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Positive health programme for British South Asian women with postnatal depression: a multiperspective qualitative study

Por: Miah · J. · Bee · P. E. · Lunat · F. · McPhillips · R. · Taylor · A. K. · Aseem · S. · Sharma · D. · Husain · N. · Chew-Graham · C.
Objectives

To explore the views and perspectives of British South Asian (BSA) women and Positive Health Programme (PHP) facilitators on the usefulness and experiences of the PHP intervention for managing postnatal depression (PND) in primary care settings.

Design

Qualitative study with semi-structured interviews to explore perceptions of acceptability and implementation. A patient and public involvement group provided their insights and feedback on study topic guides, analysis and outcomes.

Setting and participants

We sampled trial participants from the PHP intervention database to ensure variation in geographic setting, age, socioeconomic status and ethnicity. PHP facilitators involved in the trial were also invited to participate in an interview.

Interviews with study participants were conducted at participants’ homes, and community centres, or via phone. Interviews with PHP facilitators were conducted via phone or online. Interview recordings were transcribed verbatim and analysed using thematic analysis and subsequently the Theoretical Framework of Acceptability (TFA) was applied. Recruitment took place between February 2017 and March 2020.

Results

Thirty interviews were conducted—19 trial participants and 11 PHP facilitators. The PHP intervention was viewed positively, with appreciation of its therapeutic content and components such as childcare and refreshments that facilitated engagement. Participants reported improved confidence and well-being and supported their needs. Participants understood the intervention’s purpose. Both intervention participants and facilitators noted strengthened self-efficacy.

Some participants experienced difficulties balancing childcare and attendance, implying a need for logistical assistance. Stigma about mental health in the BSA community was viewed as persistent, recommending future programmes efforts on strategies to reduce stigma and develop supportive environment.

Conclusion

This study demonstrates the possibility of PHP intervention being integrated into routine care by providing culturally tailored support for BSA women with PND, primarily through family engagement and facilitator support. Future research on scalability, alongside community engagement efforts, will strengthen its acceptability and broader applicability.

Trial registration number

ISRCTN10697380.

From knowledge to action: protocol for a mixed-methods evaluation of First Nations-led knowledge mobilisation on prenatal opioid exposure

Por: Medeiros · P. · Mazzucco · A. · Wilkinson · L. · Altiman · M. · Glover · J. · Stone · A. · Taylor · B. · Guttmann · A. · Kerpan · S.
Introduction

First Nations communities in Canada are disproportionately impacted by prenatal opioid exposure (POE) and neonatal abstinence syndrome (NAS). In response, we developed a research partnership with 13 First Nations communities in Ontario. Phase I of the research project, initiated in 2018, included the development of mixed-methods reports on the impact of POE for each community. This protocol outlines the evaluation of phase II, during which nine communities individually co-designed and implemented community-specific knowledge mobilisation (KMb) plans informed by findings from phase I. The evaluation aims to assess advisory working group engagement, KMb implementation and perceived community-level impacts.

Methods and analysis

This mixed-methods evaluation integrates survey and qualitative data to assess First Nations-led KMb products and activities. The Public and Patient Engagement Evaluation Tool, a validated survey instrument, will be administered to advisory group members and analysed descriptively. Focus groups and interviews will be conducted to explore advisory working group members’ experiences and analysed using phenomenological methods. Qualitative findings will be mapped to the Engage with Impact framework to assess outcomes across engagement domains.

Ethics and dissemination

Ethics approval has been granted by Vancouver Island University. All community contacts and advisory working group members will provide informed consent prior to data collection. Phase II activities are governed by formal community agreements. In alignment with First Nations Principles of OCAP (Ownership, Control, Access and Possession), First Nations community partners retain ownership of their KMb products and are actively involved in the design, implementation and dissemination of the project evaluation. Results will be shared through peer-reviewed publications, community reports and knowledge-sharing events.

Study protocol for a randomised controlled trial to determine the efficacy of lisdexamfetamine for the treatment of acute methamphetamine withdrawal in inpatient settings

Por: Acheson · L. S. · Siefried · K. J. · Lintzeris · N. · Dunlop · A. J. · Haber · P. S. · Arunogiri · S. · Christmass · M. · Doyle · M. · Donoghoe · M. · Nagle · J. · Clifford · B. · McKetin · R. · Lubman · D. I. · Brett · J. · Taylor · N. · Carr · A. · Levin · F. R. · Shoptaw · S. · Ezard · N
Introduction

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

Methods and analysis

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

Ethics and dissemination

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

Trial registration number

ACTRN12624001061527.

Impact of barcode medication administration on patient safety in UK hospital settings: protocol for a mixed-methods realist evaluation

Por: Mahmoud · A. · Abdelaziz · S. · McErlean · M. · Jani · Y. · Slatter · M. · Villena · A. · Bird · J. · Grailey · K. · Taylor · A. · Franklin · B. D.
Introduction

Barcode medication administration (BCMA) systems are increasingly being implemented in hospital settings, with the aim of decreasing medication administration errors. However, the majority of the literature demonstrating the value of BCMA in supporting patient safety is from the USA. Furthermore, little is known about the underlying mechanisms that support its use. This study aims to explore the impact of BCMA on patient safety including medication admisntration errors and nursing time spent providing direct patient care, in terms of what works, for whom, under what circumstances, and how.

Methods and analysis

We will use a mixed-methods realist evaluation. The study will be conducted in four phases, at two London NHS teaching trusts and one South West Region NHS Trust using different electronic health record systems. Phase 1 will involve documentary analysis and a narrative review to develop an initial programme theory for how BCMA is expected to work. Phase 2 will use interviews with key informants to refine this programme theory. The programme theory will then be tested in phase 3 using mixed methods: (1) observation of nurses’ medication administration; (2) analysis of alert data from the BCMA systems to understand the alerts’ clinical significance and utility and (3) interviews with nurses and hospital inpatients to explore their views. These data will be triangulated to refine and finalise the programme theory in phase 4, together with recommendations for practice.

Ethics and dissemination

The Study Coordination Centre has obtained approval (24/SC/0326) from the Oxford B NHS Research Ethics Committee and the Health Research Authority. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals. Additionally, summaries of the findings will be produced, targeted at relevant groups such as healthcare professionals, policy-makers and study participants.

Equity of digital self-management tools in adults with multiple long-term conditions: a scoping review protocol

Por: Walker · H. · Robbins · T. · El-Osta · A. · Stirland · L. · Taylor · D. · Jones · A. · McBride · E. · Aslam · A.
Introduction

Adults living with multiple long-term conditions (MLTC)—defined as the presence of two or more physical or mental health conditions—often face fragmented and complex care. Digital tools offer scalable self-management solutions but may exacerbate inequities due to the digital divide and other factors. The aim of this scoping review is to map and summarise the existing literature on digital self-management tools used in MLTC, with a particular focus on how equity of access is considered in their development, implementation and evaluation.

Methods and analysis

Scoping review methodology will be based on the Joanna Briggs Institute guidance for scoping reviews and Arskey and O’Malley’s framework and will be reported in alignment with Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Reviews. Comprehensive search terms based on ‘multimorbidity’, ‘digital tools’ and ‘self-management’ have been developed. Peer-reviewed publications will be identified using MEDLINE, Embase, Emcare, Scopus, CINAHL and PubMed. Two reviewers will independently screen titles and abstracts, with subsequent full text review also being performed in duplicate to ensure they meet the eligibility criteria. Discrepancies will be resolved by discussion with a third reviewer. Included studies will focus on digital tools for the self-management of MLTC in adults (≥18 years old) in any setting. Equity dimensions will include, but are not limited to, digital literacy, treatment burden, socioeconomic status, polypharmacy and access disparities.

Ethics and dissemination

Ethical approval is not required for this scoping review. The results of the scoping review will be published in an open access, peer-reviewed journal for wider dissemination. Additionally, findings will contribute to topic guides and mapping of a research networking event with key stakeholders (including patient and public involvement and engagement members, clinicians, researchers and industry) in MLTC, around the same subject area.

The DEXACELL trial--a protocol for a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial to assess the effectiveness and cost-effectiveness of DEXAmethasone as an adjunctive therapy for the manag

Por: Joyce · K. · Lear · R. · Hamilton · F. W. · Arnold · D. · Chaudhuri · E. · Connors · J. · Cook · H. · Creanor · S. · Dawe · P. · Goodwin · E. · Hawton · A. · Hayward · C. · Lasserson · D. S. · Ridd · M. J. · Rowe · D. · Shipley · D. · Taylor · H. · Wainman · H. E. · Williams · O. M. · Carlto
Introduction

Cellulitis is a common bacterial skin infection causing significant pain, swelling and impact on daily activities, frequently leading to emergency department presentations and hospital admissions. While antibiotics are the mainstay of treatment, they do not directly address inflammation, often resulting in persisting or worsening symptoms in the initial days. Corticosteroids, with their potent anti-inflammatory effects, have shown benefit in other acute infections but are not currently standard care for patients with cellulitis. This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary care settings.

Methods and analysis

This is a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial, with an internal pilot and parallel health economic evaluation. Adult patients (≥16 years) with a clinical diagnosis of cellulitis (at any body site except the orbit) presenting to urgent secondary care will be screened for eligibility. 450 participants will be randomised (1:1) to receive either two 8 mg doses of oral dexamethasone or matched placebo, administered approximately 24 hours apart, in addition to standard antibiotic therapy. The primary outcome is total pain experienced over the first 3 days postrandomisation, calculated using the standardised area under the curve from pain scores (Numerical Rating Scale 0–10) across up to seven timepoints. Secondary outcomes include health-related quality of life (EuroQol 5 Dimension 5 Level), patient global impression of improvement, analgesia and antibiotic usage, hospital (re)admissions, complications, unscheduled healthcare use, cellulitis recurrence and cost-effectiveness at 90 days. The primary estimand will apply a treatment policy approach to intercurrent events.

Ethics and dissemination

The trial has received ethical approval from South Central—Oxford B Research Ethics Committee (reference: 24/SC/0289) and will be conducted in compliance with Good Clinical Practice and applicable regulations. Informed consent will be obtained from all participants. A model consent form can be seen in . Findings will be disseminated through peer-reviewed publications and conference presentations, and to patient groups and relevant clinical guideline committees.

Trial registration number

ISRCTN76873478.

Prevention and Early Delirium Identification Carer Toolkit (PREDICT): A Study Protocol for a Stepped‐Wedge, Cluster Randomised Controlled Trial

ABSTRACT

Background

Delirium, a common, serious and often preventable complication in older hospitalised adults, contributes to significant health and social care costs. Carers are uniquely positioned to identify early signs and support delirium prevention. The Prevention & Early Delirium Identification Carer Toolkit (PREDICT), a novel model of care designed to educate carers about delirium management and prevention strategies, enables them to actively participate in the care and recovery of their person. Developed through a comprehensive literature review, a co-designed eDelphi and pilot study, PREDICT demonstrated acceptability and feasibility.

Aims

To evaluate the effectiveness, implementation and cost-benefit of a PREDICT in hospital settings.

Method

A stepped-wedge cluster randomised controlled trial (SW-cRCT), consisting of a cohort study, healthcare service evaluation, and process evaluation. The study will assess carer and staff knowledge of delirium, carer care giving stress, health service outcomes (e.g., incidence, length of stay, readmissions) and cost-benefit.

Discussion

PREDICT is a scalable, person-centred approach that supports both patients and carers, with the potential to embed best-practice delirium management into routine healthcare.

Public and Patient Involvement

This study was developed in consultation with older adults, carers and healthcare staff. Two consumer representatives joined the project steering committee and contributed to shaping the research question, refining the study protocol and selecting outcome measures relevant to families and healthcare staff. Carers were involved in reviewing participant information sheets and the PREDICT website, providing feedback to ensure clarity and accessibility. Results will be shared with participants and the wider community through plain-language summaries and public presentations.

Trial Registration

Australian and New Zealand Clinical trial: ACTRN12625000705482 registered on the 3rd of July 2025

Expansive Learning in Practice: A Rapid Evaluation of a Student Nurse Placement Model (Empirical Research Mixed Methods)

ABSTRACT

Aim

The aim of this study was to document the process of the implementation and the perceived impact and sustainability of the Expansive Learning in Practice Model and its associated costs to inform future rollout.

Design

A mixed-method rapid evaluation was conducted, comprising both qualitative and economic workstreams to document the implementation of the Expansive Learning in Practice Model and its associated costs. Semi-structured interviews (n = 44) were carried out with student nurses, student assessors, and staff involved in the delivery of the Model. The qualitative workstream utilised a rapid cycle evaluation approach, where data were collected and analysed in parallel, and preliminary findings were shared with stakeholders as the study was ongoing. The quantitative workstream relied on routinely collected data about non-staff-related costs, staff-related costs, and data on students' participation.

Results

The main themes developed from the qualitative data included the organisation of the Expansive Learning Experiences, the supportive environment, the enhanced learning experience, and capacity building. Participants perceived that the model had a positive impact on student practice (including preparation and confidence) and on student nurse satisfaction. At the end of the programme, it is estimated that the programme will have cost about £523,572.

Conclusion

This model can be used as a framework for hospitals aiming to improve the learning experiences for student nurses. Improvements could be made by increasing staff buy-in and the streamlining of spoke opportunities. Future studies should focus on evaluating the long-term impact of the model, particularly the impact on generating student placement capacity. The evaluation also highlights the need for solutions for potential educational staff shortages, which could pose a risk to maintaining sufficient practice placement capacity for student nurses in healthcare settings.

Impact

Study participants perceived an improvement in student nurses' learning experiences and student nurse placement capacity as a result of the implementation of this model.

Reporting Method

The relevant EQUATOR guidelines followed for reporting were the GRAMM guidelines (Good Reporting of a Mixed Methods Study).

No Patient or Public Contribution

The study centred around student nurse and staff experiences.

Comparison of inguinal fist compression versus commercial windlass tourniquet for reduction in femoral artery blood flow by untrained providers: a protocol for a superiority, assessor-blinded, cross-over, randomised controlled trial

Por: Bruce · K. · Snelling · P. J. · Abery · P. · Kemp-Smith · K. · Lamond · D. · Taylor · N. · Patel · B. · Jones · P. · Furness · J.
Introduction

Effective haemorrhage control is crucial in cases of limb trauma involving arterial injury, such as shark attacks, to prevent potentially fatal outcomes. International first aid consensus recommends the use of arterial tourniquets (proprietary or makeshift) as a primary treatment for life-threatening external bleeding. Manual pressure applied directly over a major artery proximal to the injury, such as inguinal fist compression (IFC), is more accessible in a first-aid situation, but is currently not recommended due to limited evidence. The purpose of this study is to determine whether the application of IFC is superior to commercial windlass tourniquets (CWTs) in reducing blood flow in the femoral artery when performed by untrained bystanders.

Methods and analysis

Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-2) is a superiority, assessor-blinded, cross-over, randomised controlled trial conducted with healthy untrained adult volunteers in non-clinical settings. Participants will be rotated as providers and recipients of both IFC and CWT, with providers randomised to the order that they perform the techniques. Providers will be exposed to an educational infographic before applying that technique to a recipient behind a drop sheet. A sonographer, blinded to the technique, will measure the peak systolic velocity of blood flow in the superficial femoral artery using Doppler ultrasound at baseline and then during application of each technique for 5 min. The mean percentage reduction in peak systolic velocity will be compared between IFC and CWT groups.

Ethics and dissemination

Ethics approval for this study was granted by the Bond University Human Research Ethics Committee (BUHREC JF01036) on 23 January 2023. All participants will be provided with written informed consent prior to enrolment and the trial will involve healthy adult volunteers. To minimise risk, preintervention screening, sonographic assessment and postintervention follow-up will be implemented with adverse events monitored and reported in accordance with HREC guidelines. Results will be disseminated through peer-reviewed journals, academic conferences, local resuscitation forums and public health education initiatives. A lay summary will also be shared with relevant community groups and via social media platforms to enhance public accessibility.

Trial registration number

ACTRN12624001054505.

Prepectoral no mesh versus mesh immediate implant-based reconstruction after mastectomy (Restore-B): a multicentre single-blinded randomised controlled feasibility study protocol

Por: Rolph · R. · Ziebland · S. · Cook · J. A. · Iglesias · C. · Wakefield-Scurr · J. · Malyon · C. · Scaife · J. · Taylor · A. · Hennessy · A. · Markham · S. · Bernstein · M. · Douek · M. · Restore-B Feasibility Collaborative Group · Roy · Rusby · Bonomi · St-John · Agrawal · Smith · Beta
Introduction

Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.

Methods and analysis

UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).

Ethics and dissemination

This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.

Trial registration numbers

NCT06112977; ISRCTN17470747.

Tobacco-related toxicant exposure among people with and without experience of psychosis: findings from the US Population Assessment of Tobacco and Health study

Por: Taylor · E. · McNeill · A. · Tattan-Birch · H. · Marczylo · T. · East · K. · Robson · D.
Objective

Smoking and vaping are especially prevalent among people with experience of psychosis (EoP), potentially increasing their toxicant exposure. Switching from tobacco smoking to vaping e-cigarettes reduces exposure to tobacco-related toxicants and likely associated diseases. We compared levels of nicotine and tobacco-related toxicant exposure among people with versus without EoP.

Design

Cross-sectional study, secondary data analysis of Wave 5 (2018) of the Population Assessment of Tobacco and Health Study.

Setting

Data collection took place in the USA at the home of participants.

Participants

Data were from 5750 adults (aged >18 years) with and without EoP who smoked, vaped, did both or did neither. EoP was defined as ever being told by a health professional that you have schizophrenia, schizoaffective disorder, psychosis, a psychotic illness or psychotic episode.

Primary outcome

Levels of urinary toxicants: nicotine metabolites, metals, volatile organic compounds (VOCs) and tobacco-specific nitrosamines (TSNAs) among people with and without EoP. Analyses were adjusted for demographics, cannabis use and past 30-day smoking/vaping status, and were repeated after stratifying by smoking /vaping status.

Results

Of the 5750 participants, 6.3% (n=361) reported EoP, and 93.7% reported no EoP. Levels of nicotine and TSNA metabolites, cadmium, uranium and some VOCs were significantly higher among participants with EoP compared with those without. However, when smoking, vaping and cannabis use were taken into account, the associations of EoP with nicotine and TSNA metabolites, and most of the VOCs, were attenuated and no longer significant.

Conclusion

Participants with EoP are exposed to more nicotine and tobacco-related toxicants than those without EoP, likely largely due to the high prevalence of smoking, vaping and cannabis use among this population.

FAST MRI: DYAMOND trial protocol (can an abbreviated MRI scan detect breast cancers missed by mammography for screening clients with average mammographic density attending their first screening mammogram?)--a diagnostic yield study within the NHS populati

Por: Jones · L. I. · Geach · R. · Loose · A. · McKeown-Keegan · S. · Marshall · A. · Halling-Brown · M. · Curtis · S. · Harding · S. · Rose · J. · Matthews · H. · Vinnicombe · S. · Shaaban · A. M. · Taylor-Phillips · S. · Dunn · J. · On behalf of The FAST MRI Study Group
Introduction

First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.

Methods and analysis

Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.

Ethics and dissemination

The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.

Trial registration number

ISRCTN74193022

Swallowing prehabilitation for people with head and neck cancer: a pilot cluster-randomised feasibility trial of the SIP SMART intervention

Por: Govender · R. · Wang · J. · Marston · L. · Pizzo · E. · Taylor · S. · Nazareth · I.
Objectives

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Design

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Setting and participants

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Interventions

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Outcomes

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

Results

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

Conclusions

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

Trial registration number

ISRCTN12377415.

Advanced Practice Nurses' Roles and Responsibilities in Advance Care Planning for Older Persons—A Mixed Methods Systematic Review

ABSTRACT

Aim

To systematically identify, evaluate and synthesise the research literature about (a) the roles and responsibilities of advanced practice nurses (APNs) in the context of advance care planning (ACP) for older persons, (b) the characteristics of APNs' ACP practices and (c) the facilitators and barriers influencing APNs' involvement in ACP.

Design

Mixed-methods systematic review.

Methods

Followed the mixed methods systematic review guidelines outlined by the Joanna Briggs Institute. Three researchers independently screened studies for eligibility using the Covidence Screening Application. The screening involved two stages: titles and abstracts, followed by full-text evaluation. The Mixed Methods Appraisal Tool was used for quality assessment. A convergent integrated synthesis combined quantitative and qualitative data by ‘qualitising’ quantitative findings into text, enabling integration and thematic analysis to synthesise the results.

Data Sources

Medline, CINAHL and Embase were searched from 2012 to 2024 for original research in English, focusing on APNs involved in ACP for individuals aged 65 or older, using qualitative, quantitative or mixed method designs.

Results

The review included 19 studies: seven qualitative, nine quantitative and three mixed method designs. Thematic analysis revealed that APNs play a key role in ACP, aligning care with patient preferences through discussions and documentation. Studies from the United States (12), United Kingdom (4), Canada (2) and Australia (1) show varying APN roles and responsibilities.

Conclusion

APNs are crucial to ACP, but barriers limit their impact. Overcoming these is key to improving outcomes.

Implications for the Profession and Patient Care

APNs clinical expertise and close patient relationships are crucial for aligning care with patient preferences and needs in ACP. However, to fully maximise their contribution, it is essential to overcome barriers such as time constraints, lack of role recognition and insufficient training. Addressing these challenges will enhance the effectiveness of APNs in providing person-centred care.

Reporting Method

This review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.

Patient or Public Contribution

No patient or public contribution.

Safety and immunogenicity of rVSV{Delta}G-ZEBOV-GP vaccination when dosed concurrent with mRNA COVID-19 vaccine booster doses in healthy African adults (EbolaCov): protocol for a phase IV, single-centre, single-blinded, randomised controlled trial

Por: Gokani · K. · Taylor · A. · Packham · A. · Musabyimana · J. P. · Shema · H. · Mutabaruka · A. · Roche · S. · Takwoingi · Y. · Umuhoza · C. · Nyombayire · J. · Muvunyi · C. · Green · C.
Introduction

Ebola virus disease remains a significant public health concern. For protection from Ebola virus, the main target populations are epidemiologically identified and often include healthcare workers and refugees. These target populations are also routinely offered vaccines for other vaccine-preventable diseases. However, concomitant use of rVSVG-ZEBOV-GP with other vaccines is not recommended, given the absence of data regarding its reactogenicity and antigen-specific immunogenicity profile when co-administered. The EbolaCov trial aims to inform whether rVSVG-ZEBOV-GP can be administered concurrent to a Pfizer–BioNTech COVID-19 booster dose without an unacceptable increase in reactogenicity and/or loss of humoral immunogenicity to Ebola vaccine antigen.

Methods and analysis

This is a single-centre, randomised, single-blinded, vaccine safety and immunogenicity study in healthy adults living in Rwanda. Seventy-two participants will be randomised in a 1:1 ratio to two study groups, the first receiving rVSVG-ZEBOV-GP with a placebo, the second group receiving rVSVG-ZEBOV-GP concurrently with a Pfizer–BioNTech COVID-19 booster dose. The primary outcome measures are quantitative serum anti-glycoprotein (GP) antibody responses, as measured by ELISA, 28 days after vaccination, and frequency and severity of adverse events in the 7 days following vaccination. Secondary outcome measures include day 28 and day 180 serum anti-GP and serum SARS-CoV-2 anti-spike protein-specific geometric mean antibody titres.

Ethics and dissemination

This trial was approved by the Rwanda National Ethics Committee (reference 442/2024) and the University of Birmingham (reference ERN_2661-Jun2024). All participants were required to provide written informed consent in accordance with good clinical practice. Dissemination of results will be through conference presentations and peer-reviewed publications.

Trial registration number

Pan African Clinical Trials Registry (PACTR202407764378004) and ClinicalTrials.gov (NCT06587503)

Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol

Por: Karampatakis · G. D. · Wood · H. E. · Griffiths · C. J. · Taylor · S. J. · Toffolutti · V. · Bird · V. J. · Lea · N. C. · Ashcroft · R. · Coulson · N. S. · Panzarasa · P. · Li · X. · Sheikh · A. · Relton · C. · Sastry · N. · Watson · J. S. · Mant · J. · Marsh · V. · Day · B. · Mihaylova · B
Introduction

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

Methods and analysis

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

Ethics and dissemination

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

Trial registration number

NCT06849245.

Implementing relational continuity in general practice--understanding who needs it, when, to what extent, how and why: a realist review protocol

Por: Tzortziou Brown · V. · Park · S. · Mahtani · K. R. · Taylor · S. · Owen-Boukra · E. C. · Taylor · J. · Richards · O. · Begum · S. · Wong · G.
Introduction

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

Methods and analysis

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Dissemination and ethics

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

Efficacy of peroneal nerve functional electrical stimulation (FES) for the reduction of bradykinesia in Parkinsons disease: an assessor-blinded randomised controlled trial (STEPS II)--study protocol

Por: Tufft · A. · Neilens · H. · Marsden · J. · Creanor · S. · Ali · A. · Donovan-Hall · M. · Aspinall · P. · Lord · A. · Jones · B. · Taylor · P.
Introduction

Difficulty with walking can lead to reduced quality of life for people with Parkinson’s disease (pwPD); improving walking is considered a treatment priority. Drug therapies can control PD symptoms; however, pwPD often still experience mobility problems.

Functional electrical stimulation (FES) induces movement in weak muscles via external electrical stimulation. FES is used in stroke and multiple sclerosis patients to correct dropped foot by stimulating the common peroneal nerve and is associated with improved quality of life and mobility. The randomised feasibility study preceding this definitive study showed that daily FES can produce a clinically meaningful improvement in walking speed in pwPD; this was sustained 4 weeks after FES was withdrawn. STEPS II is the first definitive randomised controlled trial, with blinded outcome assessment, aiming to determine the efficacy of FES in pwPD.

Methods and analysis

STEPS II is a two-group, parallel, assessor-blinded, superiority randomised controlled trial with an internal pilot, designed to compare FES plus usual care versus usual care alone. 234 participants will be randomised across eight UK sites. Telephone pre-screening and face-to-face screening will determine eligibility. The intervention group will attend four unblinded FES visits to receive the device and assess walking with and without FES. All participants have blinded assessments at baseline and weeks 2, 6, 18 and 22. The primary objective is to compare whole body bradykinesia at 18 weeks post-baseline via changes in 10m walking speed. Secondary objectives will assess the wider effects of FES on Parkinsonian gait and quality of life. An embedded qualitative component will explore wider experiences of FES.

Ethics and dissemination

This study received ethical approval from the Yorkshire and The Humber-Sheffield Research Ethics Committee (reference 23/YH/0193). A Data Monitoring Committee and Trial Steering Committee will provide independent oversight. Dissemination will be via publications, conferences and social media. FES intervention and training materials will be made open access.

Trial registration number

ISRCTN13120555.

Optimising Paediatric Transition to Intensive Care for Adults (OPTICAL): study protocol for a mixed method study

Por: Huang · Q. · Kohn · C. · Abraham · S. B. · Malbon · K. · Mallick · A. · Mouncey · P. R. · Oulton · K. · Pagel · C. · Rose · L. · Seaton · S. E. · Taylor · J. · Thomas · R. · Windsor · C. · Wray · J. · Ramnarayan · P. · Crowe · S.
Introduction

An increasing number of teenagers and young adults (TYA) with chronic conditions and complex needs are transitioning from paediatric to adult services, including admission to intensive care units (ICUs). As these services are often ill-equipped to care for TYA, there is a risk of compromised care. Despite recent guidelines from the UK Paediatric Critical Care and Intensive Care Societies highlighting the importance and urgency of improving ICU transition, current recommendations are not evidence-based and established pathways for ICU transition remain limited.

Methods and analysis

This mixed-methods research study aims to generate evidence to underpin national policy on transition from paediatric to adult ICUs that will improve clinical care and patient experience. To do this, we will: (1) link and analyse UK national data (years 2017–2024) on paediatric and adult ICU admissions, hospital inpatient, outpatient and emergency care visits and survival status, to determine the clinical characteristics and healthcare resource utilisation from teenage years to early adulthood of people admitted to an ICU as a young person (admission aged 14 and 15), and how these relate to ICU admissions after age 16; (2) conduct semistructured interviews, online forums and surveys with TYA patients, carers and health professionals to understand their experience of transition in ICU services; and (3) synthesise these strands of evidence and use a structured process of stakeholder engagement to propose potential targeted improvements as appropriate.

Ethics and dissemination

This study was approved by the East of England - Cambridge South Research Ethics Committee on 1 August 2024 (research ethics committee number 24/EE/0108), and the Health Research Authority Confidentiality Advisory Group (CAG) on 7 October 2024 (CAG number 24/CAG/0068). Study results will be actively disseminated through peer-reviewed journals, conference presentations and accessible lay texts and graphic summaries for the use of charities and patients including those with learning disabilities and neurodevelopmental disorders.

Impact of left ventricular end-diastolic pressure on clinical outcomes in patients with ST-elevation myocardial infarction (Hunter LVEDP Study): a prospective, single-centre study

Por: Khan · A. A. · Williams · T. · Ray · M. · Al-Omary · M. S. · Taylor · J. · Collins · N. · Attia · J. · Boyle · A. J.
Objectives

Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.

Design

Prospective, single-centre study.

Participants

Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.

Primary outcome measure

The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.

Results

A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p

Conclusions

LVEDP is an independent predictor of adverse outcomes in STEMI patients, despite a relatively normal LVEF. Further prospective studies are needed to assess the effects of early reduction in LVEDP on the prognosis.

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