Thursday, August 6, 2020

New Systematic Review Suggests Noncordance with COI Disclosure to Reporting Databases is Widespread, but Methodological Quality of Studies is Variable

Disclosure of conflict of interest (COI) is a major point of concern in the development of guidelines as well as original research papers. Over the years, multiple studies have aimed to elucidate just how closely the disclosures of individual authors tracks with their reported COI in open databases. A new systematic review of 27 such studies, recently published online in the Journal of Clinical Epidemiology, compiles the findings of these studies into some eyebrow-raising statistics while also taking a look at the methodological quality of these studies.


In their review, El-Rayass and colleagues found that although the methodological quality for assessing the concordance of authors’ COI disclosures within papers and according to public databases varied widely, a median of 81.2% of authors across 20 studies had “noncorcordant” disclosures, (ranging from 41.8% to 98.6% across all studies) and that more than half (43.4% of all authors) of these were “completely nonconcordant” (ranging from 15% to 89.5% across all studies). What’s more, among seven studies that analyzed company reporting on the individual level, between 23.1% and 85.4% of companies did not report their payments to authors.

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For the five studies that analyzed disclosures on the study rather than the individual author level, all found at least some degree of discordance between in-study disclosures and database reports. The rate of nonconcordant disclosures among these studies ranged from 6 to 92.6%


The authors note that ulterior motives of authors are just one potential explanation for the high observed rate of nonconcordant COI disclosure and reporting. Vague instructions and parameters set by journals during the article submission process may undermine efforts to transparently report any and all potential sources of conflict, be they financial, intellectual or otherwise. In addition, the authors found that studies of COI reporting that tended to have higher methodological quality also tended to report lower estimates of nonconcordance, meaning that the overall combined estimates may be artificially inflated – for instance, due to some studies not making a distinction about the relevancy of potential COI sources to the topic of the articles analyzed. The authors note potential sources of nondirectional error as well, such as how differences in COI categories between in-paper disclosures and reference databases were handled, which additionally lowers confidence in the current estimate.

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In sum, the recent review by El-Rayess et al. points out that issues with concordance between authors’ COI disclosures in their published works seem to be at odds with publicly available reports of these relationships; however, the degree of nonconcordance overall is still uncertain. Those looking to complete future analyses of COI disclosure policies may want to use this paper as a roadmap to improving our certainty in the actual magnitude of the issue.

El-Rayess, H., Khamis, A.M., Haddad, S., Ghaddara, H.A., Hakoum, M., Ichkhanian, Y., Bejjani, M., and Akl, E.A. Assessing concordance of financial conflicts of interest disclosures with payments' databases: A systematic survey of the health literature. J Clin Epidemiol 127:19-28.

Manuscript available at the publisher's website here.