Background BNT162b2 mRNA and ChAdOx1 nCOV-19 adenoviral vector vaccines have been rapidly rolled out in the UK from December, 2020. We aimed to determine the factors associated with vaccine coverage for both vaccines and documented the vaccine effectiveness of the BNT162b2 mRNA vaccine in a cohort of health-care workers undergoing regular asymptomatic testing. MethodsThe SIREN study is a prospective cohort study among staff (aged ≥18 years) working in publicly-funded hospitals in the UK. Participants were assigned into either the positive cohort (antibody positive or history of infection [indicated by previous positivity of antibody or PCR tests]) or the negative cohort (antibody negative with no previous positive test) at the beginning of the follow-up period. Baseline risk factors were collected at enrolment, symptom status was collected every 2 weeks, and vaccination status was collected through linkage to the National Immunisations Management System and questionnaires. Participants had fortnightly asymptomatic SARS-CoV-2 PCR testing and monthly antibody testing, and all tests (including symptomatic testing) outside SIREN were captured. Data cutoff for this analysis was Feb 5, 2021. The follow-up period was Dec 7, 2020, to Feb 5, 2021. The primary outcomes were vaccinated participants (binary ever vacinated variable; indicated by at least one vaccine dose recorded by at least one of the two vaccination data sources) for the vaccine coverage analysis and SARS-CoV-2 infection confirmed by a PCR test for the vaccine effectiveness analysis. We did a mixed-effect logistic regression analysis to identify factors associated with vaccine coverage. We used a piecewise exponential hazard mixed-effects model (shared frailty-type model) using a Poisson distribution to calculate hazard ratios to compare time-to-infection in unvaccinated and vaccinated participants and estimate the impact of the BNT162b2 vaccine on all PCR-positive infections (asymptomatic and symptomatic). This study is registered with ISRCTN, number ISRCTN11041050, and is ongoing.Findings 23 324 participants from 104 sites (all in England) met the inclusion criteria for this analysis and were enrolled. Included participants had a median age of 46•1 years (IQR 36•0-54•1) and 19 692 (84%) were female; 8203 (35%) were assigned to the positive cohort at the start of the analysis period, and 15 121 (65%) assigned to the negative cohort. Total follow-up time was 2 calendar months and 1 106 905 person-days (396 318 vaccinated and 710 587 unvaccinated). Vaccine coverage was 89% on Feb 5, 2021, 94% of whom had BNT162b2 vaccine. Significantly lower coverage was associated with previous infection, gender, age, ethnicity, job role, and Index of Multiple Deprivation score. During follow-up, there were 977 new infections in the unvaccinated cohort, an incidence density of 14 infections per 10 000 person-days; the vaccinated cohort had 71 new infections 21 days or more after their first dose (incidence density of eight infections per 10 000 person-days) and nine infecti...
Introduction Doppler ultrasound cardiotocography is a non‐invasive alternative that, despite its poor specificity, is often first choice for intrapartum monitoring. Doppler ultrasound suffers from signal loss due to fetal movements and is negatively correlated with maternal body mass index (BMI). Reported accuracy of fetal heart rate monitoring by Doppler ultrasound varies between 10.6 and 14.3 bpm and reliability between 62.4% and 73%. The fetal scalp electrode (FSE) is considered the reference standard for fetal monitoring but can only be applied after membranes have ruptured with sufficient cervical dilatation and is sometimes contra‐indicated. A non‐invasive alternative that overcomes the shortcomings of Doppler ultrasound, providing reliable information on fetal heart rate, could be the answer. Non‐invasive fetal electrocardiography (NI‐fECG) uses a wireless electrode patch on the maternal abdomen to obtain both fetal and maternal heart rate signals as well as an electrohysterogram. We aimed to validate a wireless NI‐fECG device for intrapartum monitoring in term singleton pregnancies, by comparison with the FSE. Material and methods We performed a multicenter cross‐sectional observational study at labor wards of 6 hospitals located in the Netherlands, Belgium, and Spain. Laboring women with a healthy singleton fetus in cephalic presentation and gestational age between 36 and 42 weeks were included. Participants received an abdominal electrode patch and FSE after written informed consent. Accuracy, reliability, and success rate of fetal heart rate readings were determined, using FSE as reference standard. Analysis was performed for the total population and measurement period as well as separated by labor stage and BMI class (≤30 and >30 kg/m2). Results We included a total of 125 women. Simultaneous registrations with NI‐fECG and FSE were available in 103 women. Overall accuracy is −1.46 bpm and overall reliability 86.84%. Overall success rate of the NI‐fECG is around 90% for the total population as well as for both BMI subgroups. Success rate dropped to 63% during second stage of labor, similar results are found when looking at the separate BMI groups. Conclusions Performance measures of the NI‐fECG device are good in the overall group and the separate BMI groups. Compared with Doppler ultrasound performance measures from the literature, NI‐fECG is a more accurate alternative. Especially, when women have a higher BMI, NI‐fECG performs well, resembling FSE performance measures.
Intrapartum UA monitoring in daily practice via the direct mode provides a more recognizable UA trace.
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