患者报告结局纳入中医疗效评价体系的可行性及国内现状探析

Patient reported outcomes: feasibility of being subsumed the TCM efficacy evaluation system and domestic status

患者报告结局(patient reported outcomes,PRO)作为一种直接来自于患者的测量报告,为中医疗效评价方式的探索提供了新思路。文章论证了PRO纳入中医疗效评价体系的可能性与必要性,另外,笔者总结了国内PRO研制存在的问题,如:忽视翻译量表的语言调试、研制过程欠规范、对科学考核方法的认识及应用存在误区,并提出了相应的解决方法:制定语言调试的指南、研制过程进行质量监控、加强研究人员的统计知识培训等,以期为PRO的广泛应用及中医疗效评价体系的构建有所裨益。

Patient reported outcomes(PRO), a direct measurement report from the patient, is an effective way to build evaluation system of Chinese medicine. This paper demonstrates the possibility and necessity of integrating PRO into the evaluation system of TCM curative effect. Besides, in order to benefit the wide application of PRO and the construction of evaluation system of TCM curative effect, the author not only summarized the problems of PRO in China, such as ignoring the language debugging of the PRO, nonstandard development process and misunderstandings on the methods and application of the scientific evaluation method, but also proposes the solutions: developing guidelines for language debugging, quality control in the development process and strengthening the training of researchers in statistical knowledge and so on.