Since the start of the COVID-19 pandemic there has been a global call for sex/gender-disaggregated data to be made available, which has uncovered important findings about COVID-19 testing, incidence, severity, hospitalisations, and deaths. This mini review scopes the evidence base for efficacy, effectiveness, and safety of COVID-19 vaccines from both experimental and observational research, and asks whether (1) women and men were equally recruited and represented in vaccine research, (2) the outcomes of studies were presented or analysed by sex and/or gender, and (3) there is evidence of sex and/or gender differences in outcomes. Following a PubMed search, 41 articles were eligible for inclusion, including seven randomised controlled trials (RCTs), 11 cohort studies, eight cross-sectional surveys, eight routine surveillance studies, and seven case series. Overall, the RCTs contained equal representation of women and men; however, the observational studies contained a higher percentage of women. Of 10 studies with efficacy data, only three (30%) presented sex/gender-disaggregated results. Safety data was included in 35 studies and only 12 (34%) of these presented data by sex/gender. For those that did present disaggregated data, overall, the majority of participants reporting adverse events were women. There is a paucity of reporting and analysis of COVID-19 vaccine data by sex/gender. Research should be designed in a gender-sensitive way to present and, where possible analyse, data by sex/gender to ensure that there is a robust and specific evidence base of efficacy and safety data to assist in building public confidence and promote high vaccine coverage.
Background: Early diagnosis through symptom recognition is vital in the management of acute stroke. However, women who experience stroke are more likely than men to be initially given a nonstroke diagnosis and it is unclear if potential sex differences in presenting symptoms increase the risk of delayed or missed stroke diagnosis. Aims: To quantify sex differences in the symptom presentation of stroke and assess whether these differences are associated with a delayed or missed diagnosis. Methods: PubMed, EMBASE, and the Cochrane Library were systematically searched up to January 2021. Studies were included if they reported presenting symptoms of adult women and men with diagnosed stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) and were published in English. Mean percentages with 95% confidence intervals (CIs) of each symptom were calculated for women and men. The crude relative risks (RRs) with 95% CI of symptoms being present in women, relative to men, were also calculated and pooled. Any data on the delayed or missed diagnosis of stroke for women compared to men based on symptom presentation were also extracted. Results: Pooled results from 21 eligible articles showed that women and men presented with a similar mean percentage of motor deficit (56% in women vs 56% in men) and speech deficit (41% in women vs 40% in men). Despite this, women more commonly presented with nonfocal symptoms than men: generalized nonspecific weakness (49% vs 36%), mental status change (31% vs 21%), and confusion (37% vs 28%), whereas men more commonly presented with ataxia (44% vs 30%) and dysarthria (32% vs 27%). Women also had a higher risk of presenting with some nonfocal symptoms: generalized weakness (RR 1.49, 95% CI 1.09–2.03), mental status change (RR 1.44, 95% CI 1.22–1.71), fatigue (RR 1.42, 95% CI 1.05–1.92), and loss of consciousness (RR 1.30, 95% CI 1.12–1.51). In contrast, women had a lower risk of presenting with dysarthria (RR 0.89, 95% CI 0.82–0.95), dizziness (RR 0.87, 95% CI 0.80–0.95), gait disturbance (RR 0.79, 95% CI 0.65–0.97), and imbalance (RR 0.68, 95% CI 0.57–0.81). Only one study linking symptoms to definite stroke/TIA diagnosis found that pain and unilateral sensory loss are associated with lower odds of a definite diagnosis in women compared to men. Conclusion: Although women showed a higher prevalence of some nonfocal symptoms, the prevalence of focal neurological symptoms, such as motor weakness and speech deficit, was similar for both sexes. Awareness of sex differences in symptoms in acute stroke evaluation, careful consideration of the full constellation of presenting symptoms, and further studies linking symptoms to diagnostic outcomes can be helpful in improving early diagnosis and management in both sexes.
andmark trials of intravenous thrombolysis 1 and endovascular thrombectomy 2 have transformed acute stroke care in recent years. As the efficacy of these treatments is highly time-dependent, rapid pre-hospital assessment is critical for optimising outcomes, and emergency medical services play a major role in realising their potential benefits.Differences in pre-hospital activation of emergency medical services for men and women with stroke have been examined in several studies (Supporting Information, table 1). Some investigators found no sex differences, 3 others that women were more likely to be transported to hospital by ambulance, 4 or that the mean time between symptom onset and presenting to hospital was longer for women than men. 5 However, most studies were not population-based and sample sizes were small. As many investigations were not designed to detect sex differences in pre-hospital activation of emergency medical services, they did not consider important confounding factors, such as age. [3][4][5] It is recognised that atypical clinical manifestations of stroke on initial presentation are more frequent in women. 6 Further, a large United States study found that the proportion of missed stroke diagnoses was nearly seven times as large for patients aged 18-44 years presenting to emergency departments (4.0%) as for those aged 75 years or more (0.6%). 7In our population-based study, we examined the pre-hospital care and management provided by emergency medical services to people admitted to hospital in New South Wales with stroke diagnoses. We investigated whether pre-hospital emergency medical services care was different for women and men, and whether any sex differences were influenced by age. MethodsWe analysed linked administrative data for women and men admitted to NSW hospitals during 1 July 2005 -31 December 2018 with a principal diagnosis and one additional diagnosis code for stroke at separation (International Classification of Diseases, tenth revision, Australian modification [ICD-10-AM] codes I60-68, G45) and no previous admissions with a stroke diagnosis in any diagnosis field after 31 July 2001 (ie, lookback period of four years).The NSW Admitted Patient Data Collection (APDC) includes hospital records from all NSW public and private hospitals and day procedure centres. APDC records include demographic data
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