Financial Disclosures Reported by Industry Among Authors of the American Academy of Ophthalmology Clinical Practice Guidelines

Abstract

ImportanceRecommendations of clinical guidelines affect physicians’ care delivery. Potential bias and undeclared conflicts of interests (COIs) among guideline authors can impact clinical practice decisions.ObjectiveTo assess financial disclosures reported by physician authors of the American Academy of Ophthalmology (AAO) Practice Pattern Guidelines compared with those reported by industry to evaluate the disclosures’ accuracy.Design, Setting, and ParticipantsIn this cross-sectional study, all clinical guidelines in the AAO Preferred Practice Patterns (PPP) since 2013 (first year with publicly available industry payment reports) were reviewed on May 1, 2022. Guideline physician authors’ name and their reported COI disclosure were extracted from the guideline publication. Payments to physician authors reported by industry were retrieved from the US Centers for Medicare & Medicaid Open Payments database. Physician authors serving on the AAO guideline committee were included.Main Outcomes and MeasuresThe primary outcome measure was the accuracy of authors’ COIs disclosure. Secondary outcome measures were payments to physician authors reported by industry, the types of payments, and authors’ gender.ResultsA total of 24 AAO guidelines released between 2016 and 2020 were included. Per guideline, there was a mean (SD) of 7.83 (2.24) physician authors. After removing 14 nonphysician authors, 188 physician author names remained, including 83 names assigned as women (44.1%) and 105 names assigned as men (55.9%). Authors could be counted multiple times in these 188 names. According to the Open Payments database, industry reported that 112 of 188 physician authors (59.6%) had at least received 1 payment while serving on the guideline committee, with a payment mean (SD) of $29 849.35 ($54 131.56). According to AAO guidelines, 149 authors (79.3%) had no financial disclosures while serving on the guideline committee. Among these 149 authors, most authors (81 [54.4%]) had payments reported by industry on the Open Payments database not disclosed within the guideline reports. Women physicians were paid significantly more than men for total payments (median [IQR] payments, $15 265 [$598.47-$41 104.67] vs $301.48 [$218.85-$14 615.09]; difference, $14 963.52; P = .003).Conclusions and RelevanceIndustry reported physician guideline authors to have received significant industry payments, some of which were not disclosed within information of the guidelines. To strengthen author transparency regarding these reported disclosures, the authors may want to review and resolve such potential discrepancies during the review and subsequent publication of guidelines.

Challenges of Assessing Disclosure Accuracy—All We Have Is Our Integrity

“…So it would appear disappointing that, as Nyugen et al report in JAMA Ophthalmology , based on a comparison with data published in the CMS Open Payments website, a large percentage of the authors of 24 American Academy of Ophthalmology (AAO) clinical practice guidelines published between 2016 and 2020 failed to disclose their financial interests accurately or at all in connection with guideline development. The study authors point out that practice guidelines (AAO terms them preferred practice patterns ) can directly impact patient care, making the importance of transparency on the part of guideline authors all the more critical.…”

“…The Open Payments website is the most easily accessible source of data on physicians’ payments from medical device and drug manufacturers. As Nyugen et al observe, Open Payments has limitations. However, given its wide scope and easy accessibility, those for whom disclosure is critical have little excuse for failing to consult it, whether as authors required to disclose their interests, or as publishers and trusted authorities, such as specialty societies, that need to carry out and enforce disclosure standards.…”

American Academy of Ophthalmology Clinical Practice Guidelines and Financial Disclosures—Where Is the Money Going?

“…To the Editor We would like to commend Nguyen et al on their excellent study investigating the financial disclosure practices among male and female physicians. The authors use rigorous methodology in their acquisition, analysis, and interpretation of their data.…”

“…Therefore, we encourage the researchers to use gender identification that is self-reported, which can be found in reputable databases, such as the NPI. Furthermore, other available variables in the NPI data set, such as terminal degree (MD or DO) or current geographic location, could have been used as covariables in the study to account for variability in payments that results from factors other than gender and strengthen the validity of the reported findings. Of note, additional data sets provided by the federal government, such as the National Downloadable File data set, can be linked to the NPI data set to include additional covariables, such as year of medical school graduation.…”

American Academy of Ophthalmology Clinical Practice Guidelines and Financial Disclosures—Where Is the Money Going?—Reply

“…Despite its limitations (gender not considered as a spectrum and not self-reported genders), Gender API is widely used in research due to its high accuracy . In our study, Gender API determined the gender of 188 author names: 83 were assigned as women (44.1%) and 105 were assigned as men (55.9%) . To follow the recommendations made by Tinsley et al, we manually reviewed the self-reported gender of authors on the National Provider Index (NPI).…”