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Original Contribution
September 2, 2009

Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials

Author Affiliations

Author Affiliations: INSERM, U738, Paris, France, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Bichat-Claude Bernard, Département d’Epidémiologie Biostatistique et Recherche Clinique, Paris, France and Université Paris Diderot, Faculté de Médecine, Paris, France (Drs Mathieu, Boutron, and Ravaud); Hôpital Gabriel Montpied, Service de Rhumatologie, Université Clermont 1, Faculté de Médecine, Clermont-Ferrand, France (Dr Mathieu); Ottawa Methods Centre, Ottawa Hos pital Research Institute and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada (Dr Moher); and Centre for Statistics in Medicine, University of Oxford, Oxford, England (Dr Altman).

JAMA. 2009;302(9):977-984. doi:10.1001/jama.2009.1242
Abstract

Context As of 2005, the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial's findings in member journals.

Objective To assess the proportion of registered trials with results recently published in journals with high impact factors; to compare the primary outcomes specified in trial registries with those reported in the published articles; and to determine whether primary outcome reporting bias favored significant outcomes.

Data Sources and Study Selection MEDLINE via PubMed was searched for reports of randomized controlled trials (RCTs) in 3 medical areas (cardiology, rheumatology, and gastroenterology) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors.

Data Extraction For each included article, we obtained the trial registration information using a standardized data extraction form.

Results Of the 323 included trials, 147 (45.5%) were adequately registered (ie, registered before the end of the trial, with the primary outcome clearly specified). Trial registration was lacking for 89 published reports (27.6%), 45 trials (13.9%) were registered after the completion of the study, 39 (12%) were registered with no or an unclear description of the primary outcome, and 3 (0.9%) were registered after the completion of the study and had an unclear description of the primary outcome. Among articles with trials adequately registered, 31% (46 of 147) showed some evidence of discrepancies between the outcomes registered and the outcomes published. The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6% (19 of 23).

Conclusion Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent.

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