Development and validation of the chronic hepatitis C virus treatment satisfaction (HCVTSat) instrument
Article first published online: 7 JAN 2013
© 2013 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 37, Issue 5, pages 573–582, March 2013
How to Cite
Aliment Pharmacol Ther 2013; 37: 573–582
- Issue published online: 1 FEB 2013
- Article first published online: 7 JAN 2013
- Manuscript Revised: 14 DEC 2012
- Manuscript Accepted: 14 DEC 2012
- Manuscript Revised: 27 NOV 2012
- Manuscript Received: 10 NOV 2012
- Abbott Laboratories
While current medications used to treat patients with chronic hepatitis C virus (HCV) effectively produce sustained viral response (SVR), postponement of therapy is oftentimes attributed to patient perceptions of unfavourable outcomes. However, an instrument to assess patient perceptions of therapy (i.e. treatment satisfaction) has not been developed.
To describe the development and validation the chronic Hepatitis C Virus Treatment Satisfaction (HCVTSat) instrument.
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.
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: χ2 = 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).
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.