| BackgroundThe 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. We considered the Spleen and Stomach diseases (diagnosed by western medicine as functinonal gastrointestine diseases)cured by TCM which had its effect advantages as a breakthrough. The aim of the study was to develop a FGIDs-scale based on syndrome differentiation of TCM.ObjectivesTo develop and evaluate FGIDs-scale based on differentiation of symptoms by using analysis methods such as structural equation model (SEM) and item response theory (IRT).MethodsFirstly, the theory model of functional gastrointestinal disorders scale (FGIDs-scale) was based on the principles of diagnosis and practice in Traditional Chinese Medicine. The FGIDs-scale 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. Each item was rated on a five-point scale. A pilot study was carried out to the primary scale of the FGIDs-scale in a small range (10 cases).Subsequently some items were revised, added and deleted again. A primary scale was formed. Using the primary scale of the FGIDs-scale, 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 functional dyspepsia (FD) and irritable bowel syndrome (IBS).By applying 6 kinds of statistical methods, including expert's judgment for the items weightiness, coefficient of variation, factor analysis, frequency distribution, discriminant analysis and Crobach's a coefficient, 44 items were kept to form a formal scale.Result(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 0.921; the correlation coefficients for sub-scale were 0.891,0.726, 0.584 and 0.7209. The Crobach's a of the scale were 0.851, and the Crobach' s a of the scale were 0.808,0.739,0.523 and 0.528.The above results indicated that the FGIDs-scale 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 FGIDs-scale 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>0.5 and lowly correlated to other domains. In 4 dimensions, each item was correlated to it's own facet and it's own domain with r>0.6.Confirmatory factor analysis showed that the CFI of the scale was 0.87 and the CFI of 4 domains were 0.85,1.00,1.00 and 1.00 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 FGIDs-scale scale was able to reflect the difference of FGIDs-scale between healthy people and patients (P<0.05)(3) feasibility:The FGIDs-scale had good acceptance rate and finish rate, the median of the complete time was 10 minutes.ConclusionThe functional gastrointestinal disorders scale is a reliable and valid disease-specific instrument used for measuring the Traditional Chinese medicine curative effect.
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