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Quality appraisal of clinical guidelines for newborns in China: a systematic review protocol
Li Jing1, Zengzhen Liao1, Luqin Liao1
1The First Affiliated Hospital of Guilin Medical University, GuiLin, China.
Insights
This study will evaluate Chinese neonatal clinical practice guidelines for methodological quality and the credibility and implementability (CI) of their recommendations. Findings will guide improvements in guideline development and recommendation formulation for better neonatal care in China.
Area of Science:
- Neonatal Medicine
- Health Services Research
- Evidence-Based Practice
Background:
- Neonatal guidelines are crucial for improving healthcare quality and reducing mortality in China.
- Existing guidelines exhibit variable methodological quality, with unassessed credibility and implementability (CI).
- Key areas for improvement in Chinese neonatal guidelines remain unclear.
Purpose of the Study:
- To systematically appraise the methodological quality of Chinese neonatal clinical practice guidelines.
- To assess the credibility and implementability (CI) of recommendations within these guidelines.
- To identify deficiencies and provide evidence-based strategies for enhancing future guideline development.
Main Methods:
- Systematic review adhering to PRISMA-P guidelines, searching multiple databases (PubMed, Embase, CNKI, Wanfang, VIP, CBM) until December 2025.
- Inclusion of Chinese-language clinical practice guidelines for neonatal disease management.
- Evaluation using AGREE II for methodological quality and AGREE-REX for credibility and implementability (CI) of recommendations.
Main Results:
- The review will present a narrative synthesis of the strengths and limitations of Chinese neonatal guidelines.
- Methodological deficiencies in guideline development processes will be identified.
- Context-specific optimization strategies for recommendations will be derived based on AGREE-REX appraisal.
Conclusions:
- The findings will inform efforts to improve the methodological rigor of future Chinese neonatal guidelines.
- Evidence-based direction will be provided for enhancing the credibility and implementability of guideline recommendations.
- This research aims to ultimately contribute to better neonatal healthcare outcomes in China.
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).
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