Cost-effectiveness of cardiac resynchronization therapy in patients with asymptomatic to mild heart failure: Insights from the European cohort of the REVERSE (Resynchronization Reverses remodeling in Systolic Left Ventricular Dysfunction)
Linde C.,University of Stockholm |
Mealing S.,Oxford Outcomes Ltd |
Hawkins N.,Oxford Outcomes Ltd |
Eaton J.,Oxford Outcomes Ltd |
And 2 more authors.
European Heart Journal | Year: 2011
AimsTo assess the cost-effectiveness of cardiac resynchronization therapy (CRT) compared with optimal medical therapy in patients with New York Heart Association (NYHA) II heart failure (HF) or NYHA I with previous HF symptoms.Methods and resultsA proportion in state model with Monte Carlo simulation was developed to assess the costs, life years and quality-adjusted life year (QALYs) associated with CRT-ON and-OFF over a 10 year time period. Data from 262 patients in the European cohort of the REVERSE clinical trial (QRS ≥ 120 ms, left ventricular ejection fraction ≤ 40, CRT-ON, n=180, CRT-OFF, n=82) were used to model all-cause mortality, change in NYHA class and resource use. EQ-5D preference weights were taken from a previous cost-effectiveness model of CRT and unit costs from national UK databases. Costs and benefits were discounted at 3.5 p.a. Extensive deterministic and probabilistic sensitivity analyses were performed. Compared with CRT-OFF, 0.94 life years or 0.80 QALYs were gained in the CRT ON group at an additional cost of €11 455, yielding an incremental cost-effectiveness ratio of €14.278 per quality-adjusted life year (QALY) gained. At a threshold of €33 000 (£30 000) per QALY gained, the probability that CRT is cost-effective is 79.6. Cardiac resynchronization therapy becomes cost effective after ∼4.5 years. Cardiac resynchronization therapy needs only to demonstrate a modest impact on all cause mortality (hazard ratio=0.82) in order to demonstrate cost-effectiveness. The results are robust to changes in all other parameters.ConclusionCardiac resynchronization therapy is a cost-effective intervention for patients with mildly symptomatic HF and for asymptomatic patients with left ventricular dysfunction and previous HF symptoms. © 2011 The Author.
Diepgen T.L.,University of Heidelberg |
Scheidt R.,University of Heidelberg |
Weisshaar E.,University of Heidelberg |
John S.M.,University of Osnabrück |
Hieke K.,Oxford Outcomes Ltd
Contact Dermatitis | Year: 2013
Summary Background There is little knowledge about the costs of occupational hand eczema. Objectives To estimate the societal costs of patients with occupational hand eczema in Germany. Methods Resource use during the past year, disease severity and quality of life [Dermatology Life Quality Index (DLQI)] were gathered for patients with occupational hand eczema before they entered a special rehabilitation programme. Costs were calculated from the societal perspective. The analysis focused on all patients and the severity groups no signs/mild (group A) and moderate to severe (group B). Results One hundred and fifty-one patients were analysed, with a mean age of 44.9~years and a mean DLQI score of 10.9; 64.9% were male. Sickness absence was recorded for 62.9% of all patients (76.4~days on average in the last 12~months). Annual societal costs were €8799 per patient. Indirect costs represented 70% of total costs. Quality of life (DLQI) was statistically different across both severity groups (group A, 7.9; group B, 12.9), but direct treatment costs were not (€2705 versus €2610, respectively). There was a trend towards higher indirect costs in patients in severity group B (group A, €5120; group B, €6796). Conclusion The annual societal costs of patients with occupational hand eczema in this study are high, and similar to those for severe psoriasis and atopic dermatitis. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Wyrwich K.W.,United Biosource Corporation |
Norquist J.M.,Merck And Co. |
Lenderking W.R.,United Biosource Corporation |
Acaster S.,Oxford Outcomes Ltd
Quality of Life Research | Year: 2013
Purpose: Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. Methods: This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Results: Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. Conclusions: While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time. © 2012 Springer Science+Business Media B.V.
Dequen P.,University of Leicester |
Sutton A.J.,University of Leicester |
Scott D.A.,Oxford Outcomes Ltd. |
Abrams K.R.,University of Leicester
Value in Health | Year: 2014
Objective To evaluate the effect of study identification methods and network size on the relative effectiveness and cost-effectiveness of recommended pharmacological venous thromboembolic events (VTEs) prophylaxis for adult patients undergoing elective total knee replacement surgery in the United Kingdom. Methods A stepwise literature search specifically designed to identify indirect evidence was conducted to extend the original clinical review from the latest National Institute for Health and Care Excellence (NICE) VTE technology appraisal. Different network sizes or network orders, based on the successive searches, informed three network meta-analyses (NMAs), which were compared with a replicated base case. The resulting comparative estimates were inputted in an economic model to investigate the effect of network size on cost-effectiveness probabilities. Results Searches increased the number of indirect comparisons between VTE interventions, progressively widening the relevant network of studies for NMA. Precision around mean relative treatment effects was increased as the network was extended from the base case to first-order NMA, but further extensions had limited effect. Cost-effectiveness analysis results were largely insensitive to variation in clinical inputs from the different NMA orders. Conclusions No standard methodology is currently recommended by NICE to identify the most relevant network of studies for NMA. Our study showed that optimizing the identification of studies for NMA can extend the evidence base for analysis and reduce the uncertainty in relative effectiveness estimates. Although in our example network extensions did not affect the acceptability of available treatments in VTE prevention based on cost-effectiveness results, it may in other applications. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Woods B.S.,Oxford Outcomes Ltd. |
Hawkins N.,Oxford Outcomes Ltd. |
Hawkins N.,University of York |
Scott D.A.,Oxford Outcomes Ltd.
BMC Medical Research Methodology | Year: 2010
Background. Data on survival endpoints are usually summarised using either hazard ratio, cumulative number of events, or median survival statistics. Network meta-analysis, an extension of traditional pairwise meta-analysis, is typically based on a single statistic. In this case, studies which do not report the chosen statistic are excluded from the analysis which may introduce bias. Methods. In this paper we present a tutorial illustrating how network meta-analyses of survival endpoints can combine count and hazard ratio statistics in a single analysis on the hazard ratio scale. We also describe methods for accounting for the correlations in relative treatment effects (such as hazard ratios) that arise in trials with more than two arms. Combination of count and hazard ratio data in a single analysis is achieved by estimating the cumulative hazard for each trial arm reporting count data. Correlation in relative treatment effects in multi-arm trials is preserved by converting the relative treatment effect estimates (the hazard ratios) to arm-specific outcomes (hazards). Results. A worked example of an analysis of mortality data in chronic obstructive pulmonary disease (COPD) is used to illustrate the methods. The data set and WinBUGS code for fixed and random effects models are provided. Conclusions. By incorporating all data presentations in a single analysis, we avoid the potential selection bias associated with conducting an analysis for a single statistic and the potential difficulties of interpretation, misleading results and loss of available treatment comparisons associated with conducting separate analyses for different summary statistics. © 2010 Woods et al; licensee BioMed Central Ltd.
Hawkins N.,Oxford Outcomes Ltd.
Medical decision making : an international journal of the Society for Medical Decision Making | Year: 2010
The authors consider alternative mechanisms that might explain placebo responses and their implications for cost-effectiveness modeling. Three alternative placebo mechanisms are examined: a ''regression to the mean'' effect arising from natural variation and the preferential selection of patients with acutely severe disease into clinical trials, a patient expectancy effect specific to the clinical trial setting (Hawthorne effect), and a patient expectancy effect generalizable to routine clinical practice (true placebo effect). To estimate cost-effectiveness, the authors needed to generalize from trial data to estimate responses to treatment that they would see in routine clinical practice. They use an example analysis of the cost-effectiveness of adjunct epilepsy treatments to illustrate the potential effects of these different placebo mechanisms on this generalization and subsequent cost-effectiveness estimates and adoption decisions. If an acceptable willingness-to-pay threshold of 30,000 per quality-adjusted life year (QALY) is assumed, then each of the placebo effect scenarios identifies a different treatment alternative as being optimum. Estimated cost-effectiveness ratios and associated policy decisions may be sensitive to assumptions regarding the mechanism underlying placebo responses. These assumptions should, if possible, be investigated through analysis of trial or observational data and, in the absence of other evidence, sensitivity analysis.
A network meta-analysis to compare glycaemic control in patients with type 2 diabetes treated with exenatide once weekly or liraglutide once daily in comparison with insulin glargine, exenatide twice daily or placebo
Scott D.A.,Oxford Outcomes Ltd |
Boye K.S.,Eli Lilly and Company |
Timlin L.,Eli Lilly and Company |
Clark J.F.,Oxford Outcomes Ltd |
Best J.H.,Amylin Pharmaceuticals Inc.
Diabetes, Obesity and Metabolism | Year: 2013
Aims: The glucagon-like peptide-1 receptor agonists (GLP-1 RAs) exenatide once weekly (ExQW) and liraglutide once daily (QD) are indicated to improve glycaemic control in patients with type 2 diabetes. Although glycaemic control with ExQW versus liraglutide QD 1.8mg has been directly compared, no studies have compared ExQW with liraglutide QD 1.2mg or determined the probable relative efficacies of various injectable therapies for glycaemic control; therefore, a network meta-analysis was performed to address these questions. Methods: A systematic review identified randomized controlled trials of ≥24weeks that compared ExQW, liraglutide QD (1.2mg, 1.8mg), insulin glargine, exenatide twice daily (ExBID), or placebo. Twenty-two studies evaluating 11049 patients were included in the network meta-analysis. Mean differences in HbA1c relative to placebo or each other and probability rankings were estimated. Results: Estimated mean differences in HbA1c versus placebo were -1.15% (95% CrI: -1.31 to -1.00) for ExQW, -1.01% (95% CrI: -1.18 to -0.85) for liraglutide 1.2mg, and -1.18% (95% CrI: -1.32 to -1.04) for liraglutide 1.8mg. HbA1c differences for ExQW versus liraglutide 1.2mg and 1.8mg were -0.14% (95% CrI: -0.34 to 0.06) and 0.03% (95% CrI: -0.14 to 0.18), respectively. The estimated mean difference in HbA1c between liraglutide 1.2mg and 1.8mg was 0.17% (95% CrI: 0.02-0.30). Results were consistent when adjusted for background antihyperglycaemic medications and diabetes duration. Conclusions: This network meta-analysis did not identify meaningful differences in HbA1c lowering between ExQW and both liraglutide doses, suggesting that these GLP-1 RAs have similar glycaemic effects. © 2012 Blackwell Publishing Ltd.
Levy A.R.,Oxford Outcomes Ltd. |
Levy A.R.,Dalhousie University |
Szabo S.M.,Oxford Outcomes Ltd. |
Rao S.R.,Abbott Laboratories |
And 2 more authors.
Arthritis Care and Research | Year: 2014
Objective The few published estimates of the risk of renal complications in ankylosing spondylitis (AS) are established on clinic-based studies. Our objective was to estimate the age- and sex-specific risks of renal complications in a population-based cohort of AS subjects in Québec between 1996 and 2006, relative to the general population. Methods A retrospective cohort design was implemented using population-based administrative data collected from 1996 to 2006 in Québec, Canada. The study cohort included subjects diagnosed with AS on physician billing records, and the comparison cohort comprised a 1% random sample of subjects without AS. Age- and sex-stratified prevalence ratios for acute kidney injury, chronic kidney disease, amyloidosis, and hypertensive renal disease were compared between subjects with and without AS. Results The AS cohort included 4,836 men and 3,780 women. Renal complications were diagnosed among 3.4% of men and 2.1% of women with AS compared with 2.0% and 1.6% of persons without AS, respectively. Renal complications were 72% more prevalent among persons with AS and an increase was observed in each of the conditions. The magnitude of the risk of renal complications was highest among younger individuals and decreased with advancing age. Conclusion These findings indicate that renal complications may be elevated among persons with AS, especially at younger ages. Despite the limitations of administrative data pertaining to onset of disease, these findings warrant further investigation because of their clinical relevance. Copyright © 2014 by the American College of Rheumatology.
Kerr C.,Oxford Outcomes Ltd. |
Nixon A.,Oxford Outcomes Ltd. |
Wild D.,Oxford Outcomes Ltd.
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2010
In the patient-reported outcomes (PROs) field, strict regulatory requirements must be met for qualitative research that contributes to labeling claims for medicinal products. These requirements not only emphasize the importance of reaching saturation but also of providing documentary evidence that saturation has been reached. This paper reviews qualitative literature for useful definitions of the concept and for practical approaches for assessing saturation. The paper considers approaches in light of the rigorous regulatory requirements for PRO research that are used to support labeling claims for medicinal products and the wider requirements for flexibility and creativity in qualitative research in general. This assessment is facilitated by the use of examples from our past qualitative PRO studies. Based on conclusions from this assessment, we offer preliminary recommendations for future qualitative PRO studies for assessing and documenting saturation. © 2010 Expert Reviews Ltd.
Szabo S.M.,Oxford Outcomes Ltd. |
Levy A.R.,Oxford Outcomes Ltd. |
Levy A.R.,Dalhousie University |
Rao S.R.,Abbott Laboratories |
And 4 more authors.
Arthritis and Rheumatism | Year: 2011
Objective To estimate the excess risk of cardiovascular and cerebrovascular diseases among individuals with ankylosing spondylitis (AS) in Quebec compared with the general population of Quebec. Methods A retrospective cohort study was conducted using population-based administrative data from Quebec. The cohort included all adult individuals with at least 1 AS diagnosis on physician billing or hospital discharge records between 1996 and 2006. A comparison cohort was generated using a 1% random sample of individuals without AS. Cardiovascular and cerebrovascular diseases, and associated hospitalizations, were classified into 1 of 6 subcategories: congestive heart failure, valvular (aortic or nonaortic) heart disease, ischemic heart disease, cerebrovascular disease, or "other" cardiovascular disease. The age- and sex-stratified prevalence estimates, and standardized prevalence ratios, of cardiovascular or cerebrovascular disease in patients with AS, compared to that in the general population, were calculated. Results The AS cohort included 8,616 individuals diagnosed over the period 1996-2006. The prevalence of cardiovascular and cerebrovascular diseases increased with increasing age for all cardiovascular disease subgroups, and was similar for individuals of both sexes. Age- and sex-stratified prevalence ratios were highest in younger individuals with AS. The age- and sex-standardized prevalence ratios comparing the risk among those with AS to the risk in the general population were as follows: for aortic valvular heart disease 1.58 (95% confidence interval [95% CI] 1.31-1.91), for nonaortic valvular heart disease 1.58 (95% CI 1.43-1.74), for ischemic heart disease 1.37 (95% CI 1.31-1.44), for congestive heart failure 1.34 (95% CI 1.26-1.42), for "other" cardiovascular disease 1.36 (95% CI 1.29-1.44), for cerebrovascular disease 1.25 (95% CI 1.15-1.35), and for any hospitalization for a cardiovascular or cerebrovascular disease 1.31 (95% CI 1.22-1.41). Conclusion Compared with the general population, patients with AS are at increased risk for many types of cardiovascular and cerebrovascular diseases, and are more likely to be hospitalized for these diseases. The excess risk is greatest in younger patients with AS. © 2011 by the American College of Rheumatology.