Extent, transparency and impact of industry funding for pelvic mesh research: a review of the literature

Angela Coderre-Ball, Susan P. Phillips
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Abstract

Background

Conflicts of interest inherent in industry funding can bias medical research methods, outcomes, reporting and clinical applications. This study explored the extent of funding provided to American physician researchers studying surgical mesh used to treat uterine prolapse or stress urinary incontinence, and whether that funding was declared by researchers or influenced the ethical integrity of resulting publications in peer reviewed journals.

Methods

Publications identified via a Pubmed search (2014–2021) of the terms mesh and pelvic organ prolapse or stress urinary incontinence and with at least one US physician author were reviewed. Using the CMS Open Payments database industry funding received by those MDs in the year before, of and after publication was recorded, as were each study’s declarations of funding and 14 quality measures.

Results

Fifty-three of the 56 studies reviewed had at least one American MD author who received industry funding in the year of, or one year before or after publication. For 47 articles this funding was not declared. Of 247 physician authors, 60% received > $100 while 13% received $100,000-$1,000,000 of which approximately 60% was undeclared. While 57% of the studies reviewed explicitly concluded that mesh was safe, only 39% of outcomes supported this. Neither the quality indicator of follow-up duration nor overall statements as to mesh safety varied with declaration status.

Conclusions

Journal editors’ guidelines re declaring conflicts of interest are not being followed. Financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality of, and conclusions drawn, resulting in overstated benefit and overuse of pelvic mesh in clinical practice.

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行业资助骨盆网研究的程度、透明度和影响:文献综述
背景行业资助中固有的利益冲突会使医学研究方法、结果、报告和临床应用产生偏差。本研究探讨了向研究用于治疗子宫脱垂或压力性尿失禁的手术网片的美国医生研究人员提供资助的程度,以及研究人员是否申报了这些资助,或这些资助是否影响了在同行评审期刊上发表的论文的道德完整性。方法通过 Pubmed 搜索(2014-2021 年)网片和盆腔器官脱垂或压力性尿失禁等术语,对至少有一名美国医生作者的出版物进行了审查。利用 CMS Open Payments 数据库,记录了这些医学博士在发表文章的前一年、一年和一年后获得的行业资助,以及每项研究的资助声明和 14 项质量衡量指标。结果在所审查的 56 项研究中,有 53 项研究的至少一名美国医学博士作者在发表文章的前一年、一年前或一年后获得了行业资助。有 47 篇文章没有申报这一资助。在 247 位医生作者中,60% 的人获得了 100 美元的资助,13% 的人获得了 100,000 美元至 1,000,000 美元的资助,其中约 60% 的人没有申报。虽然 57% 的综述研究明确认为网片是安全的,但只有 39% 的结果支持这一观点。随访时间的质量指标和关于网片安全性的总体声明均未随申报情况的变化而变化。行业在网片研究中的财务参与非常广泛,而且往往没有申报,这可能会影响研究的质量和得出的结论,导致在临床实践中过度夸大盆腔网片的益处和过度使用。
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