title: How have research questions and methods used in clinical trials published in Clinical Rehabilitation changed over the last 30 years?
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.
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada nancy.mayo@mcgill.ca.
authors: Nancy E
authors: NE
authors: Mayo
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Navaldeep
authors: N
authors: Kaur
authors: Department of Occupational Science & Occupational Therapy, University of British Columbia, Vancouver, British Columbia, Canada.
authors: Skye P
authors: SP
authors: Barbic
authors: Department of Surgery, McGill University, Montreal, Quebec, Canada.
authors: Julio
authors: J
authors: Fiore
authors: Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
authors: Ruth
authors: R
authors: Barclay
authors: Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.
authors: Lois
authors: L
authors: Finch
authors: School of Physical Therapy, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
authors: Ayse
authors: A
authors: Kuspinar
authors: School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Miho
authors: M
authors: Asano
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Sabrina
authors: S
authors: Figueiredo
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Ala' Sami
authors: AS
authors: Aburub
authors: Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Fadi
authors: F
authors: Alzoubi
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Alaa
authors: A
authors: Arafah
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Sorayya
authors: S
authors: Askari
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Behtash
authors: B
authors: Bakhshi
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Vanessa
authors: V
authors: Bouchard
authors: École de réadaptation, Université de Montréal, Montreal, Quebec, Canada.
authors: Johanne
authors: J
authors: Higgins
authors: Montreal Neurological Institute and Hospital, Multiple Sclerosis Clinic, Montreal, Quebec, Canada.
authors: Stanley
authors: S
authors: Hum
authors: School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Mehmet
authors: M
authors: Inceer
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Marie Eve
authors: ME
authors: Letellier
authors: Departamento de Educação Integrada em Saúde, Universidade Federal do Espírito Santo, Brazil Department of Physical Therapy, University of Toronto, Toronto, Ontario.
authors: Christiane
authors: C
authors: Lourenco
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Kedar
authors: K
authors: Mate
authors: Department of Physical Therapy, University of Toronto, Toronto, Ontario.
authors: Nancy M
authors: NM
authors: Salbach
authors: Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
authors: Carolina
authors: C
authors: Moriello
mesh_terms: D035843:Biomedical Research / Q000639:trends*; D002986:Clinical Trials as Topic; D006801:Humans; D010506:Periodicals as Topic / Q000639:trends*; D011643:Publishing / Q000639:trends*; D012046:Rehabilitation / Q000639:trends*
keywords: Controlled clinical trial; outcome assessment (healthcare); rehabilitation interventions