Impact of the COVID-19 pandemic on the mental health of frontline healthcare workers in a highly affected region in Brazil.

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.

Diet quality index for Brazilian adolescents: the ERICA study.

PURPOSE: This study aimed to assess the dietary patterns of adolescents using a food-based diet quality index and their compliance with a healthy dietary guideline METHODS: Participants included 71,553 Brazilian adolescents (12-17 years old) from the Study of Cardiovascular Risks in Adolescents (ERICA), a cross-sectional school-based multicenter study.. Dietary intake was measured by one 24-h recall. A second recall was collected in a random subsample (~ 10%) to correct within-person variability. The Diet Quality Index for Adolescents adapted for Brazilians (DQIA-BR) was used to measure the overall quality of the dietary intake. The National Cancer Institute method was applied to estimate usual dietary intake. The DQIA-BR and the distribution of its components (quality, diversity, and equilibrium) were analyzed according to sex, geographical area, and type of school RESULTS: The mean (SD) DQIA-BR scores were 14.8% (6.1%) for females and 19.0% (6.3%) for males. All analyzed strata revealed low scores of DQIA-BR and its components. The median usual intake was five to sevenfold below the recommendations for vegetables and fruits and approximately twofold below the recommendations for dairy. The highest DQIA-BR mean scores were found in the northern region [17.0% (6.4%), females; 20.7% (6.3%), males]. Adolescents in both types of schools had relatively similar median intakes of snacks (~ 85 g) and sugared drinks (~ 600 ml) CONCLUSIONS: The overall diet quality of Brazilian adolescents is inadequate based on evaluated parameters in all regions and socioeconomic backgrounds.

Performance of the Gail and Tyrer-Cuzick breast cancer risk assessment models in women screened in a primary care setting with the FHS-7 questionnaire.

Breast cancer (BC) risk assessment models base their estimations on different aspects of a woman's personal and familial history. The Gail and Tyrer-Cuzick models are the most commonly used, and BC risks assigned by them vary considerably especially concerning familial history. In this study, our aim was to compare the Gail and Tyrer-Cuzick models after initial screening for familial history of cancer in primary care using the FHS-7 questionnaire. We compared 846 unrelated women with at least one positive answer to any of the seven FHS-7 questions (positive group) and 892 unrelated women that answered negatively (negative group). Concordance between BC risk estimates was compared by Bland-Altman graphics. Mean BC risk estimates were higher using the Tyrer-Cuzick Model in women from the positive group, while women from the negative group had higher BC risk estimates using the Gail model. With increasing estimates, discordance also increased, mainly in the FHS-7 positive group. Our results show that in women with a familial history of cancer, the Gail model underestimates risk and the Tyrer-Cuzick seems to be more appropriate. FHS-7 can be a useful tool for the identification of women with higher breast cancer risks in the primary care setting.

Bayesian models as a unified approach to estimate relative risk (or prevalence ratio) in binary and polytomous outcomes.

BACKGROUND: Disadvantages have already been pointed out on the use of odds ratio (OR) as a measure of association for designs such as cohort and cross sectional studies, for which relative risk (RR) or prevalence ratio (PR) are preferable. The model that directly estimates RR or PR and correctly specifies the distribution of the outcome as binomial is the log-binomial model, however, convergence problems occur very often. Robust Poisson regression also estimates these measures but it can produce probabilities greater than 1. RESULTS: In this paper, the use of Bayesian approach to solve the problem of convergence of the log-binomial model is illustrated. Furthermore, the method is extended to incorporate dependent data, as in cluster clinical trials and studies with multilevel design, and also to analyse polytomous outcomes. Comparisons between methods are made by analysing four data sets. CONCLUSIONS: In all cases analysed, it was observed that Bayesian methods are capable of estimating the measures of interest, always within the correct parametric space of probabilities.

The Brazilian founder mutation TP53 p.R337H is uncommon in Portuguese women diagnosed with breast cancer.

Since the first studies reporting the TP53 p.R337H mutation as founder mutation in Southern and Southeastern Brazil, there has been controversy on its origin. Preliminary analysis of a small subset of Brazilian mutation carriers revealed that the haplotype incided on a Caucasian background. The vast majority of carriers identified today reside in Brazil or, if identified in other countries, are Brazilian immigrants. To our knowledge, the only two exceptions of carriers without a recognizable link with Brazil are two European families, from Portugal and Germany. Haplotype analysis in the Portuguese family revealed the same haplotype identified in Brazilian individuals, but in the German family, a distinct haplotype was found. Knowing that a significant proportion of women with breast cancer (BC) in Southern Brazil are p.R337H carriers, we analyzed p.R337H in a Portuguese cohort of women diagnosed with this disease. Median age at diagnosis among the first 573 patients tested was 60 years and 100 (17.4%) patients had been diagnosed at or under the age of 45 years. Mutation screening failed to identify the mutation in the 573 patients tested. These results are in contrast with the mutation frequency observed in a study including 815 BC-affected women from Brazil, in which carrier frequencies of 12.1 and 5.1% in pre- and postmenopausal women were observed, respectively. These findings suggest that the Brazilian founder mutation p.R337H, the most frequent germline TP53 mutation reported to date, is not a common germline alteration in Portuguese women diagnosed with BC.

Fibre intake and evolution of BMI: from pre-pregnancy to postpartum.

OBJECTIVE: To evaluate the effect of fibre intake on the evolution of maternal BMI from pregnancy to postpartum and to identify dietary patterns associated with fibre intake. DESIGN: Cohort study. Food intake was obtained using an FFQ. Focused principal component analysis was used focusing on the variables: postpartum weight retention and total dietary fibre intake. Poisson regression models with robust variance were built in order to measure the effect of fibre intake during the postpartum period on obesity risk. SETTING: Primary care clinics in southern Brazil. SUBJECTS: Pregnant women (n 370) were followed until the 5th month postpartum. RESULTS: The highest contribution to fibre intake came from the consumption of beans. Consumption of bread and rice indicated a common Brazilian food pattern along with beans. Participants retained a median of 4.4 (interquartile range 0.6, 7.9) kg of weight gained during pregnancy. Obesity risk, defined as an unfavourable evolution of BMI during pregnancy and postpartum, was present in 189 (55.1%) women. Individual food items did not have an important effect on weight retention. In Poisson regression adjusting for maternal age, pre-pregnancy BMI and total gestational weight gain, inadequate postpartum fibre intake increased obesity risk by 24% (relative risk 51.24; 95% CI 1.05, 1.47). CONCLUSIONS: Important maternal weight retention occurred in these women. Adequate fibre intake may reduce obesity risk in the period following childbirth.

Modeling the impact of child vaccination (5-11 y) on overall COVID-19 related hospitalizations and mortality in a context of omicron variant predominance and different vaccination coverage paces in Brazil.

Background: Developing countries have experienced significant COVID-19 disease burden. With the emergence of new variants, particularly omicron, the disease burden in children has increased. When the first COVID-19 vaccine was approved for use in children aged 5-11 years of age, very few countries recommended vaccination due to limited risk-benefit evidence for vaccination of this population. In Brazil, ranking second in the global COVID-19 death toll, the childhood COVID-19 disease burden increased significantly in early 2022. This prompted a risk-benefit assessment of the introduction and scaling-up of COVID-19 vaccination of children. Methods: To estimate the potential impact of vaccinating children aged 5-11 years with mRNA-based COVID-19 vaccine in the context of omicron dominance, we developed a discrete-time SEIR-like model stratified in age groups, considering a three-month time horizon. We considered three scenarios: No vaccination, slow, and maximum vaccination paces. In each scenario, we estimated the potential reduction in total COVID-19 cases, hospitalizations, deaths, hospitalization costs, and potential years of life lost, considering the absence of vaccination as the base-case scenario. Findings: We estimated that vaccinating at a maximum pace could prevent, between mid-January and April 2022, about 26,000 COVID-19 hospitalizations, and 4200 deaths in all age groups; of which 5400 hospitalizations and 410 deaths in children aged 5-11 years. Continuing vaccination at a slow/current pace would prevent 1450 deaths and 9700 COVID-19 hospitalizations in all age groups in this same time period; of which 180 deaths and 2390 hospitalizations in children only. Interpretation: Maximum vaccination of children results in a significant reduction of COVID-19 hospitalizations and deaths and should be enforced in developing countries with significant disease incidence in children. Funding: This manuscript was funded by the Brazilian Council for Scientific and Technology Development (CNPq - Process # 402834/2020-8).

Binge eating during pregnancy and birth outcomes: a cohort study in a disadvantaged population in Brazil.

OBJECTIVE: To assess the impact of binge eating behavior (BE) during pregnancy on birth outcomes among 697 Brazilian women who attended primary care. METHOD: Pregnant women answered a questionnaire on sociodemographic data, obstetric history, and The Eating Disorder Examination Questionnaire (EDE-Q). Perinatal outcomes were obtained from birth records. Birth weight, prematurity, caesarean delivery, being small or large for gestational age were compared among women reporting BE (N = 119) and those without BE (N = 578). Poisson regression was used to estimate the association between BE during pregnancy and birth outcomes. RESULTS: BE during pregnancy was not significantly associated with the birth outcomes analyzed. Gestational weight gain was significantly higher among those who reported BE. DISCUSSION: Binge eating behavior during pregnancy may not influence birth outcomes as binge eating disorder does but affects gestational weight gain. Women reporting binge eating during pregnancy should undergo a diagnostic assessment for eating disorders.

Modelling optimal vaccination strategies against COVID-19 in a context of Gamma variant predominance in Brazil.

INTRODUCTION: Brazil experienced moments of collapse in its health system throughout 2021, driven by the emergence of variants of concern (VOC) combined with an inefficient initial vaccination strategy against Covid-19. OBJECTIVES: To support decision-makers in formulating COVID-19 immunization policy in the context of limited vaccine availability and evolving variants over time, we evaluate optimal strategies for Covid-19 vaccination in Brazil in 2021, when vaccination was rolled out during Gamma variant predominance. METHODS: Using a discrete-time epidemic model we estimate Covid-19 deaths averted, considering the currently Covid-19 vaccine products and doses available in Brazil; vaccine coverage by target population; and vaccine effectiveness estimates. We evaluated a 5-month time horizon, from early August to the end of December 2021. Optimal vaccination strategies compared the outcomes in terms of averted deaths when varying dose intervals from 8 to 12 weeks, and choosing the minimum coverage levels per age group required prior to expanding vaccination to younger target populations. We also estimated dose availability required over time to allow the implementation of optimal strategies. RESULTS: To maximize the number of averted deaths, vaccine coverage of at least 80 % should be reached in older age groups before starting vaccination into subsequent younger age groups. When evaluating varying dose intervals for AZD1222, reducing the dose interval from 12 to 8 weeks for the primary schedule would result in fewer COVID-19 deaths, but this can only be implemented if accompanied by an increase in vaccine supply of at least 50 % over the coming six-months in Brazil. CONCLUSION: Covid-19 immunization strategies should be tailored to local vaccine product availability and supply over time, circulating variants of concern, and vaccine coverage in target population groups. Modelling can provide valuable and timely evidence to support the implementation of vaccination strategies considering the local context, yet following international and regional technical evidence-based guidance.

Modelling the impact of school reopening and contact tracing strategies on Covid-19 dynamics in different epidemiologic settings in Brazil.

We simulate the impact of school reopening during the COVID-19 pandemic in three major urban centers in Brazil to identify the epidemiological indicators and the best timing for the return of in-school activities and the effect of contact tracing as a mitigation measure. Our goal is to offer guidelines for evidence-based policymaking. We implement an extended SEIR model stratified by age and considering contact networks in different settings - school, home, work, and community, in which the infection transmission rate is affected by various intervention measures. After fitting epidemiological and demographic data, we simulate scenarios with increasing school transmission due to school reopening, and also estimate the number of hospitalization and deaths averted by the implementation of contact tracing. Reopening schools results in a non-linear increase in reported COVID-19 cases and deaths, which is highly dependent on infection and disease incidence at the time of reopening. When contact tracing and quarantining are restricted to school and home settings, a large number of daily tests is required to produce significant effects in reducing the total number of hospitalizations and deaths. Policymakers should carefully consider the epidemiological context and timing regarding the implementation of school closure and return of in-person school activities. While contact tracing strategies prevent new infections within school environments, they alone are not sufficient to avoid significant impacts on community transmission.

Association between diet quality index and cardiometabolic risk factors in adolescents: Study of Cardiovascular Risks in Adolescents (ERICA).

OBJECTIVE: This study evaluated the association between diet quality, assessed by the Diet Quality Index for Adolescents adapted for Brazilians (DQIA-BR), and cardiometabolic markers in adolescents. METHODS: The DQIA-BR and cardiometabolic markers were assessed in 36 956 Brazilian adolescents (12-17 y old) enrolled in the Study of Cardiovascular Risks in Adolescents (ERICA), a national school-based cross-sectional multicenter study in Brazil. For analyses, the sample was stratified by sex and nutritional status. Multiple linear regressions were used to investigate the association between DQIA-BR and cardiometabolic markers (total cholesterol, HDL-c, LDL-c, triglycerides, fasting glucose and HOMA-IR). Adjusted models were constructed with two input levels of covariates. The first model was adjusted for sex, age, and socioeconomic status; in the second model, total energy intake, physical activity, and sedentary behavior were included. RESULTS: A higher DQIA-BR score was associated with a better cardiometabolic profile in girls with normal weight; however, no association was observed in those with overweight/obesity. In boys with overweight/obesity, a better quality of diet was associated with lower concentrations of total cholesterol (ß = -0.338, 95% confidence interval [CI]: -0.611 to -0.066) and LDL-c (ß = -0.227, 95% CI: -0.448 to -0.005), but only LDL-c remained significant in those with normal weight (ß = -0.115, 95% CI: -0.224 to 0.005). CONCLUSION: The effects of diet quality on cardiometabolic risk factors differ according to sex and the presence of overweight/obesity. Overall, DQIA-BR is a suitable tool to evaluate the association between diet quality and cardiometabolic markers in normal-weight adolescents, but not for adolescents, especially girls, with overweight/obesity.

Cost-effectiveness of implantable cardioverter-defibrillators in Brazil: primary prevention analysis in the public sector.

BACKGROUND: Several studies have demonstrated the effectiveness and cost-effectiveness of implantable cardioverter-defibrillators (ICDs) in chronic heart failure (CHF) patients. Despite its widespread use in developing countries, limited data exist on its cost-effectiveness in these settings. OBJECTIVE: To evaluate the cost-effectiveness of ICD in CHF patients under the perspective of the Brazilian Public Healthcare System (PHS). METHODS: We developed a Markov model to evaluate the incremental cost-effectiveness ratio (ICER) of ICD compared with conventional therapy in patients with CHF and New York Heart Association class II and III. Effectiveness was evaluated in quality-adjusted life years (QALYs) and time horizon was 20 years. We searched MEDLINE for clinical trials and cohort studies to estimate data from effectiveness, complications, mortality, and utilities. Costs from the PHS were retrieved from national administrative databases. The model's robustness was assessed through Monte Carlo simulation and one-way sensitivity analysis. Costs were expressed as international dollars, applying the purchasing power parity conversion rate (PPP US$). RESULTS: ICD therapy was more costly and more effective, with incremental cost-effectiveness estimates of PPP US$ 50,345/QALY. Results were more sensitive to costs related to the device, generator replacement frequency and ICD effectiveness. In a simulation resembling the MADIT-I population survival and ICD benefit, the ICER was PPP US$ 17,494/QALY and PPP US$ 15,394/life years. CONCLUSIONS: In a Brazilian scenario, where ICD cost is proportionally more elevated than in developed countries, ICD therapy was associated with a high cost-effectiveness ratio. The results were more favorable for a patient subgroup at increased risk of sudden death.

Development and validation of a simple questionnaire for the identification of hereditary breast cancer in primary care.

BACKGROUND: Breast cancer is a significant public health problem worldwide and the development of tools to identify individuals at-risk for hereditary breast cancer syndromes, where specific interventions can be proposed to reduce risk, has become increasingly relevant. A previous study in Southern Brazil has shown that a family history suggestive of these syndromes may be prevalent at the primary care level. Development of a simple and sensitive instrument, easily applicable in primary care units, would be particularly helpful in underserved communities in which identification and referral of high-risk individuals is difficult. METHODS: A simple 7-question instrument about family history of breast, ovarian and colorectal cancer, FHS-7, was developed to screen for individuals with an increased risk for hereditary breast cancer syndromes. FHS-7 was applied to 9218 women during routine visits to primary care units in Southern Brazil. Two consecutive samples of 885 women and 910 women who answered positively to at least one question and negatively to all questions were included, respectively. The sensitivity, specificity and positive and negative predictive values were determined. RESULTS: Of the 885 women reporting a positive family history, 211 (23.8%; CI95%: 21.5-26.2) had a pedigree suggestive of a hereditary breast and/or breast and colorectal cancer syndrome. Using as cut point one positive answer, the sensitivity and specificity of the instrument were 87.6% and 56.4%, respectively. Concordance between answers in two different applications was given by a intra-class correlation (ICC) of 0.84 for at least one positive answer. Temporal stability of the instrument was adequate (ICC = 0.65). CONCLUSION: A simple instrument for the identification of the most common hereditary breast cancer syndrome phenotypes, showing good specificity and temporal stability was developed and could be used as a screening tool in primary care to refer at-risk individuals for genetic evaluations.

World Health Organization quality of life instrument-brief and Short Form-36 in patients with coronary artery disease: do they measure similar quality of life concepts?

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.

Electronic Version of the EQ-5D Quality-of-Life Questionnaire: Adaptation to a Brazilian Population Sample.

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.

The progression rate of spinocerebellar ataxia type 2 changes with stage of disease.

BACKGROUND: Spinocerebellar ataxia type 2 (SCA2) affects several neurological structures, giving rise to multiple symptoms. However, only the natural history of ataxia is well known, as measured during the study duration. We aimed to describe the progression rate of ataxia, by the Scale for the Assessment and Rating of Ataxia (SARA), as well as the progression rate of the overall neurological picture, by the Neurological Examination Score for Spinocerebellar Ataxias (NESSCA), and not only during the study duration but also in a disease duration model. Comparisons between these models might allow us to explore whether progression is linear during the disease duration in SCA2; and to look for potential modifiers. RESULTS: Eighty-eight evaluations were prospectively done on 49 symptomatic subjects; on average (SD), study duration and disease duration models covered 13 (2.16) months and 14 (6.66) years of individuals' life, respectively. SARA progressed 1.75 (CI 95%: 0.92-2.57) versus 0.79 (95% CI 0.45 to 1.14) points/year in the study duration and disease duration models. NESSCA progressed 1.45 (CI 95%: 0.74-2.16) versus 0.41 (95% CI 0.24 to 0.59) points/year in the same models. In order to explain these discrepancies, the progression rates of the study duration model were plotted against disease duration. Then an acceleration was detected after 10 years of disease duration: SARA scores progressed 0.35 before and 2.45 points/year after this deadline (p = 0.013). Age at onset, mutation severity, and presence of amyotrophy, parkinsonism, dystonic manifestations and cognitive decline at baseline did not influence the rate of disease progression. CONCLUSIONS: NESSCA and SARA progression rates were not constant during disease duration in SCA2: early phases of disease were associated with slower progressions. Modelling of future clinical trials on SCA2 should take this phenomenon into account, since disease duration might impact on inclusion criteria, sample size, and study duration. Our database is available online and accessible to future studies aimed to compare the present data with other cohorts.

Cancer in Machado-Joseph disease patients-low frequency as a cause of death.

Since polyglutamine diseases have been related to a reduced risk of cancer, we aimed to study the 15 years cumulative incidence of cancer (CIC) (arm 1) and the proportion of cancer as a cause of death (arm 2) in symptomatic carriers of spinocerebellar ataxia type 3/Machado-Joseph disease (SCA3/MJD). SCA3/MJD and control individuals from our state were invited to participate. A structured interview was performed. CIC as published by the Brazilian National Institute of Cancer, was used as populational control. Causes of death were obtained from the Public Information System on Mortality. We interviewed 154 SCA3/MJD patients and 80 unrelated controls: CIC was 7/154 (4.5%) and 5/80 (6.3%), respectively. The interim analysis for futility showed that the number of individuals required to detect a significant difference between groups (1938) would be three times larger than the existing local SCA3/MJD population (625), for an absolute risk reduction of 1.8%. Then this study arm was discontinued due to lack of power. In the same period, cancer was a cause of death in 9/101 (8.9%) SCA3/MJD and in 52/202 (26.2%) controls, with an absolute reduction risk of 17.3% (OR 0.27, 95%CI 0.13 to 0.58, p = 0.01). A significant reduction of cancer as cause of death was observed in SCA3/MJD, suggesting a common effect to all polyglutamine diseases.

PSS Health: como calcular tamanho de amostra para testes de comparação de médias de dois grupos / PSS Health: how to calculate sample sizes for mean comparison tests between two groups

Dando continuidade à série de artigos que pretendem orientar o usuário na utilização da ferramenta PSS Health para o planejamento de uma pesquisa, esta edição apresenta um passo a passo de como realizar o cálculo e de quais informações são necessárias para comparar médias: de dois grupos dependentes ou independentes, de dois grupos independentes com duas medidas repetidas (deltas), e com duas ou mais medidas repetidas. Todos os exemplos também são ilustrados e disponibilizados em vídeos no canal da Unidade de Bioestatística.

Following the series of articles aiming to guide users in using the PSS Health tool for research planning, this issue presents a step-by-step guide on how to calculate and what information is needed to compare means between 2 dependent or independent groups, 2 independent groups with 2 repeated measures (deltas), and 2 independent groups with 2 or more repeated measures. All examples are accompanied by figures and available in video on the Biostatistics Unit's channel.

PSS Health: como calcular tamanho de amostra para testar relações de variáveis com um desfecho binário / PSS Health: how to calculate the sample size to test variables relationships with a binary outcome

Dando continuidade à série de artigos que pretendem orientar o usuário na utilização da ferramenta PSS Health para o planejamento de uma pesquisa, esta edição apresenta um passo a passo de como realizar o cálculo para tamanho de amostra e de quais informações são necessárias para testar relações estatísticas entre variáveis e um desfecho binário: comparação de proporções entre grupos independentes (dois ou mais), comparação de duas proporções dependentes e regressão logística. Todos os exemplos também são ilustrados e disponibilizados em vídeos no canal da Unidade de Bioestatística.

Following the series of articles that aim to guide the user in using the PSS Health tool for planning research, this issue presents a step-by-step guide on how to perform the sample size calculation and what information is needed to test statistical relationships between variables and a binary outcome: comparison of proportions between independent groups (two or more), comparison of two dependent proportions, and logistic regression. All examples are also illustrated and available in videos on the Biostatistics Unit's channel.

Prognostic value of serum biomarkers in association with TIMI risk score for acute coronary syndromes.

BACKGROUND: Markers of neurohormonal activation and inflammation play a pivotal role in non-ST-elevation acute coronary syndromes (NSTE-ACS). HYPOTHESIS: We hypothesized that other biochemical markers could add prognostic value on Thrombolysis In Myocardial Infarction (TIMI) risk score to predict major cardiovascular events in patients with NSTE-ACS. METHODS: In a cohort of 172 consecutive patients with NSTE-ACS, TIMI score was assessed in the first 24 h, and blood samples were collected for measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein, CD40 ligand, and creatinine. Major clinical outcomes (death and cardiovascular hospitalization) were accessed at 30 days and 6 months. Multivariate logistic regression was applied to identify markers significantly associated with outcomes and, based on individual coefficients, an expanded score was developed. RESULTS: Of 172 patients, 42% had acute myocardial infarction. The unadjusted 30-day event rate increased with age (odds ratio [OR] = 1.03; 95% confidence interval [CI] 1.00-1.06), creatinine (OR = 2.4; 1.4-4.1), TIMI score (OR = 1.6; 1.2-2.2), troponin I (OR = 3.4; 1.5-7.7), total CK (OR = 2.7; 1.2-6.1), and NT-proBNP (OR = 2.9; 1.3-6.3) levels. In multivariate analysis, TIMI risk score, creatinine, and NT-proBNP remained associated with worse prognosis. Multimarker Expanded TIMI Risk Score [TIMI score + (2 X creatinine [in mg/dl]) + (3, if NT-proBNP > 400 pg/ml)] showed good accuracy for 30-day (c statistic 0.77; p < 0.001) and 6-month outcomes (c statistic 0.75; p < 0.001). The 30-day event rates according to tertiles of expanded score were 7, 26, and 75%, respectively (p < 0.01). CONCLUSION: In NSTE-ACS, baseline levels of NT-proBNP and creatinine are independently related to cardiovascular events. Both markers combined with TIMI risk score provide a better risk stratification than either test alone.