Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.
Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.
PLoS One. 2021 Apr 30;16(4):e0249267. doi: 10.1371/journal.pone.0249267. eCollection 2021.
Conflicts of interest (COI) jeopardize the validity of Clinical Practice Guidelines (CPGs). When the Institute of Medicine promulgated COI policies in 2011, few organizations met these requirements, but it is unknown if organizations have improved their policies since that time. We sought to evaluate current adherence to IOM standards of COI policies.
We conducted a retrospective document review of COI policies and CPGs from organizations that published five or more CPGs between January 1, 2018 and December 31, 2019. Organizations were identified via CPG databases. COI policies were obtained from an internet search. We collected data on i) the number of organizations that have COI policies specific to CPG development, ii) the number of policies meeting each IOM standard and iii) the number of IOM standards met by each policy. COI disclosures from five CPGs of each organization were assessed for adherence to IOM standards. Among the 46 organizations that published 5 or more CPGs, 36 (78%) had a COI policy. Standard 2.2b (requiring divestment of financial COI) was met least frequently, by 2 of 36 (6%) organizations. Standard 2.1 (requiring disclosure of COI) was met most frequently, by 33 of 36 (92%) organizations. A total of 31 of 36 (86%) organizations met 4 or fewer of the 7 IOM standards. Among the 16 organizations limiting COI to a minority of the CPG panel (standard 2.4c) and the 15 organizations prohibiting COI among chairs or co-chairs (standard 2.4d), 12 (75%) and 10 (67%) organizations violated the respective standard in at least one CPG. The main limitations of our study are the exclusion of organizations producing fewer CPGs and ability to assess only publicly available policies.
Among organizations producing CPGs, COI policies frequently do not meet IOM standards, and organizations often violate their own policies. These shortcomings may undermine the public trust in and thus the utility of CPGs. CPG-producing organizations should improve their COI policies and their strategies to manage COI to increase the trustworthiness of CPGs.
利益冲突(COI)会危及临床实践指南(CPG)的有效性。2011 年,美国医学研究所颁布了 COI 政策,当时很少有组织符合这些要求,但此后这些组织是否改进了他们的政策尚不清楚。我们试图评估当前对医学研究所 COI 政策标准的遵守情况。
我们对 2018 年 1 月 1 日至 2019 年 12 月 31 日期间发布了 5 份或更多 CPG 的组织的 COI 政策和 CPG 进行了回顾性文件审查。通过 CPG 数据库确定了组织。从互联网搜索中获取 COI 政策。我们收集了以下数据:i)有特定于 CPG 开发的 COI 政策的组织数量,ii)符合每个医学研究所标准的政策数量,以及 iii)符合每个政策的医学研究所标准数量。评估了每个组织的 5 份 CPG 的 COI 披露情况,以评估其是否符合医学研究所的标准。在发布了 5 份或更多 CPG 的 46 个组织中,有 36 个(78%)有 COI 政策。标准 2.2b(要求财务利益冲突的剥离)被 2 个组织(6%)最少遵守。标准 2.1(要求披露利益冲突)被 33 个组织(92%)最频繁地遵守。共有 31 个组织(86%)符合 7 个医学研究所标准中的 4 个或更少。在将 COI 限制在 CPG 小组少数成员(标准 2.4c)的 16 个组织和禁止主席或联合主席之间存在 COI(标准 2.4d)的 15 个组织中,12 个(75%)和 10 个(67%)组织在至少一个 CPG 中违反了各自的标准。我们研究的主要局限性是排除了制定较少 CPG 的组织,并且只能评估公开可用的政策。
在制定 CPG 的组织中,COI 政策经常不符合医学研究所的标准,并且组织经常违反自己的政策。这些缺陷可能会破坏公众对 CPG 的信任,从而降低 CPG 的实用性。CPG 制定组织应改进其 COI 政策和管理 COI 的策略,以提高 CPG 的可信度。