[A framework for the practice of peer support]. / Pour un cadre d'exercice de la pair-aidance.

The concept of peer support is now firmly established in the psychiatric landscape. While taking into account the benefits that this approach brings to patients and teams, it is essential to consider the need to define a framework for the practice of peer support. This framework, which is essential for the development of the practice, will help to avoid overly fragile exposure, which is synonymous with difficulties for peer helpers and their teams.

[Human rights and transgender surgery]. / Droits de la personne humaine et chirurgie de la transidentité.

René Sève recalls that Contemporary Law in the Western World is based on autonomy of equal subjects, mutually recognizing the right to each carry out their own life project. The LGBTQIA+ person therefore exercises their ability to be their own species, according to Kirkegaard's word. It remains that "life project" also implies a constraint of stability and rationality. The author then shows, using Canadian and French statistical data, the difficulties of achieving this ideal for minors and, for adults, the other medical, paramedical and social conditions required. The rights of LGBT people cannot be considered independently of the physical and financial limits of the health system and therefore of the public debate on its priorities.

Real-life after sacral nerve modulation implantation: Rate, reasons, and risk factors for mid-term follow-up discontinuation.

OBJECTIVES: To evaluate follow-up after implantation of a sacral nerve modulation implantable pulse generator (IPG) and to investigate the reasons and risk factors for follow-up discontinuation. MATERIALS AND METHODS: All patients who underwent an IPG implantation to treat lower urinary tract symptoms between 2014-2019 within 6 hospital centers located in the district of "Hauts-de-France" (France) were systematically called during the year 2020 for a standardized (tele)consultation. Patients were divided into 3 distinct profiles according to the regularity of their 5-year postoperative follow-up: "Regular follow-up", "Irregular follow-up" and "Lost to follow-up". The primary outcome was the change in the annual proportion of the 3 follow-up profiles over the 5 years following IPG implantation. As secondary outcomes we described the reasons reported for follow-up discontinuation and looked for risk factors associated with. RESULTS: Overall, 259 patients were included. At the time of data collection, after a mean follow-up of 28.4 (± 19.8) months, 139 patients (53.7%) had a "Regular follow-up", 54 (20.8%) had an "Irregular follow-up" and 66 (25.5%) were "Lost to follow-up". The proportion of patients with a "Regular follow-up" decreased year by year, representing only 46.2% of patients at five-years. 175 patients (67.6%) underwent a standardized (tele)consultation. In multivariate analysis, only "lack of knowledge of the follow-up protocol" was statistically associated with follow-up discontinuation (OR=5.16; 95% CI [2.12-13.57]). CONCLUSION: The proportion of patients followed up after IPG implantation decreased steadily over the years, often related to a lack of therapeutic education.

Acide hyaluronique intra articulaire dans la gonarthrose: une étude long-terme, ouverte, de Phase IV, avec analyse détaillée par stade de Kellgren-Lawrence.

INTRODUCTION: Les injections intra articulaires (IA) d'acide hyaluronique (HA) désignées sous le nom de viscosupplémentation (VS), sont fréquemment utilisées dans le traitement symptomatique de la gonarthrose (OA), une affection ostéo-articulaire chronique douloureuse et handicapante, qui touche une fraction importante de la population âgée. La sévérité de la gonarthrose est en général décrite par la classification en stades radiologiques de Kellgren-Lawrence (KL). La VS a été largement étudiée à travers de nombreux essais cliniques; cependant, les résultats sont rarement analysés en détail, en fonction du stade KL. MÉTHODE: Une étude ouverte importante, portant sur 1 177 patients souffrant de gonarthrose, fut réalisée de 2004 à 2007. Chaque patient a reçu un traitement de VS consistant en 3 injections d'ARTHRUM H 2% (LCA Pharmaceutical, Chartres, France). A l'inclusion, les patients ont été décrits par leur profil démographique, leur indice de masse corporelle (IMC), leur stade KL et leur état clinique selon les sous-scores douleur et fonction de l'indice Western Ontario and McMaster Universities (WOMAC). Les visites de suivi étaient à M3, M6 et M9 (mois) après la VS. Cette large base de données a été entièrement retraitée en 2019, de manière à fournir une analyse séparée par stade KL, et fut complétée par l'évaluation des taux de patients répondeurs (%) au traitement, selon l'Outcome Measures in Rheumatoid Arthritis Clinical Trials & Osteoarthritis Research Society International (OMERACT-OARSI). L'analyse fut menée à la fois sur les populations en intention de traiter (ITT) et per protocole (PP) ayant terminé l'étude. RÉSULTATS: En analyse ITT du critère principal, les variations du sous-score WOMAC A (douleur) depuis l'inclusion jusqu'à la fin de l'étude, ont été respectivement de 19,8 ; 19,8 ; 17,8 et 14,2, sur une échelle de 0-100, pour les patients des stades KL I à KL IV. En analyse PP dans les mêmes conditions, ces variations ont été de 20,6 ; 19,9 ; 17,1 et 11,7. Tous ces résultats étaient significatifs par rapport aux valeurs à l'inclusion (p<0.001) et cliniquement pertinents à chaque stade KL. Des améliorations significatives ont été également observées pour le sous-score WOMAC C (fonction), et pour les autres critères secondaires. Le taux de répondeurs OMERACT-OARSI variait de 72 à 82% pour les patients KL I à III à M6 et M9. Pour les patients KL IV, le maximum atteint a été 47.7% à M6. Les autres paramètres tels que le sexe, l'IMC ou l'âge, ne furent pas identifiés comme des facteurs de pronostic pour la réponse à la VS. CONCLUSIONS: L'analyse détaillée par stade KL d'une large cohorte de patients suivis en ouvert, suggère le traitement de VS avec ARTHRUM H 2% est applicable à une grande variété de patients gonarthrosiques.

Inyección Intraarticular Única de Ácido Hialurónico en la Artrosis de Rodilla: Estudio Multicéntrico Prospectivo Abierto (ART-ONE 75) mediante Comparación Post-Hoc con Placebo.

INTRODUCCIÓN: La viscosuplementación del líquido sinovial mediante la inyección intraarticular (IA) de ácido hialurónico (AH) es un tratamiento sintomático ampliamente utilizado en la artrosis de rodilla (AR). Además de los productos diseñados para realizar inyecciones múltiples (normalmente de 3 a 5 inyecciones, en intervalos de 1 semana), se presta especial atención a los productos de una única inyección, ya que ofrecen ventajas específicas, como son un menor número de visitas al médico y de intervenciones invasivas con sus riesgos asociados. Sin embargo, aún existen dudas sobre la eficacia de estas inyecciones únicas, en comparación con los regímenes de inyecciones múltiples. MÉTODOS: Se realizó un estudio multicéntrico, abierto, prospectivo, post-mercado (ART-ONE 75) con el producto de inyección única ARTHRUM 2,5% (3 ml, 75 mg AH), en 214 pacientes que sufrían de AR. Los pacientes fueron seguidos en D30, D60, D120 y D180 (días). El perfil promedio de los pacientes en el momento de la inclusión fue de 62,9 años, 56% mujeres, grados I-III de Kellgren-Lawrence (46% KL III), IMC de 27,2 kg/m2 y 4 años desde el diagnóstico de AR. Se realizó una comparación post-hoc con una inyección IA única de placebo (326 pacientes, agrupados de 3 estudios ECA), que proporcionaron un perfil de paciente similar. RESULTADOS: el criterio principal fue la variación desde el inicio de la puntuación de la escala WOMAC A (dolor, escala 0-100) en D60, que se redujo en 28,9 (17,4) para la población por intención de tratar (ITT, por sus siglas en inglés) (199 pacientes), 28,0 (17,8) para la población por protocolo (PP) en la inclusión (175 pacientes), y en 27,7 (16,8) para la población PP al finalizar (143 pacientes).Los criterios secundarios y accesorios incluyeron WOMAC A en otras ocasiones, WOMAC B (rigidez), WOMAC C (función), calidad de vida y discapacidad en cada momento de seguimiento. Todos los índices mejoraron significativamente y continuaron mejorando al final del estudio. La evaluación terapéutica en D180 mostró que más del 75% de los pacientes se encontraban satisfechos con la reducción del dolor, la mejora de la movilidad, y la reducción de analgésicos y AINE. El porcentaje de pacientes definidos como respondedores de OMERACT-OARSI fue superior al 86%, a partir de D60 y en adelante. La tolerancia general fue buena, sin que ocurriera ningún evento adverso grave. El resultado de la comparación post-hoc para la escala WOMAC A mostró un tamaño del efecto [IC 95%] desde TE = 0,33 [0,15; 0,51] en D60 a TE = 0,65 [0,45; 0,85] en D180 (p <0,001), frente a la inyección de placebo (solución salina), lo cual es un resultado clínicamente relevante a favor de ARTHRUM 2,5%. CONCLUSIÓN: El presente estudio confirma la eficacia clínica de una única inyección IA de 3 ml de solución de AH conteniendo 75 mg de AH nativo de alto PM (> 2 MDa).

Mono-injection intra-articulaire d'acide hyaluronique dans la gonarthrose : Étude multicentrique prospective ouverte (ART-ONE 75) avec comparaison post hoc versus placebo.

INTRODUCTION: La viscosupplémentation du liquide synovial par injection intra-articulaire d'acide hyaluronique est un traitement symptomatique de l'arthrose, largement utilisé dans la gonarthrose (arthrose du genou). À côté des produits conçus pour être administrés par injections multiples (typiquement 3 à 5 injections à intervalles de 1 semaine), un intérêt particulier se porte sur produits en injection unique (mono-injection) qui offrent des avantages spécifiques tels que la réduction du nombre de visites au médecin et du nombre d'interventions invasives avec leurs risques associés. Il subsiste toutefois une question concernant l'efficacité de ces mono-injections, par rapport aux protocoles à injections multiples. MÉTHODES: Une étude post-commercialisation, prospective, multicentrique, ouverte (ART-ONE 75), a été réalisée avec le produit pour injection unique Arthrum 2,5 % (3 mL, 75 mg d'acide hyaluronique) (LCA Pharmaceutical, Chartres, France), sur 214 patients atteints de gonarthrose. Les patients ont été suivis à 30, 60, 120 et 180 jours. Le profil moyen des patients à l'inclusion était un âge de 62,9 ans, 56 % de femmes, un stade radiologique Kellgren-Lawrence de I à III (46 % KL III), un indice de masse corporelle de 27,2 kg/m2 et une antériorité de 4 ans pour la gonarthrose. Une comparaison post hoc a été réalisée par rapport à une injection intra-articulaire unique de placebo (326 patients regroupés à partir de 3 essais randomisés contrôlés), et présentant un profil similaire de patients. RÉSULTATS: Le critère principal était la variation par rapport à la baseline, de l'indice Western Ontario and McMaster Universities, sous-échelle de la douleur (WOMAC A) dont le score (base 0-100), était réduit à 60 jours, de 28,9 (17,4) pour la population en intention de traiter (199 patients), de 28,0 (17,8) pour la population per protocole à l'inclusion (175 patients), et de 27,7 (16.8) pour la population per protocole ayant terminé l'étude (143 patients). Les critères secondaires et accessoires comprenaient le score WOMAC A aux autres dates, le score WOMAC B (raideur), le score WOMAC C (fonction), la qualité de vie et le handicap à chaque date de suivi. Tous les indices étaient significativement améliorés et continuaient à s'améliorer à la fin de l'étude. L'évaluation thérapeutique à 180 jours a montré que plus de 75 % des patients étaient satisfaits de la réduction de la douleur, de l'amélioration de la mobilité et de la réduction de la consommation d'analgésiques et d'anti-inflammatoires non stéroïdiens. Le pourcentage de patients définis comme répondeurs selon les critères de l'OMERACT-OARSI Initiative était > 86 %, à partir de 60 jours. La tolérance globale était bonne, sans aucun évènement indésirable grave. Les résultats de la comparaison post hoc pour le score WOMAC A ont montré une taille d'effet variant de 0,33 (IC 95 % 0,15-0,51), à 60 jours à 0,65 (IC 95 % 0,45-0,85) à 180 jours (p < 0.001), versus placebo injecté (solution saline), qui est cliniquement significative en faveur d'Arthrum 2,5 %. CONCLUSION: La présente étude suggère l'efficacité clinique d'une mono-injection IA de 3 mL de solution viscoélastique contenant 75 mg d'AH natif de haut poids moléculaire (> 2 MDa).

Progression-free survival, overall survival and quality of life: What is their medicoeconomic importance in oncology?

Medico-economic evaluations estimate, for a given health technology, the added cost and the clinical benefit compared to a reference strategy. The objective here is to analyze the criteria used to measure clinical benefit as the basis for market access and reimbursement decisions for drugs in oncology both in France and in Europe. Prolonged overall survival is the criterion of choice to demonstrate the benefit of an anticancer drug; a survival gain of 2 to 3 months or more would be considered as relevant for a new product versus the comparator. In the absence of survival benefit or mature data on survival, progression-free survival or symptom-free survival and the availability of alternative curative treatments, decrease in drug toxicity and quality of life improvement may be considered. Differences in clinical benefit assessment between regulatory agencies and payers are not specific to France. Case studies show that it is difficult to find a consistency in reimbursement and pricing decisions and to identify factors that may fully explain reimbursement decisions when survival benefit is not demonstrated.

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 12.

In this latest update we highlight the final results from the RCT-DUPLICATE initiative, the publication of guidance from Haute Autorité de Santé (HAS), the joint viewpoint from the Institute for Quality and Efficiency in HealthCare (IQWIG) and the Belgian HealthCare Knowledge Center, and a position from the European Organization for Research and Treatment of Cancer (EORTC). Finally, we discuss how the NICE RWE framework has been implemented to allow consideration of RWE external control arms.

[Place of biomarkers in the renutrition of patients with serious Covid-19 infection: discussion around a clinical case]. / Place des biomarqueurs dans la renutrition des patients ayant une infection grave à Covid-19 : discussion autour d'un cas clinique.

Covid-19 infection is a potentially serious disease. Overweight, obesity, and diabetes are comorbidities frequently found in the severe form of the disease. Appropriate nutritional management of the patient is an integral part of care. We will discuss the renutrition of a 76-year-old, obese (BMI = 35kg/m2), malnourished patient, according to the 2021 Haute Autorité de santé criteria, with Covid-19 infection, admitted to the intensive care unit at the Bordeaux University Hospital for an acute respiratory distress syndrome. Adaptation of nutritional intakes was achieved by clinical and biological monitoring. A refeeding syndrome was treated on the first day of hospitalization in the intensive care unit. After thiamine supplementation and when kalemia and phosphatemia have been normalized, renutrition was started. Parenteral nutrition as a complement to oral nutrition was used. Parenteral nutrition was well tolerated; recommended caloric and protein intakes were achieved by the fourth day of hospitalization. The clinical evolution was favorable. In conclusion, patients with Covid-19 infection should be considered malnourished when admitted to the intensive care unit. Macro and micronutrient intakes adapted to metabolically stressed patients are essential. Biological monitoring including monitoring of ionogram, phosphate, uremia, creatinine, liver function tests and blood glucose is essential in the nutritional management of patients with serious Covid-19 infection.

[Cardiovascular drugs and renal function: Pitfall of renal adaptation]. / Médicaments du système cardiovasculaire et fonction rénale : les pièges de l'adaptation rénale.

INTRODUCTION: Chronic kidney disease is associated with a high likelihood of receiving cardiovascular drugs. The Haute Autoritéde santé in France still recommends the use of the Cockcroft and Gault formula for dosage adjustments, on the pretext that it is the main data available in the Vidal® drug database. To verify this assumption, we conducted a systematic review of the Vidal® database by looking for the method recommended for evaluating renal function for the purpose of dose adjustment of cardiovascular drugs. METHODS: Vidal® files and SPC of Cardiovascular Drug (ATC classifications B01 and C) were analyzed and classified according to the method of evaluation or measurement of renal function recommended for dose adjustments. RESULTS: A total of 196 molecules were identified, of which 62.6% required dose adjustment to renal function. The most commonly used evaluation method was creatinine clearance (without precision about estimation or measurement) with a frequency of 35.5%. The frequency of use of the Cockcroft and Gault formula was 3.9% (8.4% after review of the literature concerning the molecules stating the clearance of creatinine, as the reference method). CONCLUSION: The privileged use of Cockcroft and Gault formula for dose adjustment, as recommended by the Haute Autoritéde santé, does not seem to be justified. An overhaul of recommendations for pharmacokinetic studies and renal function assessment methods for dose adjustments appears necessary.

Neonatal low respiratory tract chlamydia trachomatis infection: Diagnostic and treatment management.

Maternal infection during pregnancy by Chlamydia trachomatis (Chlamydia t.) can result in neonatal interstitial lung disease. It remains difficult for physicians to establish this diagnosis and to select the best treatment, as there is no recommendation. In these two cases of neonatal low respiratory tract Chlamydia t. infection, we proposed successfully a diagnosis method based on Chlamydia t. determination by PCR, on any type of sampling, but more specifically on urinary and pharyngeal specimens; and a management based on oral antibiotic therapy, Josamycin 50mg/kg/day during 14 days which is commonly well accepted and not invasive.

[Are abdominal aortic aneurysm screening guidelines followed? Prospective study in Dunkerque's hospital emergency room]. / Les recommandations de dépistage de l'anévrysme de l'aorte abdominale sont-elles respectées ? Étude prospective aux urgences de Dunkerque.

AIM OF THE STUDY: Are the recommendations issued by the Haute Autorité de santé in 2012 on screening for abdominal aortic aneurysm (AAA) being applied? METHOD: We interviewed the target patients, ex. male patients aged 65 to 75, smokers or former smokers, or as young as 50 in the event of a family history of AAA in the parents or siblings, entering the emergency room of Dunkerque between May 7 and December 31, 2015. We asked them if they had had an abdominal aortic ultrasound, or an abdominal ultrasound, or an arterial Doppler ultrasound of the lower limbs, and when, to see if they had had an AAA test since November 2012. RESULTS: We included 55 patients and excluded 5 of 180 eligible patients (31 %). It was not possible to conclude for 4 patients due to missing data. Thirteen of 46 patients (28.3 %, 95 % CI [16.0-43.5]) have had AAA ultrasound screening since November 2012; 33 have not (71.7 %, 95 % CI [56.5-84.0]) and no screening was offered. Of the 13 patients screened, 7 were screened by the attending physician (53.9 %, 95 % CI [25.1-80.8]) and 6 by another specialist (46.2 %, 95 % CI [19.2-74.9]). CONCLUSION: AAA screening in our population is low. Physicians should be urged to publicize and implement the November 2012 French recommendations to reduce AAA-related mortality.

Vers une nouvelle certification des établissements de santé pour 2020.

TOWARDS A NEW CERTIFICATION OF HEALTHCARE FACILITIES FOR 2020.: The accreditation process, now a certification process for healthcare facilities, has constantly evolved since 1999 in order to improve the quality and safety of care provided to patients. In order to meet demographic, epidemiological and social challenges, it needs to be revised again. The French National Health Authority board has fixed three main objectives for the 2020 version: to medicalise certification, simplify it and adapt it to hospital groups in the public and private sector.

Evaluation of the methodological quality of two contradictory guidelines recently published by the Haute autorité de santé.

Two clinical practice guidelines published in 2012 and in 2013 by the Haute autorité de santé (HAS) respectively entitled "Adult chronic kidney disease" (clinical pathway guidelines) and "Clinical utility of vitamin D measurements" (Health technology assessment) contradict each other on a notable point: in 2012 the HAS recommend to measure blood concentrations of vitamin D once a year in all patients with chronic kidney disease whereas in 2013 the HAS recommend to use this test only for the ambulatory follow-up of patients three months after kidney transplantation. This contradiction encouraged us to evaluate the methodological quality of these two guidelines with the help of the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument which is consensual at an international level, in particular at the WHO (World Health Organization) and at the European Union. At the end of this comparative evaluation this preliminary hypothesis might be proposed: a more rigorous development (AGREE domain n̊3) as well as a higher editorial independence (AGREE domain n̊6) in 2013 than in 2012 (scores respectively are 57% and 56% in 2013 versus 24% and 25% in 2012) ensure a higher validity to the 2013 recommendations than to the 2012 recommendations. However this hypothesis is weakened by the subjective intrinsic value of the AGREE tool, and by various methodological shortcomings in these two guidelines. Therefore we conclude, using the AGREE terminology, that the methods for developing those guidelines are too uncertain, above all in 2012, for recommending their use without modifications.

[Screening of hepatocellular carcinoma in patients with uncomplicated cirrhosis in real life: Practices survey of general practionners from three towns of Seine-Saint-Denis (north-east suburb of Paris)]. / Dépistage du carcinome hépatocellulaire chez les patients atteints de cirrhose non compliquée en médecine libérale : enquête de pratiques auprès des médecins généralistes de 3 communes de Seine-Saint-Denis.

Cirrhosis is a frequent and severe pathology life threatening, due to the occurrence of complications including hepatocellular carcinoma. In order to assess the degree of conformity, of practices, with the French guidelines for the surveillance of patients with compensated cirrhosis and the primary prevention of complications, published in 2007, all general practitioners practicing in three towns from north-east suburb of Paris (Seine-Saint-Denis) representing a population pool of 186 286 inhabitants were asked during the first quarter of 2012 for the face-to-face administration of a standardized questionnaire. Based on the 20 questions, individual practices were analyzed and a compliance score limited to hepatocellular carcinoma screening was established. Of the 106 practitioners surveyed, 40 have agreed to participate (85% of men, mostly based in Aulnay-sous-Bois or Sevran with an average exercice of 22years). The declared practices were heterogeneous and did insuffisantly comply with the recommendations (mean score 1.9/3). The intent of surveillance was not influenced by the origin or severity of cirrhosis. Screening for HCC was based on appropriate tests (abdominal ultrasound, alpha-fœtoprotein serum) but with optimal half-yearly intervals in less than half of the cases. Improved communication to general private practitioners of HAS recommendations for patients with compensated cirrhosis could optimize the prescribing of screening tests for hepatocellular carcinoma.

[Recommendations for the measurement of blood 25-OH vitamin D]. / Indications du dosage de la 25-hydroxyvitamine D.

The 25-hydroxyvitamin D (25OHD) serum concentration should not be measured to everybody but recommendations for this measurement in several clinical situations are available from numerous guidelines and expert positions. It can be proposed to measure 25OHD in diseases where a target range of 25OHD concentrations associated with better outcomes is defined with a sufficient level of evidence, and when this target concentration is difficult to reach without previous measurement (or may be exceeded in case of too large doses are provided). Many National and International Medical Societies recommend to measure 25OHD at least in any situation of « bone fragility ¼ (defined by a low bone mineral density and/or a low energy fracture), in malabsorptions, in chronic kidney disease, in any « phosphocalcic pathology, in patients with clinical signs of profound vitamin D deficiency or excess, and, more generally in any biological exploration of calcium/phosphorus metabolism that includes the measurement of PTH. Although these recommandations may seem discordant with the recent French restriction in the reimbursment of 25OHD measurement, they may still be reimbursed.

Therapeutic education in coronary heart disease: position paper from the Working Group of Exercise Rehabilitation and Sport (GERS) and the Therapeutic Education Commission of the French Society of Cardiology.

Cardiovascular mortality has decreased over the past 25 years, largely because of acute coronary syndrome care and preventive actions. Nevertheless, the rate of coronary heart disease remains high, with an annual risk of 4.7% (cardiac mortality, myocardial infarction, stroke). Cardiovascular risk factor management must be a priority in primary and secondary prevention, to improve the prognosis of this severe disease, in which absence of symptoms does not mean benignity. The current goals of therapeutic patient education are smoking cessation, regular physical activity, a cardioprotective (Mediterranean) diet, management of stress, good treatment adherence (which improves compliance), judicious use of the care system and help with occupational reintegration. Current and future programmes must be in accordance with the Haute Autorité de Santé recommendations published in 2007.