Defining operational strengths and gaps relevant to post licensure Group B Streptococcus vaccine effectiveness studies: an expert stakeholder evaluation of the United Kingdom and Uganda

A future Group B Streptococcal (GBS) vaccine for pregnant women to protect neonates is likely to be licensed based on evidence of vaccine induced protective antibody levels. Post licensure surveillance to monitor the impact of any future vaccine on GBS disease therefore needs to be clearly defined (in both high and low income settings). A priority research gap is understanding health system preparedness for a GBS vaccine evaluation This expert stakeholder evaluation aimed to describe the UK and Uganda's operational strengths and gaps relevant to post-licensure GBS vaccine studies

Women’s views on accepting COVID-19 vaccination during and after pregnancy, and for their babies: A multi-methods study in the UK.

Background: COVID-19 vaccines are advised for pregnant women in the United Kingdom (UK) however COVID-19 vaccine uptake among pregnant women is inadequate. Methods: An online survey and semi-structured interviews were used to investigate pregnant women’s views on COVID-19 vaccine acceptability for themselves when pregnant, not pregnant and for their babies. 1,181 women, aged over 16 years, who had been pregnant since 23rd March 2020, were surveyed between 3rd August–11th October 2020. Ten women were interviewed. Results: The majority of women surveyed (81.2%) reported that they would ‘definitely’ or were ‘leaning towards’ accepting a COVID-19 vaccine when not pregnant. COVID-19 vaccine acceptance was significantly lower during pregnancy (62.1%, p<0.005) and for their babies (69.9%, p<0.005). Ethnic minority women were twice as likely to reject a COVID-19 vaccine for themselves when not pregnant, pregnant and for their babies compared to women from White ethnic groups (p<0.005). Women from lower-income households, aged under 25-years, and from some geographic regions were more likely to reject a COVID-19 vaccine when not pregnant, pregnant and for their babies. Multivariate analysis revealed that income and ethnicity were the main drivers of the observed age and regional differences. Women unvaccinated against pertussis in pregnancy were over four times more likely to reject COVID-19 vaccines when not pregnant, pregnant and for their babies. Thematic analysis of the survey freetext responses and interviews found safety concerns about COVID-19 vaccines were common though wider mistrust in vaccines was also expressed. Trust in vaccines and the health system were also reasons women gave for accepting COVID-19 vaccines. Conclusion: Safety information on COVID-19 vaccines must be clearly communicated to pregnant women to provide reassurance and facilitate informed pregnancy vaccine decisions. Targeted interventions to promote COVID-19 vaccine uptake among ethnic minority and lower-income women may be needed

Prediction of mental effort derived from an automated vocal biomarker using machine learning in a large-scale remote sample

IntroductionBiomarkers of mental effort may help to identify subtle cognitive impairments in the absence of task performance deficits. Here, we aim to detect mental effort on a verbal task, using automated voice analysis and machine learning.MethodsAudio data from the digit span backwards task were recorded and scored with automated speech recognition using the online platform NeuroVocalixTM, yielding usable data from 2,764 healthy adults (1,022 male, 1,742 female; mean age 31.4 years). Acoustic features were aggregated across each trial and normalized within each subject. Cognitive load was dichotomized for each trial by categorizing trials at &gt;0.6 of each participants' maximum span as “high load.” Data were divided into training (60%), test (20%), and validate (20%) datasets, each containing different participants. Training and test data were used in model building and hyper-parameter tuning. Five classification models (Logistic Regression, Naive Bayes, Support Vector Machine, Random Forest, and Gradient Boosting) were trained to predict cognitive load (“high” vs. “low”) based on acoustic features. Analyses were limited to correct responses. The model was evaluated using the validation dataset, across all span lengths and within the subset of trials with a four-digit span. Classifier discriminant power was examined with Receiver Operating Curve (ROC) analysis.ResultsParticipants reached a mean span of 6.34 out of 8 items (SD = 1.38). The Gradient Boosting classifier provided the best performing model on test data (AUC = 0.98) and showed excellent discriminant power for cognitive load on the validation dataset, across all span lengths (AUC = 0.99), and for four-digit only utterances (AUC = 0.95).DiscussionA sensitive biomarker of mental effort can be derived from vocal acoustic features in remotely administered verbal cognitive tests. The use-case of this biomarker for improving sensitivity of cognitive tests to subtle pathology now needs to be examined

Health and socio-demographic characteristics associated with uptake of seasonal influenza vaccination amongst pregnant women: retrospective cohort study

Pregnant women are at increased risk from influenza, yet maternal influenza vaccination levels remain suboptimal. This study aimed to estimate associations between socio-demographic and health characteristics and seasonal influenza vaccination uptake among pregnant women and understand trends over time to inform interventions to improve vaccine coverage. A retrospective cohort study using linked electronic health records of women in North West London with at least one pregnancy overlapping with an influenza season between September 2010 and February 2020. We used a multivariable mixed-effects logistic regression model to identify associations between characteristics of interest and primary outcome of influenza vaccination. 451,954 pregnancies, among 260,744 women, were included. In 85,376 (18.9%) pregnancies women were vaccinated against seasonal influenza. Uptake increased from 8.4% in 2010/11 to 26.3% in 2018/19, dropping again to 21.1% in 2019/20. Uptake was lowest among women: aged 15-19 years (12%) or over 40 years (15%; OR 1.17, 95% CI 1.10 to 1.24); of Black ethnicity (14.1%; OR 0.55, 95% CI 0.53 to 0.57), or unknown ethnicity (9.9%; OR 0.42, 95% CI 0.39 to 0.46), lived in more deprived areas (OR least vs most deprived 1.16, 95% CI 1.11 to 1.21), or with no known risk factors for severe influenza. Seasonal influenza vaccine uptake in pregnant women increased in the past decade, prior to the COVID-19 pandemic, but remained suboptimal. We recommend approaches to reducing health inequalities should focus on women of Black ethnicity, younger and older women, and women living in areas of greater socio-economic deprivation

Considerations for post-licensure group B streptococcus vaccine effectiveness studies.

Post-licensure studies of a Group B streptococcal vaccines for pregnant women in low and middle-income countries will require investment in electronic health records

Implementation and delivery of group consultations for young people with diabetes in socioeconomically deprived, ethnically diverse settings

BACKGROUND: Young people with diabetes experience poor clinical and psychosocial outcomes, and consider the health service ill-equipped in meeting their needs. Improvements, including alternative consulting approaches, are required to improve care quality and patient engagement. We examined how group-based, outpatient diabetes consultations might be delivered to support young people (16-25 years old) in socio-economically deprived, ethnically diverse settings. METHODS: This multi-method, comparative study recruited a total of 135 young people with diabetes across two implementation and two comparison sites (2017-2019). Informed by a 'researcher-in-residence' approach and complexity theory, we used a combination of methods: (a) 31 qualitative interviews with young people and staff and ethnographic observation in group and individual clinics, (b) quantitative analysis of sociodemographic, clinical, service use, and patient enablement data, and (c) micro-costing analysis. RESULTS: Implementation sites delivered 29 group consultations in total. Overall mean attendance per session was low, but a core group of young people attended repeatedly. They reported feeling better understood and supported, gaining new learning from peers and clinicians, and being better prepared to normalise diabetes self-care. Yet, there were also instances where peer comparison proved difficult to manage. Group consultations challenged deeply embedded ways of thinking about care provision and required staff to work flexibly to achieve local tailoring, sustain continuity, and safely manage complex interdependencies with other care processes. Set-up and delivery were time-consuming and required in-depth clinical and relational knowledge of patients. Facilitation by an experienced youth worker was instrumental. There was indication that economic value could derive from preventing at least one unscheduled consultation annually. CONCLUSIONS: Group consulting can provide added value when tailored to meet local needs rather than following standardised approaches. This study illustrates the importance of adaptive capability and self-organisation when integrating new models of care, with young people as active partners in shaping service provision. TRIAL REGISTRATION: ISRCTN reference 27989430