Background: Conflict of interest (COI) disclosure and management are essential factors for transparency in development process of clinical practice guidelines (CPGs). In 2011, Institute of Medicine (IOM) published 'Standards for Developing Trustworthy Clinical Practice Guidelines”'in Clinical Practice Guidelines We Can Trust which offered the management perspective of COI. In 2015, Guidelines International Network proposed 'Principles for Disclosure of Interests and Management of Conflicts in Guidelines'.
Objectives: To clarify COI disclosure and management situation in Japanese CPGs
Methods: CPGs published between 2011 and 2016 were evaluated by the CPG evaluation group using the Appraisal of Guidelines for Research & Evaluation II Instrument (AGREE II). AGREE II is composed of six domains consisting 23 items and overall assessment. In this study, we focused on the sixth domain, Editorial Independence based on the item 22 (funding body) and the item 23 (competing interest). In addition, we analysed how COI disclosure and management were described.
Results: The mean scores (0-100%) of Editorial Independence domain by publication date were as follows: CPGs published in 2011, 29% (n=78); CPGs published in 2012, 27% (n=76); CPGs published in 2013, 34% (n=80); CPGs published in 2014, 39% (n=92); CPGs published in 2015, 44% (n=78); and CPGs published in 2016, 59% (n=37). In all evaluated CPGs, the mean scores (range 1-7) of the item 22 and the item 23 was 3.3 and 2.8, respectively. In the way of COI disclosure, there was a tendency to describe the related company names unlinked with names of guideline development group member. Almost all CPGs did not describe the management of COI in the development process.
Conclusions: This study revealed that description regarding COI disclosure in Japanese CPGs has been improved during the past five years. However, the management of COI in CPGs development process still remains a big issue. Further studies on CPGs development process are necessary for guideline development groups to manage COI better.