Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center.

IF 3.9 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Delwen L Franzen, Maia Salholz-Hillel, Stephanie Müller-Ohlraun, Daniel Strech
{"title":"Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center.","authors":"Delwen L Franzen, Maia Salholz-Hillel, Stephanie Müller-Ohlraun, Daniel Strech","doi":"10.1186/s12874-025-02482-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":9114,"journal":{"name":"BMC Medical Research Methodology","volume":"25 1","pages":"37"},"PeriodicalIF":3.9000,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11823227/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medical Research Methodology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12874-025-02482-9","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

背景: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,各种透明度做法都有改进的余地。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的可行性,以提高临床试验的透明度:方法:我们开发了研究层面的 "报告卡",它结合了针对研究者的反馈和指导,涉及多个透明度实践,包括前瞻性注册、结果摘要的可用性和开放获取出版。报告卡通过自动管道生成,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。我们还评估了所纳入的试验在干预后透明度的提高情况:调查结果显示,参与者普遍对报告卡和信息表表示赞赏,大多数参与者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:本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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
BMC Medical Research Methodology
BMC Medical Research Methodology 医学-卫生保健
CiteScore
6.50
自引率
2.50%
发文量
298
审稿时长
3-8 weeks
期刊介绍: BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信