ISQUA17-3274PATIENT AND PUBLIC INVOLVEMENT IN JAPANESE CLINICAL PRACTICE GUIDELINE DEVELOPMENT

Abstract

Objectives: Evidence-based medicine promoting project managed by Japan Council for Quality Health Care (JQ) aims to improve the quality of healthcare by disseminating the use of clinical practice guideline (CPGs) to medical setting. In 2011, Institute of Medicine (IOM) published "Standards for Developing Trustworthy Clinical Practice Guidelines" in Clinical Practice Guidelines We Can Trust. The standards proposes patient and public involvement (PPI) in CPGs development process is equally important as the management of conflict of interest (COI) and integrating the body of evidence by systematic review. Although the social concern with PPI has been growing for the last several years, guideline development group (GDG) faces many challenges for PPI. In this study, we identified the trend and current situation of PPI in CPGs development. Method(s): CPGs (n = 441) published between 2011 and 2016 were evaluated by the CPG evaluation group using the Appraisal of Guidelines for Research & Evaluation II Instrument (AGREE II) and AGREE Reporting Checklist. Firstly, each reviewer evaluated CPGs independently, and after that, the face-to-face consensus meeting was conducted. Secondly, each reviewer reappraised CPGs independently based on the consensus meeting discussion. Finally, we summarized the secondary evaluation results and made out evaluation reports. AGREE II is composed of six domains including 23 items and overall assessment. In this study, we focused on the following scores; Domain 2-Stakeholder Involvement (items 4-6) beta Item 4: The guideline development group includes individuals from all relevant professional groups beta Item 5: The views and preferences of the target population (patients, public, etc.) have been sought beta Item 6: The target users of the guideline are clearly defined beta Domain 5-Applicability (items 18-21) beta Item 19: The guideline provides advice and/or tools on how the recommendations can be put into practice. In addition to above scoring points of AGREE II, we examined whether GDG developed plain language version of CPGs. Result(s): Among the AGREE II domains, the mean scores of Stakeholder Involvement by publication date were as follows: CPGs published in 2011, 46% (n = 78); CPGs published in 2012, 40% (n = 76); CPGs published in 2013, 47% (n = 80); CPGs published in 2014, 46% (n = 92); CPGs published in 2015, 52% (n = 78); and CPGs published in 2016, 56% (n = 37). The mean score of the item 5 was 2.6 point (range1-7), which meant the lowest score among the all of the AGREE II items. Of evaluated CPGs, 32 (32/ 441 = 7.1%) CPGs had a score of 5 point and above in the item 5 of Stakeholder Involvement domain. In these high-scoring CPGs, the mean score of Item 19 was 5.0 point and the most common disease category was cancer (7/32 = 21.8%). 8 CPGs published plain language version of CPGs (8/32 = 25%). Of high-scoring CPGs, all of the CPGs published in 2016 performed PPI in development process. Conclusion(s): This study indicates that PPI in Japanese CPGs has progressed during the past two years. Further study on CPGs development process would clarify the barriers and facilitators for PPI in Japanese CPGs.