Ren Zhilin, Webster Angela Claire, Hunter Kylie Elizabeth, Zhang Jiexin, Yao Yi, Tan-Koay Ava Grace, Tan Aidan Christopher
NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW, 1450, Australia.
Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
BMC Med Res Methodol. 2025 Apr 1;25(1):85. doi: 10.1186/s12874-025-02467-8.
Interventional studies are intended to provide robust evidence. Yet poorly designed or conducted studies may bias research results and skew resulting evidence. While there have been advances in the assessment of risk of bias, it is unclear how to intervene against risks of bias during study design and conduct.
To identify interventions to reduce or predict risk of bias in interventional studies during their design and conduct.
For this scoping review, we searched three electronic bibliographic databases (MEDLINE, Embase, and Cochrane Library) and nine grey literature sources and Google from in September 2024. This was supplemented by a natural language processing fuzzy matching search of the top 2000 relevant publications in the electronic bibliographic databases. Publications were included if they described the implementation and effectiveness of an intervention during study design or conduct aimed at reducing risk of bias in interventional studies. The characteristics and effect of the interventions were recorded.
We identified, and reviewed the title and abstracts of, a total of 41,793 publications, reports, documents and grey literature, with 24,677 from electronic bibliographic databases and 17,140 from grey literature sources. There were 67 publications from bibliographic databases and 24 items from grey literature that were considered potentially eligible for inclusion, and the full-text of these were reviewed. Only three studies met the inclusion criteria. The first intervention was offering education and training to researchers during study design. This training included the implementation of a more rigorous participant screening process and systematic participant tracking program that reduced loss to follow-up and missing data, particularly for long-term follow-up trials. The second intervention was introducing an independent clinical events committee during study conduct. This was intended to mitigate bias due to conflicts of interest affecting the analysis and interpretation of results. The third intervention was to provide participants with financial incentives in randomized controlled trials, so that participants could more actively accomplish the requirements of the trials.
Despite the major impact of risk of bias on study outcomes, there are few empirical interventions to address this during study design or conduct.
干预性研究旨在提供有力证据。然而，设计或实施不佳的研究可能会使研究结果产生偏差并歪曲所得证据。虽然在偏倚风险评估方面已有进展，但尚不清楚如何在研究设计和实施过程中针对偏倚风险进行干预。
确定在干预性研究的设计和实施过程中降低或预测偏倚风险的干预措施。
对于本范围综述，我们于2024年9月检索了三个电子文献数据库（MEDLINE、Embase和Cochrane图书馆）、九个灰色文献来源以及谷歌。此外，还对电子文献数据库中排名前2000的相关出版物进行了自然语言处理模糊匹配搜索。如果出版物描述了在研究设计或实施过程中旨在降低干预性研究偏倚风险的干预措施的实施情况和效果，则将其纳入。记录了干预措施的特征和效果。
我们共识别并审查了41793篇出版物、报告、文件和灰色文献的标题和摘要，其中24677篇来自电子文献数据库，17140篇来自灰色文献来源。有67篇来自文献数据库的出版物和24篇来自灰色文献的文章被认为可能符合纳入标准，并对其全文进行了审查。只有三项研究符合纳入标准。第一项干预措施是在研究设计期间为研究人员提供教育和培训。该培训包括实施更严格的参与者筛选过程和系统的参与者跟踪计划，这减少了失访和数据缺失，特别是对于长期随访试验。第二项干预措施是在研究实施过程中引入独立的临床事件委员会。这旨在减轻因利益冲突影响结果分析和解释而导致的偏倚。第三项干预措施是在随机对照试验中为参与者提供经济激励，以便参与者能够更积极地完成试验要求。
尽管偏倚风险对研究结果有重大影响，但在研究设计或实施过程中针对这一问题的实证干预措施很少。
