Siebert Maximilian, Gaba Jeanne Fabiola, Caquelin Laura, Gouraud Henri, Dupuy Alain, Moher David, Naudet Florian
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.
BMJ Open. 2020 May 30;10(5):e038887. doi: 10.1136/bmjopen-2020-038887.
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.
A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).
ICMJE website; PubMed/Medline.
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.
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.
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%).
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.
The protocol was registered before the start of the research on the Open Science Framework (https://osf.io/n6whd/).
探讨国际医学期刊编辑委员会（ICMJE）于2018年7月1日生效的数据共享政策在ICMJE成员期刊以及宣称遵循ICMJE建议的ICMJE附属期刊中的实施情况。
对2018年期刊网站上的数据共享政策以及随机对照试验（RCT）中的数据共享声明进行横断面调查。
ICMJE网站；PubMed/Medline。
2018年发表过RCT、拥有可访问的在线网站且未被Beall名单认定为掠夺性期刊的ICMJE成员期刊和489种ICMJE附属期刊。成员期刊和附属期刊各选取100项有数据共享政策且于2018年7月1日后提交的RCT。
政策的主要观察指标是期刊网站上，尤其是作者指南中报告的数据共享政策（明确的数据共享政策、无数据共享政策、仅提及ICMJE建议的政策）的存在情况。对于RCT，我们的主要观察指标是数据共享声明中共享个体参与者数据的意向。
14家成员期刊中有8家（57%）在其网站上有明确的数据共享政策（3家比ICMJE要求更严格，1家要求更低，4家符合要求），另有5家（35%）期刊表示遵循ICMJE要求，1家（8%）在网上没有相关政策。在这些期刊发表的RCT中，100项中有98项有数据共享声明，其中表示有意共享个体患者数据的有77项（77%；95%CI 67%至85%）。489家ICMJE附属期刊中有145家（30%；26%至34%）在其网站上有明确的数据共享政策（11家比ICMJE要求更严格，85家要求更低，49家符合要求），276家（56%；52%至61%）仅提及ICMJE要求。在有明确数据共享政策的附属期刊发表的RCT中，数据共享声明很少见（25%），表示有意共享数据的占22%（15%至32%）。
ICMJE数据共享要求在在线期刊政策中的实施情况，对于ICMJE成员期刊而言不尽人意，对于ICMJE附属期刊则很差。该政策在成员期刊中的实施情况良好，但在附属期刊中令人担忧。我们建议未来对医学期刊数据共享政策进行持续审核。
该方案在开放科学框架（https://osf.io/n6whd/）上的研究开始前进行了注册。
