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现提出一个框架,用于定义、分类和评估健康研究中的利益冲突。

A framework is proposed for defining, categorizing, and assessing conflicts of interest in health research.

机构信息

Department of Internal Medicine, American University of Beirut, Beirut, Lebanon; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Mon Health Medical Center, Morgantown, WV, USA.

出版信息

J Clin Epidemiol. 2022 Sep;149:236-243. doi: 10.1016/j.jclinepi.2022.06.001. Epub 2022 Jun 11.

Abstract

OBJECTIVE

We propose an operational definition of conflicts of interest (COI), a framework for categorizing interests, and an approach to assessing whether an interest qualifies as a COI.

STUDY DESIGN AND SETTING

We reviewed the literature and conducted methodological studies to inform the development of a draft framework for classifying interests.

RESULTS

We developed the following operational definition: "a conflict of interest exists when a past, current, or expected interest creates a significant risk of inappropriately influencing an individual's judgment, decision, or action when carrying out a specific duty". Interest refers to a benefit (e.g., money received from industry) or to an attribute of the individual (e.g., having specific religious beliefs). The proposed framework includes seven types of interests relating to individuals (direct financial benefit, benefit through professional status, intellectual, and personal) or their institution (direct financial benefit to the institution, benefit through increasing services provided by the institution, and nonfinancial). When assessing whether an interest qualifies as a COI, one could consider its relevance, nature (e.g., cash vs. educational support), magnitude, and recency.

CONCLUSION

The proposed operational definition and categorization framework may help journals, guideline organizations, professional societies, and healthcare institutions enhance transparency in health research.

摘要

目的

我们提出了利益冲突(COI)的操作性定义、利益分类框架以及评估利益是否构成 COI 的方法。

研究设计与设置

我们回顾了文献并进行了方法学研究,为制定利益分类框架草案提供了信息。

结果

我们制定了以下操作性定义:“当过去、现在或预期的利益在履行特定职责时,对个人的判断、决策或行动产生不适当影响的风险显著增加时,就存在利益冲突”。利益是指一种收益(例如,从行业获得的金钱)或个人的一种属性(例如,具有特定的宗教信仰)。所提出的框架包括与个人(直接经济利益、通过专业地位获得的利益、智力和个人)或其机构(直接经济利益给机构、通过增加机构提供的服务获得的利益和非财务利益)有关的七种类型的利益。在评估利益是否构成 COI 时,可以考虑其相关性、性质(例如,现金与教育支持)、规模和时效性。

结论

所提出的操作性定义和分类框架可能有助于期刊、指南制定组织、专业协会和医疗机构提高健康研究的透明度。

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