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Exploring perceptions of gender roles amongst sexually active adolescents in rural KwaZulu-Natal, South Africa

by Brett Marshall, Celia Mehou-Loko, Sindisiwe Mazibuko, Makhosazana Madladla, Lucia Knight, Hilton Humphries

Traditional gender and social norms reinforce asymmetrical power relations, increase the risk of experiencing gender-based violence and mediate poor engagement with sexual and reproductive health services. This study explored gender norms and expectations amongst cisgender adolescents in rural KwaZulu-Natal, South Africa. A purposive sample of 29 adolescents aged 16–19 years old were enrolled as part of a longitudinal qualitative study. The current analysis reports on the first round of in-depth interviews, which focused on the role of men and women in their community. A theoretically informed thematic analysis identified three broad themes: 1) Adolescent interpretation and understanding of gender identity, 2) Gendered essentialism and Gender roles (two sub-themes: Young men: Power through providing, and Young women: The domestication process which highlighted that gender roles were defined by being the provider for men, and the successful fulfilment of traditional domestic behaviours amongst women), 3) Gender and fertility highlighted how participants highly valued fertility as affirming of manhood/womanhood. These norms reinforce gender roles that maintain asymmetrical power relations, carrying them over into adulthood. The subtle social pressure to prove fertility could have unintended consequences for driving teenage pregnancy. Structural, gender-based interventions emphasising positive gender-role development in early childhood are needed.

High-resolution genomic analysis to investigate the impact of the invasive brushtail possum (<i>Trichosurus vulpecula</i>) and other wildlife on microbial water quality assessments

by Marie Moinet, Lynn Rogers, Patrick Biggs, Jonathan Marshall, Richard Muirhead, Megan Devane, Rebecca Stott, Adrian Cookson

Escherichia coli are routine indicators of fecal contamination in water quality assessments. Contrary to livestock and human activities, brushtail possums (Trichosurus vulpecula), common invasive marsupials in Aotearoa/New Zealand, have not been thoroughly studied as a source of fecal contamination in freshwater. To investigate their potential role, Escherichia spp. isolates (n = 420) were recovered from possum gut contents and feces and were compared to those from water, soil, sediment, and periphyton samples, and from birds and other introduced mammals collected within the Mākirikiri Reserve, Dannevirke. Isolates were characterized using E. coli-specific real-time PCR targeting the uidA gene, Sanger sequencing of a partial gnd PCR product to generate a gnd sequence type (gST), and for 101 isolates, whole genome sequencing. Escherichia populations from 106 animal and environmental sample enrichments were analyzed using gnd metabarcoding. The alpha diversity of Escherichia gSTs was significantly lower in possums and animals compared with aquatic environmental samples, and some gSTs were shared between sample types, e.g., gST535 (in 85% of samples) and gST258 (71%). Forty percent of isolates gnd-typed and 75% of reads obtained by metabarcoding had gSTs shared between possums, other animals, and the environment. Core-genome single nucleotide polymorphism (SNP) analysis showed limited variation between several animal and environmental isolates (Escherichia clones are shared between possums, other wildlife, water, and the wider environment. These findings support the potential role of possums as contributors to fecal contamination in Aotearoa/New Zealand freshwater. Our study deepens the current knowledge of Escherichia populations in under-sampled wildlife. It presents a successful application of high-resolution genomic methods for fecal source tracking, thereby broadening the analytical toolbox available to water quality managers. Phylogenetic analysis of isolates and profiling of Escherichia populations provided useful information on the source(s) of fecal contamination and suggest that comprehensive invasive species management strategies may assist in restoring not only ecosystem health but also water health where microbial water quality is compromised.

Analyzing the concept of toxic positivity for nursing: A dimensional analysis approach

Abstract

Aim

To analyze toxic positivity and its relevance to nursing.

Design

Concept analysis using Schatzman's dimensional analysis approach.

Data Sources

Two searches were conducted using Google Scholar, JSTOR, ProQuest and CINAHL (1990–2023). Keywords included “toxic positivity” (Phase 1) and “emotional suppression,” “unrealistic optimism”; “disingenuous happiness,” “forced gratitude” and “logical fallacy” (Phase 2). Retained sources (1) were in English (Phases 1 and 2); (2) used ‘toxic positivity’ as a construct reflecting the purpose of analysis (Phase 1); and (3) demonstrated relevance towards analytical findings (Phase 2). Total analytic sources were 35.

Methods

The analytic phase, identification, elucidated conceptual dimensions and contexts. The analytic phase, logistics, examined relationships among dimensions and contexts through an iterative process resulting in a dimensional matrix/conceptual model.

Results

Salient dimension is Emotional Suppression with two sub-dimensions, Logical Fallacy and Forced Gratitude. Other dimensions include Unrealistic Optimism and Disingenuous Happiness. Contexts include intra- and post-paradigmatic societal shifts and intra- and post-traumatic experiences. Analysis reveals toxic positivity as an exchange between a giver and receiver with the receiver experiencing negative outcomes.

Conclusion

The concept appears consistent in its application and use across contexts and is emerging in nursing literature.

Implications for the Profession

Acknowledging toxic positivity in nursing may inform theoretical and future research related to improving nursing burnout, bolstering retention, and enhancing well-being. Nurses across work environments may encounter toxic positivity. Leaders should consider policy adoption and inclusion of trauma-informed practices.

Impact

Nursing workforce issues require deeper examination of potential contributing factors. Findings suggest toxic positivity may be encountered in work environments impacting nursing at individual and system levels.

Patient or Public Contribution

No patient or public contribution.

Perceptions on artificial intelligence-based decision-making for coexisting multiple long-term health conditions: protocol for a qualitative study with patients and healthcare professionals

Por: Gunathilaka · N. J. · Gooden · T. E. · Cooper · J. · Flanagan · S. · Marshall · T. · Haroon · S. · DElia · A. · Crowe · F. · Jackson · T. · Nirantharakumar · K. · Greenfield · S.
Introduction

Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions.

Methods and analysis

A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants’ attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants’ opinions on how their experiences compare. Data will be analysed thematically using the Framework Method.

Ethics and dissemination

This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.

Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN

Por: Greene · L. · Barber · R. · Bingham · A. · Connors · J. · Conroy · S. · Elkhafer · K. · Fox · C. · Goodwin · V. · Gordon · A. · Hall · A. J. · Harwood · R. H. · Hulme · C. · Jackson · T. · Litherland · R. · Morgan-Trimmer · S. · Pankiewicz · S. · Parry · S. W. · Sharma · A. · Ukoumunne · O.
Introduction

Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.

Method and analysis

This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.

Ethics and dissemination

The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.

Trial registration number

ISRCTN16413728.

The role of leadership in nurses' wellbeing and performance: A cross‐sectional survey using a dual motivational pathway model

Abstract

Aim

To examine the positive motivational paths from perceived autonomy-supportive leadership, and the negative motivational paths from perceived controlling leadership to satisfaction and frustration of basic psychological needs, work motivation, work performance, work engagement and somatic symptom burden among nurses using Self-Determination Theory.

Design

The study used a cross-sectional design mapping nurses' perceptions of the various study variables through a survey.

Methods

Nurses working in the municipal healthcare in Norway were recruited through an electronic questionnaire sent out via a link to their emails between 29th of August and 29th of September 2020. Of them, 219 nurses completed the questionnaire. Study hypotheses were tested using structural equation modelling.

Results

Higher levels of perceived autonomy-supportive leadership were associated with reduced levels of somatic symptom burden and increased levels of work performance and work engagement through the satisfaction of basic psychological needs and autonomous motivation, specifically identified regulation and intrinsic motivation. Perceptions of controlling leadership were associated with heightened levels of somatic symptom burden through basic psychological need frustration, amotivation and introjected motivation, along with lower levels of work engagement through need frustration and amotivation.

Conclusion

This study underscores the positive motivational paths of perceived autonomy-supportive leadership on nurses' work performance and wellbeing through the facilitation of basic psychological need satisfaction and autonomous motivation. Conversely, the study highlights negative motivational paths of perceived controlling leadership on reduced work engagement and heightened ill-being through the basic psychological need frustration, controlled motivation and amotivation.

Impact

This study provides insights and actionable recommendations for nurses and their leaders, emphasizing the significance of understanding the adverse impact associated with perceived controlling leadership. The findings underscore the importance of addressing these issues to mitigate detrimental effects on motivation and overall work functioning.

Patient or Public Contribution

No patient or public contribution.

'DANMM thats good!: evaluating the feasibility and acceptability of the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Programme across rural, regional and metropolitan NSW-a collaborative study protocol

Por: Biles · B. · Christian · B. · Marshall · C. · McMillan · F. · Sara · G. · Anderson · J. · Davies · N. · Fealy · S. · Biles · J.
Introduction

This paper will describe the research protocol for the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Project, which will determine the feasibility and acceptability of a cultural mentoring programme designed for Aboriginal and Torres Strait Islander nurses and midwives across five diverse local health districts in New South Wales, Australia. Government and health agencies highlight the importance of culturally appropriate and safe environments for Aboriginal people. Specifically, New South Wales Health prioritises workforce strategies that support Aboriginal people to enter and stay in the health workforce. However, retaining Aboriginal nurses and midwives remains challenging. The DANMM Project aligns with these local and state-wide health plans and strategies, addressing critical issues of workforce cultural safety and retention.

Methods and analysis

A mixed-methods study design will be employed to assess feasibility, acceptability and preliminary efficacy of the DANMM Programme across five publicly funded local health districts in New South Wales, Australia. Adhering to cultural safety, a project cultural governance group will be formed. Quantitative outcome measures include the use of questionnaires (Nursing Workplace Satisfaction Questionnaire, Ganngaleh nga Yagaleh Cultural Safety assessment tool). Resource implications will be measured using the Organisational Commitment and Health Professional Program Readiness Assessment Compass. These will be triangulated with individual and group yarning circles to provide a holistic evaluation of the programme.

Ethics and dissemination

The study has ethics approval: Aboriginal Health and Medical Research Council (#2054/23); New South Wales Health Human Research Committees (Greater Western Human Research Committee #2022/ETH01971, Murrumbidgee—site-specific approval, Sydney Local Health District—site-specific approval, Western Sydney Local Health District—site-specific approval and Mid North Coast—site-specific approval); and Charles Sturt University Human Research Committee (#2054/23). Findings will be disseminated through peer-reviewed articles, conferences and through roundtable discussions with key stakeholders.

Importance of kidney function, number of chronic conditions and medications for hospitalisation in elderly in Blekinge County, Sweden: a case-control study

Por: Norstedt · I. · Thorell · K. · Halling · A.
Objectives

To study the association between risk for hospitalisation in an elderly population related to renal function, number of chronic diseases and number of prescribed drugs.

Design

A case–control study. Persons hospitalised were included and their controls were obtained from electronic hospital medical records. If data were lacking on creatinine levels, multiple imputation was used.

Setting

Blekinge County in southwestern Sweden.

Participants

Study of individuals aged 75 years or older in 2013. We identified a total of 2,941 patients with a first hospitalisation. Of these, 81 were excluded, 78 due to incomplete data and 3 because of lack of control persons. Controls were matched to the same sex and birth year, which resulted in 5720 persons.

Primary and secondary outcome measures

To analyse the OR for hospitalisation conditional logistic regression was used.

Results

A total of 695 persons lacked creatinine value. Using imputation values comparing persons with estimated glomerular filtration rate (eGFR) 2 with ≥30 univariate analyses showed an increased OR 2.35 (95% CI 1.83 to 3.03). Adjusted analyses demonstrated an OR of 1.90 (95% CI 1.46 to 2.47). Comparing eGFR2 against ≥45 univariate analyses showed OR 1.38 (95% CI 1.22 to 1.57). Adjusted analyses OR for the same group were 1.17 (95% CI 1.03 to 1.33). In both models, the OR for five or more chronic conditions and five or more medications showed a statistically increased risk for hospitalisation.

Conclusions

There is a need for systems using data collected in routine care to follow elderly patients to minimise avoidable hospitalisations that can cause adverse effects. Renal function, number of chronic conditions and medications are factors that are of significant importance. This study demonstrates the complexity of this patient group.

UPDATE trial: investigating the effects of ultra-processed versus minimally processed diets following UK dietary guidance on health outcomes: a protocol for an 8-week community-based cross-over randomised controlled trial in people with overweight or obes

Por: Dicken · S. · Makaronidis · J. · van Tulleken · C. · Jassil · F. C. · Hall · K. · Brown · A. C. · Gandini Wheeler-Kingshott · C. A. M. · Fisher · A. · Batterham · R.
Introduction

Obesity increases the risk of morbidity and mortality. A major driver has been the increased availability of ultra-processed food (UPF), now the main UK dietary energy source. The UK Eatwell Guide (EWG) provides public guidance for a healthy balanced diet but offers no UPF guidance. Whether a healthy diet can largely consist of UPFs is unclear. No study has assessed whether the health impact of adhering to dietary guidelines depends on food processing. Furthermore, our study will assess the impact of a 6-month behavioural support programme aimed at reducing UPF intake in people with overweight/obesity and high UPF intakes.

Methods and analysis

UPDATE is a 2x2 cross-over randomised controlled trial with a 6-month behavioural intervention. Fifty-five adults aged ≥18, with overweight/obesity (≥25 to 2), and ≥50% of habitual energy intake from UPFs will receive an 8-week UPF diet and an 8-week minimally processed food (MPF) diet delivered to their home, both following EWG recommendations, in a random order, with a 4-week washout period. All food/drink will be provided. Participants will then receive 6 months of behavioural support to reduce UPF intake. The primary outcome is the difference in weight change between UPF and MPF diets from baseline to week 8. Secondary outcomes include changes in diet, waist circumference, body composition, heart rate, blood pressure, cardiometabolic risk factors, appetite regulation, sleep quality, physical activity levels, physical function/strength, well-being and aspects of behaviour change/eating behaviour at 8 weeks between UPF/MPF diets, and at 6-month follow-up. Quantitative assessment of changes in brain MRI functional resting-state connectivity between UPF/MPF diets, and qualitative analysis of the behavioural intervention for feasibility and acceptability will be undertaken.

Ethics and dissemination

Sheffield Research Ethics Committee approved the trial (22/YH/0281). Peer-reviewed journals, conferences, PhD thesis and lay media will report results.

Trial registration number

NCT05627570

Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

Por: Harvey · S. · Stone · M. · Zingelman · S. · Copland · D. A. · Kilkenny · M. F. · Godecke · E. · Cadilhac · D. A. · Kim · J. · Olaiya · M. T. · Rose · M. L. · Breitenstein · C. · Shrubsole · K. · OHalloran · R. · Hill · A. J. · Hersh · D. · Mainstone · K. · Mainstone · P. · Unsworth · C. A
Introduction

People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments.

Methods and analysis

This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4).

Ethics and dissemination

Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women’s Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy

Por: Behman · R. · Auer · R. C. · Bubis · L. · Xu · G. · Coburn · N. G. · Martel · G. · Hallet · J. · Balaa · F. · Law · C. · Bertens · K. A. · Abou Khalil · J. · Karanicolas · P. J.
Introduction

Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery.

Methods and analysis

This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts.

Ethics and dissemination

This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov.

Trial registration number

ClinicalTrials.gov identifier: NCT04549662.

Social prescribing for people living with dementia (PLWD) and their carers: what works, for whom, under what circumstances and why - protocol for a complex intervention systematic review

Por: Marshall · J. · Papavasiliou · E. · Fox · C. · Hawkes · M. · Irvine · A. · Moniz-Cook · E. · Pick · A. · Polley · M. J. · Reeve · J. · Robinson · L. · Rook · G. · Sadler · E. · Wolverson · E. · Walker · S. · Cross · J. L. · the SPLENDID Collaboration · Fox · Cross · Allan · Avery · Bradbu
Introduction

Dementia is a complex medical condition that poses significant challenges to healthcare systems and support services. People living with dementia (PLWD) and their carers experience complex needs often exacerbated by social isolation and challenges in accessing support. Social prescribing (SP) seeks to enable PLWD and their carers to access community and voluntary sector resources to support them address such needs. Existing research, however, does not describe what SP interventions are currently in place in dementia care. Little is known about the needs these interventions are designed to address, the reasons that lead PLWD and their carers to participate in them, their effectiveness and the extent to which they could increase positive health outcomes if adopted and how.

Methods and analysis

A complex intervention systematic review of SP for PLWD and/or their carers will be conducted using an iterative logic model approach. Six electronic (MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and Cochrane/CENTRAL) and two grey literature databases (EThOS and CORE) were searched for publications between 1 January 2003 and June 2023, supplemented by handsearching of reference lists of included studies. Study selection, data extraction and risk of bias assessment, using Gough’s Weight of Evidence Framework, will be independently performed by two reviewers. A narrative approach will be employed to synthesise and report quantitative and qualitative data. Reporting will be informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis Complex Interventions extension statement and checklist.

Ethics and dissemination

No ethical approval is required due to this systematic review operating only with secondary sources. Findings will be disseminated through peer-reviewed publications, conference presentations and meetings with key stakeholders including healthcare professionals, patient and carer groups, community organisations (eg, the Social Prescribing Network and the Evidence Collaborative at the National Academy for Social Prescribing), policymakers and funding bodies.

PROSPERO registration number

CRD42023428625.

First‐line managers' experience of guideline implementation during the COVID‐19 pandemic

Abstract

Aim(s)

To explore first-line managers' experience of guideline implementation in orthopaedic care during the COVID-19 pandemic.

Design

A descriptive, qualitative study.

Methods

Semi-structured interviews with 30 first-line nursing and rehabilitation managers in orthopaedic healthcare at university, regional and local hospitals. The interviews were analysed by thematic analysis.

Results

First-line managers described the implementation of guidelines related to the pandemic as different from everyday knowledge translation, with a swifter uptake and time freed from routine meetings in order to support staff in adoption and adherence. The urgent need to address the crisis facilitated guideline implementation, even though there were specific pandemic-related barriers such as staffing and communication issues. An overarching theme, Hanging on to guidelines for dear life, is substantiated by three themes: Adapting to facilitate change, Anchoring safety through guidelines and Embracing COVID guidelines.

Conclusion

A health crisis such as the COVID-19 pandemic can generate enabling elements for guideline implementation in healthcare, despite prevailing or new hindering components. The experience of guideline implementation during the COVID-19 pandemic can improve understanding of context aspects that can benefit organizations in everyday translation of evidence into practice.

Implications for the Profession and/or Patient Care

Recognizing what enabled guideline implementation in a health crisis can help first-line managers to identify local enabling context elements and processes. This can facilitate future guideline implementation.

Impact

During the COVID-19 pandemic, the healthcare context and staff's motivation for guideline recognition and adoption changed. Resources and ways to bridge barriers in guideline implementation emerged, although specific challenges arose. Nursing managers can draw on experiences from the COVID-19 pandemic to support implementation of new evidence-based practices in the future.

Reporting Method

This study adheres to the EQUATOR guidelines by using Standards for Reporting Qualitative Research (SRQR).

No Patient or Public Contribution.

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J.
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

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