Xu Wei-hua, Wen Ze-huai, Liang Wei-xiong, Wang Qi
Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.
Zhong Xi Yi Jie He Xue Bao. 2012 Jul;10(7):726-37. doi: 10.3736/jcim20120702.
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.
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.
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 and 2011 and the instruments were used in many kinds of medical conditions, including cardiocerebrovascular, respiratory, digestive and infectious diseases. The number of items ranged from 10 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 construct validity by exploratory factor analysis and among them there were two studies applying confirmatory factor analysis. Content validity, responsiveness and feasibility of instruments were assessed in 11, 16 and 16 studies, respectively.
This study shows that in recent years many instruments have been developed in an attempt to evaluate the therapeutic effects of TCM, but some problems still exist in their practical implementation, including negligence in outlining the hypothesized concepts of the TCM instruments and in the reporting of instrument's content validity such as administration mode, scoring and recall period. Some instrument attributes and testing methods were misunderstood and/or misused. Revision of instruments is rarely carried out, though the development of an instrument is an iterative process. Researchers should have a thorough understanding of the general procedure and steps before starting to develop an instrument.
由于中西方文化的差异，国外研究工具的中文版可能不完全适用于评估中医药的治疗效果。中国研究人员已付出巨大努力来开发中医药治疗效果评估量表。本研究旨在了解中医药评估工具开发的研究现状。
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和中国科学期刊数据库，以识别已发表的旨在开发评估中医药疗效工具的研究，包括有关工具概念框架构建、条目生成与选择以及测量特性评估的论文。
共纳入60篇涉及36种工具的文献。每种工具的第一篇相关文章发表于2005年至2011年之间，这些工具应用于多种医疗状况，包括心脑血管、呼吸、消化和传染病等。条目数量从10条到52条不等。在这36种工具中，13种（36.1%）明确了工具所测量的假设概念，30种（83.3%）在进行测量特性测试前报告了问卷的维度，且均为多维度问卷。在32项关于条目选择和工具特性评估的研究中，14篇（43.8%）文章报告了施测方式，24篇（75%）报告了反应选项类型，10篇（31.5%）提供了量表的计分算法，但这32项研究均未明确回忆期。在29项旨在测试工具测量特性的研究中，28篇文章测试了总量表和/或分量表的Cronbach's α系数，15项研究还检测了重测信度。27项研究通过探索性因子分析评估了结构效度，其中两项研究应用了验证性因子分析。分别有11项、16项和16项研究评估了工具的内容效度、反应度和可行性。
本研究表明近年来已开发了许多工具用于评估中医药的治疗效果，但在实际应用中仍存在一些问题，包括对中医药工具假设概念的概述以及工具内容效度报告（如施测方式·计分和回忆期）的疏忽。一些工具属性和测试方法被误解和/或误用。尽管工具开发是一个迭代过程，但很少对工具进行修订。研究人员在开始开发工具之前应全面了解一般程序和步骤。
