Ideas and Methods of Establishing an Efficacy Evaluation System for Heart Failure：Combining Syndrome in Traditional Chinese and Disease Western Medicine，based on Doctors-patients Shared Reported Outcomes and Using 1+N Model / 中医杂志

ABSTRACT

Establishing an efficacy evaluation system that conforms to the laws of traditional Chinese medicine （TCM） is one of the keys in the development of TCM. With certain progress in recent years， however， the clinical efficacy evaluation systems or consensus that has been formed are not widely adopted. The main reason is the lack of objectification and standardization of efficacy evaluation， and additionally fixed efficacy evaluation system cannot meet the needs of different clinical research purposes. This paper initially analyzed the development status of clinical efficacy evaluation of heart failure （HF）， and then discussed the specific methods， advantages and difficulties in constructing a TCM clinical efficacy evaluation system for HF using the 1+N model， guided by the idea of combining traditional Chinese and western medicine， disease and syndrome， and based on the shared reported clinical outcomes by doctors and patients. Establishing an efficacy evaluation system that combines disease and syndrome can build a bridge to connect TCM with western medicine； the shared reported clinical outcomes by doctors and patients can reflect the people-centered concept and holism concept in TCM； the 1+N efficacy evaluation model can meet the general clinical research need by constructing one core outcome set （“1”）， and can match different research purposes by adding numbers of other outcomes （“N”）. One difficulty in constructing the TCM efficacy evaluation system for HF is to unify the differentiation standard for TCM syndromes of HF and the standardization to diagnose HF firstly， and then distinguish between syndrome efficacy standards and syndrome diagnostic standards. By constructing a 1+N model-based efficacy evaluation system for HF that not only conforms to the characteristics of TCM itself but also embodies the evidence-based medicine concept in western medicine， it is expected to provide ideas for evaluating clinical efficacy of TCM.