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改善研究证据在指南制定中的应用:4. 管理利益冲突。

Improving the use of research evidence in guideline development: 4. Managing conflicts of interests.

作者信息

Boyd Elizabeth A, Bero Lisa A

机构信息

Department of Clinical Pharmacy, University of California, San Francisco, 3333 California Street, Suite 420, San Francisco, CA 94143-0613, USA.

出版信息

Health Res Policy Syst. 2006 Dec 1;4:16. doi: 10.1186/1478-4505-4-16.

DOI:10.1186/1478-4505-4-16
PMID:17140441
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1693552/
Abstract

BACKGROUND

The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fourth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.

OBJECTIVES

We reviewed the literature on conflicts of interest to answer the following questions: 1. What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests? 2. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest? 3. When a conflict of interest is identified, how should the conflict be managed? 4. How could conflict of interest policies be enforced?

METHODS

We searched PubMed, the Cochrane Methodology Register and selectively searched for the published policies of several organizations, We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.

KEY QUESTIONS AND ANSWERS

What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests? Although there is little empirical evidence to guide the development of disclosure forms, minimal or open-ended formats are likely to be uninformative. We recommend the development of specific, detailed, structured forms that solicit as much information as possible about the nature and extent of the competing interests. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest?* There is no empirical evidence to suggest that explicit criteria are preferable to ad hoc committee decisions when deciding if a disclosed financial tie is a conflict of interest. However, explicit criteria may make decision-making easier. When a conflict of interest is identified, how should the conflict be managed? Descriptive studies suggest that appropriate management strategies are best determined on a case-by-case basis. Thus, WHO should use a wide range of management strategies to address disclosed conflicts of interest, with public disclosure of conflicts associated with each meeting as a minimum and recusal of conflicted individuals as the other extreme. How could conflict of interest policies be enforced? Although there are no empirical studies of the enforcement of conflict if interest policies, descriptive studies of other organizations and institutions suggest that WHO convene a standing committee to review all financial disclosure statements prior to the commencement of committee meetings/hearings and to make management recommendations when necessary. A standard policy requiring all financial ties to be made public (i.e., recorded into the meeting minutes) should reduce the number of problematic cases. In instances where the conflicts seem intractable, a recommendation of recusal may be necessary to protect the greater interests of WHO and its constituents.

摘要

背景

世界卫生组织(WHO)与世界上许多其他组织一样,认识到需要采用更严格的程序,以确保医疗保健建议基于现有最佳研究证据。这是为世界卫生组织健康研究咨询委员会向WHO提供关于如何实现这一目标的建议而编写的16篇综述系列中的第四篇。

目的

我们检索了关于利益冲突的文献,以回答以下问题:1. 获取有关财务关系和其他竞争利益的完整准确披露的最佳方法是什么?2. 如何确定已披露的财务关系或其他竞争利益何时构成利益冲突?3. 当识别出利益冲突时,应如何处理?4. 利益冲突政策应如何执行?

方法

我们检索了PubMed、Cochrane方法学注册库,并选择性地检索了几个组织已发布的政策,我们未自行进行系统综述。我们的结论基于现有证据、对WHO和其他组织正在开展工作的考量以及逻辑论证。

关键问题与答案

获取有关财务关系和其他竞争利益的完整准确披露的最佳方法是什么?尽管几乎没有实证证据可指导披露表格的制定,但最少或开放式格式可能无法提供有用信息。我们建议制定具体、详细、结构化的表格,尽可能多地征求有关竞争利益的性质和程度的信息。如何确定已披露的财务关系或其他竞争利益何时构成利益冲突?*在决定已披露的财务关系是否构成利益冲突时,没有实证证据表明明确标准比特设委员会的决定更可取。然而,明确标准可能使决策更容易。当识别出利益冲突时,应如何处理?描述性研究表明,适当的管理策略最好逐案确定。因此,WHO应采用广泛的管理策略来处理已披露的利益冲突,至少公开每次会议相关的冲突,并在另一个极端情况下让有冲突的个人回避。利益冲突政策应如何执行?尽管没有关于利益冲突政策执行情况的实证研究,但对其他组织和机构的描述性研究表明,WHO应召集一个常设委员会,在委员会会议/听证会开始前审查所有财务披露声明,并在必要时提出管理建议。要求所有财务关系公开(即记录在会议记录中)的标准政策应减少有问题的案例数量。在冲突似乎难以解决的情况下,可能需要建议回避,以保护WHO及其成员的更大利益。

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