Lin Jun-Dai, Chen Li-Li, Lin Jui-Shan, Chang Chih-Hung, Huang Yi-Chia, Su Yi-Chang
Graduate Institute of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan.
Forsch Komplementmed. 2012;19(5):234-41. doi: 10.1159/000343580. Epub 2012 Oct 18.
Nowadays, the individual differences are emphasized in personalized medicine. Traditional Chinese Medicine (TCM) which prescribes tailored treatment based on each patient's different body constitution may provide new strategy to break the bottleneck of modern medicine (MM). Therefore, to integrate TCM into MM, an objective, reliable and rigorous diagnostic tool is necessary for the assessment of TCM constitution of each individual. This study aimed to develop a provisional version of the Yin-Xu Constitution Questionnaire (BCQ-), because evaluating the level of individual's Yin deficiency (Yin-Xu) by his manifestations is frequently involved in TCM clinical trials.
The provisional version of BCQ- was developed using a step-by-step approach: 1) to form the research team and select a panel of 26 experts who had both MM and TCM educational background and professional training for Delphi method; 2) to generate questionnaire items from literature review and Delphi process, refine these items to be colloquially acceptable, and evaluate their face and content validities by Delphi process again; 3) to evaluate the difficulty of answering these questions by a pilot study with 81 participants whose age ranged from 20 to 60 years.
After 2 rounds of Delphi process, 22 colloquially appropriate questions were established and answered without difficulty by the 81 participants.
This provisional version of BCQ- appeared to have considerable face and content validities and may be the basis to develop an advanced Yin-Xu questionnaire. The reliability and validity of BCQ- were further tested in the second part of the study.
如今，个性化医疗强调个体差异。中医根据每位患者不同的体质开具量身定制的治疗方案，这可能为突破现代医学的瓶颈提供新策略。因此，为将中医融入现代医学，需要一种客观、可靠且严谨的诊断工具来评估个体的中医体质。本研究旨在开发阴虚体质问卷（BCQ-）的初步版本，因为在中医临床试验中经常涉及通过个体表现来评估其阴虚程度。
BCQ-的初步版本采用逐步推进的方法开发：1）组建研究团队，挑选26位具有现代医学和中医教育背景且接受过德尔菲法专业培训的专家组成小组；2）通过文献综述和德尔菲法流程生成问卷项目，将这些项目提炼得通俗易懂，并再次通过德尔菲法流程评估其表面效度和内容效度；3）通过一项针对81名年龄在20至60岁之间参与者的预试验来评估回答这些问题的难度。
经过两轮德尔菲法流程，确定了22个通俗易懂的问题，81名参与者回答这些问题没有困难。
BCQ-的这个初步版本似乎具有相当的表面效度和内容效度，可能是开发更高级阴虚问卷的基础。BCQ-的信度和效度在本研究的第二部分进一步进行了测试。
