Quality appraisal of clinical guidelines for newborns in China: a systematic review protocol

Introduction Neonatal guidelines are critical for enhancing healthcare quality and reducing neonatal mortality in China. However, the methodological quality of existing guidelines varies considerably, and the credibility and implementability (CI) of their recommendations has not been systematically evaluated. Consequently, key areas for improvement remain unclear. This protocol aims to appraise the methodological quality of Chinese neonatal guidelines and assess the CI of their recommendations using two evaluation frameworks. Methods and analysis This study will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols statement. We will search multiple electronic databases, including PubMed, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang Database, the Chinese Science and Technology Periodical Database (VIP) and the Chinese Biomedical Literature Database, from inception to 31 December 2025. The search will use keywords such as ‘neonatal’, ‘clinical practice guidelines’ and ‘China’. The language of publication will be limited to Chinese or English. Two researchers will independently screen title, abstract and full text. Chinese-language clinical practice guidelines focused on neonatal disease management (rather than assessment or diagnosis) will be included. Relevant information (including guideline name, publication year, disease type, leading institution and guideline development group composition) will be extracted using a pre-designed form. Cross-verification will be performed, and discrepancies will be resolved by a third reviewer. Final data will be presented in tables. We will use a narrative synthesis to address two objectives: (1) to evaluate the methodological quality of Chinese neonatal guidelines (especially those published in the past 5 years) using AGREE II (6 domains, 23 items, scored 1–7) and identify critical deficiencies in the guideline development process; and (2) appraise the CI of recommendations for guidelines scoring ≥60% in the domain 3 (‘Rigour of Development’) of AGREE II using the AGREE-REX (Appraisal of Guidelines for Research and Evaluation – Recommendation EXcellence) tool, deriving context-specific, evidence-based optimisation strategies. This review will explore the strengths and limitations of Chinese neonatal clinical practice guidelines. The findings will provide evidence-based direction for future guideline development and recommendation formulation. Ethics and dissemination No ethical approval is required. Results will be disseminated through open-access, peer-reviewed journal publications and conference presentations. The results will inform efforts to improve the methodological quality of future neonatal guidelines in China and the CI of their recommendations. PROSPERO registration number This systematic review protocol was registered on PROSPERO (registration number CRD420251106060).