Differences between information in registries and articles did not influence publication acceptance

Marlies van Lent · Joanna IntHout · Henk Jan Out

38 citations0/0 files storedJournal of Clinical Epidemiology

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Meta-analysis and systematic reviews Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

OBJECTIVES: To assess whether journals are more likely to reject manuscripts with differences between information in registries and articles. We compared differences by sponsorship and assessed whether selective reporting favored publication of significant outcomes. STUDY DESIGN AND SETTING: Drug trials submitted to eight journals (January 2010-April 2012) were included. Publication status, primary outcomes, enrollment, and sponsorship were extracted. Primary outcomes and enrollment in registries and registration timing were reviewed. Prospective registration included registration before study start. Consistency between registered and reported information was evaluated. RESULTS: For 226 submitted manuscripts, primary outcomes were specified in both article and registry. Sixty six of 226 (29.2%) had primary outcome differences; 14 of 66 manuscripts with differences (21.2%) and 46 of 160 without differences (28.8%) were accepted. Fifty manuscripts (22.4%) had sample size differences; 10 of 50 with differences (20.0%) and 49 of 173 without differences (28.3%) were accepted. Industry-sponsored trials had less differences and were more often prospectively registered. After adjustment for sponsorship, differences and/or retrospective registration were not associated with decreased chance of acceptance (odds ratio 0.56; 95% confidence interval: 0.27, 1.13). Primary outcome differences favored significant outcomes in 49% of manuscripts. CONCLUSION: Differences between registered and reported information are not decisive for rejection. Editors should assess consistency between registries and articles to address selective reporting.

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References

2004Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials 2009Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials 2004Clinical Trial Registration 2011Comparison of protocols and registry entries to published reports for randomised controlled trials 2014The Quality of Registration of Clinical Trials: Still a Problem 2013"Hardly worth the effort"? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study 2011Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy 2013Comparison of Registered and Published Primary Outcomes in Randomized Clinical Trials of Surgical Interventions

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