Literature DB >> 33763961

Examination of exclusion criteria in total knee arthroplasty rehabilitation trials: influence on the application of evidence in day-to-day practice.

Andrew J Kittelson1, Brian J Loyd1,2, Jeremy Graber3, Michael A Himawan3, Dawn Waugh4, Jacqueline Davenport4, Thomas J Hoogeboom5, Jennifer Stevens-Lapsley3,6.   

Abstract

OBJECTIVE: Total knee arthroplasty (TKA) rehabilitation trials use exclusion criteria, which may limit their generalizability in practice. We investigated whether patients seen in routine practice who meet common exclusion criteria recover differently from TKA compared to research-eligible patients. We hypothesized that research-ineligible patients would demonstrate poorer average postoperative function and slower rate of functional recovery compared to research-eligible patients.
METHODS: Patient characteristics and exclusion criteria were extracted and summarized from trials included in the three most recent systematic reviews of TKA rehabilitation. Trial participant characteristics were compared to a clinical dataset of patient outcomes collected in routine TKA rehabilitation. Where possible, individual exclusion criterion from the trials were applied to the clinical dataset to determine "eligible" and "ineligible" groups for research participation. Postoperative functional outcomes including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Timed Up and Go (TUG) were compared between "eligible" and "ineligible" groups using mixed effects models.
RESULTS: 2,528 participants from 27 trials were compared to 474 patients from the clinical dataset. Research participants were older, with lower Body Mass Index than patients in the clinical dataset. Many patients in the clinical dataset would be "ineligible" for research participation based upon common exclusion criteria from the trials. Differences were observed in average postoperative functioning between some "eligible" and "ineligible" groups in the clinical dataset. However, no differences were observed in functional recovery rate between groups, except for patients with diabetes whose TUG recovered more slowly than their "eligible" counterparts.
CONCLUSIONS: Many patients in the clinical dataset were "ineligible" for research participation based upon common TKA rehabilitation trial exclusion criteria. However, the postoperative recovery rate did not differ between "eligible" and "ineligible" groups based on individual exclusion criterion-except for individuals with diabetes. This suggests that both clinical and research populations may recover similarly from TKA.
© 2021 John Wiley & Sons Ltd.

Entities:  

Keywords:  clinical guidelines; evaluation; evidence-based medicine

Mesh:

Year:  2021        PMID: 33763961      PMCID: PMC8627122          DOI: 10.1111/jep.13564

Source DB:  PubMed          Journal:  J Eval Clin Pract        ISSN: 1356-1294            Impact factor:   2.431


  41 in total

1.  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties.

Authors:  S McConnell; P Kolopack; A M Davis
Journal:  Arthritis Rheum       Date:  2001-10

2.  Whole-body vibration strengthening compared to traditional strengthening during physical therapy in individuals with total knee arthroplasty.

Authors:  A Wayne Johnson; J William Myrer; Iain Hunter; J Brent Feland; J Ty Hopkins; David O Draper; Dennis Eggett
Journal:  Physiother Theory Pract       Date:  2010-05       Impact factor: 2.279

3.  Generalizability of antidepressant efficacy trials: differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial.

Authors:  Mark Zimmerman; Iwona Chelminski; Michael A Posternak
Journal:  Am J Psychiatry       Date:  2005-07       Impact factor: 18.112

4.  Utilization and clinical outcomes of outpatient physical therapy for medicare beneficiaries with musculoskeletal conditions.

Authors:  Julie M Fritz; Stephen J Hunter; Diane M Tracy; Gerard P Brennan
Journal:  Phys Ther       Date:  2011-01-13

5.  External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?

Authors:  Justin Travers; Suzanne Marsh; Mathew Williams; Mark Weatherall; Brent Caldwell; Philippa Shirtcliffe; Sarah Aldington; Richard Beasley
Journal:  Thorax       Date:  2006-11-14       Impact factor: 9.139

Review 6.  Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials.

Authors:  Catherine J Minns Lowe; Karen L Barker; Michael Dewey; Catherine M Sackley
Journal:  BMJ       Date:  2007-09-20

7.  Effects of balance training on functional outcome after total knee replacement in patients with knee osteoarthritis: a randomized controlled trial.

Authors:  Chun-De Liao; Tsan-Hon Liou; Yu-Yun Huang; Yi-Ching Huang
Journal:  Clin Rehabil       Date:  2013-03-05       Impact factor: 3.477

8.  Comprehensive physiotherapy exercise programme or advice for chronic whiplash (PROMISE): a pragmatic randomised controlled trial.

Authors:  Zoe A Michaleff; Chris G Maher; Chung-Wei Christine Lin; Trudy Rebbeck; Gwendolen Jull; Jane Latimer; Luke Connelly; Michele Sterling
Journal:  Lancet       Date:  2014-04-04       Impact factor: 79.321

Review 9.  Effectiveness of physiotherapy exercise following total knee replacement: systematic review and meta-analysis.

Authors:  Neil Artz; Karen T Elvers; Catherine Minns Lowe; Cath Sackley; Paul Jepson; Andrew D Beswick
Journal:  BMC Musculoskelet Disord       Date:  2015-02-07       Impact factor: 2.362

10.  The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis.

Authors:  Ahmad Alghadir; Shahnawaz Anwer; Jean-Michel Brismée
Journal:  BMC Musculoskelet Disord       Date:  2015-07-30       Impact factor: 2.362

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