Rapid response in health technology assessment: a Delphi study for a Brazilian guideline.

BACKGROUND: Rapid response in health technology assessment is a synthesis of the best available evidence prepared in a timely manner to meet specific demands. We build a consensus among Brazilian specialists in health technology assessment to propose guidelines for the development of rapid response. METHODS: Based on a systematic review that proposed eight methodological steps to conduct rapid response, we applied a modified Delphi technique (without open questions in the first round) to reach consensus among Brazilian experts in health technology assessment. Twenty participants were invited to judge the feasibility of each methodological step in a five-point Likert scale. Consensus was reached if the step had 70% positive approval or interquartile range ≤ 1. RESULTS: The achievement of consensus was reached in the second round. Between the first and the second round, we scrutinized all points reported by the experts. The Delphi panel reached consensus of eight steps: definition of the structured question of rapid response (with a restricted scope); definition of the eligibility criteria for study types (preferably systematic reviews); search strategy (language and data limits) and sources of information (minimum two); selection of studies (independently by two responders); critical appraisal of the included studies and the risk of bias for the outcomes of interest; data extraction from the included articles; summary of evidence; and preparation of the report. CONCLUSIONS: The guidelines for rapid response in health technology assessment may help governments to make better decisions in a short period of time (35 days). The adoption of methodological processes should improve both the quality and consistency of health technology assessments of rapid decisions in the Brazilian setting.

[Economic evaluation of health technologies: checklist for critical analysis of published articles]. / Estudos de avaliação econômica de tecnologias em saúde: roteiro para análise crítica.

OBJECTIVE: To propose a tool for critical analysis of economic evaluation studies based on a synthesis of checklists and guidelines available in the literature. METHODS: The following databases were searched: MEDLINE, Embase, Centre for Reviews and Dissemination, and International Society for Pharmacoeconomics and Outcomes Research. Two investigators independently selected the studies and extracted the data of interest. The number of questions that the checklists contained were counted on the following domains: study design, measurement of costs and health outcomes, analysis and interpretation of results, and general information. A matrix containing the items in each domain was constructed, and a tool for critical analysis was built based on that matrix. RESULTS: The literature search retrieved 406 non-duplicated articles, 19 of which were included in the study. Five hundred sixty-six questions were identified in the checklists employed in these studies: 109 (19%) dealt with health outcomes, 93 (16%) with quantification of costs, 73 (13%) with modeling, 54 (10%) with generalization of findings, and 52 (9%) with uncertainty. The resulting critical analysis checklist contains 32 questions organized into four domains: study design, measurement of costs and health outcomes, analysis and interpretation of results, and general information. CONCLUSIONS: The proposed critical analysis checklist is useful to standardize the assessment of the quality of evidence in all types of economic evaluations.

Judicialization of Zolgensma in the Ministry of Health: costs and clinical profile of patients.

OBJECTIVE: To investigate the costs and profile of patients who have filed a lawsuit against the Ministry of Health for the treatment of spinal muscular atrophy (SMA) with the onasemnogene abeparvovec (Zolgensma®). METHODS: This is a cross-sectional, descriptive study with a census design, based on records of lawsuits filed against the Ministry of Health between January 2019 and September 2022. Data was requested from the Ministry of Health via the Access to Information Act. Information was extracted on the epidemiological profile of the beneficiaries of the lawsuits, as well as the expenses spent by the Ministry of Health in cases where the requests were granted. RESULTS: 136 lawsuits were identified, of which 113 (83%) were favorable to patients at a cost of R$ 944.8 million in the period analyzed. Demographic (gender and age), clinical (SMA subtypes, use of ventilatory or nutritional support), and lawsuit (type of legal service) characteristics were not associated with the granting of lawsuits. Prior use of medication (nusinersena or ridisplam) was associated with the dismissal of lawsuits. Of the 113 lawsuits granted in favor of patients, only six (5.3%) would meet the criteria currently established by the National Committee for Health Technology Incorporation - Conitec (children up to six months without ventilatory and nutritional support). R$ 146 million was spent on supplying Zolgensma to children over the age of two, which is outside the recommendation contained in the drug's package leaflet. CONCLUSIONS: The Ministry of Health incurs a high cost with the judicialization of Zolgensma for SMA, representing 2.45% of total spending on medicines in the Unified Health System, including spending by the three administrative spheres. Some of the lawsuits have been granted in disagreement with the criteria established by health technology assessment agencies and the drug manufacturer's recommendations.

Inclusion of disability in primary healthcare facilities and socioeconomic inequity in Brazil.

OBJECTIVE: To describe disability-related performance and inequality nationwide in Brazil, and the changes that took place between 2012 and 2019 after the introduction of Programme for Improving Primary Care Access and Quality (PMAQ). METHODS: We derived scores for disability-related care and accessibility of primary healthcare facilities from PMAQ indicators collected in round 1 (2011-2013), and round 3 (2015-2019). We assessed how scores changed after the introduction of PMAQ. We used census data on per capita income of local areas to examine the disability-specific care and accessibility scores by income group. We undertook ordinary least squares regressions to examine the association between PMAQ scores and per capita income of each local area across implementation rounds. RESULTS: Disability-related care scores were low in round 1 (18.8, 95%CI 18.3-19.3, out of a possible 100) and improved slightly by round 3 (22.5, 95%CI 22.0-23.1). Accessibility of primary healthcare facilities was also poor in round 1 (30.3, 95%CI 29.8-30.8) but doubled by round 3 (60.8, 95%CI 60.3-61.3). There were large socioeconomic inequalities in round 1, with both scores approximately twice as high in the richest compared to the poorest group. Inequalities weakened somewhat for accessibility scores by round 3. These trends were confirmed through regression analyses, controlling for other area characteristics. Disability-related and accessibility scores also varied strongly between states in both rounds. CONCLUSIONS: People with disabilities are being left behind by the Brazilian healthcare system, particularly in poor areas, which will challenge the achievement of universal health coverage.

Profile of individuals served and presumed coverage of Psychosocial Care Centers (CAPS) in Brazil: A study of the period 2013-2019.

OBJECTIVE: To describe the profile of individuals with depression who received assistance at CAPS in Brazil between 2013 and 2019, focusing on their clinical and demographic characteristics, and to calculate the estimated coverage of CAPS across the national territory and its constituent federal units. METHODS: Descriptive, ecological, time-series study with secondary data from national databases, referring to care provided at CAPS in the country for adults aged 18 years or over-diagnosed with depression (F32-32.9 and F33-F33.9). The estimated coverage of CAPS was calculated for 2013 and 2019 using registered and active services. RESULTS: There was a 107% increase in the number of patients with depression receiving treatment at CAPS between 2013 and 2019. Women accounted for 77% of the patients, with the majority falling within the age range of 41 to 61years (49%). The predominant racial demographics were white (38%) and brown (34%). The diagnosis of depressive episodes was prevalent among 65% of the patients, and individual care was administrated to 75% of them. The presumed CAPS coverage was 71% in 2013 and increased to 87% in 2019 nationwide, although significant discrepancies were observed among different states. CONCLUSION: Progress was evident in the implementation of CAPS across Brazil during the period spanning 2013 to 2019. Nonetheless, disparities persist among the federative units, and there remains an underutilization of group and family care within CAPS services.

Consumption of alcoholic beverages in Brazil: estimation of prevalence ratios - 2013 and 2019.

OBJECTIVES: To estimate the prevalence of weekly, monthly and abusive alcohol consumption in Brazil in 2013 and 2019, compare the period estimates, and verify the magnitude of the differences. METHODS: Analysis of data on alcohol consumption in the adult population (18 years or older) from the National Health Survey (PNS), 2013 and 2019. The number of interviewees in 2013 was 60,202 and 88,531 in 2019. The samples were characterized according to demographic, socioeconomic, health, and alcohol consumption variables and differences in proportions in the period were compared using Pearson's c2 test, with Rao-Scott approximation and a 5% significance level. Multivariate Poisson regression models were estimated for the outcome variables of monthly, weekly and abusive consumption of alcoholic beverages, in order to estimate the magnitude of the differences between the 2013 and 2019 PNS estimates, using the prevalence ratio (PR). Models were adjusted per sex and age group and stratified per sex and demographic region. RESULTS: There was a difference in the distribution of the population according to race, occupation, income, age group, marital status, and education. There was an increase in alcohol consumption for all outcome variables, with the exception of weekly consumption in males. The PR of weekly consumption was 1.02 (95%CI 1.014-1.026), and in females the PR was 1.05 (95%CI 1.04-1.06). The highest PRs in the general population and per sex occur for abusive consumption. The increase in weekly consumption per region occurred in the South, Southeast, and Central-West regions. CONCLUSIONS: Males are the main alcohol consumers in Brazil; the PRs for both males and females show that there was an increase in monthly, weekly and abusive consumption in the research period; it is noteworthy that females have increased their consumption pattern with greater intensity than males.

Prevented cases of neural tube defects and cost savings after folic acid fortification of flour in Brazil.

Anencephaly, encephalocele, and spina bifida are congenital neural tube defects and are the main causes of neonatal morbidity and mortality and impose a heavy economic burden on health systems. This study to estimates the direct costs of neural tube defects from the perspective of the Brazilian Ministry of Health, and the prevented cases and cost savings during the period in which mandatory folic acid fortification was in effect in the country (2010-2019). It is a top-down cost-of-illness oriented study based on the prevalence of the disorders in Brazil. Data were collected from the Brazilian Ministry of Health's outpatient and hospital information system databases. The direct cost was estimated from the total patient-years, allocated by age and type of disorder. Prevented cases and cost savings were determined by the difference in the prevalence of the disorders in the pre- and post-fortification periods based on the total number of births and the sum of outpatient and hospital costs during the period. The total cost of outpatient and hospital services for these disorders totaled R$ 92,530,810.63 (Int$ 40,565,896.81) in 10 years; spina bifida accounted for 84.92% of the total cost. Hospital costs were expressive of all three disorders in the first year of the patient's life. Between 2010 and 2019, mandatory folic acid fortification prevented 3,499 live births with neural tube defects and resulted in R$ 20,381,586.40 (Int$ 8,935,373.25) in hospital and outpatient cost savings. Flour fortification has proved to be a valuable strategy in preventing pregnancies with neural tube defects. Since its implementation, there has been a 30% decrease in the prevalence of neural tube defects and a 22.81% decrease associated in hospital and outpatient costs.

Clinical effectiveness of screening for age-related macular degeneration: A systematic review.

INTRODUCTION: Age-related macular degeneration (AMD) is an eye disease that occurs in patients over 50 years old. Early diagnosis enables timely treatment to stabilize disease progression. However, the fact that the disease is asymptomatic in its early stages can delay treatment until it progresses. As such, screening in specific contexts can be an early detection tool to reduce the clinical and social impact of the disease. OBJECTIVE: Assess the effectiveness of screening methods for early detection of AMD in adults aged 50 years or older. METHODS: A systematic review of comparative observational studies on AMD screening methods in those aged 50 years or older, compared with no screening or any other strategy. A literature search was conducted in the MEDLINE (via PubMed), Embase, Cochrane Library and Lilacs database. RESULTS: A total of 5,290 studies were identified, three of which met the inclusion criteria and were selected for the systematic review. A total of 8,733 individuals (16,780 eyes) were included in the analysis. The screening methods assessed were based on optical coherence tomography (OCT) compared with color fundus photography, and OCT and telemedicine testing compared to a standard eye exam. CONCLUSION: The systematized data are limited and only suggest satisfactory performance in early screening of the population at risk of developing AMD. OCT and the telemedicine technique showed promising results in AMD screening. However, methodological problems were identified in the studies selected and the level of evidence was considered low.

Evolution of research funding for neglected tropical diseases in Brazil, 2004-2020.

Neglected tropical diseases are a global public health problem. Although Brazil is largely responsible for their occurrence in Latin America, research funding on the subject does not meet the population's health needs. The present study analyzed the evolution of research funding for neglected tropical diseases by the Ministry of Health and its partners in Brazil, from 2004 to 2020. This is a retrospective study of data from investigations registered on Health Research (Pesquisa Saúde in Portuguese), a public repository for research funded by the Ministry of Health's Department of Science and Technology. The temporal trend of funding and the influence of federal government changes on funding were analyzed using Prais-Winster generalized linear regression. From 2004 to 2020, 1,158 studies were financed (purchasing power parity (PPP$) 230.9 million), with most funding aimed at biomedical research (81.6%) and topics involving dengue, leishmaniasis and tuberculosis (60.2%). Funding was stationary (annual percent change of -5.7%; 95%CI -54.0 to 45.0) and influenced by changes to the federal government. Research funding was lacking for chikungunya, Chagas disease, schistosomiasis, malaria and taeniasis/cysticercosis, diseases with a high prevalence, burden or mortality rates in Brazil. Although the Ministry of Health had several budgetary partners, it was the main funder, with 69.8% of investments. The study revealed that research funding for neglected tropical diseases has stagnated over the years and that diseases with a high prevalence, burden and mortality rate receive little funding. These findings demonstrate the need to strengthen the health research system by providing sustainable funding for research on neglected tropical diseases that is consistent with the population's health needs.

Determining Medication Errors in an Adult Intensive Care Unit.

INTRODUCTION: Research addressing the costs of Medication errors (MEs) is still scarce despite issues related to patient safety having significant economic and health impacts, making it imperative to analyze the costs and adverse events related to MEs for a better patient, professional, and institutional safety. AIM: To identify the number of medication errors and verify whether this number was associated with increased hospitalization costs for patients in an Intensive Care Unit (ICU). METHOD: This retrospective cross-sectional cohort study evaluated secondary data from patients' electronic medical records to compile variables, create a model, and survey hospitalization costs. The statistical analysis included calculating medication error rates, descriptive analysis, and simple and multivariate regression. RESULTS: The omission error rate showed the highest number of errors per drug dose (59.8%) and total errors observed in the sample (55.31%), followed by the time error rate (26.97%; 24.95%). The omission error had the highest average when analyzing the entire hospitalization (170.40) and day of hospitalization (13.79). Hospitalization costs were significantly and positively correlated with scheduling errors, with an increase of BRL 121.92 (about USD $25.00) (95% CI 43.09; 200.74), and to prescription errors, with an increase of BRL 63.51 (about USD $3.00) (95% CI 29.93; 97.09). CONCLUSION: We observed an association between two types of medication errors and increased hospitalization costs in an adult ICU (scheduling and prescription errors).

Direct and indirect costs attributed to alcohol consumption in Brazil, 2010 to 2018.

INTRODUCTION: Alcohol consumption is the main risk factor for death and disability in the world population between 15 to 49 years old, is related to more than 200 causes of death, and has an important economic impact on the health and social security systems. In 2016, three million deaths were attributable to alcohol worldwide and 131.4 million DALYs. In Brazil, alcohol consumption per inhabitant was 7.8 liters in 2016; and the prevalence of abusive consumption was 17.1% in 2019. OBJECTIVE: Estimate the costs attributable of alcohol consumption in the Brazilian population 18 years-old and over, in the period 2010 to 2018. METHODS: This is a prevalence-based cost-of-illness study, with a top-down and retrospective approach, including direct costs (hospital and outpatient) and indirect costs (absenteeism from work) related to alcohol consumption. A list of diseases and conditions for which alcohol is a risk factor was used, and the Population Attributable Risk (PAR) was calculated to estimate what portion of the cost of these diseases is attributable to alcohol consumption. Prevalence was calculated by sex and level of alcohol consumption, based on data from the 2019 National Health Survey. Relative risk data were identified by disease/injury and level of daily consumption obtained from the Global Burden Disease study in 2017. The cost data used are from the Brazilian Unified Health System and social security system. All costs were adjusted for inflation for the period and converted to purchasing power parity. RESULTS: Prevalence data revealed that 73.6% of the Brazilian population reported not consuming alcoholic beverages, which included 62.9% of men and 83.0% of women. The lowest values for the PAR were found at the consumption range of 60 grams per day. Although the 12 grams per day consumption category is the least in terms of the quantity of alcohol consumed, it is one of the main ones in terms of PAR, given the higher prevalence of consumption. The total cost attributable to alcohol between 2010 and 2018 was Int$ 1,487,417,115.43, of which Int$ 737,834,696.89 was for hospital expenses, Int$ 416,052,029.75 for outpatient care, and Int$ 333,530,388.79 due to absenteeism from work. CONCLUSION: Few comprehensive studies of alcohol-related costs have been developed, which suggests a knowledge gap in Brazil and worldwide and indicates the need for more research in this area. Understanding the economic impact of alcohol consumption is essential to help measure this public health problem in all its aspects and encourage implementation of public policies.

Implementation of the e-SUS Primary Care Strategy: an analysis based on official data.

OBJETIVE: Analyze the implementation of the strategy e-SUS Atenção Básica (e-SUS AB - e-SUS Primary Care) in Brazil between the first years of the system, from 2013 to 2019. METHODS: This is a quantitative, descriptive, and exploratory study. We considered official data from the Ministry of Health, submitted by Brazilian municipalities, in the period from April 2013 to December 2019. We categorized the municipalities as 'not implemented', 'initial implementation', 'partial implementation' and 'implemented' according to the criteria defined in this study. We also verified whether the type of municipality, according to the IBGE classification, influenced the degree of implementation of the e-SUS AB strategy. We performed descriptive analyses and investigated the association between the degrees of implementation of e-SUS AB and the typology of the IBGE classification and characterization of rural and urban spaces. RESULTS: The implementation increased in the analyzed period. The implementation status of the e-SUS AB strategy in 2019 was 'implemented' in 20.2% (1,117) of the municipalities, 'partial implementation' in 32.9% (1,819), 'initial implementation' in 39.1% (2,159) and 'not implemented' in 7.8% (432). The South and Southeast regions presented the best implementation situation in all years, and the states of Rio Grande do Sul, São Paulo and Santa Catarina reached a higher percentage of municipalities with 'implemented' status in 2019. CONCLUSIONS: We confirmed the progress in the implementation of the e-SUS AB strategy over the years. Most of the municipalities are between the status 'initial implementation' and 'partial implementation'. Therefore, we conclude that investments in technological resources, training of professionals, and support are necessary to qualify the implementation and use of information systems in the country, especially for the e-SUS AB strategy.

Direct costs of prematurity and factors associated with birth and maternal conditions.

OBJECTIVE: To estimate the direct costs due to hospital care for extremely, moderate, and late preterm newborns, from the perspective of a public hospital in 2018. The second objective was to investigate whether factors associated with birth and maternal conditions explain the costs and length of hospital stay. METHODS: This is a cost-of-illness study, with data extracted from hospital admission authorization forms and medical records of a large public hospital in the Federal District, Brazil. The association of characteristics of preterm newborns and mothers with costs was estimated by linear regression with gamma distribution. In the analysis, the calculation of the parameters of the estimates (B), with a confidence interval of 95% (95%CI), was adopted. The uncertainty parameters were estimated by the 95% confidence interval and standard error using the Bootstrapping method, with 1,000 samples. Deterministic sensitivity analysis was performed, considering lower and upper limits of 95%CI in the variation of each cost component. RESULTS: A total of 147 preterm newborns were included. We verified an average cost of BRL 1,120 for late preterm infants, BRL 6,688 for moderate preterm infants, and BRL 17,395 for extremely preterm infants. We also observed that factors associated with the cost were gestational age (B = -123.00; 95%CI: -241.60 to -4.50); hospitalization in neonatal ICU (B = 6,932.70; 95%CI: 5,309.40-8,556.00), and number of prenatal consultations (B = -227.70; 95%CI: -403.30 to -52.00). CONCLUSIONS: We found a considerable direct cost resulting from the care of preterm newborns. Extreme prematurity showed a cost 15.5 times higher than late prematurity. We also verified that a greater number of prenatal consultations and gestational age were associated with a reduction in the costs of prematurity.

Development of an Index to Assess COVID-19 Hospital Care Installed Capacity in the 450 Brazilian Health Regions.

OBJECTIVE: The article seeks to assess the Brazilian health system ability to respond to the challenges imposed by the coronavirus disease 2019 (COVID-19) pandemic by measuring the capacity of Brazilian hospitals to care for COVID-19 cases in the 450 Health Regions of the country during the year 2020. Hospital capacity refers to the availability of hospital beds, equipment, and human resources. METHODS: We used longitudinal data from the National Register of Health Facilities (CNES) regarding the availability of resources necessary to care for patients with COVID-19 in inpatient facilities (public or private) from January to December 2020. Among the assessed resources are health professionals (certified nursing assistants, nurses, physical therapists, and doctors), hospital beds (clinical, intermediate care, and intensive care units), and medical equipment (computed tomography scanners, defibrillators, electrocardiograph monitors, ventilators, and resuscitators). In addition to conducting a descriptive analysis of absolute and relative data (per 10,000 users), a synthetic indicator named Installed Capacity Index (ICI) was calculated using the multivariate principal component analysis technique to assess hospital capacity. The indicator was further stratified into value ranges to understand its evolution. RESULTS: There was an increase in all selected indicators between January and December 2020. It was possible to observe differences between the Northeast and North regions and the other regions of the country; most Health Regions presented low ICI. The ICI increased between the beginning and the end of 2020, but this evolution differed among Health Regions. The average increase in the ICI was more evident in the groups that already had considerably high baseline capacity in January 2020. CONCLUSIONS: It was possible to identify inequalities in the hospital capacity to care for patients affected by COVID -19 in the Health Regions of Brazil, with a concentration of low index values in the Northeast and North of the country. As the indicator increased throughout the year 2020, inequalities were also observed. The information here provided may be used by health authorities, providers, and managers in planning and adjusting for future COVID-19 care and in dimensioning the adequate supply of hospital beds, health-care professionals, and devices in Health Regions to reduce associated morbidity and mortality. We recommend that the ICI continue to be calculated in the coming months of the pandemic to monitor the capacity in the country's Health Regions.

Cost-effectiveness of mandatory folic acid fortification of flours in prevention of neural tube defects: A systematic review.

BACKGROUND: Neural tube defects (NTDs) constitute the most frequent group among congenital malformations and are the main cause of neonatal morbimortality. Folic acid (FA) can reduce the risk of pregnancies affected by NTDs. OBJECTIVE: We aimed to investigate whether mandatory folic acid (FA) fortification of flours is cost-effective as compared to non-mandatory fortification, and to verify whether FA dosage, cost composition, and the quality of economic studies influence the cost-effectiveness of outcomes. METHODS: We conducted a systematic review. The protocol was registered on PROSPERO (CRD 42018115682). A search was conducted using the electronic databases MEDLINE/PubMed, Web of Science, Embase, Scopus, and EBSCO/CINAHL between January 2019 and October 2020 and updated in February 2021. Eligible studies comprised original economic analyses of mandatory FA fortification of wheat and corn flours (maize flours) compared to strategies of non-mandatory fortification in flours and/or use of FA supplements for NTD prevention. The Drummond verification list was used for quality analysis. RESULTS: A total of 7,859 studies were identified, of which 13 were selected. Most (77%; n = 10) studies originated from high-income countries, while three (23%) were from upper-middle-income countries. Results of a cost-effectiveness analysis showed that fortification is cost-effective for NTD prevention, except for in one study in New Zealand. The cost-benefit analysis yielded a median ratio of 17.5:1 (0.98:1 to 417.1:1), meaning that for each monetary unit spent in the program, there would be a return of 17.5 monetary units. Even in the most unfavorable case of mandatory fortification, the investment in the program would virtually payoff at a ratio of 1:0.98. All FA dosages were cost-effective and offered positive health gains, except in one study. The outcomes of two studies showed that FA dosages above 300 µg/100 g have a higher CBA ratio. The studies with the inclusion of "loss of consumer choice" in the analysis may alter the fortification cost-efficacy ratio. CONCLUSION: We expect the findings to be useful for public agencies in different countries in decision-making on the implementation and/or continuity of FA fortification as a public policy in NTD prevention.

Trends in COVID-19 case-fatality rates in Brazilian public hospitals: A longitudinal cohort of 398,063 hospital admissions from 1st March to 3rd October 2020.

BACKGROUND: Almost 200,000 deaths from COVID-19 were reported in Brazil in 2020. The case fatality rate of a new infectious disease can vary by different risk factors and over time. We analysed the trends and associated factors of COVID-19 case fatality rates in Brazilian public hospital admissions during the first wave of the pandemic. METHODS: A retrospective cohort of all COVID-19-related admissions between epidemiological weeks 10-40 in the Brazilian Public Health System (SUS) was delimited from available reimbursement records. Smoothing time series and survival analyses were conducted to evaluate the trends of hospital case fatality rates (CFR) and the probability of death according to factors such as sex, age, ethnicity, comorbidities, length of stay and ICU use. RESULTS: With 398,063 admissions and 86,452 (21.7%) deaths, the overall age-standardized hospital CFR trend decreased throughout the period, varying from 31.8% (95%CI: 31.2 to 32.5%) in week 10 to 18.2% (95%CI: 17.6 to 18.8%) in week 40. This decreasing trend was observed in all sex, age, ethnic groups, length of stay and ICU admissions. Consistently, later admission (from July to September) was an independent protective factor. Patients 80+ year old had a hazard ratio of 8.18 (95% CI: 7.51 to 8.91). Ethnicity, comorbidities, and ICU need were also associated with the death risk. Although also decreasing, the CFR was always around 40-50% in people who needed an ICU admission. CONCLUSIONS: The overall hospital CFR of COVID-19 has decreased in Brazilian public hospitals during the first wave of the pandemic in 2020. Nevertheless, during the entire period, the CFR was still very high, suggesting the need for improving COVID-19 hospital care in Brazil.

Regionalization for health improvement: A systematic review.

Regionalization is the integrated organization of a healthcare system, wherein regional structures are responsible for providing and administrating health services in a specific region. This method was adopted by several countries to improve the quality of provided care and to properly utilize available resources. Thus, a systematic review was conducted to verify effective interventions to improve health and management indicators within the health services regionalization. The protocol was registered in PROSPERO (CRD42016042314). We performed a systematic search in databases during February and March 2017 which was updated in October 2020. There was no language or date restriction. We included experimental and observational studies with interventions focused on regionalization-related actions, measures or policies aimed at decentralizing and organizing health offerings, rationalizing scarce capital and human resources, coordinating health services. A methodological assessment of the studies was performed using instruments from the Joanna Briggs Institute and GRADE was also used to assess outcomes. Thirty-nine articles fulfilled the eligibility criteria and sixteen interventions were identified that indicated different degrees of recommendations for improving the management of health system regionalization. The results showed that regionalization was effective under administrative decentralization and for rationalization of resources. The most investigated intervention was the strategy of concentrating procedures in high-volume hospitals, which showed positive outcomes, especially with the reduction of hospitalization days and in-hospital mortality rates. When implementing regionalization, it must be noted that it involves changes in current standards of health practice and in the distribution of health resources, especially for specialized services.

Judicialization of Zolgensma in the Ministry of Health: costs and clinical profile of patients / Judicialização do Zolgensma no Ministério da Saúde: custos e perfil clínico dos pacientes

ABSTRACT OBJECTIVE To investigate the costs and profile of patients who have filed a lawsuit against the Ministry of Health for the treatment of spinal muscular atrophy (SMA) with the onasemnogene abeparvovec (Zolgensma®). METHODS This is a cross-sectional, descriptive study with a census design, based on records of lawsuits filed against the Ministry of Health between January 2019 and September 2022. Data was requested from the Ministry of Health via the Access to Information Act. Information was extracted on the epidemiological profile of the beneficiaries of the lawsuits, as well as the expenses spent by the Ministry of Health in cases where the requests were granted. RESULTS 136 lawsuits were identified, of which 113 (83%) were favorable to patients at a cost of R$ 944.8 million in the period analyzed. Demographic (gender and age), clinical (SMA subtypes, use of ventilatory or nutritional support), and lawsuit (type of legal service) characteristics were not associated with the granting of lawsuits. Prior use of medication (nusinersena or ridisplam) was associated with the dismissal of lawsuits. Of the 113 lawsuits granted in favor of patients, only six (5.3%) would meet the criteria currently established by the National Committee for Health Technology Incorporation - Conitec (children up to six months without ventilatory and nutritional support). R$ 146 million was spent on supplying Zolgensma to children over the age of two, which is outside the recommendation contained in the drug's package leaflet. CONCLUSIONS The Ministry of Health incurs a high cost with the judicialization of Zolgensma for SMA, representing 2.45% of total spending on medicines in the Unified Health System, including spending by the three administrative spheres. Some of the lawsuits have been granted in disagreement with the criteria established by health technology assessment agencies and the drug manufacturer's recommendations.

RESUMO OBJETIVO Investigar os custos e o perfil dos pacientes que demandaram judicialmente o onasemnogene abeparvoveque (Zolgensma®) para o tratamento da atrofia muscular espinhal (AME) no Ministério da Saúde. MÉTODOS Estudo transversal, de natureza descritiva e desenho censitário, com base em registros de ações judiciais movidas contra o Ministério da Saúde no período de janeiro de 2019 a setembro de 2022. Os dados foram solicitados ao Ministério da Saúde, via Lei de Acesso à Informação. Foram extraídas informações sobre o perfil epidemiológico dos beneficiários das ações judiciais, bem como os gastos dispendidos pelo Ministério da Saúde nos casos de deferimento das solicitações. RESULTADOS Foram identificados 136 processos judiciais, dos quais 113 (83%) foram favoráveis aos pacientes ao custo de R$ 944,8 milhões no período analisado. Características demográficas (sexo e idade), clínicas (subtipos da AME, uso de suporte ventilatório ou nutricional) e do processo judicial (tipo de serviço advocatício) não foram associadas com o deferimento das ações judiciais. O uso prévio de medicamento (nusinersena ou ridisplam) foi associado com o indeferimento dos processos judiciais. Das 113 ações judiciais concedidas em favor dos pacientes, apenas seis (5,3%) atenderiam aos critérios estabelecidos atualmente pela Comissão Nacional de Incorporação de Tecnologias - Conitec (crianças com até seis meses sem suporte ventilatório e nutricional). Houve dispêndio de R$ 146 milhões com o fornecimento do Zolgensma para crianças com idade superior a dois anos, que está fora da recomendação contida na bula do medicamento. CONCLUSÕES O Ministério da Saúde incorre em um alto custo com a judicialização do Zolgensma para AME, representando 2,45% do gasto total com medicamentos no Sistema Único de Saúde, incluindo gastos das três esferas administrativas. Parte das demandas judiciais tem sido deferida em divergência com os critérios estabelecidos por agências de avaliação de tecnologias em saúde e recomendações do fabricante do medicamento.

Inclusion of disability in primary healthcare facilities and socioeconomic inequity in Brazil

ABSTRACT OBJECTIVE: To describe disability-related performance and inequality nationwide in Brazil, and the changes that took place between 2012 and 2019 after the introduction of Programme for Improving Primary Care Access and Quality (PMAQ). METHODS: We derived scores for disability-related care and accessibility of primary healthcare facilities from PMAQ indicators collected in round 1 (2011-2013), and round 3 (2015-2019). We assessed how scores changed after the introduction of PMAQ. We used census data on per capita income of local areas to examine the disability-specific care and accessibility scores by income group. We undertook ordinary least squares regressions to examine the association between PMAQ scores and per capita income of each local area across implementation rounds. RESULTS: Disability-related care scores were low in round 1 (18.8, 95%CI 18.3-19.3, out of a possible 100) and improved slightly by round 3 (22.5, 95%CI 22.0-23.1). Accessibility of primary healthcare facilities was also poor in round 1 (30.3, 95%CI 29.8-30.8) but doubled by round 3 (60.8, 95%CI 60.3-61.3). There were large socioeconomic inequalities in round 1, with both scores approximately twice as high in the richest compared to the poorest group. Inequalities weakened somewhat for accessibility scores by round 3. These trends were confirmed through regression analyses, controlling for other area characteristics. Disability-related and accessibility scores also varied strongly between states in both rounds. CONCLUSIONS: People with disabilities are being left behind by the Brazilian healthcare system, particularly in poor areas, which will challenge the achievement of universal health coverage.

Cost-utility analysis of outpatient parenteral antimicrobial therapy (OPAT) in the Brazilian national health system.

BACKGROUND: Outpatient parenteral antimicrobial therapy (OPAT) has been used for decades in different countries to reduce hospitalization rates, with favorable clinical and economic outcomes. This study assesses the cost-utility of OPAT compared to inpatient parenteral antimicrobial therapy (IPAT) from the perspective of a public university hospital and the Brazilian National Health System (Unified Health System -SUS). METHODS: Prospective study with adult patients undergoing OPAT at an infusion center, compared to IPAT. Clinical outcomes and quality-adjusted life year (QALY) were assessed, as well as a micro-costing. Cost-utility analysis from the hospital and SUS perspectives were conducted by means of a decision tree, within a 30-day horizon time. RESULTS: Forty cases of OPAT (1112 days) were included and monitored, with a favorable outcome in 97.50%. OPAT compared to IPAT generated overall savings of 31.86% from the hospital perspective and 26.53% from the SUS perspective. The intervention reduced costs, with an incremental cost-utility ratio of -44,395.68/QALY for the hospital and -48,466.70/QALY for the SUS, with better cost-utility for treatment times greater than 14 days. Sensitivity analysis confirmed the stability of the model. CONCLUSION: Our economic assessment demonstrated that, in the Brazilian context, OPAT is a cost-saving strategy both for hospitals and for the SUS.