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外科期刊发表随机对照试验促进研究透明度:一项调查。

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

机构信息

Department of HPB and Digestive Surgery, CHU Rennes, Pontchaillou Hospital, Rennes, France.

Rennes 1 University, Rennes, France.

出版信息

Trials. 2020 Oct 1;21(1):824. doi: 10.1186/s13063-020-04756-7.

Abstract

OBJECTIVE

To describe surgical journals' position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion.

METHODS

Only "SURGICAL" journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available. Details on research transparency promotion were also collected, namely the existence of a "prospective registration of clinical trials requirement policy", a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT.

RESULTS

Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48-3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5-20.75]. The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41). No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A "prospective registration of clinical trials requirement" was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines.

CONCLUSION

Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

摘要

目的

描述外科期刊关于数据共享政策的立场声明(主要目标),并描述其促进研究透明度的关键特征。

方法

只有影响因子高于 2(Web of Science)的“外科”期刊才有资格进行这项研究。如果官方作者指南(OIA)中有明确的临床试验发表说明,或者在 2016 年 1 月 1 日至 2018 年 12 月 31 日期间发表了随机对照试验(RCT),则将其纳入研究。主要结果是作者指南中是否存在数据共享政策。数据共享政策分为 3 类,包括数据共享政策的强制性、选择性或不可用。还收集了促进研究透明度的详细信息,包括是否存在“临床试验前瞻性注册要求政策”、利益冲突(COI)披露要求,以及是否明确提及报告指南,如 CONSORT 用于 RCT。

结果

在所确定的 87 种外科期刊中,有 82 种被纳入研究:67 种(82%)有明确的 RCT 发表说明,其余 15 种(18%)发表了至少 1 项 RCT。中位影响因子为 2.98 [IQR=2.48-3.77],2016 年和 2017 年,期刊发表的 RCT 中位数为 11.5 [IQR=5-20.75]。4 种期刊(5%)的 OIA 规定,纳入数据共享声明是强制性的,45%(n=37)是选择性的,50%(n=41)未纳入。期刊特征与数据共享政策(强制性或选择性)的存在之间没有关联。前瞻性临床试验注册要求与国际医学期刊编辑委员会(ICMJE)的暗示或隶属关系以及较高的影响因素相关。OIA 中有具体 RCT 说明的期刊和在 ICMJE 网站上引用频率更高的期刊更频繁地要求使用 CONSORT 指南。

结论

外科期刊中促进研究透明度的工作仍处于起步阶段。根据 ICMJE 指南标准化期刊要求,可能是促进外科研究透明度的第一步。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5086/7528240/1ba75e6bda2a/13063_2020_4756_Fig1_HTML.jpg

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