title: Development and initial psychometric evaluation of the hepatitis C virus-patient-reported outcomes (HCV-PRO) instrument.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Public Health Sciences, Pennsylvania State University, Suite 2300, 600 Centerview Drive, Hershey, PA, 17033, USA, rtanders@psu.edu.
authors.forename: Roger T
authors.initials: RT
authors.lastname: Anderson
authors.forename: Robert W
authors.initials: RW
authors.lastname: Baran
authors.forename: Birgitta
authors.initials: B
authors.lastname: Dietz
authors.forename: Eric
authors.initials: E
authors.lastname: Kallwitz
authors.forename: Pennifer
authors.initials: P
authors.lastname: Erickson
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006304:Health Status; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D015203:Reproducibility of Results; D057566:Self Report; D011795:Surveys and Questionnaires; D055815:Young Adult