NEW YORK (Reuters Health) – The American College of Physicians (ACP) has a comprehensive process for disclosing interests and managing potential conflicts of interest for any person involved in the development of an ACP clinical guideline or guidance statement.
“A rigorous and high-quality process for disclosure of interests and management of conflicts of interest is a critical component of a trustworthy guidelines program,” Dr. Amir Qaseem from ACP, Philadelphia, Pennsylvania told Reuters Health. “ACP’s process is based on three tenets: transparency, proportionality, and consistency.” [email interview]
Dr. Qaseem and colleagues on ACP’s Clinical Guidelines Committee (CGC) detail their methods in their August 20th Annals of Internal Medicine online report.
The guiding principle of the CGC is to prioritize the interests of the patient over any competing or professional interests by providing an evidence-based assessment of the benefits, harms, and costs of an intervention.
Any potential participant in work related to ACP clinical guidelines must report any health care-related interests in the previous 3 years and must continually update such interests throughout the development of a clinical guideline.
A Disclosure of Interests (DOI)-Conflicts of Interest (COI) Review and Management Panel independently reviews disclosures for potential conflicts and brings flagged interests to the panel for further discussion.
A high-level COI includes any active relationship with an entity that has a direct financial stake in the clinical conclusions of a guideline or guidance statement. Participants with a high-level COI can either release the interest through divestment or discontinue the association or, if unwilling or unable to do so, are restricted from further involvement in development of the clinical guideline.
Participants with a moderate-level COI (most commonly an intellectual interest that is clinically relevant to the guideline topic) can participate in committee deliberations but are not eligible to serve as an author or to vote on final approval of the guideline or statement.
A low-level COI includes any inactive high-level COI or intellectual interest that is only tangentially related to the topic under discussion. Participants with low-level COIs have no role restrictions and may participate in discussions, serve as authors, and vote on recommendations.
All ACP clinical guidelines and guidance statements include a summary of management of COIs that lists conflicts and describes any role restrictions related to moderate- or high-level conflicts for committee members who participated in the development of the guideline or guidance statement.
“It is important to understand that our process is quite different from most organizations, which tend to take the route of asking individuals to simply themselves decide if there are any financial conflicts to disclose or take the next step asking to disclose financial conflicts of interests,” Dr. Qaseem said. “ACP asks all participants to disclose all interests related to health care, and includes financial and intellectual – not limited to just disclosing conflicts of interests. In addition, we are asking for disclosures for anyone living in the same household as (that) of a participant in a project.”
“ACP believes that COIs can influence judgement, and robust management of conflicts is needed to ensure fidelity to the evidence and trustworthiness in a guideline,” he said. “It is also important to understand that there is no difference between actual bias or perceived bias, and our goal is to be fully transparent.”
Ann Intern Med 2019.