Conference Coverage

Most authors of endoscopy practice guidelines have undisclosed financial conflicts

View on the News

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


“The prevalence of conflicts of interest in the form of industry payments among physicians is well described in academic literature. A number of studies, including several from our group, have found there is a high burden of these payments among authors and chairs of CPGs in various therapeutic areas,” commented senior author Samir Grover, MD, a gastroenterologist at the University of Toronto. “Additionally, the existing literature has shown that many of these payments go undisclosed in the CPG themselves. This is concerning. Although the presence of these payments doesn’t necessarily indicate any obvious wrongdoing on the part of the recipients, it can undermine public and professional trust in guidelines.”

In its 2011 report, the National Academy of Medicine outlined three criteria for trustworthy guidelines. These include ensuring that committee chairs do not have financial conflicts of interest (COIs), limiting authors who do have financial COIs to less than half of the guideline drafting panel, and disclosing financially motivated relationships between individual health care providers and members of industry. “To our surprise, our findings demonstrated that none of the CPGs we identified met all of these criteria,” noted Dr. Grover, adding that “this finding highlights the importance of accountability at both the contributor level (to ensure conflicts are appropriately declared) and at the level of the sponsoring society (to ensure that guideline committee members and chairs are selected a priori for reasons that include impact of conflicts).”

Dr. Rumann and his colleagues conducted a cross-sectional study, including all endoscopy-related CPGs from AGA and ASGE published from 2014 through 2017. They performed a manual reconciliation between financial COIs disclosed in CPG documents and those reported in the Open Payments database maintained by CMS, which includes data from August 2013 to December 2017. “We decided to focus on CPGs of relevance to endoscopy, as the majority of the work to date has revolved around pharma and not devices, a potentially significant other source for industry payments to physicians,” explained Dr. Grover.

In the Open Payments database, payment types are recorded as general payments, research payments, or ownerships or investments. For each payment transaction, the type, amount, and date of payment are recorded, as is the payer.

In all, 91 individuals appeared as authors 581 times. The median number of CPGs per author was 2 with a range of 1-26.

About 80% of authors had payments reported in the Open Payments database. Though Dr. Grover acknowledged that reporting errors may exist in the Open Payments database, this fact, he said, “highlights the need for greater involvement of physicians in correct declaration of their payments.”

Among the guideline authors, 119 (20.5%) had originally disclosed general payments. However, more than three times that many authors had undisclosed records of general payments that showed up in the Open Payments database query. In all, 399 authors (68.6%) had received general payments, according to the database.

Though all 12 of the ownership or investment payments seen on Open Payments were disclosed, just 40 of 74 research payments were disclosed, said Dr. Rumann and coauthors.

“Given the potential impact of these undisclosed payments on CPGs, stricter policies on conflict of interest disclosures are needed,” they wrote.

When asked whether he would expect change to come from the findings, Dr. Grover replied, “First and foremost, we want to increase the awareness of the issue, among both the health professions and the public. While we believe that more research into COI in general is required, our study, along with similar papers in the field, show that CPGs authors need to be more cognizant of declaration of potential conflicts. In addition to being hopeful that readers of the article will be prompted to exert more diligence in tracking and declaring any payments they have received, we are hopeful that sponsoring societies self-regulate the membership of CPG committees and the choice of chairs in accordance with established criteria to mitigate conflicts.”

Dr. Rumann and other coauthors reported no conflicts of interest. Senior author Samir Grover, MD, reported financial relationships with several pharmaceutical companies.

koakes@mdedge.com

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

Next Article: