title: Development and validation of the chronic hepatitis C virus treatment satisfaction (HCVTSat) instrument.
abstract: BACKGROUND
  While current medications used to treat patients with chronic hepatitis C virus (HCV) effectively produce sustained viral response (SVR), postponement of therapy is often times attributed to patient perceptions of unfavourable outcomes. However, an instrument to assess patient perceptions of therapy (i.e. treatment satisfaction) has not been developed.
  
  
  OBJECTIVE
  To describe the development and validation the chronic Hepatitis C Virus Treatment Satisfaction (HCVTSat) instrument.
  
  
  METHODS
  Focus groups, expert review and cognitive debriefing were used to develop a draft 37-item instrument (scale: 1 = not important at all; 5 = extremely important). The preliminary instrument was administered to a pre-test sample of 145 patients through Mayo Clinic, Rochester, MN. A refined HCVTSat was administered to a main sample of 333 participants with a chronic HCV diagnosis through Harris Interactive.
  
  
  RESULTS
  The HCVTSat was completed by 333 participants with an average age of 51 (s.d. = 12.1) years, 55% male, current or previous HCV treatment experience, and a diagnosis of HCV for approximately 12 (s.d. = 8.9) years. Twelve items for the 3 dimensions, Treatment Experience (TE), Side Effects (SE) and Social Aspects (SA), were internally consistent (Cronbach's α range: 0.70-0.90), responsive and valid. Confirmatory factor analysis (goodness-of-fit indexes: χ(2) = 20.9, df = 23, P = 0.59; CFI = 1.00, GFI = 0.99, TFI = 1.00, RMSEA = 0.001) revealed a better fit with 9 items. All path coefficients were significant (P < 0.05). SE and SA were strong predictors of TE, while TE was positively associated with the 1-item global measure of TS (path coefficient = 0.12).
  
  
  CONCLUSIONS
  The 10-item HCVTSat demonstrated valid psychometric properties and assessed patient satisfaction with HCV therapies. However, additional studies are needed to validate the HCVTSat in conjunction with SVR and in patients in underrepresented populations.
authors.affiliation: College of Pharmacy, Ohio State University, Columbus, USA. szeinbach.1@osu.edu
authors.forename: S L
authors.initials: SL
authors.lastname: Szeinbach
authors.forename: R W
authors.initials: RW
authors.lastname: Baran
authors.forename: B
authors.initials: B
authors.lastname: Dietz
authors.forename: L
authors.initials: L
authors.lastname: Gazzouola Rocca
authors.forename: D
authors.initials: D
authors.lastname: Littlefield
authors.forename: B P
authors.initials: BP
authors.lastname: Yawn
mesh_terms: D000328:Adult; D000368:Aged; D004358:Drug Therapy / Q000523:psychology; D005260:Female; D017144:Focus Groups; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D055815:Young Adult