Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

NCT02727296.

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Asthma is a leading cause of morbidity and healthcare use among children. Risk factors of childhood asthma include atopic predisposition and severe wheezing episodes caused by rhinovirus infection in early life. In children with first-time rhinovirus-induced wheezing, we aim to study the response of a short corticosteroid treatment to prevent recurrent wheezing and asthma.

This is a double-blind, randomised, placebo-controlled, phase IV, international multicentre trial involving eight sites in Norway, Sweden and Finland. Two hundred and eighty 3–23 months old steroid-naïve children are randomised 1:1 to receive oral dexamethasone (0.3 mg/kg/day) versus placebo in 3 days for their first wheezing episode and rhinovirus infection. Rhinovirus is diagnosed with multiplex PCR. The two co-primary outcomes are time to next physician-confirmed wheezing episode, and time to asthma, within 24 months from inclusion. Asthma is defined as fulfilment of the 2007 National Asthma Education and Prevention Program—criteria for initiating asthma controller medication in children aged 0–4 years. Primary interaction analyses are age, gender, atopic predisposition, risk genotypes and viral co-detection. The optimal cut-off on the rhinovirus genome load used to define a true rhinovirus infection will be assessed by exploring interactions between rhinovirus genomic loads and study drug on the co-primary outcomes. Secondary outcomes are number of wheezing episodes, duration and severity of each wheezing episode, bronchial hyperreactivity, quality of life and safety (height/weight development) at 24 months from inclusion.

Rhinovirus positive children with acute wheezing fulfilling inclusion and exclusion criteria are enrolled after informed consent from both caregivers. This trial has received ethical approval from all sites. Results will be submitted to Competent Authorities and disseminated via peer-reviewed publications and conferences within paediatrics and other relevant fields. If proven effective, findings may be implemented directly into paediatric clinical guidelines.

NCT03889743.

The enhanced midwifery continuity of carer (eMCoC) pilot programme provided additional resource (funding) to midwifery teams operating in the 10% most deprived areas in England. The eMCoC programme aims to provide additional support to those at greatest risk of poor maternal health outcomes. We conducted a rapid formative evaluation aiming to explore the implementation of the pilot programme to (1) generate timely insights to inform ongoing service delivery; (2) generate a logical framework of the eMCoC service and; (3) inform the design of a longer-term summative evaluation.

Rapid evaluation using mixed-methods.

We explored implementation of the eMCoC service in 58 funded local midwifery teams across 23 Local Maternity and Neonatal Systems (LMNS). We undertook qualitative data collection in 10 case study sites across England, focusing on the implementation in 17 teams.

We purposively sampled 34 service users who received care from enhanced teams, and 38 staff working in enhanced teams. Inclusion criteria for the service user interviews included women who had received care from enhanced teams during our evaluation period and were more than 28 weeks pregnant. Exclusion criteria included women who had not received care from our target teams. We undertook descriptive analysis using the Maternity Services Dataset to compare the characteristics of service users in enhanced teams with service users receiving other midwifery service models.

Many of the 58 teams funded were unable to implement eMCoC during the evaluation period because of institutional and organisational barriers. The barriers identified here are indicative of the barriers associated with implementing midwifery continuity of carer. Largely, the eMCoC service successfully targeted women living in the most deprived areas and a focus on reaching women living in these areas was valued by enhanced teams. Equally, enhanced teams strived to broaden the targeted characteristics (i.e. more broadly than on the basis of deprivation) to include a wider and more diverse set of social risk factors and vulnerabilities, based on local needs and priorities. Service users reported being well supported by the enhanced teams, including receiving relational and well-being support and personalised one-to-one public health education, information and support. Service users emphasised that enhanced teams went ‘above and beyond in their care’.

Funding for eMCoC has been well received by both staff and service users. The implementation of the enhanced roles was perceived to have supported delivery of team-based care, facilitating successful release of midwifery capacity and the delivery of additional public health activities. Supporting a team-focused ethos seems an important feature of eMCoC services. This was consistent across sites and from both staff and service user perspectives. There appears to be many routes (i.e. different service delivery types) to delivering enhanced care, and the multiplicity of service delivery types found in this evaluation suggests no tightly prescribed way of meeting eMCoC’s objectives. The flexibility of the initial funding specification guidance from NHS England has been a key driver of local ownership and permitted eMCoC services to be organically built ‘from the ground up’. Our conclusions point to the value of autonomy afforded to local areas to use eMCoC funding as they deem necessary to best suit the needs of their staff and specific service user groups. Attention should be placed on the barriers to implementation and sustainability issues which can be addressed, namely: delays in releasing funding from LMNS and Integrated Care Boards to providers, and protecting maternity support worker and midwifery time to their allocated teams.

While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.

A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.

TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.

NCT06245135.

Cardiac surgery remains a high-risk procedure for bleeding despite advances in patient blood management. Conventional centrifugation-based autotransfusion devices primarily recover red blood cells, losing platelets and coagulation factors. The SAME autotransfusion device (i-SEP, Nantes, France) introduces an innovative filtration-based approach, recovering erythrocytes, leucocytes and platelets to enhance perioperative haemostasis. The main objective is to determine whether the filtration-based SAME device reduces significant perioperative bleeding compared with the centrifugation-based system in high-risk cardiac surgery patients.

The Centrifugation-based vs filtration-based intraOperative cell saLvage on qualiTy of peRioperAtive haemostasis iN cardiac surgEry (COLTRANE) trial is a multicentre, parallel-group, single-blinded, superiority-randomised clinical trial. Conducted over 19 months in 10 French hospitals, the study will target patients at high risk of bleeding undergoing on-pump cardiac surgery via sternotomy. A total of 570 patients (285 per group) are required to achieve 80% statistical power for detecting clinically significant differences. Eligible patients will be randomised to either a centrifugation-based or filtration-based autotransfusion group. Both groups will follow standardised perioperative and cardiopulmonary bypass management, with the devices used only intraoperatively. The primary outcome is the proportion of patients with clinically significant perioperative bleeding defined as classes 2 to 4 of the Universal Definition of Perioperative Bleeding. The secondary outcomes include device efficiency and safety, perioperative haemostasis, lengths of intensive care unit and hospital stays, early postoperative morbidity and 30-day all-cause mortality. Ancillary studies will be performed to evaluate cell recovery and washing performance, the viscoelastic properties of retransfused blood (Quantra Qplus; Stago, Asnières-sur-Seine, France), and the effect of salvaged leucocytes on postoperative inflammation and immune function.

This trial has received a favourable opinion from the Committee for the Protection of Persons and authorisation from the French authorities (Comité de protection des personnes Nord Ouest, IDRCB: 2023-A02566-39). Protocol V.1.1 was approved on 22 January 2024. The trial is registered on ClinicalTrials.gov (NCT06425614). The findings will be disseminated through oral communications at national and international scientific meetings and peer-reviewed journal publications. Individual participant data will be made available on reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.

ClinicalTrials.gov, NCT06425614.

Breast cancer risk can be substantially reduced with risk-reducing medications (RRMeds). Despite their efficacy, and guidelines which support their use for women at substantially increased risk of breast cancer, they are underused. Barriers to their use in Australia include a lack of awareness of RRMeds by women and clinicians, and a primary care workforce that reports a lack of knowledge and confidence in discussing and/or prescribing these medications. In contrast, Australian clinicians have reported specialist support and guidance as a key facilitator. The Preventing Cancer with Medications (PCMed) Telehealth Service was therefore developed to provide this specialist support and to bridge the evidence–implementation gap. The PCMed Service endeavours to increase the appropriate use of RRMeds and support women and their doctors throughout treatment. The aim of this research is to evaluate the effectiveness, adoption, acceptability, feasibility, fidelity and cost of this new Service, and to determine any adaptations that might be required.

The research uses a mixed methods approach. Effectiveness of the PCMed Service will be evaluated by determining whether the PCMed Service is associated with increased uptake of RRMeds compared with historical data. Secondary outcomes include: adoption of the Service, specifically, the proportion of women who attend a PCMed Service consultation; acceptability of the Service for clients and referring clinicians (using a brief survey and semistructured interviews); feasibility and fidelity by evaluating the adherence to the planned Service processes; and the cost, by reporting the difference between funding received per woman and the cost for service delivery.

This study was approved by the institutional Human Research Ethics Committee (EC00235): HREC/101142/PMCC. The findings will inform future iterations of the Service prior to scaling up. Research findings will be disseminated at scientific meetings and in peer-reviewed journals.

ISRCTN15718519.

To understand and compare women’s antenatal and postnatal views on: (1) priorities for information provided about labour and delivery and (2) decision-making in labour and delivery.

Qualitative interview study using repeat interviews at two time points: during pregnancy (≥13 weeks gestation); and after birth (≥6 weeks).

Large maternity hospital in the Southwest of England.

Pregnant women accessing antenatal care were purposively sampled and recruited antenatally by community midwives to ensure representation from different sociodemographic groups, with diverse experiences of low and high-risk care.

Telephone interviews with a single researcher using a semistructured interview topic guide.

Interviews were audio recorded, transcribed verbatim, and qualitative thematic analysis was conducted using Braun and Clarke’s six-stage process.

Twelve women participated (12 antenatal interviews; 10 follow-up postnatal interviews). Overall, women’s postnatal views were consistent with their antenatal views about what they wanted to know and the factors that influence decision-making. Three themes were generated. Theme 1 ‘Sources of information’ presents evidence of how women obtain and use information (sub-themes: ‘social influences’, ‘patient responsibility for information seeking’, ‘NHS vs non-NHS resources’). Theme 2 reports women’s views and experiences of ‘The influence of Healthcare Professionals in decision-making’ (sub-themes ‘patient and professional roles in decision-making’, ‘conflicting advice and preferences’, ‘taking authority in emergency decision-making’). The final theme, theme 3, ‘When, how, and what information women want’ shows women want time to process information (sub-themes ‘when: it’s definitely information and time’, ‘how: presentation of information’, ‘what: information required’). Cross-cutting all themes, we found an unmet need for information to be tailored to the individual.

Women understand decision-making during labour and birth is a dynamic process. Women can struggle with the volume, quality and timing of information available. In busy maternity settings, the challenge is to better equip women with the information they want, and health professionals with the information they need to provide for personalised care and shared decision-making. Antenatal interventions that warrant further research include decision aids, birth plans, and structured counselling using core information sets. Insights from both antenatal and postnatal perspectives will help inform their development.

Many women need to use medications during breastfeeding. Very few medications have been adequately monitored, tested and labelled with safety information for this use. Prednisolone is one of these drugs. We aim to conduct a multicentre low-intervention clinical trial to determine the concentration of prednisolone in plasma of breastfed infants of lactating women treated with prednisolone. In addition, we will measure the concentration in maternal plasma and breast milk and calculate the daily infant dose (DID) and relative infant dose (RID). Infant cortisol levels will be analysed as a measure of clinical effects in the infants.

The study will be conducted at departments of obstetrics and gynaecology and specialist maternity and paediatric outpatient clinics in Sweden. We aim to include 30 lactating women treated with prednisolone and their breastfed infants. Breast milk and blood will be collected merely to study the secretion of prednisolone into breast milk and transfer to the infant. Participants will be treated with prednisolone according to their physician’s prescription. Study visits take place when the infant is approximately 6–8 weeks old. Milk and blood sampling of the mother will be performed at 1 hour after drug intake, in conjunction with the infant being fed. Blood sampling of the infant will be performed 2 hours after the feed. Breast milk and plasma will be biobanked for future research. Recruitment was initiated in 2024 and is ongoing. Patient representatives from the Swedish Rheumatism Association were involved in the planning of the study, and the organisation is providing information about the study on their website.

The clinical trial was approved by the Swedish Medical Product Agency (Dnr. 5.1.1-2023-104170). The results will be published in peer-reviewed scientific journals and disseminated at scientific meetings and through patient organisations’ websites.

The clinical trial protocol is available via the Clinical Trial Information System at the European Medicines Agency (No. 2023-508913-18-00). It is also registered and publicly accessible at the EU PAS Register (EUPAS 1000000059).

The coronary artery calcium (CAC) scan serves as a crucial tool in assessing the risk of coronary atherosclerosis in patients with hyperlipidaemia, particularly when there is ambiguity surrounding pharmacotherapy decisions. In addition to CAC, advanced glycation end products (AGEs), glycated proteins and lipids involved in ageing are emerging as markers for atherosclerosis. However, the relationship between AGEs score and CAC scores has not been evaluated to date. Our primary objective is to evaluate abnormal CAC scores in patients with low and borderline ASCVD risk and normal low-density lipoprotein cholesterol (LDL-C) levels ≤100 mg/dL. The secondary objective is to explore potential associations between CAC and AGEs scores.

We will retrospectively review health records of adult patients seen at the General Internal Medicine Executive Health Program (Mayo Clinic; Rochester, Minnesota) between 1 September 2023 and 31 March 2024, where all patients were offered the option of a baseline CAC scan. For our primary aim, we will determine the percentage of patients with low and borderline 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk, not receiving pharmacotherapy for hyperlipidaemia, who have LDL-C levels ≤100 mg/dL and have an abnormal CAC score. For our secondary aim, we will examine potential associations between CAC and AGEs scores.

This study was determined to be exempt from institutional review board approval (ID 24–0 03 921; 45 CFR 46.104d, category/subcategory 4(iii)) at the Mayo Clinic, Rochester. The findings of this study will be published in a peer-reviewed journal.

Women and men/partners who experience miscarriage often report poor care experiences within health services around the time of miscarriage and beyond; less is known about recurrent miscarriage (RM) care. Research is needed to explore the potential targets for improvement, in addition to identifying factors that support or hinder service improvement efforts and the implementation and/or sustainment of desired models of RM care. This study aimed to explore the views of knowledge users regarding RM services and supports; specifically: (a) practices and experiences and (b) facilitators and barriers to providing desired services and supports.

We adopted a qualitative study design underpinned by constructivism, incorporating semistructured interviews. Data were analysed using reflexive thematic analysis.

Participants were recruited across the Republic of Ireland, incorporating perspectives from different geographical areas, hospital types and RM services.

We interviewed 13 women and 7 men/partners who had experienced ≥2 consecutive miscarriages, and 42 people involved in the delivery and/or management of RM services and supports, between June 2020 and February 2021.

We generated three themes from the data: (1) dedicated staff; (2) dedicated space and time and (3) dedicated funding and support—prioritise RM. Our analysis supports the need for a standardised, dedicated and adequately resourced and supported service. One in which people experiencing RM are offered appropriate, individualised, timely and accessible care and support—beginning following the first miscarriage, and following a graded model. Implementation requires several multilevel actions, including prioritising RM care, adequately funding and resourcing services, enhancing health professional education and support, care coordination within and between hospitals and primary care and improving public awareness of, and addressing stigma surrounding, miscarriage.

Our analysis provides context to ‘good’ and ‘poor’ care experiences and identifies what facilitators and barriers exist to affecting change in RM care within healthcare and broader systems. In light of recent debates regarding how best to deliver RM care, and changing international guidelines, this work provides timely and important knowledge that should be harnessed to inform service improvement efforts in the Republic of Ireland and beyond.

Individuals with stroke or spinal cord injury (SCI) often have poor balance control, leading to falls and activity limitations. One intervention that targets balance control—functional electrical stimulation with visual feedback balance training (FES+VFBT)—may improve balance control but needs modifications for clinical use.

To use a participatory design approach to identify potential challenges and solutions for the clinical implementation of FES+VFBT as a balance intervention.

A descriptive qualitative study involving four semi-structured focus group meetings was conducted to explore the perspectives of individuals with stroke and SCI, physical therapists and a hospital administrator on the feasibility and challenges of implementing FES+VFBT into clinical settings. The interviews were transcribed and analysed using deductive and inductive content analyses. The deductive analysis was based on the social ecological model (SEM) levels, while the inductive approach was used to identify categories and codes.

Virtual.

Two individuals with chronic SCI and one individual with chronic stroke who were able to stand but reported deficits in their balance control. Two physical therapists who had experience with FES and the rehabilitation of individuals with SCI or stroke. One hospital administrator who worked within a neurological rehabilitation setting.

Themes were organised according to the SEM’s four levels: intrapersonal, interpersonal, organisational/training environment and society/policy. Identified categories included potential challenges at the intrapersonal level (ie, lack of knowledge, safety and tolerance of user) and organisational/training environment level (ie, technical challenges, cost, physical space and time). The categories also included possible solutions at all SEM levels, such as intrapersonal (ie, reading and education), interpersonal (ie, practising together), organisational/training environment (ie, technology characteristics and creating resources) and society/policy (ie, purchasing options, guidelines and foundation grants).

End-users identified anticipated challenges and solutions to using the FES+VFBT system clinically. The results will inform the design and clinical implementation of a revised version of the system and other FES devices.