通过个性化报告卡提高研究透明度:大型大学医疗中心临床试验可行性研究

Delwen L Franzen, Maia Salholz-Hillel, Stephanie Müller-Ohlraun, Daniel Strech
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引用次数: 0

摘要

研究透明度对于确保科学发现的相关性、完整性和可靠性至关重要。然而,以往的工作表明,在透明度实践方面还有改进的余地。本研究的主要目的是开发一种可扩展的工具,为提高研究各阶段的透明度提供个性化反馈和指导。我们的次要目标是评估实施该工具以提高临床试验透明度的可行性。我们开发了研究层面的 "报告卡",该报告卡结合了针对研究者的反馈和指导,涵盖了多项透明度实践,包括前瞻性注册、摘要结果的可用性和开放获取出版。这些报告卡是通过自动管道生成的,具有可扩展性。我们还开发了一份信息表,总结了与透明度相关的法律、指南和资源。为了评估使用这些工具提高透明度的可行性,我们在柏林大学医学中心(Charité - Universitätsmedizin Berlin)开展了一项单臂干预研究。我们向 155 项临床试验的研究者(n = 92)寄送了个性化报告卡和信息表,并对其有用性进行了调查。我们还对纳入的试验进行了评估,以了解干预后透明度的提高情况。调查结果显示,大多数参与者对报告卡和信息表表示赞赏,认为它们有助于提高他们对试验透明度和透明度要求的认识。然而,在透明度实践方面的改进微乎其微,而且主要局限于将出版物与登记册联系起来。研究者还谈到了与实施透明度相关的各种挑战,包括缺乏对最佳实践的清晰认识和机构障碍。这项研究证明了开发和使用报告卡等工具的潜力,这些工具可以大规模地为研究者提供有关其研究透明度的个性化反馈。虽然这些工具得到了研究者的积极响应,但透明度实践的改进有限,这表明仅靠意识可能不足以推动改进。未来的研究和实施工作可能会调整这些工具,使其适用于更多的实践或研究领域,并探索将报告卡与激励措施和机构支持相结合的综合方法,以有效加强研究的透明度。
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Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center
Research transparency is crucial for ensuring the relevance, integrity, and reliability of scientific findings. However, previous work indicates room for improvement across transparency practices. The primary objective of this study was to develop an extensible tool to provide individualized feedback and guidance for improved transparency across phases of a study. Our secondary objective was to assess the feasibility of implementing this tool to improve transparency in clinical trials. We developed study-level ″report cards″ that combine tailored feedback and guidance to investigators across several transparency practices, including prospective registration, availability of summary results, and open access publication. The report cards were generated through an automated pipeline for scalability. We also developed an infosheet to summarize relevant laws, guidelines, and resources relating to transparency. To assess the feasibility of using these tools to improve transparency, we conducted a single-arm intervention study at Berlin′s university medical center, the Charité – Universitätsmedizin Berlin. Investigators (n = 92) of 155 clinical trials were sent individualized report cards and the infosheet, and surveyed to assess their perceived usefulness. We also evaluated included trials for improvements in transparency following the intervention. Survey responses indicated general appreciation for the report cards and infosheet, with a majority of participants finding them helpful to build awareness of the transparency of their trial and transparency requirements. However, improvement on transparency practices was minimal and largely limited to linking publications in registries. Investigators also commented on various challenges associated with implementing transparency, including a lack of clarity around best practices and institutional hurdles. This study demonstrates the potential of developing and using tools, such as report cards, to provide individualized feedback at scale to investigators on the transparency of their study. While these tools were positively received by investigators, the limited improvement in transparency practices suggests that awareness alone is likely not sufficient to drive improvement. Future research and implementation efforts may adapt the tools to further practices or research areas, and explore integrated approaches that combine the report cards with incentives and institutional support to effectively strengthen transparency in research.
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