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Phase II multicentre double-blind randomised controlled trial of a Bivalent VaccInation against Salmonella Typhi and Paratyphi A (BiVISTA) using a controlled human infection model of paratyphoid A infection: study protocol

Por: Paganotti Vicentine · M. · McCann · N. · Hennigan · O. · Maria · N. · Juarez Molina · C. I. · Koleva · S. · Islam · M. K. · Jones · E. · Flaxman · A. · Day · N. · MacDonald · A. · Adnan · M. · Singh · N. · Vernon · S. · Wilson · E. · Potey · A. V. · Dharmadhikari · A. · Gaidhane · S. · Kul
Introduction

Enteric fever, primarily caused by Salmonella enterica Typhi and Salmonella enterica Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may address this gap. Although field efficacy trials are not considered feasible, controlled human infection models (CHIMs) offer an alternative pathway for evaluating vaccine efficacy. This will be the first efficacy study of a bivalent vaccine against typhoid and paratyphoid A using a paratyphoid CHIM.

Methods and analysis

This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18–55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control.

Ethics and dissemination

The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings.

Trial registration number

ISRCTN65855590.

Canadian cross-sectional survey of healthcare, social and community service providers capacity to respond to sex trafficked persons

Por: Forte · T. · Kosa · S. D. · Macdonald · S. · Mason · R. · Du Mont · J.
Objective

To examine the impact of the extent of education and/or training on sex trafficking among healthcare, social and community service providers and the impact of education and/or training on their capacity to respond to sex trafficked persons.

Design

Cross-sectional survey.

Setting

An anonymous, online survey assessing perceptions of, and capacity to respond to, sex trafficking was distributed between February and August 2023 via social media platforms and with professional healthcare, social service and community associations and organisations across Canada to share with their members.

Participants

553 healthcare, social and community service providers.

Outcome measures

Seven 6-point Likert scale items were used, as part of a larger survey, to measure capacity to respond to sex trafficking. Specifically, respondents were asked to rate their awareness of red flags and capacity to identify, talk to, interview, enhance the safety of, provide appropriate resources or referrals for and collaborate with other professionals to support sex trafficked persons.

Results

Although most respondents (86.8%) reported having received some education and/or training on sex trafficking, the vast majority (94.8%) believed that they would benefit from additional education and/or training. Compared with those with no previous sex trafficking education and/or training, those who received less than 5 hours of education and/or training (b=3.56, p

Conclusions

As the number of hours of education and/or training on sex trafficking increased, so did respondents’ capacity to respond to sex trafficked persons. These results highlight a need for more education and training to help build capacity among healthcare, social and community service providers in identifying sex trafficked persons and providing appropriate care. Appropriately trained service providers can better support sex trafficked persons’ complex needs and potentially mitigate adverse outcomes.

Trends in incident acute rheumatic fever or rheumatic heart disease in Indigenous youth in Western Australia: a retrospective cohort study

Por: MacDonald · B. · Sodhi-Berry · N. · Stacey · I. · Robinson · M. · Carapetis · J. · Bowen · A. C. · Budgeon · C. · Nedkoff · L. · Katzenellenbogen · J. M.
Objective

To determine age-specific and age-standardised incidence trends of acute rheumatic fever (ARF) or rheumatic heart disease (RHD) among Indigenous Western Australians aged less than 35 years of age.

Design

A population-based retrospective cohort study with linked data analysis.

Setting

Western Australian hospital admissions (1996–2022) and RHD notifications to the state-based register (2011–2015).

Participants

Patients, both Indigenous and non-Indigenous aged

Results

Of 1746 incident ARF/RHD cases, 1526 (87%) were Indigenous peoples, with the highest rates observed in patients aged 5–14 years, with an annual estimated increase of 4.3% (95% CI 3.2% to 5.2%). The 0–4 years age group experienced an annual increase in incidence rates of 4.8% (95% CI 1.4% to 8.2%). Overall, Indigenous patients experienced an annual increase of 1.9% (95% CI 1.3% to 2.6%) from 1996 to 2022. However, most cases (n=894) were identified after multiple significant policy developments (2011–2022) with an annual increase of 5.7% (95% CI 3.7% to 7.5%) for this period.

Conclusion

Increasing trends of incident ARF/RHD were observed in Indigenous patients aged under 15 years, with the greatest annual increments observed after policy implementation for disease reporting and awareness in the period from 2011 to 2022. Improvement in case ascertainment of ARF/RHD may be contributing towards increasing trends with improved reporting and monitoring of incident cases in very young Indigenous Australians more recently.

Scope of practice of primary care nurses: a protocol for an umbrella review of international literature

Por: Lukewich · J. · Mathews · M. · Myles · S. · Dufour · E. · Asghari · S. · Rioux-Dubois · A. · Martin-Misener · R. · Halcomb · E. J. · Chiu · P. · Poitras · M.-E. · Leslie · K. · McGraw · M. · Ryan · D. · Curnew · D. · Meredith · L. · Morin · A. · Swab · M. · Braithwaite · S. · Macdonald · D.
Introduction

Primary care nurses (PCNs) are the second largest workforce in primary care and play a critical role in facilitating access to coordinated care and reducing health disparities. There is renewed interest in team-based primary care as a solution for health workforce challenges. Some team models enable PCNs (ie, nurse practitioners, registered nurses, licensed/registered practical nurses) to leverage one another’s expertise to work to optimal scope; the extent to which this happens depends on multiple context-dependent factors. We will conduct an umbrella review to synthesise and compare international knowledge syntheses focused on scope of practice enactment (ie., roles and activities) of PCNs in primary care.

Methods and analysis

We will conduct the umbrella review according to the Joanna Briggs Institute methodology, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines, and using the Nursing Care Organization Framework as guidance. We will search a wide range of scientific electronic databases and grey literature sources, and consider articles published in English and French by the Organization for Economic Cooperation and Development and designated key partner countries for inclusion, with no publication date limits. Two independent reviewers will screen titles, abstracts and full-text articles, and any disagreements will be resolved through discussion or by a third reviewer. We will use the Risk of Bias Assessment Tool for Systematic Reviews to assess the quality and risk of bias in the included systematic and scoping reviews.

Ethics and dissemination

Results will be presented in a PRISMA Scoping Review flow diagram. We will synthesise data from included studies in a detailed literature review table and develop visual aids to communicate the shared and unique roles and activities of PCN scope of practice. We will disseminate the results of the review through peer-reviewed publications and conferences related to this field. Ethics approval is not required.

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol

Por: Howe · B. D. · Macdonald · S. P. J. · Arendts · G. · Bellomo · R. · Burcham · J. · Delaney · A. · Egerton-Warburton · D. · Fatovich · D. · Fraser · J. F. · Higgins · A. · Jones · P. · Keijzers · G. · Milford · E. · Udy · A. A. · Williams · P. · Young · P. · Peake · S. L.
Introduction

International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.

Methods and analysis

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.

Ethics and dissemination

The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.

Trial registration number

NCT04569942

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