Claude Pellen1, Laura Caquelin2, Alexia Jouvance-Le Bail2, Jeanne Gaba2, Mathilde Vérin2, David Moher3, John P A Ioannidis4, Florian Naudet2. 1. Univ Rennes, CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], F-35000 Rennes, France. Electronic address: cld.pellen@gmail.com. 2. Univ Rennes, CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], F-35000 Rennes, France. 3. Center for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. 4. Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, United States; Departments of Epidemiology and Population Health and of Biomedical Data Science, Stanford University School of Medicine, Stanford, United States; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, United States.
Abstract
OBJECTIVE: To explore the impact of the Annals of Internal Medicine (AIM) data-sharing policy for randomized controlled trials (RCTs) in terms of output from data-sharing (i.e. publications re-using the data). STUDY DESIGN AND SETTING: Retrospective study. RCTs published in the AIM between 2007 and 2017 were retrieved on PubMed. Publications where the data had been re-used were identified on Web of Science. Searches were performed by two independent reviewers. The primary outcome was any published re-use of the data (re-analysis, secondary analysis, or meta-analysis of individual participant data [MIPD]), where the first, last and corresponding authors were not among the authors of the RCT. Analyses used Cox (primary analysis) models adjusting for RCTs characteristics (registration: https://osf.io/8pj5e/). RESULTS: 185 RCTs were identified. 106 (57%) mentioned willingness to share data and 79 (43%) did not. 208 secondary analyses, 67 MIPD and no re-analyses were identified. No significant association was found between intent to share and re-use where the first, last and corresponding authors were not among the authors of the primary RCT (adjusted hazard ratio = 1.04 [0.47-2.30]). CONCLUSION: Over ten years, RCTs published in AIM expressing an intention to share data were not associated with more extensive re-use of the data.
OBJECTIVE: To explore the impact of the Annals of Internal Medicine (AIM) data-sharing policy for randomized controlled trials (RCTs) in terms of output from data-sharing (i.e. publications re-using the data). STUDY DESIGN AND SETTING: Retrospective study. RCTs published in the AIM between 2007 and 2017 were retrieved on PubMed. Publications where the data had been re-used were identified on Web of Science. Searches were performed by two independent reviewers. The primary outcome was any published re-use of the data (re-analysis, secondary analysis, or meta-analysis of individual participant data [MIPD]), where the first, last and corresponding authors were not among the authors of the RCT. Analyses used Cox (primary analysis) models adjusting for RCTs characteristics (registration: https://osf.io/8pj5e/). RESULTS: 185 RCTs were identified. 106 (57%) mentioned willingness to share data and 79 (43%) did not. 208 secondary analyses, 67 MIPD and no re-analyses were identified. No significant association was found between intent to share and re-use where the first, last and corresponding authors were not among the authors of the primary RCT (adjusted hazard ratio = 1.04 [0.47-2.30]). CONCLUSION: Over ten years, RCTs published in AIM expressing an intention to share data were not associated with more extensive re-use of the data.
Authors: Florian Naudet; Maximilian Siebert; Claude Pellen; Jeanne Gaba; Cathrine Axfors; Ioana Cristea; Valentin Danchev; Ulrich Mansmann; Christian Ohmann; Joshua D Wallach; David Moher; John P A Ioannidis Journal: PLoS Med Date: 2021-10-25 Impact factor: 11.069