对比较效益研究GRACE准则的解析

Analysis of GRACE Principle for Comparative Effectiveness Research

比较效益研究(comparative effectiveness research,CER)是目前国际上医疗卫生改革领域里非常流行的一个新概念。虽然其所含内容并非有质的更新,但是其所倡导的是一种新医疗研究的理念,一种针对国家医疗体系层面的政策导向。欧美国家正寄希望CER开启新一轮创历史的里程碑建设。虽然已有国际权威组织对CER的设计和报告制定了相关标准,但是对于其评价准则尚未涉及,故在国际药物流行病学会的组织下,签署了好的比较效益研究(Good Research for Comparative Effectiveness,GRACE)准则即GRACE准则,该准则通过对观察性研究就如何进行评价制定了一系列的规范条例。本文通过对GRACE准则进行解析,旨在为将来中医临床研究引入提供有关观察性研究实施的参考标准。

Comparative effectiveness research （CER） now is a very popular concept in the field of inter- national heath care reformation. Although its contents are not essentially changed, it advocates a new medical i- dea, a policy orientation at the national medical system level. The European countries and America hope CER could initiate the construction of a new historical milestone. Although there are already some guidelines for the de- sign and report of CER by authorized international organizations, its assessment standards have not been in- volved. Therefore, Good Research for Comparative Effectiveness （GRACE） was signed by International Society Pharmacoepidemiology. A series of standard rules were formulated on how to assess the observational studies. In this article by analyzing the GRACE, we hope to provide the referential standards for enforcing observational studies by introducing CER in the clinical studies of Chinese medicine.