ABSTRACT
Helium is known to reduce airflow limitation. Our hypothesis was that severe COPD patients undertaking exercise would show greater improvement in endurance under a heliox mixture (80/20%) than under air alone. This hypothesis was tested in a double-blinded, randomized study. METHODS: Out of the 53 patients included, 45 were randomly assigned to two groups : Heliox (n= 23) and Air (n= 22). Patients were assessed with spirometry under air and heliox, incremental exercise test, constant workload (80% Wmax) exercise test and weekly 6-minute walk test. The two groups went through fifteen 30-minute retraining sessions in the overall framework of an identical pulmonary rehabilitation program. RESULTS: There was no significant difference in endurance improvement (Heliox : +52.5 sec, Air:+114sec, median value). FEV1 improvement under heliox exceeding 10% identified a group of 20 patients as "helium responders", who improved their endurance time by a median of 135sec compared to 50sec for the "non-responders" (non-significant difference). CONCLUSION: In patients with severe COPD, use of Heliox in exercise retraining did not produce significantly improved endurance. On the other hand, "helium responders" showed more FEV1 improvement than non-responders. Improved FEV1 under heliox should therefore be used in future studies as an inclusion criterion.
Subject(s)
Helium , Pulmonary Disease, Chronic Obstructive , Exercise Test , Helium/therapeutic use , Humans , Oxygen , Pulmonary Disease, Chronic Obstructive/rehabilitationABSTRACT
BACKGROUND: Taking into account international studies interested in the development of evidence-based practice (EBP) in the speech and language therapy field, this survey investigated key issues with regard to students' perception of EBP. AIMS: To determine how final-year students in France conceive EBP; to know if they feel competent in this area; to investigate any barriers to the use of EBP; and to assess their intention of using the EBP approach in their professional practice after graduating. METHODS & PROCEDURES: Between January and April 2019, 182 advanced French students from 15 French speech-language university training centres (SLUTC) completed an online survey addressing these questions. OUTCOMES & RESULTS: The results show that 68.7% of students in the sample had a positive perception of the EBP. Between 54.9% and 73.6% of students felt rather competent to apply part of the approach, and 17% were sure to implement it in their own practice later on. Step 3 'Critically evaluating the evidence' was the most difficult. Regardless of the different EBP steps, the most important barrier for students who felt competent was the lack of practice; for students who did not feel competent, the major barriers were both the lack of theoretical knowledge and the lack of practice. A total of 61% of students reported not seeing EBP being practised by their clinical practice placements supervisors; 55% reported never having used their EBP knowledge during their clinical practice placements. CONCLUSIONS & IMPLICATIONS: The students interviewed had a positive perception of EBP. Nevertheless, these results demonstrate a need to improve the EBP curricula and to include EBP in clinical education, under the guidance of clinical practice placements supervisors. WHAT THIS PAPER ADDS: What is already known on the subject Despite the fact that EBP is widespread, previous studies have shown that it is not sufficiently used in the practice of speech and language therapists (SLT) and that young professionals tend to seek advice from experienced professionals rather than use EBP. Some students, despite their programme, do not feel competent enough to implement EBP. What this study adds to the existing knowledge French SLT students had a positive opinion of EBP despite barriers to implementation in their future professional practice, especially regarding the critical analysis of evidence. Moreover, the study reveals a need to practise EBP during clinical practice placements, and to create specific pedagogical framework for EBP. What are the potential or actual clinical implications of this work? The potential implication of this study is the use of the questionnaire to investigate the students' perception of EBP from a theoretical and a practical point of view, in collaboration with clinical practice placement supervisors, with the aim of promoting the task value and the self-efficacy as the two best factors to enhance students' motivation in favour of EBP.
Subject(s)
Language Therapy , Speech , Evidence-Based Practice/methods , Humans , Language Therapy/education , Students , Surveys and QuestionnairesABSTRACT
OBJECTIVES: Increased nuchal translucency (NT) thickness is an antenatal marker of aneuploidy or malformation that can lead to termination of pregnancy. This study assessed the long-term neurodevelopmental prognosis of infants who had isolated increased NT in utero. METHODS: This was a prospective cohort study of infants with a NT thickness > 95th percentile in the first trimester, but with a normal karyotype and no major anomalies, and controls with normal NT matched for birth weight, Apgar score, place of birth, parity and gestational age at birth. At 2 years of corrected age, all infants underwent the psychometric Brunet-Lézine test to evaluate their developmental quotient (DQ), overall (global) and specifically for the areas of posture, language, coordination and sociability. RESULTS: A total of 203 chromosomally normal infants were included in the increased-NT group and 208 in the control group. The mean global DQ was significantly lower in the increased-NT group than in the control group (108.6 ± 9.7 vs 112.8 ± 8.3; P < 0.0001), but it was within the normal range expected for that age in both groups. Similarly, the mean DQs for coordination, sociability and language, but not for posture, were significantly lower in infants with increased NT than in controls. Only one case with increased NT had a DQ < 70 (defined as severe neurodevelopmental impairment), compared with none in the control group. The difference between the two groups remained significant for a NT threshold ≥ 99th percentile and when the data were adjusted for NT thickness, the infant's sex and the mother's educational level. In the increased-NT group, NT thickness was < 3.5 mm in over half (56%) of the infants, between 3.5 mm and 5 mm in 33% and > 5 mm in 11%, with a mean global DQ of 108.4, 110.1 and 109.7, respectively. CONCLUSIONS: Infants who had isolated increased fetal NT in the first trimester had a significantly lower, but normal, DQ at a corrected age of 2 years, when compared with controls. The findings were independent of the infant's sex, fetal NT thickness and the mother's educational level. © 2020 Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Subject(s)
Fetus/pathology , Neurodevelopmental Disorders/epidemiology , Nuchal Translucency Measurement/statistics & numerical data , Adult , Case-Control Studies , Child, Preschool , Female , Fetus/diagnostic imaging , Humans , Infant , Infant, Newborn , Karyotype , Male , Mental Status and Dementia Tests , Neurodevelopmental Disorders/diagnosis , Neurodevelopmental Disorders/etiology , Pregnancy , Pregnancy Trimester, First , Prevalence , Prospective StudiesABSTRACT
BACKGROUND: This study aimed to evaluate the accuracy of prehospital parameters, including vital signs and resuscitation (fluids, vasopressor), to predict trauma-induced coagulopathy (TIC, fibrinogen <1·5 g/l or PTratio > 1·5 or platelet count <100 × 109 /l), and a massive transfusion (MT, ≥10 RBC units within the first 24 h). METHODS: From a trauma registry (2011-2015), in which patients are prospectively included, we retrospectively retrieved the heart rate (HR), systolic blood pressure (SBP), volume of prehospital fluids and administration of noradrenaline. We calculated the shock index (SI: HR/SBP), the MGAP prehospital triage score and the Injury Severity Score (ISS). We also identified patients who had positive criteria from the Resuscitation Outcome Consortium (ROC, SBP < 70 mmHg or SBP 70-90 and HR > 107 pulse/min). For these parameters, we drew a ROC curve and defined a cut-off value to predict TIC or MT. The strength of association between prehospital parameters and TIC as well as MT was assessed using logistic regression, and cut-off values were determined using ROC curves. RESULTS: Among the 485 patients included in the study, TIC was observed in 112 patients (23%) and MT in 22 patients (5%). For the prediction of TIC, ISS had good accuracy (AUC: 0·844, 95% confidence interval, CI: 0·799-0·879), as did the volume of fluids (>1000 ml) given during prehospital care (AUC: 0·801, 95% CI: 0·752-0·842). For the prediction of MT, ISS had excellent accuracy (AUC: 0·932, 95% CI: 0·866-0·966), whereas good accuracy was found for SI (> 0·9; AUC: 0·859, 95% CI: 0·705-0·936), vasopressor administration (AUC: 0·828, 95% CI: 0·736-0·890) and fluids (>1000 ml; AUC: 0·811, 95% CI: 0·737-0·867). Vasopressor administration, ISS and SI were independent predictors of TIC and MT, whereas fluid volume and ROC criteria were independent predictor of TIC but not MT. No independent relationship was found between MGAP and TIC or MT. CONCLUSIONS: Prehospital parameters including the SI and resuscitation may help to better identify the severity of bleeding in trauma patients and the need for blood product administration at admission.
Subject(s)
Blood Coagulation Disorders/diagnosis , Blood Transfusion , Emergency Medical Services , Vital Signs , Wounds and Injuries/complications , Adult , Blood Coagulation Disorders/etiology , Female , Fibrinogen/analysis , Humans , Injury Severity Score , Logistic Models , Male , ROC Curve , Registries , Resuscitation , Retrospective Studies , Shock , Wounds and Injuries/physiopathologyABSTRACT
OBJECTIVE: Nutrient composition of human milk (HM) is highly variable. Targeted HM fortification has been proposed to address these variations and reduce the cumulative nutritional deficit in preterm infants. Near-infrared analysis is used to measure the protein and fat content in HM; however, the reliability of this technique has not been evaluated. The objective of this study is to evaluate the reproducibility and accuracy of two generations of HM analyzers (HMA1 and HMA2) in estimating protein and lipid contents. STUDY DESIGN: Reproducibility was assessed by analyzing in duplicate 146 and 128 HM samples with HMA1 and HMA2 (Miris), respectively. To evaluate the accuracy, lipid and protein concentrations were assessed in 31 and 39 samples using HMA1 or HMA2, respectively. Values were compared with measurements obtained using reference methods and correction equations were calculated. After applying the correction equations on 12 HM samples, the performance of the two devices were compared and the equation was validated according to the reference methods. RESULTS: The coefficients of variation for protein and lipid assessments were below 3% for both HMA1 and HMA2. Protein concentrations were significantly underestimated by HMA2 (-0.53±0.23 g dl-1). Lipid content was significantly overestimated by both devices, but the error was greater with HMA1 (0.76±0.48 g dl-1) than with HMA2 (0.36±0.33 g dl-1). Correction equations were specific for each generation of HMA. Finally, after correction, both instruments provided similar and accurate results. CONCLUSION: HMAs require calibration adjustment before their use in clinical practice, to avoid inappropriate HM fortification.
Subject(s)
Dietary Fats/analysis , Milk Proteins/analysis , Milk, Human/chemistry , Spectroscopy, Near-Infrared/standards , Calibration/standards , France , Humans , Linear Models , Reproducibility of ResultsABSTRACT
BACKGROUND: Criteria for transient lower esophageal sphincter relaxations (TLESRs) are well-defined for Dentsleeve manometry. As high-resolution manometry (HRM) is now the gold standard to assess esophageal motility, our aim was to propose a consensus definition of TLESRs using HRM. METHODS: Postprandial esophageal HRM combined with impedance was performed in 10 patients with gastroesophageal reflux disease. Transient lower esophageal sphincter relaxations identification was performed by 17 experts using a Delphi process. Four investigators then characterized TLESR candidates that achieved 100% agreement (TLESR events) and those that achieved less than 25% agreement (non-events) after the third round. Logistic regression and decision tree analysis were used to define optimal diagnostic criteria. KEY RESULTS: All diagnostic criteria were more frequently encountered in the 57 TLESR events than in the 52 non-events. Crural diaphragm (CD) inhibition and LES relaxation duration >10 seconds had the highest predictive value to identify TLESR. Based on decision tree analysis, reflux on impedance, esophageal shortening, common cavity, upper esophageal sphincter relaxation without swallow and secondary peristalsis were alternate diagnostic criteria. CONCLUSION & INFERENCES: Using HRM, TLESR might be defined as LES relaxation occurring in absence of swallowing, lasting more than 10 seconds and associated with CD inhibition.
Subject(s)
Deglutition/physiology , Esophageal Sphincter, Lower/physiology , Gastroesophageal Reflux/diagnosis , Gastroesophageal Reflux/physiopathology , Manometry/standards , Muscle Relaxation/physiology , Adult , Aged , Female , Humans , Male , Manometry/methods , Middle Aged , Reproducibility of ResultsABSTRACT
OBJECTIVES: Determine the frequency at which palpation of two fontanelles is possible, in order to describe a new clinical diagnosis approach: "the two fontanelles sign". MATERIALS AND METHODS: Descriptive study established in the obstetric and gynecology department at Lyon-Sud university hospital between March and November 2013. We followed-up one thousand successive singleton deliveries in cephalic presentation after 30 weeks of gestation. Before starting expulsive efforts, the number of fontanelles perceived (1, 2 or any) was documented. If the number of fontanelles were not noted, the patient was excluded. RESULTS: Nine hundred and seventy-eight patients were included. In 39.3% of cases (n=384), 2 fontanelles were found, in 57.5% (n=563) only one and in 3.2% (n=31), none. CONCLUSION: Both fontanelles palpation is frequently possible and enables quality control of fetal head presentation variety without ultrasound assessment. In order to prove the reliability of clinical examination, study comparing presentation ultrasonography and digital examination finding 2 fontanelles is needed.
Subject(s)
Cranial Fontanelles , Labor Presentation , Obstetrics/methods , Palpation/methods , Quality Control , Adult , Female , Follow-Up Studies , Humans , PregnancyABSTRACT
BACKGROUND: Peritoneal carcinomatosis is an increasingly common finding in gastric carcinoma. Previously, patients were treated as terminal, and median survival was poor. The use of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in this context is still highly debatable. OBJECTIVE: The aim of this study was to evaluate the long-term outcomes associated with CRS and HIPEC, and define prognostic factors for cure, if possible. PATIENTS AND METHODS: All patients with gastric carcinomatosis from five French institutions who underwent combined complete CRS and HIPEC and had a minimum follow-up of 5 years were included in this study. Cure was defined as a disease-free interval of more than 5 years from the last treatment until the last follow-up. RESULTS: Of the 81 patients who underwent CRS and HIPEC from 1989 to 2009, 59 had a completeness of cytoreduction score (CCS) of 0 (complete macroscopic resection), and the median Peritoneal Cancer Index (PCI) score was 6. Mitomycin C was the most commonly used drug during HIPEC (88 %). The 5-year overall survival (OS) rate was 18 %, with nine patients still disease-free at 5 years, for a cure rate of 11 %. All 'cured' patients had a PCI score below 7 and a CCS of 0. Factors associated with improved OS on multivariate analysis were synchronous resection (p = 0.02), a lower PCI score (p = 0.12), and the CCS (p = 0.09). CONCLUSION: The cure rate of 11 % for patients with gastric carcinomatosis who are deemed terminal emphasizes that CRS and HIPEC should be considered in highly selected patients (low disease extent and complete CRS).
Subject(s)
Adenocarcinoma/therapy , Carcinoma/therapy , Chemotherapy, Cancer, Regional Perfusion , Cytoreduction Surgical Procedures , Hyperthermia, Induced , Peritoneal Neoplasms/therapy , Stomach Neoplasms/therapy , Adenocarcinoma/pathology , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/pathology , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Male , Middle Aged , Peritoneal Neoplasms/secondary , Prognosis , Stomach Neoplasms/pathology , Survival Rate , Young AdultABSTRACT
BACKGROUND AND PURPOSE: To describe the characteristics of patients presenting a paraneoplastic cerebellar degeneration without classical onconeural antibodies (seronegative PCD). METHODS: Thirty-nine seronegative PCD patients from the Paraneoplastic Neurological Syndrome Euronetwork were retrospectively analyzed and compared with 180 patients with PCD associated with classical onconeural antibodies (seropositive PCD). RESULTS: No patient had anti-CASPR2 or anti-mGluR1 antibodies. No significant difference between the clinical characteristics of seronegative and seropositive PCD patients was observed. Yet the frequency of associated tumors was different. Lymphoma was more frequent in seronegative than in seropositive women (24% vs. 2%, P = 0.002) whilst gynecological cancer were less frequent (38% vs. 74%, P = 0.002). In comparison with seropositive men, seronegative men more frequently had a non-small-cell lung cancer (27% vs. 6%, P = 0.08) or a genitourinary cancer (22% vs. 0%, P = 0.04) but less frequently a small-cell lung cancer (23% vs. 74%, P = 0.002). Seronegative and seropositive PCD patients with similar tumors had a similar overall survival. CONCLUSION: The clinical characteristics of seronegative and seropositive PCD are similar but the spectrum of associated tumors is different. The immunological scenario of seronegative PCD seems to be different from that of limbic encephalitis with only few patients harboring anti-neuropile antibodies.
Subject(s)
Antibodies/blood , Membrane Proteins/immunology , Nerve Tissue Proteins/immunology , Paraneoplastic Cerebellar Degeneration/blood , Paraneoplastic Cerebellar Degeneration/immunology , Receptors, AMPA/immunology , Adult , Aged , Aged, 80 and over , Europe/epidemiology , Female , Humans , Lymphoma/blood , Male , Middle Aged , Retrospective Studies , Sex Factors , Young AdultABSTRACT
PURPOSE: Our goal was to determine how interpreting diagnostic CT together with PET-CT could improve the assessment of morphology in onco-haematology. PATIENTS AND METHODS: Fifty-nine patients with aggressive lymphoma were retrospectively included. The diagnostic CT scan was interpreted by two radiologists, followed by a combined analysis of the CT and the PET-CT carried out by two specialists in metabolic and morphological imaging. The diagnostic performances were assessed in terms of sensitivity and specificity, then concordance and discordance rates (kappa) were studied. RESULTS: A combined interpretation of CT and PET-CT showed better diagnostic performances than those of interpretations of CT only in the assessment of nodal sites (826 sites, sensitivity of 99% versus 85%, P<0.05), extranodal sites (649 sites, sensitivity of 88% versus 78%) and bone sites (one analysed per patient, sensitivity of 50% versus 27%). The combined interpretation also improved inter-observer agreement and led to an upgraded Ann Arbor staging in 15% of patients, with a change of treatment in 10%. CONCLUSION: Interpretation of diagnostic CT in onco-haematology can be improved by combining it with an assessment of PET-CT. The synergy between metabolic and morphological information leads to improved diagnostic capabilities and renders interpretations more reproducible.
Subject(s)
Energy Metabolism/physiology , Hodgkin Disease/diagnosis , Image Enhancement/methods , Image Interpretation, Computer-Assisted , Lymphoma, Follicular/diagnosis , Lymphoma, Large B-Cell, Diffuse/diagnosis , Positron-Emission Tomography/methods , Tomography, X-Ray Computed/methods , Adolescent , Adult , Aged , Bone Marrow/pathology , Cooperative Behavior , Female , Hodgkin Disease/physiopathology , Humans , Interdisciplinary Communication , Iohexol/analogs & derivatives , Lymph Nodes/pathology , Lymphoma, Follicular/physiopathology , Lymphoma, Large B-Cell, Diffuse/physiopathology , Male , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Observer Variation , Retrospective Studies , Sensitivity and Specificity , Spleen/pathology , Young AdultABSTRACT
BACKGROUND: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are considered the only curative treatment for many peritoneal surface malignancies. The purpose of this study was to evaluate feasibility and safety of CRS combined with HIPEC by laparoscopy for patients with limited peritoneal disease and to compare postoperative outcomes with those for an open procedure. METHODS: Between January 2011 and November 2012, all patients with low-grade pseudomyxoma peritonei (PMP) or multicystic mesothelioma (MM) and limited peritoneal disease (Peritoneal Cancer Index [PCI] less than 10) underwent CRS and HIPEC by a laparoscopic approach. The study cohort was matched with a historical cohort of patients with the same characteristics (completeness of cytoreduction, HIPEC agent, PCI ± 11 and age ± 20 years) treated with CRS and HIPEC by laparotomy. RESULTS: Eight patients (five low-grade PMP and three MM) treated by a laparoscopic approach were compared to eight patients treated by laparotomy. All patients underwent complete cytoreductive surgery with HIPEC, and no conversion to laparotomy was needed. The median surgical length was 210 min (150-300) vs 240 (210-360), with a median hospital stay of 12 days (9-18) vs 19 (13-33). One patient had a postoperative complication (intraperitoneal haematoma treated by radiological drainage) vs four in the laparotomy group. CONCLUSION: Laparoscopic CRS combined with HIPEC is feasible and safe for curative treatment of strictly selected patients with peritoneal surface malignancy and might reduce postoperative complications and length of hospital stay.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Chemotherapy, Cancer, Regional Perfusion , Hyperthermia, Induced , Laparoscopy , Laparotomy , Length of Stay/statistics & numerical data , Peritoneal Neoplasms/therapy , Postoperative Complications/prevention & control , Pseudomyxoma Peritonei/therapy , Adult , Aged , Case-Control Studies , Chemotherapy, Adjuvant , Chemotherapy, Cancer, Regional Perfusion/methods , Feasibility Studies , Female , France , Humans , Laparoscopy/adverse effects , Male , Middle Aged , Patient Safety , Peritoneal Cavity , Peritoneal Neoplasms/drug therapy , Peritoneal Neoplasms/surgery , Postoperative Complications/etiology , Postoperative Period , Pseudomyxoma Peritonei/drug therapy , Pseudomyxoma Peritonei/surgery , Retrospective StudiesABSTRACT
BACKGROUND: Despite a high response rate to front-line therapy, prognosis of epithelial ovarian carcinoma (EOC) remains poor. Approaches that combine Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) have been developed recently. The purpose of this study was to assess early and long-term survival in patients treated with this strategy. PATIENTS AND METHODS: A retrospective cohort multicentric study from French centres was performed. All consecutive patients with advanced and recurrent EOC treated with CRS and HIPEC were included. RESULTS: The study included 566 patients from 13 centres who underwent 607 procedures between 1991 and 2010. There were 92 patients with advanced EOC (first-line treatment), and 474 patients with recurrent EOC. A complete cytoreductive surgery was performed in 74.9% of patients. Mortality and grades 3 to 4 morbidity rates were 0.8% and 31.3%, respectively. The median overall survivals were 35.4 months and 45.7 months for advanced and recurrent EOC, respectively. There was no significant difference in overall survival between patients with chemosensitive and with chemoresistant recurrence. Peritoneal Cancer Index (PCI) that evaluated disease extent was the strongest independent prognostic factor for overall and disease-free survival in all groups. CONCLUSION: For advanced and recurrent EOC, curative therapeutic approach combining optimal CRS and HIPEC should be considered as it may achieve long-term survival in patients with a severe prognosis disease, even in patients with chemoresistant disease. PCI should be used for patient's selection.
Subject(s)
Antineoplastic Agents/administration & dosage , Carcinoma/drug therapy , Carcinoma/surgery , Chemotherapy, Cancer, Regional Perfusion , Ovarian Neoplasms/pathology , Peritoneal Neoplasms/drug therapy , Peritoneal Neoplasms/surgery , Adult , Aged , Antineoplastic Agents/therapeutic use , Carcinoma/secondary , Chemotherapy, Cancer, Regional Perfusion/adverse effects , Digestive System Fistula/etiology , Disease-Free Survival , Female , France , Humans , Hyperthermia, Induced , Kaplan-Meier Estimate , Leukopenia/chemically induced , Middle Aged , Peritoneal Neoplasms/secondary , Postoperative Hemorrhage/etiology , Proportional Hazards Models , Renal Insufficiency/etiology , Retrospective Studies , Survival RateABSTRACT
PURPOSE: Diffuse malignant peritoneal mesothelioma (DMPM) is a rare primary peritoneal malignancy. Its prognosis has been improved by an aggressive locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). Prognostic factors are currently poorly defined for this disease but are essential if treatment is to be standardized. METHODS: Twenty-eight patients with DMPM, who were considered preoperatively to be candidates for CRS and HIPEC between June 1998 and August 2010 at our institution, were selected for this study. Medical records and histopathological features were retrospectively reviewed and 24 clinical, histological, and immunohistochemical parameters were assessed for their association with overall survival by univariate and multivariate analyses. RESULTS: The following factors were significantly associated with overall survival by univariate analysis: predominant histological growth pattern in the epithelioid areas, nuclear grooves in the epithelioid areas, atypical mitoses, and calretinin and GLUT1 expression by immunohistochemistry in the epithelioid areas. Expression of the facilitative glucose transporter protein GLUT1 in the epithelioid areas was the only factor independently associated with overall survival by multivariate analysis. CONCLUSIONS: GLUT1 expression appears to be an indicator of poor prognosis in DMPM. Standard histological classification of DMPM may not be adequate to select patients for aggressive locoregional treatments, such as CRS and HIPEC. Multicenter validation of the prognostic factors identified in this preliminary study is needed to refine patient selection for potential cure.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biomarkers, Tumor/metabolism , Chemotherapy, Cancer, Regional Perfusion , Glucose Transporter Type 1/metabolism , Hyperthermia, Induced , Lung Neoplasms/therapy , Mesothelioma/therapy , Peritoneal Neoplasms/therapy , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Immunoenzyme Techniques , Lung Neoplasms/metabolism , Lung Neoplasms/mortality , Male , Mesothelioma/metabolism , Mesothelioma/mortality , Mesothelioma, Malignant , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Peritoneal Neoplasms/metabolism , Peritoneal Neoplasms/mortality , Prognosis , Retrospective Studies , Survival Rate , Tissue Array AnalysisABSTRACT
OBJECTIVE: To assess the safety and efficiency of steam vein sclerosis (SVS) of the great saphenous vein (GSV) in a multicentre open prospective cohort study. DESIGN: 75 consecutive adult patients with GSV reflux, CEAP C2-C5 and vein diameter 4-13 mm. METHODS: Patients treated using an SVS™ generator delivering homogenous pulses of superheated steam were followed up at 8 days and 1, 3, 6 and 12 months (clinical, duplex ultrasound, quality of life [QoL] with SF12). RESULTS: 88 veins were treated in 75 patients. At 6 months, 72/75 (96%) veins were obliterated (95% CI: 89-99) and Kaplan-Meier analysis found an obliteration rate of 96.1% at 12 months. QoL increased at 6 months for both the physical and mental components (p = 0.049 and p < 0.001 respectively). SVS was well tolerated: no major complications were reported. Adverse events occurred mainly at day 8 and incidents amounted to ecchymosis (n = 60) and pain (n = 7). CONCLUSIONS: SVS achieved an obliteration rate similar to that of other thermal ablation techniques. It was well tolerated with minimal post-operative pain.
Subject(s)
Ablation Techniques , Saphenous Vein/surgery , Steam , Venous Insufficiency/surgery , Ablation Techniques/adverse effects , Adult , Aged , Chronic Disease , Ecchymosis/etiology , Female , France , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Pain, Postoperative/etiology , Prospective Studies , Quality of Life , Saphenous Vein/diagnostic imaging , Steam/adverse effects , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Duplex , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/psychologyABSTRACT
INTRODUCTION: The drug and medical devices Committee of the University Hospital of Lyon faces the weakness of clinical data available to justify medical devices purchase. The Hospital of Lyon has worked with several organisms of the Rhône-Alpes region to set up a pilot programme aimed at encouraging small and medium enterprises (SMEs) to realise clinical studies for the evaluation of their medical device. We report the results of this experiment which took place from 2007 to 2010. METHODS: Eligible projects were selected on the basis of their scientific interest. A specific structure for regulatory and methodological support was set up. RESULTS: Twenty companies applied, seventeen were selected. Eight research protocols were written; four clinical studies were implemented. These studies were performed by micro-companies for medical devices that could be considered as innovative device or substantial novelty. Two draft protocols were started but deferred by choice of the company. For projects that did not lead to a research protocol or study, the main causes were: a longer than expected development phase (n = 3); a problem linked to methodological feasibility (n = 1); the unsuccessful search for a principal investigator (n = 2); or the company's choice (n = 5). DISCUSSION AND CONCLUSION: This pilot experience in France has supported and trained regional SMEs in clinical research. Its continuation could encourage manufacturers to conduct clinical trials of good quality.
Subject(s)
Equipment and Supplies/standards , Evaluation Studies as Topic , Biomedical Research , Feasibility Studies , France , Health Care Sector , Hospitals, University , Humans , Pilot ProjectsABSTRACT
OBJECTIVES: At birth, evaluation of neonatal well-being is crucial. It is though important to perform umbilical cord blood gas analysis, and then to analyze the samples. We wanted to establish the feasibility and reliability of systematic umbilical cord blood sampling in a French labour ward. PATIENTS AND METHODS: Study of systematic umbilical cord blood gas analysis was realized retrospectively from 1000 consecutive deliveries. We first established the feasibility of the samples. Feasibility was defined by the ratio of complete cord acid-base data on the number of deliveries from alive newborns. Afterwards, we established the reliability on the remaining cord samples. Reliability was the ratio of samples that fulfilled quality criteria defined by Westgate et al. and revised by Kro et al., on the number of complete samples from alive newborns. At last, we looked for factors that would influence these results. RESULTS: The systematic umbilical cord blood sample feasibility reached 91.6%, and the reliability reached 80.7%. About the delivery mode, 38.6% of emergency caesarians (IC 95% [30.8-46.3]; P<0.0001) led to non-valid samples, when only 11.3% of programmed caesarians (IC 95% [4.3-18.2]; P<0.0001) led to non-valid samples. Umbilical cord blood analysis were significantly less validated during emergency caesarians. DISCUSSION AND CONCLUSION: Realization of systematic cord blood gas analysis was followed by 8.4% of incomplete samples, and by 19.3% that were uninterpretable. Training sessions should be organized to improve the feasibility and reliability, especially during emergency caesarians.
Subject(s)
Blood Gas Analysis , Fetal Blood/chemistry , Acid-Base Equilibrium , Cesarean Section , Delivery, Obstetric/methods , Feasibility Studies , Female , France , Humans , Hydrogen-Ion Concentration , Infant, Newborn , Labor, Obstetric , Pregnancy , Reproducibility of Results , Retrospective StudiesABSTRACT
OBJECTIVE: In recent years, therapeutic approaches including cytoreductive surgery followed by intraperitoneal chemotherapy have proven effective in peritoneal carcinomatosis of colorectal origin. If cytology is to be used to include patients in aggressive treatment regimens, it is necessary to evaluate its performance, particularly in terms of specificity. The aim of this study was to assess interobserver agreement for the detection of intraperitoneal free cancer cells (IFCCs) in patients with non-gynaecological adenocarcinomas. METHODS: Over a 5-year period, 1223 patients were recruited in 19 French surgery departments. Peritoneal samples were examined in 14 dispersed pathology laboratories. Giemsa-stained slides were sent to a control reader blind to the previous diagnosis. Discordant cases, concordant positive results and a random selection of negative concordant cases were reviewed by a panel of seven cytopathologists. The 'final diagnosis' was that of the consensus meetings but took into account locally-processed slides. RESULTS: Gathering dubious cases with negative results, a 95.6% concordance was achieved between local readers and the control reader. IFCCs were ascertained by the panel in 85 cases (7.0%). Eight of 873 colorectal cancers cases viewed locally were falsely positive (0.9%). Radiotherapy and neoadjuvant therapy had no impact on the false-positive rate as assessed by final validation by the panel (P > 0.05). Samples initially considered as dubious were reclassified as negative by the panel in 24 of 25 cases (96.0%). CONCLUSIONS: The panel consensus allowed reclassification of most dubious/equivocal peritoneal cytology cases, whereas clearcut distinction between benign and malignant cases was correctly achieved in almost all cases.
Subject(s)
Adenocarcinoma/diagnosis , Colorectal Neoplasms/diagnosis , Cytodiagnosis , Peritoneum/pathology , Adenocarcinoma/pathology , Adolescent , Adult , Aged , Aged, 80 and over , Carcinoma/diagnosis , Colorectal Neoplasms/pathology , Humans , Middle Aged , Prognosis , Reproducibility of Results , Retrospective StudiesABSTRACT
OBJECTIVE: The main objective of this study was to calculate the percentage of preterm births before 28 weeks gestational age (weeks GA) outside level-3 maternity wards and determine how many could have been prevented. METHODS: This was an observational, multicenter, retrospective cohort study, which included all the deliveries that occurred between 24 and 27 weeks GA + 6 days in the Greater Lyon perinatal network (France) occurring between first of March 2008 and first of March 2009. In utero transfers (IUTs) and newborn transfers (NBTs) which were carried out outside the network, medical abortions, and foetal deaths in utero were excluded. The duration between patient's arrival in the level 1 and 2 maternity and birth was compared at the 97(th) percentile of the mother's transfer time in level-3 maternity. Births that occurred outside of level-3 maternity wards were considered avoidable each time the first duration was more than the second. RESULTS: During the study period, 113 infants were born alive between 24 and 27 weeks GA+6 days in the network. They were all included in the study. Ninety were born in a level-3 maternity ward and 23 were born in level-1 and 2 maternity wards (20%). There were 35 requests for IUT and 28 were carried out (80%). In 65% of non-level 3 births, no IUT was requested. In 17% of cases, an IUT request could have prevented births in level 1/2 maternity wards. If twin pregnancies had been transferred to a level-3 maternity ward, 26% of non-level 3 births would have been avoided. If all high-risk pregnancies had been transferred to a level-3 maternity ward, 40% of non-level 3 births would have been avoided. DISCUSSION AND CONCLUSION: Any time a pregnant woman is hospitalized in a type 1/2 maternity ward before 28 weeks GA, doctors should consider an in utero transfer to a level-3 maternity ward. It may be possible to lower the birth-rate of non-level 3 births by a targeted increase in in utero transfers and by transferring high-risk pregnancies to a level-3 maternity ward.