Self-harm represents a significant public health concern and is a common reason for contact with urgent and emergency care (UEC) services among young people. Although young people frequently interact with multiple components of the urgent care system following self-harm, there is limited system-level evidence describing patterns of service use, transitions between services and repeat emergency department (ED) attendance. An improved understanding of how young people use UEC services after self-harm is needed to inform the design of more effective and appropriate care pathways.
This protocol describes a prospective cohort study using an extract from the Centre for URgent and Emergency care research database (CUREd+) research database, which comprises routinely collected, linked healthcare data from the National Health Service 111 (NHS 111), ambulance services, urgent care centres, walk-in centres and EDs across Yorkshire and the Humber, England. The study population will include young people aged ≤25 years presenting to UEC services between April 2019 and March 2022 with self-harm coded as the reason for attendance. Analyses will describe the prevalence of self-harm presentations across UEC settings, quantify the proportion of NHS 111 and ambulance contacts resulting in ED attendance within 24 hours and examine factors associated with ED reattendance at 3 and 12 months. Mixed-effects logistic regression models will be used to account for repeated attendances, confounding variables and temporal variation, including changes related to the COVID-19 pandemic. Anticipated analysis period: January 2026–January 2027.
Ethical approval has been granted by the University of Leeds (MREC 22-079 Amd1) and the University of Sheffield (Ref 068194). The CUREd+ research database operates under Research Ethics Committee approval (23/YH/0079) and Confidentiality Advisory Group approval (18/CAG/0126). Individual consent is not required as all data are pseudonymised at source. Findings will be disseminated through peer-reviewed publications, conference presentations and public-facing outputs coproduced with patient and public involvement groups.
To explore patient and public views and experiences of health professional access to patient health records and advance care planning information to support care at the end of life.
A cross-sectional national online survey of patients and the public using a convergent-parallel approach.
The survey was distributed across the UK by Compassion in Dying and promoted via newsletters and social media channels of the Professional Records Standards Body and NHS England’s digital workstream network. These partners were purposively selected for their active involvement in end-of-life care, including hospices, clinicians and related charities.
A total of 1728 participants from 103 UK counties responded, including people with a terminal condition (n=33), with long-term condition (n=442), who provide or have provided care to a person with a long-term or terminal illness (n=229) and who identified as healthy and interested in planning for the future (n=1024).
Both quantitative data (multiple-choice responses and numerical ratings) and qualitative data (open-ended comments) asking about experiences and views of access to their health and advance care planning information to support their care at the end of life.
Confidence that recorded care preferences would be accessed when needed was low for carers (median=2, IQR 1–4) and moderate for patients (median=3, IQR 1–4). Four themes derived from free-text responses included (1) experience of sharing health information; (2) preparation, communication and understanding; (3) concerns, unknowns and assurance seeking; and (4) preserving dignity and respect: understanding individual contexts.
Respondents acknowledged the opportunity for digital systems to enable access to health and advance care planning information but expressed doubts that professionals would retrieve it when needed, citing past failures. Confidence in record accuracy could be strengthened by patient and carer access. Future research should examine whether such access improves alignment of care with patients’ wishes.
Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.
This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.
Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.
Stress is a major health issue in contemporary society, and mindfulness-based approaches reduce stress and anxiety but face practical barriers to consistent practice; this protocol evaluates a Virtual Reality (VR)-based observation meditation programme with an artificial intelligence (AI) coach (‘Otti’) that delivers real-time empathic, tailored prompts to support present-focused attention and emotion regulation in university students in the United States. A single-centre randomised controlled trial in Pennsylvania will assess immediate psychophysiological effects and user acceptability after a single 15 min session following a standardised Stroop stressor in a university laboratory setting.
An a priori power analysis (f=0.25, α=0.05, power=0.80) supports recruitment of 34 students (n=17 per group) in a single-centre randomised controlled design comparing AI-coached VR observation meditation to a no-treatment leisure control within a 30 min visit. Participants complete pre-intervention surveys Perceived Stress Scale-10 (PSS-10), Depression Anxiety Stress Scales (DASS-21), State–Trait Anxiety Inventory (STAI-State, STAI-Trait) and baseline heart rate/Heart Rate Variability (HRV) via smartwatch, undergo the 15 min intervention or control, then complete postintervention surveys and repeated heart rate/HRV recording; effects will be tested using repeated-measures analysis of variance, with heart-rate data exported and preprocessed per the prespecified plan. Primary outcomes include perceived stress (PSS-10), emotional state (DASS-21, STAI-State, STAI-Trait), physiological stress response (heart rate/HRV) and participant satisfaction via a structured postintervention survey (usability, perceived effectiveness, comfort).
The study received IRB approval from The Pennsylvania State University Institutional Review Board (PSU CATS IRB: STUDY00025978; ClinicalTrials.gov: NCT06704282), and all participants will provide written informed consent prior to procedures. Findings will be disseminated via open access publication, conference presentations and stakeholder-focused briefs, with an anonymised primary-outcome dataset available on reasonable request in line with BMJ Open policies and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)/International Committee of Medical Journal Editors (ICMJE) guidance.
To understand experiences of stigma and discrimination among adults who are homeless across multiple care and support system contexts.
Cross-sectional survey embedded within an ethnographic case study.
South London, UK, 2024.
Convenience sample of 74 people experiencing homelessness, aged over 18 years.
Participants most commonly reported unfair treatment in public settings (85%), legal settings (72%), housing and homelessness services (68%) and health settings (65%). These experiences were attributed to a range of factors and identities, with homelessness the most commonly cited; people commonly linked unfair experiences to multiple identities. People with more comorbidities reported experiencing unfair treatment across more system settings, including and beyond health systems.
Unfair treatment was reported across multiple care and support systems with greater ill-health associated with more unfair treatment. Future larger-scale surveys should measure the extent of stigma and discrimination across the population.
Frequent use of emergency departments (EDs) places a considerable burden on healthcare systems. Although frequent attenders are known to have complex physical, mental health and social needs, national-level evidence on their characteristics and patterns of attendance remains limited. This study aimed to provide a comprehensive, population-level description of frequent ED attendance in England, with a focus on age-based subgroups.
Retrospective cohort study.
EDs in England via the Hospital Episode Statistics and the Emergency Care Dataset data linked with primary care prescribing and mortality data, between March 2016 and March 2021.
The dataset received from National Health Service Digital contained approximately 150 million ED attendances by 30 million adult (>18 years) patients over the time period April 2016 to March 2021. A random sample of 5 million people was used for this analysis.
The primary outcome was the number of attendances in each financial year by frequent attenders compared with the remaining patients, split by age bands. Patients were classified as frequent attenders if they had ≥5 or ≥10 ED attendances within a rolling 12-month period. Secondary outcomes included demographic, diagnostic and prescribing characteristics, as well as the number of different ED sites visited.
A Gaussian mixture model was used to identify age-based subgroups. Descriptive statistics were used to summarise key features; 95% CIs were reported where applicable. Among 3.91 million unique adult ED attenders, there were 8.7 million attendances. Of these, 222 160 individuals (5.7%) had ≥5 attendances in a year, accounting for 12.6% of total attendances. A trimodal age distribution was identified, with three distinct peaks corresponding to ages 18–34, 35–64 and 65+. Frequent attenders were more likely to live in deprived areas and have a history of psychotropic or analgesic prescribing. Mental health diagnoses and polypharmacy were particularly common in the younger and middle-aged groups. Multisite attendance was uncommon, with over 80% of frequent attenders using only one ED site annually.
This national analysis reveals a trimodal age pattern among frequent ED attenders, with differing clinical and socio-demographic profiles across age groups. These findings highlight the need for age-tailored approaches to managing high-intensity ED use and inform targeted service development.
Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.
This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.
The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.
ClinicalTrials.gov ID: NCT06090552.
Advarra Pro 00070994.
23-38948.
Protocol Date: 24 October 2024. Protocol Version: 4.
Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.
We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.
Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.
CRD420251000482.
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.
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.
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.
The aim of this study is to investigate the use and effectiveness of equity tools in current practices of patient safety incident analyses via a scoping review of the literature.
Scoping review of the literature using the two main search term concepts "health equity" AND "safety review". The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist was used to report in this paper.
Databases including but not limited to MEDLINE, Embase and PubMed were searched from inception to 16 January 2023.
Studies that included an equity tool in patient safety reviews were included. There were no restrictions on language or setting for included studies. Review articles were excluded.
Two independent reviewers used standardised methods to search and screen included articles. Data from included studies was extracted and compiled.
Five studies out of 5026 screened studies were included in the final analysis, 4 were conducted in the USA and 1 in Norway. While all studies identified equity domains to guide their approach to the provision of more equitable care, only three proposed change ideas and one implemented their framework to evaluate the role of social determinants and bias in adverse events. Communication was the most common theme found across four of the five studies. Access to healthcare services and bias were included as equity domains in two of the five studies. Implicit bias training was one of the identified change ideas. Other change ideas included improving access and communication, for example, through increasing the use and availability of interpreter services. One of the studies piloted the implementation of their equity checklist and found adverse event causes rooted in equity in 50% of the cases.
This scoping review demonstrates that there is a gap in current patient safety incident analyses, specifically lacking the consideration of equity domains. The development of a comprehensive health equity tool is necessary to promote equitable and safe care.