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. 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: 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.

journal_name

Aliment Pharmacol Ther

authors

Szeinbach SL,Baran RW,Dietz B,Gazzouola Rocca L,Littlefield D,Yawn BP

doi

10.1111/apt.12202

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

573-82

issue

5

eissn

0269-2813

issn

1365-2036

journal_volume

37

pub_type

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