How to manage conflicts of interest in guideline development remains unclear

Jun 7 2012

By Sarah Guy

Setting an ethics framework could be useful to identify and manage conflicts of interest (COIs) in the context of developing clinical practice guidelines (CPGs), suggest researchers.

Their results indicated agreement among experts that the CPG development process should be transparent, but they also revealed "ethical uncertainty on how best, beyond disclosure, to manage COIs in CPG process."

Alan Barkun (McGill University Health Center, Montreal, Quebec, Canada) and team addressed the question of whether medical experts with COIs should be included, excluded, or limited from deliberating, drafting, or voting in CPG process in the context of an international consensus meeting to formulate a CPG for gastrointestinal bleeding.

A total of 34 experts were involved in the meeting, which followed Canadian national CPG standards, and the ethical recommendations of the Canadian Association of Gastroenterology and the Canadian Medical Association.

However, these national bodies gave limited guidance on how to manage COIs among global experts, remark Barkun and colleagues in the Annals of Internal Medicine.

The team developed an ethics framework including such "tools" as transparency in financing and decisions, disclosure of COIs, and firewalling information, and experts with COIs were invited to recuse themselves from discussing recommendations, but joined their peers at the voting stage.

"Votes would be tracked and those of recused experts could be discounted if 'conflicted' votes would determine the outcome of a recommendation," the researchers explain.

In all, 62% of experts reported at least one financial COI, and eight of the 21 recommendations that emerged from the CPG discussions were "at risk" for financial COIs. Experts with COIs removed themselves from six of these discussions.

Despite this, an average of 22 nonconflicted experts - a majority - discussed each recommendation, and the overall voting outcomes (agree vs disagree) did not change when votes of recused members were excluded.

In a post-voting ethics session, experts acknowledged the importance of addressing financial COIs, but also raised concerns. One of the 34 experts said: "I think the quality of our discussion was diminished by muzzling participants with important expertise."

How to optimally "balance the values of impartiality and expertise" remains unanswered, conclude Barkun et al; however, frameworks, interdisciplinary analysis, and international policy initiatives are recommended.

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