Elsevier

Journal of Surgical Research

Volume 218, October 2017, Pages 18-22
Journal of Surgical Research

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

https://doi.org/10.1016/j.jss.2017.05.037Get rights and content

Abstract

Background

The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD versus self-reported conflicts of interest (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 January 2014 to June 2016. Author and OPD-disclosed COIs 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 article) 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 article, P < 0.001). Percentages of authors within each disclosure category differed between specialties (P < 0.001). Hematology articles 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.

Introduction

Financial relationships between healthcare workers and industry are prevalent in the United States. Self-disclosed conflicts of interest (COI) have been associated with the publication of favorable articles, defined as articles conveying a positive impression of a product produced by a company having an affiliation with at least one author. This bias influences the opinions and decisions of healthcare providers and patients.1, 2, 3, 4, 5

Until 2010, COI among healthcare providers depended entirely on self-disclosure as no reliable method existed to verify conflicts. The Physician Payments Sunshine Act was recently enacted to increase the transparency of relationships between clinicians and industry and led the Centers for Medicare and Medicaid Services to establish the Open Payments Database (OPD) Web site.6 The OPD reports financial transactions between manufacturers, group purchasing organizations, and physicians and hospitals. As a result of the establishment of the OPD, annual payments to physicians per specialty have recently become available.

Compliance with the Sunshine Act costs $180 million annually. This burden will inevitably be transferred to patients and providers.7 Despite this expense and effort, it remains to be determined what OPD adds to the current system of self-disclosure. Few objective methods currently exist to evaluate the accuracy of the OPD. Our aims were (1) to compare industry-reported COI (e.g., OPD) with self-disclosed COI by published authors in the medical and surgical literature and identify if there are differences between the two sources of COI disclosure, (2) to compare financial payments received within each level of disclosure and assess for any associations with amounts of payments, and (3) to compare industry-reported COI, self-disclosed COI, and financial payments by specialty to identify any fields disproportionately affected by COI.

Section snippets

Search strategy

PubMed was searched for studies in the medical and surgical literature accepted for publication between January 2014 and June 2016. These publication dates were chosen because they represent time points during which at least 6 mo of OPD information is available for each author. Five specialties or subspecialties listed on the Accreditation Council for General Medical Education8 were randomly chosen using a computer-generated random number generator. The search terms used for the five

Results

More than 1200 articles were screened, chosen in chronological order from most recent to oldest per a PubMed search by the designated search term, to identify 500 articles (100 per category) that met the inclusion criteria. Exclusions included articles with authors primarily affiliated with institutions outside the United States (n = 588), letters/commentaries (n = 143), and inability to access full text (n = 17).

Among 500 articles, 333 articles (66.6%) met criteria for COI. Among all authors (n

Discussion

Financial relationships are common between medical practitioners and industry.10, 11, 12, 13, 14 In this study, approximately two-thirds of published articles and one-fourth of the published authors across the medical and surgical literature had a monetary interaction that qualified as a COI. Our data demonstrate that the majority of authors with a COI had self-disclosed COI that differed from industry-reported COI listed in the OPD. These results support the suspicion that discordant reporting

Conclusions

The overall discordance rate among articles for author self-disclosure versus industry COI disclosure on the OPD among the sampled literature was 65.0%. Issues with COI disclosure were found to affect all the medical and surgical specialties examined. Further research is needed to determine the impact of this discordance on research outcomes and if standardized, evidence-based guidelines for COI disclosure across scientific journals are needed.

Acknowledgment

None.

This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award (grant number UL1 TR000371) and the National Center for Advancing Translational Sciences (grant number KL2 TR000370). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health. These organizations

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Appendices: None.

Contributorship statement: No other contributors.

Human and animal rights: This work did not directly involve the use of human or animal subjects.

Ethics committee approval: No humans were directly involved in this study.

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