Background: Rare diseases present a global public health priority to health care practitioners and policy makers, causing significant morbidity and mortality and proposing a great clinical, economic and social burden on the affected individuals, families and communities, especially for the low-and middle-income countries. Thus, standard effectiveness strategies and rigorous clinical practice guidelines that summarize the available evidence and provide recommendations are needed to improve the care of the millions of people worldwide who suffer from rare diseases. However, creating guidelines for rare diseases presents specific challenges and so far the quality of published guidelines on rare diseases is still uncertain.

Objectives: To assess the methodological and reporting quality of published clinical practice guidelines in rare disease.

Methods: We performed a systematic search on databases (PubMed, Embase and Orphanet), relevant guideline websites, and government health agency websites from their inception to April, 2020 and selected clinical practice guidelines related to rare disease. No language restriction was applied. Four researchers independently evaluated the methodological quality of eligible guidelines using the AGREE-Ⅱ (Appraisal of Guidelines for Research and Evaluation Ⅱ) instrument, the degree of agreement was evaluated by intra-class correlation coefficient. Two researchers in pairs independently evaluated the reporting quality of eligible guidelines using the RIGHT (Reporting Items for practice Guidelines in Healthcare, for reporting quality) statement, disagreements were resolved through discussion or consulting a third researcher. Statistical analyses were conducted by using SPSS version 25.0.

Results: The results will be presented at the meeting.

Conclusions: The results will be presented at the meeting.

Patient or healthcare consumer involvement: None