Individuals experiencing moderate to severe mental illness have low rates of workforce inclusion, with a consequence of high welfare dependency, affecting both societal costs and health. Individual Placement and Support (IPS) is an approach to supported employment where the goal is to help people obtain jobs on the open rather than sheltered labour markets. Despite multiple randomised controlled trials (RCTs) indicating that the IPS model enables employment better than treatment as usual, with widespread adoption in some jurisdictions, the broader impacts of this large-scale implementation on mental health, quality of life and social functioning remain unknown.

Between 2012 and 2019, Norway introduced IPS through both local and national government projects. This study assesses the social and economic benefits of the implementation of IPS using Norwegian registry data, focusing on 18–45-year-old people receiving specialist mental healthcare, and who did not have steady employment at treatment start. Instead of assessing IPS efficacy in an RCT design, we use a naturalistic study design, evaluating IPS effectiveness by comparing aggregate population-level outcomes over time between areas where IPS was not available.

In work package (WP) 1, we mapped the availability and implementation of IPS across Norway. This involved analysing information on funding, resource and capacity levels to understand how IPS had been rolled out across the country. While completed, we include a description of WP1 here, as it informs WP2 and WP3. WP2 is an effectiveness evaluation investigating the population-level outcomes of implementing IPS, focusing on health, mortality, quality of life and social functioning. Finally, in WP3, we assess the financial implications of implementing IPS from a public purse perspective, synthesising data on resource use and costs of implementation with data from WP2.

Overall, we will examine the societal effects of IPS implementation on employment, welfare dependency, mental healthcare use, emergency care visits, self-harm and suicide, general mortality, crime and victimisation. Emphasis will be on long-term outcomes, and we will model the economic consequences of IPS. This study aims to inform policy making and strategies for implementing IPS at scale.

This is an effectiveness study using registry data. The Regional Committee for Medical Research Ethics Northern Norway, REK North has approved the use of registry data without informed consent for this project (approval number 134553).

The findings will be disseminated both in academic peer-reviewed journals, directly to informants in WP1, to the public through media and the project website, and at relevant conferences and seminars for specific relevant target groups.

Not applicable

Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.

The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.

This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.

The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.

NCT06677554; 2024-511720-13-00.

There is an unmet clinical need for the development of novel treatment strategies to improve the outcome of children with frequent relapsing or steroid-dependent nephrotic syndrome. Obinutuzumab (OBI) is a second-generation anti-CD20 monoclonal antibody that has demonstrated its superiority to rituximab (RTX) in vitro and in vivo. Our assumption is that a single infusion of low-dose OBI will induce longer B-cell depletion, longer sustained remission and reduce the frequency of relapses and the use of oral immunosuppressors compared with a single infusion of RTX.

We conduct a double-blind, multicentre, randomised, parallel group in a 1:1 ratio controlled trial. In the experimental group, patients receive 1 infusion of OBI (300 mg/1.73 m²) and in the control group, the patients receive 1 infusion of RTX (375 mg/m²). The primary outcome of the study is the occurrence of the first relapse within 12 months following the initiation of treatment and secondary outcomes include the time to first relapse, the total number of relapses during the 24-month follow-up period, and any adverse events such as infusion-related complications, infectious complications, hypogammaglobulinaemia and neutropenia.

The study has been approved by the ethics committee (Comité de Protection des Personnes) of Sud Méditerrannée 2 and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.

NCT05786768.

2022-003336-59.

For large primary spontaneous pneumothorax (PSP), drainage or simple aspiration are the two first-line treatment options. Outpatient ambulatory strategies have a success rate of almost 80% with few complications. New French recommendations suggest that an outpatient strategy should be preferred if an appropriate care network is in place. However, establishing this care network remains the main obstacle to the use of this strategy. Thus, outpatient management of PSP remains rare, which is neither optimal for the patient, with a likely impact on quality of life (QOL) and satisfaction with care, nor for the healthcare system, with increased costs. We hypothesise that outpatient treatment of PSP compared with usual inpatient management could improve quality of care and represent a more efficient, generalisable and sustainable strategy.

In this multicentre, cluster-controlled, randomised interventional study with stepped wedge implementation, patients aged 18–50 presenting to the emergency department (ED) with a first episode of large PSP will be enrolled in seven university hospitals in France. The main objective of this study is to evaluate the impact on changes in QOL of an ambulatory strategy for the management of large PSP in the ED compared with usual inpatient management. The primary outcome is the difference in QOL as measured by SF-36 score, between drain placement and 6 months. Clinical criteria (pulmonary expansion at 6 days, pain, dyspnoea, complications, recurrence), perceived quality of care (satisfaction, patient preference, anxiety) and ease of implementation of the care pathway will also be assessed. A cost-utility analysis will be carried out to evaluate the incremental cost-utility ratio at 1 year, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores.

Ethics approval has been obtained by the Comité de Protection des Personnes Nord Ouest III N° 2024-36. Study findings will be disseminated by publication in a high-impact international journal. Results will be presented at national and international emergency healthcare meetings, and participating patients notified of the main conclusions.

This trial is registered with Clinical Trials Registry NCT06471608. The trial protocol and statistical design are fully described in this study protocol. Additional data can be provided on reasonable request to the sponsor. Protocol version: V2.1 - 21/11/2024.

To assess whether emergency physicians prescribe morphine differently for patients with or without sickle cell disease (SCD). Given the difficulty of comparing strictly homogeneous patients in real clinical settings, we used a standardised clinical vignette to ensure that all clinical information was identical except for SCD status and sex.

International, randomised controlled, vignette-based study conducted online. The four vignette versions differed only in patient sex and SCD status, with all other clinical information fully standardised. Vignettes were validated by an expert panel and randomly allocated using a computer-generated sequence.

Emergency physicians practising in France, the UK, Belgium and Switzerland were invited to complete an online survey between 17 February and 17 March 2025.

A total of 1060 physicians responded, of whom 953 (90%) met eligibility criteria and were included in the analysis. Respondents were practising emergency department (ED) physicians without exclusion based on seniority or training level.

The primary outcome was the proportion of simulated patients for whom morphine was prescribed. Secondary outcomes included the number and type of analgesics prescribed and the proportion of cases meeting predefined criteria for maximal level of care (urgent triage category, lactate sampling, CT imaging and morphine administration).

Morphine was prescribed in 444 of 492 (90%) SCD vignettes and 389 of 461 (84%) non-SCD vignettes (absolute difference: 6% (95% CI 1% to 10%)). Morphine monotherapy was used in 41% of SCD cases and combined analgesia in 50%. No significant differences were observed according to patient sex or physician characteristics. Maximal level of care was recommended in 22% of SCD cases.

In this randomised vignette study, emergency physicians prescribed morphine more frequently for simulated patients with SCD than for those without SCD, despite identical clinical presentations. These findings contrast with real-world reports of inadequate analgesia in SCD and suggest that the absence of perceptual cues—such as skin colour or names—may reduce implicit bias in opioid prescribing.

NCT06835335. IRB CHU Nîmes No 25.02.01.

Prehospital notification by emergency medical services (EMS) can activate hospital resources before the patient arrives, which has been shown to improve in-hospital care for stroke patients. Optimising prehospital and handover processes in stroke care requires considering end-user perspectives to enhance acceptance and effectiveness of the developed solutions. The aim of this study was to identify current barriers in the preclinical-clinical phase of stroke care.

Within the investigator-initiated CAEHR project (CArdiovascular diseases—Enhancing Healthcare through cross-sectoral Routine data integration), an interface for transferring data from the electronic prenotification system to the hospital information system is implemented. A mixed-methods approach with semi-structured interviews as well as a cross-sectional online survey was used to gather feedback from healthcare professionals at a single stroke centre in Germany as well as from the participating EMS personnel. Data collection for the interviews was conducted between January and August 2023 and for the online survey between May and September 2023.

Interviews were conducted with 10 healthcare professionals, including seven from the neurological clinic and three from EMS. Additionally, 39 EMS employees took part in a cross-sectional online survey.

Challenges identified were educational and training aspects affecting preclinical processes and patient handover procedures, along with the opportunity for establishing more uniform protocols. Participants emphasised the importance of detailed patient information. Electronic prenotification was seen as an important step regarding structured information transmission, reducing the risk of information loss in stroke care.

The study highlights the importance of addressing organisational processes in addition to technical interfaces for implementing effective stroke care processes.

German Clinical Trials Register, DRKS00029103.

International pilot projects focusing on next-generation sequencing in newborn screening (NBS), that is, genomic NBS (gNBS), have been established thanks to continuous therapeutic progress and the massive development of new genetic technologies with rapidly decreasing costs. Given the highly encouraging results of the French SeDeN project regarding anticipated acceptability among professionals and parents, it is now appropriate to launch a similar pilot project in France, in collaboration with other international initiatives under the International Consortium on Newborn Sequencing framework.

PERIGENOMED is a large-scale project designed to provide the first concrete evidence on the relevance of gNBS in France. It includes two clinical trials. We present here the design chosen for the first clinical trial (PERIGENOMED-CLINICS 1). PERIGENOMED-CLINICS 1 aims to assess the feasibility, real-world acceptability, psychosocial impact and organisational pathways of panel-based genomic newborn screening in France, involving 2500 participants. Solo-GS targeting two lists of gene–disease dyads responsible for treatable (list 1; 400 genes, 171 diseases/group of diseases) or actionable (list 2 optional; 407 genes, 218 diseases/group of diseases) rare and severe early-onset diseases will be proposed in five health institutions. Ancillary social and impact studies will also be included.

All study procedures have been reviewed and approved by relevant French ethics committees and regulatory authorities (CPP Est II-2024-A02224-43, 1 January 2025). Results of the project will be disseminated through peer-reviewed publications, national and international conferences, and public engagement initiatives, in coordination with stakeholders.

NCT06875089.

Pre-eclampsia and fetal growth restriction (FGR) are two principal complications of pregnancy related to placental dysfunction. Nevertheless, knowledge of the underlying pathophysiological mechanisms remains inadequate, and only a few tools are available for in vivo assessment of placental perfusion. Contrast-enhanced ultrasound (CEUS) allows organ vascularisation evaluation via a strictly intravascular gas microbubble. The primary aim of this study is to compare placental vascularisation parameters obtained via CEUS between pregnancies with FGR and those without FGR.

This is a single-centre, prospective, comparative, non-randomised, feasible, open and interventional study. We will include 30 women with medical termination of pregnancy divided into two groups: one with severe FGR and the other without FGR. Severe FGR is defined as an estimated fetal weight below the third percentile for gestational age. Women will be informed and recruited in the fetal medicine unit over a period of 48 months. The primary goal of this study is to compare the placental contrast ultrasound parameter measurements according to group. The primary objective is to compare placental contrast ultrasound data in women who undergo medical termination of pregnancy at a gestational age of 16 weeks (38+6 days) between two groups: a group with FGR and a group without FGR. The secondary objectives are as follows: (1) to describe the placental vascularisation parameters measured by CEUS; (2) to describe the parameters for quantifying vascularisation at different gestational ages via CEUS; (3) to study the associations between CEUS data and placental histological data and (4) to establish a biological collection of placentas to increase our knowledge of the development and functions of the placenta during pregnancy. The statistical analysis will include descriptive analysis for all study patients, with quantitative data described by means±SDs, medians, IQRs, and extreme values and qualitative data reported as counts and percentages. Comparisons of placental contrast ultrasound parameters between the two groups will be performed via Student’s t-test or the Mann-Whitney U test on the basis of data normality. Associations between CEUS parameters and placental histology data will be analysed with Spearman or Pearson correlations. Qualitative associations will be studied via analysis of variance or the Kruskal-Wallis test. Box plot representations will be used when applicable. Analyses will be performed with R software, with significance set at p

This study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD EST II – LYON – FRANCE, on 26 April 2024, with reference number 2023-506936-34-00, and the competent authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) authorised the study on 17 May 2024. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.

NCT06497959; EU CT number: 2023-506936-34-00.