The American College of Physicians recently described its methods for developing clinical guidelines and guidance statements, in a paper published in the Annals of Internal Medicine.
Dr. Robert McLean
The ACP’s Clinical Guidelines Committee (CGC) "aims to disclose all health care–related interests and manage conflicts in a manner that is transparent, proportional, and consistent. Any person involved in the development of an ACP clinical guideline or guidance statement must disclose all financial and intellectual interests related to health care from the previous 3 years,” Amir Qaseem, MD, and Timothy J. Wilt, MD, wrote.
“The goals of our process are to mitigate any actual bias during the development of ACP’s clinical recommendations and to ensure creditability and public trust in our clinical policies by reducing the potential for perceived bias,” noted Robert M. McLean, MD, president of the ACP, in a statement.
This paper’s publication comes on the heels of authors of a Cancer paper having reported that nearly 25% of the American Society of Clinical Oncology’s guideline authors who were not exempt from reporting conflicts of interest failed to disclose receiving industry payments.
The ACP committee’s guiding principle for collection of disclosures of interest and management of conflicts of interests “is to prioritize the interests of the patient over any competing or professional interests via an evidence-based assessment of the benefits, harms, and costs of an intervention,” wrote the authors on behalf of the CGC.
The CGC created a tiered system to classify potential conflicts as low level, moderate level, or high level based on three tenets: transparency (all disclosures are freely accessible so readers can assess them for themselves), proportionality (not all conflicts of interest have equal risk), and consistency (policies should be impartially applied across all variables).
Examples of low-level conflicts of interest (COIs) include high-level COIs that have become inactive and intellectual interests tangentially related to the topic under discussion. Moderate-level COIs are usually intellectual interests clinically relevant to the guideline topic; these interests might prompt an individual to seek professional or financial advantages through association with guideline development.
High-level COIs are active relationships with high-risk entities, defined by the CGC as “an entity that has a direct financial stake in the clinical conclusions of a guideline or guidance statement.”
While the time frame for reporting health-related interests is 3 years, disclosure is an ongoing process when clinical guidelines are in development because interests change over time, the authors said. Prospective guidelines committee members complete disclosure of interest forms before working on CGC projects, and they update these forms before each in-person CGC meeting.
“The CGC’s policy does not mandate disclosure of interests related primarily to personal matters or relationships outside the household,” such as political, religious, or ideological views, they noted.
The CGC maintains a DOI-COI Review and Management Panel to reviews conflicts, and all ACP guidelines include a list of relevant conflicts for committee members.
The authors of this paper disclosed no conflicts of interest.