RCTs. Beyond deri-

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Clinical Prediction Rules for Musculoskeletal Conditions 6 Fritz JM. Clinical prediction rules in physical therapy: Coming of age [guest editorial]? J Orthop Sports Phys Ther. 2009;39:159 – 161.

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8 Whitman JM, Cleland JA, Mintken P, et al. Predicting short-term response to thrust and nonthrust manipulation and exercise in patients post inversion ankle sprain. J Orthop Sports Phys Ther. 2009;39:188 –200.

Tasha R. Stanton, Mark J. Hancock, Christopher G. Maher, Bart W. Koes

We would like to thank Fitzgerald for his thoughtful and generous commentary1 on our work.2 We believe the recent dialogue on this topic in the physical therapy community is very valuable and a sign of the maturity of the profession. We have only a few points that we would like to add. We agree with Fitzgerald on the key point that a randomized controlled trial (RCT) with appropriate analysis “must be performed to qualify that a CPR [clinical prediction rule] has indeed been developed.” In selecting the potential predictors for investigation in the RCT, we agree that a well-conducted singlearm study may be useful, along with selecting predictors based on a strong theoretical rationale or clinical experience. One note of caution relates to the suggestion by Fitzgerald that using a single-arm trial rather than an underpowered RCT is less likely to miss important predictors. We would argue that single-arm trials may be even more likely to miss true predictors of response to the intervention. As single-arm studies are designed to identify predictors of good prognosis regardless of treatment, a factor associated with a poor prognosis but a good response to treatment will likely not be identified in a single-arm trial. Therefore, singlearm trials can easily miss important predictors of response to treatment. We believe secondary analysis of the thousands of existing RCTs may provide as good, if not better, information than single-arm trials to help in selecting the best predictors for analysis in a prospective, adequately powered RCT. Secondary analyses of

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7 Mintken PE, Cleland JA, Carpenter KJ, et al. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010;90:26 – 42.

existing RCTs also are cheaper and easier to do than performing singlearm trials, which are still expensive to perform. The language regarding stages of development of CPRs is well defined in the literature.3 This language, however, was developed for studies of diagnosis and prognosis. In the physical therapy literature investigating responders to treatment, this language has been modified, resulting in much confusion. Over recent years in the physical therapy literature, a singlearm study has been considered a derivation study, with the following RCT considered a validation study. As mentioned above, we agree strongly with Fitzgerald’s emphasis that an RCT must be performed “to qualify that a CPR has indeed been developed [our emphasis].” Therefore, we do not consider that the first RCT is, in any way, a “validation” study, as referred to in the literature on development of CPRs. The single-arm study is simply a method to generate hypotheses of potential predictors in the same way as a theoretical rationale or clinical experience may be used. Because we do not know what the potential predictors arising from a single-arm study actually are (nonspecific predictors of outcome, treatment effect modifier, or error?), a CPR for a specific intervention cannot exist until we have confirmed that these potential predictors are, in fact, treatment effect modifiers, which is accomplished by performing an RCT and analyzing the predictor variable ⫻ treatment group interaction. Therefore, we argue that the initial RCT following a single-arm study con-

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firms only that a CPR exists; it does not validate a CPR, and it should be considered a derivation study according to the original literature on CPR development. A second RCT would be the true validation study. This point has been recommended in recent articles.4,5 We have previously responded to comments about the study by Hancock et al6 mentioned by Fitzgerald and will only briefly comment here. If, as mentioned above, we consider the study by Childs et al7 a derivation study (first RCT on this CPR8), then Hancock and colleagues’ study6 is the first attempt at validation. We were interested in whether the rule would generalize to a different setting including a modified treatment. This is not an unreasonable question, as evidenced by the fact that the same researchers also recently published an RCT to investigate the CPR in patients receiving different treatments (alternative manipulation and mobilization).9 To refer to the study by Hancock et al6 as flawed is, in our opinion, a misunderstanding of the aim and interpretation of the study. The study demonstrated the CPR does not generalize to this new setting including a modified treatment but says nothing about whether it will generalize in a new sample of patients if the identical manipulation is used. We await a second appropriately designed RCT to answer that question. Last, we would like to extend Fitzgerald’s call to researchers to test CPRs using RCTs. Beyond deri-

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Clinical Prediction Rules for Musculoskeletal Conditions vation and validation of CPRs, it also is important to perform an impact analysis.3 It is essential to know whether the rule changes clinician behavior, whether it improves patient outcomes, and whether it reduces costs. An accurate CPR may not change clinician behavior or improve patient outcomes for many reasons. It may be too difficult and time-consuming to apply to patients, clinicians may not be adequately trained in the treatment specified by the CPR (or may not feel comfortable performing the treatment), or for practical reasons (eg, liability) the CPR may not be used. DOI: 10.2522/ptj.20090233.ar

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References 1 Fitzgerald GK. Invited commentary on “Critical appraisal of clinical prediction rules that aim to optimize treatment selection for musculoskeletal conditions.” Phys Ther. 2010;90:855– 858. 2 Stanton TR, Hancock MJ, Maher CG, Koes BW. Critical appraisal of clinical prediction rules that aim to optimize treatment selection for musculoskeletal conditions. Phys Ther. 2010;90:843– 854. 3 McGinn TG, Guyatt GH, Wyer PC, et al; for the Evidence-Based Medicine Working Group. Users’ guides to the medical literature, XXII: how to use articles about clinical decision rules. JAMA. 2000;284:79 – 84. 4 Hancock MJ, Herbert RD, Maher CG. A guide to interpretation of studies investigating subgroups of responders to physical therapy interventions. Phys Ther. 2009;89: 698 –704. 5 Kamper SJ, Maher CG, Hancock MJ, et al. Treatment-based subgroups of low back pain: a guide to appraisal of research studies and a summary of current evidence. Best Pract Res Clin Rheumatol. 2010;24: 181–191.

6 Hancock MJ, Maher CG, Latimer J, et al. Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial. Eur Spine J. 2008;17:936 –943. 7 Childs J, Fritz J, Flynn T, et al. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004;141:920 –928. 8 Flynn T, Fritz J, Whitman J, et al. A clinical prediction rule for classifying patients with low back pain who demonstrate shortterm improvement with spinal manipulation. Spine. 2002;27:2835–2843. 9 Cleland JA, Fritz JM, Kulig K, et al. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: a randomized clinical trial. Spine. 2009;34:2720 –2729.

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Research Report

Graded Activity and Graded Exposure for Persistent Nonspecific Low Back Pain: A Systematic Review Luciana G. Macedo, Rob J.E.M. Smeets, Christopher G. Maher, Jane Latimer, James H. McAuley L.G. Macedo, MSc, is a PhD candidate at The George Institute for International Health, University of Sydney, PO Box M201, Missenden Rd, Camperdown, New South Wales 2050, Australia. Address all correspondence to Ms Macedo at: [email protected]. R.J.E.M. Smeets, MD, PhD, is Professor, Adelante Zorggroep, Hoensbroek, the Netherlands, and Department of Rehabilitation Medicine, School of Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands. C.G. Maher, PhD, is Director, Musculoskeletal Division, The George Institute for International Health, University of Sydney. J. Latimer, PhD, is Associate Professor, The George Institute for International Health, University of Sydney. J.H. McAuley, PhD, is Research Manager, The George Institute for International Health, University of Sydney. [Macedo LG, Smeets RJEM, Maher CG, et al. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010; 90:860 – 879.] © 2010 American Physical Therapy Association

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Background. Graded activity and graded exposure are increasingly being used in the management of persistent low back pain; however, their effectiveness remains poorly understood. Purpose. The aim of this study was to systematically review randomized controlled trials that evaluated the effectiveness of graded activity or graded exposure for persistent (⬎6 weeks in duration or recurrent) low back pain.

Data Sources. Trials were electronically searched and rated for quality by use of the PEDro scale (values of 0 –10).

Study Selection. Randomized controlled trials of graded activity or graded exposure that included pain, disability, global perceived effect, or work status outcomes were included in the study. Data Extraction. Outcomes were converted to a scale from 0 to 100. Trials were pooled with software used for preparing and maintaining Cochrane reviews. Results are presented as weighted mean differences with 95% confidence intervals.

Data Synthesis. Fifteen trials with 1,654 patients were included. The trials had a median quality score of 6 (range⫽3–9). Pooled effects from 6 trials comparing graded activity with a minimal intervention or no treatment favored graded activity, with 4 contrasts being statistically significant: mean values (95% confidence intervals) for pain in the short term, pain in the intermediate term, disability in the short term, and disability in the intermediate term were ⫺6.2 (⫺9.4 to ⫺3.0), ⫺5.5 (⫺9.9 to ⫺1.0), ⫺6.5 (⫺10.1 to ⫺3.0), and ⫺3.9 (⫺7.4 to ⫺0.4), respectively. None of the pooled effects from 6 trials comparing graded activity with another form of exercise, from 4 trials comparing graded activity with graded exposure, and from 2 trials comparing graded exposure with a waiting list were statistically significant. Limitations. Limitations of this review include the low quality of the studies, primarily those that evaluated graded exposure; the use of various types of outome measures; and differences in the implementation of the interventions, adding to the heterogeneity of the studies. Conclusions. The available evidence suggests that graded activity in the short term and intermediate term is slightly more effective than a minimal intervention but not more effective than other forms of exercise for persistent low back pain. The limited evidence suggests that graded exposure is as effective as minimal treatment or graded activity for persistent low back pain.

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any patients with low back pain (LBP) have concerns that are inadequately explained with a traditional biomedical model. Contemporary approaches have recognized the multifactorial etiology of LBP and the necessity to adopt a biopsychosocial model when dealing with the condition. Cognitive behavioral models propose that pain-related fear, kinesiophobia, and unhelpful beliefs about back pain may be primary factors leading to increased pain and a decreased level of activity or functioning.1,2 It has been suggested that these factors not only may represent psychosocial barriers to recovery but also may contribute to important biological changes, such as disuse and deconditioning after an injury.3 Graded activity and graded exposure are interventions commonly used in the management of persistent LBP. These treatments incorporate behavioral and cognitive approaches to improve activity tolerance. The primary difference between these interventions is that, with graded exposure, patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity. Once the negative associations are extinguished, activities associated with higher levels of anxiety are addressed in the same way. With graded activity, operant conditioning principles are used to reinforce healthy behaviors. The program focuses on functional activities and progresses in a timecontingent manner regardless of pain to achieve functional goals and increased activity. Principles of quotas, pacing, and self-reinforcement are key features of the program. Although both treatments have been endorsed in clinical guidelines for June 2010

the management of persistent LBP,4,5 the effectiveness of the 2 treatments has not been well established. Although no systematic review of graded activity or graded exposure has been published, a Cochrane systematic review of cognitive and behavioral interventions for chronic LBP has been completed. The review concluded that combined cognitive therapy/respondent therapy and progressive relaxation alone are effective treatment modalities for shortterm pain reduction in patients with chronic LBP but that there are no significant differences between the different forms of behavioral interventions.6 Because most of the studies included in that review involved only psychological interventions, with minimal or no exercise component, the effectiveness of graded activity or graded exposure cannot be established from that review. Therefore, the purpose of the present study was to systematically review randomized controlled trials that evaluated the effectiveness of graded activity and graded exposure interventions for the treatment of persistent (⬎6 weeks in duration or recurrent) nonspecific LBP at short-, intermediate-, and long-term follow-up evaluations. The outcomes of interest were pain, disability, global perceived effect, and return to work.

Method Data Sources and Searches A computerized electronic search was performed to identify relevant articles. The search was conducted on MEDLINE (1950 to February 2009), CINAHL (1982 to February 2009), PsychINFO (1806 to February 2009), PEDro (to February 2009), and EMBASE (1988 to February 2009). Key words relating to the domains of randomized controlled trials and back pain were used, as recommended by the Cochrane Back Review Group.7 Terms for graded activity and graded

exposure were included in the search by use of MeSH (Medical Subject Headings of the National Library of Medicine) terms and specific guidelines for each database (Appendix). Subject subheadings and word truncations specific for each database were used. There was no language restriction. One reviewer screened the search results for potentially eligible studies, and 2 reviewers independently reviewed the screened articles for eligibility. A third independent reviewer resolved any disagreement about the inclusion of trials. Authors were contacted when more information about a trial was needed to allow the inclusion of that trial. Many authors were contacted for additional information related to inclusion criteria.8 –16 From the latter studies, we included 5 trials11,12,14 –16 and excluded 4 trials (2 authors confirmed that their trials were not eligible,8,10 and we did not receive a response from 2 authors). Staal et al16 provided data for the subset of participants who met the inclusion criteria for this review (ie, excluding participants with acute pain). Researchers who published relevant articles were contacted to help identify gray literature and articles in press. Citation tracking was performed by use of the database Web of Science on ISI Web of Knowledge,* and a manual search of the reference lists of previous reviews * Thomson Reuters, Level 3, 100 Harris St, Pyrmont, New South Wales 2009 Australia.

Available With This Article at ptjournal.apta.org • The Bottom Line Podcast • Audio Abstracts Podcast This article was published ahead of print on April 15, 2010, at ptjournal.apta.org.

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Graded Activity and Graded Exposure for Low Back Pain and eligible trials also was performed. The International Clinical Trials Registry platform from the World Health Organization and the Cochrane Centre Register of Controlled Trials also were searched with terms for LBP, graded activity, and graded exposure. Study Selection Studies were eligible for inclusion when they were randomized controlled trials or quasi-randomized controlled trials comparing graded activity or graded exposure to placebo, no treatment, or another active treatment or when graded activity or graded exposure was added as a supplement to other interventions. The reviewers followed a research protocol that was developed before the beginning of the review process and that included a checklist for inclusion criteria. Trials were considered to have evaluated graded activity when the treatment included the following 3 features:

• The treatment involved principles of operant conditioning, such as reinforcement of healthy behaviors. • Treatment goals were functional activities. • The program included a baseline and then incremented activities in a time-contingent manner regardless of pain.

Additionally, trials in which treatments were described as graded activity and in which various handbooks2,17 were cited were deemed eligible. Trials were considered to have evaluated graded exposure when the treatment included the following 4 features: • Feared activities were identified. • A hierarchy of feared activities was created. • Exposure started with the least feared activity. • The therapist assisted the patient in appraising the exposure to feared activities and its consequences. The therapist addressed irrational be-

The Bottom Line What do we already know about this topic? Graded activity and graded exposure differ from traditional exercise because these interventions incorporate psychological principles into activity prescription. It remains unclear whether either of these interventions is effective.

What new information does this study offer? This review established that graded activity, but not graded exposure, is an effective treatment for persistent low back pain, although the effect size is small. There is no evidence that either is superior to a traditional exercise program for persistent low back pain.

If you’re a patient, what might these findings mean for you? Exercise is an effective treatment for persistent low back pain but the type of exercise does not seem particularly important.

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liefs, counterproductive beliefs, or both.

Additionally, trials in which treatments were described as graded exposure and in which various handbooks18,19 were cited were deemed eligible. Randomized or quasi-randomized controlled trials were included when they explicitly reported that a criterion for entry was nonspecific LBP (with or without leg pain) with a duration of at least 6 weeks (nonacute LBP) or recurrent LBP. There was no age or sex restriction. Trials were included when one of the following outcome measures was reported: pain, disability, quality of life, perceived effect, return to work, or recurrence. Data Extraction and Quality Assessment The methodological quality of the trials was assessed by use of the PEDro scale (values of 0 –10), with scores extracted from the PEDro database.20 Assessment of the quality of trials in the PEDro database was performed by 2 trained independent raters, and disagreements were resolved by a third rater. Methodological quality was not an inclusion criterion. Two independent reviewers extracted data from the included studies by using a standardized data extraction form. Mean scores, standard deviations, and sample sizes were extracted from the studies. When this information was not provided in the trial, the values were calculated or estimated by use of methods recommended in the Cochrane Handbook for Systematic Reviews of Interventions.21 When there was insufficient information about outcomes to allow data analysis, the authors of the included studies were contacted. All11,16,22–25 but one26 of the authors

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Graded Activity and Graded Exposure for Low Back Pain Database searches : February 2009 PsychINFO: 183 CINAHL: 89 EMBASE: 2,161 MEDLINE: 1,545 PEDro: 868 Hand search: 4 Total after removing duplicates: 3,971

74 potentially eligible after assessing titles and abstracts

Web of Science search 3 potentially eligible

Indicated by experts 6 potentially eligible

83 potentially eligible

Reasons for exclusion: 33 did not use graded activity or graded exposure,8–10,28–57 6 included patients without nonspecific low back pain,58–63 3 included patients with acute low back pain,64–66 14 were not RCTs,67–80 8 were secondary analyses of another trial,81–88 and 1 used graded activity for both treatment groups89

15 original studies included in review (18 articles)

Figure 1. Flow chart of systematic review inclusion and exclusion. RCTs⫽randomized controlled trials.

who were contacted to provide trial data responded to our queries. Means, standard deviations, and sample sizes were extracted for shortterm (less than 3 months after randomization), intermediate-term (at least 3 months but less than 12 months after randomization), and long-term (12 months or more after June 2010

randomization) follow-up evaluations. When multiple time points fell within the same category, the one that was closer to the end of treatment for the short term, closer to 6 months for the intermediate term, and closer to 12 months for the long term was used. These references for time points were based on guidelines from the Cochrane Back Re-

view Group.7 Scores for pain, disability, and global perceived effect were converted to a scale from 0 to 100. When more than 1 outcome measure was used to assess pain, disability, and work status, the outcome measure described as the primary outcome measure for the trial was included in this review.

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Graded Activity and Graded Exposure for Low Back Pain Data Synthesis and Analysis Results were pooled when trials were considered sufficiently homogeneous with respect to participant characteristics, interventions, and outcomes. I2 was calculated by use of RevMan 527 to assess statistical heterogeneity. I2 describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance). A value greater than 50% may be considered substantial heterogeneity.21 When trials were statistically homogeneous (I2⬍50%), pooled effects (weighted mean differences) were calculated by use of a fixed-effects model. When trials were statistically heterogeneous (I2⬎50%), estimates of pooled effects (weighted mean differences) were obtained by use of a random-effects model.21

Results Study Selection The initial electronic database search resulted in a total of 3,971 articles after the removal of duplicates. Of these, 74 articles were selected as potentially eligible on the basis of their title and abstract. Through a Web of Science search of these articles, 3 other potentially eligible articles were identified. A total of 77 potentially eligible articles were considered for inclusion; only 14 were found to be eligible for inclusion in this review (Fig. 1). Twenty-four experts were contacted to provide information about gray literature and articles that we may have missed. We received 12 responses suggesting 6 potentially eligible studies; only 1 of these was included in this review. Therefore, we included a total of 15 original studies with results presented in 18 different articles. The International Clinical Trials Registry platform contained 8 randomized controlled trials that were potentially eligible for inclusion. Of those, 3 were already included in our study,22,26,90 3 were still recruiting 864

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patients, and 2 were not eligible because patients with acute back pain were included. Methodological Quality The methodological quality assessment with the PEDro scale revealed a median score of 6 (range⫽3–9). Masking of the therapist was not included in any of the trials, as expected in studies of activity prescription, and masking of patients was included in only 1 trial.23 Point estimates and between-group comparisons were present in 14 of 15 trials, 12 of 15 trials had comparability at baseline, and 10 of 15 trials had concealed allocation, intention to treat, and adequate follow-up evaluations. Study Characteristics Fourteen of the randomized controlled trials included in this review compared graded activity or graded exposure with another treatment or with no treatment (Tabs. 1 and 2). One trial with a factorial design (2 ⫻ 2) was also included; the first factor was graded activity, the second factor was advice, and each factor had 2 levels (active versus sham).23 In 7 trials, graded activity was compared with a minimal intervention (usual care, waiting list, sham exercise, advice to stay active, or care by a general practitioner).12,16,22,23,26,86,92 In 6 trials, graded activity was compared with another form of exercise (motor control, high-intensity back school, general physical therapy exercises, active physical treatment, or physical therapy according to guidelines).11,14,15,22,25,26 In 4 trials, graded activity was compared with graded exposure,12,90,91,94 and in 2 trials, graded exposure was compared with a waiting list.12,94 Graded Activity Versus a Minimal Intervention Seven trials with a total of 920 patients compared graded activity with a minimal intervention.12,16,22,23,26,86,92

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The methodological quality of these trials ranged from 4 to 9. Data for pooling were available for pain and disability in the short, intermediate, and long terms and for perceived effect in the short term. Data were pooled by use of a fixed-effects model for all outcomes except pain and disability in the long term and perceived effect in the short term, for which a random-effects model was used. The pooled results favored graded activity for both pain and disability at short- and medium-term follow-up evaluations, but the effects were small; for example, for pain in the short term, the weighted mean difference on a scale from 0 to 100 was ⫺6.2 points (95% confidence interval [CI]⫽⫺9.4 to ⫺3.0). For both pain and disability at long-term follow-up evaluations, the effects were close to zero and not significant; for example, for pain the value was ⫺0.1 (95% CI⫽⫺10.4 to 10.2) (Fig. 2). Results for return to work were presented by 3 studies.26,92,95 The results of 1 trial, that of Lindstrom et al,92 were expressed in likelihood ratios and showed that return to work was faster for patients in the gradedactivity group than for patients in the control group. The median number of days to return to work for the graded-activity group was 35 days; that for the control group was 61 days. Heymans et al26 used survival analysis to show that there were no significant differences between treatment groups at short-term follow-up evaluations (hazard ratio⫽1.0; 95% CI⫽0.8 to 1.4). The median number of days of sick leave for the gradedactivity group was 85; that for the usual-care group was 75. In contrast, the results of a survival analysis conducted by Streenstra et al95 showed a significantly earlier return to work for the usual-care group (hazard ratio⫽0.52; 95% CI⫽0.32 to June 2010

Graded Activity and Graded Exposure for Low Back Pain Table 1. Details of Included Randomized Controlled Trials (RCTs)a Outcomes (Measures) and Time Points Included in This Review

Participant Characteristics, Sample Size (N), and Duration of Complaint

Interventions and Study Design

Critchley et al (2007)11

Recruited from referrals by specialist or primary care practitioners to hospital’s physical therapy department Age: ⬎18 y Main exclusions: prior spinal surgery, hematologic disease, and physical therapy in the preceding 6 mo N⫽143 Duration: ⬎12 wk

Graded activity vs motor control vs manual therapy ⫹ home exercises (RCT)

Pain (VAS) Disability (RMDQ-24) Quality of life (EuroQol Questionnaire) 6- and 12-mo follow-up evaluations

7

de Jong et al (2005)91

Referred for outpatient behavioral rehabilitation and reporting substantial fear of movement Age: 18–65 y Main exclusions: pregnancy and psychopathology N⫽6 Duration: ⬎6 mo

Graded activity ⫹ education vs graded exposure ⫹ education (crossover study)

Disability (RMDQ-24) Crossover in short term only, with 6- or 8-wk follow-up evaluations

3

Heymans et al (2006)26

Patients who visited their occupational physicians Age: 18–65 y Main exclusions: specific pathologies, pregnancy, and legal conflicts at work N⫽299 Duration: ⬎7 wk (at least 1 mo of pain and 3 wk of sick leave)

Graded activity (highintensity back school) ⫹ usual care vs low-intensity back school (one third education, two thirds exercise) ⫹ usual care vs usual care (RCT)

Pain (VAS) Disability (RMDQ-24) Global perceived effect (0–5) Sick leave (d) and return to work (d) 3- and 6-mo follow-up evaluations

8

Leeuw et al (2008)90

Recruited by physicians and from advertisements Age: 18–65 y More than 3 points on the RMDQ-24 More than 33 points on the Tampa Scale for Kinesiophobia N⫽85 Duration: ⬎3 mo

Graded activity vs graded exposure (RCT)

Pain (McGill VAS) Disability (QBPDS and PSFS) Posttreatment, 6-mo, and 12-mo follow-up evaluations

6

Lindstrom and colleagues (1992)92,93

Workers in industrial (“blue-collar”) jobs, on sick leave for 6 wk due to any low back pain diagnosis and not on sick leave for 12 wk before the current leave Main exclusions: specific pathologies, surgery, and psychiatric diagnosis N⫽103 Duration: ⬎8 wk of sick leave

Graded activity vs waiting list (RCT)

Return to work (d), sick leave (d), and % of workers returning to work 12-mo follow-up evaluations

5

Linton et al (2008)94

Recruited from primary care facilities and advertisements in local newspaper More than 35 points on the Tampa Scale for Kinesiophobia Age: 18–60 y N⫽46 Duration: ⬎3 mo

Graded exposure ⫹ usual care vs waiting list ⫹ usual care (RCT)

Pain intensity (from Orebro) Disability (QBPDS) Posttreatment follow-up evaluations

4

Nicholas et al (1991)15

Referred to a pain clinic Age: 20–60 y Main exclusion: no compensation claim within 12 mo N⫽62 Duration: ⬎6 mo

Cognitive treatment vs behavioral treatment (graded activity) vs cognitive treatment ⫹ relaxation vs behavioral treatment ⫹ relaxation vs attention control condition vs physical therapy only (RCT)

Pain rating chart 5-wk, 6-mo, and 12-mo follow-up evaluations

4

Nicholas et al (1992)14

Referred from a pain clinic and by specialist and general medical practitioners Age: 20–60 y Main exclusion: compensation claim due for settlement within 12 mo N⫽20 Duration: ⬎6 mo

Cognitive behavioral treatment ⫹ physical therapy (graded activity) vs physical therapy ⫹ attention control condition (RCT)

Pain rating chart 5-wk and 6-mo follow-up evaluations

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Participant Characteristics, Sample Size (N), and Duration of Complaint

Interventions and Study Design

Pengel et al (2007)23

Recruited by health care professionals and from hospital waiting lists Age: 18–80 y Main exclusions: spinal surgery, specific pathologies, and contraindications to exercise N⫽260 Duration: ⬎6 wk but ⬍12 wk

Graded activity ⫹ advice vs sham exercises ⫹ advice vs graded activity ⫹ sham advice vs sham graded activity ⫹ sham exercises (RCT factorial design)

Pain (VAS) Disability (PSFS) Global perceived effect (⫺5 to 5) 6-wk, 4-mo, and 12-mo follow-up evaluations

9

Smeets et al (2006)22 Smeets et al (2008)24

Recruited by general practitioners and medical specialists Age: 18–65 y More than 3 points on the RMDQ-24 Ability to walk at least 100 m Main exclusions: specific pathologies, comorbidities, and clear treatment preference N⫽227 Duration: ⬎3 mo

Graded activity ⫹ problem solving vs active physical treatment vs graded activity ⫹ problem solving ⫹ active physical treatment vs waiting list (RCT)

Pain (McGill VAS) Disability (RMDQ-24) Global perceived effect (1–7) 10-wk, 6-mo, and 12-mo follow-up evaluations

8

Staal et al (2004)16 Hlobil et al (2005)98

Workers employed by a major Dutch airline Main exclusions: signs of nerve root compression and cardiovascular problems N⫽88 Duration: ⬎6 wk (for patients included in this review)

Graded activity vs usual care (RCT)

Pain (VAS) Disability (RMDQ-24) Absence from work (d) 3-mo, 6-mo, and 12-mo follow-up evaluations

8

Steenstra et al (2006)95 Anema et al (2007)96

Recruited by occupational physicians Patients in return-to-work program at 2–6 wk of sick leave Age: 18–65 y Main exclusions: specific low back pain, cardiovascular and psychiatric contraindications, pregnancy, and sick leave granted for low back pain ⬍1 mo N⫽112 Duration: ⬎8 wk of sick leave

Graded activity vs usual care (advice to stay active ⫹ care by general practitioners) (RCT)

Pain (VAS) Disability (RMDQ-24) Sick leave (d) and return to work (d) 3-mo, 6-mo, and 12-mo follow-up evaluations

7

van der Roer et al (2008)25

Age: 18–65 y New episode of nonspecific back pain Inability to resume daily activities in the last 3 wk N⫽114 Duration: ⬎12 wk

Graded activity vs guidelines (physical therapy according to clinical guidelines) (RCT)

Pain (numerical rating scale) Disability (RMDQ-24) Global perceived effect (0–6) 6-wk, 6-mo, and 12-mo follow-up evaluations

7

Vlaeyen et al (2002)97

Referred for outpatient behavioral rehabilitation and reporting substantial fear of movement Age: 18–65 y Main exclusions: pregnancy and psychopathology N⫽6 Duration: ⬎6 mo

Graded activity vs graded exposure (crossover study)

Pain (VAS) Disability (RMDQ-24) Crossover with 12-wk and 12mo follow-up evaluations

4

Woods and Asmundson (2008)12

Recruited from newspapers, e-mail advertisements, and posters Age: 19–65 y More than 38 points on the Tampa Scale for Kinesiophobia Main exclusions: pending medical investigations and back surgery N⫽83 Duration: ⬎6 mo

Graded activity vs graded exposure vs waiting list (RCT)

Pain Disability Index McGill Pain Questionnaire (short form) 4-wk follow-up evaluations

5

Trial

PEDro Score

a VAS⫽visual analog scale, RMDQ-24⫽24-Item Roland-Morris Disability Questionnaire, QBPDS⫽Quebec Back Pain Disability Scale, PSFS⫽Patient-Specific Functional Scale, Orebro⫽Orebro Musculoskeletal Pain Questionnaire.

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Graded Activity and Graded Exposure for Low Back Pain Table 2. Details of Graded-Activity (GA) and Graded-Exposure (GE) Interventions Duration of GA and GE Interventions

Expertise of the Caregiver and Integrity Check

Critchley et al (2007)11

Maximum of 9 sessions of 90 min

Physical therapists who had at least 2 y of clinical experience and who agreed to treat according to the trial protocol were provided brief training. The hospitals had their own common internal teaching program for the leaders of the graded-activity program; otherwise, there was no further training. Adherence to the protocol was assessed by recording treatments from physical therapy notes after treatment allocation was revealed.

Not stated

Not stated

Participants reported difficulty attending classes twice/wk

de Jong et al (2005)91

Graded activity for 32 h over 8 wk and graded exposure for 24 h over 6 wk

Not stated

Not stated

Not stated

Not stated

Heymans et al (2006)26

16 sessions of 1 h over 8 wk

Supervised physical therapist

Home exercises were given during the treatment period

Not stated

Patients attended an average of 13 sessions; 70% of workers completed all treatments, and 10% received no treatment

Leeuw et al (2008)90

Graded activity in 26 sessions of 1-h treatments starting twice/wk and graded exposure in 16 sessions of 1-h treatments starting twice/wk

Physical therapists with at least 6 mo of experience were trained in both treatments and received a manual with guidelines for dealing with problems. Therapists attended collective supervision sessions 3 times/y. A sophisticated method for judging adherence to treatment and contamination was used. Thirty random samples from 265 recorded sessions were judged.

Most practice of exercises occurred at home, and progress was evaluated at sessions; home exercises were given only for the gradedactivity group

Not stated

29% of patients receiving graded exposure and 33% of patients receiving graded activity did not finish the treatments

Lindstrom et al (1992)92

3 d/wk until return to work

Physical therapist

No home exercises

Not stated

Not stated

Linton et al (2008)94

13–15 individual sessions of behavioral therapy and 8–10 sessions of exposure in vivo

Therapy was performed by psychologists who were trained by Vlaeyen et al97 and also received support from a physical therapist. A written treatment manual was developed for the study.

Sessions ended with home assignment that incorporated movements into activities of daily living at home and work

Not stated

Not stated

Study

Home Program

Plans for Future Relapse

Adherence

(Continued)

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Nicholas et al (1991)15

One 2-h session and one 1.5-h session/wk for 5 wk (only 5 sessions were cognitive behavioral therapy)

Therapy was performed by a clinical psychologist with 5 y of experience and registered physical therapists under the supervision of a senior physical therapist. Two masked raters independently and correctly identified 6 audiotapes randomly selected from cognitive behavioral, behavioral, and attention control conditions, providing evidence that the content of each condition was consistent with the treatment protocol.

Patients were verbally praised by the psychologist for practicing physical therapy exercises each week

Not stated

Not stated

Nicholas et al (1992)14

One 2-h session and one 1.5-h session/wk for 5 wk

One hour of the first session each week was conducted by a physical therapist, and the other hour was conducted by a psychologist who had 5 y of experience since completing clinical qualifications. A physical therapist under the supervision of a senior physical therapist conducted the second session each week.

Patients were encouraged by physical therapists to practice exercises at home, but no check on the practice was made and no specific reinforcement for performing exercises was provided by physical therapists

Not stated

Not stated

Pengel et al (2007)23

12 sessions over 6 wk: 3 times/wk in weeks 1 and 2, twice/wk in weeks 3 and 4, and once/wk in weeks 5 and 6; participants also attended 3 sessions of advice

Registered physical therapists received training from an experienced clinical psychologist. An investigator recorded and assessed a sample treatment session and visited each treatment site regularly to monitor delivery.

Individualized home treatment was regularly reviewed, and patients were encouraged to continue after the end of the treatment period

Not stated

Means of 9.4 (SD⫽3.2) sessions of exercises and 2.9 (SD⫽1.1) sessions of advice

Smeets et al (2006)22 Smeets et al (2008)24

18 sessions over 10 wk, changing from 3 sessions/wk to 1 session/wk, for a total of 11.5 h of treatment

All therapists received extensive training before the start of the trial and refresher courses. Social workers and psychologists had at least 5 y of experience.

Home assignment was given to allow patients to practice skills in their daily lives

Not stated

Means of 14.3 sessions (maximum⫽20) for the cognitive behavioral therapy group and 11.9 sessions (maximum⫽19) for the combination group

Staal et al (2004)16 Hlobil et al (2005)98

1-h exercise session twice/wk until return to work or a maximum of 3 mo

Three therapists provided treatment according to a protocol. Therapists were trained before the study in three 2-h sessions and practiced patient-therapist interactions. Sessions before and after the study were audiotaped and analyzed for content.

Not stated

Not stated

Not stated

Study

Home Program

Plans for Future Relapse

Adherence

(Continued)

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Steenstra et al (2006)95 Anema et al (2007)96

26 sessions of 1 h (twice/wk) over 13 wk or until return to work

Physical therapists (47 in 16 centers) were trained by the physical therapist participating in the study of Staal et al.77 A protocol was used to standardize the intervention. Physical therapists had a 2-h feedback session every 3 mo.

Not stated

Not stated

35% of patients did not adhere to the treatment; average frequency was 14.1 sessions

van der Roer et al (2008)25

10 individual sessions and 20 group sessions

Physical therapists attended 2 intensive 6-h workshops and were trained according to the study protocol. Study forms were used to assess therapist adherence to the study protocol; 18% of patients did not receive adequate treatment.

Not stated

Not stated

Not stated

Vlaeyen et al (2002)97

3 wk of treatment

Not stated

Patients were given 1 wk to practice new skills in home situations after the end of the 3-wk treatment

Not stated

Not stated

Woods and Asmundson (2008)12

Eight 45-min sessions conducted on twiceweekly basis over 4 wk

Graded activity was conducted by a registered physical therapist, and graded exposure was conducted by a clinical psychologist graduate student trained in the therapy and supervised by a registered doctorallevel psychologist.

Not stated

Not stated

Not stated

Study

0.86). The median number of days to return to work was 139 days for the graded-activity group and 111 days for the usual-care group. Graded Activity Versus Other Forms of Exercise Six trials (597 patients) with a methodological quality ranging from 4 to 8 compared graded activity with other forms of exercise.11,14,15,22,25,26 Data for pooling were available for pain, disability, and perceived effect in the short, intermediate, and long term. Data were pooled by use of a fixed-effects model for all outcomes except perceived effect in the short June 2010

Plans for Future Relapse

Home Program

and intermediate term, for which a random-effects model was used. Pooled results revealed no statistically significant differences between graded activity and other forms of exercise for pain, disability, or global perceived effect at each time point (Fig. 3). A hazard ratio for the difference in days to return to work was calculated by Heymans et al26; the results revealed no significant differences between treatment groups (hazard ratio⫽1.4; 95% CI⫽1.0 to 1.9). The median number of days of sick leave was 85 days for the graded-activity

Adherence

group and 68 days for the exercise group. Graded Exposure Versus Graded Activity Two low-quality trials (PEDro scores of 3 and 4), with 6 patients each, compared graded activity with graded exposure.91,97 Both studies had a crossover design, making it more difficult to reach any conclusion about the results because no evaluation of carryover effects was performed. Another 2 studies12,90 had information that allowed pooling for pain and disability in the short term. These 2 trials had PEDro scores

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Figure 2. Forest plot of results of randomized controlled trials comparing graded activity with a control (minimal intervention). Values represent effect sizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of a fixed-effects model for all outcomes except pain and disability in the long term and perceived effect in the short term, for which a random-effects model was used.

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Figure 3. Forest plot of results of randomized controlled trials comparing graded activity with other forms of exercise. Values represent effect sizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of a fixed-effects model for all outcomes except perceived effect in the short and intermediate term, for which a random-effects model was used.

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Figure 4. Forest plot of results of randomized controlled trials comparing graded activity with graded exposure. Values represent effect sizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of a fixed-effects model.

of 5 and 6 and included 146 patients. The results of the pooled analysis revealed no statistically significant differences between treatment groups for pain and disability in the short term (Fig. 4). Graded Exposure Versus a Minimal Intervention Two trials (104 patients) (PEDro scores of 4 and 5) compared graded exposure with a minimal intervention (waiting list or usual care).12,94 Data for pooling were available for pain and disability in the short term. Pooled results revealed no statistically significant differences between treatment groups for pain in the short term (weighted mean differ-

ence on a scale of 0 –100⫽⫺3.7 points [95% CI⫽⫺12.3 to 4.9]) and disability in the short term (weighted mean difference on a scale of 0 –100⫽⫺3.5 points [95% CI⫽ ⫺19.4 to 12.3]) (Fig. 5). No data were available for quality of life or recurrence for any of the comparisons.

Discussion

Only 4 of the pooled effect sizes were statistically significant. These statistically significant results favored graded activity over a minimal intervention for pain and disability at short- and intermediate-term follow-up evaluations. However, the effect sizes were small, approximately 7 points on a 100-point scale; this finding may indicate that they are not clinically meaningful.

In this systematic review, we compared the effects of graded activity versus a minimal intervention, graded activity versus other forms of exercise, graded activity versus graded exposure, and graded exposure versus a minimal intervention for patients with persistent LBP.

Among the studies in which graded activity was compared with a minimal intervention, 2 trials had counterintuitive results: The minimal intervention provided better outcomes than graded activity.12,95 The study of Woods and Asmundson12 poten-

Figure 5. Forest plot of results of randomized controlled trials comparing graded exposure with a control (waiting list or usual care). Values represent effect sizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of a fixed-effects model for pain and a random-effects model for disability.

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Graded Activity and Graded Exposure for Low Back Pain tially provided biased estimates of treatment effects because of a lack of masking, failure to conceal allocation, and a loss to follow-up of approximately 50%. In contrast, the study of Steenstra et al95 seemed to be well conducted, and we are unable to explain why the results for pain and disability in the long term favored a minimal intervention over graded activity.

whether the interventions were properly administered. Additionally, it is uncertain whether 2 or 3 sessions of training provided the clinicians with sufficient skills to effectively implement the treatment protocols. There is some evidence that trained physical therapists lack the skills required to effectively implement a psychologically based intervention.100

The results of the 3 trials that measured return to work after graded activity versus a minimal intervention were conflicting. In 1 of these 3 trials,92 graded activity provided a faster return to work than a minimal intervention. In the second trial,26 there were no significant differences between treatment groups. In the third study,95 a minimal intervention provided a faster return to work than graded activity. The authors of the last study suggested that the longer delay in return to work for patients in the graded-activity group was attributable to a delay in the beginning of the treatment for this group. Despite the possible bias present in these studies, the results regarding return to work are inconclusive, and further research is needed.

One important feature of both treatments considered in this review is inclusion of a plan for managing relapses. This strategy not only helps patients deal with anxiety and fear about a flare-up but also may assist in maintaining the long-term effects of the intervention. Although none of the studies mentioned the use of this strategy, it is not clear whether it was omitted from the intervention or simply was not reported.

The results for comparisons of graded activity with other forms of exercise are in accordance with the recommendations of most clinical guidelines, which suggest that no form of exercise is more effective than another.99 However, Smeets et al84 did find that graded activity was more cost-effective than active physical treatment (exercises), drawing attention to the need for more costeffectiveness studies. In many cases, the interventions were implemented by trained physical therapists. Although adherence to the treatment protocols was assessed in 6 of the 15 studies, no results of this assessment were provided; therefore, it remains unclear June 2010

There are some limitations to the conclusions of this review. These include the low quality of the studies, primarily those evaluating graded exposure, the use of various types of outcomes, and differences in the implementation of the interventions. The small number of trials testing graded exposure is also an important limitation of this review. Some authors92,97 suggested that graded exposure may have larger effects than graded activity because the former intervention more specifically targets a patient’s fears; however, the small number of trials included in this review for this comparison does not allow a reliable conclusion to be drawn. Future research should focus on the conduct of higher-quality trials evaluating issues such as return to work and compensation and the conduct of cost-effectiveness studies. Additionally, trials including patients identified as having greater fear behaviors should be carried out because these patients may respond better to both graded activity and graded exposure interventions.97

Conclusion The results of this systematic review suggest that graded activity is slightly more effective than a minimal intervention but not more effective than other forms of exercise for pain, disability, and global perceived effect in the short and intermediate terms for patients with persistent nonspecific LBP. The results also suggest that graded exposure is no more effective than a minimal intervention or graded activity. Because of the poor reporting in many of the studies, it often was unclear precisely how the interventions were implemented. Additionally, the smaller number and lower quality of graded-exposure trials limits the conclusions that can be drawn regarding this intervention. Ms Macedo, Dr Smeets, Dr Maher, and Dr Latimer provided concept/idea/research design. All authors provided writing and data collection. Ms Macedo and Dr Smeets provided data analysis. Ms Macedo provided project management. Dr Smeets, Dr Maher, and Dr Latimer provided facilities/equipment. Dr Smeets provided institutional liaisons. Dr Smeets, Dr Maher, Dr Latimer, and Dr McAuley provided consultation (including review of manuscript before submission). The authors of this systematic review thank the authors of the retrieved trials who provided additional information or data from their trials. Ms Macedo holds a PhD scholarship jointly funded by the University of Sydney and the Australian Government. Dr Maher’s research fellowship is funded by Australia’s National Health and Medical Research Council, and Dr Latimer’s research fellowship is funded by the Australian Research Council. The results of this study were presented at the Australian Physiotherapy Association Conference; October 1–5, 2009; Sydney, Australia. This article was submitted September 14, 2009, and was accepted January 24, 2010. DOI: 10.2522/ptj.20090303

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Graded Activity and Graded Exposure for Low Back Pain References 1 Vlaeyen J, Linton S. Pain-related fear and its consequences in chronic musculoskeletal pain. In: Linton S, ed. New Avenues for the Prevention of Chronic Musculoskeletal Pain and Disability, Pain Research and Clinical Management. Amsterdam, the Netherlands: Elsevier; 2002:83–103. 2 Fordyce WE. Behavioral Methods for Chronic Pain and Illness. St Louis, MO: Mosby; 1976. 3 Asmundson GJG, Norton PJ, Norton GR. Beyond pain: the role of fear and avoidance in chronicity. Clin Psychol Rev. 1999;19:97–119. 4 Rossignol M, Arsenault B, Dionne C, et al. Clinic on Low-Back Pain in Interdisciplinary Practice (CLIP) Guidelines. Montreal, Quebec, Canada: Direction de Sante´ Publique, Agence de la Sante´ et des Services Sociaux de Montre´al; 2007. 5 Airaksinen O, Brox JI, Cedraschi C, et al. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006;15(suppl 2):S192– S300. 6 Ostelo RW, van Tulder MW, Vlaeyen JW, et al. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. 2005;1:CD002014. 7 Bombardier C, Van Tulder M, Pennick V, et al; Cochrane Back Group. About the Cochrane Collaboration (Cochrane Review Groups [CRGs]). 2008, issue 3. 8 Johnson RE, Jones GT, Wiles NJ, et al. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial [with consumer summary]. Spine. 2007;32:1578 –1585. 9 Turner JA. Comparison of group progressiverelaxation training and cognitive-behavioral group therapy for chronic low back pain. J Consult Clin Psychol. 1982;50:757–765. 10 von Korff M, Balderson BH, Saunders K, et al. A trial of an activating intervention for chronic back pain in primary care and physical therapy settings. Pain. 2005; 113:323–330. 11 Critchley DJ, Ratcliffe J, Noonan S, et al. Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation. Spine. 2007;32:1474 –1481. 12 Woods MP, Asmundson GJG. Evaluating the efficacy of graded in vivo exposure for the treatment of fear in patients with chronic back pain: a randomized controlled clinical trial. Pain. 2008;136:271– 280. 13 Turner JA, Clancy S, McQuade KJ, et al. Effectiveness of behavioral therapy for chronic low back pain: a component analysis. J Consult Clin Psychol. 1990;58: 573–579. 14 Nicholas MK, Wilson PH, Goyen J. Comparison of cognitive-behavioral group treatment and an alternative nonpsychological treatment for chronic low back pain. Pain. 1992;48:339 –347.

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15 Nicholas MK, Wilson PH, Goyen J. Operant-behavioural and cognitivebehavioural treatment for chronic low back pain. Behav Res Ther. 1991;29:225– 238. 16 Staal JB, Hlobil H, Twisk JW, et al. Graded activity for low back pain in occupational health care: a randomized, controlled trial. Ann Intern Med. 2004;140:77– 84. 17 Sanders SH. Operant conditioning with chronic pain: back to basics. In: Gatchel RJ, Turk DC, eds. Psychological Approaches to Pain Management: A Practitioner’s Handbook. New York, NY: The Guilford Press; 1996:112–130. 18 Vlaeyen JWS, de Jong J, Sieben JM, et al. Graded exposure in vivo for pain-related fear. In: Turk DC, Gatchel RJ, eds. Psychological Approaches to Pain Management: A Practitioner’s Handbook. 2nd ed. New York, NY: The Guilford Press; 2002:210 –233. 19 Vlaeyen JWS, de Jong J, Leeuw M, et al. Fear reduction in chronic pain: graded exposure in vivo with behavioural experiments. In: Asmundson GJ, Vlaeyen JWS, Crombez G, eds. Understanding and Treating Fear of Pain. New York, NY: Oxford University Press; 2004:313–343. 20 Sherrington C, Herbert RD, Maher CG, et al. PEDro: a database of randomized trials and systematic reviews in physiotherapy. Man Ther. 2000;5:223–226. 21 Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6 [updated September 2006]. In: The Cochrane Library, Issue 4, 2006. Chichester, UK: John Wiley & Sons, Ltd. 22 Smeets RJEM, Vlaeyen JWS, Hidding A, et al. Active rehabilitation for chronic low back pain: cognitive-behavioral, physical, or both? First direct posttreatment results from a randomized controlled trial. BMC Musculoskelet Disord. 2006;7:5. 23 Pengel LHM, Refshauge KM, Maher CG, et al. Physiotherapist-directed exercise, advice, or both for subacute low back pain: a randomized trial. Ann Intern Med. 2007;146:787–796. 24 Smeets RJEM, Vlaeyen JWS, Hidding A, et al. Chronic low back pain: physical training, graded activity with problem solving training, or both? The one-year post-treatment results of a randomized controlled trial. Pain. 2008;134: 263–276. 25 van der Roer N, van Tulder M, Barendse J, et al. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial. Eur Spine J. 2008;17:1193–1200. 26 Heymans MW, de Vet HC, Bongers PM, et al. The effectiveness of high-intensity versus low-intensity back schools in an occupational setting: a pragmatic randomized controlled trial. Spine. 2006;31: 1075–1082.

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27 Review Manager (RevMan) [computer program]. Version 5.0. Copenhagen, Denmark: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008. 28 Menzel NN, Robinson ME. Back pain in direct patient care providers: early intervention with cognitive behavioral therapy. Pain Manag Nurs. 2006;7:53– 63. 29 Alaranta H, Rytokoski U, Rissanen A, et al. Intensive physical and psychosocial training program for patients with chronic low back pain: a controlled clinical trial. Spine. 1994;19:1339 –1349. 30 Bendix T, Bendix A, Labriola M, et al. Functional restoration versus outpatient physical training in chronic low back pain: a randomized comparative study. Spine. 2000;25:2494 –2500. 31 Fairbank J, Frost H, Wilson-MacDonald J, et al. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC Spine Stabilisation Trial. BMJ. 2005;330:1233–1239. 32 Gohner W, Schlicht W. Preventing chronic back pain: evaluation of a theorybased cognitive-behavioural training programme for patients with subacute back pain. Patient Educ Couns. 2006;64: 87–95. 33 Harkapaa K, Jarvikoski A, Mellin G, et al. Health locus of control beliefs and psychological distress as predictors for treatment outcome in low-back pain patients: results of a 3-month follow-up of a controlled intervention study. Pain. 1991; 46:35– 41. 34 Jellema P, Van Der Roer N, Van Der Windt DAWM, et al. Low back pain in general practice: cost-effectiveness of a minimal psychosocial intervention versus usual care. Eur Spine J. 2007;16: 1812–1821. 35 Magnussen L, Rognsvag T, Tveito TH, et al. Effect of a brief cognitive training programme in patients with long-lasting back pain evaluated as unfit for surgery. J Health Psychol. 2005;10:233–243. 36 Jousset N, Fanello S, Bontoux L, et al. Effects of functional restoration versus 3 hours per week physical therapy: a randomized controlled study. Spine. 2004; 29:487– 493. 37 Keller A, Brox JI, Gunderson R, et al. Trunk muscle strength, cross-sectional area, and density in patients with chronic low back pain randomized to lumbar fusion or cognitive intervention and exercises. Spine. 2003;29:3– 8. 38 Jensen IB, Bergstrom G, Ljungquist T, et al. A 3-year follow-up of a multidisciplinary rehabilitation programme for back and neck pain. Pain. 2005;115: 273–283. 39 Jensen IB, Bergstrom G, Ljungquist T, et al. A randomized controlled component analysis of a behavioral medicine rehabilitation program for chronic spinal pain: are the effects dependent on gender? Pain. 2001;91:65–78.

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Graded Activity and Graded Exposure for Low Back Pain 40 Moore JE, Von Korff M, Cherkin D, et al. A randomized trial of a cognitivebehavioral program for enhancing back pain self care in a primary care setting. Pain. 2000;88:145–153. 41 Newton-John TR, Spence SH, Schotte D. Cognitive-behavioural therapy versus EMG biofeedback in the treatment of chronic low back pain. Behav Res Ther. 1995;33:691– 697. 42 Pfingsten M, Leibing E, Harter W, et al. Fear-avoidance behavior and anticipation of pain in patients with chronic low back pain: a randomized controlled study. Pain Med. 2001;2:259 –266. 43 Rasmussen-Barr E, Ang B, Arvidsson I, et al. Graded exercise for recurrent lowback pain: a randomized, controlled trial with 6-, 12-, and 36-month follow-ups. Spine. 2009;34:221–228. 44 Schweikert B, Jacobi E, Seitz R, et al. Effectiveness and cost-effectiveness of adding a cognitive behavioral treatment to the rehabilitation of chronic low back pain. J Rheumatol. 2006;33:2519 –2526. 45 Storheim K, Brox JI, Holm I, et al. Intensive group training versus cognitive intervention in sub-acute low back pain: short-term results of a single-blind randomized controlled trial. J Rehabil Med. 2003;35:132–140. 46 Strong J. Incorporating cognitivebehavioral therapy with occupational therapy: a comparative study with patients with low back pain. J Occup Rehabil. 1998;8:61–71. 47 Turner JA, Jensen MP. Efficacy of cognitive therapy for chronic low back pain. Pain. 1993;52:169 –177. 48 Jellema P, van der Windt DA, van der Horst HE, et al. Should treatment of (sub) acute low back pain be aimed at psychosocial prognostic factors? Cluster randomised clinical trial in general practice. BMJ. 2005;331:84. 49 Heinrich RL, Cohen MJ, Naliboff BD, et al. Comparing physical and behavior therapy for chronic low back pain on physical abilities, psychological distress, and patients’ perceptions. J Behav Med. 1985;8:61–78. 50 Haldorsen EMH, Kronholm K, Skouen JS, et al. Predictors for outcome of a multimodal cognitive behavioural treatment program for low back pain patients: a 12-month follow-up study. Eur J Pain. 1998;2:293–307. 51 Bendix AF, Bendix T, Vaegter K, et al. Multidisciplinary intensive treatment for chronic low back pain: a randomized, prospective study. Cleve Clin J Med. 1996;63: 62– 69. 52 Basler HD, Ja¨kle C, Kro ¨ ner-Herwig B. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Patient Educ Couns. 1997;31: 113–124. 53 Basler H-D, Rehfisch HP. Follow-up results of a cognitive-behavioural treatment for chronic pain in a primary care setting. Psychol Health. 1990;4:293–304.

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54 Turner JA, Clancy S. Comparison of operant behavioral and cognitive-behavioral group treatment for chronic low back pain. J Consult Clin Psychol. 1988;56: 261–266. 55 Cohen MJ, Heinrich RL, Naliboff BD, et al. Group outpatient physical and behavioral therapy for chronic low back pain. J Clin Psychol. 1983;39:326 –333. 56 Keller S, Ehrhardt-Schmelzer S, Herda C, et al. Multidisciplinary rehabilitation for chronic back pain in an outpatient setting: a controlled randomized trial. Eur J Pain. 1997;1:279 –292. 57 Klaber Moffet J, Torgerson D, Bell-Syer S, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs and preferences. BMJ. 1999;319:279 –283. 58 Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care—a randomized controlled trial. BMC Musculoskelet Disord. 2008;9:172. 59 Marhold C, Linton SJ, Melin L. A cognitive-behavioral return-to-work program: effects on pain patients with a history of long-term versus short-term sick leave. Pain. 2001;91:155–163. 60 Linton SJ, Andersson T. Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain. Spine. 2000;25:2825– 2831. 61 Linton SJ, Nordin E. A 5-year follow-up evaluation of the health and economic consequences of an early cognitive behavioral intervention for back pain: a randomized, controlled trial. Spine. 2006;31:853– 858. 62 Lofvander MB. Cognitive-behavioural treatment of chronic pain in primary care: a three-year follow-up. Eur J Gen Pract. 2002;8:151–158. 63 Bliokas VV, Cartmill TK, Nagy BJ. Does systematic graded exposure in vivo enhance outcomes in multidisciplinary chronic pain management groups? Clin J Pain. 2007;23: 361–374. 64 George SZ, Fritz JM, Bialosky JE, et al. The effect of a fear-avoidance-based physical therapy intervention for patients with acute low back pain: results of a randomized clinical trial. Spine. 2003;28:2551–2560. 65 George SZ, Zeppieri G Jr, Cere AL, et al. A randomized trial of behavioral physical therapy interventions for acute and subacute low back pain (NCT00373867). Pain. 2008;140:145–157. 66 Hay EM, Mullis R, Lewis M, et al. Comparison of physical treatments versus a brief pain-management programme for back pain in primary care: a randomised clinical trial in physiotherapy practice. Lancet. 2005;365:2024 –2030. 67 Lambeek LC, Anema JR, van Royen BJ, et al. Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study. BMC Public Health. 2007;7:254.

68 Boersma K, Linton S, Overmeer T, et al. Lowering fear-avoidance and enhancing function through exposure in vivo: a multiple baseline study across six patients with back pain. Pain. 2004;108: 8 –16. 69 Kole-Snijders AM, Vlaeyen JW, Goossens ME, et al. Chronic low-back pain: what does cognitive coping skills training add to operant behavioral treatment? Results of a randomized clinical trial. J Consult Clin Psychol. 1999;67:931–944. 70 Linton SJ, Overmeer T, Janson M, et al. Graded in vivo exposure treatment for fear-avoidance pain patients with functional disability: a case study. Cogn Behav Ther. 2002;31:49 –58. 71 Vlaeyen JWS, Haazen IWCJ, Schuerman JA, et al. Behavioural rehabilitation of chronic low back pain: comparison of an operant treatment, an operant-cognitive treatment and an operant-respondent treatment. Br J Clin Psychol. 1995;34: 95–118. 72 Jensen IB, Nygren A, Lundin A. Cognitive-behavioural treatment for workers with chronic spinal pain: a matched and controlled cohort study in Sweden. Occup Environ Med. 1994;51: 145–151. 73 Kernan T, Rainville J. Observed outcomes associated with a quota-based exercise approach on measures of kinesiophobia in patients with chronic low back pain. J Orthop Sports Phys Ther. 2007; 37:679 – 687. 74 Klinger R, Nutzinger D, Geissner E, et al. Follow-up results of an in patient behavioral pain treatment program. Zeitschrift fur Klinische Psychologie. 1999;28: 267–272. 75 Laborde JM. Cognitive-behavioral techniques in the treatment of chronic low back pain: preliminary results. J South Orthop Assoc. 1998;7:81– 85. 76 Nielson WR, Weir R. Biopsychosocial approaches to the treatment of chronic pain. Clin J Pain. 2001;17:S114 –S127. 77 Rose MJ, Reilly JP, Pennie B, et al. Chronic low back pain rehabilitation programs: a study of the optimum duration of treatment and a comparison of group and individual therapy. Spine. 1997; 22:2246 –2253. 78 Van den Hout JHC, Vlaeyen JWS, KoleSnijders AMJ, et al. Graded activity and problem solving therapy in sub-acute non-specific low back pain. Physiotherapy. 1998;84:167. 79 Woby SR, Watson PJ, Roach NK, Urmston M. Are changes in fear-avoidance beliefs, catastrophizing, and appraisals of control, predictive of changes in chronic low back pain and disability? Eur J Pain. 2004;8:201–210. 80 Vlaeyen JWS, de Jong JR, Onghena P, et al. Can pain related fear be reduced? The application of cognitive-behavioural exposure in vivo. Pain Res Manag. 2002; 7:144 –153.

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Graded Activity and Graded Exposure for Low Back Pain 81 Goossens ME, Rutten-van Molken MP, Kole-Snijders AM, et al. Health economic assessment of behavioural rehabilitation in chronic low back pain: a randomised clinical trial. Health Econ. 1998;7:39 –51. 82 George SZ, Fritz JM, Childs JD. Investigation of elevated fear-avoidance beliefs for patients with low back pain: a secondary analysis involving patients enrolled in physical therapy clinical trials. J Orthop Sports Phys Ther. 2008;38:50 –58. 83 Goossens MEJB, Vlaeyen JWS, Hidding A, et al. Treatment expectancy affects the outcome of cognitive-behavioral interventions in chronic pain. Clin J Pain. 2005;21:18 –26. 84 Smeets RJ, Severens JL, Beelen S, et al. More is not always better: costeffectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back pain. Eur J Pain. 2009;13:71– 81. 85 Smeets RJ, Vlaeyen JW, Kester AD, Knottnerus JA. Reduction of pain catastrophizing mediates the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. J Pain. 2006; 7:261–271. 86 Steenstra IA, Anema JR, Bongers PM, et al. A workplace intervention, graded activity, or both to prevent long-term sick leave for subacute back pain? A randomized controlled study. Nederlands Tijdschrift Voor Fysiotherapie. 2007; 117:207–215. 87 Hlobil H, Uegaki K, Staal JB, et al. Substantial sick-leave costs savings due to a graded activity intervention for workers with non-specific sub-acute low back pain. Eur Spine J. 2007;16:919 –924.

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88 Staal JB, Hlobil H, Koke AJA, et al. Graded activity for workers with low back pain: who benefits most and how does it work? Arthritis Rheum. 2008;59: 642– 649. 89 Van den Hout JHC, Vlaeyen JWS, Heuts PHTG, et al. Secondary prevention of work-related disability in nonspecific low back pain: does problem-solving therapy help? A randomized clinical trial. Clin J Pain. 2003;19:87–96. 90 Leeuw M, Goossens MEJB, van Breukelen GJP, et al. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008;138: 192–207. 91 de Jong JR, Vlaeyen JWS, Onghena P, et al. Fear of movement/(re)injury in chronic low back pain: education or exposure in vivo as mediator to fear reduction? Clin J Pain. 2005;21:9 –17; discussion 69 –72. 92 Lindstrom I, Ohlund C, Eek C, et al. Mobility, strength, and fitness after a graded activity program for patients with subacute low back pain: a randomized prospective clinical study with a behavioural therapy approach. Spine. 1992;17:641– 652. 93 Lindstrom I, Ohlund C, Eek C, et al. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992;72:279 –293. 94 Linton SJ, Boersma K, Jansson M, et al. A randomized controlled trial of exposure in vivo for patients with spinal pain reporting fear of work-related activities. Eur J Pain. 2008;12:722–730.

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95 Steenstra IA, Anema JR, Bongers PM, et al. The effectiveness of graded activity for low back pain in occupational healthcare. Occup Environ Med. 2006;63: 718 –725. 96 Anema JR, Steenstra IA, Bongers PM, et al. Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial. Spine. 2007;32: 291–298. 97 Vlaeyen JWS, de Jong J, Geilen M, et al. The treatment of fear of movement/ (re)injury in chronic low back pain: further evidence on the effectiveness of exposure in vivo. Clin J Pain. 2002;18:251– 261. 98 Hlobil H, Staal JB, Twisk J, et al. The effects of a graded activity intervention for low back pain in occupational health on sick leave, functional status and pain: 12month results of a randomized controlled trial. J Occup Rehabil. 2005;15:569 –580. 99 Koes BW, van Tulder MW, Ostelo R, et al. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine. 2001;26: 2504 –2513. 100 van der Windt D, Hay E, Jellema P, et al. Psychosocial interventions for low back pain in primary care: lessons learned from recent trials. Spine. 2008;33:81– 89.

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Graded Activity and Graded Exposure for Low Back Pain Appendix. Search Strategies

MEDLINE 1. randomized controlled trial/ 2. controlled clinical trial/ 3. randomized controlled trials.mp. 4. random allocation/ 5. random allocation.mp. 6. double-blind method/ 7. single-blind method/ 8. exp clinical trial/ 9. (clinic$ adj25 trial$).tw. 10. ((single$ or double$ or treble$ or triple$) adj (mask$ or blind$)).tw. 11. placebos/ 12. placebo$.tw. 13. random$.tw. 14. research design/ 15. (latin adj square).tw. 16. comparative study/ 17. exp evaluation studies/ 18. follow-up studies/ 19. (control$ or prospective$ or volunteer$).tw. 20. cross-over studies/ 21. or/1–20 22. animal/not human/ 23. 21 not 22 24. low back pain/ 25. low back pain.mp. 26. backache.mp. 27. lumbago.mp. 28. sciatica/ 29. sciatica.mp. 30. back pain/ 31. or/24 –30 32. 23 and 31 33. graded activity.mp. 34. graded exposure.mp. 35. behavioral therapy.mp. 36. behavior therapy/ 37. cognitive therapy/ 38. psychology/ 39. cognitive.mp. 40. gradual exercises.mp. 41. function.mp. 42. physical therapy modalities/ 43. or/33– 42 44. 32 and 43 PsychINFO 1. randomized controlled trial$.mp 2. random allocation.mp. 3. exp clinical trials/ 4. (clinic$ adj25 trial$).tw. 5. ((single$ or double$ or treble$ or triple$) adj (mask$ or blind$)).tw. (Continued)

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Graded Activity and Graded Exposure for Low Back Pain Appendix. Continued

6. placebo$.tw. 7. random$.tw. 8. research design/ 9. (latin adj square).tw. 10. (control$ or prospective$ or volunteer$).tw. 11. or/1–10 12. low back pain.mp 13. backache.mp 14. lumbago.mp 15. sciatica.mp 16. back pain/ 17. or/12–16 18. graded activity.mp 19. graded exposure.mp 20. behavioral therapy.mp 21. behavior therapy/ 22. cognitive therapy/ 23. cognitive.mp. 24. psychology/ 25. function.mp 26. or/18 –25 27. 11 and 17 and 26 EMBASE 1. randomized controlled trial/ 2. exp controlled clinical trial/ 3. randomized controlled trial$.mp 4. exp randomization/ 5. random allocation.mp. 6. double-blind procedure/ 7. single-blind procedure/ 8. clinical trial/ 9. (clinic$ adj25 trial$).tw. 10. ((single$ or double$ or treble$ or triple$) adj (mask$ or blind$)).tw. 11. exp placebo/ 12. placebo$.mp. 13. random$.mp 14. research design.mp 15. exp comparative study/ 16. exp evaluation/ 17. exp follow-up/ 18. (control$ or prospective$ or volunteer$).tw. 19. crossover procedure/ 20. or/1–19 21. animal/not human/ 22. 20 not 21 23. exp low back pain/ 24. low back pain.mp 25. exp backache/ 26. lumbago.mp 27. sciatica.mp 28. or/23–27 (Continued)

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29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40.

graded activity.mp graded exposure.mp behavioral therapy.mp exp behavior therapy/ exp cognitive therapy/ cognitive.mp. exp psychology/ gradual exercises.mp. function.mp physical therapy modalities.mp or/29 –38 22 and 28 and 39

CINAHL S1. (MH clinical trials⫹) or (MH Cochrane Library) or (MH random assignment) S2. (double blind) or (MH double-blind studies) or (MH single-blind studies) or (MH triple-blind studies) S3. (placebo) or (MH placebos) S4. randomized controlled trial S5. (MH crossover design) or (MH experimental studies⫹) S6. (MH comparative studies) or (MH experimental studies⫹) S7. S1 or S2 or S3 or S4 or S5 or S6 S8. (MH low back pain) or (MH back pain⫹) S9. (backache) or (MH back pain⫹) S10. low back pain S11. lumbago S12. (sciatica) or (MH sciatica) S13. S8 or S9 or S10 or S11 or S12 S14. graded activity S15. graded exposure S16. (behavioral therapy) or (MH behavior therapy⫹) S17. (cognitive therapy) or (MH cognitive therapy) or (MH cognitive therapy (Iowa NIC) (non-CINAHL)⫹) S18. (cognitive) or (MH rehabilitation, cognitive) S19. (MH rehabilitation, psychosocial⫹) S20. S14 or S15 or S16 or S17 or S18 or S19 S21. S7 and S13 and S20 PEDro Therapy: No selection Problem: pain Body Part: lumbar spine, sacro-iliac joint or pelvis Subdiscipline: No selection Method: clinical trial

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Research Report A Balance Exercise Program Appears to Improve Function for Patients With Total Knee Arthroplasty: A Randomized Clinical Trial S.R. Piva, PT, PhD, OCS, FAAOMPT, is Assistant Professor, Department of Physical Therapy, University of Pittsburgh, 6035 Forbes Tower, Pittsburgh, PA 15260 (USA). Address all correspondence to Dr Piva at: [email protected]. A.B. Gil, PT, MS, is a doctoral candidate in the Department of Physical Therapy, University of Pittsburgh. G.J.M. Almeida, PT, MS, is a doctoral student in the Department of Physical Therapy, University of Pittsburgh. A.M. DiGioia III, MD, is Clinical Associate Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, Magee-Women’s Hospital, Renaissance Orthopaedics, PC, Pittsburgh, Pennsylvania. T.J. Levison, MS, ATC, is Director of Quality Management and Clinical Outcomes, The Orthopaedic Program, Magee-Women’s Hospital of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. G.K. Fitzgerald, PT, PhD, OCS, FAPTA, is Associate Professor, Department of Physical Therapy, University of Pittsburgh. [Piva SR, Gil AB, Almeida GJM, et al. A balance exercise program appears to improve function for patients with total knee arthroplasty: a randomized clinical trial. Phys Ther. 2010;90:880 – 894.] © 2010 American Physical Therapy Association Post a Rapid Response to this article at: ptjournal.apta.org 880

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Sara R. Piva, Alexandra B. Gil, Gustavo J.M. Almeida, Anthony M. DiGioia III, Timothy J. Levison, G. Kelley Fitzgerald

Background. Patients with total knee arthroplasty (TKA) have impaired balance and movement control. Exercise interventions have not targeted these impairments in this population. Objectives. The purposes of this study were: (1) to determine the feasibility of applying a balance exercise program in patients with TKA, (2) to investigate whether a functional training (FT) program supplemented with a balance exercise program (FT⫹B program) could improve physical function compared with an FT program alone in a small group of individuals with TKA, and (3) to test the methods and calculate sample size for a future randomized trial with a larger study sample.

Design. This study was a double-blind, pilot randomized clinical trial. Setting. The study was conducted in the clinical laboratory of an academic center. Participants. The participants were 43 individuals (30 female, 13 male; mean age⫽68 years, SD⫽8) who underwent TKA 2 to 6 months prior to the study. Interventions. The interventions were 6 weeks (12 sessions) of a supervised FT or FT⫹B program, followed by a 4-month home exercise program. Measurements. Feasibility measures included pain, stiffness, adherence, and attrition. The primary outcome measure was a battery of physical performance tests: self-selected gait speed, chair rise test, and single-leg stance time. Secondary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index and the Lower Extremity Functional Scale. Results. Feasibility of the balance training in people with TKA was supported by high exercise adherence, a relatively low dropout rate, and no adverse events. Both groups demonstrated clinically important improvements in lower-extremity functional status. The degree of improvement seemed higher for gait speed, single-leg stance time, and stiffness in the FT⫹B group compared with the FT group.

Limitations. Due to the pilot nature of the study, differences between groups did not have adequate power to show statistical significance. Conclusions. There is a need for conducting a larger randomized controlled trial to test the effectiveness of an FT⫹B program after TKA.

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y the year 2020, it is estimated that more than 3 million total knee arthroplasty (TKA) surgeries will be performed in the United States for end-stage arthritis in the knee joint.1 Although there is a rapid and substantial improvement in knee pain after TKA, 37% of patients have limited functional improvement 1 year after the surgery.2 The most common limitations of these patients are diminished walking speed, difficulty ascending and descending stairs, and inability to return to sports played prior to the surgery.3–5 In light of these limitations, researchers are continually testing the benefits of exercise therapy to improve the outcomes of patients after TKA.

aments are retightened to restore the joint spaces deteriorated by the arthritis, in order to restore the intraarticular geometry, some of the knee ligaments are removed or released. These alterations may affect the function of several mechanoreceptors and impair movement control and balance.12 Several studies have identified deficits in components of the balance system, such as decreased ability to detect joint position and motion, delayed muscle latency, altered amplitude of muscle activity, and decreased postural control, in patients after TKA.12–19 Therefore, exercises aimed at improving the impaired movement control and balance of patients after TKA should be considered.

Studies that investigated the effectiveness of exercises after hospital discharge have used traditional exercise programs consisting of range of motion, stretching, strengthening, and endurance exercises and have shown a small beneficial effect on pain and function.6 –9 Some studies have tested the effectiveness of functional training (FT).6,10 Functional training programs consist of more dynamic exercises and require the performance of activities generally limited by patients with TKA, such as stair ascending and descending, walking, and chair stands.6,10 Although these trials have shown better outcomes for pain, physical function, and quality of life, the effects tend to fade at follow-ups longer than 3 to 4 months,11 suggesting that exercise programs could be refined to produce long-lasting functional improvements in these patients.

We are not aware of exercise interventions that attempted to specifically target patients’ deficits related to balance and movement control. Although the FT programs used so far require patients to perform functional activities such as chair rises, bilateral and unilateral knee flexion in standing, climbing stairs, and walking in place, these activities do not seem to fully challenge patients’ balance and movement control. To improve these deficits, exercises should expose patients to activities that challenge their stability and propose movement problems that mimic more skilled abilities of everyday life such as twisting, turning, sudden starts and stops, standing over unstable surfaces, walking while changing speed and direction, using narrow paths, overcoming obstacles, and so on. If patients improve their ability to maintain stability and solve more challenging movement problems, it could help to decrease further the functional limitations and increase their confidence to safely engage in a more physically active lifestyle, ultimately resulting in a longer-term benefit in individuals with TKA. Before a more challenging balance exercise program is recommended in patients with TKA, its fea-

In refining exercise therapy approaches, it is important to consider factors that may contribute to functional deficits of patients with TKA. One such factor may be impaired movement control and balance. Although during TKA surgery several tendons, capsule, and remaining ligJune 2010

sibility should be tested, including its safety and tolerability by these patients.20 If feasibility is demonstrated and the exercise program shows a beneficial effect, it will support the need for trials with larger sample sizes to test the effectiveness of the exercise program to return patients with TKA to higher levels of physical function. This study of a small sample of patients is the initial step toward that end. The aims of this pilot study were: (1) to determine the feasibility of applying a balance exercise program in patients with TKA, (2) to investigate whether an FT program supplemented with a balance exercise program (FT⫹B program) could improve physical function compared with an FT program alone in a small group of patients with TKA, and (3) to test the methods and calculate a sample size for a future randomized trial with a larger study sample to further the research agenda on improving functional outcome in patients with TKA.

Method Design Overview This study was a double-blind, pilot randomized clinical trial. Setting and Participants Study implementation took place from January 2007 to May 2008 in the Department of Physical Therapy at the University of Pittsburgh. Participants were recruited from one orthopedic surgeon. Patients who had a TKA performed in the previous

Available With This Article at ptjournal.apta.org • The Bottom Line Podcast • Audio Abstracts Podcast This article was published ahead of print on April 8, 2010, at ptjournal.apta.org

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Balance Exercise Program for Patients With Total Knee Arthroplasty months were mailed study information. Interested participants were screened for eligibility over the telephone. All participants gave written consent prior to the study. Patients were eligible if they were at least 50 years of age and had a unilateral TKA in the previous 2 to 6 months. A minimum of 2 months after TKA was specified to avoid knee pain, effusion, or limitations in motion restricting the implementation of the exercise programs. Individuals were excluded if they reported 2 or more falls within the previous year, were unable to ambulate a distance of 30.48 m (100 ft) without an assistive device or a rest period, had an acute illness or cardiovascular disease, had high blood pressure not controlled by medication, had severe visual impairment, had a lowerextremity amputation, had a progressive neurological disorder, or were pregnant. All participants underwent a tricompartmental, cemented TKA, using a minimally invasive technique, with a quadriceps muscle– sparing incision. The same surgeon

performed all surgeries. Participants received the same rehabilitation while in the hospital. After hospital discharge, participants received inpatient, home, or outpatient physical therapy, as needed. This information was not recorded because there is no evidence to support differential TKA outcomes across rehabilitation settings.8,9,21 Randomization and Interventions A statistician who was not aware of the study aims generated the randomization plan and added it into the computer program used for the paperless data collection in this study. A research assistant who was not involved with recruitment or testing performed the randomization after the baseline session. Participants were randomly assigned to receive either the FT program or the FT⫹B program. Participants were not aware of what type of exercises the other group received until the end of the study.

The Bottom Line What do we already know about this topic? Although exercise programs have been the mainstay of treatment for the functional deficits of patients after total knee arthroplasty (TKA), their effectiveness has been limited. To date, exercise programs have not targeted the deficits in balance and movement control of these patients.

What new information does this study offer? This small study demonstrated that exercise programs that target balance and movement control are safe, well tolerated, and appear to improve functional performance, stiffness, and pain of patients after TKA.

If you’re a patient, what might these findings mean for you? Exercises that challenge a patient’s balance may be beneficial. There is a need for conducting larger studies to confirm these results before incorporating these exercises into rehabilitation after TKA.

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Supervised exercise programs. During the trial, 5 physical therapists were involved in delivering the 12 sessions of supervised exercise over 6 weeks. Sessions were individualized. The FT program consisted of warm-up, strengthening exercises, functional task-oriented exercises, endurance exercises, and cool-down. It was based on the protocol published by Moffet and colleagues.10 The FT⫹B program included all of the above components plus balance exercises (agility and perturbation techniques) and was based on the protocol published by Fitzgerald and colleagues22 (Appendix). Home exercise programs. At the end of supervised program, participants were asked to continue exercising at home 2 times per week for 4 months. Adherence to the home exercise program was recorded in an exercise log. Participants were called once a month to encourage adherence. Outcomes and Follow-up Trained study personnel who were unaware of group assignment performed all outcome assessments. At the end of the trial, each tester was asked to guess group assignment. The testers correctly guessed group assignment 56% of the time, which is close to chance guessing and suggests appropriate masking. Outcome data were collected at baseline, after the completion of the supervised program (2 months), and at the completion of the 4-month home exercise program period (6 months after randomization). The 6-month follow-up was the endpoint of major interest. Feasibility was assessed by pain, stiffness, adherence to the supervised programs, adherence to the home exercises, attrition, and adverse events. Pain was measured in 2 ways. Pain during activities was measured by the 5-item Western Ontario and McJune 2010

Balance Exercise Program for Patients With Total Knee Arthroplasty Master Universities Osteoarthritis Index pain subscale (WOMAC-PN).23–25 Intensity of knee pain was measured using an 11-point numeric pain scale, which was anchored on the left with the phrase “no pain” and on the right with the phrase “worst imaginable pain.”26 –28 Although pain intensity was measured at all measurement points in the knee that had undergone surgery (surgical knee), it was measured only at 6 months in the knee that had not undergone surgery (nonsurgical knee). We did not collect data on pain in the nonsurgical knee prior to the 6-month point because this measure was proposed during a data safety meeting after starting study implementation. Stiffness was measured by the 2-item WOMAC stiffness subscale (WOMAC-ST).23–25 Adherence to the supervised programs was calculated as the number of exercise sessions performed over the 12 sessions prescribed. Adherence to the home exercises was calculated as the number of exercises performed over the number of exercises prescribed. Attrition was calculated as the number of participants at the end of the trial over the participants originally randomized to each group. As per the recommendation of experts in arthritis, lower-extremity functional status was measured with performance-based and self-report measures.29 Performance-based measures rather than self-report measures were chosen as the primary outcome measure because patients with TKA tend to self-report their outcome as good even when they experience difficulty performing daily tasks.30,31 Moreover, self-reports of physical function are more influenced by pain.32 We chose a battery of tests easily done in the clinical setting. The battery of tests included self-selected gait speed, a timed chair rise test, and single-leg stance time. Self-selected gait speed was measured by recording the time each June 2010

participant needed to pass 2 infrared beams 4 m apart, located in the central part of a longer path of 7 m to avoid measurement during gait acceleration or deceleration. Participants were timed twice, and the faster speed was recorded. For the timed chair rise test, participants were seated in a chair without armrests with their arms crossed over their chest. They were timed during 5 repetitions of rising to a full upright position and sitting back down in the chair without assistance. The single-leg stance test was a measure of balance that consisted of recording the length of time participants balanced on one leg while keeping their hands on their hips. The test lasted up to 30 seconds and was stopped if: (1) the swing leg touched the floor, (2) the tested foot displaced on the floor, (3) the swing lower leg touched the tested limb, or (4) the arms swung away from the hips. These tests cover important domains of lower-extremity physical function such as walking ability, dynamic and static balance, muscle strength and power, and movement control. They have been shown to be reliable and responsive to interventions and to have the ability to discriminate from low to high functional ability in individuals of various ages and functional levels.33–38 Secondary functional outcome measures were the condition-specific WOMAC physical function subscale (WOMAC-PF) and the region-specific Lower Extremity Functional Scale (LEFS). The WOMAC-PF has 17 items (each scored from 0 to 4), with a total score of up to 68 points. Larger scores indicate worse function. Evidence for the validity of the WOMAC is well established.23–25 The WOMAC version LK3.1 was used. The LEFS was used as a measure of lowerextremity function. The scale consists of 20 items (each scored from 0 to 4), with the total score ranging from 0 to 80 (larger scores indicate

better function). Reliability, validity, and responsiveness have been established for this measure.39 Data Analysis Because the goal of the study was parameter estimation rather than hypotheses testing, we calculated 95% confidence intervals (CIs) around our observed point estimates of effect. Baseline characteristics were compared by visual observation of the absolute differences between the 2 groups. Adherence and attrition rates were visually compared between the groups. Point estimates and 95% CIs were compared for changes in pain, stiffness, and physical function in the FT and FT⫹B groups at the 2- and 6-month time periods. As a measure of relative improvement, we calculated the percentage of change for each group at 2 and 6 months. To test whether the within-patient changes (within-group differences) were clinically important, we compared the minimal important difference (MID) of each outcome against either the 95% CI or the percentage changes. The MID for a scale is the smallest change score associated with a patient’s perception of an important change in health status.40 Differences were considered small but clinically important when the 95% CI around the estimated size of the within-group effect included the MID.41 The MIDs for the measures were obtained from the literature and were as follows: a difference of 0.05 m/s in self-selected gait speed,42 a difference of 9 points in WOMAC-PF scores,43 a difference of 9 points in LEFS scores,39 and a difference of 2 points in numeric pain rating scale scores.44 Between-group differences at 2 and 6 months were estimated by calculating the difference in mean change between the groups and their 95% CI.

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Balance Exercise Program for Patients With Total Knee Arthroplasty Baseline Comparisons Table 1 presents baseline participant characteristics for both treatment groups. Visual observation of the differences indicated that the groups were well matched for the majority of the variables. Participants in the FT⫹B group had slightly better function (3.9 points lower on the WOMAC-PF and 2.9 points higher on the LEFS) than participants in the FT group. These differences were likely not relevant, as they represent less than half of the MID for the WOMACPF and LEFS. For the performancebased measures, participants in the FT⫹B group balanced 4.7 seconds longer on the surgical leg and were 0.05 m/s slower than the FT group. Differences in single-leg stance and gait speed seemed clinically meaningful and supported accounting for baseline scores when observing the change in both groups. The baseline differences between the groups were taken into consideration by calculating the point estimates and 95% CI of change scores, rather than using the exit scores (follow-up).

Figure 1. Participant flow during the study.

The SPSS version 16.0* was used to compute point estimates and 95% CI. To estimate sample size, we used the mean difference between groups at 6 months and the standard deviation of such differences. Sample sizes were estimated using Sample Power 2.0.* Role of the Funding Source This study was funded by the Central Research Development Fund; the University of Pittsburgh Medical Center Health System Competitive Medical Research Fund; the Claude D. Pepper Older American Independence Center (P30-AG024827); the National Center for Research Resources, a component of the National Institutes of Health, and NIH Roadmap for Medical Research (KL2

RR024154-02); and the American College of Rheumatology Research and Education Foundation New Investigator Award. The funding sources played no role in the design, conduct, or reporting of the study. The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official view of the funding sources.

Results Of the 76 participants assessed for eligibility, 43 underwent baseline testing and randomization. From the 22 participants assigned to the FT group and the 21 participants assigned to the FT⫹B group, 17 and 18 participants, respectively, completed the study and were included in the analysis (Fig. 1).

* SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606.

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Feasibility Adherence to the supervised exercises was 100% in both groups. Adherence to the home exercise program was similar: the FT⫹B group performed a mean of 64% (SD⫽38%) of the prescribed exercises, whereas the FT group performed a mean of 67% (SD⫽21%) of the prescribed exercises. The between-group difference was 3% (95% CI⫽⫺24, 19). The overall attrition rate was 16%: 10% (2/21) in the FT⫹B group and 23% (5/22) in the FT group. There were no adverse events or clinical complications related to the study interventions. The balance exercise program did not exacerbate pain or stiffness (Tab. 2). The WOMAC-PN scores decreased similarly in both groups. In the FT⫹B group, pain intensity in the surgical knee decreased minimally at 2 months (0.72 points) and slightly more at 6 months (1.1 June 2010

Balance Exercise Program for Patients With Total Knee Arthroplasty points). For the FT group, knee pain increased slightly at 2 months and returned to baseline level at 6 months. Mean pain intensity in the nonsurgical knee at 6 months was similar in both groups (we did not collect these data at baseline and at 2 months). The WOMAC-ST scores decreased 35% in the FT⫹B group and 13% in the FT group.

Table 1. Baseline Demographic and History Characteristics and Measures of Physical Function and Feasibilitya FTⴙB Group (nⴝ18)

FT Group (nⴝ17)

67⫾6

70⫾10

13

12

5

5

White

16

17

Black

1

0

Variable Age (y) Sex, n Female Male Race/ethnicity, n

Primary and Secondary Outcomes Table 3 displays the changes in physical function. Within-group increases in self-selected gait speed seemed clinically important in the FT⫹B group. Differences between groups favored the FT⫹B group (betweengroup mean difference⫽0.10 m/s). Both groups had similar decreases in chair rise times (⬎20%). In the FT⫹B group, single-leg stance on the surgical side decreased minimally at 2 months (13%) and kept decreasing at 6 months (24%). For the FT group, single-leg stance on the surgical side decreased 26% at 2 months and returned to baseline level at 6 months. Between-group differences in singleleg stance on the surgical side at 6 months favored the FT⫹B group by 25%. The decrease in single-leg stance time on the nonsurgical side was clinically important only in the FT⫹B group (38% at 2 months and 34% at 6 months). Figure 2 shows that both groups had improved scores on the performance-based tests from the baseline to the 2 follow-ups. Participants in the FT⫹B group continued to improve from 2 to 6 months, whereas the participants in the FT group maintained the same scores or had worse scores on these measures. Participants in both groups had similar improvements in WOMAC-PF and LEFS scores at the 2- and 6-month follow-ups (Tab. 3 and Fig. 2).

Latino

1

0

Married, n

10

11

Live alone in household, n College degree, n Body mass index (kg/m2)

6

5

14

10

30⫾5

31⫾5

Time since surgery, n ⱖ2 mo, but ⬍3 mo

6

5

ⱖ3 mo, but ⬍4 mo

8

4

ⱖ4 mo, but ⬍5 mo

2

4

ⱖ5 mo, but ⬍6 mo

2

4

No. of physical therapy sessions since surgeryb

19⫾8

20⫾8

No. of comorbidities,c median (25th quartile – 75th quartile)

3 (2–5)

2 (1–4)

1.07⫾0.16

1.12⫾0.15

Performance-based physical function Self-selected gait speed (m/s) Timed chair raise (s)

15.6⫾8.3

15.9⫾9.2

Single-leg stance (s), surgical side

16.4⫾10.9

11.7⫾11.9

Single-leg-stance (s), nonsurgical side

11.0⫾10.0

11.0⫾10.8

Self-reported physical function WOMAC–PN (0–68)

16.1⫾6.9

20.0⫾8.3

LEFS (0–80)

51.8⫾6.2

48.90⫾10.8

5.3⫾2.5

5.1⫾2.5

Feasibility WOMAC–PN (0–20) Pain intensity, surgical knee (0–10)

2.4⫾1.9

1.6⫾1.4

WOMAC–ST (0–8)

3.1⫾0.9

3.0⫾1.1

a When not otherwise stated, data represent mean⫾SD. FT⫹B group received functional training supplemented with balance exercise program; FT group received functional training program only. WOMAC–PN and WOMAC–ST⫽Western Ontario and McMaster Universities Osteoarthritis Index pain and stiffness subscales, respectively. LEFS⫽Lower Extremity Functional Scale. b Includes all types of physical therapy sessions (inpatient, outpatient, home care, and transitional care). c Number of health problems, including high blood pressure; stroke; diabetes; blood disorder; cancer; depression; back pain; memory problems; hip fracture; and lung, stomach, kidney, liver, or heart disease.

Sample Size Estimations The sample size for future trials was estimated based on the 3 primary June 2010

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Balance Exercise Program for Patients With Total Knee Arthroplasty Table 2. Feasibility Variables: Within-Group Changes (Follow-up – Baseline) and Between-Group Changes (FT⫹B Group – FT Group) at 2 and 6 Months After Total Knee Arthroplastya Baseline to 2-Month Follow-up Within-Group Mean Change Score (95% CI)

Variable

Baseline to 2-Month Follow-up Percentage of Change

Baseline to 2-Month Follow-up Between-Group Mean Change Score (95% CI)

Baseline to 6-Month Follow-up Within-Group Mean Change Score (95% CI)

Baseline to 2-Month Follow-up Percentage of Change

⫺0.2 (⫺1.6, 1.2)

WOMAC–PN

0.0 (⫺1.8, 1.8)

FT⫹B group

⫺1.6 (⫺0.5, ⫺2.6)

⫺30

⫺1.9 (⫺0.6, ⫺3.3)

⫺38

FT group

⫺1.4 (⫺0.4, ⫺2.3)

⫺27

⫺1.9 (⫺0.6, ⫺3.3)

⫺39

⫺0.7 (⫺1.7, 0.3)

⫺29

⫺1.1 (⫺0.2, ⫺1.9)

⫺42

0.6 (⫺0.4, 1.7)

38

⫺1.4 (⫺2.8, 0.04)

Pain intensity, surgical knee FT⫹B group FT group

Baseline to 6-Month Follow-up Between-Group Mean Change Score (95% CI)

⫺1.1 (⫺2.4, 0.3)

0.0 (⫺1.1, 1.1)

0 ⫺0.2 (⫺1.2, 0.9)b

Pain intensity, nonsurgical knee c

FT⫹B group

1.3⫾1.3

FT group

1.5⫾1.8

c

⫺0.7 (⫺1.8, 0.2)

WOMAC–ST

⫺0.7 (⫺1.8, 0.4)

FT⫹B group

⫺1.1 (⫺1.9, ⫺0.4)

⫺35

⫺1.1 (⫺1.8, ⫺0.4)

⫺35

FT group

⫺0.4 (⫺1.0, 0.3)

⫺13

⫺0.4 (⫺1.3, 0.5)

⫺13

a

FT⫹B group received functional training supplemented with balance exercise program; FT group received functional training program only. WOMAC–PN and WOMAC–ST⫽Western Ontario and McMaster Universities Osteoarthritis Index pain and stiffness subscales, respectively. 95% CI⫽95% confidence interval. b Data are not between-group change; they are the difference in means at 6 months. c Data are not within-group change; they are 6-month mean⫾SD.

outcomes (gait speed, chair rise time, and single-leg stance time), pain, and stiffness. Using an alpha level of .01 to account for 5 comparisons and a 2-sample t test to compare the groups, 88 participants per study arm will provide: 96% power to detect a difference in gait speed of 0.10 m/s (SD⫽0.155); 3% power to detect a difference in chair rise time of 0.62 second (SD⫽6.28) (would need 2,400 participants per arm to have 80% power); 91% power for a difference in single-leg stance time in the surgical side of 4.74 second (SD⫽ 7.91); 80% power for a difference in pain intensity of 1.1 second (SD⫽ 2.02); and 98% power to detect a difference in stiffness of 0.70 points (SD⫽0.98). Thus, 88 participants per study arm will allow differences in self-selected gait speed, single-leg stance balance, pain, and stiffness to be detected, although the power will be too low to detect differences in chair rise time or patient-reported 886

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physical function. Power was estimated using the Sample Power 2.0 equation for 2 independent-samples t test.

Discussion This is the first study that demonstrated the feasibility and potential efficacy of combining FT with a balance exercise program in patients after TKA. The findings demonstrated potential clinically important benefits in walking speed, single-leg stance, stiffness, and pain intensity. The lack of adverse events, the high rate of adherence during the supervised and home programs, and the acceptable attrition rate underscore the need for further studies with larger samples sizes and longer follow-ups to draw more definitive conclusions about whether the FT⫹B program should be incorporated into clinical practice. Although the pilot nature of the study does not allow conclusions to

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be drawn, the mean difference between groups in self-selected gait speed at 6 months was 0.1 m/s (approximately 0.2 mph), which is considered substantial meaningful change.42 The change observed in self-selected gait speed in the FT⫹B group was larger than the changes reported in a meta-analysis that examined the effect of therapeutic exercise on changing self-selected gait speed in community-dwelling older adults.45 Results of the meta-analysis indicated that traditional exercise training resulted in an overall gait speed change of 0.01 m/s, whereas specific exercises, such as those of high-intensity and high-dosage exercise programs, yielded gait speed changes on the magnitude of 0.02 m/s.45 With regard to the single-leg stance test, participants in the FT⫹B group could balance an average of 4 seconds longer than the baseline measurement in each leg at the 6-month follow-up. The ability to balJune 2010

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FT group

FT⫹B group

LEFS

8.1 (3.7, 12.4)

10.4 (7.3, 13.6)

17

20

⫺36 ⫺26

⫺5.7 (⫺9.1, ⫺2.4) ⫺5.2 (⫺9.2, ⫺1.1)

14

FT⫹B group

1.6 (⫺5.4, 8.6)

38

26

3.1 (0.9, 5.3)

4.2 (⫺1.7, 10.1)

13

FT group

WOMAC–PF

Self-report measures

FT group

FT⫹B group

Single-leg stance, nonsurgical knee (s)

FT group

FT⫹B group

2.2 (⫺1.7, 6.1)

⫺4.0 (⫺7.5, ⫺0.5)

Single-leg stance, surgical knee (s)

⫺21 ⫺25

⫺3.4 (⫺6.1, ⫺0.6)

3

0.03 (⫺0.02, 0.09)

FT⫹B group

7

0.07 (0.01, 0.14)

FT group

Timed chair rise (s)

FT group

FT⫹B group

Self-selected gait speed (m/s)

Baseline to 2-Month Follow-up Percentage of Change

2.3 (⫺2.7, 7.5)

⫺0.5 (⫺5.6, 4.5)

2.6 (⫺6.0, 11.3)

⫺8.9 (⫺5.2, 3.5)

0.6 (⫺3.6, 4.9)

0.04 (⫺0.04, 0.12)

Baseline to 2-Month Follow-up Between-Group Mean Change Score (95% CI)

11.1 (6.4, 15.7)

13.2 (9.5, 16.9)

⫺8.1 (⫺12.6, ⫺3.6)

⫺5.2 (⫺8.4, ⫺1.9)

2.1 (⫺4.1, 8.2)

23

26

⫺40

⫺32

19

34

⫺6

⫺0.7 (⫺3.2, 1.8)

3.8 (⫺0.9, 8.5)

24

⫺25

4.0 (⫺1.4, 9.4)

⫺3.9 (⫺6.6, ⫺1.4)

⫺29

⫺1

⫺0.01 (⫺0.08, 0.06)

⫺4.6 (⫺8.3, ⫺1.0)

8

Baseline to 6-Month Follow-up Percentage of Change

0.09 (0.02, 0.17)

Baseline to 6-Month Follow-up Within-Group Mean Change Score (95% CI)

2.2 (⫺3.5, 7.8)

2.9 (⫺2.4, 8.2)

1.7 (⫺5.6, 9.1)

4.7 (⫺1.1, 10.6)

⫺0.6 (⫺5.0, 3.7)

0.10 (0.002, 0.20)

Baseline to 6-Month Follow-up Between-Group Mean Change Score (95% CI)

FT⫹B group received functional training supplemented with balance exercise program; FT group received functional training program only. WOMAC–PF⫽Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale, LEFS⫽Lower Extremity Functional Scale, 95% CI⫽95% confidence interval.

a

Variable

Performance-based measures

Baseline to 2-Month Follow-up Within-Group Mean Change Score (95% CI)

Physical Function Variables: Within-Group Changes (Follow-up – Baseline) and Between-Group Changes (FT⫹B Group – FT Group) at 2 and 6 Months After Total Knee Arthroplastya

Table 3.

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Figure 2. Lower-extremity functional status across time. Y axis represents outcome, and X axis represents time (1⫽baseline, 2⫽2-month follow-up, and 3⫽6-month follow-up). Solid and dashed lines represent the participants who received functional training supplemented with balance exercise program (FT⫹B group) and the participants who received functional training program only (FT group), respectively. WOMAC–PF⫽Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale, LEFS⫽Lower Extremity Functional Scale.

ance longer probably indicates improved balance and more confidence in the use of the surgical lower extremity and may have important clinical implications. If balancing longer associates with longer single-leg support time on the surgical side during gait, participation in the FT⫹B program may help decrease the gait asymmetry commonly reported after TKA,46 which ultimately may help protect the other weight-bearing joints. To our knowledge, we delivered the intervention later after surgery than any other study. We enrolled participants from 2 to 6 months after TKA. Thus, the 6-week exercise program was initiated from the 9th week after 888

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TKA (for the participants enrolled 2 months after TKA) to the 23th week after TKA (for the participants enrolled 6 months after TKA) and terminated 6 weeks later (14 –28 weeks after TKA). Thus, an interesting observation of the pilot study was that participants in the FT⫹B group continued to show improved functional performance from the 2-month followup to the 6-month follow-up (Fig. 2), a period in which previous studies have shown a plateau in functional improvement.6,10,47,48 Mizner et al49 described that functional plateau around 3 months after surgery. A meta-analysis on the effectiveness of exercise therapy after TKA concluded that most improvements in physical function take place within

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3 to 4 months postoperatively.11 Kennedy et al48 reported that the greatest improvement in functional status occurred in the first 3 months after TKA, some improvement occurred at a lower rate from 3 to 6 months, and almost no improvement occurred from 6 to 12 months. Thus, in future trials, if the FT⫹B program is demonstrated to be effective when implemented several months after surgery, a time when supervised exercises generally are no longer prescribed, it may serve as the first step to justify later implementation of exercise programs following TKA. The results of this pilot work seem to indicate that the patient-reported measures of function (WOMAC-PF June 2010

Balance Exercise Program for Patients With Total Knee Arthroplasty and LEFS) do not capture the same information as the performance-based measures. This observation seems to support the use of performancebased measures as primary outcome measures in future trials and is in agreement with previous literature in TKA suggesting that performancebased measures are more sensitive to change50 and less influenced by pain32 than self-reported measures. Moreover, scores obtained with patient-report and performance-based measures seem particularly divergent in patients with TKA.31,51 In a sample of patients tested before and 8 weeks after TKA, Parent and Moffet31 reported that WOMAC-PF scores improved after 8 weeks compared with the preoperative values, whereas performance-based scores became worse. Another study showed that within 16 days after TKA, WOMACPF scores did not change, whereas LEFS scores changed moderately (function worsened) and performancebased scores markedly worsened.51 A limitation of our study is that we cannot interpret the WOMAC-PN and WOMAC-ST scores as representing symptoms specific to the surgical side. Because we did not ask the participants to focus on a particular knee during completion of the questionnaire, the WOMAC-PN and WOMAC-ST scores may have been influenced by their perception of pain and stiffness in the nonsurgical knee. Another limitation is not having collected information about the severity of osteoarthritis in the nonsurgical knee. In a future trial with a larger sample size, we intend to collect information specifically about pain and stiffness in the nonsurgical knee, as well as ascertain the degree of nonsurgical knee osteoarthritis using radiography,52 to account for their potential effects on outcome. Some of the methods tested during the pilot work included feasibility of recruitment and appropriateness June 2010

of inclusion and exclusion criteria. Recruiting participants at least 2 months after TKA by mailing study information was shown not to be difficult. From the 250 individuals informed about the study, 30% (76/ 250) were willing to participate and were assessed for eligibility, and from this group, 56% (43/76) were found to be eligible and were randomly assigned to treatment groups. In addition, because we enrolled an average of 3 to 4 participants a month while recruiting from a single surgeon, it seems that timely recruitment in a trial with a larger sample can be achieved by extending recruitment to several surgeons. We noticed that the attrition rate could have been minimized if we had had more stringent exclusion criteria. For example, if we had excluded individuals with musculoskeletal conditions that affected lower-extremity function and those who were unable to bear weight on the surgical knee, the participants who were lost to follow-up due to spinal or hip surgery or to malingering would not have been included. In a future trial, we plan to have more thorough exclusion criteria to minimize attrition even further. A lesson learned during the implementation of the pilot study related to the choice of the primary outcome measure. When we originally designed the pilot study, we planned to use the Short Physical Performance Battery (SPPB) as the primary outcome measure. The SPPB has 3 components: self-selected gait speed during a 4-m walk, the Five-Times-Sitto-Stand Test, and standing balance. Each component is scored from 0 (not able) to 4 (good function) and summed for a total score ranging from 0 to 12. The SPPB was chosen due to its good validity as a measure of lower-extremity function in older adults.53,54 However, when testing started, we observed a ceiling effect in the SPPB scores. The first partici-

pants tested reached the maximum score of 4 on gait speed (gait speed of ⱖ0.83 m/s) and standing balance (held a tandem stance for 10 seconds). This observation made us change the primary outcome measure. For gait speed and the FiveTimes-Sit-to-Stand Test, we avoided a ceiling effect by recording the scores for speed (in meters per second) and time (in seconds) as continuous measures, rather than using a score ranging from 0 to 4. The tandem condition was replaced by a more challenging test of balance: the single-leg stance test.35 Therefore, the use of the SPPB and its scoring system does not seem appropriate for patients after TKA due to its potential ceiling effect (at the end of the baseline testing, 94% of the participants had a gait speed of ⱖ0.83 m/s, and 79% could hold the tandem stance for 10 seconds). In a future randomized trial, although we plan to administer the same 3 performance-based tests used in the pilot study, self-selected gait speed will be the primary outcome measure. The rationale is that gait speed has been shown to predict functional decline, nursing home placement, and mortality.33,55–58 Specifically, a decrease in gait speed of 0.1 m/s has been associated with a 10% decrease in the ability to perform instrumental activities of daily living.59 In older adults, slowed gait speed has been related to an increased risk for falls.60 – 62 Combining this information with the fact that a change in self-selected gait speed of 0.1 m/s is considered substantial meaningful change,42 in a future trial we may want to dichotomize the outcome measure to calculate the proportion of participants in each study arm who increase their gait speed above 0.1 m/s. If we do so, the sample size estimation also seems adequate. Based on the pilot study results that 50% (9/18) of participants in the FT⫹B group and 24% (4/17)

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Balance Exercise Program for Patients With Total Knee Arthroplasty of the participants in the FT group increased their gait speed above 0.1 m/s, if we use a chi-square test to compare proportions between groups, having 88 participants per study arm (␣⫽.01) will provide 81% power to detect clinically important between-group differences. Power was estimated using the Sample Power 2.0 equation to test proportions for 2 independent samples (chisquare test). An additional concern with the sample size estimation is accounting for the attrition rate. As we intend in a future trial to determine the longterm effectiveness of the FT⫹B program (24-month follow-up), we will need to estimate the long-term attrition rate. As we anticipate ⬵12% attrition at 6-month follow-up (lower than the attrition observed in the pilot work due to the more stringent exclusion criteria planned for a future trial) and we found patients with TKA to be committed study participants, we expect attrition to be 20% at 24 months. Consequently, we will need to randomize 114 participants per study arm to warrant 88 participants per group at the end of the trial. An additional limitation of this pilot study is that, although we theorized that the balance exercise program would increase participants’ confidence to safely engage in a more physically active lifestyle, we did not measure physical activity. Anecdotal observation during trial implementation supports the need to measure physical activity. We received thankyou notes from 4 participants in this study. Coincidently, all 4 individuals participated in the FT⫹B group. The common theme of these notes was the patient’s report of being much more active than prior to the exercise program. Lastly, although the performance-based tests used as the primary outcome measure cover important domains such as walking ability, balance, muscle power, and 890

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movement control, they may not be sufficiently sensitive to capture improvements due to challenging exercises that target balance and movement control. Future trials should include performance tasks with more skilled movement such as walking over obstacles and changing speeds and directions while walking.

tional Center for Research Resources, a component of the National Institutes of Health, and NIH Roadmap for Medical Research (KL2 RR024154-02); and the American College of Rheumatology Research and Education Foundation New Investigator Award.

Conclusions

References

The results of this pilot study indicated that the FT⫹B program is safe, is well tolerated, and has the potential to decrease functional limitations in patients with TKA. In future trials, we recommend that the exclusion criteria be more stringent to minimize attrition, that the signs and symptoms of the nonsurgical lower extremity be recorded and potentially controlled in the analyses, and that more challenging performancebased tasks be included to capture improvements in more skilled movements. A randomized trial with a larger sample size to test the effectiveness of the FT⫹B program to return patients with TKA to higher levels of physical function is warranted.

1 Kurtz SM, Ong KL, Schmier J, et al. Primary and revision arthroplasty surgery caseloads in the United States from 1990 to 2004. J Arthroplasty. 2009;24:195–203. 2 Franklin PD, Li W, Ayers DC. The Chitranjan Ranawat Award: functional outcome after total knee replacement varies with patient attributes. Clin Orthop Relat Res. 2008;466:2597–2604. 3 Bradbury N, Borton D, Spoo G, Cross MJ. Participation in sports after total knee replacement. Am J Sports Med. 1998;26: 530 –535. 4 Konig A, Walther M, Kirschner S, Gohlke F. Balance sheets of knee and functional scores 5 years after total knee arthroplasty for osteoarthritis: a source for patient information. J Arthroplasty. 2000;15:289 –294. 5 Walsh MB, Woodhouse LJ, Thomas SG, Finch E. Physical impairments and functional limitations: a comparison of individuals 1 year after total knee arthroplasty with control subjects. Phys Ther. 1998;78: 248 –258. 6 Frost H, Lamb SE, Robertson S. A randomized controlled trial of exercise to improve mobility and function after elective knee arthroplasty: feasibility, results and methodological difficulties. Clin Rehabil. 2002; 16:200 –209. 7 Shepperd S, Harwood D, Jenkinson C, et al. Randomised controlled trial comparing hospital at home care with inpatient hospital care, I: three month follow up of health outcomes. BMJ. 1998;316: 1786 –1791. 8 Kramer JF, Speechley M, Bourne R, et al. Comparison of clinic- and home-based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res. 2003; 410:225–234. 9 Walsh MB Herbold J. Outcome after rehabilitation for total joint replacement at IRF and SNF: a case-controlled comparison. Am J Phys Med Rehabil. 2006;85:1–5. 10 Moffet H, Collet JP, Shapiro SH, et al. Effectiveness of intensive rehabilitation on functional ability and quality of life after first total knee arthroplasty: a single-blind randomized controlled trial. Arch Phys Med Rehabil. 2004;85:546 –556. 11 Minns Lowe CJ, Barker KL, Dewey M, Sackley M. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and metaanalysis of randomised controlled trials. BMJ. 2007;335:812.

Dr Piva and Dr Fitzgerald provided concept/ idea/research design and fund procurement. Dr Piva provided writing. Ms Gil and Mr Almeida provided data collection and clerical support. Dr Fitzgerald provided data analysis. Ms Gil, Mr Almeida, and Mr Levison provided project management. Dr DiGioia and Mr Levison provided participants and facilities/equipment. Ms Gil, Dr DiGioia, Mr Levison, and Dr Fitzgerald provided institutional liaisons. All authors provided consultation (including review of manuscript before submission). This study was approved by the University of Pittsburgh Institutional Review Board. This research was presented at the Combined Sections Meeting of the American Physical Therapy Association; February 9 –12, 2009; Las Vegas, Nevada. This study was funded by the Central Research Development Fund; the University of Pittsburgh Medical Center Health System Competitive Medical Research Fund; the Claude D. Pepper Older American Independence Center (P30-AG024827); the Na-

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This article was received May 8, 2009, and was accepted February 6, 2010. DOI: 10.2522/ptj.20090150

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Balance Exercise Program for Patients With Total Knee Arthroplasty 12 Attfield SF, Wilton TJ, Pratt DJ, Sambatakakis A. Soft-tissue balance and recovery of proprioception after total knee replacement. J Bone Joint Surg Br. 1996;78: 540 –545. 13 Barrett DS, Cobb AG, Bentley G. Joint proprioception in normal, osteoarthritic and replaced knees. J Bone Joint Surg Br. 1991;73:53–56. 14 Swanik CB, Lephart SM, Rubash HE. Proprioception, kinesthesia, and balance after total knee arthroplasty with cruciateretaining and posterior stabilized prostheses. J Bone Joint Surg Am. 2004;86:328 – 334. 15 Viton JM, Atlani L, Mesure S, et al. Reorganization of equilibrium and movement control strategies after total knee arthroplasty. J Rehabil Med. 2002;34:12–19. 16 Wada M, Kawahara H, Shimada S, et al. Joint proprioception before and after total knee arthroplasty. Clin Orthop Relat Res. 2002;403:161–167. 17 Gage WH, Frank JS, Prentice SD, Stevenson P. Organization of postural responses following a rotational support surface perturbation, after TKA: sagittal plane rotations. Gait Posture. 2007;25:112–120. 18 Gage WH, Frank JS, Prentice SD, Stevenson P. Postural responses following a rotational support surface perturbation, following knee joint replacement: frontal plane rotations. Gait Posture. 2008;27: 286 –293. 19 Mandeville D, Osternig LR, Chou LS. The effect of total knee replacement surgery on gait stability. Gait Posture. 2008;27: 103–109. 20 Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10:307–312. 21 Rajan RA, Pack Y, Jackson H, et al. No need for outpatient physiotherapy following total knee arthroplasty: a randomized trial of 120 patients. Acta Orthop Scand. 2004;75:71–73. 22 Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002;82:372–382. 23 Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–1840. 24 Bellamy N, Kean WF, Buchanan WW, et al. Double blind randomized controlled trial of sodium meclofenamate (Meclomen) and diclofenac sodium (Voltaren): post validation reapplication of the WOMAC Osteoarthritis Index. J Rheumatol. 1992; 19:153–159. 25 Hawker G, Melfi C, Paul J, et al. Comparison of a generic (SF-36) and a diseasespecific (WOMAC) (Western Ontario and McMaster Universities Osteoarthritis Index) instrument in the measurement of outcomes after knee replacement surgery. J Rheumatol. 1995;22:1193–1196.

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26 Jensen MP, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity measurement? Pain. 1994; 58:387–392. 27 Marx RG, Jones EC, Allen AA, et al. Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001;83: 1459 –1469. 28 Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999;79:231–252. 29 Bellamy N, Kirwan J, Boers M, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis: consensus development at OMERACT III. J Rheumatol. 1997;24:799 – 802. 30 Woolhead GM, Donovan JL, Dieppe PA. Outcomes of total knee replacement: a qualitative study. Rheumatology (Oxford). 2005;44:1032–1037. 31 Parent E, Moffet H. Comparative responsiveness of locomotor tests and questionnaires used to follow early recovery after total knee arthroplasty. Arch Phys Med Rehabil. 2002;83:70 – 80. 32 Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006;86:1489 –1496. 33 Hardy SE, Perera S, Roumani YF, et al. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007;55:1727–1734. 34 Jette AM, Jette DU, Ng J, et al. Are performance-based measures sufficiently reliable for use in multicenter trials? J Gerontol A Biol Sci Med Sci. 1999;54:M3–M6. 35 Curb JD, Ceria-Ulep CD, Rodriguez BL, et al. Performance-based measures of physical function for high-function populations. J Am Geriatr Soc. 2006;54:737–742. 36 Cesari M, Kritchevsky SB, Newman AB, et al. Added value of physical performance measures in predicting adverse healthrelated events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009;57:251–259. 37 Simonsick EM, Newman AB, Nevitt MC, et al. Measuring higher level physical function in well-functioning older adults: expanding familiar approaches in the Health ABC study. J Gerontol A Biol Sci Med Sci. 2001;56:M644 –M649. 38 Seeman TE, Charpentier PA, Berkman LF, et al. Predicting changes in physical performance in a high-functioning elderly cohort: MacArthur studies of successful aging. J Gerontol. 1994;49:M97–M108. 39 Binkley JM, Stratford PW, Lott SA, Riddle DL; North American orthopaedic Rehabilitation Research Network. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. Phys Ther. 1999;79: 371–383. 40 Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407– 415.

41 Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996; 313:36 – 39; erratum in BMJ. 1996;313:550. 42 Perera S, Mody SH Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical perfomance measures in older adults. J Am Geriatr Soc. 2006;54:743–749. 43 Pua YH, Cowan SM, Wrigley TV, Bennell KL. The Lower Extremity Functional Scale could be an alternative to the Western Ontario and McMaster Universities Osteoarthritis Index physical function scale. J Clin Epidemiol. 2009;62:1103–1111. 44 Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine. 2005; 30:1331–1334. 45 Lopopolo RB, Greco M, Sullivan D, et al. Effect of therapeutic exercise on gait speed in community-dwelling elderly people: a meta-analysis. Phys Ther. 2006;86: 520 –540. 46 Andriacchi TP, Galante JO, Fermier RW. The influence of total knee-replacement design on walking and stair-climbing. J Bone Joint Surg Am. 1982;64:1328 –1335. 47 Kennedy DM, Stratford PW, Hanna SE, et al. Modeling early recovery of physical function following hip and knee arthroplasty. BMC Musculoskelet Disord. 2006; 7:100. 48 Kennedy DM, Stratford PW, Riddle DL, et al. Assessing recovery and establishing prognosis following total knee arthroplasty. Phys Ther. 2008;88:22–32. 49 Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005;35:424 – 436. 50 Stratford PW, Kennedy DM, Riddle DL. New study design evaluated the validity of measures to assess change after hip or knee arthroplasty. J Clin Epidemiol. 2009; 62:347–352. 51 Stratford PW, Kennedy DM. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol. 2006;59:160 –167. 52 Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494 –502. 53 Guralnik JM, Seeman TE, Tinetti ME, et al. Validation and use of performance measures of functioning in a non-disabled older population: MacArthur studies of successful aging. Aging (Milano). 1994;6: 410 – 419. 54 Guralnik JM, Ferrucci L, Pieper CF, et al. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000;55:M221–M231. 55 Brach JS, Vanswearingen JM, Newman AB, Kriska AM. Identifying early decline of physical function in community-dwelling older women: performance-based and self-report measures. Phys Ther. 2002;82: 320 –328.

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58 Spirduso WW, Cronin DL. Exercise doseresponse effects on quality of life and independent living in older adults. Med Sci Sports Exerc. 2001;33:S598 –S608. 59 Judge JO, Schechtman K, Cress E; the FICSIT (Frailty and Injury: Cooperative Studies of Intervention Trials) Group. The relationship between physical performance measures and independence in instrumental activities of daily living. J Am Geriatr Soc. 1996;44:1332–1341. 60 Daley MJ, Spinks WL. Exercise, mobility and aging. Sports Med. 2000;29:1–12.

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61 Rubenstein LZ, Powers CM, Maclean CH. Quality indicators for the management and prevention of falls and mobility problems in vulnerable elders. Ann Intern Med. 2001;135:686 – 693. 62 Sadeghi H, Prince F, Zabjek KF, et al. Knee flexors/extensors in gait of elderly and young able-bodied men (II). Knee. 2002;9:55– 63.

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Balance Exercise Program for Patients With Total Knee Arthroplasty Appendix. Exercise Therapy Proceduresa

Supervised Exercise Program Functional Training—Performed by Both Groups Exercise

Dose/Progressionb

Description

Ankle ROM

Patient in long-sitting position, performs ankle dorsiflexion and plantar flexion.

Progress from 10 to 20 repetitions.

Knee ROM

Patient in long-sitting position. Knee and hip of exercise leg flex as far as possible by sliding the foot toward the pelvis. Extension is done by sliding the foot back.

Posterior thigh and leg stretch

Patient in supine position. With help of a belt, patient flexes exercise hip as far as possible while keeping the knee in full extension and the ankle in dorsiflexion.

Stretching is held for 30 seconds, 5 repetitions.

Knee extension strengthening in sitting position

Patient is seated on a chair with the knee flexed. Elastic band is wrapped around patient’s ankle and leg of the chair. Patient pushes against elastic band as vigorously as possible. Exercise is performed from 90 degrees to 60 degrees or from 30 degrees to 0 degrees, depending on pain tolerance.

Each contraction is held for 3 seconds. Progress from 10 to 20 repetitions.

Knee extension strengthening in standing position

Patient is standing facing away from a door and resting the hands on the back of a chair for support. The hip and knee of exercise limb are slightly flexed, with one end of an elastic band secured to the ankle and the other end secured in a door jam. Patient fully extends the knee against the resistance of the elastic band as vigorously as possible without pain.

Knee flexion strengthening in standing position

Patient is standing facing a door, with one end of an elastic band secured to the ankle and the other end secured in a doorjamb. Patient flexes knee against the resistance of the elastic band as vigorously as possible without pain (up to 60° of flexion).

Hip abduction strengthening

Patient is in side-lying position with the back against a wall and the exercise hip up. Patient abducts the exercise hip ⬇30 degrees (2 seconds to lift and 3 seconds to come down). The heel of the exercise limb touches the wall throughout the exercise. Ankle cuff weights are used for resistance.

Progress from 10 to 20 repetitions. Progress cuff weights as tolerated.

Get up from a chair and sit back down

Patient is sitting in a chair with both feet flat on the floor and the hips flexed to 90 degrees. Patient stands up and then sits back in the chair (2 seconds to stand and 3 seconds to sit down). Patient initially uses chair armrests for assistance.

Progress from 10 to 20 repetitions. Progress by not using armrest.

Bilateral knee flexion/ extension in standing position

Patient is standing with feet together and hands holding on to a handrail. Patient slowly squats down until the knees bend ⬇90 degrees and then slowly returns to a standing position. Patient starts exercise while bearing moderate body weight on handrail.

Progress from 10 to 20 repetitions. Progress by only touching handrail for balance.

Unilateral knee flexion/ extension in standing position

Patient is standing over one foot and hands holding on to a handrail. Patient will slowly squat down until the knee bends ⬇90 degrees and then slowly return to a standing position. Patient starts exercise while bearing moderate body weight on handrail.

Ascend and descend stairs

Patient climbs up and down a flight of stairs.

Progress from 10 to 30 steps. Speed as tolerated.

Stationary cycling or treadmill walking

Patient selects stationary bicycle or treadmill walking. Activity is performed from 50% to 75% of the patient’s predicted heart rate. If patient has no preference, treadmill walking is the exercise of choice. For stationary bicycle, the seat height is adjusted so that the knee can fully extend on the down stroke of cycling.

Progress from 5 to 20 minutes. Speed as tolerated.

(Continued)

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Balance Exercise Program for Patients With Total Knee Arthroplasty Appendix. Continued Balance Exercises—Performed Only by FTⴙB Group Exercise

Description

Side stepping

Patient steps sideways, moving right to left and then left to right. Repeat 2 times in each direction. Progress by stepping over low obstacles.

Braiding activities

Patient alternates front and back crossover steps while moving laterally (walking carioca). Repeat 2 times in each direction.

Tandem walk

Patient tandem walks while alternating legs with each step. Repeat 2 times during forward ambulation and 2 times during backward ambulation. Progress by stepping over low obstacles.

Cross-over steps

Patient crosses one leg in front of the other leg, alternating legs with each step to a maximum of ⬇1-ft width. Repeat 2 times during forward ambulation and 2 times during backward ambulation.

Shuttle walking

Plastic pylon markers are placed at distances of 5, 10, and 15 ft. Patient walks forward to first marker, then returns to start by walking backward. Patient then walks forward to 10-ft marker, then returns to 5-ft marker walking backward. Patient then walks to 15-ft marker, returns to 10-ft marker walking backward, and then finishes by walking to 15-ft marker. Repeat 2 times.

Multiple changes in direction

Therapist directs the patient to either walk forward, backward, sideways, or on diagonal by cueing patient with hand signals. Changes in direction are cued randomly by the therapist. One bout of ⬇30 seconds.

Foam activity

Patient stands on a soft foam surface with both feet on the ground. Therapist attempts to perturb patient’s balance in random fashion. One bout of ⬇30 seconds.

Tilt board activity

Patient stands on a tilt board with both feet on the board. The therapist perturbs the tilt board in forward and backward and sideto-side directions for approximately 30 seconds each.

Roller board and platform perturbations

Patient stands with one limb on a stationary platform and the other leg on a roller board. Therapist perturbs roller board in multiple directions, at random, and the patient attempts to resist the perturbations. One bout of ⬇30 seconds. May begin with patient in a semi-seated position, with hips resting on plinth.

Dose/Progressionb Course length progressed from 10 to 20 ft.c Width and speed of steps progressed as tolerated.

Speed progressed as tolerated.

Progress to single-leg support or ball catching while standing on foam or tilt board.

Activity progresses to full standing position.

Home Exercise Program The home exercise program was essentially the same as the supervised exercise program, with some modifications for the home. The modifications were as follows: For the FT program: Stationary cycling or treadmill walking was replaced by walking outside. For the FTⴙB program: Participants in the FT⫹B group performed all standard home program activities. In addition, they performed all agility training, with the exception of the multiple changes in direction during walking on therapist command activity. They also did not perform tilt board and roller board activities. Foam activity was replaced by single-leg standing balance. a FT⫹B group received functional training supplemented with balance exercise program; FT group received functional training program only. ROM⫽range of motion. b Exercises were progressed if patient did not experience increased pain, effusion, giving away, and decreases in ROM. c 1 ft⫽0.3048 m.

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Research Report Effect of a Home Program of Hip Abductor Exercises on Knee Joint Loading, Strength, Function, and Pain in People With Knee Osteoarthritis: A Clinical Trial Elizabeth A. Sled, Latif Khoja, Kevin J. Deluzio, Sandra J. Olney, Elsie G. Culham

Background. Hip abductor muscle weakness may result in impaired frontal-plane pelvic control during gait, leading to greater medial compartment loading in people with knee osteoarthritis (OA). Objective. This study investigated the effect of an 8-week home strengthening program for the hip abductor muscles on knee joint loading (measured by the external knee adduction moment during gait), strength (force-generating capacity), and function and pain in individuals with medial knee OA.

Design. The study design was a nonequivalent, pretest-posttest, control group

E.A. Sled, PhD, MSc, BScPT, is Assistant Professor, School of Rehabilitation Therapy, Queen’s University, L.D. Acton Building, 31 George St, Kingston, Ontario, Canada K7L 3N6. Address all correspondence to Dr Sled at: [email protected]. L. Khoja, MSc, BScPT, is Physiotherapy Resident, Limestone Health Consultants Inc, Kingston, Ontario, Canada. K.J. Deluzio, PhD, MSc, BSc, is Associate Professor, Department of Mechanical and Materials Engineering, Queen’s University.

design.

Setting. Testing was conducted in a motor performance laboratory. Patients. An a priori sample size calculation was performed. Forty participants with knee OA were matched for age and sex with a control group of participants without knee OA.

Intervention. Participants with knee OA completed a home hip abductor strengthening program. Measurements. Three-dimensional gait analysis was performed to obtain peak knee adduction moments in the first 50% of the stance phase. Isokinetic concentric strength of the hip abductor muscles was measured using an isokinetic dynamometer. The Five-Times-Sit-to-Stand Test was used to evaluate functional performance. Knee pain was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Results. Following the intervention, the OA group demonstrated significant improvement in hip abductor strength, but not in the knee adduction moment. Functional performance on the sit-to-stand test improved in the OA group compared with the control group. The OA group reported decreased knee pain after the intervention.

S.J. Olney, PhD, BSc(PT&OT), is Professor Emeritus, Queen’s University, and Certified Executive Coach, School of Rehabilitation Therapy, Queen’s University. E.G. Culham, PhD, MClSc, DipPT, is Professor and Director, School of Rehabilitation Therapy, and Associate Dean of Health Sciences, Queen’s University. [Sled EA, Khoja L, Deluzio KJ, et al. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010;90:895–904.] © 2010 American Physical Therapy Association

Limitations. Gait strategies that may have affected the knee adduction moment, including lateral trunk lean, were not evaluated in this study.

Conclusions. Hip abductor strengthening did not reduce knee joint loading but did improve function and reduce pain in a group with medial knee OA. June 2010

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xcessive knee joint loading has been shown to contribute to progression of knee osteoarthritis (OA).1 Knee joint loading during walking may be estimated by the external knee adduction moment,2– 4 which provides a valid, indirect measure of the magnitude of dynamic load on the medial compartment.3,5–7 Higher knee adduction moments have been reported in people with medial knee OA compared with participants without knee OA matched for age, sex, height, and weight.8 –11 The knee adduction moment has been shown to relate to radiographic disease severity,4,6,10 –12 varus alignment,1,6,8,13 and knee pain.1,8,14,15 It has been suggested that gait strategies and interventions focused on decreasing the knee adduction moment during gait may be effective for reducing load through the medial compartment.16 Increased toe-out angle8,17–19 and trunk lean toward the stance limb20 are 2 gait strategies adopted by individuals with knee OA that have been shown to reduce the knee adduction moment. The hip abductor muscles also may influence knee joint loading through their control of the pelvis in the frontal plane.11,21 Researchers have proposed that during the single-limb stance phase of gait, weakness of the stance-limb hip abductor muscles may lead to drop of the pelvis toward the contralateral limb, shifting the body’s center of mass away from

Available With This Article at ptjournal.apta.org • The Bottom Line Podcast • Audio Abstracts Podcast This article was published ahead of print on April 8, 2010, at ptjournal.apta.org.

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the stance limb toward the swing side.11,21 These adjustments, theoretically, could lead to higher knee adduction moments and greater medial knee joint loading. Thus, increasing the strength (force-generating capacity) of the hip abductor muscles and controlling the pelvis in the frontal plane might reduce joint loading and have a disease-modifying effect.11,21 To our knowledge, an investigation of strengthening exercises targeting the hip abductor muscles as an intervention to reduce knee joint loading in people with knee OA has not been performed. Thus, the purpose of our study was to examine the influence of an 8-week home strengthening program for the hip abductor muscles on hip strength and the knee adduction moment in people with medial compartment knee OA. Given the functional importance of the hip abductor muscles, secondary objectives were to determine whether hip abductor strengthening would improve physical function and knee symptoms in this sample of people with knee OA. We hypothesized that, following the exercise program, participants with medial knee OA would demonstrate greater strength of the hip abductor muscles, a reduction in the knee adduction moment during gait, and improved physical functioning and decreased knee pain compared with a matched group of asymptomatic participants.

Method Design Overview The design of the study was a nonequivalent, pretest-posttest, control group design. A design incorporating participants with knee OA and a control group of individuals who were healthy was selected because few studies have compared the strength of the hip abductor muscles between these groups.

Setting and Participants All testing was conducted in the Motor Performance Laboratory at Queen’s University, Kingston, Ontario, Canada, with the exception of knee radiographs, which were completed in the Radiology Department at Kingston General Hospital. Testing sessions lasted approximately 2 to 2.5 hours. All individuals gave informed consent before participating. Forty individuals with medial knee OA were recruited through newspaper advertisements and from the practices of orthopedic surgeons in Kingston, Ontario. Potential participants were included in the study if they met all of the following criteria22,23: age greater than 40 years, self-reported knee pain for most days of the month, physician diagnosis of knee OA, and radiographic evidence of medial compartment knee OA or evidence of cartilage loss in the medial compartment by arthroscopy or magnetic resonance imaging. For those participants with bilateral medial compartment OA, the more affected side (as identified by radiographic OA grade and symptoms) was selected as the test leg. Participants were excluded if they had any of the following: intraarticular corticosteroid or viscosupplementation injection into either knee within the previous 3 months, significant comorbidities, or a history of other medical conditions affecting the knee joint.24 Individuals with known hip OA, previous trauma affecting one or both hips, or previous replacement of any joint in the lower extremities also were excluded from the study. Finally, those who were receiving rehabilitation services for knee OA or performing a hip strengthening program at the time of testing were not eligible to participate. Participants with knee OA were matched by age (⫾5 years) and sex

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Home Program of Hip Abductor Exercises with a control group of individuals with no clinical diagnosis of knee OA, hip OA, or rheumatoid arthritis and no reports of hip or knee pain or previous trauma. Participants in the control group were recruited through newspaper advertisements and posters displayed in senior centers in the Kingston area. An estimate of sample size was obtained from 2 calculations (2-tailed test, power⫽80%, and significance level⫽.05) and 10% loss to attrition. All of the following values are mean (⫾SD). A within-group calculation used data from tests of isometric hip abductor strength before and after an exercise program (mean difference⫽16.42%⫾22.82%) in individuals with OA and lower-extremity functional impairment.25 A betweengroup calculation also was computed using knee adduction moment data from a group of older adults with knee OA (0.25⫾0.06 N·m/kg) and a matched, asymptomatic group (0.33⫾0.06 N·m/kg).26 Based on these 2 power calculations, at least 35 participants per group were needed for the study. Intervention All participants with knee OA were taught a home strengthening program for the hip abductor muscles by a physical therapist (E.A.S.). An exercise instruction booklet and graded resistance elastic bands were supplied to the participants. Individuals were instructed in the following program: side-lying resistive exercises for the hip abductor muscles, progressing to using resistance bands positioned around the distal thighs; standing single-leg stabilization exercises, progressing to standing hip abduction using resistance bands placed just proximal to the ankles; and single-leg standing exercise off the side of a 10-cm step (beginning with the free limb lower than the level of the step, participants contracted the stance-limb hip June 2010

abductor muscles and raised the free leg to step level while keeping the stance knee extended). Participants were instructed to perform the exercise program 3 to 4 times per week for 8 weeks, completing one set of each exercise to fatigue. All exercises were performed for both legs. Progression to greater resistance levels occurred when participants could perform the exercise without fatigue for 20 repetitions. Participants completed weekly exercise calendars in which they recorded the frequency and resistance levels of the exercises. Over the 8-week period, the physical therapist arranged 2 follow-up visits with each participant in the laboratory or the participant’s home to ensure that he or she was performing the exercises correctly and to progress resistance levels. The therapist provided telephone follow-up support every 2 weeks, and participants were encouraged to call with any questions or concerns. Participants in the control group were instructed to continue their daily activities and refrain from beginning any new exercise program over the 8-week period.

Outcomes and Follow-up Knee alignment and OA grading. In situations where participants had recent weight-bearing knee radiographs (within 6 months of the testing date), permission was requested to obtain digital images of these radiographs. For all other participants, bilateral knee radiographs in weightbearing anterior-posterior views were obtained on the initial visit, according to the hospital’s standardized protocol. Digital images of the radiographs were received from the Radiology Department on anonymous compact discs with only the subject code to identify the participant. Frontal-plane knee alignment was measured from the digital images by means of a computer software program (Horizon Image Viewer, version 1.5*), which incorporates electronic tools to define femoral and tibial bone landmarks on the digital images.27,28 An investigator (E.A.S.) trained in application of the software program completed all alignment * OAISYS Medical Inc, 797 Princess St, Suite 404, Kingston, Ontario, Canada K7L 1G1.

The Bottom Line What do we already know about this topic? Higher external knee adduction moments during gait have been shown to contribute to the progression of knee osteoarthritis. Different interventions have been tested for their potential to decrease the knee adduction moment.

What new information does this study offer? Hip abductor muscle strengthening did not influence the knee adduction moment in 40 participants with knee osteoarthritis. However, participants demonstrated improvements in function and knee symptoms.

If you’re a patient, what might these findings mean for you? Hip abductor muscle strengthening may be beneficial for increasing function and decreasing pain in individuals with knee osteoarthritis.

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Home Program of Hip Abductor Exercises measurements. As the images were of the knee joint only and not fulllimb radiographs, an estimate of mechanical axis alignment (depicted as the hip-knee-ankle [HKA] angle) was obtained from the angle formed by the intersection of femoral and tibial anatomic (shaft) axes.29,30 The femoral mechanical axis was shown to be offset from the femoral anatomic axis by 4 to 5 degrees.29,31,32 Thus, an estimate of mechanical axis alignment was derived by subtracting 5 degrees from the anatomic axis angle. Offset-corrected anatomic axis measurement from knee radiographs is considered a valid, cost-effective alternative to alignment measures from full-limb radiography.31–33 Radiographs were graded for disease severity using the Kellgren-Lawrence scale34,35 by investigators (E.A.S. and T.D.V.C) who were experienced in reading knee radiographs. Disease severity was graded as follows: 0⫽no radiographic OA findings, 1⫽questionable (doubtful joint space narrowing, possible osteophyte lipping), 2⫽mild (definite osteophytes, possible joint space narrowing), 3⫽moderate (multiple moderate osteophytes, definite joint space narrowing, some bony sclerosis, possible deformity of bone ends), and 4⫽severe (large osteophytes, marked joint space narrowing, severe bony sclerosis, definite deformity of bone ends).35,36 Gait analysis. Testing in the Motor Performance Laboratory began with an evaluation of the participants’ level walking on an 8-m-long walkway (E.A.S. and L.K.). Threedimensional kinematic data (sampled at 100 Hz) were collected using 2 Optotrak 3020 optoelectronic motion tracking cameras† placed on either side of the walkway. Two AMTI

†

Northern Digital Inc, 103 Randall Dr, Waterloo, Ontario, Canada N2V 1C5.

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forceplates‡ embedded in the center of the walkway collected ground reaction force data at a sampling frequency of 200 Hz. Participants dressed in shorts and a loose-fitting shirt and the same pair of walking shoes was worn at both sessions. Rigid clusters containing infrared light-emitting diodes (IREDs) were positioned on the dorsum of the foot (over the metatarsal area), lateral shank, lateral thigh, and sacrum to track movements of the limbs.37 The clusters were secured with Velcro straps§ to avoid movement of the IRED markers during the walking trials. Participants walked at their self-selected normal gait speed, and 5 good walking trials were obtained. Trials were considered successful if participants landed with one foot on each forceplate and all IREDs were visible by the cameras. Raw motion and forceplate data were filtered with a dual-pass Butterworth low-pass filter at a cutoff frequency of 6 Hz.

gram㛳 incorporated forceplate and Optotrak motion data, landmarking reference trials, and anthropometric parameters in order to calculate knee moments during the stance phase. Net external knee adduction moment data from the 5 walking trials were exported from the visual 3-D motion analysis software program to a Microsoft Excel (Microsoft Office 3000#) worksheet. The stance phase of the test leg was divided into 100 points representing 100% of stance, and an average moment waveform was obtained for each participant. Peak knee adduction moment values in the first 50% of the stance phase were selected as the highest peak that was preceded by at least 5 continuously ascending values and followed by at least 5 continuously descending values.20 Peak moments were normalized to body weight and height (expressed as %BW⫻Ht) to allow for comparison between participants.

Following the gait trials, participants stood in view of the cameras, and a series of reference trials were captured using a pointed probe fitted with 4 IRED markers. The tip of the probe was placed on specific bone landmarks to identify the location of the landmarks in relation to the clusters and to approximate joint centers. Ankle and knee joint centers were calculated as midpoints between the malleoli and femoral epicondyles, respectively. The hip joint center was calculated as a point located at 25% of the distance between the 2 greater trochanter landmarks to the left or right, depending on the test limb.38 Using an inverse dynamics approach, a visual 3-dimensional (3-D) motion analysis software pro-

During the 2 testing sessions, gait speed was controlled by verifying that each participant’s gait speed on final testing was within ⫾15% of their initial (baseline) gait speed. This step was to control for gait speed as a potential confounding factor that could influence the knee adduction moment10 in addition to the intervention. For 2 participants only, it was necessary to repeat final walking trials at a faster or slower speed to match their initial gait speed.

‡

㛳

Advanced Mechanical Technology Inc, 176 Waltham St, Watertown, MA 02472-4800. § Velcro USA Inc, PO Box 5218, 406 Brown Ave, Manchester, NH 03103.

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Measurement of hip muscle strength. Isokinetic concentric strength of the hip abductor muscles was measured in a standing position using the Biodex System 3 isoki-

C-Motion Inc, 20030 Century Blvd, Suite 104A, Germantown, MD 20874-1111. # Microsoft Corp, One Microsoft Way, Redmond, WA 98052-7329.

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Home Program of Hip Abductor Exercises netic dynamometer,** following hip strength testing protocols in the literature.39,40 High test-retest intraclass correlation coefficients of .96 have been reported for standing isokinetic concentric tests of hip abduction.39 Participants stood with their posterior trunk supported by a pillow placed against the back of the dynamometer chair. The trunk and pelvis were stabilized using Velcro straps. The axis of rotation of the dynamometer was aligned with the participant’s anterior superior iliac spine, and the dynamometer pad was secured snugly with a Velcro strap around the lower thigh just proximal to the knee. Hip abduction range of motion was set from 0 degrees to approximately 30 degrees, and concentric hip abductor muscle strength was measured at an angular velocity of 60°/s. Participants completed a practice set of 3 submaximal concentric hip abduction repetitions prior to each test to ensure familiarization with the test procedures. This practice set was followed by 5 consecutive repetitions of maximal concentric hip abduction, with verbal encouragement provided to facilitate maximum effort. Data were sampled at 100 Hz. The data from the first repetitions were omitted, and the last 4 of 5 peak torque values from each test were averaged to obtain mean peak hip abductor torques.41 Data processing was performed using a MATLAB software program,†† which filtered the torque data with a 6-Hz low-pass filter (Butterworth, sixth order). Mean peak torque values were normalized to body weight (expressed as newton-meters per kilogram) for comparisons between groups.

** Biodex Medical Systems Inc, 20 Ramsay Rd, Shirley, NY 11967-4704. †† The MathWorks Inc, 3 Apple Hill Dr, Natick, MA 01760-2098.

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Assessment of knee symptoms, physical function, and activity level. Knee symptoms and perceived disability experienced due to OA were assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a disease-specific, self-administered questionnaire given in a Likert scale format.42 The reliability, validity, and responsiveness of WOMAC scores have been well established in individuals with knee OA.42,43 The WOMAC consists of 24 questions, probing the dimensions of pain (5 questions), joint stiffness (2 questions), and physical functioning (17 questions). A standard scoring system was used in which responses for each subscale were rated from 0 to 4, with 4 representing extreme pain, stiffness, or difficulty functioning. Scores then were summed to produce a total score for each of the 3 subscales.42 The Five-Times-Sit-to-Stand Test (FTSST) was used as a clinical measure of lower-extremity physical function.44 This test measures the time required to rise from a chair and sit down for 5 repetitions. Test-retest reliability of FTSST measurements has been established in communitydwelling older adults,45– 47 and the correlation of FTSST scores with walking performance, lowerextremity muscle strength, and selfreported physical functioning provides evidence for the validity of the test.45,48 Participants sat on an armless chair (43-cm height, 47.5-cm depth) with their arms across their chest and their back resting against the chair initially. They were instructed to stand up fully on each repetition and not to touch the back of the chair during the sitting phase of the repetitions.49 The test was finished when participants returned to sitting after the fifth stand. Participants also completed the Physical Activity Scale for the Elderly

(PASE), a self-report measure designed to assess occupational, household, and leisure activities performed by older adults.50 Construct and convergent validity of the PASE have been established in communitydwelling older adults with knee pain and physical disability.51 Physical Activity Scale for the Elderly scores have demonstrated good test-retest reliability (r⫽.75) in 254 communitydwelling older adults.50 Respondents were asked to record the frequency for 12 types of activities over the previous week. A total PASE score for each participant was computed by multiplying weighted values for each activity with the activity frequency per week and then summing the products for all 12 activities.52 Higher PASE scores indicate greater levels of physical activity.52 At the end of the 8 weeks, both groups returned to the laboratory for a repeat of the gait and strength measures and questionnaire completion. Data Analysis Independent t tests were used to assess for significant baseline differences in demographic and clinical characteristics between the OA and control groups. Repeated-measures analysis of variance calculations determined the main effects and interactions of group and time for all outcome measures. Statistical analysis was performed using SPSS software (version 15.0.1),‡‡ and the significance level was set at P⬍.05. Role of the Funding Source This study was supported by a Bickell Foundation of Canada Medical Research grant. The funding source had no involvement in study design or reporting.

Results Forty participants with knee OA (mean age⫽62.98⫾9.73 years; 23 ‡‡

SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606-6306.

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Home Program of Hip Abductor Exercises Table 1. Baseline Demographic and Clinical Characteristics of Participants Who Completed the Study

Variable Age (y)

Osteoarthritis Group (nⴝ40) Mean (SD) [Range]

Control Group (nⴝ40) Mean (SD) [Range]

P

62.98 (9.73) [46–90]

64.13 (9.04) [47–84]

.59

82.31 (20.0)

69.71 (11.03)

Weight (kg) Height (m) Body mass index (kg/m2) Knee alignment (°)b

1.73 (0.11)

1.70 (0.86)

27.38 (5.47)

24.04 (3.24)

.23 .001a

⫺4.1 (4.3)

⫺2.2 (1.9)

.014a

2.5 (0.91)

0.28 (0.55)

.000a

1.00 (0.20)

1.12 (0.19)

.006a

Stride length (m)

1.19 (0.16)

1.26 (0.15)

.08

Stance time (s)

0.84 (0.11)

0.75 (0.07)

.000a

Double-limb support time (s)

0.39 (0.08)

0.33 (0.05)

.001a

104.60 (9.29)

.003a

Grading of osteoarthritis severity

c

.001a

Temporal-distance gait parameters Gait speed (m/s)

Cadence (steps/min) a b c

97.36 (10.48)

Significant differences between groups (P⬍.05). Negative alignment values represent varus. Kellgren-Lawrence radiographic grading scale (0 – 4).34,35

women and 17 men) and 40 matched control participants (mean age⫽64.13⫾9.04 years; 23 women and 17 men) completed the study. An additional 5 participants with knee OA completed the initial test-

ing only, 3 participants had to discontinue their participation because of death or illness in the family, and 2 participants did not want to continue after the initial testing session. Thirty-three of the OA group partic-

ipants had bilateral medial compartment knee OA. Baseline demographic and clinical characteristics for the 40 participants in each group who completed the study are displayed in Table 1. The OA group had higher values for weight and body mass index (BMI), demonstrated greater varus alignment, and walked at a slower gait speed compared to the control group (P⬍.05). The median Kellgren-Lawrence grade of disease severity for the OA group was 2, indicating an overall mild level of severity. Paired t tests confirmed that gait speed within subjects had been controlled for, as there were no significant differences in gait speed between initial and final testing in either group (P⬎.05). At baseline, the OA group demonstrated weakness of the hip abductor muscles compared with the control group (P⫽.03). Improvement in hip abductor strength occurred over time in both groups, but the significant interaction effect indicated a

Table 2. Initial and Final Means and 95% Confidence Intervals (CIs) for the Outcomes of Hip Muscle Strength, Peak Knee Adduction Moments, Chair Rise Time, and Physical Activity Scale for the Elderly (PASE) Scores in the Osteoarthritis and Control Groups Initial Testing Mean (95% CI), P Valueb

Final Testing Mean (95% CI), P Valuec

Variable

Groupa

Pd

Isokinetic hip abductor muscle strength (N䡠m/kg)

Osteoarthritis Control

0.75 (0.62–0.88) 0.96 (0.83–1.09) P⫽.03e

1.00 (0.87–1.13) 1.06 (0.93–1.19) P⫽.56

.036e

Peak knee adduction moment (%BW⫻Ht)f

Osteoarthritis Control

2.97 (2.70–3.24) 2.47 (2.28–2.66) P⫽.004e

2.96 (2.68–3.24) 2.52 (2.31–2.73) P⫽.02e

.52

FTSSTg (s)

Osteoarthritis Control

15.2 (12.6–17.9) 10.1 (9.2–11.0) P⬍.001e

12.5 (10.6–14.4) 9.3 (8.4–10.2) P⫽.004e

.021e

PASE score

Osteoarthritis Control

196.2 (175.7–216.7) 165.0 (144.9–185.2) P⫽.037e

200.9 (176.0–225.9) 147.3 (128.7–166.0) P⫽.001e

.065

a

n⫽40 participants in each group. P values for between-group differences on initial testing. P values for between-group differences on final testing. d P values for between-group differences in change over time (interaction effect). e Significant differences (P⬍.05). f %BW⫻Ht⫽percentage of body weight ⫻ height. g FTSST⫽Five-Times-Sit-to-Stand Test. b c

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Home Program of Hip Abductor Exercises time. The WOMAC pain scores showed a significant interaction effect, with the OA group reporting decreased knee pain over time compared with the control group (P⫽.03) (Tab. 3).

Figure. Average knee adduction moment waveforms for the osteoarthritis and control groups across the stance phase of the gait cycle on both initial and final testing. The waveforms were obtained by averaging across participants at each percent of stance, such that data were normalized across time to 100% of the stance phase. %BW⫻Ht ⫽ percentage of body weight ⫻ height. Both initial and final mean peak moments were higher for the osteoarthritis group than for the control group.

greater change in the OA group following the exercise intervention (F⫽4.56, P⫽.036) (Tab. 2). The OA group had higher peak knee adduction moments than the control group (main effect of group; F⫽8.02, P⫽.006), but there was no significant change in the peak knee adduction moment over time and no interaction effect (Tab. 2, Fig. 1). Analysis of physical function measures revealed that the OA group performed the FTSST more slowly than the control group (main effect of group; F⫽12.34, P⫽.001). Although an improvement in sit-tostand time was observed for both

groups over time, the improvement in the OA group was significantly greater (F⫽5.55, P⫽.021) (Tab. 2). From the evaluation of the PASE scores, the OA group demonstrated higher total scores for physical activity compared with the control group (main effect of group; F⫽9.06, P⫽.004). There were no significant changes in physical activity level over time for either group (Tab. 2). All WOMAC measures were significantly higher in the OA group compared with the control group (P⬍.05). Neither group demonstrated any change in WOMAC stiffness or physical function scores over

Adherence to the exercise program was assessed by means of the selfcompleted, weekly calendars. Participants were considered adherent if they performed at least 75% of the prescribed exercises over the 8-week period. According to this criterion, 31 of the 40 participants with OA (78%) were adherent. When only the 31 adherent participants and their matched controls were included in the statistical analyses, the same results were obtained as with 40 participants. Therefore, the results are presented for all participants.

Discussion The primary findings of the current study were that an 8-week, home strengthening program targeting the hip abductor muscles resulted in increased hip abductor strength but had no effect on reducing the knee adduction moment during gait in people with medial knee OA. Hip abductor strengthening led to an improvement in functional performance on the sit-to-stand test and reduced knee pain in the sample with knee OA.

Table 3. Initial and Final Means and 95% Confidence Intervals (CIs) for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Subscale Scoresa in the Osteoarthritis and Control Groups Groupb

Initial Testing Mean (95% CI)

Final Testing Mean (95% CI)

WOMAC pain subscale (total score: 0–20)

Osteoarthritis Control

5.55 (4.66–6.44) 0.175 (0.03–0.32)

4.78 (3.72–5.84) 0.32 (0.00–0.69)

.03c

WOMAC stiffness subscale (total score: 0–8)

Osteoarthritis Control

3.08 (2.52–3.64) 0.43 (0.16–0.70)

2.95 (2.40–3.50) 0.34 (0.13–0.57)

.83

WOMAC physical function subscale (total score: 0–68)

Osteoarthritis Control

19.60 (15.95–23.25) 1.2 (0.25–2.15)

18.15 (14.19–22.11) 1.24 (0.00–2.46)

.22

Test

a b c

P

Higher scores on the WOMAC subscales indicate greater severity of pain, stiffness, and difficulty in physical function. n⫽40 participants in each group. Significant interaction effect (P⬍.05).

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Home Program of Hip Abductor Exercises Baseline isokinetic hip abductor strength measurements revealed that the OA group was weaker compared with the control group. This hip muscle weakness was present despite the fact that the OA group was more physically active than the control group, as indicated by the PASE scores. Only one other study was identified that compared isometric hip abductor strength in women with and without knee OA, and there were no differences between the 2 groups.53 Following the exercise intervention, our sample of participants with knee OA demonstrated significant improvement in hip abductor strength. Few other studies have incorporated hip strengthening as part of exercise programs for people with knee OA or included hip muscle strength as an outcome measure in this population. McGibbon et al25 measured seated isometric hip abductor strength using a handheld dynamometer in 15 older individuals with lower-extremity impairment (not isolated to knee OA) who had been randomly assigned to receive either a 6-week lower-extremity strengthening or functional training intervention. Both groups demonstrated significant improvements in hip abductor strength following the interventions. Gait analysis revealed that peak knee adduction moments in the first 50% of the stance phase were higher in our sample of participants with knee OA compared with the control group. These results are consistent with other reported findings.1,2,4,6,10 Higher BMI and greater varus alignment could have contributed to the higher knee adduction moments in the OA group. However, there were no changes in peak knee adduction moment in either group over time. Thus, strengthening the hip abductor muscles did not influence the knee adduction moment in our participants with medial knee OA, indi902

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cating that hip abductor strengthening may not be an effective strategy for decreasing medial compartment forces and progression of joint disease. Other studies have failed to demonstrate a change in the knee adduction moment during gait following lower-extremity strengthening.54 –56 In an 8-week pilot study56 of 13 people with early knee OA who participated in a lower-extremity strengthening and functional exercise program, peak knee adduction moments during gait were not significantly reduced at the completion of the program but were significantly lower during single-leg raise. The authors suggested that peak knee adduction moments during the more demanding task of single-leg raise may be more sensitive to change than peak moments during gait.56 Similarly, a 12-week, high-intensity, isokinetic resistance training program for the knee extensor and flexor muscles had no effect on the peak knee adduction moment during gait in 14 people with medial knee OA.54 Lim et al55 performed a 12week randomized controlled trial of 107 people with medial knee OA in which participants were stratified into 2 groups according to varus malalignment or neutral alignment. The participants in each group then were randomly assigned to receive a supervised, home-based quadriceps muscle strengthening program or to receive no intervention. The results of the study showed no significant change in the knee adduction moment in the groups with more varus malalignment or neutral alignment following the exercise program.55 The WOMAC pain scores revealed reduced knee pain over time in the OA group compared with the control group. However, the change of 0.77 for the WOMAC pain scores may not be clinically meaningful. The lack of a more definite reduction

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in symptoms over the 8-week intervention period may have been related to the relatively low scores for knee pain, stiffness, and function that characterized our sample at baseline. Although functional performance on the FTSST was decreased in our participants with knee OA compared with the control group, the OA group demonstrated significant improvement (18%) in time to complete the test following the exercise intervention. The FTSST has been shown to relate to lower-extremity muscle strength, particularly quadriceps muscle strength, and balance control.45,57 One limitation of our study was that strength of the knee muscles was not assessed before and after the intervention. The weightbearing exercises performed as part of the hip strengthening program likely produced co-contraction of other lower-extremity and trunk muscles. Thus, it is possible that improvements in functional performance on the sit-to-stand test and the decrease in knee pain may have been more closely correlated with knee muscle strength gains than improvements in hip abductor strength. The design of the study was another limitation. The inclusion of a control group of individuals with knee OA in a randomized controlled trial would have strengthened the study. However, a control group of older adults who were healthy was selected due to the lack of available literature comparing hip abductor strength between those with and without knee OA. In addition, gait strategies that may have affected the knee adduction moment, including lateral trunk lean, were not evaluated for change over time in this study. Hip abductor strengthening may have increased trunk stability, thus decreasing lateral trunk lean toward the stance limb, increasing the lever arm magnitude at the knee, and potentially June 2010

Home Program of Hip Abductor Exercises nullifying a reduction in the knee adduction moment that might have occurred as a result of the exercise program. Recruitment of participants through newspaper advertising also may have introduced bias toward those individuals in the population who were wealthier and more highly educated. Finally, our participants with knee OA were highly active in recreational, household, and occupational activities, as shown by the PASE scores. Therefore, the results from this study may not be generalized to the average population of people with OA. Our results suggest the need for further studies to investigate the effects of hip abductor strengthening on lower-extremity function and knee symptoms in people with medial knee OA. Randomized controlled trials with larger cohorts are recommended. Furthermore, accumulating evidence suggests that the local mechanical environment, including OA disease severity, lower-limb alignment, and varus-valgus knee laxity, may influence response to exercise interventions in people with knee OA.55,58,59 Stratification according to biomechanical factors would provide insight as to whether hip abductor strengthening is more effective in subgroups of people with knee OA. Future studies of hip abductor strengthening in those with knee OA also should incorporate measures of knee muscle strength and lateral trunk lean during gait to better elucidate relationships between factors and to clarify the biomechanical and functional benefits of this intervention. In summary, an 8-week strengthening program for the hip abductor muscles resulted in increased hip muscle strength, reduced knee pain, and improved functional performance on a sit-to-stand task in 40 participants with medial knee OA compared with a control group without knee OA. There was no change June 2010

in the knee adduction moment with the exercise program. Further research is needed to investigate whether hip abductor strengthening would be an effective intervention for slowing disease progression and protecting against functional decline in people with medial knee OA. Dr Sled, Dr Deluzio, and Dr Culham provided concept/idea/research design and writing. Dr Sled and Mr Khoja provided data collection and participants. Dr Sled, Mr Khoja, Dr Deluzio, and Dr Culham provided data analysis. Dr Sled, Mr Khoja, and Dr Culham provided project management. Dr Sled and Dr Deluzio provided fund procurement. Dr Deluzio provided facilities/equipment. Dr Sled provided clerical support. Dr Sled, Mr Khoja, Dr Deluzio, and Dr Olney provided consultation (including review of manuscript before submission). The authors acknowledge Dr T. Derek V. Cooke, orthopedic consultant, for his input throughout the study and Martin He´roux and Alex Andrews for their assistance with MATLAB programming. The study was approved by the University Health Sciences Research Ethics Board. Podium presentations of this research were made at the Canadian Physiotherapy Association Congress; May 28 –31, 2009; Calgary, Alberta, Canada, and the 64th Annual Meeting of the Canadian Orthopaedic Association; July 3– 6, 2009; Whistler, British Columbia, Canada. This study was supported by a Bickell Foundation of Canada Medical Research grant. This clinical trial is registered with ClinicalTrials.gov (registration number: NCT00427843). This article was received September 7, 2009, and was accepted February 6, 2010. DOI: 10.2522/ptj.20090294

References 1 Miyazaki T, Wada M, Kawahara H, et al. Dynamic load at baseline can predict radiographic disease progression in medial compartment knee osteoarthritis. Ann Rheum Dis. 2002;61:617– 622. 2 Birmingham TB, Hunt MA, Jones IC, et al. Test-retest reliability of the peak knee adduction moment during walking in patients with medial compartment knee osteoarthritis. Arthritis Rheum. 2007;57: 1012–1017.

3 Hurwitz DE, Sumner DR, Andriacchi TP, Sugar DA. Dynamic knee loads during gait predict proximal tibial bone distribution. J Biomech. 1998;31:423– 430. 4 Sharma L, Hurwitz DE, Thonar EJ, et al. Knee adduction moment, serum hyaluronan level, and disease severity in medial tibiofemoral osteoarthritis. Arthritis Rheum. 1998;41:1233–1240. 5 Thorp LE, Wimmer MA, Block JA, et al. Bone mineral density in the proximal tibia varies as a function of static alignment and knee adduction angular momentum in individuals with medial knee osteoarthritis. Bone. 2006;39:1116 –1122. 6 Wada M, Maezawa Y, Baba H, et al. Relationships among bone mineral densities, static alignment and dynamic load in patients with medial compartment knee osteoarthritis. Rheumatology (Oxford). 2001;40:499 –505. 7 Zhao D, Banks SA, Mitchell KH, et al. Correlation between the knee adduction torque and medial contact force for a variety of gait patterns. J Orthop Res. 2007; 25:789 –797. 8 Hurwitz DE, Ryals AB, Case JP, et al. The knee adduction moment during gait in subjects with knee osteoarthritis is more closely correlated with static alignment than radiographic disease severity, toe out angle and pain. J Orthop Res. 2002;20: 101–107. 9 Deluzio KJ, Astephen JL. Biomechanical features of gait waveform data associated with knee osteoarthritis: an application of principal component analysis. Gait Posture. 2007;25:86 –93. 10 Mundermann A, Dyrby CO, Hurwitz DE, et al. Potential strategies to reduce medial compartment loading in patients with knee osteoarthritis of varying severity: reduced walking speed. Arthritis Rheum. 2004;50:1172–1178. 11 Mundermann A, Dyrby CO, Andriacchi TP. Secondary gait changes in patients with medial compartment knee osteoarthritis: increased load at the ankle, knee, and hip during walking. Arthritis Rheum. 2005; 52:2835–2844. 12 Thorp LE, Sumner DR, Block JA, et al. Knee joint loading differs in individuals with mild compared with moderate medial knee osteoarthritis. Arthritis Rheum. 2006;54:3842–3849. 13 Specogna AV, Birmingham TB, Hunt MA, et al. Radiographic measures of knee alignment in patients with varus gonarthrosis: effect of weightbearing status and associations with dynamic joint load. Am J Sports Med. 2007;35:65–70. 14 Hurwitz DE, Ryals AR, Block JA, et al. Knee pain and joint loading in subjects with osteoarthritis of the knee. J Orthop Res. 2000;18:572–579. 15 Hurwitz DE, Sharma L, Andriacchi TP. Effect of knee pain on joint loading in patients with osteoarthritis. Curr Opin Rheumatol. 1999;11:422– 426.

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Home Program of Hip Abductor Exercises 16 Hunt MA, Birmingham TB, Giffin JR, Jenkyn TR. Associations among knee adduction moment, frontal plane ground reaction force, and lever arm during walking in patients with knee osteoarthritis. J Biomech. 2006;39:2213–2220. 17 Chang A, Hurwitz D, Dunlop D, et al. The relationship between toe-out angle during gait and progression of medial tibiofemoral osteoarthritis. Ann Rheum Dis. 2007; 66:1271–1275. 18 Guo M, Axe MJ, Manal K. The influence of foot progression angle on the knee adduction moment during walking and stair climbing in pain free individuals with knee osteoarthritis. Gait Posture. 2007;26: 436 – 441. 19 Jenkyn TR, Hunt MA, Jones IC, et al. Toeout gait in patients with knee osteoarthritis partially transforms external knee adduction moment into flexion moment during early stance phase of gait: a triplanar kinetic mechanism. J Biomech. 2008;41:276 –283. 20 Hunt MA, Birmingham TB, Bryant D, et al. Lateral trunk lean explains variation in dynamic knee joint load in patients with medial compartment knee osteoarthritis. Osteoarthritis Cartilage. 2008;16:591–599. 21 Chang A, Hayes K, Dunlop D, et al. Hip abduction moment and protection against medial tibiofemoral osteoarthritis progression. Arthritis Rheum. 2005;52: 3515–3519. 22 Altman RD, Bloch DA, Bole GG Jr, et al. Development of clinical criteria for osteoarthritis. J Rheumatol. 1987;14 Spec No:3– 6. 23 Altman RD. Classification of disease: osteoarthritis. Semin Arthritis Rheum. 1991; 20(6 suppl 2):40 – 47. 24 Dieppe PA, Altman RD, Buckwalter JA, et al. Standardization of methods used to assess the progression of osteoarthritis of the hip or knee joints. In: Kuettner KEGVM, ed. Osteoarthritic Disorders. Rosemont, IL: American Academy of Orthopaedic Surgeons; 1995:481– 496. 25 McGibbon CA, Krebs DE, Scarborough DM. Rehabilitation effects on compensatory gait mechanics in people with arthritis and strength impairment. Arthritis Rheum. 2003;49:248 –254. 26 Messier SP, Devita P, Cowan RE, et al. Do older adults with knee osteoarthritis place greater loads on the knee during gait? A preliminary study. Arch Phys Med Rehabil. 2005;86:703–709. 27 Cooke TD, Sled EA, Scudamore RA. Frontal plane knee alignment: a call for standardized measurement. J Rheumatol. 2007;34:1796 –1801. 28 Cooke TD, Li J, Scudamore RA. Radiographic assessment of bony contributions to knee deformity. Orthop Clin North Am. 1994;25:387–393. 29 Yoshioka Y, Siu D, Cooke TD. The anatomy and functional axes of the femur. J Bone Joint Surg Am. 1987;69:873– 880. 30 Yoshioka Y, Siu DW, Scudamore RA, Cooke TD. Tibial anatomy and functional axes. J Orthop Res 1989;7:132–137.

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31 Issa SN, Dunlop D, Chang A, et al. Fulllimb and knee radiography assessments of varus-valgus alignment and their relationship to osteoarthritis disease features by magnetic resonance imaging. Arthritis Rheum. 2007;57:398 – 406. 32 Kraus VB, Vail TP, Worrell T, McDaniel G. A comparative assessment of alignment angle of the knee by radiographic and physical examination methods. Arthritis Rheum. 2005;52:1730 –1735. 33 Hinman RS, May RL, Crossley KM. Is there an alternative to the full-leg radiograph for determining knee joint alignment in osteoarthritis? Arthritis Rheum. 2006;55: 306 –313. 34 Kellgren JH, Lawrence JS. Atlas of Standard Radiographs (Department of Rheumatology and Medical Illustrations, University of Manchester). Oxford, United Kingdom: Blackwell; 1963. 35 Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494 –502. 36 Scott WW Jr, Lethbridge-Cejku M, Reichle R, et al. Reliability of grading scales for individual radiographic features of osteoarthritis of the knee: the Baltimore longitudinal study of aging atlas of knee osteoarthritis. Invest Radiol. 1993;28:497–501. 37 Manal K, McClay I, Stanhope S, et al. Comparison of surface mounted markers and attachment methods in estimating tibial rotations during walking: an in vivo study. Gait Posture. 2000;11:38 – 45. 38 Hamill J, Selbie WS. Three-Dimensional Kinetics. In: Robertson DGE, Caldwell GE, Hamill J, et al, eds. Research Methods in Biomechanics. Champaign, IL: Human Kinetics; 2004:145–160. 39 Cahalan TD, Johnson ME, Liu S, Chao EY. Quantitative measurements of hip strength in different age groups. Clin Orthop Relat Res. 1989;246:136 –145. 40 Johnson ME, Mille ML, Martinez KM, et al. Age-related changes in hip abductor and adductor joint torques. Arch Phys Med Rehabil. 2004;85:593–597. 41 Wilhite MR, Cohen ER, Wilhite SC. Reliability of concentric and eccentric measurements of quadriceps performance using the KIN-COM dynamometer: the effect of testing order for three different speeds. J Orthop Sports Phys Ther. 1992;15: 175–182. 42 Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–1840. 43 McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001;45: 453– 461. 44 Csuka M, McCarty DJ. Simple method for measurement of lower extremity muscle strength. Am J Med. 1985;78:77– 81.

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45 Lord SR, Murray SM, Chapman K, et al. Sit-to-stand performance depends on sensation, speed, balance, and psychological status in addition to strength in older people. J Gerontol A Biol Sci Med Sci. 2002; 57:M539 –M543. 46 Schaubert KL, Bohannon RW. Reliability of the sit-to-stand test over dispersed test sessions. Isokin Exerc Sci. 2005;13:119 –122. 47 Schaubert KL, Bohannon RW. Reliability and validity of three strength measures obtained from community-dwelling elderly persons. J Strength Cond Res. 2005;19: 717–720. 48 Bohannon RW, Shove M, Barreca S, et al. Five-repetition sit-to-stand test performance by community-dwelling adults: a preliminary investigation of times, determinants, and relationship with selfreported physical performance. Isokin Exerc Sci. 2007;15:77– 81. 49 Whitney SL, Wrisley DM, Marchetti GF, et al. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-TimesSit-to-Stand Test. Phys Ther. 2005;85: 1034 –1045. 50 Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993;46:153–162. 51 Martin KA, Rejeski WJ, Miller ME, et al. Validation of the PASE in older adults with knee pain and physical disability. Med Sci Sports Exerc. 1999;31:627– 633. 52 Physical Activity Scale for the Elderly (PASE): Administration and Scoring Instruction Manual. Watertown, MA: New England Research Institutes; 1991. 53 Yamada H, Koshino T, Sakai N, Saito T. Hip adductor muscle strength in patients with varus deformed knee. Clin Orthop Relat Res. 2001;386:179 –185. 54 King LK, Birmingham TB, Kean CO, et al. Resistance training for medial compartment osteoarthritis and malalignment. Med Sci Sports Exerc. 2008;40: 1376 –1384. 55 Lim BW, Hinman RS, Wrigley TV, et al. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008;59:943–951. 56 Thorstensson CA, Henriksson M, von Porat A, et al. The effect of eight weeks of exercise on knee adduction moment in early knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 2007;15: 1163– 1170. 57 Schenkman M, Hughes MA, Samsa G, Studenski S. The relative importance of strength and balance in chair rise by functionally impaired older individuals. J Am Geriatr Soc. 1996;44:1441–1446. 58 Fitzgerald GK. Therapeutic exercise for knee osteoarthritis: considering factors that may influence outcome. Eura Medicophys. 2005;41:163–171. 59 Sharma L. Examination of exercise effects on knee osteoarthritis outcomes: why should the local mechanical environment be considered? Arthritis Rheum. 2003; 49:255–260.

June 2010

Research Report

Impact of Work-Related Pain on Physical Therapists and Occupational Therapists Marc Campo, Amy R. Darragh

Background. Physical therapists and occupational therapists experience high rates of work-related pain. Although most therapists continue to work through this pain, it interferes with work and alters therapists’ work habits. However, the effects on productivity, quality of patient care, and therapists’ quality of life and long-term career plans are unknown. Objectives. The purpose of this study was to determine the impact of working with work-related pain on physical therapists and occupational therapists.

Design. Multiple methods were used in this study. It was primarily a phenomenological study.

Methods. A phenomenological approach was used to explore the meaning of work-related pain in therapists. Focus group interviews were used as the method of data collection. A questionnaire was used to supplement the qualitative analysis.

M. Campo, PT, PhD, OCS, is Associate Professor, School of Health and Natural Sciences, Mercy College, 555 Broadway, Dobbs Ferry, NY 10522 (USA). Address all correspondence to Dr Campo at: [email protected]. A.R. Darragh, PhD, OTR/L, is Assistant Professor, School of Allied Medical Professions, The Ohio State University, Columbus, Ohio. [Campo M, Darragh AR. Impact of work-related pain on physical therapists and occupational therapists. Phys Ther. 2010;90: 905–920.] © 2010 American Physical Therapy Association

Results. Nineteen therapists participated in 4 focus groups ranging from 2 to 7 participants each. The participants noted substantial effects of work-related pain at work, at home, and in their career plans. All of the therapists were concerned about their potential clinical longevity. The professional culture complicated these effects by forcing therapists into a professional ideal.

Conclusions. Work-related pain affects therapists in several personal and professional domains. It also may affect career plans. Strategies to reduce the risk of injury and physical loading of jobs are needed.

Post a Rapid Response to this article at: ptjournal.apta.org June 2010

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hysical therapists and occupational therapists experience high rates of work-related pain.1–3 The most commonly affected body regions include the low back, neck, shoulder, and hand or wrist.2,3 The prevalence of workrelated pain reported in earlier studies ranged from 40% to 80%.1,3– 6 Cromie et al2 reported a 1-year prevalence of work-related pain in any body region of 80%. Campo et al3 reported a 1-year prevalence of 58%. Additionally, 20.7% of the therapists studied had a newly developed case of work-related pain with a severity of at least 4/10 on a visual analog scale (ratings of 0 –10) and that lasted at least 1 week or was present at least once per month. Darragh et al1 reported 1-year work-related injury incidence rates of 16.5 per 100 full-time occupational therapists and 16.9 per 100 full-time physical therapists.

Evidence exists that therapists in the United States typically continue to work despite pain.1,3 In fact, fewer than one fifth of therapists with work-related pain lose any work time at all,3 and most continue to work while injured or in pain.4,7 Therapists are able to recognize symptoms, use physical agents, perform therapeutic exercises, and self-treat.6 These factors help explain why therapists choose to continue working while in pain. Work-related musculoskeletal disorders affect therapists as they continue to work. Physical therapists

Available With This Article at ptjournal.apta.org

who continued to work with pain reported modifications of their work activities, including outsourcing (seeking help from others with patients who were heavy or uncooperative) and altering or avoiding certain techniques.2 More than 70% of physical therapists and occupational therapists with work-related pain reported altering their work habits because of their pain.1,7 Approximately one third to one half of therapists with work-related pain reported that it interfered with their work.1,8 The alteration of work habits in response to work-related pain has not been explored in therapists. The effects of work-related pain on job satisfaction, career longevity, productivity, and quality of care also have not been explored. Earlier research was conducted with physical therapists who left the profession because of work-related pain9 and therapists who claimed worker’s compensation,10 but the consequences of continuing to work while experiencing work-related pain have received little attention. Work-related pain may affect clinical longevity. Research has indicated that 31% of physical therapists and 27% of occupational therapists with work-related pain considered changing jobs or changed jobs because of their condition,1 although the actual number of therapists who leave the profession has yet to be determined. Given that as many as one half of therapists in each profession experience work-related pain each year and that increased demands for both physical therapists and occupational therapists are projected by the Bureau of Labor Statistics,11 the impact of work-related pain on therapists’ career plans deserves exploration.

• Audio Abstracts Podcast This article was published ahead of print on April 8, 2010, at ptjournal.apta.org.

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The purpose of this study was to examine the experience of working with pain and how that interacts with work and nonwork activities, Number 6

job satisfaction, and career planning in occupational therapists and physical therapists. We sought to examine, qualitatively, the experience of work-related pain in occupational therapists and physical therapists who continue to work with pain.

Method Design Multiple methods were used in this study. First and foremost, a phenomenological approach was used to explore the meaning of work-related pain in currently practicing therapists. A phenomenological study is one in which the essence, or central meaning, of a shared experience is elucidated from the perspective of the participants.12,13 Focus group interviews were used as the method of data collection. They have the advantage of participant interaction, they stimulate discussion of salient topics, and they allow for the contributions of multiple participants in a limited time period.14 In addition, quantitative information on work-related pain severity, work productivity, and the impact of work-related pain on work activities was collected with a questionnaire. The questionnaire data helped to ensure that participants would provide detailed descriptions of their background information, work situations, and work-related pain. These data also were used for comparative analysis during triangulation procedures. Participants Purposive sampling was used to recruit participants and to ensure that both disciplines were represented. Participants were identified through word of mouth and informational flyers. “Snowball” sampling also was used: potential participants were encouraged to refer colleagues whom they thought would be appropriate for the study. Eligibility was determined through telephone screening or e-mail communication, depending on how the participants first conJune 2010

Impact of Work-Related Pain on Therapists tacted us. Participants were reminded that they had to be currently experiencing work-related pain to participate. No criteria with regard to duration, frequency, location, or severity of pain were used. Once participants were identified, we explained the purpose of the study and the participation requirements. All participants had to be currently working as physical therapists or occupational therapists and had to be providing direct patient care on a daily basis. Nineteen therapists (10 occupational therapists and 9 physical therapists) participated in this study (Table). Seventeen of the respondents were female and 2 were male. There were wide variations in both age (X⫽37.5 years, SD⫽13.4 years) and experience (X⫽12.9 years, SD⫽11.9 years). Three participants reported having children. Two participants had young children at home: 1 therapist had 2 children, and the other therapist had 1 child. Both of them lived with their spouses. One of the participants had 2 older children who were no longer living at home. All participants received, reviewed, and signed informed consent documents before participation in the study. Procedure Eligible participants were invited to participate in 1 of 4 focus groups. Each focus group consisted of 2 to 7 participants, and the sessions took place on a local college campus and lasted approximately 2 hours. The individual groups consisted of 2, 5, 5, and 7 participants. Two of the 4 groups consisted of occupational therapists and physical therapists, 1 group included only occupational therapists, and 1 group included only physical therapists. We facilitated the discussions by following a pre-established interview guide. The focus group discussions were recorded and transcribed. The tranJune 2010

scripts then were checked against the recordings for accuracy. After each focus group session, participants completed a 4-page questionnaire about their work-related pain. Data Collection In the focus group sessions, participants answered a series of general questions about their work-related pain (Appendix 1). Probes were used to focus and clarify participants’ answers. After each focus group meeting, we met for debriefing sessions to discuss nonverbal communications, procedural difficulties that arose, and the questions in the interview guide. The debriefing after the second focus group meeting led us to modify the interview guide. Participants reported that the effect of pain on job satisfaction was minimal. They reported changes in their work habits, but they reported more substantial effects in 2 other domains: life outside of work and career plans. The second set of questions was reorganized to address these issues more carefully. Instrumentation Once the discussions concluded, participants were asked to complete a 4-page questionnaire that relied on quantitative measures to gather information about pain, job satisfaction, and the effects of working while in pain on work activities. The questionnaire, adapted from the instrument used by Campo et al,3 included items on demographics, work setting and hours, and workrelated pain. Participants were directed to answer questions about work-related pain in the preceding 12 months. The location, frequency, duration, and severity of pain were assessed for each body region. Severity was assessed with a visual analog scale.

also were included. Decreased presenteeism occurs when workers who are injured or sick continue to work but are less productive and less effective.15 For this analysis, the Stanford Presenteeism Scale (SPS) was used.16 The SPS results in 2 scores: the Work Impairment Score (WIS) and the Work Output Score (WOS). The WIS is derived from 11 questions on perceptions of how health problems affect a person’s functioning at work. It is an estimate of the percentage of lost productivity. The WOS is the result of a single question. It is an estimate of the selfassessed percentage of usual productivity. All questions addressed a 4-week recall period. The SPS is applicable to both knowledge-based jobs and production-based jobs and has very good psychometric properties.17 The internal reliability of the WIS is high (␣⫽.82), and the WIS and the WOS are significantly negatively correlated (r⫽.60, P⬍.001). In terms of criterion (concurrent) validity, the WIS is moderately correlated (r⫽.50) with the Work Limitations Questionnaire (another instrument for measuring presenteeism). In terms of convergent validity, the WIS is significantly negatively correlated with the subscales of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire (r⫽⫺.25 to r⫽⫺.62). Further data on the validation of the SPS are described by Turpin et al.17 Data Analysis Although the questionnaire data were not intended for primary analysis in this project, they were used to determine demographic characteristics, to provide information on workrelated pain, and to confirm the qualitative findings. The data were

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Impact of Work-Related Pain on Therapists Table. Characteristics of Focus Group Participants Participant No.

Hours Worked per Week at Primary Job

Location of Work-Related Paina

Outpatient (orthopedic)

40

Neck, shoulder, wrist/hand, upper back

Pediatrics

40

Hip

Acute care, rehabilitation, outpatient (general)

36

Low back

Sex

Experience (y)

1

Physical therapy

Female

9

2

Physical therapy

Female

28

3

Occupational therapy

Female

4

Physical therapy

Female

2

Pediatrics

40

Low back, knee

5

Occupational therapy

Female

10

Acute care, rehabilitation

37

Neck, shoulder, low back, hip, knee

6

Physical therapy

Female

42

Skilled nursing

21

Knee

7

Occupational therapy

Female

26

Acute care, rehabilitation

36

Shoulder, wrist/ hand, low back

8

Physical therapy

Female

2

Acute care, rehabilitation

35

Neck, shoulder, upper back, low back, ankle/foot

9

Occupational therapy

Female

7

Acute care, rehabilitation

40

Neck, shoulder, upper back, low back

10

Occupational therapy

Female

5.5

Acute care, rehabilitation, outpatient (general)

36

Neck, shoulder, wrist/hand, low back

11

Physical therapy

Male

15

Outpatient (orthopedic)

40

Upper back

12

Occupational therapy

Female

5

Acute care, rehabilitation

40

Neck, shoulder, upper back, low back

13

Physical therapy

Female

8.5

Outpatient (orthopedic)

40

Neck, shoulder, elbow, wrist, upper back, low back, hip, knee, ankle/foot

14

Physical therapy

Female

30

Orthopedic

40

Wrist/hand

15

Occupational therapy

Female

1

Acute care, rehabilitation

36

Neck, shoulder, wrist/hand, low back, knee, ankle/foot

16

Physical therapy

Female

15

Home care

21

Neck, shoulder, elbow, wrist/ hand, upper back, low back, knee, ankle/foot

17

Occupational therapy

Male

26

Pediatrics

32

Neck, shoulder, wrist/hand

18

Occupational therapy

Female

1

Outpatient (general)

36

Neck, shoulder

19

Occupational therapy

Female

11

Subacute rehabilitation

43

Neck, shoulder, upper back, low back

Discipline

1.5

Setting

a Body regions in bold type indicate regions with work-related pain of at least moderate severity (severity of ⱖ4/10 on a visual analog scale with ratings of 0 to 10 and lasting at least 1 week or present once per month or more).

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Impact of Work-Related Pain on Therapists entered into SPSS version 16* and analyzed with descriptive statistics. A qualitative approach was used to analyze participants’ comments made during the focus group discussions. We read and coded the transcripts using a method of constant comparison: Data were compared with emerging codes and categories throughout the analysis.18 We used this method to systematically identify codes (key words or phrases summarizing comments), collapse them into larger categories (groups of related codes), and finally identify larger emergent themes (larger concepts representing the codes and categories associated with the topics covered during the interviews). This process is highly structured and requires multiple steps to identify final themes, with each step being documented and maintained in a detailed audit trail (Fig. 1).12,13,18 We read the transcripts and wrote code words in the margins to reflect the meaning of the phrase or passage. We then discussed the codes and developed a master code list. Using this list, we individually recoded the passages, again discussed our coding choices, and reached a consensus about the codes and associated passages. All quotes then were organized by code, and we individually reconsidered the codes to ensure that they accurately reflected the meaning of the quotes they represented. After this process, we reviewed our coding decisions, collapsed certain codes into clusters, and reorganized quotes that were thought to be coded inappropriately. Finally, we individually developed overall themes19 and discussed them to reach a consensus. We reviewed the comments related to each theme to ensure that com* SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606.

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ments from both physical therapists and occupational therapists contributed substantially to every theme. They also confirmed that comments supporting the themes represented all 4 focus groups. Strategies for Achieving Trustworthiness Multiple verification procedures were used before and during the study to improve the credibility and trustworthiness of the data and results. From the outset, we engaged in a process of reflection to clarify our personal and professional biases. We described and acknowledged these presuppositions and then examined the focus group questions and interpretations of the data for any undue influence of these biases throughout the analytic process.13 This process is formally referred to as epoche. These biases included the concerns that both of us were passionate about safe patient handling and the prevention of work-related pain in occupational therapists and physical therapists. They also included the concerns that both of us believed that aspects of occupational therapists’ and physical therapists’ work are not safe and can lead to or contribute to work-related pain. As a result, we attempted to ensure that the effects of injury were not being highlighted to the exclusion of other information and were not being exaggerated during the analysis. Multiple forms of triangulation, including triangulation of observers, analysts, and methods, were used.12 To triangulate observers, we both served as the primary facilitators for 2 groups.12 Although the interviewers had some similar assumptions about the demands and risks associated with the practice of occupational therapy and physical therapy, their perspectives on professional practice and culture varied because of their occupational backgrounds. Each also served as a secondary in-

terviewer and transcriptionist and listened for bias or leading questions during the discussions for 2 of the 4 groups. Each focus group meeting was followed by a debriefing session in which we reflected on the discussions and considered revising the interview guide. Triangulation of analysts also was used.12 Each researcher coded and categorized the transcripts independently, met to compare codes and reach a consensus, and then continued separately again (Fig. 1). A related strategy is member checking, in which study participants review the data analysis.13 In the present study, member checking was used to validate the themes that were identified. According to Lincoln and Guba,20 this is the “most critical technique for establishing credibility.”13 Four participants (2 occupational therapists and 2 physical therapists) reviewed and confirmed the themes. The participants were chosen so that there would be equal representation of occupational therapists and physical therapists. Four was selected as the initial number to ensure that there would be at least 2 opinions from both occupational groups. Had the participants not agreed with the themes, additional participants would have been consulted and the themes would have been reconsidered until a consensus was achieved. Triangulation of methods, a form of comparative analysis, was used to confirm pain severity, productivity at work, and job satisfaction reported by the participants.12 Questions related to pain, productivity, and job satisfaction were included in the questionnaire, and the answers were compared with the qualitative findings. Other strategies used to increase trustworthiness included comparing the interview notes and debriefing session notes to confirm our interpretations of the data.

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Figure 1. Qualitative research process. OTs⫽occupational therapists, PTs⫽physical therapists.

Role of the Funding Source This research was supported, in part, by a Mercy College Faculty Development Grant. No one involved with the grant review process had any involvement with the study or input into the way in which the study was designed or conducted. 910

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Results Participant Characteristics At the time of the focus group sessions, all of the participants had work-related pain, with one exception. She reported that she had been free of pain in the preceding 4 weeks but had experienced pain in the pre-

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ceding 12 months. So as not to disrupt the group process, she participated in the discussion. Her answers were carefully examined for any inconsistencies with those of the rest of the group, and none were detected. Overall, the participants described moderate to severe pain in June 2010

Impact of Work-Related Pain on Therapists multiple body parts and described multiple symptoms, including pain, numbness, and tingling. They identified specific diagnoses, including bursitis, thoracic outlet syndrome, degeneration, sciatica, herniated disks, torn menisci, and migraine headaches. Questionnaire Data: WorkRelated Pain, Presenteeism, and Job Satisfaction The participants rated their workrelated pain on severity, frequency, and duration across multiple body parts on the 4-page questionnaire. They reported injuries of moderate to major severity in multiple body parts (Table). Three of the 19 participants reported having lost work time in the preceding 4 weeks (5, 7, and 8 hours) because of work-related pain. On the SPS, the WOS revealed that all but 2 participants reported that their productivity was 90% or greater compared with their usual levels. The average self-reported productivity in the preceding 4 weeks was 92.3% (SD⫽6.97%). The WIS indicated an average impairment of 35.1% (SD⫽13.71%). The participants also rated their overall job satisfaction. Eighteen of the participants were either very satisfied (n⫽7) or fairly satisfied (n⫽11) with their jobs. One therapist was fairly dissatisfied. None of the participants were very dissatisfied or completely dissatisfied with their working conditions. No therapist was completely satisfied, either. Emergent Themes Four major themes emerged from the data: professional ideals, work habits, life outside of work, and career plans (Appendix 2). Professional ideals. The participants aspired to a professional ideal that included dedication, selfJune 2010

sacrifice, compassion, and clinical expertise. This professional perspective influenced their behaviors with regard to work-related pain: They all continued to care for their patients while in pain, some minimized or did not report their pain, and others engaged in self-diagnosis and treatment of symptoms (or accessed colleagues to do the same). Most of the participants did not miss any work time because of their symptoms and continued to perform activities that exacerbated these symptoms. Most emphasized that they did not take time off because of their work-related pain unless “I can’t get out of bed.” Several indicated that going to work helped them feel better “because you are helping someone else feel better.” Two aspects of the professional culture, professional identity and responsibility, help explain these behaviors. A professional identity that combined a self-image of strength, athleticism, and independence with expertise in musculoskeletal health emerged. This identity made it difficult for the participants to reconcile their pain and change their work practices to improve their comfort. One therapist commented, “I felt that, I have to be like superwoman.” Another explained that working as a therapist requires her to be “thin and athletic.” Expertise in the diagnosis and treatment of their own musculoskeletal disorders contributed to this identity, and the therapists reported that their knowledge helped them decide whether their symptoms were significant or not: . . . we usually know what’s going on with ourselves. So we say, “No, it’s OK, it’s safe for us to keep going,” or . . . we’re able to self-diagnose or diagnose each other and we know that it’ll get better.

They reported that this knowledge differentiated them from other professionals: I think that different professions have different mindsets . . . different priorities that they will set, and I think as therapists, we know what the pain is and if it’s anything to be worried about, so we will just continue to keep working, where other professions, . . . they may not realize that there’s something that you can do for it and still be able to do your job.

Experiencing work-related pain challenged their professional identity and affected their self-identity: . . . it almost changes your identity because it seems like people who get into physical therapy are athletic . . . you come from this elite kind of place where you’re very competitive and you’re athletic and you really just want to keep going through things. It changes your self-image of who you are.

They felt pressure to hide the pain, not report it, and work despite the pain. The participants blamed themselves for the pain that they experienced: That’s what we were taught. Use good body mechanics and you’re fine. So you almost pretend, “I don’t want to be looking like a bad therapist and say this hurts, so I’ll just do it and endure it, because maybe I’m not using good body mechanics.”

The participants described a strong sense of professional responsibility to patients and coworkers. Commitment to coworkers and the resultant guilt at burdening them encouraged participants to continue to work regardless of pain severity. Several identified staffing shortages, in particular, as contributing to the burden:

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Impact of Work-Related Pain on Therapists The participants felt responsibility toward their patients (eg, “I have never said, ‘No, I will not take that patient,’ because this is my job.”) and were reluctant to let their symptoms interfere with patient care (eg, “I knew I hurt myself, but I was doing an eval, and I had to do the eval—you don’t just not do it—and I sat on the floor . . . in a lot of discomfort. . . .”). They emphasized the caring nature of the profession and possessed both a desire and a sense of duty to care for others: You are the one that’s supposed to help heal, you know what I mean, you’re the one that’s taking care of the ones that are really hurting.

They found patient treatment and progress to be rewarding, and these goals motivated them to continue to work, even when they were experiencing pain: Because I enjoy what I do, and I enjoy working with the people that I work with, it’s almost like you want to be there. You want to see that patient get out of bed, you want to see that person walk because you’ve been investing all your time, and your patient’s, for this [moment].

The participants also experienced professional pressure to continue to work, and taking time off affected how they were perceived by their peers: I also think it’s perceived, perhaps by your staff or other people you work with, if you are not putting in that 100% that you’re not a good therapist.

They discussed asking others for help during activities that placed them at risk of further pain or injury. However, they were divided on whether this practice was acceptable. Many participants said that asking others for help was acceptable: 912

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I’ve let go of having to transfer that 200-pound person by myself or kind of feeling like I don’t have to ask for help.

However, some participants either were unable to obtain help or thought that it took too much time to wait for help: I will admit, sometimes I don’t, because you’re waiting for 15 to 20 minutes before someone comes and helps you.

Work habits. Work-related pain affected the participants’ daily work habits despite the dedication and responsibility cited above. They adapted their work to compensate for their discomfort, making changes in how they organized their days and modifying the ways in which they performed treatment activities. They expressed concern about the effects of their pain on the quality of patient care and engaged in a process of reflection on their ability to provide effective patient care. The participants had enough professional autonomy to be able to make changes in their daily work processes. One common adaptation was altering the daily work schedule. They used strategies such as inserting supervisory tasks in between clinical visits, reorganizing appointments so that patients requiring more challenging treatment activities could be seen in the morning, scheduling appointments when several therapists were available to help with moving and treating patients, and arranging cotreatment sessions with occupational therapists and physical therapists: . . . I literally structure my day, especially if I’m having a bad day; I’ll structure my harder patients in the morning because I know that by the end of the day, I’m just not going to be there physically.

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Many therapists adapted by avoiding certain activities or altering treatment plans because of their symptoms. Typically, these measures were taken to reduce exertion associated with transfers, gait training, and manual therapy. One therapist stated: . . . sometimes you find yourself using, doing other things with them so you don’t have to transfer them.

Another explained: I’ll just do one trigger point, tell them to “breathe through it and then go stretch yourself.” I won’t stretch it manually, I’ll just have them do it themselves.

Others changed the ways in which they performed tasks while in pain by modifying the technique or the environment: It [pain] has made me more of a cautious therapist. And I don’t think I work with the children as physically as I used to. I rely a lot more on the equipment in the gym now; if I know that they’re a hard transfer from sit to stand, then I put them on the mat and then I just elevate the mat instead of picking them up myself, so then they can do it themselves.

Some therapists asked patients to do more than they normally would have. This practice was perceived as beneficial for the patients as well as themselves: I have a patient right now . . . and he walks like a turtle. I told him today that “my back is really hurting, you have to take bigger steps, and you have to help yourself more . . .”; he speeds up, so it helps him out. . . .

Most participants expressed deep concern about maintaining the quality of care of patients and asserted that their care was not compromised. They engaged in a process of June 2010

Impact of Work-Related Pain on Therapists reflection to assess whether working in pain or adapting their work affected the quality of patient care. Many indicated that they would stop practicing if they could not provide valuable and skilled treatment. One participant stated: I really try and assess whether I am being effective with them or not.

Some participants, however, provided examples of situations in which quality of care might have been affected by their symptoms: I have one home care case, and I complain about it, and I only have one, and I shouldn’t even be complaining. But I don’t want to go there; I want to go, like my heart’s there, but it’s a child with CP [cerebral palsy] who’s now 3 years old and he’s huge, and he has no trunk control, nothing, and I want to be there, but by the time I get there, I feel like I’m not being beneficial towards him. I hate to admit it, but my 4 to 6 (pm) patients might be getting gypped.

The effectiveness and necessity of using manual therapy (which increased pain) were debated at length. Therapists working in outpatient settings, in particular, varied in the amount of manual therapy they provided and whether they thought it was necessary. While discussing the use of exercise-based interventions instead of manual therapy, several participants asserted that patients expect hands-on manual treatment and that this expectation influences treatment decisions: I have people, colleagues that I work with, that they don’t really do a lot of manual therapy, and it shows up in their kind of work and patients are not satisfied.

Interactions between therapists and patients were influenced by the therapists’ symptoms. The participants thought that at times they had worse pain than their patients: June 2010

You ever have a patient complain to you and just look at them and think, “If you only knew.”?

Some therapists expressed irritation and decreased patience with their patients: Like when someone comes in to me and says, “Oh, I have tightness in my upper trap,” I mean honestly, my first reaction, the bubble says, “Suck it up.”

Patients also noticed therapists’ discomfort. One therapist explained:

ued to treat everyone who was assigned to them. Life outside of work. In addition to work-related effects of pain, the participants described many ways in which their symptoms affected them outside of work. The participants performed all or most job-related duties but endured significant consequences in their personal lives. Many returned home at the end of the work day or weekend too fatigued or in too much pain to participate in other types of activities. One therapist noted:

I had my (cervical) collar on; the patient’s like, “You’re gonna help me? Get me a new therapist—I’ll take that guy.”

The participants reported no specific incidents in which the safety of patients was compromised but expressed concern that it could be. In particular, they worried about their symptoms affecting their ability to transfer or move a patient safely: I’m always afraid that . . . I’m going to drop somebody; it’s all of a sudden going to happen and I’m going to drop someone.

They also were concerned for their own safety, and that concern interfered with clinical decision making (eg, “. . . the fear of hurting yourself more isn’t letting you do what you have to do.”). These daily changes in the work process and concerns regarding the quality of work reflected the less immediately obvious effects of pain on therapy services. The process of the work changed, but the visible output remained the same (ie, patients were still seen and cared for). Productivity, perhaps the most obvious measure of decreased work output, did not emerge as a primary theme. Most, although not all, of the participants stated that they did not reduce their patient case loads and contin-

I never took naps in my life before. I’m just so physically exhausted; you know, pain makes you tired, it really does.

In addition, they identified multiple psychosocial consequences of pain, including depression, sadness, anxiety, frustration, and resentment (eg, “It [pain] makes me grumpy . . . complaining all the time.”). Activity limitations were pervasive and included decreased participation in leisure activities, activities of daily living, instrumental activities of daily living, and social activities. Some participants changed the ways in which they performed leisure activities, others changed the types of activities, and some no longer engaged in activities that were important to them: I haven’t been backpacking in I don’t know how long because the idea of having a 40-pound backpack, you know, I can’t do it. So those kinds of activities that bring me so much joy, I’m not able to do. . . .

Some participants reported that vacations required special planning. Travel was a distinct consideration for some, who worried about an increase in symptoms while flying or driving. Others considered the effect of vacation activities on their pain

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Impact of Work-Related Pain on Therapists and whether they would be able to return to work after the vacation. A few reported that they did not change their leisure activities and often experienced pain as a result. Work-related pain affected activities of daily living and instrumental activities of daily living, including rest and sleep, health management, home management, child rearing, decisions about whether to have children, and community mobility, in several ways. Health management was mentioned by almost all participants in all groups. In particular, eating, exercise, and weight gain were prominent topics: Sometimes if you’re in that much pain, you’re going to limit what you’re doing for your workout, ’cause you’re already doing your workout at work, and when you’re in pain, you’re like, “I’m not doing any more.”

Although most therapists limited exercise because of pain, 2 participants remarked that they exercised more: . . . last night I got out of work, I forced myself on a Friday to work out for an hour 15 minutes because it makes me feel better.

The participants asserted that pain affected their appetite and ability to control their weight. In fact, most reported weight gain since the onset of their work-related pain and attributed it to a reduction in physical exercise and a change in eating habits. Several therapists reported craving carbohydrates and other “comfort foods” as a way to cope with their physical and emotional symptoms. This behavior conflicted with their self-image of athleticism: I’ve put on a lot of weight. I’ve put on, I think, 15 to 25 pounds this year because I haven’t been able to do what I want to do.

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ipants were limited in their ability to cook, clean, and participate in home maintenance and, in some cases, relied on their partners to take over: I agree. It’s like, “OK, you want dinner, I’m not cooking it.” I can’t stand, and it’s even if I do make dinner, like the kitchen’s a disaster because I can’t stand to wash the dishes because that just puts me over the edge, that static standing.

Only 2 participants mentioned their children. In each case, pain affected their interactions with them: Sometimes like at the end of the day if I’m working early mornings or an afternoon and I come home, he’ll always want to jump and wrestle . . . but sometimes I can’t.

Some of the participants without children worried about managing the demands of child care with pain: We don’t have kids yet, but sometimes it’s kind of sad to think [about] having a major headache, or not being able to run with them, or not being able to be as patient.

Most participants experienced limited engagement in social lives. To some, this was most evident in their interpersonal communication with significant others: You don’t want to talk to anybody. You talk to the people at work, and then you don’t want to talk to anyone at home, ’cause you’re upset that you’re in pain, and you’re tired.

Career plans. Work-related pain affected long-term planning by the participants. Reflections on the future included fear and anxiety about the ability to continue this career, planning for a different career, and planning for a different direction within the profession of occupational therapy or physical therapy. Most participants were satisfied with their jobs, enjoyed working with patients, and found their work rewarding. One major concern, however, was longevity. Most participants doubted their ability to work in a clinical capacity for much longer and expressed fear and anxiety about their professional future. Often, the anxiety represented fear of the future and their ability to continue to practice (eg, “. . . I’m 33 years old and I’m thinking, ‘Oh, God, am I going to last?’ . . .”). They described frustration with their pain, and some felt resentment or anger toward patients, whom they perceived placed them at risk: I’m holding her up, so I was concerned that she could end up on the floor and I could end my career, and I was resentful. . . . I was mad. I was mad at her.

Some were actively considering leaving the profession: I told you I’m out. . . . In like 2 years, I’m out . . . something completely different.

You’ve been able to accomplish all these major goals in your life, and then it’s just too much to go out to dinner and you feel bad. I feel really bad for my [partner] sometimes.

I don’t know if OT [occupational therapy] is for me in terms of the work that I’m doing because I’m 30 and I’m not sure if I’m already having these issues, what’s going to happen, so it’s been really, really challenging.

Others reported significant limitations in social activities:

Others were planning on staying in the profession in different capacities:

. . . for me, when it comes to do something fun, if it is not a mandatory thing I’m less apt to do it.

I’ve gone back to the doctoral program. So if the day comes that I can’t be manually treating patients, then I’ll

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Impact of Work-Related Pain on Therapists have some options to still be within the field and maybe in the education realm instead of the clinical end of it.

Among participants who experienced anxiety about their professional careers, some questioned their career choice, others expressed concern about making a career change, and many had fears about their future: I’ll admit there are some days when I go home, my body hurts, and I don’t understand why I chose this profession. So that’s the honest truth. When you’re in that much pain, you’re like, “Why am I doing this to myself?” I worry about what’s the next step. Do I cut back my hours more and more?

Despite the levels of work-related pain noted by the participants, almost all of them thought that work was rewarding. They were satisfied with their jobs and valued the caring aspect of their work. Most participants enjoyed contact with patients and reported that caring for patients improved their mood and sometimes their symptoms: You go to work and you love your patients. This is what makes you feel good. You know? I like going to work.

Many were concerned about having to do something else and did not want to leave the profession, but acknowledged the physical demands of the work: I love what I do, I really enjoy it, and I want to continue it. I don’t see myself doing anything else, but yeah, you need to be strong.

Discussion The aims of the present study were to explore the experiences of therapists who continue to work while in pain and to examine the interactions between working in pain and work activities, career planning, job satisfaction, and quality of life. ParticiJune 2010

pants shared their insights on all of these topics, and our thematic analysis revealed the complexities of work-related pain in therapists. We were able to develop a conceptual model of pain that encompassed the wide-ranging and substantial effects of work-related pain. Conceptual Model of Pain in Therapists The emergent themes were interrelated and reflected more global areas for study. Impaired presenteeism and its relationship to quality of care, quality of life, and professional culture are important topics to examine in light of the findings of the present study. Figure 2 is a conceptual model of pain in occupational and physical therapists. In this model, therapists develop work-related pain but maintain a relatively full case load because of their professional ideals (professional identity and responsibility to others). Rather than burden coworkers or sacrifice patient care, they adapt their work processes and change their treatment approaches. Continuing to work in pain affects life outside of work, in particular, participation in social and health management activities. Both being unable to manage health and continuing to work at full productivity can lead to more pain. The difficulties of working with pain, altered personal lives, and concerns about quality of care force therapists with pain to reconsider their career plans. Although there is no direct relationship between professional ideals and work-related pain, ideals influence other factors in ways that can perpetuate the pain cycle. Professional Culture The present study illustrates the complexity of the experience of work-related pain in physical therapists and occupational therapists. Work-related pain profoundly affected daily work and participation in nonwork activities. Despite their

pain, therapists performed workrelated activities that they considered to be risky on an almost daily basis. They considered working with patients, manual therapy, and other tasks to be significant risk factors for pain and experienced increased pain when performing these tasks. They made decisions about their personal health and safety, in part, on the basis of a culture of caring and a professional identity of athleticism, knowledge about musculoskeletal health, and expertise in working with patients. They felt pressure from others and placed pressure on themselves to place the needs of patients and coworkers above their own. These findings can be explained from the perspectives of professional culture and professional expertise. In a study of physical therapists who left the profession because of a work-related musculoskeletal disorder, Cromie et al9 reported that therapists viewed themselves as unlikely to experience an injury because they were young, athletic, and knowledgeable. They also blamed themselves for the work-related musculoskeletal disorder, assuming that they had made a mistake that resulted in the injury, and placed themselves at risk to meet the expectations of patients and colleagues. Alnaser21 reported that occupational therapists with a work-related musculoskeletal disorder also blamed themselves for the injury, thought that they could not report the injury, and experienced anger and depression as a result of the injury. This type of behavior can perpetuate a cycle of pain and work that could eventually limit career longevity. Like the therapists in the study of Alnaser,21 the therapists in the present study thought that they would have to decide shortly whether to change settings or even careers. They all continued to work

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Figure 2. Conceptual model of emergent themes.

with pain symptoms.

despite

increased

Professional ideals and virtues receive substantial attention in the therapy literature, and a strong emphasis on the needs of patients is common. Jensen et al22 developed a model of expert practice in physical therapy. Their model of expertise comprised 4 dimensions (knowledge, movement, clinical reasoning, and virtues). Virtues implied respect for patients and a willingness of therapists to place the needs of patients above their own. Such attitudes are recognized as being integral to suc916

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cessful practice. The therapists in the present study thought that they were placing the needs of clients above their own by treating them while they were experiencing substantial levels of work-related pain. One could argue, however, that clients have the right to be treated by therapists who do not need to modify treatment, avoid certain activities, or worry about moving, lifting, or transferring clients safely because of work-related pain. Physical therapists and occupational therapists may be misinterpreting the very professional ideas that they are struggling to achieve. Placing the needs of

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clients first may mean they should not treat clients when their pain is so severe that it forces them to change the treatment plan. Future discussions of expert practice and professionalism should include more careful consideration of the health of physical therapists and occupational therapists and its relationship to quality of care. Impact of Work-Related Pain on Work The impact of work-related pain on work is not as easy to define. The participants made substantial changes in their work habits. They June 2010

Impact of Work-Related Pain on Therapists altered their schedules, avoided or adapted certain techniques, and factored their symptoms into clinical decision making. Other authors reported similar findings for physical therapists and occupational therapists.1,2,7 Despite these changes, decreased productivity did not emerge as a major theme. Few participants reported seeing fewer patients or working fewer hours. These findings were supported by the WOS of the SPS; work output remained fairly constant, with productivity at or above 90% for most participants. Physical therapy and occupational therapy are knowledge-based professions, but productivity may be viewed as the number of patients treated or as billable units completed. Our participants were able to make significant changes to compensate for their symptoms and to continue to see the same number of patients. The work impairment measures, however, revealed substantial impairments. The participants in the present study had a mean WIS of 35.1%. Turpin et al17 studied people who had a variety of health conditions and who worked in both knowledge-based and productionbased jobs. Their reported mean WISs for participants with arthritis and joint pain were 18.7% for knowledge-based jobs and 22.5% for production-based jobs. The mean WIS in the present study, therefore, was very high. According to Turpin et al,17 the WIS may provide a more precise indication of how health impairments affect work than the WOS. In the present study, the scores may have reflected effects on non– patient care activities. Therapists engage in non–patient care activities that may not be captured by measures of productivity.1,8,23 These include documentation, program development, quality initiatives, committee work, marketing, education, June 2010

and professional development. We did not specifically discuss these activities during the focus group sessions and cannot know whether these activities are affected by workrelated pain. However, the WIS may reflect such measures more completely than the WOS. The effects of pain on non–patient care activities require further exploration. The effects of these changes on quality of patient care also are unclear. Although several therapists implied that patient care was compromised, most emphasized that they reflected on their modifications to be sure that they were treating patients appropriately. Although the therapists made changes to ease their symptoms, they were still experiencing moderate to severe pain at the time of the focus group sessions. The modifications that they made were not adequate to prevent exacerbation of their work-related pain. The pervasive effects of work-related pain on activities outside of work affected therapists’ quality of life. Quality of life is characterized by an individual’s perceptions of his or her function in the physical, psychological, and social domains of health.24 Moderate to severe pain and loss of vitality (eg, fatigue) are associated with decrements in overall healthrelated quality of life. Decreased health-related quality of life also has been associated with limited selfcare ability and inability to perform activities associated with one’s primary role, such as work, school, or home management.25 Like the participants in Alnaser’s study of occupational therapists,26 the participants in the present study experienced work-related pain and fatigue that affected their interactions with friends and family, their leisure activities, their health management, and their ability to participate in social activities. Health-related quality of life in physical and occupational therapists

with pain should be studied further with larger samples. Most of the participants found their jobs to be rewarding and, in general, reported satisfaction with their career choices. These findings were consistent with the literature.27–29 Therapists value interactions with their patients and the caring nature of their professions.9,22,26 They promote client centeredness and client responsibility.9,30 Most participants in the present study reported that contact with patients and caring for others contributed to their job satisfaction, improved their mood and, in some cases, reduced their pain. Alarmingly, however, most participants expressed doubt that they could continue in their professions over the long term, and many were considering alternative careers. Current demographic trends and current rates of education and retirement predict significant shortages of physical therapists and occupational therapists.11 Patients are older and heavier and often have more medically complex issues that will require the care of experienced therapists. Therefore, experienced occupational therapists and physical therapists who are able to remain in the professions for long career spans are needed. Differences Between Occupational Therapists and Physical Therapists The differences between occupational therapists and physical therapists require consideration. Physical therapy and occupational therapy have different professional orientations and goals. Research has indicated that occupational therapists and physical therapists have similar risks of injuries from similar types of activities.1 Despite these similarities, we examined the data for distinct and specific experiences of the 2 professions. Differences were diffi-

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Impact of Work-Related Pain on Therapists cult to detect, and the experiences of the participants appeared to be similar. However, 2 phenomena that were specific to 1 discipline or the other did emerge. The occupational therapists in the present study cited pressure to prove themselves. They moved and transferred patients without asking for help because they felt pressure to demonstrate to other health care providers that they were just as capable of transferring patients as physical therapists. Another difference was the discussion of manual therapy by physical therapists. Manual therapy was cited by physical therapists as a source of pain, but it also was associated with a perception of higher quality of care. None of the occupational therapists in the present study worked in an outpatient, orthopedic setting, so there was no discussion of the role of manual therapy in their work. Our findings do not suggest that the professions are similar or that the job tasks are always similar. What they do suggest is that the work of both professions is physically demanding and that physical therapists and occupational therapists work within similar professional cultures. Limitations The participants volunteered for the present study, so their experiences may have been more intense than those of typical therapists with work-related pain. They tended to have more body regions affected by work-related pain and substantially higher levels of severity of pain than are typical for therapists with pain.1,3 In addition, although the number of participants was large for a qualitative study, generalizability was necessarily limited. However, our findings can serve as an illustration of the range of effects that work-related pain may have on physical therapists

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and occupational therapists who continue to practice with pain. One investigator knew 4 of the physical therapists professionally and 1 socially. This relationship may have affected their level of participation; analysis of the comments made by those participants revealed that they spoke more frequently and at greater length than other group members. The content of their discussions, however, did not differ from that of other participants. Recommendations Several additional studies are recommended. Larger, quantitative studies are needed to explore productivity, quality of care, quality of life, and career longevity in therapists with and without pain. Discussions about the relationship between professionalism and caring for patients while therapists are experiencing severe work-related pain also are recommended. Workers in a broad range of other occupations and professions experience work-related pain each year.31 Given that more than 50% of physical and occupational therapists experience work-related pain each year,1,3 many therapists will continue to treat patients while experiencing some degree of pain without an undue impact on the intervention. When work-related pain reaches levels that affect clinical decision making or increase frustration with clients, however, professionalism could be compromised. Therapists and clients may be better served if the therapists take time off work and address their pain more formally. This scenario will require more attention to staffing levels.

pacts of work-related pain and the physical nature of the work may limit clinical longevity. Large, national studies of work-related pain, the therapeutic activities associated with work-related pain, and the effects of work-related pain on work and nonwork activities are needed. In addition, the relationship between therapists’ adaptive behaviors and quality of care is worthy of further investigation. Aside from specific measures, a cultural shift in both professions is needed. Until the needs of therapists are considered in equal measure to the needs of patients, risky practices will continue and longevity may be compromised. The ability to practice over a long period of time without excessive effects on personal lives should be considered an important part of professionalism and expert practice. Both authors provided concept/idea/research design, writing, and data collection and analysis. Dr Campo provided project management, fund procurement, and facilities/equipment. The authors thank Paul Kochoa, PT, DPT, and Nitin Raju, PT, DPT, for their assistance with data entry, transcription, and focus group organization. The study was approved by the institutional review boards of Mercy College and The Ohio State University. This research was supported, in part, by a Mercy College Faculty Development Grant. No one involved with the grant review process had any involvement with the study or input into the way in which the study was designed or conducted. Data from this study were presented at the Safe Patient Handling and Movement Conference; March 31–April 2, 2009; Orlando, Florida; and at the APTA Combined Sections Meeting; February 9 –12, 2009; Las Vegas, Nevada. This article was submitted March 19, 2009, and was accepted January 24, 2010. DOI: 10.2522/ptj.20090092

Conclusions Work-related pain affects occupational therapists and physical therapists at work and outside of work. The physical and psychosocial im-

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Impact of Work-Related Pain on Therapists References 1 Darragh AR, Huddleston W, King P. Workrelated musculoskeletal injuries and disorders among occupational and physical therapists. Am J Occup Ther. 2009;63: 351–362. 2 Cromie JE, Robertson VJ, Best MO. Workrelated musculoskeletal disorders in physical therapists: prevalence, severity, risks, and responses. Phys Ther. 2000;80:336 – 351. 3 Campo M, Weiser S, Koenig KL, Nordin M. Work-related musculoskeletal disorders in physical therapists: a prospective cohort study with 1-year follow-up. Phys Ther. 2008;88:608 – 619. 4 West DJ, Gardner D. Occupational injuries of physiotherapists in North and Central Queensland. Aust J Physiother. 2001;47: 179 –186. 5 Glover W, McGregor A, Sullivan C, Hague J. Work-related musculoskeletal disorders affecting members of the Chartered Society of Physiotherapy. Physiotherapy. 2005;91:138 –147. 6 Bork BE, Cook TM, Rosecrance JC, et al. Work-related musculoskeletal disorders among physical therapists. Phys Ther. 1996;76:827– 835. 7 Holder NL, Clark HA, DiBlasio JM, et al. Cause, prevalence, and response to occupational musculoskeletal injuries reported by physical therapists and physical therapist assistants. Phys Ther. 1999;79:642– 652. 8 Campo M. Work-Related Musculoskeletal Disorders in Physical Therapists. New York, NY: Environmental Health Science, New York University; 2007. 9 Cromie JE, Robertson VJ, Best MO. Workrelated musculoskeletal disorders and the culture of physical therapy. Phys Ther. 2002;82:459 – 472.

10 Cromie JE, Robertson VJ, Best MO. Physical therapists who claimed workers’ compensation: a qualitative study. Phys Ther. 2003;83:1080 –1089. 11 Lacy A, Wright B. Employment outlook, 2008 –18: occupational employment projections to 2018. In: Monthly Labor Review. Washington, DC: Bureau of Labor Statistics, Department of Labor; November 2009. Available at: http://www.bls.gov/ opub/mlr/2009/11/art5full.pdf. 12 Patton M. Qualitative Evaluation and Research Methods. 2nd ed. Newbury Park, CA: Sage Publications; 1990. 13 Creswell JW. Qualitative Inquiry and Research Design: Choosing Among Five Traditions. Thousand Oaks, CA: Sage Publications; 1998. 14 Morgan DL. Focus Groups as Qualitative Research. Newbury Park, CA: Sage Publications; 1988. 15 Pilette PC. Presenteeism in nursing: a clear and present danger to productivity. J Nurs Adm. 2005;35:300 –303. 16 Koopman C, Pelletier KR, Murray JF, et al. Stanford Presenteeism Scale: health status and employee productivity. J Occup Environ Med. 2002;44:14 –20. 17 Turpin RS, Ozminkowski RJ, Sharda CE, et al. Reliability and validity of the Stanford Presenteeism Scale. J Occup Environ Med. 2004;46:1123–1133. 18 Glazer B, Strauss A. Discovery of Grounded Theory: Strategies for Qualitative Research. Chicago, IL: Aldine Press Inc; 1967. 19 Creswell JW. Research Design: Qualitative and Quantitative Approaches. Thousand Oaks, CA: Sage Publications; 1994. 20 Lincoln Y, Guba E. Naturalistic Inquiry. Beverly Hills, CA: Sage Publications; 1985.

21 Alnaser MZ. Psychosocial issues of workrelated musculoskeletal injuries and adaptation: a phenomenological study. Work. 2009;32:123–132. 22 Jensen GM, Gwyer J, Shepard KF. Expert practice in physical therapy. Phys Ther. 2000;80:28 – 43; discussion 44 –52. 23 Campo MA, Weiser S, Koenig KL. Job strain in physical therapists. Phys Ther. 2009;89:946 –956. 24 Testa MA, Simonson DC. Assesment of quality-of-life outcomes. N Engl J Med. 1996;334:835– 840. 25 Stewart ST, Woodward RM, Rosen AB, Cutler DM. The impact of symptoms and impairments on overall health in US national health data. Med Care. 2008;46:954 –962. 26 Alnaser MZ. Occupational musculoskeletal injuries in the health care environment and its impact on occupational therapy practitioners: a systematic review. Work. 2007;29:89 –100. 27 Meade I, Brown G, Trevan-Hawke J. Female and male occupational therapists: a comparison of their job satisfaction. Aust J Occup Ther. 2005;52:136 –148. 28 Hasselkus B, Dickie V. Doing occupational therapy: dimensions of satisfaction and dissatisfaction. Am J Occup Ther. 1994;38: 145–154. 29 Smith T. Job Satisfaction in the United States. Chicago, IL: NORC/University of Chicago; 2007. 30 Davis J. Occupational therapy students’ metaphors for helping. Am J Occup Ther. 2008;62:242–250. 31 Bureau of Labor Statistics. Workplace Injury and Illness Summary. Washington, DC: Bureau of Labor Statistics; 2008.

Appendix 1. Focus Group Questions

Groups 1 and 2 1. Tell us about any musculoskeletal pain or discomfort you are experiencing that you believe to be related to your work. 2. Has your pain affected you at work? 3. Has your pain affected you in other ways? 4. Do you believe that your experience is shared by other occupational therapists or physical therapists? 5. Is working while in pain different for physical therapists or occupational therapists than it would be for other professions? In what way? Groups 3 and 4 1. Tell us about any musculoskeletal pain or discomfort you are experiencing that you believe to be related to your work. 2. Has your pain affected you at work? 3. How physically demanding do you consider patient treatment to be? 4. How is your work-related pain affecting your career plans? 5. Have your symptoms affected you in other ways, outside of work? 6. Do you believe that your experience is shared by other occupational therapists or physical therapists?

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Impact of Work-Related Pain on Therapists Appendix 2. Emergent Themes

Professional Ideals Therapists’ sense of professionalism kept most of them from taking time off work or avoiding risky tasks. ● Professional identity 䡩 Therapists saw themselves as athletic and knowledgeable about injuries. They could diagnose and treat themselves. ● Responsibility 䡩 Therapists had a strong sense of responsibility toward patients and coworkers. ▫ Patients – Therapists were concerned about the quality and continuity of care. Activities and tasks could not be avoided just because the therapist was in pain. ▫ Coworkers – Avoiding certain patients or calling in sick places an unfair burden on coworkers. Work Habits Work-related pain had a wide range of effects on therapists each day at work. ● Adaptation 䡩 Therapists altered work schedules or specific treatment techniques. ● Patient care 䡩 Therapists were concerned about the effect of adaptation on quality of care but generally believed their patients were receiving the best care they could provide. Pain did affect therapist-patient interactions in some cases. Life Outside of Work Work-related pain affected therapists in several major areas of their lives outside of work. ● Leisure 䡩 Therapists avoided some previously enjoyable activities. They could not perform all of the activities they wanted to because of pain. ● Activities of daily living and instrumental activities of daily living 䡩 Pain had a wide variety of effects on therapists, including effects on sleep, health management, and the ability to exercise and gain weight. ● Social participation 䡩 Pain affected therapists’ ability to engage socially, including interactions with significant others. Career Plans Work-related pain affected the career outlook of all participants. ● Longevity 䡩 Most therapists did not think they could continue working in a clinical capacity much longer. ● Job Satisfaction 䡩 Almost all of the participants reported satisfaction with their jobs. They found therapy work to be rewarding.

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Research Report Detectable Changes in Physical Performance Measures in Elderly African Americans Kathleen Kline Mangione, Rebecca L. Craik, Alyson A. McCormick, Heather L. Blevins, Meaghan B. White, Eileen M. Sullivan-Marx, James D. Tomlinson

Background. African American older adults have higher rates of self-reported disability and lower physical performance scores compared with white older adults. Measures of physical performance are used to predict future morbidity and to determine the effect of exercise. Characteristics of performance measures are not known for African American older adults. Objective. The purpose of this study was to estimate the standard error of measurement (SEM) and minimal detectable change (MDC) for the Short Physical Performance Battery (SPPB), Timed “Up & Go” Test (TUG) time, free gait speed, fast gait speed, and Six-Minute Walk Test (6MWT) distance in frail African American adults.

Design. This observational measurement study used a test-retest design. Methods. Individuals were tested 2 times over a 1-week period. Demographic

K.K. Mangione, PT, PhD, GCS, is Professor, Department of Physical Therapy, Arcadia University, 450 S Easton Rd, Glenside, PA 19038 (USA). Address all correspondence to Dr. Mangione at: mangione@ arcadia.edu. R.L. Craik, PT, PhD, FAPTA, is Professor, Department of Physical Therapy, Arcadia University. A.A. McCormick, PT, DPT, was a DPT student in the Physical Therapy Program at Arcadia University at the time the study was completed. H.L. Blevins, PT, DPT, was a DPT student in the Physical Therapy Program at Arcadia University at the time the study was completed.

data collected included height, weight, number of medications, assistive device use, and Mini-Mental Status Examination (MMSE) scores. Participants then completed the 5 physical performance tests.

M.B. White, BA, was a DPT student in the Physical Therapy Program at Arcadia University at the time the study was completed.

Results. Fifty-two participants (mean age⫽78 years) completed the study. The

E.M. Sullivan-Marx, PhD, RN, FAAN, is Associate Professor and Associate Dean for Practice and Community Affairs, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania.

average MMSE score was 25 points, and the average body mass index was 29.4 kg/m2. On average, participants took 7 medications, and the majority used assistive devices. Intraclass correlation coefficients (ICC [2,1]) were greater than .90, except for the SPPB score (ICC⫽.81). The SEMs were 1.2 points for the SPPB, 1.7 seconds for the TUG, 0.08 m/s for free gait speed, 0.09 m/s for fast gait speed, and 28 m for 6MWT distance. The MDC values were 2.9 points for the SPPB, 4 seconds for the TUG, 0.19 m/s for free gait speed, 0.21 m/s for fast gait speed, and 65 m for 6MWT distance.

Limitations. The entire sample was from an urban area. Conclusions. The SEMs were similar to previously reported values and can be used when working with African American and white older adults. Estimates of MDC were calculated to assist in clinical interpretation.

J.D. Tomlinson, PT, MS, is Assistant Professor, Department of Physical Therapy, Arcadia University. [Mangione KK, Craik RL, McCormick AA, et al. Detectable changes in physical performance measures in elderly African Americans. Phys Ther. 2010;90: 921–927.] © 2010 American Physical Therapy Association

Post a Rapid Response to this article at: ptjournal.apta.org June 2010

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Physical Performance Measures in Elderly African Americans

A

frican American older adults have higher rates of selfreported disability and lower physical performance scores compared with white older adults. Racial differences in physical performance increase with age and are greater in women than in men.1 The prevalence of heart disease, diabetes, obesity, and arthritis also is greater in African Americans than in the white population.2,3 Although the management of each of these diseases includes recommendations for exercise,4 – 6 exercise studies targeting older African Americans are few in number and tend to focus on weight management7,8 and increasing physical activity.9,10 Elderly African Americans have not been studied in exercise trials.

properties are similar for older African Americans. Wolinsky and colleagues18 assessed reliability of the SPPB in a subsample of the African American Health Project, but the participants were all younger than 65 years of age. Older African Americans were included in the Women’s Health And Aging Study, but SPPB results were not differentiated by race.11,19 Therefore, the purpose of this study was to estimate the SEM (absolute reliability) and minimal detectable change (MDC) for the Short Physical Performance Battery (SPPB), free gait speed, fast gait speed, 6MWT distance, and Timed “Up & Go” Test (TUG) time in an understudied sample of elderly African Americans.

Method Measures of physical function are used, for example, to determine the effects of an intervention or to assign individuals to groups to predict future events such as hospitalization or mortality. Physical performance tests such as the Short Physical Performance Battery (SPPB) and the SixMinute Walk Test (6MWT) have been shown to be sensitive to change in older adult populations11–13 and predictors of morbidity.14 –17 Perera et al13 have reported the psychometric properties, including the standard error of measurement (SEM) and meaningful change, for the SPPB, gait speed, and 6MWT for several samples of predominantly white older adults. It is not known, however, whether psychometric

Available With This Article at ptjournal.apta.org

Study Design This was an observational measurement study that used a test-retest design to estimate the SEM for the physical performance tests. Written consent was obtained from all participants. Study Setting Individuals were tested 2 times over a 1-week period from January 2009 to May 2009. Participants were recruited from 2 sites: the West Oak Lane Senior Center and the University of Pennsylvania School of Nursing Living Independently for Elders Program. The sites are located in urban Philadelphia and provide social and recreational activities, health screenings and information, and hot meals. The University of Pennsylvania site is a Program of AllInclusive Care for the Elderly (PACE) participant and additionally offers primary care services, as well as rehabilitative and social services if needed.

• Audio Abstracts Podcast This article was published ahead of print on April 15, 2010, at ptjournal.apta.org.

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Participants This was a sample of convenience. Participants were recruited at the sites by word of mouth, by invitation Number 6

of the activity director, and by an advanced practice nurse. Sixty-two individuals volunteered. To be included, participants had to be 65 years of age or older, be ambulatory with or without an assistive device but not requiring human assistance, and identify themselves as African American. The exclusion criterion was a Mini-Mental Status Examination (MMSE) score less than 15. Demographic Measures At the first session, each participant reported his or her medical history, current medications, and assistive device use, which were verified with medication and medical records when available (73%). Study investigators (A.A.M., H.L.B., and M.B.W.) administered the MMSE and measured height and weight to calculate body mass index (BMI). Performance Measures Participants completed 5 performance measures in the following order during each testing session: SPPB, TUG, free gait speed, fast gait speed, and 6MWT. The SPPB is a composite of 3 timed tests: chair rise for 5 repetitions without the use of arms; standing balance in positions of side-byside stance, semi-tandem stance, and full tandem stance; and walking speed over a 2.44-m (8-ft) course. Each test is scored on a scale of 0 to 4, with a highest possible score of 12, indicating better function. The SPPB has been found to be predictive of disability and mortality.14,15 The TUG was performed by having the participants stand from a chair with armrests, walk 3.28 m (10 ft) away from the chair, then return and sit back down while being timed. Participants completed this measure twice, and the average of the 2 trials was used for data analysis. The TUG is predictive of falls and decline in activities of daily living in older people and has been found to have adequate reliability for clinical use.20,21 June 2010

Physical Performance Measures in Elderly African Americans Free gait speed and fast gait speed were measured by the Gait Mat II,* which measures spatial and temporal components of gait. Each participant was asked to walk at his or her “normal” speed across the mat for 2 trials and then as “fast as possible” for 2 trials. The 2 trials of free speed were averaged each session, as were the 2 trials of fast speed. The average speeds were used in data analysis. Gait speed can be used to predict subsequent disability and has adequate reliability for clinical use.22,23 The last performance measure was the 6MWT. Each participant was instructed to cover as much distance as possible in 6 minutes. The paths for the walk were each greater than 33 m (100 ft) long. Participants were given standardized encouragement after each minute and told how much time they had left to complete the test. The 6MWT has been found to be a measure of mobility in older adults, as well as a measure that helps to describe the impact of comorbidities on exercise capacity and endurance.24,25 Individually determined rest periods were provided for all participants. Testing time varied between 15 and 30 minutes. Blood pressure and heart rate were assessed for safety prior to each data collection session. Bias The examiners were not blinded to the purpose of the study or to the data collected. However, the examiners were trained on how to properly collect the measurements and were instructed not to familiarize themselves with the previous session data. Statistical Methods We estimated sample size based on a desired reliability coefficient of .90, * EQ Inc, PO Box 16, Chalfont, PA 189140016.

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as demonstrated by the Women’s Health and Aging Study sample,11 and an acceptable coefficient of .80. With a one-sided 95% confidence interval and 2 testing sessions and with ␣⫽.05, a minimum sample size of 21 was required.26,27 We oversampled to account for potential loss of participants during follow-up testing and to decrease the width of the resulting confidence intervals. Data were analyzed with Excel† and SPSS version 15.‡ Descriptive statistics were used to characterize the sample. We compared demographic and performance characteristics using unpaired t tests for participants who did and did not complete the testing. Means and standard deviations of the performance measures from time 1 and time 2 for all the tests were calculated. Relative reliability was determined using intraclass correlation coefficient (ICC [2,1]) for the SPPB and 6MWT distance and ICC (2,k) for averaged TUG time, averaged free gait speed, and averaged fast gait speed.28 The SEM was used to determine absolute reliability and was calculated with the following formula: SEM⫽sd公1⫺(ICC), where sd is the pooled standard deviation of the 2 testing trials. The 95% confidence intervals for SEM were estimated using the method reported by Stratford and Goldsmith.29 The MDC was computed from the SEM to indicate the amount of change needed to be confident that a true change occurred: MDC90⫽SEM ⫻ 1.65 ⫻ 公2. The MDC90 is associated with a 90% confidence level, meaning that typical variability in patients with stable performance could result in changes up to the MDC90. Any changes greater than the MDC90 value would be considered “real” change. † Microsoft Corp, One Microsoft Way, Redmond, WA 98052-6399. ‡ SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606.

Role of the Funding Source This study was funded by the Hartford Center of Geriatric Nursing Excellence–Jones Fund and by the Ellington Beavers Fund for Intellectual Inquiry. The funding sources were not involved in recruitment, data collection or analysis, or manuscript writing.

Results Sixty-two individuals met the inclusion criteria and gave their consent to participate in the study. Ten individuals (16%) failed to return for a second trial due to not being present at the center (n⫽6) or refusal to be retested (n⫽4). The 10 participants who did not complete the study were not statistically different (P⬎.05) from the other 52 participants in age, BMI, MMSE score, number of medications, or any of the performance measures. There was an average (SD) of 2.3 (0.5) days between testing sessions. Descriptive statistics for the sample are shown in Table 1. The total sample consisted of 52 participants (45 female, 7 male). The average age of the participants was 78 years. They had an average score of 25 points on the MMSE and an average BMI of 29.4 kg/m2, and they took an average of 7 medications. We recorded their medical conditions and reported the conditions that were present in at least 10 of the 52 participants. These conditions were hypertension, osteoarthritis, diabetes, renal disease, gastroesophageal reflux disease, visual impairment or blindness, peripheral vascular disease, stroke, dementia, anemia, congestive heart failure, and chronic obstructive pulmonary disease. From this list, the number of comorbid conditions an individual had ranged from 0 to 9, with the average number of conditions being 4.5. Sixty percent of the participants had an additional 1 to 2 medical conditions not reported here. Fifty-six percent

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Physical Performance Measures in Elderly African Americans Table 1. Description of Sample of African American Older Adults (n⫽52) Variable

Data

Age (y), X (SD)

78 (8)

Body mass index (kg/m2), X (SD)

29.4 (5.9)

Mini-Mental Status Examination (points), X (SD)

25 (4)

No. of medications, X (SD)

7 (4)

Sex, n (%) Female

45 (87)

Male

7 (13)

Discussion

Health conditions, n (%) Hypertension

42 (81)

Osteoarthritis

33 (63)

Diabetes

22 (42)

Renal disease

21 (40)

Gastroesophageal reflux disease

14 (27)

Visual impairment/blindness

13 (25)

Peripheral vascular disease

13 (25)

Cerebrovascular accident

12 (23)

Dementia

11 (21)

Anemia

11 (21)

Congestive heart failure

10 (19)

Chronic obstructive pulmonary disease

10 (19)

Assistive device, n (%) No assistive device

23 (44)

Cane

18 (35)

Rolling walker

11 (21)

of the participants used either a single-point cane or a rolling walker for assistance with ambulation. Mean values of the whole group for day 1 and day 2 of testing are presented in Table 2, along with the

cept for the SPPB score (ICC⫽.81). The SEM was 1.2 points for the SPPB; 1.7 seconds for the TUG; 0.08 m/s and 0.09 m/s for free and fast gait speed, respectively; and 28 m for 6MWT distance. The MDC90 values were 2.9 points for the SPPB, 4.0 seconds for the TUG, 0.19 m/s for free gait speed, 0.21 m/s for fast gait speed, and 65 m for 6MWT distance.

ICC, SEM, and MDC90 value for each test. Data from 48 participants were used for the analysis of free gait speed and fast gait speed due to technical malfunction of the Gait Mat II. Intraclass correlation coefficients were .90 or higher for all tests ex-

We have provided estimates of variability for commonly used physical performance measures for a group of older African Americans. Physical performance measures have not been reported on a sample similar to ours. Taaffe and colleagues30 reported gait speed on a subset of individuals who were well-functioning from the Health Aging and Body Composition Study. The sample had a mean age of 73 years, and mean gait speed values for the African Americans were 1.0 m/s for the women and 1.1 m/s for the men.30 Everson-Rose and colleagues31 reported SPPB scores from participants in the Chicago Health and Aging Project. On average, the sample was 74 years of age and scored 9.86 on the SPPB.31 Like the individuals reported in these studies, many of our participants were obese, based on an average BMI of 29.4 kg/m2. Our group also showed mild cognitive impairment, with the average MMSE score being 25 points. More than half of the sample used assistive devices,

Table 2. Physical Performance Measure Resultsa Time 1 Measure SPPB (points) TUG (s) Free gait speed (m/s) Fast gait speed (m/s) 6MWT (m)

Time 2

X (SD)

X (SD)

ICC (95% CI)

7.3 (2.8)

8.0 (2.9)

0.81 (0.66–0.89)

14.9 (8.7)

13.8 (7.7)

0.70 (0.29) 1.07 (0.38) 258 (115)

SEM (95% CI) 1.2 (1.0–1.5)

MDC90 2.9

0.96 (0.91–0.98)

1.7 (1.5–2.2)

4.0

0.69 (0.26)

0.90 (0.83–0.95)

0.08 (0.07–0.10)

0.19

1.09 (0.34)

0.93 (0.88–0.96)

258 (115)

0.94 (0.90–0.97)

0.09 (0.08–0.11) 28 (23.5–34.6)

0.21 65

a ICC⫽intraclass correlation coefficient, SEM⫽standard error of measurement, MDC90⫽minimal detectable change with a 90% confidence level, SPPB⫽Short Physical Performance Battery, TUG⫽Timed “Up & Go” Test, 6MWT⫽Six-Minute Walk Test.

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Physical Performance Measures in Elderly African Americans had an average free gait speed of 0.7 m/s, had multiple chronic conditions, and had an average SPPB score of 7. These values are associated with physical disability in walking 0.8 km (0.5 mile) and climbing stairs and needing help in activities of daily living.14,15 The results of this study are consistent with the values reported by other authors. Perera and colleagues13 reported SEMs of 1.42 points for the SPPB, 0.10 m/s for the 3.28-km walking speed, and 22 m for 6MWT distance. Ries and colleagues32 studied a sample of institutionalized older adults with dementia and reported SEMs of 2.48 seconds for the TUG, 20 m for 6MWT distance, and 0.06 m/s for gait speed. In people with advanced hip or knee osteoarthritis, the SEM for 6MWT distance was 26 m.33 Despite the different samples of older adults, the SEMs were very similar and suggest that African American and white older adults show similar variability in physical performance. Clinicians should be able to use the reported SEM values in clinical practice because the SEM represents how much a patient’s performance measurements vary if the test is repeated without any underlying change in the patient; that is, it represents measurement error. For example, a clinician administers the SPPB during a health screening event at a senior center, and an older adult scores an 8 on the test. If the individual is retested later that day, the SPPB score may be a 7, 8, or 9 (typical variability in performance, based on the rounded-off estimate of SEM⫽1). The score of 8 has been associated with an odds ratio of 7.6 for developing mobility disability within 3 years.34 This score would lead the clinician to advise the older adult to alter or begin an exercise program.

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The translation of measurement error (SEM) into numbers that can be used to evaluate the effectiveness of an exercise program, for example, is an area with little consensus. Some authors have advocated that the SEM be considered as the MDC or minimally important change after an exercise intervention.35,36 However, additional calculations and patient input have been used to define terms such as “minimal detectable change,”37 “minimally important change,”38 “small meaningful change,”13 “smallest detectable difference,”39 “minimal clinically important difference,”40 and “substantial meaningful change.”13 These terms connote that the change is real change and, in some cases, suggest that the change is meaningful for the person. Applying the MDC data to a patient example can highlight the complexity of interpreting clinical change. For example, did an older adult patient whose 6MWT distance increased by 42 m after completing a 1-month outpatient exercise program make a real change in endurance? According to the MDC90 of 65 m that we reported, the clinician could not be 90% confident that a real change occurred in 6MWT distance. Kennedy et al33 reported a similar value of 61 m as the MDC90 for 6MWT distance. Other clinical findings will likely support the impression that endurance has or has not improved. Researchers, however, more than clinicians, rely on a single primary outcome measure to determine the effectiveness of a program. For researchers, between-group statistical significance may be found even when within-group intervention changes are smaller than detectable change (65 m). Perera et al13 reported that distances of 50 m or more were “substantial meaningful change” and were calculated to help predict sample size for future exercise trials. The many ways to interpret clinical change warrants further study and discussion.

Of the tests that we have studied, we are least confident that the SPPB scores are suitable for detecting individual level change. The reliability coefficient was .81, which was the lowest value for the physical performance measures we tested. Additionally, a change of 3 points on the SPPB would entail an enormous increase in one area (gait speed, chair rise ability, or balance ability) or large increases in several areas. This magnitude of change might be evident in older patients acutely recovering from orthopedic surgery, but less likely in older adults who begin exercise or rehabilitation programs because of gradual declines in function. The SPPB was devised as a performance measure to be used in epidemiologic studies and appears better suited for group data. Gait speed, the TUG, and the 6MWT can be used for individual-level decisions in a wide sample of older adults. The slight variability in interpretations of detectable change in the literature may have to do with sampling and methods used. In the study by Ries and colleagues,32 consistent and frequent verbal cues were provided throughout the testing procedures to ensure that the patients with dementia were following the task. These commands may have decreased some of the testretest variability and thus explain their smaller MDC90 values. There are several limitations to this study. The sample was one of convenience, and although it represented a wide range in function and cognition, all of the participants were from an urban area and may not be representative of all older African Americans. We did not have information on social history or on educational level, which may have affected performance. The walking portion of the SPPB was conducted only once as was reported in the original article,14 but additional trials

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Physical Performance Measures in Elderly African Americans and longer lengths were recommended later. It is possible that repeated walking trials may have increased the stability of the SPPB scores; however, we used the same technique in each session. We also had an additional measure of gait speed and believe that our gait speed values accurately reflect performance. The testing sessions were not conducted in private, so the influence of other older adults or staff in the room may have affected performance on any particular day.

Conclusion The SEMs for the SPPB, TUG, free and fast gait speed, and 6MWT distance in elderly African American older adults were similar to reported values in samples of whites and can be used to estimate typical variability in performance. Estimates of MDC at the 90% confidence level were calculated to assist in clinical interpretation of change after exercise interventions. Dr Mangione, Dr Craik, Dr McCormick, Dr Blevins, and Dr Sullivan-Marx provided concept/idea/research report and writing. Dr Mangione, Dr Craik, Dr McCormick, Dr Blevins, and Ms White provided data collection. Dr Mangione, Dr Craik, Dr McCormick, Dr Blevins, Ms White, and Mr Tomlinson provided analysis. Dr Mangione and Dr SullivanMarx provided project management and fund procurement. Dr Mangione, Ms White, and Dr Sullivan-Marx provided participants. Dr Sullivan-Marx provided facilities/equipment and institutional liaisons. Mr Tomlinson provided consultation (including review of manuscript before submission). The study was approved by the institutional review boards of Arcadia University and the University of Pennsylvania. A subset of the sample data was presented orally at a local geriatrics meeting in Philadelphia. The data were presented orally at the Annual Meeting of the Gerontological Society of America; November 18 –22, 2009; Atlanta, Georgia, and as a poster at the Combined Sections Meeting of the American Physical Therapy Association; February 17– 20, 2010; San Diego, California.

Fund and by the Ellington Beavers Fund for Intellectual Inquiry. This article was received November 5, 2009, and was accepted February 25, 2010. DOI: 10.2522/ptj.20090363

References 1 Mendes de Leon CF, Barnes LL, Bienias JL, et al. Racial disparities in disability: recent evidence from self-reported and performance-based disability measures in a population-based study of older adults. J Gerontol B Psychol Sci Soc Sci. 2005;60: S263–S271. 2 African American Profile. 2009. http:// minorityhealth.hhs.gov/templates/browse. aspx?lvl⫽2&lvlid⫽51. Updated on October 21, 2009. Accessed on November 1, 2009. 3 Centers for Disease Control and Prevention, National Center for Health Statistics. Health, United States, 2006 With Chartbook on Trends in the Health of Americans. DHHS Publication 2006 –1232. 2006. Hyattsville, MD, US Department of Health and Human Services; 2006.. 4 Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005;143:659 – 672. 5 Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006;3: CD002968. 6 Bennell K, Hinman R. Exercise as a treatment for osteoarthritis. Curr Opin Rheumatol. 2005;17:634 – 640. 7 Murrock CJ, Gary FA. Culturally specific dance to reduce obesity in African American Women. Health Promot Pract. 2008 Dec 19 [Epub ahead of print]. 8 Agurs-Collins TD, Kumanyika SK, Ten Have TR, Adams-Campbell LL. A randomized controlled trial of weight reduction and exercise for diabetes management in older African-American subjects. Diabetes Care. 1997;20:1503–1511. 9 Resnick B, Luisi D, Vogel A. Testing the Senior Exercise Self-efficacy Project (SESEP) for use with urban dwelling minority older adults. Public Health Nurs. 2008;25:221–234. 10 Resnicow K, Jackson A, Braithwaite R, et al. Healthy Body/Healthy Spirit: a churchbased nutrition and physical activity intervention. Health Educ Res. 2002;17: 562–573. 11 Ostir GV, Volpato S, Fried LP, et al. Reliability and sensitivity to change assessed for a summary measure of lower body function: results from the Women’s Health and Aging Study. J Clin Epidemiol. 2002; 55:916 –921. 12 Perera S, Studenski S, Chandler JM, Guralnik JM. Magnitude and patterns of decline in health and function in 1 year affect subsequent 5-year survival. J Gerontol A Biol Sci Med Sci. 2005;60:894 –900.

This study was funded by the Hartford Center of Geriatric Nursing Excellence–Jones

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13 Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006;54:743–749. 14 Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85–M94. 15 Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995;332:556 –561. 16 Rostagno C, Olivo G, Comeglio M, et al. Prognostic value of 6-minute walk corridor test in patients with mild to moderate heart failure: comparison with other methods of functional evaluation. Eur J Heart Fail. 2003;5:247–252. 17 Alahdab MT, Mansour IN, Napan S, Stamos TD. Six minute walk test predicts longterm all-cause mortality and heart failure rehospitalization in African-American patients hospitalized with acute decompensated heart failure. J Card Fail. 2009;15: 130 –135. 18 Wolinsky FD, Miller DK, Andresen EM, et al. Reproducibility of physical performance and physiologic assessments. J Aging Health. 2005;17:111–124. 19 Ferrucci L, Guralnik JM, Salive ME, et al. Effect of age and severity of disability on short-term variation in walking speed: the Women’s Health and Aging Study. J Clin Epidemiol. 1996;49:1089 –1096. 20 Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000; 80:896 –903. 21 Okumiya K, Matsubayashi K, Nakamura T, et al. The timed “Up & Go” test and manual button score are useful predictors of functional decline in basic and instrumental ADL in community-dwelling older people. J Am Geriatr Soc. 1999;47:497– 498. 22 Jette AM, Jette DU, Ng J, et al; Musculoskeletal Impairment (MSI) Study Group. Are performance-based measures sufficiently reliable for use in multicenter trials? J Gerontol A Biol Sci Med Sci. 1999; 54:M3–M6. 23 Cesari M, Kritchevsky SB, Penninx BW, et al. Prognostic value of usual gait speed in well-functioning older people: results from the Health, Aging and Body Composition Study. J Am Geriatr Soc. 2005;53: 1675–1680. 24 Harada ND, Chiu V, Stewart AL. Mobilityrelated function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil. 1999;80:837– 841. 25 Enright PL, McBurnie MA, Bittner V, et al. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003;123:387–398. 26 Yeung TS, Wessel J, Stratford PW, MacDermid JC. The timed up and go test for use on an inpatient orthopaedic rehabilitation ward. J Orthop Sports Phys Ther. 2008;38: 410 – 417.

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Physical Performance Measures in Elderly African Americans 27 Stratford PW, Spadoni PF. Sample size estimation for the comparison of competing measures’ reliability coefficients. Physiother Can. 2003;55:225–229. 28 Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86:420 – 428. 29 Stratford PW, Goldsmith CH. Use of the standard error as a reliability index of interest: an applied example using elbow flexor strength data. Phys Ther. 1997;77: 745–750. 30 Taaffe DR, Simonsick EM, Visser M, et al. Lower extremity physical performance in hip bone mineral density in elderly black and white men and women: crosssectional associations in the Health ABC Study. J Gerontol A Biol Sci Med Sci. 2003; 58:934 –942. 31 Everson-Rose SA, Skarupski KA, Bienias JL, et al. Do depressive symptoms predict declines in physical performance in an elderly, biracial population? Psychosom Med. 2005;67:609 – 615.

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32 Ries JD, Echternach JL, Nof L, Gagnon Blodgett M. Test-retest reliability and minimal detectable change scores for the Timed “Up & Go” Test, the Six-Minute Walk Test, and gait speed in people with Alzheimer disease. Phys Ther. 2009;89:569 –579. 33 Kennedy DM, Stratford PW, Wessel J, et al. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005;6:3. 34 Vasunilashorn S, Coppin AK, Patel KV, et al. Use of the Short Physical Performance Battery Score to predict loss of ability to walk 400 meters: analysis from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2009;64:223–229. 35 Rejas J, Pardo A, Ruiz MA. Standard error of measurement as a valid alternative to minimally important difference for evaluating the magnitude of changes in patientreported outcomes measures. J Clin Epidemiol. 2008;61:350 –356. 36 Wyrwich KW. Minimal important difference thresholds and the standard error of measurement: is there a connection? J Biopharm Stat. 2004;14:97–110.

37 Binkley JM, Stratford PW, Lott SA, Riddle DL; North American Orthopaedic Rehabilitation Research Network. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. Phys Ther. 1999;79: 371–383. 38 de Vet HC, Terwee CB, Ostelo RW, et al. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change. Health Qual Life Outcomes. 2006;4:54. 39 Auleley GR, Benbouazza K, Spoorenberg A, et al. Evaluation of the smallest detectable difference in outcome or process variables in ankylosing spondylitis. Arthritis Rheum. 2002;47:582–587. 40 Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002;14:109 –114.

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Research Report A Computerized Adaptive Test for Patients With Shoulder Impairments Produced Responsive Measures of Function Dennis L. Hart, Ying-Chih Wang, Karon F. Cook, Jerome E. Mioduski D.L. Hart, PT, PhD, is Director of Consulting and Research, Focus On Therapeutic Outcomes, Inc, PO Box 11444, Knoxville, TN 37939 (USA). Address all correspondence to Dr Hart at: hart@ fotoinc.com. Y.-C. Wang, OTR/L, PhD, is Senior Data Analyst, Focus On Therapeutic Outcomes, Inc, Knoxville, Tennessee, and Postdoctoral Fellow, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Chicago, Illinois. K.F. Cook, PhD, is Research Associate Professor, Department of Rehabilitation Medicine, University of Washington, Seattle, Washington. J.E. Mioduski, MS, is Director of Programming, Focus On Therapeutic Outcomes, Inc, Knoxville, Tennessee. [Hart DL, Wang Y-C, Cook KF, Mioduski JE. A computerized adaptive test for patients with shoulder impairments produced responsive measures of function. Phys Ther. 2010;90:928 –938.] © 2010 American Physical Therapy Association

Background. Computerized adaptive tests (CATs) promise efficient outcomes data collection with little loss of measurement precision. The shoulder CAT has not been assessed for administrative efficiency, nor have prospective studies been completed to evaluate the sensitivity to change or the responsiveness of CAT-based functional status (CAT-FS) measures. Objective. The purpose of this study was to evaluate the efficiency and responsiveness of the shoulder CAT.

Design. This was a secondary analysis of prospectively collected data. Methods. Data were analyzed from patients with shoulder impairments who received outpatient rehabilitation in 518 clinics in 30 US states. Over the testing time, 30,987 patients completed the shoulder CAT at intake, and of these, 13,805 completed the CAT at discharge (45% completion rate). The efficiency of routine CAT administration was evaluated, and the sensitivity to change and responsiveness of CAT-FS measures were assessed.

Results. On average, patients took about 1.5 minutes (SD ⬍2 minutes) to answer 6 CAT items (SD⫽2), which produced precise estimates of CAT-FS measures that adequately covered the content range and had negligible floor and minimal ceiling effects. Ninety-four percent of the patients had CAT-FS scores between 20 and 80, where upper-level 95% confidence interval (CI) standard errors were between 3.2 and 4.6 (out of 100). Of patients with both intake and discharge data, 79% had CAT-FS change scores greater than minimal detectable change, and 76% had changes greater than minimal clinically important improvement.

Limitations. Because this study was a secondary analysis, the results may have been affected by patient selection bias. Future studies would benefit from more complete data. Conclusions. The results indicate the shoulder CAT was efficient and support the precision, sensitivity, and responsiveness of CAT-FS measures.

Post a Rapid Response to this article at: ptjournal.apta.org 928

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Responsiveness of Shoulder CAT Measures

M

easurement of patient-reported outcomes in health care is evolving, with patients and clinicians benefiting from the administrative efficiency and measure precision of computerized adaptive tests (CATs).1 A CAT is a method of collecting patient-reported outcomes in which a computer algorithm tailors the selection of items administered by matching item difficulty to the patient’s level of the trait being measured. A CAT administration stops when the patient’s estimated trait level meets specified criteria. The adaptive nature of CAT administration is an advantage in patientreported outcome assessment because CATs minimize the number of items that have to be administered to obtain a specified level of measurement precision. Thus, administrative burden is reduced, and measurement precision is maintained.1– 4

Computerized adaptive tests have origins in mental,5 educational,6 and military4 testing. More recently, CAT applications have been introduced in health care7,8 and rehabilitation,9 –21 including management of patients with shoulder impairments.18 Several factors positively influence increased use of CATs in rehabilitation, including the fact that national associations recommend outcomes collection and analysis,22 outcomes measures are common in outpatient rehabilitation,22 most patients have functional limitations that improve with therapy and can be measured,21,23 and payers expect justification for treatment.24 In previous work, we developed and simulated body part–specific CATs18–20 using retrospective analyses. The current study built on that work by testing administration efficiency and responsiveness of CAT-based functional status (CAT-FS) measures with prospectively collected data.9 –11 We evaluated the practical and initial psychometric adequacy of a CAT June 2010

used to assess FS. Participants were patients with shoulder impairments seeking rehabilitation in outpatient therapy clinics served by Focus On Therapeutic Outcomes, Inc (FOTO), an international medical rehabilitation outcomes database management company.25,26 For the purpose of this study, the latent trait of interest was shoulder FS, which we operationally defined as the patient’s perception of his or her ability to perform functional tasks described in the FS items.18 The FS item bank for the shoulder CAT18 was developed using items from the developmental pool for the Shoulder Flexi Scale.27 As such, measurements of FS estimated using these items represent the “activity” dimension of the World Health Organization’s International Classification of Functioning, Disability and Health.28

Data Collection Data were collected using Patient Inquiry computer software,* which the participating clinics used for routine data collection during patient management. Data were entered into computers located in the therapy facilities. Clinical staff collected initial demographic information and initiated computer data entry. Staff instructed patients to enter additional demographic data prior to the initial therapy evaluation. The shoulder CAT was administered to patients who reported having shoulder impairment. Patients completed CATs independently. Only patients who were proficient in reading and writing English entered data. Prior computer proficiency was not tested, but if the staff judged a patient as unable to use the computer, the CAT was not administered.

The purpose of this study was to assess: (1) administrative efficiency, content range coverage, and measurement precision and (2) sensitivity to change and responsiveness of FS measures estimated using the shoulder CAT.

We examined shoulder CAT data administered at intake and discharge. Each patient completed the CAT prior to initial evaluation; those data were labeled intake. When the CAT was administered at the end of rehabilitation, the data were labeled discharge.

Method Design We conducted a secondary analysis of data prospectively collected from patients with shoulder impairments prior to and at conclusion of rehabilitation. Setting and Participants Data were collected from a sample of convenience of patients (age 18 years or older) who independently (ie, without assistance from therapists or staff) completed the shoulder CAT. All patients received rehabilitation in outpatient clinics in the United States participating with FOTO (Knoxville, Tennessee).

Shoulder CAT The shoulder item bank has been developed, and in previous research we simulated administration of the bank using CAT.18,29 An operational version of the shoulder CAT was completed subsequently and is in use in clinics in the United States and * Focus On Therapeutic Outcomes, Inc, PO Box 11444, Knoxville, TN 37939.

Available With This Article at ptjournal.apta.org • Audio Abstracts Podcast This article was published ahead of print on April 15, 2010, at ptjournal.apta.org.

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Responsiveness of Shoulder CAT Measures Israel.12,30 Briefly, items in the shoulder CAT item bank represent functional activities such as “reaching overhead to a shelf.” Patients rate their ability to perform each activity using a rating scale of 5 levels (1–5) from “I can’t do this” to “no difficulty.” Unidimensionality and local independence of the 37-item bank were supported.18 Fit to the Andrich31 rating scale 1-parameter item response theory (IRT) model was supported. Item difficulty parameters supported a clinically logical hierarchical structure of the item bank. The CAT was developed following the logic of Thissen and Mislevy,32 using software developed specifically for the purpose of CAT development.33 The adaptive test started by administering the most informative34 item. After a patient responded to this initial item, his or her FS level was estimated with associated standard error (SE).35 This estimate served as the participant’s “provisional” level of FS. The final estimate occurred once the CAT stopped administering items based on either of 2 stopping rules: (1) SE for the provisional level of FS was less than 4 out of 100 FS units (FS estimates were scaled from 0 to 100 using a linear transformation, with higher FS measures representing higher functioning), or (2) change in provisional level of FS estimates for the last 3 items was less than 1 out of 100. The SE stopping rule of SE⬍4 is equivalent to ⬍0.31 standard deviation of the scale range. The final estimate of FS was labeled the CAT-FS. Data Analyses Patient selection bias. To assess the potential for patient selection bias introduced by incomplete data, we used the chi-square test with standardized deviates ((observed minus expected)/(square root of expected)) for categorical data and the Student t test for continuous variables to assess differences between patients 930

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who had both intake and discharge data compared with patients with just intake data.

improvement (MCII), defined as improvement considered important to the patient.37

Efficiency. We counted the number of items administered per CAT and timed each CAT administration to assess administrative efficiency: fewer items and less time represent higher administrative efficiency and less patient burden.

To estimate MDC, we first calculated the standard error of measurement (SEM) to estimate the amount of error associated with an individual patient assessment.38 The SEM reports measurement error in the same units as the original measurement and was calculated as the intake standard deviation times the square root of 1 minus the internal consistency reliability. Because there is no estimate of test-retest reliability using the shoulder CAT, we used internal consistency reliability (.99) and the associated standard deviation of 13 from the original developmental data set.18 To estimate the scale MDC and accommodate error associated with the difference between 2 measures39 at the 95% CI (confidence interval) (MDC95), we used the following formula: MDC95⫽1.96 ⫻ 公2 ⫻ SEM, where 1.96 represents the z value for a 95% CI.39

Measurement range coverage and item usage. We plotted shoulder CAT-FS score distributions at intake and discharge to assess how well the CAT-FS covered the measurement range of the scale. We assessed floor and ceiling effects of the scale at intake and discharge. We operationally defined a floor effect as a CAT-FS score from 0 to 5 and a ceiling effect as a CAT-FS score from 95 to 100. The numbers of patients at the extremes of the measurement continuum were tabulated, as were the number of patients who responded to all items with either the lowest response choice (floor) or to all items with the highest response choice (ceiling). Test precision. To quantify measure precision at CAT-FS levels, we calculated the average SE for patient CAT-FS estimates in 10 score ranges of the FS score continuum (ie, 0 –10, 11–20, . . . , 91–100) using the intake CAT-FS estimates. We plotted 95% CIs of the average SE estimates (average SE per FS level times ⫾ z value of 1.96) to provide a visual display that incorporates measurement precision. Assessing change in individual patients. We used 2 methods to quantify change. First, using a distributionbased approach,36 we calculated the minimal detectable change (MDC), defined as change greater than measurement error.37 Second, using an anchor-based approach,36 we calculated minimal clinically important

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The scale SEM is typically a single value that is an average estimate of measurement error for all levels of the trait being measured. This obscures the fact that a measure can be more precise in measuring some levels of the trait (typically, those near the mean) and less reliable in measuring others (typically, those at the ends of the distribution).40 Therefore, in addition to using a single SEM estimate to calculate MDC, we calculated MDCs for different FS levels by estimating 10 conditional standard errors of measurement (CSEMs): one CSEM for each of 10 scale ranges (0 –10, 11–20, . . . , 91– 100). To calculate each CSEM, we estimated the average SE associated with each of the 10 scale ranges using the intake CAT data (summed SEs divided by total number of SEs within each scale range) and multiplied the average SE per scale range by 1.96 and by the square root of June 2010

Responsiveness of Shoulder CAT Measures 2. The percentage of patients with change scores greater than the MDC95 was reported for each method of estimating MDC. We used an anchor-based approach to assess the clinically important improvement or responsiveness at the individual patient level.41 We used the global rating of change (GROC) scale described by Jaeschke et al42 as the comparison standard (anchor). Patients were asked about their perceived improvement at discharge. Using this 15-point scale (⫺7 to ⫹7), patients report deterioration (scores ⫺7 to ⫺1), no change (score of 0), or improvement (scores ⫹1 to ⫹7). Using receiver operating characteristic (ROC) analyses results, we calculated estimates of the MCII. Patients were dichotomized by their GROC scores as those who did not improve (GROC scores ⬍3) versus those who improved (GROC scores ⱖ3). We estimated MCII in 2 ways: (1) using all patients regardless of intake CAT-FS measure and (2) because change is dependent on baseline CAT-FS measures,9 –11,43– 47 using patients grouped by quartile of baseline CAT-FS scores. The MCII cut point for each analysis was identified by selecting the FS change score with the largest average specificity and sensitivity values ((specificity ⫹ sensitivity)/2). Area under the receiver operator curve (AUC), SE, and 95% CI were used to describe the ROC results. The percentage of patients whose CAT-FS change was equal to or greater than MCII was calculated for each of 5 ROC methods. As calculated, MCII represents the smallest observed improvement in those patients estimated to have clinically important improvement.37

Table 1. Patient Characteristics at Rehabilitation Intake (n⫽30,9 87 Patients)a Characteristic

Value

Diagnoses (%)b Soft tissue disorders of muscle, synovium, tendon, bursa, or enthesopathiesc (ICD-9 codes 725–729)

39

Postsurgical conditions, including tenotomy and repair of rotator cuff (CPT codes 23000 and 23929)

11

Sprains and strains, including shoulder region, acromioclavicular joint, and rotator cuff (ICD-9 code 840, including unspecified sprain or strain)

4

Fractures, including clavicle, scapula, and humerus (ICD-9 codes 810–812)

1

Arthropathies, including osteoarthroses and rheumatoid arthritis (ICD-9 codes 710–719)

1

Missing

40

Age (y), mean⫾SD, range

53⫾15, 18–100

18 to ⬍45 (%)

25

45 to 65 (%)

47

⬎65 to 75 (%)

14

⬎75 (%)

9

Missing (%)

5

Sex % female

51

Missing

5

Acuity of symptoms (%) Acute (0–21 days)

18

Subacute (22–90 days)

30

Chronic (⬎90 days)

47

Missing

5

Surgical history (%) None

70

1

25

2

3

3

1

ⱖ4

1

Missing

0

Exercise history (%) At least 3 times per week

39

1–2 times per week

26

Seldom or never

35

Missing

0 (Continued)

Results Data from 30,987 patients were analyzed (Tab. 1). All patients completed the shoulder CAT at intake, and of these patients, 13,805 completed the CAT at discharge (45% June 2010

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Responsiveness of Shoulder CAT Measures Table 1. Continued Characteristic

Value

Payer source (%) PPO

36

HMO

12

Workers’ compensation

11

Medicare part B

13

Indemnity

3

Medicaid

3

Medicare part A

4

Other

11

Missing

7

No. of functional comorbidities (%)

d

None or 1

34

2 or 3

29

4 or 5

18

ⱖ6

19

Missing

Improved (ⱖ3 to ⫹7)

15

Not improved (⫺7 to ⬍⫹3)

2

Missing

83

a HMO⫽health maintenance organization; PPO⫽preferred provider organization; ICD-9⫽International Classification of Diseases, 9th revision; CPT⫽current procedural terminology. b Diagnoses are groups of ICD-9-CM codes or surgical CPT codes. Providing diagnosis codes was optional, and only the most frequent codes are displayed, so the numbers do not sum to 100%. c Enthesopathies are disorders of peripheral ligamentous or muscular attachments. d Number of functional comorbidities were based on quartiles of 30 possible conditions.

completion rate).12 Intake CAT-FS measures averaged 51 (SD⫽15). For patients with both intake and discharge data, average FS intake scores were 51 (SD⫽15), discharge FS scores were 69 (SD⫽15), and FS change scores were 18 (SD⫽17), which produced an effect size ((discharge minus intake)/(standard deviation of intake)) of 1.2. All data (30,987 intake plus 13,805 discharge⫽44,792 CAT administrations) were used to test efficiency and content range coverage. All patients were treated for neuromusculoskeletal impairments of their shoulder. The patients received rehabilitation in 518 clinics in 30 states between August 2007 and July 2009. Patients received, on average, 11 (SD⫽11) visits over a treatf

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Efficiency When the CAT was administered (44,792 CAT administrations), on average, the CAT reached a stopping rule after 6 items were administered (SD⫽2, minimum⫽3, maximum⫽37, median⫽6). The average administration time was 1 minute 29 seconds (SD⫽90 seconds). Twelve (0.03%) patients used all 37 items.

0

Global rating of change (%)

932

conditions (standardized deviate⫽ 1.7). Compared with patients with only intake data, patients with complete (intake and discharge) data tended to be older (⬎65 years, standardized deviate⫽5.5), have one surgery (standardized deviate⫽ 4.0), and be receiving benefits from fee-for-service or Medicare part B (standardized deviate ⬎3.0).

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ment episode of 48 (SD⫽38) calendar days. There were differences between patients with just intake data and patients with both intake and discharge data (Tab. 2). For example, compared with patients with complete data, patients with just intake data tended to be younger (18 – 45 years of age, standardized deviate⫽6.7); be male (standardized deviate⫽1.6); have acute symptoms (standardized deviate⫽1.7); have no surgery (standardized deviate⫽1.9); be receiving benefits from Medicaid, health maintenance organizations, preferred provider organizations, or private pay (standardized deviate⬎2); or have 0 or 1 functional comorbid

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Measurement Range Coverage and Item Usage Of 30,987 intake CAT-FS estimates, no patient had a score of 0, and 581 patients (1.9%) had scores between 0 and 5. No patient scored 100 at intake, and 295 patients (1.0%) had scores between 95 and 100. Of 13,805 patients with discharge data, no patient had a score of 0, and 18 patients (0.1%) had scores between 0 and 5. No patient had a score of 100, and 1,409 patients (10.2%) had scores between 95 and 100. Four (0%) and 3 (0%) patients selected all lowest responses for all items administered by the CAT at intake and discharge, respectively, and 37 (0.1%) and 16 (0.1%) patients selected all highest responses for all items administered by the CAT at intake and discharge, respectively (Fig. 1). Test Precision When we plotted upper limits of 95% CIs using SEs estimated from intake CAT scores (scale of 0 –100) and percentage of patients per intake CAT-FS range, 94% of the patients had CAT-FS scores between 20 and 80, where the upper-level 95%

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Responsiveness of Shoulder CAT Measures Table 2. Comparisons of Patients Who Completed Intake and Discharge Computerized Adaptive Tests (CATs) Versus Patients Who Completed Intake CATs Onlya Intake CATs Only Variable

Intake and Discharge CATs

n

%

n

%

18–45

4,812

28

3,072

22

46–65

8,114

47

6,548

47

66–75

2,196

13

2,204

16

⬎75

1,273

7

1,267

10

787

5

714

5

Male

7,763

45

5,980

43

Female

8,632

50

7,111

52

Missing

787

5

714

5

Pb

Age (y)

Missing

⬍.001

Sex

.001

Acuity Acute

3,123

18

2,343

18

Subacute

5,040

29

4,186

30

Chronic

8,174

48

6,510

47

Missing

845

5

766

5

.002

Surgery None

12,160

71

9,389

68

1

4,043

24

3,674

27

2

599

3

478

3

3

169

1

113

1

ⱖ4

150

1

99

1

61

0

52

0

Missing

⬍.001

Exercise ⱖ3 times per week

6,673

39

5,373

39

1–2 times per week

4,534

26

3,607

26

Seldom

5,974

35

4,824

35

Missing

1

0

1

0

.96

Payer Fee-for-service

506

3

542

4

Litigation

27

0

18

0

Medicaid

587

3

258

2

Medicare part A

622

4

526

3

Medicare part B

2,022

12

2,109

15

182

1

97

1

HMO

2,168

13

1,280

9

PPO

6,395

37

4,764

35

Workers’ compensation

1,752

10

1,521

11

Other

1,897

11

1,642

12

Missing

1,024

6

1,048

8

0 or 1

5,923

34

4,531

33

2 or 3

4,867

28

4,060

29

4 or 5

3,055

19

2,596

19

ⱖ6

3,280

19

2,567

19

57

0

51

0

Patient

⬍.001

Comorbidities

Missing a b

.005

HMO⫽health maintenance organization, PPO⫽preferred provider organization. P values for chi-square statistic.

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Responsiveness of Shoulder CAT Measures measure was responsive and that MCII was dependent on intake CAT-FS baseline scores, with patients perceiving improvement with fewer CAT-FS units as intake CAT-FS scores increase.

Discussion The use of CATs is common in standardized testing for licensure, certification, and admissions tests.1 Only recently, however, have they been used to collect routine clinical data in outpatient rehabilitation clinics in the United States9 –11,13,21 and Israel12,30 to measure shoulder FS. The results of these studies suggested routine use of the shoulder CAT in daily clinical practice was feasible and efficient. The shoulder CAT reduced patient and clinician burden for outcomes data collection while producing precise and responsive measures of patients’ levels of the “activity” dimension, an important health-related domain of the World Health Organization.28 Figure 1. Shoulder computerized adaptive test functional status (FS) score distributions at intake and discharge.

CI SEs were between 3.2 and 4.6 (out of 100). Assessing Change in Individual Patients The estimated MDC95 was 3.60 (ie, 1.96 ⫻ 公2 ⫻ 13 ⫻ 公(1⫺0.99)) based on baseline SEM of 1.30 estimated using a SD of 13 and Cronbach alpha of .99 from the original development sample.18 A majority (79%) of the patients had changes in CAT-FS scores from intake to discharge that were greater than the MDC95. When estimating MDC using IRT estimated CSEMs per CAT-FS range, the mean upper limit 95% CI MDC95 values for all patients was 8.4, but the mean upper limit 95% CI MDC95 value for the 94% of patients with CAT-FS intake scores between 20 and 80 was 5.4: 76% of patients had improvement scores that ex934

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ceeded 5.4. Figure 2 presents the upper limits of MDC95 per CAT-FS range. There were 5,132 patients with both GROC and CAT-FS change data. Of these patients, 566 (11.0%) reported no change (GROC scores ⬍3) and 4,566 (89.0%) reported improvement (GROC scores ⱖ3). The ROC analyses (Tab. 3) indicated that 8 or more CAT-FS change units represented clinically meaningful improvement, and 10,463 (76%) patients with discharge data reported CAT-FS change equal to or greater than MCII. When patients were grouped by baseline CAT-FS measures and 4 ROC analyses were run (one per quartile of CAT-FS intake measures), 9,509 patients (69%) reported CAT-FS change scores equal to or greater than MCII. The results suggested that the shoulder CAT-FS

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Our results add to growing evidence supporting a transition from paperand-pencil outcomes data collection to CATs in clinical practice9 –13,21 and clinical trials.48,49 As CATs become more available for patients with shoulder impairments, studies should be conducted testing CAT implementation with respect to feasibility,9 –11,21 usability,12,13,30 and psychometric strengths9 –11,21 of the scores obtained. Current results and those of other studies9 –12,21 using CAT data from routine daily practice suggest the strengths of CAT that have been hypothesized18 are achievable in actual practice. The reduction in data collection burden possible with CATs and novel applications such as Internet-based testing may encourage the collection of multiple constructs simultaneously, such as FS, fear-avoidance beliefs of physical activities,50,51 and depression.52 Resulting databases should support multivariate patient classification and clinical decision makJune 2010

Responsiveness of Shoulder CAT Measures ing,53 which are encouraged by the World Health Organization.54 One of the benefits of using IRT methods to assess clinical outcomes data is that for each measure, such as FS, an estimate of measurement error (SE) is produced. The current results suggest that measurement error is dependent on level of FS (Fig. 2), and CAT-FS scores were most precise between scores of 20 and 80. In this score range, upper limits of 95% CI SEs were between 3.2 and 4.6 (out of 100). This result is positive because the majority (94%) of patients have FS scores where the measurement error is least (ie, between FS scores 20 and 80). The shoulder CAT was designed for the purpose of assessing FS change in patients with shoulder impairments receiving therapy in rehabilitation clinics. As such, the shoulder CAT represents a condition-specific outcomes scale. The research team started with items from an existing paper-and-pencil survey27 that were conceptually well-designed. Retrospectively, modern psychometric methods were applied, with good results.18,29 As compared with more generic health-related quality-of-life scales,55 measures estimated using conditionspecific scales tend to be more

Figure 2. Shoulder computerized adaptive test functional status (CAT-FS) measure minimal detectable change (MDC) 95% confidence interval upper limits and percentage of patients per CAT-FS range at intake (n⫽30,987). Percents⫽percentages of patients in 10 score ranges of the FS score continuum (ie, 0 –10, 11–20, . . . , 91–100) using the intake CAT-FS estimates. MDC95⫽ 1.96 ⫻ 公2 ⫻ CSEM, where 1.96 represents the z value for a 95% confidence interval and CSEM is conditional standard error of measurement. Note that, under item response theory, the standard error varies by level of functional status. Therefore, different score ranges have different magnitudes of standard errors. Extreme scores are likely to have larger standard errors because of less information obtained from patients at the extreme (ie, patients who are very low or high functioning).

sensitive to change and responsive for patients with shoulder impairments.56 To assess important change in the CAT-FS measures, we used: (1) distribution-based methods based

on IRT techniques that allowed assessment of measure precision by level of FS using standardized metrics of change and (2) anchor-based methods that controlled for baseline

Table 3. Responsiveness Estimates Using Receiver Operating Characteristic Analysesa No. of Patients Improved (Change >3)

No. of Patients With No Change (Change <3)

ROC Cut Point

AUC

SE

95% CI

% >MCII

All patients

4,566

566

8

.791

.010

.772, .811

76

Intake FS 0 to 43

1,247

140

23

.808

.019

.771, .845

92

912

118

10

.834

.019

.798, .871

81

Sample by Intake FS Scoreb

Intake FS ⬎43 to 52 Intake FS ⬎52 to 60

1,346

169

5

.818

.018

.783, .853

72

Intake FS ⬎60 to 100

1,061

139

2

.807

.017

.774, .840

56

a FS⫽functional status, ROC⫽receiver operating characteristic analysis, AUC⫽area under the ROC curve, SE⫽standard error, CI⫽confidence interval, MCII⫽minimal clinically important improvement. b All FS scores were estimated using the shoulder computerized adaptive test.

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Responsiveness of Shoulder CAT Measures functional status measures.9 –11 The results supported measure precision for most of the measurement range and MCII that was affected by baseline score. To our knowledge, the shoulder CAT is the first condition-specific CAT assessing FS for patients with shoulder impairments. However, another CAT that can be used in rehabilitation of patients with upper-extremity impairments is the Activity Measure for Post-Acute Care (AM-PAC), which is not condition-specific but provides a comparison for the shoulder CAT. In a sample of patients with similar characteristics (age, percentage female, surgical history, convenience sample from outpatient rehabilitation clinics) with upper-extremity (ie, area of specific impairment, such as shoulder, elbow, or wrist/hand not described) impairments, effect sizes were 0.34 for the Basic Mobility Scale and 0.60 for the Daily Activity Scale21 compared with an effect size of 1.2 for the shoulder CAT-FS measure. Our results add to the evidence that baseline data should be considered when assessing measure sensitivity to change and responsiveness in rehabilitation data.9 –11 Specifically, improvement between 2% and 23% of the shoulder CAT scale (Tab. 3) represented clinically important improvement depending on baseline measures. Not only is this finding statistically relevant, but also the findings are clinically logical, as it could be hypothesized that those patients with low functional abilities (ie, low intake CAT-FS scores) might need more improvement before that improvement is considered important compared with those with high CAT-FS scores, who might consider smaller improvements important. However, this hypothesis needs further testing. Regardless of future results, given the movement toward value-based purchasing24,57,58 of reha936

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bilitation services, improved responsiveness of measures may become increasingly important to clinicians, patients, payers, and policy makers. Because FS is estimated using a CAT application based on IRT methods, clinical and research application of levels of sensitivity to change and responsiveness may not be obvious. Because measurement error (SE or CSEM) is dependent on level of FS, use of a single estimate of error for the scale is not recommended. Because multiple estimates of measurement error complicate assessment and use of sensitivity to change (MDC), computer application is recommended where change in FS can be interpreted in comparison with the amount of measurement error related to initial (ie, intake) estimate of FS. The computer can automatically identify when the amount of FS change is greater than measurement error. If the clinician or researcher does not use a computer, estimates of MDC (Fig. 2) can be used in a manual application. Similarly, MCII cut scores can be applied to FS change scores given intake FS estimates to determine whether the change is expected to be important to the patient (Tab. 3). Again, computer application is recommended to reduce user burden, but a computer is not necessary. In any event, clinicians and researchers can assess whether their patient’s change is greater than measurement error or potentially important to the patient using MDC and MCII data. Limitations and Future Studies One limitation of the data collected in the routine clinical settings is the lack of control of data completion. In the current study, the percentage of patients with intake data who also had discharge data, or completion rate,12 was 45%. There also was a considerable amount of missing data for many variables, including patient demographics, diagnostic codes, and

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GROC scores. The use of an observational study based on a sample of convenience has the potential for patient selection bias and reduced generalizability of results.59 Compared with patients with just intake data, patients who had both intake and discharge data were different by age, symptom acuity, payment sources, surgical history, number of comorbid conditions, and intake CAT-FS scores. These differences might have influenced the results. Future studies should endeavor to reduce this potential for bias by using more complete data sets. Nonetheless, the results in this study were generated from 30,987 patients with shoulder impairments who were receiving outpatient physical therapy in 518 clinics in 30 US states, suggesting the results may be generalized to similar outpatient rehabilitation clinics. In our original development study,18 we identified the need to expand the item bank with new, more difficult items, as well as easier items, in an effort to reduce measurement error (large SEs that affect MDC) at high and low FS levels and address the potential for ceiling or floor effects. Results from the current analyses (10.2% of patients at discharge had scores between 95 and 100) underscore the need for more items in the item bank that target higher levels of shoulder function. We have begun seeding new, more difficult items in our CAT. Future analyses will evaluate whether the new, more difficult items reduce ceiling effects. Another limitation of patientreported outcomes is the challenge of collecting data from patients with limitations in reading ability or cognitive status, both of which influence outcomes data collection.12,13,60 Instructions to clinicians and staff emphasized the need to identify patients with reading or cognitive difficulties related to CAT applications, but no data were collected to June 2010

Responsiveness of Shoulder CAT Measures assist in these analyses. Continuing studies are needed to explore these issues. We estimated the scale SEM (1.3) using the standard deviation (13) and internal consistency reliability coefficient (.99) from the original development sample.18 Because we anticipate the test-retest reliability coefficient of shoulder CAT estimated measures of FS to be less than the internal consistency reliability coefficient, a scale SEM estimated using the test-retest reliability coefficient would be expected to be larger than the reported SEM and subsequent MDC95. In our analyses, we also estimated measurement error using conditional standard error of measurement, with SEs estimated using item response theory methods, which provided another way of conceptualizing measurement error. Because measurement error is dependent on level of functional ability, we caution against use of one estimate of measurement error, such as in a scale SEM.18 Finally, data from the shoulder CAT were collected using a proprietary database management company, FOTO Inc,25,26 and, as in almost all investigations, there is the potential for bias. However, use of proprietary database management companies offers the opportunity for studies related to practical application and psychometric adequacy of CATs in large samples9 –13,21 that would not be available under routine extramurally funded projects. Dr Hart and Dr Cook provided concept/idea/ research design. Dr Hart, Dr Wang, and Dr Cook provided writing. Dr Hart and Mr Mioduski provided data collection. Dr Hart provided data analysis and project management. Dr Wang provided consultation (including review of manuscript before submission).

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The Focus On Therapeutic Outcomes, Inc Institutional Review Board for the Protection of Human Subjects approved the project. Dr Hart is an employee of and investor in Focus On Therapeutic Outcomes, Inc, the database management company that manages the data analyzed in this study. Dr Wang and Mr Mioduski also are employees of Focus On Therapeutic Outcomes, Inc. Mr Mioduski manages the database from which the data analyzed in this study were selected. This article was received October 19, 2009, and was accepted February 26, 2010. DOI: 10.2522/ptj.20090342

References 1 Wainer H, ed. Computerized Adaptive Testing. A Primer. 2nd ed. Mahway, NJ: Lawrence Erlbaum Associates; 2000. 2 Hambleton RK, Swaminathan H, Rogers HJ. Fundamentals of Item Response Theory. Newbury Park, CA: Sage Publications; 1991. 3 Hays RD, Morales LS, Reise SP. Item response theory and health outcomes measurement in the 21st century. Med Care. 2000;38:II28 –II42. 4 Sands WA, Waters BK, McBride JR, eds. Computerized Adaptive Testing. From Inquiry to Operation. Washington, DC: American Psychological Association; 1997. 5 Lord FM, Novick MR. Statistical Theories of Mental Test Scores. Reading, MA: Addison-Wesley; 1968. 6 Lord FM. Some test theory for tailored testing. In: Holtzman W, ed. ComputerAssisted Instruction, Testing, and Guidance. New York, NY: Harper & Row; 1970:139 –183. 7 Ware JE Jr, Bjorner JB, Kosinski M. Practical implications of item response theory and computerized adaptive testing: a brief summary of ongoing studies of widely used headache impact scales. Med Care. 2000;38:II73–II82. 8 Ware JE Jr, Kosinski M, Bjorner JB, et al. Applications of computerized adaptive testing (CAT) to the assessment of headache impact. Qual Life Res. 2003;12:935–952. 9 Hart DL, Wang YC, Stratford PW, Mioduski JE. Computerized adaptive test for patients with knee impairments produced valid and responsive measures of function. J Clin Epidemiol. 2008;61:1113–1124. 10 Hart DL, Wang YC, Stratford PW, Mioduski JE. Computerized adaptive test for patients with foot or ankle impairments produced valid and responsive measures of function. Qual Life Res. 2008;17:1081–1091. 11 Hart DL, Wang YC, Stratford PW, Mioduski JE. A computerized adaptive test for patients with hip impairments produced valid and responsive measures of function. Arch Phys Med Rehabil. 2008;89:2129 –2139.

12 Deutscher D, Hart DL, Dickstein R, et al. Implementing an integrated electronic outcomes and electronic health record process to create a foundation for clinical practice improvement. Phys Ther. 2008; 88:270 –285. 13 Hart DL, Connolly JB. Pay-for-Performance for Physical Therapy and Occupational Therapy: Medicare Part B Services. Grant 18-P-93066/9 – 01. Washington, DC: Department of Health and Human Services, Centers for Medicare and Medicaid Services; 2006. 14 Haley SM, Raczek AE, Coster WJ, et al. Assessing mobility in children using a computer adaptive testing version of the pediatric evaluation of disability inventory. Arch Phys Med Rehabil. 2005;86: 932–939. 15 Ware JE Jr, Gandek B, Sinclair SJ, Bjorner J. Item response theory in computer adaptive testing: implications for outcomes measurement in rehabilitation. Rehabil Psychol. 2005;50:71–78. 16 Haley SM, Coster WJ, Andres PL, et al. Score comparability of short forms and computerized adaptive testing: simulation study with the activity measure for postacute care. Arch Phys Med Rehabil. 2004; 85:661– 666. 17 Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42:I49 –I61. 18 Hart DL, Cook KF, Mioduski JE, et al. Simulated computerized adaptive test for patients with shoulder impairments was efficient and produced valid measures of function. J Clin Epidemiol. 2006;59: 290 –298. 19 Hart DL, Mioduski JE, Stratford PW. Simulated computerized adaptive tests for measuring functional status were efficient with good discriminant validity in patients with hip, knee, or foot/ankle impairments. J Clin Epidemiol. 2005;58:629 – 638. 20 Hart DL, Mioduski JE, Werneke MW, Stratford PW. Simulated computerized adaptive test for patients with lumbar spine impairments was efficient and produced valid measures of function. J Clin Epidemiol. 2006;59:947–956. 21 Jette AM, Haley SM, Tao W, et al. Prospective evaluation of the AM-PAC-CAT in outpatient rehabilitation settings. Phys Ther. 2007;87:385–398. 22 Guide to Physical Therapist Practice. 2nd ed. Phys Ther. 2001;81:9 –746. 23 Resnik L, Hart DL. Using clinical outcomes to identify expert physical therapists. Phys Ther. 2003;83:990 –1002. 24 Centers for Medicare and Medicaid Services. 2007 Physician Quality Reporting Initiative (PQRI). Physician Quality Measures. Washington, DC: Centers for Medicare and Medicaid Services; 2007. 25 Swinkels IC, Hart DL, Deutscher D, et al. Comparing patient characteristics and treatment processes in patients receiving physical therapy in the United States, Israel and the Netherlands: cross sectional analyses of data from three clinical databases. BMC Health Serv Res. 2008;8:163.

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Responsiveness of Shoulder CAT Measures 26 Swinkels IC, van den Ende CH, de Bakker D, et al. Clinical databases in physical therapy. Physiother Theory Pract. 2007;23: 153–167. 27 Cook KF, Roddey TS, Gartsman GM, Olson SL. Development and psychometric evaluation of the Flexilevel Scale of Shoulder Function. Med Care. 2003;41:823– 835. 28 International Classification of Functioning, Disability and Health: ICF. Geneva, Switzerland: World Health Organization; 2001. 29 Crane PK, Hart DL, Gibbons LE, Cook KF. A 37-item shoulder functional status item pool had negligible differential item functioning. J Clin Epidemiol. 2006;59:478 – 484. 30 Deutscher D, Horn SD, Dickstein R, et al. Associations between treatment processes, patient characteristics, and outcomes in outpatient physical therapy practice. Arch Phys Med Rehabil. 2009;90: 1349 –1363. 31 Andrich D. A rating formulation for ordered response categories. Psychometrika. 1978; 43:561–573. 32 Thissen D, Mislevy RJ. Testing algorithms. In: Wainer H, ed. Computerized Adaptive Testing: A Primer. 2nd ed. Mahwah, NJ: Lawrence Erlbaum Associates; 2000:101– 134. 33 Hart DL, Mioduski JE. CAT Development and Testing Software User’s Guide. Knoxville, TN: FOTO, Inc; 2006. 34 Lord FM. Applications of Item Response Theory to Practical Testing Problems. Hillsdale, NJ: Lawrence Erlbaum Associates; 1980. 35 Linacre JM. Estimating measures with known polytomous item difficulties. Rasch Measurement Transactions. 1998; 12:638. 36 Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395– 407. 37 Beaton DE, Bombardier C, Katz JN, Wright JG. A taxonomy for responsiveness. J Clin Epidemiol. 2001;54:1204 –1217. 38 Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intraindividual changes in health-related quality of life. J Clin Epidemiol. 1999;52:861– 873.

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39 Hsieh YW, Wang CH, Wu SC, et al. Establishing the minimal clinically important difference of the Barthel Index in stroke patients. Neurorehabil Neural Repair. 2007;21:233–238. 40 Hays RD, Brodsky M, Johnston MF, et al. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005;28: 160 –171. 41 Schmitt JS, Di Fabio RP. Reliable change and minimum important difference (MID) proportions facilitated group responsiveness comparisons using individual threshold criteria. J Clin Epidemiol. 2004;57: 1008 –1018. 42 Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407– 415. 43 Goldsmith CH, Boers M, Bombardier C, Tugwell P. Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee. J Rheumatol. 1993;20:561–565. 44 Lauridsen HH, Hartvigsen J, Manniche C, et al. Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients. BMC Musculoskelet Disord. 2006; 7:82. 45 Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008;33:90 –94. 46 Riddle DL, Stratford PW, Binkley JM. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 2. Phys Ther. 1998; 78:1197–1207. 47 Stratford PW, Binkley J, Solomon P, et al. Defining the minimum level of detectable change for the Roland-Morris questionnaire. Phys Ther. 1996;76:359 –365; discussion 66 – 68. 48 Ader DN. Developing the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007;45:S1–S2. 49 Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45: S3–S11.

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50 Hart DL, Werneke MW, George SZ, et al. Screening for elevated levels of fearavoidance beliefs regarding work or physical activities in people receiving outpatient therapy. Phys Ther. 2009;89:770 –785. 51 Waddell G, Newton M, Henderson I, et al. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–168. 52 Haggman S, Maher CG, Refshauge KM. Screening for symptoms of depression by physical therapists managing low back pain. Phys Ther. 2004;84:1157–1166. 53 Werneke MW, Hart DL, George SZ, et al. Clinical outcomes for patients classified by fear-avoidance beliefs and centralization phenomenon. Arch Phys Med Rehabil. 2009;90:768 –777. 54 McCarthy CJ, Arnall FA, Strimpakos N. The biopsychosocial classification of nonspecific low back pain: a systematic review. Phys Ther Rev. 2004;9:17–30. 55 Ware JE Jr, Sherbourne CD. The MOS 36Item Short-Form Health Survey (SF-36), I: conceptual framework and item selection. Med Care. 1992;30:473– 483. 56 Beaton D, Richards RR. Assessing the reliability and responsiveness of 5 shoulder questionnaires. J Shoulder Elbow Surg. 1998;7:565–572. 57 Institute of Medicine. Rewarding Provider Performance: Aligning Incentives in Medicare. Washington, DC: National Academies Press; 2006. 58 Porter ME, Teisberg EO. Redefining Health Care. Creating Value-Based Competition on Results. Boston, MA: Harvard Business School Press; 2006. 59 Resnik L, Feng Z, Hart DL. State regulation and the delivery of physical therapy services. Health Serv Res. 2006;41:1296 – 1316. 60 Werneke MW, Hart DL, Resnik L, et al. Centralization: prevalence and effect on treatment outcomes using a standardized operational definition and measurement method. J Orthop Sports Phys Ther. 2008; 38:116 –125.

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Case Report Constrained Physical Therapist Practice: An Ethical Case Analysis of Recommending Discharge Placement From the Acute Care Setting Ernest Nalette

Background and Purpose. Constrained practice is routinely encountered by physical therapists and may limit the physical therapist’s primary moral responsibility—which is to help the patient to become well again. Ethical practice under such conditions requires a certain moral character of the practitioner. The purposes of this article are: (1) to provide an ethical analysis of a typical patient case of constrained clinical practice, (2) to discuss the moral implications of constrained clinical practice, and (3) to identify key moral principles and virtues fostering ethical physical therapist practice.

E. Nalette, PT, EdD, is Associate Professor, Department of Physical Therapy, Ithaca College, Rochester, New York. Mailing address: 1100 S Goodman St, Rochester, NY 14620 (USA). Address all correspondence to Dr Nalette at: [email protected].

Case. The case represents a common scenario of discharge planning in acute care health facilities in the northeastern United States.

[Nalette E. Constrained physical therapist practice: an ethical case analysis of recommending discharge placement from the acute care setting. Phys Ther. 2010;90: 939 –952.]

Methods. An applied ethics approach was used for case analysis.

© 2010 American Physical Therapy Association

Results. The decision following analysis of the dilemma was to provide the needed care to the patient as required by compassion, professional ethical standards, and organizational mission.

Discussion and Conclusions. Constrained clinical practice creates a moral dilemma for physical therapists. Being responsive to the patient’s needs moves the physical therapist’s practice toward the professional ideal of helping vulnerable patients become well again. Meeting the patient’s needs is a professional requirement of the physical therapist as moral agent. Acting otherwise requires an alternative position be ethically justified based on systematic analysis of a particular case. Skepticism of status quo practices is required to modify conventional individual, organizational, and societal practices toward meeting the patient’s best interest.

Post a Rapid Response to this article at: ptjournal.apta.org June 2010

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Constrained Physical Therapist Practice

C

onstrained physical therapist practice is encountered when the clinician understands the patient’s legitimate needs and, while acting to meet those needs, may be compelled to provide less than the necessary care.1–3 The process for determining legitimate patient needs is defined by the profession.4 Acting to meet patients’ needs requires sufficient assets such as the expertise5 and moral courage6 of the physical therapist, sufficient financial resources, and supportive laws, regulations, and institutional culture.7 As an example, care may be constrained if a physical therapist determines a patient needs a particular intervention but a third-party payer does not reimburse for physical therapy or only reimburses for a different intervention. In this situation, if the physical therapist chooses to provide less than the needed patient service, the physical therapist’s actions may be unethical.

The physical therapist is in a helping relationship, with the primary moral responsibility “to stand alongside” the patient.8 This manner of relating is crucial, as the patient is vulnerable and needs the help of the physical therapist to become well again.9 Due to this vulnerability, patient need carries a moral obligation for the physical therapist to act.10 Chronically constrained physical therapist practice erodes this helping relationship, moving the physical therapist toward moral disengagement11 and a

Available With This Article at ptjournal.apta.org • Discussion Podcast: Participants to be determined. • Audio Abstracts Podcast This article was published ahead of print on April 22, 2010, at ptjournal.apta.org.

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loss of the commitment to stand alongside the patient. The causes of constrained clinical practice may be internal or external, and the effects of constrained care may be weak or strong. A physical therapist’s clinical practice is internally constrained when he or she possesses less than sufficient moral intent, expertise, or moral courage to help meet the individual patient’s needs. Laws and regulations may be a source of external constraint on the physical therapist’s practice. When professionals follow just laws, they contribute to a well-ordered society.12 However, professionals must be vigilant and not follow unjust laws or regulations not in the patient’s best interest.13 The effect of constrained clinical practice on the patient varies from weak to strong. Weak constraint may have no discernable effect on a patient’s care, whereas strong constraint always results in harm to the patient. Evidence of constrained physical therapist clinical practice was identified by Guccione1 and Treizenberg,2 indicating physical therapists may not have sufficient resources to meet patients’ needs. Greenfield and colleagues’ qualitative study of 7 novice physical therapists also reported constraints on practice, including barriers to caring and the culture of the practice setting.14 Purtilo3 declared scarce resources to be an ongoing reality of the physical therapist practice environment. The medical profession is debating how to ensure patients’ needs are met in an environment of constrained practice that attempts to limit professional autonomy.15–18 Morreim19 proposed deceptive documentation, so-called “gaming,” as a justifiable response. In the physical therapy profession, Nalette20 reported a case of a physical therapist gaming third-party payers to ensure patients received needed care and later reported anecdotal in-

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formation from graduate student physical therapists who were involved in gaming.21 Jette et al22 proposed a clinical decision-making model used by occupational therapists and physical therapists for recommending placement of patients being discharged from an acute care setting. In the model, a clinician’s initial discharge recommendation may be constrained by various regulations. This routine constraint of practice seemed to be recognized by these occupational therapists and physical therapists as a practice reality and an accepted condition for altering an individual’s professional judgment. Moral concerns were not expressed about the acceptance of this routine constraint. The processes used by physical therapists to make good moral decisions regarding a patient’s legitimate needs are described in the physical therapy literature23–27 and are interwoven into expert clinical practice.28 The physical therapy profession defines this moral intent through its code of ethics. The American Physical Therapy Association’s (APTA) Code of Ethics (Code) “[p]rovide standards of behavior and performance that form the basis of professional accountability to the public.”29 This public professing of a moral intent creates a normative foundation from which physical therapists ought to assess their moral actions. As an example, the physical therapy profession recognizes that third parties may attempt to constrain the physical therapist’s ability to meet patient needs. However, its Code obligates physical therapists to “be accountable for making sound professional judgments” (Fig. 1, principle 3) while acting in “the best interests of patients/clients” (Fig. 1, principle 2A) and being “responsible stewards of health care resources and shall avoid overutilization or unJune 2010

Constrained Physical Therapist Practice Principles from the Code of Ethics for the Physical Therapist

A

1: Physical therapists shall respect the inherent dignity and rights of all individuals.

X

B X

2: Physical therapists shall be trustworthy and compassionate in addressing the rights and needs of patients/clients.

X

2A: Physical therapists shall adhere to the core values of the profession and shall act in the best interests of patients/clients over the interests of the physical therapist.

X

2B: Physical therapists shall provide physical therapy services with compassionate and caring behaviors that incorporate the individual and cultural differences of patients/clients.

X

2C: Physical therapists shall provide the information necessary to allow patients or their surrogates to make informed decisions about physical therapy care or participation in clinical research. 2D: Physical therapists shall collaborate with patients/clients to empower them in decisions about their health care.

X

3: Physical therapists shall be accountable for making sound professional judgments.

X

3A: Physical therapists shall demonstrate independent and objective professional judgment in the patient’s/client’s best interests in all practice settings. 3C: Physical therapists shall make judgments within their scope of practice and level of expertise and shall communicate with, collaborate with, or refer.

X X

X

4: Physical therapists shall demonstrate integrity in their relationships with patients/clients, families, colleagues, students, research participants, other health care providers, employers, payers, and the public.

X

4B: Physical therapists shall not exploit persons over whom they have supervisory, evaluative, or other authority (eg, patients/clients, students, supervisees, research participants, or employees).

X

5: Physical therapists shall fulfill their legal and professional obligations.

X

5.1: A physical therapist shall practice within the scope of his/her competence and commensurate with his/her level of education, training, and experience.

X

6: Physical therapists shall enhance their expertise through the lifelong acquisition and refinement of knowledge, skills, abilities, and professional behaviors. 7: Physical therapists shall promote organizational behaviors and business practices that benefit patients/clients and society.

X

7A: Physical therapists shall promote practice environments that support autonomous and accountable professional judgments.

X

8B: Physical therapists shall advocate to reduce health disparities and health care inequities, improve access to health care services, and address the health, wellness, and preventive health care needs of people. 8C: Physical therapists shall be responsible stewards of health care resources and shall avoid overutilization or underutilization of physical therapy services.

Figure 1. Selected ethical principles from the Code of Ethics.10 Column A indicates principles supporting choice 1 in the moral brief. Column B indicates principles supporting choice 2 in the moral brief. Reprinted from [http://www.apta.org/AM/Template. cfm?Section⫽Ethics_and_Legal_Issues1&Template⫽/CM/ContentDisplay.cfm&ContentID⫽63686], with permission of the American Physical Therapy Association.] This material is copyrighted, and any further reproduction or distribution is prohibited.

derutilization of physical therapy services” (Fig. 1, principle 8C). The physical therapist is morally obligated for meeting patients’ needs. When all is calm, the physical therapist understands a patient’s needs and is able to meet those needs. This moral calmness ought to be interrupted when the physical therapist is unable to meet patient needs. Under conditions of constraint, the physical therapist is not fulfilling the profession’s moral ideal, may not be fulfilling his or her personal moral intent, and may be practicing unethically as June 2010

a physical therapist. During professional (entry-level) education, student physical therapists are taught to meet patients’ needs and to do so in an ethical manner.30 At entry to clinical practice, the physical therapist is competent to meet patients’ needs, is capable of assessing the ethics of practice, and is legally bound by the state jurisdiction to practice within ethical boundaries. A physical therapist then is professionally obligated to apply an ethics comprised of the agent’s “personal philosophies, metaphysical beliefs, the virtues, communities, narratives, rules, principles, cir-

cumstances, consequences, feelings, intuitions, codes of ethics training and workplace norms” to the resolution of specific cases31(p147) to ensure morally good actions on behalf of patients. Ethical analysis, what Purtilo referred to as “tools for developing ‘habits of thought’ for reflection,”32(p1114) and moral action then are required when the physical therapist encounters a situation of constrained practice. After all, as Frankena stated, “being without doing, like faith without works, is dead.”33(p66)

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Constrained Physical Therapist Practice 1. Why is this case a moral dilemma? 2. What are the choices in conflict? 3. Who are the morally relevant actors? 4. Where does the action take place? Is the “where” morally relevant? 5. When does the action take place? Is the “when” morally relevant? 6. How is the manner or style of action morally relevant? 7. What are some foreseeable consequences of each decision? 8. What are some foreseeable principles involved in each decision?

moral beliefs to guide actions in relationship with patients41 under particular circumstances,40,42 ensuring their actions are in the patient’s best interest. Through this process of moral deliberation, the physical therapist as moral agent recognizes the responsibility for making good moral decisions and acting on those decisions.

9. What are some viable alternatives? 10. What does the Code of Ethics say? 11. What is your decision?

Figure 2. Nash’s moral brief framework.31(pp194 –206)

Constrained physical therapist practice is routinely encountered by physical therapists. Swisher34 stated there is a paucity of literature on ethical issues routinely encountered by physical therapists. The purposes of this article are: (1) to provide an ethical analysis of a typical patient case of constrained clinical practice, (2) to discuss the moral implications of constrained clinical practice, and (3) to identify key ethical principles and virtues that may foster ethical practice within a culture of constrained practice.

Method Design An applied ethics approach was used to analyze a patient case. Applied ethics is a systematic approach of applying ethical concepts to actual cases involving 2 or more goods in conflict, resulting in a justifiable decision.35 A systematic approach implies “a whole composed of parts in orderly arrangement according to some scheme or plan.”36 A systematic approach to ethics for physical therapists is: (1) pluralistic and accessible, (2) fostering of moral agency, and (3) comprehensive. A pluralistic and accessible approach to ethics supports various philosophical perspectives37,38 and various lev942

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els of moral development.39 Physical therapists, like the general public, possess differing mixes of moral philosophies such as deontology, utilitarianism, or virtue ethics.37 As an example, a physical therapist’s moral philosophy of practice may derive from a set of moral rules and principles with a focus on the consequences of actions. Alternatively, practice may be conceptualized from a nonconsequentialist perspective, a belief that certain actions are intrinsically good and morally obligatory regardless of consequences. A pluralistic approach to ethics is open to these and other moral philosophies. Physical therapists, again mirroring the general public, vary in level of moral development. The moral abilities of a specific physical therapist allow the individual to function at a particular level of moral agency.40 An accessible approach to ethics will have utility for physical therapists functioning at varying levels of moral agency. A systematic approach to ethics for physical therapists fosters moral agency. Physical therapists profess to be autonomous practitioners,10 thereby claiming the liberty and personal freedom to follow their own will and act as moral agents. As moral agents, physical therapists use their

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Finally, an approach to physical therapy ethics is comprehensive by encouraging reflection on the 3 realms of ethics.7 The primary focus of the physical therapist clinician’s practice is the individual patient and the inherent moral nature of the helping relationship. To lose this focus on the individual patient as the primary unit of care for the physical therapy profession would foretell its doom. However, in addition to this individual realm of practice, there also are organizational and societal realms of practice. Doing ethics without an awareness of all 3 realms of ethics would be naive. A comprehensive approach to ethics provides guidance in these 3 realms. A number of systematic applied ethics methods that meet the above criteria appear in the literature.31,41,43,44 Each approach utilizes a set of questions intended to expose the morally relevant components of a particular case and facilitate the moral agent’s arrival at an ethically justifiable decision. I am unaware of a published analysis of applied ethics methods indicating the efficacy of one approach over another. Nash’s approach31 meets the above criteria of a systematic ethics approach for physical therapists and was selected for the analysis. Nash’s moral brief framework is presented in Figure 2. Case The case (Fig. 3) and institutional mission statement (Fig. 4) were presented to the author by an experienced physical therapist with experJune 2010

Constrained Physical Therapist Practice Mary practices at the North East Region Hospital Physical Therapy Clinic, a large acute care hospital, and provides services to a variety of patients who average a 3- to 4-day length of stay. Mary has 20 years of experience in a variety of practice settings. She starts her typical workday by setting her schedule for the day and then moves on to look at the new patient referrals. There are an unusually large number of new referrals, and as is typical, the referrals do not contain sufficient information to help Mary triage these patients. Although there is not a written policy, Mary knows the expectation: all patients are seen, and then decisions are made whether or not to provide ongoing treatment. There is never a question about whether a new referral will be seen—they all are, every day. The practice does not have sufficient resources to provide all necessary services to all referred patients. Some patients receive an initial evaluation and recommendations for follow-up services, whereas others receive an initial evaluation and intervention. For those patients who qualify for transfer to an inpatient rehabilitation facility within a short period of time (approximately 3 days), only an initial evaluation is provided, with documentation regarding the patient’s abilities and rehabilitation needs. Those patients who do not qualify for rehabilitation services or who are very involved and will be remaining in the hospital for an extended time are scheduled for follow-up intervention before discharge. In these cases, the discharge settings vary from independent living at home to senior housing to long-term care in a nursing home. Mary completes an initial evaluation for Mr Smith. Her evaluation indicates that Mr Smith qualifies for transfer to a rehabilitation facility and will likely be discharged in less than 3 days. She contacts the case manager, who agrees with Mary that Mr Smith is a candidate for transfer to a local rehabilitation facility. The case manager informs Mr Smith of the decision. Mary discharges Mr Smith from physical therapy. That afternoon, Mary passes by Mr Smith’s room. He calls Mary into his room and says, “I don’t understand; my wife and I think I really need physical therapy.” Mary responds, “But you will receive all the physical therapy you need at the rehabilitation center, and you’ll be there in the next couple of days.” Mr Smith retorts, “But what about now? Wouldn’t I get better faster if I started now?” Mary replies, “Well, right now we just don’t have the ability to give you the therapy you really need. In rehabilitation, you will receive intensive physical therapy, and I’m sure you’ll be happy with the staff there.” Mr Smith asks, “Why should I trust you? How can you and this organization turn your back on me?”

Figure 3. Case study presenting a moral dilemma.

tise in acute care. The case represents a common discharge planning scenario at several acute care health facilities in the northeastern United States. The case was accepted for analysis by the author and

was not altered. No personal or organizational identifiers were present in the case. The central moral concern of the case is the patientpractitioner relationship, which is

The mission of this institution is to serve patients compassionately and effectively by: ● Providing personalized, excellent care ● Holding employees to high standards, including individual accountability, mutual respect, and collaboration ● Serving the community, caring for the underserved, and working to change disparities in access to care ● Educating the next generation of health care professionals ● Creating new knowledge through research ● Maintaining institutional financial health

Figure 4. Institution’s mission statement.

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primarily nested in the individual ethical realm.7 Procedure I reviewed the case and institutional mission statement and consulted with the therapist who provided the case to ensure a common understanding of these materials. I then responded to the moral brief (Fig. 2) as the physical therapist treating the patient might have responded. Analysis All physical therapists are responsible to act as moral agents with their patients. Ethical analysis requires that the moral agent apply general moral concepts to a particular case, arrive at a decision, and take an ethically justifiable action.31,34,42 The moral agent’s approach to a particular case emanates from life experiences and from the moral wherewithal that is accessible to the particular agent at the time of the analysis. This moral wherewithal is an accumulation of an agent’s “personal philosophies, metaphysical beliefs, the virtues, communities, narratives, rules, principles, circumstances, consequences, feelings, intuitions, codes of ethics, training and workplaces norms.”31(p147) I assumed the role of moral agent in the analysis and brought to this analysis a narrative encompassing more than 3 decades of clinical and academic physical therapist practice, respect for ethical principles, the APTA Code of Ethics, and a primary disposition toward virtue ethics,8,42,45 of which relationship ethics is a subset.46 – 48

Results The results of the case analysis are summarized in the following moral brief. The subheadings are the questions that make up the moral brief. What Are the Central Moral Issues of Your Dilemma? Mr Smith’s comments interrupt Mary’s daily routine. She is troubled

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Constrained Physical Therapist Practice and perplexed and consciously tries to bring meaning to his comments: I do wish we could treat every patient who could benefit from physical therapy, but we don’t have enough staff. Mr Smith’s needs can be met by physical therapy in [the rehabilitation facility]. Will he really gain that much more benefit from a few days of therapy here? Patients can’t possibly understand the pressures. Health care is expensive, and we get pressure from all of the administrators to contain costs. If we were to meet all the patients’ needs, health care would be even more expensive.

Mary and her colleagues recognized about a decade ago that they no longer had sufficient personnel to carry out their professional responsibilities. The administrators were informed of the lack of sufficient staff to meet patient needs, responding, “You’ll have to learn to do more with less.” Due to these externally imposed constraints, the physical therapists developed and instituted the current unwritten rationing procedure. Mary continued to reflect, My colleagues and I need to look out for each other. If I help Mr Smith, will I be turning my back on my colleagues? I have friends who practice at other acute care centers. They didn’t get necessary staff either and worked to the point of exhaustion. A number of those physical therapists got injured or left the practice, and then patients got even less help. By following our procedure, we are responding to all patient referrals in the same way and not playing favorites. If I do not follow the procedure, we will be back in the same chaos we were in before we worked out our procedure. Previously, we were making choices based on political pressure or arbitrary information. That was clearly not right.

Mary recalls a time in the past when resources were not so tightly constrained and the therapists made de944

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cisions about how much therapy a patient needed in the acute setting. In the past, the question about good patient care was, “Did you help the patient reach the needed level of function?” The new question about patient care is, “Can we afford to offer that service?” What Are the Conflicts in Your Case That Make It an Ethical Dilemma? The classic moral concern is the dilemma. A moral dilemma occurs when “an agent has a moral obligation or requirement to do each of two acts but cannot do both.”49(p508) If, at this early point in the analysis, the choice was between a good act or an evil act, no further analysis is indicated. The practitioner acts on the good.33 Mary’s moral dilemma is to choose between 2 good acts. From her knowledge of the case, she sees 2 choices: (1) to follow the rationing procedure and refer Mr Smith to the rehabilitation facility without providing care by the physical therapists in the acute setting or (2) to provide Mr Smith with physical therapy services during his stay in the acute care setting. Mary does not have the resources to carry out both choices. There is a tragedy inherent in an ethical dilemma in that a moral good will be left undone. Choice 1 produces a good for the group of patients referred to the physical therapy practice. They are treated justly12; all individual patients enter the practice under the same guidelines and receive, or do not receive, interventions based on the results of an evaluation. Therefore, benefits and burdens are fairly distributed among all patients based on defined patient needs.12 Delaying an intervention for Mr Smith seems to Mary to be a relatively small burden under chronic conditions of insufficient resources. Selecting choice 1 means Mary will maintain the status quo.

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Choice 2 also produces a good in that Mr Smith will receive a beneficial service in a timely fashion. Mary could choose to help Mr Smith and keep her choice to herself; she would only need to speak with the case manager with whom she has already consulted. Mary could quietly shift her resource of time from one patient to another. Choice 2 means Mary will disrupt the status quo. Who Are the Major Stakeholders in Your Dilemma? The moral agent now identifies the individuals who may influence the decision being made or who may be influenced by the decision made by Mary: • Mary: The physical therapist who is the moral agent and who is accountable for the decision. • Mr Smith: The patient who has come to Mary seeking her help. He may influence the decision if Mary is responsive to his input. Regardless of the decision, the outcome of the decision will have a direct bearing on his care. • Mr Smith’s family: Given that Mr Smith is competent, the family may not have a direct influence on the decision; however, the family will be affected by the decision. • Colleagues: Mary’s colleagues and the organizational leadership will be influenced if Mary selects choice 2.

What Are Some Foreseeable Consequences of the Possible Choices in Your Dilemma? If Mary selects choice 1, the status quo is maintained and no further action will be necessary. Mr Smith will leave for the rehabilitation facility in a few days, and the “problem” will appear to be resolved. However, with this upheaval of thought, Mary’s conscience may remain unsettled.

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Constrained Physical Therapist Practice If Mary selects choice 2, the results may be disruptive. First, this choice commits Mary to providing the needed intervention to Mr Smith, placing additional demands on her. Second, justice considerations12 then would require that Mary reconsider the rationing procedure. She would need to make adjustments in the practice that would allow future patients like Mr Smith to receive needed services in a similar manner. Otherwise, choice 2 and the rationing procedure would become arbitrary and capricious. Third, breaking with convention may result in negative consequences for Mary if she appears to be disloyal to her colleagues and is no longer following the procedure that is intended to provide justice for the patient population at large.50 What Are Some Foreseeable Principles Involved in Each Decision? Choice 1: To follow the established routine defined by the rationing procedure and refer Mr Smith to the rehabilitation center. Justice is the principle that Mary views to be most supportive of choice 1. Justice refers to the “fair, equitable, and appropriate treatment in light of what is due or owed to persons.”38(p327) The principle of justice is invoked in health care due to conditions of finitude.3 Limited resources may be distributed based a number of material principles of justice, including “equal share, need, effort, contribution, merit, and free market exchange.”38(p330) Of these principles, need is used as the material principle for resource distribution, as meeting patients’ needs has a moral obligation in this analysis. Autonomy is another relevant principle. Autonomy is used here in the sense of self-governance, including capacities such “as understanding, reasoning, deliberating, and independent choice.”38(p121) Mary underJune 2010

stands that fairly implementing the rationing procedure requires skillful data collection and clinical reasoning. Additionally, she must possess sufficient autonomy to implement her independent choice.16 To date, she and her colleagues have not acted with sufficient autonomy to effect organizational change. She does recognize she has sufficient autonomy to implement her choice with Mr Smith, if she is morally silent, in that no one is in a position to stop her from making and implementing either of the choices available as an outcome of this analysis. This awareness is a heightened level of moral consciousness for Mary. Two additional principles—nonmaleficence, the obligation to knowingly not inflict harm, and beneficence, the active provision of benefits38—are presumed in Mary’s everyday practice. She is not aware of any literature stating that delaying Mr Smith’s intervention by a physical therapist for less than a week will have harmful effects on his outcome. In addition, Mary believes that referring Mr Smith to the rehabilitation facility will be of benefit to him, as he will receive needed services. The past results of the rationing procedure seem to benefit patients referred to the rehabilitation center. Choice 2: Not following the established routine defined by the rationing procedure; treat Mr Smith and forgo the rehabilitation center referral. Autonomy also is a principle that Mary views as being supportive of choice 2. However, viewing this case from the perspective of choice 2 guides her not exclusively to professional autonomy, but also to respect for patient autonomy.51 Acting on the principle of respect for autonomy encourages her to actively facilitate Mr Smith’s autonomous actions. If Mary had involved Mr Smith in the original decision-making process, the current

ethical dilemma may have been averted. The moral principle of nonmaleficence calls on health care practitioners to first do no harm.38 Avoiding physical harm is crucial and is a primary concern in every patientprofessional relationship. Potential harms to Mr Smith by his physical therapist are not limited to physical harms. Mr Smith’s autonomy has certainly been ignored and thereby harmed. Although nonmaleficence, in its broadest sense, is a necessary ethical principle of a physical therapist’s practice, it is not sufficient. Beneficence, the moral obligation to create benefit for others,38 also is a moral requirement of practice. Dividing these principles may be problematic in health care. Frankena’s formulation of beneficence—(1) one ought not to inflict evil or harm, (2) one ought to prevent evil or harm, (3) one ought to remove evil, and (4) one ought to do or promote good33—sets a clearer moral ideal in health care practice. This formulation of the principle continuously calls on the practitioner to avoid harm and provide benefit. What Are Some Viable Alternatives to Ethical Courses of Action in Your Dilemma? Mary remembers a number of past alternatives and reflects on those possible options prior to making a decision in this case. Alternative 1: Misrepresent select patient populations in the medical record and on billing forms to enhance reimbursement and improve the possibility of improved staffing. A colleague from a different practice setting offered the possibility of misrepresenting patient populations in the medical records and on billing forms. He explained how his practice altered documentation in select populations, resulting in enhanced income and additional

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Constrained Physical Therapist Practice staffing. The good was that patients received additional services and the staff were under less pressure and able to be more helpful to patients. For Mary, however, choosing to lie52 in her documentation or billing forms is not a viable alternative. The good choice is to maintain her honesty and, therefore, her moral integrity. Alternative 2: Accept referrals on a preferential basis. The goods of this alternative offer additional perspectives on justice. Accepting all patient referrals on an equal basis means each patient ought to receive the same type, frequency, and duration of treatment. This egalitarian approach (material principle of equal share),38 although attractive, applies only when patients’ needs are equal.12 Preferential treatment of select patients or patient populations is justifiable only when, under conditions of constrained resources, preference is given to the most vulnerable groups within the larger population, such as poor people, children, or those who are discriminated against.12 Mary knows the premise of equal need is not true in her practice and, therefore, rejects this alternative. Alternative 3: Accept referrals only when sufficient staff are available to meet patient needs. Limiting acceptance of referrals53 based on available staffing seems to have merit. The effect might be to shift the responsibility for responding to referrals back to those (referring agents, institutional leadership) who have the authority to make a change in staffing.7 Mary presumes this decision will have a significant effect on the status quo. More pressure might be generated to change the status quo, with a resultant good of additional needed help for patients. Although this alternative may be beneficial for future consideration, the choice will not be helpful 946

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in addressing the case of Mr Smith within the necessary time frame.

her initial decision uncomfortable.

What Are Some Important Background Beliefs You Should Consider in Your Dilemma? Ethical background beliefs are personal stories that help guide us in life, including within our professional relationships with patients, colleagues, and others.31 Mary’s background beliefs emanate from her rural, small-town, Roman Catholic upbringing. She grew up drawing her moral authority from her parents, teachers, and exemplars such as Jesus, Gandhi, Martin Luther King, and Nelson Mandela. Based on this background, Mary aspires to be inclusive, fair, compassionate, persevering, nonviolent, and just. Although these beliefs are private and rarely discussed, Mary sees every human being as unique and imbued with dignity. Her professional purpose supports human dignity by helping others—relieving suffering and assisting her patients’ return to health. Mary feels that in Mr Smith’s case, and potentially with other patients, she is not living up to her own deeply held beliefs. Specifically, she feels Mr Smith has not been fairly treated and that she has added to his suffering in the name of justice. She wonders if her compassion was too thin to respond in this case.

What Choices Would You Make if You Were to Act in Character in Your Ethical Dilemma? Acting in character means Mary will think and act in a manner that is consistent with who she is and who she hopes to become, respecting her background beliefs, personal narrative, intuitions, and emotions. For Mary, acting in character means she would be responsive to Mr Smith and provide the needed care. She realizes she has not been acting fully in character. As Neoptolemus wrote, “Everything is discomfort, when someone leaves (her) own character and does what is not fitting.”55

What Are Some of Your Initial Intuitions and Feelings About This Dilemma? Intuitively, that is, based on her life experiences,54 Mary now wonders whether she made a good decision. She feels badly about not facing Mr Smith and offering him help. Emotionally, Mary feels something is wrong in this situation. Mr Smith reminds her of her father; she would be very upset if her father’s needs were deferred by a health care practitioner without an adequate explanation. Mary is now hesitant about

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The reflections being discussed in the responses to the prior few questions may be so intensely personal and private that an external perspective on the analysis may be beneficial. Mary now turns to her professional code of ethics for an objective perspective. What Does Your Profession’s Code of Ethics Say Regarding the Relevant Moral Issues in Your Dilemma? Consideration of the profession’s Code brings the accumulated wisdom of the profession in a recently updated document56 into Mary’s thinking. The Code “provides standards of behavior and performance that form the basis of professional accountability to the public”10 and “specific guidance to inform ethical decision making in their interactions with patients and clients, colleagues, other health care professionals, employers, and organizations.”57 Mary’s responsibility at this step in the brief is to apply the general guidelines from the Code to Mr Smith’s particular case and discern which of her 2 choices can be best justified. Mary first reviews the Code with the particulars of Mr Smith’s case in mind, June 2010

Constrained Physical Therapist Practice seeking justification for choice 1, and finds guidance in principles 1 and 3 (Fig. 1). Principle 1 guides Mary to reflect on the concepts of dignity and rights. She believes Mr Smith has the right to an intervention that will help him meet his needs but that deferring this intervention does not seem to infringe on his rights and will result in compassionate care. Mary recognizes her professional responsibility for making sound professional judgments (Fig. 1, principle 3) and views her assessment and evaluation of Mr Smith as being within her scope of practice (Fig. 1, principle 3C). Next, seeking justification for choice 2, Mary views the Code through a prism of compassion and reflects on principles 1, 2, 3, 4, 5, and 7 (Fig. 1). She now views principle 1 with different shading. Patient rights have continued importance, but patient dignity and practitioner compassion take on a more central meaning based on Mr Smith’s reaction to the decision to transfer him to another facility and his belief that he deserved services immediately was not given sufficient respect in the deliberations leading to the transfer decision. From the perspective of her reflections on patient rights, dignity, and practitioner compassion (Fig. 1, principle 2), Mary reconsiders her approach to patient evaluation and assessment. Mary realizes she was not mindful58 of Mr Smith’s needs when making her decision to defer intervention. Mr Smith met Mary and entrusted his health to her. He is vulnerable in this relationship due to his inability to help himself. The decision to refer Mr Smith to the rehabilitation facility may be an exploitation (Fig. 1, principle 4B) of this vulnerability. The manner in which the procedure was executed certainly did not encourage trustworthiness from Mr June 2010

Smith (Fig. 1, principle 2), nor was Mary’s manner collaborative (Fig. 1, principle 2D) in nature. Given this new reflective context, Mary reconsiders principle 3 in a different light. In reconsidering this principle, Mary has a heightened sense of compassion and patient autonomy. She is concerned that her professional judgments may not have been in the patient’s best interest (Fig. 1, principle 3A). Principle 7 (Fig. 1) highlights the necessity of involving the organization in resolving the current practice conundrum. According to the organizational mission statement, the mission of the institution is “to serve patients compassionately and effectively by providing personalized, excellent care” (Fig. 4). In Mr Smith’s case, Mary is not implementing the organizational mission. The Code provides guidance for reforming the current process. A revised process shall include a “collaborative process” (Fig. 1, principle 2D) with patients in “a practice environment supportive of autonomous and accountable professional judgments” (Fig. 1, principle 7A) while providing services in a “compassionate and caring” manner (Fig. 1, principle 2B). The current process does not foster this morally patient-centered manner of caring. Disallowing such patient involvement does not support moral practice on behalf of the patients, therefore, making the current procedure, at minimum, morally suspect. Based on these reflections, Mary now faces the responsibility of discerning which of the 2 choices considered during this analysis best matches with her professional role and character. What Is Your Decision in the Dilemma, and Do You Have Any Afterthoughts? Mary decides to change her original position by selecting choice 2—to

provide Mr Smith with physical therapy services during his stay in the acute setting. Acting on this decision means Mary will directly follow up with Mr Smith, first to acknowledge to herself that she broke her relationship with Mr Smith, ask his forgiveness for not honoring his point of view,59 invite his input to the plan of care, and initiate the intervention plan. Next, she will communicate her reasoning to her colleagues and enlist their support in reconsidering the rationing procedure. Additionally, Mary will recommend implementing alternative 3 from question 5 of the above moral brief (ie, making the moral commitment to new patients only when sufficient staff resources are available).53 Lastly, she will follow through with the organizational authorities and inform them of the change in the procedure to accept new referrals only when sufficient staff are available to meet the patient’s needs. Mary proposes to her colleagues that a revised policy be developed, printed, posted, and used in open dialogue with patients. The new policy will include the parameters under which patients will be accepted into the practice—that patients will be actively encouraged to participate in the treatment planning process (including discharge) and that they will be educated regarding the results of the treatment and recommended follow-up. She also recommends they post the APTA Code of Ethics in a prominent location in the clinic as an educational tool for patients and a reminder of ethical responsibilities to herself and her colleagues. As Mary recommits herself to a more collaborative approach to patient care, she desires to extend this collaborative character to her organizational relationships. Mary intends this interaction with organizational leadership to follow the precepts

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Constrained Physical Therapist Practice of the moral conversation60 wherein she seeks conversation and not contestation, with a focus on introducing narrative through questioning, respectfulness, and understanding. Her hope is for a better organizational understanding of ethical and legal physical therapist practice and a better understanding on her part of the organizational resource constraints. Mary has a number of afterthoughts beyond the specific actions she will take regarding this case. First, although she was quite nervous about her analysis, she feels good that she was willing to take a personal risk in the decisions that she made related to this case. Second, she is amazed how the status quo of the routine practice of not meeting patient needs seduced her into moral silence. Third, she remembers that her professionalism is grounded in providing help to patients and that without this relationship her profession is useless. She also vows to regularly revisit the Code. Fourth, Mary has realized a new integration of self and professional practice. She is moving toward being the same compassionate person in her practice as she is in her personal life.

of financial resources. In 2001, the United States spent 75% more dollars per capita on health care than Canada; however, Canadians live 2.7 years longer than US citizens.58 Rather than an insufficient financial investment in the country’s health care system, there is an unjust distribution of those financial resources.60 There is sufficient evidence of systemic dysfunction of the health care system that skepticism of conventional practices is warranted, especially when cost containment is the proposed justification.65

Discussion

The analysis in this article demonstrates a micro-ethics of resource redistribution grounded in virtue ethics and the virtuous practice of meeting individual patient needs, while providing a method for the practitioner seeking a balance between the patient’s need for help and the employer’s need for organizational vitality. Fundamental concepts key to this analysis include: (1) the moral nature of human relationships, specifically the relationship between a patient and a physical therapist; (2) the finitude of health care resources and the ethics of constraint; and (3) the practitioner’s adjunctive responsibilities in relationship to the organizational and societal realms of ethics.

Swisher34 stated that practitioners in today’s managed care environment are being asked to balance their fidelity to their patients with fiscal accountability to their employer. Balancing these interests is a moral good presuming the resources are sufficient for meeting patients’ needs, health care organization vitality, and society’s health.7 The current “balance” within health care in the United States is ineffective.61– 63 As a society, the World Health Organization ranks the United States 29th in its years of healthy living measure and ranks the US health care system 37th.64 This poor performance of the health care system is not due to lack

The moral nature of human relationships is based on mutual respectfulness, helpfulness, truthfulness, and keeping promises and secrets8 and “is concerned with relations between people and how, ultimately, they can best live in peace and harmony.”41(p8) In addition to these shared humane expectations, the physical therapist is called to help others in a relationship48 become well again—to stand alongside the patient. Helping others is a mindful practice57 wherein the practitioner learns the patient’s story. The better the patient story is understood, the more the patient’s humanity is re-

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spected and sustained in the heart of the practitioner. Humanity is nearly synonymous with compassion66(p111); therefore, the moral physical therapist knows the patient’s humanity, and his or her practice is grounded in compassion. In our case, Mary’s conventional practice is disrupted when confronted by Mr Smith’s personal narrative, by what Nussbaum referred to as an “upheaval of thought.”55(p1) Mary recognizes her “father” in Mr Smith (see question 7) and through her more “attentive openness, solicitude, patience, and listening”66 becomes more mindful of “the ordinary, the obvious and the present”57 in the situation. Mr Smith’s humanity becomes known to Mary, thereby awakening her compassion. The importance of emotions in physical therapist practice is commonly misunderstood as being irrational or lacking in objectivity. Rather, our emotions need to be fully developed to enter into moral discourse,67 and positive examples of the emotions in physical therapist practice are available in the physical therapy literature.25,41,68,69 The compassionate physical therapist knows the patient’s narrative and is emotionally moved to “do what (he or she) must”66 to relieve the patient’s suffering. In our case, Mary expresses some mixture of emotion,70 the moral virtues (prudence, justice, fortitude, and temperance),71 and theological virtues (faith, hope, and love). Additional virtues such as gentleness, generosity, and courage66 have relevance to this case. I am proposing that Mary adopted, or readopted, compassion as a cardinal virtue, which, when well practiced, fosters a continual focus on the professional’s fundamental responsibility for being responsive to the patient’s best interest. Aristotle42 would remind us, as in any consideration of June 2010

Constrained Physical Therapist Practice virtue, to avoid both a deficient and an excessive compassion. A deficient compassion, or “arrogant harshness,”55 lacks sufficient moral engagement for understanding the patient’s narrative and providing the type of help needed by the patient. An excessive compassion, or sentimentality, may not relieve suffering but may add to the total suffering in a particular situation, what Buddhists call “idiot compassion.”72 Nussbaum55 counseled that the practitioner be compassionate and take an emotional position that allows practical reasoning on behalf of the other. Mary, then, is of a certain moral character, and the case analysis reflects on what sort of person she is in her relationship with Mr Smith—what Hursthouse called “a claim that goes all the way down.”37(p12) At this individual realm of ethics, Mary is compassionate and stands alongside Mr Smith, helping meet his needs. The second fundamental concept in this ethical analysis is the finitude of health care and the ethics of constraint. The above analysis accepts Purtilo’s premise that health care resources are finite.3 This societal condition has imposed itself on the organizational level of patient care and is routinely experienced by physical therapists in their relationship with individual patients. Over time, financial resources were incrementally constrained by the organizational leadership. The consequence of this action was an insufficient number of available physical therapists within the organization for meeting patients’ needs. However, the organization did not limit the number of patients admitted to the acute care hospital who were in need of the care of physical therapists. This organizational constraint resulted in patients receiving less than needed care from their physical therapist.

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Incremental organizational constraint on physical therapist resources results in diminishing benefits to the patient and, eventually, in patient harm. Diminishing benefit may come in shades of delaying care and rationing care. Delay in care implies a patient queue due to limited resources. Delays result from various causes,73 and care may be delayed without criteria. Rationing of care may involve delay in care, but with some procedural or distributive criteria.3 Retrospectively identifying exactly when the resources were no longer sufficient, or when diminishing benefit becomes harm, probably is not possible.74 Over a number of years, Mary and her colleagues internalized a series of external constraints that negatively affected their responsibility to make sound clinical judgments (see question 1). Once constraints on practice are internalized, the practitioner conspires in the constraint of practice, and the patient harm becomes part of the practice culture. It is difficult for physical therapists to sustain moral agency in a culture of constrained practice and be “impervious to the social realities in which they are enmeshed.”11(p102) Moral conscience diminishes, individuals become morally disengaged, and moral agency fails. Practitioners then find themselves in an ethically untenable position, unable to stand with all of the referred patients and help them become well again. A moral corrective is required. Mary breaks from the culture of constraint,75 and a moral corrective begins when she chooses her compassionate self and her professional role over her employee role. As Bruckner76 discussed, when a physical therapist chooses the employee role, responsiveness to professional responsibilities diminishes; the physical therapist becomes more receptive to organizational needs and less

receptive to patient needs. This decision is morally critical; Mary recognizes her potential double agency, choosing her professional role over her employee role. The ethics of constraint demonstrate that, at some point along the continuum of diminishing resources, a balance between the professional role and the organizational role is no longer feasible. The ethical physical therapist chooses the professional role and chooses to stand next to the patient. Moral agency is strengthened. Therefore, being an ethical physical therapist in the context of constrained practice means the practitioner is receptive to the needs of the unique patient; is accountable77 to an array of normative standards such as the Code, state practice acts, and health care regulations; and is practicing in harmony with his or her own moral character. Mary takes the time to know and become morally engaged with all of her patients and to comprehensively apply professional standards for patient care/ management (Fig. 1, principle 4.1.E). Mary is integrating her knowledge, clinical reasoning, and understanding of movement with her virtuous character disposition toward expert practice.5 As Mary takes action based on the decision from her ethical analysis, she demonstrates a recapturing of her professional autonomy. She now understands her professional autonomy is nested with the individual realm of ethics and is functioning every time she accepts a new patient referral. This re-found autonomy means that Mary treats fewer total patients and that some patients she would have “treated” previously may not receive help. This reality is troubling to Mary. The residual moral tragedy of this analysis is those patients who are in need of physical therapy care but do not receive this needed care.

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Constrained Physical Therapist Practice The third fundamental concept in this ethical analysis contemplates Mary’s responsibilities in relationship to the organizational and societal realms of ethics. Our analysis, as with every true ethical dilemma, involves a moral tragedy: the patients whose needs are not met as a result of this analysis. This unmet need is beyond the authority and, therefore, the responsibility of Mary and her colleagues. The ethical responsibility for organizational vitality, while executing its publicly professed mission, resides with the organizational leadership (Fig. 4). Achieving and maintaining organizational vitality ought to occur while not harming, or being harmed by, its individual components7,12—in our case, the physical therapists’ practice. Based on the organization’s mission statement (Fig. 4), Mary and her colleagues ought to provide “compassionate care,” while not harming the organization by wasting its resources. In the past, when Mary became morally silent about unmet patient needs, the organizational leadership may not have had the necessary feedback to change the organization’s resource allocation. The organization ought not to admit patients needing physical therapist services who cannot be provided that care, or the leadership ought to change the staffing to meet the patients’ needs. Re-establishing this ethical behavior of the physical therapists begins to form a future organizational relationship that should allow “all (individual members of the organization) to justify their conduct to everyone else (when their conduct is justifiable) without self-defeating or other disturbing consequences.”12(p582) Mary ought to be able to practice within the organization without putting her professional integrity at risk.

Mary’s efforts with Mr Smith and her evolving moral practice help with improving the individual realm of ethics and may begin to influence organizational ethics. However, private virtue78 and organizational realms of ethics should not be expected to positively affect problems at the societal level7 without further specific action. Mary is seeking a societal identity32 to help her form a vision of an ethical health care system to help guide her individual and organizational ethics actions. She adopts 3 societal health care system concepts she believes support an ethical health care system: a unified system, nonprofit financing, and universal coverage.65 She hopes to express herself in public policy discussions in a manner that is supportive of these principles and that will be extensions of her personal philosophy and professional practice. Limitations Case analysis has a long history as a method of teaching ethics7,31,38 and of providing normative guidance on matters of ethics.35 However, the process of “doing ethics” by analyzing a written case is inherently different from “doing ethics” within the environment in which the case occurs. The case used in this article does not directly represent reality but is a facsimile thereof.79,80 Also, the ethical case analysis was completed outside the clinical environment, and I was not constrained by the culture of a specific clinical environment. I did not face the patient, a peer group, or organizational leadership during or following this analysis and had no responsibility to act on the decision. Moral courage6 was not required. Whether I would have come to the same decision had I completed the ethical analysis within the actual clinical setting is unknown. Nash’s approach to case analysis may be limiting because it is comprehen-

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sive, theory rich, and may not address concerns of the third realm of ethics. Adequately completing an ethical analysis similar to that demonstrated in this article may be viewed as time prohibitive in the typical clinical environment. Additionally, this approach is rich in philosophical theory, and the average physical therapist may not have the philosophical background required to take full advantage of this approach. As an example, Nash’s use of background beliefs may require more training to be accessible to many physical therapists. Also, the concerns of the third realm of ethics may not be well addressed if the moral agent is without sufficient background in the theoretical underpinnings of the concept of stakeholders (see question 3). The lack of clinical data in the case provided for analysis did not allow me to gauge the influence various physical therapist interventions81 may have on the analysis. Cases including rich clinical information ought to be considered for future publication.

Summary and Conclusions In this article, I offer an ethical analysis of a common patient case set in the context of constrained clinical practice. Constrained care is routinely encountered by physical therapists, and when resources are not sufficient to meet patients’ needs, ethical dilemmas result. The primary moral roles of the physical therapist are to be in relationship with the patient and to advocate for that patient’s best interest—to stand next to the patient and offer help. A culture of constrained physical therapist practice emphasizes the patientphysical therapist relationship, resulting in the patient receiving less care than is needed. Providing less care than is needed by the patient is unethical practice, unless a moral alternative can be explicitly justified June 2010

Constrained Physical Therapist Practice through systematic ethical analysis. Being mindful of the patient narrative morally engages the physical therapist with the patient and fosters the physical therapist’s compassion, the profession’s cardinal virtue, thereby moving the practitioner to help relieve the suffering of the patient and countering the effects of constrained care. The primary moral role of the physical therapist is in the individual realm of ethics. Although this realm is central, the physical therapist also is responsible to actively influence the organizational and societal realms of ethics. Effectiveness in these realms requires moral imagination and a passion for social justice. Skepticism is necessary when reflecting on personal practice patterns, organizational policies and procedures, and societal culture norms that may not be beneficial to meeting patients’ needs. This article was received December 22, 2005, and was accepted February 6, 2010. DOI: 10.2522/ptj.20050399

References 1 Guccione AA. Ethical issues in physical therapy practice: a survey of physical therapists in New England. Phys Ther. 1980; 60:1264 –1272. 2 Triezenberg HL. The identification of ethical issues in physical therapy practice. Phys Ther. 1996;76:1097–1108. 3 Purtilo RB. Whom to treat first, and how much is enough: ethical dilemmas that physical therapists confront as they compare individual patients’ needs for treatment. Int J Technol Assess Health Care. 1992;8:26 –34. 4 Guide to Physical Therapist Practice. 2nd ed. Phys Ther. 2001;81:9 –746. 5 Jensen GM, Gwyer J, Hack LM, Shepard KF. Expertise in Physical Therapy Practice. Boston, MA: Butterworth Heinemann; 1999. 6 Purtilo RB. Moral courage in time of change: visions for the future. JOPTE. 2000;14(3):4 – 6. 7 Glaser JW. Three Realms of Ethics: Individual, Institutional, Societal. Kansas City, MO: Sheed & Ward; 1991. 8 Drane JF. Becoming the Good Doctor. Kansas City, MO: Sheed & Ward; 1988.

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9 Pellegrino ED. What is a profession? J Allied Health. 1983;12:168 –176. 10 Code of Ethics. American Physical Therapy Association. Available at: http://www. apta.org/AM/Template.cfm?Section⫽Ethics_ and_Legal_Issues1&Template⫽/CM/Content Display.cfm&ContentID⫽63686. 11 Bandura A. Selective moral disengagement in the exercise of moral agency. J Moral Educ. 2002;31:101–119. 12 Rawls J. A Theory of Justice. Cambridge, MA: The Belknap Press of Harbard University Press; 1999. 13 Solomon LS. Rules of the game: how public policy affects local health care markets. Health Aff (Millwood). 1998;17:140 –148. 14 Greenfield BH, Anderson A, Cox B, Tanner MC. Meaning of caring to 7 novice physical therapists during their first year of clinical practice. Phys Ther. 2008;88:1154 – 1166. 15 Wynia M, Latham S, Kao A. Medical professionalism in society. N Engl J Med. 1999;341:1612–1616. 16 Morreim E. Professionalism and clinical autonomy in the practice of medicine. Mt Sinai J Med. 2002;69:370 –377. 17 Murphy M, DeBernardo C, Shoemaker W. Impact of managed care on independent practice and professional ethics: a survey of independent practitioners. Prof Psychol Res Pre. 1998;29:43–51. 18 Capozzi JD, Rhodes R. Lying for the patient’s good. J Bone Joint Surg Am. 2004; 86:187–188. 19 Morreim EH. Gaming the system: dodging the rules, ruling the dodgers. Arch Intern Med. 1991;151:443– 447. 20 Nalette E. Habits of thought: truth-telling and deception in practice. In: Ethics in Physical Therapy: Part 1. Alexandria, VA: American Physical Therapy Association; 1998:66 – 67. 21 Nalette E. Reflections on student learning. In: Purtilo RB, Jensen GM, Royeen CB. eds. Educating for Moral Action. Philadelphia, PA: FA Davis Co; 2005:251–263. 22 Jette DU, Grover L, Keck CP. A qualitative study of clinical decision making in recommending discharge placement from the acute care setting. Phys Ther. 2003;83: 224 –236. 23 Purtilo RB. Understanding ethical issues: the physical therapist as ethicist. Phys Ther. 1974;54:239 –243. 24 Clawson A. The relationship between clinical decision-making and ethical decisionmaking. Physiotherapy. 1994;80:10 –14. 25 Barnitt R, Partridge C. Ethical reasoning in physical therapy and occupational therapy. Physiother Res Int. 1997;2:178 –194. 26 Edwards JK. Enid Graham memorial lecture: personal values—professional ethics. Physiother Can. 1987;39:319 –323. 27 Elkin S, Anderson L. Ethics and physiotherapy: an introduction. New Zealand Journal of Physiotherapy. 1998;26:9 –12. 28 Jensen GM, Gwyer J, Shepard KF, Hack LM. Expert practice in physical therapy. Phys Ther. 2000;80:28 – 43.

29 APTA Professional Ethics: Overview. Available at: http://www.apta.org/AM/ Template.cfm?Section⫽Ethics_and_Legal_ Issues1&Template⫽/CM/ContentDisplay. cfm&ContentID⫽63686. 30 A Normative Model of Physical Therapist Professional Education: Version 2004. Alexandria, VA: American Physical Therapy Association; 2004. 31 Nash RJ. “Real World” Ethics: Frameworks for Educators and Human Service Professionals. 2nd ed. New York, NY: Teachers College Press; 2002. 32 Purtilo RB. Thirty-first Mary McMillan Lecture: A time to harvest, a time to sow: ethics for a shifting landscape. Phys Ther. 2000;80:1112–1119. 33 Frankena WK. Ethics. Englewood Cliffs, NJ: Prentice Hall Inc; 1973. 34 Swisher LL. A retrospective analysis of ethics knowledge in physical therapy (1970 – 2000). Phys Ther. 2002;82:692–706. 35 Jonsen AR, Toulmin S. The Abuse of Casuistry: A History of Moral Reasoning. Berkeley, CA: University of California Press; 1988. 36 Oxford English Dictionary. Available at: http://ezproxy.ithica.edu:2073/cgi/entry/ 50133691?query_type⫽word&queryword ⫽linguist&first⫽1&max_to_show⫽10& sort_type⫽alpha&result_place⫽1&search _id⫽GQYv-c6xdXc-2463&hilite⫽50133691. 37 Hursthouse R. On the Virtues. Oxford, United Kingdom: Oxford University Press; 1999. 38 Beauchamp TL, Childress JF. Principles of Bioethics. New York, NY: Oxford University Press; 1994. 39 Rest J, Narvaex D, Bebeau M, Thoma S. A neo-Kolbergian approach: the DIT and schema theory. Educ Psychol Rev. 1999; 11:291–324. 40 Rottschaefer WA. The Biology and Psychology of Moral Agency. New York, NY: Cambridge University Press; 1998. 41 Purtilo RB. Ethical Dimensions in the Health Professions. 5th ed. Philadelphia, PA: WB Saunders Co; 2005. 42 Aristotle. The Ethics of Aristotle: The Nicomachean Ethics. Thomson JAK, trans-ed. London, United Kingdom: Penguin Books; 1953. 43 Gervais K. A Model for ethical decisionmaking to inform the ethics education of future health care professionals. In: Purtilo RB, Jensen GM, Royeen CB, eds. Educating for Moral Action: A Sourcebook in Health and Rehabilitation Ethics. Philadelphia, PA: FA Davis Co; 2005:185–190. 44 Swisher LL, Arsianian LE, Davis C. The Realm-Individual Process-Situation (RIPS) model of ethical decision-making. HPA Resource. October 2005;5(3):1– 8. 45 Lebacqz K. Professional Ethics: Power and Paradox. Nashville, TN: Abingdon Press; 1985. 46 Swanton C. Virtue Ethics: A Pluralistic View. New York, NY: Oxford University Press; 2003.

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Constrained Physical Therapist Practice 47 Thomasa D. Toward a New Medical Ethics: Implications for Nursing. Thousand Oaks, CA: Sage Publications; 1994. 48 Romanello M, Knight-Abowitz K. The “ethic of care” in physical therapy practice and education: challenges and opportunities. JOPTE. 2000;14(3):20 –25. 49 Audi R. The Cambridge Dictionary of Philosophy. Cambridge, United Kingdom: Cambridge University Press; 1995. 50 Brookfield S. On impostorship, cultural suicide, and other dangers: how nurses learn critical thinking. J Contin Educ Nurs. 1993;24:197–205. 51 Purtilo RB. New respect for respect in ethics education. In: Educating for Moral Action: A Sourcebook in Health and Rehabilitation Ethics. Philadelphia, PA: FA Davis Co; 2005:1–9. 52 Bok S. Lying: Moral Choice in Public and Private Life. New York, NY: Vintage Books; 1979. 53 Goold SD. Trust and ethics of health care institutions. Hastings Cent Rep. 2001;31: 26 –33. 54 Callahan S. In Good Conscience: Reason and Emotion in Moral Decision Making. San Francisco, CA: Harper; 1991. 55 Nussbaum M. Upheavals of Thought: The Intelligence of Emotions. New York, NY: Oxford University Press; 2001. 56 Swisher LL, Hiller P; the APTA Task Force to Revise the Core Ethics Documents. The revised APTA Code of Ethics for the Physical Therapist and Standards of Ethical Conduct for the Physical Therapist Assistant: theory, purpose, process, and significance. Phys Ther. 2010;90:803– 824. 57 Epstein RM. Mindful practice. JAMA. 1999; 282:833– 839. 58 Barlett DL, Steele JB. Critical Condition: How Health Care in America Became Big Business & Bad Medicine. New York, NY: Doubleday; 2004.

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59 Purtilo RB. Beyond disclosure: seeking forgiveness [guest editorial]. Phys Ther. 2005;85:1124 –1126. 60 Zoloth L. Heroic measures: just bioethics in an unjust world. Hastings Cent Rep. 2001;31:34 – 40. 61 LeBow RH, White CR. The health care meltdown: confronting the myths and fixing our failing system. J Nucl Med. 2008; 49:1305–1319. 62 Blendon RJ, Schoen C, DesRoches R, et al. Inequities in health care: a five-country survey. Health Affairs. 2002;21:182–191. 63 Betancourt JR, Green AR, Carrillo JE, Ananeh-Firempong O. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public Health Rep. 2003; 118:293–302. 64 World Health Organization. Health statistics and health information systems. Available at: http://www.who.int/healthinfo/ statistics / mortlifeexpectancy / en / index.html. 65 Reid T. The Healing of America: A Global Quest for Better, Cheaper, and Fairer Health Care. New York, NY: The Penguin Press; 2009. 66 Comte-Sponville A. A Small Treatise on the Great Virtues. New York, NY: Metropolitan Books; 1996. 67 Callahan S. The role of emotion in ethical decision-making. Hastings Cent Rep. 1988;18:9 –14. 68 Davis C. What is empathy and can empathy be taught? Phys Ther. 1990;70:707– 715. 69 Greenfield B. The role of emotions in ethical decision making: implications for physical therapist education. JOPTE. 2007; 21(1):14 –21. 70 Stout J. Ethics After Babel: The Languages of Ethics and Discontents. Boston, MA: Beacon Press; 1988.

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71 Pieper J. The Four Cardinal Virtues. Notre Dame, IN: University of Notre Dame Press; 1966. 72 Trungpa C. Glimpses of Mahayana. Halifax, Nova Scotia, Canada: Vajradratu Publications; 2001. 73 Luepker RV, Raczynski J, Osganian S, et al. Effect of a community intervention on patient delay and emergency medical service use in acute coronary heart disease: the rapid early action for coronary treatment (REACT) trial. JAMA. 2000;284:60 – 67. 74 Schwartz SP. Why is it impossible to be moral? American Philosophical Journal. 1999;284:351–359. 75 Nalette E. Truth-telling and deception in practice. PT Magazine. 1994;2(1):66 – 67. 76 Bruckner J. Physical therapists as double agents: ethical dilemmas of divided loyalties. Phys Ther. 1987;67:383–387. 77 Purtilo RB. Professional responsibility in physiotherapy: old dimensions and new directions. Physiotherapy. 1986;72:579 – 583. 78 Coffin WS. Credo. Louisville, KY: Westminster John Knox Press; 2004. 79 Higgs R. Do studies of the natures of cases mislead about the reality of cases: a response to Pattison et al. J Med Ethics. 1999;25:47–50. 80 Pattison S, Dickenson D, Parker M, Heller T. Do case studies mislead about the nature of reality? J Med Ethics. 1999;25:42– 46. 81 Resnik LJ, Jensen GM. Using clinical outcomes to explore the theory of expert practice in physical therapy. Phys Ther. 2003;83:1090 –1106.

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Case Report Implementation of Measurement Instruments in Physical Therapist Practice: Development of a Tailored Strategy J.G. Anita Stevens, Anna J.M.H. Beurskens

Background and Purpose. The use of measurement instruments has become a major issue in physical therapy, but their use in daily practice is infrequent. The aims of this case report were to develop and evaluate a plan for the systematic implementation of 2 measurement instruments frequently recommended in Dutch physical therapy clinical guidelines: the Patient-Specific Complaints instrument and the Six-Minute Walk Test. Case Description. A systematic implementation plan was used, starting with a problem analysis of aspects of physical therapist practice. A literary search, structured interviews, and sounding board meetings were used to identify barriers and facilitators. Based on these factors, various strategies were developed through the use of a planning model for the process of change. Outcomes. Barriers and facilitators were revealed in various domains: physical therapists’ competence and attitude (knowledge and resistance to change), organization (policy), patients (different expectations), and measurement instruments (feasibility). The strategies developed were adjustment of the measurement instruments, a self-analysis list, and an education module. Pilot testing and evaluation of the implementation plan were undertaken. The strategies developed were applicable to physical therapist practice. Self-analysis, education, and attention to the practice organization made the physical therapists aware of their actual behavior, increased their knowledge, and improved their attitudes toward and their use of measurement instruments.

J.G.A. Stevens, PT, MSc, is Researcher and Teacher, Center of Research Autonomy and Participation of People With Chronic Illnesses, Department of Physiotherapy, Zuyd University, Nieuw Eyckholt 300, PO Box 550, 6400 AN Heerlen, the Netherlands. Address all correspondence to Ms Stevens at: [email protected]. A.J.M.H. Beurskens, PT, PhD, is Associate Professor, Center of Research Autonomy and Participation of People With Chronic Illnesses, Department of Physiotherapy, Zuyd University. [Stevens JGA, Beurskens AJMH. Implementation of measurement instruments in physical therapist practice: development of a tailored strategy. Phys Ther. 2010; 90:953–961.] © 2010 American Physical Therapy Association

Discussion. The use of a planning model made it possible to tailor multifaceted strategies toward various domains and phases of behavioral change. The strategies will be further developed in programs of the Royal Dutch Society for Physical Therapy. Future studies should examine the use of measurement instruments as an integrated part of the process of clinical reasoning. The focus of future studies should be directed not only toward physical therapists but also toward the practice organization and professional associations.

Post a Rapid Response to this article at: ptjournal.apta.org June 2010

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onitoring the health status of patients through the use of outcome measures is considered to be an aspect of good clinical practice in physical therapy.1–3 The clinical guidelines of the Royal Dutch Society for Physical Therapy recommend the use of measurement instruments. Until now, this recommendation has been implemented in a passive way by mailing the clinical practice guidelines containing the measurement instruments. Despite the overall positive attitude of physical therapists, the daily use of outcome measures in physical therapist practice is remarkably low.2,4 – 8 In Europe and Australia, “implementation” is a common term for what in the United States is called “knowledge translation or exchange.” In this article, the term “implementation,” which means a systematic process in which innovations or changes of proven value become structurally embedded in professional practice, was used. It is well known that passive implementation strategies are not effective.9,10 Systematic reviews of the effectiveness of implementation interventions have shown that strategies should be targeted toward specific barriers to and facilitators of change that have been assessed in a thorough problem analysis of the target group and setting.9,11–18 Although education is an important strategy, implementation should not be restricted to educational interventions for individual health professionals only. Factors concerning practice policy and organization, patients,

Available With This Article at ptjournal.apta.org • Audio Abstracts Podcast This article was published ahead of print on April 22, 2010, at ptjournal.apta.org.

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and the measurement instruments themselves also are important.4,12 The Dutch Scientific College of Physiotherapy of the Royal Dutch Society for Physical Therapy has made a systematic approach to the implementation of outcome measures in daily practice a focal point of its policy. The aims of this case report were to develop and evaluate a systematic implementation plan for the use of 2 measurement instruments frequently recommended in Dutch physical therapy clinical guidelines: the PatientSpecific Complaints (PSC) instrument,19 which is comparable to the Pain-Specific Functional Scale,20 and the Six-Minute Walk Test (6MWT).21 To meet our aims, we sought answers to 2 questions: 1. Which barriers and facilitators contribute to the use of the PSC and 6MWT in physical therapist practice? 2. Which implementation strategies can be tailored to these barriers and facilitators and applied to physical therapist practice?

Target Setting The implementation plan was aimed at physical therapists in private practice in the community. This group is the largest group of physical therapists in the Netherlands; they are easily accessible and are not restricted by complicated and formal institutional rules. It also appears that these physical therapists use fewer measurement instruments than their colleagues in hospitals and other institutions.7

Development and Application of the Process As a guideline for a systematic approach, the implementation model of Grol et al10 was used. The 5 steps in this model and the methods used in this case report are shown in the Figure. Number 6

Step 1: Proposal for Improvement We focused on the implementation of 2 easily applicable measurement instruments that are frequently recommended in Dutch physical therapy guidelines. The first instrument was the PSC, a Dutch instrument that is comparable to the Pain-Specific Functional Scale.19,20 In both instruments, patients must list 3 activities and score them. Differences are the scoring method (visual analog scale versus numerical rating scale), the time frame on which the score is based (1 week versus 1 day), and the availability of a sample activity list in the PSC to help patients identify their main complaint. The second instrument was the 6MWT, which is used to assess the aerobic exercise capacity of a patient by measuring the walking track length in 6 minutes.21 Step 2: Problem Analysis To obtain a complete and valid overview of relevant barriers and facilitators, we used various methods to collect information. First, a literature search of the PubMed and Cochrane databases was carried out to identify studies about barriers and facilitators in the use of measurement instruments and clinical guidelines. From this information a topic list was formulated (the list is available on request from the authors). Second, physical therapists in several private practices were interviewed. We searched for a wide variety in terms of expertise and number of employees and considered the use of clinimetrics (purposive sampling). The semistructured interviews (45– 60 minutes) were digitally audiotaped, summarized, and member checked by the physical therapists. The interviews started with general inquiries on the following themes: information about the practice, patient categories, and measurement instruments used. Thereafter, open June 2010

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Figure. Implementation model of Grol et al10 and the methods used in this case report. KNGF⫽Koninklijk Nederland Genootschap voor Fysiotherapie (Royal Dutch Society for Physical Therapy).

questions were asked about perceived barriers and facilitators in the use of measurement instruments in daily practice. At the end of each interview, the topic list was presented to the interviewees, and additional relevant items could be indicated. The barriers and facilitators identified were ordered in various domains: the physical therapist, the organization, patients, and the measurement instruments themselves. The number of interviews was estimated at between 15 and 20, and the interviews were stopped when a saturation of data was reached.22 Step 3: Development of Implementation Strategies The information from step 2 guided the selection of both the type and June 2010

the specific content of the implementation strategies developed; a planning model for the process of change was used.10,16 In addition, a literature survey on how to select and tailor strategies to the information from the problem analysis was performed. Until now, not many implementation studies have been based on a problem analysis. Therefore, studies about the effect of implementation on general health were used. The results from both the literature search and the interviews were discussed with the project group (experts in the field of guideline implementation) and a sounding board (the interviewed physical therapists). Subsequently, implementation strategies were selected and developed.

Steps 4 and 5: Testing and Evaluation of the Implementation Plan In the literature, recommendations were made about testing interventions initially in small groups, in which active education and professional support seemed to be effective in improving physical therapists’ attitudes and adherence.4,23,24 Therefore, pilot testing of the implementation plan was undertaken with 2 groups of physical therapists from 4 physical therapist practices. The evaluation focused on feasibility and readjustment of the strategies developed. The results of the first pilot program were used to make adjustments in the second pilot program. It was not our intention to evaluate the effectiveness of the strategies, but the

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Implementation of Measurement Instruments Table 1. Summary of Barriers to and Facilitators of the Use of Measurement Instruments Reported in the Interviews Domain

Barriers

Facilitators

Physical therapist Competence

Attitude

Lack of knowledge, education, routine, and experience

Sufficient knowledge and education

Diagnosis focused on ICFa domain: body functions

Measurement instruments are already used in daily routine

Resistance to change

Readiness to change

No conviction of additional value on the plan of care

Positive attitude toward the use of measurement instruments

Being overloaded with information

Conviction of contribution to quality of physical therapy care

Headstrong in own working method Defining therapy outcome otherwise Lack of confidence in own skills Organization Practice

Takes too much time

Patient computer system

No financial compensation

Colleagues

Patient

Absence of practice policy

Presence of practice policy

Lack of discussions, meetings, and feedback from colleagues

Regular meetings and feedback from colleagues

No adherence to the agreements made

Innovative team and cooperative colleagues

Different expectations and preferences: needs no measurement instruments, wants only therapy, and puts pressure on therapist

Patient wants objectives to evaluate outcome of therapy

Linguistic problems and lack of understanding Measurement instrument

Poor availability

Good availability

Difficult choice Feasibility: extensive, difficult interpretation, and unclear instructions a

ICF⫽International Classification of Functioning, Disability and Health.

therapists were asked whether their knowledge, attitudes, and use of measurement instruments had changed.

Outcome Step 2: Problem Analysis All of the physical therapists who were invited for the interviews attended the interviews. After 11 interviews with 13 physical therapists, a saturation of data was reached, and the interviewing was stopped. The physical therapists, whose ages ranged from 22 to 54 years (median⫽43), were interviewed in the southern region of the Netherlands. Their working experience varied from 2 to 30 years (median⫽21), and 956

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the number of colleagues in the practice varied from 1 to 11 (median⫽6). The interviewed physical therapists specialized in different areas. The report of the interview was sent to each therapist for member checking, and the reports were all in agreement. The 13 therapists indicated that they were familiar with the PSC and 6MWT, but less than half of them indicated that they used these measures. Almost all interviewed physical therapists were motivated to use the instruments and were convinced of the additional value. Barriers and

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facilitators reported in the interviews are summarized in Table 1. In the sounding board, discussions about the identified barriers and facilitators took place. During these discussions, some physical therapists were very honest and admitted that they did not use the measurement instruments as often as they claimed. Because of the gap between claiming to use and actually using the instruments, the physical therapists made a commitment to use the PSC and 6MWT for 1 month and then discuss their experiences in a subsequent meeting. In the second meeting, they indicated that the instruments June 2010

Implementation of Measurement Instruments Table 2. Planning Model for the Process of Changea Domain

Phase of Behavioral Change and Implementation Goals

Implementation Strategies

Physical therapist Competence

Orientation: Awareness, interest, and involvement Insight: Increasing knowledge and understanding

Attitude

Insight: Insight into own working method Acceptance: Positive attitude and motivation Intention and decision to change Change: Confirmation of the benefit

Organization

Education: Homework tasks Practical training and role playing Self-analysis list: Increasing awareness, self-reflection, and insight into own working method Education: Discussions about resistance, advantage, and added value of clinimetrics Coaching style, own responsibility, individual learning goals, and interactions with colleagues

Insight: Insight into own working method

Self-analysis list: Insight into practice policy

Acceptance: Positive attitude and motivation Intention and decision to change

Education: Discussions and agreements with colleagues, development of practice policy, and formulation of learning and practice goals

Change: Implementation in daily practice Preservation of change: Integration in daily routines Anchoring in the organization Measurement instrument

KNGF: Dissemination by publications Offering education possibilities

Insight: Increasing knowledge and understanding Acceptance: Positive attitude and motivation Change: Implementation in daily practice

KNGF: Embedding in future electronic patient dossier

Adjustments in PSC and 6MWT: Increasing feasibility and simplifying instructions Extending PSC activity lists Education: Practical training and homework tasks Formulation of practice policy

Preservation of change: Integration in daily routines Anchoring in the organization a

The developed implementation strategies are based on various domains and phases of behavioral change, each with specific implementation goals.10,16 KNGF⫽Koninklijk Nederland Genootschap voor Fysiotherapie (Royal Dutch Society for Physical Therapy), PSC⫽Patient-Specific Complaints instrument, 6MWT⫽Six-Minute Walk Test.

were useful in daily practice. For example, 1 therapist previously thought that he could not use the instruments because his patients only wanted therapy and no measurements; however, the patients appreciated the use of the measurement instruments and asked him to use them regularly to monitor their progress. These experiences led to the identification of new barriers and facilitators, which made the implementation a cyclic process.

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Step 3: Development of Implementation Strategies There is no consensus about the best general implementation strategy.9,17,25,26 It is clear, however, that active, multifaceted strategies tailored to a problem analysis are the most effective.13,16,18,24 In addition, different models of behavioral change are recommended, but there is no agreement about which model should be used.10,12,14 –16 Grol and colleagues10,16 described a planning model for the process of change in

which different theories of behavioral change are integrated to induce changes in professional behavior. Table 2 shows various domains, phases of behavioral change (orientation, insight, acceptance, change, and preservation of change), and specific implementation goals. On the basis of this information, we tailored the outcome of the problem analysis to the appropriate implementation strategies. The definitive strategies, resulting from the project group and sounding board discussions, were

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Implementation of Measurement Instruments critically evaluated and readjusted several times. An overview of these strategies is shown in Table 2. To improve the feasibility of using the PSC and 6MWT, we made several adjustments: • The instructions were slightly adjusted to improve interpretation. • The original PSC was developed for patients with low back pain, and the sample activity list contained activities with which only those patients would have difficulties. A list of sample activities was made for patients with other disorders. • The visual analog scale of the original PSC was replaced with an 11point numerical rating scale. Practical use by the physical therapists and information from the literature revealed that this scoring method was more feasible for some (older) patients.27 Changing the visual analog scale to a numerical rating scale did not change the principle of the test; the scoring methods are highly correlated.28 A numerical rating scale also is used in the PainSpecific Functional Scale.20

A self-analysis list was developed to provide insight into and selfawareness of barriers and phases of behavioral change. This list was based on a questionnaire on the selfreported use of outcome measures in physical therapy and was obtained, along with other items, from the problem analysis.7 It contained 3 sections with questions concerning the phases of change for the physical therapist, the organization and its policy, and an inventory of the actual use of measurement instruments in daily practice. A few examples of questions from sections 1 and 2, rated on a Likert scale, are shown in the Appendix. The self-analysis list was pretested by the physical therapists of the sounding board and was used as a guide for the education module. 958

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An education module focusing on the physical therapist and the practice organization was developed. The aims of the education module were to provide insight into the use of measurement instruments and phases of behavioral change, to optimize the use of the PSC and 6MWT in the process of clinical reasoning, and to fit the use of the PSC and 6MWT to practice policy. The education module consisted of 3 sessions of 2.5 hours. The first 2 sessions were planned to take place within 1 month, and the last session was planned to take place after 2 months. The program was not completely determined in advance but was tailored to the professionals. Active teaching methods, such as discussion and role playing, were used in a coaching style instead of a teaching style. We expected the attendees to show an active learning attitude, initiative, and responsibility. Steps 4 and 5: Testing and Evaluation of the Implementation Plan Pilot testing and evaluation of the implementation plan were undertaken. The adjusted instruments, the self-analysis list, and the education program were tested with 2 groups of physical therapists from 4 private practices in the community. The first group consisted of colleagues from the same practice (n⫽11); the second group consisted of colleagues from 3 different practices (n⫽10). After each session, the process and the program were evaluated orally; after the third session, an evaluation form was filled out. The strategies developed could be applied to physical therapist practice. The evaluation of the adjusted measurement instruments was positive. The adjusted instructions were easier to interpret, and the additional activity lists were useful for determining treatment goals. The selfanalysis list appeared to be valuable

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because physical therapists became aware of their own barriers in daily practice. The link with their phases of behavioral change was revealing and stimulated them to use the instruments in daily practice. Working with heterogeneous groups made it difficult to accommodate the individual barriers of the physical therapists but, on the other hand, they could learn from one another. After the evaluation of the first pilot education program, the second program was adjusted at several points. The program became more fixed in advance. In the first session, attendees began to devise a practice policy. Individual learning goals were discussed, and homework tasks were checked. More time was allocated for practical rehearsal of the tests. The outline of the final education program is shown in Table 3. All of the physical therapists appreciated the active teaching methods, discussions, and role playing during training. Developing a practice policy was an issue of major importance, especially for the preservation of change. During busy daily practice, the therapists never took the time to discuss these matters. The physical therapists indicated that they were interested in practicing with other instruments besides the PSC and 6MWT and would appreciate sets of short, feasible, and methodologically sound instruments. At the last meeting, most physical therapists indicated that they actually used both instruments.

Discussion In this report, we have shown that it is possible to develop and evaluate a systematic implementation plan for the use of 2 measurement instruments. A thorough analysis was used to identify practical barriers and facilitators. In the interviews and discussions, we could continue asking June 2010

Implementation of Measurement Instruments Table 3. Outline of the Education Programa Day 1

2

3

a

Main Issues

Goals

Working Methods

Introduction

Explicating expectations of therapists: active learning attitude, responsibility, initiative, active teaching methods, and coaching style

Plenary

Self-analysis list

Insight into own working method and phase of behavior

Individual

Individual learning goals and practice policy

Responsibility for own learning process in professional and practice organization domains

Working group of 3 or 4 people

Advantages and disadvantages of PSC and 6MWT

Insight and acceptance

Plenary

Training on PSC: clarification of the patient’s main complaint

Increasing knowledge and practical skills

Working group of 3 or 4 people

Homework on PSC

Using PSC in practice for the next month

Plenary

Evaluation of the session

Reflection

Plenary

Results of self-analysis list

Insight on working method and phase of behavior

Presentation

Evaluation of homework task

Insight and acceptance

Plenary

Training on 6MWT: standardization and interpretation

Knowledge and practical skills

Working group of 3 or 4 people

Use of measurement instruments in practice policy

Integration in the practice organization to obtain (or preserve) change

Working group of 3 of 4 people

Homework on 6MWT

Using 6MWT in practice for the next 2 mo

Plenary

Evaluation of the session

Reflection

Plenary

Evaluation of homework task

Insight and acceptance

Plenary

Theory of clinimetrics

Insight and knowledge

Lecture

Step-by-step plan to search for other measurement instruments

Transfer to the use of other instruments

Lecture

Evaluation of practice policy

Integration in the practice organization to obtain (preserve) change

Working group of 3 or 4 people

Integration of instruments in clinical reasoning and daily practice

Preservation of behavioral change

Plenary

Written and oral evaluations of total education module

Reflection

Plenary and individual

PSC⫽Patient-Specific Complaints instrument, 6MWT⫽Six-Minute Walk Test.

about underlying thoughts and possible solutions and strategies. In this way, the problem analysis produced a larger amount of information than earlier reports, in which only written inquiries were used.4 – 8,29 –31 The revealed factors matched the barriers and facilitators described in the literature.4,6 – 8,29,30,32 Many studies2,4 – 8,14,29 –32 have focused on identifying the extent of use of measurement instruments as well as factors that affect that use. June 2010

We took the additional steps of developing various strategies based on these factors and evaluating their applicability in a pilot program in several physical therapist practices. The involvement of a sounding board during the development phase guaranteed interest in and acceptance of the implementation strategies by the target group.12,14,15 Starting education with self-analysis provides therapists with the opportunity to formulate their own learn-

ing goals, and trainers can tailor strategies to the professionals as well as the organization. This approach has been recommended in other studies.13,18 Using the planning model of Grol and colleagues10,16 for the process of change, we were able to tailor multifaceted strategies to various barriers and phases of behavioral change. In this way, a change in behavior was initiated. The physical therapists indicated that they used the measure-

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Implementation of Measurement Instruments ment instruments more often, and they were convinced that doing so contributed to the process of clinical reasoning. For the preservation of change, more time is needed. It is evident that quality improvements should start with small, simple projects.23 This case report involved a small group of selected physical therapists in the southern region of the Netherlands; therefore, generalization of the results is unjustifiable. Further studies and additional designs with other measurement instruments are needed to evaluate the effects of implementation strategies. Our recommendations for the policy of the Royal Dutch Society for Physical Therapy are as follows. First, information about measurement instruments should be disseminated through publication in professional journals, newsletters, and guidelines. This strategy represents the orientation phase, in which awareness of the existence and use of measurement instruments is an important issue. The information should not be restricted to the measurement instruments alone but also should focus on how to use and interpret the results of the instruments in daily practice. Second, educational opportunities should be offered for physical therapists to increase their knowledge and skills regarding the use of these and other measurement instruments in the process of clinical reasoning, with attention to behavioral change. This education should be included in mainstream physical therapist schools. Third, the measurement instruments should be embedded in the future electronic patient dossier. The actual use of measurement instruments should not be the only objective in implementation programs. The integration of the instruments in the process of clinical reasoning is of major importance. Therefore, future programs should focus not only on 960

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the physical therapist but also on the practice organization and professional associations. Both authors provided concept/idea/project design, writing, and project management. Ms Stevens provided data collection and analysis. Dr Beurskens provided fund procurement and facilities/equipment. The authors are grateful to members of the project group (Dr Rob de Bie, Dr Erik Hendriks, Mr Pieter Wolters, Dr Raymond Swinkels, Mrs Anja van den Donk, and Mr John Meijers) and the sounding board (the physical therapists interviewed). This work was funded by the Dutch Scientific College Physiotherapy of the Royal Dutch Society for Physical Therapy (TD/2008/01). This work, in part, was presented at the Annual Congress of the Royal Dutch Society for Physical Therapy; November 9, 2007; Amsterdam, the Netherlands. This article was received March 30, 2009, and was accepted February 24, 2010. DOI: 10.2522/ptj.20090105

References 1 Glasziou P, Irwig L, Mant D. Monitoring in chronic disease: a rational approach. BMJ. 2005;330:644 – 648. 2 Haigh R, Tennant A, Biering-Sorensen F, et al. The use of outcome measures in physical medicine and rehabilitation within Europe. J Rehabil Med. 2001;33: 273–278. 3 Jette DU, Bacon K, Batty C, et al. Evidencebased practice: beliefs, attitudes, knowledge, and behaviors of physical therapists. Phys Ther. 2003;83:786 – 805. 4 Abrams D, Davidson M, Harrick J, et al. Monitoring the change: current trends in outcome measure usage in physiotherapy. Man Ther. 2006;11:46 –53. 5 Leemrijse CJ, Plas GM, Hofhuis H, van den Ende CH. Compliance with the guidelines for acute ankle sprain for physiotherapists is moderate in the Netherlands: an observational study. Aust J Physiother. 2006;52: 293–299. 6 Maher C, Williams M. Factors influencing the use of outcome measures in physiotherapy management of lung transplant patients in Australia and New Zealand. Physiother Theory Pract. 2005;21:201–217. 7 Van Peppen RP, Maissan FJ, Van Genderen FR, et al. Outcome measures in physiotherapy management of patients with stroke: a survey into self-reported use, and barriers to and facilitators for use. Physiother Res Int. 2008;13: 255–270.

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8 Pisters M, Leemrijse C. Het gebruik van aanbevolen meetinstrumenten in de fysiotherapiepraktijk. Weten is nog geen meten! [The use of measurement instruments in physiotherapy practice. Knowing it isn’t measuring it!] Nederlands Tijdschrift voor Fysiotherapie. 2007;5:176 –180. 9 Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an overview of systematic reviews of interventions. Med Care. 2001;39(8 suppl 2):112–145. 10 Grol R, Wensing M, Eccles M. Improving Patient Care: The Implementation of Change in Clinical Practice. Edinburgh, Scotland: Elsevier Butterworth Heineman; 2005. 11 Grimshaw JM, McAuley LM, Bero LA, et al. Systematic reviews of the effectiveness of quality improvement strategies and programmes. Qual Saf Health Care. 2003;12: 298 –303. 12 Berwick DM. Disseminating innovations in health care. JAMA. 2003;289:1969 –1975. 13 Bosch M, van der Weyden T, Wensing MG, Grol R. Tailoring quality improvement interventions to identified barriers: a multiple case analysis. J Eval Clin Pract. 2007; 13:161–168. 14 Garland AF, Kruse M, Aarons GA. Clinicians and outcome measurement: what’s the use? J Behav Health Serv Res. 2003; 30:393– 405. 15 Grol R, Grimshaw JM. From best evidence to best practice: effective implementation of change in patients’ care. Lancet. 2003; 362:1225–1230. 16 Grol R, Wensing M. What drives change: barriers to and incentives for achieving evidence-based practice. Med J Aust. 2004;180(6 suppl):S57–S60. 17 Haines A, Kuruvilla S, Borchert M. Bridging the implementation gap between knowledge and action for health. Bull World Health Organ. 2004;82:724 –731; discussion 732. 18 Shaw B, Cheater F, Baker R, et al. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2005;3: CD005470. 19 Beurskens AJ, de Vet HC, Koke AJ. Responsiveness of functional status in low back pain: a comparison of different instruments. Pain. 1996;65:71–76. 20 Stratford PW, Gill C, Westaway M, Binkley JM. Assessing disability and change on individual patients: a report of a patientspecific measure. Physiother Can. 1995; 47:258 –263. 21 Butland RJ, Pang J, Gross ER, et al. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982;284:1607–1608. 22 Strauss ALC. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Thousand Oaks, CA: Sage Publications; 1998.

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Implementation of Measurement Instruments 23 Geboers H, Mokkink H, van Montfort P, et al. Continuous quality improvement in small general medical practices: the attitudes of general practitioners and other practice staff. Int J Qual Health Care. 2001;13:391–397. 24 van der Wees PJ, Jamtvedt G, Rebbeck T, et al. Multifaceted strategies may increase implementation of physiotherapy clinical guidelines: a systematic review. Aust J Physiother. 2008;54:233–241. 25 Bekkering GE, Engers AJ, Wensing M, et al. Development of an implementation strategy for physiotherapy guidelines on low back pain. Aust J Physiother. 2003;49:208 –214.

26 Grimshaw JM, Thomas RE, MacLennan G, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8: iii–iv, 1–72. 27 Peters ML, Patijn J, Lame I. Pain assessment in younger and older pain patients: psychometric properties and patient preference of five commonly used measures of pain intensity. Pain Med. 2007; 8:601– 610. 28 Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005;14:798 – 804. 29 Metcalfe CL, Lewin R, Wisher S, et al. Barriers to implementing the evidence base in four NHS therapies: dieticians, occupational therapists, physiotherapists, speech and language therapists. Physiotherapy. 2001;87:433– 441.

30 Pollock AS, Legg L, Langhorne P, Sellars C. Barriers to achieving evidence-based stroke rehabilitation. Clin Rehabil. 2000; 14:611– 617. 31 Jette DU, Halbert J, Iverson C, et al. Use of standardized outcome measures in physical therapist practice: perceptions and applications. Phys Ther. 2009;89:125–135. 32 Copeland JM, Taylor WJ, Dean SG. Factors influencing the use of outcome measures for patients with low back pain: a survey of New Zealand physical therapists. Phys Ther. 2008;88:1492–1505.

Appendix. Examples of Questions in the Self-Analysis Lista

Questions

Fully Disagree

Disagree

Neither Agree nor Disagree

Agree

Fully Agree

Section 1: questions about yourself I am able to interpret the outcome of measurement instruments in the right way I think it is important to document patient data in an objective way I think that the use of measurement instruments does not take too much of my time The use of measurement instruments is a fixed part of my methodical approach Section 2: questions about policy in your practice In my practice, enough measurement instruments are available My supervisor supports employees in using measurement instruments The colleagues in my practice use measurement instruments a

The complete list is available on request from the authors.

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Letters to the Editor On “Increasing muscle extensibility...” Weppler CH, Magnusson SP. Phys Ther. 2010;90:438–449. This perspective article1 was very interesting and thought provoking; however, I was slightly skeptical about your conclusions in the section on neuromuscular relaxation. Specifically, I am having trouble reconciling my clinical experience with your suggestion that an increase in extensibility during a contract-relax procedure is due to a change in sensation. I acknowledge that an examiner’s perception can be misleading; however, I would be surprised if I were unwittingly applying more tension to gain more length (ie, the analog of the postintervention plot in Figure 2 of your article). In particular, I regularly carry out contract-relax stretching on the piriformis muscle, which as I am sure you are aware, frequently becomes painful to palpation and shows increased tension in many instances of lumbosacral/pelvic dysfunction. Changes in passive medial (internal) rotation of 10 degrees or more can be obtained quite easily and without forcing the situation—most definitely counterproductive for most patients. It seems as though a shift of the tension/length graph must have taken place to the right; to achieve the same degree of thigh medial rotation as before treatment does appear to me to take less effort. Do you think this empirical observation can be rationalized in terms of the fact that the patients were symptomatic, as you note that the cited studies were carried out mostly in patients who were asymptomatic?

Jonathan B. Rohll J.B. Rohll, BSc (Biochemistry), BSc (Osteopathy), PhD, is Lecturer and Osteopath, Oxford Brookes University, Oxford, United Kingdom OX3 0BP. Address all correspondence to Dr Rohll at: jonathan.rohll@tesco. net. This letter was posted as a Rapid Response on April 13, 2010, at ptjournal.apta.org.

Reference 1 Weppler CH, Magnusson SP. Increasing muscle extensibility: a matter of increasing length or modifying sensation? Phys Ther. 2010;90:438–449. [DOI: 10.2522/ptj.2010.90.6.962.1]

Author Response I am pleased that you have taken the time to read our perspective article1 thoughtfully, and I appreciate your comments and question regarding contract/relax stretching. The primary intent of our perspective article was to introduce the concept that increases in muscle extensibility observed after stretching can be due to modified sensation. This concept alone has profound implications regarding assessment of muscle extensibility and in understanding the biomechanical effects of stretching. While researching this topic, I found that there are a number of theories regarding muscle extensibility and stretching that are widely accepted as conventional wisdom but that are not supported by experimental evidence. Therefore, another underlying purpose of our article was to show how little basic research has been performed regarding these topics. What is presented in the perspective article is, to the best of my knowledge, accurate at this point in time. As with any scientific endeavor, as research continues, more evidence will likely come to light that will re-

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fine the ideas presented. I consider our article to be successful if it: (1) causes practitioners to question prevailing conventional wisdom, (2) encourages debate, and (3) inspires more research that helps to further understanding of these phenomena. The neuromuscular relaxation section was written to show that increases in muscle extensibility can occur without any evidence of neuromuscular relaxation. We did not attempt to explain the biomechanical effect of contract/ relax stretching in detail because this was not the focus of the article. However, we also did not intend to give the impression that all increases in muscle extensibility observed during contract/ relax stretching are solely due to modified sensation. I agree that, during performance of contract/relax stretching, a decreased resistance to stretch is palpable shortly after the isometric contraction is released. This decreased resistance has most often been attributed to neuromuscular relaxation. The experimental evidence available at this point in time, however, suggests instead that the decreased resistance is due to viscoelastic rather than neuromuscular relaxation.2,3 There are a number of studies that monitored electromyographic activity during contract/ relax stretching and showed no evidence that neuromuscular relaxation was responsible for the observed increases in muscle extensibility.4–8 These studies evaluated several different stretching methods, and some authors6–8 observed that the greatest increases in muscle extensibility occurred with the stretching techniques that induced the greatest increases in electromyographic activity.

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Letters to the Editor On “Increasing muscle extensibility...” Weppler CH, Magnusson SP. Phys Ther. 2010;90:438–449. This perspective article1 was very interesting and thought provoking; however, I was slightly skeptical about your conclusions in the section on neuromuscular relaxation. Specifically, I am having trouble reconciling my clinical experience with your suggestion that an increase in extensibility during a contract-relax procedure is due to a change in sensation. I acknowledge that an examiner’s perception can be misleading; however, I would be surprised if I were unwittingly applying more tension to gain more length (ie, the analog of the postintervention plot in Figure 2 of your article). In particular, I regularly carry out contract-relax stretching on the piriformis muscle, which as I am sure you are aware, frequently becomes painful to palpation and shows increased tension in many instances of lumbosacral/pelvic dysfunction. Changes in passive medial (internal) rotation of 10 degrees or more can be obtained quite easily and without forcing the situation—most definitely counterproductive for most patients. It seems as though a shift of the tension/length graph must have taken place to the right; to achieve the same degree of thigh medial rotation as before treatment does appear to me to take less effort. Do you think this empirical observation can be rationalized in terms of the fact that the patients were symptomatic, as you note that the cited studies were carried out mostly in patients who were asymptomatic?

Jonathan B. Rohll J.B. Rohll, BSc (Biochemistry), BSc (Osteopathy), PhD, is Lecturer and Osteopath, Oxford Brookes University, Oxford, United Kingdom OX3 0BP. Address all correspondence to Dr Rohll at: jonathan.rohll@tesco. net. This letter was posted as a Rapid Response on April 13, 2010, at ptjournal.apta.org.

Reference 1 Weppler CH, Magnusson SP. Increasing muscle extensibility: a matter of increasing length or modifying sensation? Phys Ther. 2010;90:438–449. [DOI: 10.2522/ptj.2010.90.6.962.1]

Author Response I am pleased that you have taken the time to read our perspective article1 thoughtfully, and I appreciate your comments and question regarding contract/relax stretching. The primary intent of our perspective article was to introduce the concept that increases in muscle extensibility observed after stretching can be due to modified sensation. This concept alone has profound implications regarding assessment of muscle extensibility and in understanding the biomechanical effects of stretching. While researching this topic, I found that there are a number of theories regarding muscle extensibility and stretching that are widely accepted as conventional wisdom but that are not supported by experimental evidence. Therefore, another underlying purpose of our article was to show how little basic research has been performed regarding these topics. What is presented in the perspective article is, to the best of my knowledge, accurate at this point in time. As with any scientific endeavor, as research continues, more evidence will likely come to light that will re-

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fine the ideas presented. I consider our article to be successful if it: (1) causes practitioners to question prevailing conventional wisdom, (2) encourages debate, and (3) inspires more research that helps to further understanding of these phenomena. The neuromuscular relaxation section was written to show that increases in muscle extensibility can occur without any evidence of neuromuscular relaxation. We did not attempt to explain the biomechanical effect of contract/ relax stretching in detail because this was not the focus of the article. However, we also did not intend to give the impression that all increases in muscle extensibility observed during contract/ relax stretching are solely due to modified sensation. I agree that, during performance of contract/relax stretching, a decreased resistance to stretch is palpable shortly after the isometric contraction is released. This decreased resistance has most often been attributed to neuromuscular relaxation. The experimental evidence available at this point in time, however, suggests instead that the decreased resistance is due to viscoelastic rather than neuromuscular relaxation.2,3 There are a number of studies that monitored electromyographic activity during contract/ relax stretching and showed no evidence that neuromuscular relaxation was responsible for the observed increases in muscle extensibility.4–8 These studies evaluated several different stretching methods, and some authors6–8 observed that the greatest increases in muscle extensibility occurred with the stretching techniques that induced the greatest increases in electromyographic activity.

June 2010

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Letters to the Editor All of these studies4–8 questioned the traditional explanation that increases in muscle extensibility observed during contract/relax stretching (as well as stretches involving contraction of antagonist muscles) are due to neuromuscular relaxation induced by neuromuscular reflexes. To my knowledge, there is only one study that additionally monitored passive torque during application of contract/relax stretching.2 That study was cited in our perspective article, and its results suggest that increases in extensibility (using subjects’ perception of pain onset as an endpoint) observed during contract/ relax stretching can be attributed to both (1) temporary increases in muscle length (as illustrated in Fig. 1 of our article) due to viscoelastic deformation and (2) modified sensation (as illustrated in Fig. 2 of our article). The intent of the study by Magnusson et al2 was to examine the differences in electromyographic activity, passive torque, and stretch perception between a static stretch and a contract/relax stretch. During both the static stretch and contract/relax stretch conditions, muscles demonstrated: (1) viscoelastic stress relaxation of similar magnitude while being held in the initial stretched position and (2) a similar right shift of the torque/angle curves observed during the subsequent stretch application. Greater increases in muscle extensibility, however, were observed when subjects performed the contract/ relax stretch versus the static stretch. The increases in extensibility that occurred in excess of those demonstrated with the static stretch could be attributed to modified sensation.

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In clinical practice, the contract/ relax stretch usually is repeated 3 to 5 times, allowing increasing end-range joint angles with each repetition. Magnusson and colleagues’ experiment2 was conducted using a single contract/relax stretch, and it would be valuable to see what occurs biomechanically when this technique is applied multiple times, as in clinical practice. Magnusson and colleagues’ study2 was performed using hamstring muscles of male subjects who were healthy and asymptomatic. The biomechanical effect may vary in different muscles and subject groups. It is possible that neuromuscular relaxation may play a role in increasing the efficacy of contract/relax stretching in subjects diagnosed with neurological impairments or in subjects who are symptomatic, but, to my knowledge, this has not been shown experimentally. The isometric contraction itself may help to decrease pain in symptomatic muscles, further enhancing the increases in extensibility and reducing muscle guarding. Thank you for your interest, comments, and question. I appreciate this opportunity to discuss the biomechanical effect of contract/relax stretching in some detail. Dr Magnusson and I chose to submit a correction, in part, to present this topic with more precision in the perspective article. The correction appears in the April issue of PTJ and can be found at: http://ptjournal.apta. org/cgi/content/full/90/4/647.

Cynthia Holzman Weppler C.H. Weppler, PT, MPT, is Independent Researcher, Am Honigbaum 20, 65817 Niederjosbach, Germany. Address all correspondence to Ms Weppler at: [email protected]. This letter was posted as a Rapid Response on April 13, 2010, at ptjournal.apta.org.

References 1 Weppler CH, Magnusson SP. Increasing muscle extensibility: a matter of increasing length or modifying sensation? Phys Ther. 2010;90:438–449. 2 Magnusson SP, Simonsen EB, Aagaard P, et al. Mechanical and physical responses to stretching with and without preisometric contraction in human skeletal muscle. Arch Phys Med Rehabil. 1996;77:373–378. 3 Chalmers G. Re-examination of the possible role of Golgi tendon organ and muscle spindle reflexes in proprioceptive neuromuscular facilitation muscle stretching. Sports Biomech. 2004;3:159–183. 4 Condon SM, Hutton RS. Soleus muscle electromyographic activity and ankle dorsiflexion range of motion during four stretching procedures. Phys Ther. 1987;67:24–30. 5 Mitchell UH, Myrer JW, Hopkins JT, et al. Neurophysiological reflex mechanisms’ lack of contribution to the success of PNF stretches. J Sport Rehabil. 2009;18:343– 357. 6 Moore MA, Hutton RS. Electromyographic investigation of muscle stretching techniques. Med Sci Sports Exerc. 1980;12:322–329. 7 Osternig LR, Robertson R, Troxel R, Hansen P. Muscle activation during proprioceptive neuromuscular facilitation (PNF) stretching techniques. Am J Phys Med. 1987;66:298–307. 8 Osternig LR, Robertson RN, Troxel RK, Hansen P. Differential responses to proprioceptive neuromuscular facilitation (PNF) stretch techniques. Med Sci Sports Exerc. 1990;22:106–111. [DOI: 10.2522/ptj.2010.90.6.962.2]

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Scholarships, Fellowships, and Grants News from the Foundation for Physical Therapy Thank You for Your Support The Foundation would like to give special thanks to the MiamiMarquette Challenge coordinators who took time out of their schedules to lead this year’s Challenge: Kyle Bisping (Marquette University), Gretchen DeGroot (Marquette University), Julio Martinez (University of Miami), and Kathleen Torre (University of Miami). To all program directors and faculty of the participating schools, thank you for conveying the importance of physical therapy research to your students and providing guidance in their fundraising efforts. The Foundation would like to express our gratitude to Marquette University Department Chair Lawrence G. Pan, PT, PhD, FAPTA, for guiding this fundraising effort over the past 22 years. Thanks also to Marquette University Assistant Professor Sheila Schindler-Ivens, PT, PhD; University of Miami Department Chair Sherrill H. Hayes, PT, PhD; and Associate Professor Kathryn E. Roach, PT, PhD, for supporting their students as they took on their roles as leaders of this year’s Challenge. Winning schools will be listed on the Foundation’s Web site later this month.

Current Funding Opportunities The Foundation for Physical Therapy is now accepting applications for the Kendall Scholarship and Research Grant programs. Students beginning their doctoral programs are encouraged to apply to win 1 of the $5,000 Kendall Scholarships. The Foundation also

awards $40,000 Research Grants to emerging investigators to help them establish a track record of funding. Applications for both funding opportunities are due at noon ET on August 18, 2010. For more details, please visit the Foundation’s Web site at www. FoundationforPhysicalTherapy.org and click on “Grants, Fellowships & Scholarships.”

KK, Craik RL, McCormick AA, Blevins HL, White MB, SullivanMarx EM, and Tomlinson JD, was published online in Physical Therapy on April 15, 2010. Kathleen Mangione, PT, PhD, GCS, and Rebecca Craik, PT, PhD, FAPTA, each received 2000 Research Grants. James Tomlinson, PT, MS, received funding from the Foundation in 1996.

Recent Publications by Foundation-Funded Researchers

“Inspiratory Muscle Training in a Child With Nemaline Myopathy and Organ Transplantation,” by Smith BK, Bleiweis MS, Zauhar J, and Martin AD, was published online in Pediatric Critical Care Medicine on April 19, 2010. Barbara Smith, MPT, received a 2008 Promotion of Doctoral Studies (PODS) I scholarship and a 2009 PODS II scholarship.

“Multiplane Loading of the Extensor Mechanism Alters the Patellar Ligament Force/Quadriceps Force Ratio,” by Powers CM, Chen YJ, Scher IS, and Lee TQ, was published in the Journal of Biomechanical Engineering (2010;132[2]:024503). Christopher Powers, PT, PhD, received a 2001 Research Grant. “Oxygen Uptake Kinetics: Associations With Ambulatory Activity and Physical Functional Performance in Stroke Survivors,” by Manns PJ, Tomczak CR, Jelani A, and Haennel RG, was printed in the Journal of Rehabilitation Medicine (2010;42[3]:259–264). Patricia Manns, PT, PhD, won a PODS II scholarship in 2001. “Functional Gait Assessment: Concurrent, Discriminative, and Predictive Validity in CommunityDwelling Older Adults,” by Wrisley DM and Kumar NA, was published online in Physical Therapy on April 1, 2010. Diane Wrisley, PT, PhD, NCS, won a 2008 Research Grant.

Do You Have News You Would Like to Share? If you would like to include any announcements in the Foundation’s section, contact our communications assistant at abegailmatienzo@ apta.org. [DOI: 10.2522/ptj.2010.90.6.964]

“Detectable Changes in Physical Performance Measures in Elderly African Americans,” by Mangione

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“Plans to Stop Cancer Screening Tests Among Adults Who Recently Considered Screening,” by Lewis CL, Couper MP, Levin CA, Pignone MP, and Zikmund-Fisher BJ, was published online in the Journal of General Internal Medicine on April 21, 2010. Cynthia Lewis, PT, PhD, received funding in 1991.

June 2010

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Scholarships, Fellowships, and Grants

Foundation PT 2010 Events Mark Your Annual Conference Calendars Kick off the evening of Thursday, June 17, with APTA’s Honors and Awards Celebration! This event is your once-a-year opportunity to applaud the achievements of colleagues from across the nation. The celebration will recognize newly elected Catherine Worthingham Fellows of APTA, the 2010 Association Award recipients, and education programs receiving awards in the Foundation for Physical Therapy’s Miami-Marquette Challenge. Immediately following the Honors and Awards Celebration, plan to join your colleagues for a special reception hosted by APTA and the Foundation. Preferred Therapy Providers, a Foundation Partner in Research, will graciously sponsor this opportunity for award recipients to interact with friends, family, and colleagues in an informal atmosphere with light refreshments. The Foundation’s annual gala, “Putting on the Ritz,” will follow the reception. Tickets for this event must be purchased by June 8, and will not be sold in Boston. Festivities include recognizing the Foundation’s annual service award recipients, announcement of the Miami-Marquette Challenge top fund raising schools, and Split Raffle winners—it’s a perfect way to end the evening! Special thanks to HPSO/ CNA, title sponsor for the 10th consecutive year.

Quality. Value. Peace of mind. All under one roof. Safety First® offers your patients a variety of ADA approved products that enhance lives by assisting in short and long term care. Our quality products are available at affordable prices at your local Home Depot® or www.homedepot.com/bathsafety

Don’t Miss Your Last Chance to Enter to Win a Trip to Hawaii! Enter the Aloha Getaway Sweepstakes before June 25, 2010, and you could win a trip for 2 to Hawaii valued at $4,000! Every $10 donation to the Foundation will receive 1 entry into the drawing, or 5 entries will be placed for a $40 donation. Enter online at www.FoundationforPhysicalTherapy. org. No Purchase Necessary to Enter or Win: The “Aloha Getaway” Sweepstakes is open to all legal residents of the United States, age 18 years or older as of January 22, 2010. The staffs of the Foundation and APTA are not eligible to participate. View the complete Official Rules, which govern the Sweepstakes, at the Foundation’s Web site. Void where prohibited.

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