Shoulder and Elbow Service, Department of Orthopaedic Surgery, Medstar Union Memorial Hospital, Baltimore, MD, USA.
University of Massachusetts, T.H. Chan School of Medicine, Worcester, MA, USA.
J Shoulder Elbow Surg. 2024 Aug;33(8):e438-e442. doi: 10.1016/j.jse.2024.03.016. Epub 2024 Apr 19.
Prior research has shown that industry funding can impact the outcomes reported in medical literature. Limited data exist on the degree of bias that industry funding may have on shoulder arthroplasty literature outside of the Journal of Shoulder and Elbow Surgery. The purpose of this study is to characterize the type and frequency of funding for recently published shoulder arthroplasty studies and the impact of industry funding on reported outcomes. We hypothesized that studies with industry funding are more likely to report positive outcomes than those without.
We performed a retrospective study searching all articles with the term "shoulder arthroplasty," "reverse shoulder arthroplasty," "anatomic total shoulder arthroplasty," or "total shoulder arthroplasty" on PubMed from the years January 2020 to December 2022. The primary outcome of studies was coded as either positive, negative, or neutral. A positive result was defined as one in which the null hypothesis was rejected. A negative result was defined as one in which the result did not favor the group in which the industry-funded implant was used. A neutral result was defined as one in which the null hypothesis was confirmed. Article funding type, subcategorized as National Institutes of Health funding or industry funding was recorded. Author disclosures were recorded to determine conflicts of interest. Statistical analysis was conducted using the χ test and Fisher exact test.
A total of 750 articles reported on either conflict of interest or funding source and were included in the study. Of the total number of industry-funded studies, the majority were found to have a positive primary endpoint (58.1%, 104 of 179), as compared to a negative (7.8%, 14 of 179) or neutral endpoint (33.5%, 60 of 179) (P = .004). Overall, 363 articles reported an author conflict of interest, and the majority of these studies had positive primary endpoint (55.6%, 202 of 363) as compared to negative (9.1%, 33 of 363) or neutral endpoints (34.4%, 125 of 363) (P = .002).
The results of this study suggest that there is a significant relationship between conflicts of interest and the primary outcome of shoulder arthroplasty studies, beyond the overall positive publication bias. Studies with industry funding and author conflicts of interest both report positive outcomes more frequently than negative outcomes. Shoulder surgeons should be aware of this potential bias when choosing to base clinical practice on published data.
先前的研究表明，产业资金会影响医学文献中报告的结果。在《肩肘外科杂志》之外，关于产业资金对肩部关节置换文献的影响程度，仅有有限的数据。本研究的目的是描述最近发表的肩部关节置换研究的资金类型和频率，以及产业资金对报告结果的影响。我们假设，有产业资金支持的研究比没有产业资金支持的研究更有可能报告积极的结果。
我们进行了一项回顾性研究，在 PubMed 上搜索了 2020 年 1 月至 2022 年 12 月期间所有带有“肩部关节置换”、“反向肩部关节置换”、“解剖学全肩部关节置换”或“全肩部关节置换”的文章。研究的主要结果被编码为阳性、阴性或中性。阳性结果的定义是拒绝了无效假设。阴性结果的定义是结果不利于使用产业资金支持的植入物的组。中性结果的定义是确认了无效假设。记录了文章的资金类型，细分为美国国立卫生研究院资金或产业资金。记录了作者的利益冲突披露，以确定利益冲突。使用 χ 检验和 Fisher 精确检验进行了统计分析。
共有 750 篇文章报告了利益冲突或资金来源，并纳入了研究。在所有产业资金支持的研究中，大多数研究的主要终点为阳性（58.1%，179 个中的 104 个），而阴性（7.8%，179 个中的 14 个）或中性终点（33.5%，179 个中的 60 个）（P=.004）。总的来说，363 篇文章报告了作者的利益冲突，这些研究中大多数的主要终点为阳性（55.6%，363 个中的 202 个），而阴性（9.1%，363 个中的 33 个）或中性终点（34.4%，363 个中的 125 个）（P=.002）。
本研究的结果表明，利益冲突与肩部关节置换研究的主要结果之间存在显著关系，超出了整体积极的发表偏倚。有产业资金支持和作者利益冲突的研究报告阳性结果的频率都高于阴性结果。肩部外科医生在选择基于发表数据制定临床实践时，应注意这种潜在的偏见。
