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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.

The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4-8 weeks and 11-13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22-4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia "usually or always" were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.

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.

International audience; Objectives: Adverse drug events (ADE) are a common cause of morbidity and mortality in elderly patients. In this study, we assessed the impact of multidisciplinary medication review (MMR) for nursing home residents on patient safety and costs incurred by the hospital and the national health service. Methods: Medical files of residents were retrospectively assessed for medications prescribed in the previous six months. A pharmacist reviewed the prescriptions and suggested modifications to the patient's medical team. Patients were followed for six months. Trivalle's ADE geriatric risk score was calculated before and after MMR, as were number of potentially inappropriate medications, and economic impact from the perspective of the health care system and the nursing home. Results: Forty-nine patients were recruited. ADE score dropped one risk level (median score of 4 before versus 1 after, p

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.

The lack of time to devote to care is a frequent complaint of nurses and nursing assistants. The results of a study show that an improvement in the nutritional status of nursing home residents could help to improve their quality of life and to optimise the working time of the nursing teams, thanks to the reduction of pressure ulcers, diarrhoea, falls, fractures and infections.

Background In a study involving 175 malnourished frail older adults, a solid oral supplement (ONS) adapted to people with poor dental status allowed an increase of weight and appetite (Protibis® cookies, France). There was a decrease of bedsores and diarrhea and a trend of a decrease of falls and infections (Pouyssegur et al., 2015). Objectives To use the database of this randomized controlled trial for an economic assessment a posteriori. Methods 1) Estimation of the medical cost of bedsores, diarrhea, falls and infections (Delphi method). 2) Comparison of the average cost per participant of the Control group (no cookies) vs. Intervention group (cookies). 3) Sensitivity analysis (Monte Carlo simulations, Tornado diagrams). Results For an 18-week period of observation, the consumption of cookies during 6 weeks generated a cost minimization for Health Insurance. For 18 weeks, the cost cutting was confirmed, mainly in the treatment of falls, with savings due to the reduction of hospital stays (83.44 €) and medical consultations (85.37 €), and in the treatment of infections, with savings due to the reduction of hospital stays (58.90 €). Savings ranged from 1.52 to 2.48 € daily and per malnourished resident, in the case of standard or full protection, respectively. For the institution, it also reduced the working time of the nursing staff by 30 min daily and per malnourished resident. Conclusion The additional cost generated by this new solid ONS in the usual care was compensated with savings generated thanks to the improvement of the nutritional status of the residents.

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.

Resume Objectifs Desir est une etude de cohorte prospective, longitudinale, multicentrique, francaise de patients souffrant de rachialgie inflammatoire evocatrice de spondyloarthrite, avec un suivi de 10 ans. Le but est d’evaluer les performances des differents systemes de criteres de classification de la spondyloarthrite axiale, et de decrire la frequence et les caracteristiques des signes cliniques de spondyloarthrite axiale. Methodes Les donnees demographiques et les items permettant la classification et le calcul des indices ont ete recueillis, ainsi que les donnees biologiques et d’imagerie. Les donnees a l’inclusion furent analysees. La performance de plusieurs systemes de criteres de classification fut evaluee (LR, rapport de vraisemblance) avec le diagnostic du medecin comme « gold standard ». Concernant la presentation clinique de la spondyloarthrite axiale, une analyse descriptive a ete realisee. Resultats Parmi les patients, 708 sont inclus ; 92 % d’entre eux satisfont a au moins un systeme de criteres de classification : mNY 26 %, 79 % Amor, ESSG 78 %, ASAS 70 % ; le niveau de confiance du medecin est de 6,8 ± 2,7. Parmi les patients, 81 et 83 % remplissent les criteres modifies (y compris IRM) d’Amor ou de l’ESSG. Une atteinte axiale est presente dans 100 % des cas. Les AINS sont pris par 90 % des patients, avec un score d’AINS de 50 ± 46. Un BASDAI superieur a 40 est note dans 60 % des cas et une CRP elevee dans 30 % des cas. L’antigene HLA-B27 est present dans 58 % des cas. Suivant l’ASDAS CRP, 12,7 % des patients ont une maladie inactive, 63 % une activite de la maladie tres elevee ; le BASFI moyen etait de 30. Une atteinte peripherique est presente dans 57 % des cas, avec une arthrite dans 37 % de ceux-ci. Une enthesite est notee chez 49 % des patients, et constitue le premier symptome chez 22,5 % des cas ; la participation de la paroi thoracique anterieure est notee dans 44,6 % des cas, et une dactylite dans 13 %. Parmi les manifestations extra-articulaires supplementaires, le psoriasis est repertorie dans 16 % des cas, une uveite dans 8,5 % et une maladie inflammatoire chronique intestinale (MICI) dans 5,1 %. Le tabagisme est present dans 36,3 % des cas et une hypertension arterielle dans 5,1 % des cas. Conclusion Ces donnees representent la base de l’evaluation du suivi de cette cohorte, permettant de futures etudes specifiques.

The lack of time to devote to care is a frequent complaint of nurses and nursing assistants. The results of a study show that an improvement in the nutritional status of nursing home residents could help to improve their quality of life and to optimise the working time of the nursing teams, thanks to the reduction of pressure ulcers, diarrhoea, falls, fractures and infections.

L’evolution demographique, les maladies chroniques en constante augmentation, l’organisation sous-optimale de la prise en charge des patients ont conduit a une hausse substantielle des depenses de sante. Le systeme de sante doit necessairement s’adapter pour prendre en compte ces evolutions dans un contexte de budget contraint. Une des reformes consiste en la necessite de mettre en place un parcours de soins organise et coordonne autour du medecin traitant qui orientera le patient vers un parcours efficient, limitant ainsi la surconsommation de soins inutiles. Le sujet fait debat sur son perimetre, son contenu et ses modalites organisationnelles. L’objectif de ce travail est de proposer une methodologie permettant de definir une tarification par parcours comme outil de regulation. Pour cela, en introduction nous revenons sur le contexte francais et international du parcours de soins. Une reflexion autour du perimetre et du contenu de celui-ci est ensuite proposee afin d’en estimer le cout puis d’etablir une tarification par parcours. Un exemple de modelisation du parcours de soins dans le cas du diagnostic du cancer de la prostate est presente a titre illustratif.

International audience; Background: Many activities contribute to reduce drug-related problems. Among them, the medication reconciliation (MR) is used to compare the best possible medication history (BPMH) and the current admission medication order (AMO) to identify and solve unintended medication discrepancies (UMD). This study aims to assess the impact of the implementation of admission MR by clinical pharmacists on UMD.Method: This prospective study was carried out in two units of general medicine and infectious and tropical diseases in a 1844-bed French hospital. A retroactive MR performed in an observational period was compared to a proactive MR realized in an interventional period. We used a logistic regression to identify risk factors of UMD.Results: During both periods, 394 patients were enrolled and 2,725 medications were analyzed in the BPMH. Proactive MR reduced the percentage of patients with at least one UMD compared with retroactive process (respectively 2.1% vs. 45.8%, p

Sore throat is a common complaint after surgery. It affects patient satisfaction and can affect activity after discharge. The supraglottic airway device (SAD) offers an alternative to traditional tracheal intubation with potential benefit in preventing sore throat.The aim of this study was to compare the incidence of sore throat following three different SADs, the laryngeal mask airway Unique (LMA-U) and the more recent LMA Supreme (LMA-S) and the I-gel.A randomised single-blind controlled three parallel-group trial.University Hospital of Nîmes, Division of Anaesthesia Intensive Care Pain and Emergency, Nîmes, France, from April 2009 to September 2012.A total of 546 patients scheduled to undergo elective surgery of less than 2 h under general anaesthesia were randomly allocated to receive the LMA-U, the LMA-S or the I-gel.Anaesthesia was induced with propofol and sufentanil and maintained with propofol or with sevoflurane in air-oxygen. After airway device insertion, intra-cuff pressure was adjusted to less than 60 mmHg (LMA-U, LMA-S) and pressure-controlled ventilation initiated.The primary study endpoint was to compare incidence of sore throat 24 h postoperatively (H+24) following placement of the LMA-U, LMA-S and the I-gel. Secondary endpoints were clinical performance (airway leak pressure, dynamic airway compliance, complications during maintenance), ease of use (device insertion time, success on first attempt, ease of insertion and removal) and other adverse events (neck or jaw pain, dysphonia, dysphagia, nausea and vomiting).The authors analysed 177, 174 and 173 patients who received LMA-U, the LMA-S and the I-gel, respectively. The primary endpoint was assessed in 436 patients. In total, 104 patients (23.9%) patients reported a H+24 sore throat, with no difference between groups (P = 0.34). H+24 dysphagia with liquids was higher (P = 0.0065) with the LMA-S (12.1%) compared with LMA-U (5.3%) and I-gel (2.9%). Airway leak pressure (cmH2O) was lower (P 0.0001) with LMA-U [21 (18 to 27)] compared with I-gel [26 (20 to 30)] and LMA-S [25 (21 to 30)]. Device insertion time (sec) was shorter (P 0.0167) with the I-gel [30 (20 to 40)] compared with the LMA-U [34 (23 to 48)] and LMA-S [32 (22 to 50)].The incidence of postoperative sore throat was not significantly different between the three SADs studied.

International audience; Background: Former studies showed a time-dependent worsening of sexual or urinary long term side effects following surgery or radiotherapy that affected prostate cancer (PCa) patients’ health-related quality of life (HRQoL) though it was not possible to discriminate between age- and treatment-related symptoms. We sought to compare HRQoL and urological dysfunction at 3 years between PCa patients and general population based on the data from the EPICAP population-based case-control study. Methods: Eligible cases were men < 75 years old, diagnosed with PCa between 2012 and 2014. Controls were recruited in the general population and paired on age. Questionnaires were given to the patients at 3 years after intervention. Primary objective was to compare HRQoL using the EORTC QLQ-C30 questionnaire at 3 years between patients and the general population. Secondary objective was to perform the same comparison for the impact of diagnosis or/and treatments on urinary (IPSS, ICS) or sexual dysfunctions (IEEF-5), anxiety (HADS), and occupational integration. Results: 376 eligible patients had sent back their questionnaires and 188 controls were paired on age (ratio 2:1). Treatments were: RP (radical prostatectomy) (187), RT (radiation therapy) or HIFU (High-intensity Focused Ultrasound) (54), combination of treatment (CT) (90) and watchful waiting (WW) (39) at the time of the study. There was no difference in global health status dimension between patients and controls (p = 0.19). Patients had worse social functioning than controls (24.3% vs 16.3%, p = 0.0209) and cognitive function score was worse in CT versus WW patients (p = 0.039). Significant differences in erectile dysfunction (IIEF6) were observed depending on treatment (81% for RP vs 65% for RT vs 72% for CT vs 33% for WW, p < 0.0001). Conclusions: Despite similar global health status dimension score at 3 years after diagnosis between patients and controls, analyzes of the EPICAP study showed differences in PCa sequelae and emphasize the balance between benefit and risk of PSA testing. This is the first study evaluating the different types of sequelae as a function of treatments.

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.

Objectives DESIR is a prospective longitudinal multicentric French cohort of patients with inflammatory back pain suggestive of spondyloarthritis, with a 10-year-follow-up. The purpose is to evaluate the performances of the different sets of classification criteria for axial spondyloarthritis, and to describe the frequency and characteristics of the clinical features of axial spondyloarthritis. Methods Demographic data and items allowing classification and indices calculation were collected, as well as biologic and imaging data. Baseline data are analyzed. The performance of the several classification criteria sets was evaluated (likelihood ratio) with the physician's diagnosis as external gold standard. For the clinical presentation of axial spondyloarthritis, a descriptive analysis was conducted. Results Seven hundred and eight patients are included. Ninety-two percent of them satisfy at least one set of classification criteria: mNY 26%, Amor 79%, ESSG 78%, ASAS 70%; physician's confidence level 6.8 ± 2.7. 81 and 83% of patients fulfil modified (including MRI) Amor or ESSG criteria. Axial involvement is present in 100% of the cases. NSAIDs are taken by 90%, with an NSAID sore of 50 ± 46. BASDAI over 40 is noted in 60% and elevated CRP in 30% of the cases. HLA-B27 is present in 58%. According to ASDAS CRP levels, 12.7% are in inactive disease, 63% in high disease activity; mean BASFI was 30. Peripheral involvement is present in 57%, with arthritis in 37% of these. Enthesitis is noted in 49% of the patients, and first symptom in 22.5%; anterior chest wall involvement is noted in 44.6%, and dactylitis in 13%. For extra articular manifestations, psoriasis is recorded in 16%, uveitis in 8.5% and IBD in 5.1%. Smoking is present in 36.3% and hypertension in 5.1% of the cases. Conclusion These data represent the base of evaluation of the follow-up of this cohort, allowing future specific studies.

67 Background: Prostate cancer (PCa) is the most common cancer in men. Former studies showed a time-dependent worsening of sexual or urinary long term side effects following surgery or radiotherapy that affected patients’ quality of life (QoL). These studies could not discriminate between age-related and treatment-related symptoms, as patients were their own controls. We conducted a case-control study evaluating at 3 years QoL and physical/psychological dysfunctions, whereas patients were on watchful waiting or received a treatment. Methods: We used data from the EPICAP population-based case-control carried out by INSERM and including 1700 participants. Eligible cases were men < 75 years old newly diagnosed with PCa in 2012-2014 living in the Hérault geographic area. Controls were men of the same age recruited in the general population of the same area. Participants answered a QoL questionnaire 3 years after intervention. Primary objective was to compare the impact of diagnosis or/and treatments on QoL as measured by the EORTC QLQ-C30 score. Secondary objective was to compare the impact of diagnosis or/and treatments on urinary dysfunctions (IPSS, ICS), sexual dysfunctions (IEEF-5), anxiety (HADS), and occupational integration. We also assessed these QoL parameters depending on the treatment that was received. Results: Median age was 67.9 years old in the cases and 68.4 years old in the control. At 3 years, 376 cases and 352 controls had sent back their questionnaires. Treatments were: RP (258), RT (90), focal therapy (52), hormone therapy (26) and watchful waiting (61) at the time of the study. The results show no difference between cases and controls for the global QoL score. Other parameters are being assessed and will be presented at the meeting. Conclusions: Though prostate cancer cases and population-based controls showed similar global QoL at 3 years after diagnosis, the large EPICAP study will provide a comprehensive framework to go further in the understanding of PCa sequelae and give some hints on the balance between benefit and risk of PSA testing. This study will be the first to evaluate the different types of sequelae as a function of treatments and the occupational integration for patients < 65 years old.

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.

Chondrocalcinosis is a result of deposition of calcium pyrophosphate dihydrate (CPPD) crystals in cartilage and fibrocartilage. Chondrocalcinosis is usually sporadic but has also been associated with a variety of metabolic diseases including hypomagnesemia. Reported cases of hypomagnesemia associated chondrocalcinosis were mostly due to renal genetic disorders such as Bartter's or Gitelman's syndrome. We describe 3 patients with chronic hypomagnesemia induced by short bowel syndrome who developed symptomatic chondrocalcinosis. CPPD crystals were identified by polarizing light microscopy in one patient. The underlying intestinal pathology was radiation enteritis in 2 patients and mesenteric arterial thrombosis in the third. Our observations strengthen the hypothesis of a role for magnesium in CPPD crystal deposition disease.