To identify profiles of compositional movement behaviour patterns among children and examine cross-sectional and 12-month associations with adiposity markers and health-related quality of life (HRQoL).

Secondary analysis of data from the TransformUs cluster randomised controlled trial with cross-sectional and 12-month follow-up analyses.

Primary schools in metropolitan and regional areas of Victoria, Australia.

Children aged 7–11 years with valid accelerometer at baseline, regardless of demographic, adiposity and HRQoL data available (n=792), were included in the analytical sample for the latent profile analysis.

Sedentary time, light-intensity physical activity (LPA) and moderate- to vigorous-intensity physical activity (MVPA) along with their respective mean bout lengths were derived from raw acceleration data. Latent profile analysis used these measures (total times, as isometric log ratios and mean bout lengths) as input variables to classify distinct profiles for us as a categorical exposure variable in regression models. Primary outcomes were age- and sex-standardised body mass index, waist circumference and parent-reported HRQoL at baseline. Secondary outcomes were the same measures assessed at 12-month follow-up.

Four distinct profiles were identified. The high MVPA-short sedentary bout profile (n=184) was characterised by the highest levels of MVPA, moderate sedentary time and the shortest mean sedentary bout duration. The low sedentary-high LPA profile (n=54) had the lowest sedentary time, the highest LPA and the longest mean LPA bout duration. Two profiles were characterised by high sedentary time: the high sedentary-long sedentary bout profile (n=149), which had the longest mean sedentary bout durations, and the high sedentary-shorter bouts profile (n=405), which also had high sedentary time but shorter bout durations for all intensities. While the omnibus Wald test for differences across profiles indicated uncertainty in the overall profile effect, the high MVPA-short sedentary bout profile had favourable adiposity levels cross-sectionally compared with the high sedentary-long sedentary bout reference profile in pairwise comparisons. No longitudinal associations were detected.

Four distinct movement profiles were identified. Few pairwise differences between health outcomes were observed. While MVPA remains a key factor for promoting healthy body weight, our findings suggest that a variety of movement patterns - including those characterised by lower sedentary time and higher LPA - may also support health in children.

This study is a secondary analysis of the TransformUs effectiveness-implementation trial, registered with the Australian Clinical Trials Registry (ACTRN12617000204347; 1 April 2017).

To determine the prevalence and clinical characteristics associated with polyneuropathy in kidney transplant recipients (KTRs).

Cross-sectional study.

SENS study at the University Medical Center Groningen, the Netherlands, December 2021–May 2023.

KTR, participating in the ongoing TransplantLines Biobank and Cohort Study, ≥12 months post-transplantation.

Participants underwent a structured neurological assessment including history taking, neurological examination, quantitative sensory testing and nerve conduction studies. An expert panel classified participants into no/possible, probable/definite large fibre polyneuropathy or small fibre neuropathy. Large-fibre subtypes included axonal or demyelinating, pure sensory, pure motor and sensorimotor. To assess potential associations with clinical characteristics, logistic regression analysis was conducted.

We included 160 KTRs with a mean age of 59.8±11.6 years at a median of 6.1 (95% CI 3.9 to 13.1) years post-transplantation, with 16 KTRs (10%) diagnosed with polyneuropathy before study inclusion. In total, 84 KTRs (53%) were identified with large fibre polyneuropathy and 7 KTRs (4%) with small fibre neuropathy. KTRs with large fibre polyneuropathy presented with either sensor-predominant polyneuropathy (40 KTR (48%)) or sensorimotor polyneuropathy (44 KTR (52%)). We found no neurophysiological characteristics of demyelination. Overall, 18% (95% CI 11% to 27%) of KTRs with large fibre polyneuropathy were asymptomatic. Higher age (OR=1.04 (1.01 to 1.08), p=0.01), male sex (OR=2.55 (1.19 to 5.60), p=0.02), diabetes (OR=5.58 (1.36 to 38.14), p=0.03) and elevated urea levels (OR=1.12 (1.04 to 1.23), p=0.01) were significantly associated with polyneuropathy in KTR.

In contrast with previous studies, axonal sensory or sensorimotor polyneuropathy is highly prevalent and often underdiagnosed in KTR. Next to higher age and male sex, it was independently associated with diabetes and higher urea levels. Further research is needed to reveal the aetiology and course of polyneuropathy in KTRs.

NCT04664426.

The survival rate of patients with life-threatening diseases primarily depends on the speed of diagnosis. Too often, diseases are detected only after symptoms appear, which usually occurs at later stages of a disease when available treatments may be less effective. Current detection techniques primarily depend on identifying metabolites in biofluids such as blood and urine. The analysis of these fluids is typically performed in laboratories, resulting in lengthy waiting times for patients to receive their results. In severe cases, invasive biopsies and radiative methods are used to diagnose conditions such as cancer. These biopsies can cause distress for patients who are already experiencing significant emotional or physical stress, while imaging techniques involving ionising radiation may pose additional health risks. Additionally, these methods can be costly. In recent years, exhaled breath has become a biofluid matrix of interest for disease detection, allowing for the identification of volatile organic compounds (VOCs) or VOC profiles associated with specific conditions. To improve early disease detection through breath analysis, the VOCORDER project aims to develop a device that provides a fast, simple, user-friendly and cost-effective method for continuous health monitoring to identify diseases in their early stages before symptoms appear.

A literature review was initially conducted to identify five reference diseases of interest (lung cancer, stomach/colon cancer, breast cancer and kidney insufficiency) and previously reported VOC profiles associated with these diseases. In this trial, the project team from the MITERA Hospital will select patients, and the hospital staff will conduct personal interviews with these subjects. Each participant will also complete a questionnaire for the acquisition of demographic and medical history data, after being informed in detail about the purposes of the questionnaire and signing a consent form. The study protocol consists of two phases. Phase 1 is a baseline study designed to detect and identify breath biomarkers for the early diagnosis of the diseases mentioned above using gas chromatography-mass spectrometry (GC-MS) and secondary electrospray ionisation high-resolution mass spectrometry (SESI-HR-MS). Prescreening will select 120 healthy controls and 175 patients for the baseline phase of the clinical trial, for which breath samples will be collected in 1 L Supel-Inert Multi-Layer Foil gas sampling bags. New biomarkers and VOC profiles will be extracted from these data, and further statistical analysis will allow for artificial intelligence (AI) models to be produced and tested. For phase 2 (validation phase), 120 healthy controls and 100 patients will be selected. Breath samples will again be collected in 1 L gas sampling bags for analyses with GC-MS and SESI-HR-MS. The VOCORDER device will also be used, and its functioning with the newly developed AI models will be evaluated.

This clinical study has been approved by the scientific council at the MITERA hospital in Athens, Greece (#513/2024). The outcomes will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

NCT06711939.

Australian studies investigating parental factors often lack meaningful inclusion of Aboriginal and Torres Strait Islander families, limiting our understanding of current influences on positive developmental trajectories within communities. There is growing recognition of the need for culturally safe and responsive longitudinal research that is co-designed and co-led by the community for the community. An Indigenous-led birth cohort study of Aboriginal and Torres Strait Islander families in Queensland, Australia, has therefore been developed to better understand health across generations.

The Strong Families Study is a co-designed prospective longitudinal birth cohort study that will follow 400 Indigenous families in Queensland from pregnancy until the child reaches 5 years of age. Eligible participants include pregnant individuals (

This study was approved by the Mater Misericordiae Ltd Human Research Ethics Committee (HREC/MML/105191) and ratified by the University of Queensland Human Research Ethics Committee (2025/HE001924). Endorsement letters were secured from partner services at each study site. Findings will be shared with partnering hospitals and funding bodies at conferences and through reports and peer-reviewed publications.

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

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

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

NCT05369520.

Cocaine use disorder (CUD) is a significant public health concern in the USA, with considerable prevalence and mortality and no Food and Drug Administration (FDA)-approved pharmacotherapies. Recent advances in addiction science emphasise the need for novel, mechanism-based treatments. Glucagon-like peptide-1 receptor agonists, such as semaglutide, have shown promise in modulating reward-related behaviours and may offer therapeutic benefits for CUD. We present a study protocol evaluating semaglutide, as an adjunct to cognitive behavioural therapy (CBT), as a novel approach for treating CUD.

This is a randomised, double-blind, placebo-controlled trial enrolling 75 treatment-seeking adults with CUD. Participants will be randomised 1:1 to receive either once-weekly semaglutide (0.25–1.0 mg) or placebo injections over 14 weeks, alongside weekly individual CBT. Primary outcomes include changes in neurophysiological reactivity to drug-related and non-drug-related motivationally relevant cues (late positive potential), behavioural economics (cocaine demand), craving (Cocaine Craving Questionnaire) and cocaine use (self-report, urine drug screens). Exploratory aims assess associations between mechanistic changes and cocaine use, consumption of other substances (ie, tobacco, alcohol and cannabis) and dose–response relationships. Data will be analysed using Bayesian statistical methods using an intention-to-treat approach.

The study has been approved by the UTHealth Committee for the Protection of Human Subjects (HSC-MS-25-0412) and is registered on ClinicalTrials.gov. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications and scientific conferences.

NCT07227948.

Congenital malformations (CMs) are the leading cause of infant mortality. Still, the aetiology remains unknown in 70% of cases. The most accepted hypothesis is that hereditary and environmental elements concur in altering embryo-fetal development. Recently, the role of the environment has been emphasised.

Women are exposed to several xenobiotics during pregnancy. This review aims to study the available literature on the exposure of pregnant women to pesticides through drinking water to see if there is any evidence of correlation to the onset of any kind of congenital anomalies.

We will conduct a systematic literature review in The Cochrane Library, Embase and PubMed for studies published between 1 January 2005 and 31 January 2026. Articles will be included if they examine pregnant women as the study population, exposure to pesticide active ingredients and metabolites present in drinking water, and any type of CM in their children as the main outcome. The screening of title, abstract and full text as well as the data extraction will be conducted independently through two investigators. A third investigator will resolve any eventual conflicts. Each included study will be evaluated according to the NIH’s quality assessment tools. Grading of Recommendations Assessment, Development and Evaluation approach will be used for summarising and assessing certainty in the bodies of evidence produced by the review. This study is registered with PROSPERO, CRD420251063011.

The completed work will be published in a scientific journal for dissemination. Due to the nature of the study, an ethical approval is not necessary since no patient data or other information will be directly collected.

The Comprehensive High-dose Aphasia Treatment (CHAT) programme is an intensive comprehensive aphasia programme, which aims to address evidence-practice gaps in aphasia rehabilitation where there are known barriers to service delivery requiring implementation strategies. The aims of this study are to (1) evaluate the clinical implementation of the CHAT programme, (2) assess the clinical effectiveness of CHAT compared with usual care in rehabilitation services and (3) determine whether the real-world implementation of CHAT compared with usual care is cost-effective.

Four participant groups will be recruited across six hospital and health services Australia-wide to participate in a type 3 hybrid effectiveness-implementation study: (1) people with aphasia, (2) support persons, (3) treating clinicians and students and (4) clinical stakeholders (eg, managers). This before-and-after study will include three time periods: (1) ‘usual care’ where people with aphasia will receive their usual care aphasia therapy, (2) ‘implementation transition’ where clinicians will be trained to deliver CHAT and (3) ‘intervention implementation’ where people with aphasia will receive the CHAT programme (ie, 50 hours of evidence-based aphasia therapy over 8 weeks). Evidence-based implementation strategies will be used to facilitate implementation within participating rehabilitation services. The primary outcome is delivery of evidence-based aphasia treatment (ie, CHAT) as measured by a composite score of quality indicators. Clinical effectiveness outcomes, measuring change in language impairment, communication effectiveness, confidence and quality of life, and implementation outcomes will also be examined. We will also conduct an embedded mixed-methods process evaluation and economic evaluation.

This study has been approved by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/2021/QRBW/72154). Outputs will include conference presentations, publications and a training package to optimise implementation of aphasia treatment in rehabilitation service contexts.

Australian New Zealand Clinical Trials Registry (ANZCTR) prospective registration ACTRN12621001765819. Trial registered 23 December 2021. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381365&isReview=true.

This study aimed to develop prediction models for symptoms of poor mental health among Lebanese adults and adult Syrian refugees or migrants residing in a suburb of Beirut, Lebanon, separately.

Nested cross-sectional study.

Sin-El-Fil, a suburb east of Beirut, Lebanon.

Lebanese and Syrian adults residing in low socio-economic status areas of Sin-El-Fil.

Primary outcome was having depressive symptoms, ascertained through the Patient Health Questionnaire-9 where a total summative score of 10 or more indicated having depressive symptoms. Secondary outcome was having anxiety symptoms, ascertained through the Generalised Anxiety Disorder-7 where a total summative score of 10 or more indicated having anxiety symptoms.

Of 1986 participants, 1322 (66.5%) were Lebanese adults, 664 (33.5%) were Syrian refugees or migrants. Among Lebanese adults and adult Syrian refugees or migrants, 324 (25.3%) and 289 (43.9%) had depressive symptoms, respectively. Having pain that impacts usual activity, having debt, not feeling safe at home and having none or one person to count on in difficult times were common predictors of depressive and anxiety symptoms among Lebanese adults and Syrian refugees or migrants. Not having a legal residency permit was also a predictor of depressive symptoms for Syrian refugees or migrants. Prediction models developed for depressive and anxiety symptoms among both nationalities had good performance measures.

The predictors of poor mental health included financial, health and social indicators for both Lebanese adults and Syrian refugees or migrants during the concurrent crisis in Lebanon. These models are most applicable in similar urban, crisis-affected and low-resource settings. Findings emphasise the need for social protection and financial support among populations with vulnerabilities.

To test a theory-informed, person-centred rehabilitation intervention for older adults following a hospital admission complicated by delirium, developed in line with the Medical Research Council framework for complex interventions, to determine whether: (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible.

Multicentre, single-arm feasibility study.

19 patient (aged >65 years old) and carer pairs were recruited from six National Health Service acute hospitals across the UK.

Home-based rehabilitation programme designed to support recovery after hospital discharge, addressing cognitive, physical, physiological and psychosocial needs. Delivered by a trained team of occupational therapists, physiotherapists and rehabilitation support workers, the intervention included a comprehensive home assessment, collaborative goal setting, up to 10 personalised sessions over 12 weeks and the use of a recovery record to guide progress, education and psychosocial support.

Examined aspects of feasibility including eligibility, recruitment, data collection, attrition, acceptability of the rehabilitation intervention and potential to calculate cost-effectiveness.

In total, 419 patients were identified as having delirium and 36 met the full eligibility. 19 patient and carer pairs agreed to participate in the study (consent rate 53%; 95% CI 35% to 70%) with 13 participants going on to start the intervention (68%; 95% CI 43% to 87%) and 10 participants completing final follow-up (53%; 95% CI 29% to 76%). Baseline assessments were conducted either during hospitalisation or postdischarge, with initial assessments occurring a mean of 18 days (SD=13.0) postdischarge, and 77% completed within 14 days. Participants completed a mean of eight sessions (SD=2.9). 19 participants completed the primary outcome at baseline, while 10 participants completed it at 6-month follow-up. The economic evaluation indicated a total cost of £1249.29 per participant, covering assessments, intervention sessions and training costs.

The intervention showed feasibility among older adults recovering from delirium, as evidenced by the trial processes for participants who entered the study. However, recruitment challenges indicate a need for better strategies and further research through a definitive randomised controlled trial to demonstrate the effectiveness and cost-effectiveness of the intervention.

ISRCTN15676570

Emergency general surgery (EGS) decisions often occur under time pressure and with reduced patient involvement in comparison to the elective setting. Variation in decision-making in the field of EGS is partly attributable to patient and contextual factors, but clinician factors also likely shape decisions.

This scoping review aims to clarify which clinician factors have been investigated in relation to decision-making in adult EGS, which have been identified as influential, and the methods used to measure them.

Any studies reporting on individual clinician factors and decision-making in EGS will be eligible. Studies must be only in adult populations (patients aged 18 and over). This review will consider quantitative, qualitative and mixed-methods study designs.

This scoping review will be conducted in accordance with the methodology developed by the Joanna Briggs Institute and reported in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. This protocol was prospectively registered with the Open Science Framework: https://osf.io/xcqp4. We will search MEDLINE, EMBASE, CINAHL, CDSR and CENTRAL. The search strategy will be adapted for each database, and no time or language restrictions will be applied.

Two independent reviewers will screen studies for eligibility and extract data using a purpose-designed data extraction form, with disagreements resolved by a third reviewer. Extracted data will be synthesised using a narrative approach to map key concepts, describe study characteristics and identify gaps in the literature.

Ethical approval is not required as this review will use publicly available data. Findings will be disseminated through peer-reviewed publication and conference presentations.

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 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.

ISRCTN36962030.

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.

ISRCTN14019493.

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.