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披露临床指南和指导声明中的利益冲突及其管理:美国医师学院临床指南委员会的方法。

Disclosure of Interests and Management of Conflicts of Interest in Clinical Guidelines and Guidance Statements: Methods From the Clinical Guidelines Committee of the American College of Physicians.

机构信息

American College of Physicians, Philadelphia, Pennsylvania (A.Q.).

Minneapolis VA Medical Center, Minneapolis, Minnesota (T.J.W.).

出版信息

Ann Intern Med. 2019 Sep 3;171(5):354-361. doi: 10.7326/M18-3279. Epub 2019 Aug 20.

Abstract

One of the hallmarks of a trustworthy clinical guideline or guidance statement is a comprehensive process for disclosure of interests (DOI) and management of conflicts of interest (COIs). The American College of Physicians (ACP) Clinical Guidelines Committee (CGC) aims to disclose all health care-related interests and manage conflicts in a manner that is transparent, proportional, and consistent. Any person involved in the development of an ACP clinical guideline or guidance statement must disclose all financial and intellectual interests related to health care from the previous 3 years. Persons complete disclosures at the start of their participation and are required to update them over the course of their involvement with the CGC, including before each CGC meeting. A DOI-COI Review and Management Panel reviews the disclosures; flags potential conflicts; grades the COI as low-, moderate-, or high-level; and manages the person's participation accordingly. A high-level COI results in recusal from authorship, voting, and all committee discussions. Participants with a moderate-level COI are recused from authorship and voting for clinically relevant topics but may participate in all discussions. A low-level COI results in no role restrictions. All disclosures and COI management decisions are publicly reported.

摘要

值得信赖的临床指南或指导声明的标志之一是全面披露利益关系(DOI)和管理利益冲突(COI)的过程。美国医师学院(ACP)临床指南委员会(CGC)旨在以透明、相称和一致的方式披露所有与医疗保健相关的利益,并管理冲突。任何参与 ACP 临床指南或指导声明制定的人都必须披露过去 3 年内与医疗保健相关的所有财务和智力利益。个人在参与的一开始就完成披露,并在与 CGC 的参与过程中(包括在每次 CGC 会议之前)更新披露。DOI-COI 审查和管理小组审查披露情况;标记潜在冲突;将 COI 评为低、中或高级;并相应地管理该人的参与。高等级 COI 导致回避作者身份、投票和所有委员会讨论。具有中级 COI 的参与者回避与临床相关主题的作者身份和投票,但可以参与所有讨论。低水平 COI 不限制角色。所有披露和 COI 管理决策都公开报告。

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