Distressing sensory experiences (DSEs) are commonly reported by children and young people accessing Child and Adolescent Mental Health Services (CAMHS) in the UK. Despite their prevalence, evidence-based tailored interventions for this population are scarce. The ChUSE trial aims to address this gap by evaluating the feasibility and acceptability of a novel brief talking therapy for children aged 8–16 years and an accompanying parent coaching programme.
A single-blind, two-arm randomised controlled feasibility trial will be conducted across three National Health Service trusts in Greater Manchester, UK. Sixty young people under the care of CAMHS experiencing DSEs and their parents/caregivers will be randomised 1:1 to receive either treatment as usual (TAU) or TAU plus the ChUSE intervention. The intervention involves four child therapy sessions and three optional parent sessions. Primary feasibility outcomes include recruitment and retention rates, treatment adherence and intervention safety. Secondary objectives assess the feasibility of data collection procedures and gather qualitative insights into trial acceptability and the influence of the intervention on young people’s well-being.
The ChUSE Trial has received ethical approval through the Health Research Authority following review by the West Midlands – South Birmingham Research Ethics Committee specialising in paediatric research (ID 327343). The feasibility trial addresses a significant clinical gap in CAMHS provision and will also capture information as to current TAU practices, contributing novel data to guide future service provision as TAU is currently understood to be heterogeneous. The information gathered through this trial will inform the design of a definitive trial evaluating the clinical effectiveness and cost-consequences of an early, age-appropriate intervention for DSEs. Findings and translational outputs will be shared through scientific and public forums to reach a variety of audiences.
by Grace Kyule, Samuel Iddi, Noreen Dadirai Mdege, Lyagamula Kisia, Terefe Gelibo Argefa, Olatunbosun Abolarin, Didier M. Mirindi, Retselisitsoe Pokothoane, Boscow Okumu, Nelson Mbaya, Franklin Koech, James Kavai, Akinsewa Akiode, Thompson Ademola, Uche Okezie, Fakorede J.I, Christelle Tchoupé, Damazo T. Kadengye, Shukri F. Mohamed
Tobacco use often begins during adolescence, increasing the risk of lifelong nicotine dependence and future non-communicable diseases. In sub-Saharan Africa, concerns are rising due to aggressive tobacco industry marketing and expanding nicotine product markets, yet nationally representative data covering both in-school and out-of-school adolescents remain limited. Understanding tobacco use patterns during early and mid-adolescence, a critical period for experimentation and initiation, is essential for informing prevention strategies. We conducted nationally representative cross-sectional household surveys between March and June 2024 using harmonized tools and multistage stratified cluster sampling in Democratic Republic of Congo (DRC), Nigeria and Kenya. Adolescents aged 10–17 years completed standardized face-to-face interviews with response rates of 96% in DRC, 94% in Nigeria and 96% in Kenya. The outcomes were current use of any tobacco, smoked tobacco and smokeless tobacco. Current tobacco use was defined as self-reported use in the past 30 days of any tobacco product including cigarettes, cigars, shisha/waterpipe and smokeless-tobacco (snuff/chewing). Analyses incorporated sampling weights to estimate prevalence, assessed subgroup differences using Rao-Scott chi-square tests, and multivariable logistic regression models were fitted separately for each country and outcome. Among 18,612 adolescents (4,675 in DRC, 7,502 in Nigeria, 6,435 in Kenya), 6·5% (95% CI: 4·9–8·6) reported current tobacco use, with variations across countries (11·9% in DRC, 3·6% in Nigeria, and 2·5% in Kenya). Similar patterns were observed for smoked and smokeless tobacco use. Tobacco use was higher among boys, older adolescents, and those engaged in work. In adjusted analyses, being a boy and older was associated with higher odds of use. Being enrolled in school was linked to lower odds of use in DRC and Kenya, while having both parents alive reduced odds of use in DRC and Nigeria. Higher parental education was associated with lower odds of tobacco use in Kenya but higher odds of use in DRC and Nigeria. Overall, adolescents’ tobacco use remains a critical public health challenge and observed cross-country differences highlight the need for tailored, context-specific interventions and strengthened tobacco control efforts.Cognitive impairment after critical illness is a common occurrence that has a profound impact on millions of people worldwide each year. Currently, no interventions after critical illness have been found to promote cognitive recovery. Cognitive training has shown promise in other populations (eg, community-dwelling adults), predominantly in improving the trained cognitive domain (eg, memory, reasoning or executive function). In pilot work, in-person cognitive training with intensive care unit (ICU) survivors was found to not only improve the trained domain but also may reduce disabilities in daily function. Computerised cognitive rehabilitation (CCR) is a more scalable option, which we have demonstrated the feasibility of use among ICU survivors. Whether CCR is efficacious in ICU survivors remains unknown.
The Returning to Everyday Tasks Utilising Rehabilitation Networks-III (RETURN-III) study is a multicentre, randomised, double-blinded, parallel group controlled trial testing the hypothesis that CCR versus active control will result in less cognitive impairment after critical illness. Adult patients who recently experienced acute respiratory failure or shock in medical and surgical ICUs at two hospitals in Nashville (TN, USA) will be enrolled. Participants will be randomised within 12 weeks of hospital discharge to a 12-week home-based programme of CCR (or control), with the goal of five 30 min sessions per week. In-person assessments will be performed at baseline, 3 months and 12 months after randomisation. The primary outcome is global cognitive function 3 months after randomisation using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score. Secondary outcomes will include 12-month RBANS global cognitive function, 3-month and 12-month subjective cognition by the Cognitive Self-Report Questionnaire, daily function related to cognition by the Functional Activities Questionnaire and processing speed/executive function by Trail Making Test part B. With an anticipated enrolment of 160 patients, the study will have at least 80% power to detect a 7-point or higher difference in RBANS cognition scores between the two groups (
The RETURN-III study was approved by the institutional review boards at each participating site. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences following completion of data collection.
Trauma, obstetric haemorrhage and severe anaemia lead to millions of deaths every year. Many of these deaths occur in regions known as ‘blood deserts’ where there is virtually no access to blood transfusions. A community or civilian walking blood bank (CWBB) is a low-resource strategy that can provide just-in-time, point-of-care tested blood transfusions in blood deserts when banked blood is not readily available and the alternative is almost-certain death. This protocol is designed to evaluate the effectiveness and implementation of a CWBB at Lodwar County Referral Hospital located in a blood desert in rural north-west Kenya.
We will use a mixed-methods approach relying on an implementation science design to evaluate effectiveness, acceptability, applicability and impact of a CWBB. The study will be conducted over 1 year in two parts: pre-emergency and post-emergency transfusion protocol (ETP) implementation. First, a previously developed ETP will be validated and finalised by key hospital stakeholders. Effectiveness will be assessed quantitatively and qualitatively. Prospective laboratory-based data collection will measure changes in blood ordering practices. We expect a sample size of approximately 140 (20/month) unmet blood transfusion requests, with 40 (5/month) of those being emergent (requiring blood in less than 2 hours). These cohorts will be compared pre-implementation and post implementation. Qualitatively, key informant interviews of hospital staff and the community will explore clinical blood demand and general understanding and perceptions about blood donation and transfusion. Lastly, we will determine the adaptability and scalability of a CWBB to other low-resource settings with in-depth interviews and a modified Delphi approach to achieve consensus regarding key components of a CWBB and its transferability to other settings.
Ethical approval was granted by the Strathmore University Institutional Scientific and Ethics Review Committee (SU-ISERC2234/24) and the Mass General Brigham (MGB) Hospital’s Institutional Review Board (#2024P001878; #2024P001879; #2024P001885; #2024P001887). The study team also secured a research licence from the National Commission for Science, Technology and Innovation (#168094) before initiating the study. Interviews will be voluntary and consent will be obtained prior to participation. Blood transfusion consent will be collected as per standard hospital process. The findings will be disseminated through academic publications, conference presentations and workshops, contributing valuable insights into emergency blood transfusion protocols. These findings will also be conveyed to Lodwar County Referral Hospital in order to facilitate quality improvement.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with reduced quality of life and increased healthcare utilisation. AF is increasingly recognised as a manifestation of an underlying cardiometabolic disease process, with obesity and related metabolic risk factors contributing to its development and progression. Consequently, upstream risk factor modification, including structured weight management, has emerged as a potential strategy to improve AF outcomes. While dietary and exercise interventions have been studied individually, the effectiveness of programmes combining both components has not been systematically reviewed in patients with AF who are overweight or obese. This review aims to assess the impact of combined nutritional and physical activity interventions on AF-related outcomes.
A systematic search will be conducted in MEDLINE, CINAHL, EMBASE and EMCARE from database inception to April 2026. Eligible studies will include randomised controlled trials, quasi-experimental studies and controlled cohort studies evaluating combined dietary and physical activity interventions in adults with AF who are overweight or obese. The primary outcome will be AF symptom burden measured using validated instruments. Secondary outcomes will include quality of life, anthropometric measures, metabolic parameters and AF arrhythmia burden. Risk of bias will be assessed using RoB 2 and Risk of Bias in Non-randomised Studies of Interventions. Where appropriate, meta-analysis will be performed using random-effects models.
Ethical approval is not required. Findings will be disseminated through peer-reviewed publications and scientific meetings.
Open Science Framework (OSF; https://doi.org/10.17605/OSF.IO/HCUZ3).
This paper explores the experience of general practice nurses implementing a nurse-led social prescribing intervention to improve older people's social connectedness.
Qualitative descriptive study within a multi-phase mixed methods project.
Eight Australian general practice nurses working in a health connector role participated in semi-structured interviews at implementation-end (n = 8) and 12 months later (n = 5), and two focus groups, held during implementation. Interviews addressed participants' reasons for engaging in the intervention, perceptions of training, the experience of intervention delivery and sustainability. Focus groups explored participants' views of challenges and achievements. Data were analysed inductively using thematic analysis.
Participants reported ‘alignment between their current nursing role and the additional health connector role’ regarding their scope of practice and philosophy of care. ‘Preparedness to be a health connector’ explained how participants' primary care nursing skills equipped them to intervene, however, additional training and resources were essential. Older people were positively impacted by the intervention, and this motivated participants to sustain elements of the intervention. With support, participants leveraged existing skills and worked to their full scope of practice. This resulted in practice improvements in caring for older people at risk of loneliness and social isolation, and professional gains for nurses.
Despite challenges in sustaining the intervention as designed, participants integrated the health connector intervention into their practice within the context of their nursing role and continued this work with older people and other patient groups.
Facilitating general practice nurses to undertake a social prescribing intervention had benefits for nurses and patients.
Nurse-led social prescribing interventions can support older people to reactivate or maintain their social connections within the context of their health.
Consolidated Criteria for Reporting Qualitative Research (COREQ) Checklist.
No patient or public contribution.
Chronic back and neck pain are commonly treated with opioid analgesics, gabapentinoids and benzodiazepines, despite their high-risk profile and potential limited efficacy. Deprescribing interventions (aimed at medicine reduction or cessation) have shown some effectiveness in reducing the use of these medications, but similar approaches tailored to individuals with complex chronic back and/or neck pain are lacking and urgently needed. This trial will evaluate the effect of the safer analgesia (SAGE) intervention (training of general practitioners (GPs) in deprescribing and support to deprescribe) on cessation and/or reduction of the target high-risk medicine (a benzodiazepine, gabapentinoid or opioid) for people with chronic back and/or neck pain.
SAGE is a pragmatic cluster randomised trial that will be conducted with at least 30 general practices in Australia randomly assigned in a 1:1 ratio to the SAGE intervention or no intervention (usual care control group). The SAGE intervention is a GP-facing intervention comprising (i) training for GPs in deprescribing and access to deprescribing resources and (ii) deprescribing support—to assist the deprescribing process for their patients, GPs can conduct a long GP consultation (20–40-min duration), refer to trained physiotherapists for the provision of psychologically informed physiotherapy sessions and provide alternate pain management options including heat wrap and diclofenac gel. A total of 320 adult patient-participants experiencing chronic back and/or neck pain (≥ 3 months duration) prescribed a target high-risk medicine (benzodiazepine, gabapentinoid or opioid) persistently for this pain will be recruited via participating general practices. The primary outcome is cessation of dispensation of the trial participant’s high-risk medicine (a benzodiazepine, gabapentinoid or opioid) prescribed by their trial GP. The primary time-point for the primary outcome will be 1-year post-enrolment with an observation window of the preceding 4 weeks. Secondary outcomes include self-reported outcomes such as pain, quality of life and adverse events. Analyses will follow an intention-to-treat approach with a nested economic evaluation and per-protocol analysis planned separately.
The study received approval from the University of Sydney Human Research Ethics Committee (2024/HE001706). The results will be disseminated via publication in a peer-reviewed scientific journal, presentation at conferences and media.
ANZCTR: ACTRN12625000953437.
Many industries where safety is a priority (eg, aviation) use safety management systems (SMSs), but evidence on their use in healthcare is needed to determine whether they could support patient safety improvement. We investigated the application of national-level SMSs to patient safety in terms of effectiveness, implementation and experience.
Systematic review using a case study approach.
We identified patient safety organisations in each country and searched their websites. We also searched MEDLINE (in December 2023) and Embase (via Ovid), CINAHL (EBSCO) and Web of Science (in February 2024).
Any evidence from five high-income countries that have publicly funded healthcare systems with universal coverage: Australia, Canada, Ireland, New Zealand and the Netherlands. We included publications on the effectiveness, implementation or experience of the patient safety approach in each country.
Included evidence was summarised and mapped onto an initial analytical framework based on analysis of SMSs in high-risk industries, enabling cross-country comparisons. Drafts were shared with experts from patient safety organisations in each country for comment. Formal quality appraisal was not possible as most evidence was non-evaluative.
53 publications were included, from Australia (5), Canada (7), Ireland (8), New Zealand (9) and the Netherlands (24). Only the Netherlands implemented a patient safety programme explicitly based on an SMS approach. Some aspects of patient safety in hospitals improved as a result, but there was significant variation in both the implementation of the programme and attributed outcomes.
In the other four countries, the main components of an SMS were identified to some extent, along with evidence that their patient safety approaches had been influenced by concepts from high-risk industries and ‘safety science’ more widely.
Emerging ideas from high-risk industries (beyond SMSs) and broader safety science have influenced all countries, reflecting increasing awareness of the need for initiatives to be context-specific to be successful. However, their implementation and impact need further evaluation.
CRD42023487512.
Randomised clinical trials (RCTs) are gold standard in evidence-based medicine, but follow-up typically relies on clinic visits and trial-specific data collection. Much of this information overlaps with routinely collected healthcare systems data (HSD), such as electronic health records and national registries. Leveraging HSD for trial follow-up has the potential to reduce cost, time and resource burden. However, concerns remain about data quality and evidence is needed to show that HSD-based outcomes are reported to an equivalent standard to trial-specific data.
The Blood Cancer Clinical Trials Long-term Follow-up Using Integrated Healthcare Systems platform will link data collected from multiple myeloma clinical trials with HSD to create a research database supporting extended follow-up and further methodological and clinical research.
This data-linkage study includes participants from multiple myeloma RCTs conducted by the University of Leeds between 2008 and 2021. NHS (National Health Service) England will link these participants to HSD, including deaths and cancer registrations, systemic anticancer therapy, radiotherapy and Hospital Episode Statistics.
We will compare trial-collected outcomes with those derived from HSD, including mortality, treatment, second cancer incidence and major adverse events. Long-term overall survival will be estimated using national mortality data. HSD-derived demographic and clinical variables will be used to assess population representativeness relative to the wider myeloma population. Time to next treatment will be derived and evaluated as a surrogate for progression-free survival. HSD-derived frailty measures will be examined for prognostic utility, and radiotherapy and hospital records will be analysed to characterise bone-related treatments and skeletal complications.
Ethical approval has been obtained from the East of England–Cambridge Central Research Ethics Committee, with Section251 support from the Health Research Authority on advice from the Confidentiality Advisory Group. Findings will be disseminated through publications, conference presentations and engagement with stakeholders and patient groups.
by Ryan D. Parsons, Sarah Bauermeister, Julian Turner, Natalie Coles, Simon Thompson, Emma Squires, Tracey Riseborough, Joshua Bauermeister, Abbie Simpkin, Naomi French, Shankly Cragg, Hazel Lockhart-Jones, Olly Robertson, Abhaya Adlakha, Ian Thompson, John Gallacher
Adolescent mental health and wellbeing are of growing concern globally with increased incidence of mental health disorders in young people. BrainWaves provides a framework for relevant and diverse research programmes into adolescent mental health and wellbeing that can translate into practice and policy. The research programme is a partnership with schools centred on establishing a large (n > 50,000) cohort and trials platform. Reported here is the BrainWaves cohort pilot study. This was designed as proof-of-concept for our recruitment and data capture pipelines, and for cost-modelling. A network of research schools was recruited and a computer-driven questionnaire administered. The eligible population was 16 + year olds who were attending the research schools. Of 41 research schools, 36 (88%) participated over one three-week and one four-week data collection period. From an eligible population of 33,531 young people, 16,010 (48%) attended the study lesson and created an account. Of the 16,010 (100%) who created an account, 15,444 (96%) consented to participate, 9,321 (60%) consented to linkage of research data with educational records, and 6,069 (39%) consented to linkage of research with school/college attendance data. Participants were aged 16–19 years, 59% female, and 76% White. Higher levels of anxiety and depression were found in females than males. Higher levels of media-based social networking were found in females, whereas higher levels of media-based gaming were found in males. Females were more likely to report insufficient sleep whilst males were more likely to report high levels of exercise. This study confirmed an ability to recruit at pace and scale. Whilst the response-rate does not indicate a representative sample, the demographics describe an inclusive and diverse sample. Data collected confirmed findings from previous studies indicating that the electronic data collection methods did not materially bias the findings. Initial cost-modelling suggests these data were collected for around £20 per participant.Examine the meaning of ‘successful feeding’ for parents of infants at risk for feeding difficulties and how this meaning evolved from 1 to 24 months post-term age.
Secondary analysis of responses to an open-ended question from a U.S. longitudinal mixed methods study.
At 1-, 6-, 12-, 18-, and 24-months post-term, parents completed surveys which included the question: What is ‘successful feeding’ to you? Using conventional content analysis, 864 responses from parents of 254 infants were coded into the following categories: Child Behaviour, Positive Response, Intake, and Time. Themes characterizing each category were identified.
Child Behaviour, Positive Response, and Intake were common at all time points. Responses related to Time (e.g., eating in a timely manner) were least frequent at 1, 6, and 12 months and were no longer mentioned thereafter. Demonstrating feeding skill/ability and satiety were common themes at all time points. Adequate quantity of food and no adverse response (e.g., emesis, choking) were common themes at 1 month; both decreased thereafter. The perception that the child was engaged in eating and eating nutritionally adequate food increased as children aged.
Parents' perspectives of successful feeding focused on indicators of their child's development and emotional and physical well-being. As their children aged, ate increasingly complex foods, and developed physiologic stability, the meaning of success focused less on the amount of intake and avoidance of an adverse response and more on child well-being.
Nurses and feeding specialists can incorporate parents' views of success as they provide feeding support.
Children having a positive behavioural and affective response to eating, and adequate intake provide evidence to parents of their success in achieving feeding goals. Understanding issues of importance to parents is an essential component of family-centered care of children with feeding difficulties.
No Patient or Public Contribution.
The authors have adhered to the Standards for reporting qualitative research.