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Developing an Evidence‐Based and Patient‐Centred Care Concept to Address Deficits in German Primary Care of Venous Leg Ulcers: Results of an Expert Survey Within the ULCUS CRURIS CARE Project

ABSTRACT

Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software-supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi-structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence-based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence-based treatment and supporting patient adherence.

Prenatal maternal mental health and neurodevelopment in congenital heart disease in France: the neuro-moms CHD multicentre prospective study protocol

Por: Deninotti · J. · Derridj · N. · Martins · S. · Laux · D. · Stos · B. · Levy · M. · Desnous · B. · Guillaumont · S. · Amedro · P. · Chabaneix · J. · Pfister · M. · Marguin · G. · Desmure · G. · Vincenti · M. · Bonnet · D. · Calderon · J.
Introduction

Neurodevelopmental impairments in congenital heart disease (CHD) are the most frequent long-term morbidity. Adverse neurodevelopmental outcomes may start in the prenatal period. Maternal mental health may be a potentially modifiable risk factor for the optimisation of neurodevelopment in CHD. We propose to assess the impact of prenatal maternal mental health on 1-year neurodevelopmental outcomes in complex CHD.

Methods and analysis

Neuro-Moms CHD is a national multi-centre, prospective study of prenatal maternal mental health and neurodevelopmental outcomes in children with complex CHD who undergo neonatal open-heart surgery. Participants (n=87 mother-child dyads) will be recruited from five major French paediatric cardiology centres (Necker Children’s Hospital in Paris, Bordeaux Cardiology Hospital, Marseille Children’s Hospital, Montpellier University Hospital and Saint-Pierre Institute). Expecting women who receive a prenatal diagnosis of fetal complex cyanotic CHD that requires a neonatal open-heart surgery for the newborn are eligible to participate. They will complete self-reports on mental health, anxiety, depression and coping skills and will participate in a semi-structured psychological interview. Mothers will provide information on medical, sociodemographic and lifestyle factors. They will be enrolled during the third trimester of pregnancy and will participate at three time points: prenatal, T1; after the newborn’s cardiac surgery, T2; and between 12 and 18 months after birth of the child with CHD, T3. Children with CHD will undergo a standardised neurodevelopmental assessment when they turn 12–18 months old. The father or co-parent of the child with CHD will also participate in T1 and will complete mental health self-reports. We will use a structural equation model to estimate simultaneously the relationships among maternal mental health, prenatal factors and child neurodevelopment outcomes.

Ethics and dissemination

This study is sponsored by the French National Institute of Health and Medical Research. It was approved by the Ethics Committee on 5 November 2024 and is registered in a public trials registry (NCT06711666). Neuro-Moms CHD targets a public health question with important societal implications. Results are expected to be broadly communicated with the scientific community and the lay public. Dissemination of findings will be in the form of scientific articles in peer-reviewed journals and presentations at conferences. Any publication or communication will comply with the international recommendations: ‘Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals’ (http://www.icmje.org/recommendations). All participants will give written informed consent or assent to participate. The anonymised data to be collected in this study will be available within the manuscripts published.

Trial registration number

NCT06711666; pre-results.

Prognosis of drug-related hospital admissions in older adults in an acute-care geriatric unit: a prospective cohort study

Por: Lomba Goncalves · N. · Dauny · V. · Cochard · A. · Genet · B. · Bannelier · H. · Phagouape · J. · Simon-Tillaux · N. · Boutitie · L. · Boddaert · J. · Minaud · A. · Zerah · L.
Objectives

Drug-related hospital admissions (DRAs) are prevalent among older adults, with a substantial proportion deemed preventable. Despite their frequency, little is known about the prognosis of DRAs in this population, particularly concerning mortality and hospital readmissions. The objectives were to assess the prognosis of DRAs in older patients, focusing on 6-month mortality and unplanned readmissions.

Design

Prospective cohort study.

Setting

A 20-bed acute-care geriatric unit within an academic hospital.

Participants

All patients aged 75 years or older hospitalised in the unit during 2023.

Primary and secondary outcome measures

The primary outcome was 6-month all-cause mortality. The secondary outcome was the rate of unplanned hospital readmissions, including emergency department visits, within 6 months. DRAs were identified using a two-step standardised review process. Kaplan–Meier survival curves and Cox proportional hazards models were used to estimate hazard ratios (HRs) for mortality. Fine and Grey competing risk models were applied for the analysis of unplanned readmissions. Multivariable models adjusted for age, sex, Charlson Comorbidity Index, medication count, activities of daily living score, long-term care residency and prior hospitalisations.

Results

Among 483 patients included (median age 86 years [IQR 81–91]), 207 (43%) were admitted for a DRA. At 6 months, mortality was significantly lower in patients with DRAs compared with those without (19% [n=39] vs 37% [n=102]; p

Conclusions

DRAs have a distinct prognosis as compared with other causes of admission among older patients. Identifying and managing DRAs are crucial for minimising preventable complications in this vulnerable population.

High flow oxygen for vaso-occlusive crisis: a multicentre, prospective, randomised, multi-arm, multi-stage clinical trial (OSONE)

Por: Mekontso Dessap · A. · Habibi · A. · Guillaud · C. · Kassasseya · C. · Larrat · C. · Agbakou · M. · Tchoubou · T. · Candille · C. · Carpentier · B. · Landais · M. · Arlet · J.-B. · Fartoukh · M. · Desclaux · A. · Masseau · A. · Oziel · J. · Bouharaoua · S. · Affo · C. · Viglino · D. · Bouk
Introduction

Sickle cell disease (SCD) is due to the mutation of haemoglobin (Hb), from HbA to HbS and characterised by recurrent vaso-occlusive crises (VOC), which can progress to acute chest syndrome (ACS), a leading cause of death in adults with SCD. Hypoxia is a key modifiable factor in the polymerisation of HbS and the pathogenesis of VOC. High-flow nasal oxygen (HFNO) delivers humidified gas at high oxygen concentrations and flow rates: the former may reverse sickling (metabolic effect) to accelerate VOC resolution and prevent ACS, while the latter may reduce the risk of ACS by mitigating hypercapnia and generating positive airway pressure that limits hypoventilation and atelectasis (pulmonary effect). The study hypothesises that HFNO is a safe and effective strategy for treating VOC and preventing secondary ACS, and will assess this using a multi-arm multi-stage (MAMS) trial design.

Methods and analysis

This is a prospective, multicentre, randomised, open-label controlled trial following an MAMS design with three phases and four arms: one control (low-flow oxygen) and three HFNO intervention arms with varying fraction of inspired oxygen levels (low, intermediate, high). The pilot stage will assess safety and feasibility, using the rate of cardiac and neurological events as the primary endpoint. In the activity stage, arms demonstrating acceptable safety will be compared for efficacy based on the rate of VOC resolution without complications by day 5, allowing selection of the most promising arm. The final efficacy stage will compare the selected HFNO strategy to control, with prevention of secondary ACS by day 14 as the primary endpoint. The study aims to enrol up to 350 VOC episodes in total.

Ethics and dissemination

The study has been granted ethical approval (CPP SUD MEDITERRANEE IV). Following the provision of informed consent, patients will be included in the study. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03976180.

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