The Chronic HCV Treatment Satisfaction Instrument
The Chronic HCV Treatment Satisfaction Instrument
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: χ = 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.
Chronic hepatitis C virus (HCV) affects more than 170 million people worldwide and is a leading cause of chronic liver disease and hepatocellular carcinoma for an estimated 3–5 million people infected with HCV throughout the United States. While pegylated interferon alfa and ribavirin provide a foundation for chronic HCV treatment, patient response to therapy varies as a function of time from diagnosis and appears to be linked to the extent of liver fibrosis, cirrhosis and baseline risk for developing hepatocellular carcinoma. Long-term effects from HCV negatively impact patient perceptions of health; however, side effects from pegylated interferon and ribavirin therapy (including anemia, fatigue, headache, upset stomach, depression, irritability, loss of appetite, difficulty with glucose control, skin reactions and insomnia) may cause patients to postpone, avoid or stop therapy. While the most recently approved regimens for chronic HCV that combine pegylated interferon and ribavirin with direct-acting-antiviral (DAA) agents are expected to improve patient outcomes, these agents also expose patients to risks of blood dyscrasia, rash, pruritis, depression and anxiety.
Considering these issues as well as other presentations (e.g. co-morbidities, alcohol, and drug abuse) frequently encountered in patients with chronic HCV, the ability to assess satisfaction with therapy could provide an opportunity to help patients overcome therapeutic challenges, reduce their reluctance to initiate and continue therapy, and improve long-term survival. Moreover, as the paradigm shifts from interferon containing regimens to newer, all oral, DAA regimens with potentially less side effect profiles and improved clinical efficacy, the development of an instrument to assess treatment satisfaction may provide prescribers with a decision tool to guide treatment choice and patient progress in a potentially complex treatment environment. The recent proposal by the Center for Disease Control and Prevention to mandate 1-time HCV screening for the 1945–1965 birth cohort would potentially identify significant numbers of additional patients for treatment and further emphasise the need to evaluate the acceptability of therapy
Patient-reported outcome (PRO) instruments are commonly used to understand how treatment satisfaction is influenced by patient perceptions of their experience with therapy. The focus on satisfaction with therapy is a natural evolution of previous constructs assessing satisfaction with the healthcare system, healthcare services and patient access to care. Conceptually, treatment satisfaction represents a culmination of experiences (e.g. perceptions of treatment, satisfaction with therapy) related to patient expectations, intentions to continue treatment, effectiveness, side effects and the impact of treatment at higher levels of cognitive functioning. Besides treatment satisfaction, patient responses to other PRO measures related to health-related quality of life and patient care are commonly used to assess functional status during and following HCV therapy. Although treatment satisfaction has been examined in other chronic disease states, there are no instruments available that use a psychometric approach to examine the effects of therapy on treatment satisfaction for patients with chronic HCV. In this study, we describe the development and validation of the Chronic Hepatitis C Virus Treatment Satisfaction (HCVTSat) Instrument to assess treatment satisfaction for patients with chronic HCV.
Abstract and Introduction
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 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: χ = 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.
Introduction
Chronic hepatitis C virus (HCV) affects more than 170 million people worldwide and is a leading cause of chronic liver disease and hepatocellular carcinoma for an estimated 3–5 million people infected with HCV throughout the United States. While pegylated interferon alfa and ribavirin provide a foundation for chronic HCV treatment, patient response to therapy varies as a function of time from diagnosis and appears to be linked to the extent of liver fibrosis, cirrhosis and baseline risk for developing hepatocellular carcinoma. Long-term effects from HCV negatively impact patient perceptions of health; however, side effects from pegylated interferon and ribavirin therapy (including anemia, fatigue, headache, upset stomach, depression, irritability, loss of appetite, difficulty with glucose control, skin reactions and insomnia) may cause patients to postpone, avoid or stop therapy. While the most recently approved regimens for chronic HCV that combine pegylated interferon and ribavirin with direct-acting-antiviral (DAA) agents are expected to improve patient outcomes, these agents also expose patients to risks of blood dyscrasia, rash, pruritis, depression and anxiety.
Considering these issues as well as other presentations (e.g. co-morbidities, alcohol, and drug abuse) frequently encountered in patients with chronic HCV, the ability to assess satisfaction with therapy could provide an opportunity to help patients overcome therapeutic challenges, reduce their reluctance to initiate and continue therapy, and improve long-term survival. Moreover, as the paradigm shifts from interferon containing regimens to newer, all oral, DAA regimens with potentially less side effect profiles and improved clinical efficacy, the development of an instrument to assess treatment satisfaction may provide prescribers with a decision tool to guide treatment choice and patient progress in a potentially complex treatment environment. The recent proposal by the Center for Disease Control and Prevention to mandate 1-time HCV screening for the 1945–1965 birth cohort would potentially identify significant numbers of additional patients for treatment and further emphasise the need to evaluate the acceptability of therapy
Treatment Satisfaction
Patient-reported outcome (PRO) instruments are commonly used to understand how treatment satisfaction is influenced by patient perceptions of their experience with therapy. The focus on satisfaction with therapy is a natural evolution of previous constructs assessing satisfaction with the healthcare system, healthcare services and patient access to care. Conceptually, treatment satisfaction represents a culmination of experiences (e.g. perceptions of treatment, satisfaction with therapy) related to patient expectations, intentions to continue treatment, effectiveness, side effects and the impact of treatment at higher levels of cognitive functioning. Besides treatment satisfaction, patient responses to other PRO measures related to health-related quality of life and patient care are commonly used to assess functional status during and following HCV therapy. Although treatment satisfaction has been examined in other chronic disease states, there are no instruments available that use a psychometric approach to examine the effects of therapy on treatment satisfaction for patients with chronic HCV. In this study, we describe the development and validation of the Chronic Hepatitis C Virus Treatment Satisfaction (HCVTSat) Instrument to assess treatment satisfaction for patients with chronic HCV.
