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血管外科学研究中自我报告的财务利益冲突评估。

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

机构信息

Department of Surgery, Tufts Medical Center, Boston, Mass.

Division of Vascular Surgery, Cardiovascular Center, Tufts Medical Center, Boston, Mass.

出版信息

J Vasc Surg. 2021 Dec;74(6):2047-2053. doi: 10.1016/j.jvs.2021.05.040. Epub 2021 Jun 23.

Abstract

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals.

METHODS

A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior.

RESULTS

A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively).

CONCLUSIONS

There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

摘要

目的/背景:随着外科医生和行业之间合作的增加,人们一直在努力提高利益冲突(COI)透明度。本研究旨在确定主要血管外科学杂志中 COI 报告的准确性。

方法

通过文献检索,从美国三个主要血管外科学杂志(《血管外科学杂志》、《血管和内脏外科学杂志》和《血管外科学年鉴》)中确定了 2018 年 1 月至 12 月期间发表的所有比较研究。使用医疗保险和医疗补助服务中心(CMS)开放支付数据库收集行业支付情况。通过将作者声明与当年和前一年的支付情况进行比较,确定 COI 差异。

结果

共确定了 239 项研究(1642 位作者)。利用 250 美元的支付金额作为截断值,221 项研究(92%)和 669 位作者(63%)获得了未披露的支付。2018 年,有 145 家公司支付了 10778 笔款项(总计 22174578 美元)。食品和饮料支付是最常见的交易(42%),但仅占报告总金额的 3%。准确披露支付的作者获得的中位一般支付明显高于未准确披露支付的作者(56581 美元[四分位距,2441-100551 美元]与 2361 美元[四分位距,525-9699 美元];P<.001)。按美元金额差异分层,随着支付阈值的增加,未披露支付的作者比例下降。多变量分析表明,第一作者和资深作者都更有可能获得未披露的支付(优势比,2.0;95%置信区间,1.1-3.6 和优势比,2.9;95%置信区间,1.6-5.2)。

结论

血管外科学研究中自我报告的 COI 与医疗保险和医疗补助服务中心开放支付数据库中收到的支付之间存在显著差异。本研究强调需要加强努力,既要改进构成相关 COI 的定义,又要鼓励血管外科学研究的标准化报告流程。

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