A QUESTIONNAIRE TO ASSESS THE GENERIC AND DISEASE-SPECIFIC HEALTH OUTCOMES OF PATIENTS WITH CHRONIC HEPATITIS-C

A 69-item questionnaire measuring generic functioning and well-being a nd disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) parti cipating in two randomized trials of interferon alpha-2b (n = 157). Th e questionnaire included all eight scales from the SF-36 and measures of nine other generic and disease-specific health concepts. Psychometr ic tests confirmed the assumptions underlying the construction and sco ring of all generic and disease-specific scales. Cross-sectional tests of 'known groups' validity showed that CHC patients scored worse on t he generic scales than patients with other chronic conditions and wors e than a healthy general population. The generic and disease-specific scale scores were lower in the presence of physical findings of CHC, a s hypothesized, but only the physical functioning and bodily pain scal es were linked to cirrhosis or extreme alanine aminotransferase (ALT) ratios. This instrument will be useful in studies of health outcome am ong patients with CHC, a condition whose health burden appears to have been underestimated in studies to date.