Medical researchers' perception of sharing of metadata from case report forms

IF 2.6 Q2 HEALTH POLICY & SERVICES

Learning Health Systems Pub Date : 2024-09-15 DOI:10.1002/lrh2.10456

Alexandra Meidt, Carolin Walter, Christoph U. Lehmann, Martin Dugas

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Abstract

Introduction

Publishing medical metadata stored in case report forms (CRFs) is a prerequisite for the development of a learning health system (LHS) by fostering reuse of metadata and standardization in health research. The aim of our study was to investigate medical researchers' (MRs) willingness to share CRFs, to identify reasons for and against CRF sharing, and to determine if and under which conditions MRs might consider sharing CRF metadata via a public registry.

Methods

We examined CRF data sharing commitments for 1842 interventional trials registered on the German Clinical Trials Registry (DRKS) from January 1, 2020, to December 31, 2021. We invited 1360 individuals registered as contacts on DRKS to participate in a web-based survey between May 10, 2022, and June 30, 2022.

Results

Only 0.3% (5/1842) of data sharing commitments in DRKS included a plan to share blank CRFs. Survey results showed high support for CRF sharing. More than 70% of respondents (223/301) were willing to share their CRFs, and 83.7% (252/301) were interested in CRF reuse. The most frequently reported reason for CRF sharing was improvement of comparability and interpretability of patient data (244/301; 81.0%). The most frequently reported reason against CRF sharing was missing approval by the sponsor (160/301; 53.2%). Researchers conducting commercial trials were significantly less likely to share CRFs than those conducting noncommercial trials (63.3% vs. 76.2%, OR 0.54, 95% CI 0.32–0.92) and they were less likely to reuse CRFs (78.5% vs. 84.6%, OR 0.66, 95% CI 0.35–1.24). The most frequently mentioned prerequisite for publication of CRFs in a public registry was its trustworthiness (244/301, 81.1%).

Conclusion

Data sharing commitments in DRKS revealed a low awareness of CRF sharing. Survey results showed generally strong support for CRF sharing, including the willingness to publish CRFs in a public registry, although legal and practical barriers were identified.

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医学研究人员对病例报告表格元数据共享的看法。

通过促进元数据的重用和卫生研究的标准化，发布存储在病例报告表（CRFs）中的医疗元数据是开发学习型卫生系统（LHS）的先决条件。本研究的目的是调查医学研究人员（MRs）共享CRF的意愿，确定支持和反对共享CRF的原因，并确定MRs是否以及在何种条件下可能考虑通过公共注册中心共享CRF元数据。方法：我们检查了2020年1月1日至2021年12月31日在德国临床试验注册中心（DRKS）注册的1842项介入试验的CRF数据共享承诺。我们邀请了1360名在DRKS上注册的联系人在2022年5月10日至2022年6月30日期间参加了一项基于网络的调查。结果：只有0.3%（5/1842）的DRKS数据共享承诺包括共享空白crf的计划。调查结果显示，政府支持共享应急基金。超过70%的受访者（223/301）愿意分享他们的CRF， 83.7%（252/301）对CRF的再利用感兴趣。报告中最常见的CRF共享原因是改善患者数据的可比性和可解释性(244/301；81.0%)。报告中最常见的反对CRF共享的原因是缺少发起人的批准(160/301；53.2%)。进行商业试验的研究人员共享CRFs的可能性明显低于进行非商业试验的研究人员（63.3%对76.2%,OR 0.54, 95% CI 0.32-0.92），并且他们不太可能重复使用CRFs（78.5%对84.6%,OR 0.66, 95% CI 0.35-1.24）。在公共登记处发布CRFs的最常提到的先决条件是其可信度（244/301,81.1%）。结论：DRKS的数据共享承诺揭示了CRF共享意识较低。调查结果显示，人们普遍强烈支持CRF共享，包括在公共登记处发布CRF的意愿，尽管已经确定了法律和实际障碍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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