Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines
Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines
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DOI：
10.1001/jamainternmed.2016.8439
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发表时间：
2017-03-01
影响因子：
39
通讯作者：
Pearson, Steven D.
中科院分区：
文献类型：
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作者：
Jefferson, Akilah A.;Pearson, Steven D.
在最近制定的重要临床指南中，关于医学研究所（IOM）管理利益冲突（COI）的标准是否得到满足，人们知之甚少。目的评估IOM商业COI限制标准的依从性、指南的制定以及2013年美国心脏病学会和美国心脏协会胆固醇管理指南和2014年美国肝病和传染病学会美国丙型肝炎病毒管理指南的证据评价。设计、环境和参与者：本研究是对2014年6月胆固醇指南印刷版和2015年9月丙型肝炎病毒指南最终印刷版的回顾性文献综述。我们评估了每个指南是否符合2011年特别报告《临床实践指南我们可以信任》中发布的IOM商业COI标准。IOM标准要求在指南委员会主席和联合主席中没有商业COI，并且少于50%的委员会成员有商业COI。使用指南和同期文章披露声明来评估对这些标准的遵守情况。每个指南也被审查是否符合其他IOM标准的指南制定和证据审查。结果在16名胆固醇指南委员会成员中，7名（44%）披露了商业COI， 7名均报道了行业赞助的研究，6名（38%）也报道了咨询。在3位指南主席和联席主席中，1位（33%）披露了商业COI。对同期文章的回顾发现了额外的商业COI。在29名丙型肝炎病毒指南委员会成员中，21名（72%）报告了商业性COI。18人（62%）披露了行业赞助的研究，10人（34%）担任顾问委员会成员，5人（17%）担任数据安全监测委员会成员，3人（10%）担任顾问，3人（10%）报告了其他酬金。在6位指南联合主席中，4位（67%）披露了商业COI。所有4位作者都在其指南披露中未列出的其他出版物中披露了额外的COI。当时的文献综述显示了与商业COI的额外联合主席。在9项IOM指南制定和证据标准中，胆固醇指南满足5项（56%），丙型肝炎病毒指南全部满足。结论和相关性胆固醇指南和丙型肝炎病毒指南都不完全符合IOM商业COI管理的标准，委员会领导指南披露与同期文章的不一致是常见的。对于指南制定和证据审查的附加IOM标准的遵守情况参差不齐。各专业学会采用一致的COI框架可能有助于确保以透明和值得信赖的方式制定临床指南。
IMPORTANCE Little is known regarding whether Institute of Medicine (IOM) standards for managing conflicts of interest (COI) have been met in the development of recent important clinical guidelines.OBJECTIVE To evaluate adherence to the IOM standards for limits on commercial COI, guideline development, and evaluation of evidence by the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America hepatitis C virus management guideline.DESIGN, SETTING, AND PARTICIPANTS This study was a retrospective document review of the June 2014 print version of the cholesterol guideline and the final September 2015 print version of the hepatitis C virus guideline. Each guideline was assessed for adherence to the IOM standards for commercial COI published in the 2011 special report Clinical Practice Guidelines We Can Trust.MAIN OUTCOMES AND MEASURES The IOM standards call for no commercial COI among guideline committee chairs and cochairs and for less than 50% of committee members to have commercial COI. Guideline and contemporaneous article disclosure statements were used to evaluate adherence to these standards. Each guideline was also reviewed for adherence to other IOM standards for guideline development and evidence review.RESULTS Among the 16 cholesterol guideline committee members, 7 (44%) disclosed commercial COI, all 7 reported industry-sponsored research, and 6 (38%) also reported consultancy. Of 3 guideline chairs and cochairs, 1 (33%) disclosed commercial COI. Review of contemporaneous articles identified additional commercial COI. Among the 29 hepatitis C virus guideline committee members, 21 (72%) reported commercial COI. Eighteen (62%) disclosed industry-sponsored research, 10 (34%) served on advisory boards, 5 (17%) served on data safety monitoring boards, 3 (10%) were consultants, and 3 (10%) reported other honoraria. Of 6 guideline cochairs, 4 (67%) disclosed commercial COI. All 4 disclosed additional COI in other publications that were not listed in their guideline disclosures. Contemporaneous literature review revealed an additional cochair with commercial COI. Of the 9 IOM guideline development and evidence standards, the cholesterol guideline met 5 (56%), and the hepatitis C virus guideline met them all.CONCLUSIONS AND RELEVANCE Neither the cholesterol guideline nor the hepatitis C virus guideline fully met the IOM standards for commercial COI management, and discordance between committee leader guideline disclosures and those in contemporaneous articles was common. Adherence to additional IOM standards for guideline development and evidence review was mixed. Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner.