Patient-reported Outcomes (PROs): An Approach to Evaluate Treatment Efficacy of Chinese Medicine or Integrative Medicine

摘要

PROs are important for evaluating treatment efficacy in any clinical trial in which the patient's self-report is the primary or sole indicator for disease activity; the particular treatment may have little impact on survival but may have significant impact, positive or negative, on health-related quality of life; the treatment arms offer e-qual clinical efficacy but differential PRO benefits. Developers and users in CM or IM should specify and label the content and type of measure for every application of a PRO and provide evidence of its appropriateness to the intended use. Developers and users will face the change of using these measures in CM or IM in establishing a theory and principle of how to link clinical treatment efficacy with PROs.