Developmental regression is when children lose one or more skills they have established. Families caring for these children need timely recognition to assist diagnosis and tailored interventions. Families also need support to develop practical skills for caregiving and strategies to promote family well-being and community participation. Given the high caring demands, flexibly delivered approaches are needed to accommodate family routines. Online delivery of health-related interventions that provide coaching, information, or both has been found to be a feasible and effective option for families. Family Focus is a new family-centred online programme, co-designed with parents and family advocates, clinicians, and researchers to support and empower primary carers.

This study is a prospective, pragmatic randomised controlled trial comparing the effectiveness of online parent coaching plus Family Focus (Coaching+FF) to Family Focus alone (FF) for primary carers of children experiencing developmental regression. A sample of 56 families will be randomised in a 1:1 ratio. Outcomes are assessed at baseline, post-intervention and 12-month post-randomisation. The primary outcome is parental stress symptoms at post-intervention. Secondary outcomes include parental depressive and anxiety symptoms, parental engagement in health-promoting activities, family empowerment, family quality of life and child global health outcomes. The study will also examine the uptake and acceptability of specific coaching and FF components and explore the facilitators and barriers to their delivery and implementation.

Ethics approvals were obtained from the participating organisations (Monash Health HREC/107806). Informed consent is obtained from parents/guardians of children prior to study enrolment. Study findings will be disseminated through peer-reviewed publications, conference presentations and lived experience agencies.

ISRCTN25513446.

Hypertension is the leading global risk factor for mortality, causing over 10 million deaths annually. In sub-Saharan Africa, hypertension prevalence is high, particularly in rural areas, where it is less likely to be diagnosed, treated or controlled effectively. This results in a high burden of complications, including heart failure, stroke and kidney disease. Community-centred approaches using community health workers (CHWs), risk-based approaches and simplified treatment regimens have shown promise in improving hypertension management. However, there is limited evidence on the effectiveness of such approaches in rural sub-Saharan Africa.

The primary aim of this study is to assess the feasibility of a community-centred intervention for hypertension management in rural Kenya and The Gambia. The objectives are to evaluate the intervention’s adoption, fidelity, reach and dose; understand the mechanisms of action and contextual factors affecting its implementation; assess acceptability from the perspectives of patients, healthcare providers and policymakers; estimate the costs associated with the intervention; and evaluate study procedures to inform the design of a future full-scale trial.

We will conduct a mixed-methods, non-randomised, single-arm feasibility study, designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) framework and checklist for feasibility and pilot studies, including best practice guidance for non-randomised feasibility studies. The study will be conducted in two rural sites: Kilifi, Kenya and Kiang West, The Gambia. The intervention was codesigned with stakeholders and includes community-based hypertension screening by CHWs, risk stratification and hypertension-mediated organ damage assessment at primary healthcare facilities, followed by treatment initiation using single-pill combination (SPC) antihypertensive therapy for eligible individuals. Training will be provided to all healthcare providers involved in the study. We will screen 500 participants aged 30–80 years at their residence (250 from each country), and we expect that about 45% will be referred for additional assessments and of these 25% (or 10% of the total sample) will be prescribed treatment with SPC. Data collection to evaluate the intervention and its implementation will involve quantitative measures of feasibility and clinical outcomes; observations to assess fidelity and costing measures; and qualitative interviews and focus group discussions with patients, healthcare providers and policymakers to understand the acceptability and contextual influences on intervention implementation.

Ethics approval was obtained from the Kenyan National Committee for Science, Technology and Innovation (ref: 415561), the Gambia Government/Medical Research Council Joint Ethics Committee (ref: 31372) and the London School of Hygiene and Tropical Medicine Ethics Committee (ref: 31372). Study findings will be disseminated through peer-reviewed publications, conferences, policy briefs, community engagement forums and accessible summaries shared via the Improving Hypertension Control in Rural sub-Saharan Africa and partner newsletters.

This study is registered with the ISRCTN- The UK’s Clinical Study Registry (ISRCTN81228019), and Pan African Clinical Trials Registry (PACTR202504839027548).

To explore healthcare professionals’ perceptions and experiences with point-of-care testing (PoCT) implementation within Australia’s healthcare system and identify potential strategies for effective governance and improvements to regulation and guidelines that facilitate coordinated integration of quality PoCT into healthcare systems.

A descriptive qualitative study with thematic analysis with codes derived inductively from the transcriptions and a structured framework analysis using the six building blocks of the WHO Health Systems Framework exploring barriers and enablers to PoCT implementation.

Healthcare settings in Australia.

Healthcare workers with patient care responsibilities and healthcare administrators with oversight or regulatory responsibility for a service. 18 participants were interviewed with four from hospitals, four from primary care, three from community care, three from pathology laboratories, two from emergency care and two from pharmacy settings.

Healthcare professionals’ perspectives on PoCT implementation were grouped into three main themes: (1) community-centric pathology testing, (2) connectivity and continuity of care and (3) quality and governance. Participants identified insufficient health system financing and health information systems as significant barriers to PoCT implementation. Improved practical guidance for workforce training and health service delivery to interpret the current regulation outside of laboratory settings was viewed as a potential enabler to establishing PoCT within healthcare services.

Participants reflected that Australia has several examples of successful PoCT programmes providing patient-centred pathology to improve healthcare equity. However, the lack of information systems, funding, workforce training and diagnostic strategies prohibits the implementation of PoCT at-scale. It was recommended that adequately financing PoCT to encompass costs for testing, quality management and workforce training would incentivise services to obtain accreditation and ensure quality healthcare delivery. Despite the potential of PoCT to improve equitable healthcare access and patient outcomes, health system strengthening is required to integrate PoCT effectively across Australian healthcare services.

People with severe mental illness (SMI) engage in less physical activity (PA) and more sedentary behaviour (SB) than the general population, contributing to poorer physical health outcomes in this population. Therefore, the aim of this study was to evaluate the feasibility of a multi-component behaviour change intervention called Walking fOR Health (WORtH), delivered by community mental health teams, aimed at increasing PA and reducing SB compared with a one-off education session in people with SMI.

Feasibility randomised controlled trial (RCT).

Study recruitment and intervention delivery took place within four community mental health teams in the UK and Ireland.

Eligible participants had a diagnosis of a SMI and no contraindications to participating in physical activity. Fifty-four participants (25 male, 29 female; mean age 51.6 years) were recruited.

Participants were randomised to the 13-week WORtH intervention, comprising education, activity tracking and health coaching or an education-only control.

Feasibility outcomes included recruitment, retention, adherence and acceptability. Clinical outcomes included device-measured (Axivity AX3) and self-reported PA and SB, body anthropometry, physical function and mental well-being.

This feasibility study met 90% target recruitment and 94% of participants provided follow-up data. Adherence to allocated intervention and engagement with all core intervention components was >80%. Qualitative feedback indicated high levels of satisfaction. Valid device-measured moderate-vigorous PA (MVPA), the intended primary outcome for a definitive trial, was obtained from 90% of participants at baseline and 75% of participants at post-intervention. Point estimates indicated a mean increase of 8.6 min/day of MVPA in the intervention group (baseline 54.7 min/day (95% CI 39.5 to 70.0); follow-up 63.3 min/day (95% CI 50.1 to 76.4)) and of 1.0 min/day in the control group (baseline 42.1 min/day (95% CI 24.6 to 59.6); follow-up 43.1 min/day (95% CI 29.6 to 56.5)).

The results of this study support the feasibility of the WORtH intervention in adults with SMI, and findings will be used to optimise the design of a definitive RCT.

NCT04134871.

In 2017, Lifeline Nehemiah Projects in Sierra Leone launched 2YoungLives, a mentoring initiative for vulnerable pregnant adolescents, including those living with disabilities. Drawing from the social model of disability, we aimed to investigate the exacerbated disabling barriers which prevent these girls and their babies from accessing available healthcare and develop comprehensive solutions to improve their access.

Qualitative methods were used in this study.

Participants were invited to participate in face-to-face interviews in one district in Sierra Leone.

Six pregnant or postnatal adolescents living with disability, alongside four caregivers and five stakeholders from various organisations participated in semi-structured interviews employing thematic analysis.

We identified four key themes: (1) discrimination and financial barriers within the healthcare system, despite laws ensuring free healthcare for persons living with disabilities, (2) societal stigma manifested through abandonment by families and inadequate support, (3) lack of understanding of disability issues, particularly of those with intellectual impairments, leading to stigmatisation and exclusion, and (4) infrastructural limitations which hinder accessibility to essential services, with many facilities remaining non-compliant with disability regulations.

Adolescent girls living with disability during pregnancy and after birth in Sierra Leone face barriers to accessing healthcare, including caregiver ignorance, lack of autonomy, disabling services, social stigma and ineffective policy implementation, despite existing supportive laws. These findings keep those women who are arguably the most vulnerable, adolescent and living with a disability, from accessing perinatal healthcare, exacerbating their risk and that of their babies. Solutions include the need to enforce disability-inclusive policies and infrastructure adaptations, awareness and training for healthcare providers and community advocacy to break down social stigma.

Spinal cord injury (SCI) impairs autonomic functions, which are ranked among the highest priorities for recovery. The loss of autonomic control, including bowel, bladder, sexual and cardiovascular functions, interferes with rehabilitation and decreases health-related quality of life (HRQoL). Preliminary evidence indicates that non-invasive transcutaneous spinal cord stimulation (TCSCS) has the potential to improve autonomic stability in people with SCI. However, the optimal stimulation site for improving autonomic responses remains to be determined. This pilot randomised clinical trial aims to explore the efficacy of non-invasive mid-thoracic and lumbosacral TCSCS (proof-of-concept) for blood pressure stability (orthostatic hypotension and autonomic dysreflexia burden) alongside end-organ autonomic functions (lower urinary tract, bowel and sexual function) and HRQoL.

30 participants with chronic (>1 year) motor-complete SCI (American Spinal Injuries Association Impairment Scale A and B) at or above T6 will be enrolled in this open-label, two-arm randomised pilot clinical trial. Participants will be block randomised into either the mid-thoracic or lumbosacral TCSCS group. Participants will then undergo 8 weeks of TCSCS (3 times per week for 60 min; 24 sessions total) while in a seated position. Post-treatment effects will be recorded following the 8-week intervention and follow-up effects will be recorded 8 weeks after the end of the intervention. Primary and secondary outcomes will assess resting blood pressure, autonomic dysreflexia, orthostatic hypotension and lower urinary tract, bowel and sexual functions as well as HRQoL.

This study is approved by The University of British Columbia’s Clinical Research Ethics Board (UBC CREB H22-00365), and by Health Canada for Investigational Testing Authorisations (ITA) for Class II medical devices used in this trial (ITA#346875 TESCoN; ITA#381 154 SCONE). The findings will be disseminated through peer-reviewed publications, conferences, seminars and SCI community outreach.

NCT05369520.

Ankle fracture fixation surgery may be performed with or without the use of a tourniquet. Surgeons who use a tourniquet report reduced intraoperative bleeding, which improves the visualisation of anatomical structures. This may facilitate more accurate fracture fixation and restoration of the anatomical configuration of the ankle joint, potentially leading to improved functional outcomes. An additional proposed benefit of tourniquet use is reduced operative time. In contrast, surgeons who choose not to use a tourniquet report concerns that it may exacerbate postoperative pain and increase the risk of venous thromboembolism, surgical site infection and other complications. However, existing clinical trials are limited by small sample sizes and high risk of bias, preventing the ability to draw robust conclusions. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the potential benefits and risks of tourniquet use in ankle fracture fixation surgery.

This study comprises a two-centre, participant-blinded and surgeon-blinded parallel-arm RCT and an integrated qualitative interview study. A computer-generated randomisation service will allocate up to 50 patients to undergo ankle fracture fixation surgery either with or without the use of a tourniquet. Participants will be followed up for 3 months postoperatively. Primary outcomes include recruitment and retention rates, data completeness, success of blinding and adherence to allocated intervention. Secondary outcomes include postoperative pain, quality of the surgical field, intraoperative blood loss, blood transfusions, procedure duration, skin assessment, awareness of tourniquet use, health-related quality of life (EuroQol-5D-5L), Olerud-Molander Ankle Score and intraoperative and postoperative complications. The integrated qualitative study will consist of semistructured interviews with up to 12 patients and 12 trauma and orthopaedic surgeons (~24 interviews). Interviews will explore perspectives on the feasibility trial, identify factors associated with unblinding and examine barriers and potential solutions to the design and delivery of a future definitive trial. Interviews will be analysed using inductive thematic analysis.

National Research Ethics Committee (East of England-Essex) approved this study on the 8 May 2025 (REC 25/EE/0051). The results will be disseminated via peer-reviewed publication.

ISRCTN91783787.

Cardiovascular disease (CVD) is the leading cause of death worldwide and is associated with a broad range of physical, emotional and social burdens. Existing tools such as Systematic Coronary Risk Evaluation and WHO CVD risk charts identify clinical risk factors but fail to capture patient-perceived burden and the risk of burden awareness. The Assessment of Burden of Chronic Conditions (ABCC)-tool, a validated, person-centred instrument, offers a more holistic approach. The aim of the current study is to develop and validate a new module within the ABCC-tool for patients with an elevated cardiovascular (CV) risk or CVD (cardiovascular risk management (CVRM) module).

A mixed-methods design was used across four phases and expert meetings to identify the items for the module. All phases took place in the Netherlands. Phase 1 (literature search) was performed in 2021, phase 2 (semistructured interviews) was completed between January and October 2021, phase 3 (survey) was completed in November 2023 and December 2024, and phase 4 (semistructured interviews) was completed in January 2025.

Phase 2 involved 14 experts by experience (patients with CVD or people at elevated risk) and 10 healthcare professionals in the field of CVD. Phase 3 included 86 healthcare professionals. Phase 4 included 12 experts by experience. In total, four expert meetings took place, attended by three experts by experience, nine healthcare professionals and seven researchers.

The module was refined iteratively, using qualitative and quantitative insights at each phase of development. The model was only finalised after thorough content validation.

No suitable patient-reported outcome measures (PROMs) focusing specifically on CVRM were identified in the literature. Interviews revealed significant burdens in terms of physical, emotional and social burdens. Feedback from expert meetings and validation rounds led to substantive refinement. The final module contains 10 items and was deemed valid by both experts by experience and healthcare professionals.

The CVRM module of the ABCC-tool has been systematically developed and validated in terms of content. The final module focuses on the multidimensional burden of CVD and dealing with its risk factors and aims to support self-management. The module complements existing risk assessment tools by focusing on the burden experienced by the patient and the burden resulting from risk awareness.

Respiratory syncytial virus (RSV) is a significant cause of respiratory infections in young children. Since 2021, RSV has been a notifiable disease in Australia. However, current surveillance systems focus on hospitalised RSV, with limited surveillance at a community level through primary care clinics. This approach only captures RSV requiring hospitalisation. Less severe illnesses, while not captured, may have significant social and economic impacts including the associated cost of care and absenteeism. The aim of this study is to establish an understanding of the broader burden of RSV in young children in a community setting.

The PATROL (Parents Actively Tracking RSV in Little Ones) project is a prospective longitudinal observational study of RSV and other respiratory viruses in children

Incidence rates of RSV illness and asymptomatic carriage will be calculated and compared with the incidence rate ratios of other respiratory viruses.

The Government of Western Australia Child and Adolescent Health Service Human Research Ethics Committee approved all study materials. Results and findings will be disseminated through manuscripts, conference abstracts and presentations, participant newsletters and appropriate general news media items.

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.

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.

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.

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.