Vital signs such as heart rate (HR) and respiratory rate (RR), crucial for clinical assessment, are often challenging to measure in paediatric populations. Remote photoplethysmography (rPPG), a video-based measurement tool, has demonstrated accuracy in adults. The objective of this study is to compare HR and RR measurements obtained using rPPG with those from standard clinical monitoring in a paediatric population.

This is a monocentric, prospective study enrolling 600 paediatric participants. Each participant will have standard monitoring electrodes (ECG/impedance) placed on the chest while seated facing a camera for rPPG recording. Simultaneous HR and RR measurements will be recorded over periods of 30 and 60 s using both the standard monitor and the rPPG device. The intraclass correlation coefficient will be calculated to assess agreement between the rPPG and standard monitor measurements.

The study protocol has been approved by the French Agency for the Safety of Health Products (ANSM (Agence nationale de sécurité du médicament) registration no. IDRCB 2023-A02524-41) and by a French ethics committee (CPP Sud Méditerranée III at 29 August 2024, n°2024-A01324-43). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through press releases.

Clinical Trials Registry (NCT06231654).

Each year, physical traumas affect over one billion people worldwide, generating a substantial burden in terms of mortality, disability and productivity loss. The period following hospital discharge, encompassing the transition to home, short-term stays in rehabilitation facilities, as well as outpatient and community-based follow-up care, represents a critical phase in the recovery process for trauma injury patients. Yet, this phase remains poorly documented. We aim to (1) Map data on assessment strategies for various outcomes among trauma survivors after hospital discharge, including the tools used and how they are administered, as well as the resources required, and the barriers and facilitators to their implementation, and (2) Compare the feasibility of implementing the assessment strategies while considering response rates, resource use, costs and sustainability.

We will conduct a scoping review using the Joanna Briggs Institute methodology. We will search MEDLINE, Embase, CINAHL, Scopus and PsycINFO for studies published since 1990 to reflect the evolution of contemporary follow-up practices, including the emergence of Patient-Reported Outcome Measures and digital tools. There will be no language restrictions. We will consider all studies involving trauma survivors, focusing on the evaluation of postdischarge health outcomes. Two independent reviewers will screen studies and extract data on population characteristics, assessment strategies and feasibility. Results will be analysed thematically and presented narratively. We will present counts and percentages for each assessment strategy, along with its characteristics and associated barriers and facilitators. Subgroup analyses will also be conducted based on clinical and social determinants and contextual factors.

Ethics approval is not required for this review. The results of this scoping review will be shared through publication in a peer-reviewed journal, conference presentations and our network of knowledge users.

DOI 10.17605/OSF.IO/KZHS4

Laparoscopic hiatal hernia (HH) repair is associated with a high recurrence rate. Repair reinforced with mesh lowers short-term recurrence but can cause dysphagia and visceral erosion. Results of the PRIME trial, in which non-absorbable mesh reinforcement of the posterior crural repair was investigated, showed equal recurrence compared with primary suture repair after 6 months. This study investigates the use of circular absorbable mesh reinforcement in primary HH repair.

Prospective double-blinded randomised controlled superiority trial comparing two laparoscopic procedures for HH repair (110 vs 110). Adult patients with proven HH Skinner types II–IV (defined by preoperative CT scan) are included. Patients are randomised to undergo a laparoscopic primary crural repair with sutures alone or suture repair augmented with biosynthetic absorbable, circular mesh at the hiatus. Radiologic integrity of the hiatal repair 1 year after surgery is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of postoperative reflux disease, postoperative side effects and satisfaction with surgical outcome. Outcome assessors are blinded to allocation. Data are collected at baseline, and follow-up includes interviews and digital questionnaires at 3, 12, 24, 36, 48 and 60 months, as well as CT scan at 12 and 60 months. All patients randomised will be analysed according to the intention-to-treat principle.

Ethics approval has been obtained by the local ethics committee at Isala, Zwolle, the Netherlands (Medical Ethics Review Committee (METc) Isala, study number: 190516). METc Isala is no longer active; all duties have been taken over by METc of the University Medical Center Groningen. The trial’s results will be submitted to a peer-reviewed international journal as well as (inter)national conferences.

Registered in the Dutch national trial registry: OMON (NL-OMON48062).

Minimally invasive endoscopic procedures constitute the cornerstone of first-line treatment for bulbar urethral strictures, although their long-term effectiveness is limited by high recurrence rates. The Optilume drug-coated balloon (DCB) is a novel intervention combining mechanical dilation with localised delivery of paclitaxel to reduce recurrence by inhibiting scar tissue formation. While its efficacy has been demonstrated in patients with recurrent strictures, its potential as a first-line option in treatment-naïve patients remains unexplored. The FIRST-CARE trial aims to assess the efficacy and safety of Optilume DCB compared with standard endoscopic treatment in treatment-naïve patients with bulbar urethral strictures.

Design: Two-arm, randomised, single-blind (participant), investigator-initiated, parallel-group, multicentre clinical trial. Patients: The study will enrol 140 adult male patients with treatment-naïve, single bulbar urethral strictures ≤3 cm in length. Interventions: All patients will undergo the assigned procedure under general anaesthesia with 1.5 g intravenous cefuroxime. Optilume group patients will receive ≥5 min balloon dilation with localised paclitaxel delivery. The control group will receive standard endoscopic treatment (eg, direct visual internal urethrotomy, laser or dilatation). In both groups, a 12–14 French Foley catheter will be left in place for 3–5 days. Primary outcome: Freedom from repeat intervention within 12 months of follow-up. Primary analysis: Time-to-event will be defined from the date of intervention to the date a repeat intervention is decided (indicated and planned) due to confirmed recurrence, with censoring at 12 months. Groups will be compared using Kaplan-Meier survival analysis and the log-rank test. Cox regression and modified Poisson regression will be used to estimate HRs and relative risks.

The trial is approved by the Danish National Committee on Health Research Ethics (2401370) and will be conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. In line with national guidelines, all eligible patients are counselled regarding available treatment options prior to enrolment. Results will be disseminated via peer-reviewed publications and scientific presentations.

NCT06827210.

Although individuals with dementia who reside in nursing homes are particularly susceptible to developing delirium, this condition is rarely recognised in these settings. Detection of delirium requires validated and reliable tools for this setting that can be applied by nursing staff. The primary objective of the study is to assess the comprehensibility, practicality and inter-rater reliability of two delirium detection tools (4 A’s test (4AT) and 4-item delirium superimposed on dementia (4-DSD)) and one tool for assessing both the diagnosis and severity of delirium (Delirium Rating Scale-Revised-98 (DRS-R-98)) in people with dementia who reside in nursing homes when used by nurses.

The comprehensibility and practicality of the German versions of the 4AT, 4-DSD and DRS-R-98 will be evaluated using cognitive interviews in accordance with the consensus-based standards for the selection of health measurement instruments framework. On the basis of the results of the cognitive interviews, a manual for each of the three tools will be developed and finalised by an expert panel. Finally, the inter-rater reliability and measurement error of the three tools will be determined using the manuals. For this purpose, a total of 70 residents from six nursing homes will be assessed by at least two nurses. The data analysis will include descriptive statistics and inter-rater reliability assessment for individual items (kappa value) and total scores (Intraclass correlation coefficients).

This study will assess the comprehensibility, practicality and inter-rater reliability of the 4AT, 4-DSD and DRS-R-98 for use in residents with dementia in nursing homes. The project was approved by the medical ethics committee of the University of Oldenburg (reference number: 2025-093).

The inter-rater reliability study was registered in the German Clinical Trials Register. Registration number: DRKS00037458 (https://www.drks.de/search/de/trial/DRKS00037458/details).

The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches. To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1).

We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial. This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes

Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences.

NCT05773859; EUCT number 2024-512353-24-01.

The study evaluated healthcare professionals’ adherence to guidelines on quality neonatal resuscitation practices in Ghana.

This study employed an observational design. A validated observational checklist for neonatal resuscitation was used to assess the adherence to quality neonatal resuscitation guidelines among healthcare professionals.

The study was conducted among healthcare professionals in six healthcare facilities, consisting of five government-owned healthcare facilities and a private non-profit health facility across the northern, middle and coastal belts of Ghana.

The study participants were 75 healthcare professionals across the six sampled healthcare facilities.

Outcome measures of interest are: initial preparation prior to resuscitation; stimulation and airway maintenance; positive pressure ventilation; coordinated positive pressure ventilation with chest compression and postresuscitation infection prevention and control measures.

The results revealed that 53% of the healthcare professionals demonstrated good (scored 80%–100%) adherence to guidelines on quality neonatal resuscitation practices; the remaining scored moderate 36% (scored 50%–79%) and 11% (scored 0%–49%) poor adherence. Binary logistic regression analysis revealed that increased staffing levels and a bachelor’s degree or higher were positively associated with the performance of positive pressure ventilation (adjusted OR (aOR) 19.3 (95% CI 2.430799, 152.8657), p=0.005) and (aOR 9.9 (95% CI 1.070278, 92.38303), p=0.043), respectively. Furthermore, professional nurses and medical practitioners were more likely to adhere to coordinated positive pressure ventilation with chest compressions than auxiliary nursing staff (aOR 13.2 (95% CI 1.917858, 92.61999), p=0.009) and (aOR 15.7 (95% CI 1.227859, 200.1105), p=0.034).

The results showed that 53% of healthcare professionals demonstrated good adherence for neonatal resuscitation practices. Addressing the identified gaps and inequalities in neonatal resuscitation practice will improve healthcare professionals’ knowledge and skills in neonatal resuscitation, which ultimately helps to reduce neonatal deaths among babies in Ghana.