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大多数作者准确披露了《肩肘外科杂志》肩关节置换术手稿的作者的行业报酬,并且这些报酬与更好的报告治疗结果没有显著关联。

Industry payments to authors of Journal of Shoulder and Elbow Surgery shoulder arthroplasty manuscripts are accurately disclosed by most authors and are not significantly associated with better reported treatment outcomes.

机构信息

Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, TX, USA.

Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, TX, USA.

出版信息

J Shoulder Elbow Surg. 2020 Apr;29(4):667-673. doi: 10.1016/j.jse.2019.09.045. Epub 2019 Dec 30.

Abstract

BACKGROUND

Author transparency in disclosing potential conflicts of interest when reporting outcomes for shoulder arthroplasty implants is important. Using the Centers for Medicare & Medicaid Services Open Payments Program (OPP) database, we analyzed articles in the Journal of Shoulder and Elbow Surgery to evaluate (1) discrepancies between the stated conflicts of interest and associated payments recorded in the database, (2) the magnitude and types of payments received, and (3) possible relationships between industry financial support and positive study outcomes.

METHODS

Articles reporting clinical outcomes of shoulder arthroplasty from 2016 and 2017 were reviewed. Articles identifying a specific shoulder arthroplasty implant and having at least 1 author based in the United States were included. Payment types, amounts, and sources were extracted from disclosure statements in the manuscript and considered relevant if they were received from the implant manufacturer. Published disclosure statements were compared against the OPP database. Study outcomes demonstrating a clinical benefit were considered "positive." Payments to authors reporting positive outcomes were compared with those reporting nonpositive outcomes.

RESULTS

Implant manufacturers provided $16,051,261 to authors of shoulder arthroplasty publications over a 2-year period. Approximately half of senior authors (46%) received royalty payments, more than 90% of which ($14,910,873; 93%) were reported in disclosure statements. Although authors of articles with positive outcomes received greater payments than those reporting nonpositive outcomes, these differences were not statistically significant.

CONCLUSION

The majority of author disclosure statements accurately reflected the OPP data. Payments were not significantly associated with positive outcomes reported for the specific implant.

摘要

背景

在报告肩关节炎置换植入物的结果时,披露潜在利益冲突的作者透明度很重要。我们利用医疗保险和医疗补助服务中心(Centers for Medicare & Medicaid Services)的公开支付计划(Open Payments Program,OPP)数据库,分析了《肩肘外科杂志》(Journal of Shoulder and Elbow Surgery)上的文章,以评估:(1)在数据库中记录的声明的利益冲突与相关支付之间的差异;(2)收到的支付的金额和类型;(3)行业财务支持与阳性研究结果之间的可能关系。

方法

回顾了 2016 年和 2017 年报告肩关节炎置换术临床结果的文章。纳入了确定特定肩关节炎置换植入物且至少有 1 位作者在美国的文章。从手稿中的披露声明中提取了支付类型、金额和来源,如果这些支付来自植入物制造商,则被视为相关。将已发表的披露声明与 OPP 数据库进行了比较。报告临床获益的研究结果被认为是“阳性”。将报告阳性结果的作者的支付与报告非阳性结果的作者的支付进行了比较。

结果

在 2 年期间,植入物制造商向肩关节炎出版物的作者提供了 16,051,261 美元。大约一半的资深作者(46%)获得了版税收入,其中超过 90%(14,910,873 美元;93%)在披露声明中报告。尽管报告阳性结果的文章作者收到的支付高于报告非阳性结果的文章作者,但这些差异没有统计学意义。

结论

大多数作者披露声明准确反映了 OPP 数据。支付与特定植入物报告的阳性结果之间没有显著关联。

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