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      Analyzing Health-Related Quality of Life Data to Estimate Parameters for Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the SHIFT Randomized Controlled Trial

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          Abstract

          Introduction

          The aim of this article is to discuss methods used to analyze health-related quality of life (HRQoL) data from randomized controlled trials (RCTs) for decision analytic models. The analysis presented in this paper was used to provide HRQoL data for the ivabradine health technology assessment (HTA) submission in chronic heart failure.

          Methods

          We have used a large, longitudinal EuroQol five-dimension questionnaire (EQ-5D) dataset from the Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial (SHIFT) (clinicaltrials.gov: NCT02441218) to illustrate issues and methods. HRQoL weights (utility values) were estimated from a mixed regression model developed using SHIFT EQ-5D data ( n = 5313 patients). The regression model was used to predict HRQoL outcomes according to treatment, patient characteristics, and key clinical outcomes for patients with a heart rate ≥75 bpm.

          Results

          Ivabradine was associated with an HRQoL weight gain of 0.01. HRQoL weights differed according to New York Heart Association (NYHA) class (NYHA I–IV, no hospitalization: standard care 0.82–0.46; ivabradine 0.84–0.47). A reduction in HRQoL weight was associated with hospitalizations within 30 days of an HRQoL assessment visit, with this reduction varying by NYHA class [−0.07 (NYHA I) to −0.21 (NYHA IV)].

          Conclusion

          The mixed model explained variation in EQ-5D data according to key clinical outcomes and patient characteristics, providing essential information for long-term predictions of patient HRQoL in the cost-effectiveness model. This model was also used to estimate the loss in HRQoL associated with hospitalizations. In SHIFT many hospitalizations did not occur close to EQ-5D visits; hence, any temporary changes in HRQoL associated with such events would not be captured fully in observed RCT evidence, but could be predicted in our cost-effectiveness analysis using the mixed model. Given the large reduction in hospitalizations associated with ivabradine this was an important feature of the analysis.

          Funding : The Servier Research Group.

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          Most cited references 4

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          Utility approach to measuring health-related quality of life.

           G W Torrance (1986)
          Quality of life is a broad concept that incorporates all aspects of an individual's existence. Health-related quality of life is a subset relating only to the health domain of that existence. The utility approach can be used to measure a single cardinal value, usually between 0 and 1, that reflects the health-related quality of life of the individual at a particular point in time. The utility approach is founded in modern utility theory, a normative rational model of decision-making under uncertainty. The measurement techniques that have been used include standard gamble, time trade-off, and rating scales. The techniques are described in the paper and compared in terms of their acceptability to subjects, reliability, precision, validity, and ease of use. It is concluded that the utility approach is beyond the experimental stage, and is now a viable alternative for investigators to use in measuring health-related quality of life.
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            Effects on outcomes of heart rate reduction by ivabradine in patients with congestive heart failure: is there an influence of beta-blocker dose?: findings from the SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) study.

            This study used the SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) database to assess the impact of background beta-blocker dose on response to ivabradine. In systolic heart failure, reduction in relatively high heart rates improves clinical outcomes when achieved with beta-blockers and even more so when the sinus node inhibitor ivabradine also is added. Among patients with systolic heart failure, sinus rhythm, and heart rate ≥70 beats/min on recommended background therapy, maximally tolerated beta-blocker doses were subgrouped as no beta-blocker, <25%, 25% to <50%, 50% to <100%, and 100% of European Society of Cardiology–suggested target doses. The impact of ivabradine on cardiovascular death or heart failure hospitalization (primary endpoint) was analyzed in each subgroup as time-to-first event using Cox models adjusted for heart rate. The statistical models assessed heterogeneity and trend of the treatment effect across subgroups, and an additional analysis was made adjusting for the interaction of randomized treatment with baseline heart rate. The primary endpoint and heart failure hospitalizations were significantly reduced by ivabradine in all subgroups with <50% of target beta-blocker dose, including no beta-blocker (p = 0.012). Despite an apparent trend to reduction in treatment-effect magnitude with increasing beta-blocker dose, no variation in treatment effect was seen in general heterogeneity interaction tests (p = 0.35). Across beta-blocker subgroups, treatment effect was borderline nonsignificant only for the primary endpoint (p = 0.056), and significance was further lost after adjusting for interaction between baseline heart rate and ivabradine effect (p = 0.14). The magnitude of heart rate reduction by beta-blocker plus ivabradine, rather than background beta-blocker dose, primarily determines subsequent effect on outcomes. (Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction. A three-year randomised double-blind placebo-controlled international multicentre study; ISRCTN70429960)
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              Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study.

              Heart failure (HF) has a major impact on health-related quality of life (HQoL). The aim was to evaluate whether heart rate (HR) reduction with ivabradine can translate into increased HQoL in parallel to a reduction of primary outcomes in SHIFT. In symptomatic patients with systolic HF treated with recommended background therapy, HQoL was assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) containing the following dimensions: overall summary score (OSS) and clinical summary score (CSS), analysed at baseline, and 4, 12, and 24 months, and last post-baseline visit. A total of 1944 patients (968 ivabradine, 976 placebo) were evaluated. At 12 months, incidence of clinical events (cardiovascular death or hospital admission for HF) was inversely associated with KCCQ scores. Ivabradine reduced HR by 10.1 bpm (placebo-corrected, P < 0.001) and improved KCCQ by 1.8 for CSS and 2.4 for OSS (placebo-corrected, P = 0.02 and P < 0.01, respectively); these changes were associated with the change in HR for both CSS (P < 0.001) and OSS (P < 0.001). The relationship was found in both allocation groups though the changes were more pronounced in the ivabradine group. Health-related quality of life at follow-up was better preserved in the ivabradine group compared with placebo; poorest outcomes were seen in the placebo group with lowest KCCQ scores (<50). In patients with systolic HF, low HQoL is associated with an increased rate of cardiovascular death or hospital admission for HF. Reduction in HR with ivabradine is associated with improved HQoL. The magnitude of HR reduction is related to the extent of improvement in HQoL.
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                Author and article information

                Contributors
                Alison.Griffiths@ResearchEconomics.co.uk
                Journal
                Adv Ther
                Adv Ther
                Advances in Therapy
                Springer Healthcare (Cheshire )
                0741-238X
                1865-8652
                15 February 2017
                15 February 2017
                2017
                : 34
                : 3
                : 753-764
                Affiliations
                [1 ]Research Economics and Consultancy in Healthcare Ltd, Solihull, UK
                [2 ]ICON plc, Abingdon, UK
                [3 ]Servier Laboratories Ltd, Suresnes, France
                [4 ]ISNI 0000 0001 2113 8111, GRID grid.7445.2, , Imperial College London (Royal Brompton Hospital), ; London, UK
                [5 ]ISNI 0000 0004 1936 9668, GRID grid.5685.e, Centre for Health Economics, , University of York, ; York, UK
                Article
                471
                10.1007/s12325-016-0471-x
                5350196
                28205056
                © The Author(s) 2017
                Categories
                Original Research
                Custom metadata
                © Springer Healthcare 2017

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