The Clinical Guidelines Committee (CGC) of the American College of Physicians (ACP) has released a new comprehensive policy guideline describing the methods used by the organization to collect disclosure of interests (DOI) and conflicts of interest (COI) from authors of clinical guidelines and guidance statements. In the paper, the ACP writing committee discuss their updated policies regarding required time frames for reporting health care-related DOI, the process of collecting DOI, which disclosures are mandated, review processes of DOI and COI, as well as the grading system of COI.
Guidelines for DOI
The CGC mandates any potential participant in a clinical guideline from the ACP, including members of the CGC, persons associated with systematic reviews commissioned by the organization, ACP staff, and any guest attending a CGC meeting or conference call to complete and maintain disclosures throughout the development of the guidance statement. Externally funded evidence reviews, however, follow the processes for DOI and COI collection of the funding entity rather than the CGC policy.
Disclosures should be reported and collected throughout all phases of guideline development, the committee reports, in an effort to ensure accurate management of interests. Prior to engaging in any CGC work, prospective authors are required to complete a DOI form, and ACP staff ask participants to review and update the initial DOI summary report several times during guideline development. Reports of all active and inactive financial and intellectual DOI related to health care are required. With regard to time frames, participants contributing to a clinical guideline from the ACP are required to report all health care-related interests from the previous 3 years.
The ACP uses a structured electronic format that contains categorical prompts to capture DOI for authors of guideline articles. The ACP also provides publicly available DOI forms for committee members on the organization’s website.
Collection and Management of COI
In their paper, the CGC describes their DOI-COI Review and Management Panel, which consists of the CGC chair, vice chair, and ACP staff. During the Panel’s review process, at least 2 associates independently review DOI for potential COI. When identified, potential COI are brought to the chair, vice chair, and vice president, which facilitates further assessment and discussion and an ultimate decision for management of disclosures.
The intensity of the COI and DOI “management strategy is proportional to the seriousness of the conflict because not all conflicts present an equal level of threat to the clinical guideline development process.”
A 3-tiered grading scheme was developed by the CGC to categorize COI into levels of significance. High-level COI include any active financial or other relationship with a high-risk entity — such as a pharmaceutical, biotech, or medical device company — that has a financial stake in the guideline’s clinical conclusions. Moderate-level COI include any intellectual interest that has a clinical relevancy to the topic of the guideline and that may make a guideline vulnerable to cognitive biases. Low-level COI are considered any inactive high-level conflict, which is defined as a high-level relationship that was terminated within the previous 3 years.
Candidates with high-level COI are prohibited from participating in guideline development. To manage high-level COI, these potential contributors are advised to release the interest either through divestment or through discontinuation of the association. Once the relationship is severed, the COI is downgraded to low level and the author’s restrictions are lifted. These candidates may also opt to restrict current and future involvement with the interest during the period in which the clinical guideline is in development. Participants with moderate-level COI are subject to partial restrictions, including limited involvement in discussions but prohibition from voting and authorship.
The committee adds that any involvement with work that is conducted on behalf of ACP, either as staff or as an appointed representative, should not be considered COI. Also, interests that were terminated more than 3 years prior to involvement in the guideline development are not considered COI. Employment with nonprofit organizations, except those involved in disease advocacy, are also not considered COI in the setting of development of clinical guidelines or guidance statements.
In September 2015, the CGC implemented the revised policy, which was subsequently approved in May 2018 following piloting and updates. The committee reported no interruptions to their workflow when the policy was implemented, and members of the CGC were receptive to implementation of the policy.
Disclosure: None of the study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Qaseem A, Wilt TJ; for the Clinical Guidelines Committee of the American College of Physicians. Disclosure of interests and management of conflicts of interest in clinical guidelines and guidance statements: methods from the Clinical Guidelines Committee of the American College of Physicians [published online August 19, 2019]. Ann Intern Med. doi: 10.7326/M18-3279