Background Primary care clinical practice guidelines provide evidence-based recommendations, support best practice in diagnosis and treatment at the primary care level, improve clinical service quality, and promote patient safety. Over the past 15 years, the development of primary care clinical guidelines in China has been rapid, and many common and frequently occurring diseases in primary care have been covered. However, there is still room for improvement in guideline quality, disease coverage, clinical applicability, and implementation support. A systematic review and comprehensive evaluation are therefore needed.
Objective To comprehensively assess the current status of the development and implementation of primary care clinical guidelines in China over the past 15 years, identify the main problems and challenges in guideline positioning, disease coverage, and clinical applicability, and develop strategies for high-quality development based on Delphi expert consensus.
Methods Chinese databases were systematically searched for primary care clinical guidelines published from database inception to April 2025 using terms such as "primary care services" and "primary health care". Two researchers independently screened the literature and extracted data, and disagreements were resolved by discussion with a third researcher. Basic information, including publication year, journal, and disease name, was extracted using Excel 2021. A comprehensive evaluation tool with 4 domains and 31 items was developed by integrating the Appraisal of Guidelines for Research and Evaluation in China (AGREE-China), the Scientificity-Transparency Applicability-Rankings (STAR), and a clinical applicability assessment tool. This tool was used to evaluate the development status and clinical applicability of the guidelines. Based on the results, a preliminary list of strategies for high-quality development was drafted and refined through two rounds of Delphi expert consultation.
Results A total of 185 primary care clinical guidelines were included; the number of published guidelines increased over time and reached a peak of 50 in 2019. Guideline development was relatively concentrated, with the Chinese Medical Association accounting for 43.2% (32/74) of the development groups. The guidelines covered 86 diseases, mainly digestive, cardiovascular, and skin diseases (48, 55.8%). In the development process, the formulation and selection of clinical questions were relatively reasonable (128, 69.2%), but the rate of protocol development and public availability was low, methodologist participation was low, involvement of primary care clinicians was insufficient, and co-design was lacking. In terms of content quality, key steps such as evidence retrieval, quality assessment, and consensus formation were poorly performed (19, 10.3%). In terms of recommendation development and implementation, the use of the GRADE approach was low (20, 10.8%), and consensus transparency, economic evaluation, and implementation evaluation and feedback mechanisms were all limited. In terms of clinical applicability, recommendations were generally clear and operable (156, 84.3%), dissemination channels were diverse, and free access was possible for 100.0% of the guidelines; however, analysis of implementation barriers and facilitators was weak (80, 43.2%). Based on the comprehensive evaluation, the existing guidelines have the following issues: (1) the guideline development process was disconnected from primary care practice: for example, the opinions of primary care practitioners and patients were not fully incorporated, so that guideline content failed to match the characteristics of primary care services, such as broad coverage and long-term stable doctor–patient relationships; (2) disease coverage did not match primary care needs: although the range of diseases covered by the guidelines had increased substantially, the coverage of common primary care diseases required by the Service Capacity Standard for Township Health Centers (2022 edition) was still low, only 20.6%, making it difficult to meet the actual needs of primary care; (3) scientific rigor and practicality were insufficient: some guidelines did not adopt rigorous evidence-based methods, the levels of evidence and strengths of recommendations were described ambiguously, and only a few guidelines contained update plans, making it difficult to adapt to the dynamic changes in the primary care environment; (4) promotion and training resources were insufficient: the awareness and acceptance of guidelines among primary care practitioners were low, and targeted training support was lacking, which impaired the practical application of primary care guidelines; and (5) primary care characteristics were insufficiently reflected: some guidelines did not adequately cover core primary care functions such as patient education, health management, and disease prevention, and their recommendations were not effectively combined with the low-cost, broad-coverage characteristics of primary care. These problems highlighted the urgent need for systematic optimization of primary care guidelines in their development, dissemination, and implementation to better meet the actual needs of primary care. Through two rounds of Delphi expert consultation, a "checklist for high-quality development of primary care clinical guidelines in China" was developed, comprising 6 core domains, 24 first-level items, and 58 second-level items. The 6 core domains were: (1) improving the rigor of guideline development; (2) enhancing the clinical applicability of guidelines; (3) highlighting the primary care characteristics of recommendations; (4) improving the guideline-use capacity of primary care physicians; (5) increasing government financial input and policy support; and (6) optimizing the implementation environment of primary care guidelines.
Conclusion Primary care clinical guidelines in China have developed rapidly in number and scope over the past 15 years, but important gaps remain in methodological quality, disease coverage, clinical applicability, and implementation support. This study developed a systematic checklist for high-quality development, which may provide useful support for the future development, dissemination, and implementation of primary care clinical guidelines in China.
