Development And Evaluation Of The Assessing Curative Effect Of TCM Scale For Patients With Liver Disease

Objective : The purpose of this study was to develop a disease- specific scale which can evaluate the curative effect of TCM for patients with Liver Disease ,and test its reliability ,validity and responsibility.Method: Based on the physiological function and pathologic character of the Liver in TCM to design the scale. At first, we put forward the item pool after individual interviews and focus group discussions. Select 10 digestive specialists of Traditional Chinese Medicine to make their choices about items and put forward their opinions about the contents. Based on the opinions from the digestive specialists of TCM, filter, modify, confinn and classify the items. Choose 50 healthy people and 50 liver patients with different culture background to carry on the pre-test. Make the items more easilly to understand by adjusting the language , and then confirm the end beforehand investigation scale. 100 healthy people and 100 patients accepted the beforehand investigation. Filter the items again according to the result of statistic analysis and confinn the end scale. The end scale was tested with reliability, validity, and responsibility by the investigation of 250 chronic liver patients and 250 healthy people. Statistic process: statistic describe, correlation analysis, factor analysis, multiple stepwise regression analysis, paired-samples T test and independent-samples T test ,etc.Results: 1. A self-reported subjective scale and a perceived objective scale were developed, including 17 self-reported subjective items and 12 objective items, for short ACEOTCMS-LD (V1.0). 2. The self-reported subjective scale's test-retest related coefficient is 0.914. The scores between twice tests were not statistically significant different (P>0.1). The two scales' split-half reliability related coefficients are 0.8584, 0.9305. The self-reported subjective scale and its two domains' Cronbach' α coefficients are 0.8441, 0.5906, 0.8216. The objective scale and its two domains' Cronbach' α coefficients are 0.8903, 0.8751, 0.7824. The scores between domains and c' related coefficients are 0.719, 0.975. The scores between domains and the objective scale' related coefficients are 0.941 , 0.947. The scores of each items with the two scales' make multiplelinear regression analysis, all of the 27 items enter the equation. The 14 items of the subjective scale were made factor analysis. 6 factors were selected and their Cum Pet is 67.035 %. The fifth factor represents"Liver take charge storing blood", and others represent"Liver take charge catharsis" . The 10 items of the objective scale were made factor analysis. 3 factors were selected and their Cum Pet is 72.412%. The first factor represents"Liver take charge storing blood" , and others represent "Liver take charge catharsis" . CFI of the model of the subjective scale is 0.984, and the objective scale' CFI is 0.954. Contrast to 40 hepatocirrhosis patients' scores between before and after treatment. The scores of the two scales and two domains before treatment were significantly different than after treatment (P<0.01). The scores of the objective scale and the "Liver take charge storing blood" domain from healthy people were significantly lower than those from the chronic liver patients(P<0.01).Conclusion: ACEOTCMS-LD' is reliable, valid and sensitive .It can used to be estimate the curative effect of TCM for patients with liver disease.