There were many problems in the methodological theory of the formulation of clinical practice guidelines in in the real world situation, and the lack of consideration of the actual situation leads to the decline of the guidance for the formulation of guidelines. Through an in-depth analysis of the various difficulties related to theory and practice in the formulation of the guidelines, including the deviation between methodological theory and practice in the formulation of guidelinesn, lack of empirical studies of large samples related to guideline development, after the empirical application of methodological theory, the reports of limitations and future research recommendations were insufficient and not standardized. To improve the guidance of future guidelines, our team put forward a number of methodology recommendations, including advocating for empirical research that validates methodological theories, develop large sample empirical research and comparative research, standardize the content and form of reports on limitations and future research recommendations after empirical research, in order to provide reference for guidelines develop methodology researchers and guideline development groups.

临床实践指南制订的方法学理论在真实的制订情境下存在诸多问题，缺乏对于实际情况的考量，致使其对于指南制订的指导性下降。本文深入剖析了指南制订中理论与实践相关的多方面难点，包括指南制订时方法学理论与实践存在偏差、缺乏大样本的指南方法学相关的实证研究、方法学理论在实证运用后对于局限性和未来研究建议的报告内容不足且形式不规范的问题。为提高未来指南制订方法学的指导性，本课题组提出了多项方法学建议，包括倡导开展对方法学理论进行验证的实证研究、促进大样本实证研究和对比研究开展、规范实证研究后对局限性和未来研究建议的报告内容和形式，以期为指南制订方法学研究者及指南制订小组提供参考。