Ethics and clinical research: How can the Ethics Committees (CPPs) and Committees for Research Ethics (CER) evolve?

In line with the spirit of the Giens workshops, this article reports on the recommended evolution of the Ethics Committees (CPPs) and the Committees for Research Ethics (CER) in France. These committees play a crucial role in the ethical evaluation of clinical research projects, a process that has become more complex, particularly in view of recent legislative, regulatory and methodological developments. This reflection highlights the current challenges faced by the CPPs, including the increasing workload, the complexity of the issues to be addressed and the need for better use of their resources.

Impact on healing of double-layered compression stocking in the treatment of severe venous leg ulcers: A prospective, multicenter, controlled trial.

Venous leg ulcer refers to chronic wounds, generally difficult to heal and often prone to recurrence. The objective of this research was to assess a double layered compression stocking VenoTrain® ulcertec on a population with mostly severe pathologies. This prospective, multicenter, interventional type II study was conducted between September 2018 and January 2022.

[Effects of a return-to -home assistance programm (PRADO-IC) on the patient journey in a cohort of cardiac heart failure patients].

Introduction: Congestive heart failure (HF) is associated with prolonged and recurrent hospitalizations; the prognosis remains poor a better follow up might be beneficial. PRADO-IC program is provided in order to improve the transition of care.

Aim Of The Study: To evaluate PRADO-IC program in term of healthcare consumption and prognosis in a cohort of patients hospitalized for decompensated HF, using the insight of the national data base SNDS (Système National de Données de Santé).

SiLaT: A paradigm shift in the treatment of pilonidal disease?

Background: Pilonidal disease (PD) is a common condition for which the global incidence is increasing. Surgery is the currently preferred approach to treatment but there is a growing interest in new minimally invasive techniques, such as sinus laser therapy (SiLaT).

Aim: Our primary objective was to assess the efficacy of SiLaT for the treatment of pilonidal disease.

Hemorrhoidal disease: Epidemiological study and analysis of predictive factors for surgical management.

Introduction: There are very few French studies on hemorrhoidal disease and its management.

Patients And Methods: Prospective single-center study from July to December 2021 including 472 patients.

Results: Bleeding, prolapse and pain were the main reasons for consultation.

Doppler echocardiography for surveillance of acute cardiac allograft rejection: a 28-year single-center experience.

Background: Endomyocardial biopsies (EMB) are recommended for the detection of acute cardiac rejection (ACR) despite limited sensitivity. We report the long-term post-transplant results of Doppler echocardiography as a noninvasive alternative of routine EMB.

Methods: Two cohorts of heart transplantation (HT) recipients were chronologically defined as follows: the Dual Monitoring Cohort (DMC) from January 1990 to December 1997 included patients who underwent routine EMB and Doppler echocardiography within 24 hours for ACR surveillance; and the "Echo-First Cohort" (EFC), including patients transplanted from January 1998 to December 2018 with Doppler echocardiography as first-line approach for ACR surveillance.

Epidemiological Study to Assess the Prevalence of Lung Cancer in patients with smoking-associated atherosclerotic cardiovascular diseases: PREVALUNG study protocol.

Introduction: Eligibility criteria definition for a lung cancer screening (LCS) is an unmet need. We hypothesised that patients with a history of atheromatous cardiovascular disease (ACVD) associated with tobacco consumption are at risk of lung cancer (LC). The main objective is to assess LC prevalence among patients with ACVD and history of tobacco consumption by using low-dose chest CT scan.

[Impact of Home Return Assistance Service in Heart Failure (PRADO-IC) on the one year re-hospitalisation and mortality in a heart failure hospitalized population of patients].

Introduction: Congestive heart failure (CHF) is associated with prolonged and recurrent hospitalizations; the prognosis remains poor. Since 2013, the Caisse Primaire d'Assurance Maladie (CPAM) has set up a support program PRADO-IC (support program for returning home after hospitalisation for heart failure). The aim of this study was to evaluate the impact of PRADO-IC on the heart failure readmission rate and death rate at one year.

Circulating IL-6 but not neutrophil extracellular traps levels can predict anakinra effectiveness in patients with severe COVID-19.

Added data on circulating IL-6 levels can predict COVID-19 severity and IL1RA efficiency.

What is the impact on work of osteoporotic fractures in active patients? A retrospective fracture-liaison-service study-Optiwork 1.

Purpose: Osteoporotic fractures have economic consequences and can alter the quality of life. Nevertheless, the direct impact on work has been infrequently reported. Our objective was to estimate the proportion of working patients resuming paid employment within the 3 months following an osteoporotic fracture, and to assess the consequences on their productivity and quality of life.

[Not Available].

Introduction: Congestiveheart failure (CHF) is associated with prolonged and recurrent hospitalizations, the prognosis remains poor. The aim of this study was to collect epidemiologic data at admission and at six month follow-up in a cohort of patients with CHF admitted to a single center between 2017 and 2019 (Saint Joseph Hospital, HSJ) and to compare these data with regional data (Ile-de-France, IdF).

Methods: Local and regional data were provided by National Health Service, Regional Department of Ile de France(DRSM) using national data base.

Electrochemical skin conductance by Sudoscan®: a new tool to predict intradialytic hypotension.

Background: Intradialytic hypotension (IDH), a common complication in haemodialysis (HD) patients, is associated with multiple risk factors including cardiac dysfunction and alterations of the peripheral autonomic nervous system. To what extent dysautonomia may contribute to the occurrence of IDH remains elusive. We sought to investigate the clinical utility of Sudocan®, a device that quantifies dysautonomia, in the prediction of IDH.

A reappraisal of the presence of small or large fiber neuropathy in patients with erythromelalgia.

Objective: To assess the contribution of large and small nerve fiber alteration in erythromelalgia (EM).

Methods: Thirty-three EM patients were included and underwent clinical evaluation based on EM severity score, DN4, and Utah Early Neuropathy Scale (UENS) score. Neurophysiological evaluation consisted in nerve conduction studies (NCS) for large nerve fibers and specific tests for small nerve fibers: electrochemical skin conductance, cold and warm detection thresholds, and laser evoked potentials.

Proposal for a New Score: Hemorrhoidal Bleeding Score.

Purpose: We conducted a prospective study to evaluate a new hemorrhoidal bleeding score (HBS).

Methods: All consecutive patients who had consulted between May 1, 2016 and June 30, 2017 for bleeding hemorrhoidal disease were prospectively assessed at a proctological department. The study was conducted in 2 stages.

Anakinra for severe forms of COVID-19: a cohort study.

Background: Coronaviruses can induce the production of interleukin (IL)-1β, IL-6, tumour necrosis factor, and other cytokines implicated in autoinflammatory disorders. It has been postulated that anakinra, a recombinant IL-1 receptor antagonist, might help to neutralise the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related hyperinflammatory state, which is considered to be one cause of acute respiratory distress among patients with COVID-19. We aimed to assess the off-label use of anakinra in patients who were admitted to hospital for severe forms of COVID-19 with symptoms indicative of worsening respiratory function.

Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia.

Objective: In patients with critical limb ischemia (CLI), blood pressure (BP) impact on mortality is unknown. We analyzed the predictive value of SBP, DBP and pulse pressure (PP) at hospital admission on 3-month mortality in patients with CLI undergoing revascularization procedure.

Methods: From November 2013 to December 2018, 297 consecutive patients were retrospectively included.

Computer-based tailored dietary counselling improves the nutrient adequacy of the diet of French pregnant women: a randomised controlled trial.

During pregnancy, mothers-to-be should adapt their diet to meet increases in nutrient requirements. Pregnant women appear to be keener to adopt healthier diets, but are not always successful. The objective of the present study was to determine whether a guided, stepwise and tailored dietary counselling programme, designed using an optimisation algorithm, could improve the nutrient adequacy of the diet of pregnant women, beyond generic guidelines.