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.

NCT03976180.

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

Type 1 diabetes mellitus (T1DM) is a chronic disease that requires lifestyle amendment, demanding treatment and regular glycaemic control, all of which can significantly impact the health-related quality of life (HRQoL) of affected children. This study aimed to assess the HRQoL of T1DM in a Tunisian paediatric population and to identify the influencing factors.

This was a cross-sectional study.

The study was conducted at a tertiary care paediatric hospital in Tunis, Tunisia, over a 6-month period from November 2022 to April 2023.

A total of 120 children with T1DM, aged 3–17 years, and their parents were enrolled. Inclusion criteria included children with a confirmed diagnosis of T1DM and regular follow-up at the study centre.

HRQoL of children with T1DM was assessed using the validated Tunisian version of the KINDL-R questionnaire. The KINDL-R scores range from 0 to 100, with higher scores indicating better perceived HRQoL.

We included 120 children with T1DM. HRQoL was considered satisfactory in 94 children (78.3%), with a mean total score of 69±20.8 (range: 21.4–99.3). Parents reported significantly lower HRQoL scores compared with their children’s self-assessments, with a mean total score of 59.2±20.4 (range: 14.3–97.5). Multivariate linear regression analysis identified several factors independently associated with impaired HRQoL, including a glycated haemoglobin level >9%, a child’s age greater than 14 years, a history of ketoacidosis decompensation, a daily insulin dose ≥0.78 IU/kg/day, more than 10 hypoglycaemic episodes per month and parental divorce. Conversely, the use of insulin analogues and good academic performance were independently associated with a more satisfactory HRQoL.

T1DM is not exclusively a clinical and biological condition, but it also affects the psychological well-being of the child and the entire family dynamic. Despite its recognised importance, psychosocial support is still insufficient. Therapeutic education programmes seem to be a relevant initiative for improving the HRQoL of children with T1DM.