Many Randomized Trials of Physical Therapy Interventions Are Not Adequately Registered: A Survey of 200 Published Trials

Author:

Pinto Rafael Zambelli1,Elkins Mark R.2,Moseley Anne M.3,Sherrington Catherine4,Herbert Robert D.5,Maher Christopher G.6,Ferreira Paulo H.7,Ferreira Manuela L.8

Affiliation:

1. R.Z. Pinto, MSc, The George Institute for Global Health and Sydney Medical School, University of Sydney, PO Box M201, Missenden Road, Sydney, New South Wales 2050, Australia.

2. M.R. Elkins, PhD, Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia, and The George Institute for Global Health and Sydney Medical School, University of Sydney.

3. A.M. Moseley, PhD, The George Institute for Global Health and Sydney Medical School, University of Sydney.

4. C. Sherrington, PhD, The George Institute for Global Health and Sydney Medical School, University of Sydney.

5. R.D. Herbert, PhD, Neuroscience Research Australia, Sydney, New South Wales, Australia, and The George Institute for Global Health and Sydney Medical School, University of Sydney.

6. C.G. Maher, PhD, The George Institute for Global Health and Sydney Medical School, University of Sydney, and EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands.

7. P.H. Ferreira, PhD, Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney.

8. M.L. Ferreira, PhD, The George Institute for Global Health and Sydney Medical School, University of Sydney.

Abstract

BackgroundClinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results.PurposeThis study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy.Data SourcesThis was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal.Data ExtractionEvidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors.Data SynthesisThe proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6–21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable.LimitationsThe inclusion of only English-language trials prevents generalization of the results to non–English-language trials.ConclusionsRegistration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.

Publisher

Oxford University Press (OUP)

Subject

Physical Therapy, Sports Therapy and Rehabilitation

Reference39 articles.

1. Publication bias and clinical trials;Dickersin;Control Clin Trials,1987

2. Publication bias in clinical trials due to statistical significance or direction of trial results;Hopewell;Cochrane Database Syst Rev,2009

3. Misconduct in medical research;Chalmers;BMJ,1989

4. Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee;Hahn;J Eval Clin Pract,2002

5. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies;Hahn;Stat Med,2000

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