Conflicts of Interest in Guideline Formation

Clinical practice guidelines (CPGs) are usually adopted as standard of care and taught as such in training programs for healthcare providers. CPGs are important in the development of initiatives to improve quality of care and are playing an emerging role in national policy on reimbursement; CPGs also serve as the standard of care in medical malpractice cases. Citing the potentially adverse effect of conflicts of interest (COIs) and improper bias during the formation and production of CPGs, researchers recently conducted a review to evaluate the scope of COIs in the production of cardiology guidelines. They examined the 17 most recent guidelines from the American College of Cardiology/American Heart Association (ACC/AHA) through 2008. Results of the review were reported in Archives of Internal Medicine [2011;171(6):577-584]. The most recent CPGs from the ACC/AHA require documented disclosures of COI, including a list of the companies and institutions involved in each COI for each author and reviewer. Each COI is sorted into at least 4 categories: receipt of research grant; receipt of honoraria or being on a speaker’s bureau (honoraria/speaker’s bureau); owning stock or having other type of ownership (stock/other ownership); or being a consultant or member of an advisory board. The guidelines also indicate whether a COI is moderate (≤$10,000) or significant (>$10,000). For purposes of the review, the researchers defined episode as 1 instance of participation in the production process of 1 guideline by 1 person. The term individual was defined as 1 person who may be involved in multiple different episodes in different guidelines. Individuals were characterized as author or reviewer and were identified as first author, chair, or cochair. Company was defined as a unique commercial industry affiliation reported by an individual in a single episode. COI was defined as 1 reported affiliation causing 1 COI by 1 individual participating in 1 guideline. In the 17 guidelines, the analysis identified 651 episodes of participation by 498 individuals. Each individual participated in an average of 1.31 episodes (range, 1-7). Overall, 277 of the 498 individuals (56%) reported a COI. More than half of the episodes (56%, n=365) involved a COI. The most common type of COI was being a consultant or a member of an advisory board. The next most common were receipt of a research grant, honoraria/speaker’s bureau, and stock/other ownership. The analysis found an association between episodes in which at least 1 COI was reported and individual guidelines (P<.001). The percentage ranged across guidelines, from 13% (2 of 15 episodes) to 87% (13 of 15 episodes). The percentage of individuals reporting a COI was higher among individuals with more episodes of participation, and the number of episodes of participation was associated with both presence of COIs (P<.001) and number of COIs (P<.001). There were 510 unique commercial companies involved in the 17 guidelines; there were only 18 unique noncommercial organizations reported to be involved in COIs. The analysis identified the commercial company involved in the greatest number of COIs in each guideline; one specific company was reported by more individuals than any other company in 7 of the 17 guidelines. Of the guidelines analyzed, 6 included information characterizing COIs as modest versus significant. In those 6, there were 232 episodes, of which 150 involved COIs. The COIs were reported as moderate in 54% of the episodes (125 of 232); significant COIs were reported in 29% of the episodes (68 of 232). In summary, the researchers commented that “conflicts of interest are prevalent in cardiology guidelines, but there seems to be a significant number of experienced experts without COIs.”