• Sylvain Mathieu, Isabelle Boutron, David Moher, Douglas G Altman, and Philippe Ravaud.
• INSERM, U738, Assistance Publique des Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, Département d'Epidémiologie Biostatistique et Recherche Clinique, Paris, France.
• JAMA. 2009 Sep 2;302(9):977-84.

ContextAs 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.ObjectiveTo 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 SelectionMEDLINE 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 ExtractionFor each included article, we obtained the trial registration information using a standardized data extraction form.ResultsOf 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).ConclusionComparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent.

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