在介入性研究的设计和实施过程中降低偏倚风险:一项范围评价。

IF 3.4 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Zhilin Ren, Angela Claire Webster, Kylie Elizabeth Hunter, Jiexin Zhang, Yi Yao, Ava Grace Tan-Koay, Aidan Christopher Tan
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引用次数: 0

摘要

背景:介入研究旨在提供有力的证据。然而,设计或实施不当的研究可能会使研究结果产生偏差,并歪曲结果证据。虽然在评估偏倚风险方面取得了进展,但在研究设计和实施过程中如何干预偏倚风险尚不清楚。目的:确定干预措施,以减少或预测干预研究在设计和实施过程中的偏倚风险。检索策略:对于这一范围综述,我们检索了三个电子书目数据库(MEDLINE, Embase和Cochrane Library)和9个灰色文献来源和谷歌,从2024年9月开始。此外,还对电子书目数据库中排名前2000位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研究偏倚风险的干预措施的实施和有效性,则纳入。记录干预措施的特点和效果。结果:共检索到41793篇出版物、报告、文献和灰色文献的标题和摘要,其中电子书目数据库检索24677篇,灰色文献来源检索17140篇。来自书目数据库的67份出版物和来自灰色文献的24项被认为可能符合纳入条件,并对这些出版物的全文进行了审查。只有3项研究符合纳入标准。第一个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,以减少随访损失和数据丢失,特别是长期随访试验。第二个干预措施是在研究过程中引入一个独立的临床事件委员会。这是为了减轻由于影响结果分析和解释的利益冲突而产生的偏见。第三个干预措施是在随机对照试验中为参与者提供经济激励,使参与者能够更积极地完成试验的要求。结论: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,很少有实证干预措施来解决这一问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Reducing risk of bias in interventional studies during their design and conduct: a scoping review.

Background: 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.

Objective: To identify interventions to reduce or predict risk of bias in interventional studies during their design and conduct.

Search strategy: 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.

Result: 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.

Conclusion: Despite the major impact of risk of bias on study outcomes, there are few empirical interventions to address this during study design or conduct.

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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.
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