Marlies van Lent1, Joanna IntHout2, Henk Jan Out3. 1. Clinical Research Centre Nijmegen, Department of Pharmacology-Toxicology, Radboud University Medical Center, Philips van Leydenlaan 15, PO Box 9101, 6500 HB Nijmegen, The Netherlands. Electronic address: Marlies.vanLent@radboudumc.nl. 2. Department for Health Evidence, Radboud University Medical Center, Geert Grooteplein noord 21, PO Box 9101, 6500 HB Nijmegen, The Netherlands. 3. Clinical Research Centre Nijmegen, Department of Pharmacology-Toxicology, Radboud University Medical Center, Philips van Leydenlaan 15, PO Box 9101, 6500 HB Nijmegen, The Netherlands; Global Medical Affairs, Teva Pharmaceuticals, Piet Heinkade 107, 1019 GM Amsterdam, The Netherlands.
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.
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.
Authors: Stuart G Nicholls; Kelly Carroll; Spencer Phillips Hey; Merrick Zwarenstein; Jennifer Zhe Zhang; Hayden P Nix; Jamie C Brehaut; Joanne E McKenzie; Steve McDonald; Charles Weijer; Dean A Fergusson; Monica Taljaard Journal: J Clin Epidemiol Date: 2021-03-28 Impact factor: 6.437
Authors: Benjamin Howard; Jared T Scott; Mark Blubaugh; Brie Roepke; Caleb Scheckel; Matt Vassar Journal: PLoS One Date: 2017-07-20 Impact factor: 3.240