The study explored patient experiences of the Call for a Kit (CFAK) intervention, a community-based initiative designed to improve bowel cancer screening uptake and examined the mechanisms that may support participation among non-responders.

A convergent parallel mixed-methods design was employed, combining quantitative surveys and qualitative interviews.

The evaluation was conducted in general practices across Lancashire and South Cumbria, Northwest England, where CFAK clinics were delivered by an external health promotion team based within the Community Voluntary Services. These clinics target practices with low screening uptake.

A total of 113 CFAK attendees aged 54 and above, and who had missed their most recent screening invitation, completed a patient experience survey. 12 participants were purposively sampled for follow-up interviews.

Statistical analyses examined associations between patient experience and screening behaviours, including kit ordering and intention to complete the screening kit. Thematic analysis explored barriers and facilitators to participation, as well as experiences of CFAK clinics.

Patient experience scores were significantly higher among women than men and were positively associated with intention to complete the kit, though not with kit ordering. Qualitative findings indicated that CFAK addressed key barriers such as low awareness, confusion and emotional discomfort by providing personalised education, reassurance and culturally sensitive support. Participants particularly valued the relational aspects of the intervention, including the face-to-face delivery and communication in preferred languages.

CFAK clinics appear to enhance psychological capability and motivation for bowel screening by offering tailored, inclusive and supportive care. These findings highlight the value of patient-centred approaches in addressing inequalities in cancer screening and offer insights for the design of future community-based interventions.

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).

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.

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.

ISRCTN63917405.

Newborn bloodspot screening (NBS) is freely and universally available to babies born in Australia, with nearly 300 000 newborns screened each year. The NBS programme screens for approximately 30 conditions; however, there are hundreds of childhood conditions that could be treated if identified earlier and asymptomatically. Contemporary screening platforms have relied on mass spectrometry-based technologies, limiting surveillance to conditions with validated biomarkers detectable within the neonatal period. Advancements in metabolic techniques and genomics have expanded the range of conditions that could be detected. The NewbornsInSA research study will develop, validate and evaluate a novel multi-omic model of newborn screening, integrating metabolomic and genomic newborn screening as complementary methodologies.

Parents can opt in to additional NBS through NewbornsInSA during pregnancy or shortly after birth. One thousand prospectively recruited families will be offered genomic NBS by whole-genome sequencing, including analysis of a virtual gene panel of over 600 genes, and concurrent metabolomic screening. Clinically actionable pathogenic or likely pathogenic genetic variants will be reported to parents and whole genome sequencing data will be available on request for diagnostic reanalysis, if required later in life.

Acceptability of the NewbornsInSA programme will be evaluated through stakeholder engagement activities with healthcare professionals, members of the public and patient advocacy groups. Family experiences will be assessed using online surveys. The diagnostic yield, accuracy and the costs and consequences of the multi-omic NBS model will be assessed by comparison to standard-of-care NBS.

NewbornsInSA will investigate the acceptability, feasibility and cost-effectiveness of a multi-omic newborn screening model in a prospectively recruited South Australian population. We hypothesise that this approach will increase the number of conditions identified, reduce the time to diagnosis and facilitate earlier care with better outcomes for newborns with genetic conditions.

This research study has been ethically approved by the Women’s and Children’s Health Network Human Research Ethics Committee (2022/HRE00258 and 2023/HRE00236). Findings will be disseminated through peer-reviewed publication and conferences.

Social camouflaging (SC; ie, the concealing of autistic traits to socially assimilate) is associated with poor mental health, self-identity and quality of life outcomes, yet its typology, consequences and contextual triggers remain unexplored in autistic adolescents. Further study is necessary to identify protective factors against the potentially negative outcomes associated with SC to promote long-term well-being.

The current project will investigate SC in youth and its mental health, cognitive and neurophysiological correlates. Camouflaging will be captured by triangulating self-reported and caregiver-reported SC behaviours, as well as SC behaviours in day-to-day contexts using intensive longitudinal methods (ie, daily diaries). Non-autistic, self-identifying autistic and formally diagnosed autistic adolescents aged 15–18 years (N=150) will be recruited. Adolescents and caregivers will complete rating scales to assess mental health, and adolescents will complete in-lab cognitive assessments of attention, executive function, intellectual ability and theory of mind. Brain neurophysiological function and cortisol concentration over time will be measured during the same visit using electroencephalography and hair samples, respectively. Over the following 7 days, adolescents will complete daily diaries using their smartphones. The daily diaries pose survey questions about the type and degree of SC behaviour used within their daily environment, including the social context, individuals who are present and current well-being. Adolescents will also complete brief performance-based cognitive assessments of attention and executive function integrated within the daily diary surveys. Finally, adolescents and their parents will complete a follow-up of SC behaviours and mental health at 3 months. Correlations and regression analyses will be conducted to explore the associations between SC and mental health/cognitive outcomes and how baseline measures of cognition, mental health and SC predict patterns seen on the daily diaries. Multilevel modelling will be used, nesting daily data to capture within-person and between-group differences in contextual predictors of camouflaging behaviour. Results will contribute to current understanding of the typology of camouflaging, as well as inform intervention to mitigate mental health challenges for autistic youth.

This project is approved by the University of Victoria Human Research Ethics Board (#23–0013) and the University of Calgary Conjoint Faculties Research Ethics Board (#23–0641). Informed consent will be obtained from caregivers and adolescent participants, and safety procedures will be put in place to support the adolescent should mental health concerns arise. Results will be disseminated through academic publications and conferences, as well as summarised and communicated to interested participants and relevant stakeholders.

For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

NCT05338944.

To explore prescribers’ awareness of medicine-related challenges of older people (≥65 years) with sensory impairment (hearing, visual or dual impaired) and identify the influences on prescribing behaviours for these patient populations.

Semistructured interviews were completed online.

Primary care-based prescribers in the UK.

Independent prescribers working in primary care. Participants were recruited through professional networks and organisations, social media and using snowballing. Purposive sampling was used to ensure variation in roles, practice/organisational settings and geographical location.

15 prescribers participated, including general practitioners (n=6), pharmacists (n=5), nurses (n=3) and one optometrist. Many demonstrated limited awareness of sensory impairment and suggested that outdated patient records contribute to it being easy to overlook. Prescribers underestimated sensory impairment prevalence, with one predicting that only a small proportion of older patients had hearing loss. Formal training on prescribing for older people with sensory impairment was minimal, and most relied on experiential learning. Prescribers employed strategies to support safe prescribing, such as simplifying regimens and selecting lower-risk medications. The prescribers also reported a lack of evidence-based guidelines or resources tailored to these patient populations.

Prescribers currently receive minimal training to support their prescribing practices for older people with sensory impairment. Given the increasing prevalence of age-related sensory impairment, evidence-based resources and training are needed to support prescribing for these patient populations.

Psoriatic arthritis (PsA) is a form of inflammatory arthritis linked to psoriasis. Previous research from the UK has found that many people feel unsupported when diagnosed with PsA and lack confidence in managing their condition. This realist review aims to understand what works and does not work for whom and in what circumstances, in relation to healthcare professionals engaging with people to support them in developing self-management skills.

This protocol was developed by defining the scope of the review, using a brief directed literature review to support discussion by an expert group of researchers, healthcare professionals and a patient partner. A theoretical domains framework was generated, consisting of nine initial programme theories. These were further refined with input from Patient and Public Involvement and Engagement groups and used to develop a database search strategy.

A systematic search of MEDLINE, CINAHL, Embase, Emcare and APA PsycINFO will be carried out, supplemented by citation tracking, exploration of grey literature and a mixed methods survey of rheumatology health professionals. Data selection will be performed by a minimum of two reviewers and data from included sources will be extracted using a template. Data will be synthesised narratively with respect to the identified initial programme theories, using these data to refine or refute these theories. This will generate refined programme theories to explain what works for whom and in what circumstances.

Ethical approval for the health professionals survey was granted through the Research Ethics Committee, University of the West of England (Project ID: 10991848). Outputs will be disseminated to the research community through conference presentations and a peer-reviewed journal article. The strategy for sharing outputs with patients and health professionals will be discussed and agreed with knowledge user groups.

Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.

The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.

The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.

NCT06714630.

The first objective was to establish the feasibility of conducting a definitive trial to evaluate the effectiveness of mobility and strength training with or without protein supplements for pre-frail/frail older people with low protein intake. The second objective was to finalise outcome measures for a definitive trial.

Multicentre feasibility randomised controlled trial.

Four National Health Service (NHS) community trust physiotherapy departments. We recruited via clinical caseloads, an existing cohort study and community advertising. Participants were adults aged ≥60 years, frail or pre-frail, reporting walking difficulties or slow walking and low protein intake (

All participants undertook two times a week mobility and strength training supported by a physiotherapist for 24 weeks. Half of the participants were randomised (1:1) to receive 24 weeks of daily protein supplements to increase protein intake up to 1.6 g/kgBW/day.

Feasibility outcomes assessed recruitment, intervention fidelity, adherence, tolerance and study retention.

We assessed clinical data collection at baseline and 5–8 month follow-up including the short physical performance battery (SPPB), 6 min walk test (6MWT) and participant-reported outcomes. Outcome assessors were blinded.

All participants were analysed in the groups as randomised provided they were not withdrawn from the study before their treatment started and contributed outcome data (modified intention to treat). Our primary feasibility and secondary outcome measures were summarised using descriptive statistics such as mean and SD, median and IQR or counts with percentages. Secondary objectives were exploratory, and mean between group differences at follow-up were estimated for each continuous outcome using linear regression models adjusted for baseline outcome score and frailty status, and presented with associated 95% CIs.

Initially, recruitment focused on existing caseloads, but patients were more unwell and disabled than anticipated and ineligible. No participants were recruited from the cohort. A community recruitment strategy was implemented. We screened 952 older adults and 20 participants were randomised. We ran out of time to reach our target.

We achieved good intervention fidelity for both interventions. The median number of exercise sessions completed was 10.5/16 (IQR 7–13). Six participants received supplements which they tolerated well and took regularly. 14 participants (70%) attended follow-up assessments with no difference in retention between arms.

The median age of participants was 76 years (IQR 68.5–80.0) and 15/20 (75%) were frail. All clinical outcomes showed a trend towards larger improvements in the exercise and protein arm, but these were not statistically significant. For example, SPPB scores (mean difference 0.93, 95% CI (–2.70 to 4.56)) and 6MWT (mean difference 41.92 m, 95% CI (–39.05 to 122.89)) were both higher in the exercise and protein arm compared to control.

The study was not feasible based on the original protocol. Recruitment was the biggest challenge. We established a more efficient route to recruitment (community advertising) which requires further refinement. Clinical outcomes consistently favoured the exercise and protein group, which should be interpreted cautiously but suggest this question is worthy of further investigation.

ISRCTN30405954.

Returning research results that indicate risk of Alzheimer disease (AD) dementia—a disease for which no meaningful treatments or cure exist—to cognitively normal participants is controversial. AD is thought to begin many years before clinical signs and symptoms begin. During this time, individuals are cognitively normal but have biomarkers that indicate pathophysiological changes in the brain. With this study, we aim to evaluate the impact of returning research results on cognitively normal participants recruited from a longitudinal observational cohort on ageing at the Knight Alzheimer Disease Research Centre (Knight ADRC) at Washington University in St. Louis.

Our study uses a 2-year, delayed-start randomised clinical trial design. Participants are randomised to receive their research results either 2 weeks or 1 year after informed consent. This study was approved to recruit up to 450 participants with existing genetic and biomarker testing results from the Knight ADRC. During the study period, 260 individuals were eligible and approached for entry into the study. The primary cognitive outcomes are 1-year change in subjective cognitive score on the clinical dementia rating sum of box scores and the objective cognitive score on cognitive composite score. The primary psychosocial outcome is change in geriatric depression scale score 1 year after return of research results. The study was powered to answer primary outcomes with 140 participants (70 per study arm).

This study has been approved by the Washington University School of Medicine (WUSM) Institutional Review Board and the Human Research Protection Office. Results from these trials are shared through conferences and publications.

NCT04699786.

The HOPSCOTCH study ‘Helping Optimise Primary Care Support During Transition From Children’s Hospice Care’ aims to develop a toolbox to enable engagement of primary care services in the care of young people with life-limiting conditions (LLC) with a specific focus on the point of transition from children’s hospice services.

Individual interviews will be held with young people with LLC, their families and healthcare professionals (HCPs). In alignment with Experience Based Co-Design (EBCD) methodology, extracts of film and audio from young people and family interviews will be combined to professionally produce a ‘catalyst film’ highlighting key points and experiences before, during and after the transition from children’s hospice care. Role-specific workshops will be held with young people with LLC, their families and HCPs working in primary care, children’s hospices and adult hospice services. The catalyst film will be used in feedback workshops to prompt prioritisation of key issues to take forward into toolbox development in a shared young people, family and HCP workshop. A documentary analysis of resources currently used to support transition and communication between care settings will support contextual understanding of the transition process. Young people, parents and professionals have shaped and continue to have influence over the study delivery as advisors alongside a multidisciplinary steering committee.

The study design has been guided by the UK Medical Research Council complex intervention framework. Intervention development draws on the principles of EBCD and is theoretically driven by the Behaviour Change Wheel.

The study is registered with the UK’s Clinical Study Registry (ISCTRN75964234).

Ethical approval was obtained from Wales 3 ethics board on 2 July 2025 (IRAS ID 334486). This study will include ongoing dissemination and knowledge transfer to key audiences (young people, parents, service providers, commissioners) via publications, national bodies, knowledge exchange events, web-based platforms, social media and clinical/academic forums.

This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.

A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.

The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.

Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.

Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.

The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.

ISRCTN74668529.