Tian Tina, Zaepfel Charlie, Bloom Joshua, Alnahhal Khaled, Chatterjee Abhishek, Allison Geneve M, Iafrati Mark, Salehi Payam
Department of Surgery, Tufts Medical Center, Boston, Massachusetts, USA.
Division of Vascular Surgery, Cardiovascular Center, Tufts Medical Center, Boston, Massachusetts, USA.
Adv Wound Care (New Rochelle). 2022 May;11(5):226-233. doi: 10.1089/wound.2021.0075. Epub 2021 Jul 30.
To systematically review the accuracy of self-reported financial conflicts of interest (COI) by authors of placental membrane allograft product studies. A PubMed search identified placental membrane allograft studies published between 2015 and 2019. Industry payments were collected using the Centers for Medicare & Medicaid Services Open Payments database. Self-declared COI were compared with recorded payments. Risk factors for positive product recommendation were determined at study and author levels. Eighty-nine studies (417 authors) were identified. Seventy-five studies (84%) had at least one author receive undisclosed payments. From 2015 to 2019, 5,841 general payments (totaling $15,558,026) and 1,234 research payments (totaling $18,290,062) were made by 46 companies. Travel/lodging was the most commonly reported transaction (34%). Authors were comprised mostly of podiatrists (27%), plastic surgeons (15%), and orthopedic surgeons (15%). Comparative studies were less likely to have a positive product recommendation compared to noncomparative studies (odds ratio [OR] 0.204, 95% confidence interval 0.06-0.066, = 0.02). Multivariate analysis showed no association between COI discrepancy and product recommendation. The accuracy of self-reported financial COI in placental membrane studies is evaluated for the first time. The majority of placental membrane product studies did not declare all industry payments. Whether these payments represent "relevant COI" remains unclear. In addition, not all placental product companies report to the Open Payments database, suggesting that the issue may be even more significant. This study highlights the need for improved definitions of "relevant COI," a standardized reporting system across journals, and the uniform participation of all medical product vendors.
系统评价胎盘膜同种异体移植产品研究作者自我报告的财务利益冲突(COI)的准确性。通过PubMed检索确定了2015年至2019年发表的胎盘膜同种异体移植研究。利用医疗保险和医疗补助服务中心的公开支付数据库收集行业支付情况。将自我声明的COI与记录的支付情况进行比较。在研究和作者层面确定产品推荐为阳性的风险因素。共识别出89项研究(417名作者)。75项研究(84%)至少有一名作者接受了未披露的支付。2015年至2019年,46家公司进行了5841笔一般支付(总计15558026美元)和1234笔研究支付(总计18290062美元)。差旅/住宿是最常报告的交易(34%)。作者大多为足病医生(27%)、整形外科医生(15%)和骨科医生(15%)。与非比较性研究相比,比较性研究产品推荐为阳性的可能性较小(优势比[OR]0.204,95%置信区间0.06 - 0.066,P = 0.02)。多变量分析显示COI差异与产品推荐之间无关联。首次评估了胎盘膜研究中自我报告的财务COI的准确性。大多数胎盘膜产品研究未声明所有行业支付。这些支付是否代表“相关COI”仍不清楚。此外,并非所有胎盘产品公司都向公开支付数据库报告,这表明该问题可能更为严重。本研究强调需要改进“相关COI”的定义、跨期刊的标准化报告系统以及所有医疗产品供应商的统一参与。