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Sociodemographic factors associated with the utilisation of specialist palliative care in individuals with end-stage kidney disease: protocol for a scoping review

Por: Jameson · E. · Brown · P. P. · Bruni · A. · Wassef · M. · Chang · R. · Milne · K. · Berry · J. · Bonares · M.
Introduction

Individuals with end-stage kidney disease (ESKD), whether receiving dialysis or conservative care, experience high symptom burden and limited life expectancy, indicating substantial palliative care needs. Integrating palliative care into kidney care is vital for comprehensive ESKD management, but access remains uneven across sociodemographic groups. Identifying and addressing these disparities is key to ensuring equitable care and improving patient outcomes. This study aims to explore sociodemographic factors associated with specialist palliative care utilisation among people with ESKD.

Methods and analysis

This study protocol outlines a scoping review of peer-reviewed and grey literature using an established methodological framework by the Joanna Briggs Institute (JBI), and reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Relevant literature will be identified through a multi-database (Ovid MEDLINE, Embase, CINAHL, PsycINFO) and grey literature search strategy designed alongside a health sciences librarian. To be included, articles must involve individuals with ESKD and report on how sociodemographic factors influence access to and utilisation of specialist palliative care services. Results of the search will be screened independently by two reviewers and data from included studies will be extracted independently and in duplicate. A narrative and thematic analysis will be conducted to identify key themes related to sociodemographic influences on specialist palliative care access and utilisation among individuals with ESKD, with particular attention to differences between kidney care modalities (dialysis vs conservative care) and the extent to which intersectionality of sociodemographic factors has been examined.

Ethics and dissemination

Ethics approval is not required for this scoping review. Findings will be submitted for publication in a peer-reviewed journal. Results will identify patient-related factors influencing access to specialist palliative care in ESKD and remaining gaps in the literature, informing future research and policy to support equitable care.

Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial

Por: Coloma · P. · Coury · D. · Wernette · S. · Beevers · V. · Dubois · C. · Di Marco · T. · Dursun · O. T. · Bruni · O.
Introduction

Insomnia disorder imposes a significant burden on children and adolescents; however, treatment options are limited. This paper describes the first controlled study to investigate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in children and adolescents with or without comorbid neurodevelopmental disorders, allowing its evaluation in a broad paediatric population.

Methods and analysis

This multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding Phase 2 trial includes male and female participants aged ≥10 to

Ethics and dissemination

This study has been approved by the respective health authorities and institutional review boards/independent ethics committees for each participating site and country and is conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained for each participating country/site. Regardless of the outcomes, the results will be published in an international peer-reviewed scientific journal.

Trial registration number

NCT05423717.

Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol

Por: Longhini · F. · Crimi · C. · Noto · A. · Pelaia · C. · Karakurt · Z. · Skoczynski · S. · Boleo-Tome · J. P. · Winck · J. C. · Esquinas · A. M. · Melhorn · J. · Corneci · D. · Pobeha · P. · Bosco · V. · Garofalo · E. · Bruni · A. · Cammarota · G. · Todorova · V. · Puci · M. V. · Sotgiu · G.
Introduction

Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.

Methods and analysis

The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.

Ethics and dissemination

The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the ‘Comitato Etico Sezione Area Centro - Regione Calabria’) and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.

Trial registration number

ClinicalTrials.gov ID: NCT05681962. Registered January 2023.

Exploring the correlations of lung ultrasound with delirium and other clinical outcomes in older patients with respiratory failure admitted in acute geriatric units (ECO-AGE): protocol for a multicentre, prospective, observational study from the GRETA Gro

Por: Okoye · C. · Ticinesi · A. · Finazzi · A. · Bruni · A. A. · Guarino · D. · Cerundolo · N. · Nouvenne · A. · Siniscalchi · C. · Meschi · T. · Lauretani · F. · Maggio · M. · Zucchini · I. · Torrini · M. · Cerasuolo · M. · Rizzo · M. R. · Monzani · F. · Antonelli Incalzi · R. · Ungar · A. · B
Introduction

Point-of-care lung ultrasound (LUS) can assist in diagnosing acute respiratory diseases for its high accuracy and immediate availability at the bedside, including older patients with frailty. Delirium represents a frequent complication of hospitalisation in this setting, frequently triggered by acute respiratory diseases. LUS may therefore help identify individuals at risk of delirium, but the association between LUS abnormalities and delirium remains unexplored.

Methods and analysis

This study is a prospective, observational, multicentre study, with the main objective of assessing the correlation between LUS abnormalities and incident delirium during hospitalisation (primary outcome). The secondary objectives are to assess correlations between lung and diaphragm ultrasound parameters and clinical outcomes including duration of delirium, severity of respiratory failure and mortality. 480 patients aged ≥65 years old, urgently hospitalised after an emergency department visit for acute respiratory complaints, will be recruited in eleven acute geriatric wards located in eight teaching hospitals across Italy. LUS examinations will be performed by skilled clinicians prior to treatment whenever feasible, and in any case within 48 hours from admission. They will also undergo comprehensive geriatric assessment, and daily delirium assessment through the 4-AT tool. The association between LUS abnormalities, related parameters (LUS score, Pleural Effusion Score) and outcomes will be assessed by linear and logistic regression models.

Ethics and dissemination

Ethics Committee approval of the coordinating centre (Comitato Etico Territoriale Lombardia 3, reference ID 4369_20.03.2024_M) and collaborative centres has been obtained. All participants will provide written informed consent. Study results will be publicly available following peer-reviewed publication in international scientific journals.

Trial registration number

NCT06670118.

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