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已披露的行业资助并不会增加踝关节下胫腓联合损伤缝线纽扣固定术研究的积极结果:一项系统评价。

Disclosed Industry Funding Does Not Increase Positive Outcomes in Studies on Suture Button Fixation for Ankle Syndesmotic Injuries: A Systematic Review.

作者信息

Feingold Cailan L, Lin Eric H, Subhash Ajith K, Tercyak Samuel C, Jagasia Aidan A, Tan Eric W, Peterson Alexander B, Liu Joseph N

机构信息

Keck School of Medicine of USC, Department of Orthopaedic Surgery, Los Angeles, CA, USA.

Harbor UCLA Medical Center, Department of Orthopaedic Surgery, Torrance, CA, USA.

出版信息

Foot Ankle Orthop. 2025 Jun 19;10(2):24730114251341305. doi: 10.1177/24730114251341305. eCollection 2025 Apr.

Abstract

BACKGROUND

Industry funding can increase the likelihood of positive outcomes. This study sought to investigate whether industry funding or conflicts of interest (COI) for studies investigating suture button fixation devices for ankle syndesmosis injuries influenced outcomes.

METHODS

PubMed, Scopus, and Embase were queried for studies investigating suture button fixation devices for the ankle. Included studies investigated suture button fixation devices for the ankle and reported funding or COI. Excluded studies were systematic reviews, meta-analyses, and case reports. Outcomes were categorized into "positive" if the null hypothesis was rejected or outcomes favored the implant, "neutral" if the null hypothesis was confirmed, or "negative" if the result was unfavorable toward the implant. Studies were grouped into industry-funded, nonfunded, and "other" funding, including specialty societies, National Institutes of Health (NIH), and grants. Studies were also grouped by the presence or absence of COI. Chi-squared test was used to test for significance defined as  <.05.

RESULTS

A total of 112 studies were included for analysis. Of these, 19 (17%) were industry-funded, 21 (19%) had other funding sources, and 72 (64%) were nonfunded. The proportion of studies with positive outcomes was 48% in industry-funded studies, 63% in studies with other funding sources, and 65% in nonfunded studies. There was no significant association between funding source and outcome ( = .063). A COI was present in 42 studies (37.5%), and no COI was present in 70 studies (62.5%). The proportion of positive studies in those with a COI was 52%, whereas in studies without a COI, it was 67%. Positive studies were significantly associated with studies without COI ( = .003).

CONCLUSION

Industry funding and COI was not found to be associated with an increased likelihood of positive outcome reporting in studies on suture-button fixation for ankle syndesmostic injuries; we found in this review that positive outcomes are more likely in studies without COI.

摘要

背景

行业资助会增加获得阳性结果的可能性。本研究旨在调查研究踝关节下胫腓联合损伤缝合纽扣固定装置的研究中,行业资助或利益冲突(COI)是否会影响研究结果。

方法

在PubMed、Scopus和Embase数据库中检索关于研究踝关节缝合纽扣固定装置的研究。纳入的研究需调查踝关节缝合纽扣固定装置并报告资助或利益冲突情况。排除的研究包括系统评价、荟萃分析和病例报告。如果原假设被拒绝或结果支持植入物,则结果分类为“阳性”;如果原假设得到证实,则为“中性”;如果结果对植入物不利,则为“阴性”。研究分为行业资助、无资助和“其他”资助,“其他”资助包括专业学会、美国国立卫生研究院(NIH)和拨款。研究也根据是否存在利益冲突进行分组。采用卡方检验来检验显著性,显著性定义为P<0.05。

结果

总共纳入112项研究进行分析。其中,19项(17%)为行业资助,21项(19%)有其他资助来源,72项(64%)无资助。行业资助研究中阳性结果的比例为48%,其他资助来源研究中为63%,无资助研究中为65%。资助来源与结果之间无显著关联(P = 0.063)。42项研究(37.5%)存在利益冲突,70项研究(62.5%)不存在利益冲突。存在利益冲突的研究中阳性研究的比例为52%,而不存在利益冲突的研究中为67%。阳性研究与不存在利益冲突的研究显著相关(P = 0.003)。

结论

在踝关节下胫腓联合损伤缝合纽扣固定研究中,未发现行业资助和利益冲突与阳性结果报告可能性增加相关;我们在本综述中发现,不存在利益冲突的研究更可能获得阳性结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e227/12181731/02f36f8b41e8/10.1177_24730114251341305-fig1.jpg

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