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支气管镜检查研究中的利益冲突:自我报告是否足够?

Conflicts of Interest in Bronchoscopy Research: Is Self-Reporting Sufficient?

作者信息

Leonard Kaele M, Khalil Timothy A, Welch Jacob, Dahlberg Greta, Ratwani Ankush, Duke Jennifer D, Paez Rafael, Gordon Elisa J, Shojaee Samira, Lentz Robert J, Maldonado Fabien

机构信息

Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Interventional Pulmonology Research, Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Multidisciplinary Assessment and Stratification of Lung Cancer with Biomarkers Laboratory (MASLAB), Vanderbilt University Medical Center, Nashville, TN.

Interventional Pulmonology Research, Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Multidisciplinary Assessment and Stratification of Lung Cancer with Biomarkers Laboratory (MASLAB), Vanderbilt University Medical Center, Nashville, TN.

出版信息

Chest. 2025 Apr;167(4):1161-1170. doi: 10.1016/j.chest.2024.10.006. Epub 2024 Oct 18.

Abstract

BACKGROUND

Robotic assisted bronchoscopy has been enthusiastically adopted in the United States and has transformed the treatment of patients with indeterminate pulmonary nodules. Unprecedented industry investments in research, development, and marketing have profoundly affected the bronchoscopy landscape, leading to concerns that conflicts of interest could influence the validity of bronchoscopy studies. Disclosures of conflicts of interest in research are predicated on open and transparent self-reporting.

RESEARCH QUESTION

Are self-reported relevant conflicts of interest in articles pertaining to robotic assisted bronchoscopy accurate when compared with publicly available payments on the Open Payments Database of the Centers for Medicare & Medicaid Services?

STUDY DESIGN AND METHODS

All articles pertaining to robotic assisted bronchoscopy indexed on PubMed between 2016 and 2022 were screened for relevance. Articles appearing in the 5 journals with the most relevant publications were selected. General, research, and associated research payments reported in the Open Payments Database were recorded for each US physician-author with available data. "Relevant payments" refers to transactions made to authors by bronchoscopy-related companies. Documentation of all payments involving these companies during the 3 years before the submission date of an article was obtained. These payments were compared with the self-reported conflicts of interest for each author, per article, and the number and value of payments were categorized and totaled.

RESULTS

Twenty-seven articles were included, accounting for 75 US physicians with data reported in the Open Payments Database. Of the $17 million in relevant payments reported, $9.9 million were not disclosed (57%). Sixty-eight of 75 authors (91%) had incomplete physician disclosures. Excluding food and beverage payments, 60 authors had incomplete disclosures (80%).

INTERPRETATION

Relevant conflicts of interest appear to be inconsistently disclosed in publications on robotic assisted bronchoscopy, suggesting that self-reporting may be an insufficient strategy. A centralized disclosure process that is automated or easier to use should be considered.

摘要

背景

机器人辅助支气管镜检查在美国已得到广泛应用,并改变了对肺部结节性质不明患者的治疗方式。行业在研究、开发和营销方面前所未有的投资深刻影响了支气管镜检查领域,引发了人们对利益冲突可能影响支气管镜检查研究有效性的担忧。研究中利益冲突的披露基于公开透明的自我报告。

研究问题

与医疗保险和医疗补助服务中心公开支付数据库中的公开支付情况相比,机器人辅助支气管镜检查相关文章中自我报告的相关利益冲突是否准确?

研究设计与方法

筛选2016年至2022年间在PubMed上索引的所有与机器人辅助支气管镜检查相关的文章以确定其相关性。选择发表相关文章最多的5种期刊上的文章。为每位有可用数据的美国医生作者记录公开支付数据库中报告的一般、研究及相关研究支付情况。“相关支付”指支气管镜检查相关公司向作者进行的交易。获取文章提交日期前3年内涉及这些公司的所有支付记录。将这些支付与每位作者每篇文章自我报告的利益冲突进行比较,并对支付的数量和价值进行分类和汇总。

结果

纳入27篇文章,涉及公开支付数据库中有数据报告的75位美国医生。在报告的1700万美元相关支付中,990万美元未被披露(57%)。75位作者中有68位(91%)医生披露不完整。排除食品和饮料支付后,60位作者披露不完整(80%)。

解读

机器人辅助支气管镜检查相关出版物中相关利益冲突的披露似乎不一致,这表明自我报告可能是一种不足的策略。应考虑采用自动化或更易于使用的集中披露程序。

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