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An overlooked source of skin dose perturbation: Commercial tattoo inks in radiotherapy

by Hongjun Park, Beechui Koo, Jungwook Shin, Byoung Hyuck Kim, James J. Sohn

Approximately one-third of US adults have tattoos, yet the dosimetric impact of intradermal tattoo pigments during radiation therapy remains uncharacterized. Commercial tattoo inks contain unregulated metallic impurities including chromium, lead, and nickel, raising concerns about dose perturbations in tattooed skin. This work quantifies radiation dose perturbations induced by high-atomic-number (Z) tattoo pigments under clinically relevant radiotherapy conditions. Monte Carlo simulations (TOPAS) modeled layered skin phantoms with a 0.3-mm intradermal tattoo layer embedded at 1.25–1.55 mm depth. Three commercial inks were evaluated: carbon-based (black) and metal-containing (Fe-rich brown, Al-containing orange) at pigment loadings of 5–100 vol% within the tattoo layer, to establish upper-bound effects. Electron (6, 18 MeV) and photon (6, 18 MV) beams were simulated with standard clinical geometry (1 × 1 cm² field, SSD = 100 cm). Photon irradiation produced pronounced, depth-localized dose enhancement, with peak dose enhancement factor (DEF) reaching 2.5 for brown ink at 18 MV, a 62% mean increase relative to non-tattooed skin driven by high-Z–mediated secondary electron production. Electron beams exhibited energy-dependent behavior: 6 MeV produced modest enhancement (peak DEF ~ 1.07), while 18 MeV unexpectedly generated dose deficits (DEF 

Early Postpartum Symptoms Differ Between Older and Younger First‐Time Mothers

ABSTRACT

Aim

To describe symptom patterns in first-time mothers through 3 months postpartum.

Design

Longitudinal, descriptive correlational.

Methods

Secondary analysis of data from a randomised clinical trial of first-time mothers. Symptoms were assessed at 1, 2 and 3 months postpartum using the Memorial Symptom Assessment Scale for dimensions of 32 symptoms.

Results

New mothers (n = 114) reported an average of 7.0 (SD 4.7) symptoms at 1 month, decreasing to 5.3 (SD 4.3) at 3 months. Physical symptoms decreased to the greatest degree. Symptoms reported by over 33% of participants included lack of energy, worrying, pain, difficulty sleeping or concentrating and feeling irritable, sad or drowsy. The most distressing were lack of energy, feeling irritable, pain, nervousness and hair loss. Symptoms did not differ by type of birth or infant feeding. Older mothers (≥ 35 years) had significantly more symptoms and distress than younger mothers.

Conclusion

Most symptoms improved over time, yet some were still prevalent at 3 months. Symptoms not appraised as particularly distressing may still be of clinical concern for safety reasons. Frequent postpartum assessments and interventions are important, particularly for older mothers.

Impact and Implications for Patient Care

In the first 3 months, postpartum symptoms not perceived as distressing may lead to adverse health outcomes. These symptoms may threaten maternal–infant welfare beyond the first 3 months postpartum. Older first-time mothers merit particular attention by clinicians.

Reporting Method

The authors complied with STROBE reporting guidelines.

Patient or Public Contribution

No patient or public contribution.

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.

Hybrid drug-coated balloon strategy for coronary bifurcation lesions: a systematic review and meta-analysis

Por: Dillen · D. M. M. · van Beek · K. A. J. · Vermeer · A. J. E. · Vlaar · P.-J. · El Farissi · M. · Demandt · J. P. A. · Eerdekens · R. · van het Veer · M. · Tonino · P. A. L. · Teeuwen · K.
Objectives

Recently, drug-coated balloons (DCB) have emerged as a promising alternative for side branch treatment in coronary bifurcation lesions, in combination with drug-eluting stent (DES) implantation in the main vessel, the hybrid DCB approach. We aimed to evaluate clinical outcomes in patients treated with the hybrid DCB approach and to compare this strategy with other bifurcation techniques.

Design

A systematic review and meta-analysis.

Data sources

MEDLINE and EMBASE were searched up until January 2025.

Eligibility criteria

We included randomised controlled trials and observational studies investigating clinical outcomes in patients treated with the hybrid DCB approach for coronary bifurcation lesions.

Data extraction and synthesis

Two independent reviewers extracted data and assessed the risk of bias. The outcome of interest was the combined endpoint of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR) at the longest available follow-up. Crude event rates, stratified by treatment strategy, were provided for the overall incidence of the primary endpoint. Furthermore, we conducted meta-analyses on the combined endpoint, comparing different bifurcation percutaneous coronary intervention (PCI) strategies. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation tool.

Results

13 studies, consisting of 2393 patients, were included in our systematic review. Investigated techniques were the hybrid DCB approach in all studies, and a two-stent strategy or the combination of DES in main vessel and balloon angioplasty (BA) in the side branch as potential comparators. Median follow-up duration was 12 months (IQR 7.5–12). The combined endpoint of cardiac death, MI or TLR was found in 5.6% in the hybrid DCB group, 15.4% in the two-stent group and in 10.0% in the BA group. The pooled analyses, including three and two studies, respectively, showed that the hybrid DCB approach was associated with a lower risk of the composite endpoint of cardiac death, MI or TLR when compared with a two-stent strategy (7.9% vs 15.4%; risk ratio (RR): 0.53; 95% CI 0.33 to 0.85) and compared with BA in the side branch (5.6% vs 10.0%; RR: 0.57; 95% CI 0.37 to 0.88). The certainty of the evidence was graded as very low.

Conclusion

The results of this systematic review and meta-analysis suggest that the hybrid DCB approach is a feasible and promising treatment approach for bifurcation lesions, when compared with other bifurcation PCI strategies. However, the results should be interpreted cautiously as the certainty of evidence was graded as very low, underlining the importance of larger trials to confirm these findings.

Trial registration number

CRD420250651469.

Annual Patient EXposure of residents in training over 20 years (APEX-trial): a retrospective analysis from a public teaching hospital

Por: Sturm Kunz · C. · Gerhards · V. · Ballmer · F. H. · Gantenbein · A. · Schwendinger · M. · Beer · J.-H. · Wertli · M. M.
Objective

To assess the clinical patient exposure of residents over 20 years following the statutory introduction of a maximum working week of 50 hours in 2005.

Design

Retrospective analysis of longitudinal cohorts of residents who worked on the medical wards between 2001 and 2023 or the emergency department (ED) between 2007 and 2023.

Setting

Cantonal Hospital of Baden, a representative, large Swiss teaching hospital affiliated with the University Hospital of Zurich.

Participants

Residents in training working on the internal medical wards and the ED.

Primary outcome measures

Annual Patient Exposure (APEX) of residents, which is the ratio of annual patients to residents and describes the annual number of patients treated per resident.

Methods and analysis

We assessed time trends of the APEX in annual cohorts of residents in training on the internal medicine wards (2001–2023) and the ED (2007–2023). We analysed the annual case severity (Case Mix Index and Emergency Severity Index (ESI)), patient age and the length of hospital stay (LOS) as a proxy for changes in the patient population over time and the readmission rate as a quality indicator.

Results

The medical ward APEX even increased by 5.2% from 325 patients to 342, despite the workhour restrictions and the increased number of residents (+90%). Inpatients increased by 100% (from 3250 to 6507). Their LOS decreased from 12.4 to 7.5 days and the readmission rate decreased from 4.2% to 3.3%.

In the ED, the APEX decreased by 21% (from 3261 to 2576), but the case complexity (ESI) and the LOS increased substantially.

Conclusions

In contrast to the general belief, work hour restrictions and the increased number of residents did not reduce the inpatient APEX over 20 years. The reduced APEX in the ED may be compensated by the increase in case complexity and the LOS.

The Barriers and Facilitators Healthcare Professionals' Experience When Assessing the Cutaneous Manifestations of Chronic Venous Insufficiency and Peripheral Arterial Disease in People With Dark Skin Tones: A Qualitative Descriptive Study

ABSTRACT

Recognising peripheral arterial disease and chronic venous insufficiency early and managing them appropriately improves patient outcomes and prevents ulceration. However, few studies consider the influence patient skin tone has on this assessment. The study aimed to explore the experiences of healthcare professionals when assessing the cutaneous manifestations of chronic venous insufficiency and peripheral arterial disease in people with dark skin tones. We conducted semi-structured online interviews with healthcare professionals working in the United Kingdom between July and December 2023. The ‘theoretical domains framework of behaviour change’ (TDF) guided the interview schedule and data analysis. 24 healthcare professionals were interviewed (18 nurses, 5 doctors, 1 physiotherapist) with an average experience of 15 years (IQR 9.75–21.75 years). We found the environmental context domain best explains clinical behaviour, which included effective teamworking, referral pathways and training, and adequate lighting. Environmental factors also influenced other aspects of the TDF such as skill development, focus and concentration, and belief about capabilities. Some participants also found personal challenges in asking questions exploring patients' behaviour and skin care practices as they did not want to cause offence. Findings will inform the development of interventions to support lower limb assessment in those with dark skin tones.

ALARUM: Active One Health surveillance in LMICs to monitor and predict Antimicrobial Resistance Using Metagenomics - a cross-sectional study protocol

Por: van der Sande · M. A. B. · Valia · D. · Tigoi · C. · Stoesser · N. · Stamm · L. · Marten · A. · Riems · B. · Musyimi · R. · Sibidou · Y. · Schurch · A. C. · Tiendrebeogo · E. W. · Mwaringa · S. · Kohns Vasconcelos · M. · Ingelbeen · B. · Tinto · H. · Bielicki · J. A. · Cooper · B. S. · B
Background

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

Methods and analysis

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

Ethics and dissemination

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

Ultra long peripheral catheter versus accelerated Seldinger technique long peripheral catheter in difficult intravenous access patients (ULAST): a pragmatic randomised controlled trial protocol

Por: Pieteraerens · W. · Vanhonacker · D. · Beeckman · K. · Torsy · T.
Introduction

Ultrasound-guided peripheral cannulation by specialised nurses is increasingly used to improve first-stick success rates in patients with difficult intravenous access (DIVA). Long peripheral catheters are indicated for extended dwell times and the reduction of central venous catheters and their associated complications. Recently, multiple types of catheters and insertion techniques have been used in clinical care.

Methods and analysis

This prospective, two-arm, single-centre, non-blinded, pragmatic randomised controlled trial will compare two types of long peripheral catheters. A 63 mm ultra-long peripheral catheter using the catheter-over-needle approach will be compared with an 80–100 mm accelerated Seldinger technique-long peripheral catheter, which is the standard of care. Adult inpatients with DIVA, requiring a long peripheral catheter, will be included. The study aims to compare the mean dwell time, therapy completion rates and incidences of catheter-related thrombosis, infections, phlebitis, infiltration, loss of catheter usability and unplanned removal among adult DIVA patients. A priori sample size calculation based on average dwell times from published studies indicates that a minimum of 52 patients (26 per group) is needed. Consecutive sampling will be used until the sample size is reached. Upon signing the informed consent form, patients will be randomised in a 1:1 ratio using sequentially numbered, opaque, sealed envelopes. Due to the distinct visual differences between the two types of long peripheral catheters, blinding the inserter during the procedure is impractical.

Ethics and dissemination

The ethics committee of Ghent University (B6702024000487) and University Hospital of Brussels approved this study. On completion of the study, results will be disseminated via publication in a relevant peer-reviewed scientific journal. No external funding was received for the execution of this trial. The authors declare no conflicts of interest.

Trial registration number

NCT07005310.

Protocol version

Version 1, 17/03/2025.

A novel approach for longitudinal analysis of serum biomarkers of joint metabolism and knee injury in military officers

by Liubov Arbeeva, Virginia B. Kraus, Amanda E. Nelson, Maryalice Nocera, Leigh F. Callahan, Richard F. Loeser, Kenneth L. Cameron, Jesse R. Trump, Stephen W. Marshall, Yvonne M. Golightly

Purpose

To investigate the longitudinal relationships between serum biomarkers of joint metabolism, knee injury, and Knee Injury and Osteoarthritis Outcome Score (KOOS) using novel methodologies.

Methods

Data were collected from military officers who enrolled as cadets between 2004–2009, with follow-up conducted between 2015–2017. Analyses included 234 officers who had no history of knee ligament/meniscal injury at the time of military academy matriculation, had serum biomarker measurements at matriculation and graduation, demographic data, and KOOS assessment at follow-up. Biomarkers included Collagen Type II (C2C) and Type I and II (C1,2C) collagenase-generated cleavage epitopes, C-terminal propeptide of Type II collagen (CPII), and C- and N-terminal telopeptides of type I collagen (CTX and NTX). Angle-based Joint and Individual Variation Explained (AJIVE) was used to determine demographic determinants of biomarker levels and individual modes of variation specific to biomarker levels at matriculation and graduation, stratified by sex.

Results

We confirmed known associations of joint metabolism biomarkers with age in both sexes and with smoking in males. Matriculation biomarker data in males suggested a protective biomarker profile characterized by high cartilage synthesis and low cleavage of type I and II collagen in association with healthy KOOS scores at follow-up. CPII measured at matriculation was negatively associated with incident injuries after adjustment for smoking status (p = 0.03, logistic regression), confirming results from AJIVE.

Conclusion

These exploratory analyses suggest that CPII alone, or in combination with other joint metabolism biomarkers, may help identify individual risk of knee injury.

Optimising regional organisation of endovascular thrombectomy for ischaemic stroke reusing a simulation model

Objectives

This study assessed whether a previously developed Monte Carlo simulation model can be reused for evaluating various strategies to minimise time-to-treatment in southwest Netherlands for endovascular thrombectomy (EVT) in patients who had an ischaemic stroke.

Design

Reuse of a previously developed simulation model to simulate various strategies in another region, using prospectively collected data from stroke centres and retrospective data from emergency medical services.

Participants

Data from 509 patients who had an ischaemic stroke (≥18 years) treated with EVT (2014–2018) were used.

Interventions

Input for the simulation model reuse included distributions of observed time delays along the acute stroke pathway. Validation of the baseline models was based on face validity and statistical measures (patient data vs model output) using the Assessment of the Validation Status of Health Economic decision models tool. We simulated strategies for a subregion: interhospital patient transfer by helicopter, transport of the neurointerventionalist to the primary stroke centre (‘drive-the-doctor’), interhospital patient transfer to a thrombectomy-capable stroke centre (TSC) outside the region and prehospital triage using the Rapid Arterial Occlusion Evaluation (RACE) scale.

Primary outcome

Onset-to-groin time was the outcome.

Results

Reuse of the original simulation model was obtained by minimal effort, implying limited adaptation. Compared with the baseline model, interhospital patient transfer by helicopter or to a TSC outside the region and prehospital routing using the RACE scale reduced mean onset-to-groin time by 16, 13 and 39 min, respectively (95% CrI for all: equal to the point estimate). ‘Drive the doctor’ reduced mean onset-to-groin time by 27 (car), 49 (ambulance) or 58 min (helicopter), each with a 95% CrI equal to the point estimate.

Conclusions

The original simulation model can be applied to different regions in the Netherlands. Strategies tested within the subregion resulted in promising results of ‘drive the doctor’ and prehospital patient routing using the RACE scale.

Pittsburgh Brain Health Initiative (BHI): protocol and methods for an observational study of cognitive function in former professional football players and controls

Por: Okonkwo · D. O. · Collins · M. W. · Kontos · A. P. · Lopez · O. · Mountz · J. M. · Wisniewski · S. R. · Edelman · K. L. · Benso · S. · Holland · C. · Beers · S. R. · Soose · R. J. · Harrison · T. · Mucha · A. · Puccio · A. · Mancinelli · M. · Borrasso · A. · Rosario · B. L. · Laymon · C.
Introduction

Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.

Methods and analysis

Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.

Ethics and dissemination

The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.

Can we Save the rectum by watchful waiting or transanal microsurgery following shorT-course radiotherapy and Additional local oR systemic Treatment for early-stage REctal Cancer? STARTREC-3 protocol for a non-randomised, multicentre, phase II platform stu

Por: de Vries · S. E. N. · Couwenberg · A. M. · Marijnen · C. A. M. · Beets · G. L. · Burger · J. W. · Chalabi · M. · de Groot · J. W. · Intven · M. · Peulen · H. M. · Roodhart · J. M. L. · de Wilt · J. H. W. · Grotenhuis · B. A.
Introduction

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

Objective

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

Methods

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

Ethics and dissemination

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

Trial registration number

CTIS EU 2024-514620-17-00

Impact assessment of neonatal care interventions on regional neonatal care capacity: a simulation study based on clinical data in the Netherlands

Por: Wagenaar · J. H. L. · Dietz · A. · Huang · Y. · Reiss · I. K. M. · Been · J. V. · Spaan · J. · Kornelisse · R. F. · Taal · H. R. · Hinrichs-Krapels · S.
Objective

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Setting

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

Participants

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

Interventions

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Main outcome measure

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

Results

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Conclusion

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Improving communication to enhance health literacy and self-management of heart failure: protocol for a multimethod study

Por: Karimi · N. · De Toni · F. · Abhayaratna · W. · Askelin · B. · Currie · P. · Edge · K. · Etherton-Beer · C. · Fewster · E. · Goncharov · L. · Jijo · N. · Macqueen · S. · Mckay · N. · Raine · S. · Rashidi · A. · Rouen · C. · Saunders · R. · Schulz · P. · Tecson · R. · Slade · D.
Introduction

Self-care plays a pivotal role in the management of heart failure (HF). Health literacy and empowerment are considered the prerequisites of effective self-care. This project aims to improve self-management in people with HF by describing, analysing and enhancing the communication practices of clinicians and patients to support people with HF to increase their health literacy skills and participate in shared decision-making.

Methods and analysis

A multimethod research design incorporating an interview component, a concurrent mixed-methods component and a pilot intervention study is used. The study is currently being conducted at two Australian hospitals in metropolitan areas (one public and one private). The interview component involves semistructured interviews with healthcare providers and hospital executives and managers at the participating sites to explore perceived barriers and facilitators to HF self-management and understand the institutional context of HF care. The concurrent mixed-methods components include: (a) tracking and audio recording the clinical interactions of patients with HF (n=30) during their hospitalisation and up to 6 months after discharge and semistructured interviews with the patient (and the carer) and the participating clinician after each clinical interaction and (b) collecting longitudinal survey data (n=180, patients) to track patients’ health literacy, empowerment and self-management over 6 months. The pilot feasibility study includes developing a complex intervention for clinicians and patients and evaluating its acceptability and potential in improving health literacy and reducing readmissions, length of stay and costs.

Ethics and dissemination

This study was approved by the Australian Capital Territory Health (2023.ETH.00007) and Edith Cowan University (023–04314-SAUNDERS) Human Research Ethics Committees. Informed consent was obtained and will continue to be sought from all participants. Study results will be disseminated in peer-reviewed journals.

Positive health programme for British South Asian women with postnatal depression: a multiperspective qualitative study

Por: Miah · J. · Bee · P. E. · Lunat · F. · McPhillips · R. · Taylor · A. K. · Aseem · S. · Sharma · D. · Husain · N. · Chew-Graham · C.
Objectives

To explore the views and perspectives of British South Asian (BSA) women and Positive Health Programme (PHP) facilitators on the usefulness and experiences of the PHP intervention for managing postnatal depression (PND) in primary care settings.

Design

Qualitative study with semi-structured interviews to explore perceptions of acceptability and implementation. A patient and public involvement group provided their insights and feedback on study topic guides, analysis and outcomes.

Setting and participants

We sampled trial participants from the PHP intervention database to ensure variation in geographic setting, age, socioeconomic status and ethnicity. PHP facilitators involved in the trial were also invited to participate in an interview.

Interviews with study participants were conducted at participants’ homes, and community centres, or via phone. Interviews with PHP facilitators were conducted via phone or online. Interview recordings were transcribed verbatim and analysed using thematic analysis and subsequently the Theoretical Framework of Acceptability (TFA) was applied. Recruitment took place between February 2017 and March 2020.

Results

Thirty interviews were conducted—19 trial participants and 11 PHP facilitators. The PHP intervention was viewed positively, with appreciation of its therapeutic content and components such as childcare and refreshments that facilitated engagement. Participants reported improved confidence and well-being and supported their needs. Participants understood the intervention’s purpose. Both intervention participants and facilitators noted strengthened self-efficacy.

Some participants experienced difficulties balancing childcare and attendance, implying a need for logistical assistance. Stigma about mental health in the BSA community was viewed as persistent, recommending future programmes efforts on strategies to reduce stigma and develop supportive environment.

Conclusion

This study demonstrates the possibility of PHP intervention being integrated into routine care by providing culturally tailored support for BSA women with PND, primarily through family engagement and facilitator support. Future research on scalability, alongside community engagement efforts, will strengthen its acceptability and broader applicability.

Trial registration number

ISRCTN10697380.

HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to study the (cost-)effectiveness of laparoscopic hernia repair compared to open hernia repair in children 0-16 years

Por: Maat · S. C. · de Vreeze · L. E. · Eurlings · R. · Anema · J. · Van Baren · R. · Been · J. V. · van den Broek · F. · Cakir · H. · van Dongen · J. M. · Ferenschild · F. · de Graaf · J. · Nijveldt · R. · Ottenhof · A. · Ploeg · A. J. · Rippen · H. · Ruiterkamp · J. · Twisk · J. W. R. · Ver
Introduction

Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.

Methods and analysis

A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.

Ethics and dissemination

The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.

Trial registration number

ClinicalTrials.gov PRS (ID NCT06451432).

Knowledge, perceptions and practices of informal medicine vendors regarding over-the-counter distribution of antibiotics and antibiotic resistance in Nanoro District, Burkina Faso: an exploratory qualitative study

Por: Kouanda · J. S. · Campbell · L. · Meudec · M. · Welgo · A. · Diagne · P. M. · Ingelbeen · B. · van Kleef · E. V. · Valia · D. · van der Sande · M. A. · Tinto · H. · Wouters · E.
Objectives

This study aimed to understand the knowledge possessed by informal medicine vendors regarding antibiotics and antibiotic resistance, identify the perceptions held by informal medicine vendors about antibiotics and their uses and examine the practices employed by informal medicine vendors in the sale and distribution of antibiotics.

Design

Exploratory qualitative study using semi-structured interviews and direct observations.

Setting

Markets and shops across 11 villages in the Nanoro health district, Burkina Faso.

Participants

23 informal medicine vendors, aged between 25 and 55 years and with 8–30 years of experience, were recruited through snowball sampling in the Nanoro health district of Burkina Faso.

Results

Informal medicine vendors exhibited a limited understanding of antibiotics, often confusing them with other treatments and referring to them using local terminologies based on perceived use and effectiveness. Antibiotics were perceived as universal remedies, supported by therapeutic belief, empirical reasoning and community solidarity, with empirical diagnosis, approximate dosing and informal preparation techniques passed on through imitation. These findings emerged across themes including perceptions, symbolic attributes and sales practices.

Conclusion

Informal medicine vendors in rural Burkina Faso demonstrated limited understanding of antibiotics and antimicrobial resistance, with practices shaped by local beliefs and empirical experience. These findings underscore the need for context-sensitive interventions that include tailored education and regulatory engagement to improve antibiotic stewardship and mitigate the spread of resistance.

Large cohort study of postnatal events over 18 months in a not-for-profit referral centre in Vellore, South India

Por: Abraham · N. A. · Nagasamudra Devendrappa · V. · Mano R · G. · Pricilla · R. A. · Rathore · S. · Yenuberi · H. · Tirkey · R. S. · Shabeer · M. · Kumar · M. · Abraham · A. · Vijayaselvi · R. · George · A. · Abraham · K. · Prasanthi · A. · Minz · S. · Abraham · S. · Kurian · S. · Premkumar
Objective

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

Design

A prospective cohort study.

Setting

A large tertiary care centre.

Participants

12 245 women who delivered after 22 weeks gestation in the year 2022.

Interventions

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary and secondary outcome measures

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Results

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Conclusion

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

Trial registration number

CTRI/2022/03/041343.

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