Publications by authors named "Rafael Marques Soares"

12 Publications

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Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial.

JAMA Cardiol 2019 05;4(5):408-417

HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.

Importance: Studies have found that patients at high cardiovascular risk often fail to receive evidence-based therapies in community practice.

Objective: To evaluate whether a multifaceted quality improvement intervention can improve the prescription of evidence-based therapies.

Design, Setting, And Participants: In this 2-arm cluster randomized clinical trial, patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied. Patients were recruited from August 2016 to August 2017, with follow-up to August 2018. Data were analyzed in September 2018.

Interventions: Case management, audit and feedback reports, and distribution of educational materials (to health care professionals and patients) vs routine practice.

Main Outcomes And Measures: The primary end point was prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) using the all-or-none approach at 12 months after the intervention period in patients without contraindications.

Results: Of the 1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary care units, and 26 (65%) were teaching institutions. Among eligible patients, those in intervention clusters were more likely to receive a prescription of evidence-based therapies than those in control clusters (73.5% [515 of 701] vs 58.7% [493 of 840]; odds ratio, 2.30; 95% CI, 1.14-4.65). There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes). Rates of education for smoking cessation were higher among current smokers in the intervention group than in the control group (51.9% [364 of 701] vs 18.2% [153 of 840]; odds ratio, 11.24; 95% CI, 2.20-57.43). The rate of cardiovascular mortality, acute myocardial infarction, and stroke was 2.6% for patients from intervention clusters and 3.4% for those in the control group (hazard ratio, 0.76; 95% CI, 0.43-1.34).

Conclusions And Relevance: Among Brazilian patients at high cardiovascular risk, a quality improvement intervention resulted in improved prescription of evidence-based therapies.

Trial Registration: identifier: NCT02851732.
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May 2019

Rationale and design for a cluster randomized quality-improvement trial to increase the uptake of evidence-based therapies for patients at high cardiovascular risk: The BRIDGE-Cardiovascular Prevention trial.

Am Heart J 2019 01 17;207:40-48. Epub 2018 Oct 17.

Research Institute HCor - Hospital do Coração, São Paulo, SP, Brazil.

Background: Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes.

Objectives: The main objectives are to evaluate the impact of a multifaceted educational intervention on adherence to local guidelines for the prescription of statins, antiplatelets and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers for high cardiovascular risk patients, as well as on the incidence of major cardiovascular events.

Design: We designed a pragmatic two arm cluster randomized trial involving 40 clusters. Clusters are randomized to receive a multifaceted quality improvement intervention or to routine practice (control). The multifaceted intervention includes: reminders, care algorithms, training of a case manager, audit and feedback reports, and distribution of educational materials to health care providers. The primary endpoint is the adherence to combined evidence-based therapies (statins, antiplatelet therapy and angiotensin converting enzyme inhibitors or angiotensin receptor blockers) at 12 months after the intervention period in patients without contra-indications for these medications. All analyses follow the intention-to-treat principle and take the cluster design into account using linear mixed logistic regression modeling.

Summary: If proven effective, this multifaceted intervention would have wide utility as a means of promoting optimal usage of evidence-based interventions for the management of high cardiovascular risk patients.
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January 2019

The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

Am Heart J 2016 Jan 15;171(1):73-81.e1-2. Epub 2015 Aug 15.

Research Institute, Hospital do Coração (IP-HCor), São Paulo, SP, Brazil.

This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease.
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January 2016

Nutritional, metabolic and cardiovascular correlations of morning cortisol in health care workers in a gastroenterology service.

Arq Gastroenterol 2015 Apr-Jun;52(2):88-93

Hospital das Clínicas, São Paulo, SP, Brasil.

Background: Workplace stress has been associated with obesity. Diminished body weight has also been anticipated in some contexts.

Objective: In a cohort of healthcare personnel, morning cortisol was compared to nutritional and metabolic variables, aiming to identify the correlates of such marker.

Methods: Population n=185, 33.8 ± 9.8 years, 88.1% females, body mass index (BMI) 25.6 ± 4.4 kg/m2, included nurses and other nosocomial professionals, the majority with high social-economic status (75.2%). Participants were stratified according to BMI, fasting blood glucose (FBG) and metabolic syndrome (MS). Fasting plasma cortisol and the Framingham Coronary Risk Score was calculated.

Results: Mean cortisol was acceptable (19.4 ± 7.9 µg/dL) although with elevation in 21.6%. No correlation with FBG or MS occurred, and nonobese persons (BMI <25) exhibited the highest values (P=0.049). Comparison of the lowest and highest cortisol quartiles confirmed reduced BMI and waist circumference in the former, with unchanged Framingham Coronary Risk Score.

Conclusion: Cortisol correlated with reduced BMI. Despite low BMI and waist circumference, Framingham Coronary Risk Score was not benefitted, suggesting that exposure to cardiovascular risk continues, besides psychological strain. Initiatives to enhance organizational and staff health are advisable in the hospital environment.
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January 2016

Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the registry.

Am Heart J 2014 Aug 2;168(2):213-9.e1. Epub 2014 May 2.

Research Institute, HCOR-Hospital do Coração, Sao Paulo, Brazil. Electronic address:

Background: Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination.

Methods: We reviewed all cardiovascular clinical trials (7,042 studies) registered in from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment.

Results: Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source-funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates.

Conclusions: Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.
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August 2014

Healthy eating index for pregnancy: adaptation for use in pregnant women in Brazil.

Rev Saude Publica 2013 Feb;47(1):20-8

Programa de Pós-Graduação em Epidemiologia, Departamento de Medicina Social, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.

Objective: To evaluate dietary quality in a sample of pregnant women based on one simple and objective parameter.

Methods: Pregnant women (n = 712), between 16 and 36 weeks, attending primary care clinics in Porto Alegre and Bento Gonçalves, Southern Brazil, in 2010 were recruited to take part. The Healthy Eating Index for Brazilian Pregnancy (HEIP-B) was created, derived from the American instrument called Alternate Healthy Eating Index for Pregnancy (AHEI-P). Questionnaires on frequency of consumption and on socio-demographic factors were completed. Focused principal component analysis (ACPF) was used to assess the relationship between the index and nutrients relevant to pregnancy.

Results: The median (interquartile range) of AHEI-P and HEIP-B were 66.6 (57.8-72.4) and 67.4 (60.0-73.4), respectively. The HEIP-B showed a good positive correlation with nutrients which are specifically recommended for pregnancy: folate (r = 0.8; p < 0.001), calcium (r = 0.6; p < 0.001) and iron (r = 0.7; p < 0.001).

Conclusions: The quality of the diet of the pregnant women in this study was classified as within the "improvements needed" cut off point, which demonstrates the need for more specific education on nutrition for this stage of life. The index showed good correlations and, thus, may be considered an effective tool for assessing the quality of nutrition during pregnancy.
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February 2013

Dietary patterns during pregnancy and the association with sociodemographic characteristics among women attending general practices in southern Brazil: the ECCAGe Study.

Cad Saude Publica 2013 May;29(5):970-80

Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil.

The assessment of the relationship between food intake and sociodemographic factors is crucial for developing effective public health policies. The present study aimed to examine dietary patterns in pregnant women and the association between these patterns and sociodemographic characteristics. Pregnant women attending general practices in southern Brazil (n = 712) answered a questionnaire and a food-frequency questionnaire with 88 items. Three dietary patterns were identified using cluster analysis. The association between the dietary patterns and sociodemographic variables was analyzed using the chi-square test and adjusted standardized residuals (p < 0,05). The restricted pattern was associated with lower maternal age, not living with a partner and being a non-working student. The varied pattern was associated with older maternal age, living with a partner, being employed and higher levels of education and income. The common-Brazilian dietary pattern included traditional Brazilian food items and was associated with lower levels of education and income, being unemployed and being a non-student.
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May 2013

Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial.

Clinics (Sao Paulo) 2012 Dec;67(12):1407-14

Hospital do Coração (IEP-HCor), Research Institute, São Paulo/SP, Brazil.

Objective: To evaluate the effectiveness of the Brazilian Cardioprotective Diet Program in reducing blood pressures, fasting glucose levels and body mass indices in patients with established atherothrombotic disease.

Method: This randomized controlled pilot trial included outpatients who were over 45 years of age with atherothrombotic cardiovascular disease. Group A, who received the Brazilian Cardioprotective Diet Program, had weekly sessions with dietitians. Groups B and C received the usual dietary therapy that is given to patients with cardiovascular diseases as proposed by the Brazilian guidelines. This diet had the same nutrient profile as that given to Group A, but it was customized by the integration of typical Mediterranean foods. The difference between Groups B and C was the number of sessions with the dietitian. Group B received weekly sessions, while group C only had monthly sessions. NCT 01453166.

Results: There was a greater reduction in systolic (7.8%) and diastolic (10.8%) blood pressures in Group A compared with Group B (2.3% and 7.3%), and Group C (3.9% and 4.9%, respectively). Fasting glucose decreased by 5.3% and 2% in Groups A and B, respectively. Fasting glucose increased by 3.7% in Group C. The BMIs decreased by 3.5% and 3.3% in Groups A and B, respectively. Group C did not present with any changes in BMI. However, none of these data showed statistical differences between the groups, which is methodologically acceptable in pilot trials.

Conclusions: The Brazilian Cardioprotective Diet Program seems to be more effective in reducing blood pressures, fasting glucose levels, weights and BMIs in patients with previous cardiovascular disease compared with the diet that has been proposed by the Brazilian guidelines.
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December 2012

Socioeconomic, demographic and nutritional factors associated with maternal weight gain in general practices in Southern Brazil.

Cad Saude Publica 2010 May;26(5):1024-34

Programa de Pós-graduação em Epidemiologia, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2600, Porto Alegre, Brazil.

In order to describe adequacy of weight gain during pregnancy and its association with pre-pregnancy nutritional status and other factors, a cohort study of pregnant women enrolled at 16-36 weeks of gestation and followed up until delivery was carried out in prenatal care in primary care services in Rio Grande do Sul State, Brazil. Maternal weight was recorded at each prenatal care visit. Weight gain was classified as "adequate," "insufficient" or "excessive" (Institute of Medicine). Poisson regression was used to measure the associations. The sample was comprised of 667 women, and insufficient and excessive weight gain incidences were 25.8% and 44.8%, respectively. Overweight and obese before pregnancy had a significant increased risk of excessive weight gain in pregnancy (RR: 1.75; 95%CI: 1.48-2.07, RR: 1.55; 95%CI: 1.23-1.96, respectively). Women with fewer than six prenatal visits had a 52% increased risk for weight gain below recommended values. Although insufficient weight gain may still be a public health problem, excessive gain is becoming a concern that needs immediate attention in prenatal care.
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May 2010

Violence and depressive symptoms during pregnancy: a primary care study in Brazil.

Soc Psychiatry Psychiatr Epidemiol 2010 Oct 25;45(10):983-8. Epub 2009 Oct 25.

Departamento de Medicina Social, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

Aim: To estimate the prevalence of violence, depressive symptoms, and associated factors during pregnancy in women attending antenatal care in Brazil.

Methods: Violence was assessed using a modified version of the abuse assessment screen (ASS), and depressive symptoms were evaluated using the primary care evaluation of mental disorders (PRIME-MD). Participants were pregnant women attending 18 primary care units in Rio Grande do Sul, Brazil, between June 2006 and April 2007. A total of 712 pregnant women participated, but only 627 of them responded the ASS.

Results: Experience of any lifetime violence was reported by 273 (43.4%) women and 114 (18.2%) reported violence during the current pregnancy. One-third of them (n = 211) reported lifetime domestic violence and 100 (15.9%) women reported this type of violence during the current pregnancy. Experience of domestic violence during pregnancy was more common in unemployed women, among those with two or more children, with a higher consumption of alcohol, and who had not planned their current pregnancy. Of the total of sample (n = 712), 198 (27.8%) women reported six or more depressive symptoms. The presence of depressive symptoms during pregnancy was associated with low educational levels, living in a household with five or more people, and with higher consumption of alcohol during pregnancy.

Conclusion: Pregnant women attending primary care are exposed to high rates of domestic violence, and many have clinically relevant depressive symptoms. Appropriate interventions to avoid or minimize the effects of violence and mental disorders to the well-being of the mothers and their babies are urgently required. Primary care services play an important role in identifying and supporting women at risk.
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October 2010

Inappropriate eating behaviors during pregnancy: prevalence and associated factors among pregnant women attending primary care in southern Brazil.

Int J Eat Disord 2009 Jul;42(5):387-93

Post Graduate Program in Epidemiology, Federal University of Rio Grande do Sul (UFRGS), Brazil.

Objective: To examine the prevalence of inappropriate eating behaviors and associated factors among pregnant women in primary care.

Method: The Eating Disorder Examination Questionnaire was used to assess eating disorders and the Primary Care Evaluation of Mental Disorders was used to examine anxiety and depressive symptoms. Body mass index (BMI) and pregestational weight were also assessed.

Results: Prevalence of binge eating during pregnancy was 17.3% [95% confidence interval (CI) 14.5-20.0], followed by excessive shape (5.6%; 95% CI 4-8) and weight concerns (5.5%; 95% CI 4-8). Binge eating during pregnancy was significantly associated with binge eating before pregnancy [prevalence ratio (PR) = 3.1; 95% CI 2.2-4.3], current anxiety symptoms (PR = 1.8; 95% CI 1.3-2.4), and prepregnancy BMI < 19.8 kg/m(2) (PR = 1.6; 95% CI 1.1-2.5). The prevalence of eating disorders was 0.6% (95% CI 0.01-1.11).

Discussion: Eating disorder symptoms should be routinely assessed and treated during prenatal care, along with other comorbid psychiatric symptoms such as anxiety.
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July 2009

Dietary fibre intake of pregnant women attending general practices in southern Brazil--the ECCAGE Study.

Public Health Nutr 2009 Sep 9;12(9):1392-8. Epub 2008 Dec 9.

Federal University of Rio Grande do Sul, Graduate Studies Program in Epidemiology, UFRGS/Departamento de Medicina Social/PPG-Epidemiologia, Rua Ramiro Barcelos, Porto Alegre, Brazil.

Background: Increase in fibre intake during pregnancy may reduce weight gain, glucose intolerance, dyslipidaemia, pre-eclampsia and constipation. Few studies have evaluated adequacy of fibre intake during pregnancy.

Objective: To assess, through an FFQ, the dietary fibre intake of pregnant women receiving prenatal care from general public practices and compare it with current guidelines.

Design And Setting: Cross-sectional analyses of a pregnancy cohort study (ECCAGE-Study of Food Intake and Eating Behaviour in Pregnancy) conducted in eighteen general practices in southern Brazil, from June 2006 to April 2007.

Subjects: Five hundred and seventy-eight pregnant women with mean (SD) age of 24.9 (6.5) years and mean gestational age of 24.5 (5.8) weeks.

Results: The mean energy intake was 11 615 kJ/d (2776 kcal/d). The mean total fibre intake (30.2 g/d) was slightly above the recommended value of 28 g/d (P < 0.001), yet 50% (95% CI 46, 54) of the women failed to meet the recommendation. Whole-grain fibre constituted only 1% of total fibre intake in the cereal group. In adjusted Poisson regression analyses, not meeting the recommendation for fibre intake was associated with alcohol intake (prevalence ratio 1.29; 95% CI 1.11, 1.50) and absence of nutritional guidance (prevalence ratio 1.22; 95% CI 1.05, 1.42) during pregnancy.

Conclusions: About half of the pregnant women failed to meet the recommended fibre intake, especially those not reporting nutritional guidance during pregnancy. For most women, whole-grain cereal intake was absent or trivial. Taken together, our data indicate the need, at least in this setting, for greater nutritional education in prenatal care.
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September 2009