How have research questions and methods used in clinical trials published in Clinical Rehabilitation changed over the last 30 years?

Author:

Mayo Nancy E123,Kaur Navaldeep123,Barbic Skye P4,Fiore Julio5,Barclay Ruth6,Finch Lois2,Kuspinar Ayse7,Asano Miho3,Figueiredo Sabrina123,Aburub Ala’ Sami123,Alzoubi Fadi23,Arafah Alaa123,Askari Sorayya123,Bakhshi Behtash123,Bouchard Vanessa123,Higgins Johanne8,Hum Stanley9,Inceer Mehmet3,Letellier Marie Eve123,Lourenco Christiane1011,Mate Kedar123,Salbach Nancy M11,Moriello Carolina123

Affiliation:

1. Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada

2. Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada

3. School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada

4. Department of Occupational Science & Occupational Therapy, University of British Columbia, Vancouver, British Columbia, Canada

5. Department of Surgery, McGill University, Montreal, Quebec, Canada

6. Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Manitoba, Canada

7. School of Physical Therapy, University of Saskatchewan, Saskatoon, Saskatchewan, Canada

8. École de réadaptation, Université de Montréal, Montreal, Quebec, Canada

9. Montreal Neurological Institute and Hospital, Multiple Sclerosis Clinic, Montreal, Quebec, Canada

10. Departamento de Educação Integrada em Saúde, Universidade Federal do Espírito Santo, Brazil

11. Department of Physical Therapy, University of Toronto, Toronto, Ontario

Abstract

Research in rehabilitation has grown from a rare phenomenon to a mature science and clinical trials are now common. The purpose of this study is to estimate the extent to which questions posed and methods applied in clinical trials published in Clinical Rehabilitation have evolved over three decades with respect to accepted standards of scientific rigour. Studies were identified by journal, database, and hand searching for the years 1986 to 2016. A total of 390 articles whose titles suggested a clinical trial of an intervention, with or without randomization to form groups, were reviewed. Questions often still focused on methods to be used (57%) rather than what knowledge was to be gained. Less than half (43%) of the studies delineated between primary and secondary outcomes; multiple outcomes were common; and sample sizes were relatively small (mean 83, range 5 to 3312). Blinding of assessors was common (72%); blinding of study subjects was rare (19%). In less than one-third of studies was intention-to-treat analysis done correctly; power was reported in 43%. There is evidence of publication bias as 83% of studies reported either a between-group or a within-group effect. Over time, there was an increase in the use of parameter estimation rather than hypothesis testing and there was evidence that methodological rigour improved. Rehabilitation trialists are answering important questions about their interventions. Outcomes need to be more patient-centred and a measurement framework needs to be explicit. More advanced statistical methods are needed as interventions are complex. Suggestions for moving forward over the next decades are given.

Publisher

SAGE Publications

Subject

Rehabilitation,Physical Therapy, Sports Therapy and Rehabilitation

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