Cognitive impairment is present in the majority of individuals with first-episode psychosis (FEP) and is a strong predictor of long-term functional disability. Despite this, evidence-based cognitive interventions are rarely available in routine mental healthcare in low-income and middle-income countries, where most young people with psychosis reside. This protocol describes the CognIFied study, a pilot randomised controlled trial evaluating the feasibility and acceptability of a culturally adapted, task-shifted compensatory cognitive training (CCT) intervention for young adults with FEP in Nigeria.
CognIFied is a multicentre, assessor-blind, parallel-group pilot randomised controlled trial with an embedded mixed-methods process evaluation. The study will recruit 180 young adults aged 18–30 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)-defined FEP (onset within the past 5 years) and objective cognitive impairment from three public psychiatric hospitals in Nigeria. Participants will be randomised 1:1 to receive either culturally adapted CCT or an active control condition, Enhanced Recreational Therapy. Both interventions comprise 12 weekly group sessions lasting 60–90 min. CCT is delivered by trained psychiatric social workers using a manualised curriculum co-designed with young people with lived experience. Primary outcomes assess feasibility (recruitment, retention, intervention adherence), acceptability (Client Satisfaction Questionnaire-8) and intervention fidelity. Secondary outcomes include preliminary signals of effectiveness on global cognitive functioning (Brief Assessment of Cognition in Schizophrenia) and functional capacity (University of California, San Diego [UCSD] Performance-Based Skills Assessment), assessed at baseline and at 3, 6 and 12 months. Quantitative analyses will be descriptive and exploratory, supplemented by qualitative inquiry guided by Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Consolidated Framework for Implementation Research frameworks and an exploratory economic evaluation.
Ethical approval has been obtained from relevant institutional review boards. Findings will be disseminated through open-access publications, policy-focused stakeholder engagement and community dissemination co-led by a Youth Research Team.
The aim of this study was to explore the experiences of emergency medical communication centre (EMCC) operators and helicopter emergency medical service (HEMS) physicians following the introduction of an on-site HEMS physician in a Norwegian EMCC.
The study was designed as a qualitative focus group study. Data from the focus groups were analysed using qualitative thematic analysis.
The intervention was implemented at the regional EMCC and one HEMS base in mid-Norway.
Seven HEMS physicians and 22 EMCC operators from the EMCC and HEMS base in Trondheim, Norway, participated in the focus groups.
From 1 February to 5 July 2024, an on-site EMCC physician was introduced in Trondheim EMCC, being responsible for medical decision-making in HEMS dispatches during working hours in the intervention period.
The analysis revealed two overarching themes: (1) perceived impact on the decision-making process in HEMS dispatch and (2) increased trust through mutual learning and closer relationships. Overall, the study participants reported positive experiences with the intervention. They experienced that an on-site physician improved the basis for decision-making in HEMS dispatch, allowing for quicker decisions. The participants were uncertain regarding whether this led to more accurate HEMS dispatch decisions. They valued the opportunity to better understand each other’s skills and build stronger professional relationships.
Both EMCC operators and HEMS physicians experienced improved decision-making and faster dispatch conclusions in HEMS dispatch following the intervention. The high level of medical education and guideline adherence among EMCC operators questions the impact on HEMS dispatch accuracy following the intervention.
Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.
In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.
The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.
Community paramedicine services (CPSs) may alleviate the increasing pressure on emergency medical services (EMSs) but lack the capacity for patient transport. The study aims to determine whether a municipality implementing the CPS between periods (CPSREGION) compared with a control municipality (CTRREGION) served by EMS only affected patient flow and safety in a rural Norwegian setting.
A quasi-experimental study evaluating patient flow and safety before and after the introduction of CPS in one of two rural municipalities.
Two rural Norwegian municipalities that were served by EMS from nearby municipalities before the study started.
Before and after the introduction of CPS, a total of 604 and 650 patients, respectively, were included in CPSREGION, and 367 and 408 patients, respectively, in CTRREGION.
CPS was introduced in CPSREGION between the two data collection periods, whereas CTRREGION continued to be served by EMS.
The outcome of patient flow was assessed by the number of admissions to nearby hospitals, the number of patient contacts and the location for delivery and treatment. The outcome for safety was assessed as the need for medical recontact within 7 days and 30-day mortality.
Hospital admission rates increased over the two study periods, being insignificant in CPSREGION (+4.7%, p=0.373) and significant in CTRREGION (+23.2%, p
Introducing CPS resulted in fewer hospital admissions, with more patients being treated locally. No safety concerns with respect to medical recontacts and 30-day mortality were observed. We conclude that CPS can alter patient flow towards more local treatment without compromising safety.
Living with epilepsy, especially drug-resistant epilepsy (DRE), imposes several challenges for people diagnosed with the condition. These challenges include the physical and mental implications of epilepsy on both caregivers and patients with epilepsy. For the more than 120 000 individuals living with this neurological disorder in the Netherlands, along with their families, daily activities become hazardous, limited and costly, significantly affecting their health-related quality of life (HRQoL). As data on the burden of epilepsy in the Netherlands are lacking, studies attempting to capture the impact of epilepsy on individuals, caregivers and society are needed to enhance understanding and help address the burden of epileptic seizures.
The study is part of the AIM@EPILEPSY project. The project aims to develop a planning suite enabling cost-saving, minimally invasive treatment for epilepsy. By surveying 330 people with epilepsy and an anticipated sample of 150–200 informal caregivers across the Netherlands, using standardised questionnaires focusing on associated societal costs and the impact on HRQoL, this bottom-up, prevalence-based prospective study aims to understand the societal burden of DRE in the Netherlands. The data will be collected at 0, 3, 6 and 12 months of follow-up. The study results will describe the economic impact of epilepsy, focusing on cost-of-illness () and HRQoL (utilities) in the Netherlands.
The proposed study was approved by the Maastricht University Medical Ethics Review Committee (Approval reference: FHML-REC/2024/067/Amendment/2024_16). The result of the study is planned to be published in a peer-reviewed journal and presented at international and local scientific conferences.
Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.
This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.
This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.