To use best practices in pharmacoepidemiology to assess the association between new use of brain-penetrant calcium channel blockers (BP-CCBs) compared with use of non-brain-penetrant CCBs (NP-CCBs) and the incidence of neuropsychiatric outcomes.

Retrospective comparative cohort study.

Secondary data from nine claims and electronic health record databases from across the globe were used.

First use of a CCB was the index date. There were 1.2 million BP-CCB patients and 9.3 million NP-CCB patients identified across all databases, with 881 758 matched in each group.

Patients were categorised as either initiating BP-CCBs or NP-CCBs. On-treatment and intention-to-treat analyses were conducted. Large-scale propensity models were used to match cohorts and control for observed confounding. Cox models were used to analyse the time to incident neuropsychiatric disorders. Negative control outcomes were used to calibrate estimates, CIs and p values to account for residual confounding. Diagnostics were used to assess the validity of the analysis.

The time to first diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) and bipolar disorder was assessed independently. HRs compared the BP-CCB group to the NP-CCB group.

For the outcome of incident MDD in the intention-to-treat design, the meta-analytic HR (95% CI) was 1.02 (0.97, 1.08). Meta-analytic HRs for bipolar disorder (1.04 (0.96, 1.13)), schizophrenia (1.05 (0.94, 1.18)) and schizoaffective disorder (1.04 (0.87, 1.23)) showed similar null effects. The on-treatment analysis was largely consistent: MDD (1.01 (0.96, 1.06)), bipolar (1.05 (0.86, 1.27)), schizophrenia (1.09 (0.87, 1.38)) and schizoaffective (1.00 (0.71, 1.40)).

There was no evidence of an association with any of the neuropsychiatric conditions of interest between use of BP-CCB and NP-CCB. This does not rule out the potential beneficial effect of CCB formulations and doses targeted specifically for the brain rather than the cardiovascular system.

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

Social connection describes how individuals connect, relate and interact with one another, and can affect quality of life (QoL) in persons with dementia. Much of the existing research on social connection does not explicitly differentiate social connection’s structure, function and quality components. Due to this, social connection is described using inconsistent terminology, making it unknown how each component is associated with health and well-being outcomes. However, for people with dementia, it is unknown which components of social connection are associated with QoL and whether factors such as gender and type of dementia influence these relationships. This scoping review will identify which components of social connection have been studied in relation to the QoL for people with dementia. This will address inconsistent definitions of social connection terminology and clarify what components of social connection are described and measured in the existing literature.

The six-stage scoping review framework developed by Arksey and O’Malley (2005), with updates from Levac et al (2010), will be used. In March 2025, a comprehensive literature search in the following databases will be conducted: MEDLINE ALL (Ovid), APA PsycInfo (Ovid), Embase Classic and Embase (Ovid), CINAHL Complete (EBSCOhost) and Scopus, from database inception. Studies will be included if they are observational studies reporting on an association between social connection and QoL in community-dwelling people with dementia. In Covidence, two reviewers will independently screen the titles and abstracts and review full-text articles based on the inclusion criteria. Data extraction will be carried out by one reviewer and cross-checked by another reviewer. A content analysis for scoping reviews will be used to analyse data and synthesise findings.

Ethical approval is not required. Dissemination activities will include peer-reviewed publications, academic presentations and lay summaries on professional websites and social media.

Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.

An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.

Online.

Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.

Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.

Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.

The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.

The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.

This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.

The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.

This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.

The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.

NCT06154889.

This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.

A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.

16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.

Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.

Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.

A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.

It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.

This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Australia New Zealand registration number ACTRN12624000732583.

Few artificial intelligence (AI) clinical decision support systems (CDSSs) are ever evaluated in practice. Although some signal of clinical effectiveness may be needed to justify AI deployment and testing, such data are typically unavailable in early-stage research. This conundrum is especially relevant in the intensive care unit (ICU), where conditions like sepsis and acute respiratory distress syndrome (ARDS) require high-stakes decisions. Our group developed the AI ventilator assistant (AVA), a novel AI CDSS for patients with sepsis ARDS receiving invasive mechanical ventilation. But the promising results of predictive performance estimates are not sufficient to assess AVA’s clinical safety and appropriateness prior to future evaluation and deployment. Therefore, we propose a Clinician Turing Test as a novel validation approach to determine whether clinicians can distinguish AVA-generated treatment recommendations from those enacted by real human clinicians. If AVA’s recommendations are consistently indistinguishable from those of real clinicians, thereby ‘passing’ this Turing test, this would provide a strong preclinical signal of safety and appropriateness.

This multisite, randomised, electronic, vignette-based Phase 1b study will use a Clinician Turing Test design. We aim to recruit 350 critical care clinicians, including physicians and advanced practice providers from six US hospitals. Participants will review nine clinical vignettes of patients with sepsis and ARDS derived from the Molecular Epidemiology of Severe Sepsis in the ICU cohort and an associated profile of a suggested treatment plan. For each participant–vignette combination, the source of the treatment profile will be randomly assigned (AI-generated by AVA vs the actually enacted treatment from real human clinicians) in a 1:1 allocation. The primary endpoint is the participants’ accuracy in identifying whether a treatment profile was AI-generated or human-generated, assessed using equivalence testing through a mixed-effects logistic regression model with random effects for participants and vignettes. Secondarily, a fitted binary classifier will assess discrimination ability using the C-statistic. Secondary endpoints include clinicians’ perceptions of the safety and appropriateness of the treatment profiles, confidence in distinguishing AI-generated and human-generated recommendations, interest in AI CDSSs for sepsis and ventilator management and the time to complete the survey. This novel Phase 1b design provides preliminary but essential information about an AI CDSS’s clinical appropriateness without the risk or cost of actual deployment, thereby informing decisions about future clinical implementation and evaluation in real clinical environments.

This protocol was approved by the Institutional Review Board of the University of Pennsylvania (Protocol #858201). Results are expected in 2026 and will be submitted for publication in peer-reviewed journals and presented at scientific conferences.

NCT07025096.

To explore existing strategies for managing sleep disorders in individuals with vision impairment (VI), identifying interventions, geographical trends and research gaps.

Scoping review.

Medline ALL (Ovid), Embase and Web of Science Core Collection, with supplementary searches in Google Scholar. The final search was completed on 28 November 2025.

Original research studies examining strategies to manage sleep disorders in adults (≥18 years) with VI, published in English. Studies focusing on animal models or unrelated to sleep management were excluded.

Two reviewers independently screened titles, abstracts and full texts using Covidence, extracted data using a predefined form and resolved discrepancies by consensus. A narrative synthesis approach was used to summarise findings by intervention type, study design and outcomes.

Of 4368 records screened, 16 studies met inclusion criteria. Participants ranged from 18 years to 85 years (median 40.5). Most studies included individuals with no light perception, though VI definitions were often inconsistent. Pharmacological interventions dominated (13/16, 81.3%), mainly melatonin or melatonin receptor agonists, with some use of zopiclone, low-dose benzodiazepines and tricyclic antidepressants. Non-pharmacological approaches were under-represented, including bright light exposure (n=1), virtual Hatha yoga (n=1) and caffeine modulation (n=1). Substantial variation existed in sleep assessment methods.

This scoping review highlights the predominant focus on pharmacological treatments, especially melatonin, while non-pharmacological strategies remain underexplored. Future research should explore accessible, non-pharmacological interventions and address sleep health inequities faced by individuals with VI.

10.17605/OSF.IO/7E83R.

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

NCT0665050.

Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.

This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.

Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).

In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.

ISRCTN (ISRCTN13317811).

Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited.

This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test.

The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal.

NCT06774820.

In 2023, 21% of deaths occurred in residential aged care facilities (RACFs), a setting expected to play an increasing role in palliative and end-of-life care (PEoLC). General practitioners (GPs) oversee and deliver PEoLC in residential and nursing homes, yet little is known about their practice. We conducted a systematic review of the published evidence concerning how GPs provide this care: what they do and the quality, challenges and facilitators of that care.

Systematic review and narrative synthesis using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Medline, Embase, CINAHL, PsycINFO, Web of Science, Scopus and NHS Evidence and grey literature via Google Scholar were searched through 9 October 2024.

We included studies presenting new empirical data from qualitative, quantitative or mixed methods, were published in the English language and conducted in the UK, the European Union, Australia, New Zealand and Canada. We excluded studies with no new empirical data, discussion papers, conference abstracts, opinion pieces, study participants under 18 years old and in care settings other than RACF.

One independent reviewer used standardised methods to search and screen study titles for inclusion. This reviewer assessed all abstracts of the included papers, and a second independent reviewer screened 60% of the abstracts to validate inclusion. Risk of bias was assessed using Gough’s Weight of Evidence assessment. Thematic analysis was used to describe the contents of the included papers; a narrative synthesis approach was taken to report the findings at a more conceptual level.

The search identified 5936 titles: 35 papers were eligible and included in the synthesis. This is a nascent evidence base, lacking robust research designs and characterised by small sample sizes; the results describe the factors observed to be important in the delivery of care. Care provision is extremely variable; no models of optimal care have been put forward or tested. Challenges to care provision occur at every level of the care system. At macro level, service-level agreements and policies vary: at meso level, team-working, communication technology solutions and equipment availability vary: at micro level, GPs’ interests in providing PEoLC vary as does their training. No study addresses residents’ and relatives’ experiences and expectations of GPs' involvement in PEoLC in RACFs.

The limited evidence base highlights that GP care at end of life for RACF residents varies greatly, with enablers and challenges at all levels in the existing care systems. Little research has examined GP PEoLC for RACF residents in its own right; insight is derived from studies that report on this issue as an adjunct to the main focus. With national policies focused on moving more PEoLC into community settings, these knowledge deficits require urgent attention.

Ambulatory care sensitive conditions (ACSCs) are conditions for which the provision of timely and skilled primary care can reduce risks of hospitalisation when preventing, treating or controlling a disease. For this reason, hospitalisations for ACSC have been commonly employed by health systems as an indicator of effectiveness for the primary level of care. This study aims to evaluate whether the provision of primary care services by physicians with residency training in family medicine is associated with rates of general hospitalisations for ACSCs in the Brazilian Unified Health System network in the city of Belo Horizonte, Brazil.

Longitudinal ecological study using a Generalised Linear Model for Gamma-distributed variables.

Primary healthcare centres in Belo Horizonte, Brazil, from January 2017 to December 2021, aggregated at the primary healthcare centres level.

Data aggregated at the primary healthcare centre level, encompassing socioeconomic, professional and health-related variables.

Incidence rates of hospitalisations for ACSCs, adjusted for age and sex.

After adjusting for age, sex and socioeconomic variables using the Health Vulnerability Index, a higher concentration of family physicians was significantly associated with a lower incidence of hospitalisations for ACSCs. If all physicians in the primary care network were family physicians, compared with a scenario in which none were, an estimated 11.89% reduction in hospitalisations would be expected (95% CI 7.3% to 16.3%, p

The findings suggest that specialisation in family medicine positively impacts health outcomes by reducing hospitalisations for ACSCs. These results can inform the development of evidence-based public policies to enhance primary care effectiveness.

Real-world data and patient-reported outcomes in diabetes in Emilia–Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia–Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.

The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019–2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0–6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.

The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.

NCT06639100.

This study aims at documenting the frequency of reported abuse, stigma and discrimination and exploring the perspectives for improving the quality of maternal-newborn care (QMNC) of migrant mothers’ reporting abuse, stigma or discrimination.

Mixed methods multicentre cross-sectional study.

All maternal facilities (tertiary and secondary levels of care, n=9) from Friuli-Venezia Giulia region, Northeast Italy, between November 2019 and January 2022 in Northeast Italy.

874 migrant and 3968 non-migrant women answering a validated WHO Standard-based questionnaire after birth.

Frequency of reported abuse, stigma and discrimination during facility-based childbirth was calculated and compared with those of non-migrant mothers. Thematic analysis was conducted on eight open questions, using WHO Standards as a framework for the analysis.

Among migrant women, 84 (9.6%) reported some type of abuse, stigma and discrimination, a frequency similar to non-migrant women (9.8%, p=0.880). The most frequently reported was verbal abuse (87.7%), followed by stigma and discrimination (15.1%). Most women (86.9%) provided at least one comment, with a frequency comparable to non-migrant women (p=0.076). Among a total of 327 comments, 104 (31.8%) were practical suggestions for improving QMNC. Experience of care was the domain with the highest frequency both of negative (64.9% of negative comments) and positive comments (51.7% of positive comments) and with the highest frequency of suggestions for improving QMNC (52.9% of suggestions). Overall, suggestions mainly focused on strengthening healthcare professionals’ communication skills, allowing companionship during childbirth, increasing healthcare professionals’ availability and timely support.

This study shows that both migrant and non-migrant mothers are exposed to abuse, stigma and discrimination during childbirth, and that both are willing to provide practical suggestions, which should be used for planning actions to improve QMNC.

Patients with acute psychiatric symptoms are often referred to the emergency department (ED) for medical evaluation to exclude medical causes before psychiatric admission. The absence of a prospectively validated medical screening tool leads to wide practice variation. This study aims to develop a new, evidence-based and consensus-based medical screening tool through a collaborative, interdisciplinary, international Delphi approach.

This modified Delphi study will include representatives from emergency medicine and psychiatry societies across four continents, as well as patient representatives with prior experience of medical screening in the ED. A minimum sample size of 24 participants is planned to account for potential dropouts. The Delphi procedure consists of four rounds. Round 1 will present current evidence and identify key items for the new medical screening tool. Round 2 will evaluate and refine statements from Round 1. Round 3 will seek consensus on the variables to be included in a medical screening tool. In Round 4, hypothetical clinical vignettes will be used to assess the agreement on the recommendations of the newly developed medical screening tool in order to test for content and construct validity. Surveys will be conducted via Research Electronic Data Capture (REDCap), with participants rating statements on a 6-point Likert scale. Response stability will be evaluated using the intraclass correlation coefficient, and consensus defined as ≥80% agreement. Results will be reported according to the ACcurate COnsensus Reporting Document guidelines and the Guidance for Reporting Involvement of Patients and the Public 2 short form.

The Ethics Committee of Northwestern and Central Switzerland exempted the project from committee approval under the Human Research Act on 11 September 2024. Written consent will be obtained from all participants. Results of this study will be summarised as a medical screening tool which will be validated in a prospective, multicentre study in a second step.

NCT06936826.

To understand why patients with chronic kidney disease (CKD) may not be treated according to international guidelines for myocardial infarction (MI).

Multicentre qualitative interview study. Interviews were analysed using reflexive thematic analysis approach as outlined by Braun and Clarke to generate themes associated with MI treatment decision-making for, and by, patients with CKD.

Four National Health Service hospital centres in the UK (February 2022 to July 2024).

A purposive sample of 46 participants (patients and clinicians). Clinicians (n=32) were senior doctors-in-training or consultants in cardiology, nephrology, acute or emergency care or cardiac surgery. Patient participants (n=14) had CKD, defined as an estimated glomerular filtration rate 2, or receipt of kidney replacement therapy (KRT).

Despite expressing strong views regarding their health priorities, patients reported minimal involvement in treatment decision-making. Decision-making by clinicians was driven by the desire to avoid causing harm to patients by ‘active’ treatment initiation. In general, despite the concept of evidence-based medicine being widely accepted, there remained scepticism of guidelines or epidemiological data, especially in the light of personal adverse experiences or anecdotes. Clinicians described how, in the absence of collaborative decision-making and a clinical safety-net for managing treatment complications, they tended to make conservative treatment decisions for patients with CKD.

Interventions to foster teamworking between specialists and ensure adequately resourced specialist clinical service safety-nets may improve access to treatments for MI for people with CKD. Intervention development and evaluation should follow to determine if outcomes for people with CKD and MI can be improved.

A substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression.

A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep.

The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences.

NCT06005103.

Suicide is a leading cause of preventable death worldwide. Evidence supports the impact of providing active contact for individuals who have attempted suicide. The current systematic review and meta-analyses aim to investigate the effects of suicide prevention strategies implemented through remote and synchronous technology-based interventions.

Systematic review, narrative synthesis and meta-analysis.

Electronic databases (PubMed, PsycINFO, Scopus and Web of Science) and grey literature sources (ClinicalTrials.gov and Google Scholar) were searched until December 2024.

Eligible articles assessed suicide prevention interventions for participants over 12 years with prior suicidal behaviour. Eligible study designs included randomised controlled trials and non-randomised clinical trials published in English or Spanish.

Screening, selection process, data extraction and risk of bias assessment were performed independently by two reviewers. Data on suicide-related factors and adherence to treatment were extracted. Meta-analyses were conducted to determine effect sizes (Hedges’ g) for suicidal ideation, risk ratios (RR) for suicide attempts and Peto odds ratios (OR) for suicide. Heterogeneity was assessed using the Cochrane’s Q test, tau² statistic and I² value. Publication bias was investigated employing funnel plots and Egger’s test.

A total of 28 studies, comprising 10 015 participants in the intervention group and 10 726 in the comparison group, were included in the systematic review and meta-analyses. Synchronous remote-based interventions were effective in preventing repeated suicide attempts at 1 month (RR 0.73, 95% CI 0.62 to 0.85, I²=0.0%, Q=0.70, tau²=0.00), 6 months (RR 0.56, 95% CI 0.34 to 0.95, I²=85.4%, Q=54.92, tau²=0.36) and 12 months (RR 0.68, 95% CI 0.49 to 0.96, I²=87.6%, Q=72.63, tau²=0.27). Additionally, these interventions were associated with a reduction in suicide-related deaths at 18 months (Peto OR 0.18, 95% CI 0.08 to 0.44, I²=0.0%, Q=0.03, tau²=0.00). Effects on suicidal ideation were not statistically significant at any time point (Hedges’ g –0.07 to –0.28, I²=0.0 to 69.3%, Q=1.16 to 7.38, tau²=0.00 to 0.14).

Synchronous remote-based interventions demonstrate a potential benefit in preventing suicide attempts and deaths by suicide and may serve as an adjunct to usual treatment; however, the effect on suicidal ideation appears limited. The observed heterogeneity warrants caution when interpreting these findings. Future research should prioritise methodological enhancements to improve the quality and consistency of evidence, as well as investigate the mediating processes underlying their effectiveness in reducing suicidal behaviour.

CRD42021275044.