中医药疗效评价量表研制现状及分析  

A review of research on the development of instruments for therapeutic efficacy evaluation of traditional Chinese medicine

作　　者：许卫华[1] 温泽淮[1,2] 梁伟雄[1] 王奇[1] 

机构地区：[1]广州中医药大学DME中心,广东广州510405 [2]广州中医药大学第二附属医院中医药临床研究方法学重点研究室,广东广州510120

出　　处：《中西医结合学报》2012年第7期726-737,共12页Journal of Chinese Integrative Medicine

基　　金：国家重大新药创制项目(No.2008ZX09312-021)

摘　　要：目的:了解目前国内中医药疗效评价量表研制现状和存在的不足。方法:采用文献分析法检索中国生物医学文献数据库、中国学术期刊网络出版总库(医药卫生科技)和重庆维普中文科技期刊数据库(医药卫生),纳入以研制中医药疗效评价量表为目的的文献,包括报告关于量表理论框架构建或条目筛选或考评的文献。结果:共有60篇文献(包含36个量表)符合纳入标准。各量表的首篇文献发表于2005～2011年,涉及心脑血管疾病、消化系统疾病、呼吸系统疾病等。纳入的36个量表中有13个(36.1%)研究定义了量表欲测量的概念;有30个(83.3%)量表报告了量表维度,其中最少为2个维度,最多为7个维度。在涉及量表条目筛选及(或)考评的32个研究中,量表条目数为10～52条。14个(43.8%)研究报告了量表填写方式,其中以由受访者自填方式为最多。24个(75%)量表文献描述了答案设置类型,以5级Likert尺度法为最多。10个(31.5%)研究描述了量表的计分方法。所有量表均无关于测量回忆跨度的描述。涉及考评的29个量表研究中,10个(34.4%)研究同时报告了量表的全量表和(或)分量表的Cronbachα系数、重测信度、结构效度及反应度。28个研究报告了全量表和(或)分量表的Cronbachα系数,其中15个量表同时报告了重测信度。27个研究评价了量表的结构效度,11个研究报告了内容效度,13个研究进行了区分效度的评价,16个研究评价了量表的反应度,16个研究评价了量表的可行性。结论:研究调查结果表明,尽管绝大多数研究者遵循量表研制的基本步骤进行量表研制,但在具体的实施过程中仍有不足之处,主要包括缺乏对量表测量概念的界定、对量表考评指标理解存在偏差、忽略量表填写方式及回忆跨度等描述。OBJECTIVE：Due to the differences between Chinese and Western cultures,Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine（TCM）.Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM.This study aims to understand the current situation of research in the development of evaluation instrument in TCM. METHODS：Database searches of Chinese Biomedical Literature Database,China Academic Journal Network Publishing Database and Chinese Scientific Journals Database were undertaken to identify published studies with the purpose of developing instruments in assessing the effectiveness of TCM,including papers regarding the construction of conceptual framework of instrument,item generation and selection and the evaluation of measurement properties. RESULTS：A total of 60 pieces of literature involving 36 instruments were included.The first article on the development of each of the instruments was published between 2005 and2011 and the instruments were used in many kinds of medical conditions,including cardiocerebrovascular,respiratory,digestive and infectious diseases.The number of items ranged from10 to 52.Of the 36 instruments,13（36.1%）defined the hypothesized concepts measured by the instrument,30（83.3%）reported the domains of the questionnaires before measurement property testing and all of them were multidomain.Of 32 studies regarding item selection and the instrument’s property evaluation,14（43.8%）articles reported the administration mode,24（75%）reported response option types,and 10（31.5%）provided scoring algorithm for the scale,but none of these 32 studies specified the recall period.In 29 studies aiming at testing instrument’s measurement property,28 articles tested the Cronbach’s α coefficient of the full scale and/or subscales,and retest reliability was also detected in 15 studies.Twenty-seven studies evaluated the cons

关 键 词：中医 中药 治疗效果 问卷调查 综述 

分 类 号：R195[医药卫生—卫生统计学]