Development Of Patient-reported Outcomes Instrument For Cirrhosis Of The Liver And Determine The Minimal Clinical Important Difference

Objective: According to the principle and processes of PRO instrument which is made by U.S.Food and Drug Administration (FDA), from the perspective of patients, develop an instrumentfor cirrhosis of the liver after writing, screening and assessment the item. And calculating theMCID to explain the score changes of PRO, So that this scale is applicable to the clinicaltreatment evaluation and clinical trial of new medicines.Method: According with the international norms of PRO instrument development standard andprocedures, the framing theory and the item pool are formed through reading previous documentand literature, and through consulting and patients, significant information of cirrhosis wasgained. And then the scale draft was formed after the correction of items in the aspect of expertsand patients. This scale was used for trial investigation in8different levels hospitals of Shaxi,and those copies were collected for correction of item selection and dimention by using theclassical test theory and item response theory (IRT), and primary scale was formed. Finnally,make use of the primary scale to do the massive investigation and using the seven methords asbefore to correct the items, the final scale was formed, and the reliability, validity wereanalysized. Surveying of100patients by using the final scale, calculate the mean scoredifference between a slight chang group and not changed group, called MCID.Results:1.The rating scale based on patient-reported outcomes suitable for cirrhosis was formedwith50items,10dimensions, and4domains. The pysical field included five dimensions, theyare abdominal symptoms, skin symptoms, appetite and sleep, cognitive function, independence;the psychological field included three dimensions,they are anxiety and depression, confidence,disease outcomes; the social field included two dimensions, they are social support, socialadaptation; therapeutic fields included two dimensions, they are satisfaction, compliance, drugside effects.2. The assessment of the reliability and validity are conducted. Reliability which wereverified by Cronbach coefficient with0.921of total scale. Structural validity result shows thatalmost the indicators of model fitting fulfilled the reference standars.3. We finally determine the the minimal clinical important difference. MCIDwhich were verifiedwith7.06of the physical field,4.65of the psychological field,3.02of the social field, and2.08of the therapeutic fields.Conclusion：The results show that the scale based on patient-reported outcomes for cirrhosis ofthe liver we have developed has good reliability and alidity and determine the MCID. This scale can be used as a tool of evaluation studies of the clinical efficacy of cirrhosis of the liver.