The overall aim of the present project is to increase healthcare professionals’ ability to ask about exposure and to identify individuals exposed to intimate partner violence (IPV). The project will evaluate the effects of three different interventions that can be assumed to increase healthcare professionals’ ability to ask and identify individuals who have been or are exposed to IPV.

This project has a quasi-experimental design. After a 2-month baseline period, participating care units (primary health centres, maternal health clinics and youth guidance clinics) will be assigned to one of three interventions to potentially increase the ability to enquire and identify patient exposure to IPV: (1) healthcare professionals’ use of a standardised questionnaire about exposure to IPV in patient meetings, (2) training through the use of a virtual patient case tailored to health professionals and (3) a combination of (1) and (2) earlier. Preintervention (baseline) and postintervention measurements of the health professionals’ enquiry and identification of patients exposed to IPV will be used to explore the effect of the interventions. Focus group interviews with the participating health professionals will be used as a qualitative method, applying thematic analysis, to explore which intervention they perceive as most effective in increasing their ability to identify victims of IPV.

Data analysis will focus on a comparison of pre- and post-measurements regarding the number of patients asked about and identified patients in each intervention arm that have been or are exposed to IPV. Measurements will be carried out per care unit at the group level. Qualitative data from focus group interviews will be analysed using thematic analysis.

All participants will sign a written consent form and the study has been approved by the Swedish Ethical Review Authority (Dnr 2023-03399-01). The study will be conducted according to good clinical practice and the Declaration of Helsinki. The results of this study will increase knowledge about how identification of violence in close relationships can be improved in the clinical setting through publications in peer-reviewed journals and presentations at national and international scientific conferences.

Recruiting since May 2024. Expected trial termination December 2026.

NCT06322251.

Research has yielded contradictory results regarding differences in physical fitness and cardiometabolic risk between children and adolescents living in rural and urban areas.

The present study aimed to analyse the moderating role of area of residence on the association of physical fitness and anthropometric parameters in Chilean adolescents.

Cross-sectional analysis of a nationally representative school-based sample from Chile.

A total of 7,833 adolescents with an average age of 15.8±0.7 years participated in both rural (n=759) and urban (n=7,074) settings. Physical fitness tests were evaluated using the Assessing Levels of Physical Activity and Fitness (ALPHA-Fitness) battery and anthropometric variables such as body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). Generalised linear models with Gaussian distributions were constructed to estimate moderation models, with anthropometric-related variables as dependent variables, physical fitness variables as independent variables and area of residence as a moderator. Moderation analyses were conducted to examine whether the area of residence influences the association between physical fitness and anthropometric indicators (WC, WHtR and BMI).

In all models, place of residence did not moderate the potential associations between physical fitness and anthropometric indicators; for example, cardiorespiratory fitness with WC (B=0.13, 95% CI 0.05 to 0.31; 0=0.160), WHtR (B=0.08, 95% CI –0.03 to 0.20; p=0.143) or BMI (B=0.08, 95% CI –0.03 to 0.20; p=0.207).

These findings suggest the associations between physical fitness and anthropometric outcomes do not differ significantly between rural and urban adolescents.

To assess the acceptability and adoption of multiparameter point-of-care testing (POCT) devices for the diagnosis and management of non-communicable diseases (NCDs) at the primary healthcare level in a resource-limited region of Peru.

Qualitative case-control process evaluation.

Eight primary healthcare facilities in northern Peru, including both urban and rural centres, where routine chronic care and laboratory services are provided.

Sixty-three participants: 36 patients, 12 laboratory technicians, 10 healthcare professionals and five facility heads. Eligible patients were ≥18 years, residing in the catchment area, with or without prior NCD diagnoses. Healthcare workers, including physicians, nurses, laboratory staff and facility managers.

Multiparameter POCT devices were installed in four intervention facilities, accompanied by staff training and community awareness activities, while four control facilities continued with conventional laboratory diagnostics.

Primary outcome: perceptions of patients and healthcare workers regarding the acceptability and adoption of POCT devices. Secondary outcomes: identification of facilitators and barriers to implementation, including infrastructure, supply chains and training gaps.

(1) Individuals: POCT was valued for speed and comfort, but concerns over accuracy were mentioned. (2) Intervention characteristics: laboratory staff valued POCT’s practicality in emergencies, but noted limitations in handling multiple samples. (3) Outer setting: urban centres outperformed rural facilities, with more staff and longer operating hours. (4) Inner setting: calibration gaps impacted POCT and conventional test reliability, requiring quality control and training. (5) Process: clear staff communication boosted patient confidence in POCT, but inconsistent training could lead to reliability doubts.

Multiparameter POCT devices show promise for enhancing NCD care in resource-limited primary healthcare settings, particularly in rural areas. However, their sustainability depends on broader health system reforms, including reliable supply chains, expanded training and stronger quality assurance mechanisms. Further research should examine strategies for embedding POCT within national regulatory and policy frameworks.

The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru).

Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities.

As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the context-specific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1.

A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only co-designed intervention and (3) the usual care arm. Data will be collected longitudinally over 18 months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others.

Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences.

NCT06989502.

Artificial intelligence (AI) in healthcare often requires large, confidential clinical datasets. However, a recent UK government survey revealed that 20–40% of the public remain sceptical of its use in health research due to concerns about data security, patient–practitioner communication and commercialisation of data. A greater understanding of public attitudes is therefore needed, particularly in the context of stroke research.

In this article, we describe the patient and public involvement work undertaken for the AI-Based-Stroke-Risk-fActor-Classification-and-Treatment (ABSTRACT) project, which aims to train AI models to predict future stroke risk from the electronic health records of 1 18 736 patients.

We aimed to evaluate the opinions of stroke/transient ischaemic attack (TIA) patients, caregivers and members of the public on the following themes: (1) the acceptability of using AI to predict stroke from electronic health records, (2) obtaining these data using an opt-out model of consent and (3) allowing access to this dataset from members both within and outside of the routine clinical care team.

A total of 83 participants were recruited via the National Health Service social media and by approaching hospital inpatients. Participants were first provided with background information on stroke, AI in medical research and ABSTRACT’s proposed data handling protocol. A mixed methods approach was then used to explore each of the above themes using online survey, semistructured focus groups and one-to-one interviews.

Nearly all participants felt that it was appropriate to use patient data to train AI models to predict stroke risk and that it was acceptable to obtain these data via an opt-out model of consent. Almost all participants also agreed that data could be shared within and outside of the routine clinical care team, provided it was General Data Protection Regulation compliant and used for medical research only.

The public and those with lived stroke/TIA experience appeared to support using deidentified medical datasets for AI-driven stroke risk prediction under an opt-out consent model. However, this is provided that the research conducted is transparent, for a clear medical purpose and adheres to strict data security measures.

Neurodegenerative disorders (NDDs) represent an unprecedented public health burden. These disorders are clinically heterogeneous and therapeutically challenging, but advances in discovery science and trial methodology offer hope for translation to new treatments. Against this background, there is an urgent unmet need for biomarkers to aid with early and accurate diagnosis, prognosis and monitoring throughout the care pathway and in clinical trials.

Investigations routinely used in clinical care and trials are often invasive, expensive, time-consuming, subjective and ordinal. Speech data represent a potentially scalable, non-invasive, objective and quantifiable digital biomarker that can be acquired remotely and cost-efficiently using mobile devices, and analysed using state-of-the-art speech signal processing and machine learning approaches. This prospective case–control observational study of multiple NDDs aims to deliver a deeply clinically phenotyped longitudinal speech dataset to facilitate development and evaluation of speech biomarkers.

People living with dementia, motor neuron disease, multiple sclerosis and Parkinson’s disease are eligible to participate. Healthy individuals (including relatives or carers of participants with neurological disease) are also eligible to participate as controls. Participants complete a study app with standardised speech recording tasks (including reading, free speech, picture description and verbal fluency tasks) and patient-reported outcome measures of quality of life and mood (EuroQol-5 Dimension-5 Level, Patient Health Questionnaire 2) every 2 months at home or in clinic. Participants also complete disease severity scales, cognitive screening tests and provide optional samples for blood-based biomarkers at baseline and then 6-monthly. Follow-up is scheduled for up to 24 months. Initially, 30 participants will be recruited to each group. Speech recordings and contemporaneous clinical data will be used to create a dataset for development and evaluation of novel speech-based diagnosis and monitoring algorithms.

Digital App for Speech and Health Monitoring Study was approved by the South Central—Hampshire B Ethics Committee (REC ref. 24/SC/0067), NHS Lothian (R&D ref. 2024/0034) and NHS Forth Valley (R&D ref. FV1494). Results of the study will be submitted for publication in peer-reviewed journals and conferences. Data from the study will be shared with other researchers and used to facilitate speech processing challenges for neurological disorders. Regular updates will be provided on the Anne Rowling Regenerative Neurology Clinic web page and social media platforms.

ClinicalTrials.gov NCT06450418 (pre-results).

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.

The study findings will provide the evidence base to inform future colorectal diagnostic services.

The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.

ISRCTN16126290.