Efficacy of high-flow nasal oxygen therapy started in the emergency room versus conventional oxygen therapy in patients with acute hypoxaemic respiratory distress: protocol for a French multicentric, prospective, open and randomised superiority study protocol (HIFLOWED)

Introduction
Acute respiratory failure is a life-threatening condition frequently found in the emergency department. High-flow nasal oxygen (HFNO) is increasingly used in emergency departments for patients with hypoxaemic acute respiratory failure. However, despite the increasing number of studies, its potential advantages regarding the need for therapeutic escalation and mortality have not been precisely evaluated. Our objective is to compare conventional oxygen therapy to HFNO when they are initiated during the first hour following the patient’s arrival at the emergency department, with the hypothesis that HFNO would reduce the need for ventilatory therapy escalation.

Methods and analysis
This is a multicentric, prospective, open and randomised superiority study. 500 inpatients will be randomised (1:1) to receive conventional oxygen therapy or HNFO. The primary outcome is a failure in the oxygen therapy defined as the need for a therapeutic escalation within 4 hours after therapy initiation.

Ethics and dissemination
The study has been submitted and approved by the Comité de Protection des Personnes Nord Ouest IV (20 October 2020). As required, a notification was sent to the Agence nationale de sécurité du médicament et des produits de santé (22 October 2020). The research results will be published in peer-reviewed publications and presented at international conferences.

Trial registration number
NCT04607967.

Read More
Agosto 2024

Patient experience in bariatric surgery: protocol of a French narrative inquiry and qualitative analysis

Introduction
The quality of hospital care, especially surgery, is traditionally assessed using indicators derived from healthcare databases or safety indicators. Given the growing importance of placing the patient at the heart of care evaluation, the use of questionnaires such as the Patient-Reported Experience Measures and Patient-Reported Outcome Measures has become widespread in recent years. However, these tools—addressing factors such as satisfaction, pain management or wait times—only imperfectly reflect the patient’s experience, and all such attempts at patient-centred care quality assessment rely on questions or indicators defined in advance by healthcare providers and health authorities. A biopsychosocial model may allow to better understand the patient experience and to improve care pathways. This study seeks to construct a narrative of the bariatric surgical care journey with instruments from narrative inquiry, propose a metanarrative that can serve as a basis for more sophisticated and reliable patient-focused care quality models and define indicators linked to patients’ feelings and stories.

Methods and analysis
To achieve these aims, 16 bariatric surgical patients at the hospital of Créteil, France (Centre Hospitalier Intercommunal de Créteil), will be included and interviewed once before and twice after surgery, at months 3 and 6. Narratives collected will be used to construct a metanarrative intended to encompass all possible narratives. This metanarrative may ultimately inform new patient care quality indicators, furthering care focused on patients and tailored to their needs and predispositions.

Ethics and dissemination
The study is funded by the Group of Clinical Research and Innovation in Île-de-France and was approved by CPP SUD-EST VI Clermont-Ferrand (France) Research Ethics Committee. The results will be submitted for publication in peer-reviewed journals. The patient associations will be approached for the dissemination of the study results.

Trial registration number
NCT05092659.

Read More
Agosto 2024

Diagnostic yield from symptomatic gastroscopy in the UK: British Society of Gastroenterology analysis using data from the National Endoscopy Database

Objective
This national analysis aimed to calculate the diagnostic yield from gastroscopy for common symptoms, guiding improved resource utilisation.

Design
A cross-sectional study was conducted of diagnostic gastroscopies between 1 March 2019 and 29 February 2020 using the UK National Endoscopy Database. Mixed-effect logistic regression models were used, incorporating random (endoscopist) and fixed (symptoms, age and sex) effects on two dependent variables (endoscopic cancer; Barrett’s oesophagus (BO) diagnosis). Adjusted positive predictive values (aPPVs) were calculated.

Results
382 370 diagnostic gastroscopies were analysed; 30.4% were performed in patients aged

Read More
Agosto 2024

Identifying suicidal risk factors in the French Overseas Territories with multimethod psychological autopsy (AUTOPSOM): a mixed-methods study protocol

Introduction
Understanding suicide in more isolated territories is a challenge because of the entanglement of cultural identity with historical, geographical and sociocultural specificities. This knowledge is a necessary precondition for the implementation of targeted prevention strategies in regions such as the French overseas territories (FOT), where data concerning suicidal risk factors is still incomplete. We aim to untangle sociocultural and clinical suicide risk factors by integrating a novel anthropological and psycholinguistic approach into the psychological autopsy method. This article describes the protocol of the clinical study ‘Contribution of Psychological Autopsy to the Understanding of Suicidal Behaviours in Overseas France’ (AUTOPSOM study), designed to identify common or new specific suicide risk factors in four FOT.

Methods and analysis
A multicentre epidemiological study will be carried out in four FOTs (French Polynesia, Martinique, La Reunion and French Guiana) and at a comparison site in mainland France (La Somme). The methodology will be based on a mixed-methods (quantitative and qualitative) approach using a psychological autopsy to collect clinical data and life events in the deceased’s life. We implemented an exploratory multimethod strategy that combines a succession of epidemiological, anthropological, psycholinguistic and psychological methods with a semiautomated analysis of the discourse of relatives bereaved by suicide.

Ethics and dissemination
The study protocol (first version) was approved by the French Ethics Committee (CPP OUEST II, approval #22.04267.000122) and the Ethics Committee of French Polynesia (JOPF of 5 April 2022; CEPF opinion n°91 of 29 March 2022). The overall results and the perspectives established at the end of the study will be communicated to the bereaved relatives according to their will and serve for local suicide prevention purposes.

Trial registration number
NCT05773898.

Read More
Luglio 2024

British Society of Gastroenterology guidelines for the management of hepatocellular carcinoma in adults

Deaths from the majority of cancers are falling globally, but the incidence and mortality from hepatocellular carcinoma (HCC) is increasing in the United Kingdom and in other Western countries. HCC is a highly fatal cancer, often diagnosed late, with an incidence to mortality ratio that approaches 1. Despite there being a number of treatment options, including those associated with good medium to long-term survival, 5-year survival from HCC in the UK remains below 20%. Sex, ethnicity and deprivation are important demographics for the incidence of, and/or survival from, HCC. These clinical practice guidelines will provide evidence-based advice for the assessment and management of patients with HCC. The clinical and scientific data underpinning the recommendations we make are summarised in detail. Much of the content will have broad relevance, but the treatment algorithms are based on therapies that are available in the UK and have regulatory approval for use in the National Health Service.

Read More
Luglio 2024