Development And Assessment Of The Liver Disease Scale Of Traditional Chinese Medicine (TCMLD-Scale)

【Backgrouds】The treatment of chronic liver disease is a tough problem.It is known to that the treatment of Traditional Chinese Medicine(TCM) has some dominances in curing symptoms,relieving suffering and improving quality of life.However,there is short of the evaluation of curative effect.It is to approve that the measuring scale is a instrument which is accepted broadly in the quantization of soft indexs and the objective evaluation.In the recent several dozens years,more and more domestic and foreign medicine experts had applied the patient reported outcomes(PRO) in the clinical practice.It is reasonable to put PRO into the evaluation of liver disease curative effect.Thus,it is essential to be established the evaluation of the liver disease scale system.【Objective】In accordance with the process of the developing principle of the PRO scale,which combined Chinese culture characteristics with the theory of TCM that knew liver disease clinical features,and PRO connotation,we would work out Liver Disease PRO Scale of Traditional Chinese Medicine.And through the clinical investigation with large samples and multicentre,we would test the reliability,validity and responsibility of the scale.The Liver Disease PRO Scale of Traditional Chinese Medicine would make the liverish evaluation of curative effect of TCM to be quantified.The scale is going to be used for liverish evaluation of curative effect of TCM,so as to get the messages from hepatopath's allround health status,and help doctors understand the most severe aspect which the disease influences patients, besides it can offer doctors reference and evaluation. So as to formulate therapeutic regimen and direct clinical medication.【Methods】According to PRO scale's developed pdnciple,refered to PRO concept and WHOQOL-100 theoretical construction,combined Chinese culture characteristics with the liver disease clinical features of TCM,we had set up the theoretical model of Liver Disease PRO Scale of Traditional Chinese Medicine.On the basis of the theoretical model, we had inquired 35 patients to form the item pool.Then,experts group classified,combined and splitted the item contents from the item pool,and the items which were important were judged by the experts.The scale was used for pilot survey (cultrue adaptation) after the experts group revised it.Then the scale should be revised again,and it was formed of the pre-questionaire.The pre-questionaire was used in the field investigation.A sample of 310 cases was taken from four areas of GuangDong province (Guangzhou,Foshan,Dongguan, Zhongshan).The sample had covered male and female,healthy people and patients with chronic hepatitis,different situation on education levels,ages,districts,and professions.After using six kinds of statistical methods,including coefficient of variation analysis,factor analysis,cluster analysis,stepwise regressive analysis,discriminatory analysis and internal consistency analysis,55 items were composed of the formal scale.Then the formal scale was tested its reliability, validity and responsibility.Reliability included test-retest reliability, split-half reliability and internal consistency;Validity included content validity, dimension dependablity,multiple linear regression analysis and construct validity;Responsibility distinguished healthy people and patients.【Results】Liver Disease PRO Scale of Traditional Chinese Medicine was mainly composed of 5 domains,13 facets and 56 items.Each Spearman coefficient correlation of the scale's indicator between 0.708 and 0.857,(P=0.000).The scale's Split-half reliability coefficient was 0.884.General scale's Cronbach'sαwas 0.964, five domains' Cronbach'sαwere 0.925,0.914,0.836,0.853,0.791.With respect to dimension dependablity,the depend- ablities of the facets and every item which belong to were better(r＞0.6), the dependablities of the domains and every facet which belong to were better(r all above 0.6,except bleeding facet was 0.543),inter-each facet dependablity analysis showed that between domains and domains,or between each domain and the scale which all had conspicuous correlativities(r＞0.6).About multiple linear regression,the scores of each item,each facet and each domain all contribute to the scale. About construct validity, five factors' cumulative% is 53.133%,the scale's CFI was 0.960,five domains'CFI were 0.990,0.986,0.997,0.994,0.978 respectively.The results of responsibility, every facet and domain had distinguished healthy people and patients effectively.【Conclusion】The scientific assessment had proved that the scale had good reliability, validity and responsibility.The scale could be taken as a standard of evaluation of liverish(chronic hepatitis) curative effect of TCM.The internal structure of the scale's theoretical model existed intimate correlation certainly,thereby it proved the scientific theory of Traditional Chinese Medicine.However,three problems which were in this research should be study deeply.Firstly,the hepatic cirrhosis patients weren't investigated in the investigation,because both hepatic cirrhosis patients and chronic hepatitis patients should be investigated on assumption,the scale could be adapted to hepatic cirrhosis and the chronic hepatitis patients at the same time which was unknown.Secondly,the investigation had area's localization, the scale could be adapted to the patients of different areas which was unknown.Thirdly,we didn't use the scale to follow up the patients'information when pretherapy and post-treatment in the investigation,so that the scale could distinguish the changes of the scale's score of the same individual(or group) followed the time's change which was unknown.The scale will be improved in clinical practice.