Published estimates of liver fibrosis progression in individuals with chronic hepatitis C virus (HCV) infection are heterogeneous. We aimed to estimate stage‐specific fibrosis progression rates and ...their determinants in these individuals. A systematic review of published prognostic studies was undertaken. Study inclusion criteria were as follows: (1) presence of HCV infection determined by serological assays; (2) available information about age at assessment of liver disease or HCV acquisition; (3) duration of HCV infection; and (4) histological and/or clinical diagnosis of cirrhosis. Annual stage‐specific transition probabilities (F0→F1, … , F3→F4) were derived using the Markov maximum likelihood estimation method and a meta‐analysis was performed. The impact of potential covariates was evaluated using meta‐regression. A total of 111 studies of individuals with chronic HCV infection (n = 33,121) were included. Based on the random effects model, the estimated annual mean (95% confidence interval) stage‐specific transition probabilities were: F0→F1 0.117 (0.104–0.130); F1→F2 0.085 (0.075–0.096); F2→F3 0.120 (0.109–0.133); and F3→F4 0.116 (0.104–0.129). The estimated prevalence of cirrhosis at 20 years after the infection was 16% (14%–19%) for all studies, 18% (15%–21%) for cross‐sectional/retrospective studies, 7% (4%–14%) for retrospective‐prospective studies, 18% (16%–21%) for studies conducted in clinical settings, and 7% (4%–12%) for studies conducted in nonclinical settings. Duration of infection was the most consistent factor significantly associated with progression of fibrosis. Conclusion: Our large systematic review provides increased precision in estimating fibrosis progression in chronic HCV infection and supports nonlinear disease progression. Estimates of progression to cirrhosis from studies conducted in clinical settings were lower than previous estimates. (HEPATOLOGY 2008.)
Breast cancer (BrC) and its treatments impair health-related quality of life (HRQoL). Utility is a measure of HRQoL that includes preferences for health outcomes, used in treatment decision-making. ...Generic preference-based instruments lack BrC-specific concerns, indicating the need for a BrC-specific preference-based instrument. Our objective was to determine dimensions of the European Organisation for Research and Treatment of Cancer (EORTC) general cancer (QLQ-C30) and breast module (BR45) instruments, the first step in our development of the novel Breast Utility Instrument (BUI).
Patients (n = 408) attending outpatient BrC clinics at an urban cancer centre, and representing a spectrum of BrC health states, completed the QLQ-C30 and BR45. We performed confirmatory factor analysis of the combined QLQ-C30 and BR45 using mean-and variance-adjusted unweighted least squares estimation. The hypothesized factor model was based on clinical relevance, item distributions, missing data, item-importance, and internal reliability of dimensions. Models were evaluated based on global and item fit, local areas of strain, and likelihood ratio tests of nested models.
Our final model had 10 dimensions: physical and role functioning, emotional functioning, social functioning, body image, pain, fatigue, systemic therapy side effects, sexual functioning and enjoyment, arm and breast symptoms, and endocrine therapy symptoms. Good overall model fit was achieved: χ2/df: 1.45, Tucker-Lewis index: 0.946, comparative fit index: 0.951, standardized root-mean-square residual: 0.069, root-mean-square error of approximation: 0.033 (0.030-0.037). All items had salient factor loadings (λ>0.4, p<0.001).
We identified important BrC HRQoL dimensions to develop the BUI, a BrC-specific preference-based instrument.
To estimate stage-specific transition probabilities in individuals coinfected with HIV and hepatitis C virus (HCV), to examine the effect of covariates on these rates, and to investigate the effect ...of HIV on HCV-related cirrhosis in the era of highly active antiretroviral therapy (HAART).
Systematic review of natural history studies among HCV-infected individuals.
Markov maximum likelihood estimation method was used to estimate stage-specific transition probabilities. A meta-analysis was performed to obtain pooled transition probabilities, and a meta-regression to investigate the impact of covariates on these rates. Risk of cirrhosis between individuals monoinfected with HCV and coinfected with HIV/HCV were compared by HAART status.
The estimated mean (95% confidence intervals) annual transition probabilities of 3567 individuals coinfected with HIV/HCV (n = 17 studies) were as follows: fibrosis stage (F) F0 --> F1 0.122 (0.098-0.153); F1 --> F2 0.115 (0.095-0.140); F2 --> F3 0.124 (0.097-0.159); and F3 --> F4 0.115 (0.098-0.135) units/year. The prevalence of cirrhosis after 20 and 30 years of HCV infection was 21% (16-28%) and 49% (40-59%), respectively. Longer duration of HCV infection was significantly associated with slower rate of fibrosis progression. The overall rate ratio of cirrhosis between individuals coinfected with HIV/HCV and monoinfected with HCV (n = 27 studies) was 2.1 (1.5-3.0), 2.5 (1.8-3.4) in the non-HAART group, and 1.7 (1.1-2.8) in the HAART group.
The rate of fibrosis progression among individuals coinfected with HIV/HCV appears constant. Our results confirm that chronic hepatitis C outcomes are worse among coinfected individuals. Over the period studied, HAART did not appear to fully correct the adverse effect of HIV infection on HCV prognosis.
Utility is a single-value, preference-based measure of health-related quality of life that represents the desirability of a health state relative to being dead or in perfect health. Clinical, ...funding, and policy decisions rely on measured changes in utility. The benefit of hearing loss treatments may be underestimated because existing utility measures fail to capture important changes in quality of life associated with hearing loss.
To develop a comprehensive profile of items that describe how quality of life is associated with hearing loss and its treatments that can be used to generate hearing-related quality of life measures, including a novel utility measure.
This qualitative study, performed from August 1, 2018, to August 1, 2019, in tertiary referral centers, comprised a systematic literature review, focus groups, and semistructured interviews. The systematic review evaluated studies published from 1982 to August 1, 2018. Focus groups included 8 clinical experts experienced in the measurement, diagnosis, treatment, and rehabilitation of hearing loss. Semistructured interviews included 26 adults with hearing loss recruited from an institutional data set and outpatient hearing aid and otology clinics using stratified convenience sampling to include individuals of diverse ages, urban and rural residency, causes of hearing loss, severity of hearing loss, and treatment experience.
A set of items and subdomains that collectively describe the association of hearing loss with health-related quality of life.
The literature search yielded 2779 articles from the MEDLINE, Embase, Cochrane, PsycINFO, and CINAHL databases. Forty-five studies including 1036 individuals (age range, 18-84 years) were included. The focus group included 4 audiologists and 4 otologists. Hour-long semistructured interviews were conducted with 26 individuals (13 women; median age, 54 years; range, 25-83 years) with a broad range of hearing loss causes, configurations, and severities. From all 3 sources, a total of 125 items were generated and organized into 29 subdomains derived from the World Health Organization's International Classification of Functioning, Disability and Health.
The association of hearing loss with quality of life is multidimensional and includes subdomains that are not considered in the estimation of health utility by existing utility measures. The presented comprehensive profile of items can be used to generate or evaluate measures of hearing-related quality of life, including utility measures.
Abstract
Managing chronic hepatitis C is challenging, as the majority of those infected are asymptomatic. Therefore, to ensure treatments are administered before the onset of severe complications, ...screening is important. In Canada, uncertainty regarding the cost-effectiveness and budget impact of screening has led to conflicting recommendations. The objective of this study is to estimate the cost-effectiveness and budget-impact of one-time HCV screening. A state-transition model was developed to evaluate the cost-effectiveness and budget-impact between a risk-based screening strategy (current-practice) and a one-time screening strategy on three different birth-cohorts. Cost and prevalence data were obtained from administrative data. Progression and utility data were based on recent systematic reviews. We used a provincial payer-perspective, life-time time-horizon and a 1.5% discount rate for the cost-effectiveness analysis, and used a 10-year time-horizon and no discounting for the budget-impact analysis. One-time screening strategy would cost more and provide more health benefits than the risk-based screening for all birth cohorts. For those born after 1964, the incremental-cost-effectiveness-ratio (ICER) per quality-adjusted-life-year (QALY) of screening versus current-practice varied from $27,422/QALY to $42,191/QALY across different provinces. One-time screening of the cohort would cost an additional $2 million to $236 million across different provinces. For those born 1945–1964, the ICER of screening versus current-practice varied from $35,217/QALY to $48,197/QALY across different provinces. For the cohort born before 1945, the ICER of screening versus current-practice was not cost-effective at a willingness-to-pay threshold of $50,000/QALY across all provinces. Our cost-effectiveness analysis suggests that a one-time HCV screening program for those born after 1945 is cost-effective. Considering the budget impact relative to other funded recommended health services and technologies, HCV screening could be considered affordable.
Objective
To evaluate the cost‐effectiveness of using a surgery, such as transurethral resection of the prostate (TURP) or photoselective vaporisation of the prostate using greenlight laser (GL‐PVP), ...as initial treatment for men with moderate‐to‐severe benign prostate hyperplasia (BPH) compared to the standard practice of using pharmacotherapy as initial treatment followed by surgery if symptoms do not resolve.
Patients and Methods
We compared a combination of eight strategies involving upfront pharmacotherapy (i.e., α‐blocker, 5α‐reductase inhibitor, or combination) followed by surgery (e.g. TURP or GL‐PVP) upon failure vs TURP or GL‐PVP as initial treatment, for a target population of men with moderate‐to‐severe BPH symptoms, with a mean age of 65 years and no contraindications for treatment. A microsimulation decision‐analytic model was developed to project the costs and quality‐adjusted life years (QALYs) of the target population over the lifetime. The model was populated and validated using published literature. Incremental cost‐effectiveness ratios (ICERs) were determined. Cost‐effectiveness was evaluated using a public payer perspective, a lifetime horizon, a discount rate of 1.5%, and a cost‐effectiveness threshold of $50 000 (Canadian dollars)/QALY. Sensitivity and probabilistic analyses were performed.
Results
All options involving an upfront pharmacotherapy followed by TURP for those who fail were economically unattractive compared to strategies involving a GL‐PVP for those who fail, and compared to using either BPH surgery as initial treatment. Overall, upfront TURP was the most costly and effective option, followed closely by upfront GL‐PVP. On average, upfront TURP costs $1015 more and resulted in a small gain of 0.03 QALYs compared to upfront GL‐PVP, translating to an incremental cost per QALY gained of $29 066. Results were robust to probabilistic analysis.
Conclusions
Surgery is cost‐effective as initial therapy for BPH. However, the health and economic evidence should be considered concurrently with patient preferences and risk attitudes towards different therapy options.
High orphan drug prices have gained the attention of payers and policy makers. These prices may reflect the need to recoup the cost of drug development from a small patient pool. However, estimates ...of the cost of orphan drug development are sparse.
Using publicly available data, we estimated the differences in trial characteristics and clinical development costs with 100 orphan and 100 non-orphan drugs.
We found that the out-of-pocket clinical costs per approved orphan drug to be $166 million and $291 million (2013 USD) per non-orphan drug. The capitalized clinical costs per approved orphan drug and non-orphan drug were estimated to be $291 million and $412 million respectively. When focusing on new molecular entities only, we found that the capitalized clinical cost per approved orphan drug was half that of a non-orphan drug.
More discussion is needed to better align on which cost components should be included in research and development costs for pharmaceuticals.
The aim of our study was to assess the initial impact of COVID-19 on total publicly-funded direct healthcare costs and health services use in two Canadian provinces, Ontario and British Columbia ...(BC). This retrospective repeated cross-sectional study used population-based administrative datasets, linked within each province, from January 1, 2018 to December 27, 2020. Interrupted time series analysis was used to estimate changes in the level and trends of weekly resource use and costs, with March 16-22, 2020 as the first pandemic week. Also, in each week of 2020, we identified cases with their first positive SARS-CoV-2 test and estimated their healthcare costs until death or December 27, 2020. The resources with the largest level declines (95% confidence interval) in use in the first pandemic week compared to the previous week were physician services Ontario: -43% (-49%,-37%); BC: -24% (-30%,-19%) (both p<0.001) and emergency department visits Ontario: -41% (-47%,-35%); BC: -29% (-35%,-23%) (both p<0.001). Hospital admissions declined by 27% (-32%,-23%) in Ontario and 21% (-26%,-16%) in BC (both p<0.001). Resource use subsequently rose but did not return to pre-pandemic levels. Only home care and dialysis clinic visits did not significantly decrease compared to pre-pandemic. Costs for COVID-19 cases represented 1.3% and 0.7% of total direct healthcare costs in 2020 in Ontario and BC, respectively. Reduced utilization of healthcare services in the overall population outweighed utilization by COVID-19 patients in 2020. Meeting the needs of all patients across all services is essential to maintain resilient healthcare systems.
Valuing Health State: An EQ-5D-5L Value Set for Ethiopians Welie, Abraham G.; Gebretekle, Gebremedhin Beedemariam; Stolk, Elly ...
Value in health regional issues,
September 2020, 2020-Sep, 2020-09-00, 20200901, Letnik:
22
Journal Article
Recenzirano
Odprti dostop
There is a growing interest in health technology assessment and economic evaluations in developing countries such as Ethiopia. The objective of this study was to derive an EQ-5D-5L value set from the ...Ethiopian general population to facilitate cost utility analysis.
A nationally representative sample (N = 1050) was recruited using a stratified multistage quota sampling technique. Face-to-face, computer-assisted interviews using the EuroQol Portable Valuation Technology (EQ-PVT) protocol of composite time trade-off (c-TTO) and discrete choice experiments (DCEs) were undertaken to elicit preference scores. The feasibility of the EQ-PVT protocol was pilot tested in a sample of the population (n = 110). A hybrid regression model combining c-TTO and DCE data was used to estimate the final value set.
In the pilot study, the acceptability of the tasks was good, and there were no special concerns with undertaking the c-TTO and DCE tasks. The coefficients generated from a hybrid model were logically consistent. The predicted values for the EQ-5D-5L ranged from −0.718 to 1. Level 5 anxiety/depression had the largest impact on utility decrement (−0.458), whereas level 5 self-care had the least impact (−0.222). The maximum predicted value beyond full health was 0.974 for the 11112 health state.
This is the first EQ-5D-5L valuation study in Africa using international valuation methods (c-TTO and DCE) and also the first using the EQ-PVT protocol to derive a value set. We expect that the availability of this value set will facilitate health technology assessment and health-related quality-of-life research and inform policy decision making in Ethiopia.
•There is a growing interest in health technology assessment and economic evaluation in low-resource settings such as Ethiopia.•This study developed a value set for the EQ-5D-5L using an Ethiopian general population sample with the EuroQol Group–Portable Valuation Technology (EQ-PVT) protocol administered in Amharic.•The new value set provides local users with societal preferences that are relevant.•The study also established the feasibility of using the less resource-intensive EQ-PVT, which is relevant for future studies.
The long‐term effects of direct‐acting antiviral therapies (DAAs) for chronic hepatitis C (CHC) remain uncertain. The objective of this systematic review and meta‐analysis was to assess the impact of ...DAAs on CHC progression and mortality. We searched Ovid MEDLINE, Ovid EMBASE and PubMed databases (January 2011 to March 2020) for studies that compared the efficacy of DAAs to a non‐DAA control in patients with CHC. Main outcomes were the adjusted hazard ratios (HRs) for mortality, liver decompensation, HCC occurrence and recurrence. Pooled estimates of HRs were determined using random‐effects meta‐analyses with inverse variance weighting, with sensitivity analyses and meta‐regression to explore the effects of clinical factors. We identified 39 articles for the primary analysis. Compared with unexposed individuals, patients treated with DAA had a reduced risk of death (HR; CI = 0.44; 0.38‐0.52), decompensation (HR; CI = 0.54; 0.38‐ 0.76) and HCC occurrence (HR; CI = 0.72; 0.61‐ 0.86). The protective effect of DAA on HCC recurrence was less clear (HR; CI = 0.72; 0.44‐1.16). Sustained virologic response (SVR) attainment was a significant predictor of reduced mortality (HR; CI = 0.33; 0.23‐0.46), decompensation (HR; CI = 0.11; 0.05‐0.24), HCC occurrence (HR; CI = 0.31; 0.27‐0.37) and HCC recurrence (HR; CI = 0.32; 0.20‐0.51). Meta‐regression showed no evidence of effect modification by patient age, sex, presence of cirrhosis or length of follow‐up. In conclusion, our findings show protective effects of DAA treatment and DAA‐related SVR on CHC progression and mortality.
PDF
