Abstract
BackgroundThe aim of the study is to develop a specific patient-reported scale of liver cirrhosis according to the Patient Reported Outcome guidelines of the Food and Drug Administration (FDA), and to examine its capacity to fill gaps in this field.MethodsA conceptual framework was developed and a preliminary item pool developed through literature review and interviews of 10 patients with liver cirrhosis. With the preliminary items, we performed a pilot survey that included a cognitive test with patients and interviews with experts; the focus was on content and language of the scale. In the item selection stage, seven statistical methods including discrete trends method, discrimination analysis, exploratory factor analysis, Cronbach’s α coefficient, correlation coefficient, test-retest reliability, Item-Response Theory were applied to survey data from 200 subjects (150 liver cirrhosis patients and 50 controls). This produced the preliminary Liver Cirrhosis Patient-reported Outcome Measure (LC-PROM). In the next stage, we conducted the survey with 620 subjects (500 patients and 120 controls) to validate reliability, validity and acceptability of this scale.ResultsThe 55 items and 13 dimensions addressed four domains: physical, psychological, social, and therapeutic. Cronbach’s α coefficients were 0.921 for the total scale; the confirmatory factor analysis, t-tests and ANOVA supported scale validity; the model fit index as Root Mean Square Error of Approximation (RMSEA), Root Mean Square Residual (RMR), Normed Fit Index (NFI), Non-Normed Fit Index (NNFI), Comparative Fit Index (CFI) and Incremental Fit Index (IFI) met the criterion generally. The acceptance ratio and response rate indicated good feasibility.ConclusionsThis study developed an accurate and stable patient-reported outcome scale of liver cirrhosis, which is able to evaluate clinical effects effectively, is helpful to patients in recognizing their health condition, and contributes to clinical decision making both for patients and physicians. Additionally, the LC-PROM can perform as an ultimate assessment of medical and health care effects and can inform clinical trials of new drugs for liver cirrhosis.
Highlights
The aim of the study is to develop a specific patient-reported scale of liver cirrhosis according to the Patient Reported Outcome guidelines of the Food and Drug Administration (FDA), and to examine its capacity to fill gaps in this field
The aim of this study is to develop such a patient-reported outcome (PRO) scale that meets the following criteria: (I) specific to liver cirrhosis; (II) addresses all physical symptoms, psychological feelings, daily activities, and therapeutic status related to Liver cirrhosis (LC); (III) comprises items that are founded on the patients’ own perspective; (IV) has good internal consistency, a reasonable theoretical framework and can distinguish different severities of the disease; and (V) is of appropriate length and has strong feasibility
The Liver Cirrhosis Patient-reported Outcome Measure (LC-PROM) focused on 4 domains: Physical (PHD), Psychological (PSD), Social (SOD), and Therapeutic (TRD)
Summary
The aim of the study is to develop a specific patient-reported scale of liver cirrhosis according to the Patient Reported Outcome guidelines of the Food and Drug Administration (FDA), and to examine its capacity to fill gaps in this field. Liver cirrhosis (LC) is a potential consequence of the progression of any of various kinds of liver disease, and the high incidence of hepatitis will lead to a large number of patients suffering from liver cirrhosis. Patients’ health status and treatment effects are evaluated by hepatic function test and serological markers, or reflected by hospital stays and symptom improvement over time. With the continued development of a biopsychosocial medical model the use of scales to assess patients’ fitness has been widely accepted and applied internationally; that is, patients’ personally reported data, dubbed patient-reported outcome (PRO), are used to measure clinical results. One of the arguments for using questionnaires to ask patients to judge their own
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