利用开放式付费数据库评估单克隆抗体治疗慢性鼻炎伴鼻息肉病文献中的利益冲突。

IF 7.2 2区 医学 Q1 OTORHINOLARYNGOLOGY
Christina Liu, Conrad W Safranek, Rhys Richmond, Trinithas Boyi, Zachary Pickell, Ryan Rimmer, R Peter Manes
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引用次数: 0

摘要

背景:准确的利益冲突(COI)信息对于提高研究的透明度和信任度至关重要。我们旨在利用开放支付数据库(OPD)评估慢性鼻炎伴鼻息肉病(CRSwNP)的单克隆抗体(MABs)研究中的 COI 披露模式:通过 PubMed 查找了 2019 年至 2021 年间发表的、至少有一位美国作者参与的、经 FDA 批准用于 CRSwNP 的 MABs(dupilumab、omalizumab、mepolizumab)研究。收集了生产商(赛诺菲、再生元、基因泰克、诺华和葛兰素史克)在 2018 年至 2021 年期间在 OPD 的一般付款类别中的行业报告付款。作者使用之前发布的基于 ChatGPT 的算法与 OPD 元数据进行了交叉核对。此外,这种新型算法还分析了COI声明中相关作者-公司的具体披露情况,确定了发表前3-15个月已披露和未披露的付款情况:结果:共纳入了 76 项研究中的 214 位作者。在30篇至少收到一笔相关付款的文章中,有21篇(70%)被发现有未披露的COI,未披露的付款总额平均值为4890美元,中位数为10331美元。56位作者有相关的OPD付款,40位作者(71.4%)没有申报潜在的COI。有趣的是,158 位作者没有相关付款,62 位作者(39.2%)申报了潜在的 COI。作者顺序与潜在的未充分披露或过度披露没有明显关系:本研究采用一种新颖的自动方法,描述了鼻炎相关人与生物圈计划研究中的 COI 披露模式。鉴于披露的信息与行业报告的付款之间存在差异,我们的研究结果表明有必要改进披露教育和实践。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of conflicts of interest in literature on monoclonal antibodies for chronic rhinosinusitis with nasal polyposis using the Open Payments Database.

Background: Accurate conflict of interest (COI) information is essential for promoting transparency and trust in research. We aim to assess COI disclosure patterns in monoclonal antibodies (MABs) research for chronic rhinosinusitis with nasal polyposis (CRSwNP) using the Open Payments Database (OPD).

Methods: Studies on FDA-approved MABs for CRSwNP (dupilumab, omalizumab, mepolizumab) published between 2019 and 2021 with at least one US author were identified through PubMed. Industry-reported payments from the manufacturers (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline) between 2018 and 2021 in OPD's General Payments category were collected. Authors were cross-checked against OPD metadata using a previously published ChatGPT-based algorithm. Additionally, this novel algorithm analyzed COI statements for relevant author‒company specific disclosures, identifying disclosed and undisclosed payments made 3‒15 months prior to publication.

Results: A total of 214 unique authors from 76 studies were included. Of 30 articles that received at least one relevant payment, 21 (70%) were found to have an undisclosed COI, with a mean total undisclosed payment of $4890 and a median of $10,331. Fifty-six authors had relevant OPD payments and 40 (71.4%) authors did not declare a potential COI. Interestingly, 158 authors had no relevant payments and 62 (39.2%) declared a potential COI. Author order was not significantly associated with potential under- or over-disclosure.

Conclusion: This study characterizes COI disclosure patterns in rhinosinusitis-relevant MABs research using a novel automated approach. Given the discrepancy between disclosures and industry-reported payments, our findings suggest a need for improved disclosure education and practices.

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来源期刊
CiteScore
11.70
自引率
10.90%
发文量
185
审稿时长
6-12 weeks
期刊介绍: International Forum of Allergy & Rhinologyis a peer-reviewed scientific journal, and the Official Journal of the American Rhinologic Society and the American Academy of Otolaryngic Allergy. International Forum of Allergy Rhinology provides a forum for clinical researchers, basic scientists, clinicians, and others to publish original research and explore controversies in the medical and surgical treatment of patients with otolaryngic allergy, rhinologic, and skull base conditions. The application of current research to the management of otolaryngic allergy, rhinologic, and skull base diseases and the need for further investigation will be highlighted.
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