Effect of Nuts on Anthropometric and Glycemic Indexes and Blood Pressure in Secondary Cardiovascular Prevention: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

CONTEXT: Nut-enriched diets have a positive impact on cardiovascular risk factors, such as body mass, blood pressure, and fasting blood glucose. However, studies in individuals undergoing secondary cardiovascular prevention show controversial results. OBJECTIVE: This systematic review with meta-analysis assessed the effect of nut supplementation on anthropometric, glycemic, and blood pressure indices in patients with atherosclerotic cardiovascular disease, as well as the frequency of adverse events. DATA SOURCES: Six databases were used for the search-PubMed, Cochrane Library, EMBASE, BVS (Biblioteca Virtual da Saude), Web of Science, and ClinicalTrials.gov-until February 2023, with no language restrictions. DATA EXTRACTION: The Cochrane Handbook for Systematic Reviews of Interventions methodology and the PICOS (Population, Intervention, Comparison, Outcome, Setting/design) strategy were used. Seven independent reviewers were involved in data extraction and resolution of disagreements. Certainty of the evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. DATA ANALYSIS: From 5187 records identified, 6 publications containing data referring to 5 randomized clinical trials (n = 436) were included in the final analyses. The nuts evaluated were almonds, pecans, Brazil nuts, and mixed nuts, with portions that varied between 5 g and 85 g (median: 30 g/day). The intervention period varied between 6 and 12 weeks. The nuts had no effect on fasting glucose and anthropometric indices, although the certainty of the evidence for most of these outcomes was low or very low. They also had no effect on systolic (mean difference [MD]: -1.16 mmHg [95% CI, -5.68 to 3.35], I2 = 0%-moderate certainty of evidence) or diastolic (MD: 0.10 mmHg [95% CI, -2.30 to 2.51], I2 = 0%-high certainty of evidence) blood pressure. It was not possible to aggregate data on adverse events. CONCLUSION: Nut supplementation had no effect on blood pressure, fasting glucose, or anthropometric profile in the context of atherosclerotic cardiovascular disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42020163456.

Effectiveness of a two-component nutritional strategy for blood pressure control in individuals with hypertension users of a public health system: a randomized controlled clinical trial.

OBJECTIVE: To evaluate the effectiveness of a nutritional strategy based on two components and adapted for the public health system on blood pressure, cardiometabolic features, self-care, qualify of life and diet quality in individuals with hypertension. METHODS: NUPRESS was an open-label, parallel-group, superiority randomized controlled clinical trial in which participants at least 21 years with hypertension and poorly controlled blood pressure were randomly assigned (1 : 1 allocation ratio) to either an individualized dietary prescription according to nutritional guidelines (control group, n = 205); or a two-component nutrition strategy, including a goal-directed nutritional counseling and mindfulness techniques (NUPRESS [intervention] group, n = 205). Primary outcomes were SBP (mmHg) after 24 weeks of follow up and blood pressure control, defined as either having SBP more than 140 mmHg at baseline and achieving 140 mmHg or less after follow-up or having SBP 140 mmHg or less at baseline and reducing the frequency of antihypertensive drugs in use after follow-up. RESULTS: In total, 410 participants were randomized and submitted to an intention-to-treat analysis regarding primary outcomes. Both groups decreased blood pressure, but after adjusting for baseline values, there was no significant difference between them on SBP [intervention-control difference: -0.03 (-3.01; 2.94); P = 0.98] nor blood pressure control [odds ratio 1.27 (0.82; 1.97); P = 0.28]. No differences between groups were also detected regarding secondary and tertiary outcomes. CONCLUSION: There was no difference between a two-component nutritional strategy and an established dietary intervention on blood pressure in participants with hypertension.

Adequacy of Fatty Acids Consumption Among Individuals in Secondary Cardiovascular Prevention. / Adequação do Consumo de Ácidos Graxos entre Pacientes em Prevenção Cardiovascular Secundária.

BACKGROUND: Adhering to a diet adequate in macronutrients is crucial for the secondary prevention of cardiovascular diseases. OBJECTIVE: To assess the prevalence of adherence to recommendations for the consumption of dietary fatty acids for the prevention and treatment of cardiovascular diseases and to estimate whether the presence of certain cardiovascular risk factors would be associated with adherence. METHODS: Cross-sectional study using baseline data from 2,358 participants included in the "Brazilian Cardioprotective Nutritional Program Trial". Dietary intake and cardiovascular risk factors were assessed. Adequate intake of polyunsaturated fatty acids (PUFA) was considered as ≥10% of total daily energy intake; for monounsaturated fatty acids (MUFA), 20%; and for saturated fatty acids (SFA), <7% according to the Brazilian Society of Cardiology. A significance level of 5% was considered in the statistical analysis. RESULTS: No participant adhered to all recommendations simultaneously, and more than half (1,482 [62.9%]) did not adhere to any recommendation. Adherence exclusively to the SFA recommendation was the most prevalent, fulfilled by 659 (28%) participants, followed by adherence exclusively to the PUFA (178 [7.6%]) and MUFA (5 [0.2%]) recommendations. There was no association between the number of comorbidities and adherence to nutritional recommendations (p = 0.269). Participants from the Brazilian Northeast region showed a higher proportion of adherence to SFA consumption recommendations (38.42%) and lower adherence to PUFA intake (3.52%) (p <0.001) compared to other regions. CONCLUSIONS: Among the evaluated sample, there was low adherence to nutritional recommendations for dietary fatty acid consumption.

FUNDAMENTO: A adesão à uma alimentação adequada em macronutrientes é fundamental para a prevenção secundária de doenças cardiovasculares. OBJETIVO: Avaliar a prevalência de adesão às recomendações de consumo de ácidos graxos para prevenção e tratamento de doenças cardiovasculares, e estimar se a presença de determinados fatores de risco cardiovascular estaria associada à adesão. MÉTODOS: Estudo transversal com os dados de linha de base de 2358 participantes do estudo "Brazilian Cardioprotective Nutritional Program Trial". Dados de consumo alimentar, e fatores de risco cardiovascular foram avaliados. Foi considerada, de acordo com a Sociedade Brasileira de Cardiologia, uma ingestão adequada de ácidos graxos poli-insaturados (AGPI) ≥10% do consumo total de energia diária, para ácidos graxos monoinsaturados (AGM), 20% e para ácidos graxos saturados (AGS), <7%. Na análise estatística foi considerando nível de significância de 5%. RESULTADOS: Nenhum participante aderiu a todas as recomendações de forma simultânea e mais da metade (1482 [62,9%]) não aderiu a nenhuma recomendação. A adesão exclusivamente à recomendação de AGS foi a mais prevalente, sendo cumprida por 659 (28%) dos participantes, seguida da adesão exclusivamente à recomendação de AGP (178 [7,6%]) e de AGM (5 [0,2%]). Não houve associação entre o número de comorbidades e a adesão às recomendações nutricionais (p =0,269). Os participantes da região Nordeste do país apresentaram maior proporção de adesão às recomendações para consumo de AGS (38,42%), e menor para ingestão de AGPI (3,52%) (p <0,001) em comparação às demais. CONCLUSÕES: Na amostra avaliada, evidenciou-se baixa adesão às recomendações nutricionais para consumo de ácidos graxos.

Adequação do consumo de ácidos graxos entre pacientes em prevenção cardiovascular secundária / Adequacy of Fatty Acids Consumption Among Individuals in Secondary Cardiovascular Prevention

FUNDAMENTO: A adesão à uma alimentação adequada em macronutrientes é fundamental para a prevenção secundária de doenças cardiovasculares. OBJETIVO: Avaliar a prevalência de adesão às recomendações de consumo de ácidos graxos para prevenção e tratamento de doenças cardiovasculares, e estimar se a presença de determinados fatores de risco cardiovascular estaria associada à adesão. MÉTODOS: Estudo transversal com os dados de linha de base de 2358 participantes do estudo "Brazilian Cardioprotective Nutritional Program Trial". Dados de consumo alimentar, e fatores de risco cardiovascular foram avaliados. Foi considerada, de acordo com a Sociedade Brasileira de Cardiologia, uma ingestão adequada de ácidos graxos poli-insaturados (AGPI) ≥10% do consumo total de energia diária, para ácidos graxos monoinsaturados (AGM), 20% e para ácidos graxos saturados (AGS), <7%. Na análise estatística foi considerando nível de significância de 5%. RESULTADOS: Nenhum participante aderiu a todas as recomendações de forma simultânea e mais da metade (1482 [62,9%]) não aderiu a nenhuma recomendação. A adesão exclusivamente à recomendação de AGS foi a mais prevalente, sendo cumprida por 659 (28%) dos participantes, seguida da adesão exclusivamente à recomendação de AGP (178 [7,6%]) e de AGM (5 [0,2%]). Não houve associação entre o número de comorbidades e a adesão às recomendações nutricionais (p =0,269). Os participantes da região Nordeste do país apresentaram maior proporção de adesão às recomendações para consumo de AGS (38,42%), e menor para ingestão de AGPI (3,52%) (p <0,001) em comparação às demais. CONCLUSÕES: Na amostra avaliada, evidenciou-se baixa adesão às recomendações nutricionais para consumo de ácidos graxos.

Food intake, plasma copeptin and cardiovascular risk in patients with type 2 diabetes: A cross-sectional analysis.

BACKGROUND AND AIM: Increased consumption of ultra-processed foods has been linked to both mortality and cardiovascular risk. Copeptin levels may serve as potential risk markers for cardiovascular death and events. This cross-sectional analysis seeks to assess the potential correlation between the intake of ultra-processed foods and copeptin levels in outpatients diagnosed with type 2 diabetes, based on estimates of cardiovascular risk. METHODS AND RESULTS: Outpatients underwent clinical and nutritional assessments. Dietary information was gathered using a validated quantitative food frequency questionnaire, and the consumption of all foods, beverages, and food products was assessed according to the NOVA food classification system. Fasting plasma-EDTA samples were collected and preserved at -80 °C. Plasma copeptin measurements were analyzed using an enzyme-linked immunosorbent assay based on the competition principle. Participants were categorized into two groups: high risk and very high risk, based on cardiovascular risk calculated by the HEARTS calculator. A total of 190 participants were included in the evaluation, with an average age of 60 ± 9 years, glycated hemoglobin of 8.4 ± 1.4%, and a diabetes duration of 11 (5-19) years. Patients at a very high cardiovascular risk exhibited higher plasma copeptin levels compared to those at high cardiovascular risk. Notably, 92.1% of patients reported consuming more than 10% of total energy intake from ultra-processed foods, although this proportion did not differ between the two groups. CONCLUSION: This patient sample reported elevated consumption of ultra-processed foods; nevertheless, the correlation between ultra-processed foods and plasma copeptin has not been substantiated.

Mindful eating questionnaire: Validation and reliability in Brazilian adults with type 2 diabetes mellitus.

OBJECTIVE: The objective was to evaluate the psychometric properties of the Mindful Eating Questionnaire (MEQ) in Brazilian subjects with type 2 diabetes mellitus (T2DM) and validate a Brazilian version of the MEQ for adults with T2DM (MEQ-DM). METHODOLOGY: Baseline data from the multicentre Nutritional Strategy for Glycaemic Control in Patients with Type 2 Diabetes Mellitus (NUGLIC) trial were used. Construct validity was assessed using exploratory factor analysis (EFA). The root mean square error of approximation (RMSEA), comparative fit index (CFI) and Tucker‒Lewis index (TLI) fit indices indicated the adequacy of the model. The reliability of the questionnaire was evaluated considering the different factor loadings. Criterion validity was tested by correlating the MEQ-DM with sociodemographic variables, body mass index (BMI) and physical activity levels. RESULTS: A total of 370 participants were included, who were mostly female (60.8 %) and had a median age of 61 (54-67) years. The EFA results supported the two-factor structure of the 25-item MEQ-DM: disinhibition and awareness. The results of the fit indices (RMSEA = 0.04; CFI = 0.95 and TLI = 0.94) and composite reliability (disinhibition = 0.84 and awareness = 0.81) were consistent. The criterion validity analysis indicated a significant association between MEQ-DM scores and age, sex, civil status, education level, BMI and physical activity (p < 0.05). CONCLUSION: When explored with Brazilian adults with T2DM, the MEQ-DM presented a factorial model with two dimensions: disinhibition and awareness. This model must be confirmed in future studies with Brazilians with T2DM.

Could the Wheel of Cardiovascular Health Diet Be a Tool for Diet Quality in Nutritional Counseling? Comparison with Healthy Eating Index-2020.

OBJECTIVE: The Wheel of Cardiovascular Health Diet was recently elaborated based on current nutritional recommendations for healthy eating and was made for person-centered nutritional counseling, thus it may be an interesting tool to improve food awareness. However, its validity is yet to be tested. We hypothesized that the self-perception of patients diagnosed with chronic diseases, evaluated by the Wheel of Cardiovascular Health Diet, is satisfactory in assessing the quality of their diets, compared with the Healthy Eating Index-2020. METHODS: This is a cross-sectional analysis of adults with uncontrolled hypertension or type 2 diabetes. The patients answered the Wheel of Cardiovascular Health Diet, and then, based on the food frequency questionnaire, we analyzed the Healthy Eating Index-2020. RESULTS: A total of 330 patients were included in the study: 91.5% had hypertension, 58.5% had type 2 diabetes, and the median age was 58 (50-65) years. The mean difference observed between the percentage of the graphic area assessed by the patients' self-perception from the Wheel of Cardiovascular Health Diet and Healthy Eating Index-2020 was -10.0% (95%CI -35.3 to 15.3), and a moderate correlation was observed. Linear Regression models showed that a 10-point increase in patients' self-perception in the Wheel of Cardiovascular Health Diet is associated with a 2.9% increase (95%CI 2.08 to 3.70) in the diet quality by the Healthy Eating Index-2020 and is associated with lower BMI values: ß = -0.42 kg/m2 (95%CI -0.83 to -0.01). CONCLUSION: The Wheel of Cardiovascular Health Diet performed satisfactorily regarding validity and reliability by BMI and was associated with higher overall dietary quality, with the Healthy Eating Index-2020 as a relative reference.

The Brazilian Cardioprotective Nutritional (BALANCE) Program improves diet quality in patients with established cardiovascular disease: Results from a multicenter randomized controlled trial.

Dietary modifications are essential strategies for cardiovascular disease prevention. However, studies are needed to investigate the diet quality of individuals undergoing secondary prevention in cardiology and who received dietary intervention based on cardiovascular disease management. We prospectively evaluated the diet quality in the Brazilian Cardioprotective Nutritional Program Trial (BALANCE Program Trial). We hypothesized that the BALANCE Program could improve patients' dietary pattern according to different indices of diet quality such as the Dietary Inflammatory Index (DII); the dietary total antioxidant capacity; overall, healthful, and unhealthful Plant-Based Diet Index (PDI, hPDI, and uPDI, respectively); and modified Alternative Healthy Eating Index (mAHEI). This multicenter randomized, controlled trial included patients aged ≥45 years randomly assigned to either the experimental or control group. Data from 2185 participants at baseline and after 12, 24, 36, and 48 months showed that the intervention group (n = 1077) had lower mean values of DII and higher dietary total antioxidant capacity, PDI, hPDI, and mAHEI than the control group. The results also showed differences between the follow-up times for DII, hPDI, and uPDI (48 months vs baseline) and for PDI and mAHEI (24 months vs baseline), regardless of group. The interaction analysis demonstrated that the intervention group showed better results than the control group at 12, 24, 36, and 48 months for the DII and at months 12, 36, and 48 for the mAHEI. Our results provide prospective evidence that the BALANCE Program improved the diet quality in those in secondary cardiovascular prevention according to different indices, with the intervention group showing better results than the control group.

Linking Adiposity to Interstitial Lung Disease: The Role of the Dysfunctional Adipocyte and Inflammation.

Adipose tissue has functions beyond its principal functions in energy storage, including endocrine and immune functions. When faced with a surplus of energy, the functions of adipose tissue expand by mechanisms that can be both adaptive and detrimental. These detrimental adipose tissue functions can alter normal hormonal signaling and promote local and systemic inflammation with wide-ranging consequences. Although the mechanisms by which adipose tissue triggers metabolic dysfunction and local inflammation have been well described, little is known about the relationship between adiposity and the pathogenesis of chronic lung conditions, such as interstitial lung disease (ILD). In this review, we detail the conditions and mechanisms by which adipose tissue becomes dysfunctional and relate this dysfunction to inflammatory changes observed in various forms of ILD. Finally, we review the existing basic and clinical science literature linking adiposity to ILD, highlighting the need for additional research on the mechanisms of adipocyte-mediated inflammation in ILD and its clinical implications.

Factors associated with diet quality among Brazilian individuals with cardiovascular diseases.

BACKGROUND: An individual's dietary pattern contributes in different ways to the prevention and control of recurrent cardiovascular events. However, the quality of the diet is influenced by several factors. The present study aimed to evaluate the quality of the diet of individuals with cardiovascular diseases and determine whether there is an association between sociodemographic and lifestyle factors. METHODS: This is a cross-sectional study carried out with individuals with atherosclerosis (coronary artery disease, cerebrovascular disease or peripheral arterial disease) recruited from 35 reference centres for the treatment of cardiovascular disease in Brazil. Diet quality was assessed according to the Modified Alternative Healthy Eating Index (mAHEI) and stratified into tertiles. For comparing two groups, the Mann-Whitney or Pearson's chi-squared tests were used. However, for comparing three or more groups, analysis of variance or Kruskal-Wallis was used. For the confounding analysis, a multinomial regression model was used. p < 0.05 was considered statistically significant. RESULTS: In total, 2360 individuals were evaluated: 58.5% male and 64.2% elderly. The median (interquartile range [IQR]) of the mAHEI was 24.0 (20.0-30.0), ranging from 0.4 to 56.0 points. When comparing the odds ratios (ORs) for the low (first tertile) and medium (second tertile) diet quality groups with the high-quality group (third tertile), it was observed that there was an association between diet quality with a family income of 1.885 (95% confidence intervals [CI] = 1.302-2.729) and 1.566 (95% CI = 1.097-2.235), as well as physical activity of 1.391 (95% CI = 1.107-1.749) and 1.346 (95% CI = 1.086-1.667), respectively. In addition, associations were observed between diet quality and region of residence. CONCLUSIONS: A low-quality diet was associated with family income, sedentarism and geographical area. These data are extremely relevant to assist in coping with cardiovascular disease because they enable an assessment of the distribution of these factors in different regions of the country.

Pre-exercise meal on oxidation of energy substrates during maximal exercise test in non-trained individuals.

Objective: This study aimed to compare the influence of a high carbohydrate meal versus high-fat meal on the oxidation of substrates during an exercise incremental test. Materials and methods: Ten untrained male subjects underwent two days of the protocol. Randomly, they received a high carbohydrate meal or a high-fat meal, receiving the other one in the next protocol. On both days, they performed an incremental treadmill test, with heart rate and maximal oxygen consumption to estimate the oxidation of substrates. Results: The high-fat meal showed an increase in the absolute amount of oxidized fat along with the incremental test (P < 0.05; effect size = 0.9528), and a reduction in the respiratory exchange ratio at low intensities (P < 0.05; effect size = 0.7765). Conclusion: The meals presented no difference when compared to maximum oxidation point of substrates, the oxidation rate of substrates over time, and heart rate. A pre-test high-fat meal in untrained individuals was shown to be a modulating factor of total oxidized fats throughout the exercise, although it did not exert a significant effect on the rate of this oxidation over time.

Antivirals for adult patients hospitalised with SARS-CoV-2 infection: a randomised, phase II/III, multicentre, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn trial.

Background: Repurposed drugs for treatment of new onset disease may be an effective therapeutic shortcut. We aimed to evaluate the efficacy of repurposed antivirals compared to placebo in lowering SARS-CoV2 viral load of COVID-19 patients. Methods: REVOLUTIOn is a randomised, parallel, blinded, multistage, superiority and placebo controlled randomised trial conducted in 35 centres in Brazil. We include patients aged 18 years or older admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, symptoms onset 9 days or less and SpO2 94% or lower at room air were eligible. All participants were randomly allocated to receive either atazanavir, daclatasvir or sofosbuvir/daclatasvir or placebo for 10 days. The primary outcome was the decay rate (slope) of the SARS-CoV-2 viral load logarithm assessed in the modified intention to-treat population. This trial was registered with ClinicalTrials.gov, number NCT04468087. Findings: Between February 09, 2021, and August 04, 2021, 255 participants were enrolled and randomly assigned to atazanavir (n = 64), daclatasvir (n = 66), sofosbuvir/daclatasvir (n = 67) or placebo (n = 58). Compared to placebo group, the change from baseline to day 10 in log viral load was not significantly different for any of the treatment groups (0.05 [95% CI, -0.03 to 0.12], -0.02 [95% CI, -0.09 to 0.06], and -0.03 [95% CI, -0.11 to 0.04] for atazanavir, daclatasvir and sofosbuvir/daclatasvir groups respectively). There was no significant difference in the occurrence of serious adverse events between treatment groups. Interpretation: No significant reduction in viral load was observed from the use of atazanavir, daclatasvir or sofosbuvir/daclatasvir compared to placebo in hospitalised COVID-19 patients who need oxygen support with symptoms onset 9 days or less. Funding: Ministério da Ciência, Tecnologia e Inovação (MCTI) - Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPQ); Cia Latino-Americana de Medicamentos (Clamed); Cia Industrial H. Carlos Schneider (Ciser); Hospital Research Foundation Incorporation, Australia, HCor São Paulo; Blanver Farmoquímica; Instituto de Tecnologia em Fármacos (Farmanguinhos) da Fundação Oswaldo Cruz (Fiocruz); Coordenação Geral de Planejamento Estratégico (Cogeplan)/Fiocruz; and Fundação de apoio a Fiocruz (Fiotec, VPGDI-054-FIO-20-2-13).

Consumption of unprocessed or minimally processed foods and their association with cardiovascular events and cardiometabolic risk factors in Brazilians with established cardiovascular events.

Consumption of food in its natural form has an inverse relationship with cardiometabolic risk factors; however, the relationship between consumption of unprocessed or minimally processed foods and the presence of cardiovascular diseases (CVD) remains unclear in individuals receiving secondary care for CVD. Thus, we aimed to evaluate the association between the consumption of unprocessed or minimally processed foods and the presence of CVD and cardiometabolic risk factors in individuals with established CVD. Baseline data from 2357 participants in a Brazilian multicentre study showed that the consumption of unprocessed or minimally processed foods corresponded to most of the daily caloric intake (69.3%). Furthermore, regression analyses showed that higher consumption of unprocessed or minimally processed foods (>78.0% of caloric intake) was associated with a lower prevalence of elevated waist circumference (WC1; PR: 0.889; CI: 0.822-0.961; WC2; PR: 0.914; CI: 0.873-0.957) and overweight (PR: 0.930; CI: 0.870-0.994), but also was associated with simultaneous occurrence of coronary and peripheral artery disease and stroke (OR: 2.802; CI: 1.241-6.325) when compared with a lower intake (<62.8% of caloric intake). These findings reinforce the importance of nutritional guidance that considers the profile of the target population and the composition and quality of the meals consumed.

Pre-exercise meal on oxidation of energy substrates during maximal exercise test in non-trained individuals

ABSTRACT Objective: This study aimed to compare the influence of a high carbohydrate meal versus high-fat meal on the oxidation of substrates during an exercise incremental test. Materials and methods: Ten untrained male subjects underwent two days of the protocol. Randomly, they received a high carbohydrate meal or a high-fat meal, receiving the other one in the next protocol. On both days, they performed an incremental treadmill test, with heart rate and maximal oxygen consumption to estimate the oxidation of substrates. Results: The high-fat meal showed an increase in the absolute amount of oxidized fat along with the incremental test (P < 0.05; effect size = 0.9528), and a reduction in the respiratory exchange ratio at low intensities (P < 0.05; effect size = 0.7765). Conclusions: The meals presented no difference when compared to maximum oxidation point of substrates, the oxidation rate of substrates over time, and heart rate. A pre-test high-fat meal in untrained individuals was shown to be a modulating factor of total oxidized fats throughout the exercise, although it did not exert a significant effect on the rate of this oxidation over time.

Automated documentation of vital parameters in wards using portable stations - Effect on proper triggering of the rapid response team: a study protocol of a cluster randomized clinical trial. / Documentação automatizada de parâmetros vitais em enfermarias utilizando estações portáteis - Efeito no acionamento adequado do time de resposta rápida: um protocolo de um ensaio clínico randomizado em clusters.

OBJECTIVE: To evaluate the effectiveness of the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ solution in activating the rapid response team in a timely manner compared to manual activation. METHODS: The Hillrom study is a single-center, open-label, superiority, cluster-randomized, parallel-group (1:1 allocation ratio) clinical trial that will be conducted in a tertiary hospital. Two sets of three wards with 28 beds will be included (one as the intervention cluster and the other as the control). The wards will be randomly assigned to use the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution (intervention cluster) or to maintain the usual routine (control cluster) regarding rapid response team activation. The primary outcome will be the absolute number of episodes of rapid response team triggering in an appropriate time; as secondary outcomes, clinical features (mortality, cardiac arrest, need for intensive care unit admission and duration of hospitalization) will be assessed according to clusters in an exploratory way. A sample size of 216 rapid response team activations was estimated to identify a possible difference between the groups. The protocol has been approved by the institutional Research Ethics Committee. EXPECTED RESULTS: The Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution is expected to be more effective in triggering the nurse call system to activate the rapid response team in a timely and adequate manner compared to manual triggering (usual practice). CLINICALTRIALS.GOV: NCT04648579.

OBJETIVO: Avaliar a eficácia da solução Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ em acionar o time de resposta rápida em tempo hábil, em comparação com o acionamento manual. MÉTODOS: O estudo Hillrom é um ensaio clínico unicêntrico, aberto, de superioridade, randomizado em clusters em paralelo (taxa de alocação 1:1) realizado em um hospital terciário. Serão incluídos dois grupos de três enfermarias com 28 leitos (um grupo intervenção e um grupo controle). As enfermarias serão distribuídas aleatoriamente para utilizar a solução automatizada Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ (grupo intervenção) ou para manter a rotina habitual (grupo controle) em relação ao acionamento do time de resposta rápida. O desfecho primário será o número absoluto de ocorrências de acionamento do time de resposta rápida em tempo hábil. Como desfechos secundários, características clínicas como mortalidade, parada cardíaca, necessidade de internação em unidade de terapia intensiva e duração da hospitalização serão avaliadas de forma exploratória de acordo com os grupos. Estimou-se uma amostra de 216 acionamentos de time de resposta rápida, para identificar uma possível diferença entre os grupos. O protocolo foi aprovado pelo Comitê de Ética em Pesquisa institucional. RESULTADOS ESPERADOS: Espera-se que a solução automatizada Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ seja mais eficaz no acionamento do sistema de chamada de enfermeiros, para acionar o time de resposta rápida em tempo hábil e de maneira adequada, em comparação com o acionamento manual (prática habitual). CLINICALTRIALS.GOV: NCT04648579.

Documentação automatizada de parâmetros vitais em enfermarias utilizando estações portáteis - Efeito no acionamento adequado do time de resposta rápida: um protocolo de um ensaio clínico randomizado em clusters / Automated documentation of vital parameters in wards using portable stations - Effect on proper triggering of the rapid response team: a study protocol of a cluster randomized clinical trial

RESUMO Objetivo: Avaliar a eficácia da solução Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ em acionar o time de resposta rápida em tempo hábil, em comparação com o acionamento manual. Métodos: O estudo Hillrom é um ensaio clínico unicêntrico, aberto, de superioridade, randomizado em clusters em paralelo (taxa de alocação 1:1) realizado em um hospital terciário. Serão incluídos dois grupos de três enfermarias com 28 leitos (um grupo intervenção e um grupo controle). As enfermarias serão distribuídas aleatoriamente para utilizar a solução automatizada Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ (grupo intervenção) ou para manter a rotina habitual (grupo controle) em relação ao acionamento do time de resposta rápida. O desfecho primário será o número absoluto de ocorrências de acionamento do time de resposta rápida em tempo hábil. Como desfechos secundários, características clínicas como mortalidade, parada cardíaca, necessidade de internação em unidade de terapia intensiva e duração da hospitalização serão avaliadas de forma exploratória de acordo com os grupos. Estimou-se uma amostra de 216 acionamentos de time de resposta rápida, para identificar uma possível diferença entre os grupos. O protocolo foi aprovado pelo Comitê de Ética em Pesquisa institucional. Resultados esperados: Espera-se que a solução automatizada Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ seja mais eficaz no acionamento do sistema de chamada de enfermeiros, para acionar o time de resposta rápida em tempo hábil e de maneira adequada, em comparação com o acionamento manual (prática habitual). ClinicalTrials.gov: NCT04648579

ABSTRACT Objective: To evaluate the effectiveness of the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ solution in activating the rapid response team in a timely manner compared to manual activation. Methods: The Hillrom study is a single-center, open-label, superiority, cluster-randomized, parallel-group (1:1 allocation ratio) clinical trial that will be conducted in a tertiary hospital. Two sets of three wards with 28 beds will be included (one as the intervention cluster and the other as the control). The wards will be randomly assigned to use the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution (intervention cluster) or to maintain the usual routine (control cluster) regarding rapid response team activation. The primary outcome will be the absolute number of episodes of rapid response team triggering in an appropriate time; as secondary outcomes, clinical features (mortality, cardiac arrest, need for intensive care unit admission and duration of hospitalization) will be assessed according to clusters in an exploratory way. A sample size of 216 rapid response team activations was estimated to identify a possible difference between the groups. The protocol has been approved by the institutional Research Ethics Committee. Expected results: The Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution is expected to be more effective in triggering the nurse call system to activate the rapid response team in a timely and adequate manner compared to manual triggering (usual practice). ClinicalTrials.gov: NCT04648579

Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocol and statistical analysis plan. / Antivirais para pacientes adultos hospitalizados com infecção por SARS-CoV-2: Um estudo de Fase II/III, randomizado, multicêntrico, controlado por placebo, adaptativo, com múltiplos braços e estágios. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocolo e plano de análise estatística.

Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial. ClinicalTrials.gov identifier: NCT04468087.

Os medicamentos reaproveitados são importantes em contextos de recursos limitados porque as intervenções estão mais rapidamente disponíveis, já foram testadas com segurança em outras populações e são, em geral, mais baratas. Os medicamentos reaproveitados são uma solução eficaz, especialmente para doenças emergentes, como a COVID-19. O estudo REVOLUTIOn visa avaliar três medicamentos antivirais reaproveitados: atazanavir, daclatasvir e sofosbuvir, já utilizados em pacientes infectados pelo HIV ou pelo vírus da hepatite C, em um estudo randomizado, controlado por placebo, adaptativo, multibraço e em múltiplos estágios. Os medicamentos serão testados simultaneamente em um ensaio de Fase II para primeiro identificar se algum deles, isoladamente ou em combinação, reduz a carga viral. Se reduzirem, será iniciado um estudo de Fase III para investigar se tais medicamentos são capazes de aumentar o número de dias sem suporte respiratório. Os participantes devem ser adultos hospitalizados com idade ≥ 18 anos com início dos sintomas ≤ 9 dias e saturação de oxigênio ≤ 94% em ar ambiente ou necessidade de oxigênio suplementar para manter saturação de oxigênio > 94%. O tamanho total esperado da amostra varia entre 252 e 1.005 participantes, dependendo do número de estágios que serão concluídos no estudo. Assim, o protocolo é aqui descrito em detalhes, juntamente do plano de análise estatística. Em conclusão, o estudo REVOLUTIOn foi concebido para fornecer evidências se o atazanavir, o daclatasvir ou o sofosbuvir reduzem a carga viral de SARS-CoV-2 em pacientes com COVID-19 e aumentam o número de dias em que os pacientes ficam sem suporte respiratório. Neste artigo de protocolo, descrevem-se a fundamentação, o desenho e a situação do ensaio. Identificador do ClinicalTrials.gov: NCT04468087.

Absolute and Relative Agreement between the Current and Modified Brazilian Cardioprotective Nutritional Program Dietary Index (BALANCE DI) and the American Heart Association Healthy Diet Score (AHA-DS) in Post Myocardial Infarction Patients.

The American Heart Association Diet Score (AHA-DS) defines the cardiovascular health, and the Brazilian Cardioprotective Nutritional Program Dietary Index (BALANCE DI) was designed to evaluate diet quality in secondary cardiovascular prevention settings. Our aim was to assess the absolute and relative agreement between both tools in Brazilian adults after a myocardial infarction (MI). In this cross-sectional study, 473 individuals were included and had their diet assessed by a 24 h food recall and a semi-quantitative Food Frequency Questionnaire. The weighted Kappa between BALANCE DI and primary AHA-DS was 0.66 (95% CI: 0.08-0.21), and between BALANCE DI and total AHA-DS was 0.70 (95% CI: 0.20-0.32). To improve the agreement between the tools, modifications were made to the BALANCE DI scoring system. The weighted Kappa between New BALANCE DI and primary AHA-DS was 0.77 (95% CI: 0.36-0.48), and between BALANCE DI and total AHA-DS was 0.76 (95% CI: 0.34-0.46). The mean bias observed between the New BALANCE DI as compared to the primary and total AHA-DS was -16% (-51 to 19) and -8% (-41 to 24), respectively. Our results suggest that the New BALANCE DI may be a useful tool to evaluate diet quality in post MI patients.

The AHA Recommendations for a Healthy Diet and Ultra-Processed Foods: Building a New Diet Quality Index.

The American Heart Association (AHA) has developed the concept of "ideal cardiovascular health" (ICH), a seven-component score, which includes health dietary metrics. Higher ultra-processed foods intake is related with several cardiometabolic and cardiovascular diseases. We propose to develop and validate the Cardiovascular Health Diet Index (CHDI), a diet quality index that combines the AHA's recommendations of a healthy diet for cardiovascular health and ultra-processed foods. We used dietary data obtained through a 114-item FFQ from 14,779 participants of the Brazilian Longitudinal Study of Adults Health (ELSA-Brasil). The CHDI had 11 components and a total score ranging from 0 to 110 points. Validation and reliability analyses were performed, including principal component analyses, association with selected nutrients, means differences between groups (for example, smokers vs. non-smokers), Cronbach's alpha, and linear regression analyses between CHDI and overall dietary quality. The mean CHDI was 57.1 points (95% CI 47.9:66.0). The CHDI had four dimensions; in addition, it was associated with nutrients related to cardiovascular health, and the points were significantly (p < 0.001) lower in smokers (52.1) than in non-smokers (57.8). Cronbach's alpha value was 0.50. After age and sex adjustment, the CHDI score remained associated with a higher overall dietary quality (ß 0.87, 95%CI 0.84:0.89, p < 0.001). The CHDI proved to be valid and reliable for use, in addition to being associated with higher overall dietary quality. The use of CHDI is expected to assess the population's compliance with dietary recommendations for promoting cardiovascular health and preventing cardiovascular disease.

Antivirais para pacientes adultos hospitalizados com infecção por SARS-CoV-2: Um estudo de Fase II/III, randomizado, multicêntrico, controlado por placebo, adaptativo, com múltiplos braços e estágios. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocolo e plano de análise estatística / Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocol and statistical analysis plan

RESUMO Os medicamentos reaproveitados são importantes em contextos de recursos limitados porque as intervenções estão mais rapidamente disponíveis, já foram testadas com segurança em outras populações e são, em geral, mais baratas. Os medicamentos reaproveitados são uma solução eficaz, especialmente para doenças emergentes, como a COVID-19. O estudo REVOLUTIOn visa avaliar três medicamentos antivirais reaproveitados: atazanavir, daclatasvir e sofosbuvir, já utilizados em pacientes infectados pelo HIV ou pelo vírus da hepatite C, em um estudo randomizado, controlado por placebo, adaptativo, multibraço e em múltiplos estágios. Os medicamentos serão testados simultaneamente em um ensaio de Fase II para primeiro identificar se algum deles, isoladamente ou em combinação, reduz a carga viral. Se reduzirem, será iniciado um estudo de Fase III para investigar se tais medicamentos são capazes de aumentar o número de dias sem suporte respiratório. Os participantes devem ser adultos hospitalizados com idade ≥ 18 anos com início dos sintomas ≤ 9 dias e saturação de oxigênio ≤ 94% em ar ambiente ou necessidade de oxigênio suplementar para manter saturação de oxigênio > 94%. O tamanho total esperado da amostra varia entre 252 e 1.005 participantes, dependendo do número de estágios que serão concluídos no estudo. Assim, o protocolo é aqui descrito em detalhes, juntamente do plano de análise estatística. Em conclusão, o estudo REVOLUTIOn foi concebido para fornecer evidências se o atazanavir, o daclatasvir ou o sofosbuvir reduzem a carga viral de SARS-CoV-2 em pacientes com COVID-19 e aumentam o número de dias em que os pacientes ficam sem suporte respiratório. Neste artigo de protocolo, descrevem-se a fundamentação, o desenho e a situação do ensaio. Identificador do ClinicalTrials.gov:NCT04468087

ABSTRACT Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial. ClinicalTrials.gov identifier:NCT04468087