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      Cost-Effectiveness of Extended and One-Time Screening Versus No Screening for Non-Valvular Atrial Fibrillation in the USA

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          Abstract

          Background

          There is limited evidence on the clinical and cost benefits of screening for atrial fibrillation (AF) with electrocardiogram (ECG) in asymptomatic adults.

          Methods

          We adapted a previously published Markov model to evaluate the clinical and economic impact of one-time screening for non-valvular AF (NVAF) with a single 12-lead ECG and a 14-day extended screening with a hand-held ECG device (Zenicor single-lead ECG, Z14) compared with no screening. Clinical events considered included ischemic stroke, systemic embolism, major bleeds, myocardial infarction, and death. Epidemiology and effectiveness data for extended screening were from the STROKESTOP study. Risks of clinical events in NVAF patients were derived from ARISTOTLE. Analyses were conducted from the perspective of a third-party payer, considering a population with undiagnosed NVAF, aged 75 years in the USA. Costs and utilities were discounted at a 3% annual rate. Parameter uncertainty was formally considered via deterministic and probabilistic sensitivity analyses (DSA and PSA). Structural uncertainty was assessed via scenario analyses.

          Results

          In a hypothetical cohort of 10,000 patients followed over their lifetimes, the number of additional AF diagnoses was 54 with 12-lead ECG and 255 with Z14 compared with no screening. Both screening strategies led to better health outcomes (ischemic strokes avoided: ECG 12-lead, 9.8 and Z14, 42.2; quality-adjusted life-years gained: ECG 12-lead, 31 and Z14, 131). Extended screening and one-time screening were cost effective compared with no screening at a willingness-to-pay (WTP) threshold of $100,000 per QALY gained ($58,728/QALY with ECG 12-lead and $47,949/QALY with Z14 in 2016 US dollars). ICERs remained below $100,000 per QALY in all DSA, most PSA runs, and in all scenario analyses except for a scenario assuming low anticoagulation persistence.

          Conclusions

          Our analysis suggests that, screening the general population at age 75 years for NVAF is cost effective at a WTP threshold of $100,000. Both extended screening and one-time screening for NVAF are expected to provide health benefits at an acceptable cost.

          Electronic supplementary material

          The online version of this article (10.1007/s40258-019-00542-y) contains supplementary material, which is available to authorized users.

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          Most cited references29

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          Preference-Based EQ-5D index scores for chronic conditions in the United States.

          The Panel on Cost-Effectiveness in Health and Medicine has called for an "off-the-shelf" catalogue of nationally representative, community-based preference scores for health states, illnesses, and conditions. A previous review of cost-effectiveness analyses found that 77% did not incorporate community-based preferences, and 33% used arbitrary expert or author judgment. These results highlight the necessity of making a wide array of appropriate, community-based estimates more accessible to cost-effectiveness researchers. To provide nationally representative EQ-5D index scores for chronic ICD-9 codes. The nationally representative Medical Expenditure Panel Survey (MEPS) was pooled (2000-2002) to create a data set of 38,678 adults. Ordinary least squares (OLS), Tobit, and censored least absolute deviations (CLAD) regression methods were used to estimate the marginal disutility of each condition, controlling for age, comorbidity, gender, race, ethnicity, income, and education. Most chronic conditions, age, comorbidity, income, and education were highly statistically significant predictors of EQ-5D index scores. Homoskedasticity and normality assumptions were rejected, suggesting only CLAD estimates are theoretically unbiased. The magnitude and statistical significance of coefficients varied by analytic method. OLS and Tobit coefficients were on average 60% and 143% greater than CLAD, respectively. The marginal disutility of 95 chronic ICD-9 codes as well as unadjusted mean, median, and 25th and 75th percentiles are reported. This research provides nationally representative, community-based EQ-5D index scores associated with a wide variety of chronic ICD-9 codes that can be used to estimate quality-adjusted life-years in cost-effectiveness analyses.
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            Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration.

            Approximately 10% of ischemic strokes are associated with atrial fibrillation (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. The AF-SCREEN international collaboration was formed in September 2015 to promote discussion and research about AF screening as a strategy to reduce stroke and death and to provide advocacy for implementation of country-specific AF screening programs. During 2016, 60 expert members of AF-SCREEN, including physicians, nurses, allied health professionals, health economists, and patient advocates, were invited to prepare sections of a draft document. In August 2016, 51 members met in Rome to discuss the draft document and consider the key points arising from it using a Delphi process. These key points emphasize that screen-detected AF found at a single timepoint or by intermittent ECG recordings over 2 weeks is not a benign condition and, with additional stroke factors, carries sufficient risk of stroke to justify consideration of anticoagulation. With regard to the methods of mass screening, handheld ECG devices have the advantage of providing a verifiable ECG trace that guidelines require for AF diagnosis and would therefore be preferred as screening tools. Certain patient groups, such as those with recent embolic stroke of uncertain source (ESUS), require more intensive monitoring for AF. Settings for screening include various venues in both the community and the clinic, but they must be linked to a pathway for appropriate diagnosis and management for screening to be effective. It is recognized that health resources vary widely between countries and health systems, so the setting for AF screening should be both country- and health system-specific. Based on current knowledge, this white paper provides a strong case for AF screening now while recognizing that large randomized outcomes studies would be helpful to strengthen the evidence base.
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              Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation

              Opportunistic screening for atrial fibrillation (AF) is recommended, and improved methods of early identification could allow for the initiation of appropriate therapies to prevent the adverse health outcomes associated with AF.
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                Author and article information

                Contributors
                mustafa.oguz@evidera.com
                tereza.lanitis@evidera.com
                shawn.li@bms.com
                gail.wygant@bms.com
                desinger@mgh.harvard.edu
                keith.friend@bms.com
                patrick.hlavacek@pfizer.com
                andreas.nikolaou@evidera.com
                soeren.mattke@gmail.com
                Journal
                Appl Health Econ Health Policy
                Appl Health Econ Health Policy
                Applied Health Economics and Health Policy
                Springer International Publishing (Cham )
                1175-5652
                1179-1896
                17 December 2019
                17 December 2019
                2020
                : 18
                : 4
                : 533-545
                Affiliations
                [1 ]Evidera, The Ark, 2nd Floor, 201 Talgarth Road, London, W6 8BJ UK
                [2 ]GRID grid.419971.3, Bristol-Myers Squibb, ; Lawrenceville, NJ USA
                [3 ]GRID grid.32224.35, ISNI 0000 0004 0386 9924, Massachusetts General Hospital, Harvard Medical School, ; Boston, MA USA
                [4 ]GRID grid.410513.2, ISNI 0000 0000 8800 7493, Pfizer, ; New York, NY USA
                [5 ]GRID grid.42505.36, ISNI 0000 0001 2156 6853, University of Southern California, ; Los Angeles, CA USA
                Article
                542
                10.1007/s40258-019-00542-y
                7347708
                31849021
                ed202de9-139d-40af-8cf5-063807bd045b
                © The Author(s) 2019

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100002491, Bristol-Myers Squibb;
                Funded by: FundRef http://dx.doi.org/10.13039/100004319, Pfizer;
                Categories
                Original Research Article
                Custom metadata
                © Springer Nature Switzerland AG 2020

                Economics of health & social care
                Economics of health & social care

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