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.

Hormone-dependent gynaecological disorders and contraceptive modalities in women with a history of venous thromboembolic event: The THROMBOGYN study.

Context: Hormone-dependent gynaecological disorders, such as polycystic ovary syndrome (PCOS) or endometriosis, have been recently discussed as potential risk factors for venous thromboembolism (VTE). Combined hormonal contraceptive (CHC) therapy, which is a well-known risk factor for VTE, is usually used to alleviate symptoms related to these gynaecological disorders. Nevertheless, prevalence of hormone-dependent gynaecological disorders at the time of VTE event and the management of hormonal contraceptives are not well known.

Artificial intelligence and high-resolution anoscopy: automatic identification of anal squamous cell carcinoma precursors using a convolutional neural network.

Background: High-resolution anoscopy (HRA) is the gold standard for detecting anal squamous cell cancer (ASCC) precursors. Although it is superior to other diagnostic methods, particularly cytology, the visual identification of areas suspected of having high-grade squamous intraepithelial lesions remains difficult. Convolutional neural networks (CNNs) have shown great potential for assessing endoscopic images.

[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.

Extensive suppuration and being overweight are factors associated with the failure of laser treatment for pilonidal disease: lessons from the first French retrospective cohort.

Background: The aim of our study was to assess the efficacy of sinus laser therapy (SiLaT) for the treatment of pilonidal disease.

Methods: All adult patients treated with SiLaT in our department between June 1, 2018, and August 23, 2019, were included in the study. Success was defined as the closure of cutaneous orifices and the absence of discharge or abscesses.

Hemorrhoidal surgery in patients with IBD: caution is the parent of safety.

Background: The aim of this study was to evaluate the outcome of hemorrhoidal surgery in patients with inflammatory bowel disease (IBD) undergoing surgery at our center.

Methods: All adult patients with IBD undergoing hemorrhoidal surgery in our department between November 1, 2013 and July 7, 2020 were included in the study. At the time of surgery, the patients' IBD was in clinical, biological and endoscopic remission, and none of the patients had specific primary anoperineal lesions.

[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.

Patients with atherosclerotic peripheral arterial disease have a high risk of lung cancer: Systematic review and meta-analysis of literature.

Purpose: Lung cancer and atherosclerosis share common risk factors. Literature data suggest that the prevalence of lung malignancy in patients with peripheral arterial disease (PAD) is higher than in the general population. Our goal was to determine, through a systematic literature review, the prevalence of lung cancer in patients with PAD.

Influence of clinical suspicion on CT accuracy of acute mesenteric ischemia: Retrospective study of 362 patients.

Purpose: Acute mesenteric ischemia (AMI) may be underdiagnosed when not clinically suspected before CT is performed. We assessed the influence of a clinical suspicion of AMI on the CT accuracy.

Method: This retrospective single-centre study included patients who underwent CT in 2014-2019 and had clinically suspected AMI and/or confirmed AMI.