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.

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.

Immunization against covid-19 and mortality in hospitalized patients: a retrospective cohort / Imunização contra covid-19 e mortalidade em pacientes hospitalizados: coorte retrospectiva

ABSTRACT OBJECTIVE To evaluate the effectiveness of vaccines developed against covid-19 in reducing mortality in people hospitalized with severe acute respiratory syndrome (SARS) caused by SARS-CoV-2. METHODS This is a retrospective cohort that evaluated risk factors and the effectiveness of the two-dose vaccination schedule in reducing the mortality of people hospitalized for covid-19 in the state of Paraíba from February to November 2021. The explanatory variables were vaccination status, presence of comorbidities, socioeconomic and demographic characteristics. Descriptive analyses and bivariate and multivariable logistic regression were performed. RESULTS Most hospitalizations and deaths occurred until May 2021. The percentage of patients with a complete vaccination schedule was similar across patients admitted to public and private hospitals and higher in residents of less developed municipalities. Multivariable analysis demonstrated that women (OR = 0.896; 95%CI 0.830-0.967) and people admitted to private hospitals (OR = 0.756; 95%CI 0.679-0.842) were less likely to die. Presence of any comorbidity (OR = 1.627; 95%CI 1.500-1.765) and age ≥ 80 years (OR = 7.426; 95%CI 6.309-8.741) were risk factors for death. Patients with complete vaccination schedule at the time of admission were 41.7% less likely to die (OR = 0.583; 95% CI 0.501-0.679) from covid-19 in the adjusted analysis, as compared to unvaccinated patients. CONCLUSIONS The study reveals that immunization was effective in reducing the likelihood of death from covid-19. The results suggest that greater vaccination coverage in the first half of 2021 would prevent thousands of deaths in the country.

RESUMO OBJETIVO Avaliar a efetividade das vacinas desenvolvidas contra a covid-19 na redução da mortalidade em pessoas internadas com síndrome respiratória aguda grave (SRAG) causada pelo SARS-CoV-2. MÉTODOS Trata-se de uma coorte retrospectiva que avaliou fatores de riscos e a efetividade do esquema vacinal com duas doses na redução da mortalidade de pessoas internadas por covid-19 no estado da Paraíba entre fevereiro e novembro de 2021. As variáveis explicativas foram situação vacinal, presença de comorbidades, características socioeconômicas e demográficas. Foram realizadas análises descritivas e regressão logística bivariada e multivariável. RESULTADOS A maior parte das internações e óbitos ocorreram até maio de 2021. O percentual de pacientes com esquema vacinal completo foi similar entre pacientes internados em hospitais públicos e privados e superior em residentes de municípios com menor desenvolvimento. A análise multivariável demonstrou que mulheres (OR = 0,896; IC95% 0,830-0,967) e pessoas internadas em hospitais privados (OR = 0,756; IC95% 0,679-0,842) apresentaram menor chance de morte. A presença de alguma comorbidade (OR = 1,627; IC95% 1,500-1,765) e idade ≥ 80 anos (OR = 7,426; IC95% 6,309-8,741) foram fatores de risco de óbito. Pacientes com esquema vacinal completo no momento da internação apresentaram uma chance 41,7% menor de morte (OR = 0,583; IC95% 0,501-0,679) por covid-19 na análise ajustada, quando comparados com pacientes não vacinados. CONCLUSÕES O estudo revela que a imunização foi efetiva na redução da chance de óbito por covid-19. Os resultados sugerem que uma maior cobertura vacinal no primeiro semestre de 2021 evitaria milhares de mortes no país.

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.

Factors associated with delayed initiation of breast cancer treatment at an oncology referral center in Juiz de Fora, Minas Gerais state, from 2010 to 2019: a cohort study / Factores asociados al retraso en el inicio del tratamiento del cáncer de mama en un centro oncológico de referencia en Juiz de Fora, de 2010 a 2019: estudio de cohorte / Fatores associados ao atraso para o início do tratamento para câncer de mama em um centro oncológico de referência em Juiz de Fora, de 2010 a 2019: estudo de coorte

ABSTRACT Objectives To analyze factors associated with delayed initiation of breast cancer treatment at an oncology referral center in Juiz de Fora, Minas Gerais state, between 2010 and 2019. Methods This was a cohort study using data from the Hospital-based Cancer Registry. The probability of not starting treatment within 60 days, in accordance with Brazilian law, was estimated using Kaplan-Meier, method and its association with the factors studied was assessed using the Cox model, presenting hazard ratios (HR) and respective 95% confidence intervals (95%CI). Results Among the 911 participants, the probability of delayed treatment initiation was 18.8% (95%CI 16.4;21.5). Those who underwent treatment at a health service other than the one where the cancer was diagnosed had a significantly higher risk (HR: 3.49; 95%CI 3.00;4.07). Conclusion Receiving a diagnosis and treatment at the same institution may help reduce waiting time to initiate cancer treatment.

RESUMEN Objetivos Determinar los retrasos en el inicio del tratamiento de cáncer de mama en un centro de referencia en oncología de Juiz de Fora, MG, entre 2010 y 2019. Métodos Se trata de una cohorte con datos del Registro Hospitalario de Cáncer. La probabilidad de no iniciar tratamiento dentro de los 60 días, según la legislación brasileña, fue estimada mediante el método de Kaplan-Meier, y su asociación con los factores estudiados mediante el modelo de Cox, con la presentación del Hazard Ratios (HR) y los respectivos intervalos de confianza de 95% (IC95%). Resultados Se evaluaron 911 participantes, la probabilidad de iniciar el tratamiento con retraso fue del 18,8% (IC95% 16,4;21,5). Quienes se sometieron a tratamiento en un servicio de salud distinto al que estableció el diagnóstico de cáncer tuvieron un riesgo significativamente mayor (HR: 3,49; IC95% 3,00;4,07). Conclusión La realización del diagnóstico y tratamiento en una misma institución puede contribuir a reducir el tiempo de espera para el inicio del tratamiento.

RESUMO Objetivos Analisar fatores associados ao atraso para o início do tratamento do câncer de mama em um centro de referência em oncologia em Juiz de Fora, MG, entre 2010 e 2019. Métodos Trata-se de coorte com dados do Registro Hospitalar de Câncer. A probabilidade de não iniciar o tratamento em até 60 dias, conforme legislação brasileira, foi estimada pelo método de Kaplan-Meier, e sua associação com os fatores estudados pelo modelo de Cox, com apresentação das hazard ratios (HR) e respectivos intervalos de confiança de 95% (IC95%). Resultados Entre as 911 participantes, a probabilidade de iniciar o tratamento com atraso foi de 18,8% (IC95% 16,4;21,5). Aquelas que realizaram o tratamento em um serviço de saúde diferente do que estabeleceu o diagnóstico de câncer apresentaram risco significativamente maior (HR: 3,49; IC95% 3,00;4,07). Conclusão Realizar diagnóstico e tratamento na mesma instituição pode contribuir para a redução do tempo de espera para o início do tratamento.

Criptococosis meníngea: características y desenlace clínico en un hospital de tercer nivel de Bogotá, Colombia / Meningeal cryptococcosis: characteristics and clinical outcome in a tertiary care hospital in Bogotá, Colombia

Introducción: La criptococosis meníngea es una infección oportunista universal que presenta factores pronósticos variables, especialmente en pacientes inmunosuprimidos. Objetivo: Identificar variables clínicas y paraclínicas asociadas con el desenlace, al final de la hospitalización, en pacientes con criptococosis meníngea atendidos en un hospital de tercer nivel en Bogotá, Colombia. Materiales y métodos: Estudio observacional descriptivo. La información se obtuvo por medio de registros de historias clínicas de pacientes con diagnóstico confirmado de criptococosis meníngea durante el periodo 2016-2021. Resultados: Se analizaron 54 casos, el 85,2 % de ellos de sexo masculino, con una mediana de edad de 38 años. El síntoma principal fue cefalea (74,1 %), con un promedio de duración de 30 días antes del ingreso. El 83,3 % tenía diagnóstico de VIH, con niveles de CD4 por debajo de 50 células/mm3 y recuentos elevados de carga viral. El líquido cefalorraquídeo mostró en más del 50 % hipertensión intracraneal, pleocitosis de predominio linfocitario, hiperproteinorraquia e hipoglucorraquia. El tipo de patógeno aislado más frecuente fue C. neoformans var neoformans. Las variables más prevalentes en el grupo de pacientes que fallecieron fueron la presencia de pleocitosis en LCR (p = 0,025), cultivo para hongo positivo (p = 0,02) y aislamiento C. neoformans var neoformans (p = 0,03). Discusión: La criptococosis meníngea es una patología frecuente en hombres en la cuarta década de la vida y con infección por VIH, sin embargo, los factores relacionados con la mortalidad parecen variar dependiendo de la localización geográfica. Conclusión: En nuestro estudio los factores más prevalentes fueron la presencia de pleocitosis en LCR, cultivo positivo, aislamiento de C. neoformans var neoformans.

Introduction: Meningeal cryptococcosis is a universal opportunistic infection that presents variable prognostic factors, especially in immunosuppressed patients. Objective: To identify clinical and paraclinical variables associated with the outcome at the end of hospitalization in patients with meningeal cryptococcosis treated at a tertiary care hospital in Bogotá, Colombia. Materials and methods: Descriptive observational study. The information was obtained through records of medical records of patients with a confirmed diagnosis of meningeal cryptococcosis during the period 2016-2021. Results: 54 cases were analyzed. 85,2 % men, with a median age of 38 years. The main symptom was headache (74,1 %), with an average duration of 30 days prior to admission. 83,3 % had a diagnosis of HIV, with CD4 levels below 50 cell/mm3 and high viral load counts. The cerebrospinal fluid showed in more than 50 % intracranial hypertension, pleocytosis of lymphocyte predominance, hyperprotein- orrhachia and hypoglycorrhachia. The most frequent type of pathogen isolated was C. neoformans var neoformans. And the most prevalent variables in the group of patients who died were the presence of pleocytosis in CSF (p = 0,025), culture for positive fungus (p = 0,02) and isolation of C. neoformans var neoformans (p = 0,03). Discussion: Meningeal cryptococcosis is a frequent pathology in men, in the fourth decade of life and with HIV infection, however, the factors related to mortality seem to vary depending on the geographical location. Conclusion: In our study, the most prevalent factors were the presence of pleocytosis in CSF, positive culture, isolation of C. neoformans var neoformans.

Evaluación del neurodesarrollo en niños con exposición intrauterina al virus del Zika: estudio observacional transversal / Developmental assessment of children with intrauterine exposure to Zika virus: cross-sectional observational study

El virus del Zika produce desenlaces adversos para el desarrollo del sistema nervioso. Este estudio describe el neurodesarrollo cognitivo, adaptativo, comunicativo, social y motor de niños expuestos intrauterinamente al virus del Zika y hace una evaluación del neurodesarrollo con la escala de Battelle a los tres años después del nacimiento. Participaron 30 niños con una media de edad al momento de la evaluación de 37,5 (RIC: 35,7-39,2) meses. Se halló una edad equivalente en meses en las áreas: motora 25,8 (DE: 7,8), adaptativa 26,7 (DE: 5,8), comunicativa 30,2 (DE: 6,9), personal social 33,5 (DE: 8,3) y cognitiva 35,6 (DE: 5,9). Los niños presentaron retraso en el desarrollo para la edad cronológica, 25 niños presentaban retraso en una de las cinco áreas evaluadas. Una alta proporción de niños expuestos al virus del Zika durante la gestación presentaron retraso en el desarrollo, principalmente en el dominio adaptativo y motor.

Zika virus infection affects the development of the nervous system. This study describes the cognitive, adaptative, communicative, social and motor neurodevelopment of children exposed to Zika virus in utero. We used the Batelle scale to assess neurodevelopment three years after birth. Thirty children were included, who had a mean age at evaluation of 37.5 (IQR: 35.7-39.2) months. We found the following equivalent ages in months for each area: motor 25.8 (SD: 7.8), adaptive 26.7 (SD: 5.8), communicative 30.2 (SD: 6.9), social personal 33.5 (SD: 8.3) and cognitive 35.6 (SD: 5.9). Children showed development delay for their chronological age, 25 children were delayed in one of the five areas assessed. A high rate of children exposed to Zika virus during gestation presented delayed developmental age, mainly regarding the adaptive and motor areas.

Life-style behavior upon admission to higher education in Chilean university students: A longitudinal observational study / Comportamiento de estilo de vida al ingresar a la educación superior en estudiantes universitarios chilenos: Un estudio observacional longitudinal

AIM: The main objective of this study was to analyze the change in physical activity, quality of diet, and weight upon admission to higher education and at one-year follow-up in Chilean university students. MATERIALS AND METHODS: 376 Chilean university students were prospectively recruited. All participants were assessed at bas eline and one-year follow-up. Sociodemographics and other co-variables were described. Physical activity, healthy eating behavior, height, weight, and body mass index (BMI) were assessed using the Global Physical Activity Questionnaire (GPAQ), and quality of diet (with Healthy Eating Index), SECA 213 stadiometer and TANITA HD-351, respectively. RESULTS: At the one-year follow-up, high-intensity METs (Metabolic equivalents) decreased by 147.9 (95% CI: 79.5 to 216; p = 0.000), moderate-intensity METs decreased by 85.0 (95% CI: 52.2 to 117.7; p = 0.000), sedentary behavior increased by 45.0 min/week (95% CI: 54.6 to 35.4; p = 0.000), total METs decreased by 793.6 (95% CI: 613.0 to 974.1; p = 0.000), HEI decreased by 45.4 points (95% CI: 48.5 to 82.1; p = 0.000), weight increased by 5.9 kg (95% CI: 3.5 to 6.3; p = 0.002), and BMI increased by 2.8 kg/m2 (95% CI: 2.7 to 3.2; p = 0.000). The correlation between total METs and the HEI was r = 0.21 (p = 0.013). CONCLUSIONS: There are statistically significant differences at one-year follow-up in Chilean university students in decreased physical activity, impaired healthy eating behavior, and increased weight and BMI.

OBJETIVO: El objetivo principal fue analizar los cambios en la actividad física, calidad de la dieta y el peso al ingreso a la educación superior y al año de seguimiento en estudiantes universitarios chilenos. MATERIALES Y MÉTODOS: Un total de 376 estudiantes universitarios chilenos fueron prospectivamente reclutados. Todos los participantes fueron evaluados al ingreso y al año de seguimiento. Se describieron las variables sociodemográficas y otras co-variables. La actividad física, el comportamiento de alimentación saludable, el peso, talla y el Índice de Masa Corporal (IMC) fueron evaluados con el Cuestionario Global de Actividad Física (CGAF), el Índice de Alimentación Saludable (IAS), estadiómetro SECA 213 y el TANITA HD-351, respectivamente. RESULTADOS: Al año de seguimiento, los METs a alta intensidad disminuyeron 147,9 (95% IC: 79,5 a 216; p = 0,000), METs a moderada intensidad disminuyeron 85,0 (95% IC: 52,2 a 117,7; p = 0,000), el comportamiento sedentario incremento 45,0 min/semana (95% IC: 54,6 a 35,4; p = 0,000), los METs totales disminuyeron 793,6 (95% CI: 613,0 a 974,1; p = 0,000), IAS disminuyó 45,4 puntos (95% IC: 48,5 a 82,1; p = 0,000), el peso aumento 5,9 kg (95% IC: 3,5 a 6,3; p = 0,002), y el IMC incrementó 2,8 kg/m2 (95% IC: 2,7 a 3,2; p = 0,000). La relación entre los METs totales y el IAS fue r = 0,21 (p = 0,013). CONCLUSIONES: Al año de seguimiento, hubo diferencias estadísticamente significativas en la disminución de la actividad física, deterioro del comportamiento de alimentación saludable, e incremento del peso e IMC en estudiantes universitarios chilenos.

Gravidade da depressão, resposta ao tratamento e PRO (incapacidade e QoL) em pacientes com DRT em um ano de acompanhamento com tratamento padrão: análise do subgrupo brasileiro do estudo observacional multinacional TRAL / Depression severity, treatment response and PRO (disability and QoL) in TRD patients over a 1-year follow-up with standard of care: Analysis of the Brazilian subset of the multicenter, observational TRAL study

Objetivo: A depressão resistente ao tratamento (DRT) é uma preocupação primária no Brasil devido à sua natureza onerosa e complexa, enquanto o diagnóstico e o tratamento geralmente são desafiadores. O presente manuscrito apresenta os resultados clínicos de um ano de acompanhamento em pacientes com DRT em tratamento padrão (SOC) no subgrupo brasileiro do estudo de Depressão Resistente ao Tratamento na América Latina (TRAL). Métodos: Essa fase longitudinal do estudo TRAL tinha como meta caracterizar alterações nos resultados clínicos e outras variáveis de interesse (p. ex., qualidade de vida, incapacidade) em um ano de acompanhamento em pacientes com DRT em 10 centros no Brasil. Os pacientes incluídos tinham diagnóstico clínico de DRT com base nos critérios DSM-5 e confirmado por MINI. A Escala de Depressão de Montgomery-Asberg (MADRS) era usada para avaliar a gravidade da doença e os resultados clínicos. Outras escalas de depressão e instrumentos classificados pelo paciente eram usadas para medir resultados correlacionados. Resultados: Cento e cinquenta e oito pacientes com DRT, na maioria mulheres (84,4%) com idade média de 48,55 anos, foram incluídos na análise. Apenas 31,4% dos pacientes apresentaram uma resposta clinicamente significativa, 10,3% tiveram recidiva e 26,7% alcançaram remissão, conforme medido pela MADRS no final do estudo (EOS). Aproximadamente 55% dos pacientes apresentavam depressão grave/moderadamente grave no EOS. Problemas de mobilidade, cuidados pessoais, problemas nas atividades usuais e dor e desconforto foram relatados pela maioria dos pacientes no EOS, assim como comprometimento marcado/extremo das atividades no trabalho/escola e da vida social/das atividades de lazer no EOS. Conclusões: Os resultados clínicos alcançados atualmente ainda são notavelmente insatisfatórios para DRT. Portanto, o envolvimento de todas as partes interessadas é essencial para implementar protocolos de tratamento mais eficazes no Brasil.

Objective: Treatment-resistant depression (TRD) is a primary concern in Brazil due to its burdensome and complex nature, while diagnosis and treatment is often challenging. The current manuscript presents the clinical outcomes in a one-year follow-up of TRD patients under Standard-of-care (SOC) in the Brazilian subset of the Treatment-Resistant Depression in America Latina (TRAL) study. Methods: This longitudinal phase of TRAL aimed to characterize changes in the clinical outcomes and other variables of interest (e.g. quality of life, disability) in a one-year follow-up of TRD patients in 10 centers in Brazil. Included patients were clinically diagnosed with TRD based on DSM-5 criteria and confirmed by MINI. Montgomery-Asberg Depression Rating Scale (MADRS) was used to assess disease severity and clinical outcomes. Other depression scales and patient rated instruments were used to measure correlated outcomes. Results: One hundred fifty-eight TRD patients, mostly female (84.4%), averaging 48.55 years, were included in the analysis. Only 31.4% of the patients showed a clinically significant response, 10.3% had a relapse and 26.7% achieved remission, as measured through MADRS at end-of-study (EOS). Almost 55% of the patients showed moderately severe/severe depression at EOS. Mobility issues, self-care, problems with usual activities and pain and discomfort were reported by the majority of the patients at EOS, as well as marked/extreme disruption of school/work and social life/leisure activities at EOS. Conclusions: Currently achieved clinical outcomes are still remarkably unsatisfactory for TRD. Therefore, the involvement of all relevant stakeholders is essential to implement more effective treatment protocols in Brazil.

Spiritual needs among hospitalized patients at a public hospital in Brazil: a cross-sectional study

ABSTRACT BACKGROUND: The relationship between spirituality and health has been the object of growing discussion. There is a lack of data on spiritual needs assessments in Brazil. OBJECTIVE: This study aimed to assess the spiritual needs of patients admitted to a public tertiary hospital and perform a comparative analysis between patients with and without indications for palliative care. DESIGN AND SETTING: A cross-sectional observational study included patients hospitalized between August and December 2020 in Hospital do Servidor Publico Municipal, Sao Paulo, Brazil. METHODS: The included patients answered a questionnaire consisting of sociodemographic data, the Duke religiosity scale, and the Spiritual Needs Assessment for Patients (SNAP) tool for a spiritual needs assessment. The World Health Organization Palliative Needs tool (NECPAL) was used to evaluate the indications for palliative care. The level of significance adopted was 5%. RESULTS: A total of 66 patients were included in this study. Most participants (97%) declared themselves as belonging to a religion. The group without indication for palliative care by the NECPAL showed greater spiritual (P = 0.043) and psychosocial needs (P = 0.004). No statistically significant difference was observed in the religious needs domain (P = 0.176). There were no statistically significant differences in the Duke scale scores between the two groups. CONCLUSION: Spiritual, psychosocial, and religious needs are prevalent among hospitalized patients, and multidisciplinary teams must consider these needs in their management approach. In addition, this study suggests that psychosocial and spiritual needs can be even higher in patients who do not receive palliative care.

Desenlace funcional asociado al ataque cerebrovascular menor en una población colombiana: un estudio de cohorte / Functional outcome associated with minor stroke in a colombian population: a cohort study

RESUMEN INTRODUCCIÓN. El ACV menor hace referencia a un evento isquémico que cursa con síntomas leves. Se ha señalado que estos pacientes pueden presentar un desenlace clínico desfavorable. OBJETIVO: Evaluar el desenlace funcional a 90 días de pacientes con ACV isquémico menor, atendidos en dos hospitales de Bucaramanga, Colombia, entre los años 2015 y 2017. MÉTODOS. Estudio de cohorte en pacientes con ACV isquémico agudo y un puntaje NIHSS ≤ 5 puntos. Un desenlace clínico desfavorable a 90 días de seguimiento fue medido como un puntaje Rankin-m ≥ 3 puntos. Se realizó un análisis bivariado a través de modelos de regresión binomial simple y ajustado por edad y sexo. Un valor p <0,05 fue considerado estadísticamente significativo. RESULTADOS. Se incluyeron 90 pacientes (edad de 66,6± 13,5 años, 54,4% (n=49) de sexo masculino). El 36,5% (n=23) de los pacientes presentó un puntaje Rankin-m de 3 a 6 puntos. El antecedente de diabetes mellitus (RR: 2,50 IC 95%:1,33-4,70) y un Rankin-m previo de 2 (RR 2,12 IC 95%:1,39-3,24) fueron variables independientemente asociadas a discapacidad significativa. CONCLUSIÓN. Un estado funcional previamente comprometido, sumado a la disfunción endotelial que genera la diabetes mellitus, contribuye a un desenlace desfavorable en los pacientes con ACV menor.

ABSTRACT INTRODUCTION. Minor stroke refers to an ischemic vascular event that start with discrete symptoms. It has been suggested that these patients may have an unfavorable clinical outcome. AIM. To evaluate the functional outcome at 90 days in patients with minor ischemic stroke in two hospitals in Bucaramanga, between 2015 and 2017. METHODS. Cohort study in patients with acute ischemic stroke and NIHSS ≤ 5 points. An unfavorable clinical outcome was measured according to the modified Rankin Scale as ≥ 3 points. A bivariate analysis was performed through simple binomial regression models adjusted for age and sex. A p-value <0.05 was considered statistically significant. RESULTS. 90 patients were included (Aged 66.6 ± 13.5 years, 49 males (54%); 23 (36,5%) presented a modified Rankin score of 3-6 points. A history of diabetes (RR: 2.50 CI 95%: 1.33-4.70) and a modified Rankin score of 2 points prior to the event (RR 2.12 CI 95%: 1.39-3.24) were independently associated with significant disability CONCLUSION. A previously compromised functional state, added to the endothelial dysfunction generated by diabetes mellitus, contribute significantly to an unfavorable outcome in patients with minor stroke.

Age and Type of Delivery as Risk Indicators for Maternal Mortality / Idade e tipo de parto como indicadores de risco para mortalidade materna

Abstract Objective: This study assessed maternal mortality (MM) and related factors in a large-sized municipality in the Southeastern region of Brazil (Campinas, São Paulo) during the period 2000-2015. Methods: This study consisted of two phases: 1. An analytical nested case-control phase that assessed the impact of individual and contextual variables on MM; and 2. an ecological phase designed to contextualize maternal deaths by means of spatial analysis. The case group consisted of all maternal deaths (n = 87) and the control group consisted of 348 women who gave birth during the same period. Data analysis included descriptive statistics, association, and multiple logistic regression (MLR) tests at p < 0.05 as well as spatial analysis. Results: Maternal Mortality Ratio was 37 deaths per 100.000 live births. Deaths were dispersed throughout the urban territory and no formation of cluster was observed. MLR showed that pregnant women aged > 35 years old (OR = 2.63) or those with cesarean delivery (OR = 2.51) were more prone to maternal death. Conclusion: Maternal deaths were distributed dispersedly among the different socioeconomic levels and more prone to occur among older women or those undergoing cesarean deliveries.

Resumo Objetivo: Esse estudo avaliou a mortalidade materna (MM) e fatores relacionados em um município de grande porte da região sudeste do Brasil (Campinas, São Paulo) no período de 2000-2015. Métodos: Esse estudo consistiu de duas fases: 1. Uma fase analítica de caso-controle que avaliou o impacto de variáveis individuais e contextuais na MM; 2. Uma fase ecológica delineada para contextualizar as mortes maternas por meio de análise espacial. O grupo caso consistiu de 87 mortes maternas e o grupo controle de 348 mulheres que tiveram bebês durante o mesmo período. Os dados foram analisados por estatística descritiva, testes de associação e regressão logística múltipla (RLM) (p < 0,05) assim como análise espacial. Resultados: A taxa de mortalidade materna foi de 37 mortes para cada 100.000 nascidos vivos. As mortes foram dispersas por todo o território urbano e não se observou formação de clusters. Na RLM observou-se que mulheres grávidas com idade > 35 anos (OR = 2,63) ou aquelas que passaram por cesárea (OR = 2,51) foram mais propensas à morte materna. Conclusão: As mortes maternas foram distribuídas dispersamente entre os diferentes níveis socioeconômicos e mais propensas a ocorrer entre mulheres > 35 anos de idade ou que passaram por cesárea.

Tamanho do efeito em estudos observacionais na área de Saúde Bucal Coletiva: importância, cálculo e interpretação / Size effect in observational studies in Public Oral Health: importance, calculation and interpretation

Resumo O objetivo deste estudo foi analisar a literatura científica da área de saúde bucal coletiva quanto ao cálculo, apresentação e discussão do tamanho do efeito em estudos observacionais. A literatura cientifica na área (2015 a 2019) foi analisada quanto: a) informações gerais (periódico e diretrizes aos autores, número de variáveis e desfechos), b) objetivo e coerência com o cálculo amostral apresentado; c) tamanho do efeito (apresentação, medida utilizada e coerência com a discussão dos dados e conclusão). Foram analisados 123 artigos, de 66 periódicos. A maioria dos artigos avaliados apresenta um único desfecho (74%) e não menciona a realização de cálculo amostral (69,9%). Dentre os que realizaram, para 70,3% havia coerência entre o cálculo amostral utilizado e o objetivo. Apenas 3,3% dos artigos mencionam o termo tamanho do efeito e 24,4% não o consideram na discussão dos resultados, apesar de terem calculado. A regressão logística foi a metodologia estatística mais utilizada (98,4%) e o Odds Ratio a medida de tamanho do efeito mais utilizada (94,3%), embora não tenha sido citada e discutida como uma medida de tamanho do efeito na maioria dos estudos (96,7%). Os pesquisadores, em sua maioria, restringiram a discussão dos resultados apenas à significância estatística encontrada nas associações testadas.

Abstract The objective of this study was to analyze the scientific literature in public oral health regarding calculation, presentation, and discussion of the effect size in observational studies. The scientific literature (2015 to 2019) was analyzed regarding: a) general information (journal and guidelines to authors, number of variables and outcomes), b) objective and consistency with sample calculation presentation; c) effect size (presentation, measure used and consistency with data discussion and conclusion). A total of 123 articles from 66 journals were analyzed. Most articles analyzed presented a single outcome (74%) and did not mention sample size calculation (69.9%). Among those who did, 70.3% showed consistency between sample calculation used and the objective. Only 3.3% of articles mentioned the term effect size and 24.4% did not consider that in the discussion of results, despite showing effect size calculation. Logistic regression was the most commonly used statistical methodology (98.4%) and Odds Ratio was the most commonly used effect size measure (94.3%), although it was not cited and discussed as an effect size measure in most studies (96.7%). It could be concluded that most researchers restrict the discussion of their results only to the statistical significance found in associations under study.

Relação entre variáveis antropométricas e de aptidão física em crianças e adolescentes estratificados por sexo / Relationship between anthropometric and physical fitness variables in children and adolescents stratified by sex / Relación entre variables antropométricas y de aptitud física en niños y adolescentes estratificados por sexo

A aptidão física (ApF) pode estar associada à saúde, ao desempenho esportivo e refere-se a capacidade de apresentar um determinado desempenho motor quando submetido a situações que envolvam esforços físicos. O objetivo deste estudo foi relacionar as variáveis antropométricas e de aptidão física em crianças e adolescentes da cidade de Pelotas/RS, estratificados por sexo. Foram avaliados 1720 escolares da rede municipal de Pelotas/RS, sendo 896 crianças (idade = 9,91 ± 1,21 anos) e 824 adolescentes (idade = 13,11 ± 1,04 anos), através de uma bateria de avaliações das medidas antropométricas (estatura [EST], massa corporal [MC], envergadura [ENV], índice de massa corporal [IMC]) e de testes físicos (flexibilidade [FLEX], potência de membros superiores [PMS], potência de membros inferiores [PMI], velocidade com troca de direção [VTD], velocidade linear [VL], resistência muscular localizada [RML] e capacidade cardiorrespiratória [CC]). O estudo de caráter de diagnóstico com cunho observacional utilizou o teste de correlação através do r de Pearson e classificou-as como muito fraca (0-0,19), fraca (0,2-0,39), moderada (0,4-0,69), forte (0,7-0,89) e muito forte (0,9-1). Destacou-se que no sexo feminino houve correlação moderada com IMC e PMS, as variáveis antropométricas EST, ENV e MC apresentaram pelo menos uma correlação com as variáveis de ApF, enquanto que estas variáveis demonstraram correlações moderadas entre PMS, VL e VTD. Já no sexo masculino foi observada correlação moderada entre IMC e CC, além de correlações fracas e moderadas entre EST, ENV e MC com pelo menos uma das variáveis de ApF, enquanto as variáveis de ApF demonstraram correlações moderadas entre PMI, VL e VTD. Portanto, ressalta-se a importância do diagnóstico destas variáveis para controle dos fatores de risco à saúde bem como para identificar potenciais relacionados ao desempenho esportivo.

Physical fitness (PhF) can be associated with health, sports performance and refers to the ability to present a certain motor performance when submitted to situations involving physical efforts. The aim of this study was to relate anthropometric and physical fitness variables in children and adolescents from the city of Pelotas/RS, stratified by sex. A total of 1720 schoolchildren from the municipal schools of Pelotas/RS were evaluated, 896 children (age = 9.91 ± 1.21 years) and 824 adolescents (age = 13.11 ± 1.04 years), through a battery of the anthropometric measurements (height [HT], body mass [BM], wingspan [WP], body mass index [BMI]) and physical tests (flexibility [FLEX], upper limb power [ULP], lower limb power [LLP], change of direction speed [CODS], linear speed [LS], localized muscular endurance [LME] and cardiorespiratory capacity [CC]). The study of a diagnostic character with an observational nature used the correlation test through Pearson's r and classified them as very small (0-0.19), small (0.2- 0.39), moderate (0.4- 0.69), large (0.7-0.89) and very large (0.9-1). It was highlighted that in females there was moderate correlation with BMI and ULP, the anthropometric variables HT, WP and BM showed at least one correlation with the PhF variables, while these variables showed moderate correlations between ULP, LS and CODS. In males, a moderate correlation was observed between BMI and CC, in addition to small and moderate correlations between HT, WP and BM with at least one of the PhF variables, while the PhF variables showed moderate correlations between LLP, LS and CODS. Therefore, it emphasizes the importance of diagnosing these variables to control health risk factors as well as to identify potentials related to sports performance.

La aptitud física (AF) puede estar asociada a la salud, al rendimiento deportivo y se refiere a la capacidad de presentar un determinado desempeño motor cuando sometido a situaciones que impliquen esfuerzos físicos. El objetivo de este estudio fue relacionar variables antropométricas y de aptitud física en niños y adolescentes de la ciudad de Pelotas/RS, estratificados por sexo. Fueron evaluados 1720 escolares de las escuelas municipales de Pelotas/RS, 896 niños (edad = 9,91 ± 1,21 años) y 824 adolescentes (edad = 13,11 ± 1. 04 años), a través de una batería de medidas antropométricas (altura [HT], masa corporal [BM], envergadura [WP], índice de masa corporal [IMC]) y pruebas físicas (flexibilidad [FLEX], potencia de miembros superiores [ULP], potencia de miembros inferiores [LLP], velocidad de cambio de dirección [CODS], velocidad lineal [LS], resistencia muscular localizada [LME] y capacidad cardiorrespiratoria [CC]). El estudio, de carácter diagnóstico y observacional, utilizó la prueba de correlación mediante la r de Pearson y las clasificó en muy pequeñas (0-0,19), pequeñas (0,2-0,39), moderadas (0,4- 0,69), grandes (0,7-0,89) y muy grandes (0,9-1). Se destacó que en las hembras hubo una correlación moderada con el IMC y el ULP, las variables antropométricas HT, WP y BM mostraron al menos una correlación con las variables PhF, mientras que estas variables mostraron correlaciones moderadas entre ULP, LS y CODS. En los varones, se observó una correlación moderada entre IMC y CC, además de correlaciones pequeñas y moderadas entre HT, WP y BM con al menos una de las variables PhF, mientras que las variables PhF mostraron correlaciones moderadas entre LLP, LS y CODS. Por lo tanto, se destaca la importancia del diagnóstico de estas variables para controlar los factores de riesgo para la salud, así como para identificar potenciales relacionados con el rendimiento deportivo.

Target Trial Emulation and Feasibility in Traditional Chinese Medicine Researches / 中医杂志

Target trial emulation， using observational data to emulate a target trial， applies the study design principles of randomized controlled trials to observational studies that aim to estimate the effect of an intervention. The advantage of target trial emulation is that observational data is used to emulate a target trial when it is not appropriate to conduct randomized controlled trials. Target trial emulation can control bias caused by the design of observational studies， and improve the effectiveness of causal inference from observational data. This paper introduced the methodological framework and key points in terms of eligibility criteria， treatment strategies， assignment procedures， grace period， outcomes， follow-up period， effect contrasts， and statistical plan for implementing target trial emulation. This article elucidated the feasibility and necessity of applying target trail emulation in the realm of traditional Chinese medicine researches， and highlighted the challenges encountered in its implementation， such as the need for specialized personnel， data collection and integration， and the control of confounding factors.

Observational study on improvement of hypotension in hemodialysis with blood volume feedback control system / 中华肾脏病杂志

Objective:To study the effect of blood volume feedback control system on improving intradialytic-hypotension (IDH) in maintenance hemodialysis (MHD) patients.Methods:It was a prospective cohort study. Thirty MHD patients with recurrent IDH in the Dialysis Center of the First Affiliated Hospital of Zhejiang University School of Medicine from March 2021 to March 2022 were selected. A self-control study was conducted in MHD patients. The patients were treated with routine hemodialysis in both baseline phase (A1) and reversal phase (A2), while with hemodialysis under the blood volume feedback control system in intervention phase (B). Each phase lasted for 4 weeks (12 hemodialysis sessions). The average occurrences of IDH and IDH-related adverse events (IDH-RAE, stopping dehydration for more than 10 minutes or getting off the hemodialysis machine 10 minutes earlier due to IDH) of each patient between phase A1, B, and A2 were calculated and compared. In a total of 1 080 dialysis records, a logistic regression analysis model was established with age, sex and intervention as independent variables and with the occurrence of IDH-RAE as the outcome.Results:A total of 30 eligible patients were included in the study, including 14 males (46.7%) and 16 females (53.3%), aged 63.0 (56.5, 72.5) years old, with a median dialysis age of 84.0 (37.2, 120.0) months. The average times of IDH in 30 MHD patients decreased from 1.17 (0.83, 1.67) in stage A1 (before intervention) to 0.33 (0.25, 0.58) in stage B (after intervention) ( P<0.05). The frequency of IDH-RAE decreased significantly from 0.29 (0.19, 0.47) in stage A1 to 0.17 (0,0.25) in stage B ( P<0.05). Logistic regression analysis results indicated that the use of blood volume feedback control system reduced the risk of IDH-RAE by 53% ( OR=0.47, 95% CI 0.34-0.64, P<0.001). Conclusions:The application of blood volume feedback control system can effectively reduce the occurrences of IDH and the risk of IDH-RAE in MHD patients.

Introduction to informed consent mode of health data utilization in medical institutions and analysis of key points of selection / 中华医学科研管理杂志

Objective:With the rapid increase in the number of real world studies, especially the use of health data in medical institutions, ethical issues such as the use of patient health data and the protection of patient′s privacy rights and the right to know have been gradually exposed. To strike a good balance between promoting data sharing and maintaining subjects′ personal privacy, the mode of informed consent appears to be crucial. This paper provided guidance for the selection of informed consent models for real world research health data utilization.Methods:The authors extensively studied the relevant laws and regulations of health data utilization worldwide, conducted extensive searches in Chinese and English databases, sorted out and analyzed various alternative informed consent models, and summarized their characteristics and applications.Results:At present, five alternative informed consent models were used to conduct real world research based on health data utilization. Researchers can choose informed consent models according to the research purpose, research design, research risk, operability of informed consent, and vulnerable groups.Conclusions:Different alternative informed consent models have varied characteristics. Researchers need to choose informed consent models based on the above factors to ensure the maximum protection of patients' privacy rights while using health data.

Estimation of Average Treatment Effect Using Bayesian Additive Regression Tree in Observational Study / 中国卫生统计

Objective To explore the statistical performance and applicable conditions of Bayesian additive regression tree(BART)for estimating average treatment effect in observational studies.Methods The difference of estimates between BART and multivariate regression,propensity score matching,and inverse probability weighting through simulations and actual epidemiological data was compared.Results The results of these simulations showed that under the linear assumption,the performance of BART was close to that of the commonly used methods;when the relationship among variables in the data was complex and non-linear,BART performed markedly better than the others.When the ignorability assumption was not satisfied and there was unobserved confounding,all methods performed worse,but BART was still significantly better than the others and relatively robust.In the actual epidemiological data,this method was used to estimate the average treatment effect of smoking cessation on weight change.Conclusion In most observational studies,outcomes are influenced by multiple factors,making it difficult for researchers to properly specify relationships between variables.It is difficult to identify all these variables or determine the relationship between them.In terms of model fitting and result accuracy,BART is worth recommending.

Dental Fear/Anxiety in Children and Child Emotional and Behavioural Problems

ABSTRACT Objective: To investigate the association between emotional and behavioural problems and dental fear/anxiety (DFA) in children aged four to 12 years treated at a clinic in southern Brazil. Material and Methods: In this cross-sectional study where mother-child dyads were interviewed, emotional and behavioural problems were investigated using the Strengths and Difficulties Questionnaire (SDQ) (considering five subscales). Children's DFA was evaluated through the Venham Picture Test. For each SDQ subscale, Poisson regression model was explored. Prevalence ratios (PR) were estimated, considering a significant level of p ≤ 0.05. Results: Overall, 128 children participated in this study. Most children were female (54.7%) and aged between 7 and 9 years (39.8%). The prevalence of emotional problems was 47.7% and behavioural problems were 46.1%. The prevalence of DFA was 18.8%. Children with emotional problems had a 2.3 higher prevalence of DFA (95%CI 1.06-5.04). In general, behavioural problems were not associated with DFA (95%CI 0.84-3.34) only when conduct problems were considered (2.20; 95%CI 1.02-4.70). Conclusion: Children aged between 4 and 12 years who present emotional and conduct problems tend to show higher DFA.

A Hospital-based Observational Study of Newly diagnosed Sthula Prameha Subjects with special reference to type 2 Diabetes Mellitus from Maharashtra, India

Abstract The aim of this study is to provide a real picture of the disease burden of Prameha in society. The study was performed in Government Ayurved College and Hospital, Nagpur, Maharashtra during Oct 2015-Mar 2016. Total 60 patients of newly diagnosed type 2 diabetes mellitus attending the Kayachikitsa Opd of GAC Nagpur were included for the study. The subjects details were recorded in case report form. The CRF included many variables such as sociodemographic factors, presenting symptoms, risk factors such as hypertension, obesity and glycaemic status, family history of diabetes and physical activity. Other parameters like BMI, glycosylated haemoglobin, fasting and post prandial blood sugar and fasting lipid profile were documented. Descriptive and bivariate analyses were carried out using the XLSTAT software (2020). Amongst 60 subjects, 65% were male and 93.3% were adults. 78% of subjects were following sedentary lifestyle and 40% had family history of diabetes. The results revealed that, obesity, family history of diabetes, uncontrolled glycemic status, sedentary lifestyles, and hypertension were prevalent among the Prameha subjects. The characterization of this risk profile and early detection of prameha by observing poorvarupa will contribute to designing more effective and specific strategies for screening and controlling Prameha in Maharashtra, India.