Teaching Hospitals In France Research Articles

Vedolizumab to prevent postoperative recurrence of Crohn's disease (REPREVIO): a multicentre, double-blind, randomised, placebo-controlled trial.

Approximately half of patients with Crohn's disease require ileocolonic resection. Of these, 50% will subsequently have endoscopic disease recurrence within 1 year. We aimed to evaluate the efficacy and safety of vedolizumab to prevent postoperative recurrence of Crohn's disease. REPREVIO was a double-blind, randomised, placebo-controlled trial conducted at 13 academic or teaching hospitals in France, Italy, the Netherlands, and Spain. Eligible participants were adult patients aged 18 years or older with Crohn's disease who underwent ileocolonic resection and had one or more risk factors for recurrence. Patients were randomly assigned within 4 weeks of surgery (1:1 ratio) to receive intravenous vedolizumab (300 mg) or placebo at weeks 0, 8, 16, and 24. Randomisation was performed centrally with a computer-generated validated variable block model and patients were stratified according to disease behaviour (fibrostenotic vs inflammatory or perforating). Ileocolonoscopy was performed at week 26 and videorecorded. Endoscopic recurrence was centrally assessed with the modified Rutgeerts score, a categorial score ranging from i0 to i4. The primary endpoint was the distribution of modified Rutgeerts scores between treatment groups at week 26, analysed by non-parametric methods. The first-ranked secondary endpoint was the proportion of patients with severe endoscopic recurrence of Crohn's disease at week 26 (modified Rutgeerts score ≥i2b). Primary and safety analyses included all patients who underwent randomisation and received at least one dose of study drug. The trial is registered with the EU Clinical Trial Register (EudraCT; 2015-000555-24). Between May 16, 2017, and April 8, 2022, 84 patients were randomly assigned to treatment, of whom four did not receive study treatment, leaving 43 patients in the vedolizumab group and 37 in the placebo group. At week 26, the probability of a lower modified Rutgeerts score with vedolizumab versus placebo was 77·8% (95% CI 66·4 to 86·3; p<0·0001). Severe endoscopic recurrence was observed in ten (23·3%) of 43 patients in the vedolizumab group versus 23 (62·2%) of 37 patients in the placebo group (difference -38·9% [95% CI -56·0 to -17·3]; p=0·0004). Serious adverse events occurred in three (7·0%) of 43 patients who received vedolizumab (bilateral tubo-ovarian abscesses, thrombosed haemorrhoids, and pancreatic adenocarcinoma) and in two (5·4%) of 37 patients who received placebo (intestinal perforation related to Crohn's disease and severe abdominal pain). Vedolizumab treatment within 4 weeks of ileocolonic resection was more likely to prevent endoscopic Crohn's disease recurrence than placebo, making this an attractive option for postoperative management in patients with risk factors for recurrence. Larger studies with longer follow-up would be desirable. Takeda Nederland.

Time to source control and outcome in community-acquired intra-abdominal infections: The multicentre observational PERICOM study.

Optimal management of community-acquired intra-abdominal infections (IAI) requires timely surgical source control and adequate anti-infective treatment. To describe the initial management of community-acquired IAI admitted to the emergency department and assess the association between the length of time to either diagnosis or therapeutic procedures and patient outcomes. A prospective, multicentre, observational study. Thirteen teaching hospitals in France between April 2018 and February 2019. Two hundred and five patients aged at least 18 years diagnosed with community-acquired IAI. The primary outcome was hospital length of stay. The secondary outcome was hospital mortality. Patients had a mean age of 56 (± 21) years and a median [interquartile] SAPS II of 26 [17 to 34]. Among the study cohort, 18% were postoperatively transferred to intensive care unit and 7% had died by day 28. Median [IQR] time to imaging, antibiotic therapy and surgery were 4 [2 to 6], 7.5 [4 to 12.5] and 9 [5.5 to 17] hours, respectively. The length of time to surgical source control [0.99, 95% confidence interval (CI), 0.98 to 0.99], SOFA greater than 2 [0.36 (95% CI, 0.26 to 0.651)], age greater than 60 years [0.65 (95% CI, 0.45 to 0.94)], generalized peritonitis [0.7 (95% CI, 0.56 to 0.89)] and laparotomy surgery [0.657 (95% CI, 0.42 to 0.78)] were associated with longer hospital length of stay. The duration of time to surgical source control [1.02 (95% CI, 1.01 to 1.04)], generalized peritonitis [2.41 (95% CI, 1.27 to 4.61)], and SOFA score greater than 2 [6.14 (95% CI, 1.40 to 26.88)] were identified as independent risk factors for 28-day mortality. This multicentre observational study revealed that the time to surgical source control, patient severity and generalized peritonitis were identified as independent risk factors for increased hospital LOS and mortality in community-acquired IAI. Organisational strategies to reduce the time to surgical management of intra-abdominal infections should be further evaluated. ClinicalTrials.gov on 1 April 2018, NCT03544203.

Efficacy of a new membrane obturator prosthesis in terms of speech, swallowing, and the quality of life of patients with acquired soft palate defects: study protocol of the VELOMEMBRANE randomized crossover trial

BackgroundSoft palate defects created during oral cancer surgery may prevent complete palatal closure and trigger palatopharyngeal insufficiency. One current treatment employs a rigid obturator prosthesis; an extension of acrylic resin at the level of the hard palate ensures surface contact with the remaining musculature. Unfortunately, airflow escape often causes hypernasality, compromises speech intelligibility, and creates swallowing problems (including leakage of food and fluid into the nasal airway). We plan to test a new removable denture featuring a thick dental dam that serves as a membrane obturator. The principal objective of the clinical trial is a comparison of speech handicap levels after 1 month in patients with acquired velar insufficiencies who wear either the new device or a conventional, rigid obturator. The secondary objectives are between-device comparisons of the swallowing handicaps and the health-related qualities of life.MethodsThe VELOMEMBRANE trial is a superiority, open-labeled, two-way, random crossover clinical trial. Adult patients exhibiting velar or palatovelar substance loss after tumor excision and who are indicated for rigid obturator-mediated prosthetic rehabilitation will be recruited in two teaching hospitals in France. Fourteen participants will be randomly allocated to wear both prostheses for 1-month periods in either order. The new membrane obturator is a removable resin prosthesis incorporating a rigid extension that holds a dental dam to restore the soft palate. The primary outcome will be the extent of phonation-related disability (the overall score on the Voice Handicap Index [VHI]). The secondary outcomes will be the Deglutition Handicap Index and health-related quality of life scores of the European Organization for Research and Treatment of Cancer (EORTC).DiscussionHigh-quality evidence will be provided to document the utility of a new medical device that may greatly improve the management and quality of life of patients with acquired velar insufficiency.Trial registrationClinicalTrials.govNCT04009811. Registered on 4 July 2019

Two Intravenous Injections of Ketamine at 24h-Interval for the Acute Treatment of Severe Suicidal Ideas: A Randomised Double-Blind Placebo-Controlled Superiority Trial

Background: Ketamine is suggested to have rapid-onset anti-suicidal benefits. This must be confirmed in a large sample, alongside a potential moderating effect of comorbid mental disorders. Methods: Double-blind superiority trial comparing ketamine (0•5mg/kg) to placebo, conducted in seven teaching hospitals in France (KETIS). Participants aged 18 and older with current suicidal ideation were electronically randomised and stratified by centre and main diagnosis: bipolar, depressive, or other (non-psychotic) disorders. Two 40-min intravenous injections were administered at baseline and after 24 hours in addition to usual treatment. The primary outcome was the rate of patients in full suicidal remission at Day 3, according to clinician-rated Scale for Suicidal Ideation total score < 3. Analyses were conducted on an intention-to-treat basis. Registered on ClinicalTrials.gov (NCT02299440)(trial closed). Findings: 156 participants were recruited between April 13, 2015 and March 12, 2019 and randomised to placebo (n=83) or ketamine (n=73). More patients reached full remission of suicidal ideas at Day 3 in the ketamine than placebo arm (63•0 vs. 31•6%). However, this effect differed according to diagnoses (treatment: p<0•001; interaction: p=0•02): bipolar (Odds Ratio (OR 95% confidence interval)=14•1 (3•0 – 92•2), p=0•0005), depressive (OR=1•3 (0•3 – 5•2), p=0•6), or other disorders (OR=3•7 (0•9 – 17•3, p=0•07)). Side effects were limited. No manic or psychotic symptom was observed. Moreover, a mediating effect of mental pain was found. At Week 6, the ketamine arm remained superior to placebo for full suicidal remission (69•5 vs. 56•3%). Interpretation: This study confirmed the rapid, safe and persistent benefits of ketamine for acute care in suicidal patients. However, comorbid mental disorders appear to be important moderators. An analgesic effect on mental pain could explain ketamine’s anti-suicidal effects. Clinical Trial Registration Details: This study is listed on www.ClinicalTrials.gov (NCT02299440), and EudraCT: 2014-001324-30 (trial closed). Funding Information: The study was funded by a national public grant (PHRC-N 2013). Declaration of Interests: FJ has no declaration of interests for the last 5 years. PG received during the last 5 years fees for presentations at congresses or participation in scientific boards from Alcediag-Alcen, Angelini, GSK, Janssen, Lundbeck, Otsuka, SAGE and Servier. Wissam El-Hage reports personal fees from EISAI, Janssen, Lundbeck, Otsuka, UCB and Chugai. PC received speaker and consultation fees from Exeltis, Janssen and Pfizer. GV is part of a scientific board for Janssen. RG has received compensation as a member of the scientific advisory board of Janssen, Lundbeck, Roche, SOBI, Takeda. He has served as consultant and/or speaker for Astra Zeneca, Boehringer-Ingelheim, Pierre Fabre, Lilly, Lundbeck, MAPREG, Otsuka, Pileje, SANOFI, Servier, LVMH and received compensation, and he has received research support from Servier. Co-founder and stock shareholder: Regstem. PM has received compensation as consultant and member of a scientific advisory board for Janssen. LS declares fees for advisory board, travel support activities of consultant and lecturer in the last 5 years received from Janssen, Lundbeck and Otsuka. PML declares fees for Advisory board, travel support activities of consultant, lecturer and faculty member in the last 5 years received from Eisai, Janssen, Lundbeck, Otsuka, Sanofi, Teva. MA declares fees from Astra Zeneca and Lundbeck, and has been invited to congresses by Janssen-Cilag, Otsuka, Lundbeck, Servier and Astra Zeneca. CD and PF have no conflicts of interests to declare Ethics Approval Statement: Ethics approval was obtained on July 18, 2014 from the Research Ethics Board “Comite de Protection des Personnes (CPP) Sud Mediterranee III”.All patients gave their informed, written and signed consent before inclusion.

Species Distribution and Comparison between EUCAST and Gradient Concentration Strips Methods for Antifungal Susceptibility Testing of 112 Aspergillus Section Nigri Isolates.

Aspergillus niger, the third species responsible for invasive aspergillosis, has been considered as a homogeneous species until DNA-based identification uncovered many cryptic species. These species have been recently reclassified into the Aspergillus section Nigri However, little is yet known among the section Nigri about the species distribution and the antifungal susceptibility pattern of each cryptic species. A total of 112 clinical isolates collected from 5 teaching hospitals in France and phenotypically identified as A. niger were analyzed. Identification to the species level was carried out by nucleotide sequence analysis. The MICs of itraconazole, voriconazole, posaconazole, isavuconazole, and amphotericin B were determined by both the EUCAST and gradient concentration strip methods. Aspergillus tubingensis (n = 51, 45.5%) and Aspergillus welwitschiae (n = 50, 44.6%) were the most common species while A. niger accounted for only 6.3% (n = 7). The MICs of azole drugs were higher for A. tubingensis than for A. welwitschiae The MIC of amphotericin B was 2 mg/liter or less for all isolates. Importantly, MICs determined by EUCAST showed no correlation with those determined by the gradient concentration strip method, with the latter being lower than the former (Spearman's rank correlation tests ranging from 0.01 to 0.25 depending on the antifungal agent; P > 0.4). In conclusion, A. niger should be considered as a minority species in the section Nigri The differences in MICs between species for different azoles underline the importance of accurate identification. Significant divergences in the determination of MIC between EUCAST and the gradient concentration strip methods require further investigation.

Who is doing what in emergency departments to ensure memory recovery after self-poisoning? A survey of university hospital centers in France

• Deliberate self-poisoning (DSP) with a drug constitutes the majority of suicide attempts. • Most ingested drugs in DSP are known to lead to cognitive impairment. • In 2006, an expert from the American College of Emergency Physicians Clinical Policies (Subcommittee on Critical Issues in the Diagnosis and Management of the Adult Psychiatric Patient in the Emergency Department) recommended that, in order to achieve adherence to the care instructions provided, cognitive recuperation should have occurred before a psychiatric assessment is conducted. • We investigate how the clinicians perform this cognitive evaluation in their current practice in psychiatric emergency department of University Hospital in France. Suicide prevention is a critical issue, and is related to the care and follow-up provided after a suicide attempt. This treatment is, however, linked to a patient's ability to memorize the information given to them in the emergency department, even though their memory may be impaired due to the drugs ingested after a self-poisoning suicide attempt. There is therefore a recommendation that a patient's cognitive-function should be evaluated in these circumstances. The aim of this study was to examine how this advice is applied in practice. We performed a telephone survey of the 30 teaching hospitals in France. The psychiatric team at each center was asked about the cognitive tests or other methods they employed to evaluate a patient's cognitive-function. We also examined the other markers used. Only one of the hospitals contacted used a cognitive test. The others determined cognitive recuperation based on factors such as clinical opinion, vigilance or the plasma half-life of the drugs ingested. There was no consensus on whether and which cognitive tests should be used following a self-poisoning suicide attempt. Indeed, these tests were very rarely employed. Most of the hospitals contacted used clinical markers, even though these have major limitations. The issue of conducting cognitive evaluations after deliberate self-poisoning must therefore be addressed in order to harmonize clinical practice throughout the country.

Inadequate conflict of interest policies at most French teaching hospitals: A survey and website analysis.

BackgroundThere are 32 teaching hospitals in France, including 30 University hospitals and two Regional teaching hospitals. Teaching hospitals have three roles: health care provision, training of healthcare professionals, and medical research. These roles lead to frequent interactions with pharmaceutical and medical device companies, inevitably raising risks of conflicts of interests. Therefore, policies to manage conflict of interests (COI) are crucial. This study aims to examine COI policies in French teaching hospitals.MethodsAll French teaching hospitals (n = 32) were included in this study. All hospitals websites were screened for institutional COI policies and curriculum on COI, using standardized keyword searches. More data were collected through a questionnaire addressed to each chief executive officer (CEO) of the teaching hospital. We used predefined criteria (n = 20) inspired by similar surveys on COI policies in French, US and Canadian medical schools, with some additions to reflect the local hospital context. A global score for each hospital, ranging from 0 to 60 (higher scores denoting stronger policies) was calculated by summing points obtained for each criterion.ResultsAll 32 hospitals had websites; 21 hospitals listed policies or regulations on their websites or provided them on request. In December 2017, 17 (53.1%) had rules and regulations for some items only, four of which (12.5%) have considered implementing a policy, and only two (6.3%) have begun implementation. 15 (46.9%) had no evidence of COI policies and a null score. The maximum score was 24 out of 60.ConclusionThis is the first systematic assessment of COI policies in teaching hospitals in France. Such policies are needed to protect patients, clinicians and students from undue commercial influence. Despite public and political pressure for better management of COI, few teaching hospitals have implemented comprehensive and protective policies, and some hospitals lacked policies altogether. These results highlight the need for greater attention to management of COI within teaching hospitals. One potential solution would be to integrate COI policies into hospital accreditation procedures, in order to ensure a baseline of management at all teaching hospitals.

Chemoradiation in rectal squamous cell carcinoma: Bi-institutional case series

Background and purposePrimary rectal squamous cell carcinoma (SCC) is an uncommon disease. Early reports stated that surgery is the most effective treatment. However, recent publications suggest conservative strategy with chemoradiation provides satisfactory results. Patients and methodsWe have retrospectively studied the medical charts of 23 patients treated for a rectal SCC in two teaching hospitals in France between 1992 and 2013. Twenty-one patients received an exclusive chemoradiotherapy (CRT) and two a pre-operative CRT followed by a planned surgery. Patients received pelvic irradiation with a dose ranging from 36–45 Gy followed by a boost of 15–23 Gy. Twenty-two patients received a concurrent chemotherapy. ResultsAfter CRT, the rate of clinical complete response was 83%. With a median follow-up of 85 months, 5-year overall survival rate was 86%. Five patients presented with a relapse. The 5-year disease-free survival rate was 81%. The 5-year colostomy-free survival rate was 65%. Three patients (13%) presented with grade III–IV late rectal toxicity. ConclusionsAlthough retrospective, this is the largest cohort of patients treated with CRT for a rectal SCC. Exclusive CRT could result in high local control rate and prolonged survival in rectal SCC patients with a high rate of organ preservation.

Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises

Pregnancy is a major cause of urinary incontinence (UI) in women. Urinary incontinence occurs during pregnancy or postpartum in about 30% to 50% of patients. The use of pelvic floor muscle training (PFMT) supervised by a therapist as a treatment for women with UI has demonstrated effectiveness for postpartum UI; however, the value of PFMT for prevention of postnatal UI is less well established. Some trials, including those with the largest number of patients, reported negative results. Other trials suggested efficacy in late pregnancy and postpartum. Pelvic floor training in the majority of these trials was supervised by teams specializing in this type of care. This multicenter randomized controlled trial was designed to test the hypothesis that supervised prenatal pelvic floor exercises would prevent or reduce the severity of postnatal UI compared with written instructions alone in an unselected population of nulliparous pregnant women. A total of 282 nulliparous women 18 years or older recruited from 5 university teaching hospitals in France were randomized during the second trimester of pregnancy to a control group or a physiotherapy group. All women in both groups received written instructions about how to perform exercises at home. In addition to written instructions, each woman in the physiotherapy group received individual PFMT supervised by a therapist. Blinded assessments were performed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome assessed was UI severity at 12 months postpartum, measured with an International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form score (range, 0–21, with 0 = no incontinence, 21 = all the time incontinence, and between 1 and 5 = slight incontinence). Secondary outcomes included UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a difference of 1 point, 12 months postpartum in the UI severity score, 182 patients were needed, 91 in each group (SD, 2.4; α = 0.05, β = 0.20; and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized into the physiotherapy group and 142 into the control group. There was no significant difference between groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. The primary outcome was available from 190 women (67.4%) at 12 months postpartum (93 in the physiotherapy group and 97 in the control group); mean UI severity was 1.9 in the physiotherapy group and 2.1 in the control group (P = 0.38). No treatment-related adverse effects were reported in the physiotherapy group. These data show that prenatal supervised pelvic floor contraction exercises are not superior to written instructions in prevention of postpartum UI in primiparous women.

In-hospital organization of primary care of patients presenting a life-threatening emergency: A French national survey in 32 university hospitals

IntroductionThe development of specialized units dedicated to life-threatening management has demonstrated to improve the prognosis of patients requiring such treatments. However, apart those focused on trauma and stroke, networks are still lacking in France. Despite, the implementation of standardisation of practices and guidelines, particularly in prehospital care, in-hospital clinical practices at admission remain heterogenous. This survey aimed to assess the structural and human organization of teaching hospitals in France concerning the primary in-hospital care for critically ill patients. Material and methodA questionnaire of 45 items was sent by e-mail to 32 teaching hospitals between January and March 2013. It included information related to the description of the emergency department, of ICUs, and both structural and human organizations for primary in-hospital care of life-threatening patients. ResultsSeventy-five percent of teaching hospitals answered to the survey. Seven hundred to 1400 patients were admitted to emergency units per week and among them 10 to 20 were admitted for critically ill conditions. These latter were addressed in a specialized room of the emergency unit (Service d’admission des urgences vitales [SAUV]) in 40% of hospitals and in specialized room in ICU in 18% of cases. Intensivists were involved in 50% of hospitals, emergency physicians in 26% and it was mixed in 24% of hospitals. ConclusionThis survey is the first to assess the in-hospital organization of primary care for instable and life-threatening patients in France. Our results confirmed the extreme heterogeneity of structural and human organizations for primary in-hospital care of patients presenting at least one organ failure. Thus, a consensus is probably needed to homogenize and improve our practices.

Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial.

To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI). In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38). Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551. I.

Toxicities and outcome in elderly patients treated with targeted therapies for metastatic renal cell carcinoma

with a median age of diagnosis of 65 years. Data from randomized controlled trials suggest similar choice of chemotherapy drugs, toxicities and feasibility in young and older patients. There was a lack of observational data from real-life setting. Objectives: To assess 1) associated factors of prescription of the combination of gemcitabine and cisplatin (GC), 2) chemotherapy feasibility in older patients aged 70 years or more with metastatic bladder cancer and 3) prognostic value of feasibility of chemotherapy. Methods: Between1999and2011, consecutive patients aged70 years ormorewithmetastatic bladder cancer referred to four teaching hospitals in France (Creteil, Lyon, Montpellier and Villejuif) were included. At baseline, we recorded clinical and biological parameters (nutrition, functional status assessed by Performance Status PS, creatinine clearance, hemoglobin level) and tumor characteristics (histologic subtype, grade and number of metastases). Non-feasibility was defined by a number of cycles less than 3. We used a propensity score method to assess probability of initial prescription of GC. Multivariate logistic regression and Cox Proportional Hazard Model were used to estimate predictors of chemotherapy non-feasibility and overall 1-year mortality. Results: 193 patients were included (mean age 76 ± 4.3 years, 85% males, 92.2% urothelial carcinoma, 96.3% grade 3) with two metastases in median [1–3]. Among them 25.3% had PS of ≥2, 42.1% had poor nutritional status and 43% had renal dysfunction. For first cycle prescription, 43.5% had GC, 36.3% had a combination of gemcitabin and carboplatin and 20.2% had gemcitabin alone. Probability of GC prescription decreased with age independent of functional status and creatinine clearance, respectively 0.59 for [70– 75] years, 0.32 for [75–80] years and 0.13 for ≥70 years (p b 0.0001). In multivariate analysis, factors associated with chemotherapy nonfeasibility were age (adjusted odds ratio (aOR)1 year increase = 1.11; CI 95% = 1.02–1.20; p = 0.01) and PS ≥2 (aOR = 2.10; 1.36–6.06; p = 0.005). Median survival was 9.6 months [5.2–15.4]. In a multivariate analysis, factors associated with overall 1-year mortality were chemotherapy non-feasibility (adjusted hazard ratio (aHR) = 4.52; 2.60–7.85 for patients with PS b2 and aHR= 24.87; 11.40–54.54 for patients with PS ≥2; p b 0,0001), age (aHR= 1.06; 1.01–1.13; p= 0.02), number of metastases (aHR= 1.2; 1.01–1.42; p= 0.03) and hemoglobin decrease (aHR1 point decrease = 1.19; 1.03–1.37; p= 0.01). Conclusion: The prescription of a combination of gemcitabine and cisplatin decreased with age independent of functional status and creatinine clearance in patients aged 70 years or more with metastatic bladder cancer. Increasing age was an independent predictor of chemotherapy non-feasibility. The association between non-feasibility and overall 1-year mortalitywasmodified by baseline functional status. Disclosure of interest: None declared.

MALDI‐TOF mass spectrometry identification of filamentous fungi in the clinical laboratory

This study aimed to validate the effectiveness of a standardised procedure for the MALDI-TOF mass spectrometry (MS)-based identification on a large sample of filamentous fungi routinely identified in university hospitals' laboratories. Non-dermatophyte filamentous fungi prospectively isolated in the routine activity of five teaching hospitals in France were first identified by conventional methods in each laboratory and then by MS in one centre. DNA sequence-based identification resolved discrepancies between both methods. In this study, of the 625 analysed filamentous fungi of 58 species, 501 (80%) and 556 (89%) were correctly identified by conventional methods and MS respectively. Compared with the conventional method, MS dramatically enhanced the performance of the identification of the non-Aspergillus filamentous fungi with a 31-61% increase in correct identification rate. In conclusion, this study on a large sample of clinical filamentous fungi taxa demonstrates that species identification is significantly improved by MS compared with the conventional method. The main limitation is that MS identification is possible only if the species is included in the reference spectra library. Nevertheless, for the routine clinical laboratory, MS provides the means to attain markedly accurate results in filamentous fungi identification, which was previously restricted to only a few reference laboratories.

Is Hormonal Therapy Associated with Better Quality of Life in Transsexuals? A Cross‐Sectional Study

Although the impact of sex reassignment surgery on the self-reported outcomes of transsexuals has been largely described, the data available regarding the impact of hormone therapy on the daily lives of these individuals are scarce. The objectives of this study were to assess the relationship between hormonal therapy and the self-reported quality of life (QoL) in transsexuals while taking into account the key confounding factors and to compare the QoL levels between transsexuals who have, vs. those who have not, undergone cross-sex hormone therapy as well as between transsexuals and the general population (French age- and sex-matched controls). This study incorporated a cross-sectional design that was conducted in three psychiatric departments of public university teaching hospitals in France. The inclusion criteria were as follows: 18 years or older, diagnosis of gender identity disorder (302.85) according to the Diagnostic and Statistical Manual, fourth edition text revision (DSM-IV TR), inclusion in a standardized sex reassignment procedure following the agreement of a multidisciplinary team, and pre-sex reassignment surgery. QoL was assessed using the Short Form 36 (SF-36). The mean age of the total sample was 34.7 years, and the sex ratio was 1:1. Forty-four (72.1%) of the participants received hormonal therapy. Hormonal therapy and depression were independent predictive factors of the SF-36 mental composite score. Hormonal therapy was significantly associated with a higher QoL, while depression was significantly associated with a lower QoL. Transsexuals' QoL, independently of hormonal status, did not differ from the French age- and sex-matched controls except for two subscales of the SF-36 questionnaire: role physical (lower scores in transsexuals) and general health (lower scores in controls). The present study suggests a positive effect of hormone therapy on transsexuals' QoL after accounting for confounding factors. These results will be useful for healthcare providers of transgender persons but should be confirmed with larger samples using a prospective study design.

Bilan de l’activité de chirurgie d’exérèse des tumeurs cutanées en dermatologie en France en 2009

Dermatosurgery has been gaining in importance in recent years. The aim of our study was to describe this activity to increase its value and to inform the other specialists and the general public. We performed a national prospective study during one month in the hospital centers and university teaching hospitals in France and among the members of the Surgical Group of the Société française de dermatologie. Data were collected with a pre-established questionnaire. They were captured on EpiData 3.1 and Excel software package and were analysed using the SPSS 15.0 software package. The participation of dermatology departments in hospital was 66.7 %. For the members of the surgical group, it was 43.1 %. A total of 2308 dermatological surgical procedures was performed. The mean age was 55.5 years ± 20.7. Three hundred and thirty-six (14.6 %) procedures were performed with antiplatelet agents or anticoagulants. The excisions of skin cancers were carry out with no previous biopsy in 71.3 % of cases. We described repairs in one time in the majority of cases (92.2 %), and the most frequent type of procedure was direct closure (83.4 %). Complete excision was obtained directly in 95.2 % of cases and the clinicopathological correlation was also excellent (89.5 %). Three percent of patients suffered complications during or following surgery and these complications were more frequent with the patients treated by antithrombotic medications. This is, in our knowledge, the first prospective study on dermatosurgery activity practised by dermatologists in France. The important rate of participation exemplified the implications of dermatologists in the treatment of skin cancers with an optimal follow-up.

Active versus expectant management for preterm prelabor rupture of membranes at 34‐36 weeks of completed gestation: comparison of maternal and neonatal outcomes

To compare maternal and neonatal outcomes in deliveries managed by a policy of expectant management and active management of women with preterm prelabor rupture of membranes (pPROM), at 34-36 completed weeks of gestation. Retrospective multicenter cohort study. Three tertiary care teaching hospitals in France. Women with pPROM were identified from the databases of three perinatal centers. Maternal and neonatal complications were compared according to the hospital policy in effect at pPROM--expectant or active management. Clinical chorioamnionitis, neonatal morbidity including neonatal infection, respiratory problems, and metabolic disorders. During the seven-year study period, 634 women were admitted for pPROM at 34-36 completed weeks of gestation, 241 of whom were included in the study: 126 in the group with a policy of expectant management and 115 in the active management group. The incidence of clinical chorioamnionitis was 4.8% in the former and 0.9% in the latter (p = 0.07). Neonatal oxygen was still needed at 24 hours significantly more often in the active than in the expectant management group (7.0 vs. 1.6%, p = 0.05). However, after adjustment for gestational age at birth, only delivery at 34 weeks of gestation remained associated with the need for neonatal oxygen at 24 hours. The rate of hypoglycemia or hypocalcemia was 5.6% in the expectant management group versus 12.3% in the active management group (p = 0.07). There were no neonatal deaths. A policy of active management, especially at 34 weeks of gestation, was associated with greater neonatal morbidity, whereas an expectant management policy tended to be associated with an increased rate of clinical chorioamnionitis.

Pratique de l’anesthésie réanimation en milieu pénitentiaire. Un détenu peut-il bénéficier d’une anesthésie ambulatoire ?

Ambulatory anaesthesia is an anesthesia allowing the return of the patient home the same day. Even if the ambulatory hospitalization can, in theory, be applied to a prisoner as to every patient, caution is essential in such approach. Every anaesthetist reanimator doctor practicing in public hospitals may give care to patient prisoners while he is far from dominating all features of the prison world and while he must put down his therapeutic indications. The ambulatory anaesthesia in prison environment does not guarantee full security for the patient. Procedures could be set up between hospital complexes, caretakers practicing within penal middle (Unit of Consultation and Ambulatory Care [UCAC]) the prison service and hospital, the prefecture, to identify possible ambulatory interventions for a patient prisoner and to set up all guarantees of patient follow-up care in his return in prison environment. The development of interregional secure hospital units (ISHU) within teaching hospitals, allows an easier realization of interventions to the prisoners, but exists only in seven teaching hospitals in France.

Early markers of prolonged hospital stay in demented inpatients: a multicentre and prospective study.

Dementia is a serious, chronic, and costly public health problem. Prior studies have described dementia as increasing length of hospital stay, but so far no explanations have been proposed. To identify early markers for prolonged hospital stay in demented elderly inpatients, 178 community-dwelling or institutionalized subjects aged 75+, hospitalized through an emergency department in 9 teaching hospitals in France, were analyzed. Prolonged hospital stays were defined according a limit adjusted for Diagnosis Related Group. All patients underwent a comprehensive geriatric assessment at admission. Logistic regression multifactorial mixed model was performed. Center effect was considered as a random effect. Of the 178 stays, 52 were prolonged. Most concerned community-dwelling patients (86%). Multifactor analysis demonstrated that demographic variables had no influence on the length of stay, while diagnosis of delirium (OR 2.31; 95% CI 1.77 - 2.91), walking difficulties (OR 1.94; 95% CI 1.62 - 2.43) and report by the informal caregiver of moderate or severe burden (OR 1.52; 95% CI 1.19 - 1.86) or low social quality-of-life score (OR 1.25; 95% CI 1.03 - 1.40), according to the Zarit's Burden Inventory short scale (12 items) and the Duke's Health Profile respectively, were identified as early markers for prolonged hospital stays. At the time of the rising incidence of cognitive disorders, these results suggest that preventive approaches might be possible. In a hospital setting as well as in a community-dwelling population, more specific, specialized and coordinated care, using the expertise of multiple disciplines appears as a probable effective measure to limit prolonged hospital stay. Such approaches require (i) clear patient-oriented goal definition, (ii) understanding and appreciation of roles among various health care and social disciplines and, (iii) cooperation between partners in patient's management. However, the cost- and health-effectiveness of such approaches should be evaluated.

Occurrence of qnrA-positive clinical isolates in French teaching hospitals during 2002–2005

Bacteria harbouring the novel qnrA plasmid-mediated mechanism of quinolone resistance have been described in different countries, but the frequency of their occurrence has not been investigated. In total, 1,468 clinical isolates of Enterobacteriaceae with quinolone resistance or extended-spectrum beta-lactamase (ESBL) phenotypes were collected from eight teaching hospitals in France during 2002-2005 and screened for qnrA. Overall, 28 isolates (22 Enterobacter cloacae, three Klebsiella pneumoniae, one Citrobacter freundii, one Klebsiella oxytoca and one Proteus mirabilis) were positive for qnrA, representing 1.9% of all isolates, 3.3% of ESBL-producing isolates (22% of the E. cloacae isolates) and 0% of non-ESBL-producing isolates. The prevalence of qnrA among consecutive ESBL-producing isolates in 2004 from the eight hospitals was 2.8% (18/639). Of the qnrA-positive isolates, 100% were intermediately-resistant or resistant to nalidixic acid, and 75% to ciprofloxacin. Twenty-one of the 22 qnrA-positive E. cloacae isolates were obtained from two hospitals in the Paris area, and molecular typing and plasmid content analysis showed clonal relationships for five, three and two isolates, respectively. The qnrA genetic environment was similar to that of the In36 integron. The remaining two isolates had qnrA variants (30 and 29 nucleotide differences, respectively, compared with the original sequence) and an unknown genetic environment. The ESBL gene associated with qnrA was bla(SHV-12) in most of the isolates, but bla(PER-1) and bla(SHV-2a) were found in two isolates. In France, it appears that qnrA-positive isolates are predominantly E. cloacae isolates producing SHV-12, and may be associated with the dissemination of an In36-like integron.

Intrathecal Morphine Infusion for Chronic Non-Malignant Pain: A Multiple Center Retrospective Survey

Intrathecal morphine (ITM) is commonly used for the treatment of cancer pain. There is reluctance for its use in France to treat chronic noncancer pain. In order to appreciate its popularity, efficacy, dose escalation with time, and long-term tolerance, we carried out a retrospective study in the neurosurgery departments of university teaching hospitals in France involved in intrathecal drug therapy. Only 44 patients with chronic noncancer pain used implanted pumps for ITM treatment. Nineteen patients were available for detailed analysis. This survey concerns these 19 patients. There were 13 women and six men. Their average age was 48.8 years (range: 30-69y). The mean duration of pain before pump implantation was 100months (range: 12-240 m). The mean follow-up since implantation was 54m (range: 4-144m). Thirteen patients were suffering from postsurgery lumbar and radicular pain. The average initial and final dose per day of morphine was 1.3mg (range: 1-2mg) and 2.5mg (range: 1-6.7mg) for patients with nociceptive pain and 1.2mg (range: 0.7-2mg) and 3mg (range: 1-10mg) for patients with mixed pain, respectively. Five (26.3%) of 19 patients returned to their initial jobs. Increase in activity level was reported as good in seven patients (36.8%). Patient satisfaction rate was 90%. The VAS rate was reduced to 49.2% of the initial values while the subjective pain relief was estimated at 67.8%. Two cases (10.5%) of late pump site infection and two patients (10.5%) with catheter displacements were recorded. Side effects imputable to morphine included; constipation, somnolence, decreased libido, weight gain, amenorrhoea, vomiting, nightmares, and itching. No development of tolerance or addiction were recorded. We conclude that in well selected cases ITM should be considered as a possible therapeutic option in the treatment of intractable chronic benign pain.