French National Health Agency Research Articles

Online self-sampling kits to screen multipartner MSM for HIV and other STIs: participant characteristics and factors associated with kit use in the first 3 months of the MemoDepistages programme, France, 2018

ObjectivesIn 2017, to reduce the proportion of men who have sex with men (MSM) in the undiagnosed HIV population in France (38%), HIV screening is advised each 3 months and...

COVID-19 impact in abortions’ practice, a regional French evaluation

IntroductionOn March 14, 2020, France has entered into stage 3 of the COVID-19 pandemic. The French National Health Agency (Haute Autorité de Santé) has urgently recommended the use of medical abortion at home between 7 and 9 weeks of gestation and telemedicine for medical abortion consultations. The main objective of this study was to assess whether the emergency measures undertaken for the management of abortions during the COVID-19 pandemic led to practice changes, and to obtain practitioners' opinions regarding the continuation of these measures. Material and methodsThis was a retrospective, quantitative, online self-administered survey from August 6, 2020 to October 2, 2020, aimed at health workers performing abortions (midwives, general practitioners, gynecologists obstetricians and medical gynecologists) in the South and Corse regions in France. ResultsAmong the 124 practitioners included, 59/77 (76.6 %) offered medical abortion at home between 7 and 9 weeks of gestation and 61/89 (68.5 %) of them wished to carry on this practice. 55/123 (44.7 %) practitioners offered telemedicine for medical abortion at home and 71/115 (61.7 %) of them wished to carry on this practice. DiscussionThe emergency measures implemented by the the French National Health Agency (Haute Autorité de Santé) for medical abortion are approved and followed by the majority of health workers performing abortions in the South and Corse regions. This measure may be extended out of the COVID-19 epidemic.

Re-aligning scientific and lay narratives of Alzheimer's disease

It is unsettling to realise that Amazon's best-selling books on Alzheimer's disease claim that scientists have so far got it all wrong, and that the disease can be reversed with appropriate nutrients and lifestyle changes. In March 2019, the number one hit of a Google image search for “top world Alzheimer's physicians“ was the cover of a book with similar claims. Others go even further and suggest that Alzheimer's disease is a medical construct artfully devised to expand the drug market. With evident disregard for the many clinical trials of symptomatic treatments, the French national health agency has withdrawn reimbursement of dementia drugs and forbidden producers of amyloid positron emission tomography (PET) tracers to sell their regulatory approved products in the country. Some practitioners claim that the diagnostic workup of academic memory clinics, consisting of imaging and CSF biomarkers, is but an expensive intellectual exercise, as it is not actionable (ie, followed by effective interventions). In these circumstances, we argue that the disease narratives of scientists and society are increasingly divergent and that the scientific community should become aware of the divide, try to align the two narratives, and progress in synergy with society towards finding a cure. Preclinical Alzheimer's disease: a valid conceptIn The Lancet Neurology, Frisoni and colleagues1 present a thoughtful and topical Insight, but I disagree with their recommendations. They point out that, although the National Institute on Aging–Alzheimer's Association (NIA-AA) research framework2 recommends defining the disease biologically (by abnormal biomarkers denoting both amyloid and tau deposits) independent from symptomatic presentation, most in the lay community understand the term Alzheimer's disease to mean a progressive cognitive impairment that leads to dementia. Full-Text PDF

Incidence of paediatric pneumococcal meningitis and emergence of new serotypes: a time-series analysis of a 16-year French national survey

Successive implementation of seven-valent then 13-valent pneumococcal conjugate vaccines (PCVs) led to a marked decrease in pneumococcal disease burden, including pneumococcal meningitis. We assessed the long-term effect of implementation of PCVs on incidence of pneumococcal meningitis in children in France over a 16-year period. We did a quasi-experimental, population-based interrupted time-series analysis with a nationwide prospective survey over 16 years in France, recruiting children aged younger than 15 years from 227 paediatric wards from January, 2001, to December, 2016. The main outcome by the time-series model was the estimated incidence of pneumococcal meningitis per 100 000 children (of a population of 12·6 million children in 2017) before and after PCV7 and PCV13 implementation. The time-series model was based on segmented regression with autoregressive error. We enrolled 1778 children with pneumococcal meningitis. PCV13 implementation led to a significant reduction in monthly incidence of pneumococcal meningitis from 0·12 per 100 000 children before PCV13 to a nadir of 0·07 in December, 2014 (-38%, 95% CI -56·1 to -20·4; p<0·0001). A sharp increase occurred during 2015 and 2016, (+2·3% per month, incidence of 0·13 per 100 000 children at the end of the study period, p=0·0002), mainly related to an increase of serotype 24F, which was frequently penicillin resistant. The early effect of PCV13 implementation greatly reduced the incidence of pneumococcal meningitis in children less than 15 years old. However, a sharp rebound in incidence linked to the emergence of serotype 24F compromised the long-term PCV efficacy. If confirmed in future studies and in other countries, pneumococcal meningitis incidence rebound and 24F emergence should be considered when developing next-generation PCVs. The French Pediatric Infectious Diseases Group, Association Clinique et Thérapeutique Infantile du Val de Marne, Pfizer, and for the National Reference Centre for Pneumococci, the French National Health Agency.

PP20 Assessment Of The First Software Combined With Telemonitoring Support

Introduction:More and more software programs, including those with medical device status, are coming into the market that aim to facilitate management of diabetic patients. In France, their coverage requires a positive opinion from the French National Health Agency (HAS) dedicated committee. To understand the utility of these products for patients, real-life experiments are in progress. Since the evaluation principles are similar for all medical devices, it was important to find out with this first connected software if specific methods or evaluation criteria are necessary.Methods:After obtaining CE marking, the manufacturer submitted a dossier to HAS outlining the clinical data and technical performance of the software. HAS assessed the dossier and the opinion of stakeholders (i.e. professionals and patient associations) in order to determine the actual clinical benefit of this software. At the same time, HAS set technical features in particular to secure patient data and limit access to only those involved in telemonitoring. Terms of prescription and use of this connected software had also been defined.Results:Two feasibility studies and one randomized controlled trial were analyzed. Specific clinical data demonstrated that the risk-benefit balance was positive in type 1 diabetic patients.Conclusions:In addition to the need to keep personal data confidential and to integrate the technology in the organization of healthcare, this assessment shows that randomized clinical trials are feasible and necessary to demonstrate the clinical benefit of connected software; however, specificities exist regarding data collection methods and the scope of healthcare organization that should be taken into account. A specific guide to connected medical devices for industry has been developed by HAS to help them build their application dossier for reimbursement. The second step for HAS is to develop guidelines on the specificities of the assessment of these connected devices.

The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

BackgroundIn 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone.Methods/DesignDICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France’s new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in the control and targeted groups respectively, a sample size of 140,000 patients was estimated corresponding to 8,750 patients per ED and per period. Inclusions started in June 2014. Results are expected by mid-2016.DiscussionThe DICI-VIH study is the first large randomized controlled trial designed to assess nurse-driven targeted HIV screening. This study can provide valuable information on HIV screening in health care settings.Trial registrationClinicalTrials.gov: NCT02127424 (29 April 2014).

Quelle place pour les anticoagulants oraux directs en pratique hospitalière quotidienne ?

PurposeMore than one million patients received an oral anticoagulant treatment in France. This medication is the first aetiology of iatrogenic events. Recently, direct oral anticogulant (DOA) provided efficacy and safety in the treatment of atrial fibrillation and venous thromboembolic events. Given the growing increase in the prescription of these molecules, with many advantages but also disadvantages, it seemed interesting to assess in routine hospital medical practice, the proportion of patients for which the initiation of AOD could be safe. MethodsThis prospective, observational study was conducted in the department of internal medicine from October 2012 and September 2013. All inpatients receiving oral anticoagulant treatment have been included. Demographic data, indication of anticoagulant treatment, contraindications and interactions have been reported. From these information, we have established the percentage of patients who could benefit from DOA safely and securely. ResultsTwo hundred and ninety inpatients were included with a mean age of 76.3±15.2 years old. Atrial fibrillation and thromboembolic venous disease were the most prevalent indications of anticoagulant treatments (67.2% and 22.4% of cases respectively). Among all patients, 260 had an indication of DOA (89.7%), authorized by the French National health agency. Eighty percent had both indication and no contraindication for DOA. However, only 53.1% of patients neither had drug–drug interaction. Main contraindications were severe renal failure (clearance<30mL/min) in 10.7% of cases, and recent history of gastric ulcer in 15.3% of cases. The most frequent interactions with DOA were antiplatelet agent (14.5%) and amiodarone (11.6%). Almost two thirds of inpatients (65.1%) had at least one drug-drug interaction with VKA. ConclusionThese results, coming from “real life”, provide that only 53.1% of inpatients under anticoagulants could receive DOA safely. Caution is warranted, and VKA still have a preponderant role among anticoagulant drugs.

De l’évaluation des pratiques professionnelles à la pertinence des transfusions

Clinical practice evaluation programme is now a mandatory process for healthcare institutions. Integrative part of the certification procedures conducted by the French National Health Agency (Haute Autorité de Santé [HAS]), it has became a new major approach to improve both the quality and the safety of healthcare. It concerns also transfusional practices.

MRI for the size assessment of pure ductal carcinoma in situ (DCIS): A prospective study of 33 patients

Objective To determine whether MRI assesses the size of ductal carcinomas in situ (DCIS) more accurately than mammography, using the histopathological dimension of the surgical specimen as the reference measurement. Materials and methods This single-center prospective study conducted from March 2007 to July 2008 at the Antoine-Lacassagne Cancer Treatment Center (Nice, France) included 33 patients with a histologically proven DCIS by needle biopsy, who all underwent clinical examination, mammography, and MRI interpreted by an experienced radiologist. All patients underwent surgery at our institution. The greatest dimensions of the DCIS determined by the two imaging modalities were compared with the histopathological dimension ascertained on the surgical specimen. The study was approved by the local Ethical Research Committee and was authorized by the French National Health Agency (AFSSAPS). Results The mean age of the 33 patients was 59.7 years (±10.3). Three patients had a palpable mass at clinical breast examination; 82% underwent conservative surgical therapy rather than radical breast surgery (mastectomy); 6% required repeat surgery. MRI detected 97% of the lesions. Non-mass-like enhancement was noted for 78% of the patients. In over 50% of the cases, distribution of the DCIS was ductal or segmental and the kinetic enhancement curve was persistent. Lesion size was correctly estimated (±5 mm), under-estimated (<5 mm), or over-estimated (>5 mm), respectively, by MRI in 60%, 19% and 21% of cases and by mammography in 38%, 31% and 31% ( p = 0.05). Mean lesion size was 25.6 mm at histopathology, 28.1 mm at MRI, and 27.2 mm on mammography (nonsignificant difference). The correlation coefficient between histopathological measurement and MRI was 0.831 versus 0.674 between histopathology and mammography. The correlation coefficient increased with the nuclear grade of the DCIS on mammography; this coefficient also increased as the mammographic breast density decreased. Conclusion MRI appears to assess the size of DCIS better than mammography by limiting the number of under- and over-estimations compared to histopathology findings.