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阳光法案:揭示妇科年会上不准确的披露情况

Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting.

作者信息

Thompson Jennifer C, Volpe Katherine A, Bridgewater Lindsay K, Qeadan Fares, Dunivan Gena C, Komesu Yuko M, Cichowski Sara B, Jeppson Peter C, Rogers Rebecca G

机构信息

Department of Obstetrics and Gynecology, Division of Urogynecology, University of New Mexico, Albuquerque, NM.

Clinical and Translational Science Center, University of New Mexico, Albuquerque, NM.

出版信息

Am J Obstet Gynecol. 2016 Nov;215(5):661.e1-661.e7. doi: 10.1016/j.ajog.2016.06.015. Epub 2016 Jun 16.

Abstract

BACKGROUND

Physicians and hospital systems often have relationships with biomedical manufacturers to develop new ideas, products, and further education. Because this relationship can influence medical research and practice, reporting disclosures are necessary to reveal any potential bias and inform consumers. The Sunshine Act was created to develop a new reporting system of these financial relationships called the Open Payments database. Currently all disclosures submitted with research to scientific meetings are at the discretion of the physician. We hypothesized that financial relationships between authors and the medical industry are underreported.

OBJECTIVES

We aimed to describe concordance between physicians' financial disclosures listed in the abstract book from the 41st annual scientific meeting of the Society of Gynecologic Surgeons to physician payments reported to the Center for Medicaid and Medicare Services Open Payments database for the same year.

STUDY DESIGN

Authors and scientific committee members responsible for the content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons were identified from the published abstract book; each abstract listed disclosures for each author. Abstract disclosures were compared with the transactions recorded on the Center for Medicaid and Medicare Services Open Payments database for concordance. Two authors reviewed each nondisclosed Center for Medicaid and Medicare Services listing to determine the relatedness between the company listed on the Center for Medicaid and Medicare Services and abstract content.

RESULTS

Abstracts and disclosures of 335 physicians meeting inclusion criteria were reviewed. A total of 209 of 335 physicians (62%) had transactions reported in the Center for Medicaid and Medicare Services, which totaled $1.99 million. Twenty-four of 335 physicians (7%) listed companies with their abstracts; 5 of those 24 physicians were concordant with the Center for Medicaid and Medicare Services. The total amount of all nondisclosed transactions was $1.3 million. Transactions reported in the Center for Medicaid and Medicare Services associated with a single physician ranged from $11.72 to $405,903.36. Of the 209 physicians with Center for Medicaid and Medicare Services transactions that were not disclosed, the majority (68%) had at least 1 company listed in the Center for Medicaid and Medicare Services that was determined after review to be related to the subject of their abstract.

CONCLUSION

Voluntary disclosure of financial relationships was poor, and the majority of unlisted disclosures in the abstract book were companies related to the scientific content of the abstract. Better transparency is needed by physicians responsible for the content presented at gynecological scientific meetings.

摘要

背景

医生和医院系统通常与生物医学制造商建立关系,以开发新想法、产品并开展进一步教育。由于这种关系可能影响医学研究和实践,因此需要报告披露信息,以揭示任何潜在的偏见并告知消费者。《阳光法案》旨在建立一个名为“公开支付数据库”的关于这些财务关系的新报告系统。目前,所有随研究提交给科学会议的披露信息都由医生自行决定。我们假设作者与医疗行业之间的财务关系报告不足。

目的

我们旨在描述在妇科外科医生协会第41届年度科学会议摘要书中列出的医生财务披露与同年向医疗保险和医疗补助服务中心公开支付数据库报告的医生付款之间的一致性。

研究设计

从已发表的摘要书中确定负责妇科外科医生协会第41届年度科学会议内容的作者和科学委员会成员;每篇摘要列出了每位作者的披露信息。将摘要中的披露信息与医疗保险和医疗补助服务中心公开支付数据库中记录的交易进行比较,以确定一致性。两位作者审查了医疗保险和医疗补助服务中心每一项未披露的记录,以确定医疗保险和医疗补助服务中心列出的公司与摘要内容之间的相关性。

结果

审查了符合纳入标准的335名医生的摘要和披露信息。335名医生中有209名(62%)在医疗保险和医疗补助服务中心有交易报告,交易总额为199万美元。335名医生中有24名(7%)在摘要中列出了公司;这24名医生中有5名与医疗保险和医疗补助服务中心的记录一致。所有未披露交易的总额为130万美元。医疗保险和医疗补助服务中心报告的与一名医生相关联的交易金额从11.72美元到405,903.36美元不等。在209名有医疗保险和医疗补助服务中心交易但未披露的医生中,大多数(68%)在医疗保险和医疗补助服务中心列出了至少一家经审查后确定与他们摘要主题相关的公司。

结论

财务关系的自愿披露情况不佳,摘要书中大多数未列出的披露信息是与摘要科学内容相关的公司。负责妇科科学会议所展示内容的医生需要提高透明度。

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