1. How have research questions and methods used in clinical trials published in Clinical Rehabilitation changed over the last 30 years?
- Author
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Sabrina Figueiredo, Stanley Hum, Ruth Barclay, Fadi Alzoubi, Miho Asano, Alaa M Arafah, Vanessa Bouchard, Marie Eve Letellier, Johanne Higgins, Lois Finch, Christiane Lourenco, Behtash Bakhshi, Navaldeep Kaur, Julio F. Fiore, Ayse Kuspinar, Kedar K.V. Mate, Carolina Moriello, Nancy E. Mayo, Nancy M. Salbach, Sorayya Askari, Mehmet Inceer, Skye Barbic, and Ala' S Aburub
- Subjects
030506 rehabilitation ,medicine.medical_specialty ,Blinding ,Biomedical Research ,medicine.medical_treatment ,Alternative medicine ,Psychological intervention ,Physical Therapy, Sports Therapy and Rehabilitation ,Rigour ,03 medical and health sciences ,0302 clinical medicine ,Controlled clinical trial ,medicine ,Humans ,outcome assessment (healthcare) ,Publishing ,Clinical Trials as Topic ,Rehabilitation ,business.industry ,Publication bias ,Articles ,Clinical trial ,Sample size determination ,Family medicine ,Physical therapy ,Periodicals as Topic ,0305 other medical science ,business ,030217 neurology & neurosurgery ,rehabilitation interventions - 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.
- Published
- 2016