Financial Conflicts of Interest in Studies Related to the Use of Placental Membrane Allografts

Introduction Determine accuracy of self-reporting of conflicts of interest (COI) among studies of placental membrane allograft products and evaluate factors associated with increased discrepancies between self-reported and published COI. Methods A PubMed search identified all publications related to the use of placental membrane allograft products in various surgical specialties between 2015 – 2019. Publications with at least one American author were included for analysis. Industry payments were collected using the Centers for Medicare & Medicaid Services (CMS) Open Payments database for the year of publication and the year prior. Declared COI were compared with the CMS database. Authors were considered to have COI if they received >$100 per company. Risk factors for undeclared COI were determined at the study and author levels. Results A total of 92 publications (423 authors) were identified. 63/92 studies (68%) had at least one author who received an undisclosed industry payment. From 2015 to 2019, 5,841 general payments (totaling $15,558,025) and 1,233 research payments (totaling $18,201,277) were made by 46 companies. Travel and lodging was the most frequent category (34%), followed by consulting (22%) and food/beverage (21%). Most frequent specialties were podiatrists (27%), plastic surgeons (17%) and orthopedic surgeons (14%). Studies recommending placental membrane products were less likely to have undeclared COI (OR 0.204, 95% CI 0.06 – 0.066). Middle authors were less likely to have undeclared payments while senior authors were more likely (OR 0.534, 95% CI 0.34 – 0.83 and OR 1.905, 95% CI 1.12 – 3.23, respectively). Conclusions The majority of studies investigating the use of placental membrane products did not accurately declare COI. This study highlights the need for increased efforts to improve the transparency of industry sponsorship.