Development And Evaluation Of TCM Evaluation Scale Of Qi Deficiency Syndrome

Purpose:This study aims to establish a Patient reported syndrome scale: Qi-Deficiency Syndrome. And Providing a common module for the work to develop a Patient reported syndrome scale: Qi-Deficiency Syndrome with different diseases.Material and method:By means of literature review, criteria collection, textbooks sort out, in-depth patient interview and discussion between the topic group, we form the item pool. And then through the item screening from the item pool by expert consensus, we form the initial scale. We screen items by clinical study and statistics analysis. Then the final scale is established. The feasibility, reliability and validity and reaction degree are studied for the final scale. The final scale is used in the evaluation of the curative effect of Coronary heart disease angina qi deficiency syndrome, to study the curative effect evaluation of effectiveness.Results:The final scale consists 3 dimensions as fatigue, shortness of breath and lack of energy; 10 item as need rest, lack of appetite, affect daily activity and become lazy due to fatigue, disinclination to talk, shortness of breath when talking and breathing, hobby, sleep and moods influenced by insufficient energy. The acceptance rate of the scale is 95.83%, and all subjects complete the scale. There is no ceiling or floor effect existed. The test-retest reliability of 10 items for the scale is greater than 0.7(0.872-0.972). The Cronbach’s α of the scale, fatigue dimension, shortness of breath dimension, and lack of energy dimension is 0.827、0.674、0.768、0.614, and the Spearman correlation coefficient between total score and all items(except from lack of appetite) are above 0.4. Three factors are extracted through the exploratory factor analysis, and the cumulative proportion of variance is 62.358%. The study use hemoglobin concentration as the criterion validity. There is negative correlation between the scale score, fatigue dimension, shortness of breath dimension, lack of energy dimension and hemoglobin concentration. And with the reduction of hemoglobin concentration the scale score is increasing(trend). Each item of the scale can distinguish different people with different ages well. There is no distinction in different diseases with the same Traditional Chinese Medicine syndrome by the scale score. It also can reflect the characteristics of different diseases. Through preliminary clinical practice, the scale can Evaluate the curative effect.Conclusion:1. This study forms the PRO scale of qi deficiency syndrome curative effect evaluation. And The scale is validated and reliable.2. After preliminary clinical validation, this scale can evaluate the curative effect of coronary heart disease angina qi deficiency syndrome.3. This scale sums up the life inconvenience of the patients with qi deficiency syndrome. And we pay more attention to the perspective of daily life for patients survival quality evaluation.