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PubMed | Besancon University Hospital Center, EOS Imaging, Johnson & Johnson, 3M and 12 more.
Type: Journal Article | Journal: Therapie | Year: 2015

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.


Bonne G.,French Institute of Health and Medical Research | Bonne G.,University Pierre and Marie Curie | Bonne G.,French National Center for Scientific Research | Bonne G.,Groupe Hospitalier Pitie Salpetriere | And 3 more authors.
Handbook of Clinical Neurology | Year: 2013

The nuclear envelopathies, more frequently known as laminopathies are a rapidly expanding group of human hereditary diseases caused by mutations of genes that encode proteins of the nuclear envelope. The most frequent and best known form is Emery-Dreifuss muscular dystrophy (EDMD), a skeletal myopathy characterized by progressive muscular weakness, joint contractures, and cardiac disease. EMD gene, encoding emerin, causes the X-linked form of EDMD, while LMNA gene encoding lamins A and C, is responsible for autosomal forms, usually with a dominant transmission. In the last years, the spectrum of conditions has been extraordinarily enlarged, from a congenital muscular dystrophy with severe paralytic or rapidly progressive picture due to de novo mutations in LMNA (L-CMD) to a limb-girdle muscular dystrophy with adult onset and much milder weakness (LGMD1B). LMNA has also been involved in a form of isolated cardiomyopathy associated with cardiac conduction disease and in an axonal form of hereditary neuropathy. Identification of this gene has been reported also in a number of non-neuromuscular disorders including lipodystrophy syndromes and a wide spectrum of premature aging syndromes ranging from mandibuloacral dysplasia to restrictive dermopathy. Mutations in other genes implicated in the processing or maturation of nuclear lamins have also been found. The extraordinary complexity of the molecular and pathophysiological mechanisms of these diseases is still not well known and the occurrence of modifying factors or genes is highly suspected. Identification of new genes and investigation of new therapeutic approaches are in progress. © 2013 Elsevier B.V.


Ozguler A.,Hopital University Raymond Poincare | Loeb T.,Hopital University Raymond Poincare | Baer M.,Hopital University Raymond Poincare
Gerontechnology | Year: 2014

Purpose: Unnecessary interventions to rule out non-lifethreatening situations among the elderly are increasing by number and cost. This has an impact not only on the helpers (family, caretakers or friends) but also on the ambulance/fire/emergency doctor/volunteers' services whose policies and budgets are not prepared for unnecessary interventions. QuoVADIS was a project aimed at improving Homecare Services and providing help for the disabled, elderly, and cognitively impaired, funded by the French National Research Agency (ANR) from 2008 to 2010. It had a telemedicine platform including a pulse sensor, an actimetry sensor and a robot equipped with camera and microphone. One of the project's main goals was to assess a remote monitoring system teleoperated by emergency dispatchers to rule out non-life-threatening situations. Method: This project was assessed from the end-users' point of view: among many parameters, user friendliness and feasibility were recorded according to 4 different scenarios in a smart-home environment. Results & Discussion: Eight emergency dispatchers routinely working as teleoperators in a tele-health alarm center tested the 4 different scenarios performed by actors in the smart-home environment. The results show a reduced time in the detection of emergency situations (fall, bradycardia, and "power off" alarms) compared with routine tele-health alarm systems. The emergency dispatchers appreciated the system as a whole (mean score= 6.75 on a scale from 1 to 8). They suggested improving the appearance of the robot and upgrading the quality of its transmitted videos and remote monitoring. Conclusion: Introducing a teleoperated robot with the usual sensors and alarms can add value to the detection of emergency situations among the elderly, thus helping to avoid unnecessary interventions. However, this system needs some improvements before it can be implemented. The above solution paves the way towards a reduction in the number of unnecessary interventions, which are today decided merely to rule out life-threatening situations.


Saleh-Mghir A.,Hopital University Raymond Poincare | Saleh-Mghir A.,University of Versailles | Dumitrescu O.,University of Lyon | Dinh A.,Hopital University Raymond Poincare | And 10 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2012

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) can cause osteomyelitis with severe sepsis and/or local complications in which a Panton-Valentine leukocidin (PVL) role is suspected. In vitro sub-MIC antibiotic effects on growth and PVL production by 11 PVL+ MRSA strains, including the major CA-MRSA clones (USA300, including the LAC strain; USA400; and USA1000), and 11 PVL+ methicillin-susceptible S. aureus (MSSA) strains were tested in microplate culture. Time-kill analyses with ceftobiprole at its MIC were also run with LAC. Efficacies of ceftobiprole (40 mg/kg of body weight subcutaneously [s.c.] four times a day [q.i.d.]) or vancomycin (60 mg/kg intramuscularly [i.m.] twice a day [b.i.d.]) alone or combined with rifampin (10 mg/kg b.i.d.) against rabbit CA-MRSA osteomyelitis, induced by tibial injection of 3.4 × 107 CFU of LAC, were compared. Treatment, started 14 days postinoculation, lasted 14 days. In vitro, 6/11 strains cultured with sub-MICs of ceftobiprole produced 1.6- to 4.8-fold more PVL than did the controls, with no link to specific clones. Rifampin decreased PVL production by all tested strains. In time-kill analyses at the LAC MIC (0.75 mg/liter), PVL production rose transiently at 6 and 8 h and then declined 2-fold at 16 h, concomitant with a 2-log10-CFU-count decrease. In vivo, the mean log10 CFU/g of bone for ceftobiprole (1.44 ± 0.40) was significantly lower than that for vancomycin (2.37 ± 1.22) (P = 0.034), with 7/10 versus 5/11 bones sterilized, respectively. Combination with rifampin enhanced ceftobiprole (1.16 ± 0.04 CFU/g of bone [P = 0.056], 11/11 sterile bones) and vancomycin (1.23 ± 0.06 CFU/g [P = 0.011], 11/11 sterile bones) efficacies. Ceftobiprole bactericidal activity and the rifampin anti-PVL effect could play a role in these findings, which should be of interest for treating CA-MRSA osteomyelitis. Copyright © 2012, American Society for Microbiology. All Rights Reserved.


Saleh-Mghir A.,Hopital University Raymond Poincare | Saleh-Mghir A.,University of Versailles | Muller-Serieys C.,University Paris Diderot | Dinh A.,Hopital University Raymond Poincare | And 4 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2011

Daptomycin is an attractive option for treating prosthetic joint infection, but the 6-mg/kg of body weight/day dose was linked to clinical failure and emergence of resistance. Using a methicillin-resistant Staphylococcus aureus (MRSA) knee prosthesis infection in rabbits, we studied the efficacies of high-dose daptomycin (22 mg/kg given intravenously [i.v.] once daily [o.d.]; equivalent to 8 mg/kg/day in humans) or vancomycin (60 mg/kg given intramuscularly [i.m.] twice daily [b.i.d.]), both either alone or with adjunctive rifampin (10 mg/kg i.m. b.i.d.). After partial knee replacement with a silicone implant, 10 7 MRSA CFU was injected into the knees. Treatment started 7 days postinoculation and lasted 7 days. Positive cultures were screened for the emergence of mutant strains, defined as having 3-fold-increased MICs. Although in vivo mean log10 CFU/g of daptomycin-treated (4.23 ± 1.44; n = 12) or vancomycin-treated (4.63 ± 1.08; n = 12) crushed bone was significantly lower than that of controls (5.93 ± 1.15; n = 9) (P < 0.01), neither treatment sterilized bone (2/12 and 0/12 rabbits with sterile bone, respectively). Daptomycin mutant strains were found in 6/12, 3/12, and 2/9 daptomycintreated, vancomycin-treated, and control rabbits, respectively; no resistant strains emerged (MIC was always <1 mg/liter). Adjunctive rifampin with daptomycin (1.47 ± 0.04 CFU/g of bone [detection threshold]; 11/11 sterile bones) or vancomycin (1.5 ± 0.12 CFU/g of bone; 6/8 sterile bones) was significantly more effective than monotherapy (P < 0.01) and prevented the emergence of daptomycin mutant strains. In this MRSA joint prosthesis infection model, combining rifampin with daptomycin was highly effective. Daptomycin mutant strains were isolated in vivo even without treatment, but adjunctive rifampin prevented this phenomenon, previously found after monotherapy in humans. Copyright © 2011, American Society for Microbiology. All Rights Reserved.


PubMed | Hopital University Raymond Poincare
Type: Journal Article | Journal: International journal of antimicrobial agents | Year: 2016

The use of antibiotics, as any other drug, is regulated by the terms of its marketing authorisation, notified in the Summary of Product Characteristics (SPC). If a prescription is not in accordance with the SPC, the physician prescribes off-label. There is very little literature regarding off-label use of antibiotics in adult healthcare facilities. A prospective monocentric study was conducted during 11 days from February to June 2015 in hospitalised patients from a tertiary teaching hospital with a high prevalence of multidrug-resistant organism colonisation to evaluate off-label use of antibiotics. Two independent experts assessed whether prescriptions complied with the latest guidelines in infectious diseases and whether off-label use of antibiotics was associated with an increased risk of adverse events. In total, 160 antibiotic prescriptions were analysed, of which 76 (47.5%) were off-label. Of the 76 off-label prescriptions, 50 (65.8%) were off-label regarding indications and 26 (34.2%) regarding doses. Nevertheless, 46/50 off-label indications (92.0%) and only 14/26 off-label doses (53.8%) were approved by experts, especially because of dose adjustment requirements. During follow-up, the rate of reported adverse events was not statistically different between patients with (n=76) and without (n=84) off-label prescriptions (P=0.35). In a context of multidrug resistance and a lack of new drugs, high rates (47.5%) of antibiotic off-label use were observed in our hospital, but without an increased rate of adverse events. Moreover, 78.9% of off-label uses were in accordance with guidelines. Therefore, the SPC is not the warrant of an appropriate use of antibiotics.


PubMed | Hopital University Raymond Poincare
Type: Journal Article | Journal: The Journal of infectious diseases | Year: 2014

Severe sepsis, combining acute osteomyelitis and lung involvement, has been described increasingly in healthy children with the spread of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA).Outcomes (mortality, hematogenous spread, lung and bone involvements) of rabbit osteomyelitis caused by CA-MRSA LAC(WT) USA300 and its Panton-Valentine leukocidin (PVL)- and -hemolysin (Hla)-negative isogenic derivatives (LACpvl and LAChla, respectively) were compared.Three days after inoculation (D3), all LAC(WT)- and LACpvl-, and 72% of LAChla-infected rabbits had no hematogenous spread and similar lung and bone bacterial densities. LACpvl and LAChla caused less severe histological lung lesions than LAC(WT) (P .01). Between D3 and D9, 10 (53%) LAC(WT)-, 11 (55%) LACpvl-, but no LAChla-infected rabbits (P < .005) died of severe sepsis with disseminated infection. Unlike deceased animals, most LAC(WT), LACpvl, and LAChla D14 survivors had no hematogenous spread (P < .001). LAC(WT) (88%) caused more bone abscesses than LACpvl (0, P = .001) or LAChla (30%, P = .01).In this model, both PVL and Hla seemed to be required for early lung involvement via hematogenous spread. Hla, but not PVL, significantly impacted severe sepsis-related mortality. PVL was the predominant factor determining late-stage bone abscesses.


PubMed | Hopital University Raymond Poincare
Type: | Journal: The Journal of antimicrobial chemotherapy | Year: 2017

To determine whether aztreonam is still an effective drug for the treatment of gonorrhoea.Observational study of patients with gonorrhoea diagnosed by urine multiplex PCR, with a past medical history of allergy to -lactams or relapse after treatment with a third-generation cephalosporin. Patients received a single 1g dose of aztreonam in accordance with the manufacturers instructions.Five patients (four males, one female) were enrolled, comprising two who were allergic to -lactams and three previously treated with cephalosporins who relapsed. Median age was 38 years (range 23-51). Following treatment with aztreonam all were cured without any adverse event. All the men were free of symptoms, and the woman tested negative for gonorrhoea 1 month after treatment.Aztreonam appears to be an effective alternative to cephalosporins in the treatment of uncomplicated gonorrhoea, particularly when patients are suspected of being infected by strains with reduced susceptibility to ceftriaxone or are known to be allergic to penicillin.


PubMed | Hopital University Raymond Poincare
Type: Journal Article | Journal: Antimicrobial agents and chemotherapy | Year: 2012

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) can cause osteomyelitis with severe sepsis and/or local complications in which a Panton-Valentine leukocidin (PVL) role is suspected. In vitro sub-MIC antibiotic effects on growth and PVL production by 11 PVL(+) MRSA strains, including the major CA-MRSA clones (USA300, including the LAC strain; USA400; and USA1000), and 11 PVL(+) methicillin-susceptible S. aureus (MSSA) strains were tested in microplate culture. Time-kill analyses with ceftobiprole at its MIC were also run with LAC. Efficacies of ceftobiprole (40 mg/kg of body weight subcutaneously [s.c.] four times a day [q.i.d.]) or vancomycin (60 mg/kg intramuscularly [i.m.] twice a day [b.i.d.]) alone or combined with rifampin (10 mg/kg b.i.d.) against rabbit CA-MRSA osteomyelitis, induced by tibial injection of 3.4 10(7) CFU of LAC, were compared. Treatment, started 14 days postinoculation, lasted 14 days. In vitro, 6/11 strains cultured with sub-MICs of ceftobiprole produced 1.6- to 4.8-fold more PVL than did the controls, with no link to specific clones. Rifampin decreased PVL production by all tested strains. In time-kill analyses at the LAC MIC (0.75 mg/liter), PVL production rose transiently at 6 and 8 h and then declined 2-fold at 16 h, concomitant with a 2-log(10)-CFU-count decrease. In vivo, the mean log(10) CFU/g of bone for ceftobiprole (1.44 0.40) was significantly lower than that for vancomycin (2.37 1.22) (P = 0.034), with 7/10 versus 5/11 bones sterilized, respectively. Combination with rifampin enhanced ceftobiprole (1.16 0.04 CFU/g of bone [P = 0.056], 11/11 sterile bones) and vancomycin (1.23 0.06 CFU/g [P = 0.011], 11/11 sterile bones) efficacies. Ceftobiprole bactericidal activity and the rifampin anti-PVL effect could play a role in these findings, which should be of interest for treating CA-MRSA osteomyelitis.


PubMed | Hopital University Raymond Poincare
Type: Journal Article | Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology | Year: 2016

29-69% of pneumonias are microbiologically documented because it can be considered as an invasive procedure with variable test sensitivity. However, it drastically impacts therapeutic strategy in particular the use of antibiotics. Serum protein electrophoresis (SPEP) is a routine and non-invasive test commonly used to identify serum protein disorders. As virus and bacteria may induce different globulins production, we hypothesize that SPEP can be used as an etiological diagnosis test. Retrospective study conducted from 1/1/13 until 5/1/15 among patient hospitalized for an acute community-acquired pneumonia based on fever, crackles and radiological abnormalities. /, /, / globulins and albumin/globulin (A/G) ratio were calculated from SPEP. Data were analyzed in 3 groups: documented viral (DVP) or bacterial pneumonia (DBP) and supposedly bacterial pneumonia (SBP). We used ANOVA statistic test with multiple comparisons using CI95 and ROC curve to compare them. 109 patients included divided into DBP (n=16), DVP (n=26) and SBP (n=67). Mean age was 6218year-old with a sex ratio M/F of 1.3. Underlying conditions (e.g. COPD, diabetes) were comparable between groups in multivariate analysis. Means of A/G ratio were 0.80 [0.76-0.84], 0.96 [0.91-1.01], 1.08 [0.99-1.16] respectively for DBP, SBP and DVP (p=0.0002). A/G ratio cut-off value of 0.845 has a sensitivity of 87.5% and a specificity of 73.1%. A/G ratio seems to be an easy diagnostic tool to differentiate bacterial from viral pneumonia. A/G ratio cut-off value below 0.845 seems to be predictable of a bacterial origin and support the use of antibiotics.

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