Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services

Abstract

BACKGROUND The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD- versus self-reported COI is unknown. MATERIALS AND METHODS Our objectives were to compare 1) industry and self-disclosed COI in clinical literature, 2) payments within each disclosure level, and 3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clinical studies accepted for publication from 1/2014 to 6/2016. Author and OPD-disclosed COI were compared. Articles and authors were divided into Full Disclosure; Incomplete Industry Disclosure; Incomplete Self-Disclosure; and No COI. Primary outcome (differences in reported COI per manuscript) was assessed using McNemar’s test. Payment differences were compared using Kruskal-Wallis Test. RESULTS OPD- and self-disclosed COI differed (65.0% discordance rate by manuscript, p<0.001). Percentages of authors within each disclosure category differed between specialties (p<0.001). Hematology manuscripts exhibited the highest discordance rate (79.0%) and received the highest median payment for Incomplete Self-Disclosure ($30,812). CONCLUSIONS Significant discordance exists between self- and OPD-reported COI. Additional research is needed to determine reasons for these differences.

Association of Compensation From the Surgical and Medical Device Industry to Physicians and Self-declared Conflict of Interest

“…Of the 303 studies in which at least 1 author received a general payment from Intuitive Surgical Inc, only 63 (20.8%) declared the payments in the COI statement. In another study by Cherla et al, 7 500 publications were analyzed from January 2014 through June 2016. They reported 65% discordance between the OPD and self-disclosed COI (P < .001).…”

Industry Payments to Academic Physicians: a Comparison of Reporting to Two Government Agencies

“…and industry. 6 However, our findings highlight two major limitations of Open Payments which researchers and policymakers should recognize. First, three-fifths of physician-director relationships we identified involved healthcare companies not listed in Open Payments.…”

Meaningful and Accurate Disclosure of Conflict of Interest at the ASTRO National Meeting: A Need for Reassessment of Current Policies

“…Our report is in agreement with others that show that self-reported financial COI disclosures may not be accurate or reliable because of their own biases regarding the definition and nature of COIs. 15,16 One potential solution to improve the content of disclosures may be for professional societies to provide authors with a link to the Open Payments database and explicit instructions to every presenter to review the data. Perhaps organizers can prepopulate a list of COIs extrapolated from the public database and ask each speaker to either confirm or dispute the payment, with justification, before their presentation.…”

“…This online database was previously used to cross-reference self-reported COIs by other specialties to look for discrepancies. 15,16 Binomial and Poisson regression evaluated end points as appropriate for P values and odds ratios (ORs); for changes over time, the year was treated as an independent variable. All statistical analysis was performed using R, version 3.2.2.…”