Point-of-care technologies (POCTs) are essential to providing clinical care for patients, with their potential for rapid and accurate results on site supporting efficient clinical decision-making.

To understand the current key needs, barriers and challenges of POCT developers for effective development and implementation of POCTs across diverse settings particularly in the domain of cancer, nutrition and infections.

A qualitative semi-structured focus group discussion (FGDs) was employed. The FGDs were guided by the needs assessment process and the Phase Gate Framework. The qualitative data were coded and analysed in NVivo and refined into various themes.

The study was conducted in person at Cornell Tech Campus in May 2024, New York, USA.

24 participants were purposively sampled from the PORTENT (Point-of-Care Technologies for Nutrition, Infection and Cancer) network. Participants included technical developers (eg, engineers, scientists, startup leads) and expert stakeholders (eg, funders, policy advisors, clinicians and academic partners) involved in POCT development, evaluation and implementation.

A total of 24 participants participated in the in-person FGDs in New York (n=24). Key themes identified included gaps in stakeholder engagement, limited regulatory preparedness, insufficient market analysis, challenges in scaling and manufacturing and the need for context-specific adaptation in low- and middle-income country (LMIC) settings. Participants emphasised the importance of user-centred and context-responsive design, strategic partnerships and early planning for regulatory and implementation pathways.

Technical developers and expert stakeholders in the POCT landscape face various barriers to efficient and effective development and implementation of POCTs. It is important to consider their needs when adapting POCTs in LMICs and diverse settings.

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.

Although several systematic reviews and meta-analyses have demonstrated the benefits of exercise interventions in older adults with frailty, the potential harm associated with these interventions has not been systematically synthesised. This systematic review aims to examine the adverse events reported in exercise intervention trials involving older adults with frailty and to compare the risk of adverse events between the intervention and control groups.

Searches will be performed in four electronic databases (PubMed, Cochrane Library, Web of Science and SPORTDiscus) for published trials. Eligible studies will be randomised controlled trials of exercise interventions, including older adults with frailty aged ≥60 years, with frailty identified using a validated method. Five reviewers and three referees, all with expertise in exercise interventions, will be assigned to three independent review teams to ensure efficient screening. Reviewers will independently screen titles, abstracts and full texts using Rayyan, and then extract trial and adverse event data into an Excel spreadsheet. The risk of bias in eligible trials will be assessed using the Cochrane Risk of Bias 2 (RoB-2) tool. The referees will resolve any disagreements between the two reviewers throughout the screening, data extraction and risk-of-bias assessment processes. The primary outcome is adverse events, defined as any unfavourable, unintended signs, symptoms or disease that occurred during the study period. An independent biostatistician will perform a random-effects meta-analysis using a generalised linear mixed model with a binomial likelihood and a logit link to estimate the pooled risk ratios (RRs) for adverse events in the intervention group relative to the control group. Publication bias will be evaluated using funnel plots and Egger’s regression test. Depending on the number of available studies, subgroup analyses will be conducted to examine differences in RRs according to the study quality, duration of intervention, exercise frequency, setting and supervision.

Ethical approval was not required because we did not use specific patient data. The findings of the systematic review and meta-analysis will be disseminated through publication in a peer-reviewed journal and presentation at appropriate conferences.

CRD420251180645.

To examine whether the use of a venous access-site closure device is associated with the occurrence of postoperative nausea and vomiting (PONV) after atrial fibrillation (AF) ablation under propofol sedation.

Observational study.

A single-centre retrospective observational study in Okayama, Japan.

We retrospectively analysed consecutive patients who underwent AF ablation under deep propofol sedation with adaptive servo-ventilation. A total of 686 patients were included. Patients were managed using a standardised sedation protocol with or without low-dose pentazocine. Patients treated with conventional manual compression for haemostasis (n=383) were compared with those treated using a venous access-site closure device (n=303).

Postprocedural bed rest duration and the incidence and timing of PONV were compared between groups. Associations between closure device use and PONV were evaluated using logistic regression analysis.

The primary outcome was the occurrence of PONV following AF ablation.

All procedures were completed under propofol sedation without conversion to general anaesthesia. The duration of postprocedural bed rest was shorter in the device group than in the conventional-compression group (mean difference –14.7 hours, 95% CI –15.2 to –14.0).

PONV occurred in 6/303 patients (2.0%) in the device group and 20/383 patients (5.2%) in the conventional-compression group, corresponding to a relative risk of 0.38 (95% CI 0.15 to 0.93), an OR 0.25 (95% CI 0.10 to 0.62) and a risk difference of –3.2% (95% CI –6.0% to –0.5%).

In multivariable analysis, use of a venous closure device was associated with a lower likelihood of PONV.

In this single-centre observational study, use of a venous access-site closure device was associated with a lower occurrence of PONV after AF ablation under propofol sedation. These findings suggest that postprocedural management strategies enabling earlier mobilisation may be associated with improved patient comfort; however, causal inference is limited by the observational design.

To explore healthcare professionals’ perspectives on the potential role of molecular breast imaging (MBI) for breast cancer imaging and to inform future clinical study design and implementation.

Qualitative interview study.

UK National Health Service (NHS) breast screening and diagnostic pathways.

Purposively sampled stakeholders.

Semistructured interviews with key professional stakeholders explored potential MBI pathways and routes to adoption, including barriers and facilitators. Data were analysed thematically.

22 participants were recruited between January 2020 and October 2021. Barriers to MBI adoption were identified at three levels: scan-related, system-level, and cultural within the screening programme. Overcoming these is likely necessary for implementation. A further theme highlighted the potential for MBI to improve screening in selected patient groups, contingent on addressing these barriers. Specifically, adoption would require advances in next-generation MBI systems, particularly reductions in radiation dose and scan time, alongside prospective clinical studies in UK populations to assess diagnostic accuracy.

Once identified barriers are overcome, participants perceived that MBI could improve screening pathways, particularly for women with dense breast tissue.

To estimate the burden of household air pollution (HAP) on chronic obstructive pulmonary disease (COPD) and lung cancer in Morocco in 2019 using population attributable fractions (PAFs).

Secondary analytical study based on sex-specific PAF estimation combining Moroccan exposure prevalence from a Moroccan population-based survey conducted in 2010–2011, pooled relative risks from an international meta-analysis, national disease frequency estimates (for COPD, two prevalence sources were used: 2010–2011 observed Moroccan data and 2019 modelling-based estimates), 2019 burden indicators and direct medical costs.

Morocco.

Adults aged 40 years and older included in the Burden of Obstructive Lung Disease (BOLD I) survey in Fez, Morocco.

Sex-specific PAFs, attributable COPD and lung cancer cases, disability-adjusted life years (DALYs) and annual direct medical costs attributable to HAP.

In Morocco, HAP accounted for 14.4% (95% CI 8.4% to 21.6%) of COPD cases in men and 25.3% (95% CI 17.0% to 34.0%) in women, and for 14.2% (95% CI 7.9% to 21.8%) of lung cancer cases in men and 25.0% (95% CI 16.1% to 34.2%) in women. The estimated number of COPD cases attributable to HAP ranged from 661 717 (95% CI 411 046 to 948 444) using modelling-based prevalence estimates to 815 368 (95% CI 509 160 to 1 163 973) using Moroccan BOLD I prevalence estimates, while 1356 (95% CI 775 to 2041) lung cancer cases were attributable to HAP. Total attributable DALYs were estimated at 62 561.2 (95% CI 37 588.4 to 91 439.2). Total annual direct medical costs attributable to HAP ranged from US$529.9 million (95% CI US$328.9 million to US$760.0 million) to US$651.6 million (95% CI US$406.6 million to US$930.6 million), depending on the COPD prevalence source used.

HAP contributes substantially to the respiratory and economic burden in Morocco. These estimates should be interpreted considering the regional source of exposure data and the application of pooled international relative risks to the Moroccan context.

Patient engagement is the practice of "meaningful and active collaboration [of patient partners] in governance, priority setting, conducting research and knowledge translation." Patient engagement has been implemented in various settings including clinical, research, and quality improvement, with varying levels of patient contributions and decision-making responsibility. However, little is known about the experiences of patient partners who are in leadership roles in patient-led events. For Patients, By Patients (PxP) is an annual, virtual, patient-led conference that focuses on topics important to patient partners in research. Each year’s PxP steering committee is comprised of those with patient experiences and consequently, offers an opportunity for our research team to explore patient leadership within a conference setting. Understanding more about the intricacies of patient-led events is necessary if we wish to support patient leadership as a valuable form of patient engagement.

The aim of this study was to explore (1) the benefits and challenges experienced by PxP steering committee members in a patient-led event and (2) how to better support patient leadership.

We conducted a qualitative descriptive study of semi-structured virtual interviews with PxP conference steering committee members. Thematic analysis was used to identify core themes that were salient to the data.

The Canadian Institutes of Health Research-Institute of Musculoskeletal Health and Arthritis in Vancouver, Canada, and an international virtual setting via Zoom from January 2025 to April 2025.

Purposive sampling was used to conduct interviews with thirteen PxP patient partner steering committee members.

Four core themes were identified in the data: (1) institutional support: how institutions can support patient leadership, (2) steering committee environmental characteristics: what characteristics are conducive to patient leadership, (3) personal growth: how patient leadership promotes growth among patient partners and (4) new possibilities: how patient-led events foster future expansion and opportunities. Power dynamics, intersectionality, and accessibility were also identified as central to supporting patient leadership and building safe and supportive environments.

Patient partners are capable of leading events which promote interpersonal relationships and advance patient engagement practices and governance. Important facilitators include institutional support and governance that considers power dynamics, accessibility and intersectionality.

To explore the acceptability of the Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS) intervention and trial procedures for participants.

A mixed-method approach and a single-blind randomised controlled trial design with 1:1 allocation to either COPESS plus treatment as usual or treatment as usual alone.

Primary care.

Fifteen semistructured interviews were conducted with participants in the COPESS trial; eight were randomised to the intervention arm, and seven were randomised to the treatment-as-usual arm. Interviews lasted 30–60 min.

COPESS is a brief, relational psychotherapy delivered over 4 weekly sessions plus a follow-up, focusing on understanding difficult emotional states and their links to self-harm through here-and-now relational and emotional processes.

Thematic analysis allowed exploration of themes important to participants in their experiences in the COPESS trial and their experiences of care for self-harm more generally.

Five themes were identified as associated with the acceptability of the COPESS intervention and trial: self-harm as a primary problem, what I needed when I needed it, being heard and understood, online delivery of the intervention and lasting impacts. Participants generally expressed positive views about the intervention, citing a need for services that specifically target self-harm and an appreciation of the rapid access to help. Strong relationships with the therapist were highly valued and not diminished by online delivery of the intervention. Positive impacts continued post therapy sessions.

These results support the acceptability of the COPESS intervention, the need for self-harm specific services and support moving forward to a full trial.

Pre-registered on clinicaltrials.gov (NCT04191122) on 9 December 2019.

Miscarriage, defined in the UK as loss of pregnancy prior to 24 weeks gestation, can have long-term psychological implications. Clinical guidelines for perinatal bereavement care do not provide guidance on how best to support the mental health of women, and their partners, after miscarriage. Peer support (support from those who share common characteristics) is often sought, but there is little understanding of its access and use. We conducted a systematic review to understand the barriers to and facilitators of the implementation of peer support to improve mental health outcomes for parents after miscarriage.

Systematic review and thematic synthesis.

A comprehensive systematic search across nine databases (MEDLINE, CINAHL, APA PsycINFO, Web of Science (all databases), EMBASE, CENTRAL, LENS.org, British Nursing Index and Health Management Information Consortium) was conducted in June 2025. Grey literature was identified through website searching, contact with topic experts and a national Call for Evidence.

Qualitative and mixed-methods studies exploring motivations, experiences and preferences for peer support after miscarriage were included.

Two independent reviewers used standardised methods to search, screen, extract and code included studies. Suitable studies were evaluated using the Critical Appraisal Skills Programme Qualitative Research Checklist. Findings were extracted and subjected to a thematic synthesis.

Across nine studies included in the review, three overarching themes were developed, with seven subthemes, capturing both barriers and facilitators. ‘Engaging in relational recognition’ reflects the validation and connection that arise through experiential resonance, often heightened by the context of exclusion from broader social or clinical support. ‘Mechanisms of Communality’ describe how communality is enacted through dynamic peer interactions, including modelling and facilitating grief, benchmarking physical change and mattering through reciprocity, highlighting mutual support and shared coping. ‘Dynamics of Access’ consider factors which shape engagement, including changing needs of individuals across time and modalities of support and their effects.

These findings form the first synthesis of peer support after miscarriage and bring a nuanced service user perspective of barriers and facilitators by examining evidence from diverse studies. Peer support after miscarriage was seen to be a dynamic, relational process shaped by shared experience, mutual exchange and context-specific factors. Findings underscore key policy and practice considerations, including the use of trauma-informed, loss-sensitive approaches and consideration of intersectionality, that should be reflected when offering peer support services, with and for, those who have experienced miscarriage.

CRD42024518248.

Our aim was to compare the incidence and outcomes of civil legal cases in Canada involving international medical graduate (IMG) physicians to physicians who graduated from medical schools in Canada or the US.

We conducted a retrospective cohort study with multilevel, multivariate modelling of civil legal cases against physicians licensed to practise in Canada.

We used the Canadian Medical Protective Association’s national repository of medicolegal case data.

We extracted data on physicians’ demographic characteristics, geographical characteristics and undergraduate medical education.

Outcomes included physician medicolegal case rates (the number of civil legal actions a physician is involved in per year) and case outcomes (when a case proceeds and is either dismissed, settled or proceeds to trial). Our multilevel models examined associations between physician factors and the rate of civil legal actions and the distribution of civil legal outcomes.

The case rate model included 433 038 physician-year observations from 98 960 physicians (2015–2019), with 7657 civil legal cases (mean case rate per physician-year 0.0221; 98% had no cases). Case rates did not differ significantly between IMGs and Canadian/US graduates (p=0.0516). The case outcome model included 8046 cases (2016–2023). Unadjusted, cases favoured the plaintiff slightly more often for IMGs (39.1% vs 36.6%, ² (2, N=8046)=14.03, p

Our study suggests that where physicians receive their medical degree has no effect on their level of medicolegal risk in civil legal actions in Canada.

Diabetes mellitus is a highly prevalent metabolic disorder associated with chronic, low-grade inflammation. Of recent interest is the association between diabetes and circadian rhythm disruption. The aim of this review is to evaluate and synthesise clinical evidence for whether diabetes affects homeostatic diurnal patterns to proinflammatory markers in the human body. This could inform the optimal timing of immune-targeted therapies over the course of the day.

This systematic review will include primary clinical research studies reporting on diurnal variations, defined as an afternoon/evening (PM) minus a morning (AM) value, within a timeframe of 12±4 hours, for predefined proinflammatory markers, in individuals with diabetes (type 1 or type 2) compared with healthy controls. A search of online databases (Cochrane CENTRAL, Ovid MEDLINE and Ovid Embase) will be performed. Grey literature searches will be performed in clinical trial registries. Two review authors will independently screen retrieved citation records at the title/abstract and full-text levels. Study quality will be assessed using an appropriate National Institute of Health quality assessment tool. A meta-analysis will be performed if more than one study reports equivalent data for any outcome. Statistical heterogeneity will be assessed using the ² test. Where a meta-analysis is not possible or unlikely to be meaningful, a narrative synthesis of the findings will be provided.

Ethics approval is not required for this systematic review as no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations.

CRD420251115780.

This systematic review and meta-analysis aimed to determine the prevalence, patterns and associated factors of complementary and alternative medicine (CAM) use among pregnant women in Iran.

A systematic review and meta-analysis of observational studies.

A comprehensive search was conducted in PubMed/MEDLINE, Web of Science, Scopus, ScienceDirect and major Iranian databases from inception to 30 November 2024.

We included observational studies published in peer-reviewed journals that assessed CAM use among pregnant women in Iran and reported prevalence estimates or relevant associated factors.

Data extraction and quality assessment were performed independently by two reviewers using a standardised form and the Quality Assessment Tool. Meta-analyses of proportions were performed using the DerSimonian and Laird random effects model. The between-study heterogeneity was assessed using the I-squared (I²) statistic. Subgroup analysis, 95% prediction intervals (95% PrIs) and sensitivity analysis were conducted to explore the sources of heterogeneity and to evaluate the robustness of the overall effects, respectively. This study followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered with PROSPERO.

20 studies with a total of 8106 participants were included. The pooled prevalence of CAM use was 49% (95% CI 39% to 59%). The between-study heterogeneity was very high (I²=94.69%) with a wide 95% PrIs range of 3%–94%. The very high between-study heterogeneity and the wide range of PrI for the pooled prevalence were not explained by the quality of the studies, geographical regions of Iran or the methods of data collection. Mentha longifolia, Zataria multiflora and Boswellia thurifera were the most commonly used herbs. Across the included studies, the first trimester of pregnancy was most frequently reported as the period of CAM use, with socioeconomic factors identified as significant predictors. Family and friends were the primary sources of information regarding CAM. The most common reasons for CAM use included gastrointestinal issues, respiratory problems such as colds and coughs, and the desire to improve general health. Only 31% of participants disclosed their use of CAM to their healthcare provider.

Nearly half of pregnant women in Iran use CAM, yet disclosure to healthcare providers is low. An actionable implication is the critical need to integrate routine enquiry about CAM use into standard antenatal care to ensure safe practice. Further research is recommended to evaluate the effectiveness, safety and outcomes of CAM use among pregnant women.

CRD42024618490

Embryo aneuploidy increases substantially with maternal age, contributing to implantation failure and miscarriage. Conventional morphological assessment cannot determine euploidy. Non-invasive preimplantation genetic testing (ni-PGT) evaluates cell-free DNA in spent embryo culture medium, potentially improving embryo selection without trophectoderm biopsy. Robust evidence of clinical benefit in women aged 35–42 years remains limited.

This is a multicentre, open-label, parallel-group randomised controlled trial conducted in three centres in China. Infertile women aged 35–42 years undergoing their first intracytoplasmic sperm injection cycle and having ≥2 good-quality days 5–6 blastocysts (Gardner grade ≥4BC,defined as an expansion grade of at least 4, with an inner cell mass grade of B or better and a trophectoderm grade of C or better) will be randomised 1:1 to ni-PGT-guided embryo selection or conventional morphology-based selection. Randomisation will be stratified by study centre using variable permuted block sizes of 4 and 6 and implemented through a unified centralised randomisation system. After a multicentre set-up period for investigator training and harmonisation of spent culture-medium sampling procedures, during which no participant was enrolled or randomised, recruitment and randomisation commenced on 14 February 2025 at the lead site; additional sites started recruitment after local ethics approval and site initiation. A freeze-all strategy will be applied; frozen-thawed single blastocyst transfer will start from the second menstrual cycle after oocyte retrieval.

For the primary endpoint, embryo transfers using embryos from the index retrieval cycle that occur within 12 months after randomisation and within the first three frozen-thawed single embryo transfer attempts will contribute to the cumulative outcome, whichever occurs first. Clinical care will not be restricted beyond this prespecified analysis range. The primary outcome is the cumulative ongoing pregnancy rate within 12 months after randomisation, defined as the proportion of participants achieving at least one ongoing pregnancy (clinical pregnancy continuing to ≥12 weeks’ gestation) following a qualifying embryo transfer within the prespecified analysis range. Key secondary outcomes include early miscarriage rate (

The trial will be conducted according to the Declaration of Helsinki. Ethics approval has been obtained from all participating centres before participant recruitment at each site. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed publication and conference presentations.

ChiCTR2400088283

Maternal and newborn morbidity and mortality are a global concern. Understanding the epidemiology of post-discharge complications could identify opportunities for interventions. We aimed to quantify mortality, care-seeking events and readmission among mothers and newborns in Uganda following facility-based delivery.

This prospective observational study (Apr 2022-Sep 2023) enrolled women presenting for delivery at two regional referral hospitals in Uganda. Data were collected during admission and 6 weeks after delivery by phone.

Overall, 7131 women delivered 7359 newborns, of whom 7129 (99%) women and 6968 (94%) newborns were discharged alive. The newborn mortality rate was 2.7% and 32% of deaths occurred post-discharge. Following discharge, 230 (3%) women and 287 (4%) newborns were readmitted. Suspected sepsis and infections were the most common reasons for readmission among mothers (62.2%) and newborns (89.9%). Caesarean delivery (OR:2·26 (1·75-2·93)) and perinatal death (OR:3·18 (2·09-4·69)) were associated with post-discharge maternal readmission. Both maternal and newborn readmission were associated with household food insecurity during pregnancy (maternal OR:1·56 (1·15-2·08); newborn OR: 1·73 (1·31-2·25)). Newborn resuscitation with oxygen was associated with maternal readmission (OR:2.24 (1.24–3·78)), newborn readmission (OR: 2·74 (1·54-4·56)) and newborn death (OR: 4·01 (1·73-8·21)). Although >99% of women had ≥1 antenatal care visit, only 511 (7%) had ≥1 routine postnatal care visit. There were no routine postnatal care visits among 211 (91·7%) readmitted mothers, 276 (96·2%) newborns and 57 (91·9%) newborns who died.

Post-discharge complications occur in a context of low routine postnatal care use. Risk-informed discharge planning, postnatal care and health education strategies may improve outcomes in mothers, newborns and their families.

To investigate the prevalence of depression, anxiety and stress among primary caregivers of children with childhood-onset systemic lupus erythematosus (cSLE) in China and to explore their psychosocial correlates based on the stress process model.

A cross-sectional study.

3 tertiary public hospitals in Hunan Province, China.

242 primary caregivers were invited, and 211 completed the study (87.2% response rate). Convenience sampling was used. Eligible participants were unpaid adult caregivers (aged ≥18 years) of children (aged 1 month. Exclusion criteria included inability to complete questionnaires independently, cognitive impairment due to major physical or mental disorders and current participation in other psychological interventions.

Primary outcomes (depression, anxiety and stress) were measured using the Depression Anxiety and Stress Scale-21. Correlates included threat/challenge appraisal, coping style and perceived social support.

Among 211 caregivers (mean age 40.55±8.22 years; 77.3% female), 31.8% reported depression, 27.0% anxiety and 24.2% stress. Higher threat appraisal was consistently associated with depression (regression coefficients (B) =1.012, p

Caregivers of children with cSLE face substantial psychological distress, with threat perception and negative coping as key modifiable correlates. Interventions to reshape cognitive appraisal and promote adaptive coping, alongside expanded health insurance coverage and optimised caregiving role distribution, are needed to alleviate caregiver burden.

Asthma is one of the most prevalent long-term health conditions affecting pregnant women. Poorly controlled asthma during pregnancy is associated with adverse maternal and fetal outcomes and may predispose offspring to long-term respiratory morbidity. The current ‘one size fits all’ approach to asthma management during pregnancy is not optimally effective for approximately half of the pregnant women with asthma. A personalised medicine approach to managing airways disease is required. The treatable traits approach focuses on the identification and treatment of traits in the pulmonary, extra-pulmonary and behavioural domains, which are identifiable, measurable, clinically relevant (linked to exacerbation risk or poor asthma control) and treatable. This manuscript outlines the protocol for the Treatable Traits for Asthma Management in Pregnancy (TTAP) study. The purpose of the TTAP study is to prospectively determine the prevalence of a range of treatable traits from these three domains in pregnant women with asthma and determine which traits are associated with exacerbation risk, poor asthma control and poor asthma-related quality of life. Additionally, this study will assess differences in trait prevalence and clinical relevance in pregnant women from regional versus metropolitan hospitals in Australia and in different antenatal models of care.

The TTAP study is a multicentre, prospective observational cohort study. Study participants are pregnant women with asthma attending antenatal clinics at 10 metropolitan and regional hospitals (public and private) in NSW and Victoria, Australia. Assessment of traits from the pulmonary, extrapulmonary and behavioural domains as well as asthma outcomes is conducted at three gestational timepoints: 12–16 weeks, 22–26 weeks and 32–36 weeks of pregnancy. A follow-up assessment of asthma outcomes is conducted at 2–4 weeks postpartum. The outcomes assessed are asthma exacerbations requiring medical intervention (primary outcome), asthma symptom control and asthma-related quality of life. Traits and outcomes will be assessed using questionnaires, direct questioning, measurement of biomarkers, physical measurements and assessment of routinely collected data from medical records.

The Hunter New England Human Ethics Committee (2024/ETH01289) has approved the TTAP study protocol. Outcomes will be published in peer-reviewed journals, presented at scientific conferences and disseminated online to participants, clinicians and other pregnant women with asthma and their families via the Asthma in Pregnancy Toolkit website https://asthmapregnancytoolkit.org.au/.

Atosiban may confer therapeutic benefits to specific subpopulations in assisted reproductive technology. The Phase I Atosiban study indicated potential improvements in live birth rates among women with previous implantation failure undergoing frozen-thawed blastocyst transfer who exhibited abnormal uterine contractions, although these findings did not reach statistical significance. Therefore, further investigations are warranted to thoroughly elucidate the efficacy of atosiban and to evaluate whether uterine contractions can serve as a reliable biomarker for its targeted application.

This is a single-centre, randomised, triple-blind, placebo-controlled trial aiming to enrol 792 infertile women aged 20–40 years with a history of at least one previous embryo implantation failure and abnormal uterine contractions prior to single blastocyst-stage embryo transfer. Eligible participants will be randomly assigned in a 1:1 ratio to receive either intravenous atosiban or a placebo before embryo transfer. The primary outcome is live birth rate, with secondary outcomes encompassing various pregnancy and perinatal parameters. Randomisation will be stratified by age and transfer type. Intention-to-treat analysis will be performed using generalised linear models. The trial will be monitored by an independent data and safety monitoring committee, including one interim analysis.

This study has been approved by the Institutional Ethics Committee of Northwest Women’s and Children’s Hospital (No. 2025-058-02). Written informed consent will be obtained from all participants. The study results will be disseminated at scientific conferences and published in peer-reviewed journals.

NCT07185230.

Patient safety is crucial in healthcare, especially in home-based settings where unregulated environments and limited supervision pose unique challenges. With the expansion of home healthcare due to an ageing population and healthcare workforce shortages, there is a pressing need for tools to assess patient safety culture in this context. Current instruments, developed for hospitals, do not adequately address the specific dynamics of home healthcare, such as patient autonomy and caregiver involvement. This protocol outlines the development and validation of the Patient Safety Culture in Home Health Care Centers Instrument (PSCHCI), using a sequential exploratory mixed-methods approach.

This sequential exploratory mixed-methods protocol consists of three phases. Phase 1 fieldwork (semi-structured interviews with 15 participants, 3 participant observations and field notes) has been completed. Qualitative data are currently being analysed using conventional content analysis. The scoping review component of Phase 1 is planned but has not yet been conducted. Phase 2 (instrument development) is planned to include item generation from qualitative results followed by expert panel review. Phase 3 (psychometric evaluation), scheduled for late 2026, will employ a cross-sectional study to assess face, content and construct validity; reliability; interpretability; and feasibility. This phase features pilot testing (n=30–50), face and content validity assessment (n=10 each), test-retest reliability (n=15) and exploratory and confirmatory factor analyses (n=300–400).

Ethical approval was obtained from the Ethics Committee of Iran University of Medical Sciences. All participants will provide written informed consent. Confidentiality, voluntary participation and withdrawal rights are guaranteed. Findings will be published in peer-reviewed journals, presented at conferences and shared with participating home healthcare centres, policymakers and stakeholders.

Intracerebral haemorrhage (ICH) accounts for approximately 15% of all strokes in Denmark and remains associated with high mortality and morbidity. It is challenging to distinguish neoplastic from non-neoplastic causes of ICH in the acute setting, and CT findings that may aid early differentiation have not been fully characterised. Existing ICH-classification systems (SMASH-U, H-ATOMIC and CLAS-ICH) have not been directly compared for diagnostic accuracy in this setting. Identifying radiological and clinical factors associated with underlying aetiology may support faster diagnosis, reduce time to workup related to potential underlying cancer and facilitate early targeted treatment of the underlying cause of ICH.

This study is a retrospective observational cohort including all patients admitted with acute ICH to the Department of Neurology, University Hospital of Southern Denmark, Aabenraa between January 2014 and December 2024 (estimated approximately n=610). Medical records and initial non-enhanced CT scans will be reviewed. Two neurologists and two radiologists, blinded to final diagnosis, will independently extract clinical presentation, topographical and volumetric haemorrhage characteristics, and classify each case using the abovementioned ICH-classification systems. Primary analyses will assess associations between clinical and radiological features and underlying neoplastic vs non-neoplastic aetiology. Secondary analyses will compare diagnostic performance of classification systems using sensitivity, specificity and receiver operating characteristic curves. Multivariate logistic regression models will be applied with Holm correction for multiple comparisons.

The study has been submitted to the National Danish Research Ethics Committee and the Danish Data Protection Agency. As data derive from completed disease courses, no patient contact is expected. Results will be disseminated through peer-reviewed journals, conferences and scientific presentations.

Cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy (HIPEC) is a treatment for peritonitis carcinomatosa. These procedures often involve significant blood and fluid loss, leading to hyperdynamic circulation and vasodilation, necessitating intraoperative fluids and vasoconstrictors such as catecholamines. Excessive fluid administration to counteract vasodilation can cause intraoperative fluid overload, which is linked to increased postoperative complications. Vasopressin has emerged as a potential alternative to catecholamines, restoring vascular tone via non-adrenergic pathways and supporting perfusion pressure, potentially reducing the need for compensatory fluids solely administered to compensate for vasodilation. We hypothesise that compared with norepinephrine, vasopressin reduces cumulative intraoperative fluid administration during CRS-HIPEC within a goal-directed fluid therapy (GDFT) protocol, ultimately leading to a lowering of postoperative complications.

HiPress is a two-centre, two-arm randomised clinical trial with blinding of both patients and outcome assessors. A total of 70 adult patients undergoing CRS-HIPEC will be included. Patients will be randomised to receive either continuous low-dose argipressin or continuous low-dose norepinephrine. Both groups will receive standardised GDFT during the procedure. The primary endpoint is cumulative intraoperative fluid administration (mL). Secondary endpoints include direct fluid-related outcomes (eg, cumulative intraoperative fluid (ml/kg/hour), postoperative fluid balance until day five and ultrasound-assessed pulmonary oedema and venous congestion) and indirect fluid-associated outcomes (eg, quality of recovery, surgical and abdominal complications, acute kidney injury (AKI), pulmonary complications, length of ICU and hospital stay and 30-day mortality).

The study is enrolling patients since February 2025. The trial is approved by the Medical Research Ethics Committee (hereinafter: MREC) NedMec, The Netherlands (Ref: D-25-500202). Results of the trial will be published in an international peer-reviewed journal and announced at national and international scientific meetings.

Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024–5 13 598-33-00