• Jeffrey L Jackson, Ethan M Balk, Noorie Hyun, and Akira Kuriyama.
• General Medicine Section, Zablocki VAMC, Milwaukee, WI, USA. jjackson@mcw.edu.
• J Gen Intern Med. 2022 Apr 1; 37 (5): 124712531247-1253.

BackgroundSelective or non-reporting of study outcomes results in outcome reporting bias.ObjectiveWe sought to develop and assess tools for detecting and adjusting for outcome reporting bias.DesignUsing data from a previously published systematic review, we abstracted whether outcomes were reported as collected, whether outcomes were statistically significant, and whether statistically significant outcomes were more likely to be reported. We proposed and tested a model to adjust for unreported outcomes and compared our model to three other methods (Copas, Frosi, trim and fill). Our approach assumes that unreported outcomes had a null intervention effect with variance imputed based on the published outcomes. We further compared our approach to these models using simulation, and by varying levels of missing data and study sizes.ResultsThere were 286 outcomes reported as collected from 47 included trials: 142 (48%) had the data provided and 144 (52%) did not. Reported outcomes were more likely to be statistically significant than those collected but for which data were unreported and for which non-significance was reported (RR, 2.4; 95% CI, 1.9 to 3.0). Our model and the Copas model provided similar decreases in the pooled effect sizes in both the meta-analytic data and simulation studies. The Frosi and trim and fill methods performed poorly.LimitationsSingle intervention of a single disease with only randomized controlled trials; approach may overestimate outcome reporting bias impact.ConclusionThere was evidence of selective outcome reporting. Statistically significant outcomes were more likely to be published than non-significant ones. Our simple approach provided a quick estimate of the impact of unreported outcomes on the estimated effect. This approach could be used as a quick assessment of the potential impact of unreported outcomes.© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

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