Development And Evaluation Of The Liver Disease PRO Scale For Liver Cirrhosis Patient

Objective:Through the clinical investigation with large samples and multicentre,test the reliability,validity and responsiveness of the pre-questionaire,the Liver Disease Patient Reported Outcome(PRO)Scale of Traditional Chinese Medicine(TCM)is going to be used for liverish evaluation of curative effect of TCM.Methods:1.on the basis of Chen Feifan' s study,which was Development and Assessment of the Liver Disease scale of Traditional Chinese Meicine (TCMLD-Scale)for chronic liver desease,the pre-questionaire was used in the field investigation.By applying 6 kinds of statistical methods,including the coefficient of variation analysis,factor analysis,cluster analysis, stepwise regressive analysis,Crobach' sαcoefficient analysis and discriminatory analysis,63 items were composed of the formal scale.Then the formal scale was tested its reliability,validity and responsiveness. Reliability included split-half reliability and internal consistency; Validity included content validity,construct validity and discriminated validity.2.On the basis of Luo Shijuan' s study on physical sign scale,two doctors carried on alone separately in the same day to identified the same patient and then filled out the form.Through the T-test and correlation analysis, we assessed the value of the liver disease clinical curative effect physical sign scale in clinical application.Results:1.The Liver Disease(Liver Cirrhosis)PRO Scale of Traditional Chinese Medicine was mainly composed of 5 domains,14 facets and 63 items. The scale's Split-half reliability coefficient was 0.8760,The scale's Split-half reliability coefficient of physiological domain,psychological domain,social relationship domain,environmental domain and independent domain were 0.8901,0.8367,0.8592,0.7022 and 0.6606;The scale's Cronbach'αcoefficient was 0.9712,the Cronbach'αcoefficient of physiological domain, psychological domain,social relationship domain,environmental domain and independent domain were 0.9416,0.9407,0.9093,0.8444,0.7632 respectinely. About construct validity,five factors' dedication rate was 55.241%;every facet and domain had distinguished healthy people and patients effectively (P＜0.05).Responsiveness:there was significant difference between pre and post treatment on blooding,controlling dredging emotion,transporting spleen-stomach,controlling dredging bile,positive feeling,attention, physiological domain and total scores(P＜0.05),the correlation coefficients on the Liver Disease(Liver Cirrhosis)PRO Scale of Traditional Chinese Medicine,subjective response scale and the standard of liver cirrhosis ascites clinical curative effect was smaller than 0.4.2.The result of the physical sign scale which can evaluate the curative effect of TCM for patients with liver disease had statistical significance (P=0.009),with which different doctors give the test for the same patients. By correlation analysis for each patient' s objective items,related coefficient is 0.032-0.938 and 0.174-0.823.Conclusion:The scientific assessment had proved that the Liver Disease (Liver Cirrhosis)PRO Scale of Traditional Chinese Medicine had good reliability,validity and certain responsiveness.It was very effective to test the curative effect of TCM for patients with Liver Disease.On the other hand,because of the different results by giving different doctors the test for the same patients,the scale is inconformity for clinical application.