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

Economic and health-related quality-of-life (HRQoL) comparison of lopinavir/ritonavir (LPV/r) and atazanavir plus ritonavir (ATV+RTV) based regimens for antiretroviral therapy (ART)-naïve and -experienced United Kingdom patients in 2011.

BACKGROUND: Using a United Kingdom (UK)-based National Health Services perspective for 2011 this study first estimated the cost-effectiveness and budget impact implications for lopinavir/ritonavir (LPV/r) vs atazanavir plus ritonavir (ATV+RTV) treatment of antiretroviral therapy (ART)-naïve patients and secondly examined the long-term health-related quality-of-life (HRQoL) and economic implications for LPV/r vs ATV+RTV treatment of ART-experienced patients. METHODS: A previously published Markov model that integrates epidemiological data of human immunodeficiency virus (HIV) with predictors of coronary heart disease (CHD) was modified under a clearly specified set of assumptions to reflect viral load (VL) suppression profiles and other differences for these two regimens, applying results from the CASTLE study in ART-naïve patients and using data from BMS-045 in ART-experienced patients. ART costs were referenced to current (2011) pricing guidelines in the UK. Medical care costs reflected UK treatment patterns and relevant drug pricing. Costs and outcomes were discounted at 3.5% per year. Costs are expressed in British pounds (£) and life expectancy in quality-adjusted life years (QALYs). RESULTS: In the ART-naïve subjects, the model predicted a marginal improved life expectancy of 0.031 QALYs (11 days) for the ATV+RTV regimen as a result of predicted CHD outcomes based on lower increases in cholesterol levels compared with the LPV/r regimen. The model demonstrated cost savings with the LPV/r regimen. The total lifetime cost savings was £4070 per patient for the LPV/r regimen. LPV/r saved £2133 and £3409 per patient at 5 and 10 years, respectively. Referenced to LPV/r, the incremental cost-effectiveness ratio (ICER) for ATV+RTV was £149,270/QALY. For ART-experienced patients VL suppression differences favored LPV/r, while CHD risk associated with elevated total cholesterol marginally favored ATV+RTV, resulting in a net improvement in life expectancy of 0.31 QALYs (106 days) for LPV/r. Five-year costs were £5538 per patient greater for ATV+RTV, with a discounted lifetime saving of £1445 per LPV/r patient. LPV/r was modestly dominant economically, producing better outcomes and cost savings. LIMITATIONS: The limitations of this study include uncertainty related to how well the model's assumptions capture current practice, as well as the validity of the model parameters used. This study was limited to using aggregated data in the public domain from the two clinical trials. Thus, some of the model parameters may reflect limitations due to trial design and data aggregation bias. This study has attempted to illuminate the effect of these limitations by presenting the results of the comprehensive sensitivity analysis. CONCLUSIONS: Based on 2011 costs of HIV in the UK and the published efficacy data from the CASTLE and BMS-045 studies, ATV+RTV-based regimens are not expected to be a cost-effective use of resources for ART-naïve patients similar to patients in the CASTLE study, nor for ART-experienced patients based on the only published comparison of ATV+RTV and LPV/r.

Drugs and the elderly, Part 2: Strategies for improving prescribing in a managed care environment.

OBJECTIVE: In part 1 of "Drugs and the Elderly" (December 2000 issue), we reviewed and summarized the vast amount of clinical information on medication use in the elderly for healthcare providers and administrators within managed care. In part 2, we explore the literature on improving prescribing, focusing on those approaches most likely to be useful within a managed care environment. STUDY DESIGN: We reviewed the general literature on medication use in the elderly, focusing on problems and systems approaches to the improvement of medication use in managed care. We created a topic list of general interest to health professionals within managed care and fit the available information into those topics. Thus, the result is an authoritative review rather than a systematic literature review. PATIENTS AND METHODS: Nonquantitative evaluation of the medical literature. RESULTS: We identified several hundred articles describing issues related to medication use in the elderly but only a trivial number that in any way addressed the managed care community directly. There is very little literature on how managed care can best incorporate the lessons of geriatric pharmacology and pharmacy. CONCLUSIONS: There is a paucity of literature for the managed care community of health professionals regarding pharmacology, pharmacoepidemiology, drug utilization review, and other issues related to the use of medication in the elderly population.

Drugs and the elderly, Part 1: The problems facing managed care.

OBJECTIVE: In part 1 of "Drugs and the Elderly," we review and summarize the vast amount of clinical information on medication use in the elderly for healthcare providers and administrators within managed care. In part 2, we explore the literature on improving prescribing, focusing on those approaches most likely to be useful within a managed care environment. STUDY DESIGN: We reviewed the general literature on medication use in the elderly, focusing on problems and systems approaches to the improvement of medication use in managed care. We created a topic list of general interest to health professionals within managed care and fit the available information into those topics. Thus, the result is an authoritative review rather than a systematic literature review. PATIENTS AND METHODS: Nonquantitative evaluation of the medical literature. RESULTS: We identified several hundred articles describing issues related to medication use in the elderly but only a trivial number that in any way addressed the managed care community directly. There is very little literature on how managed care can best incorporate the lessons of geriatric pharmacology and pharmacy. CONCLUSIONS: There is a paucity of literature for the managed care community of health professionals regarding pharmacology, pharmacoepidemiology, drug utilization review, and other issues related to the use of medication in the elderly population.

Pharmacy student expectations for professional practice.

The professional employment market for pharmacists has changed radically in recent years. Additionally, data regarding perception of future practice among pharmacy students are limited. The purpose of this study was to characterize expectations for professional practice among pharmacy students and to identify curriculum support at a college of pharmacy. A survey examining student educational experiences, career preferences, and demographic variables was distributed to 1,297 students enrolled in the first to sixth year. Six hundred thirty responses were evaluated. Doctor of Pharmacy students indicated that their education better prepared them for their expected career than did Bachelor of Science students (P < .03). The former also had a more positive outlook regarding future career opportunities than the latter (P < .01) and indicated to a greater extent that HMOs and pharmacy benefit management companies are growing sources of employment for pharmacists (P < .001).