运用混合方法研究构建中医疗效评价指标体系初探  

Developing Traditional Chinese Medicine Outcome Indicator System for Effectiveness Evaluation through Mixed Method Research

作　　者：陈千吉 陈红 张英 万颖 翁志文 孙亚男[3] 于长禾 CHEN Qianji;CHEN Hong;ZHANG Ying;WAN Ying;WENG Zhiwen;SUN Yanan;YU Changhe(First School of Clinical Medicine,Beijing University of Chinese Medicine,Beijing,100700;Dongzhimen Hospital,Beijing University of Chinese Medicine;Xuanwu Hospital,Capital Medical University)

机构地区：[1]北京中医药大学第一临床医学院,北京市100700 [2]北京中医药大学东直门医院 [3]北京首都医科大学宣武医院

出　　处：《中医杂志》2021年第6期488-493,共6页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81803956)。

摘　　要：中医疗效评价指标体系由患者健康状态相关的核心结局指标集和干预措施相关的特色结局指标集构成,前者是针对特定健康领域的所有临床研究中应当报告的最小集合,后者是针对具有代表性中医干预措施的特色结局指标集合。中医疗效评价指标体系的核心基础是结局指标及其测量工具,满足测量学性能是构建中医疗效评价指标体系的前提条件。混合方法研究是一种将定性研究与定量研究有机地结合在一起的研究范式,符合中医疗效评价指标体系关于目标人群主观选择与临床客观测量的研究内容,让研究者从不同角度去分析问题,丰富研究证据以深入诠释研究问题,提高体系中结局指标的普遍性和特异性。运用混合方法研究构建国际公认、临床可行、反映中医特色结局指标的中医疗效评价指标体系,有利于为临床试验或实践提供结局指标,突出中医干预措施的特色,提高患者参与循证决策的能力,增强中医疗效评价指标体系的全面性、科学性,并为其提供新的方法学思路。Traditional Chinese medicine(TCM) effectiveness evaluation system is consisted of patient health-related core outcome sets and TCM-specific outcome sets. The core outcome set is a minimum set of outcomes that should be measured and reported in all clinical trials in specific areas of healthcare, while TCM-specific outcome set complies the outcomes that can reflect the specific characteristics of TCM. Outcome indicators and measurement tools lay the foundation of the TCM effectiveness evaluation system, while the measurement property is a prerequisite for system construction. Mixed methods research obeys a research design whereby qualitative and quantitative data collection and analysis are organically integrated in the same study. It satisfies the needs of subjective selection of target population and objective measurement of clinical research content, allowing researchers to analyze problems from different perspectives, enriching research evidence for further interpretation, and improving the universality and specificity of outcome indicators in the system. Mixed method research can be used to build an internationally recognized, clinically feasible, and TCM-specific effectiveness evaluation system, which will provide outcome indicators for clinical trials or practice, highlight the characteristics of TCM interventions, promote patients′ involvement in evidence-based decision-making, enhance the comprehensiveness and scientificity of TCM effectiveness evaluation, and provide new methodological ideas.

关 键 词：混合方法研究 结局指标 中医疗效评价指标 定性评价 定量评价 

分 类 号：R288[医药卫生—中药学]