To explore the motivations, barriers and potential solutions from professionals’ perspectives for achieving effective interdisciplinary practice, focusing on communication and collaboration to support work participation and facilitate patients’ return-to-work (RTW).
Qualitative exploratory interview study using thematic analysis.
Primary and work-focused healthcare.
22 healthcare professionals, including occupational physicians (n=5), social insurance physicians (n=5), general practitioners (n=7) and occupational physiotherapists (n=5), were purposively recruited. All participants had at least 1 year of experience and were actively involved in patient care.
None.
Identified motivations, experienced barriers and proposed solutions for improving communication and collaboration across disciplines in work-focused healthcare.
Participating healthcare professionals emphasised the importance of early, proactive and person-centred communication across care domains, particularly in complex or stagnating RTW trajectories. Key barriers included a lack of shared knowledge and common goals, limited understanding of each other’s roles, time constraints, fragmented systems and regulatory restrictions. Proposed solutions focused on clearer coordination of care, improved role clarity and development of a secure, cross-domain digital communication platform to streamline information exchange.
Effective work-focused healthcare requires improved interprofessional communication and patient-centred collaboration. This study highlights when collaboration is most valuable, identifies key barriers and outlines feasible practical solutions. Future research should focus on developing and implementing guidelines that clarify communication pathways and coordination mechanisms within interdisciplinary teams.
Ovarian cancer patients often experience persistent symptoms such as fatigue and pain, impacting their quality of life. Current follow-up care, focused primarily on recurrence detection, may not adequately address these symptoms and can be burdensome. This study evaluates the feasibility of remote monitoring using patient-reported outcome measures (PROMs) and measurements of weight and abdominal circumference as an alternative to standard hospital visits. We aim to assess feasibility (ie, usability and satisfaction) of this approach and identify implementation barriers and facilitators.
This study is a single-centre longitudinal observational pilot that uses both qualitative and quantitative data to evaluate the feasibility of an innovative remote monitoring system for ovarian cancer follow-up care (Controle op Afstand, CopA). It is accessible to both healthcare professionals in the electronic health record and patients through the patient portal. Instead of 3-monthly in-hospital visits, patients are invited to complete regular surveys assessing PROMS about symptoms and quality of life and home measurements of weight and abdominal circumference. Feasibility will be assessed by (1) analysing patient and healthcare professional (HCP) experiences with CopA with the Measurement Instrument for Determinants of Innovations questionnaire for HCPs, and the ‘Experienced Usability and Satisfaction with Self-monitoring in the Home Setting’ questionnaire for patients, (2) investigating implementation barriers and facilitators using qualitative method and (3) performing a process evaluation of the intervention, assessing components such as reach, fidelity and compliance, time to response and number of (tele)consultations during the study period. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic analysis.
This study was reviewed by the Ethics Committee of the Amsterdam University Medical Centre (METC 2022.0256) and exempted it from further review as this study was not subject to the Dutch Medical Research Involving Human Subject Act. Results will be disseminated via peer-reviewed open-access publications, scientific conferences and targeted communication to patient organisations, healthcare providers and the wider public.
To review current evidence on the implementation and impact of virtual nursing care in long-term aged care.
An integrative rapid literature review.
Medline, CINAHL, Web of Science, Embase, Ageline and Scopus.
The review included studies involving virtual care interventions provided by nurses (or by a multidisciplinary team including nurses) to older people in residential aged care that reported health outcomes or stakeholder experiences. Consistent with PRISMA guidelines, databases were systematically searched in July and August 2024, focusing on literature published since 2014. Studies were screened in Covidence by three team members, with conflicts resolved by additional reviewers. Studies not involving nurses or not set in aged care were excluded.
The search identified 13 studies, which included quantitative, qualitative and mixed-method approaches, conducted in both Australian and international settings, as well as in rural and metropolitan locations. Nurses were often involved as part of an existing virtual care programme, typically located in a hospital setting. The training and credentials of nurses delivering VN varied in terms of specialisation and advanced practice. The model of care in general was ad hoc, though in some cases there were regular, scheduled VN consultations. The time requirements for onsite staff and nurses were not well articulated in any of the studies, and information on the funding models used was also lacking.
There is some evidence that VN interventions in aged care may improve communication, enhance person-centred care and reduce emergency department presentations and hospitalisations.
Rigorous, ongoing evaluation of VN interventions is required to ensure their appropriate application in residential aged care.
To explore patient and clinician experiences of participation in the MACRO randomised controlled trial (RCT)—which found endoscopic sinus surgery (ESS) to be clinically effective whereas clarithromycin was no better than placebo for chronic rhinosinusitis (CRS)—and to identify barriers and facilitators to the implementation of the trial results.
Qualitative study embedded within the multicentre MACRO RCT. Semistructured interviews with patients and clinicians were analysed using thematic analysis.
21 secondary and tertiary ear, nose and throat centres in England and Scotland participating in the MACRO RCT.
20 CRS patients (16 with nasal polyps, 4 without) were interviewed approximately 6 months after trial completion, and 17 clinical staff including principal investigators (PIs), associate PIs and research nurses.
This study explored patients’ and clinicians’ experiences of the trial to identify barriers and facilitators to implementing the findings. Adopting the outcomes of the trial would involve recommending surgery to more patients with CRS. Yet patient and clinician interviews highlighted polarised views on ESS among patients, between those with positive experiences and expectations of ESS and those expressing fear of complications and hesitancy to receive surgery. During the trial, many participants randomised to surgery reported rapid improvement in symptoms, but with postoperative challenges for some patients including pain, unexpected symptoms and variations in recovery period. Priorities for implementation include providing patients with information about risks and support to make informed choices. Clinicians also reflected on the resource implications for offering ESS to more patients.
ESS is effective for CRS, but patient hesitancy and recovery concerns persist. Implementation requires clear communication, recognition and respect for individual preferences, tailored support for decision-making and post-surgical care to optimise acceptance and outcomes.
Pain, including phantom limb pain (PLP), residual limb pain (RLP) and low back pain (LBP), is highly prevalent after lower limb amputation (LLA) and compromises quality of life. Although both pain and function have been studied extensively, methods of assessment and reporting vary, limiting comparability. A clearer overview of how these domains are measured and interrelated is needed to guide research and practice.
To synthesise evidence on how postamputation pain and functional outcomes have been assessed and reported in adults with LLA, and to examine reported relationships between pain and mobility/function.
Scoping review guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
MEDLINE, Embase and PsycINFO (inception to 15 August 2025).
Quantitative studies that measured pain and functional outcome in adults with LLA.
Two reviewers independently extracted study characteristics, pain measures and functional outcomes in Covidence; findings were narratively synthesised.
Eighty-four studies were included. RLP (n=46), LBP (n=32) and PLP (n=28) were most frequently examined. Pain was mainly assessed by self-report scales; mobility was typically assessed by clinical tests and less often by biomechanical instrumentation. PLP was associated with altered gait and balance deficits; RLP with limited walking distance, asymmetric weight-bearing and reduced community participation; LBP with gait asymmetry, trunk–pelvis discoordination and increased energy cost of walking.
Postamputation pain is often linked to reduced mobility and functional limitations. However, heterogeneous definitions and inconsistent methodology hinder synthesis across studies. Future research should combine validated pain scales with objective analysis, wearable sensors and musculoskeletal modelling to clarify mechanisms and inform rehabilitation.
Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.
We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.
The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.
ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.
A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.
542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.
Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.
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.
To assess the impact of a National Enhanced Service (NES) incentive for weight management that financially rewarded practices for each eligible patient referred to a weight management programme.
Interrupted time-series analysis to examine the rate of weight management referral and weight management advice.
Primary healthcare records from January 2018 to December 2024 in the Oxford Clinical Informatics Digital Hub, covering 8.3 million patients in 1198 primary care clinics around England.
NES payments to practices for weight management were introduced in April 2021.
The rate of referral increased from 1 referral per 1000 patients per month before the incentive to around 4 referrals per 1000 patients per month afterwards. There was no evidence that the increase differed by age, gender, ethnic group or socioeconomic status. The occurrence of weight management advice was unchanged by the introduction of the NES and was at least three times more common than referral to weight management services.
The NES was associated with a fourfold increase in referrals to weight management services. However, clinicians are much more likely to offer advice rather than a referral to a weight management programme. There is a clear opportunity to improve outcomes for patients by encouraging greater use of referrals to effective weight management services in place of advice.
This community-led research study protocol emphasises placing black youth impacted by the legal system, their families and their communities at the forefront of substance use treatment development research and decision-making. The study, the Cultural Adaptation of a Substance Use Treatment (CAST) Project, challenges traditional top-down approaches to treatment creation, advocating for a grassroots model that centres community knowledge, values and active participation.
The CAST project is a US-based mixed-methods study with an exploratory design that examines the impact of racial discrimination on substance use in black youth impacted by the legal system. The study participants are black youth impacted by the legal system (N=15), parents of black youth impacted by the legal system (N=10) and community members who serve black youth (N=10) (total N=35 study participants). Study participants from each group (youth, parents and community members) will participate in three separate focus groups, respectively, to provide feedback on the culturally responsive content needed to best support black youth impacted by the legal system around substance use and mental health. The eight-step Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing framework will be used as a guide to inform adaptations to the Motivational Enhancement Therapy and Cognitive Behavioural Therapy (MET/CBT12) for black youth impacted by the legal system. Once the cultural adaptation process has been completed, the study will conclude with an open feasibility and accessibility trial of the culturally adapted MET/CBT12 manual. The primary outcomes of this study are the feasibility and acceptability of the culturally adapted manual, measured by treatment attendance and participant feedback. Secondary outcomes include reductions in substance use and discrimination distress, and improvements in mental health symptoms.
This study was approved by the Institutional Review Board (IRB) at the University of California, San Francisco (IRB Protocol Number: 23-40126). All study procedures will be conducted in accordance with the ethical standards outlined by the institutional review board. The results from this study will be shared through peer-reviewed publications, academic conferences, community forums and policy briefs to support broader implementation of culturally adapted adolescent substance use interventions that address discrimination-related stress and substance use among black individuals impacted by the legal system.
This study aimed to investigate the association between smoking behaviours during early pregnancy and the risk and severity of gestational diabetes mellitus (GDM), with a particular focus on smoking status, smoking intensity and secondhand smoke exposure.
Secondary analysis of prospectively collected cohort data.
Multi-centre study conducted in South Korea (Korean Pregnancy Outcome Study) between March 2013 and January 2017.
From 4537 pregnant women initially enrolled, 3457 singleton pregnancies were included after excluding cases with transfer, loss to follow-up, twin pregnancies, miscarriages and pre-existing diabetes mellitus. All participants were women of Korean ethnicity.
Primary outcome was GDM and its subtypes (A1GDM: diet-controlled; A2GDM: insulin-requiring). Secondary outcomes were associations with active smoking (before pregnancy and during early pregnancy), smoking intensity dose–response relationships (pack-years) and secondhand smoke exposure among never-smokers.
Among 3457 participants, 231 women (6.7%) were diagnosed with GDM (198 A1GDM, 33 A2GDM). Active smoking before pregnancy (adjusted OR (aOR) 3.98, 95% CI 1.58 to 9.30) and during early pregnancy (aOR 9.90, 95% CI 2.97 to 29.45) were significantly associated with A2GDM, while no significant association was observed with A1GDM. A clear dose-response relationship was observed, with smoking intensity >4 pack-years markedly increasing A2GDM risk (aOR 20.68, 95% CI 6.75 to 59.39). Detailed pack-year analysis showed 4–6 pack-years (aOR 20.57, 95% CI 5.80 to 65.46) and >6 pack-years (aOR 25.98, 95% CI 3.21 to 146.45). Among never-smokers, secondhand smoke exposure showed a borderline association with overall GDM risk (aOR 1.33, 95% CI 0.98 to 1.81).
Maternal active smoking before and during early pregnancy, as well as higher smoking intensity, was associated with an increased risk of pharmacologically treated GDM (A2GDM). Although secondhand smoke exposure did not reach statistical significance, the trend suggested a potential association with GDM risk among never-smokers. These findings provide important evidence for public health strategies for prenatal care, as smoking cessation and environmental smoke avoidance during prenatal and early antenatal care in women reduce the risk of gestational diabetes.
Type 2 diabetes mellitus has been associated with an increased risk of cognitive decline and dementia, with patients being 1.5–2 times more likely to develop these conditions. While both sodium-glucose co-transporter 2 (SGLT2) inhibitors and thiazolidinediones (TZDs) have shown potential neuroprotective effects in previous studies, their comparative effectiveness for preventing neurodegenerative outcomes has not been established. This study aimed to compare the risk of stroke, dementia and Alzheimer’s disease (AD) between patients treated with SGLT2 inhibitors and those treated with TZDs.
Multicentre, retrospective, observational, new-user, active-comparator cohort study.
Electronic health record-based databases from 11 secondary and tertiary institutions in South Korea from 1 January 2014 to 31 July 2025. The study period began in 2014, following the post-marketing surveillance initiation of SGLT2 inhibitors in Korea (November 2013), to ensure adequate drug availability and clinical adoption.
Patients aged 40 years or older who were newly prescribed either SGLT2 inhibitors or TZDs without prior exposure.
Propensity score matching (1:1) was performed using sex as the primary covariate due to data availability constraints in the Observational Medical Outcomes Partnership Common Data Model framework. The HRs with 95% CIs were measured via Cox regression analysis.
The study analysed 24 172 matched pairs for stroke outcomes (40 483 person-years in the SGLT2 inhibitor group and 39 363 person-years in the TZD group), 25 111 matched pairs for dementia (41 924 person-years in the SGLT2 inhibitor group and 40 726 person-years in the TZD group) and 25 237 matched pairs for AD (42 139 person-years in the SGLT2 inhibitor group and 40 895 person-years in the TZD group) across 11 participating hospitals. After a 1:1 propensity score matching, the SGLT2 inhibitors showed no significant difference in stroke risk (HR 1.18, 95% CI 0.62 to 2.23, p=0.62), while having significant reductions in dementia risk (HR 0.66, 95% CI 0.45 to 0.98, p=0.04) and AD risk (HR 0.54, 95% CI 0.35 to 0.83, p=0.005). Moreover, these protective effects for neurodegenerative outcomes were shown to be consistent across multiple hospital sites.
SGLT2 inhibitors are associated with a reduced risk of dementia and AD compared with TZDs in patients aged 40 years or older with type 2 diabetes and have neutral effects on stroke risk. These findings confirm the potential selective neuroprotective benefits of SGLT2 inhibitors for neurodegenerative outcomes, which may inform therapeutic decision-making for diabetic patients at risk of cognitive decline.
The REgulate your SItting Time (RESIT) is a tailored intervention targeting reductions and breaks in sitting in adults with type 2 diabetes mellitus (T2DM). A feasibility trial of RESIT had been conducted and the purpose of this paper is to report findings from the process evaluation.
A mixed-methods process evaluation within a randomised controlled feasibility trial.
The study was conducted remotely in the community.
Ambulatory individuals with T2DM aged 18–85 years.
A tailored intervention comprising an online education session, regular health coaching and technology for self-monitoring behaviour and prompting breaks in sitting.
Questionnaires (intervention participants n=22 at both 3 and 6 months; control participants n=21 at 3 months, n=29 at 6 months) and interviews (n=30, with n=13 intervention participants, n=12 control participants, n=5 health coaches) to assess perceptions of the intervention components, strategies and barriers for sitting less, the role of the study evaluation measures, and reasons for taking part.
The trial operated a largely successful online education element for those in the intervention group (82% completion; ≥76% engagement in individual educational elements). There was good use of self-monitoring and prompt technology (apps and wearables) with 73% of participants reporting using these at 6 months. Health coaching had high engagement and was perceived as enjoyable and useful. Data revealed strategies used for behaviour change (eg, active functional tasks) alongside barriers to change (eg, restrictions at work). There were also potential behavioural influences from the study evaluation measures (eg, activity measures increasing awareness and execution of behaviours) for both intervention and control participants.
A comprehensive process evaluation identified successful intervention elements (ie, online education, health coaching, wearables and smartphone apps) alongside strategies and barriers to behaviour change. These findings can inform future sedentary behaviour interventions for adults with T2DM and a definitive randomised controlled trial evaluating RESIT.
To date, few studies have investigated the factors associated with musculoskeletal patients’ willingness to donate biological samples and their knowledge regarding the use of such samples. We investigated the associations between these distinct knowledge factors, patients’ willingness to donate and socio-demographic factors.
Cross-sectional survey.
Musculoskeletal outpatient clinics across four sites in England, representing varied demographic populations.
A total of 469 adult patients attending musculoskeletal appointments were recruited through convenience sampling.
Ordinal regression models were employed to identify socio-demographic and clinical predictors of patients’ willingness to donate biological samples. Other outcome measures specifically in two areas of patient knowledge include: (1) knowledge of sample use and (2) knowledge of surgical waste tissue value and management.
Only 37% of participants were aware of the term ‘biobank’. Despite this, participants showed a high level of knowledge regarding both biological sample use and surgical waste tissue management, although their understanding varied considerably by ethnicity and education. Participants with no formal education exhibited a lower level of knowledge in both areas related to sample use and surgical waste tissue management for biomedical research ((OR 0.30, 95% CI 0.14 to 0.61; p=0.001); (OR=0.29, 95% CI 0.16 to 0.52, p
Despite low awareness, musculoskeletal patients showed a high willingness to participate in biobanking. However, significant disparities by ethnicity and education persist. Targeted, inclusive engagement strategies are needed to address under-representation and foster informed, equitable participation of musculoskeletal patients in biomedical research.
The aims of this study were to explore how health visitors (HVs) and community health nurses (CHNs) assess unsettled baby behaviours, how their perceptions of these behaviours influence decisions about support offered, and how able they feel to deliver support to families of unsettled babies.
Qualitative semi-structured interviews were conducted, recorded and transcribed. Data were analysed using Reflexive Thematic Analysis.
Potential participants were invited nationally via social media and via Health Visiting Service managers from an NHS Trust. Interviews took place remotely.
17 HVs and 3 CHNs were purposively selected to include a wide range of perspectives.
Three themes were developed, (1) HVs’ perceptions of parents’ sense-making which explains how HVs/CHNs understand parents’ beliefs around unsettled babies; (2) care pathway which highlights the importance HVs place on creating emotional space for the baby, the parent and the health visitor within the pathway (containment); and (3) service delivery decline, which outlines the impact of funding cuts to the services on the HVs’ ability to provide support for families. Lastly, a new concept – the Tipping Point model - was created to holistically conceptualise the experiences of HVs providing support for unsettled babies in the UK.
Policy makers need to organise services to value and support the role of the health visiting team in ‘containment’. HVs identified a training need around assessing and advising about unsettled babies to place them in a stronger position to support families. Further research is needed into different models of support for families of unsettled babies from the wider primary care team and/or from digital services.
Poor access to surgical wound swabbing in the community often results in delayed or inappropriate antibiotic prescribing for surgical site infections. This delay can contribute to prolonged wound healing and poor antimicrobial stewardship. Patient self-swabbing at home could improve access to diagnostic testing, but its feasibility and acceptability remain unexplored.
TREASURE is a multicentre, mixed-methods feasibility study. A total of 40 patient participants and 10 staff stakeholders will be included. 40 adult patients undergoing cardiac surgery via median sternotomy will be recruited from Harefield Hospital (n=25) and the Royal Sussex County Hospital (n=15). Eligible participants will receive a coproduced self-swabbing set of instructions and kit at discharge and perform wound swabbing at home within 1–21 days, observed remotely by a researcher via Microsoft Teams. Swabs will be couriered to a central laboratory for bacterial culture with antimicrobial susceptibility testing for pathogens.
The primary feasibility outcome is the proportion of patients successfully completing self-swabbing at home to obtain usable culture swabs with samples received at the laboratory within 24 hours and deemed suitable for processing. Secondary safety and acceptability outcomes include usability of the kit and instructions; patient satisfaction; viability of samples for laboratory analysis; and recruitment and retention rates. A 30-day follow-up will capture wound complications, antibiotic prescribing and healthcare utilisation via patient questionnaires, case note review, general practitioner confirmation and patient interviews. 10 staff stakeholders will be interviewed to inform pathway development.
Quantitative data will be analysed descriptively, with proportions reported alongside 95% CIs. Qualitative data from patients will undergo thematic analysis, and stakeholder interviews will be coded using Normalisation Process Theory. An early health economic model will be developed to explore resource use, costs and proportions of appropriate and timely antibiotic use between current pathways and a proposed pathway, including self-swabbing.
West of Scotland Research Ethics Service has reviewed and approved the study (REC reference: 25/WS/0079). Findings will be disseminated through the study website, a webinar, peer-reviewed publications, conference presentations, patient and public involvement-led activities and engagement with National Health Service (NHS) stakeholders.
Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.
This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.
Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.
The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.
Rubella and parvovirus B19 (B19V) infections can present with arthritis-like symptoms in adults instead of typical dermatological symptoms. We quantify associations between rubella and B19V, respectively, with arthritis-like complications using real-world diagnostic testing.
Cross-sectional and retrospective cohort study.
Reference laboratories across the USA.
Participants with IgM tests for rubella (N=211 917) or B19V (N=644 473) performed at Labcorp from 2014 to 2023. Among these participants, participants with IgM tests for rubella (N=1867) or B19V (N=22 683) and longitudinal laboratory testing through Labcorp were followed for diagnostic tests for rheumatoid arthritis (RA) up to 1.5 years after the viral IgM tests.
Primary outcomes were arthritis-like suspicions by providers and diagnostic testing for RA-associated biomarkers.
Higher proportions of suspicions of arthritis (1.4%, p
Increased awareness of non-typical RA symptoms may facilitate differential diagnosis between rubella, B19V and RA. Recent B19V infections do not occur concurrently with RA; recent B19V infections should be considered in the differential diagnosis for RA when patients present with polyarticular joint symptoms.
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). While etrasimod demonstrated efficacy in randomised controlled trials, understanding its effectiveness in an observational setting is crucial.
EFFECT-UC is a prospective, multinational, non-interventional study to evaluate the real-world effectiveness of etrasimod in adults with moderately to severely active UC. The study consists of a 52-week treatment period and a 28-day safety follow-up period and aims to enrol ~300 patients per cohort. Eligible patients (18–64 years) are advanced therapy naïve or experienced and are initiating etrasimod in a real-world clinical setting. Treatment will be guided independently by the clinician’s judgement. Patient-reported outcomes will be collected electronically throughout the study and daily for the first 2 weeks. Exploratory data, including faecal calprotectin, endoscopy and intestinal ultrasound, will be collected at predefined visits or during standard care. Primary endpoints are symptomatic remission at week 12 and week 52. Secondary endpoints include patient-reported outcome 2 (combined rectal bleeding and stool frequency subscores) response at week 12 and week 52 and corticosteroid-free symptomatic remission at week 52.
Ethics approval was obtained for all sites. Recruitment is underway for cohort 1, comprising patients from the UK, Germany and Canada. Interim results for this cohort are expected in 2026 and final results in 2028; these will be submitted for publication in peer-reviewed journals and presented at appropriate congresses.
Compared with other high-income countries, the USA continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic black pregnancies. Over 80% of pregnancy-related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multilevel digital intervention to reduce PRAMM and evaluate its effects using a site-randomised trial.
The Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers—who can facilitate access to local services—will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster-randomised trial in 10 antenatal care clinics throughout Michigan (N=500 pregnant participants aged 18+ years receiving Medicaid). We will compare intervention and control arms on two coprimary outcomes: total PRAMM through 1 year post partum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM.
The Michigan State University Institutional Review Board has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals.