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Le Touquet – Paris-Plage, France

Wood C.,Center Hospitalier University Robert Debre | von Baeyer C.L.,University of Saskatchewan | Falinower S.,A4 SAS Agency | Moyse D.,Statistician | And 2 more authors.
BMC Pediatrics | Year: 2011

Background: Assessment of pain in children is an important aspect of pain management and can be performed by observational methods or by self-assessment. The Faces Pain Scale-Revised (FPS-R) is a self-report tool which has strong positive correlations with other well established self-report pain intensity measures. It has been recommended for measuring pain intensity in school-aged children (4 years and older). The objective of this study is to compare the concordance and the preference for two versions, electronic and paper, of the FPS-R, and to determine whether an electronic version of the FPS-R can be used by children aged 4 and older.Methods: The study is an observational, multicenter, randomized, cross-over, controlled, open trial. Medical and surgical patients in two pediatric hospitals (N = 202, age 4-12 years, mean age 8.3 years, 58% male) provided self-reports of their present pain using the FPS-R on a personal digital assistant (PDA) and on a paper version. Paper and electronic versions of the FPS-R were administered by a nurse in a randomized order: half the patients were given the PDA version first and the other half the paper version first. The time between the administrations was planned to be less than 30 minutes but not simultaneous. Two hundred and thirty-seven patients were enrolled; 35 were excluded from analysis because of misunderstanding of instructions or abnormal time between the two assessments.Results: Final population for analysis comprised 202 children. The overall weighted Kappa was 0.846 (95%CI: 0.795; 0.896) and the Spearman correlation between scores on the two versions was rs= 0.911 (p < 0.0001). The mean difference of pain scores was less than 0.1 out of 10, which was neither statistically nor clinically significant; 83.2% of children chose the same face on both versions of the FPS-R. Preference was not modified by order, sex, age, hospitalization unit (medical or surgical units), or previous analgesics. The PDA was preferred by 87.4% of the children who expressed a preference.Conclusion: The electronic version of the FPS-R can be recommended for use with children aged 4 to 12, either in clinical trials or in hospitals to monitor pain intensity. © 2011 Wood et al; licensee BioMed Central Ltd.

Panel P.,Center Hospitalier Of Versailles | Bajka M.,University of Zurich | Le Tohic A.,Center Hospitalier Of Versailles | El Ghoneimi A.,Center Hospitalier University Robert Debre | And 2 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2012

Study objective: To assess face and construct validity of a new virtual reality (VR) training simulator for hysteroscopic placement of tubal sterilization implants. Design Nonrandomized, controlled trial comparing responses and performance of novices and experts on the simulator. Design classification: Canadian task force II-1. Setting: Forty-six gynecologists were personally invited or recruited at the 33rd Conference of the French National College of Gynecologists and Obstetricians (CNGOF) from December 9 to 12, 2009, grouped as 20 experts and 26 novices. They all performed the defined sequence of virtual procedures on the simulator (case 1 for familiarization, case 4 for study assessment) and finally completed the study questionnaire. Measurements and main results: Responses to realism, educational potential, and general opinion were excellent, proving face validity. Significant differences between novices and experts were assessed for 7 of the 15 metrics analyzed, proving construct validity. Conclusions: We established face and construct validity for EssureSim™, an educational VR simulator for hysteroscopic tubal sterilization implant placement. The next steps are to investigate convergent and predictive validity to affirm the real capacity of transferring the skills learned on the training simulator to the patient in the operating room. © Springer Science+Business Media, LLC 2012.

Conroy T.,University of Lorraine | Desseigne F.,Center Leon Berard | Ychou M.,Center Val dAurelle | Bouche O.,Center Hospitalier University Robert Debre | And 16 more authors.
New England Journal of Medicine | Year: 2011

BACKGROUND: Data are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. METHODS: We randomly assigned 342 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival. RESULTS: The median overall survival was 11.1 months in the FOLFIRINOX group as compared with 6.8 months in the gemcitabine group (hazard ratio for death, 0.57; 95% confidence interval [CI], 0.45 to 0.73; P<0.001). Median progression-free survival was 6.4 months in the FOLFIRINOX group and 3.3 months in the gemcitabine group (hazard ratio for disease progression, 0.47; 95% CI, 0.37 to 0.59; P<0.001). The objective response rate was 31.6% in the FOLFIRINOX group versus 9.4% in the gemcitabine group (P<0.001). More adverse events were noted in the FOLFIRINOX group; 5.4% of patients in this group had febrile neutropenia. At 6 months, 31% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 66% in the gemcitabine group (hazard ratio, 0.47; 95% CI, 0.30 to 0.70; P<0.001). CONCLUSIONS: As compared with gemcitabine, FOLFIRINOX was associated with a survival advantage and had increased toxicity. FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer and good performance status. (Funded by the French government and others; ClinicalTrials.gov number, NCT00112658.) Copyright © 2011 Massachusetts Medical Society.

Purpose: To compare epirubicin, cisplatin, and capecitabine (ECX) with fluorouracil, leucovorin, and rinotecan (FOLFIRI) as first-line treatments in patients with advanced gastric or esophagogastric junction (EGJ) adenocarcinoma.Patients and Methods: This open, randomized, phase III study was carried out in 71 centers. Patients with locally advanced or metastatic gastric or EGJ cancer were randomly assigned to receive either ECX as first-line treatment (ECX arm) or FOLFIRI (FOLFIRI arm). Second-line treatment was predefined (FOLFIRI for the ECX arm and ECX for the FOLFIRI arm). The primary criterion was time-totreatment failure (TTF) of the first-line therapy. Secondary criteria were progression-free surviva (PFS), overall survival (OS), toxicity, and quality of life.Results: In all, 416 patients were included (median age, 61. 4 years; 74% male). After a median follow-up of 31 months, median TTF was significantly longer with FOLFIRI than with ECX (5. 1 v 4. 2 months; P =. 008). There was no significant difference between the two groups in median PFS (5. 3 v 5. 8 months; P =. 96), median OS (9. 5 v 9. 7 months; P =. 95), or response rate (39. 2% v 37. 8%) First-line FOLFIRI was better tolerated (overall rate of grade 3 to 4 toxicity, 69% v84%; P <. 001; hematologic adverse events [AEs], 38% v64. 5%; P<. 001; nonhematologic AEs: 53% v53. 5%; P =. 81).Conclusion: FOLFIRI as first-line treatment for advanced gastric and EGJ cancer demonstrated significantly better TTF than did ECX. Other outcome results indicate that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents. © 2014 by American Society of Clinical Oncology.

Perrault I.,University of Paris Descartes | Saunier S.,University of Paris Descartes | Hanein S.,University of Paris Descartes | Filhol E.,University of Paris Descartes | And 26 more authors.
American Journal of Human Genetics | Year: 2012

Mainzer-Saldino syndrome (MSS) is a rare disorder characterized by phalangeal cone-shaped epiphyses, chronic renal failure, and early-onset, severe retinal dystrophy. Through a combination of ciliome resequencing and Sanger sequencing, we identified IFT140 mutations in six MSS families and in a family with the clinically overlapping Jeune syndrome. IFT140 is one of the six currently known components of the intraflagellar transport complex A (IFT-A) that regulates retrograde protein transport in ciliated cells. Ciliary abundance and localization of anterograde IFTs were altered in fibroblasts of affected individuals, a result that supports the pivotal role of IFT140 in proper development and function of ciliated cells. © 2012 by The American Society of Human Genetics. All rights reserved.

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