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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (7): 726-737.doi: 10.3736/jcim20120702

Special Issue: Traditional Chinese Medicine

• Literature Research • Previous Articles     Next Articles

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

Wei-hua Xu1(), Ze-huai Wen1,2, Wei-xiong Liang1, Qi Wang1   

  1. 1. DME Center, Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China
    2. Key Unit of Methodology in Clinical Research of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China
  • Received:2012-01-19 Accepted:2012-03-08 Online:2012-07-20 Published:2018-07-15
  • Contact: Wei-hua Xu

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 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.
Conclusion: 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.

Key words: traditional Chinese medicine, drugs, Chinese herbal, treatment outcome, questionnaires, review


编号 量表名称 相关文献
文献研究内容 构建
条目筛选 考评
1 原发性高血压肝阳上亢证评定量表 1[4] 2006 2 14
2 基于心血管疾病病人报告的临床疗效评价量表 1[5] 2008 3 28
3 中医特色冠心病生存质量量表 2[6,7] 2008 7 29
4 基于冠心病心绞痛患者报告临床结局评价量表 3[8,9,10] 2010 5 36
5 慢性心力衰竭中西医结合生存质量量表 2[11,12] 2008 6 36
6 基于中风痉挛性瘫痪患者报告的临床结局评价量表 4[13,14,15,16] 2008 3 19
7 中风病患者生存质量量表 2[17,18] 2006 4 36
8 中医中风生存质量量表 2[19,20] 2008 4 15
9 基于偏头痛患者报告的结局评价量表 1[21] 2011 未说明 23
10 颈椎病(神经根型)中医证候测评量表 2[22,23] 2006 6 21
11 神经根型颈椎病“病证结合”评价量表 2[24,25] 2011 3 47
12 慢性阻塞性肺疾病稳定期患者报告结局量表 3[26,27,28] 2011 3 23
13 慢性阻塞性肺疾病稳定期患者报告结局量表 1[29] 2011 3 17
14 中医慢性阻塞性肺疾病患者自报告量表 2[30,31] 2010 5 27
15 强直性脊柱炎患者生存质量测定量表 1[32] 2005 4 37
16 基于类风湿关节炎患者报告的临床结局测量量表 1[33] 2009 3 16
17 中医脾胃系疾病PRO量表 2[34,35] 2008 4 44
18 肝硬化中医生存质量量表 1[36] 2009 未说明 不详
19 慢性萎缩性胃炎癌前病变患者报告临床结局评价量表 1[37] 2011 3 30
20 中医肝病临床疗效评价量表 1[38] 2010 2
21 慢性乙型肝炎肝胆湿热证评定量表 1[39] 2007 未说明 13
22 慢性乙型肝炎脾虚证候量表 1[40] 2008 6 10
23 慢性乙型肝炎患者中医生存质量量表 1[41] 2010 4
24 慢性湿疹中医生存质量量表 1[42] 2008 未说明 26
25 银屑病患者生存质量量表 1[43] 2008 3 25
26 白癜风患者生存质量量表 1[44] 2010 3 25
27 斑秃中医生活质量量表 1[45] 2010 3 29
28 艾滋病生存质量量表 2[46,47] 2009 4 46
29 重症肌无力患者PRO量表 3[48,49,50] 2009 5 52
30 乳腺癌术后抑郁障碍中医量表 1[51] 2010 3 36
31 乳腺癌中医PRO调查问卷的研究** 1[52] 2011 5
32 绝经综合征疗效评定量表 7[53,54,55,56,57,58,59] 2007 3 40
33 外科术后康复量表 1[60] 2007 未说明 10
34 中西医结合围手术期康复量表 1[61] 2011 6
35 小儿脑性瘫痪中医证候量表 1[62] 2010 4 64
36 中草药牙膏清热祛火功效评价量表 1[63] 2010 未说明 15
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