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AnteayerBMJ Open

Clinical outcomes, patient satisfaction and operational efficiency of AI-powered chatbots in medicine and healthcare: protocol for an AI-aided scoping review

Por: Goossens · E. · Kemajou · P. M. · Coorevits · P. · Probst · S. · Beeckman · D.
Introduction

Artificial intelligence (AI)-powered chatbots are increasingly integrated into healthcare to support administrative processes, health education and chronic disease management. These systems simulate human dialogue through natural language processing and machine learning, enabling dynamic and context-aware interactions. Despite their rapid adoption, there is limited synthesis of existing research describing how these technologies are applied across different healthcare contexts and what outcomes have been reported. This scoping review aims to map and describe the existing literature on the use of AI-powered chatbots in healthcare with a focus on clinical outcomes, patient satisfaction and operational efficiency. It will identify the types of studies conducted, their key characteristics and existing research gaps to guide future research.

Methods and analysis

Following the Joanna Briggs Institute methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines, a comprehensive search will be conducted across Medline (PubMed), CINAHL, Embase, Web of Science, The Cochrane Library and MedRxiv from database inception to 10 September 2025. Studies published in English, French, Dutch or German, involving AI-powered chatbots in any healthcare context reporting on clinical outcomes and/or patient satisfaction and/or operational efficiency will be included. Studies without full-text availability, protocols, trial registrations, reviews and studies conducted solely in educational settings will be excluded. Title and abstract screening will be supported by ASReview LAB, an AI-based active learning tool to enhance efficiency. Screening and data extraction will be conducted independently by two reviewers with disagreements resolved by a third reviewer. Findings will be synthesised narratively and presented using structured evidence tables categorised by chatbot type, clinical healthcare context and reported outcomes.

Ethics and dissemination

Ethical approval is not required, as this study involves the analysis of published data only. The results of this scoping review will be disseminated through publication in a peer-reviewed journal, presentations at academic conferences and established professional networks.

Trial registration number

Open Science Framework (OSF), https://doi.org/10.17605/OSF.IO/8UE3B.

Strong Families Study: protocol for a co-designed birth cohort study with Aboriginal and Torres Strait Islander families in Queensland, Australia

Por: Ahmed · S. M. · Dorey · E. S. · Smith · D. · Weatherall · L. · Friday · R. · Massi · L. F. · Rooney · R. · Hermith-Ramirez · D. · Kendall · E. · Wheeler · K. · Eades · A.-M. · Toombs · M. · Boyd · R. N. · Marriott · R. · Eades · S. J. · Benfer · K. · Reid · N. · Whittingham · K. · Ware · R.
Introduction

Australian studies investigating parental factors often lack meaningful inclusion of Aboriginal and Torres Strait Islander families, limiting our understanding of current influences on positive developmental trajectories within communities. There is growing recognition of the need for culturally safe and responsive longitudinal research that is co-designed and co-led by the community for the community. An Indigenous-led birth cohort study of Aboriginal and Torres Strait Islander families in Queensland, Australia, has therefore been developed to better understand health across generations.

Methods and analysis

The Strong Families Study is a co-designed prospective longitudinal birth cohort study that will follow 400 Indigenous families in Queensland from pregnancy until the child reaches 5 years of age. Eligible participants include pregnant individuals (

Ethics and dissemination

This study was approved by the Mater Misericordiae Ltd Human Research Ethics Committee (HREC/MML/105191) and ratified by the University of Queensland Human Research Ethics Committee (2025/HE001924). Endorsement letters were secured from partner services at each study site. Findings will be shared with partnering hospitals and funding bodies at conferences and through reports and peer-reviewed publications.

Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD): consensus on obesity and cardiometabolic comorbidities in inflammatory bowel disease using systematic reviews and the RAND/UCLA appropriateness me

Por: Devi · J. · Samaan · S. · Sehgal · P. · Mohamed · M. · Vincent · M. · Coombs · S. · Doering · M. · Barnes · E. L. · Johnson · A. M. · Yarur · A. J. · Deepak · P.
Introduction

Obesity and related cardiometabolic comorbidities, including hypertension, dyslipidaemia, diabetes, metabolic dysfunction-associated steatotic liver disease and atherosclerotic cardiovascular disease, are increasingly prevalent among individuals with inflammatory bowel disease (IBD). These conditions influence disease activity, therapeutic response, surgical outcomes and overall quality of life, yet evidence remains fragmented. The Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD) initiative aims to synthesise evidence and generate consensus recommendations to guide practice and future research in this area. This study describes a protocol for a structured evidence synthesis and Research ANd Development/University of California, Los Angeles (RAND/UCLA) Appropriateness Method (RUAM) consensus process.

Methods and analysis

We will conduct three systematic reviews and a structured evidence synthesis organised into three domains: (1) the impact of obesity on IBD outcomes, (2) the burden of cardiometabolic complications in IBD and (3) the management of overweight, obesity and cardiometabolic comorbidities in IBD. A multidisciplinary international panel of gastroenterologists, surgeons, endocrinologists, hepatologists, cardiologists and dietitians will assess each statement using the RAND/UCLA appropriateness method. Panellists will rate the appropriateness of each statement (only those that fall within their area of expertise) on a 1–9 scale (1–3=inappropriate, 4–6=uncertain and 7–9=appropriate), with medians rounded up (eg, 6.5=appropriate). Agreement will be assessed using the RAND Disagreement Index (DI

Ethics and dissemination

This study will not involve direct patient participation, as it is based on evidence synthesis and expert consensus; therefore, formal research ethics committee approval will not be required. Patient representatives will contribute to the consensus process to provide contextual perspectives but no identifiable data will be collected.

Findings will be disseminated through publication in peer-reviewed journals, presentation at major gastroenterology and IBD conferences and communication with professional societies. A lay summary and patient-friendly infographic will also be developed to facilitate translation of recommendations into clinical practice.

PROSPERO registration numbers

CRD420251178843: a systematic review of the impact of obesity on inflammatory bowel disease outcomes.

CRD420251178799: a systematic review of cardiometabolic complications in inflammatory bowel disease.

CRD420251174653: management of overweight, obesity and cardiometabolic comorbidities in inflammatory bowel disease: a systematic review.

Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol

Por: Wane · S. · Aveyard · P. · Wielsoe · S. · Larsen · S. C. · Scragg · J. · Lindschou · J. · Jakobsen · J. C. · Engstrom · J. · Specht · I. O. · Christiansen · A.-K. L. · Jensen · A. K. G. · Bandholm · T. · Albury · C. · Overbeck · G. · Reventlow · S. · Olsen · K. R. · Farr · P. · Bojsen-Mo
Introduction

Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.

Methods and analysis

LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m2 with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups. The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication. The control group will receive usual care, typically comprising brief behavioural support for weight loss and treatment of the complications of obesity or occasionally referral to specialist weight management services. The two co-primary outcomes are cardiometabolic risk, assessed with metabolic syndrome severity Z-score, and body weight assessed at 2 years. The secondary outcomes include the Short Form-36 mental component scale, 4-metre gait speed and proportion of participants achieving ≥20% weight loss. The key adverse effects will be the proportion of participants with at least one serious adverse event, incidence of eating disorders and disproportional loss of bone mass. Incremental cost-effectiveness will be assessed over the trial period and over the lifetime through modelling.

Ethics and dissemination

Ethical approval was granted in the UK (August 2024, 24/SC/0211) and Denmark (December 2023, H-23065222). Findings will be disseminated through peer-reviewed journals and scientific conferences and to participants in the trial and clinicians.

Trial registration number

NCT06321458.

Cost of emergency hospital admissions to acute general wards for mental health problems among children and young people in England, 2012-2022: a retrospective observational study

Por: Pilvar · H. · Cornaglia · F. · Ward · J. L. · Vazquez-Vazquez · A. · Phillips · K. · Settle · K. · Gibson · F. · Nicholls · D. · Roland · D. · Roberts · H. · Viner · R. M. · Hudson · L. D.
Objectives

To examine trends in the frequency and costs of emergency hospital admissions in acute wards for mental health conditions among children and young people in England between 2012 and 2022 and to assess socioeconomic and geographic disparities in these costs.

Design

Retrospective observational cohort study using routinely collected administrative data.

Setting

Secondary care acute wards; analysis includes all National Health Service (NHS) hospital admissions in England.

Participants

All emergency hospital admissions in acute wards for individuals aged 5–18 years with a primary or secondary mental health diagnosis recorded between 2012 and 2022. Exclusion criteria included admissions without a mental health diagnosis or outside the defined age range.

Primary and secondary outcome measures

Primary outcomes were the annual number and total cost of mental health-related emergency admissions. Secondary outcomes included length of stay, diagnostic categories contributing to cost, and variation by socioeconomic deprivation and geographic location.

Results

Between 2012 and 2022, the total cost of emergency admissions for mental health among children and young people rose markedly, driven by increases in both admission rates and length of stay. Children from the most socioeconomically deprived areas experienced higher admission rates and greater associated costs. Substantial regional variation in the financial burden was also observed. Eating disorders and self-harm were the main diagnostic categories contributing to the rise in costs. Following the COVID-19 pandemic, total admission numbers declined, but overall costs remained high due to a shift in diagnostic mix towards conditions associated with longer hospital stays and higher per-admission costs.

Conclusions

The increasing financial burden of paediatric mental health crises highlights the urgency of addressing upstream drivers of poor mental health. Policies should prioritise early intervention, reduce regional and socioeconomic disparities, and ensure equitable allocation of mental health resources. Further research should explore the effectiveness of community-based alternatives to hospital care.

Screening for hyperglycaemia in pregnancy and pregnancy outcomes among Aboriginal women in remote communities of the Northern Territory, Australia: a retrospective cohort study

Por: Wood · A. J. · OHara · C. · Joyce-Tubb · A. · Webster · V. · Wicks · M. · Van Dokkum · P. · Maple-Brown · L. J. · Hare · M. J. L.
Background

Aboriginal women in the remote Northern Territory (NT) experience high rates of adverse pregnancy outcomes related to hyperglycaemia in pregnancy. Oral glucose tolerance test (OGTT) screening was recommended in early pregnancy but barriers to uptake exist.

Objectives

To examine uptake of screening for hyperglycaemia in pregnancy among Aboriginal women in remote NT communities and explore adverse pregnancy outcome rates among women who did not have early OGTT screening compared with women who did undergo screening in early pregnancy and those with pre-existing diabetes.

Design

Retrospective observational cohort study of pregnancies among Aboriginal women in remote NT clinics from January 2017 to December 2019. Screening for hyperglycaemia in pregnancy included having an early OGTT (

Results

Among 1191 pregnancies in 52 remote communities, pre-existing type 2 diabetes (T2D) was diagnosed in 6.4% (n=76) and gestational diabetes mellitus (GDM) was diagnosed in 13% (154/1191). Excluding women with pre-existing diabetes, 226 (20%) had an early OGTT. Guideline-directed screening (with either (a) an early OGTT diagnosing GDM or (b) a negative early OGTT followed by a routine OGTT) occurred in 14% of pregnancies (n=158). Compared with women who had an early pregnancy OGTT, the combined adverse pregnancy outcome was more common among women with pre-existing T2D (89% vs 54%, adjusted OR 6.06 (95% CI 2.75 to 13.35)) and similar among women who did not undergo early OGTT (50%, adjusted OR 0.97 (95% CI 0.71 to 1.32)).

Conclusion

Uptake of guideline-directed screening in Aboriginal women in remote NT was low, although there was no difference in pregnancy outcomes for women who were and were not screened with an early OGTT. Rates of adverse pregnancy outcomes were concerningly high in women with pre-existing T2D, highlighting a need to strengthen diabetes care for these women.

Type 3 hybrid effectiveness-implementation study implementing and evaluating the Comprehensive High-dose Aphasia Treatment (CHAT) programme in Australian rehabilitation services: a protocol

Por: McSween · M.-P. · Dignam · J. K. · Shrubsole · K. · Levine · R. · Power · E. · Lannin · N. A. · Wallace · S. J. · Cadilhac · D. A. · Kilkenny · M. F. · Hill · A. J. · Ryan · B. J. · Copland · D. A.
Introduction

The Comprehensive High-dose Aphasia Treatment (CHAT) programme is an intensive comprehensive aphasia programme, which aims to address evidence-practice gaps in aphasia rehabilitation where there are known barriers to service delivery requiring implementation strategies. The aims of this study are to (1) evaluate the clinical implementation of the CHAT programme, (2) assess the clinical effectiveness of CHAT compared with usual care in rehabilitation services and (3) determine whether the real-world implementation of CHAT compared with usual care is cost-effective.

Methods and analysis

Four participant groups will be recruited across six hospital and health services Australia-wide to participate in a type 3 hybrid effectiveness-implementation study: (1) people with aphasia, (2) support persons, (3) treating clinicians and students and (4) clinical stakeholders (eg, managers). This before-and-after study will include three time periods: (1) ‘usual care’ where people with aphasia will receive their usual care aphasia therapy, (2) ‘implementation transition’ where clinicians will be trained to deliver CHAT and (3) ‘intervention implementation’ where people with aphasia will receive the CHAT programme (ie, 50 hours of evidence-based aphasia therapy over 8 weeks). Evidence-based implementation strategies will be used to facilitate implementation within participating rehabilitation services. The primary outcome is delivery of evidence-based aphasia treatment (ie, CHAT) as measured by a composite score of quality indicators. Clinical effectiveness outcomes, measuring change in language impairment, communication effectiveness, confidence and quality of life, and implementation outcomes will also be examined. We will also conduct an embedded mixed-methods process evaluation and economic evaluation.

Ethics and dissemination

This study has been approved by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/2021/QRBW/72154). Outputs will include conference presentations, publications and a training package to optimise implementation of aphasia treatment in rehabilitation service contexts.

Registration details

Australian New Zealand Clinical Trials Registry (ANZCTR) prospective registration ACTRN12621001765819. Trial registered 23 December 2021. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381365&isReview=true.

Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a systematic review with meta-analysis and trial sequential analysis

Por: Petersen · J. J. · Faltermeier · P. · Juul · S. · Kamp · C. B. · Sillassen · C. D. B. · Dos Santos · T. J. · Jakobsen · J. C.
Objectives

To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes.

Design

Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

Data sources

CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026.

Study selection

Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes.

Analyses

Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Primary outcomes

Severe hypoglycaemia, ketoacidosis and serious adverse events.

Results

10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I2=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I2=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I2=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered.

Conclusions

Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain.

PROSPERO registration number

CRD42024508625.

Research priorities in the field of interprofessional healthcare education: a James Lind Alliance Priority Setting Partnership

Por: Kumlien · C. · Ask · E. · Axelsson · M. · Gudmundsson · P. · Hugosson · O. · Jakobsson · J. · Stollenwerk · M. M. · Carlson · E.
Objectives

Interprofessional education (IPE) is a key factor, preparing students for collaboration to improve quality in healthcare. Current literature implies that IPE research needs to be relevant for students, teachers and stakeholders ensuring that research answers the most important research issues. Therefore, the objective of this study was to establish outcomes of a partnership between students, teachers and clinicians to rank the top 10 research priorities for IPE.

Design

James Lind Alliance Priority Setting Partnership (JLA).

Setting

Higher health education in Sweden.

Participants

Students, teachers and healthcare professionals (clinicians).

Method

According to the JLA process, a steering committee was established. A pilot survey to gather research uncertainties highly relevant for participants was performed and tested by the content validity index. The pilot survey was followed by a main survey with 53 participants and a final workshop to determine the top 10 research priorities.

Results

The content validity index was satisfactory for 23 out of 27 research uncertainties, followed by minor changes and removal of three uncertainties. After processing the 24 uncertainties from the main survey, 21 remained in the workshop. The final top 10 research priorities included measurements to evaluate IPE, promoting and hindering factors for IPE, educational models for IPE, longitudinal studies on effects from IPE and implementation of IPE.

Conclusion

The priorities represent consensus areas from students, teachers and clinicians to guide future research and justify and inform strategic allocation of research funding.

Breaking barriers: mental health literacy and stigma in Addis Ababas schools - a qualitative study in Ethiopia

Por: Megersa · S. W. · Ware · F. A. · Dehning · S. · Jobst · A. · Girma · E.
Objectives

To explore the mental health literacy of school communities and stigma against students with mental disorders in Ethiopia’s specific context.

Design

Qualitative study using in-depth and key informant interview guides.

Participants

Nine teaching and psychosocial support staff participants (five men and four women; years of experience ranging between 2 and 35; three school counsellors, two clinical nurses, two special needs teachers, one counselling psychologist and one class principal teacher) were purposefully recruited on the basis of their proximity to the students’ academic Journeys and health-related issues.

Setting

Key Informant Interviews were conducted with nine participants working at four high schools (two private schools, one affiliated with a church and two public schools, one with a programme for special needs students) in Addis Ababa, Ethiopia.

Results

This study revealed that there is a significant lack of awareness and misconceptions about mental health issues within the school community, and that students suffering from mental disorders often face discrimination and stigma. These factors contribute to delays in seeking care, which may result in poor coping strategies. School-based programmes aimed at promoting mental well-being and reducing the stigma observed at the study sites are inadequate for addressing these challenges effectively.

Conclusions

In this study, we identified key challenges among school communities, as perceived and reported by school-based professionals, including a lack of awareness, misconceptions and notable stigma against schoolchildren with mental disorders. To establish a well-coordinated school mental health system, governance should focus on (1) establishing comprehensive mental health literacy and promotion, (2) reducing stigma and (3) implementing service delivery and/or referral programmes within schools in Addis Ababa. To ensure a holistic and inclusive mental health support in Ethiopian schools, future studies should engage students and their parents directly triangulating these professional observations.

Healthcare utilisation patterns among frail individuals aged 50+ years: results from the Lolland-Falster Population Study (LOFUS)

Por: Jacobsen · K. K. · Christensen · M. G. · Nilsson · C. · Jepsen · R. · Thygesen · L. · Suetta · C. · Holm · E. A.
Objectives

Frailty is a clinical syndrome characterised by impaired homeostatic mechanisms and reduced physiological reserve. Hospital admissions for ambulatory care sensitive conditions (ACSCs) are commonly used as indicators of quality in primary healthcare. We aimed to examine the association between frailty and the use of healthcare resources, including unplanned hospital visits due to ACSCs and non-ACSCs and visits to general practitioners (GPs) and medical specialists (MSs) in primary care. We hypothesised that frail individuals would have similar odds of hospital visits due to ACSCs and non-ACSCs.

Design

Registry-based epidemiological study.

Setting

Data from the Danish Lolland-Falster Health Study and national health registers. Data were collected in a rural region of Denmark between February 2016 and February 2020.

Participants

10 154 randomly selected individuals aged ≥50 years participating in the Lolland-Falster Health Study with valid frailty measurements.

Outcome measures

Hospital visits due to any diagnosis, hospital visits due to ACSCs and non-ACSCs, and visits to GPs and MSs in the primary care sector.

Results

After adjustment for age, sex, comorbidity and socioeconomic factors, frail participants had higher odds of hospital visits due to any diagnosis (OR 1.27, 95% CI 1.02 to 1.57; p=0.03). The odds of hospital visits due to ACSCs (OR 1.42, 95% CI 0.97 to 2.08; p=0.07) and non-ACSCs (OR 1.16, 95% CI 0.91 to 1.47; p=0.22) were not significantly different. Frail individuals had higher odds of visiting their GP (OR 1.21, 95% CI 1.00 to 1.46; p=0.047) but not a medical specialist (OR 0.82, 95% CI 0.62 to 1.07; p=0.15).

Conclusions

Among frail individuals, the distinction between unplanned hospital visits due to ACSCs and non-ACSCs is not meaningful. This finding is consistent with the understanding of frailty as a state of reduced physiological reserve, in which minor stressors may lead to hospital care regardless of diagnostic category.

Mapping same day, urgent and emergency care services across the UK: a mixed methods study protocol

Introduction

In the UK, a range of services provide same day, urgent and emergency care (UEC). Urgent medical needs can be addressed through pharmacy services, same day general practice (GP) appointments, phone or online triage services, out-of-hours GP appointments and urgent treatment centres (or equivalents). For emergency medical needs, patients can access emergency departments (EDs) and ambulance services. These services are highly vulnerable to excessive strain due to rising, unpredictable demand and limitations in patient flow across the system. The workforce operates in time-critical situations, often with limited resources, which can lead to staff burnout, low job satisfaction and retention and poor health. The organisation of services and their workforce continues to evolve in response to local and national pressures and varies considerably across the UK, where there are four distinct, publicly funded healthcare systems managed separately in each country. This makes it difficult to describe and compare services within and across regions and understand the impact of workforce organisation on service delivery, staff well-being and patient care. This study aims to develop a comprehensive understanding of the range and types of UK UEC services, the relative experiences of the workforce and the available workforce data.

Methods and analysis

This mixed-methods study includes two components, integrated through an explanatory sequential design. Study 1 will use data on NHS service availability and direct enquiry to map UEC services and populate a structured database, which will facilitate the generation of a UEC typology of the range and types of services and regional variation across the UK. Multiple case studies will be conducted in a subset of services using qualitative interviews (n=136–220) with service leaders (n=3–5), workforce (n=10–12), and patients or carers (n=4–5), as well as document analysis where relevant, in each service of interest (n=8–10). Study 2 will create a metadata catalogue of workforce data and produce descriptive summaries of key metrics (eg, staffing levels and skill mix). The study will be supported by our Community Inclusion and Engagement (CIE) panel and Patient and Public Advisory Group (PPAG) to ensure relevance, inclusivity and impact.

Ethics and dissemination

This study received ethical approval from Yorkshire and The Humber - Sheffield Research Ethics Committee (04/08/2025, IRAS ID: 357276, REC Reference: 25/YH/0125) and HRA and Health and Care Research Wales approval (12/08/2025). Data collection poses minimal risk, informed consent will be obtained, and participants may withdraw at any time. Dissemination will follow knowledge mobilisation principles to maximise impact. We will build on our existing networks and work with our CIE panel and PPAG to tailor study outputs to different audiences. The outputs will improve understanding of the variation in how UEC services and workforces are organised across the UK, as well as the type and format of available workforce data, and provide benchmarks for future research.

Registration

Research Registry (REF: researchregistry11555; https://www.researchregistry.com/register-now/%23home/registrationdetails/68d402672341e502cd0ce888/)

Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol

Por: Ledingham · D. · Mills · R. · Gibbs · M. · Maynes · M. · Pal · A. · Iredale · R. · Foster · V. · Ong · S. · Sathyanarayana · S. · Jenkins · A. · Nicholson · C. · Hussain · M. · Baker · M. R. · Pavese · N.
Introduction

Deep brain stimulation (DBS) for dystonia is effective but programming optimisation can take months. Local field potentials (LFPs) recorded by the Medtronic Percept device may provide biomarkers to guide stimulation. This study will prospectively evaluate whether chronic LFP profiles correlate with clinical outcomes and can inform DBS programming strategies.

Methods and analysis

LFP-DYT is a single-centre, multi-phase observational study at Newcastle upon Tyne National Health Service (NHS) Foundation Trust. An internal pilot (Cohort 1) will refine recording workflows, followed by Cohort 2 (traditional programming with LFP recordings) and Cohort 3 (LFP-informed programming). 20–25 adults with primary dystonia undergoing globus pallidus internus DBS will be recruited. The study combines chronic LFP sensing with neurophysiology (electromyography, electroencephalography), motor inhibition testing (stop-signal reaction time), patient-reported outcomes and wearable sensor monitoring (STAT-ON) to provide a comprehensive multi-modal assessment framework. Primary outcome: reproducibility of alpha–theta frequency LFP peaks and concordance with optimal stimulation site. Secondary outcomes include stimulation and medication effects on LFP profiles, clinical improvement (Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS-2), Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS)) and beta-band activity as a marker of stimulation-related bradykinesia. Analyses will be descriptive and exploratory. Feasibility outcomes, including recruitment rates, retention and data completeness, will inform design and power calculations for future multi-centre trials.

Ethics and dissemination

The study has NHS Research Ethics Committee approval from the East Midlands—Derby Research Ethics Committee (REC reference: 24/EM/0246; IRAS ID: 337426). All participants will provide informed consent. Data will be pseudonymised and stored on secure NHS servers. Results will be disseminated via peer-reviewed publications, conferences and participant summaries. De-identified data and analysis code will be available on reasonable request.

Trial registration number

NCT07309133.

Experiences of families participating in a 10-week family-focused e-Health healthy lifestyle programme for school-aged children with overweight or obesity: a qualitative study

Por: Zhu · D. · Dordevic · A. L. · Davidson · Z. E. · Gibson · S.
Objective

To explore families’ experiences participating in a 10-week web-based lifestyle programme for school-aged children with overweight or obesity.

Design

A qualitative study using inductive analysis of semi-structured interview data.

Setting

Victoria, Australia.

Participants

Families (children aged 7–13 years with overweight or obesity—body mass index ≥85th percentile—and accompanying parent) recruited for a randomised controlled trial that evaluated the effectiveness of the web-based programme and who received the programme (n=102 children/85 families) were invited to participate in a semi-structured interview at 3 months post-programme.

Intervention

Families received a 10-week family-focused electronic health (e-Health; web-based) lifestyle programme with health coaching sessions—an evidence-based programme adapted from its in-person, group-based counterpart.

Results

A total of 28 families, including 34 children (eight siblings) and mostly mothers, shared their experiences. 10 themes were identified on family members’ experiences and aligned with the socioecological model: intrapersonal—knowledge development on healthy living; experiences and stigma related to overweight, obesity or weight; engaging with structural features of the web-based programme, interpersonal—family dynamic; connections with others (non-healthcare professionals) outside of home; relationship with healthcare professionals, environmental/institutional—impact of COVID-19 lockdowns; health-promoting environments; promotion of and access to overweight or obesity management programmes; web-based programme as part of a larger or established system. Each theme highlighted factors that influenced programme uptake and engagement.

Conclusions

Valuable insights were gained on ways to better adapt e-Health (web-based) lifestyle programmes for children with overweight or obesity. Families perceived advantages in a web-based lifestyle programme and highly regarded humanised features and elements comparable to conventional in-person programmes. Further research is needed to explore the perspectives of families from diverse populations, fathers and families who decline participation in the follow-up period. Web-based lifestyle programmes that incorporate contemporary e-Health technologies, including responsive AI, also warrant further investigation to maximise programme benefits.

Trial registration number

ACTRN12621001762842.

Days alive and out of hospital after burr-hole drainage for chronic subdural haematoma: a national cohort study using Hospital Episode Statistics in England

Por: Thompson · D. · Wahba · A. · Davies · B. · Williams · A. · Hutchinson · P. J. · Stubbs · D. · Helmy · A. · Cromwell · D. A.
Objectives

The objective of this study was to investigate the utility of the days alive and out of hospital (DAOH) metric within a cohort of patients undergoing burr-hole drainage of a chronic subdural haematoma (CSDH). We evaluate the validity of the DAOH metric in a national CSDH cohort and examine how the DAOH metric compares to its constituent outcomes (mortality and hospital bed days) at an organisational level.

Methods

Retrospective cohort study using Hospital Episode Statistics data linked to the national death registry to identify patients who underwent burr-hole drainage of CSDH in English National Health Service neurosurgical units between 1 April 2013 and 31 March 2020. Construct validity was assessed by measuring the patterns of DAOH across categories of known perioperative risk factors. Variation between units in the risk-adjusted values for DAOH, postoperative mortality and days in hospital was explored using funnel plots. Linear regression and logistic regression were used to derive the risk-adjusted rates.

Results

Overall, 16 450 patients who underwent at least one burr-hole drainage of CSDH were identified during the time period. The median 30-day DAOH was 16 (IQR, 0–24); the median for the 90-day DAOH was 74 (42–84), and was better at measuring the complete stay associated with the index admission. Worse 90-day DAOH values were associated with older age, increasing comorbidities and greater frailty. Risk-adjusted 90-day DAOH values for neurosurgical units varied more markedly than for its constituent outcomes.

Conclusions

The 90-day DAOH looks to be a valid outcome metric for patients undergoing burr-hole drainage for CSDH that is feasible to derive using national hospital data. Future work should explore how to estimate a minimally important clinical difference for DAOH and evaluate its utility as an outcome measure.

Colchicine and dialysis patients (CAD): protocol for a feasibility study

Por: Wong · Y. T. D. · Hughes · L. D. · Norton · S. · Robson · M. G.
Introduction

Colchicine has been shown to reduce cardiovascular events and may improve outcomes in arteriovenous fistulas used for haemodialysis due to antiproliferative effects. However, it is often avoided in patients receiving dialysis. Therefore, a large trial assessing the potential benefits of colchicine in dialysis patients cannot begin without further data on feasibility. The primary objective of this study is to assess the feasibility of carrying out future trials of colchicine in dialysis patients.

Methods and analysis

This is an open-label, single centre, single arm study with 100 participants. The primary outcome is feasibility and the decision to progress to a full-scale trial. This will be based on the consent rate and the colchicine discontinuation rate. Secondary objectives are testing the feasibility of data collection procedures relating to quality-of-life measures, vascular access interventions and safety. Other secondary objectives are to assess the utility of the electronic health record for collecting trial data and to explore patients’ and healthcare providers’ experiences and attitudes towards colchicine and a feasibility study.

Ethics and dissemination

The study has Research Ethics Committee approval (Wales REC 6; 24/WA/0277). It is intended that the results of the study will be reported in peer-reviewed scientific journals.

Trial registration number

ISRCTN91308625.

Open-label randomised controlled trial of aripiprazole/sertraline combination in comparison with quetiapine for the clinical and cost-effectiveness of treatment of bipolar depression (the ASCEnD study): study protocol

Por: Azim · L. · Al-Ashmori · S. · Butcher · C. · Cipriani · A. · Chew-Graham · C. A. · Clare · E. · Clark · E. · Cole · M. · Carella · S. · Dixon · L. · Evans · J. · Gergel · T. · Gibson · J. · Hancock · H. C. · Hoppe · I. · Kessler · D. · Kabir · T. · Lewis · G. · Mathias · A. · Morris · R. · Nix
Introduction

Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).

Methods and analysis

ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.

Ethics and dissemination

A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.

Trial registration number

ISRCTN63917405.

Top 10 research priorities for adolescent and young adult cancer in Canada: a James Lind Alliance priority setting partnership

Por: Tutelman · P. R. · Thurston · C. · Ranger · T. · Rader · T. · Henry · B. · Abdelaal · M. · Blue · M. · Buckland · T. W. · Del Gobbo · S. · Dobson · L. · Gallant · E. · Heykoop · C. · Jansen · M. · Larsen · L. · Maseja · N. · Oberoi · S. · Ramasamy · V. · Smith · M. · Wendowsky · N. · Beattie
Objectives

Cancer in adolescents and young adults (AYAs; ages 15–39 years) is a rising global epidemic. Yet, AYAs remain an understudied population, and little is known about what research topics should be prioritised according to those with lived experience. The AYA Cancer Priority Setting Partnership (PSP) was established to identify the top 10 research priorities for AYA cancer in Canada according to patients, caregivers, and clinicians.

Design

This project followed the James Lind Alliance (JLA) Priority Setting Partnership (PSP) methodology that included two national cross-sectional surveys and a final priority setting workshop following an adapted nominal group technique.

Setting

A national sample was recruited to participate from across Canada.

Participants

Participants were patients, caregivers, and clinicians with lived personal and/or professional experience of AYA cancer in Canada.

Outcome measures

In the first survey, open-ended responses were collected from participants about questions they would like answered by research. Responses were collated into overarching summary questions and a literature search was undertaken to verify if questions were true uncertainties and not fully answered by existing evidence. Unanswered questions were ranked by participants in a second survey. The top-ranked questions were prioritised through consensus at the final priority setting workshop. The final outcome was the top 10 priorities for AYA cancer research in Canada.

Results

In the initial survey, 1916 potential research questions were submitted by 275 patients, caregivers, and clinicians. Following data processing, summary question formation, and the evidence check, 58 questions were put forward for interim prioritisation in a second survey (n=285 patients, caregivers, and clinicians). The top 20 questions from the interim prioritisation were ranked at the final priority setting workshop attended by a diverse group of 23 patients, caregivers and clinicians from across Canada. The resulting top 10 priorities reflect topics across the cancer continuum including: diagnostic delays, screening and early detection, novel therapies, psychosocial impacts, end-of-life concerns, and survivorship issues.

Conclusions

This patient-directed research agenda will guide researchers, funding agencies, and policymakers to ensure that future research is aligned with what matters most to the AYA cancer community.

Can topical coconut oil reduce late-onset sepsis in extremely preterm infants? A pragmatic cluster-randomised controlled trial protocol

Por: Strunk · T. · Mountain · J. · Gordon · A. · Deshpande · G. · van den Boom · J. · DePaoli · A. G. · Jacobs · S. · Giannoutsos · N. · Doherty · D. A. · Patole · S.
Introduction

Infants born before 28 weeks’ gestation account for approximately 75% of neonatal morbidity and mortality. Late-onset sepsis (LOS) affects around 25% of these infants and is associated with an increased risk of adverse long-term outcomes. The topical application of coconut oil has been used for centuries in newborn care. Coconut oil is rich in saturated fatty acids, several of which have demonstrated antimicrobial properties. It is considered safe for extremely preterm infants, improves skin condition and may reduce the incidence of LOS.

Methods and analysis

This is a pragmatic, cluster-randomised, two-arm, parallel-group, multicentre, phase III clinical trial evaluating the effect of topical coconut oil versus routine skin care on the incidence of LOS in extremely preterm infants. Participating neonatal units will be cluster-randomised, and all infants born at

Ethics and dissemination

Following ethical approval, patients will be recruited at participating sites under a waiver of consent with opt-out framework. The trial results will be disseminated through conferences, media sources and publication in relevant peer-reviewed journals.

Trial registration number

ACTRN12620001332910.

Detecting undiagnosed hypertension using repeated blood pressure measurements: a cross-sectional study in rural Sidama Region, Ethiopia

Por: Birhanu · B. E. · Likka · M. H. · Areru · H. A. · Hibstu · D. T. · Lindtjorn · B.
Objective

To determine the prevalence of undiagnosed hypertension and its risk factors among adults in rural Sidama Region, Ethiopia, using a two-step diagnostic method.

Design

A community-based cross-sectional study was conducted from 1 April to 31 July 2024. Data were collected among adults aged 45 years and above using the World Health Organization STEPwise Approach to Surveillance questionnaire. The Demographic and Health Survey questionnaire was also used to collect data on household characteristics.

Setting

Selected rural kebeles of Shebedino district, Sidama, Ethiopia.

Participants

2875 adults aged ≥45 years identified via census.

Outcome measures

Undiagnosed hypertension was defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, in individuals with no history of the condition.

Results

The prevalence of undiagnosed hypertension ranged from 7.7% (95% CI: 6.7% to 8.7%) to 14.3% (95% CI: 13.0% to 15.6%). The previously diagnosed hypertensive cases were found in 3.3% (95% CI: 2.7% to 4.1%). Female sex (AOR 2.02; 95% CI: 1.44 to 2.82), age ≥ 65 years (AOR 1.48; 95%CI: 1.01 to 2.15), and history of alcohol drinking and khat chewing (AOR 2.94; 95%CI: 1.52 to 5.66) were significantly associated with undiagnosed hypertension. Lack of awareness of salt-related health risks (AOR 3.14; 95% CI: 2.30 to 4.30) and no prior blood pressure measurement (AOR 5.60; 95% CI: 1.73 to 18.07) were also associated with undiagnosed hypertension.

Conclusions

Undiagnosed hypertension is common among adults aged ≥45 years in the rural Sidama Region. Female sex, older age, substance use, limited awareness of salt-related health risks, and lack of prior blood pressure measurement were the identified risk factors. Regular screening should be implemented to detect cases at an early stage.

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