Liu Yingxin, Zhang Jingyi, Peng Xinru, Bai Xuerui, Li Guowei, Cheng Zhixiong
Center for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, China.
School of Public Health, Guangdong Pharmaceutical University, Guangzhou, Guangdong, China.
BMJ Open. 2025 Jul 22;15(7):e097148. doi: 10.1136/bmjopen-2024-097148.
The International Committee of Medical Journal Editors requires data sharing statements in trial publications, but whether cardiology journals request data sharing statements in clinical trial submissions is unclear. We performed a survey to assess whether cardiology journals request data sharing statements in clinical trials.
DESIGN, SETTING, DATA SOURCE AND PARTICIPANTS: All cardiac and cardiovascular systems journals that published clinical trials from January 2019 to December 2022 were included. The study outcome was journal requests for data sharing statements. Multivariable logistic regression analysis was used to examine the association between journal characteristics and journal requests. We also explored whether journal requests aligned with their subsequently published clinical trials.
A total of 126 journals were included, among which 96 (76.2%) requested data sharing statements in clinical trials. Elsevier journals and Consolidated Standards of Reporting Trials endorsement had increased adjusted odds of requesting data sharing statements, with an OR of 5.74 (95% CI 1.45 to 22.70) and 7.21 (2.69 to 19.32), respectively. In the 78 journals that requested statements, 24 (30.8%) indeed did not publish any data sharing statement in their trial reports.
Approximately one in four cardiology journals did not request data sharing statements on clinical trial submissions, while a substantial inconsistency existed between journal requests and the actual publications of statements in their published trial reports.
国际医学期刊编辑委员会要求在试验出版物中提供数据共享声明，但心脏病学期刊在临床试验投稿时是否要求提供数据共享声明尚不清楚。我们进行了一项调查，以评估心脏病学期刊在临床试验中是否要求提供数据共享声明。
设计、设置、数据来源和参与者：纳入了2019年1月至2022年12月期间发表临床试验的所有心脏和心血管系统期刊。研究结果是期刊对数据共享声明的要求。采用多变量逻辑回归分析来检验期刊特征与期刊要求之间的关联。我们还探讨了期刊要求与其随后发表的临床试验是否一致。
共纳入126种期刊，其中96种（76.2%）要求在临床试验中提供数据共享声明。爱思唯尔旗下期刊以及《报告试验的统一标准》认可的期刊要求提供数据共享声明的调整后优势增加，比值比分别为5.74（95%置信区间1.45至22.70）和7.21（2.69至19.32）。在要求提供声明的78种期刊中，有24种（30.8%）在其试验报告中确实未发表任何数据共享声明。
约四分之一的心脏病学期刊在临床试验投稿时未要求提供数据共享声明，而期刊要求与其发表的试验报告中声明的实际发表情况之间存在重大不一致。
