Clinical profile of early- and late-onset colorectal cancer patients in a referral medical center in Medellín, Colombia: A comparative analysis / Perfil clínico de pacientes con cáncer colorrectal de aparición temprana y tardía en un centro médico de referencia en Medellín, Colombia: Un análisis comparativo

Introduction. Incidence of early-onset colorectal cancer (EOCRC), defined as colorectal cancer (CRC) in individuals aged < 50 years, is rising worldwide. Despite the increasing international scientific production on EOCRC, research is limited in Colombia. The objective of this study was to characterize the clinical features of adults with EOCRC and late-onset CRC (LOCRC, CRC in individuals aged ≥ 50 years). Methods. An observational, retrospective, cross-sectional study was conducted with CRC patients ≥ 18 years old at one medical center in Medellín, Colombia. Clinical and pathological data were retrieved from the Institutional Cancer Registry. Two analysis groups were established: EOCRC and LOCRC. The Chi-Square test was applied to compare the variables of interest between both groups. Results. The sample included 1,202 patients, 53.5% were female (N=643) and the median age was 65 years (interquartile range: 55-73). EOCRC represented 15.9% (N=192). LOCRC tended to have more history of cardiometabolic diseases and smoking (p<0.001) than EOCRC. CRC family history was proportionally more frequent in EOCRC (7.3% vs 3.8%; p=0.028) than in LOCRC. Right-sided tumors were more common in LOCRC (30.4% vs 21.9%; p=0.041) and left-sided tumors in EOCRC (30.7% vs 23.2%; p=0.041). Only one patient had inflammatory bowel disease history. Conclusion. EOCRC is clinically distinct from LOCRC regarding pathological and toxicological history as well as tumor location. Our findings provide valuable insights for enhancing clinical decision-making, particularly in relation to age at onset in Colombian CRC patients.

Introducción. La incidencia de cáncer colorrectal (CCR) de aparición temprana (CCR-ATem), definido como CCR en individuos menores de 50 años, está aumentando en todo el mundo. A pesar del incremento en la producción científica internacional sobre CCR-ATem, la investigación es limitada en Colombia. El objetivo de este estudio fue caracterizar clínicamente los adultos con CCR-ATem y CCR de aparición tardía (CCR-ATar, CCR en individuos ≥ 50 años). Métodos. Estudio observacional, retrospectivo, transversal, en el que se incluyeron los pacientes adultos con CCR atendidos en un centro médico de Medellín, Colombia. Los datos se obtuvieron del Registro Institucional de Cáncer. Se establecieron dos grupos de análisis: CCR-ATem y CCR-ATar. Se aplicó la prueba de Chi cuadrado para comparar las variables de interés entre ambos grupos. Resultados. La muestra incluyó 1.202 pacientes, 53,5 % fueron mujeres (N=643), y la mediana de edad fue de 65 años (rango intercuartil: 55-73). CCR-ATem representó el 15,9 % (N=192). CCR-ATar tuvo más casos de enfermedades cardiometabólicas y tabaquismo (p<0,001). El antecedente familiar de CCR fue proporcionalmente más frecuente en CCR-ATem (7,3 % vs. 3,8 %; p=0,028). Los tumores del colon derecho fueron más frecuentes en CCR-ATar (30,4 % vs. 21,9 %; p=0,041) y los del colon izquierdo en CCR-ATem (30,7 % vs. 23,2 %; p=0,041). Solo un paciente tuvo antecedente de enfermedad inflamatoria intestinal. Conclusión. CCR-ATem es clínicamente distinto de CCR-ATar con respecto a antecedentes patológicos y toxicológicos, y localización tumoral. Nuestros hallazgos proporcionan información útil para mejorar la toma de decisiones clínicas, particularmente en relación con la edad de inicio en pacientes colombianos con CCR.

Factors related to mortality in patients with chronic obstructive pulmonary disease in Colombian population / Factores relacionados con la mortalidad en pacientes con enfermedad pulmonar obstructiva crónica en población colombiana

Introduction. Data in low- and middle-income countries on mortality and its related risk factors in patients with chronic obstructive pulmonary disease are limited. Objective. To identify the incidence of death and its relationship with variables in a Colombian population during 12 months of follow-up. Materials and methods. We carried out a retrospective study in subjects diagnosed with chronic obstructive pulmonary disease in a third-level hospital in Colombia. Odds ratios were calculated using multivariable logistic regression analysis with the outcome variable "mortality at 12 months". Results. We included 524 patients, 18.1% (95 / 524) died. The average age was 69.7 (SD = 8.92), and 59.2% (310 / 524) were women. The variables associated with mortality were age (OR = 6.54; 95% CI = 3.65-11.36; p < 0.001), years of exposure to wood smoke (OR = 4.59; 95% CI = 1.64-2.82; p = 0.002), chronic heart failure (OR = 1.81; 95% CI = 1.13-2.91; p = 0.014), cerebrovascular disease (OR = 3.35; 95% CI = 1.04-10.75; p = 0.032), and chronic kidney disease (OR = 6.96; 95% CI = 1.15-41.67; p=0.015). When adjusting the variables in the multivariate analysis, only an association was found for sex (OR = 1.55; 95% CI = 0.95-2.54; p = 0.008) and age (OR = 5.94; 95% CI = 3.3-10.69; p < 0.001). Conclusion. Age, years of exposure to wood smoke, chronic heart failure, and cerebrovascular and chronic kidney disease were the clinical variables associated with a fatal outcome. However, age and sex were the only variables related to mortality when adjusted for confounding factors.

Introducción. En los países de medianos y bajos ingresos, los datos sobre la mortalidad y los factores de riesgo en pacientes con enfermedad pulmonar obstructiva crónica son limitados. Objetivo. Identificar la incidencia de muerte y sus variables relacionadas en una población colombiana durante 12 meses de seguimiento. Materiales y métodos. Se llevó a cabo un estudio retrospectivo de sujetos con diagnóstico de enfermedad pulmonar obstructiva crónica en una clínica de tercer nivel en Colombia. Los cocientes de probabilidades se calcularon mediante un análisis de regresión logística multivariable con la variable de resultado "mortalidad a los 12 meses". Resultados. Ingresaron 524 pacientes, de los cuales el 18,1 % (95 / 524) murió. La edad promedio fue de 69,7 (DE = 8,92) y el 59,2 % (310 / 524) eran mujeres. Las variables asociadas con la mortalidad fueron la edad (OR = 6,54; IC95%: 3,65-11,36; p < 0,001), años de exposición al humo de leña (OR = 4,59; IC95%: 1,64-12,82; p = 0,002), insuficiencia cardiaca crónica (OR = 1,81; IC95%: 1,13-2,91; p = 0,014), enfermedad cerebrovascular (OR = 3,35; IC95%: 1,04-10,75; p = 0,032) y enfermedad renal crónica (OR=6,96; IC 95%:1,15-41,67; p = 0,015). Al ajustar las variables en el análisis multivariado únicamente se mostró asociación entre el sexo (OR = 1,55; IC95%: 0,95-2,54; p = 0,008) y la edad (OR = 5,94; IC95%: 3,3-10,69; p < 0,001). Conclusión. La edad, los años de exposición al humo de leña, la insuficiencia cardiaca crónica, la enfermedad cerebrovascular y la renal crónica fueron variables clínicas asociadas a un desenlace fatal. Sin embargo, la edad y el sexo fueron las únicas relacionadas con la mortalidad al ajustarlas por factores de confusión.

Biomarker panels for fruit intake assessment: a metabolomics analysis in the ELSA-Brasil study.

INTRODUCTION: Food intake biomarkers are used to estimate dietary exposure; however, selecting a single biomarker to evaluate a specific dietary component is difficult due to the overlap of diverse compounds from different foods. Therefore, combining two or more biomarkers can increase the sensitivity and specificity of food intake estimates. OBJECTIVE: This study aimed to evaluate the ability of metabolite panels to distinguish between self-reported fruit consumers and non-consumers among participants in the Longitudinal Study of Adult Health. MATERIALS AND METHODS: A total of 93 healthy adults of both sexes were selected from the Longitudinal Study of Adult Health. A 24-h dietary recall was obtained using the computer-assisted 24-h food recall GloboDiet software, and 24-h urine samples were collected from each participant. Metabolites were identified in urine using liquid chromatography coupled with high-resolution mass spectrometry by comparing their exact mass and fragmentation patterns using free-access databases. Multivariate receiver operating characteristic curve (ROC) analysis and partial least squares discriminant analysis were used to verify the ability of the metabolite combination to classify daily and non-daily fruit consumers. Fruit intake was identified using a 24 h dietary recall (24 h-DR). RESULTS: Bananas, grapes, and oranges are included in the summary. The panel of biomarkers exhibited an area under the curve (AUC) > 0.6 (Orange AUC = 0.665; Grape AUC = 0.622; Bananas AUC = 0.602; All fruits AUC = 0.679; Citrus AUC = 0.693) and variable importance projection score > 1.0, and these were useful for assessing the sensitivity and predictability of food intake in our population. CONCLUSION: A panel of metabolites was able to classify self-reported fruit consumers with strong predictive power and high specificity and sensitivity values except for banana and total fruit intake.

Survival at 3, 6 and 12 months in patients diagnosed with community-acquired pneumonia in Colombia: a retrospective cohort study.

BACKGROUND: The primary aim of this study is to assess the survival rates of individuals diagnosed with Community-Acquired Pneumonia (CAP) post-hospitalization in Colombia. Additionally, explore potential risk factors associated with decreased long-term survival. METHODS: A retrospective cohort study was conducted in a hospital in Colombia, evaluating survival at 3, 6 and 12 months in CAP patients, using the Kaplan-Meier method. Stratifications were made by age, sex, comorbidity, and severity. The comparison of survival curves was performed using the Log-Rank test, a multivariate analysis with Cox regression was performed to study possible risk factors that affected 12-month survival in patients with CAP. RESULTS: 3688 subjects were admitted, with a mortality of 16.3 % per year. Survival at three, six, and twelve months was 92.9 % (95 % CI 92-93 %), 88.8 % (95 % CI 87-90 %), and 84.2 % (95 % CI 82-85 %), respectively. Analysis stratified by pneumonia severity index, 12-month survival was 98.7 % in Class I, 95.6 % in Class II, 87.41 % in Class III, 77.1 % in Class IV, and 65.8 % in class-V (p < 0.001). Cox-regression showed that being male (HR = 1.44; 95 % CI 1.22‒1.70; p < 0.001), an elevated pneumonia severity index (HR = 4.22; 95 % CI 1.89‒9.43; p < 0.001), a high comorbidity index (HR = 2.29; 95 % CI 1.89‒2.84; p < 0.001) and vasopressor requirement (HR = 2.22; 95 % CI < 0.001) were associated with a lower survival at twelve months of follow-up. CONCLUSION: Survival in patients with CAP who require hospitalization decreases at 3, 6, and 12 months of follow-up, being lower in patients older than 65 years, men, high comorbidity, and in subjects with severe presentation of the disease.

Performance of risk scores in predicting mortality at 3, 6, and 12 months in patients diagnosed with community-acquired pneumonia.

BACKGROUND: Risk scores (RS) evaluate the likelihood of short-term mortality in patients diagnosed with community-acquired pneumonia (CAP). However, there is a scarcity of evidence to determine the risk of long-term mortality. This article aims to compare the effectiveness of 16 scores in predicting mortality at three, six, and twelve months in adult patients with CAP. METHODS: A retrospective cohort study on individuals diagnosed with CAP was conducted across two hospitals in Colombia. Receiver Operating Characteristic (ROC) curves were constructed at 3, 6, and 12 months to assess the predictive ability of death for the following scoring systems: CURB-65, CRB-65, SCAP, CORB, ADROP, NEWS, Pneumonia Shock, REA-ICU, PSI, SMART-COP, SMRT-CO, SOAR, qSOFA, SIRS, CAPSI, and Charlson Comorbidity Index (CCI). RESULTS: A total of 3688 patients were included in the final analysis. Mortality at 3, 6, and 12 months was 5.2%, 8.3%, and 16.3% respectively. At 3 months, PSI, CCI, and CRB-65 scores showed ROC curves of 0.74 (95% CI: 0.71-0.77), 0.71 (95% CI: 0.67-0.74), and 0.70 (95% CI: 0.66-0.74). At 6 months, PSI and CCI scores showed performances of 0.74 (95% CI: 0.72-0.77) and 0.72 (95% CI: 0.69-0.74), respectively. Finally at 12 months, all evaluated scores showed poor discriminatory capacity, including PSI, which decreased from acceptable to poor with an ROC curve of 0.64 (95% CI: 0.61-0.66). CONCLUSION: When predicting mortality in patients with CAP, at 3 months, PSI, CCI, and CRB-65 showed acceptable predictive performances. At 6 months, only PSI and CCI maintained acceptable levels of accuracy. For the 12-month period, all evaluated scores exhibited very limited discriminatory ability, ranging from poor to almost negligible.

Psychological distress, health-promoting lifestyle and sociodemographic factors in Honduran university students: a structural equation model.

This study sought to analyze an explanatory model on the relationship among sociodemographic factors, health-promoting lifestyle behaviors and psychological distress (depression, anxiety and stress) in college students. This is an observational, analytical and cross-sectional study conducted on a national sample of 4203 students who entered a macro university in Honduras in 2021, 2022 and 2023. We used a sociodemographic survey, the Health-Promoting Lifestyle Profile (HPLP-II) and the Depression, Anxiety and Stress Scales (DASS-21). Univariate analysis and a multivariate structural equation model were conducted. The average HPLP-II score was 117.45 (±â€…23.41), and the average DASS-21 score was 20.06 (±â€…14.16). The multivariate model showed a good data fit (comparative fit index = 0.951; Tucker-Lewis index = 0.957; root mean square error of approximation = 0.067 [90% CI = 0.067-0.068]). Results indicate that being a woman (ß = 0.11; p < 0.001) and being enrolled in biological and health sciences (ß = 0.09; p < 0.001) significantly predict HPLP-II scores. Furthermore, being a woman (ß = 0.17; p < 0.001), age (ß = 0.10; p < 0.001) and having pre-existing medical conditions (ß = 0.16; p < 0.001) significantly explain part of the variance of DASS-21. A significant reverse relationship between health-promoting behavior and psychological distress was shown (r = -0.36; p < 0.001). This study identifies protective and risky sociodemographic factors linked to health-promoting lifestyle behaviors and psychological distress. Our findings have implications for developing comprehensive intervention policies and strategies to promote health in higher education settings.

Clinical and demographic features of patients undergoing video-capsule endoscopy management: A descriptive study.

BACKGROUND: Video-capsule endoscopy (VCE) is an efficient tool that has proven to be highly useful in approaching several gastrointestinal diseases. VCE was implemented in Colombia in 2003, however current characterization of patients undergoing VCE in Colombia is limited, and mainly comes from two investigations conducted before the SARS-CoV-2 pandemic period. AIM: To describe the characteristics of patients undergoing VCEs and establish the main indications, findings, technical limitations, and other outstanding features. METHODS: A descriptive study was carried out using data from reports of VCE (PillCam SB3 system) use in a Gastroenterology Unit in Bogotá, Colombia between September 2019 and January 2023. Demographic and clinical variables such as indication for the VCE, gastric and small bowel transit times (GTT, SBTT), endoscopic preparation quality, and limitations were described [n (%), median (IQR)]. RESULTS: A total of 133 VCE reports were analyzed. Most were in men with a median age of 70 years. The majority had good preparation (96.2%), and there were technical limitations in 15.8% of cases. The main indications were unexplained anemia (91%) or occult bleeding (23.3%). The median GTT and SBTT were 14 and 30 minutes, respectively. The frequencies of bleeding stigma (3.79%) and active bleeding (9.09%) were low, and the most frequent abnormal findings were red spots (28.3%), erosions (17.6%), and vascular ectasias (12.5%). CONCLUSION: VCE showed high-level safety. The main indication was unexplained anemia. Active bleeding was the most frequent finding. Combined with artificial intelligence, VCE can improve diagnostic precision and targeted therapeutic interventions.

Brazilian undergraduates' and dentists' knowledge on preventing, diagnosing and managing dentin hypersensitivity: A cross-sectional questionnaire study.

OBJECTIVES: To analyse the knowledge of dental undergraduates and dentists on the prevention, diagnosis and management of dentin hypersensitivity (DH); to compare their knowledge scores; and to understand the related variables using a regression model. METHODS: An original online questionnaire investigated the attitudes, self-reported knowledge ('how much they thought they knew') and real knowledge ('how much they really knew') of 132 students and 338 dentists. Data were analysed descriptively, both knowledge scores were compared using Mann-Whitney and Wilcoxon signed-rank tests and data were subjected to two multiple linear regression analyses considering real knowledge scores as the dependent variable (α < 0.05). RESULTS: The self-reported knowledge on DH was higher than the real knowledge for both students and dentists, but dentists presented the highest scores. Gingival recession and acidic diet were reported as the main predisposing factors for DH by undergraduates and dentists. Students normally managed DH with dietary and hygiene instructions followed by a desensitizing agent application, while dentists managed with occlusal adjustments. The mechanism of glutaraldehyde/HEMA and bioactive fillers on DH is widely unknown by students and dentists. The majority of the questioned individuals cannot differentiate DH from sensitivity of caries or molar-incisor hypomineralization. CONCLUSION: Both students and dentists overestimate their knowledge of DH, revealing deficiencies in prevention, diagnosis and management. Students' knowledge improves towards the end of the Dentistry course, while younger dentists and PhD holders are more knowledgeable. Institutions should implement ongoing DH education for undergraduates and conduct interventions for experienced professionals, especially older ones.

An observational study investigating soluble immune checkpoints as indicators of severe COVID-19.

This study aimed to investigate the immunomodulatory behavior of soluble immune checkpoints (sICPs) and other biomarkers in the pathophysiology of SARS-CoV-2 infection. The study included 59 adult participants, 43 of whom tested positive for SARS-CoV-2. Patients were divided into three cohorts: those with moderate disease (n = 16), recovered patients with severe disease (n = 13), and deceased patients with severe disease (n = 16). In addition, 16 participants were pre-pandemic subjects negative for SARS-CoV-2. The relative activity of neutralizing antibodies (rNAbs) against SARS-CoV-2 and the values of 14 sICPs in peripheral blood were compared between the four groups. Because the increase of markers values of inflammation [NLR > 12; CRP > 150 mg/L] and venous thromboembolism [D-dimer > 0.5 mg/L] has been associated with mortality from COVID-19, the total and differential leukocyte counts, the NLR, and CRP and D-dimer values were obtained in patients with severe disease. No differences in rNAbs were observed between the cohorts. Only the levels of five sICPs, sCD27, sHVEM sTIM-3, sPD-1, and sPDL-1, were significantly higher in patients with severe rather than moderate disease. The sPDL-2 level and NLR were higher in deceased patients than in recovered patients. However, there was no difference in CRP and D-dimer values between the two groups. Of the five soluble biomarkers compared among patients with severe disease, only sPDL-2 was higher in deceased patients than in recovered patients. This suggests that immuno-inhibitory sICPs might be used as indicators for severe COVID-19, with sPDL-2 used to assess individual risk for fatality.IMPORTANCECOVID-19, the disease caused by a SARS-CoV-2 infection, generates a broad spectrum of clinical symptoms, progressing to multiorgan failure in the most severe cases. As activation of the immune system is pivotal to eradicating the virus, future research should focus on identifying reliable biomarkers to efficiently predict the outcome in severe COVID-19 cases. Soluble immune checkpoints represent the function of the immune system and are easily determined in peripheral blood. This research could lead to implementing more effective severity biomarkers for COVID-19, which could increase patients' survival rate and quality of life.

Location-based clinical and angiographic profile of brain arteriovenous malformations - a single-center observational study.

BACKGROUND: The location of brain arteriovenous malformations (bAVM) is one of the most relevant prognostic factors included in surgical, endovascular and radiosurgical scores. However, their characteristics according to location are seldom described. The goal of this study was to describe the clinical and angiographic characteristics of bAVM classified according to their location. METHODS: This retrospective observational study included patients diagnosed with bAVM and attending a national referral hospital during the period 2010-2020. Data regarding clinical and angiographic variables were extracted, including characteristics on nidus, arterial afferents, venous drainage and associated aneurysms. BAVM were classified in 8 groups according to their location: frontal, temporal, parieto-occipital, periventricular, deep, cerebellar, brainstem and mixed. Data distribution for each group was determined and between-group differences were assessed. RESULTS: A total of 269 bAVM (in 258 patients) were included. The most frequent location was parieto-occipital; and the least frequent, brainstem. Statistically significant differences were observed between groups for most studied variables, including: clinical presentation, functional status at admission; nidus size and density, classification according to the Spetzler-Martin, Buffalo and modified Pollock-Flickinger scales; number, diameter, origin and type of afferents; number, diameter, type and direction of venous drainage, retrograde venous flow; and presence and size of flow-related aneurysms. CONCLUSION: The clinical and angiographic differences observed between brain AVM groups allow the formulation of profiles according to their location.

Effectiveness of methotrexate and leflunomide as corticoid-sparing drugs in patients with polymyalgia rheumatica.

Objectives: The need for glucocorticoid-sparing drugs (GCSD) remains an important issue and is an unmet need in the treatment of polymyalgia rheumatica (PMR). We therefore aimed to assess the effectiveness and safety of methotrexate (MTX) and of leflunomide (LEF) in daily clinical practice in PMR patients from Argentina. Methods: A multicentre and observational study (medical records review) of PMR patients seen between 2007 and 2023, who had at least three months of follow-up after starting a GCSD, either MTX or LEF, was performed. Results are expressed as medians and interquartile ranges [25th-75th (IQR)] for continuous variables and percentages for categorical ones. The two treatment groups were compared using χ2 test for categorical variables, Mann-Whitney U test for continuous variables and the log-rank test for time-to-event data. Crude and adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using logistic regression. In all cases, a p-value <0.05 was considered statistically significant. Results: One-hundred and eighty-six patients (79% female) with a median age of 72 years (IQR, 65-77 years) were included. One-hundred and forty-three patients (77%) were prescribed MTX (15, IQR 10-15) and 43 (23%) LEF (20 mg, fixed dose). Flare-ups (relapses and recurrences) occurred in 13 patients (7%) and were comparable between both groups. Persistent GCSD intake was observed in 145 patients (78%). Glucocorticoid (GC) withdrawal was achieved in 67 of these 145 patients (46%) and this occurred more frequently in the LEF group (P = 0.001). Furthermore, time until prednisone discontinuation was shorter in the LEF-treated patients (4.7 months, IQR 3-20 on LEF versus 31.8 months, IQR 10-82 on MTX, P = 0.000). Remission was found more frequently in the LEF group (P = 0.003). In the multivariate analysis, the probability of remission was higher with LEF therapy (P = 0.010) and this finding persisted in the subgroup analysis who were followed up < 40 months (OR 3.12, 95% CI = 1.30-7.47, P = 0.011). Conclusions: This study demonstrated the clinical effectiveness of LEF and even its superiority in achieving remission when compared with MTX as GCSD in PMR patients. Further research is needed to support these findings.

The role of childhood cumulative trauma in the risk of lifetime PTSD: An epidemiological study.

Cumulative trauma is usually devastating and can lead to severe psychological consequences, including posttraumatic stress disorder (PTSD). Exposure to various types of traumas, particularly during childhood, can be even more deleterious than the sheer number of events experienced. This epidemiological study is the first to investigate the impact of discrete childhood traumatic exposure on the risk of developing lifetime PTSD in a representative sample of the general population of the two biggest Brazilian cities. Participants were aged between 15 and 75 years old, living in São Paulo and Rio de Janeiro, Brazil, who had experienced traumatic events (N = 3,231). The PTSD diagnosis was assessed using the DSM-IV criteria through the version 2.1 of Composite International Diagnostic Interview. To operationalize childhood cumulative trauma, we considered the sum of 15 different childhood trauma categories that occurred before PTSD onset. The final multivariate logistic regression model indicated a strong relationship between the number of discrete types of childhood traumas and the likelihood of the lifetime PTSD development. The lifetime PTSD risk increased 28 % with each different type of childhood trauma when adjusted by confounds. Our study strengthens the evidence associating childhood cumulative trauma to increased lifetime PTSD risk.

Ketogenic diet therapies as a non-pharmacological adjuvant in resistant epilepsy: retrospective analysis of adult outpatients in Colombia.

Twelve patients between 18 and 53 years of age were included. MAD plus nutritional supplementation was administered to 75% (n = 10) of the participants, one (8.3%) received MAD alone, and 16.7 (n = 2) received Classic Ketogenic Diet (cKD) plus nutritional supplementation. Oral nutritional supplementation, administered in the outpatient setting, provided patients with between 31 and 55% of the total caloric value. In the first month of KDT treatment, 83.3% (n = 10) of patients reduced the number of weekly seizures by 40% (median). At six months of treatment, 75% of patients had at least halved the number of weekly seizures. At 12 months of treatment, the number of weekly seizures had been reduced by 85.7% (median). KDT was well tolerated, and there was no need to discontinue treatment. This study provides real-world information on the use of KDT, particularly MAD in adults, in developing countries. Future studies in larger cohorts will provide further information on different types of KDT, adherence, and patient-reported outcomes.

Desenho de Estudo de um Estudo Observacional Brasileiro sobre o uso de Edoxabana em Pacientes com Fibrilação Atrial (EdoBRA) / Study Design of a Brazilian Observational Study of Edoxaban in Patients with Atrial Fibrillation (EdoBRA)

Resumo Fundamento: Os ensaios clínicos demonstraram a segurança da Edoxabana, um anticoagulante oral não dependente de vitamina K (NOAC), e a sua eficácia na prevenção de acidente vascular cerebral e embolia sistémica em pacientes com fibrilação atrial não valvar (FANV) e também na prevenção e tratamento de tromboembolismo venoso. No entanto, pesquisas adicionais são necessárias para avaliar a segurança e a eficácia da Edoxabana em um cenário real na população brasileira. Objetivo: A fim de compreender os riscos e benefícios do uso da Edoxabana em cenários clínicos de rotina, o estudo EdoBRA está sendo conduzido para obter informações sobre a segurança e eficácia do uso da Edoxabana em pacientes não pré-selecionados com FANV no Brasil. Métodos: O estudo EdoBRA é um estudo multicêntrico, prospectivo e observacional, realizado em 36 centros no Brasil. São elegíveis para este estudo pacientes com FANV, ≥ 18 anos de idade, tratados com Edoxabana disponível comercialmente, que iniciaram o tratamento por pelo menos 14 dias e não mais do que 90 dias antes da data de inclusão no estudo, e que não estão participando de nenhum outro estudo de intervenção. Ao todo, 700 pacientes devem ser inscritos e acompanhados por um ano, com coletas de dados programadas para o período basal e 3, 6 e 12 meses após a inscrição no estudo. O objetivo primário de segurança é o sangramento clinicamente relevante (de acordo com critérios da Sociedade Internacional de Trombose e Hemostasia - ISTH), e o objetivo secundário de eficácia são desfechos cardiovasculares relevantes relacionados à FANV. Conclusão: O estudo observacional EdoBRA gerará informações adicionais relevantes sobre a Edoxabana enquanto NOAC em diversos aspectos do manejo de pacientes no atendimento clínico de rotina, como perfil de segurança e efetividade em pacientes com FANV no Brasil.

Abstract Background: Clinical trials showed the safety of Edoxaban, a non-vitamin K-dependent oral anticoagulant (NOAC), and its efficacy to prevent stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients and also to prevent and treat venous thromboembolism. However, additional research is needed to evaluate the safety and effectiveness of Edoxaban in a real-world scenario in the Brazilian population. Objective: In order to understand the risks and benefits of Edoxaban use in routine clinical settings, the EdoBRA study is being conducted to gain insight into the safety and effectiveness of Edoxaban use in non-preselected patients with NVAF in Brazil. Methods: The EdoBRA study is a multicenter, prospective, observational study conducted in 36 sites in Brazil. NVAF patients ≥ 18 years treated with commercially available Edoxaban who initiated treatment for at least 14 days and no longer than 90 days prior to enrollment, and who are not simultaneously participating in any interventional study are eligible for this study. Seven hundred patients are planned to be enrolled and one-year of follow up, with data collections expected at baseline and 3, 6, and 12 months after the study enrollment. The primary safety objective is ISTH Clinically Relevant Bleeding, and the secondary effectiveness objective focuses on relevant cardiovascular outcomes related to NVAF. Conclusion: EdoBRA observational study will generate relevant additional information about NOAC Edoxaban on various aspects of patient management in routine care, such as its safety and effectiveness profile in patients with NVAF in Brazil.

The effectiveness and safety of octocog alfa in patients with hemophilia A: up to 7-year follow-up of the real-world AHEAD international study.

Background: Real-world data assessing treatment outcomes in patients with hemophilia A in routine clinical practice are limited. Objective: To evaluate the effectiveness and safety of octocog alfa in patients with moderate/severe hemophilia A receiving treatment in clinical practice. Design: The international Antihemophilic Factor Hemophilia A Outcome Database study is an observational, noninterventional, prospective, multicenter study. Methods: This planned interim data read-out was conducted following 7 years of observation of patients receiving octocog alfa (cut-off, 30 June 2020). The primary endpoint was joint health status, assessed by the Gilbert Score. Secondary endpoints included annualized bleeding rates (ABRs), Hemophilia Joint Health Score (HJHS), health-related quality of life, consumption, and safety. This post hoc analysis stratified data by hemophilia severity at baseline [moderate, factor VIII (FVIII) 1-5%; severe, FVIII <1%]. Results: Of the 711 patients in this analysis, 582 (82%) were receiving prophylaxis with octocog alfa at enrollment, and 498 (70%) had severe disease. Median Gilbert Scores were higher with on-demand therapy versus prophylaxis and scores were comparable in moderate and severe disease. In patients receiving prophylaxis, there was an improvement in HJHS Global Gait Score over 7 years of follow-up overall and in patients with severe disease. ABRs and annualized joint bleeding rates were low across all 7 years. An ABR of zero was reported in 34-56% of prophylaxis patients versus 20-40% in the on-demand group. ABRs were similar in severe and moderate disease. In total, 13/702 (1.9%) patients experienced 18 treatment-related adverse events. Conclusion: These data demonstrate the long-term effectiveness and safety of octocog alfa in patients with moderate and severe hemophilia A, especially in those receiving prophylaxis. The high number of patients receiving on-demand treatment experiencing zero bleeds could be due to selection bias within the study, with patients with less severe disease more likely to be receiving on-demand treatment. Trial registration: ClinicalTrials.gov: NCT02078427.

Effects of a Conventional Treatment Plus Scapular Exercises Program in Patients With Chronic Lateral Elbow Tendinopathy: A Pre-Post Single-Group Study.

BACKGROUND: Weakness of the shoulder girdle muscles has been reported in patients with chronic lateral elbow tendinopathy. The aim of this study was to assess the short- and long-term effects of a conventional treatment plus scapular exercises program in patients with chronic lateral elbow tendinopathy. METHODS: A single-group prestudy and poststudy were conducted. The primary outcome was the Patient-Rated Tennis Elbow Evaluation questionnaire score. Secondary outcomes were grip strength; Disabilities of the Arm, Shoulder, and Hand questionnaire score; Visual Analogue Scale score at rest and at grip, and presence of scapular dyskinesis. RESULTS: A total of 65 patients (72.3% females), with a mean age of 41.8 years, were analyzed. At the end of 6 weeks, the results showed clinically and statistically significant differences (P < .05). At 1-year follow-up, the differences were: Patient-Rated Tennis Elbow Evaluation -31 points (P < .001); grip strength +33.6% (P < .001); Disabilities of the Arm, Shoulder, and Hand -34.2 points (P < .001); Visual Analogue Scale at rest -2.5 cm (P < .001); and Visual Analogue Scale at grip -2.3 cm (P < .001). CONCLUSION: At the end of 6 weeks and at 1-year follow-up, conventional treatment plus scapular exercises program showed statistically and clinically significant differences in all functional outcomes assessed in patients with lateral elbow tendinopathy.

Oral health literacy and its association with oral health-related quality of life amongst pregnant women: a cross-sectional study.

PURPOSE: This study aimed to evaluate the association of oral health literacy (OHL) and oral health-related quality of life (OHRQoL) of pregnant women. METHODS: This cross-sectional study evaluated a representative sample of pregnant women assisted in public health services in southern Brazil. Demographic, socioeconomic, psychosocial and behavioural data were collected through structured questionnaires. The Oral Health Impact Profile (OHIP-14) questionnaire was used to evaluate the OHRQoL. The Brazilian Rapid Estimate of Adult Literacy in Dentistry (BREALD-30) was used to measure OHL. Dental caries and gingival bleeding were evaluated by clinical examinations. Adjusted multilevel Poisson regression models with a hierarchical approach were used to assess the associations. The results are presented as rate ratio (RR) and 95% confidence interval (95% CI). RESULTS: A total of 520 pregnant women were evaluated. Pregnant women with lower levels of OHL presented overall OHIP-14 scores 14% higher (RR 1.14; 95% CI 1.07-1.22) than their counterparts. High household income and high education level were related to low overall OHIP-14 scores. Furthermore, less dental attendance, low social support, untreated dental caries and gingival bleeding were also associated with high overall OHIP-14 scores. CONCLUSION: Our findings reinforce that health literacy levels influence patient-reported outcomes. Pregnant women with lower OHL were more likely to present poorer OHRQoL.

Impact of licit and illicit substances on the oral health-related quality of life in adolescents.

OBJECTIVE: To assess the impact of the consumption of licit and illicit substances on the oral health-related quality of life (OHRQoL) of adolescents from public schools in the south of Brazil. METHODS: This cross-sectional study was carried out with a random sample of adolescents aged between 17 and 18 years old from Santa Maria, Brazil. The consumption of licit and illicit substances was measured through a self-administered questionnaire with questions from the National Survey of Scholar Health. The OHRQoL was collected using the Brazilian short version of Child Perceptions Questionnaire 11-14 (CPQ11-14). Multilevel Poisson regression models were used to estimate the association between the outcome and the explanatory variables where the adolescents (first level) were nested in their schools (second level). RESULTS: A total of 768 adolescents were evaluated. Of these, about 15.6% have already used illegal substances. Adolescents who reported the use of illicit substances had 28% higher CPQ11-14 scores when compared to their counterparts. Alcohol use was also related to worse levels of OHRQoL, while the consumption of cigarettes acted as a protective factor. CONCLUSIONS: This study found an association between the use of alcohol and illicit drugs with worse levels of OHRQoL.

Breastfeeding and autism spectrum disorder: case-control study / Transtorno do espectro do autismo e aleitamento materno: estudo de caso controle

Abstract Objectives: to evaluate the association between breastfeeding and Autism Spectrum Disorder (ASD) in children and adolescents. Methods: this is a case-control study carried out in the north of the state of Minas Gerais, Brazil, which included 248 children and adolescents diagnosed with ASD (case group) and 886 children and adolescents without a diagnosis of ASD (control group).Interviews were conducted with the mothers of children and adolescents and a semi-structured questionnaire was used to collect data. For data analysis, a multiple logistic regression model was adopted. The magnitude of associations was estimated by the odds ratio (OR). Three multiple models were fitted: Model 1: presence or absence of breastfeeding; Model 2: duration of breastfeeding; Model 3: duration of exclusive breastfeeding. Results: ASD was associated with the absence of breastfeeding in the three adjusted models: Model 1: OR=2.1, CI95%=1.1-4.1; Model 2: OR=2.3, CI95%=1.2-4.5; Model 3: OR=2.3, CI95%=1.2-4.5. Conclusions: individuals with ASD were more likely to have not received breastfeeding, however, due to the nature of case control studies, it cannot be stated that breastfeeding prevents ASD. Conducting a cohort study may clarify this relationship.

Resumo Objetivos: avaliar a associação entre aleitamento materno e Transtorno do Espectro do Autismo (TEA) em crianças e adolescentes. Métodos: trata-se de um estudo caso-controle realizado no norte de Minas Gerais, Brasil, que incluiu 248 crianças e adolescentes com diagnóstico de TEA (grupo caso) e 886 crianças e adolescentes sem diagnóstico de TEA (grupo controle). Foram realizadas entrevistas com as mães das crianças e adolescentes e utilizado um questionário semiestruturado para coleta dos dados. Para análise dos dados foi adotado modelo de regressão logística múltipla. A magnitude das associações foi estimada pela Odds Ratio (OR). Três modelos múltiplos foram ajustados: Modelo 1: presença ou ausência de aleitamento materno; Modelo 2: duração do aleitamento materno; Modelo 3: duração do aleitamento materno exclusivo. Resultados: o TEA foi associado à ausência de aleitamento materno nos três modelos ajustados: Modelo 1: OR=2,1, IC95%=1,1-4,1; Modelo 2: OR=2,3, IC95%=1,2-4,5; Modelo 3: OR=2,3, IC95%=1,2-4,5. Conclusões: os indivíduos com TEA tiveram maiores chances de não terem recebido aleitamento materno, no entanto, devido à natureza dos estudos de caso-controle, não se pode afirmar que o aleitamento materno previna o TEA. A realização de um estudo de coorte poderá esclarecer essa relação.

Predictors of excess fluid volume in hemodialysis patients: an observational study / Preditores de volume excessivo de líquidos em pacientes em hemodiálise: estudo observacional / Predictores de volumen excesivo de líquidos en pacientes en hemodiálisis: estudio observacional

ABSTRACT Objectives: to assess risk factors for excess fluid volume in hemodialysis patients. Methods: a retrospective case-control study was conducted. A total of 392 patients (196 cases and 196 controls) from two hemodialysis centers were included. Sociodemographic data and 23 risk factors for excess fluid volume were assessed using a data collection form. Data were analyzed using a multivariate logistic regression model. Results: the insufficient knowledge (OR=2.06), excessive fluid intake (OR=2.33), inadequate fluid removal during hemodialysis (OR=2.62) and excessive sodium intake (OR=1.91) risk factors may increase the chance of occurrence of excess fluid volume in hemodialysis patients by approximately two times. Education level (OR=0.95) and age (OR=0.97) are protective factors for excessive fluid volume. Conclusions: knowing these risk factors may help nurses with accurate and rapid diagnostic inference of the risk of excessive fluid volume.

RESUMO Objetivos: avaliar os fatores de risco para o excesso de volume de líquidos em pacientes em hemodiálise. Métodos: estudo retrospectivo caso-controle. Foram incluídos 392 pacientes (196 casos e 196 controles) de dois centros de hemodiálise. Dados sociodemográficos e 23 fatores de risco para excesso de volume de líquidos foram avaliados por meio de formulário de coleta de dados. Os dados foram analisados por meio de modelo de regressão logística multivariada. Resultados: os fatores de risco conhecimento insuficiente (OR=2,06), ingestão excessiva de líquidos (OR=2,33), retirada inadequada de líquidos durante hemodiálise (OR=2,62) e ingestão excessiva de sódio (OR=1,91) podem aumentar a chance de ocorrência de excesso de líquidos volume em pacientes em hemodiálise em aproximadamente duas vezes. Escolaridade (OR=0,95) e idade (OR=0,97) são fatores de proteção para volume excessivo de líquidos. Conclusões: conhecer esses fatores de risco pode auxiliar enfermeiros na inferência diagnóstica precisa e rápida do risco de volume excessivo de líquidos.

RESUMEN Objetivos: evaluar los factores de riesgo del exceso de volumen de líquido en pacientes en hemodiálisis. Métodos: estudio retrospectivo de casos y controles. Se incluyeron 392 pacientes (196 casos y 196 controles) de dos centros de hemodiálisis. Se evaluaron datos sociodemográficos y 23 factores de riesgo de exceso de volumen de líquido mediante un formulario de recolección de datos. Los datos se analizaron mediante un modelo de regresión logística multivariado. Resultados: factores de riesgo conocimiento insuficiente (OR=2,06), ingesta excesiva de líquidos (OR=2,33), retirada inadecuada de líquidos durante la hemodiálisis (OR=2,62) e ingesta excesiva de sodio (OR=1,91) pueden aumentar aproximadamente dos veces la posibilidad de que se produzca un exceso de volumen de líquido en pacientes en hemodiálisis. La educación (OR=0,95) y la edad (OR=0,97) son factores protectores del volumen excesivo de líquido. Conclusiones: conocer estos factores de riesgo puede ayudar a las enfermeras a realizar una inferencia diagnóstica precisa y rápida del riesgo de volumen excesivo de líquidos.