Reporting of Financial Conflicts of Interest in Studies of Placental Membrane Allografts

Objective: To systematically review the accuracy of self-reported financial conflicts of interest (COI) by authors of placental membrane allograft product studies. Approach: 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. Results: 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, p = 0.02). Multivariate analysis showed no association between COI discrepancy and product recommendation. Innovation: The accuracy of self-reported financial COI in placental membrane studies is evaluated for the first time. Conclusion: 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.