[Impact of the new European regulation 2017/745 on medical devices on hospital pharmacies activity: Example on pharmaceutical supply function within a French university hospital center]. / Impact du nouveau règlement européen 2017/745 relatif aux dispositifs médicaux sur l'activité des pharmacies hospitalières : exemple de la fonction d'approvisionnement pharmaceutique au sein d'un centre hospitalo-universitaire français.

OBJECTIVE: The new European regulation (MDR) on medical devices (MD) is expected to have major impacts on the industrial sector, but also consequences on healthcare professionals. Our objective was to evaluate the impact of the MDR on the supply of MDs in hospital pharmacies at the level of a French university hospital. MATERIAL AND METHODS: We conducted a prospective follow-up of marketing cessations and supply disruptions directly related to the MDR between November 2019 and September 2020. The data were analyzed accounting for the nature of the suppliers (status/size), the nature of the MDs (route/class), and the proposed alternatives. The economic impact on hospital pharmacies was also estimated. RESULTS: Over this period, 96 MD product designations were declared out of stock or in cessation (total of 402 references), of which half corresponded to class IIa MDs, mainly used for surgical procedures. Of the 14 companies concerned (36% French), the majority were manufacturers, of small/medium-size or intermediate size. Substitutions were proposed for only 15 products (15.6%). The cost of pharmaceutical management of these disruptions/marketing cessations was estimated at 3052€. CONCLUSION: Even before the official date of its application, the impacts of the MDR on the supply function of hospital pharmacies are already visible. In the short, medium and long term, prospective monitoring of the impacts, positive or negative, would seem to be justified at the level of manufacturers, healthcare professionals and end users of MDs.

[Economic evaluation of porous metal cones in total knee arthroplasty]. / Étude de l'impact économique des cônes en métal poreux dans les arthroplasties totales du genou.

INTRODUCTION: The use of porous metal cones (PMC) to fill bone loss during knee replacements is increasing, but these medical devices are not reimbursed in addition to diagnosis related tariffs (DRTs). The economic impact of PMC may be significant for hospitals. MATERIAL AND METHODS: This multicenter observational study includes all patients who benefited of a total knee prosthesis, with reconstruction by PMC, between June 2014 and June 2019, in two French university hospitals. The costs of each diagnosis related group (DRG) was evaluated using the "étude nationale des coûts à méthodologie commune (ENC)". The PMC costs were compared with the amounts of DRG and with the fares perceived by the hospital from the French sickness fund (DRTs). RESULTS: 96 patients (103 stays) benefited from the implantation of 195 cones. The hospital incomes were 10,970±1401€ /stay. Spending associated with PMC represented 35% of DRGs and 44% of DRTs. The average additional cost related to the cones was 2709±1138€ /stay. If the reconstructions had been performed by allograft, the average gain for hospitals would have been 108€ /stay. CONCLUSION: If PMC have clinical benefits for surgeons in reducing the incidence of revision, this study shows the inadequacy of the funding of these devices for French hospitals. This suggests the need to expand the possibilities of supporting innovative technologies.

Cost-effectiveness of stent-retriever thrombectomy in large vessel occlusion strokes of the anterior circulation: Analysis from the French societal perspective.

OBJECTIVES: To determine the cost-effectiveness of stent retriever thrombectomy (SRT) added to standard of care (SOC) in large vessel occlusion (LVO) strokes, adopting the French societal perspective given the lack of published studies with such perspective. METHODS: We developed an hybrid model (decision tree until one year post-stroke followed by a Markov model from one year onward). The time horizon was 20 years. We calculated transition probabilities across the modified Rankin Scale (mRS) based on a published meta-analysis. The main outcome measure was quality adjusted life-years (QALYs) gained. Resources and input costs were derived from a literature search. We calculated the incremental cost-effectiveness ratio (ICER) expressed as cost/QALY. We used 1-way deterministic and probabilistic sensitivity analysis (PSA) to evaluate the model uncertainty. RESULTS: In the base-case, adding SRT to SOC resulted in increased effectiveness of 0.73 QALY while total costs were reduced by 3,874€ (ICER of -5,400€/QALY). In the scenario analysis adopting the French healthcare system perspective, the ICER was 4,901€/QALY. Parameters the most influential were the relative risks of SRT over SOC for 90-days mortality and for 90-days mRS 0-2, and the time horizon. PSA showed the 95% confidence interval of the ICER was -21,324 to 4,591€/QALY, with SRT having 85.5% chance to be dominant and 100% to be cost-effective at a threshold of 50,000€/QALY. CONCLUSION: SRT was dominant from a French societal perspective, from 9 years post-stroke onwards. Cost-effectiveness of SRT added to SOC becomes undisputable with evidences from payer and societal viewpoints.

A direct aspiration first pass technique for acute stroke therapy: a systematic review and meta-analysis.

BACKGROUND AND PURPOSE: A direct aspiration first pass technique (ADAPT), involving the first-line use of a large-bore distal aspiration catheter, is a new strategy in the mechanical thrombectomy of acute ischemic stroke caused by large-vessel occlusion. However, its impact on reperfusion rates, clinical outcomes and complication rates has not been fully examined. METHODS: We conducted a systematic review of the literature searching multiple databases for reports on thrombectomy of acute stroke with ADAPT and performed meta-analyses of clinical and radiographic outcomes. RESULTS: We selected 16 articles that included a total of 1378 patients treated with ADAPT. The mean admission National Institutes of Health Stroke Scale score was 17 and pre-treatment intravenous thrombolysis was used in 51% of cases. The successful recanalization (thrombolysis in cerebral ischemia 2b-3) rate was 66% [95% confidence interval (CI), 59-72%] with ADAPT and a rescue stent retriever was used in 31% of cases (95% CI, 24-37%) yielding an overall thrombolysis in cerebral ischemia 2b-3 rate of 89% (95% CI, 85-92%). We found a pooled estimate of 50% (95% CI, 45-54%) for functional independence (modified Rankin Scale score 0-2) at 90 days, 15% (95% CI, 10-21%) for mortality within 90 days and 5% (95% CI, 3-7%) for symptomatic intracranial hemorrhage. CONCLUSIONS: ADAPT therapy is associated with similar reperfusion rates, clinical outcomes and complication rates compared with thrombectomy with stent retrievers. However, the major limitations of current evidence (i.e. retrospective studies and selection bias) indicate a need for adequately powered, multicenter randomized controlled trials to determine the best strategy.

Thrombectomy outcomes for acute stroke patients with anterior circulation tandem lesions: a clinical registry and an update of a systematic review with meta-analysis.

BACKGROUND AND PURPOSE: Although mechanical thrombectomy (MT) appears to be superior in stroke patients with extracranial carotid disease (ECD) compared to thrombolysis alone, the impact of emergent carotid stenting during MT remains unclear. The MT outcomes were assessed in anterior stroke patients with ECD, especially when combined with carotid stenting. METHODS: A retrospective analysis of our registry was performed and an update of a systematic review and meta-analysis of MT studies with or without stenting for anterior circulation stroke with ECD published between November 2010 and April 2017 was conducted. RESULTS: In our registry, 46 patients with ECD underwent MT. In the meta-analysis including 13 primary studies plus our prospective registry data (590 patients in total), the successful reperfusion rate (modified thrombolysis in cerebral infarction score ≥2b) reached 75% [95% confidence interval (CI) 69%-81%]. The rate of symptomatic intracranial haemorrhage (sICH) was 8% (95% CI 6%-11%), 90-day favourable outcome was achieved in 50% (95% CI 42%-59%) and mortality rate was 16% (95% CI 11%-22%). When using carotid stenting, rates of successful reperfusion, sICH, 90-day favourable outcome and mortality were 80% (95% CI 73%-87%), 7% (95% CI 4%-12%), 53% (95% CI 43%-62%) and 14% (95% CI 9%-19%), respectively. CONCLUSIONS: Our data report an association between acute stenting and successful reperfusion rates in stroke patients with tandem lesion treated with MT. Further studies are warranted to determine the intracranial bleeding risk after MT and stenting according to the antiplatelet therapy.

Stent retriever thrombectomy for acute ischemic stroke: A systematic review and meta-analysis of randomized controlled trials, including THRACE.

BACKGROUND AND PURPOSE: Endovascular thrombectomy has become the reference therapy for patients with large vessel occlusion (LVO). However, no meta-analysis including the THRACE Trial has yet been reported. Thus, the present review assessed the outcomes of stent retriever thrombectomy added to medical care compared with medical care alone in LVO patients. MATERIALS AND METHODS: A systematic review was conducted of all randomized controlled trials (RCTs) examining stent retrievers added to medical care vs medical care alone in the MEDLINE, Embase and Web of Science databases. Meta-analyses of 90-day functional outcomes and mortality, and the occurrence of symptomatic intracranial hemorrhage (sICH), with thrombectomy plus medical care vs medical care alone were performed. RESULTS: Six multicenter RCTs involving 1673 patients were included. Successful recanalization (modified thrombolysis in cerebral ischemia grades 2b-3) was seen in 71% of patients (95% CI: 62-79%) after thrombectomy. These patients also had significantly higher rates of 90-day functional independence (mRS scores 0-2) compared with those receiving medical care only (OR: 2.14, 95% CI: 1.72-2.67; P<0.00001), as well as excellent outcomes (mRS scores 0-1, OR: 2.05, 95% CI: 1.58-2.67; P<0.00001). Also, the rate of functional independence was higher (OR: 2.39, 95% CI: 1.88-3.04; P<0.00001) in the subgroup analysis without the THRACE Trial. The effect of endovascular therapy on 90-day mortality was inconclusive (OR: 0.82, 95% CI: 0.62-1.07; P=0.15), and there was no increased occurrence of sICH (OR: 1.11, 95% CI: 0.66-1.88; P=0.70). CONCLUSION: Stent retriever thrombectomy added to medical care improved 90-day functional outcomes compared with medical care alone with no impact on mortality and risk of sICH in LVO patients.

Prevalence of drug-related problems associated with direct oral anticoagulants in hospitalized patients: a multicenter, cross-sectional study.

WHAT IS KNOWN AND OBJECTIVE: The complex dose regimens of the direct-acting oral anticoagulants (DOAC) make their appropriate prescribing highly challenging. Inappropriate prescribing of the DOAC remains poorly addressed. We studied the patterns of DOAC prescription and estimated the prevalence of drug-related problems (DRPs) associated with their use. METHODS: A cross-sectional study was conducted using data from medical records system of the Lyon teaching hospitals. DRPs, identified among patients who received a DOAC, between 1 January 2010 and 31 July 2013, were categorized according to the Pharmaceutical Care Network Europe Classification System. The prevalence of hospital stays with a DRP was estimated, and a subgroup analysis according to DOAC and their indication for use was provided. Clinical outcomes were not assessed. RESULTS: Of the 4154 hospital stays with at least one DOAC administration [3412 patients; median age (range): 71 years (14-98), 57% female], 70·8% were excluded from the analysis mainly due to missing information for renal function and/or patient weight. Of the 1188 hospital stays that were screened, 100 DRPs were identified (prevalence 8·4%; 95% CI, 6·8-10·0). The highest prevalence was found among patients who received rivaroxaban for atrial fibrillation (14·6%; 95% CI, 10·7-18·5). A too low drug dose was the most frequent DRP (n = 56; 4·7%), followed by a too high drug dose (n = 37; 3·1%), contraindication (n = 5; 0·4%), and pharmacokinetic problem requiring dose adjustment (n = 2; 0·2%). WHAT IS NEW AND CONCLUSION: Drug-related problems associated with the DOACs occur quite commonly among hospitalized patients. Although these DRPs were considered to be of minor severity, prescribing protocols to support better prescribing should be disseminated to reduce the risk to patients. Renal function and body weight data should be mandatory on prescriptions to allow cross-checking.

[Medico-economic evaluation of therapeutic strategies at hospital: A systematic review of French studies]. / L'évaluation médico-économique des stratégies thérapeutiques en milieu hospitalier : une revue systématique des travaux français.

INTRODUCTION: Therapeutic innovation contributes to the increase of health care expenditures in France. Medico-economic evaluation has still a minor role in the decision-making for the registration of drugs and medical devices in hospitals. This study aimed to systematically review published works on medico-economic studies conducted within French hospitals. METHODS: A literature review was carried out to search for medico-economic studies conducted by hospital teams on therapeutic or diagnostic strategies employed within French hospitals and published from 2010 to 2014. Quality assessment of selected studies was performed according to Drummond et al.'s checklist, which is also used within French guidelines. RESULTS: Of the 44 analyzed articles, methods for identification and measure of costs and results complied with guidelines in 95 % of cases. For results interpretation, compliance was 91 %. Costs discounting (29 %) and the use of sensitivity analysis to account for results uncertainty (70 %) were the parameters with the lowest compliance to guidelines. CONCLUSION: A good training of health professionals in using economic and statistic tools, and the transferability of results of medico-economic studies are essential and should be optimized to enable a broader use of medico-economic evaluation within the scope of decision-making in French hospitals.

Current trends in vasopressor use to the operating room: A pharmacoepidemiologic study in French teaching and military hospitals.

OBJECTIVES: Phenylephrine, ephedrine and norepinephrine are the vasopressors most commonly used in the operating room to treat anaesthesia-induced hypotension. Two new diluted forms of phenylephrine were released in 2011 (500µg/10mL and 500µg/5mL). We initiated a study to evaluate trends in the use of vasopressors in the operating room in French hospitals over the period 2011-2014. METHODS: We conducted a longitudinal, retrospective, observational study between 2011 and 2014 in French teaching and military hospitals. A questionnaire was sent in February 2015 to hospital pharmacists of each centre to retrospectively collect the consumption of each type of vasopressor. Yearly numbers of vasopressor ampoules were divided by the yearly numbers of anaesthetics recorded. For each vasopressor, we calculated the number of ampoules per 100 anaesthetics recorded (/100A). RESULTS: Thirty-two hospitals (82%) completed the questionnaire. One hundred per cent of hospitals had registered the diluted form of phenylephrine (61% had chosen the dilution 500µg/10mL), whereas concentrated ampoules were available in 68% of hospitals. Over the period, an exponential increase in the use of diluted phenylephrine was observed (from 1.0 ampoule/100A in 2012 to 31.7 in 2014), the use of ephedrine remained stable (26 ampoules and 17 prefilled syringe/100A), and use of norepinephrine trended upwards (from 6.7 to 8.2 ampoules/100A). CONCLUSIONS: The use of diluted phenylephrine has exponentially increased without reducing consumption of other vasopressors. This trend might be secondary to practice changes in hypotension treatment following the release of French guidelines in 2013 related to fluid management, the restriction of indications of hydroxylethyl-starch solutions in 2013, and a better knowledge of the benefit of blood pressure optimisation to reduce postoperative morbidity.

[Economic evaluation of medical devices not included in the French list of products and services qualifying for reimbursement: Example of biologic meshes]. / Impact économique à l'hôpital de dispositifs médicaux non remboursés en sus des GHS : exemple des prothèses de renfort biologiques.

OBJECTIVES: To present a method aimed to evaluate the economic impact associated with the use of medical devices (DM) not reimbursed in addition to diagnosis related groups (DRGs) tariffs using the example of biological meshes for parietal reinforcement. METHODS: In this multicenter retrospective cohort study, we included all patients who received a biological mesh between January 2010-April 2014 (University hospitals of Saint-Étienne, France) or between January 2010-March 2015 (Lyon University hospitals, France). Measured costs associated with biologic meshes were compared to those of the "Étude nationale des coûts à méthodologie commune" (2012) to weigh the economic impact of biologic meshes with the French DRGs costs. We also compared these costs to the fares perceived by the hospital from the French sickness fund (GHS). RESULTS: Thirty-six patients received a biological mesh and were treated by a total of 38 biological meshes. Of these, the implant was Protexa®, Permacol® and Strattice® in 66%, 29% and 5% of cases respectively. The hospitals incomes were 10,496±5562€ per stay. Meshes-related expenditures represented in average 28% of DRGs costs and 38% of GHS tariffs. The mean additional cost for biological meshes was 3793±2292 euros compared to the mean cost on implantable medical devices in the French DRGs. CONCLUSION: Given their currently restricted use, the hospital budget impact of biological meshes remains limited although the incremental cost per patient is substantial. Analytic costs data can be useful within the scope of decision-making related to DM not refunded by the French health system.

Estimated economic impact of pre-filled ephedrine syringes in the operating room.

BACKGROUND: Syringes of ephedrine are usually prepared ahead of time in order to reduce the time to injection. Commercial pre-filled syringes of ephedrine have been introduced to minimize the amount of waste. Our primary objective was to determine the economic impact of commercial syringes. We hypothesized that costs could be reduced compared to standard syringes. METHODS: Using data extracted from our medical records system, we retrospectively measured the total dose of ephedrine received per patient in 2013 to estimate the number of administered standard syringes. The proportion of administered standard syringes was calculated as the total number of administered standard syringes divided by the number of delivered ampoules in 2013. Thereafter, we calculated the annual cost difference as the difference between the cost for commercial syringes and the cost for standard syringes. Endpoints were calculated overall and for each operating room. RESULTS: At least one dose of ephedrine was given in 19,422 patients (44,943 administrations). The overall proportion of administered standard syringes was estimated to 52.8%. The threshold proportion of administered standard syringes for which commercial syringes would add no extra cost was 20.4%. In 30/32 operating rooms, the proportion of administered standard syringes was higher than 20.4%. The overall cost increase with commercial syringes was estimated to 51,567 €. Among operating rooms, incremental costs varied between -703 and 5086 €. CONCLUSION: Based on our findings, pre-filled ephedrine commercial syringes do not appear to reduce costs.

Current trends in the management of glioblastoma in a French University Hospital and associated direct costs.

WHAT IS NEW AND OBJECTIVES: Trends in the care of glioblastoma in actual practice settings are poorly described. In a previous pharmacoepidemiologic study, we highlighted changes in the management of patients with glioblastoma (GBM) newly diagnosed between 2004 and 2008. Our aim was to complete and to extend the previous report with a study of a cohort of patients diagnosed in 2011 to emphasize the trends in the pharmacotherapy of GBM over the last decade. METHODS: A single-centre study was undertaken of three historic cohorts of GBM patients newly diagnosed during years 2004, 2008 and 2011 (corresponding to groups 1, 2 and 3, respectively) but limited to patients eligible for radiotherapy after initial diagnosis. The type of medical management was described and compared, as well as overall survival and total cost from diagnosis to death or the last follow-up date. Cost analysis was performed from the French sickness fund perspective using tariffs from 2014. RESULTS: Two hundred and seventeen patients (49 in Group 1, 73 in Group 2, 95 in Group 3) were selected with similar baseline characteristics. Fluorescence-guided surgery using 5-ALA was increasingly used over the three periods. There was a strong trend towards broader use of temozolomide radiochemotherapy (39%, 73% and 83% of patients, respectively) as first-line treatment as well as bevacizumab regimen at recurrence (6%, 48% and 58% of patients, respectively). The increase in overall survival between Group 2 and Group 1 was confirmed for patients in Group 3 (17·5 months vs. 10 months in Group 1). The mean total cost per patient was 53368 € in Group 1, 70 201 € in Group 2 and 78355 € in Group 3. Hospital care represented the largest expenditure (75%, 59% and 60% in groups 1, 2 and 3, respectively) followed by chemotherapy drug costs (11%, 30% and 29%, respectively). WHAT IS NEW AND CONCLUSION: This is the first study to report on changes in the management of GBM in real-life practice. The ten-year study indicates an improvement in overall survival but also an increase in total cost of care. The data should be useful for informing the care of GBM patients in settings similar to ours.

Management of glioblastoma: comparison of clinical practices and cost-effectiveness in two cohorts of patients (2008 versus 2004) diagnosed in a French university hospital.

WHAT IS KNOWN AND OBJECTIVE: Therapeutic options for the management of glioblastoma (GBM) have greatly evolved over the last decade with the emergence of new regimens combining radiotherapy plus temozolomide and the use of bevacizumab at recurrence. Our aim was to assess the clinical and economic impacts of those novel strategies in our center. METHODS: A single-center retrospective chart review was conducted on patients newly diagnosed with a GBM over two periods (year 2004, group 1 or year 2008, group 2) with limitations to those eligible to radiotherapy after initial diagnosis. The type of medical management was described and compared, as well as overall survival and total costs from diagnosis to death or the last follow-up date. Cost analysis was performed under the French Sickness Fund perspective using tariffs from 2012. RESULTS: One hundred twenty-two patients were selected (49 in group 1 and 73 in group 2) with similar baseline characteristics within the two groups. Patients from group 2 received more frequently temozolomide radiochemotherapy (71% vs. 39%, P < 0·05) as first-line treatment as well as bevacizumab regimen at recurrence (48% vs. 6%, P < 0·05); the median overall survival was increased between the two periods (respectively 17 vs. 10 months, P < 0·05). The mean total cost per patient was 54,388 € in group 1 and 71,148 € in group 2 (P < 0·05). Hospital care represented the largest expenditure (76% and 58% in groups 1 and 2 respectively) followed by chemotherapy drugs costs (11% and 30% respectively). The total cost difference between the two groups was explained by the increasing use of temozolomide and bevacizumab. The incremental cost-effectiveness ratio was estimated at 54,355 € per life-year gained. WHAT IS NEW AND CONCLUSION: As far as we know, this is the first study reporting the total cost of GBM management based on the French perspective, as well as the cost-effectiveness of clinical practices in term of cost per life-year gained. Those novel strategies have contributed to improve overall survival while inducing a substantial, but acceptable, increase of total costs.

A new perfusion system to reduce the burden of central-venous-line-associated bloodstream infections in neonates.

BACKGROUND: Central-venous-line-associated bloodstream infection (CLABSI) is a significant cause of morbidity and mortality in preterm infants. As there is large variation in the reported effect of multi-modal preventive strategies, it could be relevant to propose new additional strategies. AIM: To assess the impact of a new perfusion system on CLABSI rate. METHODS: A before-and-after study was performed in infants born at <32 weeks of gestation or with birth weight <1500 g who required a multi-perfusion system connected to a central venous line. In the first 12-month period ('before'), the pre-existing perfusion system (multiple stopcocks) was used. An intervention period then occurred with implementation of a new perfusion closed system, without change in 'bundles' related to various aspects of central line care. During the second 12-month period ('after'), the CLABSI rate was assessed and compared with the pre-intervention period. FINDINGS: In total, 313 infants were included in this study (before: N=163; after: N=150), and 46% had birth weight <1000 g. The change in perfusion system resulted in a significant decrease in CLABSI rate from 11.3 to 2.2 per 1000 catheter-days (P<0.001). The period was independently associated with an 88% reduction in the risk of CLABSI after implementation of the new perfusion system [odds ratio (OR) 0.12, 95% confidence interval (CI) 0.03-0.39; P<0.001]. The duration of central line use was also associated with CLABSIs (for each additional day: OR 1.05, 95% CI 1.02-1.07; P<0.001). CONCLUSIONS: Implementation of the new perfusion system was feasible in a large neonatal unit, and reduced the CLABSI rate soon after implementation.

Cost-effectiveness of a new multi-lumen infusion device to reduce central venous line-associated bloodstream infections in neonates.

BACKGROUND: A new medical device was developed for multi-infusion in neonatal intensive care units (NICUs) with the aim to address issues related to drug incompatibilities and central line-associated bloodstream infections (CLABSI). AIM: To assess the cost-effectiveness of implementing this new perfusion system in a NICU setting. METHODS: We conducted a single-centre, observational study in all infants admitted to the NICU within the first 3 days after birth and who required central-venous line, to evaluate the cost and effectiveness before (Year 2019) and after (Year 2020) the implementation of the new perfusion system. We calculated the costs from the hospital perspective, and we examined the incidence of CLABSI, over a time horizon spanning from admission to NICU discharge. We measured the resource utilisation (infusion medical device, infection treating drugs and biological analyses), and valued corresponding costs using tariffs for year 2019. We calculated incremental cost-effectiveness ratio (ICER) expressed as euros per CLABSI avoided, and conducted one-way and multivariate sensitivity analyses. FINDINGS: Among 609 infants selected, clinical characteristics were similar across both periods. The CLABSI rate significantly decreased (rate ratio: 0.22; IC95% [0.07-0.56]), and total costs were reduced (from €65,666 to €63,932 per 1000 catheter days respectively; p<0.001), yielding to an ICER of €251 saved per CLABSI avoided. The majority of sensitivity analyses showed the new intervention remaining economically dominant. CONCLUSION: This single-centre study showed a significant decrease in the incidence of CLABSI without incurring additional costs. Further prospective multicentre randomised studies are needed to confirm these results in other NICU.

[Economic and organizational impact of the use of a disposable sheath with a flexible cystoscope]. / Cystoscope flexible à gaine stérile à usage unique: impact organisationnel et économique et sécurité bactériologique.

PURPOSE: To assess both economical and organizational impact as well as bacteriologic safety of a flexible cystoscope with sterile disposable sheath (FCSDS) compared to standard flexible cystoscopy (SFC) in two French urologic academic units. PATIENTS: Two-center prospective study, comparing the use of the FCSDS to the SFC on two consecutive periods of time. Two hundred and five patients were included and divided into each group. Duration procedures and costs were analysed in the two techniques. The urinary tract infection rate was also described. A dedicated sheaths leaks test after use was performed systematically. RESULTS: The preparation time of the fibroscope was longer for the sheathed cystoscopy group: 16.2 minutes versus 10.9 minutes for the standard group. The mean duration of disinfection was significantly shorter for the sheathed cystoscopy group: 53.8 minutes saved compared to the standard group; 99.01% of the tested sheaths, after their use, had no breaches. Urinary tract infections rate were similar in the two groups. The average cost of a sheathed cystoscopy compared to the standard was significantly cheaper in Lyon and almost equivalent in Marseille. CONCLUSION: The FCSDS allows significant saving over the disinfection duration, consumable costs and staff costs, while ensuring patient bacteriologic safety similar to SFC.

Management of relapsed or refractory multiple myeloma in French hospitals and estimation of associated direct costs: a multi-centre retrospective cohort study.

WHAT IS KNOWN AND BACKGROUND: For relapsed or refractory multiple myeloma (RRMM), a series of novel agents (thalidomide, bortezomib and lenalidomide) has emerged during the latest decade, but their use in routine clinical practice is not well documented as well as the cost of RRMM. OBJECTIVE: Our aim is to review the therapeutic management of such patients in France and to estimate the associated costs. METHODS: A retrospective cohort study, based on chart reviews, was conducted in French Haematology Departments over the period 2004-2007 and the associated direct costs estimated. RESULTS: One hundred and two patients with a relapse after first-line therapy were selected from five centres. The average follow-up from diagnosis or the date of first relapse to death or to the latest news was respectively 56.25 and 23.53 months. Novel agents were used in 73% of all cases, and in all cases of first relapse. Thalidomide and bortezomib were respectively the most frequently used second-line (57%) and third-line treatments (44%). The average number of lines of treatment received per patient as from first relapse was 2.75 (min 1; max 8) and the mean direct cost per month was estimated at 3130 € after the first relapse. This cost was represented in greater part by the cost of chemotherapy drugs (66%). WHAT IS NEW AND CONCLUSION: The use of novel agents such as thalidomide, bortezomib and lenalidomide for RRMM is highly prevalent in France from the first relapse. The associated medical cost is substantial mainly due to the cost of the new agents.

[Best practice agreement: implementation of best practice guidelines in HCL hospitals in Lyon, France]. / Contrat de bon usage : mise en oeuvre opérationnelle des référentiels de bon usage aux hospices civils de Lyon.

Since 2004, the Hospices Civils de Lyon (HCL) hospitals are committed to comply with best practice guidelines for healthcare products that are reimbursed in addition to diagnosis related groups' (DRGs) tariffs in France, and that, even before the publication of the law concerning best practice agreement. It has been necessary to adapt national drugs best practice guidelines to every-day practice. A working group, COPIL RBU, has been created in HCL hospitals to manage the best practice guidelines locally. This group has two main activities: it conducts a scientific and regulatory information watch and follows up emerging indications at HCL. The group's best practice guidelines contain a classification of indications into three categories: approved indications (market authorization and temporary protocol of treatment), currently-assessed indications and contra-indications. Our best practice guidelines are more than a rewriting of national guidelines since they include emerging indications validated by prescribing physicians at HCL hospitals. A scientific argumentation is made for each emerging indication that is classified in our guidelines, based on the level of scientific evidence available. The practical use of our best practice guidelines is made through a best practice prescription that enables the traceability of drugs from the prescription to the administration to the patient. These prescriptions are accompanied with best practice guidelines made by medical and pharmaceutical professional groups. Audits will then be conducted to assess the indications' conformity to our guidelines and to have a better knowledge of current medical practice.

Optimization of high-grade glioma resection using 5-ALA fluorescence-guided surgery: A literature review and practical recommendations from the neuro-oncology club of the French society of neurosurgery.

BACKGROUND: When feasible, the surgical resection is the standard first step of the management of high-grade gliomas. 5-ALA fluorescence-guided-surgery (5-ALA-FGS) was developed to ease the intra-operative delineation of tumor borders in order to maximize the extent of resection. METHODS: A Medline electronic database search was conducted. English language studies from January 1998 until July 2018 were included, following the PRISMA guidelines. RESULTS: 5-ALA can be considered as a specific tool for the detection of tumor remnant but has a weaker sensibility (level 2). 5-ALA-FGS is associated with a significant increase in the rate of gross total resection reaching more than 90% in some series (level 1). Consistently, 5-ALAFGS improves progression-free survival (level 1). However, the gain in overall survival is more debated. The use of 5-ALA-FGS in eloquent areas is feasible but requires simultaneous intraoperative electrophysiologic functional brain monitoring to precisely locate and preserve eloquent areas (level 2). 5-ALA is usable during the first resection of a glioma but also at recurrence (level 2). From a practical standpoint, 5-ALA is orally administered 3 hours before the induction of anesthesia, the recommended dose being 20 mg/kg. Intra-operatively, the procedure is performed as usually with a central debulking and a peripheral dissection during which the surgeon switches from white to blue light. Provided that some precautions are observed, the technique does not expose the patient to particular complications. CONCLUSION: Although 5-ALA-FGS contributes to improve gliomas management, there are still some limitations. Future methods will be developed to improve the sensibility of 5-ALA-FGS.

Lenalidomide in the treatment of multiple myeloma: a review.

Lenalidomide is an immunomodulatory drug derived from thalidomide. It was developed to maximize the anti-inflammatory and anti-neoplasic properties of thalidomide and to reduce its toxicity. The molecular mechanism of action of lenalidomide is unclear, but its therapeutic activity is mainly due to its well defined anti-inflammatory, immunomodulatory, anti-proliferative and anti-angiogenic properties. In relapsed or refractory multiple myeloma (MM), lenalidomide, combined with standard dose dexamethasone, is superior to dexamethasone alone in terms of time to progression, response rate and overall survival. The most commonly reported adverse events include haematological toxicity with manageable neutropenia and thrombopenia. Lenalidomide does not trigger the limiting toxicities of thalidomide: somnolence, neuropathy and constipation. Lenalidomide, in combination with dexamethasone, is indicated for the treatment of MM patients who have received at least one prior therapy and is administered orally at the dose of 25 mg q.d. for 21 days of 28-day cycles. The drug is being investigated for the treatment of newly diagnosed MM. In this review, we summarize the pharmacokinetic, pharmacodynamic and clinical trial data on lenalidomide.