Mayo Benjamin C, Ravella Krishna C, Onsen Leonard, Bobko Aimee, Schwarzman Garrett R, Steffes Matthew J, Miller Adam, Hutchinson Mark R
University of Illinois at Chicago, Chicago, Illinois, USA.
Orthop J Sports Med. 2021 Feb 9;9(2):2325967120979988. doi: 10.1177/2325967120979988. eCollection 2021 Feb.
Autologous chondrocyte implantation (ACI) is an increasingly popular technique for the treatment of articular cartilage defects. Because several companies have financial interests in ACI, it is important to consider possible conflicts of interest when evaluating studies reporting outcomes of ACI.
To determine whether there is an association between authors' financial conflicts of interest and the outcomes of ACI studies.
Cross-sectional study.
A search of PubMed and MEDLINE databases for "autologous chondrocyte implantation" was performed. Clinical studies published after 2012 through May 15, 2019, and in English were included. Studies were determined to have financial conflicts of interest if any contributing author had relevant conflicts, either self-reported in the published study's disclosures section or reported online in the American Academy of Orthopaedic Surgeons Disclosure database or the Centers for Medicare & Medicaid Services Open Payments database. The outcomes of each study were rated as favorable, equivocal, or unfavorable based on predefined criteria and then tested for association with conflicts of interest through use of the Fisher exact test.
A total of 79 studies met the inclusion criteria. Nearly all studies were of level 3 or 4 evidence. Conflicts of interest were established in 51.90% of studies (n = 41). Conflicts that were not self-reported by the authors were discovered in 18% of studies. The level of evidence was not associated with conflict of interest. No statistically significant difference was found in the rate of favorable outcomes between studies with conflicts (92.68%) and those with no conflicts (81.58%) ( = .126). Publications by US authors were more likely to have financial conflicts of interest ( = .003).
Favorable results were reported in a majority of studies involving ACI. No statistical association was found between the frequency of favorable outcomes and the presence of financial conflicts of interest, country of authorship, or level of evidence. There was a trend toward more favorable outcomes in studies with conflicts of interest. Additionally, nearly 20% of publications had possible conflicts found online that were not self-reported. It is critical for orthopaedic surgeons to judiciously evaluate published studies and consider financial conflicts of interest before performing ACI techniques on patients.
自体软骨细胞植入术（ACI）是一种越来越受欢迎的治疗关节软骨缺损的技术。由于几家公司在ACI方面存在经济利益，因此在评估报告ACI治疗结果的研究时，考虑可能存在的利益冲突非常重要。
确定作者的经济利益冲突与ACI研究结果之间是否存在关联。
横断面研究。
在PubMed和MEDLINE数据库中检索“自体软骨细胞植入”。纳入2012年以后至2019年5月15日发表的英文临床研究。如果任何一位参与作者存在相关冲突，这些研究即被判定存在经济利益冲突，相关冲突可以是已发表研究的披露部分中自我报告的，也可以是在美国骨科医师学会披露数据库或医疗保险与医疗补助服务中心公开支付数据库中在线报告的。根据预定义标准，将每项研究的结果评为良好、不明确或不佳，然后通过Fisher精确检验来测试与利益冲突的关联。
共有79项研究符合纳入标准。几乎所有研究的证据等级为3级或4级。51.90%的研究（n = 41）存在利益冲突。在18%的研究中发现了作者未自我报告的冲突。证据等级与利益冲突无关。存在冲突的研究中良好结果的发生率（92.68%）与无冲突的研究（81.58%）之间未发现统计学上的显著差异（P = 0.126）。美国作者发表的文章更有可能存在经济利益冲突（P = 0.003）。
大多数涉及ACI的研究报告了良好的结果。在良好结果的频率与经济利益冲突的存在、作者所属国家或证据等级之间未发现统计学关联。存在利益冲突的研究有取得更良好结果的趋势。此外，近20%的出版物存在未自我报告的、在网上发现的可能冲突。对于骨科医生来说，在对患者实施ACI技术之前，审慎评估已发表的研究并考虑经济利益冲突至关重要。
