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- Embolia pulmonar em Portugal : epidemiologia e mortalidade intra-hospitalarPublication . Gouveia, Miguel; Pinheiro, Luís; Costa, João; Borges, MargaridaIntroduction: In Portugal, the epidemiology of acute pulmonary embolism is poorly understood. In this study, we sought to characterize the pulmonary embolism from the hospital data and evaluate its in-hospital mortality and respective prognostic factors. Material and Methods: The study used diagnostic related groups data from National Health System hospitals from 2003 to 2013 and National Statistics Institute population data to establish the evolution of admissions with the diagnosis of pulmonary embolism, their in hospital mortality rates and the population incidence rates. Diagnosis-related group microdata were used in a logit regression modeling in-hospital mortality as a function of individual characteristics and context variables. Results: Between 2003 and 2013 there were 35,200 episodes of hospitalization in patients with 18 or more years in which one of the diagnoses was pulmonary embolism (primary diagnosis in 67% of cases). The estimated incidence rate in 2013 was 35/100,000 population (≥ 18 years). Between 2003 and 2013, the annual number of episodes kept increasing, but the in-hospital mortality rate decreased (from 31.8% to 17% for all cases and from 25% to 11.2% when pulmonary embolism was the main diagnosis). The probability of death decreases when there is a computerized tomography scan registry or when patients are females and increases with age and the presence of co-morbidities. Discussion: In the last decade there was an increased incidence of pulmonary embolism likely related to an increased number of dependents and bedridden. However, there was a in-hospital mortality reduction of such size that the actual mortality in the general population was reduced. One possible explanation is that there has been an increase in episodes of pulmonary embolism with incrementally lower levels of severity, due to the greater capacity of diagnosis of less severe cases. Another possible explanation is greater effectiveness of hospital care. According to the logistic regression analysis, improvements in hospital care effectiveness in recent years are primarily responsible for the mortality reduction. Conclusion: About 79% of the reduction of in-hospital mortality of pulmonary embolism between 2003 and 2013 can be attributed to greater effectiveness of hospital care and the rest to the favorable change in patient characteristics associated with risk of death.
- The current and future burden of heart failure in PortugalPublication . Gouveia, Miguel; Ascenção, Raquel; Fiorentino, Francesca; Costa, João; Caldeira, Daniel; Broeiro-Gonçalves, Paula; Fonseca, Candida; Borges, MargaridaAIMS: Heart failure (HF) is a clinical syndrome with significant social and economic burden. We aimed to estimate the burden of HF in mainland Portugal over a 22-year time horizon, between 2014 and 2036. METHODS AND RESULTS: Heart failure burden was measured in disability-adjusted life years (DALYs), resulting from the sum of years of life lost (YLL) due to premature death and years lost due to disability (YLD). YLL were estimated based on the Portuguese mortality rates reported by the European Detailed Mortality Database. For YLD, disease duration and the overall incidence were estimated using an epidemiological model developed by the World Health Organization (DISMOD II). Disability weights were retrieved from published literature. The impact of ageing was estimated with a shift-share analysis using official demographic projections. In 2014, 4688 deaths were attributed to HF, corresponding to 4.7% of the total deaths in mainland Portugal. DALYs totalled 21 162, 53.9% due to premature death (YLL: 11 398) and 46.1% due to disability (YLD: 9765). Considering only population ageing over a 22-year horizon, the deaths and burden of HF are expected to increase by 73.0% and 27.9%, respectively, reaching 8112 deaths and 27 059 DALYs lost due to HF in 2036. DALY's growth is mainly driven by the increase of YLL, whose contribution to overall burden will increase to 62.0%. CONCLUSIONS: Heart failure is an emerging and growing health problem where significant health gains may be obtained. The projected significant increase of HF burden highlights the need to set HF as a priority for healthcare system.
- Estudo de custo-efectividade do aliscireno no tratamento da hipertensão em doentes com diabetes tipo 2 e nefropatia em PortugalPublication . Gouveia, Miguel; Borges, Margarida; Costa, João; Pinheiro, Luís; Vaz Carneiro, AntónioObjectives: aliskiren is a direct human renin inhibitor that is efficacious in the treatment of high blood pressure in patients with diabetes mellitus type 2 and nephropathy. The purpose of this study is to provide an economic evaluation of aliskiren in a social perspective. We estimated the incremental cost-effectiveness of a therapeutical strategy based on aliskiren and losartan versus a strategy based on a losartan and placebo. The measures of effectiveness used were life expectancy, quality adjusted life years, and the incidence of end stage renal disease. Methods: the estimates of efficacy in clinical trials and other studies were extrapolated for a 20 years time horizon by using Markov chains with six month length cycles. We estimated the direct costs of the alternative strategies in the context of Portuguese clinical practice, including costs with aliskiren, losartan, other drugs, tests, doctor visits, and the costs of renal transplants. We also estimated indirect costs due to absenteeism and premature retirement from the labor market. Results: In the baseline case the strategy with aliskiren always dominates the placebo strategy, with mean costs inferior by €552,32 and superior effectiveness. The dominance result was robust to plausible variations in the time horizon, the management costs for patients with hypertension and type 2 diabetes and the transplant costs. The result was also robust to using different discount rates and to the non inclusion of indirect costs in the analysis. In a pessimistic alternative scenario with lower aliskiren efficacy in the initial cycle the incremental cost utility was €7246 per QALY ganied. Probabilistic sensitivity analysis shows that aliskiren is dominant witha 56,8% probability and that for willingnesses to pay between €20 000 and 30 000€ the probability aliskirenis cost-effective goes from 72,3% up to 76,6%. Conclusions: In the context of the Portuguese health system, the use of aliskiren is cost-effective. Thus aliskiren is a valuable addition to the therapeutic arsenal for the treatment of patients with diabetes mellitus type 2, high blood pressure and nephropathy.
- O custo e a carga da esquizofrenia em Portugal em 2015Publication . Gouveia, Miguel; Ascenção, Raquel; Fiorentino, Francesca; Pascoal, João; Costa, João; Borges, MargaridaIntrodução: A esquizofrenia é uma importante causa de incapacidade e consumo de recursos económicos. Neste estudo pretendemos estimar os custos e a carga da esquizofrenia para 2015 em Portugal Continental. Métodos: A carga da doença foi medida pelos anos de vida ajustados pela incapacidade (DALY- Disability-adjusted life years), uma métrica adotada pela Organização Mundial de Saúde. O custo da doença foi estimado com base na prevalência adotando a perspetiva global da sociedade. Os custos incluíram os consumos de recursos e os custos indiretos dos doentes e cuidadores (perdas de produtividade). As principais fontes de informação de custos foram: a base de dados GDH; os contratos programa; dados de consumo de medicamentos e opinião de peritos. Resultados: A prevalência da esquizofrenia será cerca de 48 mil doentes, sendo que o número de doentes seguidos pelo sistema de saúde (público e privado) deverá estar na ordem dos 41 mil doentes. Em 2015, estima-se que se tenham perdido 28.588 DALY (84% por incapacidade; 16% por mortalidade prematura). A preços de 2015, o total estimado de custos diretos e indiretos da esquizofrenia foi respetivamente de € 96,1 e € 340,3 milhões (97% gerados pelos doentes). Conclusão: A esquizofrenia tem um importante impacto social em Portugal devido essencialmente à morbilidade gerada, podendo-se-lhe atribuir em 2015 um custo total de € 436,3 milhões, cerca de 0,24% do produto interno bruto. Os custos diretos representam 0,6 % de todas as despesas de saúde em 2015, enquanto a totalidade dos custos (diretos e indiretos) representam 2,7% da despesa em saúde.
- Burden of disease and cost of illness of atrial fibrillation in PortugalPublication . Gouveia, Miguel; Costa, João; Alarcão, Joana; Augusto, Margarida; Caldeira, Daniel; Pinheiro, Luís; Carneiro, António Vaz; Borges, MargaridaIntroduction and Objectives: Atrial fibrillation is the most prevalent sustained arrhythmia. This paper estimates the burden and cost of illness attributable to atrial fibrillation in Portugal based on demographic and health statistics. Methods: Mortality data by cause of death came from the European Detailed Mortality Database of the World Health Organization (WHO). Hospital data were taken from the Portuguese diagnosis-related groups database. The burden of disease was measured using DALYs (disability-adjusted life years), a metric adopted by the WHO. Costs studied included resource use and lost productivity. The burden and cost of illness are those attributable to atrial fibrillation and its main complication, ischemic stroke. Results: In Portugal, 4070 deaths were attributable to atrial fibrillation in 2010, corresponding to 3.8% of all deaths. In total, the burden of disease attributable to atrial fibrillation was estimated at 23 084 DALYs: 10 521 resulting from premature deaths (1.7% of the total DALYs due to death in 2010 in Portugal), and 12 563 resulting from disability. The total estimated direct costs attributable to atrial fibrillation at 2013 prices were 115 MD (million euros): 34 MD for inpatient care and 81 MD for outpatient care. Indirect costs resulting from lost production due to disability were estimated at 25 MD. Conclusions: Atrial fibrillation has an important social impact in Portugal due to its associated mortality and morbidity, and was responsible in 2013 for a total cost of 140 MD , about 0.08% of gross domestic product.
- Indicadores (outcomes) primários e secundários em ensaios clínicos oncológicos : definição e usosPublication . Carneiro, António Vaz; Luz, Ricardo; Borges, Margarida; Costa, JoãoIntroduction: The proof of efficacy from a therapeutic intervention in oncology must be defined through well conducted clinical trials. One of the most important methodological issue is the outcome selection needed to calculate measures of association allowing definition of clinical efficacy. Material and Methods: We designed a narrative revision based on some of the international regulatory instructions from drug agencies, as well as consensus papers from scientific oncology societies, listing and critically assessing each outcome used in oncology clinical trials. Results: We identified as being the most important outcomes in oncology trials the overall survival, the progression free survival/disease-free survival, the toxicity, the quality of life/patient-reported outcomes and the objective response rate. Discussion: The selection of the primary outcome must be based on therapeutic efficacy as well as toxicity, expected survival, alternative drug regimens and even disease prevalence. Conclusion: The selection of efficacy outcomes for clinical trials in oncology is very important and its selection must be well justified, and depends on the type of disease, the patients and the drug being studied.
- Cost and burden of non-small cell lung cancer's in PortugalPublication . Borges, Margarida; Gouveia, Miguel; Alarcão, Joana; Sousa, Rita; Teixeira, E.; Barata, F.; Laranjeira, E.; Lopes, F.; Parente, B.; Pinheiro, L.; Carneiro, António Vaz; Costa, JoãoObjectives: This study estimates the impact of Non-Small Cell Lung Cancer (NSCLC) on population health levels and its economic impact in Portugal in 2012.
- Atrial fibrillation’s burden of disease in PortugalPublication . Gouveia, M.; Borges, Margarida; Alarcão, J.; Caldeira, Daniel; Pinheiro, L.; Sousa, R.; Ascenção, R.; Costa, João; Carneiro, António VazObjectives: To estimate the Disability Adjusted Life-Years (DALY) attributable to Atrial Fibrillation (AF) during 2010 in Portugal, including both AF and AF related stroke.
- Clinical comparability of the new antiepileptic drugs in refractory partial epilepsy : a systematic review and meta-analysisPublication . Costa, João; Fareleira, Filipa; Ascenção, Raquel; Borges, Margarida; Sampaio, Cristina; Carneiro, António VazPurpose: Evaluate the clinical comparability of new antiepileptic drugs (AEDs) in partial refractory epilepsy. Methods: Systematic review of randomized trials (RCTs) comparing a new AED (add-on treatment) with placebo or another AED. Primary outcomes: responder (≥50% seizure reduction) and withdrawal (tolerability) rates. Pooled estimates of odds ratios (ORs) and number needed treat/harm (NNT/NNH) taking into account baseline risk were derived by random-effects meta-analysis. Adjusted frequentist indirect comparisons between AEDs were estimated. Key Findings: Sixty-two placebo-controlled (12,902 patients) and eight head-to-head RCTs (1,370 patients) were included. Pooled ORs for responder and withdrawal rates (vs. placebo) were 3.00 [95% confidence interval (CI) 2.63–3.41] and 1.48 (1.30–1.68), respectively. Indirect comparisons of responder rate based on relative measurements of treatment effect (ORs) favored topiramate (1.52; 1.06–2.20) in comparison to all other AEDs, whereas gabapentin (0.67; 0.46–0.97) and lacosamide (0.66; 0.48–0.92) were less efficacious, without significant heterogeneity. When analyses were based on absolute estimates (NNTs), topiramate and levetiracetam were more efficacious, whereas gabapentin and tiagabine were less efficacious. Withdrawal rate was higher with oxcarbazepine (OR 1.60; 1.12–2.29) and topiramate (OR 1.68; 1.07–2.63), and lower with gabapentin (OR 0.65; 0.42–1.00) and levetiracetam (OR 0.62; 0.43–0.89). Significance: The differences found are of relatively small magnitude to allow a definitive conclusion about which new AED(s) has superior effectiveness. This uncertainty probably reflects the limitations of conclusions based on indirect evidence. The process of pharmacologic clinical decision making in partial refractory epilepsy probably depends more on other aspects, such as individual patient characteristics and pharmacoeconomics, than on available controlled randomized evidence.
- Cost-effectiveness of sacubitril/valsartan for the treatment of patients with heart failure with reduced ejection fraction in PortugalPublication . Borges, Margarida; Afonso Silva, Marta; Laires, Pedro A.; Gouveia, Miguel; Alarcão, Joana; Ascenção, Raquel; Costa, JoãoObjectives: This study assesses the cost-effectiveness of sacubitril/valsartan versus enalapril in patients with symptomatic heart failure with reduced ejection fraction (HFrEF). Methods: We used a previously developed Markov model calibrated with patient-level data from the PARADIGM-HF trial, adapted to the Portuguese setting. The model considers two health states (alive or dead) and uses regression analyzes to estimate hospitalizations and deaths over time. A panel of experts estimated resource consumption in the outpatient setting. To estimate resource consumption with hospitalizations, the National Health Service Diagnosis Related Groups database was used. Unit costs were based on national legislation, and on the Infomed database. The model considers a societal perspective, a time horizon of 30-years, and a 5% annual discount rate. Sensitivity analyses assessed the robustness of results. Results: Sacubitril/valsartan increases life expectancy by 0.5 life-years, corresponding to 0.4 incremental quality adjusted life-years (QALY) versus enalapril. The estimated incremental cost-effectiveness ratio (ICER) is 22,702€/QALY. Sensitivity analysis shows that results are robust, but sensitive to the parameter estimates of the cardiovascular survival curve. Conclusion: Sacubitril/valsartan is a cost-effective therapeutic option in the treatment of Portuguese patients with HFrEF and translate into significant health gains and increased life expectancy versus the current standard of care.