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Real-world effectiveness of perinatal RSV immunoprophylaxis: protocol for a test-negative case-control study

Por: Aparicio Llorente · C. · Wats · A. · Araujo · B. L. · Moniz Ganem · J. · Oliva · I. O. · Xu · H. · Brodsky · N. N. · Lucas · C. L. · Aronson · P. L. · Grubaugh · N. D. · Breban · M. · Redmond · S. · Shapiro · E. D. · Niccolai · L. M. · Weinberger · D. M. · Oliveira · C. R.
Introduction

Respiratory syncytial virus (RSV) is a leading cause of hospitalisation in infants worldwide. New immunoprophylactic products, including long-acting monoclonal antibodies and maternal vaccines, have demonstrated high efficacy in prelicensure clinical trials. Understanding how these interventions perform outside controlled trials, and how viral evolution or host factors influence protection, is essential for sustaining confidence in RSV prevention programmes.

Methods and analysis

We will conduct a 5-year, test-negative case–control study among infants ≤12 months of age who present with acute respiratory illness (ARI) within a large healthcare delivery network serving a demographically diverse population. Cases will be infants testing positive for RSV by PCR, and controls will be RSV-negative infants meeting the same ARI criteria. Data will be obtained from electronic health records, structured caregiver surveys and state immunization registries to ensure accurate classification of exposures and covariates. Vaccine effectiveness will be estimated using multivariable logistic regression controlling for potential confounding. RSV-positive specimens will undergo full-genome sequencing to identify variant lineages and potential immune-escape mutations. A subset of participants will provide acute and convalescent blood samples for single-cell immune profiling to define innate and adaptive responses associated with breakthrough infection.

Ethics and dissemination

The study protocol has been approved by the Yale Human Investigation Committee (HIC #2000036550). Written informed consent will be obtained from all parents or legal guardians prior to participation. Study findings will be disseminated through peer-reviewed publications, scientific meetings and public repositories, with fully de-identified participant data to protect privacy and confidentiality. Viral genomic data will be shared in accordance with the National Institutes of Health Genomic Data Sharing Policy, and analytical code will be made publicly available to ensure reproducibility.

Trial registration number

NCT06172660.

VR-CARE: a protocol for a mixed-methods study and pilot trial with embedded process evaluation to develop and evaluate virtual reality training for risk reduction in care homes

Por: Gasteiger · N. · Ford · C. R. · Hawley-Hague · H. · Wilkinson · J. · Jones · D. · Whittaker · W. · Ullah · A. · Kislov · R. · Stanmore · E. · Laverty · L. · Chantrell · J. · Callaghan · C. · Edmondson · V. · Dowding · D.
Introduction

Risk reduction training for UK care home staff is limited, not standardised and challenging to implement. Virtual reality (VR) is an immersive, engaging method of education delivery that is being adopted in health and social care. VR may be an effective education tool in care homes, but this research has yet to be conducted.

The VR-CARE project aims to create a new VR risk reduction training programme for care homes that combines hand hygiene and falls prevention modules, and to evaluate this through a pilot trial to inform a future randomised controlled trial (RCT).

Methods and analysis

There are two research phases with patient and public involvement and engagement (PPIE) activities embedded throughout. Care home stakeholders are collaborating to design the training and toolkit, oversee methods, review resources for accessibility, support recruitment and ensure the project meets the needs of the workforce and positively impacts resident care.

In phase 1, we will use a mixed-methods and user-centred design approach to develop the VR training and an accompanying implementation toolkit needed to deliver it. The training will be developed and tested by 15 care home staff across three rounds to identify and inform changes that maximise usability and acceptability. We will conduct up to 20 interviews with staff from VR companies and care homes to support toolkit development.

Phase 2 is a mixed-methods pilot cluster RCT, with a waitlist control and process evaluation with up to 80 unregistered staff members from six North England care homes, to develop the measures and methods to inform a future trial. The process evaluation will generate knowledge about VR as a training mechanism in care homes. This phase will focus on the practicality of using VR, broader impacts (eg, on residents), contextual considerations and how it might be scaled up.

Ethics and dissemination

The University of Manchester Proportionate University Research Ethics Committee has approved phase 1 (Reference: 2025-24416-44642). We will obtain further approval before commencing phase 2.

Outputs will include user-friendly and acceptable VR risk reduction training for care homes, accompanied by an implementation toolkit adaptable for other VR training in social care settings. Materials (eg, training overviews, infographics and videos) will be developed to support uptake. Findings will be presented at conferences and published in journals. Lay summaries will be co-created with our PPIE group, and additional dissemination methods will be co-developed to broaden reach.

Impact of COVID‐19 on Telephone‐Triage Nurses' Emotional Well‐Being: A Qualitative Study

ABSTRACT

Aims

To describe telephone-triage nurses' perceptions of their well-being and the system factors that influenced their well-being while conducting telephone-triage for COVID-19 during the pandemic.

Design

This descriptive, qualitative study applied both inductive and deductive analysis to generate themes.

Methods

We interviewed a convenience sample of 27 nurses from two health systems about their perceptions of well-being when triaging patient calls about COVID-19 and reasons for those perceptions. Data collection occurred between November 2020 and June 2021. Themes were organised using the National Academies of Science, Engineering and Medicine framework.

Results

Telephone-triage nurses' well-being was significantly impacted by COVID-19. Uncertainty regarding evolving COVID-19 guidance, increased call volumes and difficult patient responses were some of the key work system challenges that impacted nurses' well-being.

Conclusions

Our findings suggest the need to revisit work system factors that impact the well-being of telephone-triage nurses and develop organisational interventions to support nurses to provide optimal care during crisis situations.

Practice Implications

Organisational information infrastructure should be bolstered for future pandemic responses to minimise impacts on nurses' well-being. Additionally, leaders need to realign tasks, workflows and workload of telephone triage during pandemic surges to prevent excessive demands on nurses.

Impact

This work contributes to understanding telephone-triage nurses' well-being during COVID-19. The increased demands they faced and impact on their well-being point to opportunities for organisational well-being interventions and development of crisis standards for tele-triaging to support nurses during high-stress, crisis situations.

Reporting

The authors have adhered to COREQ guidelines for reporting.

Patient or Public Contribution

No patient or public contribution.

Outcomes following a behaviour change intervention within hospitals to improve birth registrations and hospital utilisation for Aboriginal and/or Torres Strait Islander infants: a quasi-experimental and cohort study

Por: McAuley · K. · Strobel · N. A. · Christensen · D. · Edmond · K. M. · Jacoby · P. · McAullay · D.
Objectives

The primary objective was to determine whether a behaviour change intervention delivered to hospital staff would (1) improve the proportion of Aboriginal and/or Torres Strait Islander (Aboriginal) babies being registered and (2) reduce hospital admissions and emergency presentations for babies

Design

Quasi-experimental design and cohort study.

Setting

Five tertiary birthing hospitals in WA.

Participants

The intervention was delivered to health service providers who were in the five tertiary birthing hospitals. Outcome data were collected on Aboriginal babies born between 1 January 2016 and 30 June 2018 who were delivered within these hospitals. Babies in the control group (n=226) were born 6 months before the intervention and intervention babies (n=232) were born 6 months following the intervention. For the secondary objective, there were 4573 babies included in the analysis.

Interventions

A behaviour change intervention delivered to hospital staff in five hospitals.

Primary and secondary outcome measures

The primary outcomes were the proportion of babies who were registered and whether a baby had been admitted to hospital or an emergency department by 3 and 6 months old. The secondary outcome was to determine factors that might influence the proportion of registered Aboriginal births in WA (cohort study).

Results

There was evidence of a 38% reduction in emergency presentations within 6 months for babies born to hospitals 6 months following the staff training (OR 0.62, 95% CI 0.42 to 0.91), and little evidence of improvements in birth registrations, hospital admissions within 3 or 6 months of birth or emergency department presentations within 3 months of birth. Of the 4573 babies included in the cohort study, 3769 (82.4%) babies had their births registered and 804 (17.6%) babies did not. Factors that were associated with not having a birth registered included low birth weight babies with a 34% decrease in odds of having a registered birth compared with those with a normal birth weight (adjusted OR (aOR) 0.66, 95% CI 0.51 to 0.86). Timing of first antenatal visit was associated with reduced odds of having a birth registered if this occurred in the second (aOR 0.77, 95% CI 0.64 to 0.93) or third trimester (aOR 0.59, 95% CI 0.45 to 0.77) compared with the first trimester.

Conclusions

Our study identifies the complexities surrounding birth registrations and improved hospital utilisation for Aboriginal babies, the importance of targeted interventions and ongoing efforts needed to address this issue comprehensively.

Trial registration number

ACTRN12615000976583.

Building a baby‐friendly community: Development, strategy, implementation and evaluation of a BFCI program

Abstract

Aim

The aim of the study was to investigate the impact of the use of baby-friendly community initiative (BFCI) model on various stakeholders in the community.

Design

Quasi-experimental research design.

Method

The study was conducted in public premises and online workshops from April 2019 to September 2022. Participants were followed up for a period of 1 month, except for those employed at public premises. The program involved training based on an accredited BFCI framework to cultivate a breastfeeding-friendly attitude and knowledge. A paired sample t-test was used to examine breastfeeding attitude and knowledge scores before and after BFCI training among staff employed from public premises. An analysis of variance was conducted to examine the breastfeeding self-efficacy and attitude scores, measured repeatedly at different timepoints over 1-month timepoint (T0, T1 and T2) among pregnant and postpartum women.

Results

A total of 2340 perinatal women and 1339 staff from public premises were recruited. For staff, there was an increase in the mean score of breastfeeding knowledge and attitude by 5.8 and 6.1, respectively, at T1. Similarly, for perinatal women, there was an increase in the mean score of breastfeeding self-efficacy and attitude by 6.6 and 3.3, respectively, at T1.

Conclusion

In summary, a BFCI model, with active community participation, accreditation and an award system, has been effective in promoting breastfeeding. Adapting the baby-friendly hospital initiative to local contexts and employing a social theory model can enhance breastfeeding promotion and improve infant health outcomes. Prioritizing culturally sensitive breastfeeding education is crucial for successful BFCI implementation.

Implications for the profession and/or patient care

Healthcare professionals should consider clients' culture and socio-economic backgrounds when providing breastfeeding education to maximize effectiveness. The target audience for breastfeeding education should be expanded to include various community stakeholders beyond families.

Impact

What problem did the study address? This study addressed the problem of knowledge gaps among stakeholders in building a breastfeeding-friendly community, particularly in implementing a baby-friendly community initiative (BFCI) as part of a baby-friendly hospital initiative (BFHI). The research filled a service gap by providing effective interventions targeting community stakeholders and assessing the impact of a BFCI program on their knowledge and attitudes towards breastfeeding.

What were the main findings? The findings highlighted the effectiveness of a BFCI program in enhancing breastfeeding knowledge and attitudes among frontline staff and increasing breastfeeding confidence among mothers. These findings contribute to the understanding of the program's impact on different stakeholders in the community.

Where and on whom will the research have an impact? It impacts on global policymakers by providing insights for developing comprehensive guidelines for future BFCI implementations. It also contributes to the creation of a more baby-friendly community, benefiting breastfeeding families and their infants by promoting and supporting breastfeeding families.

Reporting Method

This study has adhered to relevant EQUATOR guidelines using the TREND reporting guideline.

Patient or Public Contribution

No patient or public contribution.

What Does This Paper Contribute to the Wider Global Clinical Community?

This study provides an overview of the establishment of a localized BFCI program. It also opens up a new direction for the community to investigate BFCI strategies for community stakeholders. It also provides evidence to support other countries in following a similar process, as each country approaches becoming breastfeeding-friendly in its own unique way.

Trial and Protocol Registration

No protocol.

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