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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.
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.
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.
Infectious diseases are a major global health concern, responsible for significant morbidity and mortality. To advance the understanding and treatment of these diseases, biobanks and biorepositories play a crucial role in guaranteeing sample traceability through their entire life cycle (collection, acquisition and registration, processing, storage, distribution) and future analysis of clinical and biological data.
The INfectious DIsease REgistry BIObank (INDI-REBIO) is an observational, prospective, monocentric, open-ended registry with ad hoc procedures and a systematic collection of uniform clinical, laboratory, imaging and therapeutic data of patients with suspected or microbiologically documented bacterial, viral, fungal and parasitic infectious diseases from the IRCCS San Raffaele Hospital (Milan, Italy). The study aims to collect both uniform data and biological samples such as blood and other relevant specimens. The registry aims to include significant patient numbers across various conditions (among others: bloodstream infections, endovascular infections as infective endocarditis, central nervous system infections, bone and joint infections, multidrug-resistant organisms (MDROs) colonisation, sexually transmitted infections, HIV infection, emerging and re-emerging infectious diseases), enabling comprehensive research on disease evolution, treatment outcomes and the identification of biomarkers.
The study adheres to ethical principles outlined by the Helsinki Declaration and Good Clinical Practice guidelines. It has received ethical approval (Comitato Etico CET Lombardia 1, CET 138–2023) and is registered on clinicaltrials.gov (NCT06418048). Participants will provide informed consent and can withdraw at any time. The study results will be disseminated through major international conferences and submitted to peer-reviewed research journals.
ClinicalTrials.gov, NCT06418048.
This study aims to describe the prototype development and testing of a serious game designed for Brazilian children with diabetes. Following an approach of user-centered design, the researchers assessed game's preferences and diabetes learning needs to develop a Paper Prototype. The gameplay strategies included diabetes pathophysiology, self-care tasks, glycemic management, and food group learning. Diabetes and technology experts (n = 12) tested the prototype during audio-recorded sessions. Next, they answered a survey to evaluate the content, organization, presentation, and educational game aspects. The prototype showed a high content validity ratio (0.80), with three items not achieving the critical values (0.66). Experts recommended improving the game content and food illustrations. This evaluation contributed to the medium-fidelity prototype version, which after testing with diabetes experts (n = 12) achieved high content validity values (0.88). One item did not meet the critical values. Experts suggested increasing the options of outdoor activities and meals. Researchers also observed and video-recorded children with diabetes (n = 5) playing the game with satisfactory interaction. They considered the game enjoyable. The interdisciplinary team plays an important role guiding the designers in the use of theories and real needs of children. Prototypes are a low-cost usability and a successful method for evaluating games. Elopement jeopardizes patient safety, affects the hospital's reputation, and results in financial ramifications. In an academic community hospital, executive leadership approached a team of nurse leaders for expertise following the elopement of a vulnerable patient.
The team's goal was to identify evidence-based strategies to mitigate future elopement events. Following an extensive literature review and gap analysis, the organization recognized opportunities pertaining to elopement management, including patient assessment, prevention strategies, and facility-wide response when events occur. The nurse leader team thoroughly searched current literature to answer the Population, Intervention, Comparison, and Outcome (i.e., PICO) questions of interest. Following a critical appraisal of 55 articles, 26 were utilized to make practice change recommendations. The body of evidence included a variety of age groups and diagnoses.
After the synthesis of the literature, the team provided recommendations to the organization. These recommendations included the assessment of patient-specific risks and the implementation of elopement prevention measures as fundamental elements for incidence reduction. The team partnered with multidisciplinary stakeholders for the revision of policies, processes, and electronic medical record documentation.
The organization monitored elopement events and the duration of each event throughout the phases of implementation. Pre-implementation data, collected from January to June 2021, demonstrated 34 individual elopement cases lasting an average of 118 min each. In comparison, post-implementation data collected during the same time frame in 2022 found only 12 events lasting an average of 24 min each.
The organization implemented evidence-based recommendations to standardize the facility's approach to elopement. With structured assessment, precautions, and response, the organization demonstrated a notable decline in the number and duration of elopement events. Hardwiring processes, analyzing data, and adjusting expectations within an evidence-based framework should assist the organization's drive to further enhance patient safety surrounding elopement events.
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