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有分层利益冲突政策的研究证据:方法学综述。

Evidence for stratified conflicts of interest policies in research contexts: a methodological review.

机构信息

Department of Rhetoric & Writing, University of Texas at Austin, Austin, Texas, USA

Department of English, The University of Texas at Austin, Austin, Texas, USA.

出版信息

BMJ Open. 2022 Sep 19;12(9):e063501. doi: 10.1136/bmjopen-2022-063501.

Abstract

OBJECTIVES

The purpose of this study was to conduct a methodological review of research on the effects of conflicts of interest (COIs) in research contexts.

DESIGN

Methodological review.

DATA SOURCES

Ovid.

ELIGIBILITY CRITERIA

Studies published between 1986 and 2021 conducting quantitative assessments of relationships between industry funding or COI and four target outcomes: positive study results, methodological biases, reporting quality and results-conclusions concordance.

DATA EXTRACTION AND SYNTHESIS

We assessed key facets of study design: our primary analysis identified whether studies stratified industry funding or COI variables by magnitude (ie, number of COI or disbursement amount), type (employment, travel fees, speaking fees) or if they assessed dichotomous variables (ie, conflict present or absent). Secondary analyses focused on target outcomes and available effects measures.

RESULTS

Of the 167 articles included in this study, a substantial majority (98.2%) evaluated the effects of industry sponsorship. None evaluated associations between funding magnitude and outcomes of interest. Seven studies (4.3%) stratified industry funding based on the mechanism of disbursement or funder relationship to product (manufacturer or competitor). A fifth of the articles (19.8%) assessed the effects of author COI on target outcomes. None evaluated COI magnitude, and three studies (9.1%) stratified COI by disbursement type and/or reporting practices. Participation of an industry-employed author showed the most consistent effect on favourability of results across studies.

CONCLUSIONS

Substantial evidence demonstrates that industry funding and COI can bias biomedical research. Evidence-based policies are essential for mitigating the risks associated with COI. Although most policies stratify guidelines for managing COI, differentiating COIs based on the type of relationship or monetary value, this review shows that the available research has generally not been designed to assess the differential risks of COI types or magnitudes. Targeted research is necessary to establish an evidence base that can effectively inform policy to manage COI.

摘要

目的

本研究旨在对研究背景下利益冲突(COI)对研究结果的影响进行方法学综述。

设计

方法学综述。

资料来源

Ovid。

入选标准

1986 年至 2021 年间发表的研究,采用定量评估方法,评估产业资金或 COI 与以下四个目标结果之间的关系:阳性研究结果、方法学偏差、报告质量和结果结论一致性。

资料提取与综合

我们评估了研究设计的关键方面:我们的主要分析确定了研究是否根据数量(即 COI 数量或支出金额)、类型(雇佣、旅行津贴、演讲费)对产业资金或 COI 变量进行分层,或者它们是否评估了二分类变量(即存在或不存在冲突)。二次分析侧重于目标结果和可用的效果指标。

结果

本研究纳入的 167 篇文章中,绝大多数(98.2%)评估了产业赞助的影响。没有研究评估资金数量与感兴趣的结果之间的关联。仅有 7 篇(4.3%)文章根据支出机制或资助者与产品的关系(制造商或竞争对手)对产业资金进行分层。五分之一的文章(19.8%)评估了作者 COI 对目标结果的影响。没有研究评估 COI 数量,有 3 篇文章(9.1%)根据支出类型和/或报告实践对 COI 进行分层。产业雇佣作者的参与在研究中显示出对结果有利性的最一致影响。

结论

大量证据表明,产业资金和 COI 可能会影响生物医学研究的偏倚。制定基于证据的政策对于减轻 COI 相关风险至关重要。尽管大多数政策都对管理 COI 的准则进行分层,但根据关系类型或货币价值对 COI 进行区分,但本综述表明,现有研究通常并未设计用于评估 COI 类型或数量的差异风险。需要进行有针对性的研究,以建立能够有效为管理 COI 提供政策依据的证据基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab17/9486359/9e13e4d4d0c8/bmjopen-2022-063501f01.jpg

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