Health-related quality of life (HRQOL) concerns how well people are able to function and how they feel about physical, mental, and social dimensions of their lives. HRQOL data are most often collected using self-report methods of assessment (e.g., questionnaires or interviews). There are generic and targeted profile measures that yield multiple HRQOL scores as well as preference-based measures that summarize HRQOL in a single score. There are several attributes of good HRQOL measures that include a conceptual model, reliability, validity, interpretation of scores, respondent and administrative burden, alternative assessment modalities, and availability of translations. HRQOL measures are used in research, population surveillance, and in clinical practice. © 2008 Copyright © 2008 Elsevier Inc. All rights reserved.

Background

To better understand symptoms experienced by patients infected with chronic hepatitis C virus (HCV), valid and reliable patient-reported outcome (PRO) measures are needed.

Aim

To assess the reliability and validity of 10 patient-reported outcomes measurement information system (PROMIS) measures and the Headache Impact Test-6 (HIT-6) in a large national sample of patients with HCV.

Methods

Pre-treatment data from 961 patients with HCV starting direct acting antiviral therapy at 11 U.S. liver centers were analyzed. Internal reliability was evaluated using Cronbach's alpha coefficient; frequency distributions were examined for floor and ceiling effects; structural validity was investigated via item-response-theory models; convergent validity was evaluated using correlations with theoretically-similar items from the HCV-PRO and memorial symptom assessment scale (MSAS); and known-groups validity was investigated by observing PRO differences by liver disease status and number of comorbidities.

Results

The HIT-6 and the majority of the PROMIS measures yielded excellent reliability (alphas ≥ 0.87). Ceiling effects were infrequent ( < 4%), while 30%-59% of patients reported no symptoms (floor effects). The data supported structural validity of the HIT-6 and most PROMIS measures. The PROMIS measures showed moderate to strong correlations with theoretically-similar items from the HCV-PRO and MSAS (0.39-0.77). Trends were observed between worse PRO scores and advanced cirrhosis and greater number of comorbidities, lending support for known-groups validity.

Conclusions

The psychometric properties of the HIT-6 and PROMIS measures performed satisfactorily in this large cohort of patients with HCV starting direct acting antiviral therapy. Opportunities exist for further refinement of these PROs. Evaluation of performance over time and in under-represented subgroups is needed.