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Background The COVID-19 pandemic had a major impact on the mental health of healthcare workers (HCWs), especially in low and middle-income countries, which had to face additional political, social, and economic challenges. We thus aimed to assess the prevalence of mental health outcomes and the associated factors in HCWs treating COVID-19 patients in one of the most affected regions in Brazil. Methods We used the Respondent-Driven Sampling method to assess the risks of COVID-19 infection and symptoms of mental disorders in nurses, nursing technicians, and physicians who worked on the frontline in the metropolitan region of Recife. 865 healthcare workers completed a survey regarding sociodemographic data, work-related risks, and symptoms of mental disorders - SRQ-20 for common mental disorders (CMD); AUDIT-C for problematic alcohol use; GAD-7 for anxiety; PHQ-9 for depression; PCL-5 for post-traumatic stress disorder (PTSD). Gile’s successive sampling estimator was used to produce the weighted estimates by professional category. A Poisson regression model with robust variance was used to analyze factors associated with a positive screening for CMD. We will present the results of a cross-sectional analysis of the mental health outcomes after the first peak of COVID-19 – from August 2020 to February 2021. Results The prevalence ratios for a positive screening for CMD were 34.9% (95% CI: 27.8–41.9) in nurses, 28.6% (95% CI: 21.3–36.0) in physicians, and 26.6% (95% CI: 16.8–36.5) in nursing technicians. Nurses presented a higher prevalence of depressive symptoms (23%). Positive screening for problematic alcohol use (10.5 to14.0%), anxiety (10.4 to 13.3%), and PTSD (3.3 to 4.4%) were similar between the professional categories. The main factors associated with CMD in nurses and physicians were related to an intrinsic susceptibility to mental illness, such as previous or family history of psychiatric disorder, and female sex. Among nurse technicians, work-related factors, such as accidents with biological material, presented the strongest association with CMD. Conclusion The mental health of HCWs fighting COVID-19 in Recife was severely affected. It is crucial that healthcare services provide adequate working conditions and psychological support, investing in programs to promote and protect HCWs mental health.

Background Health providers are under unprecedented pressures to perform in the COVID-19 health crisis and under unprecedented risks. We initiated a large mixed-method survey of health professionals in five large metropolitan areas in Brazil to document the risks and needs of health professionals. To initiate the study, we conducted formative research. Methods We conducted 77 open-ended semi-structured interviews online in a convenience sample of physicians, nurses, nurse technicians, and physiotherapists in Belem, Fortaleza, Porto Alegre, Recife, and São Paulo, Brazil. Design, data collection, and analysis were informed by Rapid Ethnographic Analysis (REA). Results Responses are organized into three themes that emerged in the interviews: the lack of preparation – both locally and nationally—for the pandemic and its effects on staffing and training; the overlap of personal, family, and professional risk and consequences; and inadequately addressed anxiety and suffering among health staff. Conclusions Our respondents were unprepared for the epidemic, especially the institutional sequelae and psychological cost. These consequences were exacerbated by both lack of leadership and sweeping changes undercutting the Brazilian health system noted by almost all participants.

BackgroundPsychiatric disorders are associated with more than 90% of reported suicide attempts worldwide, but few treatments have demonstrated a direct effect in reducing suicide risk. Ketamine, originally an anesthetic, has been shown anti-suicide effects in clinical trials designed to treat depression. However, changes at the biochemical level were assessed only in protocols of ketamine with very limited sample sizes, particularly when the subcutaneous route was considered. In addition, the inflammatory changes associated with ketamine effects and their correlation with response to treatment, dose-effect, and suicide risk warrant further investigation. Therefore, we aimed to assess whether ketamine results in better control of suicidal ideation and/or behavior in patients with depressive episodes and whether ketamine affects psychopathology and inflammatory biomarkers.Materials and methodsWe report here the design of a naturalistic prospective multicenter study protocol of ketamine in depressive episodes carried out at Hospital de Clínicas de Porto Alegre (HCPA) and Hospital Moinhos de Vento (HMV). The study was planned to recruit adult patients with Major depressive disorder (MDD) or Bipolar disorder (BD) types 1 or 2, who are currently in a depressive episode and show symptoms of suicidal ideation and/or behavior according to the Columbia-Suicide Severity Rating Scale (C-SSRS) and have been prescribed ketamine by their assistant psychiatrist. Patients receive ketamine subcutaneously (SC) twice a week for 1 month, but the frequency can be changed or the dose decreased according to the assistant physician’s decision. After the last ketamine session, patients are followed-up via telephone once a month for up to 6 months. The data will be analyzed using repeated measures statistics to evaluate the reduction in suicide risk as a primary outcome, as per C-SSRS.DiscussionWe discuss the need for studies with longer follow-ups designed to measure a direct impact on suicide risk and that additional information about the safety and tolerability of ketamine in particular subset of patients such as those with depression and ideation suicide. In line, the mechanism behind the immunomodulatory effects of ketamine is still poorly understood.Trial registrationhttps://clinicaltrials.gov/, identifier NCT05249309.

A pandemia ocasionada pela Coronavirus disease (covid-19) tem impactado a sociedade como um todo, exigindo adaptação a um novo contexto, tanto pessoal quanto profissional. As condições de trabalho dos profissionais de saúde têm sido objeto de interesse de pesquisas atuais, com ênfase no risco de transmissão e da sua repercussão na saúde mental. Nesse sentido, o presente estudo analisa as diferentes implicações dessa pandemia nas esferas privada e de trabalho entre médicos, enfermeiros e técnicos de enfermagem que atuam na Região Metropolitana de São Paulo, Brasil. A partir de uma abordagem qualitativa e quantitativa, foram exploradas as entrevistas realizadas principalmente a distância, com o auxílio de mediação tecnológica, com a aplicação de um roteiro semiestruturado. Verificou-se que as adaptações para viver e trabalhar na pandemia se expressaram de forma heterogênea entre as diferentes categorias de profissionais da saúde, identificadas na intersecção entre gênero e classe social, sendo as mulheres as grandes responsáveis pela articulação de novas formas de apoio em rede. As intervenções a serem implementadas para a recuperação dos efeitos da pandemia não poderão abstrair as iniquidades já presentes na sociedade que se reproduzem no ambiente profissional.

Objective: The objective of this study was to estimate treatment costs of Hematopoietic stem cell transplantation (HSCT) at a reference center in Brazil. Methods: The study population consisted of patients from the Unified Health System HSCT who underwent HSCT in southern Brazil between 2016 and 2019. Costs were measured using a micro-costing approach, based on Time-Driven Activity-based Costing (TDABC) adapted for economic studies in health and included the following steps: definition of the research question, structured data collection, and statistical analysis of results. Results: The total cost of HSCT was $155,110 ($92,794 – $249,146 USD). Matched unrelated donor HSCT was more expensive than matched related donor HSCT. The major cost factors involve post-ransplant complications, mainly the occurrence of infections. Concerning cost composition, exams and procedures represent the largest expense in HSCT (45%). Conclusion: These estimates could be applicable to further evaluations for HSCT cost-effectiveness and help healthcare decision-makers in middle-income countries

IntroductionThe disparities in the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among frontline health care workers (HCWs) and the unique work circumstances are poorly documented for low-and middle-income countries.MethodsWe assessed the frequency of SARS-CoV-2 infection, personal protective equipment (PPE) shortages, PPE use, and accidents involving biological material among HCWs in the Recife metropolitan area, Northeast Brazil. Using respondent driven sampling, we included HCWs attending suspected or confirmed COVID-19 patients from May 2020 to February 2021.ResultsWe analyzed 1,525 HCWs (527 physicians, 471 registered nurses, 263 nursing assistants/technicians, and 264 physical therapists). Women predominated in all categories (81.1%). Nurses were older and had more comorbidities (hypertension and overweight/obesity) than the other HCWs. The overall prevalence of SARS-CoV-2 infection was 61.8% after adjustment for the cluster random effect, weighted by network, and reference population size. The independent risk factors for a positive RT-PCR test were being a nursing assistant (OR adjusted: 2.56), not always using all recommended PPE in routine practice (ORadj: 2.15), and reporting a splash of biological fluid/respiratory secretion in the eyes (ORadj: 3.37).ConclusionsThe high risk of infection among HCWs reflects PPE shortages and younger, possibly less experienced, frontline HCWs. There were disparities in the risk of SARS-CoV-2 infection among HCWs, with nursing assistants being the most vulnerable, possibly due to their longer and frequent contact with COVID-19 patients.

Micro-costing studies still deserving for methods orientation that contribute to achieve a patient-specific resource use level of analysis. Time-driven activity-based costing (TDABC) is often employed by health organizations in micro-costing studies with that objective. However, the literature shows many deviations in the implementation of TDABC, which might compromise the accuracy of the results obtained. One reason for that can be attributed to the non-existence of a step-by-step orientation to conduct cost analytics with the TDABC specific for micro-costing studies in healthcare. This article aimed at exploring the literature and practical cases to propose an eight-step framework to apply TDABC in micro-costing studies for health care organizations. The 8-step TDABC framework is presented and detailed exploring online spreadsheets already coded to demonstrate data structure and math formula building. A list of analyses that can be performed is suggested, including an explanation about the information that each analysis can provide to increase the organization capability to orient decision making. The case study developed show that actual micro-costing of health care processes can be achieved with the 8-step TDABC framework and its use in future researches can contribute to increase the number of studies that achieve high-quality level in cost information, and consequently, in health resource evaluation.

Monitoring the costs is one of the key components underlying value-based health care. This study aimed to evaluate the cost-saving opportunities of interventional coronary procedures (ICPs). Data from 90 patients submitted to elective ICP were evaluated in five Brazilian hospitals. Time-driven activity-based costing, that guides the cost estimates using the time consumed and the capacity cost rates per resource as the data input, was used to assess costs and the time spent over the care pathway. Descriptive cost analyses were followed by a labour cost-saving estimate potentially achieved by the redesign of the ICP pathway. The mean cost per patient varied from $807 to $2639. The length of the procedure phase per patient was similar among the hospitals, while the post-procedure phase presented the highest variation in length. The highest direct cost saving opportunities are concentrated in the procedure phase. By comparing the benchmark service with the most expensive one, it was estimated that redesigning physician practices could decrease 51% of the procedure cost. This application is pioneered in Brazil and demonstrates how detailed cost information can contribute to driving health care management to value by identifying cost-saving opportunities.

RESUMO Objetivo: Fornecer recomendações para nortear o manejo clínico do potencial doador em morte encefálica. Métodos: O presente documento foi formulado em dois painéis compostos por uma força tarefa integrada por 27 especialistas de diferentes áreas que responderam a questões dirigidas aos seguintes temas: ventilação mecânica, hemodinâmica, suporte endócrino-metabólico, infecção, temperatura corporal, transfusão sanguínea, e uso de checklists. Os desfechos considerados foram: parada cardíaca, número de órgãos retirados ou transplantados e função/sobrevida dos órgãos transplantados. A qualidade das evidências das recomendações foi avaliada pelo sistema Grading of Recommendations Assessment, Development, and Evaluation. Resultados: Foram geradas 19 recomendações a partir do painel de especialistas. Dessas, 7 foram classificadas como fortes, 11 fracas e uma foi considerada boa prática clínica. Conclusão: Apesar da concordância entre os membros do painel em relação à maior parte das recomendações, o grau de recomendação é fraco em sua maioria. Abstract Objective: To contribute to updating the recommendations for brain-dead potential organ donor management. Methods: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, answered questions related to the following topics were divided into mechanical ventilation, hemodynamics, endocrine-metabolic management, infection, body temperature, blood transfusion, and checklists use. The outcomes considered were cardiac arrests, number of organs removed or transplanted as well as function / survival of transplanted organs. The quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system to classify the recommendations. Results: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong, 11 as weak and 1 was considered a good clinical practice. Conclusion: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak.

ObjectivesWe assessed the prevalence of SARS-CoV-2 infection, personal protective equipment (PPE) shortages and occurrence of biological accidents among front-line healthcare workers (HCW).Design, setting and participantsUsing respondent-driven sampling, the study recruited distinct categories of HCW attending suspected or confirmed patients with COVID-19 from May 2020 to February 2021, in the Recife metropolitan area, Northeast Brazil.Outcome measuresThe criterion to assess SARS-CoV-2 infection among HCW was a positive self-reported PCR test.ResultsWe analysed 1525 HCW: 527 physicians, 471 registered nurses, 263 nursing assistants and 264 physical therapists. Women predominated in all categories (81.1%; 95% CI: 77.8% to 84.1%). Nurses were older with more comorbidities (hypertension and overweight/obesity) than the other staff. The overall prevalence of SARS-CoV-2 infection was 61.8% (95% CI: 55.7% to 67.5%) after adjustment for the cluster random effect, weighted by network, and the reference population size. Risk factors for a positive RT-PCR test were being a nursing assistant (OR adjusted: 2.56; 95% CI: 1.42 to 4.61), not always using all recommended PPE while assisting patients with COVID-19 (OR adj: 2.15; 95% CI: 1.02 to 4.53) and reporting a splash of biological fluid/respiratory secretion in the eyes (OR adj: 3.37; 95% CI: 1.10 to 10.34).ConclusionsThis study shows the high frequency of SARS-CoV2 infection among HCW presumably due to workplace exposures. In our setting, nursing assistant comprised the most vulnerable category. Our findings highlight the need for improving healthcare facility environments, specific training and supervision to cope with public health emergencies.

Background: The disparities in the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among frontline health care workers (HCWs) and the unique work circumstances are poorly documented for low-and middle-income countries. Methods: We assessed the frequency of SARS-CoV-2 infection, personal protective equipment (PPE) shortages, PPE use, and accidents involving biological material among HCWs in the Recife metropolitan area, Northeast Brazil. Using respondent driven sampling, we included HCWs attending suspected or confirmed COVID-19 patients from May 2020 to February 2021. Findings: We analyzed 1,525 HCWs (527 physicians, 471 registered nurses, 263 nursing assistants/technicians, and 264 physical therapists). Women predominated in all categories (81·1%). Nurses were older and had more comorbidities (hypertension and overweight/obesity) than the other HCWs. The overall prevalence of SARS-CoV-2 infection was 61·8% after adjustment for the cluster random effect, weighted by network, and reference population size. The independent risk factors for a positive RT-PCR test were being a nursing assistant (OR adjusted: 2·56), not always using all recommended PPE in routine practice (ORadj: 2·15), and reporting a splash of biological fluid/respiratory secretion in the eyes (ORadj: 3·37). Interpretation: The high risk of infection among HCWs reflects PPE shortages and younger, possibly less experienced, frontline HCWs. There were disparities in the risk of SARS-CoV-2 infection among HCWs, with nursing assistants being the most vulnerable, possibly due to their longer and frequent contact with COVID-19 patients. Funding Information: This investigation was funded by Health Technology Assessment Institute (IATS) and by MCTIC/CNPq/FNDCT/MS/SCTIE/Decit No 07/2020. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: Providing electronic informed consent was mandatory to participate and access the questionnaire. The project was approved by the National Ethics Committee (CONEP; CAAE: 30629220.8.0000.0008).

Background: Adopting value-based health care management strategies requires monitoring the real costs and care delivered to patients. This study aimed to evaluate the cost-saving opportunities of interventional coronary procedures (ICPs) by assessing patients’ processes of care and costs in five public academic hospitals.Methods: Data from 90 patients submitted to elective ICP were evaluated in five hospitals in Brazil. Time-driven activity-based costing (TDABC) was used to assess real-world costs and the time spent over the care pathway. Descriptive cost analyses were followed by a labour cost-saving estimate potentially achieved by the redesign of the ICP pathway, considering the benchmark of the patient care cycle identified in the sample of hospitals studied.Results: The mean cost per patient of interventional angioplasty was $1,677 (SD $881). The length of the procedure phase per patient was similar among the hospitals, while the post- procedure phase presented the highest variation in length. However, it was possible to demonstrate that the highest direct cost saving opportunities are concentrated in the procedure phase in which labour and non-labour resources are more consumed. Physician involvement redesign can account for a 51% decrease in procedure cost.Conclusion: This study demonstrated how the level of detailing on cost information provided by the TDABC can contribute to driving health care management to value by identifying cost-saving opportunities in health service delivery.

BackgroundAdopting value-based health care management strategies requires monitoring of real costs and care delivered to patients. In unified health systems, recognizing institutions that provide high-quality services, demands understanding their processes of care and costs. This study aimed to evaluate processes and costs of interventional coronary procedures performed in public academic hospitals of a middle-income country.MethodsData from 90 patients submitted to the coronary angioplasties were evaluated in five hospitals in Brazil. Time-driven activity-based costing (TDABC) was used to assess real-world costs and time spent over the care pathway. Descriptive cost analyses were followed by a labor cost-saving estimate potentially achieved by the redesign of the ICP pathway, considering the benchmark of patient care cycle identified in the sample of hospitals studied.ResultsThe mean cost per patient of interventional angioplasties was $1,677 (SD $881). The procedure phase duration per patient was similar between the hospitals, while the post procedure presented the highest length of time variation. However, it was possible to demonstrate that the highest direct cost saving opportunities are concentrated in the procedure phase, due to the way that labor and non-labor resources are consumed. The physician involvement redesign can account for a 51% ICP cost decrease. ConclusionThis study demonstrated how the level of detailing provided by microcosting methods such as TDABC can contribute to driving health care management to value. In a public health system, turning transparent how resources are allocated in an individual level basis along an entire episode of care might allow managers to identify cost-saving opportunities and ways to improve the health service delivery.

Background Measures of health-related quality of life (HRQoL) have been used to express the impact of neglected diseases and to generate indicators for health economic assessments. Schistosomiasis mansoni is a neglected disease with various clinical manifestations, including severe repercussions, caused by parasitic worms. Here we describe the quality of life of chronic schistosomiasis mansoni patients and estimate the quality-adjusted life years (QALYs) associated with chronic schistosomiasis mansoni in Brazil in 2015. Methods A HRQoL study was carried out using the three-level European Quality of Life 5-Dimensions (EQ-5D-3L) questionnaire in 147 chronic schistosomiasis mansoni patients at an outpatient monitoring facility of an endemic state for schistosomiasis. Results Losses in HRQoL were observed in all five dimensions of the EQ-5D-3L. Patients >60 y and 40-49 y of age reported the highest frequencies of problems. The average utility index was 0.71, and the median index was significantly lower among female patients and patients with comorbidities (0.68; p

To establish the prevalence of physical, cognitive and psychiatric disabilities, associated factors and their relationship with the qualities of life of intensive care survivors in Brazil.A prospective multicenter cohort study is currently being conducted at 10 adult medical-surgical intensive care units representative of the 5 Brazilian geopolitical regions. Patients aged ≥ 18 years who are discharged from the participating intensive care units and stay 72 hours or more in the intensive care unit for medical or emergency surgery admissions or 120 hours or more for elective surgery admissions are consecutively included. Patients are followed up for a period of one year by means of structured telephone interviews conducted at 3, 6 and 12 months after discharge from the intensive care unit. The outcomes are functional dependence, cognitive dysfunction, anxiety and depression symptoms, posttraumatic stress symptoms, health-related quality of life, rehospitalization and long-term mortality.The present study has the potential to contribute to current knowledge of the prevalence and factors associated with postintensive care syndrome among adult intensive care survivors in Brazil. In addition, an association might be established between postintensive care syndrome and health-related quality of life.Avaliar a prevalência de incapacidades físicas, cognitivas e psiquiátricas, fatores associados e sua relação com qualidade de vida em pacientes sobreviventes de internação em unidades de terapia intensiva brasileiras.Um estudo de coorte prospectivo multicêntrico está sendo conduzido em dez unidades de terapia intensiva adulto clínico-cirúrgicas representativas das cinco regiões geopolíticas do Brasil. Pacientes com idade ≥ 18 anos que receberam alta das unidades de terapia intensiva participantes e permaneceram internados na unidade de terapia intensiva por 72 horas ou mais, nos casos de internação clínica ou cirúrgica de urgência, e por 120 horas ou mais, nos casos de internação cirúrgica eletiva, serão incluídos de forma consecutiva. Estes pacientes serão seguidos por 1 ano, por meio de entrevistas telefônicas estruturadas 3, 6 e 12 meses pós-alta da unidade de terapia intensiva. Dependência funcional, disfunção cognitiva, sintomas de ansiedade e depressão, sintomas de estresse pós-traumático, qualidade de vida relacionada à saúde, re-hospitalizações e mortalidade em longo prazo serão avaliados como desfechos.O presente estudo tem o potencial de contribuir para o conhecimento a respeito da prevalência e dos fatores associados à síndrome pós-cuidados intensivos na população de pacientes adultos sobreviventes de internação em unidades de terapia intensiva brasileiras. Ademais, a associação entre síndrome pós-cuidados intensivos e qualidade de vida relacionada à saúde poderá ser estabelecida.

Objective To contribute to updating the recommendations for brain-dead potential organ donor management. Method A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, joined a task force formed by the General Coordination Office of the National Transplant System/Brazilian Ministry of Health (CGSNT-MS), the Brazilian Association of Intensive Care Medicine (AMIB), the Brazilian Association of Organ Transplantation (ABTO), and the Brazilian Research in Intensive Care Network (BRICNet). The questions were developed within the scope of the 2011 Brazilian Guidelines for Management of Adult Potential Multiple-Organ Deceased Donors. The topics were divided into mechanical ventilation, hemodynamic support, endocrine-metabolic management, infection, body temperature, blood transfusion, and use of checklists. The outcomes considered for decision-making were cardiac arrest, number of organs recovered or transplanted per donor, and graft function/survival. Rapid systematic reviews were conducted, and the quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Two expert panels were held in November 2016 and February 2017 to classify the recommendations. A systematic review update was performed in June 2020, and the recommendations were reviewed through a Delphi process with the panelists between June and July 2020. Results A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong (lung-protective ventilation strategy, vasopressors and combining arginine vasopressin to control blood pressure, antidiuretic hormones to control polyuria, serum potassium and magnesium control, and antibiotic use), 11 as weak (alveolar recruitment maneuvers, low-dose dopamine, low-dose corticosteroids, thyroid hormones, glycemic and serum sodium control, nutritional support, body temperature control or hypothermia, red blood cell transfusion, and goal-directed protocols), and 1 was considered a good clinical practice (volemic expansion). Conclusion Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak. The observed lack of robust evidence on the topic highlights the importance of the present guideline to improve the management of brain-dead potential organ donors.

Objectives: To summarize the main points from the Brazilian’s Ministry of Health Economic Evaluations (HEE) guideline. Methods: The guideline was developed through multiple rounds of iterative work, conducted by a multidisciplinary team of specialists in health economics, and where submitted to public consultation. Results: The decision problem should be defined through a structured research question. The study can be either primary data or model-based; in the first case, there is greater internal validity, while the second generates a superior generalizability. When the study is model-based and focused on a chronic disease, a Markov model can be usually employed, except for situations that points towards the need of a discrete event simulation (such as competition of individuals for scarce resources) or a dynamic transition model (for example, vaccination models and infectious diseases with high transmission rates between individuals). The preferred time horizon is the lifetime one, and the default discount rate is 5% for both costs and effectiveness. Costs should represent the Unified Health System (SUS) perspective and can be estimated through either gross-costing or micro-costing. Results should be presented as costs per quality adjusted life years (QALYs) whenever possible, to facilitate comparison with other studies. Sensitivity analyses should be widely employed, in order to evaluate the impact of uncertainty in the results produced by the model. Conclusions: It is expected that, with the methodological standardization proposed in this guideline, the HEE production in Brazil has gains in quality and reproducibility.

Cost-effectiveness models that present results in terms of cost per quality-adjusted life-year for health technologies are used to inform policy decisions in many parts of the world. Health state utilities (HSUs) are required to calculate the quality-adjusted life-years. Even when clinical studies assessing the effectiveness of health technologies collect data on HSUs to populate a cost-effectiveness model, which rarely happens, analysts typically need to identify at least some additional HSUs from alternative sources. When possible, HSUs are identified by a systematic review of the literature, but, again, this rarely happens. In 2014, ISPOR established a Good Practices for Outcome Research Task Force to address the use of HSUs in cost-effectiveness models. This task force report provides recommendations for researchers who identify, review, and synthesize HSUs for use in cost-effectiveness models; analysts who use the results in models; and reviewers who critically appraise the suitability and validity of the HSUs selected for use in models. The associated Minimum Reporting Standards of Systematic Review of Utilities for Cost-Effectiveness checklist created by the task force provides criteria to judge the appropriateness of the HSUs selected for use in cost-effectiveness models and is suitable for use in different international settings.

BACKGROUND Schistosomiasis mansoni is a poverty-related parasitic infection that has a variety of clinical manifestations. We consider the disability and deaths caused by schistosomiasis unacceptable for a tool-ready disease. Its condition in Brazil warrants an analysis that will enable better understanding of the local health losses and contribute to the complex decision-making process. OBJECTIVE This study estimates the cost of schistosomiasis in Brazil in 2015. METHODS We conducted a cost of illness study of schistosomiasis mansoni in Brazil in 2015 based on a prevalence approach and from a societal perspective. The study included 26,499 schistosomiasis carriers, 397 hepatosplenic cases, 48 cases with the neurological form, 284 hospitalisations, and 11,368.26 years of life lost (YLL) of which 5,187 years are attributable to economically active age groups. RESULTS The total cost of schistosomiasis mansoni in Brazil was estimated to be US$ 41,7million in 2015 with 94.61% of this being indirect costs. CONCLUSIONS The economic burden of schistosomiasis mansoni in Brazil is high and results in the loss of productivity. Its persistence in Brazil is a challenge to public health and requires inter-sectorial interventions in areas such as indoor water supply, basic sanitation, and education.

Micro-costing studies still deserving for methods orientation that contribute to achieve a patient-specific resource use level of analysis. Time-driven activity-based costing (TDABC) is often employed by health organizations in micro-costing studies with that objective. However, the literature shows many deviations in the implementation of TDABC, which might compromise the accuracy of the results obtained. One reason for that can be attributed to the non-existence of a step-by-step orientation to conduct cost analytics with the TDABC specific for micro-costing studies in healthcare. This article aimed at exploring the literature and practical cases to propose an eight-step framework to apply TDABC in micro-costing studies for health care organizations. The 8-step TDABC framework is presented and detailed exploring online spreadsheets already coded to demonstrate data structure and math formula building. A list of analyses that can be performed is suggested, including an explanation about the information that each analysis can provide to increase the organization capability to orient decision making. The case study developed show that actual micro-costing of health care processes can be achieved with the 8-step TDABC framework and its use in future researches can contribute to increase the number of studies that achieve high-quality level in cost information, and consequently, in health resource evaluation.

Background Chagas disease is a neglected tropical disease. About 6 to 8 million people are chronically infected and 10% to 15% develop irreversible gastrointestinal disorders, including megaesophagus. Treatment focuses on improving symptoms, and isosorbide and nifedipine may be used for this purpose. Methodology We conducted a systematic review to evaluate the effectiveness of pharmacological treatment for Chagas’ megaesophagus. We searched MEDLINE, Embase and LILACS databases up to January 2018. We included both observational studies and RCTs evaluating the effects of isosorbide or nifedipine in adult patients with Chagas’ megaesophagus. Two reviewers screened titles and abstracts, selected eligible studies and extracted data. We assessed the risk of bias using NIH ‘Quality Assessment Tool for Before-After (Pre-Post) Studies with No Control Group’ and RoB 2.0 tool. Overall quality of evidence was assessed using GRADE. Principal findings We included eight studies (four crossover RCTs, four before-after studies). Three studies evaluated the effect of isosorbide on lower esophageal sphincter pressure (LESP), showing a significant reduction (mean difference −10.52mmHg, 95%CI −13.57 to−7.47, very low quality of evidence). Three studies reported the effect of isosorbide on esophageal emptying, showing a decrease in esophageal retention rates (mean difference −22.16%, 95%CI −29.94 to −14.38, low quality of evidence). In one study, patients on isosorbide reported improvement in the frequency and severity of dysphagia (moderate quality of evidence). Studies evaluating nifedipine observed a decrease in LESP but no effect on esophageal emptying (very low and low quality of evidence, respectively). Isosorbide had a higher incidence of headache as a side effect than nifedipine. Conclusions Although limited, available evidence shows that both isosorbide and nifedipine are effective in reducing esophageal symptoms. Isosorbide appears to be more effective, and its use is supported by a larger number of studies; nifedipine, however, appears to have a better tolerability profile. Trial registration PROSPERO CRD42017055143. ClinicalTrials.gov CRD42017055143., Author summary Chagas disease is a chronic neglected tropical disease that has increased in prevalence in the last decade. About 10% of chronically infected patients develop the digestive form of the disease. Megaesophagus is a common manifestation, and symptoms include difficulty or discomfort in swallowing and regurgitation. Treatment approaches include dietary interventions, medications, and endoscopic and surgical interventions. Regarding pharmacological treatment, only a few small studies have evaluated the effects of isosorbide and nifedipine, mainly on surrogate outcomes. According to our systematic review, the use of isosorbide reduced lower esophageal sphincter pressure, esophageal retention after meal ingestion, and the frequency and severity of dysphagia, while nifedipine reduced esophageal retention after meal ingestion. In light of this, both medications are effective in the treatment of symptoms associated with Chagas disease. Isosorbide appears to be more effective, and its use is supported by a larger number of studies; nifedipine, however, appears to have a better tolerability profile. Both drugs are valid alternatives, and the decisions about pharmacological treatment should be tailored to each patient.

Background Chagas disease is a neglected chronic condition caused by Trypanosoma cruzi, with high prevalence and burden in Latin America. Ventricular arrhythmias are common in patients with Chagas cardiomyopathy, and amiodarone has been widely used for this purpose. The aim of our study was to assess the effect of amiodarone in patients with Chagas cardiomyopathy. Methodology We searched MEDLINE, Embase and LILACS up to January 2018. Data from randomized and observational studies evaluating amiodarone use in Chagas cardiomyopathy were included. Two reviewers selected the studies, extracted data and assessed risk of bias. Overall quality of evidence was accessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Principal findings We included 9 studies (3 before-after studies, 5 case series and 1 randomized controlled trial). Two studies with a total of 38 patients had the full dataset, allowing individual patient data (IPD) analysis. In 24-hour Holter, amiodarone reduced the number of ventricular tachycardia episodes in 99.9% (95%CI 99.8%-100%), ventricular premature beats in 93.1% (95%CI 82%-97.4%) and the incidence of ventricular couplets in 79% (RR 0.21, 95%CI 0.11–0.39). Studies not included in the IPD analysis showed a reduction of ventricular premature beats (5 studies), ventricular tachycardia (6 studies) and ventricular couplets (1 study). We pooled the incidence of adverse side effects with random effects meta-analysis; amiodarone was associated with corneal microdeposits (61.1%, 95%CI 19.0–91.3, 5 studies), gastrointestinal events (16.1%, 95%CI 6.61–34.2, 3 studies), sinus bradycardia (12.7%, 95%CI 3.71–35.5, 6 studies), dermatological events (10.6%, 95%CI 4.77–21.9, 3 studies) and drug discontinuation (7.68%, 95%CI 4.17–13.7, 5 studies). Quality of evidence ranged from moderate to very low. Conclusions Amiodarone is effective in reducing ventricular arrhythmias, but there is no evidence for hard endpoints (sudden death, hospitalization). Although our findings support the use of amiodarone, it is important to balance the potential benefits and harms at the individual level for decision-making., Author summary Chagas disease is a chronic neglected tropical disease, with high prevalence and burden in Latin America. About 30% of chronically infected patients develop Chagas cardiomyopathy. Ventricular arrhythmias are common in patients with Chagas cardiomyopathy and treatment approaches include medications, resynchronization therapy, and implantable cardioverter defibrillator. Studies published from 1980 to 1990 have evaluated the effect of amiodarone. According to our systematic review and individual patient meta-analysis, amiodarone reduced ventricular tachycardia, ventricular premature beats and incidence of ventricular couplets. Although the strong evidence of clinical benefit with arrhythmia reduction, this information should be interpreted with caution, since arrhythmia is a surrogate outcome and since its clinical impact on death and hospitalization reduction over time is not clear. Little information was identified related to hard endpoints. Regarding side effects, our systematic review observed that amiodarone was associated with corneal microdeposits, gastrointestinal events, sinus bradycardia, dermatological events, pneumonitis, hypothyroidism and drug discontinuation. The currently available evidence shows that amiodarone seems to be an effective antiarrhythmic drug for patients with Chagas disease, especially in settings where an implantable cardioverter defibrillator is not available or affordable, but that a balance between potential benefits and harms at the individual level is needed.

Background. Most EQ-5D-3L valuation studies include the same sample of health states that was used in the protocol of the original UK Measurement and Valuation of Health (MVH) study. Thus far, no studies using a time tradeoff utility elicitation method have been carried out using all 243 EQ-5D health states. Because the values and preferences regarding health outcomes differ among countries, it is essential to have country-specific data to enable local high-level decisions regarding resource allocation. This study developed a country-specific set of values for EQ-5D-3L health states. Methods. A multicentric study was conducted in 4 Brazilian areas. A probabilistic sample of the general population, aged 18 to 64 y, stratified by age and gender, was surveyed. The interview followed a revised version of the MVH protocol, in which all 243 health states were valued. Each respondent ranked and valued 7 health states using the TTO in a home interview. Results. Data were collected from 9148 subjects. The best-fitting regression model was an individual-level mixed-effects model without any interaction terms. The dimensions “Mobility” and “Usual Activities” were associated with higher losses in health state utility value. The “Anxiety/Depression” dimension was the domain that contributed to lower losses in health state utility value. Conclusions. This study generated significant insight into the Brazilian population’s health preferences that can be applied to health technology assessment and economic analyses in Brazil. This information represents an important new tool that can be used in Brazilian health policy creation and evaluation.

Objectives To evaluate the effectiveness of an algorithm for the treatment of mixed episodes in bipolar disorder (BD) using the medications available under the Unified Health System (Sistema Unico de Saude) in Brazil. Methods The study included 107 individuals with BD in a current mixed episode, assessed biweekly for the outcomes of response and remission. The subjects were randomly assigned to start treatment with lithium, valproic acid, or carbamazepine, following a clinical protocol at a public outpatient clinic. Eligibility screening instruments, semistructured interview, and clinical psychiatric evaluation were used for diagnosis. To measure response and remission, the Hamilton Rating Scale for Depression and the Young Mania Rating Scale were used. A parameter of 50% or less in the symptom scales was used to define responses, as assessed by Kaplan-Meier time-event analysis. Results For the main outcome, response to treatment, all interventions proposed were proven to be effective, with no difference in response time for any of them. There was a lack of placebo control and blinding for intervention or outcomes. Individuals with mixed episodes in BD often face contradictory symptoms, and these inherent difficulties are the main obstacles to stabilize such a condition. Conclusions The findings presented in this study show that the treatments available under the Unified Health System are able to reduce the overall burden of disease in terms of symptom reduction.

Objective To assess the effectiveness of three mood disorder treatment algorithms in a sample of patients seeking care in the Brazilian public healthcare system. Methods A randomized pragmatic trial was conducted with an algorithm developed for treating episodes of major depressive disorder (MDD), bipolar depressive episodes and mixed episodes of bipolar disorder (BD). Results The sample consisted of 259 subjects diagnosed with BD or MDD (DSM-IV-TR). After the onset of symptoms, the first treatment occurred ∼6 years and the use of mood stabilizers began ∼12 years. All proposed algorithms were effective, with response rates around 80%. The majority of the subjects took 20 weeks to obtain a therapeutic response. Conclusions The algorithms were effective with the medications available through the Brazilian Unified Health System. Because therapeutic response was achieved in most subjects by 20 weeks, a follow-up period longer than 12 weeks may be required to confirm adequate response to treatment. Remission of symptoms is still the main desired outcome. Subjects who achieved remission recovered more rapidly and remained more stable over time. Clinical trial registration NCT02901249, NCT02870283, NCT02918097.

Objectives To assess the measurement equivalence of the original paper version of an adapted tablet version of the EuroQol five-dimensional questionnaire (EQ-5D). Methods A randomly selected sample of 509 individuals aged 18 to 64 years from the general population responded to the EQ-5D at two time points separated by a minimum interval of 24 hours and were allocated to one of the following groups: test-retest group (tablet-tablet) or crossover group (paper-tablet and tablet-paper). Agreement between methods was determined using the intraclass correlation coefficient (ICC) and the κ coefficient. Results In the crossover group, the following ICC values were obtained: 0.76 (confidence interval [CI] 0.58–0.89) for EQ-5D scores and 0.77 (CI 0.68–0.84) for visual analogue scale in subjects responding first to the tablet version; 0.83 (CI 0.75–0.89) for EQ-5D scores and 0.75 (CI 0.67–0.85) for visual analogue scale in subjects responding first to the paper version. In the test-retest group, the ICC was 0.85 (CI 0.73–0.91) for EQ-5D scores and 0.79 (CI 0.66–0.87) for visual analogue scale. The κ values were higher than 0.69 in this group. The internal consistencies of the paper and tablet methods were similar. Conclusions The paper and tablet versions of the EQ-5D are equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar among individuals. Objetivos Avaliar a equivalência de medidas da versão original em papel de uma versão adaptada para tablet do questionário de cinco dimensões EuroQol (EQ-5D). Métodos Uma amostra selecionada aleatoriamente de 509 indivíduos com idade entre 18 e 64 anos da população geral respondeu ao EQ-5D em dois momentos separados por um intervalo mínimo de 24 horas e foram alocados em um dos seguintes grupos: grupo teste-reteste (tablet -tablet) ou grupo crossover (papel-tablet e tablet-papel). A concordância entre os métodos foi determinada por meio do coeficiente de correlação intraclasse (ICC) e do coeficiente κ. Resultados No grupo crossover, os seguintes valores de ICC foram obtidos: 0,76 (intervalo de confiança [IC] 0,58–0,89) para escores EQ-5D e 0,77 (IC 0,68–0,84) para escala visual analógica em indivíduos que responderam primeiro à versão tablet; 0,83 (IC 0,75–0,89) para pontuações EQ-5D e 0,75 (IC 0,67–0,85) para escala visual analógica em indivíduos que responderam primeiro à versão em papel. No grupo teste-reteste, o ICC foi de 0,85 (IC 0,73–0,91) para os escores do EQ-5D e 0,79 (IC 0,66–0,87) para a escala visual analógica. Os valores de κ foram superiores a 0,69 neste grupo. As consistências internas dos métodos de papel e tablet foram semelhantes. Conclusões As versões em papel e tablet do EQ-5D são equivalentes. A concordância teste-reteste e crossover foi alta e a aceitabilidade dos métodos foi semelhante entre os indivíduos.

IntroductionSince 2007, 23 Núcleos de Avaliação de Tecnologias em Saúde or hospital-based health technology assessment (HB-HTA) units have been established in teaching hospitals across Brazil. These units aim to promote the development of health technology assessment in hospitals, assisting the decision-making process for implementing new technologies and evaluating and promoting the rational use of widespread technologies.MethodsAn online questionnaire was sent by e-mail to all HB-HTA units registered in the Brazilian Network for Evaluation of Health Technologies. Information was acquired to comprehensively assess the activity of the units.ResultsAll 23 HB-HTA units answered the questionnaire. Of these, 65 percent had a technology prioritization process. The technologies assessed included drug therapies (73%), equipment (64%), medical devices (64%), clinical protocols (46%), and emerging technologies (27%). The dimensions of health technology assessment (HTA) evaluated by these organizations were: efficacy (76%); effectiveness (67%); safety (67%); costs (52%); cost effectiveness or cost utility (52%); and budget impact (43%). The hospital departments that required more HTA studies were: cardiology (50%); infectious diseases (45%); hospital management (45%); oncology (40%); surgery (40%); and endocrinology (20%). HTA studies supported: incorporation of new technologies (81%); protocol or guideline development (57%); new indications for already approved technologies (38%); and withdrawal of obsolete technologies (29%). Half of the institutions also conducted educational or training activities. The main difficulties reported were a lack of trained professionals (78%), funding (70%), and material resources (48%).ConclusionsFor low- and middle-income countries, the process of implementing HB-HTA units remains a challenge. Even though human resources and funding are scarce, HB-HTA units continue to develop. Given their importance in the decision-making process, it is imperative that every effort is made to ensure their activities continue.

The objective of this study was to provide normative SF-36 scores in a general population sample in Brazil and to describe differences in mean scores according to socio-demographic characteristics. The SF-36 questionnaire was distributed to a randomly selected sample of the general population of Porto Alegre in the State of Rio Grande do Sul. The response rate was 68% and 755 subjects were included (38% male, 62% female). Lower health status was revealed among females in the 30 to 44 year age bracket, from the lower income class, with less education and self-reported chronic medical conditions. The results and percentiles of scores of the SF-36 are reported as normative data for the general population. The SF-36 was an acceptable and practical instrument for measuring health-related quality of life in a sample of Brazilians. The results of this study can be useful for researchers using the SF-36 questionnaire in other groups to compare the scores with normative data. The SF-36 may prove a valuable tool for discovering vulnerable groups in epidemiological studies due to the ability to discriminate between different population subgroups.

Background: As the responsibility and demand on health care grows and resources do not increase at the same pace, the healthcare system has been forced to reconsider the benefits and costs of their actions, to ensure a rational and effective decision-making process regarding the adoption of interventions and allocation of resources. Cost-effectiveness (CE) studies represent one of the basic tools to achieve this goal. Aims: To present the current state of Health Technology Assessment (HTA) and health economics in mental health in Brazil and its importance to the decision-making process. Methodology: Descriptive paper on HTA and health economics in Brazil. Databases from government and universities as well as some scientific databases to assess the information are presented. Results and Conclusion: Economic analysis to evaluate interventions in mental health care is a relatively recent addition to the field of health economics; in Brazil, it is also considered a topic within Epidemiology research area. There have been an increased number of studies developed in high-income countries. However, there are fewer CE studies in low- and middle-income ones. Psychiatric disorders represent a significant burden in developing countries, where resources devoted to health care are even scarcer.

This chapter focuses on a review the cost-effectiveness studies of bipolar disorder (BD) published in the past 10 years in order to present the main methodological issues related to economic evaluations of this topic. A systematic search of the was performed to include articles on the cost-effectiveness of any management strategy for BD, published in English, and spanning the period of January 2005 to June 2016. Five electronic databases were assessed, namely, the National Health Services–Health Economic Evaluation Database, the Health Technology Assessment Database, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature. A total of 141 citations were found. After screening, 24 studies were selected, of which 18 were original articles and 6 were systematic reviews. Of the eligible studies, the majority were from the United Kingdom and United States. Few studies were not funded by the pharmaceutical industry. Considering methodology, four studies were trial-based economic evaluations and the others were model-based economic evaluations. The number of subjects enrolled in the reported trials varied from 103 to 431. Most studies focused on the maintenance phase of BD treatment. New atypical antipsychotics were the most commonly evaluated interventions, with placebo and traditional treatments as comparators. Few articles evaluated classical mood stabilizers (lithium, valproate, carbamazepine) in an economic assessment. Atypical antipsychotics were the most cost-effective intervention studied. When one considers the economic evaluations, quetiapine, olanzapine, and aripiprazole are considered to be good strategies in the maintenance treatment of BD.

Introduction:Extracorporeal circulatory membrane oxygenation (ECMO) is a technology that allows recovery of adults in cardiorespiratory failure with encouraging results, but is not available in the Brazilian universal public health system (SUS) due to high implementation costs. Time-driven activity based costing (TDABC) is applied to measure processes in an economic perspective by identifying opportunities to make processes more efficient through the reduction of resources used in each activity. The literature has explored the use of TDABC to measure costs related with clinical procedures and technologies in microcosting studies, identifying opportunities to improve the process by making it more efficient. This research measures the real costs to implement ECMO in Brazil to compare with the current public reimbursement system.Methods:This study applied TDABC using data from 6 patients to measure costs of ECMO intervention considering the public perspective in Brazil. In sequence, standard price payed by SUS was used to estimate the current reimbursement amount received by the hospital for ECMO procedure. Cost variable analysis was conducted to understand when and how patients receiving ECMO are using hospital resources. Cost data were collected from an academic public hospital using an average of 18 months (2016–2017) for the department costs.Results:The real average cost was USD 128,923. Most significant resource costs was medical staff, particularly for the three survivor patients, and the ECMO equipment presented the second highest cost. ECMO activities were separated into: before implantation of ECMO, period using ECMO, intensive care post-ECMO and rehabilitation, being the period where ECMO is the most expensive, particularly in nurse and physician costs. The SUS average was USD 31,437, which shows a difference of USD 97,485 between the real ECMO cost and the public reimbursement in Brazil.Conclusions:A critical element of the propagation of ECMO in Brazil and its reimbursement by public health system is the high cost and out-of-date standard payments by the Ministry of Health. Effort to implement a trustworthy method to guide decisions of SUS for the adoption and financing new technologies is essential to contribute to the optimization of public health policies in a country with a universal health system and limited resources dedicated to health sectors.

Introduction:Chagas disease (ChD), also known as American trypanosomiasis, is a neglected tropical disease caused by the protozoan parasite Trypanosoma cruzi. About 6 to 7 million people worldwide are estimated to be infected, most in Latin America. Health-related quality of life (HRQoL) and utility measures are still poorly employed for assessment of ChD lifetime impairments. Brazilian HRQoL published data showed that the cardiac subgroup of patients have worse scores than other ChD chronic groups. For the time being, utility scores are not available yet for the ChD population. The present study aims to assess quality of life (QoL), as utility scores, of patients with chronic Chagas Disease.Methods:This is a cross-sectional study. Data were collected from 183 outpatients with chronic ChD in a reference center in Brazil. Information pertaining to sociodemographics, clinical status, and quality of life were collected using self-administered questionnaires. Utilities were obtained by the European Quality of Life – 5 Dimensions (EQ-5D) questionnaire. Comparisons were made between clinical subtypes and population normative values. Continuous variables were compared using t-test or ANOVA, and categorical variables were compared using Chi-square test. Associations between QoL and patient characteristics stratified by demographics, clinical status were identified by linear regression models.Results:Most subjects were female (61 percent). The average age of men was 53.3 years and women 56.6. When analyzing the EQ-5D utility scores, it was observed that the results were lower for cardiac patients (0.610–95% CI 0.582–0.638) in comparison to indeterminate form patients (0.659–0.632–0.687). When comparing patients with the general population of the same age and sex, patients with ChD showed lower utility scores than normative values (0.624–95% CI 0.596–0.652).Conclusions:Chronic ChD causes a negative impact on quality of life, physical functioning, as well as psychosocial function, with the impairment becoming worse in cardiac patients.

OBJECTIVE: To assess the effectiveness of home visits for advising mothers about breastfeeding and weaning on pacifier use in the first year of life. METHOD: A randomized field trial was conducted on mothers who gave birth within the public health system in the Brazilian city of Sao Leopoldo (intervention group = 200; controls = 300). The intervention group received the advice 10 days after the childs birth monthly up to 6 months at 8 10 and 12 months based on the Ten Steps for Healthy Feeding a Brazilian national health policy for primary care which follows WHO guidelines. Relative risk (RR) was used to estimate the effects of the intervention on the risk of using a pacifier. RESULTS: 55.4% of the children in the intervention group and 66.1% of the controls used a pacifier in the first year of life. The risk of using a pacifier was 16% lower for the intervention group (RR = 0.84; 95% CI 0.71-0.99). A multivariable Poisson regression model showed higher adjusted risk of using a pacifier for children who had breastfeeding interrupted in the first month of life (RR = 1.43; 95% CI 1.21-1.69) and whose mothers presented higher level of depression (RR = 1.40; 95% CI 1.17-1.66). CONCLUSIONS: Pacifier use is highly prevalent in the population studied. The home visits for dietary advice appear to help in reducing pacifier use in infants. These findings suggest the need for public health strategies that address early advice on pacifier use to promote child oral and general health. (c) 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

IntroductionIn Brazil, hospital-based health technology assessment (HB-HTA) units have been implemented countrywide since early 2000 to improve decision-making processes. Multiple-criteria decision analysis (MCDA) can provide a deeper understanding of a given subject. The present study used MCDA to evaluate capacity building among HB-HTA units in Brazil.MethodsThis study analyzed preliminary data from a survey developed and sent to all HB-HTA units in Brazil in 2018. The survey comprised 116 questions covering a wide range of aspects. Initially, an expert panel was organized, and 46 objective questions (out of 116) were selected by four experts. Next, these experts classified the selected questions by weighting them according to their relative importance. A Likert scale was used to identify the levels of importance, which were converted to weights ranging from zero to one. The experts then defined a final importance score threshold of 60 percent to classify units as fully operational. Grades below this threshold indicated the need for a more detailed evaluation. Of the 80 survey questionnaires, 23 were evaluated by the proposed method.ResultsImportance weights for each classification were defined as follows: personnel (25%); level of expertise (31%); work production (31%); and infrastructure (13%). The mean final importance score for the HB-HTA units was 68 percent. The maximum and minimum scores achieved were 95 percent and 15 percent, respectively. The HB-HTA units had been established for an average of 6 years, and ten of the 23 units were classified as fully operational.ConclusionsThe multicriteria method presented by this study simplified HB-HTA unit evaluation, reducing the subjectivity of results. Final importance scores for each unit's categories indicated which areas need improvement. Results from the study indicated that infrastructure and personnel could be greatly enhanced, even though the production profile was satisfactory.

Normative data for WHOQOL-bref are scarce in the literature and unavailable in Latin American countries. The main objective of this study was to provide normative scores of WHOQOL-bref in a general population sample in Brazil and to describe differences in mean scores according to some socio-demographic characteristics. WHOQOL-bref was applied to a randomly selected sample of the general population of Porto Alegre. Participants were literate people aged 20 to 64 years. The questionnaires were self-administered in the presence of an interviewer in the respondent’s home. The response rate was 68%, and the final sample contained 751 respondents (38% men, 62% women). Low quality of life was observed in the following subgroups: female gender, lower economic class, lower educational level, and the subgroup reporting a chronic medical condition. The mean scores of the WHOQOL-bref and percentiles of scores are reported as normative data for the general population. Our results can be useful to researchers using the WHOQOL-bref to compare their results with normative data from a randomly selected sample of general population. Additionally, the ability of WHOQOL-bref to discriminate different population subgroups makes it an important tool to identify vulnerable groups in epidemiological surveys.

This study aimed to assess the validity and reliability of World Health Organization Quality of Life Instrument (WHOQOL)-brief and SF-36 in patients with coronary artery disease (CAD). Considering that depression is known to be associated with bad outcomes in CAD and it is highly associated with poor Quality of Life (QOL), we tested the correlation between WHOQOL and SF-36 and an instrument to screen depressive symptoms. It is a cross-sectional survey conducted in 103 patients with documented CAD. QOL was measured through WHOQOL-brief and SF-36 and depressive symptoms were assessed by the Beck Depression Inventory (BDI). To evaluate convergent validity, the correlations between both QOL assessment instruments were examined; discriminant validity was assessed through BDI and QOL instruments correlations. Coefficient Cronbach's alpha was used to test reliability. Percentages of floor and ceiling effects were higher in SF-36 scores than the WHOQOL-brief ones. Although WHOQOL-brief showed a maximum of 1% of floor effect and 9% of ceiling effect, SF-36 presented 40 and 32%, respectively. Internal consistency reliability ranged from 0.65 to 0.85 for the WHOQOL-brief and 0.57 to 0.89 for the SF-36. Correlations between subscales of WHOQOL-brief and BDI ranged from -0.74 to -0.61 and correlations between subscales of SF-36 and BDI ranged from -0.68 to -0.26. SF-36 and WHOQOL-brief seem to be valid and consistent QOL measures in patients with CAD. Researchers should define the aims of their studies before choosing which instrument to use, because they appear to measure different constructs of QOL.

Objective: To perform a cost-utility analysis on the treatment of attention deficit hyperactivity disorder (ADHD) with methylphenidate immediate-release (MPH-IR) in children and adolescents from Brazil. Method: A Markov model was constructed to compare MPH-IR vs. no treatment. A 24-week naturalistic study was conducted to collect transition probabilities and utility data. Effectiveness was expressed as quality-adjusted life-years (QALY), and costs reported in 2014 international dollars (I$). The perspective was the Brazilian Unified Health System as payer, and the time horizon was 6 years. Results: Of 171 patients, 73 provided information at baseline, and 56 at week 24. Considering the MPH-IR monthly cost of I$ 38, the incremental cost-effectiveness ratio (ICER) of treatment was I$ 9,103/QALY for children and I$ 11,883/QALY for adolescents. In two-way sensitivity analysis, considering one Gross National Product per capita (I$ 11,530) as willingness-to-pay, a cost of no-treatment lower than I$ 45/month would render MPH-IR a cost-saving strategy. Discussion: MPH-IR treatment of children and adolescents is cost-effective for ADHD patients from the Brazilian public health system perspective. Both patients and the healthcare system might benefit from such a strategy. Trial registration number: NCT01705613.

INTRODUCTION:Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.METHODS:A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.RESULTS:Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.CONCLUSIONS:Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.

INTRODUCTION:Chagas disease, caused by the parasite Trypanosoma cruzi, affects more than seven million people worldwide and it is considered by the World Health Organization (WHO) a neglected tropical disease (1). About one third of Chagas patients develop gastrointestinal disorders, such as dysphagia and achalasia. Management of the disease focuses on symptom improvement and drugs that relax the lower esophageal sphincter pressure (LESP), such as isosorbide and nifedipine. However, the use of these therapies is doubtful because of their side effects and palliative approach (2). The objective of this systematic review is to assess the effectiveness of isosorbide and nifedipine on gastrointestinal manifestation of Chagas disease.METHODS:We searched MEDLINE, EMBASE and LILACS databases to retrieve potentially relevant articles from inception to December 2016. Inclusion criteria: clinical trials, cohorts or cross-sectional design; adults (>18 years old); assessment of effects of isosorbide or nifedipine on gastrointestinal symptoms in Chagas patients. Two reviewers independently screened titles and abstracts, selected eligible studies and extracted data from each study. PROSPERO registration number: CRD42017055143.RESULTS:Eight studies were included (two case series, two clinical trials and four crossovers). Three studies evaluated the effect of isosorbide in LESP and three in esophageal emptying. All of them found that isosorbide rapidly reduces LESP and increases esophageal emptying rates, improving dysphagia. However, several patients reported collateral effects, such as gastroesophageal reflux, headaches and dizziness. One study evaluated the effect of nifedipine on LESP and one on esophageal emptying. Nifedipine decreased LESP, but there was no effect on esophageal emptying.CONCLUSIONS:The available evidence shows isosorbide is effective in the management of gastrointestinal symptoms. Frequently health care of Chagas disease patients is delivered by primary care physicians. So, information on effectiveness of interventions can be aggregated to clinical guidelines, having an important value to inform general practitioners on the decision-making process regarding treatment of this group of patients, avoiding referencing to a specialized care.

INTRODUCTION:Chagas disease, caused by the protozoan parasite Trypanosoma cruzi, is a neglected chronic condition with a high burden of morbidity and mortality. It affects about 6 million people in twenty-one countries of Latin America, and has recently become a global health concern (1), especially due to immigration from endemic areas into the developed world. Cardiac arrhythmias are common in patients with Chagas cardiomyopathy and amiodarone has been widely used as an antiarrhythmic drug. Amiodarone has been recommended as the treatment of choice for all patients with sustained ventricular tachycardia (2). The objective of this systematic review is to evaluate the effect of amiodarone in arrhythmia patients with the cardiac form of chronic Chagas disease.METHODS:Searches was conducted in MEDLINE (PubMed), EMBASE and LILACS from the inception to December 2016. Studies regarding the use of amiodarone to treat arrhythmia in patients affected by Chagas disease were included, and the outcomes were arrhythmia, adverse effects and sudden death. Selection of articles and data extraction were made by two independent reviewers.RESULTS:The database search found 378 articles but only 9 studies with 373 subjects fulfilled the eligibility criteria. The nine studies selected were composed of case series (two), crossover clinical trials (two), and clinical trials (five). Results showed that amiodarone reduced ventricular extrasystoles in all studies and ventricular tachycardia in eight studies. During treatment with amiodarone, patients in eight studies had side effects. Corneal microdeposits and gastric discomfort were the most common adverse effects present in studies. Three studies reported sudden death during follow-up.CONCLUSIONS:Amiodarone seems to be an effective antiarrhythmic drug for Chagasic patients, reducing uncomfortable symptoms such as tachycardia. This information can be useful in the primary care context, supporting general practitioners to manage Chagas cardiopathy, mainly when specialized cardiologic consultants are not available.

Introduction:Venoarterial extracorporeal life support (ECLS) is increasingly used in patients during cardiogenic shock, due to favorable results in this very high-risk scenario. However, it is a costly intervention that requires heavy financial investment and specialized human resources.Methods:Cost-effectiveness analysis to evaluate ECLS in the perspective of the Brazilian public health system (SUS) in the population of adult patients with cardiogenic shock. A decision tree comparing ECLS and usual care was built, using efficacy data from a systematic review of literature, and cost data from SUS reimbursement values. Impact of parameter variability and uncertainty were ascertained with deterministic and probabilistic sensitivity analysis.Results:Usual care resulted in thirty percent probability of survival, at an average cost of 3,000 international dollars (Int$/USD); the strategy that includes ECLS resulted in sixty-two percent survival rate, and average cost of Int$ 23,000, with incremental cost-effectiveness ratio (ICER) of Int$ 62.215 per averted in-hospital death. Results were sensitive to device cost, and survival difference between strategies. In probabilistic sensitivity analysis, ECLS was consistently more costly and more effective than usual care; based on a willingness-to-pay of three times Brazilian gross domestic product (GDP) per capita (Int$ 45,000), there was twenty-seven percent probability of ECLS being cost-effective.Conclusions:ECLS has the potential to increase survival for cardiogenic shock, but would significantly increase costs. In the Brazilian public health system, the cost per averted in-hospital death is 4.1 times the domestic GDP per capita.

Supplemental Digital Content is available in the text, Objectives: This study evaluated the utility and quality-of-life year measurements for patients with coronary artery disease who underwent any of 3 therapeutic strategies with a 5-year follow-up. Methods: Quality-of-life data were obtained from the Medicine, Angioplasty, or Surgery Study II trial. To obtain utilities, the 36-Item Short-Form questionnaire was converted to a 6-Dimensional Health State Classification System. Results: Of the 611 initial patients, 579 completed the questionnaire. In all, 188 patients received the surgical treatment—194 the percutaneous, and the remaining 197 the medical. The median utility scores for the 5 years analyzed were 0.809 (95% confidence interval [CI] 0.794–0.842) for patients assigned to percutaneous coronary intervention, 0.755 (95% CI 0.723–0.774) for medical treatment, and 0.780 (95% CI 0.761–0.809) for coronary artery bypass graft surgery. The difference between percutaneous coronary intervention and medical treatment was statistically significant (P

BACKGROUND Long-term nitrate treatment of stable angina is associated with side effects that can interfere with health-related quality of life (HRQoL) and medication adherence. The aim of the present study was to compare HRQoL and adherence to treatment in patients with stable angina undergoing nitrate withdrawal or maintenance. METHODS This study is a randomized clinical trial. Patients were allocated to an intervention group (nitrate withdrawal followed by introduction of placebo) or a control group (nitrate maintenance). The assessments were made at baseline and 30 and 120 days using the Short Form Health Survey and the Seattle Angina Questionnaire. Treatment adherence was measured on the basis of the Morisky scale and pill count. RESULTS A total of 105 patients with stable angina were randomized for replacement of nitrate with placebo (n=51) and for maintenance of treatment with nitrate (n=54). After 4 months, Short Form Health Survey scores increased for bodily pain (P=0.005) and general health (P=0.004) in the nitrate maintenance group. Decreased Seattle Angina Questionnaire scores were also noted for physical limitations (P=0.039) and angina frequency (P=0.011) in the nitrate maintenance group. However, the effect size was small (≤0.44) when the intervention and control groups were compared. At the end of the study, adherence was significantly higher in the placebo group (P=0.041), but no difference was detected between the groups with the pill count method. CONCLUSION HRQoL was similar in patients with stable angina using nitrate regularly as compared with patients undergoing nitrate withdrawal. However, adherence to treatment was lower in nitrate users according to the Morisky scale.

Objective: Technological advances in medicine have given rise to a dilemma concerning the use of new health technologies in a context of limited financial resources. In the field of psychiatry, health economic evaluation is a recent method that can assist in choosing interventions with different cost and/or effectiveness for specific populations or conditions. This article introduces clinicians to the fundamental concepts required for critical assessment of health economic evaluations. Methods: The authors conducted a review with systematic methods to assess the essential theoretical framework of health economic evaluation and mental health in Brazil through textbooks and studies indexed in the PubMed, Cochrane Central, LILACS, NHS CRD, and REBRATS databases. A total of 334 studies were found using the specified terms (MeSH - Mental Health AND Economic, Medical) and filters (Brazil AND Humans); however, only five Brazilian economic evaluations were found. Results and conclusions: Economic evaluation studies are growing exponentially in the medical literature. Publications focusing on health economics as applied to psychiatry are increasingly common, but Brazilian data are still very incipient. In a country where financial resources are so scarce, economic analyses are necessary to ensure better use of public resources and wider population access to effective health technologies.