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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 Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients’ hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. Methods This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and having given their consent to be called for a 30-day and 90-day follow-up can be enrolled. For each 14-day period, 15 patients will be recruited in each care unit to obtain a total of 630 patients enrolled in all centers. Patients with a hospital stay of more than 21 days will be excluded. During the control period, there will be no clinical pharmacist in the care unit, whereas during the experimental period a clinical pharmacist will perform medication reconciliation and review with the healthcare team. The primary outcome will assess the impact of collaborative pharmaceutical care on preventable medication error rate. The secondary outcomes will evaluate the clinical impact of the strategy, the acceptance rate of pharmaceutical interventions, the induced and avoided costs of the strategy (cost-consequence analysis), and the healthcare team’s satisfaction. Discussion This study will assess the impact of collaborative pharmaceutical care associating medication reconciliation and review at patient admission to hospital in terms of preventable medication error rate and costs. This activity will prevent and correct medication errors arising earlier in the hospitalization. Trial registration ClinicalTrials.gov, NCT02598115. Registered on 4 November 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2412-7) contains supplementary material, which is available to authorized users.

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.

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.

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.

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.