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Conflicts of Interest in Guideline Development: What to Do When Everyone Has a Conflict

Anne R. Bass, MD  |  Issue: March 2023  |  March 12, 2023

At the ACR, guideline voting panels are independent of the core team leading guideline development, allowing for a layer of independent review.5 The principal investigator must be free of COI for at least one year prior to submission of their letter of intent, and no more than 49% of team members can have a COI. Individuals directly employed by commercial interests cannot participate.

Although, in an ideal world, no member of the guideline team will be conflicted, in a field as small as rheumatology this is often not possible.

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Disclosure, an Imperfect Solution

ACR policy is that guideline project development group members, and others who contribute intellectually to the guideline development effort, must disclose all information regarding their relationships, including any possible COI, financial or otherwise. However, investigators don’t always disclose all payments.

In a study that used the Open Payments Database to analyze COI among authors of ACR clinical practice guidelines published in 2014, 36% of payments relevant to the guideline ($699,561 out of $1,961,362) went undisclosed.6 The ACR now provides reminders and links to the Open Payments Database as part of the disclosure process to help address this issue.

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Ironically, some studies suggest that disclosure can actually lead to more biased recommendations. Two mechanisms are proposed: 1) strategic exaggeration (i.e., the tendency to provide more biased advice to counteract anticipated discounting) and 2) moral licensing (i.e., the often unconscious feeling that biased advice is justifiable because the audience has been warned).7

Educating guideline teams about such issues as confirmation bias is an important component of COI management. Parker and Bero, in a review of COI in clinical practice guideline development, recommend using predetermined criteria to assess and respond to the risk of bias in the interests of prospective members. They use this principle as a guide in the formation of the clinical practice guideline teams, but provide little guidance on how to manage conflicts during the actual process of guideline development.3 This may be less important in such fields as cardiology in which the pool of experts is large and conflicted members can be excluded from guideline panels, but in rheumatology, managing COI over the entire arc of guideline creation is needed.

At the ACR, “disclosure of relationships and management of potential or real COI are important at every level from prioritizing topics and selecting projects, through development and approval of final papers.”5 In practice, however, it is easy to lose track of COI over the long process of guideline development, which can take more than two years.

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Filed under:Clinical Criteria/GuidelinesEthicsProfessional Topics Tagged with:Conflict of interest

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