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Ayer — Junio 24th 2026Tus fuentes RSS

Childhood socio-emotional and cognitive development and adolescents NEET (not in education, employment or training): findings from the UK Millennium Cohort Study

Por: Akanni · L. · Black · M. · Udu · K. · Chen · Y. · Cattermore · R. · Esan · O. B. · Creese · H. · Melendez-Torres · G. J. · Hargreaves · D. · Adjei · N. K. · Taylor-Robinson · D.
Background

There is a growing concern about the increasing number of young people who are not in employment, education or training (NEET) globally. This study investigates the impact of concurrent cognitive and socio-emotional development trajectories in childhood on NEET status in adolescence in a UK cohort.

Method

We analysed longitudinal data on 8368 children from the UK Millennium Cohort Study. Exposure trajectories of cognitive and socio-emotional development from age 3 to 14 years were characterised using group-based multi-trajectory models. We used Poisson regression to examine associations between developmental trajectories and NEET status at age 17, adjusting for confounders. Population-attributable fractions were estimated to quantify NEET proportions attributable to the developmental problems.

Results

At age 17, 3.5% of participants were NEET, of which about one-third (38%) were not economically active. Children with persistent cognitive and socio-emotional development problems had a fourfold increased risk of being NEET (adjusted risk ratio (ARR) 3.5; 95% CI 2.3 to 5.3), and those with late socio-emotional problems had a threefold increased risk (3.0; 95% CI 2.1 to 4.3), compared with children in the no problem group. Early and resolving socio-emotional and cognitive problems were not associated with being NEET. An estimated 28% (95% CI 18% to 36%) of NEET cases were attributable to cognitive and socio-emotional behaviour problems in childhood.

Conclusion

Childhood cognitive and socio-emotional development plays a critical role in shaping pathways to education and employment in adolescence. Policies and strategies aiming to reduce NEET should target early social and emotional skills alongside efforts to support academic achievement.

Implementing womens sexual and reproductive health interventions in prisons: a realist review

Por: Rickard · J. · Melendez-Torres · G. J.
Objectives

To explore what works for whom, how and why when implementing women’s sexual and reproductive health interventions in prisons to understand the barriers and facilitators to implementation and to generate recommendations for policymakers.

Design

Realist review using the Realist And Meta-narrative Evidence Synthesis: Evolving Standards guidelines.

Data sources

We systematically searched Ovid MEDLINE, Global Health, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the American Psychological Association (APA) PsycINFO databases and hand-searched unpublished literature and reference lists, January–June 2025.

Eligibility criteria for selecting studies

Primary studies of implementing women’s sexual and/or reproductive health interventions, including those addressing sexually transmitted infections, cervical health, breast screening, contraception and women’s health holistically. Study populations included people in prisons that detain women in high-income countries.

Data extraction and synthesis

We extracted and analysed data relating to implementation processes using a grounded theory approach and retroductive inference to articulate cross-case Intervention-Context-Actor-Mechanism-Outcome configurations (ICAMOCs) and refine programme theory. We discussed findings in relation to existing theories from the literature to elicit recommendations for policymakers.

Results

Of 4617 deduplicated records, 26 met the inclusion criteria. Ten ICAMOCs were constructed from cross-case analyses, grouped into three themes: (1) planning (teaming, team leadership, assessing needs and capacity, tailoring and planning), (2) doing (piloting, standardisation and support, trauma-informed engagement and peer advocacy) and (3) sustaining (evaluation-adaptation cycles). The ICAMOCs indicated three overarching mechanisms as being key to effective implementation, namely, perceived utility of the intervention, motivation and empowerment.

Conclusions

For women’s sexual and reproductive health interventions to be effective in prisons, everyone involved in implementation needs to perceive the intervention’s benefit and be both motivated and empowered to take action. We recommend policymakers build a resilient and empowered delivery workforce, invest in research partnerships to increase awareness and understanding and promote trauma-informed approaches to women’s healthcare in prisons.

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.

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Effects of argipressin on intraoperative fluid administration in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC): study protocol of a randomised clinical trial (HiPress Trial)

Por: van Zwol · J. · Aalbers · A. G. J. · van den Brom · C. E. · Hollmann · M. W. · Hulst · A. H. · Lameris · W. · Tuinman · P. R. · Vlaar · A. P. J. · Veelo · D. P. · Hemmes · S. N. T.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

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

Risk-based selection for carotid revascularisation using the IMPROVE score versus standard care in symptomatic carotid artery disease: a model-based cost-effectiveness analysis using pooled-data

Por: Nies · K. P. H. · Ramaekers · B. · Bierens · J. · Auer · D. P. · Schindler · A. · Saam · T. · Bos · D. · de Jong · P. A. · Nederkoorn · P. J. · de Borst · G. J. · van Oostenbrugge · R. J. · Joore · M. A. · Kooi · M. E. · Smits · L. J. M.
Background

A clinical prediction model (IMPROVE) for ipsilateral ischaemic stroke risk in symptomatic patients with carotid disease was recently developed with good performance. We aim to evaluate the model-based cost-effectiveness of IMPROVE-based triage versus triage in care-as-usual (CAU) for optimal medical treatment (OMT) alone or carotid endarterectomy plus OMT.

Methods

A dataset of 678 patients with carotid disease and a recent ipsilateral ischaemic stroke, transient ischaemic attack or amaurosis fugax from four cohort studies informed a decision-analytic model. Stratification of patients for carotid endarterectomy was based on ≥50% carotid stenosis (CAU arm) or a range of 3-year ipsilateral ischaemic stroke risk thresholds (IMPROVE arm). The threshold resulting in the lowest number of ipsilateral strokes and perioperative strokes and deaths was selected as the optimal threshold. Patients with

Results

IMPROVE-based triage reduced ipsilateral ischaemic strokes and perioperative strokes and deaths by 34.5% (CAU: 4.3%, IMPROVE: 2.8%) over 3 years. Revascularisations decreased by 20% with IMPROVE, while Quality-Adjusted Life Years slightly increased. Procedural stroke occurred in 1.8% of patients in CAU versus 1.4% of patients for IMPROVE. Societal costs decreased on average by 1441/patient for IMPROVE versus CAU for a 3-year time horizon (lifetime cost reduction: 6101/patient). Subgroup analyses identified IMPROVE as the superior strategy for 50–69% and 70–99% stenosis (3-year and lifetime horizon) and

Conclusions

In this modelling analysis, triage of symptomatic patients with carotid disease with the IMPROVE model can lead to the prevention of one-third of ipsilateral ischaemic strokes and perioperative strokes and deaths, while also reducing societal costs. These findings should be validated in a clinical trial.

Dual versus single implant fixation for geriatric distal femur fractures: protocol for a randomised, controlled pilot study at five US level 1 trauma centres

Por: Haller · J. · Achebe · C. C. · Oman · G. · Konda · S. · Garner · M. · Yuan · B. · Marchand · L. S. · DeKeyser · G. J.
Introduction

Geriatric distal femur fractures are associated with mortality rates exceeding 20%, comparable to hip fractures. Traditional single implant fixation often requires weight-bearing restrictions that delay recovery. This pilot study aims to assess the feasibility of conducting a multicentre randomised controlled trial comparing dual vs single implant fixation for geriatric distal femur fractures.

Methods and analysis

This multicentre, prospective, randomised controlled pilot trial will enrol 80 participants aged 60 years or older with displaced distal femur fractures at five US level 1 trauma centres. Patients will be randomly allocated 1:1 to receive either single implant (lateral plate or retrograde nail) or dual implant (nail-plate or dual plate) fixation. All patients will be permitted immediate weight-bearing. The primary outcome is feasibility assessed through enrolment rate (80 patients in 12 months), protocol adherence (≥90%) and follow-up retention (≥85% at 12 months). Secondary outcomes include post-surgical mobility (AM-PAC, TUG), patient-reported outcomes (PROMIS-PF, PROMIS-29), mortality (90-day and 1 year) and complication rates. Analyses will be on an intention-to-treat basis.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board (IRB_00149119) and IRBs at all participating centres. Written informed consent will be obtained from participants or legally authorised representatives. Findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT05292313.

Randomised controlled trial comparing antibiotic cement bead pouch versus negative pressure wound therapy for the management of severe open tibia fracture wounds: Beads versus VAC (BvV) protocol

Por: Marchand · L. S. · Slobogean · G. · OHara · N. N. · Harris · A. D. · Grainger · D. W. · Thabane · L. · Bhandari · M. · Della Rocca · G. J. · Kellam · P. J. · Zura · R. D. · Marvel · D. · Wells · J. L. · Gitajn · I. L. · Jeray · K. J. · OToole · R. V. · Working · Z. M. · Natoli · R. M.
Introduction

Early open fracture management aims to minimise the risk of complications. For the most severe open fracture wounds, multiple irrigation and debridement surgeries are required to overcome severe wound contamination, to reassess the evolving tissue injury or to temporise and plan further surgery. When multiple irrigation and debridement surgeries are needed, uncertainty remains about how the open fracture wound should be managed to best minimise complications. The primary aim of this trial is to compare the antibiotic cement bead pouch vs negative pressure wound therapy in the management of patients with severe open tibia fracture wounds.

Methods and analysis

BvV is a multicentre, pragmatic, parallel arm randomised controlled trial that aims to enrol 312 adult patients admitted to a participating centre with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Participants will be randomly allocated on a 1:1 basis to either antibiotic cement bead pouch or negative pressure wound therapy. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomisation. Using the win ratio approach, we will hierarchically assess the composite outcome in the following order: (i) all-cause mortality, (ii) injury-related amputation of the lower extremity, (iii) unplanned reoperation to manage wound complications, an infection or promote fracture healing and (iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.

Ethics and dissemination

The BvV trial has been approved by a central institutional review board (IRB) (Advarra) for clinical sites in the USA, the ethics board at the coordinating centre at McMaster University (Hamilton Integrated Research Ethics Board), and participating sites not using the central institutional IRB (Fraser Health Research Ethics Board, The University of British Columbia Clinical Research Ethics Board, Newfoundland and Labrador Health Research Ethics Board, University of Manitoba Biomedical Research Ethics Board). Additional clinical sites who are in the start-up phase, as well as any new selected clinical sites, will obtain local approvals prior to initiating trial activities. This will include a clinical site in the UK who is in the process of obtaining the necessary approvals. Recruitment began in November 2023. Both interventions are frequently used to manage severe open fracture wounds, ensuring that the trial results can be easily transitioned into clinical practice. The results of this trial will be disseminated to national and international partners through peer-reviewed publications, academic conferences and stakeholder engagement activities.

Trial registration number

NCT05615844.

Mapping the evidence on anaemia across trimesters of pregnancy and risk of adverse birth outcomes in sub-Saharan Africa: a scoping review protocol

Por: Adjei-Gyamfi · S. · Zeng · I. · Aryee · P. A. · Mearns · G. J.
Introduction

Pregnancy-related anaemia significantly affects human development across life stages. In sub-Saharan Africa (SSA), country-specific epidemiological variations primarily driven by nutritional practices, socioeconomic factors and health-system disparities contribute to heterogeneity in prevalence, severity and adverse birth outcomes (ABOs). While anaemia and micronutrient deficiencies in pregnancy are well studied globally, comprehensive trimester-specific evidence and their associations with ABOs in SSA remain scarce. This review, therefore, examines the breadth and nature of existing evidence on these associations within SSA, thereby updating current knowledge and informing regionally tailored interventions and future research.

Methods and analysis

A scoping review methodology will be employed due to the limited volume of literature addressing the specific research questions and population. The review will follow the Joanna Briggs Institute (JBI) framework, applying the population-concept-context approach. Comprehensive searches will be conducted across CINAHL, MEDLINE, Cochrane Library, Scopus, Google Scholar, EBSCO Open Dissertations and relevant organisational websites. The planned search period will span from 1 January 2016 to 31 December 2025. Two reviewers will independently screen and extract data using JBI-adapted protocols within the Rayyan review platform. Any discrepancies will be resolved via discussion with the research team. Findings will be synthesised narratively through descriptive content analysis and visual mapping.

This review will include peer-reviewed studies and grey literature that investigate the associations between anaemia or deficiencies in iron, folate and vitamin B12 during pregnancy trimesters and ABOs in SSA. All relevant sources of evidence will be considered, regardless of study design or methodology, provided they report on women of reproductive age who experienced anaemia in any trimester and were subsequently identified with ABOs. Birth outcomes of interest include low birth weight, macrosomia, small or large for gestational age, preterm birth, post-term birth and stillbirth. Only sources published in English from 2016 onward will be included. The studies’ quality will be evaluated using Cochrane’s risk of bias assessment and mixed methods appraisal tools and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review.

Ethics and dissemination

This scoping review will not require ethical approval as it will synthesise published data and reports. It has been registered with the Open Science Framework. This review does not involve human participants. The final report will be submitted for publication in a peer-reviewed journal. The findings will be used to shape subsequent research, serving as a fundamental element of the evidence and knowledge mapping framework. As this study protocol was not reviewed by an ethics committee, the appropriate contact for research integrity matters is the Faculty of Health and Environmental Sciences, Auckland University of Technology.

Stimulating amyloid-{beta} clearance in cerebral amyloid angiopathy with low-sodium oxybate and/or non-invasive vagus nerve stimulation (Clear-Brain): study protocol for a randomised pre-post trial

Por: Schriemer · S. E. · Hirschler · L. · van Etten · E. S. · van Zwet · E. W. · Lammers · G. J. · Liebler · E. J. · van Walderveen · M. A. A. · Slats · A. M. · van Es · A. C. G. M. · Verbeek · M. M. · van Osch · M. J. P. · Wermer · M. J. H. · Fronczek · R.
Introduction

Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.

Methods and analysis

We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.

Ethics and dissemination

The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.

Trial registration

EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.

How public health practitioners in the UK are using parental guidance on talking to children about weight: a qualitative study

Por: Brockman · R. · Gillison · F. · Grey · E. B. · Jago · R. · MacArthur · G. J. · Gutteridge · C. · Langford · R.
Objective

To understand how public health practitioners (PHPs) are using parental guidance on talking to children in their work with parents. In 2021, evidence-based guidance was produced for parents of young children to facilitate these conversations, but it is unclear how this guidance is being promoted to parents or used by PHPs.

Design

Qualitative study, consisting of in-depth, semistructured interviews.

Setting

Local authority, National Health Service or other healthy weight service providers in the UK.

Participants

Participants were PHPs working on children’s healthier lifestyles programmes in the UK as part of the UK’s National Child Measurement Programme (NCMP). Invitations to participate were distributed via the Department of Health and Social Care and regional and national networks.

Results

24 participants were interviewed. Practice varied between organisations with the guidance being used in NCMP letters to parents, in follow-up phone calls with parents and in training NCMP staff and other health or education professionals. Participants valued the evidence-based guidance and its compassionate tone, feeling it gave them and parents, confidence in addressing a sensitive topic. Some felt it was too lengthy for parents with learning disabilities or low literacy levels. Others identified a need for similar guidance for older children. Though helpful, participants acknowledged the guidance was only one small part of a necessary systems-wide approach to promoting healthy weight.

Conclusions

The guidance is a useful tool but needs systematic promotion to increase use and effectiveness. Further work is warranted to develop adapted versions for other populations.

Research waste in total knee arthroplasty studies: an observational study on registered trials

Por: Iken · A. R. · Schaap · M. · Poolman · R. W. · Gademan · M. G. J.
Background

Timely publication of preregistered study outcomes is not self-evident. Discrepancies can lead to significant research waste.

Objectives

To assess timely (within 7 years) and consistent publication of preregistered primary outcomes and associated factors of total knee arthroplasty (TKA) studies registered between 2000 and 2017 over time.

Design

An observational study.

Data sources

ClinicalTrials.Gov, MEDLINE, Embase, Cochrane Library, Web of Science, PubMed and Google Scholar.

Participants

Registered TKA trials at ClinicalTrials.Gov between 2000 and 2017.

Data extraction and synthesis

ClinicalTrials.Gov’s required and optional data elements for registering a study and the preregistered and published primary outcome, defined as the outcome stated in the primary outcome field on ClinicalTrials.Gov. We used descriptive statistics, Kaplan-Meier curves and Cox regression analyses.

Results

1352 registered TKA (1072 interventional; 280 observational) studies were included, with 967 (811 interventional; 156 observational) unique references. Regarding the publication of preregistered primary outcomes within 7 years, the results for interventional trials were 0% (2000), which increased to 59.6% (2017). Observational studies were timely published in 0% (2000) and 37.5% (2017). Interventional trials and observational studies not funded by industry were more likely to have timely and consistent publication of their primary outcomes. Drug intervention trials were more likely to be timely and consistently published than procedure-focused trials. Phase 3 interventional trials were more likely, while phase 1 trials were less likely to be consistently published on time.

Conclusion

Despite ongoing efforts to improve publication rates, over a third of interventional trials remain unpublished within 7 years. For observational studies, the rate is even lower, with only two-fifths published on time, contributing to significant research waste.

PROSPERO registration number

CRD42021246599.

Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial

Por: de Roos · B. M. · Yeh · L.-L. Y. · van den Hooff · P. S. · Nuijten · M. A. H. · Twisk · J. W. R. · Liem · R. S. L. · van Acker · G. J. D. · Severens · J. L. · Kambic · T. · Serlie · M. J. M. · Monpellier · V. M. · Eijsvogels · T. M. H. · Hopman · M. T. E. · Karregat · J. H. M.
Introduction

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

Methods and analysis

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

Ethics and dissemination

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

Trial registration number

NCT07156552.

Patterns of symptom deterioration can support multimorbidity management in COPD: Perspectives of patients and healthcare professionals

by Sanne H. B. van Dijk, Marjolein G. J. Brusse-Keizer, Bente Rodenburg, Anke Lenferink

Introduction

Comorbidities significantly complicate COPD management. Remote monitoring could aid real-time disease and symptom management, assisting both patients with multimorbidity and healthcare professionals (HCPs). This study aimed to explore how insight in patterns of symptom deterioration, derived from remote monitoring, could enhance multimorbid COPD management as perceived by patients and HCPs.

Methods

Using daily symptom data collected via a mobile diary in the prospective RE-SAMPLE cohort study, patterns of symptom deterioration of COPD, chronic heart failure, anxiety, and depression were visualized per patient (follow-up duration of ≥4 months). Semi-structured individual interviews were conducted with Dutch patients with COPD and ≥1 comorbidity, and with HCPs from pulmonology, cardiology, and medical psychology who were involved in care for patients with multimorbidity. Interviews addressed current multimorbid COPD management, its challenges, and the way pattern visualizations of symptoms deterioration could support disease management. Transcripts were thematically analyzed using an inductive approach.

Results

7 patients (69–80 years, 4 men) and 7 HCPs were interviewed in the hospital (patients and HCPs), at home (patients) or online (HCPs). Three overarching themes were identified, representing the elements of multimorbid COPD management that could be supported by the pattern visualizations: 1) relationship between diseases, 2) decision-making, and 3) self-management. According to patients and HCPs, pattern visualizations can be an informative source to explain the relation between COPD and comorbidities, function as a conversation starter facilitating communication between patients and HCPs as well as between medical disciplines, and educate patients in adequately recognizing their care needs.

Conclusion

Three elements of personalized multimorbid COPD management were identified through qualitative analysis, which can all be supported by visualizing patterns of symptom deterioration via remote monitoring. The visualizations could enhance patients’ understanding of their diseases, improve shared decision-making, improve in-hospital multidisciplinary collaboration, and support multimorbid COPD (self-)management.

Promising solution for standardised length of hospital stay based on time-to-event models and contemporary Australian administrative data

Por: Duke · G. J. · Hirth · S. · Santamaria · J. D. · Li · Z. · Read · C. · Hamilton · A. · Lapiz · E. · Le · T. · Fernando · T. · Merlo · R.
Objective

Hospital length of stay (LOS) is a key indicator of hospital efficiency and quality of care, but a reliable metric for benchmarking LOS remains problematic. This report describes a time-to-event methodology to generate a hospital standardised LOS ratio (HSLR).

Design

Retrospective observational analysis of LOS from a jurisdictional administrative dataset using a time-to-event (hazard of discharge) analytic approach to generate risk-adjusted LOS (predicted LOS—pLOS), and the HSLR (= (sum observed LOS)/(sum total pLOS)).

Setting

219 (public and private) acute-care hospitals in the State of Victoria, Australia, adult population 5.28 million.

Participants

2.73 million adult multiday separations and 15.53 million bed-days from July 2019 to June 2024.

Interventions

Nil.

Outcome measures

Descriptive statistics for annual mean LOS (aLOS), pLOS and HSLR at the hospital level with model fit assessed for calibration (Cox-Snell residuals), classification (aLOS and HSLR results for hospital-years compared to benchmark), variance (intraclass correlation coefficient (ICC) at provider level) and model dispersion (value () and random effect SD ()) characteristics.

Results

Observed LOS was markedly right skewed and autocorrelated (p3 SD of benchmark); whereas 936 (99.5%) HSLR values were inliers (

Conclusions

aLOS is a simple descriptor but poor comparator. Time-to-event survival analytic models furnish risk-adjusted pLOS and HSLR metrics which indicate that the majority of LOS variation is due to patient-related, not hospital, factors.

Acute myocardial infarction diagnosis and treatment following implementation of a multicomponent intervention in Tanzania: the MIMIC pilot trial

Por: Hertz · J. T. · Nworie · J. E. · Shayo · F. · Galson · S. W. · Coaxum · L. A. · Daniel · I. · Makambay · P. S. · Akrabi · A. M. · Manyangu · G. J. · Thielman · N. M. · Bloomfield · G. · Sakita · F. M.
Background

In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).

Methods

This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.

Results

A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p

Conclusions

The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.

Trial registration number

NCT04563546.

Examining the role of staff and team communication in reducing seclusion, restraint and forced tranquilisation in acute inpatient mental health settings: protocol for the Communication and Restraint Reduction (CaRR) study

Por: Cibelli · F. · Forbes · T. · McCabe · R. · Anderson · J. E. · Hoe · J. · Tahir · S. · McKeown · G. J. · Brew · B. · Deamer · F. · Lavelle · M.
Introduction

Over 100 000 service users are admitted to acute mental health wards annually, many involuntarily. Wards are under incredible pressure due to high bed occupancy rates and staff shortages. In a recent survey, over 80% of mental health nurses reported experiencing aggression and violence within their role. National and international policy dictates that mental health ward staff manage incidents of aggression and violence using communication, known as de-escalation. However, de-escalation practice is variable, and there is little empirical evidence to underpin training. As such, there is still a reliance on more restrictive practices, including seclusion and physical restraint.

Aim

The aim of this study is to identify the communication and organisational factors that characterise effective management of service users’ behaviour and distress in acute adult inpatient mental health wards, reducing the reliance on more restrictive practices (eg, seclusion and restraint).

Methods and analysis

This observational study will be conducted on mental health wards in England. It will be comprised of three work packages (WPs).

  • A microanalysis of communication during de-escalation incidents from Body Worn Camera footage on wards (n=64), to identify staff communication practices that lead to effective management of service users’ distress.

  • Ethnographic observations of ward routine practice, alongside interviews and questionnaires with staff and service users, to examine how challenging behaviour is anticipated, planned for and responded to on wards, and staff experiences and perceptions of this process.

  • Triangulation of the findings from WPs 1 and 2 to examine the relationship between approaches to aggression management and staff communication, exploring the similarities and differences within and between wards.

  • Ethics and dissemination

    Ethical approval for sites in England has been granted by the Wales Research Ethics Committee 3, REF 22/WA/0066. Findings will be disseminated through peer-reviewed journals, scientific conferences and service user and clinical networks.

    Emphysema detection by qualitative and quantitative analysis and relationship to spirometric obstruction in an urban comprehensive lung cancer screening programme: the Temple Healthy Chest Initiative (THCI) - a retrospective cohort study

    Por: Dachert · S. · Seigo · M. · Ahearn · O. · Zhao · H. · Criner · G. J.
    Objective

    Patients eligible for lung cancer screening are at risk for structural lung abnormalities, especially emphysema. Our aim was to assess the association between emphysema as determined by radiologist and quantitative CT (QCT) analysis, and the presence of spirometric abnormalities in an urban largely minority population undergoing lung cancer screening.

    Design

    Retrospective cohort study.

    Setting

    Centralised lung cancer screening programme in an urban academic medical centre in Philadelphia, Pennsylvania, USA.

    Participants

    2111 individuals who underwent low-dose CT (LDCT) from October 2021 to October 2022 had CT scans interpreted by radiologists for the presence of emphysema, 629 of whom underwent spirometry. 181 patients underwent AI-assisted QCT analysis for emphysema at –950 and –910 HU, all of whom underwent spirometry.

    Primary and secondary outcome measures

    Diagnostic tests for presence of emphysema as defined by radiologist and by AI-assisted QCT analysis for emphysema and the association with spirometric obstruction.

    Results

    A total of 2111 individuals underwent LDCT from October 2021 to October 2022. 323 (51.4%) individuals with radiology-determined emphysema had airflow obstruction. 108 (17.2%) individuals without emphysema had no airflow obstruction. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of radiology detected emphysema for airflow obstruction are 81.3%, 53.4%, 72.2%, 59.34%, respectively. In the Temple Healthy Chest Initiative (THCI) QCT subcohort of 181 individuals who underwent spirometry and low-attenuation area (%LAA)-910 HU, 91 (50%) individuals had %LAA-910 HU≥6% and airflow obstruction. 33 (18%) individuals with %LAA-910

    Conclusions

    Data from the THCI demonstrates high rates of emphysema as detected by radiologic qualitative interpretation and quantitative analysis. Using a cut-off of ≥6% for LAA at –910 HU, there is a high sensitivity and PPV for associated spirometric obstruction and thus should drive providers to obtain prebronchodilator spirometry to detect chronic obstructive pulmonary disease at an earlier stage.

    Multidimensional determinants to adoption, use and effectiveness of digital technologies for healthy ageing in migrant populations: a scoping review protocol

    Por: Stanciu · A. · Dominguez Rodriguez · A. · Westerhof · G. J.
    Introduction

    Digital technology can be effective in providing personalised healthcare in contexts of ageing societies and increasing international migration trends. However, the literature is scarce and unsystematic, considering healthy ageing in migrant populations. This knowledge gap delays the development of interventions, policies and technology that are inclusive of the healthcare needs and limitations in older migrants. We aim to map the scientific literature addressing structural, psychological, technical and ethical determinants to adoption, use and effectiveness of digital technology for healthy ageing in migrants. We aim to uncover major challenges, highlight solutions and derive an agenda for future research.

    Methods and analysis

    We plan a scoping review of peer-reviewed articles published in English, German and Spanish after 2010 without a geographical limitation. We will perform the review across specialised and interdisciplinary databases (EBSCO, IEEE Xplore, IET Digital Library, PsycINFO, PubMed, Scopus and Web of Science) and manage articles at Covidence.org. Our review will adhere to the Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review guidelines for conducting and reporting reviews.

    Ethics and dissemination

    No primary data will be collected, and therefore, ethical approval is not required.

    The results of this scoping review will be published in a peer-reviewed outlet and presented at conferences. A shiny web application will accompany the publication.

    Side effect profile and comparative tolerability of newer generation antidepressants in the acute treatment of major depressive disorder in children and adolescents: protocol for a systematic review and network meta-analysis

    Por: Türkmen · C. · Sacu · S. · Furukawa · Y. · de Cates · A. N. · Schoevers · R. A. · Kamphuis · J. · Chevance · A. · Weisz · J. R. · Emslie · G. J. · Strawn · J. R. · Hetrick · S. E. · Efthimiou · O. · Salanti · G. · van Dalfsen · J. H. · Furukawa · T. A. · Cipriani · A.
    Introduction

    Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

    Methods and analysis

    The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

    Ethics and dissemination

    The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

    PROSPERO registration number

    CRD420251011399.

    Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

    Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
    Importance

    Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

    Objective

    We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

    Design

    The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

    Setting

    In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

    Participants

    Former COVID-19 patients and controls participated in this cohort study.

    Main outcomes and measures

    Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Results

    A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

    Conclusions

    Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

    Trial registration number

    The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

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