Conflict of interest policies in practice guideline development: a systematic survey of published guidance

Article type
Authors
Khabsa J1, Itani Z2, Noureldine HA3, Nonino F4, Khamis MM5, Bejjani J6, Schünemann HJ7, Akl EA8
1Clinical Research Institute, American University of Beirut Medical Center
2Department of Epidemiology and Population Health, Faculty of Health Sciences, American University of Beirut
3Faculty of Medicine, Lebanese American University
4IRCCS Institute of Neurological Sciences of Bologna
5Faculty of Medicine, Fayoum University
6Faculty of Medicine, American University of Beirut
7Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University; Department of Medicine, McMaster University
8Department of Internal Medicine, American University of Beirut
Abstract
Background: Conflict of interest (COI) can influence different steps of the guideline development process, from topic selection to that of guideline dissemination. In 2011, the Institute of Medicine (IOM) published standards for trustworthy clinical practice guidelines, focusing on the importance of COI recognition and management in the guideline development process.
Objectives: To survey guideline development guidance regarding their COI policies, including disclosure, management and reporting.
Methods: We included guidance documents and COI policies related to guideline development. We compiled a comprehensive list of guideline-producing organizations using multiple sources. We searched for the organizations’ guidance documents and policies on their websites, Pubmed, using Google, and reviewing the references lists of relevant articles. Two reviewers assessed the organizations and documents for eligibility, and abstracted data on organizations’ characteristics and COI policies, including disclosure of relationships of interest, verification of disclosures, assessment of the risk of COI, management of those conflicts, and their reporting.
Results: We identified a total of 137 guideline-producing organizations, of which 96 had a COI policy, either in the form of a non-brief section in their guideline development guidance (64%), or as separate dedicated document (36%). The median date of last update of the COI policies was 2017 (IQR: 2015 – 2018). A disclosure form was made publicly available by 50% of organizations. The vast majority of organizations required panelists to disclose their relationships of interest (90%), followed by executive committee, oversight committee, or board (38%), peer reviewers (40%), and outside experts, consultants and presenters (26%). Only 20% of organizations mentioned disclosure by systematic reviewers and/or methodologists.
Assessment of risk of COI was mentioned by 50% of organizations. However, only 25% of the total sample provided details on the criteria considered and/or the method of doing so. Most common management strategies were exclusion from the group (63%), from discussion (40%), and from voting (40%). Very few organizations addressed COI management issues related to the systematic review (SR) process, which included exclusion of conflicted individuals from the SR process, restrictions during participation in the SR process (e.g. exclusion from performing evidence selection, verification by another group member, recusal from assessment of the quality of the evidence). The majority of organizations mention publicly reporting on their COI (73%). Very few explicitly mention reporting on amount of COI (3%), and 25% report on the method of evaluation and and management of COI.
Conclusions: There is large variability in how guideline-producing organizations handle COI. While most address requirements related to panelists and management issues related to developing recommendations, very few specifically address the SR team and the SR process.
Patient or healthcare consumer involvement: None.