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Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations.

作者信息

Siebert Maximilian, Gaba Jeanne Fabiola, Caquelin Laura, Gouraud Henri, Dupuy Alain, Moher David, Naudet Florian

机构信息

Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), F-35000, Rennes, France

Univ Rennes, CHU Rennes, REPERES (Recherche en Pharmaco-épidémiologie et Recours aux Soins), EA 7449, 35000, Rennes, France.

出版信息

BMJ Open. 2020 May 30;10(5):e038887. doi: 10.1136/bmjopen-2020-038887.


DOI:10.1136/bmjopen-2020-038887
PMID:32474433
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7264700/
Abstract

OBJECTIVE: To explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations. DESIGN: A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs). SETTING: ICMJE website; PubMed/Medline. ELIGIBILITY CRITERIA: ICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall's list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018. MAIN OUTCOME MEASURES: The primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors. For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement. RESULTS: Eight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%). One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements. In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%). CONCLUSION: The implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals. The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future. REGISTRATION: The protocol was registered before the start of the research on the Open Science Framework (https://osf.io/n6whd/).

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9244/7264700/dcfc4462d915/bmjopen-2020-038887f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9244/7264700/dcfc4462d915/bmjopen-2020-038887f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9244/7264700/dcfc4462d915/bmjopen-2020-038887f01.jpg

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[6]
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[7]
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本文引用的文献

[1]
Status, use and impact of sharing individual participant data from clinical trials: a scoping review.

BMJ Open. 2021-8-18

[2]
A manifesto for reproducible science.

Nat Hum Behav. 2017-1-10

[3]
Research transparency promotion by surgical journals publishing randomised controlled trials: a survey.

Trials. 2020-10-1

[4]
Predatory journals: no definition, no defence.

Nature. 2019-12

[5]
Blacklists and Whitelists To Tackle Predatory Publishing: a Cross-Sectional Comparison and Thematic Analysis.

mBio. 2019-6-4

[6]
Potential predatory journals are colonizing the ICMJE recommendations list of followers.

Neth J Med. 2019-2

[7]
Data availability, reusability, and analytic reproducibility: evaluating the impact of a mandatory open data policy at the journal .

R Soc Open Sci. 2018-8-15

[8]
Assessing scientists for hiring, promotion, and tenure.

PLoS Biol. 2018-3-29

[9]
Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in and .

BMJ. 2018-2-13

[10]
Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

Ann Intern Med. 2017-7-4

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