Development and initial psychometric evaluation of the hepatitis C virus-patient-reported outcomes (HCV-PRO) instrument
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Chronic hepatitis C virus (HCV) infection is an important public health issue owing to its worldwide prevalence and its profound effects on patients’ well-being and function. We developed a new patient self-report tool, the HCV patient-reported outcomes (HCV-PRO) instrument, to assess patients’ function and well-being reflecting both HCV disease and treatment burdens.
Items were developed through a qualitative phase including scientific literature review, expert appraisal, and semi-structured patient interviews. The item pool was initially psychometrically tested in 60 adult HCV patients, 18 years of age or older at a university hepatology clinic. A final psychometric test was conducted in 241 members of the online Harris International Panel to examine scale reliability, confirm factor structure, and assess convergent and discriminant validity.
A single-factor 16-item HCV-PRO instrument demonstrated good model fit. The HCV-PRO items and total score (range 0–100) showed excellent item response (few floor and ceiling effects) and reliability (alpha > 0.90). Convergent validity was established from moderate to high (r > 0.50) correlation with symptom burden, life satisfaction (ladder of life), and SF-36v2 scales scores. Mean HCV-PRO scores differentiated between currently treated patients, those previously treated, and patients never treated (p < 0.01), suggesting strong known-groups validity.
The results provide initial evidence that the HCV-PRO can yield reliable and valid measurement of the effects of HCV and its treatment on the well-being and function of HCV-infected patients.
KeywordsPsychometric methods Questionnaires Health status Quality of life
Medical writing and editing services were provided by Amanda Perry, BA Palmyra PA, and Fabian Camacho MS Hershey PA for statistical support. Medical writing support was funded by Abbott Laboratories Inc., Abbott Park, Illinois.
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