〔Abstract〕 Objective Objective To scientifically, objectively and roundly evaluate the clinical effect of traditional Chinese Medicine (TCM) by developing the TCM quality of life (QOL) scale for chronic liver disease. Methods According to the programmed method of international scale, based on liver physiological function and characteristic study of zang manifestation theory, combined with the patient reported outcomes (PRO), theoretical models of clinical efficacy scale for liver disease were built. A primary clinical scale was established af...