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Ayer — Junio 24th 2026Tus fuentes RSS

LATAM-AKID registry: an international multicentre, observational study of acute kidney injury requiring dialysis in Latin America

Por: Rehman · A. U. · Nombera-Aznaran · N. · Renzi · S. · Ghazi · L. · Tolwani · A. J. · Molano Trivino · A. · Reis · T. · Vega-Vega · O. · Rizo-Topete · L. · Claure-Del Granado · R. · Neyra · J. A.
Background

Acute kidney injury requiring dialysis (AKI-D) is a major contributor to morbidity and mortality worldwide, with the highest burden observed in low- and lower-middle-income countries (LLMICs). In Latin America (LATAM), a region composed largely of LLMICs, the lack of region-specific data leads to variable clinical practices and inconsistent health policies for AKI, which remain major barriers to optimal kidney care. The LATAM-AKID registry aims to fill this gap and systematically characterise the epidemiology, processes of care and outcomes of patients with AKI-D across representative countries of LATAM.

Methods and analysis

LATAM-AKID is an international, multicentre, retrospective cohort study that will enrol consecutive critically ill adults with Kidney Disease: Improving Global Outcomes stage 3 AKI requiring dialysis. Different hospitals across 10 Latin American countries will contribute data through a standardised REDCap platform hosted at the University of Alabama at Birmingham. Deidentified data will be collected at baseline, intensive care unit (ICU) admission and renal replacement therapy (RRT) initiation, with follow-up for up to 7 days to capture ICU- and RRT-related clinical data. Study outcomes will be assessed at ICU and hospital discharge and at 90-day follow-up. The primary outcome is in-hospital mortality. Secondary outcomes include ICU mortality, 90-day mortality, ICU and hospital lengths of stay, status of renal recovery and RRT dependence at hospital discharge and at 90-day follow-up, and RRT processes and complications related to anticoagulation, catheter dysfunction, infection and circuit interruptions. Data will be analysed using multivariable logistic and Cox regression models, with planned subgroup analyses by RRT modality (continuous vs intermittent), patient-level illness severity, hospital characteristics and country gross national income categories.

Ethics and dissemination

This study has been approved by the institutional review board of the University of Alabama at Birmingham (IRB-300013633). Local ethics committee approvals will also be obtained at all participating sites. Results from this work will be disseminated by publications in peer-reviewed journals and presentations at national and international scientific meetings.

Trial registration number

This study has been registered with clinicaltrials.gov (NCT07262320).

Leave policy after stillbirth in LMICs: how much are we thinking about bereaved mothers? A scoping review

Por: Pandey · A. K. · Gautam · D. · Sachdeva · R. · Sheikh · N. · Sharma · P. · Agarwal · P. · Pandey · A. · Sehrawat · A. · M · B. T. · Sah · R. K. · Neogi · S. B.
Introduction

Low-income and-middle-income countries (LMICs) contribute to the maximum burden of stillbirth globally, which affects parents in various tangible and intangible ways, emphasising the need for having a provision of parental leave to recover from the physical and mental/emotional drain. In response to this, we conducted a scoping review with the objective of identifying provision of leave within maternity benefit policies after stillbirth in LMICs.

Methodology

The study is conducted in accordance with Joanna Briggs Institute guidelines, using the population, concept and context framework to define the research questions. The International Labour Organization (ILO) global care policy portal and documents from selected international United Nations (UN) organisations were reviewed to assess the inclusion of stillbirth within maternity leave policies. Additionally, country-specific maternity leave policies were retrieved from official government sources for LMICs. Fuerther, databases including PubMed, Web of Science, Scopus and ProQuest were searched for studies from LMICs to identify literature with recommendations around leave policy. Study selection and data extraction were conducted by two independent reviewers with arbitration by a third reviewer.

Results

This study noted a stark difference in the leave policy; although all 49 LMICs included in the review had a national maternity leave policy, 67.3% did not align with ILO’s Convention number 183. In contrast, only 10 countries (

Conclusion

Leave grant showed stark disparity. Ignoring the need for physical rest may have long-term health implications. Organisations should have a provision to support women having a stillbirth. Having a provision for flexible leave options allows women to decide when they are emotionally and physically ready to return, rather than forcing a one-size-fits-all solution.

Leader perspectives on implementing Time Together: a qualitative process evaluation using the Consolidated Framework for Implementation Research

Por: Glantz · A. · Lindgren · B.-M. · Nilsson · I. · Westerlund · A. · Graneheim · U. H. · Molin · J.
Objectives

Time Together (TT) is a nursing intervention designed with a focus on increasing the possibility of patients and staff engaging in joint activities. Previous research points towards implementation difficulties but there are no studies specifically investigating the process of implementing TT in psychiatric inpatient care (PIC). Therefore, the aim of this study is to explore mid-level leaders’ and implementation leads’ perspectives on implementing TT in PIC, analysed through the Consolidated Framework for Implementation Research (CFIR).

Design

This qualitative study used semistructured interviews with 11 mid-level leaders and implementation leads who took part in implementing TT. The interviews were analysed using deductive qualitative content analysis, with the CFIR applied as a structured matrix in the analysis.

Setting

The study was conducted in PIC settings at three wards within secondary care healthcare services in northern Sweden.

Participants

Participants were 11 mid-level leaders and implementation leads involved in the implementation of TT in PIC.

Interventions

TT is scheduled for 1 hour, 5 days a week. During this hour, nursing staff and patients engage in joint activities, while one or two staff members oversee administrative duties. No meetings, visits or other ward-related activities are scheduled during this hour.

Results

Deductive content analysis resulted in 15 categories sorted into 4 domains and 11 constructs. TT was perceived as advantageous and aligned with the wards’ mission. However, one key finding was that mid-level leaders and implementation leads found implementation challenging as they perceived that some innovation deliverers viewed joint activities within TT as lacking value and not being ‘proper work’. Furthermore, there was a need for more information and a clearer rationale for the intervention in order to improve implementation and delivery.

Conclusions

The findings indicate a discrepancy in values and attitudes between leaders and innovation deliverers regarding what constitutes meaningful care in psychiatric inpatient settings. Implementation was further influenced by challenges related to leadership and motivating others. Barriers to implementing TT may not be addressable through implementation and intervention training alone. Instead, implementation planning should also consider intervention deliverers’ values and beliefs.

Effects of auricular vagal neuromodulation therapy combined with slow-paced diaphragmatic breathing in individuals with postural tachycardia syndrome: a randomised controlled trial protocol

Por: Brandl · T. · Pichler · F. · Grabovac · I. · Waldhoer · T. · Keller · H. · Fenneker · D. · Niessner · A. · Kapan · A.
Introduction

Postural orthostatic tachycardia syndrome (POTS) is a multifactorial disorder of the autonomic nervous system characterised by an excessive increase in heart rate (HR) on standing and a wide range of debilitating symptoms, including fatigue, exercise intolerance, cognitive impairment and a high prevalence of depression, anxiety and sleep disturbances. Conventional pharmacological strategies often offer limited relief and do not sufficiently address non-cardiac symptoms. Auricular vagal neuromodulation therapy (AVNT) and slow-paced diaphragmatic breathing (SDB) have each demonstrated promise in modulating autonomic function and alleviating symptom burden but their combined effects in POTS have yet to be investigated.

Methods and analysis

This single-centre, partially blinded, 12-week randomised controlled trial will be conducted at the Medical University of Vienna. A total of 100 participants with confirmed POTS will be recruited, with 25 per group. This sample size is already accounting for an anticipated 30% dropout rate. Participants will be randomised using stratified block randomisation with a 1:1:1:1 allocation ratio, stratified based on the presence or absence of post-exertional malaise (yes/no) to one of four groups: (1) AVNT+SDB, (2) AVNT+normal breathing, (3) sham AVNT+SDB and (4) sham AVNT+normal breathing. The primary endpoint is the change in orthostatic HR (HR) during a 70° head-up tilt test. Secondary outcomes include beat-to-beat blood pressure responses, respiratory sinus arrhythmia, end-tidal CO2, handgrip strength, activity monitoring and validated patient-reported measures, including Chalder Fatigue Scale, Malmö POTS Symptom Score, Nijmegen Questionnaire, Short Form Health Survey, Hospital Anxiety and Depression Scale and Vanderbilt Orthostatic Symptom Score. Interventions consist of daily 60-minute AVNT (or sham) sessions combined with standardised breathing training (10–15 min/day).

Ethics and dissemination

This study has been approved by the Ethics Committee of the Medical University of Vienna (EK number 1270/2024) and will be conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation-Good Clinical Practice guidelines. Results will be disseminated through peer-reviewed publications, conference presentations and reporting in the trial registry. Participants will receive study results in an accessible format.

Trial registration number

NCT06996314.

Caregiver experiences of social isolation and loneliness in chronic kidney disease: systematic review of qualitative studies

Por: Farzana · N. · Guha · C. · Jasim · N. · Sluiter · A. · Jaure · A. · Manera · K.
Objectives

This qualitative systematic review aimed to describe the experiences and perspectives of loneliness and social isolation among informal caregivers of people with chronic kidney disease (CKD).

Methods

Terms for caregivers, qualitative research, loneliness and social isolation and CKD were entered into MEDLINE, Embase, CINAHL and PsycINFO and searched from inception to May 2025. Qualitative studies that described social isolation and loneliness among caregivers of people with CKD were included in this review. Study characteristics were extracted into Microsoft Excel. Qualitative data from each study were imported into HyperRESEARCH and analysed using thematic synthesis.

Results

We included 19 articles involving 598 caregivers of people with CKD from 28 countries. Four major themes with subthemes were identified: confined by the patient’s needs (social withdrawal due to unrelenting demands, separated from communities due to treatment, torn between work and caregiving responsibilities, foregoing social outings with family and friends, restricted by patient’s diet, feeling protective against infection risk); limited care assistance exacerbating isolation (inadequate familial support, absence of respite care, lacking accessible guidance from health professionals); disrupting relationships and social roles (sacrificing social needs and identity, family conflicts worsening isolation, withdrawing to avoid stigma and ridicule, grappling with hopelessness, reluctance to share struggles); and coping with support resources (connecting with other families, seeking assistance from support services, finding support through faith).

Conclusions

Caregivers of people with CKD experience restricted social participation and loss of social roles and identity, which can exacerbate feelings of loneliness and social isolation. Support services are needed to prevent and address social isolation and loneliness in CKD caregivers.

PROSPERO registration number

CRD420250637194.

Family or caregiver outcomes after critical illness (FOCUS): a protocol for a core outcome set development study

Por: Brown · C. · Hartley · P. · Malyon · A. · Connolly · B. · Lone · N. I. · McPeake · J.
Introduction

Family members of survivors of critical illness are known to experience adverse outcomes in the months following the critical care admission, which can impact their physical, social and emotional health. This protocol describes the Family or Caregiver Outcomes after critical illness (FOCUS) study, which aims to develop a core outcome set (COS) for trials involving family members of critical care patients across the continuum of care.

Methods and analysis

A modified Delphi consensus process with researcher, clinician and patient/caregiver stakeholder groups and consensus meetings for ratification of findings, resolving uncertainty and developing an action plan for COS implementation.

Ethics and dissemination

The FOCUS COS will inform relevant stakeholders about important outcomes for family members of critical care patients and may enhance the future design and conduct of trials in this area. This study has been approved by the University of Cambridge Psychology Research Ethics Committee. The COS will be disseminated through peer-reviewed publications and engagement with key stakeholders.

Trial registration number

COMET database (https://comet-initiative.org/Studies/Details/1977).

Preoperative stress markers as predictors of postoperative neuropsychological disorders in cardiac surgery patients: protocol for a single-centre prospective observational study (CAVALIR)

Por: Butz · M. · Meyer · R. · Gerriets · T. · Hänsel · C. · Schmidt · H. · Bach · J. Y. · Marek · A. · Tschernatsch · M. · Alhaj-Omar · O. · Schramm · P. · Krämer · H. H. · Choi · Y.-H. · Sossalla · S. · Keller · T. · Schoenburg · M. · Juenemann · M.
Introduction

Postoperative neuropsychological disorders including delirium, cognitive dysfunction and emotional distress are common after cardiac surgery and are linked to reduced quality of life, morbidity and mortality. Reliable preoperative risk factors remain difficult to identify. This study investigates stress-related parameters as predictors of postoperative neuropsychological disorders in patients undergoing cardiac surgery.

Methods and analysis

In this prospective study, 240 patients undergoing elective cardiac surgery (coronary artery bypass grafting: n=120, aortic valve replacement: n=120) with extracorporeal circulation at the Kerckhoff-Clinic Bad Nauheim (Germany) will be enrolled. Preoperative stress factors will be assessed using measures of stress-related personality traits, perceived stress, anxiety, depression, salivary cortisol and heart rate variability. Postoperative neuropsychological disorders will be evaluated through diagnosis of delirium in both the intensive care unit and on the standard ward. Additional neurocognitive dysfunctions and emotional distress will be assessed at hospital discharge and 3 months postoperatively, with corresponding preoperative baseline measurements.

Discussion

If stress measures prove to be predictive, they may enhance understanding of postoperative neurocognitive and emotional disorders and facilitate the development of risk stratification algorithms, enabling more effective preventive strategies for high-risk patients.

Ethics and dissemination

The study was approved by the Ethics Committee of Justus Liebig University Giessen (Ref.: 54/24) and is conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from the patients. Results will be disseminated through peer-reviewed publications and scientific conferences.

Trial registration number

Prospectively registered with the German Clinical Trials Register (DRKS00035318).

Diagnostic yield of electroencephalographyin the emergency department: protocol for the EMINENCE-M multicentre retrospective observational study

Por: Scarpino · M. · Piccardi · B. · Nencioni · A. · Nazerian · P. · Lettieri · F. · Grassi · E. · Marra · E. · Mannini · A. · Maiorelli · A. · Liuzzi · P. · Grippo · A. · The Eminence Study Group
Introduction

Emergency EEG (emEEG) is increasingly used in the emergency department (ED), but its diagnostic yield remains uncertain. This protocol describes a multicentre observational study aiming to evaluate emEEG findings and their relationship with diagnostic pathways and therapeutic management of patients admitted to the ED.

Methods and analysis

This multicentre retrospective study will analyse emEEGs performed on patients admitted to the ED of some Italian teaching and community hospitals over a 1-year period with a target sample size of 3850 patients. The diagnostic yield of emEEG will be evaluated by assessing abnormal and epileptiform findings and the relationship between emEEG findings and subsequent clinical decisions, including confirmation or revision of the initial diagnostic suspicion, decisions regarding home discharge or hospitalisation and medication changes. EEG will be classified according to the terminology of the American Clinical Neurophysiology Society. Clinical and instrumental data will be respectively reviewed by emergency physicians and neurologists/neurophysiologists. In particular, via traditional biostatistics and interpretable machine learning models, the study will evaluate the diagnostic yield of emEEG and its association with subsequent clinical management across defined clinical scenarios in the ED.

Ethics and dissemination

This first large-scale multicentre protocol will provide valuable insights for emergency department (ED) clinicians in selecting appropriate candidates for an emergency EEG (emEEG), supporting ethically sound, proportionate use of this resource in a time- and risk-critical setting. By clarifying diagnostic yield and its relationship with subsequent clinical decisions, the study is expected to generate robust evidence to guide emEEG ordering, reduce unnecessary testing and delays, and promote safer, more equitable decision-making (including appropriate home discharge) while minimising potential harms from misdiagnosis or overtreatment. The study has been approved by the Ethics Committee Regione Toscana - Area Vasta Centro (n. 27241). Findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant clinical societies to inform international recommendations and facilitate translation into ED practice. Furthermore, developed models will be made openly available for external and public validation.

Preoperative Risk Evaluation for Cancer Treatment (PREdiCT): protocol for an international cohort study evaluating a trimodal screening tool to predict outcomes following gastrointestinal cancer surgery

Por: Reeves · J. · Koh · C. · Alexander · K. · Solomon · M. · Karunaratne · S. · Petridis · A. · Carey · S. · Dhillon · H. · White · K. · Pillinger · N. · Gillis · C. · Hirst · N. · Shadid · Z. · Rahman · M. I. · Boden · I. · Mahoney · A. · Woodfield · J. · Vagg · D. · De Boer · H. D. · Sutton · P
Introduction

Gastrointestinal cancer surgery commonly leads to postoperative complications and other adverse outcomes. While prehabilitation shows promise in reducing adverse postoperative outcomes, most hospitals have resource limitations that preclude its use as standard of care. Additionally, the need to expedite surgery from diagnosis often creates a narrow window for prehabilitation initiatives. Online, self-reported screening tools may address these challenges by facilitating early identification of high-risk patients and enabling targeted preoperative interventions, thereby allowing equitable allocation of limited resources. Therefore, the primary aim of this study is to evaluate the predictive utility of a tri-modal (physical, nutritional, psychological) screening tool for patients undergoing gastrointestinal cancer surgery.

Methods

This prospective international cohort study will recruit 1214 adults undergoing elective gastrointestinal cancer surgery across 35 sites from 19 countries. Participants will complete an online screening tool developed through a comprehensive, multistep, predefined process. The screening tool comprises the Duke Activity Status Index, Patient-Generated Subjective Global Assessment Short Form and the Patient Health Questionnaire-4, in English, Spanish, French or Portuguese. These tools were selected based on a scoping review, followed by an international Delphi consensus process. The primary outcomes include rate of postoperative complications, major complications (Clavien-Dindo Classification grade III–V) and overall complication severity assessed by the Comprehensive Complications Index; all assessed 30 days postoperatively. Secondary outcomes include hospital length of stay, readmission rate within 30 days, discharge destination (home vs other), days at home and alive in 30 days postsurgery, 30-day all-cause mortality and 12-month survival. Primary analyses will establish optimal screening tool cut-points to stratify patients into clinically actionable risk categories for postoperative complications and examine the independent predictive value of these screening scores after adjusting for established clinical risk factors.

Ethics and dissemination

This study has received ethical approval from the Sydney Local Health District Human Research and Ethics Committee (X25-0333 and 2025/ETH02465) and has been registered on the Open Science Framework (10.17605/OSF.IO/HVCGD). The results of Preoperative Risk Evaluation for Cancer Treatment will be submitted to reputable journals and presented at national and international conferences.

Narrative exposure therapy in early intervention in psychosis services (NETp): protocol of a multi-site feasibility randomised controlled trial study

Por: Fornells-Ambrojo · M. · Plaistow · J. · Hardy · A. · Martin · P. · Lyons · N. · Khan · Z. · Mberi · A. · Morris · T. · Johnson · S.
Introduction

Cumulative interpersonal traumatisation increases the risk of psychosis and is linked to psychotic symptom severity and reduced recovery rates. Psychosis and treatment themselves can also be traumatising, with a first episode of psychosis posing challenges to one’s identity. Despite a growing evidence base for the safety and effectiveness of trauma therapies for psychosis, implementation remains poor in early intervention for psychosis (EIP) services, partly due to resource constraints. Narrative exposure therapy (NET) is an effective intervention for post-traumatic stress disorder in ethnically diverse populations. Crucially it has potential to address barriers to implementation of trauma therapies in EIP as it has a brief duration with minimal training requirements. This feasibility study will evaluate the feasibility and acceptability of conducting a definite trial of NET in people with early psychosis.

Methods and analysis

An individually randomised parallel groups feasibility randomised controlled trial with embedded qualitative evaluation will be conducted. 50 individuals with first episode psychosis and a history of multiple trauma under the care of an EIP service in two NHS trusts in England will be recruited. Participants will be randomised to receive either 15 sessions of NET in addition to treatment as usual or treatment as usual alone. Assessor blinded assessments will be conducted at baseline, 4 months (post-intervention) and 8 months (follow-up). Analyses will focus on feasibility outcomes (recruitment, retention and completion rates) and preliminary estimates of intervention effects to inform planning for a fully powered trial. Qualitative interviews will be carried out with participants allocated to NET and clinicians to investigate acceptability, barriers and facilitators, possible mechanisms of change, potential benefits or harms and recommendations. A sub-study in the NET group will investigate acceptability of completing Experience Sampling Data daily during therapy to monitor changes on candidate primary and secondary outcomes.

Ethics and dissemination

This study received REC/HRA ethical approval from the London - City & East Research Ethics Committee (REC) (25/LO/0350). The results of the study will be reported and disseminated at international conferences and in open-access peer-reviewed scientific journals.

Trial registration number

ISRCTN39471182.

Oral oxycodone versus sublingual buprenorphine for postoperative pain control after pelvic exenteration (PROSPER): a pilot, registry-embedded, multi-centre, double-blind, placebo-controlled, randomised controlled trial

Por: Johnstone · C. · Koh · C. · Mathieson · S. · Steffens · D. · White · K. · Gray · P. · Harris · C. · Heriot · A. · Kramer · K. · Law · C. K. · Lin · C.-W. C. · Liu · X. · Machado · G. · McLachlan · A. · Penm · J. · Riedel · B. · Sammour · T. · Sanders · R. · Solomon · M. · Whitehead · L. · Wint
Objectives

This study aims to estimate the rate of recruitment of participants.

Design

This is a pilot, multicentre, double-blind, placebo-controlled, randomised controlled trial of oral oxycodone and sublingual placebo vs sublingual buprenorphine and oral placebo for postoperative pain management for 7 days after pelvic exenteration.

Setting

Patients will be recruited from three metropolitan quaternary referral centres that offer advanced gastrointestinal surgery in Australia.

Participants

The inclusion criteria will be patients over the age of 18 years undergoing pelvic exenteration surgery and exclusion criteria are previous adverse events related to the study drugs, currently requiring monoamine oxidase inhibitor medications and if epidural analgesia is planned in the perioperative period.

Interventions

Enrolled patients will undergo pelvic exenteration surgery and be initiated postoperatively on patient-controlled analgesia. In the postoperative period, when clinically appropriate to take oral medications, patients will be commenced on trial analgesia for 7 days. Participants will be randomised to receive either oral active oxycodone 5–10 mg up to 3 hourly as required (with sublingual placebo) or sublingual active buprenorphine 200–400 mcg 3 hourly as required (with oral placebo).

Main outcome measures

The primary outcome measure is the rate of recruitment over a 6-month period. Secondary outcomes include an assessment of missing data, protocol adherence and acceptability of the trial to participants.

Ethics and dissemination

The trial received ethics approval from Sydney Local Health District, Royal Prince Alfred Hospital Human Research Ethics Committee (No: X25-0128 & 2025/ETH01058). The results of the study will be disseminated by publication and presentation at local annual scientific meetings in Australia.

Trial registration number

The study protocol is prospectively registered at the Australian New Zealand Clinical Trials Registry (ANZCTR) (www.anzctr.org.au; ACTRN12625000901404).

Uptake and predictors of newborn respiratory syncytial virus (RSV) immunisation with nirsevimab in Irelands national pilot programme: a cross-sectional study

Por: Masukume · G. · McMorrow · A. · Dawood · I. · Rafdhy · K. · OBrien · F. · Desmond · C. · OConnell · D. · Murphy · B. · Ronan · E. · Purtill · H. · Philip · R. K.
Objectives

To assess uptake of nirsevimab, a long-acting monoclonal antibody for respiratory syncytial virus (RSV) prevention, during the first season of Ireland’s Pathfinder pilot universal newborn immunisation programme and to identify socio-demographic and perinatal predictors of uptake.

Design

Cross-sectional analysis of routinely collected programme data.

Setting

Ireland’s Mid-West region, served by University Maternity Hospital Limerick, the sole maternity and neonatal hospital for the region.

Participants

Infants born 1 September 2024 to 28 February 2025.

Outcome measure

Uptake of nirsevimab before hospital discharge.

Results

Overall uptake was 89.4% (1600/1790) and did not vary by month (p=0.119); it was similar by sex (male 89.5%, female 89.2%; p=0.838). Preterm infants had higher uptake than term (96.9% vs 88.7%; p=0.001), and those admitted to the neonatal unit also had higher uptake (93.0% vs 88.4%; p=0.009). In adjusted analyses, maternal age (adjusted OR (aOR) 1.06 per year, 95% CI 1.03 to 1.09, p

Conclusions

During the first season of Ireland’s Pathfinder RSV pilot programme in the Mid-West region, nearly 90% of newborns received nirsevimab before discharge. Uptake was consistently high across months, indicating effective implementation but lower among infants of Irish Traveller and other white background mothers, highlighting the need for targeted, culturally adaptable equity strategies within a high-uptake programme. These findings may inform national and international policies and offer practical lessons for universal RSV immunisation.

Development of phenotype algorithms for the detection of adverse events in electronic health record data: a multicentre study

Por: Redeker · L. · Haerdtlein · A. · Wermund · A. M. · Mussawy · B. · Rottenkolber · M. · Coenen · M. · Dürr · P. · Federbusch · M. · Jüttner · C. P. · Schuster · A. K. · Seidling · H. M. · Uciteli · A. · Beger · C. · Neumann · D. · Loeffler · M. · Dreischulte · T. · Schmiedl · S. · on b
Objectives

To develop phenotype algorithms for the detection of adverse events (AEs) or AE-proxies in electronic health records (EHRs), accounting for varying data availability.

Design

Multicentre study conducted as part of the Use Case POLAR_MI (POLypharmacy, drug interActions, Risks) of the German Medical Informatics Initiative (MII).

Setting

Germany.

Participants

Multidisciplinary teams from 10 German university sites within the MII.

Interventions

Not applicable.

Main outcome measures

Literature- and consensus-based development and operationalisation of AE algorithms using structured EHR data, including a standardised, multicentre expert review process. Data categories used: International Classification of Diseases, 10th Revision (ICD-10) codes for diagnoses; Anatomical Therapeutic Chemical (ATC) codes and ‘Pharmazentralnummern’ (PZN; German eight-digit identification code for pharmaceutical products) for medications (used in the treatment of AEs); Logical Observation Identifiers Names and Codes (LOINC) for laboratory values and medical findings; and ‘Operationen- und Prozedurenschlüssel’ (OPS; German procedure classification) codes for medical and surgical procedures.

Results

We developed 82 algorithms for 48 AEs. Algorithms for the same AE varied by data categories or code selections. At the AE level, 31 AEs were covered exclusively by newly developed algorithms, and 17 AEs by at least one modified algorithm.

Overall, 52 algorithms were based on a single data category, while 30 required multiple categories. ICD-10 codes were most commonly used (n=65 AE algorithms), followed by LOINC (n=27), ATC codes (n=18), OPS codes (n=11) and PZN (n=2). All phenotype algorithms were semantically modelled and can be executed using the publicly available Terminology- and Ontology-based Phenotyping (TOP) Framework, which supports export in various formats.

Conclusion

We present a peer-reviewed set of algorithms for a large number of AEs, which can be implemented in structured routine electronic data sources and (pending validation studies) may support pharmacoepidemiologic research. The algorithms will be implementable across all 39 participating sites of the German MII. As a next step, we will empirically validate the algorithms against all information (including free text) contained in EHRs.

Trial registration

Not applicable.

Long-term disparities and mediators of psychological distress in mothers with and without out-of-home care experience: analysis of prospective cohort data

Por: Park · J. · Hiller · R. M. · Shelton · K. · Carter · B. · Sprecher · E. A. · Mckeaveney · E. · Damman · J. L. · Robinson · C. · Ramsay-Patel · T. · Holmes · L.
Objectives

Care-experienced individuals are at elevated risk of mental health difficulties, yet less is known about their mental health needs in motherhood. This study aims to explore (a) disparities in trajectories of psychological distress in care-experienced versus non-care-experienced mothers as they raise their child from age 3 to 14, and (b) putative postpartum-associated pathways shaping disparities in maternal distress at child age 14.

Design and setting

We conducted longitudinal secondary data analysis using the prospective United Kingdom Millennium Cohort Study data.

Participants

11 252 mothers and their children were included in the analysis, including mothers who experienced out-of-home care in their childhood (N=156).

Outcomes

The primary outcomes were psychological distress of mothers at child ages 3, 5, 7, 11 and 14.

Results

Relative to non-care-experienced mothers, care-experienced mothers were consistently more likely to experience distress across child ages 3–14 (coefficient (B)=1.36 (95% CI 0.85 to 1.87) pp=0.005), lower locus of control (B=0.31 (95% CI 0.11 to 0.51) p=0.002), lower income (B=0.28 (95% CI 0.15 to 0.41) pp=0.006) in their child’s infancy.

Conclusions

Our evidence underscores the potential value of holistically considering postpartum mental health, psychosocial and financial resources in maternal and early childhood public health interventions to disrupt the cumulative inequity likely faced by care-experienced mothers and prevent their mental ill-health in the long term.

Addressing the gaps: a mixed-methods scoping review on comprehensive sexuality education training for school educators

Por: Isa · A. · Shalash · A. · Ghanem · M. · Nemer · M.
Introduction

Comprehensive sexuality education is an educational approach that addresses the cognitive, emotional, physical and social aspects of sexuality. When taught consistently and age-appropriately, it expands survival, health and life benefits for young people everywhere. To provide an efficient, comprehensive sexuality education curriculum, educators must be equipped with proper training.

Objective

This scoping review aimed to map and identify research gaps in the existing literature on educators’ training in comprehensive sexuality education, examine facilitators and barriers to training and curriculum implementation, and highlight areas requiring further investigation.

Methods

A comprehensive search of six academic databases was conducted, followed by a mixed-methods approach to analyse the data. Narrative synthesis and data mapping were used to analyse study characteristics for all the included studies. Descriptive statistics were used to analyse quantitative data and thematic analysis guided by an inductive approach was used to analyse common themes and sub-themes for qualitative data.

Results

A total of 74 studies (qualitative n=31; quantitative n=24; mixed methods n=19) were included in this review. The results of this review found that preservice educator training to be the most effective training approach. Additionally, results found that the best training duration is context-dependent but should incorporate a combination of in-person and online training methods that include follow-up technical support strategies.

Conclusions

Due to the regional disparities identified in this review, future research needs to focus on the Eastern Mediterranean and Southeast Asia regions. The findings of this scoping review provide researchers with evidence-based knowledge to make practical recommendations for an efficient comprehensive sexuality education training programme for educators while addressing barriers to training, as well as facilitators and barriers to implementation.

Local performance and fairness testing of an AI Scribe in a paediatric developmental assessment clinic in South Australia: a silent trial protocol

Por: McCradden · M. D. · Tng · S. · Jeyaseelan · D. · Leane · C. · Campbell · M. · Braund · T. · Earle-Bandaralage · L. · Ebrahimi · M. · Sharma · A. · Tang · J.
Introduction

Any tool that can reduce the administrative burden on healthcare providers while preserving safe, accountable and high-quality medical documentation is of immense value both to healthcare institutions and consumers. The key question we need to answer is whether a prospective tool can reduce these burdens while maintaining (and, ideally elevating) quality documentation standards. The goal of this study is to describe the local performance of a large language model-based documentation assistive tool to draft safe, high-quality documentation in the Child Development Unit at the Women’s and Children’s Hospital. By generating local evidence of performance, we can assess the suitability of the artificial intelligence (AI) Scribe and inform a larger interventional study protocol and establish evidence-based governance.

Methods and analysis

Using an algorithmic audit framework developed specific to our context, we will compare clinician-written clinical notes to AI-generated notes produced in parallel to the standard of care (ie, a ‘silent’ or translational trial paradigm). We will compare the time required to review clinical documentation per the standard of care compared with the AI-supported workflow with consideration to the accuracy of the final documentation. Finally, we will qualitatively describe AI-generated notes and compare them to the current standard to identify specific areas where clinical guidelines (eg, performance information, risk mitigation) would support appropriate clinical use.

Ethics and dissemination

Ethics approval has been obtained by the Women’s and Children’s Health Network Human Research Ethics Committee (HREC) (HRE00067) and the South Australian Aboriginal HREC (#04-25-1185). This protocol offers an accessible example for health institutions looking to apply an evidence-based approach to AI Scribe assessment that prioritises clinical documentation standards. We will publish our study results in an academic journal and include a publicly accessible summary for the general public on the Women’s and Children’s website.

Trial registration number

10.17605/OSF.IO/P6TM5.

How the introduction of a new patient pathway impacts diagnosis and treatment of acute abdominal pain in the emergency department: a qualitative study based on expert interviews

Por: Wagenknecht · A. · Verleger · K. · Möckel · M. · Stier · B. · Huscher · D. · Slagman · A. · Schenk · L.
Objective

This study aimed to explore (1) facilitating and inhibiting factors influencing the implementation of the Abdominal Pain Unit (APU) process, (2) physicians’ acceptance of the pathway and (3) typical experiential patterns and professional rationales emerging in clinical practice.

Design

Within a mixed-method framework, a qualitative evaluation study was conducted. Semi-structured expert interviews were conducted.

Setting, participants

36 physicians experienced in emergency care from 10 different emergency departments (EDs) involved in treating APU patients were interviewed. Years of work experience and professional status guided the selection.

Results

Seven major themes emerged: (1) physicians’ understanding of APU as a complex symptom associated with diagnostic uncertainties, (2) changes in clinical routines, (3) diagnostic certainty, (4) influence of professional experience, (5) the role of the digital APU application, (6) interdisciplinary cooperation and (7) obstacles to broad implementation. Overall, physicians perceived APU as beneficial for structuring clinical routines and standardising care, particularly for less experienced physicians. The pathway prompted more systematic documentation, repeated pain scoring and greater diagnostic reflection. The digital application was largely seen as intuitive, though its integration into existing IT systems and workflows posed challenges. No substantial changes were reported in interdisciplinary cooperation. Barriers to large-scale implementation included concerns about overdiagnosis, loss of clinical autonomy and additional documentation effort.

Conclusion

The APU pathway supports the structured care of acute abdominal pain (AAP) in the ED. Its successful integration requires alignment with clinical routines, IT infrastructure and professional cultures. Balancing standardisation with clinical autonomy is key for sustainable implementation.

Trial registration

DRKS00021052

Adolescent perspectives on the barriers and facilitators of engagement in healthy lifestyle behaviours: a focus group study from the European SEEDS project

Por: Wargers · A. · Senequier · A. · Elphick · C. M. · Mölenberg · F. J. M. · Williams · C. A. · Llaurado · E. · Sola · R. · Manios · Y. · Mavrogianni · C. · Murray · C. · Jansen · W. · Vlachopoulos · D.
Background

Adolescent obesity is increasing worldwide, and a minority of adolescents are meeting recommended physical activity (PA) and dietary guidelines, particularly among adolescents from low socioeconomic areas. There are limited studies qualitatively investigating the engagement in healthy lifestyle behaviours in this population. Therefore, this study aimed to gain a greater understanding of perceived barriers and facilitators of healthy lifestyle behaviours, specifically PA and dietary behaviours, in this under-represented population.

Methods

Eight semistructured qualitative focus groups with 35 adolescents aged 13–15 years old were conducted across four European countries (Spain, the Netherlands, Greece, UK) following the Theory of Planned Behaviour framework which states that individual behavioural intentions are grounded on attitudes, subjective norms and perceived behavioural control. Discussions were centred on adolescents’ PA and healthy eating behaviours and were thematically analysed.

Results

Regarding attitudes, adolescents understood the importance of healthy lifestyle behaviours but often failed to engage in them. Concerning subjective norms, friends and peers were perceived as barriers to PA, except during physical education (PE) classes. Positive relationships between pupils and teachers facilitated PA, and family influence primarily affected dietary behaviours. Regarding perceived behavioural control, the school structures including lack of space and time, as well as limited healthy food options in canteens and the COVID-19 pandemic were barriers to healthy lifestyle behaviours, while mandatory PE classes and school clubs facilitated PA.

Conclusions

In conclusion, despite adolescents recognising the significance of healthy lifestyle behaviours they often fail to engage in them. Their healthy lifestyle behaviours were influenced by their friends, families and teachers. The school structure and the COVID-19 pandemic were considered barriers to healthy lifestyle behaviours among adolescents.

Trial registration number

NCT05002049.

Effect of a multimodal intervention in general and digestive surgery wards on carbapenem use and antimicrobial resistance: protocol for a prospective, quasi-experimental interrupted time-series study

Por: Vazquez-Piqueras · N. · Padulles · A. · Sabe · N. · Shaw · E. · Abelenda-Alonso · G. · Suarez-Lledo · A. · Costa · R. M. · Pelaez · N. · Molina Molina · G. J. · Dordal · M. T. · Andres · B. · Jimenez-Martinez · E. · Laguna · M. d. M. · Penafiel · J. · Carratala · J. · Oriol · I.
Introduction

Infections are particularly common among hospitalised patients in surgical wards. Carbapenem antibiotics, major drivers of antimicrobial resistance, are frequently prescribed in this setting, often inappropriately and for unnecessarily prolonged durations. International guidelines emphasise the need for comprehensive multimodal antimicrobial stewardship programmes to optimise antibiotic use; however, evidence supporting their routine application in surgical wards remains scarce and is mostly derived from retrospective analyses or single-component interventions. This study aims to evaluate the impact of an integrated, multimodal antimicrobial stewardship intervention on carbapenem consumption, antimicrobial resistance patterns and stewardship-related outcomes in surgical wards, with a concurrent focus on maintaining patient safety and clinical effectiveness.

Methods and analysis

We conducted a single-centre, quasi-experimental interrupted time-series study among adult patients admitted to the general and digestive surgery wards of a tertiary-care Spanish hospital. The study includes a retrospective pre-intervention period (1 January 2022–31 December 2023) and a prospective intervention period (1 April 2024–31 March 2026). The multimodal antimicrobial stewardship intervention comprises educational activities, updated local guidelines delivered via a dedicated web-based platform and mobile application, PAF on carbapenem prescriptions and structured reassessment of β-lactam allergy labels. The primary outcome is the temporal trend in monthly carbapenem consumption, expressed as defined daily doses per 100 patient-days. Secondary outcomes include temporal trends of monthly carbapenem days of therapy per 100 patient-days, overall antibiotic consumption, the proportion of patients receiving carbapenems and clinical safety outcomes (length of hospital stay, in-hospital mortality and 30-day readmission rates). In addition, the acceptance of stewardship recommendations, the accuracy of β-lactam allergy labelling and the monthly incidence of selected antimicrobial-resistant organisms, including Enterococcus faecium bloodstream infection and Clostridioides difficile infection, will be analysed. Aggregated data from routine clinical practice are extracted from electronic medical records, and pharmacy and microbiology databases, supplemented by anonymous surveys. Interrupted time-series regression models will be applied to assess changes in trends attributable to the intervention.

Ethics and dissemination

Approval for the protocol was granted by the Clinical Research Ethics Committee of Bellvitge University Hospital (PR332/23). The protocol complies with European and national data protection regulations. Findings will be disseminated through scientific conferences and publication in peer-reviewed journals.

Strategic Amyotrophic Lateral Sclerosis Australia-Systems Genomics Consortium (SALSA-SGC): cohort profile

Por: Henders · A. K. · Ziser · L. · Garton · F. C. · Adams · L. · Ernst · K. · Furlong · S. · Heads · J. A. · Heggie · S. · Krasniqi · R. · Bhadravathi Lokeshappa · M. · Mazumder · S. · McNamara · E. · MacShane · A. · Mekhael · L. · Nunn · L. · Orden · B. · Ryder · J. · Thorpe · K. · Toubia · M.
Purpose

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative motor neuron disease (MND) with heterogeneity in disease onset, progression and treatment response. The Strategic ALS Australia–Systems Genomics Consortium (SALSA-SGC) was established in recognition of the need for large data sets of clinical data matched with biological samples to enable and foster ALS research and better understanding of aetiology and biological mechanisms. SALSA-SGC brought together the major Australian MND clinics to set up sustainable infrastructure that could facilitate long-term human ALS research and clinical trials nationally and internationally.

Participants

Between April 2016 and December 2024, SALSA-SGC recruited 1813 participants, including 1386 ALS/MND cases, 388 controls and 39 others (asymptomatic relatives and ALS mimics). Clinical data and biospecimens are available for 1333 and 1189 ALS cases, respectively, with longitudinal data spanning 4442 total clinic visits and 3201 samples. An open-access online data explorer showcases collected datasets.

Findings to date

Detailed clinical and questionnaire data allow an in-depth description of the cohort, informing clinical and health policy research. Screening for known ALS large-effect risk variants identified 125 mutation carriers (11.5% from N=1059), including 70 with C9orf72 expansions. Single Nucleotide Polymorphism (SNP)-array data (N=1088 cases; N=244 controls) have supported multiple published studies. SALSA-SGC resources are actively used by national and international researchers.

Future plans

Ongoing efforts aim to expand recruitment into regional Australia and enhance sample processing for cell-based studies. The SALSA-SGC resource is accessible by researchers under agreements governed by participant consent, human ethics committee guidelines and agreed use of data and samples.

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