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Most authors of endoscopy practice guidelines have undisclosed financial conflicts

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Comment from AGA

The authors bring awareness to an important issue. Conflict of interest (COI) in guideline development has received a lot of attention over the past few years. COI, whether actual or perceived, can lead to mistrust of recommendations, limit uptake and dissemination of guidelines, and possibly lead to low-quality care.

As part of the AGA Institute’s mission, the Clinical Guidelines Committee (CGC) is charged with advancing the practice of gastroenterology through developing clinical practice guidelines that promote high-quality, evidence-based care. In accordance with the National Academies of Medicine (formerly Institute of Medicine) report for trustworthy guidelines, the CGC’s COI policy is in agreement with the following standards: more than 50% of guideline members have no financial COI, the methodologist cochair is completely free of COI, and the guideline cochair has no direct clincal practice guideline–relevant financial COI.

Guidelines developed by the AGA CGC are informed by a technical review or evidence synthesis. All panel members considered for the technical review and guideline panel must go through a stringent vetting process, which includes completion of a comprehensive COI disclosure form. All authors are asked to report any financial and intellectual interests from the past 3 years including stocks/stock options, speaking engagements, board and committee memberships, legal testimony, research grants, employment, patents, or intellectual property. A review of the Centers for Medicare & Medicaid Services Open Payments database is also performed. Open Payments is a national disclosure program and public database established in 2014 that reports financial relationships and lists any payment or gift to U.S. health care providers (physicians and teaching hospitals) valued at more than $10. While the AGA strives to form technical review and guideline panels that are free from financial and intellectual COI, technical review panels may, on occasion, include recognized clinical experts who have relationships deemed to be manageable because technical review authors serve as content experts and do not contribute to the actual recommendations in the guideline.

Furthermore, all official journals of the AGA Institute adhere to the standards set forth by the Committee on Publication Ethics and the International Committee of Medical Journal Editors. As such, at the time of publication, a uniform detailed self-report disclosure form is used to publicly disclose all relevant financial and nonfinancial COIs.

In light of the negative impact of perceived COI, substantial efforts have been made by professional organizations and medical editors to ensure proper disclosure of conflicts and the AGA CGC committee strengthened its COI policy further in 2018. The AGA CGC is committing to minimizing panel members with financial and nonfinancial COI and ensuring adequate disclosure and management of COI when present.

Shahnaz Sultan, MD, MHSc, AGAF, chair of the AGA Clinical Guideline Committee, and Yngve Falck-Ytter, MD, AGAF, chair emeritus of the AGA Clinical Guideline Committee.


 

REPORTING FROM DDW 2019

– Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Dr. Samir Grover, a gastroenterologist at the university of Toronto

Dr. Samir Grover

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

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