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...
Despite systematic review evidence describing validated depression screening tools and effective treatment and prevention strategies for depression after stroke, there has not been a significant reduction in the proportion of people experiencing depression after stroke. There is a pressing need for increased clinical uptake of evidenced-based strategies to screen for, prevent, and treat depression after stroke.
anzctr.org.au Identifier: ACTRN12611000161921.
Abstract-Poststroke depression (PSD) is common, affecting approximately one third of stroke survivors at any one time after stroke. Individuals with PSD are at a higher risk for suboptimal recovery, recurrent vascular events, poor quality of life, and mortality. Although PSD is prevalent, uncertainty remains regarding predisposing risk factors and optimal strategies for prevention and treatment. This is the first scientific statement from the American Heart Association on the topic of PSD. Members of the writing group were appointed by the American Heart Association Stroke Council's Scientific Statements Oversight Committee and the American Heart Association's Manuscript Oversight Committee. Members were assigned topics relevant to their areas of expertise and reviewed appropriate literature, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion. This multispecialty statement provides a comprehensive review of the current evidence and gaps in current knowledge of the epidemiology, pathophysiology, outcomes, management, and prevention of PSD, and provides implications for clinical practice. (Stroke. 2017;48:e30-e43.
Background and Purpose-Although depression is an important sequelae of stroke, there is uncertainty regarding its frequency and outcome. Methods-We undertook a systematic review of all published nonexperimental studies (to June 2004) with prospective consecutive patient recruitment and quantification of depressive symptoms/illness after stroke. Results-Data were available from 51 studies (reported in 96 publications) conducted between 1977 and 2002. Although frequencies varied considerably across studies, the pooled estimate was 33% (95% confidence interval, 29% to 36%) of all stroke survivors experiencing depression. Differences in case mix and method of mood assessment could explain some of the variation in estimates across studies. The data also suggest that depression resolves spontaneously within several months of onset in the majority of stroke survivors, with few receiving any specific antidepressant therapy or active management. Conclusions-Depression is common among stroke patients, with the risks of occurrence being similar for the early, medium, and late stages of stroke recovery. There is a pressing need for further research to improve clinical practice in this area of stroke care.
Early identification of patients at high risk of depression after stroke, those with a history of depression and physical disability after stroke, would enable the early implementation of effective management and prevention strategies for depression. The reciprocal relationship between depression and physical disability highlights the need for interventions that reduce disability after stroke, which may in turn improve mood and overall recovery for an increasingly large number of stroke survivors.
Background and Purpose-The consequences of stroke are a major health concern. This study was conducted to compare the health-related quality of life among long-term survivors of stroke with that of the general population. Methods-Our data are taken from a population-based case-control study of all 6-year survivors of stroke with an age-and sex-matched control population. SF-36 mean scores for cases were compared with raw and standardized control and New Zealand norm mean scores. Results-Of the original 1761 registered cases, 639 were still alive at 6-year follow-up, and all of these participated in the study. Case patients were more likely than control subjects to be dependent in all basic activities of daily living. Crude mean scores were lower for women; as age increased; for those living in institutions; when the SF-36 was completed by proxy; and when help was required with the activities of daily living. Cases had statistically lower mean scores than both the control group and New Zealand norms for physical functioning and general health. After standardization for age and sex, no differences were found between cases and controls in mental health and bodily pain. Conclusions-Health-related quality of life appears to be relatively good for the majority of patients 6 years after stroke.Despite significant ongoing physical disability, survivors of stroke appear to adjust well psychologically to their illness. Key Words: cerebrovascular disorders Ⅲ stroke outcome Ⅲ quality of life Ⅲ health outcome Ⅲ case control
Background and Purpose-Although depression is common after stroke, there is uncertainty over its etiology and risk factors, which complicates management. Knowledge of the predictors of depression associated with stroke may allow for the better targeting of therapy, both prevention and treatment. Methods-We undertook a systematic review of all published, nonexperimental, population-, hospital-, and rehabilitationbased stroke studies (to June 2004) with prospective, consecutive patient recruitment undertaken to identify variables associated with depressive symptoms (or "illness") after stroke. Assessments were made of the quality of studies including the validity of prognostic models. Results-Data were available from 3 population-based studies including 492 patients, 8 hospital-based studies including 15 272 patients, and 9 rehabilitation-based studies including 2170 patients. Physical disability, stroke severity and cognitive impairment were consistently associated with depression. In addition to the common problem of selection bias, major limitations of these studies included variable selection and poor statistical quality and reporting; small sample sizes meant that only a limited range of variables were analyzed in multivariate models. Conclusions-There is a paucity of well-designed studies of sufficient size to allow stable multivariate predictive models of depression after stroke to be developed. Other than showing that depression is associated with more severe strokes, current evidence does not allow for ready identification of patients most at risk of developing this important complication of stroke.
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