| Background: The importance of assessing the patient reported outcomes has become more and more significant along with the change in disease pattern and concept of health and medical model. No valid and reliable measuring instruments are available to assess the clinical cure effect of the Traditional Chinese Medicine in the Spleen and Stomach disease. The aim of the study was to develop a disease-specific scale of TCM to fill up the blankness.Methods: Firstly, the theory model of the Spleen and Stomach disease PRO scale (SSD-PRO) was based on the principles of diagnosis and practice in Traditional Chinese Medicine. The SSD-PRO includes 4 dimensions (physiology, independence, psychology and environment). According to the theory model, initial development focused on extensive pretesting patients, primary care physicians and gastroenterologists, and items considered to be important collected through literature reviews, individual interviews and illation. Than optimizing the items in order to each item express only one meaning. Each item was rated on a five-point scale. A pilot study was carried out to the primary scale of the SSD-PRO in a small range (20 cases).Subsequently some items were revised, added and deleted again. A primary scale was formed. Using the primary scale of the SSD-PRO, a field study was carried out. A sample of 300 cases was taken which covered male and female, healthy people and patients, different situation on education levels, ages, and professionals. The sample of patients covered peptic ulcer disease, chronic gastritis, functional dyspepsia and irritable bowel syndrome.By applying 6 kinds of statistical methods, including expert's judgment for the items weightiness, coefficient of variation, factor analysis, stepwise regression, discriminant analysis and Crobach's a coefficient, 44 items were kept to form a formal scale.Results:(1) Reliability:Reliability of a scale can be defined as the ratio of the variance attributable to true differences among subjects to the total variance. The reliability was tested by split-half method and the Crobach's a coefficient method.The correlation coefficient between the subtotal of odd and that of even item was 0.8805; the correlation coefficients for sub-scale were 0.8564, 0.8545, 0.6457 and 0.7218. The Crobach's a of the scale were 0.9433, and the Crobach's a of the scale were 0.9172, 0.8526, 0.7393 and 0.7951.The above results indicated that the SSD-PRO had a satisfactory reliability.(2) Validity:The Validity of a scale refers to the extent to which it measures what it is intended to measure, in this case that it truly reflects the concept of PRO.Construct validity: Construct validity refers to the extent to which the scale measures the dimensions hypothesized to underlie the scale item. Construct validity of the SSD-PRO was tested by dimension correlation, exploring factor and confirmatory factor analysis.The result of Correlation analysis showed that each facet was correlated to it's own domain with r＞0.7 and lowly correlated to other domains. In physiology dimension, each item was correlated to it's own facet and it's own domain with r＞0.5 except the items of satiety and heavy crash feeling in belly. In the other dimensions, each item was correlated to it's own facet and it's own domain with r＞0.7.Confirmatory factor analysis showed that the CFI of the scale was 0.950 and the CFI of 4 domains were 0.791, 0.996, 0.911 and 0.953 respectively.A scale not only should be reliable and valid but also should be able to detect a difference of health people and patients. The t-test showed that the SSD-PRO scale was able to reflect the difference of SSD-PRO between healthy people and patients (P＜0.01) .(3) feasibility: The SSD-PRO had good acceptance rate and finish rate, the median of the complete time was 10 minutes. Conclusion: The Spleen and Stomach disease PRO scale is a reliable and valid disease-specific instrument used for measuring the Traditional Chinese medicine curative effect.
|
PDF Full Text Request