scholarly journals Comparative Effectiveness of Implantable Defibrillators for Asymptomatic Brugada Syndrome: A Decision‐Analytic Model

Author(s):  
Shaan Khurshid ◽  
Wanyi Chen ◽  
Weeranun D. Bode ◽  
Jason H. Wasfy ◽  
Jagpreet Chhatwal ◽  
...  

Background Optimal management of asymptomatic Brugada syndrome (BrS) with spontaneous type I electrocardiographic pattern is uncertain. Methods and Results We developed an individual‐level simulation comprising 2 000 000 average‐risk individuals with asymptomatic BrS and spontaneous type I electrocardiographic pattern. We compared (1) observation, (2) electrophysiologic study (EPS)‐guided implantable cardioverter‐defibrillator (ICD), and (3) upfront ICD, each using either subcutaneous or transvenous ICD, resulting in 6 strategies tested. The primary outcome was quality‐adjusted life years (QALYs), with cardiac deaths (arrest or procedural‐related) as a secondary outcome. We varied BrS diagnosis age and underlying arrest rate. We assessed cost‐effectiveness at $100 000/QALY. Compared with observation, EPS‐guided subcutaneous ICD resulted in 0.35 QALY gain/individual and 4130 cardiac deaths avoided/100 000 individuals, and EPS‐guided transvenous ICD resulted in 0.26 QALY gain and 3390 cardiac deaths avoided. Compared with observation, upfront ICD reduced cardiac deaths by a greater margin (subcutaneous ICD, 8950; transvenous ICD, 6050), but only subcutaneous ICD improved QALYs (subcutaneous ICD, 0.25 QALY gain; transvenous ICD, 0.01 QALY loss), and complications were higher. ICD‐based strategies were more effective at younger ages and higher arrest rates (eg, using subcutaneous devices, upfront ICD was the most effective strategy at ages 20–39.4 years and arrest rates >1.37%/year; EPS‐guided ICD was the most effective strategy at ages 39.5–51.3 years and arrest rates 0.47%–1.37%/year, and observation was the most effective strategy at ages >51.3 years and arrest rates <0.47%/year). EPS‐guided subcutaneous ICD was cost‐effective ($80 508/QALY). Conclusions Device‐based approaches (with or without EPS risk stratification) can be more effective than observation among selected patients with asymptomatic BrS. BrS management should be tailored to patient characteristics.

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Brianna Lauren ◽  
Sassan Ostvar ◽  
Elisabeth Silver ◽  
Myles Ingram ◽  
Aaron Oh ◽  
...  

Background. The 5-year survival rate of patients with metastatic gastric cancer (GC) is only 5%. However, trials have demonstrated promising antitumor activity for targeted therapies/immunotherapies among chemorefractory metastatic GC patients. Pembrolizumab has shown particular efficacy among patients with programmed death ligand-1 (PD-L1) expression and high microsatellite instability (MSI-H). The aim of this study was to assess the effectiveness and cost-effectiveness of biomarker-guided second-line GC treatment. Methods. We constructed a Markov decision-analytic model using clinical trial data. Our model compared pembrolizumab monotherapy and ramucirumab/paclitaxel combination therapy for all patients and pembrolizumab for patients based on MSI status or PD-L1 expression. Paclitaxel monotherapy and best supportive care for all patients were additional comparators. Costs of drugs, treatment administration, follow-up, and management of adverse events were estimated from a US payer perspective. The primary outcomes were quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold of $100,000/QALY over 60 months. Secondary outcomes were unadjusted life years (survival) and costs. Deterministic and probabilistic sensitivity analyses were performed to evaluate model uncertainty. Results. The most effective strategy was pembrolizumab for MSI-H patients and ramucirumab/paclitaxel for all other patients, adding 3.8 months or 2.0 quality-adjusted months compared to paclitaxel. However, this strategy resulted in a prohibitively high ICER of $1,074,620/QALY. The only cost-effective strategy was paclitaxel monotherapy for all patients, with an ICER of $53,705/QALY. Conclusion. Biomarker-based treatments with targeted therapies/immunotherapies for second-line metastatic GC patients substantially improve unadjusted and quality-adjusted survival but are not cost-effective at current drug prices.


F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 253
Author(s):  
Rashidah T. Uthman ◽  
Olalekan A. Uthman

Background: The most challenging issue physicians are facing is the appropriate timing of introducing antiretroviral therapy (ART) along with ongoing tuberculosis (TB) therapy in HIV and TB co-infected patients. This study examined the cost-effectiveness of early versus delayed ART initiation in TB patients, infected with HIV (co-infected patients) in a sub-Saharan Africa setting. Methods: A decision analytic model based on previously published and real-world evidence was applied to evaluate clinical and economic outcomes associated with early versus delayed ART in TB and HIV co-infection. Incremental cost-effectiveness ratio (ICER) was calculated with both costs and quality-adjusted life years (QALYs). Different assumptions of treatment benefits and costs were taken to address uncertainties and were tested with sensitivity analyses. Results: In base case analysis, the expected cost of giving early ART to TB patients infected with HIV was $1372, with a QALY gain of 0.68, while the cost of delayed ART was $955, with a QALY gain of 0.62. The ICER shows $6775 per QALYs, which suggests that it is not as cost-effective, since it is greater than 3 x GDP per capita ($5,086) for sub-Saharan Africa willingness to pay (WTP) threshold. At $10,000 WTP, the probability that early ART is cost effective compared to delayed ART is 0.9933. At cost-effectiveness threshold of $5086, the population expected value of perfect information becomes substantial (≈US$5 million), and is likely to exceed the cost of additional investigation. This suggests that further research will be potentially cost-effective. Conclusions: From the perspective of the health-care payer in sub-Saharan Africa, early initiation of ART in HIV and TB co-infection cannot be regarded as cost-effective based on current information. The analysis shows that further research will be worthwhile and potentially cost-effective in resolving uncertainty about whether or not to start ART early in HIV and TB co-infection.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043791
Author(s):  
Jan Bauer ◽  
Dieter Moormann ◽  
Reinhard Strametz ◽  
David A Groneberg

ObjectivesThis study wants to assess the cost-effectiveness of unmanned aerial vehicles (UAV) equipped with automated external defibrillators (AED) in out-of-hospital cardiac arrests (OHCA). Especially in rural areas with longer response times of emergency medical services (EMS) early lay defibrillation could lead to a significant higher survival in OHCA.Participants3296 emergency medical stations in Germany.SettingRural areas in Germany.Primary and secondary outcome measuresThree UAV networks providing 80%, 90% or 100% coverage for rural areas lacking timely access to EMS (ie, time-to-defibrillation: >10 min) were developed using a location allocation analysis. For each UAV network, primary outcome was the cost-effectiveness using the incremental cost-effectiveness ratio (ICER) calculated by the ratio of financial costs to additional life years gained compared with current EMS.ResultsCurrent EMS with 3926 emergency stations was able to gain 1224 life years on annual average in the study area. The UAV network providing 100% coverage consisted of 1933 UAV with average annual costs of €43.5 million and 1845 additional life years gained on annual average (ICER: €23 568). The UAV network providing 90% coverage consisted of 1074 UAV with average annual costs of €24.2 million and 1661 additional life years gained on annual average (ICER: €14 548). The UAV network providing 80% coverage consisted of 798 UAV with average annual costs of €18.0 million and 1477 additional life years gained on annual average (ICER: €12 158).ConclusionThese results reveal the relevant life-saving potential of all modelled UAV networks. Furthermore, all analysed UAV networks could be deemed cost-effective. However, real-life applications are needed to validate the findings.


2021 ◽  
pp. neurintsurg-2020-017017
Author(s):  
Henk van Voorst ◽  
Wolfgang G Kunz ◽  
Lucie A van den Berg ◽  
Manon Kappelhof ◽  
Floor M E Pinckaers ◽  
...  

BackgroundThe effectiveness of endovascular treatment (EVT) for large vessel occlusion (LVO) stroke severely depends on time to treatment. However, it remains unclear what the value of faster treatment is in the years after index stroke. The aim of this study was to quantify the value of faster EVT in terms of health and healthcare costs for the Dutch LVO stroke population.MethodsA Markov model was used to simulate 5-year follow-up functional outcome, measured with the modified Rankin Scale (mRS), of 69-year-old LVO patients. Post-treatment mRS was extracted from the MR CLEAN Registry (n=2892): costs per unit of time and Quality-Adjusted Life Years (QALYs) per mRS sub-score were retrieved from follow-up data of the MR CLEAN trial (n=500). Net Monetary Benefit (NMB) at a willingness to pay of €80 000 per QALY was reported as primary outcome, and secondary outcome measures were days of disability-free life gained and costs.ResultsEVT administered 1 min faster resulted in a median NMB of €309 (IQR: 226;389), 1.3 days of additional disability-free life (IQR: 1.0;1.6), while cumulative costs remained largely unchanged (median: -€15, IQR: −65;33) over a 5-year follow-up period. As costs over the follow-up period remained stable while QALYs decreased with longer time to treatment, which this results in a near-linear decrease of NMB. Since patients with faster EVT lived longer, they incurred more healthcare costs.ConclusionOne-minute faster EVT increases QALYs while cumulative costs remain largely unaffected. Therefore, faster EVT provides better value of care at no extra healthcare costs.


2021 ◽  
Vol 9 ◽  
Author(s):  
Benjamin Kelly ◽  
Aidan Innes ◽  
Marc Holl ◽  
Laura Mould ◽  
Susan Powell ◽  
...  

Introduction: High levels of physical, cognitive, and psychosocial impairments are anticipated for those recovering from the COVID-19. In the UK, ~50% of survivors will require additional rehabilitation. Despite this, there is currently no evidence-based guideline available in England and Wales that addresses the identification, timing and nature of effective interventions to manage the morbidity associated following COVID-19. It is now timely to accelerate the development and evaluation of a rehabilitation service to support patients and healthcare services. Nuffield Health have responded by configuring a scalable rehabilitation pathway addressing the immediate requirements for those recovering from COVID-19 in the community.Methods and Analysis: This long-term evaluation will examine the effectiveness of a 12-week community rehabilitation programme for COVID-19 patients who have been discharged following in-patient treatment. Consisting of two distinct 6-week phases; Phase 1 is an entirely remote service, delivered via digital applications. Phase 2 sees the same patients transition into a gym-based setting for supervised group-based rehabilitation. Trained rehabilitation specialists will coach patients across areas such as goal setting, exercise prescription, symptom management and emotional well-being. Outcomes will be collected at 0, 6, and 12 weeks and at 6- and 12-months. Primary outcome measures will assess changes in health-related quality of life (HR-QOL) and COVID-19 symptoms using EuroQol Five Dimension Five Level Version (EQ-5D-5L) and Dyspnea-12, respectively. Secondary outcome measures of the Duke Activity Status Questionnaire (DASI), 30 s sit to stand test, General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Patient Experience Questionnaire (PEQ) and Quality Adjusted Life Years (QALY) will allow for the evaluation of outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment.Discussion: This evaluation will investigate the immediate and long-term impact, as well as the cost effectiveness of a blended rehabilitation programme for COVID-19 survivors. This evaluation will provide a founding contribution to the literature, evaluating one of the first programmes of this type in the UK. The evaluation has international relevance, with the potential to show how a new model of service provision can support health services in the wake of COVID-19.Trial Registration: Current Trials ISRCTN ISRCTN14707226Web: http://www.isrctn.com/ISRCTN14707226


2018 ◽  
Vol 3 ◽  
pp. 156
Author(s):  
May Ee Png ◽  
Melina Dritsaki ◽  
Alastair Gray ◽  
Rafael Pinedo-Villanueva ◽  
Oliver Rivero-Arias ◽  
...  

Dupuytren’s disease (DD) is a common fibroproliferative condition of the palmar and digital fascia of the hand; however, there is currently no approved treatment for early stage DD. The objective of this paper is to describe the methods applied to assess the cost-effectiveness of adalimumab injections compared to placebo for controlling the progression of early stage DD in the Repurposing Anti-TNF for Treating Dupuytren’s Disease (RIDD) trial. Measure of effectiveness and resource use will be obtained from a randomised clinical trial, carried out in three healthcare centres, and recruiting a minimum of 138 patients aged 18 years and above with a diagnosis of early stage DD. Resource use and utility measures (quality-adjusted life years) will be collected at 3, 6, 9, 12 (primary outcome endpoint) and 18 months post-randomisation. A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs. The analysis will be performed from a health system (National Health Service and personal social services) perspective. Sensitivity analysis will be conducted to assess the robustness of the results. RIDD is the first randomised controlled trial with an economic evaluation conducted among patients with early stage DD. The protocol described here records our intent to conduct both a within-trial CUA alongside the RIDD study and a lifetime CUA using decision-analytic modelling.


2021 ◽  
Author(s):  
Leonardo Rojas ◽  
María Rojas-Reyes ◽  
Diego Rosselli ◽  
Andres F. Cardona

Abstract BackgroundThe best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) in Colombia is unknown. This study aimed to identify the cost-effectiveness of various strategies to establish the necessity of adjuvant chemotherapy.MethodsThis study used an adapted decision-analytic model to compare cost and outcomes of care that includes Oncotype DX™ (ODX) or Mammaprint™ (MMP) test with routine care without ODX or MMP tests (application of adjuvant chemotherapy for all patients) over a 5-year time horizon, and the from the perspective of the Colombian National Health System (NHS) perspective (payer). Data were obtained from published literature and clinical trial database. The study population was composed of women with EBC, hormone-receptor positive (HR+), Her2-negative, lymph-node negative (LN0), with high-risk clinical criteria for recurrence. The outcome measures were incremental cost-effectiveness ratio (ICER; 2019 United States Dollar [USD] per quality-adjusted life years [QALY] gained) and net monetary benefit (NMB).ResultsODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2,445 and $570 compared with the standard strategy, respectively. The ICER for ODX was −$41,857 and that for MMP was −$18,253 per QALY; NMB was $2,821 and $771, respectively. Both tests were cost effective under defined threshold. When the two tests were compared, ODX was more cost effective than MMP. Sensitivity analysis revealed that, with a threshold of 1 GDP per capita, ODX will be cost effective in 95.5% of the cases compared with 70.2% of MMP. Probabilistic sensitivity analysis revealed that ODX was a consistently superior strategy.ConclusionsGenomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and Her2 − EBC is a cost-effective strategy that allows Colombian NHS saving money.


Global Heart ◽  
2016 ◽  
Vol 11 (2) ◽  
pp. e46
Author(s):  
K.Y. Juarez ◽  
M.E. Guevara Valdivia ◽  
F.J. Leon Hernandez ◽  
P.I. Orosa Fernandez ◽  
M.D.R. Lozano Perez

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3730
Author(s):  
Parsa Charkhchi ◽  
Cezary Cybulski ◽  
Jacek Gronwald ◽  
Fabian Oliver Wong ◽  
Steven A. Narod ◽  
...  

Ovarian cancer is the second most lethal gynecological malignancy. The tumour biomarker CA125 has been used as the primary ovarian cancer marker for the past four decades. The focus on diagnosing ovarian cancer in stages I and II using CA125 as a diagnostic biomarker has not improved patients’ survival. Therefore, screening average-risk asymptomatic women with CA125 is not recommended by any professional society. The dualistic model of ovarian cancer carcinogenesis suggests that type II tumours are responsible for the majority of ovarian cancer mortality. However, type II tumours are rarely diagnosed in stages I and II. The recent shift of focus to the diagnosis of low volume type II ovarian cancer in its early stages of evolution provides a new and valuable target for screening. Type II ovarian cancers are usually diagnosed in advanced stages and have significantly higher CA125 levels than type I tumours. The detection of low volume type II carcinomas in stage IIIa/b is associated with a higher likelihood for optimal cytoreduction, the most robust prognostic indicator for ovarian cancer patients. The diagnosis of type II ovarian cancer in the early substages of stage III with CA125 may be possible using a higher cutoff point rather than the traditionally used 35 U/mL through the use of point-of-care CA125 assays in primary care facilities. Rapid point-of-care testing also has the potential for effective longitudinal screening and quick monitoring of ovarian cancer patients during and after treatment. This review covers the role of CA125 in the diagnosis and management of ovarian cancer and explores novel and more effective screening strategies with CA125.


2019 ◽  
Vol 111 (11) ◽  
pp. 1161-1169 ◽  
Author(s):  
Andrea Gini ◽  
Reinier G S Meester ◽  
Homa Keshavarz ◽  
Kevin C Oeffinger ◽  
Sameera Ahmed ◽  
...  

Abstract Background Childhood cancer survivors (CCS) are at increased risk of developing colorectal cancer (CRC) compared to the general population, especially those previously exposed to abdominal or pelvic radiation therapy (APRT). However, the benefits and costs of CRC screening in CCS are unclear. In this study, we evaluated the cost-effectiveness of early-initiated colonoscopy screening in CCS. Methods We adjusted a previously validated model of CRC screening in the US population (MISCAN-Colon) to reflect CRC and other-cause mortality risk in CCS. We evaluated 91 colonoscopy screening strategies varying in screening interval, age to start, and age to stop screening for all CCS combined and for those treated with or without APRT. Primary outcomes were CRC deaths averted (compared to no screening) and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per life-years gained (LYG) was used to determine the optimal screening strategy. Results Compared to no screening, the US Preventive Services Task Force’s average risk screening schedule prevented up to 73.2% of CRC deaths in CCS. The optimal strategy of screening every 10 years from age 40 to 60 years averted 79.2% of deaths, with ICER of $67 000/LYG. Among CCS treated with APRT, colonoscopy every 10 years from age 35 to 65 years was optimal (CRC deaths averted: 82.3%; ICER: $92 000/LYG), whereas among those not previously treated with APRT, screening from age 45 to 55 years every 10 years was optimal (CRC deaths averted: 72.7%; ICER: $57 000/LYG). Conclusions Early initiation of colonoscopy screening for CCS is cost-effective, especially among those treated with APRT.


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