First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.

Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.

The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.

ISRCTN74193022

Non-communicable diseases (NCDs) are a leading cause of global mortality, disproportionately affecting low and middle-income countries (LMICs). Physical inactivity, a key contributor to NCDs, is prevalent worldwide despite evidence supporting the health benefits of physical activity (PA). Cities, while often associated with barriers to PA, also present unique opportunities to enhance PA through systemic, context-sensitive interventions or so-called actions. However, evidence on effective city-level PA strategies, particularly in LMICs, remains limited. The CITY based interventions to stimulate active MOVEment for health (CITY-MOVE) project aims to accelerate, support and evaluate the implementation of PA actions at the city level by adapting the WHO Global Action Plan on Physical Activity into locally relevant strategies across six cities worldwide, accompanied by a cross-contextual evaluation framework to ensure transferability and scalability.

This multicase study examines 13 PA actions in six cities (Bogotá, Lima, Kampala, Antwerp, Rotterdam and Ljubljana) across three continents, addressing both early (design and implementation) and late (evaluation) action stages. Early-stage actions employ action research in Living Labs to codesign and implement PA initiatives with local stakeholders, while late-stage interventions focus on retrospective evaluations of implementation outcomes. The framework integrates the Medical Research Council guidance on complex interventions with the Context and Implementation of Complex Interventions. Mixed methods are employed, including document review, interviews, participatory workshops and quantitative analysis of PA and NCD indicators. A cross-contextual Multi-Criteria Decision Analysis (MCDA) framework will synthesise findings to inform scalability and transferability of actions.

Ethics approvals were obtained from local review boards in the participating cities.

Dissemination will occur at three levels: local, regional and global. Locally, findings will be shared with city authorities, non-governmental organisations (NGOs) and healthcare providers through Living Labs and policy dialogues. At the regional level, knowledge will be spread across cities in Europe, Latin America and East Africa through Communities of Practice and the use of tools like the MCDA framework. Globally, the project will contribute to the scientific community and international organisations such as the WHO and UN-Habitat, by sharing results through open access publications, conferences and global networks to ensure widespread dissemination and sustainability of the project’s impacts.

This study and its outcomes are publicly accessible on OSF (https://osf.io/mn8zd/) and ZENODO (https://zenodo.org/communities/citymove/).

To compare the quality and time efficiency of physician-written summaries with customised large language model (LLM)-generated medical summaries integrated into the electronic health record (EHR) in a non-English clinical environment.

Cross-sectional non-inferiority validation study.

Tertiary academic hospital.

52 physicians from 8 specialties at a large Dutch academic hospital participated, either in writing summaries (n=42) or evaluating them (n=10).

Physician writers wrote summaries of 50 patient records. LLM-generated summaries were created for the same records using an EHR-integrated LLM. An independent, blinded panel of physician evaluators compared physician-written summaries to LLM-generated summaries.

Primary outcome measures were completeness, correctness and conciseness (on a 5-point Likert scale). Secondary outcomes were preference and trust, and time to generate either the physician-written or LLM-generated summary.

The completeness and correctness of LLM-generated summaries did not differ significantly from physician-written summaries. However, LLM summaries were less concise (3.0 vs 3.5, p=0.001). Overall evaluation scores were similar (3.4 vs 3.3, p=0.373), with 57% of evaluators preferring LLM-generated summaries. Trust in both summary types was comparable, and interobserver variability showed excellent reliability (intraclass correlation coefficient 0.975). Physicians took an average of 7 min per summary, while LLMs completed the same task in just 15.7 s.

LLM-generated summaries are comparable to physician-written summaries in completeness and correctness, although slightly less concise. With a clear time-saving benefit, LLMs could help reduce clinicians’ administrative burden without compromising summary quality.

Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

ISRCTN61218504. EU CT: 2025-520538-49-00.

Publication based on the UK protocol V.3.0, 08 May 2025

The Kun–Qi birth cohort (KQBC) was established to investigate the incidence, aetiology and risk factors of chronic kidney disease (CKD) in early childhood (0–6 years). Additionally, the study analysed developmental phenotypic trajectories and their associated paediatric diseases.

Infants registered or residing in Kunshan and Qidong, Jiangsu Province, who participated in the Chinese Child Healthcare Programme (0–6 years) were enrolled. The baseline population was stratified into enhanced and basic cohorts. General characteristics, periconceptional and perinatal information and health check-up data were collected from each participant. Dual screening (urinary ultrasound and urine dipstick tests) was conducted during scheduled check-ups. Structured CKD questionnaires were administered, and biosamples (urine and dried blood spots) were obtained for the long-term storage and analysis using standard procedures. Based on the proposed referral procedure, participants with abnormal results were referred for further diagnosis and evaluation.

The KQBC enrolled 10 127 infants (5392 boys and 4735 girls) with a mean age of 2.11±1.68 months. Urinary system ultrasound and urine dipstick screening showed positivity rates of 8.9% (900/10 083) and 6.5% (532/8233), respectively. Baseline ultrasound screening facilitated timely surgical intervention in six children. Among the 7965 respondents, only 13% demonstrated awareness of paediatric CKD. Additionally, 7273 dried blood spots and 7990 urine specimens were collected and stored. A paediatric CKD screening platform was developed.

According to our plan, the KQBC will be followed up for 3–6 years to investigate the incidence, aetiology and risk factors of early onset CKD. In-depth developmental phenotypes, such as urinary multiomics and ultrasound imaging, should be studied for longitudinal paediatric kidney health. We aim to develop multimodal risk prediction models by integrating genomics and artificial intelligence algorithms. The KQBC also enables prospective cohort studies addressing extensive research questions.

NCT06018831.

Infectious diseases are a major global health concern, responsible for significant morbidity and mortality. To advance the understanding and treatment of these diseases, biobanks and biorepositories play a crucial role in guaranteeing sample traceability through their entire life cycle (collection, acquisition and registration, processing, storage, distribution) and future analysis of clinical and biological data.

The INfectious DIsease REgistry BIObank (INDI-REBIO) is an observational, prospective, monocentric, open-ended registry with ad hoc procedures and a systematic collection of uniform clinical, laboratory, imaging and therapeutic data of patients with suspected or microbiologically documented bacterial, viral, fungal and parasitic infectious diseases from the IRCCS San Raffaele Hospital (Milan, Italy). The study aims to collect both uniform data and biological samples such as blood and other relevant specimens. The registry aims to include significant patient numbers across various conditions (among others: bloodstream infections, endovascular infections as infective endocarditis, central nervous system infections, bone and joint infections, multidrug-resistant organisms (MDROs) colonisation, sexually transmitted infections, HIV infection, emerging and re-emerging infectious diseases), enabling comprehensive research on disease evolution, treatment outcomes and the identification of biomarkers.

The study adheres to ethical principles outlined by the Helsinki Declaration and Good Clinical Practice guidelines. It has received ethical approval (Comitato Etico CET Lombardia 1, CET 138–2023) and is registered on clinicaltrials.gov (NCT06418048). Participants will provide informed consent and can withdraw at any time. The study results will be disseminated through major international conferences and submitted to peer-reviewed research journals.

ClinicalTrials.gov, NCT06418048.

While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The ‘SPARX-UK’ study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an ‘eCoach’) vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation.

The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention.

Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149).

Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences.

ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

The necessity of enhancing resuscitation training has been encouraged by The International Liaison Committee on Resuscitation and the American Heart Association to reduce mortality, disability and healthcare costs. Resuscitation training is a complicated approach that encompasses various components and their mixture. It is essential to identify the most effective of these components and their combinations, to measure the corresponding effect size and to understand which participant groups may enjoy the greatest advantage.

We will systematically search 12 databases and two clinical trial registries for randomised controlled trials (RCTs) that examine different resuscitation training methods from inception to April 2025. The analysis will be carried out using the standard network meta-analysis and component network meta-analysis models. Resuscitation skills of staff will be the primary outcome of this analysis. Paired reviewers will independently screen and extract data. A consensus will be sought with the principal investigators to resolve any disagreements that cannot be achieved through regular meetings. Each intervention in each RCT will be decomposed according to its constituent components, such as delivery method, interactivity, teamwork, digitalisation and type of simulator. The analysis will be conducted using the frequentist and bayesian approach in the R environment. RoB V.2.0 and Confidence in Network Meta-Analysis will, respectively, be used to assess the risk of bias and the certainty of the evidence.

As we will use only aggregated secondary data without individual identities, ethical approval is not required. Results of this review will be shared through a peer-reviewed publication and presentation of papers at any relevant conferences.

CRD42024532878

To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.

We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.

Primary Care Health Madrid region (Spain).

Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).

Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.

The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

DRKS00034899.

V2.1, 6 June 2024.

There are no clearly defined family profiles with an overall view of the predictors of early childhood caries (ECCs). The aim of our study was to identify the profiles of families that are particularly affected by ECCs. We also examined the factors that can be acted on to promote oral health.

In this single-centre cross-sectional study, the researchers examined the mouths of 300 children with caries and recorded the Decayed, Missing and Filled Teeth Index (dmft). These observations were supplemented by a questionnaire completed by the families, focusing in particular on their sociodemographic characteristics (e.g. age, parents’ professions and jobs, social assistance and family composition).

This work was conducted at Lille University Hospital between 2019 and 2024.

The participants included 300 caregiver-child dyads with children under the age of 6 years.

Childhood Caries Index (dmft) and family characteristics associated with ECCs.

A multiple correspondence analysis was used, followed by a hierarchical clustering on principal components analysis, to identify the family profiles associated with ECC risk.

Of the patients included in the study, 42% were girls, 58% were boys and their mean age was 4 years (±1.1 years). The mean dfmt index was 8.7 (±4.6); 77% of the participants had lesions on the smooth surfaces of the teeth, and 80% of the participants had a severe stage of caries disease. The analysis revealed three high-risk profiles based on the characteristics of the child’s mother and the family sibling composition. The first profile was larger families where the focal child was not the eldest. The second profile was families with foreign-born mothers and a low socioeconomic level. The third profile was families with mothers facing geographical and financial difficulties in accessing healthcare.

This study enabled us to identify the profiles of families at risk of caries. These at-risk profiles highlight the need to implement specific interventions acting at different levels and focused on oral health education in interprofessional practice during the key period of the first 1000 days of life. These factors could help to bridge the gap between oral health and general health, improve children’s oral health and reduce social health inequalities.

This human study has been ethically approved by the French Committee for the Protection of Individuals (N° 2019-A00827-50).

The protocol is recorded on clinicaltrials.gov, with ID: NCT04195607.

The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.

Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.

The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.

ClinicalTrials.gov, NCT06679595.

To determine associations between arm and ankle systolic blood pressures (SBPs), develop and validate a multivariable model predicting arm SBP from ankle SBP, and investigate associations between ankle SBP, cardiovascular disease and mortality.

Ankle-arm SBP differences were examined in two-stage individual participant data (IPD) meta-analyses using multivariable hierarchical linear regression models. Models were used to derive and validate a prediction model for arm SBP based on ankle SBP. Model performance was assessed using area under the receiver operating characteristic (AUROC) curve analyses. Prognostic associations of ankle SBP with outcomes were examined using Cox proportional hazards models.

Searches identified cohorts for the Inter-arm Blood Pressure Difference IPD (INTERPRESS-IPD) Collaboration from Medline, Old Medline, Medline in process, Embase and CINAHL databases from inception until January 2017; unpublished data were also sought. Required primary outcomes were all-cause mortality, cardiovascular mortality, and/or fatal and non-fatal cardiovascular events.

Prospective studies from community, primary care or general clinic settings, without language restriction, that recorded SBP in both arms were eligible. Adults aged ≥18 years with SBP measured in all four limbs, in a supine position, were included in the current analyses. People with peripheral artery disease were excluded.

Anonymised datasets were individually cleaned and then combined into a single dataset for the INTERPRESS-IPD Collaboration.

The current dataset included 33 710 participants from 14 studies; mean age 58 years, 45% female, mean baseline arm blood pressure 138/80 (SD: 20/12) mm Hg. Mean ankle SBP was 12.0 mm Hg (95% CI 8.8 to 15.2) higher than arm SBP. The multivariable model predicting arm SBP from ankle SBP demonstrated excellent performance (AUROC curves, sensitivities and specificities were >0.82, 0.80 and 0.82, respectively, at all BP thresholds from 130 to 160 mm Hg). Model performance was superior to existing arithmetic formulae.

Ankle SBP was neither associated with all-cause nor cardiovascular mortality (HR 1.000 (0.997 to 1.002; p=0.682) and 1.001 (0.996 to 1.005; p=0.840), respectively). However, lower-reading ankle SBP was associated with fatal or non-fatal cardiovascular events (HR 1.005 (1.002 to 1.007; p

On average, ankle SBP is 12 mm Hg higher than arm SBP. Estimating individual arm SBP from ankle SBP measurements with a multivariable model is more accurate than existing fixed arithmetic formulae. This model, operationalised in an online calculator (https://ablebp.research.exeter.ac.uk/), could facilitate hypertension management and cardiovascular care for people unable to have arm SBP measured.

CRD42015031227.

To provide insight into how people cope with living with atrial fibrillation (AF) and taking oral anticoagulants (OACs), informing how services and healthcare delivery could be improved to offer the appropriate support patients require, thereby optimising their quality of life and well-being.

A qualitative study employing focus group discussions (FGDs).

11 primary care units in a socioeconomically deprived area of the Butantan district in São Paulo, Brazil.

Adults (≥18 years) with AF purposively recruited based on sex, age and socioeconomic status.

Saturation was met with three FGDs comprising seven, five and five participants, respectively. Theme one focused on self-management, where many participants discussed their methods for adhering to dietary restrictions and alternative medications, including plant-based options and specific foods, and how they modified their daily activities to reduce AF complications and symptoms. Theme two was rationality, where participants described three main ways that they cope with taking long-term medication (often warfarin): thinking that it controls their AF symptoms; it is an obligation; it prevents morbidity and premature death. Theme three was attitude and emotions, where participants described their initial reactions of shock and fear after diagnosis and ongoing emotions of sadness and frustration due to required self-management activities and regular blood tests. Theme four was medication regimen, where participants discussed difficulties with polypharmacy, changes to AF medication (particularly from non-vitamin K antagonist OACs (NOACs) to warfarin), side effects from taking warfarin and various methods of medication management.

This study presents three key findings with implications for patient care and support. First, the shock and fear experienced during diagnosis due to a lack of knowledge about AF suggests that improvements in public knowledge about AF are needed. Second, people with additional chronic conditions may need improved care and support, given the concern participants had regarding when and how to take their medications safely. Third, improved access to NOACs may reduce the difficulties, frustrations and concerns participants had regarding warfarin use (eg, diet, dose adjustments, self-management and monthly international normalised ratio tests).

Patients with node-positive breast cancer having primary surgery currently undergo axillary node clearance (ANC) to reduce the risk of breast cancer recurrence. Evidence that this highly morbid procedure improves survival is lacking, but approximately 30% of patients will develop lifelong complications which significantly impact their quality of life.

Targeted axillary dissection (TAD) may be a safe, less morbid alternative to ANC and will be evaluated in the upcoming Targeted Axillary Dissection versus axillary node clearance in patients with POsitive axillary Lymph nodes in Early breast cancer (TADPOLE) randomised controlled trial.

TAD is not currently routine practice in patients having primary surgery, so it is vital that the procedure is performed in an agreed upon, standardised way within the trial and procedure fidelity monitored to ensure the results are generalisable and will be accepted by the surgical community. Robust surgical quality assurance (SQA) is essential. Here we describe the first phase of the TADPOLE SQA, a consensus process with the breast surgical community to agree upon how (1) surgery should be performed and standardised; (2) procedure fidelity will be monitored and (3) requirements for surgeon credentialling within the trial.

The consensus process will have three phases:

Ethical approval has been obtained from the University of Bristol Faculty of Health Sciences Ethics Committee. Educational materials including videos and webinars will be developed and shared with surgeons participating in TADPOLE. Results will be presented at national/international meetings and published in peer-reviewed journals.

Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.

ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.

Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).

(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.