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Original Article

Development and validation of the chronic hepatitis C virus treatment satisfaction (HCVTSat) instrument

  1. S. L. Szeinbach1,*,
  2. R. W. Baran2,
  3. B. Dietz3,
  4. L. Gazzouola Rocca4,
  5. D. Littlefield4,
  6. B. P. Yawn4

Article first published online: 7 JAN 2013

DOI: 10.1111/apt.12202

Issue

Alimentary Pharmacology & Therapeutics

Alimentary Pharmacology & Therapeutics

Volume 37, Issue 5, pages 573–582, March 2013

Additional Information

How to Cite

Aliment Pharmacol Ther 2013; 37: 573–582

Author Information

  1. 1

    College of Pharmacy, Ohio State University, Columbus, OH, USA

  2. 2

    Global Health Economics and Outcomes Research, Abbott Laboratories, Abbott Park, IL, USA

  3. 3

    Global Health Economics and Outcomes Research, Abbott GmbH & Co. KG, Ludwigshafen, Germany

  4. 4

    Department of Research, Olmsted Medical Center, Rochester, MN, USA

* Correspondence to:
Prof. S. L. Szeinbach, College of Pharmacy, 500 West 12th Avenue, Room 136A, Ohio State University, Columbus, OH 43210, USA.
E-mail: Szeinbach.1@osu.edu

Publication History

  1. Issue published online: 1 FEB 2013
  2. Article first published online: 7 JAN 2013
  3. Manuscript Revised: 14 DEC 2012
  4. Manuscript Accepted: 14 DEC 2012
  5. Manuscript Revised: 27 NOV 2012
  6. Manuscript Received: 10 NOV 2012

Funded by

  • Abbott Laboratories

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Summary

Background

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.

Aim

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: 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).

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.

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