Development And Evaluation Of The Irritable Bowel Syndrome Subscale In Spleen And Stomach Disease PRO Scale (SSDPRO-IBS)

BACKGROUND and OBJECTIVE:The Spleen and Stomach disease PRO scale(SSD-PRO) is a reliable and valid disease-specific instrument, which is used for measuring the Traditional Chinese medicine curative effect. Based on it, this study was going to develop the Irritable Bowel Syndrome (IBS) subscale in Spleen and Stomach disease PRO scale(SSDPRO-IBS), and then evaluate it.METHODS:According to the structured group methods of instrument development, the instrument with Chinese cultural background was developed, and evaluated by analyzing the data from 200 IBS patients. By applying 5 kinds of nonparametric statistical methods, which include factor analysis, stepwise regression, discriminant analysis, ANOVA analysis, expert's judgment for the items weightiness and Crobach's a coefficient,42 items were kept to form a formal scale.RESULTS:The SSDPRO-IBS scale include 4 domains with 8 facets in it. The correlation coefficient between the subtotal of odd and that of even item was 0.950; the correlation coefficients for each domain were 0.767,0.873,0.767 and 0.505. The Crobach's a of the whole scale was 0.949, when each domain were 0.942,0.873,0.766,0.591.The result of Correlation analysis shows that, except the enviroment domain, each domain was correlated to the whole scale (r>0.6). and in physiology dimension, each item was correlated to it's own facet and it's own domain except the items of "pain eased after stool", "felt dizzy", "normal times of stool". Confirmatory factor analysis showed that the CFI of the scale was 0.8 and of 4 domains were 0.967,0.966,0.957 and 0.973 respectively, the results of IRT showed that all items didn't have uniform DIF and non-uniform DIF. The t-test showed that the SSDPRO-IBS scale was able to reflect the difference between healthy people and patients (P<0.01)CONCLUSION:The SSDPRO-IBS subscale is a reliable and valid disease-specific instrument.