The Economic Burden of Heart Conditions in Brazil.

BACKGROUND: Heart conditions impose physical, social, financial and health-related quality of life limitations on individuals in Brazil. OBJECTIVES: This study assessed the economic burden of four main heart conditions in Brazil: hypertension, heart failure, myocardial infarction, and atrial fibrillation. In addition, the cost-effectiveness of telemedicine and structured telephone support for the management of heart failure was assessed. METHODS: A standard cost of illness framework was used to assess the costs associated with the four conditions in 2015. The analysis assessed the prevalence of the four conditions and, in the case of myocardial infarction, also its incidence. It further assessed the conditions' associated expenditures on healthcare treatment, productivity losses from reduced employment, costs of providing formal and informal care, and lost wellbeing. The analysis was informed by a targeted literature review, data scan and modelling. All inputs and methods were validated by consulting 15 clinicians and other stakeholders in Brazil. The cost-effectiveness analysis was based on a meta-analysis and economic evaluation of post-discharge programs in patients with heart failure, assessed from the perspective of the Brazilian Unified Healthcare System (Sistema Unico de Saude). RESULTS: Myocardial infarction imposes the greatest financial cost (22.4 billion reais/6.9 billion USD), followed by heart failure (22.1 billion reais/6.8 billion USD), hypertension (8 billion reais/2.5 billion USD) and, finally, atrial fibrillation (3.9 billion reais/1.2 billion USD). Telemedicine and structured telephone support are cost-effective interventions for achieving improvements in the management of heart failure. CONCLUSIONS: Heart conditions impose substantial loss of wellbeing and financial costs in Brazil and should be a public health priority.

The Economic Burden of Heart Conditions in Brazil / Os Custos das Doenças Cardíacas no Brasil

Abstract Background: Heart conditions impose physical, social, financial and health-related quality of life limitations on individuals in Brazil. Objectives: This study assessed the economic burden of four main heart conditions in Brazil: hypertension, heart failure, myocardial infarction, and atrial fibrillation. In addition, the cost-effectiveness of telemedicine and structured telephone support for the management of heart failure was assessed. Methods: A standard cost of illness framework was used to assess the costs associated with the four conditions in 2015. The analysis assessed the prevalence of the four conditions and, in the case of myocardial infarction, also its incidence. It further assessed the conditions' associated expenditures on healthcare treatment, productivity losses from reduced employment, costs of providing formal and informal care, and lost wellbeing. The analysis was informed by a targeted literature review, data scan and modelling. All inputs and methods were validated by consulting 15 clinicians and other stakeholders in Brazil. The cost-effectiveness analysis was based on a meta-analysis and economic evaluation of post-discharge programs in patients with heart failure, assessed from the perspective of the Brazilian Unified Healthcare System (Sistema Unico de Saude). Results: Myocardial infarction imposes the greatest financial cost (22.4 billion reais/6.9 billion USD), followed by heart failure (22.1 billion reais/6.8 billion USD), hypertension (8 billion reais/2.5 billion USD) and, finally, atrial fibrillation (3.9 billion reais/1.2 billion USD). Telemedicine and structured telephone support are cost-effective interventions for achieving improvements in the management of heart failure. Conclusions: Heart conditions impose substantial loss of wellbeing and financial costs in Brazil and should be a public health priority.

Resumo Fundamento: As doenças cardíacas impõem limitações à qualidade de vida nos aspectos físicos, sociais, financeiros e de saúde no Brasil. Objetivos: Este estudo avaliou o custo de quatro importantes doenças cardíacas no Brasil: hipertensão, insuficiência cardíaca, infarto do miocárdio e fibrilação atrial. Além disso, avaliou a relação de custo-efetividade de telemedicina e suporte telefônico estruturado para o manejo de insuficiência cardíaca. Métodos: Um custo padrão da estrutura de enfermidade foi usado para avaliar os custos associados às quatro condições em 2015. Analisou-se a prevalência das quatro doenças e, em caso de infarto do miocárdio, também sua incidência. Avaliaram-se ainda as despesas associadas ao tratamento, a perda de produtividade a partir da redução do emprego, os custos do fornecimento de assistência formal e informal e o bem-estar perdido referentes às condições. A análise teve por base uma revisão de literatura-alvo, varredura de dados e modelagem. Todos os inputs e métodos foram validados por 15 clínicos consultores e outras partes interessadas no Brasil. A análise de custo-efetividade baseou-se em uma meta-análise e uma avaliação econômica de programas após a alta de pacientes com insuficiência cardíaca, considerados a partir da perspectiva do Sistema Único de Saúde do Brasil. Resultados: Infarto do miocárdio acarretou o mais alto custo financeiro (R$ 22,4 bilhões/6,9 bilhões de dólares), seguido de insuficiência cardíaca (R$ 22,1 bilhões/6,8 bilhões de dólares), hipertensão (R$ 8 bilhões/2,5 bilhões de dólares) e, finalmente, fibrilação atrial (R$ 3,9 bilhões/1,2 bilhão de dólares). Telemedicina e suporte telefônico estruturado são intervenções custo-efetivas para o aprimoramento do manejo da insuficiência cardíaca. Conclusões: As doenças cardíacas determinam substanciais custos financeiros e perda de bem-estar no Brasil e deveriam ser uma prioridade de saúde pública.

La carga económica de las condiciones cardíacas en venezuela / The economic burden of heart conditions in venezuela

En Venezuela, las condiciones cardíacas imponen limitaciones físicas, sociales, financieras y de salud relacionadas con la calidad de vida de los individuos. Objetivos: Este estudio valoró la carga económica de cuatro condiciones cardíacas en Venezuela: hipertensión, insuficiencia cardíaca, infarto de miocardio y fibrilación auricular. Adicionalmente se evaluó el costo-efectividad de la telemedicina y el soporte telefónico estructurado para el manejo de la insuficiencia cardíaca.Métodos: Se utilizó un marco de costo de enfermedad estándar para valorar los costos asociados con las cuatro condiciones en 2015. El análisis evaluó la prevalencia e (en caso de infarto de miocardio) incidencia de las condiciones, los gastos asociados con el tratamiento médico, las pérdidas de productividad por reducción en el empleo, los costos de proveer cuidado formal e informal y la pérdida de bienestar. El análisis estuvo basado en información recolectada mediante una revisión de literatura y estadísticas, y modulación de datos. Todas las entradas de datos y métodos fueron validados mediante la consulta de quince clínicos y expertos en Venezuela. El análisis de costo-efectividad fue basado en un meta-análisis y en una evaluación económica de programas para pacientes con insuficiencia cardíaca dados de alta, valorado desde la perspectiva del Programa Nacional de Salud. Resultados: El infarto de miocardioimpone el mayor costo financiero (3,5 millones de bolívares/553 millones de USD), seguido por hipertensión arterial (3,4 millones de bolívares/539 millones de USD), la insuficiencia cardíaca (3,3 millones debolívares/522 millones de USD) y, finalmente, fibrilación auricular (0,4 miles de millones de bolívares/66 millones de USD). La telemedicina y el soporte telefónico estructurado son intervenciones costo-efectivas para alcanzar mejoras en el manejo de la insuficiencia cardíaca. Conclusiones: Las condiciones cardíacas imponen una pérdida sustancial de bienestar y de costos financieros en Venezuela y deberían ser una prioridad de salud pública

Heart conditions impose physical, social, financial and health related quality of life limitations on individuals in Venezuela. Objectives: This study assessed the economic burden of four main heart conditions in Venezuela: hypertension, heart failure, myocardial infarction, and atrial fibrillation. In addition, the cost-effectiveness of telemedicine and structured telephone support for the management of heart failure was assessed. Methods: A standard cost of illness framework was used to assess the costs associated with the four conditions in 2015. The analysis was informed by a targeted literature review, data scan and modeling. All inputs and methods were validated by consulting fifteen clinicians and other stakeholders in Venezuela. The cost-effectiveness analysis was based on a meta-analysis and economic evaluation of post-discharge programs in patients with heart failure, assessed from the perspective of the National Health Fund. Results: Myocardial infarction imposes the greatest financial cost (3.5 million bolivares/553 million USD), followed by hypertension (3.4 million bolivares/539 million USD), heart failure (3.3 million bolivares/522 million USD) and, finally, atrial fibrillation (0.4 billion bolivares/66 million USD).Telemedicine and structured telephone support are cost effective interventions for achieving improvements in the management of heart failure. The analysis assessed the prevalence and (in the case of myocardial infarction) incidence of the conditions, the associated expenditures on health care treatment, productivity losses from reduced employment, costs of providing formal and informal care, and lost wellbeing. Conclusions: Heart conditions impose substantial loss of wellbeing and financial costs in Venezuela and should be a public health priority(AU)

A qualitative investigation of patients' and caregivers' experiences of severe sepsis*.

OBJECTIVES: To explore and describe the subjective experiences and long-term impact of severe sepsis on survivors of severe sepsis and their informal caregivers (e.g., spouse or family member) through qualitative research methods. DESIGN: A qualitative exploratory study using semi-structured interviews with survivors of severe sepsis and their informal caregivers in the United Kingdom and United States. Participants also completed a demographic background form and sites provided medical history details. Transcripts were analyzed using a thematic analysis approach. SETTING: Patients were recruited from a large National Health Service hospital in the United Kingdom and a level 1 trauma center hospital in the United States. Caregivers were recruited through eligible patients. Interviews were conducted either face to face in participant's homes or another convenient location or over the telephone. PATIENTS: Patients who were 18 years old or older and had experienced an episode of severe sepsis in the previous 12 months were recruited by clinical staff in each hospital. Caregivers were family members or friends who had provided informal care for the patient after their episode of severe sepsis. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Thirty-nine interviews were conducted with 22 patients and 17 informal caregivers (of these 28 were conducted face-to-face and 11 by telephone). Five main themes were identified in the qualitative analysis: awareness and knowledge of severe sepsis; experience of hospitalization, ongoing impact of severe sepsis; impact on caregivers; and support after severe sepsis. Experiences varied depending on the patients' health prior to the severe sepsis, with the worst affected reporting lasting impacts on multiple aspects of their life. CONCLUSIONS: The study extends what was understood about severe sepsis from the patients' and caregivers' perspectives from the previous limited literature. Caregivers as well as patients reported enduring impact. The study also identified problems of lack of awareness of diagnosis and understanding of severe sepsis by patients and caregivers and difficulties accessing appropriate healthcare providers and ancillary services after discharge from hospital.

The efficacy and tolerability of perampanel and other recently approved anti-epileptic drugs for the treatment of refractory partial onset seizure: a systematic review and Bayesian network meta-analysis.

OBJECTIVES: This paper compares the efficacy and tolerability of perampanel (PER) relative to other recently approved anti-epileptic drug (AEDs) - lacosamide (LCS), retigabine (RTG), and eslicarbazepine (ESL) for the adjunctive treatment of partial onset seizures with or without secondary generalization and specifically in the secondary generalization subgroup. MATERIALS AND METHODS: A systematic literature review of all RCTs of PER and selected AEDs in EMBASE, Medline, and the Cochrane Central from 1998 to January 2011 with an update in PubMed in March 2013 was performed. A network meta-analysis was conducted for 50% responder rate for overall seizures; withdrawal due to adverse events; seizure freedom; and 50% responder rate for secondary generalized seizures. RESULTS: Twelve RCTs (three PER, three LCS, three RTG and three ESL) were included. PER performed significantly better than placebo for 'responder rate' (OR 2.151, 95% CrI 1.348-3.472) and 'seizure freedom' (OR 2.507, 95% CrI 1.067-7.429). When compared to other agents, PER was found to be equally effective. For 'withdrawal due to adverse events', PER had the lowest odds ratio vs. placebo compared with other AEDs. In the analysis for the subgroup of patients with secondary generalization, only four RCTs (three PER and one LCS) met the inclusion criteria for one outcome (responder rate) for LCS. In this subgroup, PER was statistically significantly better than placebo (OR 2.448, 95% CrI 1.088-5.828). CONCLUSION: PER was statistically significantly superior to placebo in responder rate, seizure freedom, and responder rate in the secondary generalization population. Though PER had statistically significant greater withdrawal compared to placebo, it had the lowest ORs vs. placebo, suggesting a superior safety profile among the comparators included in this analysis. In patients with partial onset seizure with secondary generalization, PER had a statistically significant effect on responder rate compared to placebo.

The cost effectiveness of rufinamide in the treatment of Lennox-Gastaut syndrome in the UK.

Lennox-Gastaut syndrome (LGS) is a catastrophic childhood form of epilepsy. The syndrome is characterized by mental impairment, frequent seizures of multiple types that are particularly resistant to treatment, and high rates of seizure-related injury. With the introduction of newer, but more costly, antiepileptic drugs (AEDs), it is important that decision makers are able to assess their value in the management of this rare and difficult-to-treat condition. To evaluate the cost effectiveness, from the UK NHS perspective, of rufinamide in patients with LGS. An individual patient-simulation model was developed to estimate the total treatment-related costs and clinical benefits of rufinamide compared with topiramate and lamotrigine over a 3-year time horizon. The model examines the treatment scenarios of adding rufinamide, lamotrigine or topiramate to older AEDs (standard therapy), or standard therapy alone within a primary-care or community setting. Three placebo-controlled clinical trials of adjunctive AED treatment for children with LGS were analysed. There are no head-to-head comparator studies. Between 98 and 139 patients were randomized in each study and the mean age in each study was 10, 11 and 14 years. A mixed-treatment comparison using a random-effects model was carried out on the number of patients in each response category, using the placebo arms of the respective trials. The primary outcome measure was the percentage of successfully treated patients, defined as >50% reduction in the frequency of total seizures and drop attacks. The hypothesis being tested was formulated after data collection. Costs ( pound, year 2006/07 values) of patient monitoring, switching treatments, hospitalization due to seizure, treatment of adverse effects, and personal and social services were included in the analysis. Results of 10,000 Monte Carlo simulations were bootstrapped to conduct probabilistic sensitivity analysis. Over 3 years, adjunctive rufinamide resulted in higher total costs than topiramate and lamotrigine; however, with more patients being treated successfully, this leads to acceptable incremental cost-effectiveness ratios. If society is prepared to pay at least 250 pounds for a 1% increase in the number of successfully treated LGS patients, in terms of a 50% reduction in the frequency of drop attacks, the probability of the treatment with rufinamide being cost effective is >80%. This cost-effectiveness analysis suggests that rufinamide results in more LGS patients being treated successfully at a reasonable cost from a UK NHS perspective.

Lennox-Gastaut syndrome (LGS): development of conceptual models of health-related quality of life (HRQL) for caregivers and children.

LGS is a severe form of childhood epilepsy which is characterized by multiple seizures and cognitive impairment. Semi-structured interviews were conducted with 40 parents of children with LGS in the US, UK, and Italy. Parents were asked to report on their perceptions of the HRQL of their child and also to describe the impact on their own HRQL. Thematic analysis was conducted to develop themes relating to the impact on HRQL. The themes were organized into conceptual models of the impact of LGS on the HRQL of the parent and the child. The models demonstrate the complex relationships between the components of LGS and their impact on HRQL.

Cost-utility analysis of rufinamide versus topiramate and lamotrigine for the treatment of children with Lennox-Gastaut Syndrome in the United Kingdom.

PURPOSE: To estimate the cost-effectiveness of rufinamide relative to topiramate and lamotrigine as adjunctive treatment for children with Lennox-Gastaut Syndrome (LGS). METHODS: A Markov decision analytic model was developed to estimate the incremental cost-effectiveness ratio over a three-year time horizon in patients with LGS uncontrolled by up to three antiepileptic drugs. Utilities were assigned to health states, defined according to a patient's response to treatment (> or =75%, > or =50% and <75%, and <50% reduction in tonic-atonic [drop attack] seizure frequency and death). Efficacy and safety estimates were made using indirect/mixed-treatment comparisons of data obtained from published literature. Outcomes included costs and quality-adjusted life-years (QALYs), allowing the incremental cost-effectiveness ratio to be estimated as cost per QALY gained. RESULTS: Over three years, the total cumulative costs for rufinamide, topiramate, and lamotrigine were pound24,992, pound23,360, and pound21,783, respectively. Rufinamide resulted in an incremental QALY gain of 0.079 relative to topiramate and 0.021 relative to lamotrigine. The incremental costs of rufinamide were pound1632 and pound3209, relative to topiramate and lamotrigine, resulting in an incremental cost per QALY gained of pound20,538 and pound154,831, respectively. CONCLUSIONS: Considering the underlying assumptions, this current economic evaluation demonstrates that rufinamide is likely to be a cost-effective alternative to topiramate as adjunctive treatment for children with LGS in the UK. In addition, when compared to lamotrigine, which is an inexpensive treatment, rufinamide should be considered as a cost-effective alternative due to the importance of patient choice and equity of access in such a rare and devastating condition.

Impact of Lennox-Gastaut Syndrome (LGS) on health-related quality of life (HRQL) of patients and caregivers: literature review.

The aim of this study was to conduct a review of the literature to evaluate the impact of LGS on the HRQL of children with LGS and their caregivers. The literature search revealed that there is limited published research on the impact of LGS on the HRQL of the child or caregiver. LGS has a major physical impact on a child, with a high frequency of seizures, and a high rate of seizure-related injuries. It interferes with all aspects of the child's intellectual and social development. The patient, and also his/her entire family are affected. Caring for a child with LGS is described as a 'burden', with increased anxiety about injury from seizures as well as the strain associated with providing continuous care. Overall, there is a lack of research on LGS, specifically the extent of the impact of LGS on the HRQL of the child and caregiver is under-explored.