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Context Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports. Objective To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials.

Design Cohort study using protocols and published reports of randomized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, in The number and characteristics of reported and unreported trial outcomes were recorded from protocols, journal articles, and a survey of trialists. An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta-analysis.

Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias.

Protocols and published articles were also compared to identify discrepancies in primary outcomes. Main Outcome Measures Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes; consistency between primary outcomes defined in the most recent protocols and those defined in published articles. Results One hundred two trials with published journal articles and outcomes were identified. Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy pooled odds ratio, 2.

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