Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...
The purpose of this community-based study was to assess the prevalence of chronic diseases among 18-65 year old Bhutanese refugee women resettled in Northeast Ohio, United States (US). A Nepali-language questionnaire was administered in a face-to-face mode. Anthropometric measurements included height, weight, and hip and waist circumferences. The overall prevalence (95 % confidence interval) of self-reported hypertension, diabetes, asthma, heart disease, and cancer were 15.3 % (9.2-23.4), 6.4 % (2.3-10.9), 5.5 % (2.0-11.5), 2.7 % (0.6-7.8), and 1.8 % (0.2-6.4), respectively. Overweight/obesity was observed in 64.8 % of the women; 69.5 and 74.1 % had waist circumference >80 cm and waist-to-hip ratio ≥85, respectively. Length of time in the US was not associated with the prevalence of the chronic conditions. This study suggests chronic conditions may be significant health issues among US resettled Bhutanese refugees and a larger population-based study to confirm the findings is warranted.
Studies of obesity and related health conditions among the Bhutanese, one of the largest refugee groups resettled in the United States in the past five years, are limited. This study examined the factors associated with excess body weight (body mass index ≥ 23 kg/m2) and abdominal obesity (waist circumference > 80 cm) in a community-based sample of 18–65 year old Bhutanese refugee women in Northeast Ohio. A Nepali-language questionnaire was used to measure socio-demographic and dietary factors. Height, weight, and waist circumference were measured to define excess body weight and abdominal obesity. The mean (±standard deviation) age of the 108 participants was 36.5 (±12.2) years and length of time in the U.S. was 19.4 (±11.9) months. Overall, 64.8% and 69.4% of the women had excess body weight and abdominal obesity, respectively. Age was significantly associated with both excess body weight (odds ratio: 1.10; 95% confidence interval: 1.05–1.16) and abdominal obesity (1.09; 1.04–1.14). Consuming meat (4.01; 1.14–14.60) was significantly associated with excess body weight but not abdominal obesity. These findings suggest the need for lifestyle and dietary change education programs among this new and vulnerable group to reduce the prevalence of excess body weight and abdominal obesity and their health consequences.
Background: Medical decision making is a critical, yet understudied, aspect of medical education. Aims: To develop the Medical Judgment Metric (MJM), a numerical rubric to quantify good decisions in practice in simulated environments; and to obtain initial preliminary evidence of reliability and validity of the tool. Methods: The individual MJM items, domains, and sections of the MJM were built based on existing standardized frameworks. Content validity was determined by a convenient sample of eight experts. The MJM instrument was pilot tested in four medical simulations with a team of three medical raters assessing 40 participants with four levels of medical experience and skill. Results: Raters were highly consistent in their MJM scores in each scenario (intraclass correlation coefficient 0.965 to 0.987) as well as their evaluation of the expected patient outcome (Fleiss’s Kappa 0.791 to 0.906). For each simulation scenario, average rater cut-scores significantly predicted expected loss of life or stabilization (Cohen’s Kappa 0.851 to 0.880). Discussion: The MJM demonstrated preliminary evidence of reliability and validity.
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