Adverse events following immunization of elderly with COVID-19 inactivated virus vaccine (CoronaVac) in Southeastern Brazil: an active surveillance study.

Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.

Adverse events following immunization of elderly with COVID-19 inactivated virus vaccine (CoronaVac) in Southeastern Brazil: an active surveillance study

ABSTRACT Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.

Delirium and Adverse Outcomes in Hospitalized Patients with COVID-19.

BACKGROUND: Little is known about the association between acute mental changes and adverse outcomes in hospitalized adults with COVID-19. OBJECTIVES: To investigate the occurrence of delirium in hospitalized patients with COVID-19 and explore its association with adverse outcomes. DESIGN: Longitudinal observational study. SETTING: Tertiary university hospital dedicated to the care of severe cases of COVID-19 in São Paulo, Brazil. PARTICIPANTS: A total of 707 patients, aged 50 years or older, consecutively admitted to the hospital between March and May 2020. MEASUREMENTS: We completed detailed reviews of electronic medical records to collect our data. We identified delirium occurrence using the Chart-Based Delirium Identification Instrument (CHART-DEL). Trained physicians with a background in geriatric medicine completed all CHART-DEL assessments. We complemented our baseline clinical information using telephone interviews with participants or their proxy. Our outcomes of interest were in-hospital death, length of stay, admission to intensive care, and ventilator utilization. We adjusted all multivariable analyses for age, sex, clinical history, vital signs, and relevant laboratory biomarkers (lymphocyte count, C-reactive protein, glomerular filtration rate, D-dimer, and albumin). RESULTS: Overall, we identified delirium in 234 participants (33%). On admission, 86 (12%) were delirious. We observed 273 deaths (39%) in our sample, and in-hospital mortality reached 55% in patients who experienced delirium. Delirium was associated with in-hospital death, with an adjusted odds ratio of 1.75 (95% confidence interval = 1.15-2.66); the association held both in middle-aged and older adults. Delirium was also associated with increased length of stay, admission to intensive care, and ventilator utilization. CONCLUSION: Delirium was independently associated with in-hospital death in adults aged 50 years and older with COVID-19. Despite the difficulties for patient care during the pandemic, clinicians should routinely monitor delirium when assessing severity and prognosis of COVID-19 patients.

AMPI-AB validity and reliability: a multidimensional tool in resource-limited primary care settings.

BACKGROUND: The early identification of individuals at high risk for adverse outcomes by a Comprehensive Geriatric Assessment (CGA) in resource-limited primary care settings enables tailored treatments, however, the evidence concerning its benefits are still controversial. The main objective of this study was to examine the validity and reliability of the "Multidimensional Assessment of Older People in Primary Care (AMPI-AB)", a CGA for primary care in resource-limited settings. METHODS: Longitudinal study, with median follow-up time of 16 months. Older adults from a public primary care unit in São Paulo, Brazil, were consecutively admitted. Reliability was tested in a sample from a public geriatric outpatient clinic. Participants were classified by the AMPI-AB score as requiring a low, intermediate or high complexity of care. The Physical Frailty Phenotype was used to explore the AMPI-AB's concurrent validity. Predictive validity was assessed with mortality, worsening of the functional status, hospitalizations, emergency room (ER) visits and falls. The area under the ROC curve and logistic regression were calculated for binary outcomes, and a Cox proportional hazards model was used for survival analysis. RESULTS: Older adults (n = 317) with a median age of 80 (74-86) years, 67% female, were consecutively admitted. At the follow-up, 7.1% of participants had died, and increased dependency on basic and instrumental activities of daily living was detected in 8.9 and 41.1% of the participants, respectively. The AMPI-AB score was accurate in detecting frailty (area under the ROC curve = 0.851), predicted mortality (HR = 1.25, 95%CI = 1.13-1.39) and increased dependency on basic (OR = 1.26, 95%CI = 1.10-1.46) and instrumental (OR = 1.22, 95%CI = 1.12-1.34) activities of daily living, hospitalizations (OR = 2.05, 95%CI = 1.04-1.26), ER visits (OR = 1.20, 95%CI = 1.10-1.31) and falls (OR = 1.10, 95%CI = 1.01-1.20), all models adjusted for sex and years of schooling. Reliability was tested in a sample of 52 older adults with a median age of 72 (85-64) years, 63.5% female. The AMPI-AB also had good interrater (ICC = 0.87, 95%CI = 0.78-0.92), test-retest (ICC = 0.86, 95%CI = 0.76-0.93) and proxy reliability (ICC = 0.84, 95%CI = 0.67-0.93). The Cronbach's alpha was 0.69, and the mean AMPI-AB administration time was 05:44 ± 02:42 min. CONCLUSION: The AMPI-AB is a valid and reliable tool for managing older adults in resource-limited primary care settings.

Hemorragia alveolar associada a nefrite lúpica / Alveolar hemorrhage associated with lupus nephritis

Hemorragia alveolar, como causa de insuficiência respiratória, é pouco freqüente, com diversas etiologias possíveis. Entre elas, o lúpus eritematoso sistêmico, que se apresenta geralmente como síndrome pulmão-rim, possui alta morbimortalidade. Acredita-se que a patogênese da microangiopatia, tanto renal como pulmonar, esteja associada ao depósito de imunocomplexos, que ativariam as vias de apoptose celular. Relatam-se dois casos de pacientes com nefrite lúpica que evoluíram com hemorragia alveolar associada à insuficiência respiratória necessitando de ventilação mecânica com evoluções totalmente distintas frente às terapias farmacológicas. O achado de anticorpos antimembrana basal em um dos casos evidencia a multiplicidade de mecanismos fisiopatológicos possivelmente envolvidos, que poderiam justificar as respostas heterogêneas frente aos tratamentos disponíveis.

Aleitamento materno e condições socioeconômico-culturais: fatores que levam ao desmame precoce / Breast-feeding and socioeconomic cultural status: factors that lead to early weaning

Objetivos: avaliar o aleitamento materno, ressaltando os fatores que levaram ao desmame precoce conforme as condições socioeconômico-culturais. Métodos: analisou-se uma amostra de 599 crianças e seus responsáveis que procuraram o Pronto Socorro do Instituto da Criança, São Paulo, de agosto a dezembro de 1998. Utilizou-se um questionário incluindo: idade, profissão e escolaridade dos pais, condições de moradia, renda familiar, trabalho materno, duração da amamentação exclusiva, introdução de novos alimentos, causas de desmame e importância do leite materno. Resultados: 86,1 por cento das mães amamentaram e 92 por cento referiram saber a importância do leite materno. A idade média do desmame foi de 3,3 meses, sendo que 75,9 por cento das mães suspenderam a amamentação sem orientação médica. 38,9 por cento referiram que o leite era "fraco", ou "secou" ou que a criança "largou" o peito. Maior escolaridade da mãe e presença de rede de esgoto mostraram relação com maior tempo de aleitamento (p = 0,016 e p= 0,011 respectivamente). Não houve associação entre acompanhamento da criança no posto de saúde e tempo de aleitamento materno. Conclusões: embora a grande maioria das mães saiba a importância do leite materno e tenha amamentado seu filho, a duração do aleitamento materno exclusivo é menor do que o preconizado pela Organização Mundial da Saúde, sendo a baixa escolaridade um fator para o desmame precoce.