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Introduction - L’étude OCCO (Outpatient Care-Cost Optimization) porte sur l’optimisation du financement des prises en charge ambulatoires non couvertes par la circulaire frontière. Son objectif est de proposer un modèle innovant d’organisation et de financement de ces prises en charge. Le présent travail, vise à quantifier l’impact de la mise en œuvre d’une nouvelle solution de financement à travers l’exemple de la prise en charge diagnostique de la syncope. Méthodes – La méthodologie des arbres de décision a été utilisée pour estimer et comparer les coûts globaux des différentes stratégies de financement. Une analyse de Monte Carlo probabiliste a été réalisée et une analyse de sensibilité a permis d’appréhender la robustesse des résultats. Résultats - Le coût moyen de prise en charge dans la stratégie actuelle est estimé à 888€ (sd=92€) contre 854€ (sd=73€) dans la stratégie de demain incluant la nouvelle solution de financement des soins à hauteur d’un financement forfaitaire compris entre 221.37€ (correspondant à l’évaluation du coût de la prise en charge) et 247.91€ (correspondant aux coûts évitables estimés). En l’absence de différence significative sur la différence de coût moyenne, nous pouvons montrer que l’implémentation d’un nouveau mode de financement pour la prise en charge des syncopes pourrait permettre une prise en charge optimale en terme d’organisation des soins, sans surcoût pour la collectivité. Discussion/Conclusion - La mise en place de cet ajustement financier et l’adéquation entre les besoins cliniques, humains et financiers sont les atouts majeurs pour la réussite et le recours à cette solution de financement.

BackgroundChronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease whose evolution depends on the patient’s adherence to inhaler devices. Pharmacists may play a role in adherence to medication therapy in hospital and in primary care interacting with patients to provide advice on proper use. This paper presents the protocol for a randomized controlled trial conducted at a university hospital to assess the clinical impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. MethodsThis trial will include 226 COPD patients treated with inhaler devices: 94 in a control group with the usual hospital care, 66 receiving a pharmaceutical consultation at the hospital and 66 receiving several pharmaceutical consultations at their community pharmacy. The aim of these interventions is to inform patients about COPD and medication therapy, train them in the proper use of inhaler devices and make them aware of good therapeutic adherence. Patients will be randomized to either the control group or the experimental hospital group by the clinical pharmacist at the hospital. Community pharmacists will include patients in the experimental community group. All patients will be monitored for 12 months by their community pharmacists (CPs). The primary outcome is the mean number of COPD exacerbations. Secondary outcomes include the number of medical consultations, emergency visits and hospitalizations; patients’ adherence to inhaler devices and ability to use them and quality of life. DiscussionOur study is the first randomized controlled trial in France to assess the effect of pharmaceutical interventions on COPD exacerbations. Study limitations include patient recruitment and the CPs’ adherence to follow-up. Indeed, the success of this trial depends on the willingness of CPs to collect the data. However, we envisage this work as the first step towards building a network of CPs trained for clinical research. Trial registrationClinicaltrials.gov, NCT03704545. Registered on October 12th, 2018. https://clinicaltrials.gov/ct2/show/NCT03704545?cond=COPD&cntry=FR&city=nimes&draw=2&rank=1

International audience; Background: Good management of disposable and reusable supplies may improve surgical efficiency in the operating room (OR) and also corresponds to the best eco-responsible approach. The purpose of this study was to assess the impact of a clinical pharmacist's intervention in the OR on the non-compliant use of medical devices. We also assessed the economic impact of the pharmaceutical intervention.Materials and methods: We conducted a monocentric prospective study in the OR of a University hospital over one year. Three surgical specialties: urologic, digestive and gynecologic were audited after a preparatory phase to optimize usage of medical devices used for surgeries. The supply costs concerning the three specialties were compared before and after the pharmacist intervention.Results: One hundred and fifty surgical procedures were audited in digestive (33.3%, n = 50), gynecologic (32%, n = 48) and urologic (34.7%, n = 52) surgeries. With the pharmacist in OR, 51 procedures (34% CI95%[26.4%; 41.6%]) with a non-compliance concerning at least one medical device were found compared to the 50% rate without the pharmacist reported previously (P < .0001). Eighteen percent of surgical procedures had at least one circulator retrieval for the reason "incomplete case cart despite device listed on the case cart list" versus 29.1% before pharmacist intervention (P = .0028). A €33 014 saving associated with the presence of the pharmacist in OR was observed.Conclusions: This prospective interventional study showed that the intervention of a pharmacist specialized in the medical device field could significantly reduce non-compliances in medical device use and reduce costs in OR.

Background Prostate cancer patients are known to suffer from poor sexual and urinary long-term side-effects following treatment, potentially impacting quality of life. The purpose of our study was to compare health-related quality of life at 3 years between prostate cancer patients and healthy controls according to key life-style characteristics. Secondary objectives were to compare urological dysfunction, sexual function, anxiety and depression.Methods Multicentric, case-control, observational prospective, open, follow-up study including 819 prostate cancer patients Results In total, 564 participants were included (mean age 67.9 years): 376 patients and 188 controls. Treatment breakdown was: 258 underwent RP, 90 received EBRT, 52 brachytherapy or HIFU, 15 CT, 26 ADT and 61 AS. There was no difference in median global quality of life between patients and controls (94.87 vs 94.15, p = 0.71). Multivariate analysis showed poorer social functioning in patients (24.3% vs. 16.3%, p = 0.0209), more dyspnea (22% vs. 12.4%, p = 0.0078), and yet less current pain (23% vs 33%, p = 0.0151).Conclusions Global health status score at 3 years after diagnosis was similar between patients and controls, though patients showed a significantly worse social functioning. Prostate cancer diagnosis per se does not impact the quality of life of patients. However, the therapeutic option that will be chosen following diagnosis should be carefully discussed with the medical staff in terms of benefit-risk ratios as it could have a long-term impact on urinary or erectile dysfunction.Trial registration: clinicaltrials.gov, NCT02854982. Registered 4 August 2016 – retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02854982

International audience; Purpose: The present study aimed at assessing the efficiency of ropivacaine on post-operative pain for extraction of third molars.Methods: In a single centre, prospective, parallel, double blind randomised trial, patients scheduled for removal of all four third molars, ASA I-III patients3/10, followed by oral tramadol 50mg after discharge), patient satisfaction, chronic pain (1-3 month), time in PACU and total hospitalization time were also recorded.Results: A total of 50 patients were analysed in each group with similar characteristics (ropivacaine vs. control, for age (years) 18 [17-21] vs. 18 [17-21], for sex (female) 33 (66%) vs. 25 (50%), and BMI (kg/m2): 20 [19-23] vs. 21 [19-23]). Area Under the Curve for VAS pain (0 to 4h) was lower for Ropivacaine group: 0.43 [0.19-0.66] vs. 0.63 [0.43-0.87], P=0.005. Use of morphine in PACU (8 vs. 18, P=0.02) and median length of stay in ambulatory setting (5 vs. 6h, P=0.03) were reduced in Ropivacaine vs. Placebo group. At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05). At month 1 and 3, pain and DN4 score were similar between groups, with a median VAS pain score at 0 for both groups (P=0.42). No difference was observed for patient satisfaction and adverse events.Conclusions: Ropivacaine provides an immediate efficient pain relief after extraction of third molars without benefit after discharge.Clinicaltrial registration: NCT01541059.

Background Prostate cancer patients are known to suffer from poor sexual and urinary long-term side-effects following treatment, potentially impacting quality of life. The purpose of our study was to compare health-related quality of life at 3 years between prostate cancer patients and healthy controls according to key life-style characteristics. Secondary objectives were to compare urological dysfunction, sexual function, anxiety and depression. Methods Multicentric, case-control, observational prospective, open, follow-up study including 819 prostate cancer patients Results In total, 564 participants were included (mean age 67.9 years): 376 patients and 188 controls. Treatment breakdown was: 258 underwent RP, 90 received EBRT, 52 brachytherapy or HIFU, 15 CT, 26 ADT and 61 AS. There was no difference in median global quality of life between patients and controls (94.87 vs 94.15, p = 0.71). Multivariate analysis showed poorer social functioning in patients (24.3% vs. 16.3%, p = 0.0209), more dyspnea (22% vs. 12.4%, p = 0.0078), and yet less current pain (23% vs 33%, p = 0.0151). Conclusions Global health status score at 3 years after diagnosis was similar between patients and controls, though patients showed a significantly worse social functioning. Prostate cancer diagnosis per se does not seem to impact the quality of life of patients Trial registration clinicaltrials.gov, NCT02854982. Registered 4 August 2016, retrospectively registered.

Introduction A l’heure ou le partage responsable des donnees d’essai clinique est en plein essor et ou l’exigence de qualite des etudes cliniques ne cesse de croitre, la question de l’efficacite du processus de « data management » (DTM) est au cœur de nos problematiques organisationnelle et technique. L’enjeu est de pouvoir garantir la qualite des donnees tout en assurant une mise a disposition rapide. Ainsi, la conjugaison de ces deux aspects se traduit par le besoin d’optimisation du « workflow » du DTM. Methodes La methode se decline en trois etapes : etablir un etat des lieux detaille du « workflow » actuel, permettant de definir la structure du DTM, elaborer un « workflow » optimise et enfin, eprouver ce nouveau processus au travers d’un outil informatique specialement developpe pour l’automatisation du DTM que nous avons denomme BLANKA. Resultats (i) Etat des lieux – le « workflow » actuel du DTM est structure en trois tâches principales et successives : la conception de l’eCRF, le controle de qualite et le gel de la base de donnees. Chacune d’entre elles donne lieu a une phase de conceptualisation et a une phase de production. Cette organisation en cascade implique un « input » specifique pour chacune des tâches et rend les modifications complexes, augmente le risque d’erreur et diminue par consequent la qualite des livrables. En consequence, face au volume et a la complexite des tâches a realiser, le « data manager » doit imperativement optimiser son temps. (ii) Proposition d’optimisation – le « workflow » optimise propose deux changements majeurs. Le premier est conceptuel et vise a restructurer le DTM par phase et non par tâche ; le deuxieme est technique et prend forme dans l’automatisation de la phase de production. Ainsi, la premiere phase de conceptualisation est regroupee en amont du projet et considere toutes les tâches. Le « data manager » (DM) a d’emblee une vision globale de l’ensemble du projet et des livrables a produire. Operationnellement, le cahier des charges, l’e-crf, les controles de coherences et la mise en forme des donnees sont produits lors la meme phase, et en amont du projet. Techniquement, il est necessaire d’automatiser la phase de production pour reduire les difficultes de programmation et les risques d’erreur liees aux actions repetitives et manuelles, pour ameliorer et standardiser la qualite des livrables, et enfin, optimiser le temps. (iii) Mise en place-BLANKA – BLANKA est un complement Excel (add-in) programme en VBA permettant, a partir d’un dictionnaire de donnees (DD) specifique au logiciel, de generer un e-crf sur RedCap, le « Data Management Plan » (DMP), les programmes SAS de controles de coherence, de mise en forme des donnees et de gel des donnees. Le DD est ainsi la synthese et la centralisation de toute la phase de conceptualisation. Il est l’unique « input » de tous les livrables. Conclusion Le « workflow » optimise a permis une reduction considerable du temps dedie a la production des livrables. Ce temps est ainsi alloue au temps de suivi et de gestion du DTM de l’etude. D’autre part, le risque lie aux erreurs de programmation manuelle est minimise, et les livrables standardises. Ce « workflow » offre au DM la possibilite de s’investir plus a la conceptualisation du DTM, de son etude et de sa gestion plutot qu’a la production tout en ayant une vision globale du projet, ce qui augmente significativement le niveau de qualite du DTM.

Introduction Les alterations de la sante orale aggravent le risque de denutrition, avec une lassitude liee aux aliments mous et mixes. C’est pourquoi un CNO solide sous forme de petites galettes hyperprotidiques et hypercaloriques ayant une texture innovante lui permettant d’etre croque et mastique meme par des personnes ayant un mauvais etat bucco-dentaire (Galettes Protibis, Solidages, France) a ete mis au point. Un essai clinique randomise multicentrique aupres de 175 residents d’Ehpad a valide son efficacite avec une augmentation du poids, une diminution des diarrhees et une cicatrisation plus rapide des escarres (Pouyssegur et al., 2014). Les sujets du groupe Galettes ont recu en supplement huit galettes de 6,5 g/j (11,5 g de proteines, 244 kcal) pendant six semaines. L’objectif est d’effectuer une evaluation medico-economique pour estimer l’impact de l’introduction des galettes « Protibis » sur le cout de prise en charge et de comparer ce cout de prise en charge a celui des patients ne recevant pas ce type de galettes. Methodes (1) Etude a posteriori de minimisation de couts a partir de la base de donnees de l’etude clinique (simulation de Monte-Carlo) ; (2) Avis d’experts (methode Delphi) pour estimer le cout de la prise en charge des diarrhees, escarres, infections et chutes ; (3) Methodologie des arbres de decision, simulation de Monte Carlo, analyse de sensibilite et graphique de Tornado. Resultats Pour l’Assurance maladie, la difference de cout moyen par patient avec une prise en charge standard etait de −191 € [−660,47 € ; 265,89 €], p = 0,76 (versus −312€ [−989€ ; 355€], p = 0,82 en prise en charge a 100 %) sur 18 semaines en faveur de la strategie Galettes. Cette difference n’etait pas significative, mais sur les 10 000 simulations realisees, la strategie Galettes etait preferee dans 79 % des cas (versus 81 % en prise en charge a 100 %). Les couts etaient principalement des frais d’hospitalisation (67,5 %) et de consultations (26,3 %). L’analyse de sensibilite montre que les resultats obtenus sont robustes malgre les variations introduites sur les parametres influencant. Pour l’Ehpad, l’etude a montre une difference de 30 mn/jour/patient en moyenne en faveur du bras Galettes en temps de sollicitation du personnel infirmier/aide-soignant. Discussion La revue de la litterature a montre l’absence de donnees de couts concernant les evenements valorises (escarres, diarrhees, infections, chutes). Le recours a la methodologie Delphi dans notre etude apporte des elements de reponse non negligeables. Le caractere declaratif de ces donnees devrait cependant donner lieu a de nouvelles etudes basees sur des donnees observees. Conclusion L’etude medico-economique a montre que la strategie Galettes etait aussi dominante en termes de cout et de temps passe par le personnel infirmier/aide-soignant sur un horizon temporel fixe a 18 semaines. Ainsi, le cout supplementaire genere par ce nouveau CNO solide dans les soins habituels a ete compense par des economies realisees grâce a l’amelioration de l’etat nutritionnel des residents.

Summary Background Although predicting the risk of venous thrombosis (VT) in an individual from a family with inherited thrombophilia is of major importance, it is often not feasible. Objectives To develop a simple risk assessment model that improves prediction of the risk of VT for individuals of families with inherited thrombophilia. Patients/methods 1201 relatives from 430 families with inherited thrombophilia (deficiencies of antithrombin, protein C or protein S, and the factor V Leiden and F2 20210A mutations) were recruited at the referral center for thrombophilia in Marseilles, France, from 1986 to 2008. One hundred and twenty-two individuals had a personal history of VT. Sixteen preselected clinical and laboratory variables were used to derive the VT risk score. Results The scores based on the 16 variables and on the five most strongly associated variables performed similarly (areas under receiver operating characteristic curves of 0.85 and 0.83, respectively). For the five-variable score, named the MARNI score, derived from family history score of VT, von Willebrand factor antigen levels, age, severity of thrombophilia, and FGG rs2066865, the risk of VT ranged from 0.2% for individuals with a score of 0 (n = 186) to > 70% for individuals with a score of ≥ 7 (n = 27). The model was validated with an internal bootstrap method. Conclusions With the use of a simple scoring system, assessment of the risk of VT in subjects from families with inherited thrombophilia can be greatly improved. External validation is now needed to replicate these findings.

Objective— We aimed to study the association among ABO blood group, von Willebrand factor, factor VIII plasma levels, and the risk of venous thrombosis (VT) in a cohort of 1774 relatives from 500 families with inherited thrombophilia. Methods and Results— One hundred sixty-one of the 1774 relatives had a VT. Different risk groups were formed: no, low-(factor V Leiden or F2G20210A heterozygous carriers), and high-risk thrombophilia (antithrombin, protein C, protein S, factor V Leiden, or F2G20210A homozygous carriers and combined defects). Compared with group O, AB blood group was associated with increased risk of VT: hazard ratio (HR)=3.8 (2.0–7.2). The effect of blood group A and B was milder (HR=1.6 [1.1–2.5] and 1.8 [1.0–3.3], respectively). An increased risk of VT was observed with increasing levels of von Willebrand factor and factor VIII plasma levels (HR=2.96 [1.92–4.56] and HR=2.60 [1.92–4.56] for third versus first tertile of von Willebrand factor and factor VIII plasma levels, respectively). In multivariate analysis, AB group (HR=2.3 [1.1–4.8]), high-risk thrombophilia (HR=2.8 [1.6–4.6]), and high von Willebrand factor levels (HR=2.3 [1.3–4.0]) were significantly associated with increased risk of VT. The risk of VT in individuals with high-risk thrombophilia and AB group was 14.4× higher than in those without thrombophilia and O group (5.0–41.4). Conclusion— ABO blood group modifies the risk of VT in families with hereditary thrombophilia. Phenotyping of the ABO blood group should be performed to better assess the risk of VT in asymptomatic individuals from thrombophilic families.

Quality of transitions of care is one of the first concerns in patient safety. Redesigning the discharge process to incorporate clinical pharmacy activities could reduce the incidence of postdischarge adverse events by improving medication adherence. The present study investigated the value of pharmacist counseling sessions on primary medication adherence after hospital discharge.This study was conducted in a 1844-bed hospital in France. It was divided in an observational period and an interventional period of 3 months each. In both periods, ward-based clinical pharmacists performed medication reconciliation and inpatient follow-up. In interventional period, initial counseling and discharge counseling sessions were added to pharmaceutical care. The primary medication adherence was assessed by calling community pharmacists 7 days after patient discharge.We compared the measure of adherence between the patients from the observational period (n = 201) and the interventional period (n = 193). The rate of patients who were adherent increased from 51.0% to 66.7% between both periods (P

Osteosarcoma is the most common primary bone tumour in young adults. Despite improved prognosis, resistance to chemotherapy remains responsible for failure of osteosarcoma treatment. The identification of signals that promote apoptosis may provide clues to develop new therapeutic strategies for chemoresistant osteosarcoma. Here, we show that lipophilic statins (atorvastatin, simvastatin, cerivastatin) markedly induce caspases-dependent apoptosis in various human osteosarcoma cells, independently of bone morphogenetic protein (BMP)-2 signaling and cell differentiation. Although statins increased BMP-2 expression, the proapoptotic effect of statins was not prevented by the BMP antagonist noggin, and was abolished by mevalonate and geranylgeranylpyrophosphate, suggesting the involvement of defective protein geranylgeranylation. Consistently, lipophilic statins induced membrane RhoA relocalization to the cytosol and inhibited RhoA activity, which resulted in decreased phospho-p42/p44- mitogen-activated protein kinases (MAPKs) and Bcl-2 levels. Constitutively active RhoA rescued phospho-p42/p44-MAPKs and Bcl-2 and abolished statin-induced apoptosis. Thus, lipophilic statins induce caspase-dependent osteosarcoma cell apoptosis by a RhoA-p42/p44 MAPKs-Bcl-2-mediated mechanism, independently of BMP-2 signaling and cell differentiation.