Introduction: Assessing an individual's level of Yang deficiency (Yang-Xu) by its manifestations is a frequent issue in traditional Chinese medicine (TCM) clinical trials. To this end, an objective, reliable and rigorous diagnostic tool is required. This study aimed to develop a first final version of the Yang-Xu Constitution Questionnaire.
Methods: We conducted 3 steps to develop such an objective measurement tool: 1) the research team was formed and a panel of 26 experts was selected for the Delphi process; 2) items for the questionnaire were generated by literature review and a Delphi process; items were reworded into colloquial questions; face and content validity of the items were evaluated through a Delphi process again; 3) the difficulty of the questionnaire was evaluated in a pilot study with 81 subjects aged 20-60 years.
Results: The literature review retrieved 35 relevant items which matched the definition of 'constitution' and 'Yang-Xu'. After a first Delphi process, 22 items were retained and translated into colloquial questions. According to the second part of the Delphi process, the content validity index of each of the 22 questions ranged between 0.85-1. These 22 questions were evaluated by 81 subjects, 2 questions that were hard to tell the difference were combined; 3 questions were modified after the research team had discussed the participants' feedback. Finally, the questionnaire was established with 21 questions.
Conclusions: This first final version of a questionnaire to assess Yang-Xu constitution with considerable face and content validity may serve as a basis to develop an advanced Yang-Xu questionnaire.
2008 S. Karger AG, Basel.