Construction of Clinical Evidence Grading System of TCM Intervention Based on Evidence-based Medicine Principles

To develop a clinical evidence grading system for Chinese medicine (CM) interventions based on the Grading of Recommendations Assessment,Development and Evaluation (GRADE) system. The CM clinical evidence grading system was the outcome of systematic review and synthesis of inputs from classical literature, famous doctors' experience and modern clinical evidence according to the literature review and group discussion. Through literature research and core group discussion, clinical evidence of traditional Chinese medicine intervention includes ancient books of CM, famous doctors' experience, and modern clinical research evidence. Delphi method was used to determine the scope, evaluation items and specific grading level of the evidence grading system. Among them, the evaluation factors for intervention evidence in CM ancient books included the source of ancient medical records, the completeness of diagnosis and treatment contents, and the inheritance of ancient books. The evaluation factors of famous doctors' experience included qualification of famous doctors, content integrity, and inheritance of experiences. The evaluation items are weighted, the evidence of ancient books and famous doctors' experiences were leveled as high,moderate, and low. The clinical evidence grading level of CM intervention was consistent with the GRADE grading of modern clinical research, divided into four levels: high,moderate,low, and very low, aiming to provide reference for clinical practice and future research of CM. The constructed clinical evidence grading system of CM intervention not only followed the principles of evidence-based medicine, but also reflected the characteristics of clinical evidence of CM. It was expected to more comprehensively and objectively evaluate the multi-source evidence supporting clinical practice of CM.