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

Nancy E Mayo¹, Navaldeep Kaur², Skye P Barbic³, Julio Fiore⁴, Ruth Barclay⁵, Lois Finch⁶, Ayse Kuspinar⁷, Miho Asano⁸, Sabrina Figueiredo², Ala' Sami Aburub², Fadi Alzoubi⁹, Alaa Arafah², Sorayya Askari², Behtash Bakhshi², Vanessa Bouchard², Johanne Higgins¹⁰, Stanley Hum¹¹, Mehmet Inceer⁸, Marie Eve Letellier², Christiane Lourenco¹², Kedar Mate², Nancy M Salbach¹³, Carolina Moriello²

Affiliations

¹ 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.
² 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.
³ Department of Occupational Science & Occupational Therapy, University of British Columbia, Vancouver, British Columbia, Canada.
⁴ Department of Surgery, McGill University, Montreal, Quebec, Canada.
⁵ Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
⁶ Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.
⁷ School of Physical Therapy, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
⁸ School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
⁹ 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.
¹⁰ École de réadaptation, Université de Montréal, Montreal, Quebec, Canada.
¹¹ Montreal Neurological Institute and Hospital, Multiple Sclerosis Clinic, Montreal, Quebec, Canada.
¹² Departamento de Educação Integrada em Saúde, Universidade Federal do Espírito Santo, Brazil Department of Physical Therapy, University of Toronto, Toronto, Ontario.
¹³ Department of Physical Therapy, University of Toronto, Toronto, Ontario.

PMID: 27496695
PMCID: PMC4976657
DOI: 10.1177/0269215516658939

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

Nancy E Mayo et al. Clin Rehabil. 2016 Sep.

. 2016 Sep;30(9):847-64.

doi: 10.1177/0269215516658939.

Authors

Affiliations

¹ 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.
² 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.
³ Department of Occupational Science & Occupational Therapy, University of British Columbia, Vancouver, British Columbia, Canada.
⁴ Department of Surgery, McGill University, Montreal, Quebec, Canada.
⁵ Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
⁶ Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.
⁷ School of Physical Therapy, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
⁸ School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
⁹ 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.
¹⁰ École de réadaptation, Université de Montréal, Montreal, Quebec, Canada.
¹¹ Montreal Neurological Institute and Hospital, Multiple Sclerosis Clinic, Montreal, Quebec, Canada.
¹² Departamento de Educação Integrada em Saúde, Universidade Federal do Espírito Santo, Brazil Department of Physical Therapy, University of Toronto, Toronto, Ontario.
¹³ Department of Physical Therapy, University of Toronto, Toronto, Ontario.

PMID: 27496695
PMCID: PMC4976657
DOI: 10.1177/0269215516658939

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.

Keywords: Controlled clinical trial; outcome assessment (healthcare); rehabilitation interventions.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

**Figure 1.**
Selection of studies for review.

**Figure 2.**
Number of trials published per year in *Clinical Rehabilitation*.

**Figure 3.**
Three types of interventions.

See this image and copyright information in PMC

Cited by

Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation.
Kaur N, Figueiredo S, Bouchard V, Moriello C, Mayo N. Kaur N, et al. Clin Rehabil. 2017 Sep;31(9):1238-1248. doi: 10.1177/0269215517692129. Epub 2017 Feb 1. Clin Rehabil. 2017. PMID: 28786333 Free PMC article.
Influence of humanistic care based on Carolina care model for ovarian cancer patients on postoperative recovery and quality of life.
Gao M, Zhang L, Wang Y, Li L, Wang C, Shen Q, Wang Y, Liao B. Gao M, et al. Am J Transl Res. 2021 Apr 15;13(4):3390-3399. eCollection 2021. Am J Transl Res. 2021. PMID: 34017514 Free PMC article.
Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review.
Borschmann K, Hayward KS, Raffelt A, Churilov L, Kramer S, Bernhardt J. Borschmann K, et al. Stroke Res Treat. 2018 Oct 30;2018:8087372. doi: 10.1155/2018/8087372. eCollection 2018. Stroke Res Treat. 2018. PMID: 30515288 Free PMC article. Review.
Dose Articulation in Preclinical and Clinical Stroke Recovery: Refining a Discovery Research Pipeline and Presenting a Scoping Review Protocol.
Dalton E, Churilov L, Lannin NA, Corbett D, Hayward KS. Dalton E, et al. Front Neurol. 2019 Nov 6;10:1148. doi: 10.3389/fneur.2019.01148. eCollection 2019. Front Neurol. 2019. PMID: 31781018 Free PMC article.
The Families First Program to Prevent Child Abuse: Results of a Cluster Randomized Controlled Trial in West Java, Indonesia.
Ruiz-Casares M, Thombs BD, Mayo NE, Andrina M, Scott SC, Platt RW. Ruiz-Casares M, et al. Prev Sci. 2022 Nov;23(8):1457-1469. doi: 10.1007/s11121-022-01433-w. Epub 2022 Sep 13. Prev Sci. 2022. PMID: 36098893 Free PMC article. Clinical Trial.

See all "Cited by" articles

References

1. Kocak FU, Unver B, Karatosun V. Level of evidence in four selected rehabilitation journals. Arch Phys Med Rehabil 2011; 92(2): 299–303. - PubMed
1. Mayo NE. Randomized trials and other parallel comparisons of treatment. In: Bailar JC, Hoaglin DC. (eds) Medical uses of statistics. Hoboken, New Jersey: A John Wiley & Sons, Inc & The New England Journal of Medicine; 2009: 51–89.
1. Mosteller F, Gilbert JP, McPeek B. Controversies in design and analysis of clinical trials. In: Shapiro SH, Louis TA. (eds) Clinical trials: Issues and approaches. New York: Marcel Dekker, 1983.
1. Sherrington C, Herbert RD, Maher CG, Moseley AM. PEDro. A database of randomized trials and systematic reviews in physiotherapy. Man Ther 2000; 5(4): 223–226. - PubMed
1. Medical Research Council Investigation. STREP-TOMYCIN treatment of pulmonary tuberculosis. Br Med J 1948; 2(4582): 769–782. - PMC - PubMed

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical