Letter: new treatments for hepatitis C have implications for quality of life in people who inject drug – authors' reply

Stepanova, Maria; Younossi, Zobair M.

doi:10.1111/apt.13545

Cited by 1 publication

(1 citation statement)

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“…These PROs were chosen to capture a range of burdensome symptoms; however it would be interesting to explore positive patient experiences after being cured of HCV, that are not captured by these surveys (eg, positive growth, psychological freedom, happiness) that are not just the absence of symptoms, but altogether different human experiences. Future studies might evaluate the responsiveness of the PRO measures over time and in other patient subpopulations who might have worse symptomatology (eg, patients with certain sociodemographic characteristics or those with alcohol, drug use and mental health issues) …”

Section: Discussionmentioning

confidence: 99%

Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy

Evon

Amador

Stewart

et al. 2018

Aliment Pharmacol Ther

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Summary 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.

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Section: Discussionmentioning

confidence: 99%