The development process followed fo

The development process followed for the CLDQ-NAFLD wasnot clearly described in the study report and so it does not meetthe most recent standards for PROM development. In particular,the concept elicitation stage involving patients is not describedand the rationale for the selection of 75 original items is notexplained. Construct validity was however reported to beadequate; worse scores being correlated with increased diseaseseverity in all scales. Correlations were reported between theactivity, emotional, fatigue and systemic symptoms domains ofCLDQ-NAFLD and similar domains of SF-36, providing evidenceof convergent validity of the measure. In patients with NAFLD,the CLDQ-NAFLD was able to discriminate between those withobesity, type 2 diabetes and metabolic syndrome, but no evidence was presented of a difference between cirrhotic and noncirrhotic patients.59 The Cronbach’s alpha coefficient was reported to be between 0.74 and 0.9 suggesting good to excellentinternal consistency of the domains. Test-retest reliability datacame from a small subgroup of patients (n = 27) and so may lacksufficient statistical power to detect differences. Furthermore, noformal evidence of content validity for a NASH population hasbeen published to date