FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Effectiveness of a co-adapted virtual discharge education app on disease knowledge and health behaviours in patients following heart attack: a multicentre, randomised controlled trial protocol in Sydney, Australia

Por: Zhang · L. · Shi · W. · Zhao · E. · Hyun · K. K. · Zecchin · R. · Gao · Y. · Brunorio · L. · Stanaway · F. · Ellis · T. · Redfern · J. · Clark · R. · Du · H. · Gallagher · R.
Introduction

Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.

Methods and analysis

This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.

Ethics and dissemination

The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.

Trial registration number

ACTRN12624000408583.

An Exploration of Emergency Healthcare Provision When Intimate Partner Abuse Is Identified

ABSTRACT

Aim

This paper aims to synthesise the current, global evidence on addressing psychological concerns of women presenting with domestic and family violence within the ED and suggest avenues for future research.

Design

This discursive paper draws on clinical experience and research of the authors and critical synthesis of current literature on management of victim-survivors of DFV presenting with psychological symptoms in ED.

Methods

Academic databases and grey literature were systematically searched to identify relevant sources, and findings were narratively synthesised.

Results

DFV victim-survivors often present with mental health symptoms in ED; however, many health professionals in EDs fail to correctly identify the underlying trauma and offer support to address DFV. The most reported barriers to DFV screening/identification include time constraints, privacy issues, and lack of education/training about DFV and its support mechanisms. As a result, only mental health symptoms are being treated, ignoring the broader psychosocial needs of DFV victim-survivors. Use of trauma-informed support models is recommended to address the mental and psychosocial needs of DFV victim-survivors visiting the ED.

Conclusions

DFV victim-survivors visiting the ED are often treated for their mental health symptoms without addressing their underlying trauma and risk of future victimisation. To address the ongoing adverse impact of DFV, it is necessary to ensure holistic and continual support from ED professionals for victims.

Implications for the Profession and Patient Care

The importance of not only education but the implementation of sustained education and training programs surrounding DFV identification, screening, and cannot be understood. DFV is a global problem whereby many victim-survivors become healthcare patients. It would be poor decision making for clinicians to not prioritise appropriate responses to this societal problem within their clinical practice.

Can provision of near vision glasses as an early intervention improve visual outcomes in infants at risk of perinatal brain insult? The Babies in Glasses (BiG) randomised feasibility trial

Por: Bullaj · R. · Dyet · L. · Mitra · S. · Bunce · C. · Clarke · C. S. · Saunders · K. · Dale · N. · Horwood · A. · Williams · C. · St Clair Tracy · H. · Marlow · N. · Bowman · R.
Objectives

We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment.

Design

A three-arm, parallel-group, open-label randomised feasibility trial.

Setting

Tertiary neonatal intensive care in London, UK.

Participants

We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (±8.00D) were not included. Infants with retinopathy of prematurity were not excluded.

Interventions

At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses).

Outcomes

Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term.

Results

Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant).

Conclusions

We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study.

Trial registration numbers

ISRCTN14646770; NCT05048550.

Key protective factors that mitigate the impact of childhood trauma on poor mental health in adulthood: a scoping review protocol

Por: Clarke · A. · Hallett · N. · Brown · Y. · Cunnington · C. · Dauvermann · M. R. · Jordan · G. · Reniers · R. · Taylor · J.
Introduction

A significant proportion of adults in England and Wales report experiencing childhood trauma, which is often associated with poor health and negative social outcomes including a significant increase in the risk of poor mental health outcomes in adulthood. This proposed scoping review adopts a broad definition of childhood trauma and applies both a salutogenic framework and ecological systems theory to explore how protective factors at five ecological levels can support mental well-being. The review will also examine how protective factors vary across different population groups and contexts.

Methods and analysis

The scoping review will follow the Joanna Briggs Institute (JBI) protocol for scoping reviews. The databases that will be searched are Embase, PubMed, Web of Science, PsycINFO, CINAHL and Medline. Studies will be included if they include protective factors and involve adults aged 18 and over who have experienced childhood trauma, whether self-identified, retrospectively self-reported or measured using a validated instrument. Studies will be excluded if they focus on participants under the age of 18.

All search results will be uploaded to Covidence, duplicates removed, and titles/abstracts screened by at least two reviewers based on inclusion criteria. Full texts of potentially relevant sources will be imported into EndNote 21. Reasons for exclusions will be documented and disagreements resolved through discussion or a third reviewer. The full process will be reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted by at least two reviewers using a tool developed by the team based on the JBI guidance. A best-fit framework analysis will be used, using a matrix developed by the researchers including the four salutogenic domains and the five levels of the ecological framework.

Ethics and dissemination

Formal ethical approval is not necessary for this scoping review as it does not involve the collection of primary data. The outcomes of this study will be disseminated through peer-reviewed journal articles, conference/seminar presentations, and developed into resources for stakeholders and collaborators.

Trial registration number

Open Science Framework (DOI 10.17605/OSF.IO/CJRUY).

Chronic intestinal immune activation reveals separable impacts of inflammation and barrier loss on hallmarks of ageing

by Jeanette Alcaraz, Charlotte Keyse, Charles Hall, David W. Walker, David P. Doupé, Rebecca I. Clark

Inflammaging is considered a driver of age-associated pathology across tissues. Similarly, intestinal permeability is a feature of ageing and underlies a range of inflammatory and age-related diseases. Increased intestinal permeability has been described as both a cause and a consequence of inflammation. Both intestinal permeability and inflammation are closely associated with microbial dysbiosis, epithelial dysplasia and mortality but dissecting the complex interplay between these phenotypes remains challenging. Here we genetically induce intestinal immune activation in Drosophila and stratify animals by their intestinal barrier status using the Smurf assay. We demonstrate that intestinal barrier failure has a distinct impact on the microbiota. Further, immune activation, both within the intestine and systemically, drives intestinal barrier failure and mortality even in the absence of the microbiota. Importantly, immune-induced intestinal barrier failure takes time to develop and is closely associated with the onset of mortality. Our work adds to building evidence that the impact of intestinal permeability on the microbiota and on animal health needs to be considered independently of its relationship with inflammation.

Barriers and Facilitators in Implementing Clinical Practice Guidelines Among Nurses in Emergency Departments and Critical Care Units: A Systematic Review

ABSTRACT

Aim

This systematic review explored the barriers and facilitators to the implementation of clinical practice guidelines (CPGs) among nurses in emergency departments (EDs) and critical care units (CCUs).

Design

Systematic review.

Method

A systematic review was performed using both qualitative and quantitative studies from five databases (CINAHL, Web of Science, Embase, Scopus and PubMed). The literature search was conducted in May 2024. The PRISMA framework was used to guide the review process. Findings were subject to a narrative, thematic analysis and critical appraisal.

Results

Eighteen studies were identified that met the inclusion criteria, yielding three themes related to barriers and facilitators of guideline implementation: individual-level, guideline-level and organisational-level. Key barriers included lack of awareness of guidelines, lack of knowledge and skills, attitudes towards guidelines, resource limitations, lack of perceived support, complexity of guidelines and lack of training. Facilitators to guideline use included colleague support, adequate training, effective leadership and refinement of guidelines to ensure relevance, local adaptation and user-friendly content.

Discussion

Numerous barriers to nurse implementation of CPGs exist in ED and CCU settings, reflecting a complex interplay of individual, CPG-related and organisational factors. To facilitate CPG implementation, it is important for staff to be educated and trained in their use, supported to implement (including resource allocation) and that CPGs are designed to be easily implemented in practice.

Conclusion

This systematic review highlights risk factors for poor CPG implementation and highlights the importance of addressing awareness, knowledge, resources and support for CPG use through targeted training, leadership and CPG design.

Relevance to Clinical Practice

An analysis of barriers and facilitators to CPG implementation among nurses in ED and CCU settings provides an important opportunity to address a gap in the literature, facilitating the development of strategies to promote CPG use and enhance care quality among nurses in these specific contexts.

Does CMR improve aetiological sub-phenotyping beyond echocardiography in patients with elevated LV filling pressure? A prospective registry study (PREFER-CMR)

Por: Bana · A. · Li · R. · Mehmood · Z. · Rogers · C. · Grafton-Clarke · C. · Bali · T. · Hall · D. · Jamil · M. · Ramachenderam · L. · Dudhiya · U. · Spohr · H. · Underwood · V. · Girling · R. · Kasmai · B. · Nair · S. · Matthews · G. · Garg · P.
Objectives

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Design

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

Setting

A single NHS hospital in the UK.

Main outcome measures

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

Results

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

Conclusions

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab: protocol for an Australian safety, feasibility and dose-finding study

Por: Brown · M. P. · Matos · M. · Clarke · S. · Coates · P. T. · Pollock · C. · Kurtkoti · J. · Grau · G. · Edinburg · K. · Bloesch · A. · de Necochea Campion · R. · Khin · N. Y. · Shin · J. · LaRosa · S. P.
Background

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

Methods

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

Ethics and dissemination

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number

Australia New Zealand registration number ACTRN12624000732583.

A Concept Analysis of Expertise Associated With Practicing Clinical Nurses in Hospital Settings

ABSTRACT

Aim

Analyse the concept of expertise among practicing clinical nurses in hospital settings.

Background

The generational loss of expert clinical nurses was exacerbated globally by the novel coronavirus. This ongoing loss combined with the increased complexity of hospitalised patients has prompted an urgent need to understand expertise among clinical nurses who practice in hospital settings.

Methods

Walker and Avant's concept analysis method was used. PubMed, Medline, CINAHL and Access Medicine were searched (1982–2025) for research studies and literature reviews published in English that addressed clinical nursing expertise in hospitals.

Results

Expertise is the knowledge and skills that are enculturated from immersion in a domain. Common attributes include obtaining salient information from different sources, interpreting patient situations rapidly and holistically, and performing actions that are individualised, immediate and appear instinctive. Common antecedents include deliberate accumulation of relevant experience and contextual connections within the hospital. Facilitating improved outcomes and facilitating improved outcomes are common consequences.

Conclusion

The attributes, antecedents and consequences of clinical nursing expertise are complementary and cross specialties. Experts' apparently instinctive actions are not intuitive but rather related to relevant past experiences, pattern recognition and skilled know-how. The requirements to develop expertise have evolved with the increased volume of available knowledge.

Implications for the Profession

Expertise requires cultivating relevant experiences through active engagement with patients and creating contextual connections with others regarding hospital systems and processes. Experts should be formally included when developing processes and guidelines. Low-fidelity proxy measures like years of experience should be replaced with psychometrically validated instruments to measure expertise.

Impact

This concept analysis addresses the ambiguity of clinical nursing expertise by synthesising over 40 years of literature and provides insights for clinical nurses and researchers regarding the importance of context and the growing complexity of care delivery.

Patient or Public Contribution

No patient or public involvement.

Impact of physical activity on sleep in adults recovering from substance use disorders: a protocol for an N-of-1 observational study

Por: Thal · S. · Richardson · C. · McVeigh · J. · Thompson · C. · Wan · P. · Pang · B. · Riddell · H. · Bright · S. · Clarke · J. · Myers · B.
Introduction

Sleep impairments are prevalent among individuals recovering from substance use disorders (SUDs) and are associated with poorer treatment outcomes and increased relapse risk. Physical activity (PA) is known to enhance sleep in general populations, but its day-to-day effects on sleep during SUD recovery remain underexplored, especially across different recovery stages.

Methods and Analysis

In this observational n-of-1 study, we aim to examine within-person associations between daily PA and sleep quality in three groups of individuals at varying stages of substance use recovery (early treatment, continuing care and long-term recovery). A substudy will validate the agreement between two wearable sleep-monitoring devices. A total of 90 participants (30 per recovery group) from Western Australia will complete daily ecological momentary assessments and wear the SENS Motion sensor and/or Withings Sleep Analyzer over a 30-day period. Outcomes include device-derived sleep and PA measures, self-reported affect, craving, well-being and recovery outcomes. Multilevel models will explore within-person and between-person associations. This study will generate individualised evidence on associations between PA and sleep to inform tailored SUD care. It will also assess the feasibility of using wearable sleep monitors in real-world SUD recovery settings. Results may support the future development of just-in-time adaptive intervention procedures.

Ethics and Dissemination

The study was approved by the Human Research Ethics Committee of Curtin University (HRE2025-0379). Findings will be shared through peer-reviewed publications and conference presentations, with lay summaries provided to treatment facilities and interested participants to support translation into community and service settings.

Trial registration number

ACTRN12625000835448.

Study protocol for a multi-site case study evaluation of a Canadian quality improvement collaborative to improve Baby-Friendly practices in community health services

Por: Turner · S. E. · Enns · J. E. · Seager · E. · LeDrew · M. · Benoit · B. · Semenic · S. · Snelgrove-Clarke · E. · Shittu · B. · Gordon Pappas · D. · CBFI-C Implementation and Evaluation Team · Nickel · N. C. · Campbell-Yeo · Frittenburg · Haiek · McClure · Rashid · Swan · Abbass-Di
Introduction

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

Methods and analysis

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics and dissemination

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

Use of electronic point-of-care resources by early-career general practitioners and associations with their use during consultations: A cross-sectional analysis of consultation data.

Por: Mitchell · B. · Magin · P. · van Driel · M. L. · Tapley · A. · Ralston · A. · Davey · A. · Holliday · E. · Dizon · J. · Moad · D. · Fielding · A. · Fisher · K. · Clarke · L. · Spurling · G.
Objectives

To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.

Design

Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.

Setting

Australian training general practices.

Participants

3024 GP trainees in community-based vocational training.

Primary and secondary outcome measures

The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.

Results

A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.

Conclusions

Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.

Identification of novel molecular drivers, prognostic and diagnostic biomarkers for Inflammatory Bowel Disease (IBD): protocol for the Nottingham/AstraZeneca prospective IBD observational cohort study

Por: Serna-Valverde · A. L. · Rodriguez-Suarez · E. · Marks · D. J. B. · Gehrmann · U. · Neisen · J. · Clarke · S. · Chew · T. S. · Cummings · F. · De Silva · S. · Gordon · J. N. · Knight · P. · Limdi · J. · Patel · K. · Crooks · B. · Sebastian · S. · Polytarchou · C. · Hannan · N. R. F. · Mo
Introduction

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

Methods and analysis

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethics and dissemination

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

Smoking, nicotine and pregnancy 3 (SNAP3) trial: protocol for a randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction in pregnancy

Por: Campbell · K. A. · Clark · M. M. · Montgomery · A. A. · Partlett · C. · Dickinson · A. · Bradshaw · L. · Jones · M. · Huang · Y. · Aveyard · P. · Jiang · Y. · Holmes · C. M. · Coleman · T.
Introduction

Nicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting (‘preloading’), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead.

Methods and analysis

A two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care,

Ethics and dissemination

Ethics approval was granted by the West Midlands—Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers.

Trial registration number

ISRCTN84798566.

Healthcare professionals views of physiotherapy after cardiac surgery in children with congenital heart disease: a UK and Ireland survey

Por: Clarke · S. L. · Shkurka · E. · Menzies · J. C. · Drury · N. E.
Objectives

To understand healthcare professionals’ views on current physiotherapy service provision in children with congenital heart disease (CHD), how physiotherapy could be better used post-cardiac surgery and perceived barriers to service expansion.

Design

Cross-sectional survey using a one-off self-completed online questionnaire, with open and closed questions, in June–August 2024.

Setting

Each of the 12 level 1 paediatric cardiac surgical centres in the UK National Health Service and Children’s Health Ireland.

Participants

Healthcare professionals providing clinical care to children undergoing cardiac surgery.

Results

80 responses were obtained, with at least one response from each centre. Healthcare professionals conduct motor, developmental and functional evaluations across all age groups, with referrals to physiotherapy primarily based on physical examination (39, 87%). They expressed dissatisfaction with community physiotherapy services (64, 81%) compared with inpatient services (29, 36%), although they indicated that expanding services would positively impact patients and families. There is a lack of consensus regarding intervention frequency, duration and which patient groups should be prioritised. Respondents identified a lack of funding as the primary barrier to service expansion (76, 95%). Reported barriers for families included volume of medical appointments (69, 86%), transportation (66, 83%) and finances (62, 78%).

Conclusions

Healthcare professionals appreciate the positive impact physiotherapy can have on post-surgical management of children with CHD. The importance of expanding services was emphasised. However, to effectively support clinical practice, it is crucial to understand which patient groups should be prioritised and at what stage, as well as determining the optimal amount of physiotherapy that positively impacts patient outcomes.

Validity of the International Classification of Diseases, 10th Revision codes for lithium toxicity in adult patients at hospital admission: a cohort study in Canada

Por: Ahmadi · F. · Muanda · F. T. · Ehiwario · J. · McArthur · E. · Jandoc · R. · Slater · J. · Vasudev · A. · Weir · M. A. · Clark · E. G. · Rej · S. · Herrmann · N. · Garg · A. X.
Objective

To assess the validity of the International Classification of Diseases, 10th Revision (ICD-10) healthcare database diagnosis codes for lithium toxicity at hospital admission in Ontario, Canada.

Design

Population-based retrospective validation study.

Setting

A total of 152 hospitals linked to a provincial laboratory database in Ontario, Canada, from 2007 to 2023.

Participants

Patients 50 years of age or older taking lithium with hospital-based serum lithium laboratory measurements during admission to the hospital (n=2804).

Outcome measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) comparing an ICD-10 diagnostic coding algorithm for lithium toxicity to a serum lithium concentration of 1.5 mmol/L or more. The codes used in the algorithm were T568, T435, Y495, X41 and X49. Serum lithium values and changes in the concentration of serum lithium from baseline levels in patients with and without a diagnosis code for lithium toxicity (code-positive and code-negative, respectively).

Results

The sensitivity of the ICD-10 coding algorithm for identifying a serum lithium level≥1.5 mmol/L was 84% (95% CI 81% to 87%). The specificity and the NPV were over 88%, and the PPV was 63% (95% CI 60% to 66%). The median (IQR) serum lithium measurement in code-positive patients was 1.7 (1.2 to 2.2) mmol/L, and it was 0.6 (0.4 to 0.9) mmol/L in code-negative patients. The median (IQR) increase in serum lithium concentration compared with the most recent prehospital baseline values was 0.7 (0.2 to 1.3) mmol/L in code-positive patients and 0.0 (–0.2 to 0.2) mmol/L in code-negative patients.

Conclusion

In Ontario, the sensitivity of the ICD-10 coding algorithms was moderate for identifying a serum lithium level≥1.5 mmol/L at hospital admission. The presence or absence of the ICD-10 codes for lithium toxicity at hospital admission successfully differentiated two groups of patients with distinct serum lithium measurements.

Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

Abstract

Aim

Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role.

Background

Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction.

Design

This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research.

Conclusion

The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues.

Relevance to workforce development

This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.

Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study

Por: Jiwa · A. · Cameron · M. M. · Ademuyiwa · A. O. · Adisa · A. · Aguilera Arevalo · M. L. · Bahrami Hessari · M. · Bhangu · A. · Brennan · P. M. · Clark · N. · Cresswell · K. · Czerwinska · I. · DAdderio · L. · Gunn · E. · Haque · P. D. · Ikegwuonu · T. · Lawani · I. · Morton · D. · Nganwa
Introduction

Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.

Methods and analysis

This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.

Ethics and dissemination

Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.

Trial registration number

NCT06565559.

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Utilisation of ambulatory ECG monitoring for prediction of heart failure and stroke events and healthcare expenditure in treated and untreated patients: a retrospective cohort study

Por: Schwennesen · H. · Li · Z. · Hammill · B. G. · Clark · A. G. · Pokorney · S. D. · Hytopoulos · E. · Turakhia · M. P. · Cambra · J. · Piccini · J. P.
Objective

We evaluated the performance of risk models that incorporate ambulatory ECG data and clinical information for prediction of healthcare expenditures related to heart failure (HF) and stroke events in treated and untreated patients.

Design and setting

A retrospective cohort study of Medicare patients who underwent Zio XT ambulatory monitoring in the USA was conducted between 2014 and 2020.

Participants and outcomes

14-day ambulatory ECG data and claims data were evaluated in the study sample which included 89 923 patients in the HF hospitalisation group, 75 870 in the new-onset HF group and 90 159 in the stroke hospitalisation group. Predictive models for new-onset HF, HF hospitalisation and stroke hospitalisation were generated using LASSO Cox regression with ambulatory ECG variables and components of the CHA2DS2-VASc. For each outcome, we scored patients using standardised linear predictors from three composite risk models, and we evaluated the association between risk score and total Medicare cost.

Results

The following hazard ratios per one SD increase in the new risk score were observed for the model that included all CHA2DS2-VASc components and ECG variables: HF hospitalisation in treated 2.94, 95% CI 2.75 to 3.15; new-onset HF in treated 1.84, 95% CI 1.75 to 1.93; HF hospitalisation in untreated 3.51, 95% CI 3.23 to 3.82; and new-onset HF in untreated 1.92, 95% CI 1.85 to 2.00. Risk scores generated by the model were also predictive of Medicare cost in both treated and untreated patients, with patients in the high-risk category for all outcomes having the greatest Medicare costs during 1 year of follow-up.

Conclusions

Integrating arrhythmia data from ambulatory ECG monitoring into clinical risk models allows for better prediction of healthcare utilisation and cost in both treated and untreated patients at high risk for HF and stroke events.

❌