Background: There is no common agreement on conflicts of interests (COI) definition, disclosure and management. As a result, the understanding of COI and how it should be declared and managed differs among authors, reviewers and editorial boards. In addition, although most of the organisations involved in guideline development have policies for COI disclosure to ensure transparency, it is not clear how these policies are integrated in the process of making recommendations to ensure guideline trustworthiness.
Objective: To develop a tool for COI disclosure and management in clinical practice guidelines.
Methods: We conducted a systematic literature review panel with experts from different areas, and online Delphi rounds. Among experts, we included guideline developers, bioethicists, lawyers, clinicians and representatives from the Brazilian Health Surveillance Agency and the Brazilian Ministry of Health.
Results: We defined COI as "divergences between interests and obligations of an individual so that an observer may question whether his/her actions or decisions are motivated by explicit, latent, or potential benefits or influenced by his/her convictions or beliefs, thus precluding an unbiased performance of his/her functions". We provided definitions for financial and non-financial COI, as well for direct and indirect conflicts. We developed a COI disclosure form with 11 items, including questions related to financial, intellectual and ideological COI. In addition, strategies for active search of COI were proposed. In the framework, COI are assessed for each guideline question and classified in four levels (high, moderate, low, and no impact), according to the probability of resulting in biased judgment by the participant. We suggested, in the framework, avoiding a guideline chair with high or moderate COI for any questions and to limit the involvement of methodologists and panel members to questions in which they do not have high or moderate COI.
Conclusions: We developed a comprehensive framework for disclosure and management of COI in guidelines. So far this framework has been used in a scoping meeting for the development of one guideline.