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Sample records for case-mix system multicentre

  1. The relationship between effectiveness and costs measured by a risk-adjusted case-mix system: multicentre study of Catalonian population data bases

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    Flor-Serra Ferran

    2009-06-01

    Full Text Available Abstract Background The main objective of this study is to measure the relationship between morbidity, direct health care costs and the degree of clinical effectiveness (resolution of health centres and health professionals by the retrospective application of Adjusted Clinical Groups in a Spanish population setting. The secondary objectives are to determine the factors determining inadequate correlations and the opinion of health professionals on these instruments. Methods/Design We will carry out a multi-centre, retrospective study using patient records from 15 primary health care centres and population data bases. The main measurements will be: general variables (age and sex, centre, service [family medicine, paediatrics], and medical unit, dependent variables (mean number of visits, episodes and direct costs, co-morbidity (Johns Hopkins University Adjusted Clinical Groups Case-Mix System and effectiveness. The totality of centres/patients will be considered as the standard for comparison. The efficiency index for visits, tests (laboratory, radiology, others, referrals, pharmaceutical prescriptions and total will be calculated as the ratio: observed variables/variables expected by indirect standardization. The model of cost/patient/year will differentiate fixed/semi-fixed (visits costs of the variables for each patient attended/year (N = 350,000 inhabitants. The mean relative weights of the cost of care will be obtained. The effectiveness will be measured using a set of 50 indicators of process, efficiency and/or health results, and an adjusted synthetic index will be constructed (method: percentile 50. The correlation between the efficiency (relative-weights and synthetic (by centre and physician indices will be established using the coefficient of determination. The opinion/degree of acceptance of physicians (N = 1,000 will be measured using a structured questionnaire including various dimensions. Statistical analysis: multiple regression

  2. Multicentre evaluation of the Bayer DAX system.

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    Morosini, L; Rossetti, M; Berti, P; Pallotti, G; Fabbri, V; Mambelli, M C; Franceschin, A; Dell'Anna, L; Cappelletti, P; Brocco, G

    1993-12-01

    The analytical performance of the DAX, a high-throughput random access analyser, was studied according to ECCLS guidelines (ECCLS Document Vol. 3, No. 2, Beuth Verlag, Berlin, 1986) in a multicentre evaluation involving four laboratories. The trial took about 4 months. Determinations of 12 analytes produced more than 60,000 data. The imprecision study on 3 control sera for all analytes gave a within-run CV (median of 4 laboratories) which never exceeded 3% and was below 2% in 94% of the results. The median between-day CV was less than 3% in 92% of the results, with a highest value of 5.0%. No significant drift was detected during the 5-hour work period. No relevant sample- and cuvette-related carry-over was found. The manufacturer's claims concerning linearity were fulfilled or exceeded. The recovery of the assigned values for the control sera (median of 4 laboratories) ranged from 94 to 106%. In the method comparison on patients' samples, deviations were statistically significant in some cases, due to differences either in the methods used or in the calibration of the systems used for comparison; the regression lines, as inspected visually, and the coefficients of correlation were, however, generally acceptable. Imprecision and inaccuracy were within the acceptability limits as recommended by the Société Française de Biologie Clinique (SFBC) (Biochim. Clin. 12 (1988) 284-327) and the Deutsche Gesellschaft für Klinische Chemie (DGKC) (Dt. Arztebl. 85 (11) (1988) A697-A712). The limits of acceptance, proposed more recently by Fraser et al. (Eur. J. Clin. Chem. Clin. Biochem. 30 (1992) 311-317), were met in thirty-three of thirty-six cases. The alpha-amylase assay was significantly affected by bilirubin and haemolysis; interferences for the remaining analytes were predictable and well-known from the literature. The rate of sample throughput was found to be in agreement with that claimed by the manufacturer. The software did not present problems and was readily

  3. Masquerade Syndrome of Multicentre Primary Central Nervous System Lymphoma

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    Silvana Guerriero

    2011-01-01

    Full Text Available Purpose. In Italy we say that the most unlucky things can happen to physicians when they get sick, despite the attention of colleagues. To confirm this rumor, we report the sad story of a surgeon with bilateral vitreitis and glaucoma unresponsive to traditional therapies. Methods/Design. Case report. Results. After one year of steroidal and immunosuppressive therapy, a vitrectomy, and a trabeculectomy for unresponsive bilateral vitreitis and glaucoma, MRI showed a multicentre primary central nervous system lymphoma, which was the underlying cause of the masquerade syndrome. Conclusions. All ophthalmologists and clinicians must be aware of masquerade syndromes, in order to avoid delays in diagnosis.

  4. The application of the Ten Group classification system (TGCS in caesarean delivery case mix adjustment. A multicenter prospective study.

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    Gianpaolo Maso

    Full Text Available BACKGROUND: Caesarean delivery (CD rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this study was to evaluate whether the Ten Group classification system (TGCS can be used in case-mix adjustment. METHODS: Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index, obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction. RESULTS: Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively. In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024. CONCLUSIONS: The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the

  5. Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis : A multicentre, placebo-controlled, dose-comparison study

    NARCIS (Netherlands)

    Black, CM; Halkier-Sorensen, L; Belch, JJF; Ullman, S; Madhok, R; Smit, AJ; Banga, JD; Watson, HR

    1998-01-01

    Objective. To identify the optimal dose of oral iloprost bn the basis of efficacy and tolerability in patients with Raynaud's phenomenon secondary to systemic sclerosis. Design. Multicentre, randomized, parallel-group comparison of two different doses of oral iloprost and placebo. Setting. European

  6. On the use of administrative databases to support planning activities: the case of the evaluation of neonatal case-mix in the Emilia-Romagna region using DRG and APR-DRG classification systems.

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    Fantini, M P; Cisbani, L; Manzoli, L; Vertrees, J; Lorenzoni, L

    2003-06-01

    There are several versions of the Diagnosis Related Group (DRG) classification systems that are used for case-mix analysis, utilization review, prospective payment, and planning applications. The objective of this study was to assess the adequacy of two of these DRG systems--Medicare DRG and All Patient Refined DRG--to classify neonatal patients. The first part of the paper contains a descriptive analysis that outlines the major differences between the two systems in terms of classification logic and variables used in the assignment process. The second part examines the statistical performance of each system on the basis of the administrative data collected in all public hospitals of the Emilia-Romagna region relating to neonates discharged in 1997 and 1998. The Medicare DRG are less developed in terms of classification structure and yield a poorer statistical performance in terms of reduction in variance for length of stay. This is important because, for specific areas, a more refined system can prove useful at regional level to remove systematic biases in the measurement of case-mix due to the structural characteristics of the Medicare DRGs classification system.

  7. A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Petersen, J; Ullman, S;

    1998-01-01

    In this Danish multicentre study, predictive clinical factors of mortality and survival were calculated for 513 patients with systemic lupus erythematosus (SLE), 122 of whom died within a mean observation period of 8.2 years equalling a mortality rate of 2.9% per year. Survival rates were 97%, 91...... influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival...

  8. [Occult multicentric breast cancer].

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    Vtorushin, S V; Zab'ialova, M V; Glushchenko, S A; Perel'muter, V M; Slonimskaia, E M

    2009-01-01

    The study included 92 patients with invasive ductal breast cancer (T2-4N0-2M0-1). In 38 cases, tumor growth was unicentric while histologically identifiable ones as multicentric in 44. Multicentricity mostly occurred in cases of macroscopically-identifiable nodes located in the central segments of the breast. Clinically-identifiable nodes of multicentric tumor growth measured more than 3 cm. Multicentric tumors were mostly grade III, featured lower expression of sex hormone receptors and positive Her2 status.

  9. QuaDoSta - a freely configurable system which facilitates multi-centric data collection for healthcare and medical research

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    Albrecht, Ulrike

    2007-07-01

    Full Text Available This article describes QuaDoSta (quality assurance, documentation and statistics, a flexible documentation system as well as a data collection and networking platform for medical facilities. The user can freely define the required documentation masks which are easily expandable and can be adapted to individual requirements without the need for additional programming. To avoid duplication, data transfer interfaces can be configured flexibly to external sources such as patient management systems used in surgeries or hospital information systems. The projects EvaMed (Evaluation Anthroposophical Medicine and the Network Oncology are two scientific research projects which have been successfully established as nationally active networks on the basis of QuaDoSta. The EvaMed-Network serves as a modern pharmacovigilance project for the documentation of adverse drug events. All prescription data are electronically recorded to assess the relative risk of drugs. The Network Oncology was set up as a documentation system in four hospitals and seven specialist oncology practices where a complete record of all oncological therapies is being carried out to uniform standards on the basis of the ‘basic documentation for tumour patients’ (BDT developed by the German Cancer Society. The QuaDoSta solution system made it possible to cater for the specific requirements of the presented projects. The following features of the system proved to be highly advantageous: flexible setup of catalogues and user friendly customisation and extensions, complete dissociation of system setup and documentation content, multi-centre networkability, and configurable data transfer interfaces.

  10. Image reporting and characterization system for ultrasound features of thyroid nodules: Multicentric Korean retrospective study

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    Kwak, Jin Young [Dept. of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine, Seoul (Korea, Republic of); Jung, In Kyung [Dept. of Biostatistics, Yonsei University College of Medicine, Seoul (Korea, Republic of); Beak, Jung Hwan [Dept. of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seou (Korea, Republic of); and others

    2013-01-15

    The objective of this retrospective study was to develop and validate a simple diagnostic prediction model by using ultrasound (US) features of thyroid nodules obtained from multicenter retrospective data. Patient data were collected from 20 different institutions and the data included 2000 thyroid nodules from 1796 patients. For developing a diagnostic prediction model to estimate the malignant risk of thyroid nodules using suspicious malignant US features, we developed a training model in a subset of 1402 nodules from 1260 patients. Several suspicious malignant US features were evaluated to create the prediction model using a scoring tool. The scores for such US features were estimated by calculating odds ratios, and the risk score of malignancy for each thyroid nodule was defined as the sum of these individual scores. Later, we verified the usefulness of developed scoring system by applying into the remaining 598 nodules from 536 patients. Among 2000 tumors, 1268 were benign and 732 were malignant. In our multiple regression analysis models, the following US features were statistically significant for malignant nodules when using the training data set: hypoechogenicity, marked hypoechogenicity, non-parallel orientation, microlobulated or spiculated margin, ill-defined margins, and microcalcifications. The malignancy rate was 7.3% in thyroid nodules that did not have suspicious-malignant features on US. Area under the receiver operating characteristic (ROC) curve was 0.867, which shows that the US risk score help predict thyroid malignancy well. In the test data set, the malignancy rates were 6.2% in thyroid nodules without malignant features on US. Area under the ROC curve of the test set was 0.872 when using the prediction model. The predictor model using suspicious malignant US features may be helpful in risk stratification of thyroid nodules.

  11. Suboptimal management of central nervous system infections in children: a multi-centre retrospective study

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    Kelly Christine

    2012-09-01

    Full Text Available Abstract Objective We aimed to audit the regional management of central nervous system (CNS infection in children. Methods The study was undertaken in five district general hospitals and one tertiary paediatric hospital in the Mersey region of the UK. Children admitted to hospital with a suspected CNS infection over a three month period were identified. Children were aged between 4 weeks and 16 years old. Details were recorded from the case notes and electronic records. We measured the appropriateness of management pathways as outlined by national and local guidelines. Results Sixty-five children were identified with a median age of 6 months (range 1 month to 15 years. Ten had a CNS infection: 4 aseptic meningitis, 3 purulent meningitis, 3 encephalitis [2 with herpes simplex virus (HSV type 1]. A lumbar puncture (LP was attempted in 50 (77% cases but only 43 had cerebrospinal fluid (CSF available for analysis. Of these 24 (57% had a complete standard set of tests performed. Fifty eight (89% received a third generation cephalosporin. Seventeen (26% also received aciclovir with no obvious indication in 9 (53%. Only 11 (65% of those receiving aciclovir had CSF herpes virus PCR. Seventeen had cranial imaging and it was the first management step in 14. Treatment lengths of both antibiotics and aciclovir were highly variable: one child with HSV encephalitis was only treated with aciclovir for 7 days. Conclusions The clinical management of children with suspected CNS infections across the Mersey region is heterogeneous and often sub-optimal, particularly for the investigation and treatment of viral encephalitis. National guidelines for the management of viral encephalitis are needed.

  12. Using case-mix information in strategic hospital marketing. Deriving market research from patient data.

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    Little, A

    1992-01-01

    Hospital survival requires adaptation, adaptation requires understanding, and understanding requires information. These are the basic equations behind hospital strategic marketing, and one of the answers may lie in hospitals' own patient-data systems. Marketers' and administrators' enlightened application of case-mix information could become one more hospital survival tool.

  13. FDG-PET/CT findings in systemic mastocytosis: a French multicentre study

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    Djelbani-Ahmed, S. [Assistance Publique - Hopitaux de Paris (APHP), Department of Nuclear Medicine, Avicenne Hospital, Bobigny (France); Paris 13 University, Sorbonne Paris Cite, Bobigny (France); Chandesris, M.O. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Necker Children' s Hospital, APHP, Department of Haematology, Paris (France); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (France); Mekinian, A.; Fain, O. [Saint Antoine Hospital, Department of Internal Medicine and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), AP-HP, Paris (France); Canioni, D. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (France); Necker Children' s Hospital, APHP, Department of Pathology, Paris (France); Brouzes, C. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (France); Necker Children' s Hospital, APHP, Laboratory of Haematology, Paris (France); Hanssens, K. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Aix-Marseille University, INSERM U1068, Centre de Recherche en Cancerologie de Marseille (Signaling, Hematopoiesis and Mechanism of Oncogenesis), Paoli Calmettes Institute, Marseille (France); Pop, G.; Eder, V. [Assistance Publique - Hopitaux de Paris (APHP), Department of Nuclear Medicine, Avicenne Hospital, Bobigny (France); Durieu, I.; Durupt, S. [Universite de Lyon, Department of Internal and Vascular Medicine, Hospices Civils de Lyon, Groupe Hopitalier Sud, Pierre-Benite (France); Grosbois, B.; Besnard, S. [Rennes University Hospital, Department of Internal Medicine, Rennes (France); Tournilhac, O. [Clermont-Ferrand University Hospital, Department of Internal Medicine, Clermont-Ferrand (France); Beyne-Rauzy, O. [Purpan University Hospital, Department of Internal Medicine, Toulouse (France); Agape, P. [Saint-Denis University Hospital, Department of Oncology and Haematology, Saint-Denis de la Reunion (France); Delmer, A. [Reims University Hospital, Department of Haematology, Reims (France); Ranta, D. [Brabois University Hospital, Department of Haematology, Vandoeuvre les Nancy (France); Jeandel, P.Y. [Nice University Hospital, Department of Internal Medicine, Nice (France); Georgin-Lavialle, S. [Tenon Hospital, Department of Internal Medicine, Paris (France); Frenzel, L.; Hermine, O. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (FR); Necker Children' s Hospital, APHP, Department of Haematology, Paris (FR); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (FR); Damaj, G. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (FR); Caen University Hospital, Department of Haematology, Caen (FR); Lortholary, O. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (FR); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (FR); Pasteur Institute, Department of Infectious Diseases and Tropical Medicine, Necker Children' s Hospital, APHP, Paris (FR); Soussan, M. [Assistance Publique - Hopitaux de Paris (APHP), Department of Nuclear Medicine, Avicenne Hospital, Bobigny (FR); Paris 13 University, Sorbonne Paris Cite, Bobigny (FR)

    2015-12-15

    Mastocytosis is a clonal haematological disease characterized by uncontrolled proliferation and the activation of mast cells. The value of FDG-PET/CT (FDG-PET) in mastocytosis has yet to be determined. We retrospectively identified patients with an established diagnosis of systemic mastocytosis (SM), according to the WHO criteria, who underwent PET using the French Reference Centre for Mastocytosis database. Semi-quantitative and visual analysis of FDG-PET was performed and compared to the clinico-biological data. Our cohort included 19 adult patients, median age 65 years [range 58-74], including three with smouldering SM (SSM), three with aggressive SM (ASM), 10 with an associated clonal haematological non-mast-cell lineage disease (SM-AHNMD), and three with mast cell sarcoma (MCS). FDG-PET was performed at the time of the SM diagnosis (15/19), to evaluate lymph node (LN) activity (3/19) or the efficacy of therapy (1/19). FDG uptake was observed in the bone marrow (BM) (9/19, 47 %), LN (6/19, 32 %), spleen (12/19, 63 %), or liver (1/19, 5 %). No significant FDG uptake was observed in the SSM and ASM patients. A pathological FDG uptake was observed in the BM of 6/10 patients with SM-AHNMD, appearing as diffuse and homogeneous, and in the LN of 5/10 patients. All 3 MCS patients showed intense and multifocal BM pathological uptake, mimicking metastasis. No correlation was found between the FDG-PET findings and serum tryptase levels, BM mast cell infiltration percentage, and CD30 and CD2 expression by mast cells. FDG uptake does not appear to be a sensitive marker of mast cell activation or proliferation because no significant FDG uptake was observed in most common forms of mastocytosis (notably purely aggressive SM). However, pathological FDG uptake was observed in the SM-AHNMD and in MCS cases, suggesting a role of FDG-PET in their early identification and as a tool of therapeutic assessment in this subgroup of patients. (orig.)

  14. Validation of ACG Case-mix for equitable resource allocation in Swedish primary health care

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    Kronogård Maria

    2009-09-01

    Full Text Available Abstract Background Adequate resource allocation is an important factor to ensure equity in health care. Previous reimbursement models have been based on age, gender and socioeconomic factors. An explanatory model based on individual need of primary health care (PHC has not yet been used in Sweden to allocate resources. The aim of this study was to examine to what extent the ACG case-mix system could explain concurrent costs in Swedish PHC. Methods Diagnoses were obtained from electronic PHC records of inhabitants in Blekinge County (approx. 150,000 listed with public PHC (approx. 120,000 for three consecutive years, 2004-2006. The inhabitants were then classified into six different resource utilization bands (RUB using the ACG case-mix system. The mean costs for primary health care were calculated for each RUB and year. Using linear regression models and log-cost as dependent variable the adjusted R2 was calculated in the unadjusted model (gender and in consecutive models where age, listing with specific PHC and RUB were added. In an additional model the ACG groups were added. Results Gender, age and listing with specific PHC explained 14.48-14.88% of the variance in individual costs for PHC. By also adding information on level of co-morbidity, as measured by the ACG case-mix system, to specific PHC the adjusted R2 increased to 60.89-63.41%. Conclusion The ACG case-mix system explains patient costs in primary care to a high degree. Age and gender are important explanatory factors, but most of the variance in concurrent patient costs was explained by the ACG case-mix system.

  15. Multicentric Castleman's Disease in a Child Revealed by Chronic Diarrhea

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    Benmiloud, Sarra; Chaouki, Sana; Atmani, Samir; Hida, Moustapha

    2015-01-01

    Multicentric Castleman's disease is a rare benign and unexplained lymphoproliferative disorder that is extremely uncommon in children. It presents with fever, systemic symptoms, generalized lymphadenopathy, and laboratory markers of inflammation. Its treatment is not standardized and its prognosis is poor. We report a novel case of multicentric Castleman's disease in a 13-year-old girl who had presented with chronic diarrhea as the only initial presenting symptom. The diagnosis of celiac or inflammatory bowel diseases was suspected, but two and a half years later, the diagnosis of multicentric Castleman's disease was brought following the appearance of abdominal mass whose biopsy revealed Castleman's disease in the plasma cell form. The outcome was favorable after treatment by corticosteroid, chemotherapy, and surgery. The occurrence of diarrhea as the initial symptom of multicentric Castleman's disease without lymph node involvement is very rare. This case report underlines the diagnostic difficulties and the long interval between onset and diagnosis when diarrhea occurs first. PMID:25737793

  16. European multicentre evaluation of the Du Pont Dimension 380 under the auspices of the European Group for the Evaluation of Analytical Systems in Laboratory Medicine (EGE-Lab).

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    Hänseler, E; Vonderschmitt, D; Haeckel, R; Römer, M; Collombel, C; Goudable, J; Pourcher, E

    1991-01-01

    The Clinical Chemistry Analyzer Dimension 380 manufactured by Du Pont de Nemours was tested in a multicentre evaluation according to the guide-lines of the European Committee for Clinical Laboratory Standards (ECCLS) and in part to the protocol of the Société Française de Biologie Clinique (SFBC). The instrument and the reagents were evaluated as a system, since both reagents and reagent cartridges are specifically designed for the instrument. Fourteen analytes including electrolytes, substrates and enzymes were tested. The evaluators summarized their experience as follows: 1. All parameters tested yield results comparable to established procedures. 2. Very good performance of the ion-selective-electrode unit. 3. The imprecision data of the system are, for most parameters, between 1 and 4% CV and thus equal to or better than those of the instruments compared. 4. No reagent or sample carry-over was detected after a minor modification of the instrument. 5. The linearity of Dimension test methods in general covers the range stated by the manufacturer. 6. Very good stability of the calibration curves (up to 2 months). 7. Good practicability of the whole system, including handling of reagents and a very user-friendly software.

  17. Coalesced Multicentric Analysis of 2,351 Patients With Myelodysplastic Syndromes Indicates an Underestimation of Poor-Risk Cytogenetics of Myelodysplastic Syndromes in the International Prognostic Scoring System

    Science.gov (United States)

    Schanz, Julie; Steidl, Christian; Fonatsch, Christa; Pfeilstöcker, Michael; Nösslinger, Thomas; Tuechler, Heinz; Valent, Peter; Hildebrandt, Barbara; Giagounidis, Aristoteles; Aul, Carlo; Lübbert, Michael; Stauder, Reinhard; Krieger, Otto; Garcia-Manero, Guillermo; Kantarjian, Hagop; Germing, Ulrich; Haase, Detlef; Estey, Elihu

    2011-01-01

    Purpose The International Prognostic Scoring System (IPSS) remains the most commonly used system for risk classification in myelodysplastic syndromes (MDSs). The IPSS gives more weight to blast count than to cytogenetics. However, previous publications suggested that cytogenetics are underweighted in the IPSS. Here we investigate the prognostic impact of cytogenetic subgroups compared with that of bone marrow blast count in a large, multicentric, international patient cohort. Patients and Methods In total, 2,351 patients with MDS who have records in the German-Austrian and the MD Anderson Cancer Center databases were included and analyzed in univariate and multivariate models regarding overall survival and risk of transformation to acute myeloid leukemia (AML). The data were analyzed separately for patients treated with supportive care without specific therapy, with AML-like chemotherapy, or with other therapy regimens (low-dose chemotherapy, demethylating agents, immune modulating agents, valproic acid, and cyclosporine). Results The prognostic impact of poor-risk cytogenetic findings (as defined by the IPSS classification) on overall survival was as unfavorable as an increased (> 20%) blast count. The hazard ratio (compared with an abnormal karyotype or a bone marrow blast count < 5%) was 3.3 for poor-risk cytogenetics, 4.8 for complex abnormalities harboring chromosomes 5 and/or 7, and 3.1 for a blast count of 21% to 30% (P < .01 for all categories). The predictive power of the IPSS cytogenetic subgroups was unaffected by type of therapy given. Conclusion The independent prognostic impact of poor-risk cytogenetics on overall survival is equivalent to the impact of high blast counts. This finding should be considered in the upcoming revision of the IPSS. PMID:21519021

  18. Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding : a multicentre randomised controlled trial

    NARCIS (Netherlands)

    Herman, Malou C.; van den Brink, Marian; Geomini, Peggy M.; van Meurs, Hannah S.; Huirne, Judith A.; Eising, Heleen P.; Timmermans, Anne; Pijnenborg, Johanna M. A.; Klinkert, Ellen R.; Coppus, Sjors F.; Nieboer, Theodoor E.; Catshoek, Ruby; van der Voet, Lucet F.; van Eijndhoven, Hugo W. F.; Graziosi, Giuseppe C. M.; Veersema, Sebastiaan; van Kesteren, Paul J.; Langenveld, Josje; Smeets, Nicol A. C.; van Vliet, Huib A. A. M.; van der Steeg, Jan Willem; Lisman-van Leeuwen, Yvonne; Dekker, Janny H.; Mol, Ben W.; Berger, Marjolein Y.; Bongers, Marlies Y.

    2013-01-01

    Background: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As

  19. Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial

    NARCIS (Netherlands)

    Herman, M.C.; Brink, M.J. van den; Geomini, P.M.; Meurs, H.S. van; Huirne, J.A.; Eising, H.P.; Timmermans, A.; Pijnenborg, J.; Klinkert, E.R.; Coppus, S.F.P.J.; Nieboer, T.; Catshoek, R.; Voet, L.F. van der; Eijndhoven, H.W. van; Graziosi, G.; Veersema, B.S.; Kesteren, P.J.M. van; Langenveld, J.; Smeets, Nathalie; Vliet, H.A. Van; Steeg, J.W. van der; Leeuwen, Y.L.; Dekker, J.H.; Mol, B.W.; Berger, M.Y.; Bongers, M.Y.

    2013-01-01

    BACKGROUND: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As

  20. A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value

    DEFF Research Database (Denmark)

    Jacobsen, S; Petersen, J; Ullman, S;

    1998-01-01

    influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival...

  1. Diffuse large B-cell lymphoma arising from a multicentric mixed variant of Castleman′s disease

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    Venizelos I

    2004-01-01

    Full Text Available This case report describes a patient with multicentric mixed type Castleman′s disease and concomitant non-Hodgkin′s lymphoma of diffuse large B cell type in the neck. Multicentric CD is a systemic illness with disseminated lymphadenopathy; its aggressive and usually fatal course is associated with infectious complications and risk for malignant tumors, such as lymphoma or Kaposi sarcoma.

  2. Complexity of case mix in a regional allergy service

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    Kaminski Edward R

    2012-02-01

    Full Text Available Abstract Background Currently in the United Kingdom (UK, there is a mismatch between limited financial resources and the large proportion of patients with suspected allergies actually being referred to specialist allergy clinics. To better understand the case mix of patients being referred, we audited referrals to a regional allergy service over an 8 year period. The main source of data was consultant letters to General Practitioners (GP summarising the diagnosis of patients, archived from January 2002 to September 2009. Letters were reviewed, extracting the clinic date, doctor seen, gender, date of birth, postcode, GP, and diagnoses. Diagnoses were classified into seven groups and illustrative cases for each group noted. Findings Data from 2,028 new referrals with suspected allergy were analysed. The largest group of patients (43% were diagnosed with a type I hypersensitivity. The other diagnostic groups were chronic idiopathic (spontaneous urticaria (35%, suspected type I hypersensitivity but no allergen identified (8%, idiopathic (spontaneous angioedema (8%, physical urticaria (2.5%, non-allergic symptoms (1.6%, type IV hypersensitivity (0.8% and ACE inhibitor sensitivity (0.5%. Two thirds of patients seen were female with a higher percentage of female patients in the non type-I hypersensitivity group (71% than the type 1 hypersensitivity (66% (χ2 = 5.1, 1df, p = 0.024. The type 1 hypersensitivity patients were younger than other patients (38 Vs 46 years, t = -10.8, p Conclusions This study highlights the complexity of specialist allergy practice and the large proportion of patients referred with non-type I hypersensitivities, chronic idiopathic (spontaneous urticaria being by far the largest group. Such information is critical to inform commissioning decisions, define referral pathways and in primary care education.

  3. Multicentric Castleman's disease & HIV infection.

    LENUS (Irish Health Repository)

    Cotter, A

    2009-10-01

    We report the case of a 35 year patient from Nigeria who presented with fever and splenomegaly. The initial diagnosis was Salmonellosis. However, relapsing symptoms lead to a re-evaluation and ultimately a diagnosis of Multicentric Castleman\\'s Disease (MCD). There is no gold standard treatment but our patient responded to Rituximab and Highly active anti-retroviral therapy. MCD is a rare, aggressive disease that should be considered in a HIV positive patient presenting with fever and significant lymphadenopathy.

  4. Establishment and Management of Multicentral Collection Bio-sample Banks of Malignant Tumors from Digestive System%消化系统恶性肿瘤多中心标本库的建立及管理

    Institute of Scientific and Technical Information of China (English)

    沈思; 沈君炜; 朱樑; 吴超群; 李东良; 余宏宇; 邱媛媛; 周薏; 姚定康

    2015-01-01

    为探讨建立及管理消化道恶性肿瘤多中心标本库的有效策略,该文设计了多中心标本库管理系统并制定标准化操作流程(SOPs)。牵头全国十家医院合作收集标本。建库半年收集消化道恶性肿瘤患者标本共695份。标本临床资料全面完整,统一编号,分类管理。以标本库为基础进行了临床及分子生物学研究,取得了一定成果,为多地区、多种类消化系统恶性肿瘤的研究提供了平台。%To establish and manage of multicentral colection bio-sample banks of malignant tumors from digestive system, the paper designed a multicentral management system, established the standard operation procedures (SOPs) and leaded ten hospitals nationwide to colect tumor samples. The biobank has been established for half a year, and has colected 695 samples from patients with digestive system malignant tumor. The clinical data is ful and complete, labeled in a unified way and classified to be managed. The clinical and molecular biology researches were based on the biobank, and obtained achievements. The biobank provides a research platform for malignant tumor of digestive system from different regions and of different types.

  5. Case report 375: Multicentric reticulohistiocytosis

    Energy Technology Data Exchange (ETDEWEB)

    Scutellari, P.N.; Orzincolo, C.; Trotta, F.

    1986-06-01

    In summary, a case of multicentric reticulohistiocytosis in an 18-year-old girl is presented, with dramatic demonstration of the progressive lesions of the hands demonstrated in xeroradiographs. The association of nodules in the skin, particularly around the distal interphalangeal joints of the hands is stressed and the generally progressive nature of the disorder is emphasized and illustrated in this patient. The end result in most instances is that of an 'arthritis mutilans', with extensive deformities, particularly of the distal phalanges of the hands. The clinical, radiological and pathological aspects of the disorder are discussed and a review of the literature is included. The differential diagnosis, particularly including rheumatoid arthritis, is described in detail. The pathogenesis of the disorder is considered. (orig.(SHA).

  6. Multicentric reticulohistiocytosis: a critical review.

    Science.gov (United States)

    Selmi, Carlo; Greenspan, Adam; Huntley, Arthur; Gershwin, M Eric

    2015-06-01

    The literature reports approximately 300 cases of multicentric reticulohistiocytosis (MRH) worldwide, mostly women of Caucasian origin. MRH manifests as a symmetric erosive polyarthritis mimicking rheumatoid arthritis with the subsequent appearance of typical papulonodular skin lesions. The disease may rapidly progress towards mutilans arthritis in the majority of cases, but it generally remits spontaneously in 10 years. The only diagnostic hallmark for MRH is the observation at histology of numerous histiocytes and multinucleated giant cells and ground glass eosinophilic cytoplasm. Despite its rarity, clinical and pathogenetic challenging features characterize the condition. First, the differential diagnosis with other forms of arthritis and the frequent coexistence of neoplasms or autoimmune diseases warrant a careful evaluation of suspected cases. Second, data from isolated MRH cases are consistent in supporting a role for monocyte/macrophage cells and for an enhanced osteoclastic activity in the affected tissues. Third, beside anti-inflammatory treatments, promising reports suggest that biologics targeting TNF-alpha and bisphosphonates may prove beneficial in MRH. Based on these observations, we are convinced that our understanding of this rare condition may prove beneficial in mechanistic advancement for other more prevalent inflammatory conditions such as arthritidies and other bone diseases.

  7. HIV-associated multicentric Castleman’s disease

    Directory of Open Access Journals (Sweden)

    Fauzia de Fátima Naime

    2012-09-01

    Full Text Available Multicentric Castleman’s disease (MCD is a rare lymphoproliferative disorder. It is found with higher frequency in patients with HIV infection, with systemic symptoms and poor prognosis. We present the case of a 32-year old man with HIV disease, Kaposi’s sarcoma, lymphadenopathy, fever and hemolytic anemia. A diagnosis of Castleman’s disease is confirmed through biopsy and treatment is often based only on published case reports. Systemic treatments for MCD have included chemotherapy, anti-herpes virus, highly active antiretroviral therapy and, more recently, monoclonal antibodies against both IL6 and CD20.

  8. Multicentric Castleman disease: Where are we now?

    Science.gov (United States)

    Wang, Hao-Wei; Pittaluga, Stefania; Jaffe, Elaine S

    2016-09-01

    Multicentric Castleman disease (MCD) encompasses a spectrum of conditions that give rise to overlapping clinicopathological manifestations. The fundamental pathogenetic mechanism involves dysregulated cytokine activity that causes systemic inflammatory symptoms as well as lymphadenopathy. The histological changes in lymph nodes resemble in part the findings originally described in the unicentric forms Castleman disease, both hyaline vascular and plasma cell variants. In MCD caused by Kaposi sarcoma-associated herpesvirus/human herpesvirus-8 (KSHV/HHV8), the cytokine over activity is caused by viral products, which can also lead to atypical lymphoproliferations and potential progression to lymphoma. In cases negative for KSHV/HHV8, so-called idiopathic MCD, the hypercytokinemia can result from various mechanisms, which ultimately lead to different constellations of clinical presentations and varied pathology in lymphoid tissues. In this article, we review the evolving concepts and definitions of the various conditions under the eponym of Castleman disease, and summarize current knowledge regarding the histopathology and pathogenesis of lesions within the MCD spectrum.

  9. Variation in case-mix between hospitals treating colorectal cancer patients in the Netherlands

    NARCIS (Netherlands)

    Kolfschoten, N.E.; Marang van de Mheen, P.J.; Gooiker, G.A.; Eddes, E.H.; Kievit, J.; Tollenaar, R.A.E.M.; Wouters, M.W.; Bemelman, W.A.; Busch, O.R.; Dam, R.M. van; Harst, E. van der; Jansen-Landheer, M.L.E.A; Karsten, T.M.; Krieken, J.H.J.M. van; Kuijpers, W.G.T.; Lemmens, V.E.; Manusama, E.R.; Meijerink, W.J.H.J.; Rutten, H.J.; Wiggers, T.; Velde, C.J. van de

    2011-01-01

    AIMS: The purpose of this study was to determine how expected mortality based on case-mix varies between colorectal cancer patients treated in non-teaching, teaching and university hospitals, or high, intermediate and low-volume hospitals in the Netherlands. MATERIAL AND METHODS: We used the databas

  10. Case-mix adjustment for evaluation of mortality in cystic fibrosis.

    Science.gov (United States)

    O'Connor, Gerald T; Quinton, Hebe B; Kahn, Richard; Robichaud, Priscilla; Maddock, Joanne; Lever, Thomas; Detzer, Mark; Brooks, John G

    2002-02-01

    Comparison of patient mortality rates in cystic fibrosis (CF) obtained from different institutions requires the use of case-mix adjustment methods to account for baseline differences in patient and disease characteristics. There is no current professional consensus on the use of case-mix adjustment methods for use in comparing mortality rates in CF. Characteristics used for this case-mix adjustment should include those that are different across institutions and are associated with patient survival. They should not include characteristics of disease severity that may be a consequence of effectiveness of treatment. The goal of these analyses was to identify a set of these characteristics of patients or disease that would be useful for case-mix adjustment of CF mortality rates. Data from the Cystic Fibrosis Foundation Patient Registry and from the United States Census of the Population (1990) were used in these analyses. Kaplan-Meier techniques, the log-rank test, and Cox proportional hazards regression were used to estimate survivorship, calculate hazard ratios (HR), 95% confidence intervals (CI(95%)), and to conduct tests of statistical significance. The data set included all 30,469 CF patients seen at CF Care Centers from 1982-1998. There were 5,906 deaths during 508,721 person-years of follow-up. In multivariate analyses, female gender (HR 1.30, CI(95%) (1.16, 1,47), P $50,000/year (corrected for the 1999 consumer price index) were compared with those living in areas with a median household income uses patient and disease characteristics available at the time of diagnosis of CF, and is not believed to be influenced by subsequent treatment to predict the risk of death. If these case-mix adjustment methods are adopted broadly, they will make it possible to study treatment effects and differences in mortality outcomes, while adjusting for baseline differences in patient and disease characteristics.

  11. Hypercalcaemic multicentric lymphoma in a dog presenting as clitoromegaly

    Directory of Open Access Journals (Sweden)

    Anthony B. Zambelli

    2013-02-01

    Full Text Available Clitoromegaly is a clinical manifestation of various local and systemic conditions in all species. The external genitalia are a very rare site of primary or metastatic lymphoma in canines, with only one previously-reported case in a dog and only sparse reports in the medical literature. Lymphoma is also very rare in dogs less than four years of age. This account reports on a T-cell multicentric lymphoma in a 16-month-old Basset hound presented primarily for clitoromegaly. The patient survived for 68 days with cyclophosphamide-vincristine-prednisolone therapy. The causes of clitoromegaly in all species, including humans, are tabulated with references.

  12. Fibromatoses of multicentric origin: a case report.

    Science.gov (United States)

    Suzuki, Y; Yamamoto, A; Ku, Y; Minami, R; Hanioka, K; Shimizu, M; Kuroda, Y

    2000-06-01

    We experienced a very rare case with fibromatoses of multicentric origin. One of the 2 intraabdominal fibromatoses showed a extremely rapid growing and another fibromatosis arising from the abdominal wall showed an invasive behavior. All lesions were diagnosed and resected simultaneously. This patient has been followed for 2 years postoperatively and no recurrent lesion has been detected so far.

  13. Treating KSHV-Associated Multicentric Castleman Disease

    Science.gov (United States)

    In this study, patients with KSHV-associated multicentric Castleman disease will receive IV tocilizumab every other week for up to 12 weeks. Patients who do not benefit may go on to receive high-dose AZT and valganciclovir as well.

  14. Multicentre comparison of a diagnostic assay: Aquaporin-4 antibodies in neuromyelitis optica

    NARCIS (Netherlands)

    P. Waters (Patrick); M. Reindl (Markus); A. Saiz (Albert Abe); K. Schanda (Kathrin); F. Tuller (Friederike); V. Kral (Vlastimil); P. Nytrova (Petra); O. Sobek (Ondrej); H.H. Nielsen (Helle Hvilsted); T. Barington (Torben); S.T. Lillevang (Søren T.); Z. Illes (Zsolt); K. Rentzsch (Kristin); A. Berthele (Achim); T. Berki (Tímea); L. Granieri; A. Bertolotto (Antonio); B. Giometto; L. Zuliani (Luigi); D. Hamann (Dörte); J.L. Van Pelt (Joost L.); R.Q. Hintzen (Rogier); R. Höftberger (Romana); C. Costa (Carme); M. Comabella (Manuel); X. Montalban (Xavier); M. Tintoré; A. Siva (Aksel); A. Altintas (Ayse); G. Deniz (Gunnur); M. Woodhall (Mark); J. Palace (Jacqueline); F. Paul (Friedemann); H.P. Hartung; O. Aktas (Orhan); S. Jarius (Sven); B. Wildemann (Brigitte); C. Vedeler (Christian); A. Ruiz (Anne); M.I. Leite (M. Isabel); P. Trillenberg (Peter); M. Probst (Monika); S. Saschenbrecker (Sandra); A.J.P.E. Vincent (Arnoud); R. Marignier (Romain)

    2016-01-01

    textabstractObjective Antibodies to cell surface central nervous system proteins help to diagnose conditions which often respond to immunotherapies. The assessment of antibody assays needs to reflect their clinical utility. We report the results of a multicentre study of aquaporin (AQP) 4 antibody (

  15. Multicentric Castleman’s Disease in a Child Revealed by Chronic Diarrhea

    Directory of Open Access Journals (Sweden)

    Sarra Benmiloud

    2015-01-01

    Full Text Available Multicentric Castleman’s disease is a rare benign and unexplained lymphoproliferative disorder that is extremely uncommon in children. It presents with fever, systemic symptoms, generalized lymphadenopathy, and laboratory markers of inflammation. Its treatment is not standardized and its prognosis is poor. We report a novel case of multicentric Castleman’s disease in a 13-year-old girl who had presented with chronic diarrhea as the only initial presenting symptom. The diagnosis of celiac or inflammatory bowel diseases was suspected, but two and a half years later, the diagnosis of multicentric Castleman’s disease was brought following the appearance of abdominal mass whose biopsy revealed Castleman’s disease in the plasma cell form. The outcome was favorable after treatment by corticosteroid, chemotherapy, and surgery. The occurrence of diarrhea as the initial symptom of multicentric Castleman’s disease without lymph node involvement is very rare. This case report underlines the diagnostic difficulties and the long interval between onset and diagnosis when diarrhea occurs first.

  16. Cutaneous and systemic plasmacytosis in an Asian male born in the North American continent: a controversial entity potentially related to multicentric Castleman disease.

    Science.gov (United States)

    Shadel, Brooke N; Frater, John L; Gapp, Joshua D G; Hurley, M Yadira

    2010-06-01

    Cutaneous and systemic plasmacytosis is a rare condition primarily affecting middle-aged individuals of Japanese descent and has principally been reported in cases originating from Asia. Its relationship, if any, to Castleman disease, is controversial. The authors report a case of cutaneous and systemic plasmacytosis involving a 36-year-old man of Chinese ancestry born in North America. The biopsy of an involved lymph node revealed changes resembling Castleman disease. Significantly, this case to our knowledge represents the first case of cutaneous and systemic plasmacytosis presenting in a patient of Chinese ancestry born on the North American mainland.

  17. Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis

    DEFF Research Database (Denmark)

    Dougados, Maxime; Jousse-Joulin, Sandrine; Mistretta, Frederic

    2010-01-01

    To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter....

  18. Irreversible Kidney Damage due to Multicentric Castleman’s Disease

    Directory of Open Access Journals (Sweden)

    Mårten Segelmark

    2008-01-01

    Full Text Available Castleman’s Disease (CD is a rare lymphoproliferative disorder accompanied by marked systemic inflammatory response. Morphological diagnosis of CD requires biopsy of the whole of the involved lymph node tissue. Three histologic variants have already been described in CD morphology (hyaline vascular, plasma-cell, and mixed. In this study, we report a case of a multicentric Castleman’s disease of the plasma cell variant type with negative Herpes Virus 8. The clinical presentation of this patient was of systemic amyloidosis as a result of both a delayed diagnosis and medical management. Previously described cases of CD with secondary amyloidosis have been of the localized type. Regardless, long-standing clinical remission of CD by cytotoxic drugs and anti-CD20 antibody therapy was achieved, but the nephrotic syndrome remained irreversible.

  19. Use of functioning-disability and dependency for case-mix and subtyping of schizophrenia

    Directory of Open Access Journals (Sweden)

    Susana Ochoa

    2012-03-01

    Full Text Available Background and Objectives: To evaluate the utility of the constructs functioning and disability (F & D and dependency for case-mix and subtyping of patients with schizophrenia by psychosocial, clinical, use of services and attention received from informal carers. Methods: A randomly selected total of 205 people with schizophrenia, and their careers were evaluated through PANSS, DAS-sv, Objective and Subjective Burden Scale (ECFOS-II and use of services. Results: Two groups and Four profiles were identified according to levels of Dependency: The non-dependent group was made of two profiles: independent (I, and persons with disability in the community (DiC. The dependent group included persons with dependency in the community (DeC and persons with dependency in hospital care (DeH. There are clinical and psychosocial differences between these profiles being the dependent the most severe. Regarding use of services, DeC use the most resources, with the exception DeH (more hospitalization resources. The DeC profile generate greater family burden in the following areas; taking medication, being accompanied to appointments, and management than the DiC, despite both groups showing a high need for support. Conclusions: Dependency is a relevant construct for case-mix and subtyping in schizophrenia, and it is related to severity both at the social and clinical level. DeC generate more family burden than the other profiles, followed by DiC (patients with schizophrenia with disability but non-dependent.

  20. Abnormal glomerular basement membrane in idiopathic multicentric osteolysis

    NARCIS (Netherlands)

    Bakker, SJL; Vos, GD; Verschure, PDMM; Mulder, AH; Tiebosch, TMG

    1996-01-01

    The primary cause of nephropathy in idiopathic multicentric osteolysis is as yet unknown. We report a young girl with idiopathic multicentric osteolysis and nephropathy. An abnormal glomerular basement membrane was the only abnormality found in a renal biopsy taken 2 years before the development of

  1. Prognosis for recovery from multiple organ system failure: the accuracy of objective estimates of chances for survival. The French Multicentric Group of ICU Research.

    Science.gov (United States)

    Rauss, A; Knaus, W A; Patois, E; Le Gall, J R; Loirat, P

    1990-01-01

    This study evaluated the accuracy and reliability of predictions for recovery from multiple organ system failure (OSF). A previous analysis had provided estimates of the probabilities of recovery from various combinations of OSF for 2,843 intensive care unit (ICU) patients treated in 13 U.S. hospitals. These estimates were applied prospectively to 2,405 ICU admissions in 27 French hospitals. Despite variations in the incidences of underlying disease and the distributions of OSF between the two countries, clinical outcomes were similar for the 5,248 total patients. In both countries, two OSFs persisting for more than one day resulted in a hospital death rate of 60%. Hospital mortality rates for patients with three or more OSFs persisting after one day consistently exceeded 90%. Isolated neurologic failure had the poorest overall prognosis, but various other combinations of OSFs did not result in significantly different outcomes. The stability of the prognostic estimates in the two countries suggests that, despite pathogenetic variations, persistent multiple OSF results in consistent clinical outcomes. These mortality projections provide firm reference data for assessing efficacy of new treatments within institutions with similar standards of care. The narrow confidence intervals associated with these estimates also provide objectively defined opportunities to review future treatment plans for individual patients.

  2. [Systemic Antimicrobials Consumption and Expenditures in Departments of Surgery of Multi-Profile Hospitals in the Russian Federation and the Republic of Belarus: Results of Multicentre Pharmacoepidemiological Study].

    Science.gov (United States)

    Belkova, Yu A; Rachina, S A; Kozlov, R S; Mishchenko, V M; Pavlukov, R A; Abubakirova, A I; Berezhanskiy, B V; Eliseeva, E V; Zubareva, N A; Karpov, I A; Kopylova, I A; Palyutin, Sh Kh; Portnyagina, U S; Pribytkova, O V; Samuylo, E K

    2016-01-01

    The results of the systemic antimicrobials (AM) consumption and expenditures assessment in the departments of surgery of multi-profile hospitals in different regions of the Russian Federation and the Republic of Belarus in 2009-2010 based on retrospective collection and analysis of the data from the hospital expenditure notes using ATC/DDD methodology are presented. The average AM consumption and expenditure rates in the above mentioned departments varied from 24.9 DDD/100 bed-days to 61.7 DDD/100 bed-days depending on the department profile, with beta-lactams (cephalosporins and penicillins) share in the consumption being as high as 70-90%, followed by fluoroquinolones and aminoglycosides. Only 55-70% of the consumed AM belonged to the drugs of choice, whereas the improper AM consumption and expenditure rates amounted up to 10-18%. The study outputs can be used for the budget allocation and AM distribution improvement in the departments of surgery, as well as for the development and efficacy control of the local antimicrobial stewardship programs.

  3. Treatment of Children With Central Nervous System Primitive Neuroectodermal Tumors/Pinealoblastomas in the Prospective Multicentric Trial HIT 2000 Using Hyperfractionated Radiation Therapy Followed by Maintenance Chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Gerber, Nicolas U., E-mail: nicolas.gerber@kispi.uzh.ch [Department of Pediatric Oncology, University Children' s Hospital, Zurich (Switzerland); Hoff, Katja von; Resch, Anika [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Ottensmeier, Holger [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Kwiecien, Robert; Faldum, Andreas [Institute of Biostatistics and Clinical Research, University of Muenster (Germany); Matuschek, Christiane [Department of Radiation Oncology, Medical Faculty, Heinrich Heine University of Duesseldorf, Duesseldorf (Germany); Hornung, Dagmar [Department of Radiotherapy and Radio-Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Bremer, Michael [Institute for Radiation Therapy and Special Oncology, Hannover Medical School, Hannover (Germany); Benesch, Martin [Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz (Austria); Pietsch, Torsten [Department of Neuropathology, University of Bonn, Bonn (Germany); Warmuth-Metz, Monika [Department of Neuroradiology, University of Wuerzburg, Wuerzburg (Germany); Kuehl, Joachim [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Rutkowski, Stefan [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kortmann, Rolf D. [Department of Radiation Oncology, University of Leipzig, Leipzig (Germany)

    2014-07-15

    Purpose: The prognosis for children with central nervous system primitive neuroectodermal tumor (CNS-PNET) or pinealoblastoma is still unsatisfactory. Here we report the results of patients between 4 and 21 years of age with nonmetastatic CNS-PNET or pinealoblastoma diagnosed from January 2001 to December 2005 and treated in the prospective GPOH-trial P-HIT 2000-AB4. Methods and Materials: After surgery, children received hyperfractionated radiation therapy (36 Gy to the craniospinal axis, 68 Gy to the tumor region, and 72 Gy to any residual tumor, fractionated at 2 × 1 Gy per day 5 days per week) accompanied by weekly intravenous administration of vincristine and followed by 8 cycles of maintenance chemotherapy (lomustine, cisplatin, and vincristine). Results: Twenty-six patients (15 with CNS-PNET; 11 with pinealoblastoma) were included. Median age at diagnosis was 11.5 years old (range, 4.0-20.7 years). Gross total tumor resection was achieved in 6 and partial resection in 16 patients (indistinct, 4 patients). Median follow-up of the 15 surviving patients was 7.0 years (range, 5.2-10.0 years). The combined response rate to postoperative therapy was 17 of 20 (85%). Eleven of 26 patients (42%; 7 of 15 with CNS-PNET; 4 of 11 with pinealoblastoma) showed tumor progression or relapse at a median time of 1.3 years (range, 0.5-1.9 years). Five-year progression-free and overall survival rates (±standard error [SE]) were each 58% (±10%) for the entire cohort: CNS-PNET was 53% (±13); pinealoblastoma was 64% (±15%; P=.524 and P=.627, respectively). Conclusions: Postoperative hyperfractionated radiation therapy with local dose escalation followed by maintenance chemotherapy was feasible without major acute toxicity. Survival rates are comparable to those of a few other recent studies but superior to those of most other series, including the previous trial, HIT 1991.

  4. Retinal vein occlusion during flare of multicentric Castleman's disease

    Directory of Open Access Journals (Sweden)

    Kozak I

    2013-08-01

    Full Text Available Igor Kozak,1,2 Erin G Reid31King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia; 2University of California San Diego, Jacobs Retina Center at the Shiley Eye Center, La Jolla, CA, USA; 3University of California San Diego, Moores Cancer Center, AIDS Malignancy Consortium, La Jolla, CA, USAAbstract: We report a case of successive bilateral retinal vein occlusion in a human immunodeficiency virus (HIV-positive male with multicentric Castleman's disease treated successfully with a single injection of intravitreal bevacizumab. Castleman's disease should be a differential diagnosis of occlusive retinovascular disease and, occasionally, ocular manifestation can lead to systemic diagnosis.Keywords: retinal vein occlusion, Castleman's disease, intravitreal bevacizumab

  5. Corticosteroid contact allergy: an EECDRG multicentre study

    DEFF Research Database (Denmark)

    Dooms-Goossens, A; Andersen, Klaus Ejner; Brandäo, F M;

    1996-01-01

    This article describes the results of an EECDRG multicentre study on contact allergy to corticosteroids. A total of 7238 patients were investigated: 6238 in 13 centres in the course of 1993, and 1000 patients in 1 centre in 1993 and 1994. The 5 corticosteroids tested were budesonide 0.1% pet......., betamethasone-17-valerate 1% pet., clobetasol-17-propionate 1% pet., hydrocortisone-17-butyrate 1% eth., and tixocortol-21-pivalate 1% pet.; 189 (2.6%) gave a positive patchtest reaction (+, ++, + + +) to at least 1 of the corticosteroids. The data regarding the corticosteroid-sensitive patients, as well...

  6. [Multicentric reticulohistiocytosis: clinical and ultrastructural study of a case].

    Science.gov (United States)

    Peteiro, C; Fernández-Redondo, V; Zulaica, A; Caeiro, J L; Beiras, A; Toribio, J

    1987-01-01

    A case of multicentric reticulohistiocytosis associated with bilateral Dupuytren's disease and xanthelasmas of the eyelids is described. Ultrastructural examination showed electron-dense intracytoplasmic granules, collagen entrapment and interdigitation of adjacent cytoplasmic membranes.

  7. Genitourinary brucellosis: results of a multicentric study.

    Science.gov (United States)

    Erdem, H; Elaldi, N; Ak, O; Gulsun, S; Tekin, R; Ulug, M; Duygu, F; Sunnetcioglu, M; Tulek, N; Guler, S; Cag, Y; Kaya, S; Turker, N; Parlak, E; Demirdal, T; Ataman Hatipoglu, C; Avci, A; Bulut, C; Avci, M; Pekok, A; Savasci, U; Kaya, S; Sozen, H; Tasbakan, M; Guven, T; Bolukcu, S; Cesur, S; Sahin-Horasan, E; Kazak, E; Denk, A; Gonen, I; Karagoz, G; Haykir Solay, A; Alici, O; Kader, C; Senturk, G; Tosun, S; Turan, H; Baran, A I; Ozturk-Engin, D; Bozkurt, F; Deveci, O; Inan, A; Kadanali, A; Sayar, M S; Cetin, B; Yemisen, M; Naz, H; Gorenek, L; Agalar, C

    2014-11-01

    This study reviewed the clinical, laboratory, therapeutic and prognostic data on genitourinary involvement of brucellosis in this largest case series reported. This multicentre study pooled adult patients with genitourinary brucellar involvement from 34 centres treated between 2000 and 2013. Diagnosis of the disease was established by conventional methods. Overall 390 patients with genitourinary brucellosis (352 male, 90.2%) were pooled. In male patients, the most frequent involved site was the scrotal area (n=327, 83.8%), as epididymo-orchitis (n=204, 58%), orchitis (n=112, 31.8%) and epididymitis (n=11, 3.1%). In female patients, pyelonephritis (n=33/38, 86.8%) was significantly higher than in male patients (n=11/352, 3.1%; pbrucellosis occurred in one patient. A localized scrotal infection in men or pyelonephritis in women in the absence of leucocytosis and with mild to moderate increases in inflammatory markers should signal the possibility of brucellar genitourinary disease.

  8. All patient refined-diagnostic related group and case mix index in acute care palliative medicine.

    Science.gov (United States)

    Lagman, Ruth L; Walsh, Declan; Davis, Mellar P; Young, Brett

    2007-03-01

    The All Patient Refined-Diagnostic Related Group (APR-DRG) is a modification of the traditional DRG that adds four classes of illness severity and four classes of mortality risk. The APR-DRG is a more accurate assessment of the complexity of care. When individuals with advanced illness are admitted to an acute inpatient palliative medicine unit, there may be a perception that they receive less intense acute care. Most of these patients, however, are multisymptomatic, have several comorbidities, and are older. For all patients admitted to the unit, a guide was followed by staff physicians to document clinical information that included the site(s) of malignancy, site(s) of metastases, disease complications, disease-related symptoms, and comorbidities. We then prospectively compared DRGs, APR-DRGs, and case mix index (CMI) from January 1-June 30, 2003, and February 1-July 31,2004, before and after the use of the guide. The overall mean severity of illness (ASOI) increased by 25% (P < 0.05). The mean CMI increased by 12% (P < 0.05). The average length of stay over the same period increased slightly from 8.97 to 9.56 days. Systematic documentation of clinical findings using a specific tool for patients admitted to an acute inpatient palliative medicine unit based on APR-DRG classifications captured a higher severity of illness and may better reflect resource utilization.

  9. Multicentric Osteoid Osteoma Presenting a Diagnostic Dilemma.

    Science.gov (United States)

    Bush, Lisabeth A; Gayle, Robert B; Berkey, Bryan D

    2008-01-01

    We present a case of a relatively common benign tumor that was a diagnostic dilemma because of its atypical appearance in multiple imaging modalities. Our patient was a 22-year-old man who presented with complaint of three months of shin pain with running. The radiographically demonstrated sclerotic lesion in his right tibia initially was thought most likely to be a stress fracture, but on further evaluation, it had features that suggested a subacute osteomyelitis or Brodie's abscess with focal sequestra. It was in fact, biopsy proven to be an osteoid osteoma with multiple, closely adjacent nidi. Its elongate, multicentric, "string of beads" arrangement as well as its intramedullary location is uncommon and it was larger than normally expected. Because of the unusual presentation and appearance of this lesion it caused a diagnostic dilemma. This lesion was evaluated with a full spectrum of modalities including radiographs, CT, MRI, Technetium 99m-MDP bone scan and Indium-111 white blood cell scan. After biopsy achieved a definite diagnosis, this tumor was successfully treated with radiofrequency ablation of all nidi in one session.

  10. European multicentre evaluation of the ABBOTT Spectrum clinical chemistry analyzer.

    Science.gov (United States)

    Blijenberg, B G; Braconnier, F; Vallez, J M; Burlina, A; Plebani, M; Celadin, M; Haeckel, R; Römer, M; Hänseler, E; De Schrijver, G

    1989-06-01

    The analytical performance of the selective multitest ABBOTT Spectrum analyser was studied according to the ECCLS guidelines and partly the CERMAB protocol in a multicentre evaluation involving laboratories from six European countries. Fifteen analytes, including the electrolytes sodium, potassium and chloride, were measured each in at least 3 laboratories, all at 37 degrees C, except the electrolytes, which are measured at room temperature. The trial lasted approximately three months and involved the collection of over 60,000 data points. It yielded the following results: 1. The precision was at least as good as the precision obtained with the comparison instruments. The majority of the coefficients of variation were between 1 and 4%. 2. The recovery for method assigned control sera values was, with few exceptions, within 10%. 3. Good agreement with respect to the method assigned values of control materials and method comparison with patient specimens to different instruments (e.g. SMAC, Hitachi 737, RA 1000) was found. 4. No drift was observed. 5. Reagent-related carry-over was not found. Specimen-related carry-over was detected in some cases, the deviation being of little or no clinical significance. 6. The manufacturer's claims regarding method linearity were as stated or exceeded. 7. The open system capability was tested and rated as very convenient. 8. The practicability of the instrument was very good.

  11. Skin fragility syndrome in a cat with multicentric follicular lymphoma.

    Science.gov (United States)

    Crosaz, Odile; Vilaplana-Grosso, Federico; Alleaume, Charline; Cordonnier, Nathalie; Bedu-Leperlier, Anne-Sophie; Marignac, Geneviève; Hubert, Blaise; Rosenberg, Dan

    2013-10-01

    An 11-year-old, spayed female domestic shorthair cat was presented for a right flank wound. On clinical examination, a single non-painful skin tear lesion with irregular edges was detected. During the examination, star-shaped cigarette paper-like skin lesions appeared spontaneously. An abdominal mass was also palpated. Feline skin fragility syndrome (FSFS) was suspected and a multicentric lymphoma was diagnosed by fine needle aspiration. The cat's condition declined and it died spontaneously. Post-mortem examination confirmed the diagnosis of lymphoma. Neoplastic lymphocytes were not observed in the skin. Histological analysis of the skin was consistent with the morphological aspects of FSFS. A possible direct link between the two conditions remains a matter of speculation, but this case report provides the first description of FSFS associated with multicentric follicular lymphoma. Thus, multicentric follicular lymphoma should be considered as a differential diagnosis in cats presenting with FSFS.

  12. Multicentric Giant Cell Tumor of Bone: Synchronous and Metachronous Presentation

    Directory of Open Access Journals (Sweden)

    Reiner Wirbel

    2013-01-01

    Full Text Available A 27-year-old man treated 2.5 years ago for synchronous multicentric giant cell tumor of bone located at the right proximal humerus and the right 5th finger presented now with complaints of pain in his right hip and wrist of two-month duration. Radiology and magnetic resonance revealed multicentric giant cell tumor lesions of the right proximal femur, the left ileum, the right distal radius, and the left distal tibia. The patient has an eighteen-year history of a healed osteosarcoma of the right tibia that was treated with chemotherapy, resection, and allograft reconstruction. A literature review establishes this as the first reported case of a patient with synchronous and metachronous multicentric giant cell tumor who also has a history of osteosarcoma.

  13. Multicentric Reticulohistiocytosis Presenting with Papulonodular Skin Lesions and Arthritis Mutilans

    Directory of Open Access Journals (Sweden)

    Raya Saba

    2013-01-01

    Full Text Available Multicentric reticulohistiocytosis is a rare multisystem disorder of unknown etiology that is characterized by erosive polyarthritis and papulonodular lesions on the skin, mucous membranes, and internal organs. We report the case of a 54-year-old female who was misdiagnosed as having rheumatoid arthritis and underwent numerous joint replacement surgeries for progressively destructive arthritis in her hands, shoulders, hips, and knees. The patient finally received a diagnosis of multicentric reticulohistiocytosis after histopathological examination of the patient’s left knee arthroplasty which revealed a diffuse histiocytic infiltrate, multinucleated giant cells, and finely granulated eosinophilic cytoplasm with a ground-glass appearance.

  14. Conservative surgery for multifocal/multicentric breast cancer.

    Science.gov (United States)

    Nijenhuis, Matthijs V; Rutgers, Emiel J Th

    2015-11-01

    Multifocal (MF) and multicentric (MC) breast cancer is regularly considered a relative contraindication for breast-conserving therapy (BCT). There are two reasons for this wide spread notion: However, we concur that if optimal 'cytoreductive surgery' is achieved this will result in good local control (i.e. in-breast relapse breast irradiation and systemic treatments as indicated by primary cancer biology. Careful planning and adaptive application of oncoplastic techniques will result in an optimal cosmetic results. The meticulous work of Roland Holland and coworkers(1) in the early 1980's on whole breast specimen showed invasive foci at more then 2 cm distance from the invasive primary cancer in more then 40% of specimen. Although multiple tumor foci may occur in up to 60% of mastectomy specimens, equivalent survival outcomes were observed in prospective trials comparing BCT and mastectomy for clinically unifocal lesions, suggesting that the majority of these foci are not, or do not become, biologically relevant or clinically significant with appropriate treatment. As diagnostic tools advance, MF and MC tumors are more commonly diagnosed. Cancers that previously would have been classified as unifocal now can be detected as MF or MC. In addition, locoregional treatment modalities have improved significantly over the past decade. More recent studies reflect these advances in diagnosis and treatment. Studies evaluated staging MRI showed that up to 19% of woman with diagnosed breast cancer harbor a second malignant ipsilateral lesion. These findings should only have consequences when additional lesions are proven cancer. Multiple enhancing lesions on MRI are in itself not an indication for a mastectomy. The Z0011 trial and the AMAROS trial demonstrated a similar phenomenon for axillary treatment; less surgery does not necessarily lead to inferior local control or survival outcomes. Recent studies supplement the growing evidence that treatment of patients with MF

  15. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian;

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them...

  16. Is RoAsT tougher than StEAk?: The effect of case mixing on perception of multi-letter graphemes

    Directory of Open Access Journals (Sweden)

    Jelena Havelka

    2010-03-01

    Full Text Available Case mixing is a technique that is used to investigate the perceptual processes involved in visual word recognition. Two experiments examined the effect of case mixing on lexical decision latencies. The aim of these experiments was to establish whether different case mixing patterns would interact with the process of appropriate visual segmentation and phonological assembly in word reading. In the first experiment, case mixing had a greater effect on response times to words when it led to visual disruption of the multi-letter graphemes (MLGs as well as the overall word shape (e.g. pLeAd, compared to when it disrupted overall word shape only (e.g. plEAd. A second experiment replicated this finding with words in which MLGs represent either the vowel (e.g. bOaST vs. bOAst or the consonant sound (e.g. sNaCK vs. sNAcK. These results confirm that case mixing can have different effect depending on the type of orthographic unit that is broken up by the manipulation. They demonstrate that graphemes are units that play an important role in visual word recognition, and that manipulation of their presentation by case mixing will have a significant effect on response latencies to words in a lexical decision task. As such these findings need to be taken into account by the models of visual word recognition.

  17. The impact of payer-specific hospital case mix on hospital costs and revenues for third-party patients.

    Science.gov (United States)

    Lee, Keon-Hyung; Roh, M P H Chul-Young

    2007-02-01

    Competition among hospitals and managed care have forced hospital industry to be more efficient. With higher degrees of hospital competition and managed care penetration, hospitals have argued that the rate of increase in hospital cost is greater than the rate of increase in hospital revenue. By developing a payer-specific case mix index (CMI) for third-party patients, this paper examined the effect of hospital case mix on hospital cost and revenue for third-party patients in California using the hospital financial and utilization data covering 1986-1998. This study found that the coefficients for CMIs in the third-party hospital revenue model were greater than those in the hospital cost model until 1995. Since 1995, however, the coefficients for CMIs in the third-party hospital revenue model have been less than those in hospital cost models. Over time, the differences in coefficients for CMIs in hospital revenue and cost models for third-party patients have become smaller and smaller although those differences are statistically insignificant.

  18. Multicentric Myxoid Liposarcoma; a Case Report and Literature Review

    Directory of Open Access Journals (Sweden)

    Mohammad Gharehdaghi

    2014-03-01

    Full Text Available Liposarcoma is a common malignant soft tissue tumor, accounting for 10% to 16% of all sarcomas. Multicentric myxoid liposarcoma is an uncommon condition. Differentiation between several primary tumors and metastasis of a single liposarcoma represents the main difficulty in diagnosis. A 47-years old woman presented with right thigh myxoid liposarcoma and underwent wide margin tumor resection. Other investigations like CXR, abdominal and pelvic CT-scans were negative. After 18 months another myxoid liposarma was found in her ipsi-lateral breast without any evidence of other organs metastasis. Second lesion location, time between two presentation and cytogenetic differences are accepted criteria to site a sarcoma in multicentric category, but in myxoid liposarcoma these can be explained by the special features inherent to this tumor.

  19. Multicentric Myxoid Liposarcoma; a Case Report and Literature Review

    Directory of Open Access Journals (Sweden)

    Mohammad Gharehdaghi

    2014-03-01

    Full Text Available   Liposarcoma is a common malignant soft tissue tumor, accounting for 10% to 16% of all sarcomas. Multicentric myxoid liposarcoma is an uncommon condition. Differentiation between several primary tumors and metastasis of a single liposarcoma represents the main difficulty in diagnosis. A 47-years old woman presented with right thigh myxoid liposarcoma and underwent wide margin tumor resection. Other investigations like CXR, abdominal and pelvic CT-scans were negative. After 18 months another myxoid liposarma was found in her ipsi-lateral breast without any evidence of other organs metastasis. Second lesion location, time between two presentation and cytogenetic differences are accepted criteria to site a sarcoma in multicentric category, but in myxoid liposarcoma these can be explained by the special features inherent to this tumor.  

  20. Remissão de retículo-histiocitose multicêntrica com terapia combinada com infliximabe Remission of multicentric reticulohistiocytosis with combined terapy witb infliximab

    Directory of Open Access Journals (Sweden)

    Sílvia Arroyo Rstom

    2008-12-01

    Full Text Available A retículo-histiocitose multicêntrica é doença sistêmica rara e de etiologia desconhecida. Caracterizase por poliartrite simétrica, que pode evoluir para artrite mutilante, e por lesões papulonodulares na pele e nas mucosas. O diagnóstico definitivo é histopatológico. Em aproximadamente um terço dos casos de retículo-histiocitose multicêntrica em adultos, observa-se associação com malignidade. Ainda não foi estabelecida uma terapia-padrão. Descreve-se o caso de mulher de 46 anos com quadro clínico característico de retículo-histiocitose multicêntrica. Realizou-se tratamento inovador à base de infliximabe, obtendo-se ótimos resultados.Multicentric reticulohistiocytosis is an extremely rare systemic disorder of unknown etiology. It is characterized by a severe symmetric polyarthritis which can progresses to a mutilant arthritis and papulonodular skin and mucosal lesions. The diagnostic of multicentric reticulo histiocytosis is histopathologic. Approximately one-third of the adults patients have association with malignancies. There is no uniform treatment regimen for multicentric reticulohistiocytosis. We present a case of a 46-year woman with a classical clinical picture of multicentric reticulohistiocytosis. The patient received treatment with biological immunemodulators with marked results.

  1. Multicentric glioblastoma arising in two unusual sites : cerebellum and thalamus

    OpenAIRE

    Cambruzzi, Eduardo; Pêgas,Karla Lais; Simão,Mariana Fernandez; Stüker, Guilherme

    2013-01-01

    Multicentric glioblastomas (MGBM) arising in infra/supratentorial regions are uncommon lesions. The authors report a case of MGBM in a 61 year-old female patient, who presented a sudden onset of left hemiplegia. The magnetic resonance imaging (MRI) showed two expansive large lesions affecting cerebellum and thalamus, with strong contrast enhancement. The patient underwent resection of the cerebellar lesion. Microscopy revealed a high grade glial neoplasm exhibiting high mitotic index, areas o...

  2. Multicentric extra-abdominal desmoid tumors arising in bilateral lower limbs

    Directory of Open Access Journals (Sweden)

    Nobuhiro Fukushima

    2010-03-01

    Full Text Available Extra-abdominal desmoid tumors preferentially affect the shoulders, arms, backs, buttocks, and thighs of young adults. Multicentric occurrence is rather rare but seems to be another distinctive feature of extra-abdominal desmoid tumors. In this article we report a rare case of multicentric extra-abdominal desmoid tumors arising in bilateral lower limbs.

  3. Immune reconstitution inflammatory syndrome, human herpesvirus 8 viremia, and HIV-associated multicentric Castleman disease

    Directory of Open Access Journals (Sweden)

    Marc O. Siegel

    2016-07-01

    Full Text Available Kaposi's sarcoma and multicentric Castleman Disease are HIV-related disease processes that are associated with human herpesvirus 8 (HHV-8 infection. The development of multicentric Castleman disease can often be a manifestation of the immune reconstitution inflammatory syndrome phenomenon and is associated with markedly elevated levels of HHV-8 viremia, as illustrated by this case.

  4. Loss of interleukin-21 leads to atrophic germinal centers in multicentric Castleman's disease.

    Science.gov (United States)

    Yajima, Hidetaka; Yamamoto, Motohisa; Shimizu, Yui; Sakurai, Nodoka; Suzuki, Chisako; Naishiro, Yasuyoshi; Imai, Kohzoh; Shinomura, Yasuhisa; Takahashi, Hiroki

    2016-01-01

    Both multicentric Castleman's disease (MCD) and immunoglobulin (Ig)G4-related disease (IgG4-RD) are systemic diseases, presenting with hypergammaglobulinemia and elevated serum levels of IgG4. However, with regard to histopathological findings, MCD shows atrophic germinal centers. On the other hand, expanded germinal centers are detected in IgG4-RD. We extracted germinal centers from specimens of each disorder by microdissection and analyzed the expression of mRNAs by real-time polymerase chain reaction to clarify the mechanisms underlying atrophied germinal centers in MCD. This analysis disclosed loss of interleukin (IL)-21 and B cell lymphoma (Bcl)-6 in the germinal centers of MCD. Loss of IL-21 is considered to be involved in the disappearance of Bcl-6 and leads to atrophied germinal centers in MCD.

  5. Prescription errors in Brazilian hospitals: a multi-centre exploratory survey.

    Science.gov (United States)

    Miasso, Adriana Inocenti; Oliveira, Regina Célia de; Silva, Ana Elisa Bauer de Camargo; Lyra Junior, Divaldo Pereira de; Gimenes, Fernanda Raphael Escobar; Fakih, Flávio Trevisan; Cassiani, Sílvia Helena De Bortoli

    2009-02-01

    In Brazil, millions of prescriptions do not follow the legal requirements necessary to guarantee the correct dispensing and administration of medication. This multi-centre exploratory study aimed to analyze the appropriateness of prescriptions at four Brazilian hospitals and to identify possible errors caused by inadequacies. The sample consisted of 864 prescriptions obtained at hospital medical clinics in January 2003. Data was collected by three nurse researchers during one week using a standard data sheet that included items about: the type of prescription; legibility; completeness; use of abbreviations; existence of changes and erasures. There were statistically significant differences between incomplete electronic prescriptions at hospital A, and handwritten ones from hospitals C (C2 = 12.703 and p system at the hospitals. Physicians, pharmacists and nurses should therefore jointly propose strategies to avoid these prescription errors.

  6. Multicentric osteoid osteoma with a nidus located in the epiphysis

    Energy Technology Data Exchange (ETDEWEB)

    Tamam, Cueneyt [Kasimpasa Military Hospital, Kasimpasa Asker Hastanesi, Orthopedics and Traumatology, Istanbul (Turkey); Yildirim, Duezguen [Kasimpasa Military Hospital, Department of Radiology, Istanbul (Turkey); Tamam, Muge [Okmeydani Training and Research Hospital, Nuclear Medicine, Istanbul (Turkey)

    2009-11-15

    We present a 13-year-old girl who was referred to our clinic with a 5-month history of right leg pain relieved by salicylates. Initial CT examination demonstrated a lesion in the posterior tibial cortex in keeping with an osteoid osteoma. This was resected and the diagnosis confirmed by histology. However, her pain recurred 2 weeks after the operation and further imaging identified a further nidus in the epiphysis. We present the imaging findings in this unique case of multicentric osteoid osteoma with one nidus located in the epiphysis. (orig.)

  7. Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY) : essential study design and rationale of a randomised clinical multicentre trial

    NARCIS (Netherlands)

    Lindhardt, Morten; Persson, Frederik; Currie, Gemma; Pontillo, Claudia; Beige, Joachim; Delles, Christian; von der Leyen, Heiko; Mischak, Harald; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Ruggenenti, Piero Luigi; Rychlik, Ivan; Spasovski, Goce; Rossing, Peter

    2016-01-01

    Introduction Diabetes mellitus affects 9% of the European population and accounts for 15% of healthcare expenditure, in particular, due to excess costs related to complications. Clinical trials aiming for earlier prevention of diabetic nephropathy by renin angiotensin system blocking treatment in no

  8. Assessment and effective targeting of Interleukin-1 in multicentric reticulohistyocytosis.

    Science.gov (United States)

    Aouba, Achille; Leclerc-Mercier, Stéphanie; Fraitag, Sylvie; Martin-Silva, Nicolas; Bienvenu, Boris; Georgin-Lavialle, Sophie

    2015-07-01

    Multicentric reticulohistyocytosis (MRH) is a rare multisystemic non-Langerhans histiocytosis characterized by cutaneous nodules and severe destructive polyarthritis, sometimes associated with constitutional symptoms and various organ involvements. Its treatment remains empirical and challenging. We first report herein, the successful treatment of a multicentric reticulohistiocytosis patient with anakinra based on cutaneous biopsy immunostaining and serum cytokines features. A first-line treatment associating methotrexate, cortisone and hydoxychloroquine showed none improvement. Therefore, while further tests were performed to rule out an associated malignancy, auto-immune disease or mycobacterial infection, a treatment with anakinra was chosen instead of anti-TNF-alpha drugs. As soon as the 5th day, anakinra allowed control of fever, then rapid improvement of constitutional symptoms, arthritis, cutaneous lesions, and normalization of C-reactive protein, IL-6, and especially IL-1β levels. Then methotrexate was added, while anakinra was removed at the 12th month, with persistent and complete remission over the two-year follow up. Further assessment of IL-1 pathogenic role and blockade on larger cohorts of patient could open new therapeutic perspectives for refractory/relapsing MRH, considering the good tolerance profile of specific targeting drugs.

  9. Multicentric hyaline-vascular Castleman's disease in the retroperitoneum

    Institute of Scientific and Technical Information of China (English)

    Li-Ying Wang; Tian-An Jiang; Xiao-Dong Teng; Qi-Yu Zhao; Fen Chen

    2009-01-01

    BACKGROUND: Castleman's disease is a rare lymphopro-liferative disease of unknown cause. Most multicentric cases described have been of the plasma-cell variety. This article presents a case of multicentric hyaline-vascular Castleman's disease in the retroperitoneum with the ultrasonographic and computed tomography (CT) imaging manifestations. METHODS: During routine physical examination, a mass was detected in the left abdomen of a 53-year-old man with no signs or symptoms. The patient underwent ultrasound-guided aspiration biopsy and operative excision after laboratory examination, ultrasonography, and CT. RESULTS: Ultrasonography demonstrated a dominant hypoechogenic mass with hypervascularity in the retroperitoneum. CT detected a relatively homogenous enhanced lesion and several satellite nodules. After the mass and several lymph nodes were resected, histopathologic examination demonstrated a lymphocyte-predominant infiltrate surrounding the germinal centres and extensive capillary proliferation, consistent with the hyaline-vascular type of Castleman's disease. The patient received postoperative chemotherapy and remained free of recurrence 3 months later. CONCLUSION: Ultrasonography and contrast-enhanced CT can provide a positive differential diagnosis of hyaline-vascular Castleman's disease which is a kind of giant lymph node hyperplasia with hypervascularity.

  10. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

    OpenAIRE

    2013-01-01

    Background Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Methods...

  11. Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research

    Directory of Open Access Journals (Sweden)

    Caloto Teresa

    2001-12-01

    Full Text Available Abstract Background The Multicentre Project for Tuberculosis Research (MPTR was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. Methods The study was divided in three phases: 1 preliminary phase, 2 field work 3 final phase. Quality control procedures during the three phases are described. Results: Preliminary phase: a organisation of the research team; b design of epidemiological tools; training of researchers. Field work: a data collection; b data computerisation; c data transmission; d data cleaning; e quality control audits; f confidentiality. Final phase: a final data cleaning; b final analysis. Conclusion The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

  12. Multicentric fibromyxoid peripheral nerve sheath tumor (multicentric schwannoma) in a dromedary camel (Camelus dromedarius): morphopathological, immunohistochemical, and electron microscopic studies.

    Science.gov (United States)

    Khodakaram-Tafti, A; Khordadmehr, M

    2011-11-01

    During postslaughter inspection of a 4-year-old male dromedary camel (Camelus dromedarius), numerous small nodules to large masses up to 4 cm in diameter were found on the serosal surfaces of forestomachs, large intestines, mesentery, liver, and spleen. Grossly, the masses were discrete, round, smooth, and white to gray that bulged from the serosal layer. Cut surfaces of the masses were discrete, round, white, and relatively homogeneous without any necrotic foci. Histopathologically, the masses were encapsulated and composed of a mixture of round and spindle-shaped cells in loose whorls of neoplastic cells with small elongated hyperchromatic wavy nuclei and a small amount of pale eosinophilic, poorly defined cytoplasm. Masson's trichrome staining showed mild amounts of collagen fibers forming an irregular, loose stroma. In immunohistochemistry, immunoreactivity for the Schwann cell marker (S100) was diffusely positive in the neoplastic cells. The immunoreactivity for CK, c-kit, and CD34 were negative. Ultrastructural examination confirmed the tumor was entirely formed of neoplastic Schwann cells. On the basis of the histopathological, immunohistochemical, and ultrastructural findings, the tumors were diagnosed as multicentric fibromyxoid peripheral nerve sheath tumor (multicentric schwannoma). This tumor has not been previously recorded in camel worldwide.

  13. Design and internal validation of an obstetric early warning score: secondary analysis of the Intensive Care National Audit and Research Centre Case Mix Programme database.

    Science.gov (United States)

    Carle, C; Alexander, P; Columb, M; Johal, J

    2013-04-01

    We designed and internally validated an aggregate weighted early warning scoring system specific to the obstetric population that has the potential for use in the ward environment. Direct obstetric admissions from the Intensive Care National Audit and Research Centre's Case Mix Programme Database were randomly allocated to model development (n = 2240) or validation (n = 2200) sets. Physiological variables collected during the first 24 h of critical care admission were analysed. Logistic regression analysis for mortality in the model development set was initially used to create a statistically based early warning score. The statistical score was then modified to create a clinically acceptable early warning score. Important features of this clinical obstetric early warning score are that the variables are weighted according to their statistical importance, a surrogate for the FI O2 /Pa O2 relationship is included, conscious level is assessed using a simplified alert/not alert variable, and the score, trigger thresholds and response are consistent with the new non-obstetric National Early Warning Score system. The statistical and clinical early warning scores were internally validated using the validation set. The area under the receiver operating characteristic curve was 0.995 (95% CI 0.992-0.998) for the statistical score and 0.957 (95% CI 0.923-0.991) for the clinical score. Pre-existing empirically designed early warning scores were also validated in the same way for comparison. The area under the receiver operating characteristic curve was 0.955 (95% CI 0.922-0.988) for Swanton et al.'s Modified Early Obstetric Warning System, 0.937 (95% CI 0.884-0.991) for the obstetric early warning score suggested in the 2003-2005 Report on Confidential Enquiries into Maternal Deaths in the UK, and 0.973 (95% CI 0.957-0.989) for the non-obstetric National Early Warning Score. This highlights that the new clinical obstetric early warning score has an excellent ability to

  14. Cardiac phantom measurement validating the methodology for a cardiac multi-centre trial with positron emission tomography.

    Science.gov (United States)

    Nuyts, Johan; Mortelmans, Luc; Van de Werf, Frans; Djian, Jacques; Sambuceti, Gianmario; Schwaiger, Marcus; Touboul, Paul; Maes, Alex

    2002-12-01

    In an ongoing international multi-centre trial, positron emission tomography (PET) is being used to evaluate the effect of a new P-selectin antagonist on the infarct size in patients with acute myocardial infarction, treated with thrombolysis. Although it is possible to correct for site-dependent factors, it is desirable to reduce these factors to a minimum. Therefore, acquisition and reconstruction protocols have been defined that can be closely followed by all participating centres. The resulting reconstructed images are transferred to the core centre for central processing with semi-automatic software. This paper reports on the multi-centre phantom experiment that was carried out to assess the inter-centre reproducibility of defect size determination with this protocol. Also, the spatial resolution of the short axis slices was examined. In addition, the analysis procedure was applied to normal PET studies to evaluate the specificity of perfusion defect detection. The transmural cold defect in the phantom occupied 14.8% of the left ventricular area. The automated analysis was applied to the phantom measurements from the 14 participating PET cameras. It yielded an accurate estimate of 15.1% with a standard deviation of 0.6%, indicating excellent reproducibility. The spatial resolution in the short axis slices was similar for all PET systems: 9.6+/-0.8 mm. The same procedure produced a defect size of zero in the studies of normal volunteers. This study indicates that cardiac studies from multiple PET systems can be pooled for statistical analysis.

  15. Cardiac phantom measurement validating the methodology for a cardiac multi-centre trial with positron emission tomography

    Energy Technology Data Exchange (ETDEWEB)

    Nuyts, Johan; Mortelmans, Luc; Maes, Alex [Nuclear Medicine, UZ Gasthuisberg, K.U. Leuven, Herestraat 49, 3000 Leuven (Belgium); Van de Werf, Frans [Cardiology, UZ Gasthuisberg, K.U. Leuven, Leuven (Belgium); Djian, Jacques [Wyeth Research, Paris la Defense Cedex (France); Sambuceti, Gianmario [Instituto di Fisiologia Clinica CNR, Pisa (Italy); Schwaiger, Marcus [Nuklearmedizinische Klinik und Poliklinik, TU Muenchen, Muenchen (Germany); Touboul, Paul [Hopital Cardio-Vasculaire et Pneumologique, Lyon (France)

    2002-12-01

    In an ongoing international multi-centre trial, positron emission tomography (PET) is being used to evaluate the effect of a new P-selectin antagonist on the infarct size in patients with acute myocardial infarction, treated with thrombolysis. Although it is possible to correct for site-dependent factors, it is desirable to reduce these factors to a minimum. Therefore, acquisition and reconstruction protocols have been defined that can be closely followed by all participating centres. The resulting reconstructed images are transferred to the core centre for central processing with semi-automatic software. This paper reports on the multi-centre phantom experiment that was carried out to assess the inter-centre reproducibility of defect size determination with this protocol. Also, the spatial resolution of the short axis slices was examined. In addition, the analysis procedure was applied to normal PET studies to evaluate the specificity of perfusion defect detection. The transmural cold defect in the phantom occupied 14.8% of the left ventricular area. The automated analysis was applied to the phantom measurements from the 14 participating PET cameras. It yielded an accurate estimate of 15.1% with a standard deviation of 0.6%, indicating excellent reproducibility. The spatial resolution in the short axis slices was similar for all PET systems: 9.6{+-}0.8 mm. The same procedure produced a defect size of zero in the studies of normal volunteers. This study indicates that cardiac studies from multiple PET systems can be pooled for statistical analysis. (orig.)

  16. Blau syndrome : cross-sectional data from a multicentre study of clinical, radiological and functional outcomes

    NARCIS (Netherlands)

    Rose, Carlos D.; Pans, Steven; Casteels, Ingele; Anton, Jordi; Bader-Meunier, Brigitte; Brissaud, Philippe; Cimaz, Roland; Espada, Graciella; Fernandez-Martin, Jorge; Hachulla, Eric; Harjacek, Miroslav; Khubchandani, Raju; Mackensen, Friederike; Merino, Rosa; Naranjo, Antonio; Oliveira-Knupp, Sheila; Pajot, Christine; Russo, Ricardo; Thomee, Caroline; Vastert, SJ; Wulffraat, Nico; Arostegui, Juan I.; Foley, Kevin P.; Bertin, John; Wouters, Carine H.

    2015-01-01

    Objective. To report baseline articular, functional and ocular findings of the first international prospective cohort study of Blau syndrome (BS). Methods. Three-year, multicentre, observational study on articular, functional (HAQ, Childhood HAQ and VAS global and pain), ophthalmological, therapeuti

  17. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an interm

  18. Early complications of stenting in patients with congenital heart disease : a multicentre study

    NARCIS (Netherlands)

    van Gameren, Menno; Witsenburg, Maarten; Takkenberg, Johanna J. M.; Boshoff, Derize; Mertens, Luc; van Oort, Anton M.; de Wolf, DanieL; Freund, Matthias; Sreeram, Narayanswani; Bokenkamp, Regina; Talsma, Melle D.; Gewillig, Marc

    2006-01-01

    Aims Stenting has become an established interventional cardiology procedure for congenital heart disease. Although most stent procedures are completed successfully, complications may occur. This multicentre study evaluated early complications after stenting in patients with congenital heart disease,

  19. Multicentric Squamous Odontogenic Tumor: A Case Report and Review of the Literature.

    Science.gov (United States)

    Elmuradi, Sophia; Mair, Yasmin; Suresh, Lakshmanan; DeSantis, James; Neiders, Mirdza; Aguirre, Alfredo

    2016-09-08

    Squamous odontogenic tumor (SOT) is a rare benign epithelial odontogenic neoplasm of the jaws. Both intraosseous and peripheral SOTs have been described in the English language literature. While most intraosseous SOTs occur as solitary lesions, a multicentric variant has also been previously described. Although the radiographic and microscopic features are identical for both solitary and multicentric clinical presentations, there are three significant differences between them. More specifically, multicentric SOT presents at an earlier age (third decade of life), has a slightly higher male to female ratio than the solitary type and has a marked predilection for African-Americans. Here we document the eighth reported case of multicentric SOT, which was diagnosed in a 43-year-old African-American male. In addition, we feature focal sebaceous metaplasia, a heretofore unknown microscopic feature of SOT. Clinical, radiological, and histopathological findings are discussed. The differential diagnosis, biological behavior and management modalities for SOT are also addressed.

  20. Perfil de la casuística hospitalaria de la población inmigrante en Barcelona Profile of the hospital case mix of the immigrant population in Barcelona, Spain

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    F. Cots

    2002-10-01

    la envejecida estructura de edad de los pacientes autóctonos y plantea la necesidad de recuperar el mayor peso de los servicios de ginecología-obstetricia y pediatría. El hecho de que exista menor consumo de recursos por alta hospitalaria en la población inmigrante de países de renta baja contradice la relación esperada de inmigrante-peor situación socioeconómica-mayor intensidad de consumo de recursos por alta hospitalaria. Deben proponerse nuevas hipótesis de trabajo y análisis que permitan explicar esta realidad.Objective: Although the immigrant population in cities such as Barcelona has tripled in the last five years, until now the impact of this group on the health system has not been rigorously evaluated. The aim of this study was to compare hospital resource utilization among the immigrant population with that among the native population through case mix, demographic characteristics and hospital day use. Material and methods: We analyzed 15,057 discharges from Hospital del Mar in Barcelona in 2000. This hospital attends 60% of admissions from the Ciutat Vella district. In 2000, 21% of the population of this district were immigrants. Socio-demographic patient characteristics and case mix were compared between the immigrant and the native population. Hospital resource use was compared according to age, case mix (diagnosis related groups and seriousness (severity, complications and comorbidities of the events requiring medical care. Results: The case mix of the immigrant population differed from that of the autochthonous population due to pronounced ge differences and a higher fertility rate. Thirty-three percent of immigrant admissions were for deliveries. The mean cost of discharge of immigrants from low-income countries was 30% lower than that for the remaining discharges. After adjusting for age, case mix and severity, length of stay among the immigrant population was significantly shorter. A 5% reduction was found after adjusting for case mix and a

  1. Multicentric glioblastoma arising in two unusual sites: cerebellum and thalamus

    Directory of Open Access Journals (Sweden)

    Eduardo Cambruzzi

    2013-04-01

    Full Text Available Multicentric glioblastomas (MGBM arising in infra/supratentorial regions are uncommon lesions. The authors report a case of MGBM in a 61 year-old female patient, who presented a sudden onset of left hemiplegia. The magnetic resonance imaging (MRI showed two expansive large lesions affecting cerebellum and thalamus, with strong contrast enhancement. The patient underwent resection of the cerebellar lesion. Microscopy revealed a high grade glial neoplasm exhibiting high mitotic index, areas of necrosis and microvascular proliferation. The neoplastic cells showed positive immunoexpression for glial fibrillary acidic protein (GFAP. The morphological findings were consistent with glioblastoma (GBM. The patient was referred to radiotherapy, with discrete signs of tumor regression after a 60-day clinical follow-up.

  2. Multicentric Castleman's disease in a child with subpectoral involvement

    Energy Technology Data Exchange (ETDEWEB)

    Kosucu, Polat; Ahmetoglu, Ali; Guemele, Halit Resit [Department of Radiology, Farabi Hospital, Medical School of Karadeniz Technical University, 61080 Trabzon (Turkey); Imamoglu, Mustafa; Cay, Ali [Department of Pediatric Surgery, Farabi Hospital, Medical School of Karadeniz Technical University, Trabzon (Turkey); Cobanoglu, Uemit [Department of Pathology, Farabi Hospital, Medical School of Karadeniz Technical University, Trabzon (Turkey)

    2003-08-01

    Castleman's disease is a benign lymphoproliferative disorder characterised by enlarged hyperplastic lymph nodes. It is rare in children and usually presents as localised disease. Subpectoral involvement has not been previously described in multicentric Castleman's disease in children. We present the CT, US and Doppler US findings of hyaline-vascular type multicentric Castleman's disease in a 5 year-old-boy with masses in the left subpectoral region and supraclavicular and axillary lymphadenopathy. (orig.)

  3. A multicentre report from the Mexican Retinoblastoma Group

    Science.gov (United States)

    Leal-Leal, C; Flores-Rojo, M; Medina-Sansón, A; Cerecedo-Díaz, F; Sánchez-Félix, S; González-Ramella, O; Pérez-Pérez, F; Gómez-Martínez, R; Quero-Hernández, A; Altamirano-Álvarez, E; Alejo-González, F; Figueroa-Carbajal, J; Ellis-Irigoyen, A; Tejocote-Romero, I; Cervantes-Paz, R; Pantoja-Guillén, F; Vega-Vega, L; Carrete-Ramírez, F

    2004-01-01

    Background: Retinoblastoma (RB) is a relatively uncommon tumour in childhood. The incidence of retinoblastoma in Mexico is probably higher than the incidence reported worldwide, however there is not enough information about the characteristics of this illness in Mexico. This report aims to present the results of a multicentre clinical survey of RB in Mexico. Methods: A retrospective study was carried out on all RB cases treated in 16 institutions during the last six years. The variables analysed were age at diagnosis, sex, affected eyes, treatment modalities, and pathological staging. Overall survival was obtained. Results: The authors analysed 500 cases; age range was 0–182 months. There were 364 unilateral cases (72.8%). Enucleation was performed in 84.9% of the patients. The St Jude’s staging was: 7.4% stage I, 52.8% stage II, 18.0% stage III, 11.4% stage IV, 7.2% not evaluated, and 3.2% missing data. Chemotherapy was used in 74.4% of the patients. Disease free survival was 89% at 73 months follow up. Conclusions: The paper presents a great number of cases and pioneers multicentre studies in paediatric ophthalmology and oncology in this country. Given the great number of patients in advanced stages and the variability on treatment schemes, it is evident that it is mandatory to work in a cooperative group and develop a national early detection programme as well as a treatment protocol which include all specialists involved in the care of patients with RB. PMID:15258028

  4. Multicentric Castleman's disease and Kaposi's sarcoma in a cyclosporin treated, HIV-1 negative patient: case report

    Directory of Open Access Journals (Sweden)

    van Oers MHJ

    2003-12-01

    Full Text Available Abstract Background Multicentric Castleman's disease (MCD is a rare disease, but is more frequent in AIDS patients. MCD has only been reported twice before in patients receiving immunosuppressive therapy after renal transplantation, and never in patients receiving immunosuppressive therapy without transplantation. About half of the cases of MCD are human herpesvirus 8 (HHV8 – related, in contrast to Kaposi's sarcoma, a more common complication arising after immunosuppression, where the virus is found in virtually all cases. Case presentation We report a HIV-1 negative, non-transplant patient who developed HHV8-associated multicentric Castleman's disease and Kaposi's sarcoma after 17 years of immunosuppressive treatment with cyclosporin A for a minimal change nephropathy. Chemotherapy with liposomal doxorubicin resolved both symptoms of multicentric Castleman's disease and Kaposi's sarcoma in this patient. A concomitant decline in the HHV8 viral load in serum/plasma, as determined by a quantitative real-time PCR assay, was observed. Conclusions Multicentric Castleman's disease can be a complication of cyclosporin A treatment. Both multicentric Castleman's disease and Kaposi's sarcoma in this patient were responsive to liposomal doxorubicin, the treatment of choice for Kaposi's sarcoma at the moment, again suggesting a common mechanism linking both disorders, at least for HHV8-positive multicentric Castleman's disease and Kaposi's sarcoma. HHV8 viral load measurements can be used to monitor effectiveness of therapy.

  5. Implementation of the WHO Multicentre Growth Reference Study in Brazil.

    Science.gov (United States)

    Araújo, Cora L; Albernaz, Elaine; Tomasi, Elaine; Victora, Cesar G

    2004-03-01

    The World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) South American site was Pelotas, Brazil. The sample for the longitudinal component was drawn from three hospitals that account for approximately 90% of the city's deliveries. The cross-sectional sample was drawn from a community survey based on households that participated in the longitudinal sample. One of the criteria for site selection was the availability of a large, community based sample of children whose growth was unconstrained by socioeconomic conditions. Local work done in 1993 demonstrated that children of families with incomes at least six times the minimum wage had a stunting rate of 2.5%. Special public relations and implementation activities were designed to promote the acceptance of the study by the community and its successful completion. Among the major challenges of the site were serving as the MGRS pilot site, low baseline breastfeeding initiation and maintenance rates, and reluctance among pediatricians to acknowledge the relevance of current infant feeding recommendations to higher socioeconomic groups.

  6. TAFRO syndrome: New subtype of idiopathic multicentric Castleman disease

    Directory of Open Access Journals (Sweden)

    Gordan Srkalovic

    2017-01-01

    Full Text Available Castleman disease (CD describes a group of three rare and poorly understood lymphoproliferative disorders that have heterogeneous clinical symptoms and common lymph node histopathological features. Unicentric CD (UCD involves a single region of enlarged nodes. Multicentric CD (MCD involves multiple regions of enlarged lymph nodes, constitutional symptoms, and organ dysfunction due to a cytokine storm often including interleukin 6. MCD is further divided into Human Herpes Virus-8 (HHV-8-associated MCD, which occurs in immunocompromised individuals, and HHV-8-negative/idiopathic MCD (iMCD. Recently, iMCD has been further sub-divided into patients with TAFRO syndrome, which involves thrombocytopenia (T, anasarca (A, fevers (F, reticulin myelofibrosis (R, organomegaly (O, and normal or only slightly elevated immunoglobulin levels, and those who do not have TAFRO syndrome. Non-TAFRO iMCD patients typically have thrombocytosis, less severe fluid accumulation, and hypergammaglobulinemia. iMCD patients with TAFRO syndrome may have a worse prognosis, but more research is needed.

  7. Multicentre dose audit for clinical trials of radiation therapy in Asia.

    Science.gov (United States)

    Mizuno, Hideyuki; Fukuda, Shigekazu; Fukumura, Akifumi; Nakamura, Yuzuru-Kutsutani; Jianping, Cao; Cho, Chul-Koo; Supriana, Nana; Dung, To Anh; Calaguas, Miriam Joy; Devi, C R Beena; Chansilpa, Yaowalak; Banu, Parvin Akhter; Riaz, Masooma; Esentayeva, Surya; Kato, Shingo; Karasawa, Kumiko; Tsujii, Hirohiko

    2016-11-17

    A dose audit of 16 facilities in 11 countries has been performed within the framework of the Forum for Nuclear Cooperation in Asia (FNCA) quality assurance program. The quality of radiation dosimetry varies because of the large variation in radiation therapy among the participating countries. One of the most important aspects of international multicentre clinical trials is uniformity of absolute dose between centres. The National Institute of Radiological Sciences (NIRS) in Japan has conducted a dose audit of participating countries since 2006 by using radiophotoluminescent glass dosimeters (RGDs). RGDs have been successfully applied to a domestic postal dose audit in Japan. The authors used the same audit system to perform a dose audit of the FNCA countries. The average and standard deviation of the relative deviation between the measured and intended dose among 46 beams was 0.4% and 1.5% (k = 1), respectively. This is an excellent level of uniformity for the multicountry data. However, of the 46 beams measured, a single beam exceeded the permitted tolerance level of ±5%. We investigated the cause for this and solved the problem. This event highlights the importance of external audits in radiation therapy.

  8. Calibration test of PET scanners in a multi-centre clinical trial on breast cancer therapy monitoring using 18F-FLT.

    Directory of Open Access Journals (Sweden)

    Francis Bouchet

    Full Text Available UNLABELLED: A multi-centre trial using PET requires the analysis of images acquired on different systems We designed a multi-centre trial to estimate the value of 18F-FLT-PET to predict response to neoadjuvant chemotherapy in patients with newly diagnosed breast cancer. A calibration check of each PET-CT and of its peripheral devices was performed to evaluate the reliability of the results. MATERIAL AND METHODS: 11 centres were investigated. Dose calibrators were assessed by repeated measurements of a 68Ge certified source. The differences between the clocks associated with the dose calibrators and inherent to the PET systems were registered. The calibration of PET-CT was assessed with an homogeneous cylindrical phantom by comparing the activities per unit of volume calculated from the dose calibrator measurements with that measured on 15 Regions of Interest (ROIs drawn on 15 consecutive slices of reconstructed filtered back-projection (FBP images. Both repeatability of activity concentration based upon the 15 ROIs (ANOVA-test and its accuracy were evaluated. RESULTS: There was no significant difference for dose calibrator measurements (median of difference -0.04%; min = -4.65%; max = +5.63%. Mismatches between the clocks were less than 2 min in all sites and thus did not require any correction, regarding the half life of 18F. For all the PET systems, ANOVA revealed no significant difference between the activity concentrations estimated from the 15 ROIs (median of difference -0.69%; min = -9.97%; max = +9.60%. CONCLUSION: No major difference between the 11 centres with respect to calibration and cross-calibration was observed. The reliability of our 18F-FLT multi-centre clinical trial was therefore confirmed from the physical point of view. This type of procedure may be useful for any clinical trial involving different PET systems.

  9. Multi-Centrality Graph Spectral Decompositions and Their Application to Cyber Intrusion Detection

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Pin-Yu; Choudhury, Sutanay; Hero, Alfred

    2016-03-01

    Many modern datasets can be represented as graphs and hence spectral decompositions such as graph principal component analysis (PCA) can be useful. Distinct from previous graph decomposition approaches based on subspace projection of a single topological feature, e.g., the centered graph adjacency matrix (graph Laplacian), we propose spectral decomposition approaches to graph PCA and graph dictionary learning that integrate multiple features, including graph walk statistics, centrality measures and graph distances to reference nodes. In this paper we propose a new PCA method for single graph analysis, called multi-centrality graph PCA (MC-GPCA), and a new dictionary learning method for ensembles of graphs, called multi-centrality graph dictionary learning (MC-GDL), both based on spectral decomposition of multi-centrality matrices. As an application to cyber intrusion detection, MC-GPCA can be an effective indicator of anomalous connectivity pattern and MC-GDL can provide discriminative basis for attack classification.

  10. Sporadic multicentric right atrial and right ventricular myxoma presenting as acute pulmonary thromboembolism

    Directory of Open Access Journals (Sweden)

    Satyajit Singh

    2016-01-01

    Full Text Available Multicentric cardiac myxoma is a rare syndrome; usually it is familial. We report a rare case of sporadic right atrium (RA and right ventricle (RV myxoma in a 26-year-old female presenting to our hospital for the evaluation of sudden onset of dyspnea and left precordial pain attributed to the embolization of degenerating tumor fragments to the pulmonary artery (PA. The exact incidence of sporadic multicentric RA and RV myxoma presenting as acute pulmonary embolism is unknown as multicentric RA and RV myxoma are very rare. Myxomas presenting as pulmonary embolism is <10%. Majority of cardiac myxomas present as exertional dyspnea, chest pain, positional syncope, fever, weight loss and other constitutional symptoms. Any young patient presenting with acute onset dyspnea with multiple cardiac masses may have tumor embolization to the PA diagnosis with transthoracic echocardiography and high-resolution computed tomography of thorax, fast-tracks patient transfer for urgent cardiac surgery to prevent further embolization.

  11. Synchronous Multicentric Giant Cell Tumour of Distal Radius and Sacrum with Pulmonary Metastases

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    Varun Sharma Tandra

    2015-01-01

    Full Text Available Giant cell tumour (GCT is an uncommon primary bone tumour, and its multicentric presentation is exceedingly rare. We report a case of a 45-year-old female who presented to us with GCT of left distal radius. On the skeletal survey, osteolytic lesion was noted in her right sacral ala. Biopsy confirmed both lesions as GCT. Pulmonary metastasis was also present. Resection-reconstruction arthroplasty for distal radius and thorough curettage and bone grafting of the sacral lesion were done. Multicentric GCT involving distal radius and sacrum with primary sacral involvement is not reported so far to our knowledge.

  12. Multicentric Gliomas Misdiagnosed as Metastatic Tumors: One Case Report and Literature Review

    Institute of Scientific and Technical Information of China (English)

    Peng WANG; Ming-can WU; Shi-jie CHEN; Yong YANG; Guang-rui ZHAO

    2010-01-01

    @@ Introduction Multicentric gliomas are considered to be well recognized but uncommon; often scatter widely in different lobes or hemispheres; and cannot be attributed to a definite pathway[1]. A patient diagnosed as multicentric gliomas is presented in this paper. He was fi rstly misdiagnosed as cerebral metastatic tumors, but later the histopathological examination revealed them to be glioblastoma (WHO grade IV). Additionally, the aim of the paper was to describe the case history of the patient and the problems encountered in the pathogenesis, pathophysiology, diagnosis and treatment.

  13. Osteoid Osteoma with a Multicentric Nidus: Interstitial Laser Ablation under MRI Guidance

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    David Kaul

    2013-01-01

    Full Text Available Osteoid osteoma (OO is a common benign tumor of the bone and is typically treated by thermal ablation with computed tomography (CT guidance. Only a few cases of multicentric OO have been described. We here report the case of an 11-year-old boy with multicentric OO of the right femur treated with laser ablation under open high-field MRI guidance. The steps of the interventional MRI procedure are described, discussing the benefits and disadvantages of MRI versus CT guidance especially with regard to younger patients.

  14. Sensitivity of imaging for multifocal-multicentric breast carcinoma

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    Viale Giuseppe

    2008-09-01

    Full Text Available Abstract Background This retrospective study aims to determine: 1 the sensitivity of preoperative mammography (Mx and ultrasound (US, and re-reviewed Mx to detect multifocal multicentric breast carcinoma (MMBC, defined by pathology on surgical specimens, and 2 to analyze the characteristics of both detected and undetected foci on Mx and US. Methods Three experienced breast radiologists re-reviewed, independently, digital mammography of 97 women with MMBC pathologically diagnosed on surgical specimens. The radiologists were informed of all neoplastic foci, and blinded to the original mammograms and US reports. With regards to Mx, they considered the breast density, number of foci, the Mx characteristics of the lesions and their BI-RADS classification. For US, they considered size of the lesions, BI-RADS classification and US pattern and lesion characteristics. According to the histological size, the lesions were classified as: index cancer, 2nd lesion, 3rd lesion, and 4th lesion. Any pathologically identified malignant foci not previously described in the original imaging reports, were defined as undetected or missed lesions. Sensitivity was calculated for Mx, US and re-reviewed Mx for detecting the presence of the index cancer as well as additional satellite lesions. Results Pathological examination revealed 13 multifocal and 84 multicentric cancers with a total of 303 malignant foci (282 invasive and 21 non invasive. Original Mx and US reports had an overall sensitivity of 45.5% and 52.9%, respectively. Mx detected 83/97 index cancers with a sensitivity of 85.6%. The number of lesions undetected by original Mx was 165/303. The Mx pattern of breasts with undetected lesions were: fatty in 3 (1.8%; scattered fibroglandular density in 40 (24.3%, heterogeneously dense in 91 (55.1% and dense in 31 (18.8% cases. In breasts with an almost entirely fatty pattern, Mx sensitivity was 100%, while in fibroglandular or dense pattern it was reduced to 45

  15. Variability in prescription drug expenditures explained by adjusted clinical groups (ACG case-mix: A cross-sectional study of patient electronic records in primary care

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    Serrat Josep

    2008-03-01

    Full Text Available Abstract Background In view of rapidly increasing prescription costs, case-mix adjustment should be considered for effective control of costs. We have estimated the variability in pharmacy costs explained by ACG in centers using patient electronic records, profiled centers and physicians and analyzed the correlation between cost and quality of prescription. Methods We analyzed 65,630 patient records attending five primary care centers in Spain during 2005. Variables explored were age, gender, registered diagnosed episodes of care during 2005, total cost of prescriptions, physician and center. One ACG was assigned to each patient with ACG case-mix software version 7.1. In a two-part model, logistic regression was used to explain the incurrence of drug expenditure at the first stage and a linear mixed model that considered the multilevel structure of data modeled the cost, conditional upon incurring any expense. Risk and efficiency indexes in pharmacy cost adjusted for ACG were obtained for centers and physicians. Spearman rank correlation between physician expenditure, adjusted for ACG, and a prescription quality index was also obtained. Pediatric and adult data were analyzed separately. Results No prescription was recorded for 13% of adults and 39.6% of children. The proportion of variance of the incurrence of expenditure explained by ACGs was 0.29 in adults and 0.21 in children. For adults with prescriptions, the variance of cost explained by ACGs was 35.4%, by physician-center was 1.8% and age 10.5% (residual 52.3%. For children, ACGs explained 22.4% of cost and physician-center 10.9% (residual 66.7%. Center efficiency index for adults ranged 0.58 to 1.22 and for children 0.32 to 2.36. Spearman correlation between expenditure and prescription quality index was -0.36 in family physicians (p = 0.019, N = 41 and -0.52 in pediatricians (p = 0.08, N = 12. Conclusion In our setting, ACG is the variable studied that explains more variability in

  16. Multicentre prospective validation of a urinary peptidome-based classifier for the diagnosis of type 2 diabetic nephropathy

    Science.gov (United States)

    Siwy, Justyna; Schanstra, Joost P.; Argiles, Angel; Bakker, Stephan J.L.; Beige, Joachim; Boucek, Petr; Brand, Korbinian; Delles, Christian; Duranton, Flore; Fernandez-Fernandez, Beatriz; Jankowski, Marie-Luise; Al Khatib, Mohammad; Kunt, Thomas; Lajer, Maria; Lichtinghagen, Ralf; Lindhardt, Morten; Maahs, David M; Mischak, Harald; Mullen, William; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Persson, Frederik; Petrie, John R.; Roob, Johannes M.; Rossing, Peter; Ruggenenti, Piero; Rychlik, Ivan; Serra, Andreas L.; Snell-Bergeon, Janet; Spasovski, Goce; Stojceva-Taneva, Olivera; Trillini, Matias; von der Leyen, Heiko; Winklhofer-Roob, Brigitte M.; Zürbig, Petra; Jankowski, Joachim

    2014-01-01

    Background Diabetic nephropathy (DN) is one of the major late complications of diabetes. Treatment aimed at slowing down the progression of DN is available but methods for early and definitive detection of DN progression are currently lacking. The ‘Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria trial’ (PRIORITY) aims to evaluate the early detection of DN in patients with type 2 diabetes (T2D) using a urinary proteome-based classifier (CKD273). Methods In this ancillary study of the recently initiated PRIORITY trial we aimed to validate for the first time the CKD273 classifier in a multicentre (9 different institutions providing samples from 165 T2D patients) prospective setting. In addition we also investigated the influence of sample containers, age and gender on the CKD273 classifier. Results We observed a high consistency of the CKD273 classification scores across the different centres with areas under the curves ranging from 0.95 to 1.00. The classifier was independent of age (range tested 16–89 years) and gender. Furthermore, the use of different urine storage containers did not affect the classification scores. Analysis of the distribution of the individual peptides of the classifier over the nine different centres showed that fragments of blood-derived and extracellular matrix proteins were the most consistently found. Conclusion We provide for the first time validation of this urinary proteome-based classifier in a multicentre prospective setting and show the suitability of the CKD273 classifier to be used in the PRIORITY trial. PMID:24589724

  17. The financial benefits of acute inpatient palliative medicine: an inter-institutional comparative analysis by all patient refined-diagnosis related group and case mix index.

    Science.gov (United States)

    Davis, Mellar P; Walsh, Declan; LeGrand, Susan B; Lagman, Ruth L; Harrison, Betty; Rybicki, Lisa

    2005-01-01

    Financial comparisons of acute care hospital services are possible using the Centers for Medicare & Medicaid Services case mix index (CMI) and All Patient Refined-Diagnosis Related Group (APR-DRG) data. We compared The Cleveland Clinic's Inpatient Palliative Medicine (CCIPM) acute care unit's CMI and APR-DRG data with national and peer institution data. Total mean charges per admission to the CCIPM unit were 7,800 dollars lower than at other peer institutions despite an equivalent severity of illness and longer length of stay and higher mortality in the CCIPM unit. The lower charges were due primarily to lower laboratory and pharmaceutical charges. We conclude that an acute inpatient palliative medicine unit operating within a comprehensive integrated palliative medicine program is cost-effective in providing specialized care for people with advanced disease.

  18. Lung volume reduction coil treatment for patients with severe emphysema : a European multicentre trial

    NARCIS (Netherlands)

    Deslee, Gaetan; Klooster, Karin; Hetzel, Martin; Stanzel, Franz; Kessler, Romain; Marquette, Charles-Hugo; Witt, Christian; Blaas, Stefan; Gesierich, Wolfgang; Herth, Felix J. F.; Hetzel, Juergen; van Rikxoort, Eva M.; Slebos, Dirk-Jan

    2014-01-01

    Background The lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial

  19. Violent women : A multicentre study into gender differences in forensic psychiatric patients

    NARCIS (Netherlands)

    de Vogel, Vivienne; Stam, Jeantine; Bouman, Yvonne H. A.; Ter Horst, P.R.M.; Lancel, Marike

    2016-01-01

    To gain insight into the relatively small, but increasing group of women in forensic psychiatry, a retrospective multicentre study was started gathering information from the files of 275 female patients of four Dutch forensic psychiatric hospitals on characteristics and violence risk factors. Overal

  20. An international multicentre study on the allergenic activity of air-oxidized R-limonene

    DEFF Research Database (Denmark)

    Bråred Christensson, Johanna; Andersen, Klaus; Bruze, Magnus;

    2013-01-01

    Limonene is a common fragrance terpene that, in its pure form, is not allergenic or is a very weak allergen. However, limonene autoxidizes on air exposure, and the oxidation products can cause contact allergy. Oxidized R-limonene has previously been patch tested in multicentre studies, giving 2...

  1. Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

    NARCIS (Netherlands)

    de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

    1999-01-01

    Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

  2. Effects of acarbose (Glucobay) in persons with type 1 diabetes : a multicentre study

    NARCIS (Netherlands)

    Sels, J P; Verdonk, H E; Wolffenbuttel, B H

    1998-01-01

    The aim of this multicentre study was to investigate the effect--in everyday life--of long term administration of acarbose on parameters of glycaemic control, daily insulin requirements, lipid parameters and tolerability in ambulant type 1 diabetic subjects insufficiently controlled with diet and in

  3. Psychometric Properties of the Manchester Child Attachment Story Task: An Italian Multicentre Study

    Science.gov (United States)

    Barone, Lavinia; Del Giudice, Marco; Fossati, Andrea; Manaresi, Francesca; Perinetti, Barbara Actis; Colle, Livia; Veglia, Fabio

    2009-01-01

    The paper describes a multicentre study of the psychometric properties of the Manchester Child Attachment Story Task in a sample of 230 Italian children aged 4 to 8 years. The task's internal consistency and inter-rater reliability were investigated; in addition, multiple discriminant analysis was used to explore the contribution of individual…

  4. Het sluitstuk van de laparotomie : een prospectief, gerandomiseerd, multicentre onderzoek naar de resultaten van fasciesluiting

    NARCIS (Netherlands)

    J.C. Wissing

    1988-01-01

    textabstractDit proefschrift beschrijft de resultaten van een perspectief gerandcmiseerd multicentre onderzoek bij 1539 patienten naar de wondgenezing na een mediane laparotamie en dan met nane de genezing van de fascie, waarbij de invloed van diverse hechtmaterialen en van twee verschillende hechtt

  5. Multicentre chest computed tomography standardisation in children and adolescents with cystic fibrosis

    DEFF Research Database (Denmark)

    Kuo, Wieying; Kemner-van de Corput, Mariette P. C.; Perez-Rovira, Adria

    2016-01-01

    was found in CT protocols, image quality and radiation dose usage among the centres. However, the performance of all CT scanners was found to be very similar, when taking spatial resolution and radiation dose into account. We conclude that multicentre standardisation of chest CT in children and adolescents...

  6. Prophylactic efficacy of lithium administered every second day: a WHO multicentre study

    DEFF Research Database (Denmark)

    Plenge, P; Amin, M; Agarwal, A K

    1999-01-01

    OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montreal...

  7. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

  8. Violent women : a multicentre study into gender differences in forensic psychiatric patients

    NARCIS (Netherlands)

    de Vogel, Vivienne; Stam, Jeantine; Bouman, Yvonne H. A.; Ter Horst, P.R.M.; Lancel, Marike

    2016-01-01

    To gain insight into the relatively small, but increasing group of women in forensic psychiatry, a retrospective multicentre study was started gathering information from the files of 275 female patients of four Dutch forensic psychiatric hospitals on characteristics and violence risk factors. Overal

  9. Proposal for the standardisation of multi-centre trials in nuclear medicine imaging

    DEFF Research Database (Denmark)

    Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez;

    2012-01-01

    Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...

  10. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  11. Prevalence of β-thalassemia and other haemoglobinopathies in six cities in India: a multicentre study.

    Science.gov (United States)

    Mohanty, D; Colah, R B; Gorakshakar, A C; Patel, R Z; Master, D C; Mahanta, J; Sharma, S K; Chaudhari, U; Ghosh, M; Das, S; Britt, R P; Singh, S; Ross, C; Jagannathan, L; Kaul, R; Shukla, D K; Muthuswamy, V

    2013-01-01

    The population of India is extremely diverse comprising of more than 3,000 ethnic groups who still follow endogamy. Haemoglobinopathies are the commonest hereditary disorders in India and pose a major health problem. The data on the prevalence of β-thalassemias and other haemoglobinopathies in different caste/ethnic groups of India is scarce. Therefore the present multicentre study was undertaken in six cities of six states of India (Maharashtra, Gujarat, West Bengal, Assam, Karnataka and Punjab) to determine the prevalence of haemoglobinopathies in different caste/ethnic groups using uniform methodology. Fifty-six thousand seven hundred eighty individuals (college students and pregnant women) from different caste/ethnic groups were screened. RBC indices were measured on an automated haematology counter while the percentage of HbA(2), HbF and other abnormal Hb variants were estimated by HPLC on the Variant Hemoglobin Testing System. The overall prevalence of β-thalassemia trait was 2.78 % and varied from 1.48 to 3.64 % in different states, while the prevalence of β-thalassemia trait in 59 ethnic groups varied from 0 to 9.3 %. HbE trait was mainly seen in Dibrugarh in Assam (23.9 %) and Kolkata in West Bengal (3.92 %). In six ethnic groups from Assam, the prevalence of HbE trait varied from 41.1 to 66.7 %. Few subjects with δβ-thalassemia, HPFH, HbS trait, HbD trait, HbE homozygous and HbE β-thalassemia as well as HbS homozygous and HbS-β-thalassemia (India.

  12. Relationship between radiological grading and clinical status in knee osteoarthritis. a multicentric study

    Directory of Open Access Journals (Sweden)

    Hernández-Vaquero Daniel

    2012-10-01

    Full Text Available Abstract Background Controversy exists regarding the relationship between radiographic findings and clinical status in knee osteoarthritis. Although the surgical indication for total knee arthroplasty (TKA should be based on pain, clinical status, and the deterioration of quality of life, the radiographic study is the most commonly used criterion for preoperative evaluation. The objective of this study is to find out the relationship between the Ahlbäck classification and clinical status in patients undergoing TKA. Methods 1329 protocols were collected from preoperative studies in four multicentric working groups (the Interax, Duracon, Scorpio, and Triathlon Spanish groups in 30 Spanish hospitals. Mean age was 70.4 years (SD: 6.8; range: 35 to 98; 76.3% of patients were women. Patients entered the study whenever the surgeon found that medical treatment was insufficient to control pain and functional limitation. Data were collected using electronic Case Report Forms, and included Ahlbäck grading scores, Hospital for Special Surgery Knee Score (HSS, SF-12, and other clinical and epidemiologic variables. Results According to the Ahlbäck grading system, patients were divided as follows: 243 grade I (18.3%, 358 grade II (26.9%, 416 grade III (31.3%, 241 grade IV (18.1%, and 71 grade V (5.3%. As for HSS, the following scores were obtained: Conclusions We found a relationship between Ahlbäck grading and the preoperative clinical score. The range of variability of the HSS score between the different Ahlbäck grades is small.

  13. 76 FR 47835 - Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal...

    Science.gov (United States)

    2011-08-05

    ... factors, we have continued to find unusually large year-to-year fluctuations in the teaching status... for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology and.... Analysis and Responses to Public Comments IV. Update to the Case-Mix Group (CMG) Relative Weights...

  14. E-learning in radiology: An Italian multicentre experience

    Energy Technology Data Exchange (ETDEWEB)

    Carriero, A., E-mail: profcarriero@virgilio.it [Istituto di Radiologia Diagnostica ed Interventistica, AOU Maggiore della Carità, Corso Mazzini 18, 28100 Novara (Italy); Bonomo, L., E-mail: lbonomo@rm.unicatt.it [Istituto di Radiologia, Università Cattolica del S.Cuore, Largo Gemelli 8, 00168 Roma (Italy); Calliada, F., E-mail: f.calliada@smatteo.pv.it [Istituto di Radiologia c/o IRCCS Policlinico San Matteo Ospedale Generale Regionale, Piazzale Golgi 27100, Pavia (Italy); Campioni, P., E-mail: paolo.campioni@unife.it [Dipartimento di Scienze Chirurgiche, Radiologiche e Anestesiologiche, Sezione di Diagnostica per Immagini, Università di Ferrara Corso della Giovecca No. 203, 44100, Ferrara (Italy); Colosimo, C., E-mail: colosimo@rm.unicatt.it [Istituto di Radiologia, Università Cattolica del S.Cuore, Largo Gemelli 8, 00168 Roma (Italy); Cotroneo, A., E-mail: ar.cotroneo@rad.unich.it [Istituto di Radiologia, Università degli Studi Di Chieti (Italy); Cova, M., E-mail: cova@gnbts.univ.trieste.it [UCO di Radiologia, Ospedale di Cattinara, Strada di Fiume 447, 34149 Trieste (Italy); Ettorre, G.C., E-mail: g.ettorre@unict.it [Dip. Materno-Infantile e Scienze Radiologiche, Az. Ospedaliero-Universitaria Policlinico, Via S. Sofia 86, 95123 Catania (Italy); Fugazzola, C., E-mail: carlo.fugazzola@uninsubria.it [Dipartimento di Radiologia Ospedale Di Circolo, Viale Borri, No. 57, 21100, Varese (Italy); Garlaschi, G., E-mail: giacomog@unige.it [Dipartimento di Medicina interna e Specialità mediche (DIMI) Via L.B. Alberti, 4, 16132 Genova (Italy); Macarini, L., E-mail: l.macarini@unifg.it [Radiologia Universitaria Ospedali Riuniti di Foggia, Viale Pinto, No. 1, 71100, Foggia (Italy); and others

    2012-12-15

    the band speed and technology of the Internet connection. Conclusions: Technological evolution is overcoming all barriers, and technology is also having a positive impact on the approach to teaching. Our multicentre teaching experience merits the following considerations: the quality of the teaching product was certified by the students’ judgements of its didactic content and the quality of reception; the economic cost of the teaching had a minimal impact on the post-graduate schools (€ 18 per lesson). In terms of breaking down national barriers, it is to be hoped that the coordination and integration of diagnostic imaging e-learning projects, with the participation of post-graduate schools in different European countries, can be developed not only in a spirit of “cultural sharing” and the exchange of teaching experiences.

  15. Papillary tumor of the pineal region: report of a rapidly progressive tumor with possible multicentric origin

    Energy Technology Data Exchange (ETDEWEB)

    Sato, Takashi S. [University of Iowa, Carver College of Medicine, Iowa City, IA (United States); Kirby, Patricia A. [University of Iowa, Department of Pathology, Iowa City, IA (United States); Buatti, John M. [University of Iowa, Department of Radiation Oncology, Iowa City, IA (United States); Moritani, Toshio [University of Iowa Hospitals and Clinics, Department of Radiology, Iowa City, IA (United States)

    2009-02-15

    Papillary tumor of the pineal region (PTPR) is an uncommon tumor recently added to the WHO classification of CNS tumors. We report a case of PTPR in a young boy that was noteworthy for early CSF dissemination and relentless progression. In spite of intensive chemotherapy and comprehensive radiotherapy, the boy died. The neuroimaging appearance is unique with possible multicentric origin of the tumor and intense uptake of {sup 111}In-DTPA-pentetreotide. (orig.)

  16. B-cell multicentric lymphoma as a probable cause of abortion in a Quarter horse broodmare.

    Science.gov (United States)

    Canisso, Igor F; Pinn, Toby L; Gerdin, Jodie A; Ollivett, Theresa L; Buckles, Elizabeth L; Schweizer, Christine M; Ainsworth, Dorothy M

    2013-03-01

    A 5-year-old Quarter horse broodmare was evaluated for inappetence, depression, and diarrhea 13 days after aborting a 9-month gestation fetus. Clinical and laboratory examination ruled out uterine rupture and peritonitis. Ultrasonography of the uterus combined with cytological analysis of peritoneal fluid suggested the existence of diffuse lymphoma. A multicentric B-cell lymphoma involving the uterus and ovary was confirmed at necropsy and histopathological examination.

  17. A large-scale multicentre cerebral diffusion tensor imaging study in amyotrophic lateral sclerosis

    OpenAIRE

    Muller, Hans-Peter; R Turner, Martin; Grosskreutz, Julian; Abrahams, Sharon; Bede, Peter; Govind, Varan; Prudlo, Johannes; Ludolph, Albert C.; Filippi, Massimo; Kassubek, Jan

    2016-01-01

    Objective: Damage to the cerebral tissue structural connectivity associated with amyotrophic lateral sclerosis (ALS), which extends beyond the motor pathways, can be visualized by diffusion tensor imaging (DTI). The effective translation of DTI metrics as biomarker requires its application across multiple magnetic resonance imaging scanners and patient cohorts. A multi-centre study was undertaken to assess structural connectivity in ALS at a large sample size. Methods: Four-hundred-and-forty-...

  18. Correcting waveform bias using principal component analysis: Applications in multicentre motion analysis studies.

    Science.gov (United States)

    Clouthier, Allison L; Bohm, Eric R; Rudan, John F; Shay, Barbara L; Rainbow, Michael J; Deluzio, Kevin J

    2017-01-01

    Multicentre studies are rare in three dimensional motion analyses due to challenges associated with combining waveform data from different centres. Principal component analysis (PCA) is a statistical technique that can be used to quantify variability in waveform data and identify group differences. A correction technique based on PCA is proposed that can be used in post processing to remove nuisance variation introduced by the differences between centres. Using this technique, the waveform bias that exists between the two datasets is corrected such that the means agree. No information is lost in the individual datasets, but the overall variability in the combined data is reduced. The correction is demonstrated on gait kinematics with synthesized crosstalk and on gait data from knee arthroplasty patients collected in two centres. The induced crosstalk was successfully removed from the knee joint angle data. In the second example, the removal of the nuisance variation due to the multicentre data collection allowed significant differences in implant type to be identified. This PCA-based technique can be used to correct for differences between waveform datasets in post processing and has the potential to enable multicentre motion analysis studies.

  19. Reliability of the North Star Ambulatory Assessment in a multicentric setting.

    Science.gov (United States)

    Mazzone, E S; Messina, S; Vasco, G; Main, M; Eagle, M; D'Amico, A; Doglio, L; Politano, L; Cavallaro, F; Frosini, S; Bello, L; Magri, F; Corlatti, A; Zucchini, E; Brancalion, B; Rossi, F; Ferretti, M; Motta, M G; Cecio, M R; Berardinelli, A; Alfieri, P; Mongini, T; Pini, A; Astrea, G; Battini, R; Comi, G; Pegoraro, E; Morandi, L; Pane, M; Angelini, C; Bruno, C; Villanova, M; Vita, G; Donati, M A; Bertini, E; Mercuri, E

    2009-07-01

    The aim of this study was to investigate the suitability of the North Star Ambulatory Assessment as a possible outcome measure in multicentric clinical trials. More specifically we wished to investigate the level of training needed for achieving a good interobserver reliability in a multicentric setting. The scale was specifically designed for ambulant children with Duchenne Muscular Dystrophy and includes 17 items that are relevant for this cohort. Thirteen Italian centers participated in the study. In the first phase of the study we provided two training videos and an example of the scale performed on a child. After the first session of training, all the 13 examiners were asked to send a video with an assessment performed in their centre and to score all the videos collected. There were no difficulties in performing the items and in obtaining adequate videos with a hand held camera but the results showed a poor interobserver reliability (<.5). After a second training session with review and discussion of the videos previously scored, the same examiners were asked to score three new videos. The results of this session had an excellent interobserver reliability (.995). The level of agreement was maintained even when the same videos were rescored after a month, showing a significant intra-observer reliability (.95). Our results suggest that the NSAA is a test that can be easily performed, completed in 10 min and can be used in a multicentric setting, providing that adequate training is administered.

  20. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  1. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liang Zhao-Hui

    2012-07-01

    Full Text Available Abstract Background Neck pain is one of the chief symptoms of cervical spondylosis (CS. Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ and The Short Form (36 Health Survey (SF-36 are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA for primary and secondary outcomes of group and time differences. Adverse events (AEs will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the

  2. A toolbox for tuberculosis diagnosis: an Indian multicentric study (2006-2008: microbiological results.

    Directory of Open Access Journals (Sweden)

    Philippe H Lagrange

    Full Text Available BACKGROUND: The aim of this multicentric prospective study in India was to assess the value of several microbiological tools that contribute to the diagnosis of tuberculosis (TB according to HIV status. METHODS: Standard microbiological tools on individual specimens were analyzed. RESULTS: Among the 807 patients with active TB, 131 were HIV-infected, 316 HIV-uninfected and 360 had HIV-unknown status. Among the 980 non-active TB subjects, 559 were at low risk and 421 were at high risk of M. tuberculosis (Mtb exposure. Sensitivity of smear microscopy (SM was significantly lower in HIV-infected (42.2% than HIV-uninfected (75.9% (p = 0.0001 and HIV-unknown pulmonary TB patients (61.4% (p = 0.004. Specificity was 94.5% in non-TB patients and 100% in health care workers (HCW and healthy family contacts. Automated liquid culture has significantly higher diagnostic performances than solid culture, measured by sensitivity (74.7% vs. 55.9% (p = 0.0001 and shorter median time to detection (TTD (12.0 vs. 34.0 days (p = 0.0001. Specificity was 100% in HCW and cured-TB patients, but was lower in non-TB patients (89% due to isolation of Mycobacteria other than tuberculosis (MOTT. TTD by both methods was related to AFB score. Contamination rate was low (1.4%. AccuProbe hybridization technique detected Mtb in almost all culture-positive specimens, but MOTT were found in 4.7% with a significantly higher frequency in HIV-infected (15% than HIV-uninfected TB patients (0.5% (p = 0.0007. Pre-test classification significantly increased the diagnostic value of all microbiological tests in pulmonary TB patients (p<0.0001 but to a lesser degree in extrapulmonary TB patients. CONCLUSIONS: Conventional microbiological tools led to results similar to those already described in India special features for HIV-infected TB patients included lower detection by SM and culture. New microbiological assays, such as the automated liquid culture system, showed increased accuracy and

  3. End-Stage Renal Disease Prospective Payment System

    Data.gov (United States)

    U.S. Department of Health & Human Services — This final rule implements a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities...

  4. Endocervical glandular involvement, multicentricity, and extent of the disease are features of high-grade cervical intraepithelial neoplasia.

    Science.gov (United States)

    Güdücü, Nilgün; Sidar, Güliz; Başsüllü, Nuray; Türkmen, Ilknur; Dünder, Ilkkan

    2013-08-01

    This study aimed to evaluate the rate of endocervical glandular involvement, positive surgical margins, multicentricity, and disease extent between low-grade and high-grade cervical intraepithelial lesions after loop electrosurgical excision procedure (LEEP). Pathology medical records of patients who underwent LEEP were reviewed retrospectively. Patients with negative LEEP results were excluded. Loop electrosurgical excision procedure reports of patients with cervical intraepithelial neoplasia (CIN) 1, 2, and 3 were compared. There was no statistically significant difference between patients with CIN 1 (n=24), CIN 2 (n=27), and CIN 3 (n=64) when age and surgical margin positivity were considered. Endocervical glandular involvement, multicentricity, and disease extent were higher in patients with CIN 3 (P=.001, P=.002, and P=.001, respectively). In conclusion, we recommend that patients with endocervical glandular involvement, lesions involving more than two-thirds of the LEEP specimen, and multicentricity be followed up more closely.

  5. Interphase cytogenetics of multicentric renal cell tumours confirm associations of specific aberrations with defined cytomorphologies

    Science.gov (United States)

    Amo-Takyi, B K; Mittermayer, C; Günther, K; Handt, S

    2000-01-01

    To demonstrate associations of certain chromosomal aberrations with defined renal cell tumour (RCT) subtypes, we analysed 239 tumour nephrectomy cases for specimens with multicentric tumours. Chromosomal in situ hybridization was then performed on 15 cases with 34 foci (16 conventional renal cell carcinomas (RCCs), and 18 papillary RCTs (11 carcinomas and seven adenomas) for specific chromosomal aberrations, using α-satellite probes for chromosomes 3, 7 or 17. Particular preference was given to cases which had separate foci with different cytomorphologies. Furthermore, we compared aberrations in relation to tumour size, stage, grade and between different foci in a specimen. Thirty-four cases had multiple tumours. Forty-seven per cent of the multicentric tumours were conventional RCCs and 53% papillary RCTs (against 83% solitary conventional RCCs and 5% solitary papillary RCTs). Three conventional RCCs sized 8 mm (G3), 13 cm (pT2, G2) and 15 cm (pT3b, G3), respectively, revealed monosomy 3, and 13 were disomic. Seventeen papillary RCTs (11 carcinomas and six adenomas) displayed trisomy 17, irrespective of size or grade. Four papillary carcinomas and six papillary adenomas had trisomy 7, and the rest (seven papillary carcinomas and one papillary adenoma) revealed disomy 7. In conclusion, papillary RCTs were tendentially multicentric. Although specific for conventional RCCs heedless of size, monosomy 3 was only observed in high-grade and/or advanced tumours. Trisomy 17 was only detectable in papillary RCTs irrespective of tumour state, showing increased copies with tumour growth. Papillary RCTs also appeared to lose some copies of chromosome 7 with tumour progress, possibly reflecting malignancy. © 2000 Cancer Research Campaign PMID:10780519

  6. Obstetric risk indicators for labour dystocia in nulliparous women: a multi-centre cohort study

    DEFF Research Database (Denmark)

    Kjaergaard, H.; Olsen, J.; Ottesen, Bent Smedegaard

    2008-01-01

    BACKGROUND: In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors...... for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. METHODS: A multi-centre population based cohort study with prospectively collected data from 2810......: The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix

  7. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial

    OpenAIRE

    Kraft Matthias; Kraft Kathleen; Gärtner Simone; Mayerle Julia; Simon Peter; Weber Eckhard; Schütte Kerstin; Stieler Jens; Koula-Jenik Heide; Holzhauer Peter; Gröber Uwe; Engel Georg; Müller Cornelia; Feng You-Shan; Aghdassi Ali

    2012-01-01

    Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g) or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM)...

  8. Non conventional psychiatric rehabilitation in schizophrenia using therapeutic riding: the FISE multicentre Pindar project

    Directory of Open Access Journals (Sweden)

    Stefania Cerino

    2011-12-01

    Full Text Available The FISE (Federazione Italiana Sport Equestri Pindar is a multicentre research project aimed at testing the potential effects of therapeutic riding on schizophrenic patients. Twenty-four subjects with a diagnosis of schizophrenia were enrolled for a 1 year-treatment involving therapeutic riding sessions. All subjects were tested at the beginning and at the end of treatment with a series of validated test batteries (BPRS and 8 items-PANSS. The results discussed in this paper point out an improvement in negative symptoms, a constant disease remission in both early onset and chronic disease subjects, as well as a reduced rate of hospitalization.

  9. Evaluation of multicentre clinical trial data using adaptations of the Mosteller-Tukey procedure.

    Science.gov (United States)

    Ciminera, J L; Heyse, J F; Nguyen, H H; Tukey, J W

    1993-06-15

    Two procedures, based on proposals discussed by Mosteller and Tukey, are described for obtaining a combined estimate of the difference between two treatment means and its confidence interval from multicentre clinical trial data. Both procedures provide estimates in the possible presence of heteroscedasticity. The first procedure is designated the primary analysis for efficacy assessment. It omits treatment-by-centre interaction from the error term for treatment, unless there is substantial evidence of qualitative interaction (Ciminera et al.) or other special circumstances. The second procedure is the primary analysis whenever there is substantial evidence of qualitative interaction, and can be used whenever there are other reasons to make an analysis allowing for interaction.

  10. Concomitant Kaposi sarcoma and multicentric Castleman's disease in a heart transplant recipient.

    Science.gov (United States)

    Patel, Ami; Bishburg, Eliahu; Zucker, Mark; Tsang, Patricia; Nagarakanti, Sandhya; Sabnani, Indu

    2014-01-01

    Post-transplant human herpes virus -8 (HHV-8)/Kaposi sarcoma herpes virus (KSHV) infection is associated with neoplastic and non-neoplastic diseases. Kaposi sarcoma (KS), multicentric Castleman's disease (MCD), and primary effusion lymphomas (PEL) are the most common HHV-8-associated neoplastic complications described in solid organ transplant (SOT) patients. Concurrent KS and MCD have been previously described after transplantation only twice - once after liver transplantation and once after renal transplantation. We describe a unique heart transplant patient who also developed concurrent KS and MCD. To our knowledge this is the first documented case of a heart transplant recipient presenting with these two HHV-8-mediated complications at the same time.

  11. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran

    OpenAIRE

    Mohsen MOLLA MOHAMMADI; TONEKABONI, Seyed Hassan; Khatami, Alireza; Azargashb, Eznollah; Tavasoli, Azita; Javadzadeh, Mohsen; Zamani, Gholamreza

    2013-01-01

    How to Cite This Article: Molla Mohammadi M, Tonekaboni SH, Khatami AR, Azargashb E, Tavasoli A, Javadzadeh M, Zamani GR. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran. Iran J Child Neurol. 2013 Autumn; 7(4):24-31.ObjectiveSeizure is an emergency in pediatrics. It really matters to the parents of the involved child to have information about the causes, management and prognosis.First unprovoked seizures (FUS) are seizures that occur in patients without feve...

  12. A Case of Multicentric Carcinoid in a Patient with Psoriatic Spondyloarthropathy

    Directory of Open Access Journals (Sweden)

    Nabil George

    2015-01-01

    Full Text Available We describe the first case of a patient presenting with multicentric carcinoid occurring in the lung and subsequently in the rectum, with chronic psoriatic arthritis. Although reports have been published regarding carcinoid syndrome occurring alongside rheumatoid arthritis, no reports have been made on such a case. Initial presentation of carcinoid syndrome in this patient was insidious and atypical with few symptoms, including shortness of breath and long standing abdominal bloating. Several years later a sudden change in bowel habit prompted a colonoscopy with biopsy that revealed a carcinoid rectal polyp. The case we report describes a rare presentation of carcinoid syndrome in chronic psoriatic arthropathy.

  13. Impacto de la adecuada codificación de la desnutrición y procesos asociados sobre el índice case-mix en patologías médicas y quirúrgicas

    Directory of Open Access Journals (Sweden)

    Jesús Manuel Morán López

    Full Text Available Introducción: la clasificación por procesos según el sistema de los grupos relacionados con el diagnóstico permite clasificar los diferentes procesos acorde a un consumo de recursos equivalentes. La complejidad de los procesos según el índice case-mix permite solicitar un mayor o menor presupuesto para la atención de los pacientes. La desnutrición tiene capacidad para aumentar el índice case-mix si bien en muchos casos este diagnóstico y el de los procesos nutricionales no se realizan de forma adecuada. Objetivo: determinar si la adecuada codificación de la desnutrición es capaz de aumentar el índice case-mix y si este aumento es dependiente de la documentación del mismo por un médico especialista, el tipo de proceso o el servicio de ingreso. Resultados: en una serie aleatorizada de 100 pacientes, la documentación de desnutrición y procesos asociados por parte de un médico especialista en Endocrinología y Nutrición produjo un aumento de 0,68 puntos en el índice case-mix (IC95: 0,48-0,88. El impacto fue mayor en procesos médicos que en quirúrgicos (0,42 puntos [IC95: 0,03-0,81]. Por servicios, el impacto fue positivo en Medicina Interna y Cirugía General. El tamaño muestral para el cálculo del resto de servicios no alcanzó tamaño muestral suficiente. Conclusión: el aumento de recursos humanos (médicos especialistas en Endocrinología y Nutrición es viable en términos de gestión por el aumento del índice case-mix dependiente de su presencia en un contexto de práctica clínica habitual, no de investigación.

  14. Familial aggregation of tinnitus: a European multicentre study.

    NARCIS (Netherlands)

    Hendrickx, J.J.; Demeester, K.; Topsakal, V.; Eyken, E. van; Fransen, E.; Maki-Torkko, E.; Hannula, S.; Jensen, M.; Tropitzsch, A.; Bonaconsa, A.; Mazzoli, M.; Espeso, A.; Verbruggen, K.; Huyghe, J.; Huygen, P.L.M.; Kremer, H.; Kunst, S.J.W.; Manninen, M.; Diaz-Lacava, A.N.; Steffens, M.; Parving, A.; Pyykko, I.; Dhooge, I.J.; Stephens, D.; Orzan, E.; Pfister, M.H.; Bille, M.; Sorri, M.; Cremers, C.W.R.J.; Laer, L. van; Camp, G. van; Wienker, T.F.; Heyning, P. van de

    2007-01-01

    INTRODUCTION AND AIM: Tinnitus is a common condition affecting approximately 20% of the older population. There is increasing evidence that changes in the central auditory system following cochlear malfunctioning are responsible for tinnitus. To date, few investigators have studied the influence of

  15. Pregnancy, chimerism and lupus nephritis : a multi-centre study

    NARCIS (Netherlands)

    Hovinga, I. C. L. Kremer; Koopmans, M.; Grootscholten, C.; van der Wal, A. M.; Bijl, M.; Derksen, R. H. W. M.; Voslcuyl, A. E.; de Heer, E.; Bruijn, J. A.; Berden, J. H. M.; Rajema, I. M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may he involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  16. Pregnancy, chimerism and lupus nephritis: a multi-centre study.

    NARCIS (Netherlands)

    Hovinga, I.C. Kremer; Koopmans, M.; Grootscholten, C.; Wal, A.M. van der; Bijl, M. van der; Derksen, R.H.; Voskuyl, A.E.; Heer, E. de; Bruijn, J.A.; Berden, J.H.M.; Bajema, I.M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may be involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  17. MULTICENTRIC T-CELL LYMPHOMA AND CUTANEOUS HEMANGIOSARCOMA IN A CAPTIVE CHEETAH (ACINONYX JUBATUS).

    Science.gov (United States)

    Lindemann, Dana M; Carpenter, James W; Nietfeld, Jerome C; Gonzalez, Estehela; Hallman, Mackenzie; Hause, Ben M

    2015-12-01

    A 13-yr-old intact male cheetah (Acinonyx jubatus) presented for evaluation after a 4-mo history of intermittent lethargy and increased expiratory effort. The clinical signs were initially noted after the diagnosis and death of its 13-yr-old male sibling with solitary hepatic T-cell lymphoma. Physical examination findings included thin body condition, harsh lung sounds, peripheral lymphadenopathy, and a cutaneous mass on the right medial tarsus and scrotum. Excisional biopsies diagnosed well-differentiated cutaneous hemangiosarcomas. Thoracic radiographs revealed a cranial mediastinal mass. Complete blood count and serum biochemical analyses showed a leukocytosis with persistent lymphocytosis, progressive azotemia, and markedly elevated alkaline phosphatase. Because of the cheetah's declining quality of life, euthanasia was elected. Postmortem examination, histopathology, and immunohistochemical staining revealed multicentric T-cell lymphoma. Feline leukemia virus (FeLV) enzyme-linked immunosorbent assay, FeLV polymerase chain reaction (whole blood), and viral metagenomic analysis were negative. This is the first case of cutaneous hemangiosarcoma and multicentric T-cell lymphoma reported in a FeLV-negative cheetah.

  18. Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

    Directory of Open Access Journals (Sweden)

    Alba Gómez-Cabello

    Full Text Available BACKGROUND: The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. PURPOSE: To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. MATERIALS AND METHODS: A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. RESULTS: For height, intra-rater technical errors of measurement (TEMs were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. CONCLUSION: The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

  19. Efficacy and safety of cerivastatin in the treatment of primary hypercholesterolemia: a multicentre, randomized, double-blind study.

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    Objective: To assess the efficacy and safety of cerivastatin in Chinese with primary hypercholesterolemia. Methods: The multicentre, randomized, double-blind, placebo-controlled, parallel group trial was conducted in 3 hospitals. After a 5-week single-blind run-in period (period A), 470 patients were randomized to receive cerivastatin 0.1mg (n=119), 0.2mg (n=

  20. Synchronous multicentric small hepatocellular carcinomas: Defining the capsule on high-frequency intraoperative ultrasonography with pathologic correction

    Energy Technology Data Exchange (ETDEWEB)

    Ahn, Jae Hong; Eom, Dae Woon; Ryu, Dae Shick; Park, Man Soo; Jung, Seung Mun; Choi, Kun Moo; Cheon, Gab Jin; Choi, Soo Jung; Jang, Hyuk Jai [Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung (Korea, Republic of)

    2016-08-15

    The aim of this study was to define the capsules of synchronous multicentric small hepatocellular carcinomas (HCCs) with use of high-frequency intraoperative ultrasonography (IOUS). Among the 131 consecutive patients undergoing hepatic resection and high-frequency IOUS for HCC, 16 synchronous multicentric small HCCs in 13 patients were histologically diagnosed in the resected specimens. High-frequency IOUS and pathologic findings of these lesions were compared, with particular focus on the presence and appearance of the capsule in or around each lesion. Synchronous multicentric small HCCs were pathologically classified into distinctly nodular (n=12) or vaguely nodular (n=4) types. All 12 distinctly nodular HCCs including six subcentimeter lesions showed detectable capsules on high-frequency IOUS and pathology. The capsules appeared as a hypoechoic rim containing hyperechoic foci (n=6), hypoechoic rim (n=5), or hyperechoic rim (n=1) with varying degrees of coverage around each lesion. Histologically, the capsules were composed of a combination of one to four layers consisting of a fibrous capsule, peritumoral fibrosis, prominent small vessels, and entrapped hepatic parenchyma. Synchronous multicentric small HCCs with distinctly nodular type, even at subcentimeter size, can show capsules with varying coverage and diverse echogenicity on high-frequency IOUS.

  1. Complete en bloc urinary exenteration for synchronous multicentric transitional cell carcinoma with sarcomatoid features in a hemodialysis patient

    Directory of Open Access Journals (Sweden)

    Tiberio M. Siqueira Jr

    2006-10-01

    Full Text Available The incidence of transitional cell carcinoma (TCC in patients submitted to hemodialysis is low. The presence of TCC with sarcomatoid features in this cohort is even scarcer. Herein, we describe a very rare case of synchronous multicentric muscle invasive bladder carcinoma with prostate invasion in a hemodialysis patient, submitted to complete en bloc urinary exenteration.

  2. Effects of an alert system on implantable cardioverter defibrillator-related anxiety

    DEFF Research Database (Denmark)

    Duru, Firat; Dorian, Paul; Favale, Stefano

    2010-01-01

    failing to receive needed therapy for the same reason. New devices include programmable vibrating patient notifiers (PN), which, by warning patients of a possible device dysfunction, might lower device-related anxiety. PAtient NOtifier feature for Reduction of Anxiety: a Multicentre ICD study (PANORAMIC......) is a multicentre, randomized, clinical trial designed to examine the effects of the awareness of an active vibrating alert system on device-related anxiety....

  3. Splinting after contracture release for Dupuytren's contracture (SCoRD: protocol of a pragmatic, multi-centre, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chojnowski Adrian J

    2008-04-01

    Full Text Available Abstract Background Splinting as part of the overall post-surgical management of patients after release of Dupuytren's contracture has been widely reported, though there is variation in practice and criteria for using it. The evidence on its effectiveness is sparse, of poor quality and contradictory with studies reporting negative and positive effects. Methods/Design A multi-centre, pragmatic, randomized, controlled trial is being conducted to evaluate the effect of static night splinting for six months on hand function, range of movement, patient satisfaction and recurrence at 1 year after fasciectomy or dermofasciectomy. Using a centrally administered computer randomization system consented patients will be allocated to one of two groups: i splint group who will be given a static splint at approximately 10 to 14 days after surgery to be worn for 6 months at night time only as well as hand therapy; ii non-splint group, who will receive hand therapy only. The primary outcome measure is the patient-reported Disabilities of the Arm, Hand and Shoulder Questionnaire (DASH. Secondary outcomes are total active flexion and extension of fingers, patient satisfaction and recurrence of contracture. Outcome measures will be collected prior to surgery, 3 months, 6 months and 1 year after surgery. Using the DASH as the primary outcome measure, where a difference of 15 points is considered to be a clinically important difference a total of 51 patients will be needed in each group for a power of 90%. An intention-to-treat analysis will be used. Discussion This pragmatic randomized controlled trial will provide much needed evidence on the clinical effectiveness of post-operative night splinting in patients who have undergone fasciectomy or dermofasciectomy for Dupuytren's contracture of the hand. Trial Registration Current Controlled Trials ISRCTN 57079614

  4. Quantification of FDG PET studies using standardised uptake values in multi-centre trials : effects of image reconstruction, resolution and ROI definition parameters

    NARCIS (Netherlands)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-01-01

    Purpose: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multicentre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of diffe

  5. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis : pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study)

    NARCIS (Netherlands)

    Koek, Mayke B. G.; Buskens, Erik; van Weelden, Huib; Steegmans, Paul H. A.; Bruijnzeel-Koomen, Carla A. F. M.; Sigurdsson, Vigfus

    2009-01-01

    Objective To determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis. Design Pragmatic multicentre single blind randomised clinical trial (PLUTO study). Setting Dermatology departmen

  6. ''Beaded'' osteoid osteoma: a possible transition between solitary and multicentric tumor

    Energy Technology Data Exchange (ETDEWEB)

    Chiou, Yi-You [Department of Radiology, Taipei Veterans General Hospital, 201 Sec. 2 Shih-Pai Road, 11217, Taipei (Taiwan); Rosenthal, Daniel I. [Department of Radiology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 (United States); Rosenberg, Andrew E. [Department of Pathology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 (United States)

    2003-07-01

    An extremely rare example of an elongated (3 cm) osteoid osteoma is presented. The tumor demonstrated three focal enlargements connected by narrow areas, suggesting a ''string of beads'' in appearance. The elongated shape suggested the possibility that lesional tissue was stretched in a longitudinal fashion as a result of the rapid skeletal growth. The tumor closest to the growth plate was densely ossified, while the furthest lesion was almost completely lytic, suggesting that the tumor enlarged in a centripetal direction. This case is believed to illustrate a continuum from solitary to multicentric osteoid osteoma. The tumor was treated successfully with three separate percutaneous radiofrequency ablations during a single session. (orig.)

  7. Bisphosphonates in multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder – an alternative therapeutic approach

    Science.gov (United States)

    Pichler, Karin; Karall, Daniela; Kotzot, Dieter; Steichen-Gersdorf, Elisabeth; Rümmele-Waibel, Alexandra; Mittaz-Crettol, Laureane; Wanschitz, Julia; Bonafé, Luisa; Maurer, Kathrin; Superti-Furga, Andrea; Scholl-Bürgi, Sabine

    2016-01-01

    Multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder is a rare inherited progressive skeletal disorder caused by mutations in the matrix metalloproteinase 2 (MMP2) gene. Treatment options are limited. Herein we present successful bisphosphonate therapy in three affected patients. Patients were treated with bisphosphonates (either pamidronate or zoledronate) for different time periods. The following outcome variables were assessed: skeletal pain, range of motion, bone densitometry, internal medical problems as well as neurocognitive function. Skeletal pain was dramatically reduced in all patients soon after initiation of therapy and bone mineral density increased. Range of motion did not significantly improve. One patient is still able to walk with aids at the age of 14 years. Neurocognitive development was normal in all patients. Bisphosphonate therapy was effective especially in controlling skeletal pain in MONA spectrum disorder. Early initiation of treatment seems to be particularly important in order to achieve the best possible outcome. PMID:27687687

  8. Attachment Styles of Dermatological Patients in Europe: A Multi-centre Study in 13 Countries.

    Science.gov (United States)

    Szabó, Csanád; Altmayer, Anita; Lien, Lars; Poot, Françoise; Gieler, Uwe; Tomas-Aragones, Lucía; Kupfer, Jörg; Jemec, Gregor B E; Misery, Laurent; Linder, M Dennis; Sampogna, Francesca; Middendorp, Henriët van; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Dalgard, Florence

    2017-01-25

    Attachment styles of dermatological outpatients and satisfaction with their dermatologists were investigated within the framework of a multicentre study conducted in 13 European countries, organized by the European Society for Dermatology and Psychiatry. Attachment style was assessed with the Adult Attachment Scale. Patient satisfaction with the dermatologist was assessed with an 11-degree scale. A total of 3,635 adult outpatients and 1,359 controls participated in the study. Dermatological outpatients were less able to depend on others, were less comfortable with closeness and intimacy, and experienced similar rates of anxiety in relationships as did the controls. Participants who had secure attachment styles reported stressful life events during the last 6 months significantly less often than those who had insecure attachment styles. Patients with secure attachment styles tended to be more satisfied with their dermatologist than did insecure patients. These results suggest that secure attachment of dermatological outpatients may be a protective factor in the management of stress.

  9. Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

    DEFF Research Database (Denmark)

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn;

    2006-01-01

    OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. RESULTS: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

  10. The INTEGRATE project: Delivering solutions for efficient multi-centric clinical research and trials.

    Science.gov (United States)

    Kondylakis, Haridimos; Claerhout, Brecht; Keyur, Mehta; Koumakis, Lefteris; van Leeuwen, Jasper; Marias, Kostas; Perez-Rey, David; De Schepper, Kristof; Tsiknakis, Manolis; Bucur, Anca

    2016-08-01

    The objective of the INTEGRATE project (http://www.fp7-integrate.eu/) that has recently concluded successfully was the development of innovative biomedical applications focused on streamlining the execution of clinical research, on enabling multidisciplinary collaboration, on management and large-scale sharing of multi-level heterogeneous datasets, and on the development of new methodologies and of predictive multi-scale models in cancer. In this paper, we present the way the INTEGRATE consortium has approached important challenges such as the integration of multi-scale biomedical data in the context of post-genomic clinical trials, the development of predictive models and the implementation of tools to facilitate the efficient execution of postgenomic multi-centric clinical trials in breast cancer. Furthermore, we provide a number of key "lessons learned" during the process and give directions for further future research and development.

  11. Retrospective exposure assessment and quality control in an international multi-centre case-control study

    DEFF Research Database (Denmark)

    Tinnerberg, H; Heikkilä, P; Huici-Montagud, A;

    2003-01-01

    The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high...... frequency of chromosomal aberrations (CA) in peripheral lymphocytes for increased cancer risk. Occupational hygienists assessed exposures in each participating country: Denmark, Finland, Italy, Norway and Sweden. The exposure status to a carcinogen or a clastogen was coded in the cohort according...... country-specific differences, differences in information available to the home assessor and the others and misunderstandings or difficulties in translation of information. To ensure the consistency of exposure assessments in international retrospective case-control studies it is important to have a well...

  12. A Novel Segment Classification for Multifocal and Multicentric Breast Cancer to Facilitate Breast-Conservation Treatment.

    Science.gov (United States)

    Tan, Mona P

    2015-01-01

    Breast conservation treatment (BCT) is an appropriate alternative to mastectomy for the treatment of unifocal breast cancer. Multifocal and multicentric breast cancers (MFMCBC) challenge conventional indications for BCT and are often treated with mastectomy. Following progress in treatment strategies for unifocal tumors, there was a movement to evaluate the use of BCT for MFMCBC. Now a growing body of evidence from retrospective data has emerged, demonstrating acceptable local control and overall survival rates with BCT for MFMCBC. Prospective studies are needed to confirm these findings. One of the possible barriers to such trials is the absence of a standardized classification and nomenclature for MFMCBC at this point in time. A novel segment classification is presented in this article in an endeavor to overcome this deficiency and allow future work on this issue.

  13. A comparison of functional outcome in patients sustaining major trauma: a multicentre, prospective, international study.

    Directory of Open Access Journals (Sweden)

    Timothy H Rainer

    Full Text Available OBJECTIVES: To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. SUMMARY BACKGROUND DATA: Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR. METHODS: Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE functional outcome and risk-adjusted Short-Form 12 (SF-12 health status at 6 and 12 months after injury. RESULTS: 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17, and at 12 months was 0.83 (95% CI: 0.60, 1.12. Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: -1.2, 3.6 and 12-months (adjusted mean difference: -0.4, 95% CI: -3.2, 2.4 compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: -2.1, 2.8 or 12-months (adjusted mean difference: 1.8, 95% CI: -0.8, 4.5. CONCLUSION: The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions.

  14. Imaging features of multicentric Castleman's disease in HIV infection

    Energy Technology Data Exchange (ETDEWEB)

    Hillier, J.C. E-mail: chris_julia.hillier@talk21.com; Shaw, P.; Miller, R.F.; Cartledge, J.D.; Nelson, M.; Bower, M.; Francis, N.; Padley, S.P

    2004-07-01

    AIM: To describe the computed tomography (CT) features of human immunodeficiency virus (HIV)-associated Castleman's disease. MATERIALS AND METHODS: Nine HIV-positive patients with biopsy-proven Castleman's disease were studied. Clinical and demographic data, CD4 count, histological diagnosis and human herpes type 8 (HHV8) serology or immunostaining results were recorded. CT images were reviewed independently by two radiologists. RESULTS: CT findings included splenomegaly (n=7) and peripheral lymph node enlargement (axillary n=8, inguinal n=4). All nodes displayed mild to avid enhancement after intravenous administration of contrast material. Hepatomegaly was evident in seven patients. Other features included abdominal (n=6) and mediastinal (n=5) lymph node enlargement and pulmonary abnormalities (n=4). Patterns of parenchymal abnormality included bronchovascular nodularity (n=2), consolidation (n=1) and pleural effusion (n=2). On histological examination eight patients (spleen n=3, lymph node n=9, lung n=1 bone marrow n=1) had the plasma cell variant and one had mixed hyaline-vascular/plasma cell variant. The majority had either positive immunostaining for HHV8 or positive serology (n=8). CONCLUSION: Common imaging features of multicentric Castleman's disease in HIV infection are hepatosplenomegaly and peripheral lymph node enlargement. Although these imaging features may suggest the diagnosis in the appropriate clinical context, they lack specificity and so biopsy is needed for diagnosis. In distinction from multicentric Castleman's disease in other populations the plasma cell variant is most commonly encountered, splenomegaly is a universal feature and there is a strong association with Kaposi's sarcoma.

  15. Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT)

    Energy Technology Data Exchange (ETDEWEB)

    Brouwer, O.R. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Antoni van Leeuwenhoekhospital, Amsterdam (Netherlands); Vermeeren, L.; Valdes Olmos, R.A. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Ploeg, I.M.C. van der; Rutgers, E.J.T.; Oldenburg, H.S.A. [Antoni van Leeuwenhoek Hospital, Department of Surgery, Netherlands Cancer Institute, Amsterdam (Netherlands); Loo, C.E. [Antoni van Leeuwenhoek Hospital, Department of Radiology, Netherlands Cancer Institute, Amsterdam (Netherlands); Pereira-Bouda, L.M.; Smit, F. [Rijnland Hospital, Department of Nuclear Medicine, Leiderdorp (Netherlands); Neijenhuis, P. [Rijnland Hospital, Department of Surgery, Leiderdorp (Netherlands); Vrouenraets, B.C. [Sint Lucas Andreas Hospital, Department of Surgery, Amsterdam (Netherlands); Sivro-Prndelj, F. [Sint Lucas Andreas Hospital, Department of Nuclear Medicine, Amsterdam (Netherlands); Jap-a-Joe, S.M.; Borgstein, P.J. [Onze Lieve Vrouwe Gasthuis, Department of Nuclear Medicine, Amsterdam (Netherlands)

    2012-07-15

    To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of {sup 99m}Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64 %). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34 %)). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

  16. A multi-centre investigation towards reaching a consensus on the immunohistochemical detection of ERbeta in archival formalin-fixed paraffin embedded human breast tissue.

    Science.gov (United States)

    Carder, Pauline J; Murphy, Claire E; Dervan, Peter; Kennedy, Maria; McCann, Amanda; Saunders, Philippa T K; Shaaban, Abeer M; Foster, Christopher S; Witton, Caroline J; Bartlett, John M S; Walker, Rosemary A; Speirs, Valerie

    2005-08-01

    Estrogen receptor (ER) alpha is a well-established independent prognostic factor in breast cancer whose presence determines the clinical implications of adjuvant endocrine therapy. A second receptor, ERb has been described, and a number of studies have examined its expression in breast tissue. However elucidation of the role played by ERb has been hampered by published immunohistochemical studies employing a variety of protocols and scoring systems such that inter-laboratory comparisons are difficult. Here we present a multi-centre study designed to critically evaluate inter-laboratory differences in methodology. Six UK and Irish centres participated in this study. A small series of breast cancers were stained using centre-specific laboratory protocols and scored using both centrespecific and standard scoring protocols. There was generally poor agreement as to what constituted a positive or negative case when centre-specific scoring systems were used with less than half of all cases in agreement. Concordance was improved when a standard scoring system was used but varied according to threshold for positivity employed and primary antibody. Our results emphasise the need for further studies addressing the role of ERb to be based on a wider consensus on criteria for positivity. Ideally this should be based on calibration against clinical outcome.

  17. Video-based feedback of oral clinical presentations reduces the anxiety of ICU medical students: a multicentre, prospective, randomized study

    OpenAIRE

    Schmidt, Matthieu; Freund, Yonathan; Alves, Mickael; Monsel, Antoine; Labbe, Vincent; Darnal, Elsa; Messika, Jonathan; Bokobza, Jerome; Similowski, Thomas; Duguet, Alexandre

    2014-01-01

    International audience; Background: Oral presentations of clinical cases by medical students during medical rounds in hospital wards are a source of anxiety and little is known about how this anxiety can be alleviated. The objective of this study was to investigate whether video-based feedback of public oral presentations can reduce anxiety in 4th year medical students. Methods: Multicentre randomized study conducted in six intensive care units (ICU) and emergency departments (ED) in France o...

  18. MULTICENTRIC GIANT CELL TUMOR OF IPSILATERAL ACETABULUM AND FEMORAL HEAD WITH PATHOLOGICAL FRACTURE OF FEMORAL NECK: A CASE REPORT

    Directory of Open Access Journals (Sweden)

    Jayant

    2015-02-01

    Full Text Available INTRODUCTION: Multicentric Giant Cell Tumor is extremely rare; here we are presenting a case of pathological neck femur fracture in case of multicentric giant cell tumor involving ipsilateral acetabulum along with femoral head and neck. CASE PRESENTATION: 24 years old male presented with pain in groin region and inability to walk after he fell down while walking. He had pain in left groin on weight bearing for last six months. Radiological examination shows pathological trans - cervical femoral neck fracture with sub - articular lytic lesion in femoral head and neck suggestive of Giant cell tumor. MRI has been done to define the extent of involvement and to rule out soft tissue infiltration. Fine needle aspiration cytology which was done through anterior route was inconclusive. After review of literature, patient has been planned for excisional biopsy and un - cemented total hip arthroplasty. Intra - operatively, frozen section confirms the giant cell tumor and surprisingly acetabulum was found to be involved which was curetted and hydrogen - peroxide treated. Post - operatively, patient was pain - free with good range of movements at hip. CONCLUSION: Giant cell tumor involving femoral head and neck with pathological fracture though uncommon, but may present as multicentric with acetabular involvement.

  19. Multicentre epidemiological survey on the incidence of Streptococcus agalactiae in pregnancy

    Directory of Open Access Journals (Sweden)

    Leonardo Lodolo

    2010-03-01

    Full Text Available ß-hemolytic streptococci group B (GBS cause infections of the urinary tract, endometrium, amnion, and superinfection of wounds, with complications in 2% -4% of cases in pregnant woman.The infection transmitted to newborns is a cause of sepsis and meningitis with high incidence of mortality.A recent report on a multicentric study of the ISS, showed that detection of S. agalactiae in pregnant women in different realities of healthcare, ranging from 3.9% to 19.4%. This survey covers a sample of 29607 women screened in a total of 36852 childbirths, with a positivity of 4183 subjects equal to 14.1%. Thanks to the GBS Study Group of Piemonte and Valle d’Aosta microbiology laboratories, with the support of 42 study centres have been involved. Collection techniques, types of medium, environmental of incubation of the culture, possible enrichment in broth, of the swabs of 28491 women during 2006/2007 have been considered. 24.36% were vaginal swab while 75.64% vagino/rectal. According to data collected at 31 centers with eligible data (22,175 pregnant GBS positivity was 12.7% (CI [Confidence Interval] + / -95%: 13.1% -12.2% with wide variability between individual centers (2% -22.6%. The enrichment broth is used by 6 out of 9 centers with positivity> 15% (M: 20.05%, from 6 to 14 with positivity between 10-15% (M: 12.61%, from none to 8 centers with less than 10% positivity (M: 4.95%.This multicentre survey underlined the preference for vagino/rectal swab, as recommended by the literature. The frequency of GBS positivity of pregnant women on the whole samples is similar to that found in other national surveys, even if with large differences between the different centers.The sensitivity tends to increase with the use of enrichment techniques, whose use is uneven between the centers, perhaps indicating the need for greater uniformity of protocols based on the results of microbiological analysis EBM (Evidence Based Medicine.

  20. Characterization of methicillin-susceptible and -resistant staphylococci in the clinical setting: a multicentre study in Nigeria

    Directory of Open Access Journals (Sweden)

    Shittu Adebayo

    2012-11-01

    Full Text Available Abstract Background The staphylococci are implicated in a variety of human infections; however, many clinical microbiology laboratories in Nigeria do not identify staphylococci (in particular coagulase negative staphylococci - CNS to the species level. Moreover, data from multi-centre assessment on antibiotic resistance and epidemiology of the staphylococci are not available in Nigeria. This study investigated 91 non-duplicate staphylococcal isolates obtained from the microbiology laboratories of eight hospitals in Nigeria during the period January to April 2010. Methods Identification and antibiotic susceptibility testing was performed using the VITEK 2 system, detection of resistance genes by PCR, and molecular characterization was determined by SCCmec typing, spa and multilocus sequence typing (MLST. Results All the isolates were susceptible to mupirocin, tigecycline, vancomycin and linezolid, but 72.5% of CNS and 82.3% of Staphylococcus aureus were resistant to cotrimoxazole, while multiresistance was observed in 37 of the 40 CNS isolates. Untypeable SCCmec types (ccrC/Class A mec and ccr-negative/Class C2 mec gene complex in two methicillin-resistant S. aureus (MRSA were identified. Additionally, ccr-negative/Class A mec and ccr type 4/Class C2 mec gene complex was detected in one isolate each of S. sciuri and S. haemolyticus, respectively. The S. aureus isolates were classified into 21 spa types including two new types (t8987, t9008 among the methicillin-susceptible S. aureus (MSSA isolates. Two (CC8-SCCmecnon-typeable and CC88-SCCmec IV and four (CC8-SCCmec III/IV/V; CC30-SCCmec II/III; CC88-SCCmec IV; and ST152-SCCmecnon-typeable MRSA clones were identified in Maiduguri (North-East Nigeria and South-West Nigeria, respectively. The proportion of Panton-Valentine leukocidin (PVL-positive MSSA was high (44.4% and 56.3% of these strains were associated with sequence type (ST 152. Conclusions The identification of multiresistant mecA positive

  1. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  2. SU-C-BRD-01: Multi-Centre Collaborative Quality Assurance Program for IMRT Planning and Delivery: Year 3 Results

    Energy Technology Data Exchange (ETDEWEB)

    McNiven, A; Jaffray, D; Letourneau, D [Princess Margaret Cancer Centre and Department of Radiation Oncology, University of Toronto, Toronto, ON (Canada)

    2015-06-15

    Purpose: A multi-centre quality assurance program was developed to enable quality improvement by coupling measurement of intensity modulated radiotherapy (IMRT) planning and delivery performance for site-specific planning exercises with diagnostic testing. The third year of the program specifically assessed the quality of spine stereotactic body radiotherapy (SBRT) planning and delivery amongst the participating centres. Methods: A spine SBRT planning exercise (24 Gy in 2 fractions) was created and completed by participants prior to an on-site visit. The delivery portion of the on-site visit included spine SBRT plan delivery and diagnostic testing, which included portal image acquisition for quantification of phantom positioning error and multi-leaf collimator (MLC) calibration accuracy. The measured dose was compared to that calculated in the treatment planning system (TPS) using 3%/2mm composite analysis and 3%/3mm gamma analysis. Results: Fourteen institutions participated, creating 17 spine SBRT plans (15 VMAT and 2 IMRT). Three different TPS, two beam energies (6 MV and 6 MV FFF), and four MLC designs from two linac vendors were tested. Large variation in total monitor units (MU) per plan (2494–6462 MU) and dose-volume parameters was observed. The maximum point dose in the plans ranged from 116–149% and was dependent upon the TPS used. Pass rates for measured to planned dose comparison ranged from 89.4–100% and 97.3–100% for 3%/2mm and 3%/3mm criteria respectively. The largest measured MLC error did Result in one of the poorer pass rates. No direct correlation between phantom positioning error and pass rates overall. Conclusion: Significant differences were observed in the planning exercise for some plan and dose-volume parameters based on the TPS used. Standard evaluation criteria showed good agreement between planned and measured dose for all participants, however on an individual plan basis, diagnostic tests were able to identify contributing

  3. The effectiveness of 2-implant overdentures - a pragmatic international multicentre study.

    LENUS (Irish Health Repository)

    Rashid, F

    2011-03-01

    The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a \\'real world\\' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located in North America, South America and Europe. The patients were provided with new mandibular conventional dentures or implant overdentures supported by two implants and ball attachments. At baseline and at 6 months post-treatment, they rated their satisfaction with their mandibular prostheses on 100-mm visual analogue scale questionnaires. One hundred and two (50·2%) participants had valid baseline and 6-month satisfaction data. Although both groups reported improvements, the implant overdenture group reported significantly higher ratings of overall satisfaction, comfort, stability, ability to speak and ability to chew. These results suggest that edentulous patients who choose mandibular implant overdentures have significantly greater improvements in satisfaction, despite their relatively higher cost, than those who choose new conventional dentures.

  4. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

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    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  5. Variability in drug use among newborns admitted to NICUs: a proposal for a European multicentre study

    Directory of Open Access Journals (Sweden)

    Laura Cuzzolin

    2014-01-01

    Full Text Available The use of drugs in newborns admitted to NICUs is characterized by a great variability. This widespread phenomenon, observed both within and between different countries, has been highlighted by reporting data on the treatment of neonatal sepsis and PDA throughout Europe: the dosages and the intervals between administrations of ciprofloxacin and fluconazole varied significantly and a wide variation was also observed as regards the use of NSAIDs to treat PDA. Given the unique characteristics of the neonatal population, the use of drugs on an individual basis could be sometimes justified. However, other factors such as the lack of evidence-based guidelines and the common use of drugs in an off-label manner (more than 80% of newborns receive this kind of treatment could contribute to the variability in medicine use, making the neonatal population vulnerable to adverse drug reactions (ADRs and medication errors: the potential ADRs rate, 3 times higher in pediatric wards, is more significantly higher in NICUs and the frequency of medication errors (mostly dose errors widely exceeds the medium value. The differences in clinical practices observed between NICUs need to be addressed at a European level and a multicentre study could be useful to harmonize drug use in newborns.

  6. A prospective naturalistic multicentre study of intravenous medications in behavioural emergencies: haloperidol versus flunitrazepam.

    Science.gov (United States)

    Hatta, Kotaro; Nakamura, Mitsuru; Yoshida, Kenichi; Hamakawa, Hiroshi; Wakejima, Toru; Nishimura, Takao; Furuta, Ko; Kawabata, Toshitaka; Hirata, Toyoaki; Usui, Chie; Nakamura, Hiroyuki; Sawa, Yutaka

    2010-06-30

    A prospective naturalistic multicentre study for deep sedation was conducted in intensive care with continuous electrocardiogram (ECG) monitoring. Clinical purpose was enough sedation, which made uncooperative and disrupted patients receive brain computed tomography (CT), magnetic resonance imaging (MRI), or fluid therapy, with minimum drug doses. A first infusion was either haloperidol (HAL group) or flunitrazepam (FNP group). If enough sedation was not achieved, a second infusion, which was the opposite drug to the first infusion, was given. The proportion requiring a second infusion was higher in the HAL group than in the FNP group (82% vs. 36%, PFNP first group (FNP+HAL group) than the HAL first group (HAL+FNP group) (68% [S.D. 17] vs. 54% [S.D. 31], P=0.02). The mean dose of flunitrazepam in the HAL+FNP group was significantly lower than that in the FNP+HAL-group (1.3 mg vs. 3.5 mg, P=0.0003). Thus, in terms of monotherapy and speed of action, flunitrazepam has advantages over haloperidol as a first infusion for deep sedation. Regarding drug dosages, haloperidol has an advantage over flunitrazepam as a first infusion in safety.

  7. Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study

    Directory of Open Access Journals (Sweden)

    Ottesen Bent

    2008-10-01

    Full Text Available Abstract Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR and 95% confidence intervals (CI are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI: dilatation of cervix Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern.

  8. Multicentre quality control evaluation of different biomarker candidates for amyotrophic lateral sclerosis.

    Science.gov (United States)

    Lehnert, Stefan; Costa, Julia; de Carvalho, Mamede; Kirby, Janine; Kuzma-Kozakiewicz, Magdalena; Morelli, Claudia; Robberecht, Wim; Shaw, Pamela; Silani, Vincenzo; Steinacker, Petra; Tumani, Hayrettin; Van Damme, Philip; Ludolph, Albert; Otto, Markus

    2014-09-01

    Abstract Amyotrophic lateral sclerosis (ALS) is a progressive motor neuron disease that mainly causes degeneration of the upper and lower motor neurons, ultimately leading to paralysis and death within three to five years after first symptoms. The pathological mechanisms leading to ALS are still not completely understood. Several biomarker candidates have been proposed in cerebrospinal fluid (CSF). However, none of these has successfully translated into clinical routine. Part of the reason for this failure to translate may relate to differences across laboratories. For this reason, several of the most commonly used ALS biomarker candidates were evaluated on clinically well-defined ALS samples from six European centres in a multicentre sample-collection approach with centralized sample processing. Results showed that phosphorylated neurofilament heavy chain differentiated between ALS and control cases in all centres. We therefore propose that measurement of phosphorylated neurofilaments in CSF is the most promising candidate for translation into the clinical setting and might serve as a benchmark for other biomarker candidates.

  9. Rituximab plus liposomal doxorubicin in HIV-infected patients with KSHV-associated multicentric Castleman disease

    Science.gov (United States)

    Polizzotto, Mark N.; Aleman, Karen; Wyvill, Kathleen M.; Marshall, Vickie; Whitby, Denise; Wang, Victoria; Pittaluga, Stefania; O’Mahony, Deirdre; Steinberg, Seth M.; Little, Richard F.; Yarchoan, Robert

    2014-01-01

    Kaposi sarcoma (KS) herpesvirus–associated multicentric Castleman disease (KSHV-MCD) is a lymphoproliferative disorder, most commonly seen in HIV-infected patients, that has a high mortality if untreated. Concurrent KS is common. Although rituximab has reported activity in KSHV-MCD, its use is often associated with KS progression. Within a natural history study of KSHV-MCD, we prospectively evaluated rituximab 375 mg/m2 combined with liposomal doxorubicin 20 mg/m2 (R-Dox) every 3 weeks in 17 patients. Patients received a median of 4 cycles (range 3-9). All received antiretroviral therapy, 11 received consolidation interferon-α, and 6 received consolidation high-dose zidovudine with valganciclovir. Using NCI KSHV-MCD response criteria, major clinical and biochemical responses were attained in 94% and 88% of patients, respectively. With a median 58 months’ potential follow-up, 3-year event-free survival was 69% and 3-year overall survival was 81%. During R-Dox therapy, cutaneous KS developed in 1 patient, whereas 5 of 6 patients with it had clinical improvement. R-Dox was associated with significant improvement in anemia and hypoalbuminemia. KSHV viral load, KSHV viral interleukin-6, C-reactive protein, human interleukin-6, and serum immunoglobulin free light chains decreased with therapy. R-Dox is effective in symptomatic KSHV-MCD and may be useful in patients with concurrent KS. This trial was registered at www.clinicaltrials.gov as #NCT00092222. PMID:25331113

  10. Comparison between repaglinide and glipizide in Type 2 diabetes mellitus: a 1-year multicentre study

    DEFF Research Database (Denmark)

    Madsbad, Sten; Kilhovd, B; Lager, I

    2001-01-01

    AIMS: To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes. METHODS: Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI......) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily. RESULTS......: Changes in fasting blood glucose (FBG) and HbA1c during the 12 months of treatment showed a significant difference in favour of repaglinide. In oral hypoglycaemic agents (OHA)-naive patients, HbA1c decreased in the repaglinide and glipizide groups by 1.5% and 0.3%, respectively (P

  11. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    Directory of Open Access Journals (Sweden)

    Andrea Turolla

    2013-01-01

    Full Text Available Background. Haptic robots allow the exploitation of known motorlearning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  12. Reappraisal of known malaria resistance loci in a large multi-centre study

    Science.gov (United States)

    Rockett, Kirk A.; Clarke, Geraldine M.; Fitzpatrick, Kathryn; Hubbart, Christina; Jeffreys, Anna E.; Rowlands, Kate; Craik, Rachel; Jallow, Muminatou; Conway, David J.; Bojang, Kalifa A.; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A.; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D.; Bougouma, Edith C.; Sirima, Sodiomon B.; Modiano, David; Amenga-Etego, Lucas N.; Ghansah, Anita; Koram, Kwadwo A.; Wilson, Michael D.; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M.; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N.; Manjurano, Alphaxard; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J.; Phu, Nguyen Hoan; Ngoc Quyen, Nguyen Thi; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy M. E.; Michon, Pascal; Mueller, Ivo; Green, Angie; Molloy, Sile; Johnson, Kimberly J.; Kerasidou, Angeliki; Cornelius, Victoria; Hart, Lee; Vanderwal, Aaron; SanJoaquin, Miguel; Band, Gavin; Le, Si Quang; Pirinen, Matti; Sepúlveda, Nuno; Spencer, Chris C.A.; Clark, Taane G.; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P.

    2015-01-01

    Many human genetic associations with resistance to malaria have been reported but few have been reliably replicated. We collected data on 11,890 cases of severe malaria due to Plasmodium falciparum and 17,441 controls from 12 locations in Africa, Asia and Oceania. There was strong evidence of association with the HBB, ABO, ATP2B4, G6PD and CD40LG loci but previously reported associations at 22 other loci did not replicate in the multi-centre analysis. The large sample size made it possible to identify authentic genetic effects that are heterogeneous across populations or phenotypes, a striking example being the main African form of G6PD deficiency, which reduced the risk of cerebral malaria but increased the risk of severe malarial anaemia. The finding that G6PD deficiency has opposing effects on different fatal complications of P. falciparum infection indicates that the evolutionary origins of this common human genetic disorder are more complex than previously supposed. PMID:25261933

  13. Perspectives of Cosmesis following Breast Conservation for Multifocal and Multicentric Breast Cancers

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    Mona P. Tan

    2015-01-01

    Full Text Available Background. Contemporary data suggest that breast conservation treatment (BCT for multifocal and multicentric breast cancer (MFMCBC may be appropriate with noninferior local control rates. However, there is a paucity of data to evaluate patient’s satisfaction with cosmetic outcomes after BCT for MFMCBC. This study was performed to bridge this information gap. Methods. All patients treated at the authors’ healthcare facility were included in the study. Patients with MFMCBC who were assessed to be eligible for BCT underwent tumour resection using standard surgical techniques with direct parenchymal closure through a single incision. After at least three years of follow-up, they were invited to participate in a survey regarding their cosmetic outcomes. Results. Of a total of 160 patients, 40 had MFMCBC, of whom 34 (85% underwent successful BCT. Five-year cancer-specific survival and disease-free survival were 95.7%. Twenty of the 34 patients responded to the survey. No patient rated her cosmetic outcome as “poor.” Analysis indicated low agreement between patients’ self-assessment and clinician-directed evaluation of aesthetic results. Conclusion. BCT for MFMCBC is feasible with acceptable survival and cosmetic outcomes. However, there appears to be a disparity between patient and clinician-directed evaluation of cosmetic results which warrant further research.

  14. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed.

  15. Clinical features of primary headache in children: a multicentre hospital-based study in France.

    Science.gov (United States)

    Cuvellier, J-C; Donnet, A; Guégan-Massardier, E; Nachit-Ouinekh, F; Parain, D; Vallée, L

    2008-11-01

    The aim of this study was to evaluate the concordance between clinical diagnosis and the International Classification of Headache Disorders, 2nd edn (ICHD-II) in children and adolescents with primary headaches. This 6-month prospective multicentre study of 486 patients (mean 9.8 +/- 3.1 years; 52.6% girls) assessed the headache features through a structured questionnaire. In 398 patients with a single type of headache, headaches were bilateral (78.1%), frontal (62.4%), pulsatile (56.1%), with associated symptoms in 84.4%. The most frequently assigned diagnoses were migraine without aura (50.8%), probable migraine (14.1%), migraine with aura (11.1%) and frequent episodic tension-type headache (7.5%). For most of the diagnostic categories, the consistency of the investigator's diagnosis with the ICHD-II criteria was good (kappa > 0.6 and 0.8). We conclude that migraine was predominant with regard to headache diagnoses repartition and that the ICHD-II seems usable in practice for evaluation of primary headache in French children and adolescents.

  16. A multicentre study on LMW-heparin effectiveness in preventing postsurgical thrombosis.

    Science.gov (United States)

    Verardi, S; Casciani, C U; Nicora, E; Forzano, F; Origone, A; Valle, I; Catania, G; Salanitri, G; Salcuni, P; Azzarone, M

    1988-01-01

    A multicentric study was carried out involving six italian departments of general surgery to assess the efficacy of a low molecular weight (LMW) heparin called Fluxum compared to standard calcium heparin in low doses for prevention of postoperative thromboembolic complications (deep vein thrombosis and pulmonary embolism). 610 patients were treated; 308 (50.5%) of whom were treated with Fluxum at doses of 4,000 or 8,000 I.U. Axa once a day by subcutaneous injection and 302 (49.5%) with heparin calcium at doses of 5,000 I.U. two or three times a day by subcutaneous injection. We observed a total of 29 deep vein thrombosis (4.7%); 10 (3.2%) from the group treated with LMW heparin and 19 (6.3%) from the comparative group. During the study 4 (0.65%) pulmonary embolism were found, 1 (0.32%) in the group treated with LMW heparin and 3 (1%) in the group treated with calcium heparin. None serious hemorrhagic accident was reported during the study. The antithrombotic prophy laxis carried out with Fluxum was on the whole better tolerated than the treatment of the other group, registering a lower frequency of hematomas at the injection and surgical wound sites.

  17. Multicentric Castleman's Disease in a Hepatitis C-Positive Intravenous Drug User: A Case Report

    Directory of Open Access Journals (Sweden)

    D. Y. Talukder

    2011-01-01

    Full Text Available Introduction. We report a rare presentation of Castleman's disease in a hepatitis C-positive patient and present a short review of treatments described in other similar case reports and studies. Case Presentation. A 46-year-old male with untreated hepatitis C and a 16-year history of intravenous drug use presented with pleuritic chest pain and bony pain in the knee, hip, and lower back, on a background of unexplained weight loss of 40 kilograms, fevers, night sweats, and repeated infections over the last two years. Examination discovered tender hepatomegaly, a warm right knee effusion, and painless lymphadenopathy. The patient was reactive to Epstein Barr virus and cytomegalovirus; however, HIV and HHV-8 viral testing was negative. Osteomyelitis of vertebrae T8–T11 and septic arthritis of the knee were found on investigation. A lymph node biopsy revealed histology suggestive of plasmacytic Castleman's disease. The patient is to commence rituximab treatment. Conclusion. Castleman's disease continues to present in novel ways, which may lead to difficulties in clinicopathologic diagnosis. A growing body of evidence suggests larger studies are required to determine the best treatment for multicentric Castleman's disease, particularly in patients with a concomitant disease, including hepatitis C.

  18. Current management of intracerebral haemorrhage in China: a national, multi-centre, hospital register study

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

    Full Text Available Abstract Background We aimed to examine current practice of the management and secondary prevention of intracerebral haemorrhage (ICH in China where the disease is more common than in Western populations. Methods Data on baseline characteristics, management in-hospital and post-stroke, and outcome of ICH patients are from the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment study, a multi-centre, prospective, 62 hospital registry in China during 2006-07. Results Nearly all ICH patients (n = 1572 received an intravenous haemodiluting agent such as mannitol (96% or a neuroprotectant (72%, and there was high use of intravenous traditional Chinese medicine (TCM (42%. Neurosurgery was undertaken in 137 (9% patients; being overweight, having a low Glasgow Coma Scale (GCS score on admission, and Total Anterior Circulation Syndrome (TACS clinical pattern on admission, were the only baseline factors associated with this intervention in multivariate analyses. Neurosurgery was associated with nearly three times higher risk of death/disability at 3 months post-stroke (odd ratio [OR] 2.60, p Conclusions The management of ICH in China is characterised by high rates of use of intravenous haemodiluting agents, neuroprotectants, and TCM, and of antihypertensives for secondary prevention. The controversial efficacy of these therapies, coupled with the current lack of treatments of proven benefit, is a call for action for more outcomes based research in ICH.

  19. Bone multicentric epithelioid hemangioendothelioma of the lower and upper extremities with pulmonary metastases: A case report

    Science.gov (United States)

    ZHANG, HUA; FU, YANBIAO; YE, ZHAOMING

    2015-01-01

    The present study reports a rare case of bone multicentric epithelioid hemangioendothelioma (EH) involving the upper and lower extremities simultaneously, with visceral involvement of the lung. Osteolytic lesions were first identified in the right distal femur and proximal tibia. Slight increased radionuclide uptake was observed in the right shoulder joint on bone scintigraphy, however, this was ignored, as no clinical symptoms were present. The patient was initially misdiagnosed with multifocal chondroblastoma, and an extra-articular curettage of lesions was performed in the proximal tibia and medial femoral condyle, which was filled with bone cement. The histopathological diagnosis was corrected post-operatively following immunohistochemical analysis, which indicated EH, and subsequently, an amputation of the right leg at thigh level was performed. In addition, multiple lytic lesions in the right shoulder joint and pulmonary metastases were identified on whole-body radiological examination. Radiotherapy was administered to the right shoulder joint, however, the patient refused chemotherapy or further surgery. At 15 months after the initial surgery, the patient currently remains alive. This case indicates that an improved understanding with regard to the clinical features of this disease may prevent misdiagnosis and improve EH treatment. PMID:26137035

  20. Management of pelvic lymphoceles after radical prostatectomy: A multicentre community based study

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    Khoder WY

    2011-06-01

    Full Text Available Abstract Introduction Pelvic lymphoceles (LC following radical prostatectomy (LC-RP have an incidence up to 27%. LC-managements constitute 50% of surgical interventions performed in post-RP patients. Objectives To describe a therapeutic algorithm for LC-managements based on a community based representative retrospective study. Patients and methods: Multicentre data from 304 patients with LC-RP were retrospectively examined for LC-managements. RPs were performed by various surgeons from 67 urological departments. All patients had undergone 3 weeks rehabilitation in a specialized hospital where the data base was generated. Indications and results of therapeutic manoeuvres were used to develop a general concept for planning therapy decisions. Results Median age was 64 years. Complications occurred in 9% (28/304 of patients. Median LC-volume was 36 ml (range 20-1800 ml. There were more complications for LCs with ≥100 ml volume than those Conclusions This study based treatment algorithm provides a rationale approach with an accurate LC-classification as regard the indications and decision making for the available LC-RP-therapies. This could facilitate management decisions. Evaluation of this concept prospectively in large patient cohort is mandatory.

  1. Multicentre investigation of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in German hospitals.

    Science.gov (United States)

    Kaase, Martin; Schimanski, Sven; Schiller, Reinhold; Beyreiß, Bettina; Thürmer, Alexander; Steinmann, Jörg; Kempf, Volkhard A; Hess, Christina; Sobottka, Ingo; Fenner, Ines; Ziesing, Stefan; Burckhardt, Irene; von Müller, Lutz; Hamprecht, Axel; Tammer, Ina; Wantia, Nina; Becker, Karsten; Holzmann, Thomas; Furitsch, Martina; Volmer, Gabriele; Gatermann, Sören G

    2016-09-01

    Aim of this study was to determine the incidence and molecular epidemiology of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in Germany. E. coli and K. pneumoniae isolates from clinical samples which were non-susceptible to carbapenems were collected in laboratories serving 20 hospitals throughout Germany from November 2013 to April 2014. The isolates were tested for the presence of carbapenemases by PCR and phenotypic methods and typed by multilocus sequence typing. Risk factors including a previous hospitalization abroad were analysed. Carbapenemases were detected in 24 isolates from 22 patients out of 464,514 admissions. Carbapenemases included OXA-48 (n=14), KPC-2 (n=8) and NDM-1 (n=2). Except for two K. pneumoniae isolates with ST101, all OXA-48 producing strains belonged to different clones. In contrast, half of KPC-2 producing K. pneumoniae were of ST258 and both NDM-1 producing strains were of ST11. Compared to carbapenem-susceptible controls, patients with carbapenemase-producing strains differed by a significantly higher proportion of males, a higher proportion of isolates from wound samples and a more frequent previous stay abroad in univariate analysis. This multicentre study demonstrated an incidence of carbapenemase-producing E. coli and K. pneumoniae from clinical samples in Germany of 0.047 cases per 1000 admissions. OXA-48 was more frequent than KPC-2 and NDM-1 and showed a multiclonal background.

  2. Therapy of uncomplicated falciparum malaria in Europe: MALTHER – a prospective observational multicentre study

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    Bouchaud Olivier

    2012-06-01

    Full Text Available Abstract Background Malaria continues to be amongst the most frequent infectious diseases imported to Europe. Whilst European treatment guidelines are based on data from studies carried out in endemic areas, there is a paucity of original prospective treatment data. The objective was to summarize data on treatments to harmonize and optimize treatment for uncomplicated malaria in Europe. Methods A prospective observational multicentre study was conducted, assessing tolerance and efficacy of treatment regimens for imported uncomplicated falciparum malaria in adults amongst European centres of tropical and travel medicine. Results Between December 2003 and 2009, 504 patients were included in 16 centres from five European countries. Eighteen treatment regimens were reported, the top three being atovaquone-proguanil, mefloquine, and artemether-lumefantrine. Treatments significantly differed with respect to the occurrence of treatment changes (p = 0.005 and adverse events (p = 0.001, parasite and fever clearance times (p  Conclusions This study highlights the heterogeneity of standards of care within Europe. A consensus discussion at European level is desirable to foster a standardized management of imported falciparum malaria.

  3. A multicentric study to evaluate the use of relative retention times in targeted proteomics.

    Science.gov (United States)

    Vialas, Vital; Colomé-Calls, Núria; Abian, Joaquín; Aloria, Kerman; Alvarez-Llamas, Gloria; Antúnez, Oreto; Arizmendi, Jesus M; Azkargorta, Mikel; Barceló-Batllori, Silvia; Barderas, María G; Blanco, Francisco; Casal, J Ignacio; Casas, Vanessa; de la Torre, Carolina; Chicano-Gálvez, Eduardo; Elortza, Felix; Espadas, Guadalupe; Estanyol, Josep M; Fernandez-Irigoyen, Joaquín; Fernandez-Puente, Patricia; Fidalgo, María José; Fuentes, Manuel; Gay, Marina; Gil, Concha; Hainard, Alexandre; Hernaez, Maria Luisa; Ibarrola, Nieves; Kopylov, Arthur T; Lario, Antonio; Lopez, Juan Antonio; López-Lucendo, María; Marcilla, Miguel; Marina-Ramírez, Anabel; Marko-Varga, Gyorgy; Martín, Luna; Mora, Maria I; Morato-López, Esperanza; Muñoz, Javier; Odena, Maria Antonia; de Oliveira, Eliandre; Orera, Irene; Ortea, Ignacio; Pasquarello, Carla; Ray, Kevin B; Rezeli, Melinda; Ruppen, Isabel; Sabidó, Eduard; Del Pino, Manuel M Sanchez; Sancho, Jaime; Santamaría, Enrique; Vazquez, Jesus; Vilaseca, Marta; Vivanco, Fernando; Walters, James J; Zgoda, Victor G; Corrales, Fernando J; Canals, Francesc; Paradela, Alberto

    2017-01-30

    Despite the maturity reached by targeted proteomic strategies, reliable and standardized protocols are urgently needed to enhance reproducibility among different laboratories and analytical platforms, facilitating a more widespread use in biomedical research. To achieve this goal, the use of dimensionless relative retention times (iRT), defined on the basis of peptide standard retention times (RT), has lately emerged as a powerful tool. The robustness, reproducibility and utility of this strategy were examined for the first time in a multicentric setting, involving 28 laboratories that included 24 of the Spanish network of proteomics laboratories (ProteoRed-ISCIII). According to the results obtained in this study, dimensionless retention time values (iRTs) demonstrated to be a useful tool for transferring and sharing peptide retention times across different chromatographic set-ups both intra- and inter-laboratories. iRT values also showed very low variability over long time periods. Furthermore, parallel quantitative analyses showed a high reproducibility despite the variety of experimental strategies used, either MRM (multiple reaction monitoring) or pseudoMRM, and the diversity of analytical platforms employed.

  4. Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

    Science.gov (United States)

    Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  5. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN - a randomized multicentre trial

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    Kraft Matthias

    2012-07-01

    Full Text Available Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4% in controls (p  Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

  6. Japanese variant of multicentric castleman's disease associated with serositis and thrombocytopenia--a report of two cases: is TAFRO syndrome (Castleman- Kojima disease) a distinct clinicopathological entity?

    Science.gov (United States)

    Masaki, Yasufumi; Nakajima, Akio; Iwao, Haruka; Kurose, Nozomu; Sato, Tomomi; Nakamura, Takuji; Miki, Miyuki; Sakai, Tomoyuki; Kawanami, Takafumi; Sawaki, Toshioki; Fujita, Yoshimasa; Tanaka, Masao; Fukushima, Toshihiro; Okazaki, Toshiro; Umehara, Hisanori

    2013-01-01

    Multicentric Castleman's disease (MCD) is a polyclonal lymphoproliferative disorder that manifests as marked hyper-γ-globulinemia, severe inflammation, anemia, and thrombocytosis. Recently, Takai et al. reported a new disease concept, TAFRO syndrome, named from thrombocytopenia, anasarca, fever, reticulin fibrosis, and organomegaly. Furthermore, Kojima et al. reported Japanese MCD cases with effusion and thrombocytopenia (Castleman-Kojima disease). Here, we report two cases of MCD associated with marked pleural effusion, ascites, and thrombocytopenia, and discuss the independence of the TAFRO syndrome (Castleman-Kojima disease). Case 1: A 57-year-old woman had fever, anemia, anasarca, and some small cervical lymphadenopathy. Although she had been administered steroid therapy, and full-coverage antibiotics, her general condition, including fever, systemic inflammation, and anasarca, deteriorated steadily. We administered chemotherapy [CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisolone) regimen], but despite a transient improvement, she died due to septic shock. Case 2: A 73-year-old man with a history of aplastic anemia and remission presented with fever, severe inflammation, and anasarca. Prednisolone was administered (15 mg daily), and his hyperinflammation once improved. Nevertheless, his general condition, including pleural effusion and ascites, worsened, and C-reactive protein and interleukin-6 levels showed marked increases. The patient died due to multiorgan failure. Cases of TAFRO syndrome (Castleman-Kojima disease) are still rare. Therefore, it is necessary to conduct multicenter clinical surveys including similar cases, such as ours, to reach a consensus regarding diagnostic criteria, therapeutic strategy, and pathophysiological etiology for this syndrome.

  7. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

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    David Noriega

    2015-01-01

    Full Text Available This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF of traumatic origin. We enrolled 103 patients (median age: 61.6 years with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS. Secondary outcomes were Oswestry Disability Index (ODI, EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score and in quality of life (increase 21.1% of EQ-VAS score were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°; p<0.001, remained at 12 months (-4.4±6.0°, p=0.002. No adverse events were implant-related and none required device removal. Three patients (2.9% experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  8. MRI of the wrist in juvenile idiopathic arthritis: proposal of a paediatric synovitis score by a consensus of an international working group. Results of a multicentre reliability study

    Energy Technology Data Exchange (ETDEWEB)

    Damasio, Maria Beatrice; Mattiuz, Chiara; Magnano, GianMichele [Ospedale Pediatrico Gaslini, Department of Radiology, Genova (Italy); Malattia, Clara; Martini, Alberto [University of Genova, Department of Paediatrics, Genova (Italy); Tanturri de Horatio, Laura; Barbuti, Domenico; Toma, Paolo [Ospedale Pediatrico Bambino Gesu, Department of Radiology, Rome (Italy); Pistorio, Angela [Ospedale pediatrico Gaslini, Department of Epidemiology and Biostatistics, Genova (Italy); Bracaglia, Claudia [Ospedale Pediatrico Bambino Gesu, Department of Rheumatology, Rome (Italy); Boavida, Peter; Ording, Lil Sophie Mueller [Great Ormond Street Hospital for Children, Department of Radiology, London (United Kingdom); Juhan, Karen Lambot [Hopital Necker Enfants Malades, Department of Radiology, Paris (France); Rosendahl, Karen [University Hospital North Norway, Department of Radiology, Tromsoe (Norway)

    2012-09-15

    MRI is a sensitive tool for the evaluation of synovitis in juvenile idiopathic arthritis (JIA). The purpose of this study was to introduce a novel MRI-based score for synovitis in children and to examine its inter- and intraobserver variability in a multi-centre study. Wrist MRI was performed in 76 children with JIA. On postcontrast 3-D spoiled gradient-echo and fat-suppressed T2-weighted spin-echo images, joint recesses were scored for the degree of synovial enhancement, effusion and overall inflammation independently by two paediatric radiologists. Total-enhancement and inflammation-synovitis scores were calculated. Interobserver agreement was poor to moderate for enhancement and inflammation in all recesses, except in the radioulnar and radiocarpal joints. Intraobserver agreement was good to excellent. For enhancement and inflammation scores, mean differences (95 % CI) between observers were -1.18 (-4.79 to 2.42) and -2.11 (-6.06 to 1.83). Intraobserver variability (reader 1) was 0 (-1.65 to 1.65) and 0.02 (-1.39 to 1.44). Intraobserver agreement was good. Except for the radioulnar and radiocarpal joints, interobserver agreement was not acceptable. Therefore, the proposed scoring system requires further refinement. (orig.)

  9. Computers and internet in dental education system of Kerala, South India: A multicentre study

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    Kanakath Harikumar

    2015-01-01

    Full Text Available Computers and internet have exerted a tremendous effect on dental education programs all over the world. A multicenter study was done to assess trends in computer and internet usage among the dental students and faculty members across the South Indian state, Kerala. A total of 347 subjects participated in the study. All participants were highly competent with the use of computers and internet. 72.3% of the study subjects preferred hard copy textbooks to PDF format books. 81.3% of the study subjects thought that internet was a useful adjunct to dental education. 73.8% of the study subjects opined that computers and internet could never be a replacement to conventional classroom teaching. Efforts should be made to provide greater infrastructure with regard to computers and internet such as Wi-Fi, free, unlimited internet access to all students and faculty members.

  10. CT diagnosis for multicentric type in Castlemans disease%多中心型 Castleman 病的CT诊断

    Institute of Scientific and Technical Information of China (English)

    王镇; 夏从羊; 邢曜耀; 王德阳

    2012-01-01

    Objective:To improve the recognition of CT imaging features of multicentric type in Castleman's disease. Methods:To observe the CT imaging featares of 3 patients with multiple - center Castleman's disease proven by surgery and pathology or biopsy. Results; All 3 cases were multicentricly distributed,the plasma cell type in the histo-pathology was faund in 2 cases and mixed type in 1 case. On dynamic contrast CT images,all of masses showed slight enhancement and sustained enhancement at delay. Conclusion:The symptom of multi -lesions distributed,slight enhancement and branch shape calcification could suggest the diagnosis of multicentric type Castleman's. Its final diagnosis must be conbined with biopsy and laboratory tests.%目的:提高对多中心型Castleman病CT征象的认识.方法:分析3例经手术病理或穿刺活检证实为多中心型Castleman病的CT征象,总结其特征.结果:3例均为多中心分布,病理分型为浆细胞型1例,混合型2例.动态增强扫描病灶均表现轻度强化,延迟期表现为持续强化.结论:多中心型Castleman病的多病灶性分布,轻度强化及分枝状钙化等征象可提示该病的诊断,确诊需要靠穿刺活检及实验室检查.

  11. Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial.

    OpenAIRE

    Ali Giuseppa; Burnand Bernard; Herzig Lilli; Vaucher Paul; Favrat Bernard; Boulat Olivier; Bischoff Thomas; Verdon François

    2011-01-01

    Abstract Background Evidence regarding the effectiveness of oral vitamin B12 in patients with serum vitamin B12 levels between 125-200 pM/l is lacking. We compared the effectiveness of one-month oral vitamin B12 supplementation in patients with a subtle vitamin B12 deficiency to that of a placebo. Methods This multicentre (13 general practices, two nursing homes, and one primary care center in western Switzerland), parallel, randomised, controlled, closed-label, observer-blind trial included ...

  12. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    Science.gov (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  13. Incidence of nutritional support complications in patient hospitalized in wards. multicentric study

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    Gloria María Agudelo Ochoa

    2012-06-01

    Full Text Available Introduction: Nutritional support generates complications that must be detected and treated on time. Objective: To estimate the incidence of some complications of nutritional support in patients admitted to general hospital wards who received nutritional support in six high-complexity institutions. Methods: Prospective, descriptive and multicentric study in patients with nutritional support; the variables studied were medical diagnosis, nutritional condition, nutritional support duration, approach, kind of formula, and eight complications. Results: A total of 277 patients were evaluated; 83% received enteral nutrition and 17% received parenteral nutrition. Some 69.3% presented risk of malnourishment or severe malnourishment at admittance. About 35.4% of those receiving enteral nutrition and 39.6% of the ones who received parenteral nutrition had complications; no significant difference per support was found (p = 0.363. For the enteral nutrition, the most significant complication was the removal of the catheter (14%, followed by diarrhea (8.3%; an association between the duration of the enteral support with diarrhea, constipation and removal of the catheter was found (p < 0.05. For parenteral nutrition, hyperglycemia was the complication of highest inci­dence (22.9%, followed by hypophosphatemia (12.5%; all complications were associated with the duration of the support (p < 0.05. Nutritional support was suspended in 24.2% of the patients. Conclusions: Complications with nutritional support in hospital-ward patients were frequent, with the removal of the catheter and hyperglycemia showing the highest incidence. Duration of the support was the variable that revealed an asso­ciation with complications. Strict application of protocols could decrease the risk for complications and boost nutritional support benefits.

  14. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study

    Science.gov (United States)

    Lefèvre, Thierry; Kappetein, Ari Pieter; Wolner, Ernst; Nataf, Patrick; Thomas, Martyn; Schächinger, Volker; De Bruyne, Bernard; Eltchaninoff, Hélène; Thielmann, Matthias; Himbert, Dominique; Romano, Mauro; Serruys, Patrick; Wimmer-Greinecker, Gerhard

    2011-01-01

    Background Transcatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis. Aims PARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach. Methods and results Primary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively. Conclusion This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes. PMID:21075775

  15. Occupational factors and risk of adult bone sarcomas: a multicentric case-control study in Europe.

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    Merletti, Franco; Richiardi, Lorenzo; Bertoni, Franco; Ahrens, Wolfgang; Buemi, Antoine; Costa-Santos, Cristina; Eriksson, Mikael; Guénel, Pascal; Kaerlev, Linda; Jöckel, Karl-Heinz; Llopis-Gonzalez, Agustin; Merler, Enzo; Miranda, Ana; Morales-Suárez-Varela, Maria M; Olsson, Håkan; Fletcher, Tony; Olsen, Jorn

    2006-02-01

    We investigated the association between occupational factors and risk of bone sarcoma, a rare tumor with a largely unknown aetiology. A multicentric case-control study was conducted in 7 European countries in 1995-97. Ninety-six cases aged 35-69 years with a centrally reviewed diagnosis of bone sarcoma (68 chondrosarcomas and 28 osteosarcomas) were compared to 2,632 population (68%) or colon cancer (32%) controls. Subjects were interviewed to obtain information on occupational, medical and reproductive history, smoking and alcohol consumption and selected exposures including use of pesticides. Response proportions were 90% among cases and 66% among controls. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for selected categories of job titles and branches of industry and for use of pesticides. We found an increased OR for bone sarcoma among blacksmiths, toolmakers, machine-tool operators (OR = 2.14, 95% CI 1.08-4.26), woodworkers (OR = 2.68, 95% CI 1.36-5.29) and construction workers (OR = 1.62, 95% CI 0.92-2.87). Ever users of pesticide had an OR of 2.33 (95% CI 1.31-4.13), with similar risks for exposure to insecticides and exposure to herbicides. Neither duration of employment in any of the analyzed occupational categories nor duration of use of pesticides showed an increasing trend in the risk of bone sarcoma. ORs of bone sarcoma were 1.03 (95% CI 0.23-4.57), 3.13 (95% CI 1.26-7.76) and 1.44 (95% CI 0.43-4.85) for the first, second and third tertile of days of use of pesticides. Our study suggests that novel and previously reported (woodworking) occupational factors play a role in the aetiology of bone sarcomas.

  16. Is testis-sparing surgery safe in small testicular masses? Results of a multicentre study

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    Keske, Murat; Canda, Abdullah Erdem; Yalcin, Serdar; Kilicarslan, Aydan; Kibar, Yusuf; Tuygun, Can; Onder, Evrim; Atmaca, Ali Fuat; Yildirim, Asif; Ozkanli, Sidika Seyma; Kandemir, Olcay; Kargi, Taner; Sar, Mehmet; Tugcu, Volkan; Resorlu, Berkan; Aslan, Yilmaz; Sarikaya, Selcuk; Boylu, Ugur; Cicek, Ali Fuat; Basar, Halil; Tuncel, Altug; Balbay, Mevlana Derya

    2017-01-01

    Introduction Our goal was to evaluate benign and malignant lesions and testicular intraepithelial neoplasia (TIN) in the neighbouring normal-appearing testis tissue in men who underwent radical orchiectomy for testicular mass with a pathologic tumour size of ≤3cm. Methods In this retrospective, multicentre study, data of 252 patients from 11 different institutions were included. Patients were divided into three groups based on tumour size: Group 1 (0–1 cm; n=35), Group 2 (1.1–2cm; n=99), and Group 3 (2.1–3 cm; n=118). Benign lesions and TIN were sought in the neighbouring testicular tissue and compared between groups. Results Mean patient age was 32.3 years. Benign lesions were reported in 54.3%, 33.3%, and 14.4% of Groups 1, 2, and 3, respectively (p0.05 for Groups 2 vs. 3). Multifocality was detected in 8.6%, 4%, and 0% of Groups 1, 2, and 3, respectively (p0.05 for Group 1 vs. Group 2). A tumour cutoff size of 1.5 cm was found to be significant for detecting benign tumour. TIN and multifocality rates were similar in patients with a tumour size of ≤1.5 vs. >1.5 cm (p>0.05). Conclusions Benign lesions and TIN in the neighbouring testis were significantly decreased and multifocality was increased in patients with a tumour mass size of ≤1 cm. Testis-sparing surgery should be performed with caution and a safety rim of normal tissue should also be excised.

  17. Post-partum weight change patterns in the WHO Multicentre Growth Reference Study.

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    Onyango, Adelheid W; Nommsen-Rivers, Laurie; Siyam, Amani; Borghi, Elaine; de Onis, Mercedes; Garza, Cutberto; Lartey, Anna; Baerug, Anne; Bhandari, Nita; Dewey, Kathryn G; Araújo, Cora Luiza; Mohamed, Ali Jaffer; Van den Broeck, Jan

    2011-07-01

    The interplay of factors that affect post-partum loss or retention of weight gained during pregnancy is not fully understood. The objective of this paper is to describe patterns of weight change in the six sites of the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) and explore variables that explain variation in weight change within and between sites. Mothers of 1743 breastfed children enrolled in the MGRS had weights measured at days 7, 14, 28 and 42 post-partum, monthly from 2 to 12 months and bimonthly thereafter until 24 months post-partum. Height, maternal age, parity and employment status were recorded and breastfeeding was monitored throughout the follow-up. Weight change patterns varied significantly among sites. Ghanaian and Omani mothers lost little or gained weight post-partum. In Brazil, India, Norway and USA, mothers on average lost weight during the first year followed by stabilization in the second year. Lactation intensity and duration explained little of the variation in weight change patterns. In most sites, obese mothers tended to lose less weight than normal-weight mothers. In Brazil and Oman, primiparous mothers lost about 1 kg more than multiparous mothers in the first 6 months. In India and Ghana, multiparous mothers lost about 0.6 kg more than primiparas in the second 6 months. Culturally defined mother-care practices probably play a role in weight change patterns among lactating women. This hypothesis should stimulate investigation into gestational weight gain and post-partum losses in different ethnocultural contexts.

  18. Role of capsule endoscopy in suspected celiac disease: A European multi-centre study

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    Luján-Sanchis, Marisol; Pérez-Cuadrado-Robles, Enrique; García-Lledó, Javier; Juanmartiñena Fernández, José-Francisco; Elli, Luca; Jiménez-García, Victoria-Alejandra; Egea-Valenzuela, Juan; Valle-Muñoz, Julio; Carretero-Ribón, Cristina; Fernández-Urién-Sainz, Ignacio; López-Higueras, Antonio; Alonso-Lázaro, Noelia; Sanjuan-Acosta, Mileidis; Sánchez-Ceballos, Francisco; Rosa, Bruno; González-Vázquez, Santiago; Branchi, Federica; Ruano-Díaz, Lucía; Prieto-de-Frías, César; Pons-Beltrán, Vicente; Borque-Barrera, Pilar; González-Suárez, Begoña; Xavier, Sofía; Argüelles-Arias, Federico; Herrerías-Gutiérrez, Juan-Manuel; Pérez-Cuadrado-Martínez, Enrique; Sempere-García-Argüelles, Javier

    2017-01-01

    AIM To analyze the diagnostic yield (DY), therapeutic impact (TI) and safety of capsule endoscopy (CE). METHODS This is a multi-centre, observational, analytical, retrospective study. A total of 163 patients with suspicion of celiac disease (CD) (mean age = 46.4 ± 17.3 years, 68.1% women) who underwent CE from 2003 to 2015 were included. Patients were divided into four groups: seronegative CD with atrophy (Group-I, n = 19), seropositive CD without atrophy (Group-II, n = 39), contraindication to gastroscopy (Group-III, n = 6), seronegative CD without atrophy, but with a compatible context (Group-IV, n = 99). DY, TI and the safety of CE were analysed. RESULTS The overall DY was 54% and the final diagnosis was villous atrophy (n = 65, 39.9%), complicated CD (n = 12, 7.4%) and other enteropathies (n = 11, 6.8%; 8 Crohn’s). DY for groups I to IV was 73.7%, 69.2%, 50% and 44.4%, respectively. Atrophy was located in duodenum in 24 cases (36.9%), diffuse in 19 (29.2%), jejunal in 11 (16.9%), and patchy in 10 cases (15.4%). Factors associated with a greater DY were positive serology (68.3% vs 49.2%, P = 0.034) and older age (P = 0.008). On the other hand, neither sex nor clinical presentation, family background, positive histology or HLA status were associated with DY. CE results changed the therapeutic approach in 71.8% of the cases. Atrophy was associated with a greater TI (92.3% vs 45.3%, P disease. CE is safe procedure with a high degree of concordance with histology and it helps in the differential diagnosis of CD. PMID:28216978

  19. Knowledge, Attitudes, and Smoking Behaviours among Physicians Specializing in Public Health: A Multicentre Study

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    Giuseppe La Torre

    2014-01-01

    Full Text Available Background. Healthcare professionals have an important role to play both as advisers—influencing smoking cessation—and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS approach. Materials and Methods. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance, therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors. The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P≤0.05. Results. A total of 388 answered the questionnaire on the website (85%, of which 81 (20.9% declared to be smokers, 309 (79.6% considered health professionals as behavioural models for patients, and 375 (96.6% affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7% heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. Conclusions. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  20. Analysis of GPR101 and AIP genes mutations in acromegaly: a multicentric study.

    Science.gov (United States)

    Ferraù, Francesco; Romeo, P D; Puglisi, S; Ragonese, M; Torre, M L; Scaroni, C; Occhi, G; De Menis, E; Arnaldi, G; Trimarchi, F; Cannavò, S

    2016-12-01

    This multicentric study aimed to investigate the prevalence of the G protein-coupled receptor 101 (GPR101) p.E308D variant and aryl hydrocarbon receptor interacting protein (AIP) gene mutations in a representative cohort of Italian patients with acromegaly. 215 patients with GH-secreting pituitary adenomas, referred to 4 Italian referral centres for pituitary diseases, have been included. Three cases of gigantism were present. Five cases were classified as FIPA. All the patients have been screened for germline AIP gene mutations and GPR101 gene p.E308D variant. Heterozygous AIP gene variants have been found in 7 patients (3.2 %). Five patients carried an AIP mutation (2.3 %; 4 females): 3 patients harboured the p.R3O4Q mutation, one had the p.R304* mutation and the last one the IVS3+1G>A mutation. The prevalence of AIP mutations was 3.3 % and 2.8 % when considering only the patients diagnosed when they were <30 or <40-year old, respectively. Furthermore, 2.0 % of the patients with a pituitary macroadenoma and 4.2 % of patients resistant to somatostatin analogues treatment were found to harbour an AIP gene mutation. None of the patients was found to carry the GPR101 p.E308D variant. The prevalence of AIP gene mutations among our sporadic and familial acromegaly cases was similar to that one reported in previous studies, but lower when considering only the cases diagnosed before 40 years of age. The GPR101 p.E308D change is unlikely to have a role in somatotroph adenomas tumorigenesis, since none of our sporadic or familial patients tested positive for this variant.

  1. Blunt Cardiac Injury in the Severely Injured - A Retrospective Multicentre Study.

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    Marc Hanschen

    Full Text Available Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients.In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009, characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6, the revised injury severity score (RISC allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6 (2.3% of patients.Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%. The overall mortality rate was 13.9%, minor cardiac injury (AIS 1 and severe cardiac injury (AIS 2-6 are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6 is associated with a higher mortality (OR 2.79 and 4.89, respectively as compared to the predicted average mortality (OR 2.49 of the study collective.Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients' outcome is dependent on the severity of cardiac injury.

  2. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial

    Science.gov (United States)

    Forestier, R; Desfour, H; Tessier, J-M; Françon, A; Foote, A M; Genty, C; Rolland, C; Roques, C-F; Bosson, J-L

    2010-01-01

    Objective To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. Methods Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). Main Endpoint The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. Results The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (χ2=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated. Trial registration number NCT00348777. PMID:19734131

  3. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

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    Kang Kyung-Won

    2009-07-01

    Full Text Available Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China, randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group. The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping. The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial

  4. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial.

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    Vas, Jorge; Aranda, José Manuel; Modesto, Manuela; Benítez-Parejo, Nicolás; Herrera, Antonia; Martínez-Barquín, Dulce María; Aguilar, Inmaculada; Sánchez-Araujo, Max; Rivas-Ruiz, Francisco

    2012-09-01

    Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. Patients were treated from February 2006 to January 2008. The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture.

  5. Linezolid-resistant staphylococcal bacteraemia: A multicentre case-case-control study in Italy.

    Science.gov (United States)

    Russo, Alessandro; Campanile, Floriana; Falcone, Marco; Tascini, Carlo; Bassetti, Matteo; Goldoni, Paola; Trancassini, Maria; Della Siega, Paola; Menichetti, Francesco; Stefani, Stefania; Venditti, Mario

    2015-03-01

    The aim of this multicentre study was to analyse the characteristics of patients with bloodstream infections due to staphylococcal strains resistant to linezolid. This was a retrospective case-case-control study of patients hospitalised in three large teaching hospitals in Italy. A linezolid-resistant (LIN-R) Staphylococcus spp. group and a linezolid-susceptible (LIN-S) Staphylococcus spp. group were compared with control patients to determine the clinical features and factors associated with isolation of LIN-R strains. All LIN-R Staphylococcus spp. strains underwent molecular typing. Compared with the LIN-S group, central venous catheters were the main source of infection in the LIN-R group. The LIN-R and LIN-S groups showed a similar incidence of severe sepsis or septic shock, and both showed a higher incidence of these compared with the control group. Overall, patients in the LIN-R group had a higher 30-day mortality rate. Multivariate analysis found previous linezolid therapy, linezolid therapy >14 days, antibiotic therapy in the previous 30 days, antibiotic therapy >14 days, previous use of at least two antibiotics and hospitalisation in the previous 90 days as independent risk factors associated with isolation of a LIN-R strain. The G2576T mutation in domain V of 23S rRNA was the principal mechanism of resistance; only one strain of Staphylococcus epidermidis carried the cfr methylase gene (A2503), together with L4 insertion (71GGR72) and L3 substitution (H146Q). LIN-R strains are associated with severe impairment of clinical conditions and unfavourable patient outcomes. Reinforcement of infection control measures may have an important role in preventing these infections.

  6. A multicentre analysis of epidemiology of the nosocomial bloodstream infections in Japanese university hospitals.

    Science.gov (United States)

    Nagao, M

    2013-09-01

    Nosocomial bloodstream infections (BSIs) are an important cause of morbidity and mortality. The current study analysed data from a concurrent surveillance programme to examine the current epidemiological trends for nosocomial BSIs at 22 Japanese university hospitals from 1 April 2008 to 31 March 2012. The number of blood culture sets taken, the rate of multiple blood culture sets and the rates of antibiotic-resistant isolates among six major nosocomial BSI pathogens (Staphylococcus aureus, Enterococcus spp., Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa, and Candida spp.) not including coagulase-negative staphylococci, were evaluated. The clinical characteristics of nosocomial BSIs caused by these pathogens were also collected for 2941 patients. The number of blood culture sets taken per bed increased during the 4-year study period (from 4.07 in 2008 to 5.37 in 2011), and the rates of multiple blood culture sets also increased (from 29.9% in 2008 to 50.0% in 2011). Methicillin resistance was detected in 50.2% of S. aureus isolates. The prevalence rates of extended-spectrum beta-lactamase-producing E. coli and Klebsiella spp. isolates increased annually during the study period, and the average prevalence rates were 12.3% and 5.8%, respectively. The overall crude mortality of nosocomial BSIs due to the six pathogens evaluated was 24.5% (43.2% in ICU settings and 20.5% in non-ICU settings). Thus, our multicentre study evaluated the current epidemiological trends for nosocomial BSIs, and we found that further efforts are needed to increase the use of multiple blood culture sets and improve the prognosis of nosocomial BSIs in Japanese university hospitals.

  7. Different patient case mix by applying the 2003 SCCM/ESICM/ACCP/ATS/SIS sepsis definitions instead of the 1992 ACCP/SCCM sepsis definitions in surgical patients: a retrospective observational study

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    Kron Martina

    2009-05-01

    Full Text Available Abstract Background Revised consensus sepsis definitions have been published in 2003. The present study was performed to compare the prevalence of different stages of sepsis and ICU mortality rates and find out the case mix within the same collective of postoperative/posttraumatic patients applying either the original 1992 ACCP/SCCM or the revised 2003 SCCM/ESICM/ACCP/ATS/SIS sepsis definitions. Methods Retrospective observational single-centre study in surgical critically ill patients admitted to an University adult ICU. From 01/2007 to 12/2007, 742 patients were surveyed daily computer-assisted with respect to different stages of sepsis. Results Within the same patient collective, applying the 2003 definitions instead of the 1992 definitions, prevalence of severe sepsis (61 vs. 56 and septic shock (205 vs. 162 was higher (p Conclusion The prevalence and mortality rates of various sepsis severity stages differ if defined by the 1992 or the 2003 definitions. Thus, transferring conclusions drawn from data sets regarding severity of sepsis generated with the 1992 definitions to the same population applying the 2003 definitions may be misleading. The 1992 definitions may under-classify patients with severe sepsis.

  8. Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial

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    Mueller Joachim M

    2009-03-01

    Full Text Available Abstract Background The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe. Methods In the settings of a multicentre (three University Hospitals prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD or 0.25% povidone-iodine (control intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall level of IL-1beta in peritoneal fluid. Results Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36, the cancer-related death rate (17 vs. 19, p = .2, the local recurrence rate (7 vs. 12, p = .16, the distant metastasis rate (13 vs. 18, p = 0.2 as well as the time to relapse were not statistically significant different. Conclusion Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection. Trial registration ISRCTN66478538

  9. Metachronous multicentric giant-cell tumor of the bone in the lower limb. Case report and Ki-67 immunohistochemistry study.

    Science.gov (United States)

    Rousseau, Marc-Antoine; Handra-Luca, Adriana; Lazennec, Jean-Yves; Catonné, Yves; Saillant, Gérard

    2004-07-01

    Multicentric giant-cell tumors of the bone (GCTs) are rare. Little is known about the mechanisms by which these tumors spread and how 1% of GCT turn out to be multicentric. We report the case of a 19-year-old woman with metachronous multiple and recurrent GCTs that were unusual in their pattern of progression along the right lower limb over a 23-year period. Histology showed no evidence of malignant transformation. The treatment was repeated curettage and packing with cement. This did not permit a wide surgical margin, but avoided amputation and preserved full limb function. We tested the proliferation index marker Ki-67 in the tumor specimens. Ki-67 expression was limited to the mononuclear cell component of the tumors. The proliferation index was similar in each new tumor and higher in recurrences for each location. In this case, proliferation was initially low in the new tumor location, despite the time difference and independent from the initial clone evolution. Proliferation index increased in recurrent GCTs after marginal margin resection.

  10. Disease-Specific Regions Outperform Whole-Brain Approaches in Identifying Progressive Supranuclear Palsy: A Multicentric MRI Study

    Science.gov (United States)

    Mueller, Karsten; Jech, Robert; Bonnet, Cecilia; Tintěra, Jaroslav; Hanuška, Jaromir; Möller, Harald E.; Fassbender, Klaus; Ludolph, Albert; Kassubek, Jan; Otto, Markus; Růžička, Evžen; Schroeter, Matthias L.

    2017-01-01

    To identify progressive supranuclear palsy (PSP), we combined voxel-based morphometry (VBM) and support vector machine (SVM) classification using disease-specific features in multicentric magnetic resonance imaging (MRI) data. Structural brain differences were investigated at four centers between 20 patients with PSP and 20 age-matched healthy controls with T1-weighted MRI at 3T. To pave the way for future application in personalized medicine, we applied SVM classification to identify PSP on an individual level besides group analyses based on VBM. We found a major decline in gray matter density in the brainstem, insula, and striatum, and also in frontomedian regions, which is in line with current literature. Moreover, SVM classification yielded high accuracy rates above 80% for disease identification in imaging data. Focusing analyses on disease-specific regions-of-interest (ROI) led to higher accuracy rates compared to a whole-brain approach. Using a polynomial kernel (instead of a linear kernel) led to an increased sensitivity and a higher specificity of disease detection. Our study supports the application of MRI for individual diagnosis of PSP, if combined with SVM approaches. We demonstrate that SVM classification provides high accuracy rates in multicentric data—a prerequisite for potential application in diagnostic routine. PMID:28326008

  11. Cerebral sinus venous thromboses in children with acute lymphoblastic leukaemia - a multicentre study from the Nordic Society of Paediatric Haematology and Oncology

    DEFF Research Database (Denmark)

    Ranta, Susanna; Tuckuviene, Ruta; Mäkipernaa, Anne

    2014-01-01

    We present a prospective multicentre cohort of 20 children with acute lymphoblastic leukaemia (ALL) and cerebral sinus venous thrombosis (CSVT). The study covers a period of 5 years and comprises 1038 children treated according to the Nordic Society of Paediatric Haematology and Oncology (NOPHO...

  12. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

    DEFF Research Database (Denmark)

    Rettenbacher, M; Andersen, A N; Garcia-Velasco, J A;

    2015-01-01

    Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm...

  13. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - a double-blind, randomised, multicentre study in adults

    DEFF Research Database (Denmark)

    Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

    2013-01-01

    The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

  14. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

    DEFF Research Database (Denmark)

    Nyboeandersen, A; Al Humaidan, Peter Samir Heskjær; Fried, G;

    2008-01-01

    BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use e...

  15. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    BACKGROUND: The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 un

  16. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    BACKGROUND: The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined typ

  17. Tolerability of the capsaicin 8% patch following pretreatment with lidocaine or tramadol in patients with peripheral neuropathic pain: A multicentre, randomized, assessor-blinded study

    NARCIS (Netherlands)

    Jensen, T.S.; Hoye, K.; Fricova, J.; Vanelderen, P.J.L.; Ernault, E.; Siciliano, T.; Marques, S.

    2014-01-01

    BACKGROUND: Application of the capsaicin 8% patch is associated with treatment-related discomfort. Consequently, pretreatment for 60 min with anaesthetic cream is recommended; however, this may be uncomfortable and time consuming. METHODS: We conducted a multicentre, randomized (1:1), assessor-blind

  18. Effectiveness of different modalities of psychotherapeutic treatment for patients with cluster C personality disorders: results of a large prospective multicentre study.

    NARCIS (Netherlands)

    A. Bartak (Anna); M.D. Spreeuwenberg (Marieke); H. Andrea (Helene); L. Holleman (Lot); P. Rijnierse (Piet); B. van Rossum (Bert); E.F.M. Hamers (Elisabeth); A.M.M.A. Meerman (Anke); J. Aerts (Janneke); J.J. van Busschbach (Jan); R. Verheul (Roel); Th. Stijnen (Theo); P.M.G. Emmelkamp (Paul)

    2011-01-01

    textabstractAbstract BACKGROUND: No previous studies have compared the effectiveness of different modalities of psychotherapeutic treatment, as defined by different settings and durations, for patients with cluster C personality disorders. The aim of this multicentre study was to compare the effect

  19. Effectiveness of different modalities of psychotherapeutic treatment for patients with cluster C personality disorder: results of a large prospective multicentre study

    NARCIS (Netherlands)

    A. Bartak; M.D. Spreeuwenberg; H. Andrea; H. Holleman; P. Rijnierse; B.V. Rossum; E.F.M Hamers; A.M.M.A. Meerman; J. Aerts; J.J.V. Busschbach; R. Verheul; T. Stijnen; P.M.G. Emmelkamp

    2010-01-01

    Background: No previous studies have compared the effectiveness of different modalities of psychotherapeutic treatment, as defined by different settings and durations, for patients with cluster C personality disorders. The aim of this multicentre study was to compare the effectiveness of 5 treatment

  20. Invasive Candida infections in surgical patients in intensive care units: a prospective, multicentre survey initiated by the European Confederation of Medical Mycology (ECMM) (2006-2008)

    NARCIS (Netherlands)

    Klingspor, L.; Tortorano, A.M.; Peman, J.; Willinger, B.; Hamal, P.; Sendid, B.; Velegraki, A.; Kibbler, C.; Meis, J.F.G.M.; Sabino, R.; Ruhnke, M.; Arikan-Akdagli, S.; Salonen, J.; Doczi, I.

    2015-01-01

    A prospective, observational, multicentre study of invasive candidosis (IC) in surgical patients in intensive care units (ICUs) was conducted from 2006 to 2008 in 72 ICUs in 14 European countries. A total of 779 patients (62.5% males, median age 63 years) with IC were included. The median rate of ca

  1. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

    NARCIS (Netherlands)

    Leontjevas, R.; Gerritsen, D.L.; Smalbrugge, M.; Teerenstra, S.; Vernooij-Dassen, M.J.F.J.; Koopmans, R.T.C.M.

    2013-01-01

    BACKGROUND: Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. METHODS: Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of t

  2. NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease

    NARCIS (Netherlands)

    Lawlor, B.; Kennelly, S.; O'Dwyer, S.; Cregg, F.; Walsh, C.; Coen, R.; Kenny, R.A.; Howard, R.; Murphy, C.; Adams, J.; Daly, L.; Segurado, R.; Gaynor, S.; Crawford, F.; Mullan, M.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Wallin, A.; Borjesson, A.; Molloy, W.; Tsolaki, M.; Olde Rikkert, M.G.M.

    2014-01-01

    INTRODUCTION: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 week

  3. The effect of rater training on scoring performance and scale-specific expertise amongst occupational therapists participating in a multicentre study

    DEFF Research Database (Denmark)

    Hansen, Tina; Madsen, Esben Elholm; Sørensen, Annette

    2016-01-01

    Purpose: In order to enhance the quality of the data collected in a multicentre validation study of a revised Danish version of the McGill Ingestive Skills Assessment (MISA), the authors developed a rater training programme. The purpose of the present study was to evaluate the effect of the train...

  4. Benefit of particle therapy in re-irradiation of head and neck patients. Results of a multicentric in silico ROCOCO trial

    NARCIS (Netherlands)

    Eekers, D.B.; Roelofs, E.; Jelen, U.; Kirk, M.; Granzier, M.; Ammazzalorso, F.; Ahn, P.H.; Janssens, G.O.; Hoebers, F.J.; Friedmann, T.; Solberg, T.; Walsh, S.; Troost, E.G.; Kaanders, J.H.A.M.; Lambin, P.

    2016-01-01

    BACKGROUND AND PURPOSE: In this multicentric in silico trial we compared photon, proton, and carbon-ion radiotherapy plans for re-irradiation of patients with squamous cell carcinoma of the head and neck (HNSCC) regarding dose to tumour and doses to surrounding organs at risk (OARs). MATERIAL AND ME

  5. Evaluation of real-time PCR and conventional diagnostic methods for the detection of Clostridium difficile-associated diarrhoea in a prospective multicentre study.

    NARCIS (Netherlands)

    Berg, R.J.F. van den; Vaessen, N.; Endtz, H.P.; Schulin, T.; Vorm, E.R. van der; Kuijper, E.J.

    2007-01-01

    In this prospective multicentre study, an enzyme-linked fluorescent assay (VIDAS CDA2; bioMerieux), an enzyme-linked assay [Premier Toxins A and B (PTAB); Meridian] and an in-house real-time PCR amplifying the tcdB gene were compared with the cell cytotoxicity assay used as the 'gold standard' for d

  6. Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study

    NARCIS (Netherlands)

    Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

    2015-01-01

    This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted l

  7. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

    DEFF Research Database (Denmark)

    Nyboeandersen, A.; Humaidan, P.; Fried, G.

    2008-01-01

    BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use...

  8. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients : a prospective randomized multicentre study

    NARCIS (Netherlands)

    Scheeren, Thomas W. L.; Wiesenack, Christoph; Gerlach, Herwig; Marx, Gernot

    2013-01-01

    Perioperative hemodynamic optimisation improves postoperative outcome for patients undergoing high-risk surgery (HRS). In this prospective randomized multicentre study we studied the effects of an individualized, goal-directed fluid management based on continuous stroke volume variation (SVV) and st

  9. Effects of long-term exposure to air pollution on natural-cause mortality : an analysis of 22 European cohorts within the multicentre ESCAPE project

    NARCIS (Netherlands)

    Beelen, Rob; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul; Nieuwenhuijsen, Mark; Vineis, Paolo; Xun, Wei W.; Katsouyanni, Klea; Dimakopoulou, Konstantina; Oudin, Anna; Forsberg, Bertil; Modig, Lars; Havulinna, Aki S.; Lanki, Timo; Turunen, Anu; Oftedal, Bente; Nystad, Wenche; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L.; Ostenson, Claes-Goeran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Goeran; Eriksen, Kirsten Thorup; Overvad, Kim; Ellermann, Thomas; Eeftens, Marloes; Peeters, Petra H.; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, Bas; Sugiri, Dorothea; Kraemer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Ineichen, Alex; Schaffner, Emmanuel; Probst-Hensch, Nicole; Kuenzli, Nino; Schindler, Christian; Schikowski, Tamara; Adam, Martin; Phuleria, Harish; Vilier, Alice; Clavel-Chapelon, Francoise; Declercq, Christophe; Grioni, Sara; Krogh, Vittorio; Tsai, Ming-Yi; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Tamayo, Ibon; Amiano, Pilar; Dorronsoro, Miren; Katsoulis, Michail; Trichopoulou, Antonia; Brunekreef, Bert; Hoek, Gerard

    2014-01-01

    Background Few studies on long-term exposure to air pollution and mortality have been reported from Europe. Within the multicentre European Study of Cohorts for Air Pollution Effects (ESCAPE), we aimed to investigate the association between natural-cause mortality and long-term exposure to several a

  10. Mortality and causes of death of 513 Danish patients with systemic lupus erythematosus

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Petersen, Jørgen; Ullman, S;

    1999-01-01

    A multicentre cohort of 513 clinic attenders with systemic lupus erythematosus (SLE) was retrospectively identified, representing 4185 patient-years of follow-up. Expected numbers of death were calculated by means of age- and sex-specific mortality rates of the general Danish population. The obse......A multicentre cohort of 513 clinic attenders with systemic lupus erythematosus (SLE) was retrospectively identified, representing 4185 patient-years of follow-up. Expected numbers of death were calculated by means of age- and sex-specific mortality rates of the general Danish population...

  11. A multicentre molecular analysis of hepatitis B and blood-borne virus coinfections in Viet Nam.

    Directory of Open Access Journals (Sweden)

    Linda Dunford

    Full Text Available Hepatitis B (HBV infection is endemic in Viet Nam, with up to 8.4 million individuals estimated to be chronically infected. We describe results of a large, multicentre seroepidemiological and molecular study of the prevalence of HBV infection and blood-borne viral coinfections in Viet Nam. Individuals with varying risk factors for infection (n = 8654 were recruited from five centres; Ha Noi, Hai Phong, Da Nang, Khanh Hoa and Can Tho. A mean prevalence rate of 10.7% was observed and levels of HBsAg were significantly higher in injecting drug users (IDUs (17.4%, n = 174/1000 and dialysis patients (14.3%, n = 82/575 than in lower-risk groups (9.4%; p<0.001. Coinfection with HIV was seen in 28% of HBV-infected IDUs (n = 49/174 and 15.2% of commercial sex workers (CSWs; n = 15/99. HCV infection was present in 89.8% of the HBV-HIV coinfected IDUs (n = 44/49 and 40% of HBV-HIV coinfected CSWs (n = 16/40. Anti-HDV was detected in 10.7% (n = 34/318 of HBsAg positive individuals. Phylogenetic analysis of HBV S gene (n = 187 showed a predominance of genotype B4 (82.6%; genotypes C1 (14.6%, B2 (2.7% and C5 (0.5% were also identified. The precore mutation G1896A was identified in 35% of all specimens, and was more frequently observed in genotype B (41% than genotype C (3%; p<0.0001. In the immunodominant 'a' region of the surface gene, point mutations were identified in 31% (n = 58/187 of sequences, and 2.2% (n = 4/187 and 5.3% (n = 10/187 specimens contained the major vaccine escape mutations G145A/R and P120L/Q/S/T, respectively. 368 HBsAg positive individuals were genotyped for the IL28B SNP rs12979860 and no significant association between the IL28B SNP and clearance of HBsAg, HBV viral load or HBeAg was observed. This study confirms the high prevalence of HBV infection in Viet Nam and also highlights the significant levels of blood-borne virus coinfections, which have important implications for hepatitis-related morbidity and development of effective

  12. Multi-centre reproducibility of diffusion MRI parameters for clinical sequences in the brain

    Science.gov (United States)

    Grech-Sollars, Matthew; Hales, Patrick W; Miyazaki, Keiko; Raschke, Felix; Rodriguez, Daniel; Wilson, Martin; Gill, Simrandip K; Banks, Tina; Saunders, Dawn E; Clayden, Jonathan D; Gwilliam, Matt N; Barrick, Thomas R; Morgan, Paul S; Davies, Nigel P; Rossiter, James; Auer, Dorothee P; Grundy, Richard; Leach, Martin O; Howe, Franklyn A; Peet, Andrew C; Clark, Chris A

    2015-01-01

    The purpose of this work was to assess the reproducibility of diffusion imaging, and in particular the apparent diffusion coefficient (ADC), intra-voxel incoherent motion (IVIM) parameters and diffusion tensor imaging (DTI) parameters, across multiple centres using clinically available protocols with limited harmonization between sequences. An ice–water phantom and nine healthy volunteers were scanned across fives centres on eight scanners (four Siemens 1.5T, four Philips 3T). The mean ADC, IVIM parameters (diffusion coefficient D and perfusion fraction f) and DTI parameters (mean diffusivity MD and fractional anisotropy FA), were measured in grey matter, white matter and specific brain sub-regions. A mixed effect model was used to measure the intra- and inter-scanner coefficient of variation (CV) for each of the five parameters. ADC, D, MD and FA had a good intra- and inter-scanner reproducibility in both grey and white matter, with a CV ranging between 1% and 7.4%; mean 2.6%. Other brain regions also showed high levels of reproducibility except for small structures such as the choroid plexus. The IVIM parameter f had a higher intra-scanner CV of 8.4% and inter-scanner CV of 24.8%. No major difference in the inter-scanner CV for ADC, D, MD and FA was observed when analysing the 1.5T and 3T scanners separately. ADC, D, MD and FA all showed good intra-scanner reproducibility, with the inter-scanner reproducibility being comparable or faring slightly worse, suggesting that using data from multiple scanners does not have an adverse effect compared with using data from the same scanner. The IVIM parameter f had a poorer inter-scanner CV when scanners of different field strengths were combined, and the parameter was also affected by the scan acquisition resolution. This study shows that the majority of diffusion MRI derived parameters are robust across 1.5T and 3T scanners and suitable for use in multi-centre clinical studies and trials. © 2015 The Authors NMR in

  13. Multi-centre reproducibility of diffusion MRI parameters for clinical sequences in the brain.

    Science.gov (United States)

    Grech-Sollars, Matthew; Hales, Patrick W; Miyazaki, Keiko; Raschke, Felix; Rodriguez, Daniel; Wilson, Martin; Gill, Simrandip K; Banks, Tina; Saunders, Dawn E; Clayden, Jonathan D; Gwilliam, Matt N; Barrick, Thomas R; Morgan, Paul S; Davies, Nigel P; Rossiter, James; Auer, Dorothee P; Grundy, Richard; Leach, Martin O; Howe, Franklyn A; Peet, Andrew C; Clark, Chris A

    2015-04-01

    The purpose of this work was to assess the reproducibility of diffusion imaging, and in particular the apparent diffusion coefficient (ADC), intra-voxel incoherent motion (IVIM) parameters and diffusion tensor imaging (DTI) parameters, across multiple centres using clinically available protocols with limited harmonization between sequences. An ice-water phantom and nine healthy volunteers were scanned across fives centres on eight scanners (four Siemens 1.5T, four Philips 3T). The mean ADC, IVIM parameters (diffusion coefficient D and perfusion fraction f) and DTI parameters (mean diffusivity MD and fractional anisotropy FA), were measured in grey matter, white matter and specific brain sub-regions. A mixed effect model was used to measure the intra- and inter-scanner coefficient of variation (CV) for each of the five parameters. ADC, D, MD and FA had a good intra- and inter-scanner reproducibility in both grey and white matter, with a CV ranging between 1% and 7.4%; mean 2.6%. Other brain regions also showed high levels of reproducibility except for small structures such as the choroid plexus. The IVIM parameter f had a higher intra-scanner CV of 8.4% and inter-scanner CV of 24.8%. No major difference in the inter-scanner CV for ADC, D, MD and FA was observed when analysing the 1.5T and 3T scanners separately. ADC, D, MD and FA all showed good intra-scanner reproducibility, with the inter-scanner reproducibility being comparable or faring slightly worse, suggesting that using data from multiple scanners does not have an adverse effect compared with using data from the same scanner. The IVIM parameter f had a poorer inter-scanner CV when scanners of different field strengths were combined, and the parameter was also affected by the scan acquisition resolution. This study shows that the majority of diffusion MRI derived parameters are robust across 1.5T and 3T scanners and suitable for use in multi-centre clinical studies and trials.

  14. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  15. Acute ischaemic brain lesions in intracerebral haemorrhage: multicentre cross-sectional magnetic resonance imaging study.

    Science.gov (United States)

    Gregoire, Simone M; Charidimou, Andreas; Gadapa, Naveen; Dolan, Eamon; Antoun, Nagui; Peeters, Andre; Vandermeeren, Yves; Laloux, Patrice; Baron, Jean-Claude; Jäger, Hans R; Werring, David J

    2011-08-01

    Subclinical acute ischaemic lesions on brain magnetic resonance imaging have recently been described in spontaneous intracerebral haemorrhage, and may be important to understand pathophysiology and guide treatment. The underlying mechanisms are uncertain. We tested the hypothesis that ischaemic lesions are related to magnetic resonance imaging markers of the severity and type of small-vessel disease (hypertensive arteriopathy or cerebral amyloid angiopathy) in a multicentre, cross-sectional study. We studied consecutive patients with intracerebral haemorrhage from four specialist stroke centres, and age-matched stroke service referrals without intracerebral haemorrhage. Acute ischaemic lesions were assessed on magnetic resonance imaging (imaging. White matter changes and cerebral microbleeds were rated with validated scales. We investigated associations between diffusion-weighted imaging lesions, clinical and radiological characteristics. We included 114 patients with intracerebral haemorrhage (39 with clinically probable cerebral amyloid angiopathy) and 47 age-matched controls. The prevalence of diffusion-weighted imaging lesions was 9/39 (23%) in probable cerebral amyloid angiopathy-related intracerebral haemorrhage versus 6/75 (8%) in the remaining patients with intracerebral haemorrhage (P = 0.024); no diffusion-weighted imaging lesions were found in controls. Diffusion-weighted imaging lesions were mainly cortical and were associated with mean white matter change score (odds ratio 1.14 per unit increase, 95% confidence interval 1.02-1.28, P = 0.024) and the presence of strictly lobar cerebral microbleeds (odds ratio 3.85, 95% confidence interval 1.15-12.93, P = 0.029). Acute, subclinical ischaemic brain lesions are frequent but previously underestimated after intracerebral haemorrhage, and are three times more common in cerebral amyloid angiopathy-related intracerebral haemorrhage than in other intracerebral haemorrhage types. Ischaemic brain lesions are

  16. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  17. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  18. Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial

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    Valery Patricia C

    2012-08-01

    Full Text Available Abstract Background The prevalence of chronic suppurative lung disease (CSLD and bronchiectasis unrelated to cystic fibrosis (CF among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis. Methods/design We are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis with no underlying disease identified (such as CF or primary immunodeficiency, and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week or placebo (once a week for 12–24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children ≥6 years, and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical

  19. Brazilian multicentre study on preterm birth (EMIP: prevalence and factors associated with spontaneous preterm birth.

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    Renato Passini

    Full Text Available BACKGROUND: Preterm birth rate is increasing and is currently a worldwide concern. The purpose of this study was to estimate the prevalence of preterm birth in a sample of health facilities in Brazil and to identify the main risk factors associated with spontaneous preterm births. METHODS AND FINDINGS: This was a multicentre cross sectional study on preterm births in 20 referral obstetric hospitals with a case-control component to identify factors associated with spontaneous preterm birth. Surveillance was implemented at all centres to identify preterm births. For eligible consenting women, data were collected through a post-delivery questionnaire completed with information from all mother-newborn medical records until death or discharge or at a maximum of 60 days post-delivery, whichever came first. The risk of spontaneous preterm birth was estimated with OR and 95%CI for several predictors. A non-conditional logistic regression analysis was then performed to identify independently associated factors. The overall prevalence of preterm birth was 12.3%. Among them, 64.6% were spontaneous and 35.4% therapeutic. In the case-control component, 2,682 spontaneous preterm births were compared to a sample of 1,146 term births. Multivariate analyses identified the following as risk factors for spontaneous preterm birth among women with at least one previous birth: a previous preterm birth (ORadj = 3.19, 2.30-4.43, multiple pregnancy (ORadj = 29.06, 8.43-100.2, cervical insufficiency (ORadj = 2.93, 1.07-8.05, foetal malformation (ORadj = 2.63, 1.43-4.85, polyhydramnios (ORadj = 2.30, 1.17-4.54, vaginal bleeding (ORadj = 2.16, 1.50-3.11, and previous abortion (ORadj = 1.39, 1.08-1.78. High BMI (ORadj = 0.94, 0.91-0.97 and weight gain during gestation (ORadj = 0.92, 0.89-0.95 were found to be protective factors. CONCLUSIONS: The preterm birth rate in these health facilities in Brazil is high and spontaneous preterm births

  20. β blockers and mortality after myocardial infarction in patients without heart failure: multicentre prospective cohort study

    Science.gov (United States)

    Riant, Elisabeth; Aissoui, Nadia; Soria, Angèle; Ducrocq, Gregory; Coste, Pierre; Cottin, Yves; Aupetit, Jean François; Bonnefoy, Eric; Blanchard, Didier; Cattan, Simon; Steg, Gabriel; Schiele, François; Ferrières, Jean; Juillière, Yves; Simon, Tabassome; Danchin, Nicolas

    2016-01-01

    Objective To assess the association between early and prolonged β blocker treatment and mortality after acute myocardial infarction. Design Multicentre prospective cohort study. Setting Nationwide French registry of Acute ST- and non-ST-elevation Myocardial Infarction (FAST-MI) (at 223 centres) at the end of 2005. Participants 2679 consecutive patients with acute myocardial infarction and without heart failure or left ventricular dysfunction. Main outcome measures Mortality was assessed at 30 days in relation to early use of β blockers (≤48 hours of admission), at one year in relation to discharge prescription, and at five years in relation to one year use. Results β blockers were used early in 77% (2050/2679) of patients, were prescribed at discharge in 80% (1783/2217), and were still being used in 89% (1230/1383) of those alive at one year. Thirty day mortality was lower in patients taking early β blockers (adjusted hazard ratio 0.46, 95% confidence interval 0.26 to 0.82), whereas the hazard ratio for one year mortality associated with β blockers at discharge was 0.77 (0.46 to 1.30). Persistence of β blockers at one year was not associated with lower five year mortality (hazard ratio 1.19, 0.65 to 2.18). In contrast, five year mortality was lower in patients continuing statins at one year (hazard ratio 0.42, 0.25 to 0.72) compared with those discontinuing statins. Propensity score and sensitivity analyses showed consistent results. Conclusions Early β blocker use was associated with reduced 30 day mortality in patients with acute myocardial infarction, and discontinuation of β blockers at one year was not associated with higher five year mortality. These findings question the utility of prolonged β blocker treatment after acute myocardial infarction in patients without heart failure or left ventricular dysfunction. Trial registration Clinical trials NCT00673036. PMID:27650822

  1. At-Risk Phenotype of Neurofibromatose-1 Patients: A Multicentre Case-Control Study

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    Ferkal Salah

    2011-07-01

    Full Text Available Abstract Objectives To assess associations between subcutaneous neurofibromas (SC-NFs and internal neurofibromas in patients with neurofibromatosis type 1 (NF-1 and to determine whether the association between SC-NFs and peripheral neuropathy was ascribable to internal neurofibromas. Patients and methods Prospective multicentre case-control study. Between 2005 and 2008, 110 NF-1 adults having two or more SC-NFs were individually matched for age, sex and hospital with 110 controls who had no SC-NF. Patients underwent standardized MRI of the spinal cord, nerve roots and sciatic nerves and an electrophysiological study. Analyses used adjusted multinomial logistic regression (ORa to estimate the risk of the presence of internal neurofibromas or peripheral neuropathies associated with patients presented 2 to 9 SC-NFs, at least 10 SC-NFs as compared to patients without any (referential category. Results Cases had a mean age of 41 (± 13 years; 85 (80% had two to nine SC-NFs and 21 (19% at least ten SC-NFs. SC-NFs were more strongly associated with internal neurofibromas in patients with ten or more SC-NFs than in patients with fewer NF-SCs (e.g., sciatic nerve, aOR = 29.1 [8.5 to 100] vs. 4.3 [2.1 to 9.0]. The association with SC-NFs was stronger for diffuse, intradural, and > 3 cm internal neurofibromas than with other internal neurofibromas. Axonal neuropathy with slowed conduction velocities (SCV was more strongly associated with having at least ten SC-NFs (aOR = 29.9, 5.5 to 162.3 than with having fewer SC-NFs (aOR = 4.4, 0.9 to 22.0. Bivariate analyses showed that the association between axonal neuropathy with SCV and sciatic neurofibromas was mediated by the association between SC-NFs and sciatic neurofibromas. Conclusion The at-risk phenotype of NF-1 patients (i.e. NF-1 patients with SC-NFs is ascribable to associations linking SC-NFs to internal neurofibromas at risk for malignant transformation and to axonal neuropathies with slowed

  2. Chasing the effects of Pre-analytical Confounders - a Multicentre Study on CSF-AD biomarkers

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    Maria Joao Leitao

    2015-07-01

    Full Text Available Core cerebrospinal fluid (CSF biomarkers-Aβ42, Tau and pTau–have been recently incorporated in the revised criteria for Alzheimer’s disease (AD. However, their widespread clinical application lacks standardization. Pre-analytical sample handling and storage play an important role in the reliable measurement of these biomarkers across laboratories. In this study, we aim to surpass the efforts from previous studies, by employing a multicentre approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification. Four different centres participated in this study and followed the same established protocol. CSF samples were analysed for three biomarkers (Aβ42, Tau and pTau and tested for different spinning conditions (temperature: Room temperature (RT vs. 4oC; speed: 500g vs. 2000g vs. 3000g, storage volume variations (25%, 50% and 75% of tube total volume as well as freezing-thaw cycles (up to 5 cyles. The influence of sample routine parameters, inter-centre variability and relative value of each biomarker (reported as normal/abnormal, was analysed. Centrifugation conditions did not influence biomarkers levels, except for samples with a high CSF total protein content, where either non centrifugation or centrifugation at RT, compared to 4ºC, led to higher Aβ42 levels. Reducing CSF storage volume from 75% to 50% of total tube capacity, decreased Aβ42 concentration (within analytical CV of the assay, whereas no change in Tau or pTau was observed. Moreover, the concentration of Tau and pTau appears to be stable up to 5 freeze-thaw cycles, whereas Aβ42 levels decrease if CSF is freeze-thawed more than 3 times. This systematic study reinforces the need for CSF centrifugation at 4ºC prior to storage and highlights the influence of storage conditions in Aβ42 levels. This study contributes to the establishment of harmonized standard operating procedures that will help reducing inter-lab variability of CSF

  3. Chikungunya infection in India: results of a prospective hospital based multi-centric study.

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    Pratima Ray

    Full Text Available BACKGROUND: Chikungunya (CHIKV has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. METHODS AND FINDINGS: A total of 540 patients with fever of up to 7 days duration were enrolled at Karnataka Institute of Medical Sciences (KIMS, Karnataka (South; Sawai Man Singh Medical College (SMS Rajasthan (West, and All India Institute of Medical Sciences (AIIMS New Delhi (North from June 2008 to May 2009. Serum specimens were screened for chikungunya infection concurrently through RT-PCR and serology (IgM. Phylogenetic analysis was performed using Bioedit and Mega2 programs. Chikungunya infection was detected in 25.37% patients by RT-PCR and/or IgM-ELISA. Highest cases were detected in south (49.36% followed by west (16.28% and north (0.56% India. A difference in proportion of positives by RT-PCR/ELISA with regard to duration of fever was observed (p<0.05. Rashes, joint pain/swelling, abdominal pain and vomiting was frequently observed among chikungunya confirmed cases (p<0.05. Adults were affected more than children. Anti-CHIK antibodies (IgM were detected for more than 60 days of fever onset. Phylogenetic analysis based on E1 gene from KIMS patients (n = 15 revealed ∼99% homology clustering with Central/East African genotype. An amino acid change from lysine to glutamine at position 132 of E1 gene was frequently observed among strains infecting children. CONCLUSIONS: The study documented re-emergence of chikungunya in high frequencies and severe morbidity in south and west India but rare in north. The study emphasizes the need for continuous surveillance for disease burden using multiple diagnostic tests and also warrants the need for an appropriate

  4. Patient’s satisfaction after 2-piece inflatable penile prosthesis implantation: An Italian multicentric study

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    Giorgio Gentile

    2016-03-01

    Full Text Available Introduction: Penile prosthesis implant represents a valuable solution for pts with severe erectile dysfunction (ED, non-responders to medical management. The aim of our study was to evaluate the satisfaction of patients (pts after 2-pieces inflatable penile prosthesis (IPP. Aim of the study: to evaluate safety, reliability and post-operative patient’s satisfaction after implantation of two-pieces IPP. Materials and Methods: This retrospective multicentric analysis concerns a group of 42 patients undergone 2-pieces IPP implantation from November 2005 to November 2013, in four Centers of proven experience. As a first step, a detailed review of all clinical reports was performed. Secondly, every patient was asked to fill the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS specifically modified, in order to assess their own satisfaction after surgery and, its impact on patient’s quality of sexual life. Results: 42 pts were evaluated (AMS-Ambicor: 28; Coloplast- Excell: 14; mean age, at time of operation: 60,7 years; mean follow up: 27,6 months; etiology of ED: vascular 23,8%, diabetes 19%, La Peyronie D. 7,1%, consequence of radical prostatectomy 31%, consequence of other pelvic surgery 11,9%, spinal trauma 7%. Mean operative time: 117 ± 58 min, mean postoperative hospital stay 3 ± 1,6 days. Post operative short-term complications: 4 pts (9,5%. Post operative long-term complications: 4 pts (9,5%. Long-term functional results (Questionnaire: 71% of pts (30 reported regular use of the prosthesis, at least 1 time/week, the satisfaction was good in 42% of pts (18, quite good in 33,3% (14, quite bad in 2,4% (1, very bad in 7,1% (3, 6 pts (14,4% didn’t answer. Conclusions: 2 pieces IPP appears to be associated with a low complication rate and good satisfaction of pts especially in the elderly. It also assures satisfactory rates of aesthetics and functional results.

  5. Clinical Manifestations of Kaposi Sarcoma Herpesvirus (KSHV Lytic Activation: Multicentric Castleman Disease (KSHV-MCD and the KSHV Inflammatory Cytokine Syndrome (KICS

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    Mark N. Polizzotto

    2012-03-01

    Full Text Available Soon after the discovery of Kaposi sarcoma associated herpesvirus (KSHV, it was appreciated that this virus was associated with most cases of multicentric Castleman disease (MCD arising in patients infected with human immunodeficiency virus (HIV. It has subsequently been recognized that KSHV-MCD is a distinct entity from other forms of MCD. Like MCD that is unrelated to KSHV, the clinical presentation of KSHV-MCD is dominated by systemic inflammatory symptoms including fevers, cachexia and laboratory abnormalities including cytopenias, hypoalbuminemia, hyponatremia, and elevated C-reactive protein. Pathologically KSHV-MCD is characterized by polyclonal, IgM-lambda restricted plasmacytoid cells in the intrafollicular areas of affected lymph nodes. A portion of these cells are infected with KSHV and a sizable subset of these cells express KSHV lytic genes including a viral homolog of interleukin-6 (vIL-6. Patients with KSHV-MCD generally have elevated KSHV viral loads in their peripheral blood. Production of vIL-6 and induction of human (h IL-6 both contribute to symptoms, perhaps in combination with overproduction of IL-10 and other cytokines. Until recently, the prognosis of patients with KSHV-MCD was poor. Recent therapeutic advances targeting KSHV-infected B cells with the anti-CD20 monoclonal antibody rituximab and utilizing KSHV enzymes to target KSHV-infected cells have substantially improved patient outcomes. Recently another KSHV-associated condition, the KSHV inflammatory cytokine syndrome (KICS has been described. Its clinical manifestations resemble those of KSHV-MCD but lymphadenopathy is not prominent and the pathologic nodal changes of KSHV-MCD are absent. Patients with KICS exhibit elevated KSHV viral loads and elevation of vIL-6, hIL-6 and IL-10 comparable to those seen in KSHV-MCD; the cellular origin of these is a matter of investigation. KICS may contribute to the inflammatory symptoms seen in some patients with severe Kaposi

  6. Modified Uvulopalatopharyngoplasty and Coblation Channeling of the Tongue for Obstructive Sleep Apnea: A Multi-Centre Australian Trial

    Science.gov (United States)

    MacKay, Stuart G.; Carney, A. Simon; Woods, Charmaine; Antic, Nick; McEvoy, R. Doug; Chia, Michael; Sands, Terry; Jones, Andrew; Hobson, Jonathan; Robinson, Samuel

    2013-01-01

    Study Objectives: To investigate the surgical outcomes and efficacy of modified uvulopalatopharyngoplasty (mod UPPP) and Coblation channelling of the tongue (CCT) as a treatment for obstructive sleep apnea (OSA). Methods: Adult patients with simple snoring or obstructive sleep apnea were treated with combined modified UPPP, bilateral tonsillectomy, and CCT (N = 48). Full polysomnography was performed preoperatively and 3 months postoperatively. Postoperative clinical assessment, sleep questionnaires, and patient demographics including body mass index were compared to preoperative data. All polysomnograms were re-scored to AASM recommended criteria by 2 sleep professionals. Results: The preoperative AHI (median and interquartile range) of 23.1 (10.4 to 36.6) was lowered to a postoperative AHI of 5.6 (1.9 to 10.4) (p coblation channeling of the tongue for obstructive sleep apnea: a multi-centre australian trial. J Clin Sleep Med 2013;9(2):117–124. PMID:23372463

  7. Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study

    DEFF Research Database (Denmark)

    Agner, T.; Andersen, K.E.; Brandao, F.M.

    2009-01-01

    Background Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. Objectives To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. Methods The study was performed...... as a multi-centre, cross-sectional study from 10 European clinics. All patients were patch tested, and severity of hand eczema assessed by Hand Eczema Severity Index. A multi-variate analysis was performed to explore which factors influenced severity, QoL and sick leave. Results A total 416 patients were...... and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were independent...

  8. Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study

    DEFF Research Database (Denmark)

    Agner, Tove; Andersen, Klaus Ejner; Brandao, Francisco M;

    2009-01-01

    BACKGROUND: Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. OBJECTIVES: To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. METHODS: The study...... was performed as a multi-centre, cross-sectional study from 10 European clinics. All patients were patch tested, and severity of hand eczema assessed by Hand Eczema Severity Index. A multi-variate analysis was performed to explore which factors influenced severity, QoL and sick leave. RESULTS: A total 416...... eczema and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were...

  9. Determinants of Attrition to Follow-Up in a Multicentre Cohort Study in Children-Results from the IDEFICS Study

    DEFF Research Database (Denmark)

    Hense, Sabrina; Pohlabeln, Hermann; Michels, Nathalie;

    2013-01-01

    at 훼 = 0 . 0 1 to account for the large sample size. The strongest associations were seen for baseline item non-response, especially when information on migration background (odds ratio (OR) = 1.55; 99% confidence interval (CI): 1.04, 2.31), single parenthood (OR = 1.37; 99% CI: 1.12, 1.67), or well......-being (OR = 1.46; 99% CI: 1.19, 1.79) was lacking. Drop-out proportion rose with the number of missing items. Overweight, low education, single parenthood and low well-being scores were independent determinants of attrition. Baseline participation, and the individual determinant effects seemed unrelated......Cohort participant retention is a crucial element and may depend on several factors. Based on data from a multicentre cohort of European children, the effect of baseline participation on attrition and the association with and the impact of single determinants in relation to the extent of attrition...

  10. [Dynamics of functional parameters in different schemes for bronchial asthma therapy: results of the STRELA-ACT multicentre study].

    Science.gov (United States)

    Ogorodova, L M; Kulikov, E S; Deev, I A; Cherniak, B A; Fassakhov, R S

    2011-01-01

    Different strategies for disease control in real clinical practice are compared in terms of dynamics of functional parameters in patients with persistent bronchial asthma. This prospective multicentre surveillance study was carried out in 19 Russian clinics using the common protocol. The patients were divided in 3 groups in accordance with the changes of basal antiinflammatory therapy during the study period. Group A--stepwise increase in the extent of combined salmoterol/fluticason therapy, group B--long-term stable-dose salmoterol/fluticason therapy, group C--salmoterol/fluticason therapy with gradual decrease of the dose and/or transition to an alternative variant. Statistical analysis using Statistica 6.0 program included data from 543 patients. The results suggest that the two first modalities increased the level of control (ACT test) and improved characteristics of external respiration throughout the study period. Strategy 3 was associated with a decrease in the external respiration function and the level of control.

  11. Multicentre evaluation of multidisciplinary team meeting agreement on diagnosis in diffuse parenchymal lung disease: a case-cohort study

    DEFF Research Database (Denmark)

    Walsh, Simon L F; Wells, Athol U; Desai, Sujal R;

    2016-01-01

    . This difference is of particular importance, because accurate and consistent diagnoses of IPF are needed if clinical outcomes are to be optimised. Inter-multidisciplinary team agreement for a diagnosis of hypersensitivity pneumonitis is low, highlighting an urgent need for standardised diagnostic guidelines......-multidisciplinary team agreement for the diagnosis of diffuse parenchymal lung disease. METHODS: We did a multicentre evaluation of clinical data of patients who presented to the interstitial lung disease unit of the Royal Brompton and Harefield NHS Foundation Trust (London, UK; host institution) and required...... multidisciplinary team meeting (MDTM) characterisation between March 1, 2010, and Aug 31, 2010. Only patients whose baseline clinical, radiological, and, if biopsy was taken, pathological data were undertaken at the host institution were included. Seven MDTMs, consisting of at least one clinician, radiologist...

  12. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  13. Management of postoperative pain in abdominal surgery in Spain. A multicentre drug utilization study

    Science.gov (United States)

    Vallano, Antonio; Aguilera, Cristina; Arnau, Josep Maria; Baños, Josep-Eladi; Laporte, Joan-Ramon

    1999-01-01

    Participating centres: Hospital Universitario San Juan, Alicante: Maria Jesús Olaso, Javier Agulló, Clara Faura. Hospital Torrecárdenas, Almería: Carmen Fernández Sánchez, Miguel Lorenzo Campos, Juan Manuel Rodríguez Alonso. Hospital Quirúrgic Adriano, Barcelona: Carmen Alerany Pardo, Paquita Alvarez González, Teresa Martín Benito. Hospital Universitari del Mar-IMIM, Barcelona: Magí Farré, Maite Terán. Corporació Sanitària Parc Taulí, Sabadell: Montserrat Cañellas, Sergio Zavala, Josep Planell. Hospital Universitari de la Santa Creu i Sant Pau: Gonzalo Calvo, Rosa Morros, Silvia Mateo. Hospital General Vall d’Hebron, Barcelona: Carmen Bosch, María José Martínez. Hospital Universitario Virgen de la Victoria, Málaga: Maribel Lucena, José Antonio González, Gabriel Carranque. Hospital Clínico Universitario San Carlos, Madrid: Emilio Vargas, Amparo Gil López-Oliva, Míriam García Mateos. Hospital Universitario Marqués de Valdecilla, Santander: Mario González, Antonio Cuadrado. Hospital Universitario Virgen de la Macarena, Sevilla: Juan Antonio Durán, Pilar Máyquez, María Isabel Serrano. Hospital Universitario Virgen del Rocío, Sevilla: Jaume Torelló, Juan Ramón Castillo, María de las Nieves Merino. Aims Postoperative pain is common in hospital-admitted patients. Its management is determined by different therapeutic traditions and by the attitudes of health professionals in each hospital. The aim of this study was to describe the patterns of prescription and administration of analgesic drugs used for postoperative pain after abdominal surgery in Spanish hospitals, to know the prevalence and the severity of postoperative pain, and to determine the extent of variability in the management of postoperative pain among the participating centres. Methods The study was a multicentre descriptive cross-sectional drug utilization study in 12 Spanish hospitals. The subjects were an unselected sample of consecutive patients undergoing abdominal

  14. Comparison of ADC values in different malignancies of the skeletal musculature: a multicentric analysis

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    Surov, Alexey [Martin-Luther-University Halle-Wittenberg, Department of Radiology, Halle (Germany); University of Leipzig, Department of Diagnostic and Interventional Radiology, Leipzig (Germany); Nagata, Shuji [Kurume University School of Medicine, Department of Radiology, Kurume (Japan); Razek, Ahmed A. Abd [Mansoura Faculty of Medicine, Department of Diagnostic Radiology, Mansoura (Egypt); Tirumani, Sree Harsha [Harvard Medical School, Department of Imaging, Dana-Farber Cancer Institute and Department of Radiology, Brigham and Women' s Hospital, Boston, MA (United States); Wienke, Andreas [Martin-Luther-University Halle-Wittenberg, Institute of Medical Epidemiology, Biometry, and Statistics, Halle (Germany); Kahn, Thomas [University of Leipzig, Department of Diagnostic and Interventional Radiology, Leipzig (Germany)

    2015-04-28

    Diffusion-weighted imaging (DWI) provides essential information regarding tumor composition, such as cellularity and/or perfusion. DWI is helpful in distinguishing between malignant and benign lesions. Malignant intramuscular/soft tissue lesions consist of a wide spectrum of tumors that have different cell counts and matrix. It is presumed that these different tumors have different DWI findings and have different apparent diffusion coefficient (ADC) values. The aim of this study was to analyze DWI findings of different intramuscular malignancies in a multicentric study by using a standardized DWI protocol, and to compare the ADC values acquired. The data banks of four radiology departments were screened retrospectively for malignant intramuscular tumors. Only lesions that were investigated by MRI (with a 1.5-T scanner) using DWI (multishot EPI sequence with b values of 0 and 1,000 s/mm{sup 2}) were included in the study. Overall, 51 patients (28 women, 23 men; mean age 58.8 ± 16.1 years) with 57 different malignant intramuscular lesions were collected. In every case apparent diffusion constant (ADC) maps were calculated. In 14 patients muscle lymphoma, 11 patients intramuscular metastases from different primary tumors, and in 26 cases several muscle sarcomas were identified. The mean ADC value of the estimated lesions was 1.24 ± 0.53 x 10{sup -3} mm{sup 2}s{sup -1}, median value, 1.11 x 10{sup -3} mm{sup 2}s{sup -1}, range, 0.54-2.9 x 10{sup -3} mm{sup 2}s{sup -1}. The mean ADC value in muscle metastases was 1.28 ± 0.24 x 10{sup -3} mm{sup 2}s{sup -1}, in muscle lymphoma 0.76 ± 0.14 x 10{sup -3} mm{sup 2}s{sup -1}, and in muscle sarcomas 1.82 ± 0.63 x 10{sup -3} mm{sup 2}s{sup -1}. Muscle lymphoma showed statistically significant lower ADC values in comparison to muscle metastases (p = 0.01) and muscle sarcoma (p = 0.001). There was no significant differences between ADC values in muscle metastases and sarcomas (p = 0.48). ADC values in muscle lymphoma were

  15. Test for CCR5 tropism and treatment with maraviroc in Sicily: an observational retrospective multicentre study

    Directory of Open Access Journals (Sweden)

    B Celesia

    2012-11-01

    Full Text Available Purpose of the study: Maraviroc (MVC is the first CCR5 inhibitor licensed for clinical use. A pre-treatment test is mandatory to identify R5 tropic patients. Aim of this study is to detect indications and results of tropism test and to evaluate efficacy and tolerability of MVC-based regimen. Methods: An observational retrospective multicentre study was performed in Sicily in 15 Infectious Diseases Units. Clinical records of 213 screened for tropism HIV+ subjects were reviewed for age, sex, risk, clinical stage (CDC, CD4 cell count, HIV RNA viral load, therapeutic line, indication and result of test for tropism; within subjects treated with MVC, HIV RNA, CD4 cell count and metabolic parameters trend and adverse events were analysed. Summary of results: Median age 44 (IQR 30–50 years, 67.1% males; 46.3% heterosexuals, 28.6% MSMs, 21.4% IVDUs; 23.7% CDC A, 32.1% CDC B, 44.2% CDC C; median CD4 was 217 (IQR 121–374 cells/µl and mean of HIV RNA was 4.72 (Cl 95% 4.07–4.67 log10 copies/ml; median therapeutic line was 4 (IQR 2–7. 80.8% were submitted to Trofile™ test, 19.2% to genotypic test, 75.5% after a therapeutic failure. 56.8% of subjects screened were R5, 7.5% X4, 21.6% DM, 14% undefined. All X4 patients were tested after a therapeutic failure; patients screened for toxicity were more frequently R5 (75% (p<0.01. 76 (35.7% multi-experienced (at baseline 8% HIV RNA<50 copies/ml, median CD4 cell count 219 (IQR 124–345 cells/µl subjects were treated with MVC plus an optimized background treatment: MVC was associated in 74% of cases with a protease inhibitors (56% darunavir/ritonavir, in 42% with raltegravir, in 56% with a NUC-sparing regimen. After 12 months of treatment 56.8% (ITT analysis and 61.7% (AT of patients had HIV RNA<50 copies/ml; median CD4 cell count was 387 (IQR 222–455 cells/µl. After 24 months 64.8% (ITT 80% (AT had HIV-RNA<50 copies/ml. Median CD4 cell count was 381 (IQR 218.515 cells/µl with a median increase of 168

  16. Characteristics and survival for HIV-associated multicentric Castleman disease in Malawi

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    Satish Gopal

    2015-08-01

    Full Text Available Introduction: Clinical reports of multicentric Castleman disease (MCD from sub-Saharan Africa (SSA are scarce despite high prevalence of HIV and Kaposi sarcoma-associated herpesvirus (KSHV. Our objective is to describe characteristics and survival for HIV-associated MCD patients in Malawi. To our knowledge, this is the first HIV-associated MCD case series from the region. Methods: We describe HIV-positive patients with MCD in Lilongwe, and compare them to HIV-associated lymph node Kaposi sarcoma (KS and non-Hodgkin lymphoma (NHL patients treated at our centre. All patients were enrolled into a prospective longitudinal cohort study at a national teaching hospital and cancer referral centre serving half of Malawi's 16 million people. We included adult patients≥18 years of age with HIV-associated MCD (n=6, lymph node KS (n=5 or NHL (n=31 enrolled between 1 June 2013 and 31 January 2015. Results and discussion: MCD patients had a median age of 42.4 years (range 37.2–51.8. All had diffuse lymphadenopathy and five had hepatosplenomegaly. Concurrent KS was present for one MCD patient, and four had performance status ≥3. MCD patients had lower median haemoglobin (6.4 g/dL, range 3.6–9.3 than KS (11.0 g/dL, range 9.1–12.0, p=0.011 or NHL (11.2 g/dL, range 4.5–15.1, p=0.0007. Median serum albumin was also lower for MCD (2.1 g/dL, range 1.7–3.2 than KS (3.7 g/dL, range 3.2–3.9, p=0.013 or NHL (3.4 g/dL, range 1.8–4.8, p=0.003. All six MCD patients were on antiretroviral therapy (ART with median CD4 count 208 cells/µL (range 108–1146, and all with HIV RNA <400 copies/mL. Most KS and NHL patients were also on ART, although ART duration was longer for MCD (56.4 months, range 18.2–105.3 than KS (14.2 months, range 6.8–21.9, p=0.039 or NHL (13.8 months, range 0.2–98.8, p=0.017. Survival was poorer for MCD patients than lymph node KS or NHL. Conclusions: HIV-associated MCD occurs in Malawi, is diagnosed late and is associated with high

  17. A multi-centric prospective study: Anxiety and associated factors among parents of children undergoing mild surgery in ENT

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    Mehmet Akdağ

    2014-06-01

    Full Text Available Objective: The aim of this study to evaluate the anxiety and expectancy among parents of children undergoing surgery in the multi-centric surgery units. Methods: Following approval from the ethics committee, a questionnaire was given to the parents of 123 children who were undergoing surgery in the multi-centric surgery units. The parents were informed that their answers would not affect the care given to their children. The questionnaire was evaluated using the State-Trait Anxiety Inventory (STAI-I and STAI-II. Results: The STAI results indicated that the parents’ anxiety level increased before their children underwent surgery. In addition, there was a negative correlation between STAI-II scores and high levels of wealth (p= 0.004. Also, those with steady employment and higher levels of education had lower anxiety levels and difference was significant (p=0.001. The state anxiety levels were unaffected by family income and education, but the trait anxiety levels decreased with increasing income and education. Mothers were less anxious if their child had undergone surgery in the past, while this result was not significant statistically (p>0.05. Parents were most commonly concerned with possible complications from the surgery and/or anesthesia. Conclusion: Results of our study indicate that parents of children undergoing surgery that have steady employment, to be informed, previously has been administered anesthesia or surgery, high level of wealth and education was observed less anxiety than others. J Clin Exp Invest 2014; 5 (2: 206-210

  18. Comparison of manual and semi-automatic measuring techniques in MSCT scans of patients with lymphoma: a multicentre study

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    Hoeink, A.J.; Wessling, J.; Schuelke, C.; Kohlhase, N.; Wassenaar, L.; Heindel, W.; Buerke, B. [University Hospital Muenster, Department of Clinical Radiology, Muenster (Germany); Koch, R. [University of Muenster, Institute of Biostatistics and Clinical Research (IBKF), Muenster (Germany); Mesters, R.M. [University Hospital Muenster, Department of Haematology and Oncology, Muenster (Germany); D' Anastasi, M.; Graser, A.; Karpitschka, M. [University Hospital Muenchen (LMU), Institute of Clinical Radiology, Muenchen (Germany); Fabel, M.; Wulff, A. [University Hospital Kiel, Department of Clinical Radiology, Kiel (Germany); Pinto dos Santos, D. [University Hospital Mainz, Department of Diagnostic and Interventional Radiology, Mainz (Germany); Kiessling, A. [University Hospital Marburg, Department of Diagnostic and Interventional Radiology, Marburg (Germany); Dicken, V.; Bornemann, L. [Institute of Medical Imaging Computing, Fraunhofer MeVis, Bremen (Germany)

    2014-11-15

    Multicentre evaluation of the precision of semi-automatic 2D/3D measurements in comparison to manual, linear measurements of lymph nodes regarding their inter-observer variability in multi-slice CT (MSCT) of patients with lymphoma. MSCT data of 63 patients were interpreted before and after chemotherapy by one/tworadiologists in five university hospitals. In 307 lymph nodes, short (SAD)/long (LAD) axis diameter and WHO area were determined manually and semi-automatically. Volume was solely calculated semi-automatically. To determine the precision of the individual parameters, a mean was calculated for every lymph node/parameter. Deviation of the measured parameters from this mean was evaluated separately. Statistical analysis entailed intraclass correlation coefficients (ICC) and Kruskal-Wallis tests. Median relative deviations of semi-automatic parameters were smaller than deviations of manually assessed parameters, e.g. semi-automatic SAD 5.3 vs. manual 6.5 %. Median variations among different study sites were smaller if the measurement was conducted semi-automatically, e. g. manual LAD 5.7/4.2 % vs. semi-automatic 3.4/3.4 %. Semi-automatic volumetry was superior to the other parameters (2.8 %). Semi-automatic determination of different lymph node parameters is (compared to manually assessed parameters) associated with a slightly greater precision and a marginally lower inter-observer variability. These results are with regard to the increasing mobility of patients among different medical centres and in relation to the quality management of multicentre trials of importance. (orig.)

  19. Questing for circadian dependence in ST-segment-elevation acute myocardial infarction: A multicentric and multiethnic study

    KAUST Repository

    Ammirati, Enrico

    2013-05-09

    Rationale: Four monocentric studies reported that circadian rhythms can affect left ventricular infarct size after ST-segment-elevation acute myocardial infarction (STEMI). Objective: To further validate the circadian dependence of infarct size after STEMI in a multicentric and multiethnic population. Methods and Results: We analyzed a prospective cohort of subjects with first STEMI from the First Acute Myocardial Infarction study that enrolled 1099 patients (ischemic time <6 hours) in Italy, Scotland, and China. We confirmed a circadian variation of STEMI incidence with an increased morning incidence (from 6:00 am till noon). We investigated the presence of circadian dependence of infarct size plotting the peak creatine kinase against time onset of ischemia. In addition, we studied the patients from the 3 countries separately, including 624 Italians; all patients were treated with percutaneous coronary intervention. We adopted several levels of analysis with different inclusion criteria consistent with previous studies. In all the analyses, we did not find a clear-cut circadian dependence of infarct size after STEMI. Conclusions: Although the circadian dependence of infarct size supported by previous studies poses an intriguing hypothesis, we were unable to converge toward their conclusions in a multicentric and multiethnic setting. Parameters that vary as a function of latitude could potentially obscure the circadian variations observed in monocentric studies. We believe that, to assess whether circadian rhythms can affect the infarct size, future study design should not only include larger samples but also aim to untangle the molecular time-dynamic mechanisms underlying such a relation. © 2013 American Heart Association, Inc.

  20. Intra- and interobserver analysis in the morphological assessment of early stage embryos during an IVF procedure: a multicentre study

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    Devroe Johanna

    2011-09-01

    Full Text Available Abstract Background Quality control programs are necessary to maintain good clinical practice. Embryo grading has been described as one of the external quality assurance schemes. Although the evaluation of embryos is based on the assessment of morphological characteristics, considerable intra- and inter-observer variability has been described. In this multicentre study, the variability in the embryo evaluation has been evaluated using morphological characteristics on day 1, day 2 and day 3 of embryo development. Methods Five embryologists of four different IVF centers participated in this study. Multilevel images of embryos were presented on a website at different time points to evaluate intra-and inter-observer agreement in the assessment of embryo morphology. The embryos were evaluated on day 1, day 2 and day 3 of their development and each embryologist had to decide if the embryo had to be transferred, cryopreserved or discarded. Results Both intra-observer agreement and inter-observer agreement were good to excellent for the position of the pronuclei on day 1, the number of blastomeres on day 2 and day 3 and the clinical decision (transfer, cryopreservation, discard. For all other characteristics (size of pronuclei, presence of cytoplasomic halo, degree of fragmentation and size of blastomeres the intra- and inter-observer agreement was moderate to very poor. Conclusions Mono- or multicentre quality control on embryo scoring by morphological assessment can easily be performed through the design of a simple website. In the future the website design can be adapted to generate statistical feedback upon scoring and can even include a training module.

  1. Case-Mix, Care Processes, and Outcomes in Medically-Ill Patients Receiving Mechanical Ventilation in a Low-Resource Setting from Southern India: A Prospective Clinical Case Series.

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    Balasubramanian Karthikeyan

    Full Text Available Mechanical ventilation is a resource intensive organ support treatment, and historical studies from low-resource settings had reported a high mortality. We aimed to study the outcomes in patients receiving mechanical ventilation in a contemporary low-resource setting.We prospectively studied the characteristics and outcomes (disease-related, mechanical ventilation-related, and process of care-related in 237 adults mechanically ventilated for a medical illness at a teaching hospital in southern India during February 2011 to August 2012. Vital status of patients discharged from hospital was ascertained on Day 90 or later.Mean age of the patients was 40 ± 17 years; 140 (51% were men. Poisoning and envenomation accounted for 98 (41% of 237 admissions. In total, 87 (37% patients died in-hospital; 16 (7% died after discharge; 115 (49% were alive at 90-day assessment; and 19 (8% were lost to follow-up. Weaning was attempted in 171 (72% patients; most patients (78 of 99 [79%] failing the first attempt could be weaned off. Prolonged mechanical ventilation was required in 20 (8% patients. Adherence to head-end elevation and deep vein thrombosis prophylaxis were 164 (69% and 147 (62% respectively. Risk of nosocomial infections particularly ventilator-associated pneumonia was high (57.2 per 1,000 ventilator-days. Higher APACHE II score quartiles (adjusted HR [95% CI] quartile 2, 2.65 [1.19-5.89]; quartile 3, 2.98 [1.24-7.15]; quartile 4, 5.78 [2.45-13.60], and new-onset organ failure (2.98 [1.94-4.56] were independently associated with the risk of death. Patients with poisoning had higher risk of reintubation (43% vs. 20%; P = 0.001 and ventilator-associated pneumonia (75% vs. 53%; P = 0.001. But, their mortality was significantly lower compared to the rest (24% vs. 44%; P = 0.002.The case-mix considerably differs from other settings. Mortality in this low-resource setting is similar to high-resource settings. But, further improvements in care processes

  2. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  3. Patterns and predictors of sitting time over ten years in a large population-based Canadian sample: Findings from the Canadian Multicentre Osteoporosis Study (CaMos)

    OpenAIRE

    Gebel, Klaus; Pont, Sarah; Ding, Ding, W.; Bauman, Adrian E.; Chau, Josephine Y; Berger, Claudie; Prior, Jerilynn C; ,

    2017-01-01

    Our objective was to describe patterns and predictors of sedentary behavior (sitting time) over 10 years among a large Canadian cohort. Data are from the Canadian Multicentre Osteoporosis Study, a prospective study of women and men randomly selected from the general population. Respondents reported socio-demographics, lifestyle behaviors and health outcomes in interviewer-administered questionnaires; weight and height were measured. Baseline data were collected between 1995 and 1997 (n = 9418...

  4. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

  5. Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: A national multicentre study

    DEFF Research Database (Denmark)

    Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole;

    2012-01-01

    Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely...... unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning....

  6. A surprisingly poor correlation between in vitro and in vivo testing of biomaterials for bone regeneration:results of a multicentre analysis

    OpenAIRE

    2016-01-01

    New regenerative materials and approaches need to be assessed through reliable and comparable methods for rapid translation to the clinic. There is a considerable need for proven in vitro assays that are able to reduce the burden on animal testing, by allowing assessment of biomaterial utility predictive of the results currently obtained through in vivo studies. The purpose of this multicentre review was to investigate the correlation between existing in vitro results with in vivo outcomes ob...

  7. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran

    Directory of Open Access Journals (Sweden)

    Mohsen MOLLA MOHAMMADI

    2013-11-01

    Full Text Available How to Cite This Article: Molla Mohammadi M, Tonekaboni SH, Khatami AR, Azargashb E, Tavasoli A, Javadzadeh M, Zamani GR. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran. Iran J Child Neurol. 2013 Autumn; 7(4:24-31.ObjectiveSeizure is an emergency in pediatrics. It really matters to the parents of the involved child to have information about the causes, management and prognosis.First unprovoked seizures (FUS are seizures that occur in patients without fever, trauma or infection. Due to the rapid improvement in diagnostic techniques in the last few decades, the etiology will be revealed and this term will no longer exist. This Study was designed to evaluate brain imaging findings in FUS patients. Materials & MethodsNinety-six children with FUS, who were admitted in three major children’s hospitals in Tehran, underwent brain imaging and were enrolled into the study.The decision about the type of imaging (CT or MRI was based on the patient’s medical and financial conditions. An expert radiologist in the field of pediatric neuroimaging interpreted the images. ResultsAltogether, 27.1% had abnormal findings of which 29.2% were in the brain MRI group and 14.3% were in the brain CT scan group.Abnormal results were gliosis (10.4%, hemorrhage (4.2%, dysgenesis (2.1%, dysmyelination (7.3%, encephalomalacy (1%, atrophy (5.2% and infarction (2.1%. In some patients, the lesions were in 2 or 3 sites and some had more than one type of lesion.There was no association between the duration, age and type of seizure and imaging abnormlities. However, we found an association between the location of the lesion and the type of seizure. ConclusionWe recommend brain imaging in all patients with FUS and apart from some exceptions, brain MRI is superior to CT. ReferencesJohnston MV. Siezure in childhood. In: Kliegman RM, Behrman RE, editors. Nelson text book of pediatrics. 18th ed. Philadelphia: Saunders; 2010. p. 2457

  8. Sarcoma granulocítico multicêntrico como recidiva de leucemia mieloide aguda Multicentric granulocytic sarcoma as relapse of acute myelogenous leukemia

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    Taciana G. S. Aguiar

    2009-01-01

    Full Text Available Sarcoma granulocítico (SG é um tumor sólido extramedular, constituído por células precursoras de granulócitos. É geralmente associado a leucemia mieloide aguda ou raramente a outras desordens mieloproliferativas. O tumor geralmente ocorre precedendo uma leucemia mieloide aguda, durante o seu curso ou após a remissão ter sido alcançada. O prognóstico é pobre e tem como principais modalidades terapêuticas a quimioterapia e a radioterapia. Relata- se um caso de SG multicêntrico, de evolução rápida, com acometimento difuso de pele, mamas, gânglios linfáticos, tecido celular subcutâneo e líquor, em mulher de 45 anos, fora de tratamento para leucemia mieloide aguda e em remissão hematológica há 18 meses. A paciente apresentava dor intensa em membro inferior direito há uma semana e estava em anticoagulação oral há seis meses por trombose venosa profunda neste membro. Diagnosticado o SG, a paciente foi tratada com radioterapia e quimioterapia com boa resposta. Após três meses de seguimento, em vigência do tratamento quimioterápico, evoluiu com recidiva do SG neste membro, associado ao acometimento das mamas e posteriormente do sistema nervoso central, evoluindo para óbito em aplasia e sepses.Granulocytic sarcoma is an extramedullary solid tumor consisting of immature granulocytic cells. It is often associated with acute myelogenous leukemia and more rarely with other myeloproliferative disorders. The tumor generally occurs before acute myeloid leukemia, during its course or after disease remission. It has a poor prognosis with the main therapeutic options being chemotherapy and radiotherapy. A multicentric accelerated case of granulocytic sarcoma of a 45- year- old woman with diffuse skin, breast, lymphatic ganglia and subcutaneous tissue presentations no longer undergoing treatment for acute myeloid leukemia and in hematologic remission for 18 months is reported. The patient presented with severe pain of right lower

  9. Prostatic Inflammation is Determinant for Prostate Overgrowth and Luts Severity in Men with Metabolic Syndrome: Highlights from Two Recently Published Multicentre Studies

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    Mauro Gacci

    2013-12-01

    Full Text Available Introduction: Several evidences have pointed out the possible association between Metabolic Syndrome (MetS and low urinary tract symptoms (LUTS/benign prostate hyperplasia (BPH. Recent epidemiological and histopatological evidences suggested chronic inflammation is a crucial event in BPH pathogenesis. Aim of this study is to demonstrate the correlation among pre-operatory LUTS/BPH severity, MetS features and inflammatory infiltrates in prostatectomy specimens of patients with BPH, highlighting the results of two recently published multicentre studies analyzing all the data from a preclinical and clinical point of view. Materials and methods: We conducted two retrospective study in 271 and 244 consecutive men treated with simple prostatectomy for LUTS/BPH in two tertiary referral centres. Prostate diameters and volume were measured by transrectal ultrasound, LUTS were scored by IPSS, and obstruction diagnosed by uroflowmetry. MetS was defined according to DF & AHA/NHLBI criteria. The inflammatory infiltrate was investigated according to the scoring system of chronic prostatitis (CP-CPPS and scored as inflammation score (IS ranging 3 to 9 and glandular disruption (GD. In addition, we investigated the in vitro inflammatory effects of metabolic insults on human prostatic myofibroblast cells isolated from BPH patients (hBPH. Results: Of 271 men, 86 (31.7% were affected by MetS. Prostatic volume and the anterior-posterior (AP diameter were positively associated to the number of MetS components. Among MetS determinants, only dyslipidaemia (increased serum triglycerides and reduced serum HDL levels was significantly associated with an increased risk of having a prostatic volume >60cm3. IS in prostatectomy specimens showed a step- wise association with number of MetS factors (p=0.001. Dyslipidaemia was the only factor significantly associated with IS. Positive significant correlations among MetS, IS, GD and IPSS Scores were observed. In myofibroblastic h

  10. Evaluation of strategies towards harmonization of FDG PET/CT studies in multicentre trials: comparison of scanner validation phantoms and data analysis procedures

    Energy Technology Data Exchange (ETDEWEB)

    Makris, Nikolaos E.; Huisman, Marc C.; Lammertsma, Adriaan A.; Boellaard, Ronald [VU University Medical Centre, Department of Radiology and Nuclear Medicine, Amsterdam (Netherlands); Kinahan, Paul E. [University of Washington, Imaging Research Laboratory, Department of Radiology, Seattle, WA (United States)

    2013-10-15

    PET quantification based on standardized uptake values (SUV) is hampered by several factors, in particular by variability in PET acquisition settings and data analysis methods. Quantitative PET/CT studies acquired during a multicentre trial require harmonization of imaging procedures to maximize study power. The aims of this study were to determine which phantoms are most suitable for detecting differences in image quality and quantification, and which methods for defining volumes of interest (VOI) are least sensitive to these differences. The most common accreditation phantoms used in oncology FDG PET/CT trials were scanned on the same scanner. These phantoms were those used by the Society of Nuclear Medicine Clinical Trials Network (SNM-CTN), the European Association of Nuclear Medicine/National Electrical Manufacturers Association (EANM/NEMA) and the American College of Radiology (ACR). In addition, tumour SUVs were derived from ten oncology whole-body examinations performed on the same PET/CT system. Both phantom and clinical data were reconstructed using different numbers of iterations, subsets and time-of-flight kernel widths. Subsequently, different VOI methods (VOI{sub A50%,} VOI{sub max}, VOI{sub 3Dpeak,} VOI{sub 2Dpeak}) were applied to assess the impact of changes in image reconstruction settings on SUV and recovery coefficients (RC). All phantoms demonstrated sensitivity for detecting changes in SUV and RC measures in response to changes in image reconstruction settings and VOI analysis methods. The SNM-CTN and EANM/NEMA phantoms showed almost equal sensitivity in detecting RC differences with changes in image characteristics. Phantom and clinical data demonstrated that the VOI analysis methods VOI{sub A50%} and VOI{sub max} gave SUV and RC values with large variability in relation to image characteristics, whereas VOI{sub 3Dpeak} and VOI{sub 2Dpeak} were less sensitive to these differences. All three phantoms may be used to harmonize parameters for

  11. Predictive value of {sup 18}F-FDG PET/CT in restaging patients affected by ovarian carcinoma: a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Caobelli, Federico [Medizinische Hochschule Hannover, Klinik fuer Nuklearmedizin, Hanover (Germany); Alongi, Pierpaolo [University of Milano-Bicocca, Nuclear Medicine Unit, Milan (Italy); IRCSS San Raffaele Scientific Institute, Nuclear Medicine Department, Milan (Italy); Evangelista, Laura; Saladini, Giorgio [Veneto Institute of Oncology IOV - IRCCS, Radiotherapy and Nuclear Medicine Unit, Padua (Italy); Picchio, Maria [IRCSS San Raffaele Scientific Institute, Nuclear Medicine Department, Milan (Italy); Rensi, Marco; Geatti, Onelio [Hospital of Udine, Nuclear Medicine Department, Udine (Italy); Castello, Angelo; Laghai, Iashar [University of Florence, Nuclear Medicine Department, Florence (Italy); Popescu, Cristina E. [Niguarda Ca' Granda Hospital, Nuclear Medicine Department, Milan (Italy); Dolci, Carlotta; Crivellaro, Cinzia [University of Milan-Bicocca, Nuclear Medicine Department, San Gerardo Hospital, Tecnomed Foundation, Milan (Italy); Seghezzi, Silvia [Hospital of Treviglio, Nuclear Medicine Department, Treviglio, Bergamo (Italy); Kirienko, Margarita [University of Milano-Bicocca, Nuclear Medicine Unit, Milan (Italy); De Biasi, Vincenzo [Nuclear Medicine Department, Arcispedale Santa Maria Nuova, Reggio Emilia (Italy); Cocciolillo, Fabrizio [Catholic University of the Sacred Heart, Nuclear Medicine Department, Rome (Italy); Quartuccio, Natale [University of Messina, Nuclear Medicine Unit, Department of Biomedical Sciences and of Morphological and Functional Images, Messina (Italy); Collaboration: Young AIMN Working Group

    2016-03-15

    Ovarian cancer is the eighth most common malignancy among women and has a high mortality rate. Prognostic factors able to drive an effective therapy are essential. {sup 18}F-Fluoro-2-deoxyglucose positron emission tomography/computed tomography ({sup 18}F-FDG PET/CT) has been investigated in patients with epithelial ovarian cancer and showed promise in diagnosing, staging, detecting recurrent lesions and monitoring treatment response. Conversely, its prognostic role remains unclear. We aimed at assessing the prognostic value of {sup 18}F-FDG PET/CT performed in the restaging process in a multicentre study. We evaluated 168 patients affected by ovarian carcinoma, who underwent a restaging {sup 18}F-FDG PET/CT. The presence of local recurrences, lymph node involvement and distant metastasis was recorded as well as lesion dimensions, maximum and mean standardized uptake values (SUV{sub max} and SUV{sub mean}, respectively). Progression-free survival (PFS) and overall survival (OS) at 3 and 4 years were computed by using Kaplan-Meier curves. Increased odds ratio was assessed using Cox regression analysis testing all lesion parameters measured by PET/CT. PFS was significantly longer in patients with a negative than a positive restaging PET/CT study (3- and 4-year PFS 64 and 53 % vs 23 and 12 %, respectively; p < 0.001). Similarly, a negative study was associated with a significantly higher OS rate after 4 years of follow-up (67 vs 25 % in negative and positive groups, respectively; p < 0.001). Lymph node or distant involvement were also independently associated with an increased risk of disease progression [hazard ratio (HR) 1.6 and 2.2, respectively; p = 0.003]. Moreover, PET/CT showed an incremental prognostic value compared to the International Federation of Gynecology and Obstetrics (FIGO) staging system. In the analysis of patient subsets, individuals with the same FIGO stage I-II but with negative PET had a significantly better 4-year OS than patients with low

  12. Positron emission tomography changes management and prognostic stratification in patients with oesophageal cancer: results of a multicentre prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Chatterton, B.E. [Royal Adelaide Hospital, Department of Nuclear Medicine and PET, Adelaide, SA (Australia); Ho Shon, I. [Liverpool Hospital, Department of Nuclear Medicine and PET, Sydney (Australia); Baldey, A. [MIA at Monash Medical Centre, Melbourne (Australia); Lenzo, N.; Patrikeos, A. [Sir Charles Gairdner Hospital, WA PET/Cyclotron Service, Perth (Australia); Kelley, B.; Wong, D. [The Wesley Hospital, Southern X-Ray Clinics, Brisbane (Australia); Ramshaw, J.E. [Australian and New Zealand Association of Physicians in Nuclear Medicine, Melbourne (Australia); Scott, A.M. [Austin Hospital, Centre for PET, and Ludwig Institute for Cancer Research, Melbourne (Australia)

    2009-03-15

    The aims of this study were (1) to determine the incremental information provided by {sup 18}F-FDG positron emission tomography (PET) in staging patients with oesophageal cancer, and (2) to determine the impact of PET staging on post-PET clinical management of oesophageal cancer, and on prognosis. In a multicentre, single-arm open study, patients with proved oesophageal cancer without definite distant metastases and regarded as suitable for potentially curative treatment were examined by PET. Clinicians were requested to supply a management plan before and another plan after being supplied with the PET scan results. Patients were followed for at least 1 year for outcome analysis. A total of 129 patients (104 men, mean age 67 y) were recruited. PET detected additional sites of disease in 53 patients (41%). Significant changes in management (high or medium impact) were observed in 38% of patients, primarily as a result of identifying additional sites of disease and/or confirming previously equivocal regional and distant metastases. Progression-free survival was significantly shorter in patients found to have additional lesions on PET (p < 0.05), but was not related to SUV{sub max}. These findings demonstrate the significant impact of PET on the clinical management of patients with newly diagnosed oesophageal carcinoma, and on prognostic stratification of these patients. (orig.)

  13. Multicentric T-cell lymphoma associated with feline leukemia virus infection in a captive namibian cheetah (Acinonyx jubatus).

    Science.gov (United States)

    Marker, Laurie; Munson, Linda; Basson, Peter A; Quackenbush, Sandra

    2003-07-01

    This case report describes a multicentric lymphoma in a 4 yr old female wildborn captive cheetah (Acinonyx jubatus) in Namibia after being housed in an enclosure adjacent to a feline leukemia virus (FeLV) infected cheetah that had previously been in contact with domestic cats. The year prior to the onset of clinical signs, the wild-born cheetah was FeLV antigen negative. The cheetah subsequently developed lymphoma, was found to be infected with FeLV, and then rapidly deteriorated and died. At necropsy, the liver, spleen, lymph nodes, and multiple other organs were extensively infiltrated with neoplastic T-lymphocytes. Feline leukemia virus DNA was identified in neoplastic lymphocytes from multiple organs by polymerase chain reaction and Southern blot analysis. Although the outcome of infection in this cheetah resembles that of FeLV infections in domestic cats, the transmission across an enclosure fence was unusual and may indicate a heightened susceptibility to infection in cheetahs. Caution should be exercised in holding and translocating cheetahs where contact could be made with FeLV-infected domestic, feral, or wild felids.

  14. Collaborative Depression Trial (CADET: multi-centre randomised controlled trial of collaborative care for depression - study protocol

    Directory of Open Access Journals (Sweden)

    Kessler David

    2009-10-01

    Full Text Available Abstract Background Comprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment model can replicate benefits for patients outside the US. This Phase III trial was preceded by a Phase II patient level RCT, following the MRC Complex Intervention Framework. Methods/Design A multi-centre controlled trial with cluster-randomised allocation of GP practices. GP practices will be randomised to usual care control or to "collaborative care" - a combination of case manager coordinated support and brief psychological treatment, enhanced specialist and GP communication. The primary outcome will be symptoms of depression as assessed by the PHQ-9. Discussion If collaborative care is demonstrated to be effective we will have evidence to enable the NHS to substantially improve the organisation of depressed patients in primary care, and to assist primary care providers to deliver a model of enhanced depression care which is both effective and acceptable to patients. Trial Registration Number ISRCTN32829227

  15. Designed sound and music environment in postanaesthesia care units--a multicentre study of patients and staff.

    Science.gov (United States)

    Thorgaard, Per; Ertmann, Ellen; Hansen, Vibeke; Noerregaard, Anni; Hansen, Vibeke; Spanggaard, Lene

    2005-08-01

    A multicentre study in five postanaesthesia care units (PACUs) was performed to investigate patient and staff opinion of a specially designed music environment (DME), related to geographical location. Patients (325) and staff (91) described their opinion by means of a questionnaire-anonymously in the case of staff. Patients were not asked beforehand for permission to play music. Amongst patients 267 (83%) found the sound environment with DME pleasant or very pleasant, 26 (6%) found it unpleasant, whereas 32 (11%) answered "no opinion". The opinion of the patients did not differ significantly with geographical location. A strong correlation (P<0.05) between a positive attitude towards DME and degree of relaxation and satisfaction with stay was found. The staff had an equally positive attitude towards the DME; but theirs varied significantly with location. The opinion of the staff was more similar concerning the beneficial effect on working conditions and distress, but varied still significantly. The opinion of the staff had no demonstrable impact on that of the patients.

  16. Roxatidine versus ranitidine in the treatment of duodenal ulcers: a randomized double-blind controlled multicentre study in Singapore.

    Science.gov (United States)

    Fock, K M; Kang, J Y; Ng, H S; Ng, T M; Gwee, K A; Lim, C C

    1995-01-01

    Roxatidine acetate, a new H2 receptor antagonist, was compared with ranitidine in the treatment of duodenal ulcers in a double-blind multicentre study. Eighty-four patients with endoscopically proven duodenal ulcer were randomized to receive 150 mg roxatidine acetate or 300 mg ranitidine at bedtime. Repeat endoscopy was performed after 4 weeks (25-33 days) and if the ulcer had not healed, another endoscopy was performed after a further 4 weeks of treatment. Using per protocol analysis 73.6% of ulcers treated with roxatidine healed at 4 weeks compared to 72.2% of ulcers treated with ranitidine (P = NS). The healing rates at 8 weeks were 92% with roxatidine and 83.3% with ranitidine (P = NS). Using equivalence tests, the healing rate of roxatidine was found to be equivalent to that of ranitidine within a 20% region. Roxatidine users took significantly less antacids than ranitidine users (P roxatidine or ranitidine. Roxatidine is a safe effective drug in the treatment of duodenal ulcers with a healing rate comparable to that of ranitidine.

  17. Management of dental extraction in patients undergoing anticoagulant treatment. Results from a large, multicentre, prospective, case-control study.

    Science.gov (United States)

    Bacci, Christian; Maglione, Michele; Favero, Lorenzo; Perini, Alessandro; Di Lenarda, Roberto; Berengo, Mario; Zanon, Ezio

    2010-11-01

    Following favourable results from a previous study, a large, multicentre, prospective, case-control study was performed to further assess the incidence of bleeding complications after dental extraction in patients taking oral anticoagulant therapy (OAT). Four hundred fifty-one patients being treated with warfarin who required dental extraction were compared with a control group of 449 non-anticoagulated subjects undergoing the same procedure. In the warfarin-treated group, the oral anticoagulant regimen was maintained unchanged, such that the patients had an International Normalised Ratio ranging between 1.8 and 4, and local haemostatic measures (i.e. fibrin sponges, silk sutures and gauzes saturated with tranexamic acid) were adopted. All the procedures were performed in an outpatient setting. Seven bleeding complications occurred in the OAT group and four in the control group; the difference in the number of bleeding events between the two groups was not statistically significant (OR=1.754; 95% CI 0.510 - 6.034; p=0.3727). No post-operative late bleeds requiring hospitalisation and/or blood transfusions were recorded, and the adjunctive local haemostatic measures were adequate to stop the bleeding. The results of our protocol applied in this large, multicenter study show that dental extractions can be performed easily and safely in anticoagulated outpatients without any modification of the ongoing anticoagulant therapy, thus minimising costs and reducing discomfort for patients.

  18. Etiology of newly-diagnosed cases of chronic liver disease in Southern Italy: results of a prospective multicentric study

    Directory of Open Access Journals (Sweden)

    Antonio Ascione

    2013-11-01

    Full Text Available The pattern of liver diseases has radically changed in our country over the last few decades. We prospectively collected data on the newly-diagnosed cases of chronic liver diseases in a region of southern Italy after about a decade from the last epidemiological study. We conducted a multicentric prospective study that enrolled 631 patients from 21 Liver Centers of the Campania region (Southern Italy at their first hospital admission or at their first outpatient visit. In our cohort of 631 patients (367 males, 263 females, 397 (62.9% were hepatitis C virus (HCV positive, 75 (11.9% were hepatitis B virus (HBV positive, 8 (1.3% were co-infected by HBV and HCV, 73 (11.6% had an alcoholic liver disease and 64 (10.1% had a nonalcoholic fatty liver disease. HBV infection was present in young people with a higher-than-expected prevalence, despite the vaccination program which should have involved this population. HCV chronic hepatitis still remains the most common cause of liver disease in our region. HBV infection still continues to represent a health problem in young people, despite the vaccination program.

  19. Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial.

    Science.gov (United States)

    Endres, Heinz G; Böwing, Gabriele; Diener, Hans-Christoph; Lange, Stefan; Maier, Christoph; Molsberger, Albrecht; Zenz, Michael; Vickers, Andrew J; Tegenthoff, Martin

    2007-10-01

    Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as > or =10 headache days per month of which superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as >50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar ( approximately 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.

  20. Prospective multicentre PCR-based Aspergillus DNA screening in high-risk patients with and without primary antifungal mould prophylaxis.

    Science.gov (United States)

    Springer, J; Lackner, M; Nachbaur, D; Girschikofsky, M; Risslegger, B; Mutschlechner, W; Fritz, J; Heinz, W J; Einsele, H; Ullmann, A J; Löffler, J; Lass-Flörl, C

    2016-01-01

    Invasive aspergillosis (IA) is associated with significant morbidity and mortality, and, among other factors, this is due to a delay in diagnosis performed with conventional techniques. A prospective, multicentre study was conducted to evaluate the efficacy of Aspergillus DNA screening in the early diagnosis of IA. Patients undergoing haematopoietic stem cell transplantation or chemotherapy for acute leukaemia were enrolled for biomarker screening. Three centres applied the same protocol for in-house PCR, which was compliant with the European Aspergillus PCR Initiative recommendations, to guarantee the highest diagnostic standards. Two thousand one hundred and twenty-eight sera from 213 patients were investigated and stratified according to the revised European Organization for the Research and Treatment of Cancer/Mycoses Study Group criteria for invasive fungal disease. The incidence rates of probable and possible IA were 18% and 38%, respectively. The sensitivity, specificity and positive predictive value (PPV) of PCR were superior in antifungal drug-naive patients, being 71.4%, 92.3%, and 62.5%, respectively. The last of these key performance indicators (PPV) was moderate in patients receiving primary prophylaxis, at 5.4%. Negative predictive values for both strategies applied were 100% with and 98.3% without antifungal mould prophylaxis. PCR has the potential to play a decisive role in the diagnosis and management of Aspergillus infections in centres not applying primary antifungal mould prophylaxis.

  1. Pressure ulcer knowledge of registered nurses, assistant nurses and student nurses: a descriptive, comparative multicentre study in Sweden.

    Science.gov (United States)

    Gunningberg, Lena; Mårtensson, Gunilla; Mamhidir, Anna-Greta; Florin, Jan; Muntlin Athlin, Åsa; Bååth, Carina

    2015-08-01

    The aim of this study was to describe and compare the knowledge of registered nurses (RNs), assistant nurses (ANs) and student nurses (SNs) about preventing pressure ulcers (PUs). PU prevention behaviours in the clinical practice of RNs and ANs were also explored. A descriptive, comparative multicentre study was performed. Hospital wards and universities from four Swedish county councils participated. In total, 415 participants (RN, AN and SN) completed the Pressure Ulcer Knowledge Assessment Tool. The mean knowledge score for the sample was 58·9%. The highest scores were found in the themes 'nutrition' (83·1%) and 'risk assessment' (75·7%). The lowest scores were found in the themes 'reduction in the amount of pressure and shear' (47·5%) and 'classification and observation' (55·5%). RNs and SNs had higher scores than ANs on 'aetiology and causes'. SNs had higher scores than RNs and ANs on 'nutrition'. It has been concluded that there is a knowledge deficit in PU prevention among nursing staff in Sweden. A major educational campaign needs to be undertaken both in hospital settings and in nursing education.

  2. Coffee, tea and decaffeinated coffee in relation to hepatocellular carcinoma in a European population: multicentre, prospective cohort study.

    Science.gov (United States)

    Bamia, Christina; Lagiou, Pagona; Jenab, Mazda; Trichopoulou, Antonia; Fedirko, Veronika; Aleksandrova, Krasimira; Pischon, Tobias; Overvad, Kim; Olsen, Anja; Tjønneland, Anne; Boutron-Ruault, Marie-Christine; Fagherazzi, Guy; Racine, Antoine; Kuhn, Tilman; Boeing, Heiner; Floegel, Anna; Benetou, Vasiliki; Palli, Domenico; Grioni, Sara; Panico, Salvatore; Tumino, Rosario; Vineis, Paolo; Bueno-de-Mesquita, H B; Dik, Vincent K; Bhoo-Pathy, Nirmala; Uiterwaal, Cuno S P M; Weiderpass, Elisabete; Lund, Eiliv; Quirós, J Ramón; Zamora-Ros, Raul; Molina-Montes, Esther; Chirlaque, Maria-Dolores; Ardanaz, Eva; Dorronsoro, Miren; Lindkvist, Björn; Wallström, Peter; Nilsson, Lena Maria; Sund, Malin; Khaw, Kay-Tee; Wareham, Nick; Bradbury, Kathryn E; Travis, Ruth C; Ferrari, Pietro; Duarte-Salles, Talita; Stepien, Magdalena; Gunter, Marc; Murphy, Neil; Riboli, Elio; Trichopoulos, Dimitrios

    2015-04-15

    Inverse associations of coffee and/or tea in relation to hepatocellular carcinoma (HCC) risk have been consistently identified in studies conducted mostly in Asia where consumption patterns of such beverages differ from Europe. In the European Prospective Investigation into Cancer and nutrition (EPIC), we identified 201 HCC cases among 486,799 men/women, after a median follow-up of 11 years. We calculated adjusted hazard ratios (HRs) for HCC incidence in relation to quintiles/categories of coffee/tea intakes. We found that increased coffee and tea intakes were consistently associated with lower HCC risk. The inverse associations were substantial, monotonic and statistically significant. Coffee consumers in the highest compared to the lowest quintile had lower HCC risk by 72% [HR: 0.28; 95% confidence intervals (CIs): 0.16-0.50, p-trend coffee intake with HCC were apparent for caffeinated (p-trend = 0.009), but not decaffeinated (p-trend = 0.45) coffee for which, however, data were available for a fraction of subjects. Results from this multicentre, European cohort study strengthen the existing evidence regarding the inverse association between coffee/tea and HCC risk. Given the apparent lack of heterogeneity of these associations by HCC risk factors and that coffee/tea are universal exposures, our results could have important implications for high HCC risk subjects.

  3. Concordance between four European centres of PET reporting criteria designed for use in multicentre trials in Hodgkin lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Barrington, Sally F.; Somer, Edward J.; O' Doherty, Michael J. [Kings College London Division of Imaging, PET Imaging Centre at St Thomas' , London (United Kingdom); Qian, Wendi [MRC Clinical Trials Unit, London (United Kingdom); Franceschetto, Antonella; Bagni, Bruno [University of Modena and Reggio Emilia, Department of Nuclear Medicine, Modena (Italy); Brun, Eva; Almquist, Helen [Lund University Hospital, Departments of Oncology and Clinical Physiology, Lund (Sweden); Loft, Annika; Hoejgaard, Liselotte [Copenhagen University Hospital, PET and Cyclotron Unit, Rigshospitalet, Copenhagen (Denmark); Federico, Massimo [University of Modena and Reggio Emilia, Department of Haematology and Oncology, Modena (Italy); Gallamini, Andrea [Azienda Ospedaliera S. Croce e Carle, Hematology Department, Cuneo (Italy); Smith, Paul [Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom); Johnson, Peter [Cancer Research UK Clinical Centre, Southampton (United Kingdom); Radford, John [The Christie NHS Foundation Trust and the University of Manchester, Manchester (United Kingdom)

    2010-10-15

    To determine if PET reporting criteria for the Response Adapted Treatment in Hodgkin Lymphoma (RATHL) trial could enable satisfactory agreement to be reached between 'core' laboratories operating in different countries. Four centres reported scans from 50 patients with stage II-IV HL, acquired before and after two cycles of Adriamycin/bleomycin/vinblastine/dacarbazine. A five-point scale was used to score response scans using 'normal' mediastinum and liver as reference levels. Centres read scans independently of each other. The level of agreement between centres was determined assuming (1) that uptake in sites involved at diagnosis that was higher than liver uptake represented disease (conservative reading), and (2) that uptake in sites involved at diagnosis that was higher than mediastinal uptake represented disease (sensitive reading). There was agreement that the response scan was 'positive' or 'negative' for lymphoma in 44 patients with a conservative reading and in 41 patients with a sensitive reading. Kappa was 0.85 (95% CI 0.74-0.96) for conservative reading and 0.79 (95% CI 0.67-0.90) for sensitive reading. Agreement was reached in 46 and 44 patients after discussion for the conservative and sensitive readings, respectively. The criteria developed for reporting in the RATHL trial are sufficiently robust to be used in a multicentre setting. (orig.)

  4. Regulatory T cells in dogs with multicentric lymphoma: peripheral blood quantification at diagnosis and after initial stage chemotherapy

    Directory of Open Access Journals (Sweden)

    T.D. Munhoz

    2016-02-01

    Full Text Available Lymphoma is the most common hematopoietic malignancy in dogs and one of the most frequent among all neoplastic diseases in this species. It can occur in several anatomical locations with distinct histological and immunophenotypes. Depending on the host immune response towards the tumor, prognosis information could be collected. Because its well established immunosuppressant, antitumor activity, the function of regulatory T cells (Tregs in canine neoplasias has been investigated. In this study, we sought to quantify, using flow cytometry, the Tregs subpopulation in peripheral blood of healthy dogs (10 and in those diagnosed with type-B (14 and type-T (8 multicentric lymphoma before (at diagnosis and after the first cycle (5-week of 19-week Madison-Wisconsin (MW protocol of chemotherapy. Our results indicated that dogs with lymphoma showed higher percentage of Tregs (18,84±2,56 when compared to healthy dogs (4,70±0,50 (P0,05. There was no difference in Tregs percentage between B-type (17,45±2,77 and T-type (21,27±5,27 lymphoma (P>0,05. With this, we conclude that canine lymphoma increases Tregs in the peripheral blood and the MW protocol of chemotherapy reduces this cell subpopulation to control values.

  5. Geometries of low spin states of multi-centre transition metal complexes through extended broken symmetry variational Monte Carlo

    Science.gov (United States)

    Barborini, Matteo; Guidoni, Leonardo

    2016-09-01

    The correct description of the ground state electronic and geometrical properties of multi-centre transition metal complexes necessitates of a high-level description of both dynamical and static correlation effects. In di-metallic complexes, the ground state low spin properties can be computed starting from single-determinants High-Spin (HS) and Broken Symmetry (BS) states by reconstructing an approximated low spin potential energy surface through the extended broken symmetry approach, based on the Heisenberg Hamiltonian. In the present work, we first apply this approach within the variational Monte Carlo method to tackle the geometry optimization of a Fe2S2(SH)42- model complex. To describe the HS and BS wavefunctions, we use a fully optimized unrestricted single determinant with a correlated Jastrow factor able to recover a large amount of dynamical correlation. We compared our results with those obtained by density functional theory and other multiconfigurational approaches, discussing the role of the nodal surface on the structural parameters.

  6. Live birth after artificial oocyte activation using a ready-to-use ionophore: a prospective multicentre study.

    Science.gov (United States)

    Ebner, Thomas; Montag, Markus; Montag, M; Van der Ven, K; Van der Ven, H; Ebner, T; Shebl, O; Oppelt, P; Hirchenhain, J; Krüssel, J; Maxrath, B; Gnoth, C; Friol, K; Tigges, J; Wünsch, E; Luckhaus, J; Beerkotte, A; Weiss, D; Grunwald, K; Struller, D; Etien, C

    2015-04-01

    Artificial oocyte activation has been proposed as a suitable means to overcome the problem of failed or impaired fertilization after intracytoplasmic sperm injection (ICSI). In a multicentre setting artificial oocyte activation was applied to 101 patients who were diagnosed with fertilization abnormalities (e.g. less than 50% fertilized oocytes) in a previous conventional ICSI cycle. Female gametes were activated for 15 min immediately after ICSI using a ready-to-use Ca(2+)-ionophore solution (A23187). Fertilization, pregnancy and live birth rates were compared with the preceding cycle without activation. The fertilization rate of 48% in the study cycles was significantly higher compared with the 25% in the control cycles (P splitting of the historical control group into failed (0%), low (1-30%) and moderate fertilization rate (31-50%) showed that all groups significantly benefitted (P embryo transfer cancelled compared with their previous treatments (1/101 versus 15/101). In total, 99% of the patients had an improved outcome with A23187 application resulting in a 28% live birth rate (35 babies). These data suggest that artificial oocyte activation using a ready-to-use compound is an efficient method.

  7. MRI in multiple sclerosis: an intra-individual, randomized and multicentric comparison of gadobutrol with gadoterate meglumine at 3 T

    Energy Technology Data Exchange (ETDEWEB)

    Saake, Marc; Weibart, Marina; Doerfler, Arnd [University of Erlangen-Nuremberg, Department of Neuroradiology, Erlangen (Germany); Langner, Soenke; Hosten, Norbert [University Medicine Greifswald, Institute for Diagnostic Radiology and Neuroradiology, Greifswald (Germany); Schwenke, Carsten [SCO:SSiS, Statistical Consulting, Berlin (Germany); Jansen, Olav [University of Kiel, Department of Radiology and Neuroradiology, Kiel (Germany)

    2016-03-15

    To compare contrast effects of gadobutrol with gadoterate meglumine for brain MRI in multiple sclerosis (MS) in a multicentre, randomized, prospective, intraindividual study at 3 T. Institutional review board approval was obtained. Patients with known or suspected active MS lesions were included. Two identical MRIs were performed using randomized contrast agent order. Four post-contrast T1 sequences were acquired (start time points 0, 3, 6 and 9 min). If no enhancing lesion was present in first MRI, second MRI was cancelled. Quantitative (number and signal intensity of enhancing lesions) and qualitative parameters (time points of first and all lesions enhancing; subjective preference regarding contrast enhancement and lesion delineation; global preference) were evaluated blinded. Seventy-four patients (male, 26; mean age, 35 years) were enrolled in three centres. In 45 patients enhancing lesions were found. Number of enhancing lesions increased over time for both contrast agents without significant difference (median 2 for both). Lesions signal intensity was significantly higher for gadobutrol (p < 0.05 at time points 3, 6 and 9 min). Subjective preference rating showed non-significant tendency in favour of gadobutrol. Both gadobutrol and gadoterate meglumine can be used for imaging of acute inflammatory MS lesions. However, gadobutrol generates higher lesion SI. (orig.)

  8. 75 FR 42835 - Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal...

    Science.gov (United States)

    2010-07-22

    ... factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the... PPS) B. Operational Overview of the Current IRF PPS II. Summary of Provisions of the Notice III.... Updates to the Facility-Level Adjustment Factors V. FY 2011 IRF PPS Federal Prospective Payment Rates...

  9. Cross-centre replication of suppressed burrowing behaviour as an ethologically relevant pain outcome measure in the rat: a prospective multicentre study

    Science.gov (United States)

    Wodarski, Rachel; Delaney, Ada; Ultenius, Camilla; Morland, Rosie; Andrews, Nick; Baastrup, Catherine; Bryden, Luke A.; Caspani, Ombretta; Christoph, Thomas; Gardiner, Natalie J.; Huang, Wenlong; Kennedy, Jeffrey D.; Koyama, Suguru; Li, Dominic; Ligocki, Marcin; Lindsten, Annika; Machin, Ian; Pekcec, Anton; Robens, Angela; Rotariu, Sanziana M.; Voß, Sabrina; Segerdahl, Marta; Stenfors, Carina; Svensson, Camilla I.; Treede, Rolf-Detlef; Uto, Katsuhiro; Yamamoto, Kazumi; Rutten, Kris; Rice, Andrew S.C.

    2016-01-01

    Abstract Burrowing, an ethologically relevant rodent behaviour, has been proposed as a novel outcome measure to assess the global impact of pain in rats. In a prospective multicentre study using male rats (Wistar, Sprague-Dawley), replication of suppressed burrowing behaviour in the complete Freund adjuvant (CFA)-induced model of inflammatory pain (unilateral, 1 mg/mL in 100 µL) was evaluated in 11 studies across 8 centres. Following a standard protocol, data from participating centres were collected centrally and analysed with a restricted maximum likelihood-based mixed model for repeated measures. The total population (TP—all animals allocated to treatment; n = 249) and a selected population (SP—TP animals burrowing over 500 g at baseline; n = 200) were analysed separately, assessing the effect of excluding “poor” burrowers. Mean baseline burrowing across studies was 1113 g (95% confidence interval: 1041-1185 g) for TP and 1329 g (1271-1387 g) for SP. Burrowing was significantly suppressed in the majority of studies 24 hours (7 studies/population) and 48 hours (7 TP, 6 SP) after CFA injections. Across all centres, significantly suppressed burrowing peaked 24 hours after CFA injections, with a burrowing deficit of −374 g (−479 to −269 g) for TP and −498 g (−609 to −386 g) for SP. This unique multicentre approach first provided high-quality evidence evaluating suppressed burrowing as robust and reproducible, supporting its use as tool to infer the global effect of pain on rodents. Second, our approach provided important informative value for the use of multicentre studies in the future. PMID:27643836

  10. Retraction statement: Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers.

    Science.gov (United States)

    2015-09-01

    The following article from Journal of Clinical Nursing, 'Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers' by Georgina Gethin and Seamus Cowman published online on 25 August 2008 in Wiley Online Library (wileyonlinelibrary.com) and in Volume 18, pp. 466-474, has been retracted by agreement between the journal Editor-in-Chief, the authors and John Wiley & Sons, Ltd. The retraction has been agreed due to errors in the data analysis which affect the article's findings.

  11. Validity and reliability of the braden scale and the influence of other risk factors: a multi-centre prospective study.

    Science.gov (United States)

    Halfens, R J; Van Achterberg, T; Bal, R M

    2000-08-01

    The Braden scale is one of the most intensively studied risk assessment scales used in identifying the risk of developing pressure sores. However, not all studies show that the sensitivity and specificity of this scale is sufficient. This study, therefore, investigated whether adding new risk factors can enhance the sensitivity and specificity of the Braden scale. The Braden scale was tested in a prospective multi-centre design. The nurses of 11 wards filled in the Braden scale every 5 days for each patient who was admitted without pressure sores and who had a probable stay of at least 10 days. Based on a literature study and in-depth interviews with experts, the Braden scale was extended by the risk factor blood circulation. In addition, other risk factors, which are more or less stable patient characteristics, were measured during the admission of the patient. Independent research assistants measured the presence of pressure sores twice a week. As the external criterion for the risk of developing pressure sores, the presence of pressure sores and/or the use of preventive activities was used. Results showed that the original Braden scale was a reliable instrument and that the sensitivity and specificity was sufficient. However, reformulating the factors moisture and nutrition, and adding the risk factor age could enhance the sensitivity and specificity. Furthermore, results showed that the factors sensory perception, and friction and shear were especially important risk factors for the Braden scale. In fact, using only the factors sensory perception, friction and shear, moisture (a reformulated factor) and age give the highest explained variance of the risk of developing pressure sores. The added risk factor blood circulation, did not enhance the sensitivity and specificity of the original Braden scale. Suggestions are given on how to use risk assessment scales in practice.

  12. Alcohol and Tobacco Use Among Undergraduate and Postgraduate Medical Students in India: A Multicentric Cross-sectional Study

    Directory of Open Access Journals (Sweden)

    Nidhi Goel

    2015-02-01

    Full Text Available Background: Substance use among medical fraternity is a well-known phenomenon among both undergraduate (UG and postgraduate (PG medical students. Yet, there have been very few multi-centric studies to estimate the actual burden of this problem in this important population group in India. This study was conducted to estimate the prevalence of alcohol and tobacco use, assess the knowledge and attitudes towards this issue, and identify factors associated with substance use among UG and PG medical students in India.Methods: A pre-tested, self-report, anonymous questionnaire was administered to medical undergraduates and post graduate medical residents of eight medical colleges across India. This study used a convenience sample of medical colleges with random selection of study participants within each college for each group, UG and PG.Results: Prevalence of alcohol and tobacco use among UG students was 16.6%, 95% CI [14.5, 18.9] and 8.0%, 95% CI [6.4, 9.6], respectively, whereas prevalence was 31.5%, 95% CI [26.3, 37.0] and 14.5%, 95% CI [10.7, 18.9], respectively for PGs. For both substances, males had a higher prevalence of use compared to females in both groups (p < 0.001. Positive family history of substance use (p < 0.001 for both groups and early age of initiation (p = 0.011 for tobacco; p > 0.05 for alcohol were associated with a greater difficulty to quit the habit. Over 90% of study participants felt that substance use adversely affected their skills and reported not using substances prior to managing their patients.Conclusions: Since substance use is a relatively common phenomenon among UG and PG medical students in India, future prospective studies and interventions are required to better understand the pattern of substance use and reduce its prevalence. 

  13. A Multicentre Study of CLa Implant and Sino-implant Expanded Application (two-year follow-up)

    Institute of Scientific and Technical Information of China (English)

    方可娟; 关艳敏; 范慧民; 高尔生; 杨丹; 薜丽; 韩耀玲; 刘宝

    1997-01-01

    A multicentre comparative clinical study of CLa implant and Sino-implant was carried out at 100 subcentres in 11 provinces, and a total of 19673 subjects were recruited. Two year follow up has been finished. The follow-up rate at the end of two years was 94,29%. Two-year cumulative continuation rate per 100 women for Sino-implant(89.93) was significantly higher than that for CLa implant (88.89). Two-year cumulative pregnancy rates per 100 women were 0.0462(CLa implant) and 0.281(Sino-implant) respectively; there was statistically significant difference between them. No ectopic pregnancy was recorded among CLa implant users and three ectopic pregnancies were reported among Sino implant users,resulting in an ectopic pregnancy rate of 0.163 per 1000 women years. The incidence of side-effects appeared to diminish with time. The major side effects were the menstrual disturbances, which accounted for more than 90% of the total sideeffects, and the incidence of frequent menstruation, irregular bleeding and spotring was higher than that of infrequentjscanty menstruation and amenorrhea. Use of CLa implant had higher incidence of amenorrhea and infrequentjscanty menstruation than that of Sin-imptant. During two-year follow-up, the number of discontinuation due to menstrual problems contributed 78% of the total number of discontinuation; two year menstrual-related cumulative discontinuation rates were 8.96 per 100 women for CLa implant and 7.84 for Sino-implant; there was statistically significant difference(P< 0.01). Two-year study shows that the two types of implant are similar to Norplant in the incidence of side-effects and contraceptive efficacy as well as two year continuation rates.

  14. Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. A multicentre French GEHT study.

    Science.gov (United States)

    Gouin-Thibault, Isabelle; Flaujac, Claire; Delavenne, Xavier; Quenet, Sara; Horellou, Marie-Hélenè; Laporte, Silvy; Siguret, V; Lecompte, T

    2014-02-01

    While laboratory monitoring is not required in patients treated with apixaban, a direct factor-Xa inhibitor, assessment of its concentration is useful in some critical situations. However, few data are available on its effect on coagulation tests and on the suitability of anti-Xa assays for its quantification. It was the objective of this study to identify laboratory tests suitable for apixaban concentration assessment. Coagulation tests - PT and aPTT- and anti-Xa assays were performed in apixaban-spiked plasma samples. To evaluate the sensitivity of PT and aPTT to apixaban, we conducted a first monocenter part, with a wide range of concentrations (50-1,000 ng/ml), a large panel of reagents (20 reagents), and two coagulometers (STAR®, Stago and ACL TOP®, IL), and a second multicenter part involving 13 laboratories using either a common PT reagent (RecombiPlastin2G®) or the local PT and aPTT reagents. In the multicentre part, five blinded apixaban-spiked plasma samples (0/100/200/400/800 ng/ml - checked by HPLC-MS/MS) were used; apixaban concentrations were measured with three anti-Xa assays, apixaban calibrators and controls (Stago). PT and aPTT tests using a large panel of reagents displayed a low sensitivity to a wide range of apixaban concentrations. The concentrations to double PT ranged from 400 to >1,000 ng/ml with the 10 reagents. With the three anti-Xa assays, inter-laboratory precision and accuracy were below 11% and 12%, respectively. In conclusion, whereas PT and aPTT tests were not sensitive enough to detect apixaban, the three anti-Xa assays tested using lyophilised apixaban calibrators and controls allowed to reliably quantify a wide range of apixaban concentrations.

  15. A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

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    Dykes Anna-Karin

    2011-02-01

    Full Text Available Abstract Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1% met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4% women reported experience of violence, and among these, 66 (2.5% women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26 of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08, OR 0.90, 95% CI (0.54-1.50, respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96. Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

  16. Human and viral interleukin-6 and other cytokines in Kaposi sarcoma herpesvirus-associated multicentric Castleman disease

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    Uldrick, Thomas S.; Wang, Victoria; Aleman, Karen; Wyvill, Kathleen M.; Marshall, Vickie; Pittaluga, Stefania; O’Mahony, Deirdre; Whitby, Denise; Tosato, Giovanna; Steinberg, Seth M.; Little, Richard F.

    2013-01-01

    Kaposi sarcoma herpesvirus (KSHV)-associated multicentric Castleman disease (MCD) is a polyclonal B-cell lymphoproliferative disorder. Human (h) IL-6 and a KSHV-encoded homolog, viral IL-6, have been hypothesized to contribute to its pathogenesis, but their relative contributions to disease activity is not well understood. We prospectively characterized KSHV viral load (VL), viral (v) and hIL-6, and other cytokines during KSHV-MCD flare and remission in 21 patients with 34 flares and 20 remissions. KSHV-VL, vIL-6, hIL-6, IL-10, and to a lesser extent TNF-α, and IL-1β were each elevated during initial flares compared with remission. Flares fell into 3 distinct IL-6 profiles: those associated with elevations of vIL6-only (2 flares, 6%), hIL-6 elevations only (17 flares, 50%), and elevations in both hIL-6 and vIL-6 (13 flares, 38%). Compared with hIL-6–only flares, flares with elevated hIL-6 plus vIL-6 exhibited higher C-reactive protein (CRP) (P = .0009); worse hyponatremia (P = .02); higher KSHV VL (P = .016), and higher IL-10 (P = .012). This analysis shows vIL-6 and hIL-6 can independently or together lead to KSHV-MCD flares, and suggests that vIL-6 and hIL-6 may jointly contribute to disease severity. These findings have implications for the development of novel KSHV-MCD therapies targeting IL-6 and its downstream signaling. This trial was registered at clinicaltrials.gov as #NCT099073. PMID:24174627

  17. Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial

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    Diwedi S

    2005-05-01

    Full Text Available Background : Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK. Aim: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK and natural streptokinase (Streptase, n-SK. Settings and Design: Double blind, randomized, non-inferiority, multicentric, parallel study. Materials and Methods: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V1- V6 or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > 50% ST segment were used to assess reperfusion. Statistical analysis: Difference in the groups was assessed by chi-square or paired t test as required. Probability value Results: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58 and 69.4% (34 patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%, hypotension in 3 (3.6%, nausea in 2 (2.4% patients. Minor bleeding were seen in 4 (4.8% of patients. Conclusion: Indigenous recombinant Streptokinase (r-SK is as efficacious as natural streptokinase (n-SK in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile..

  18. Screening for diabetes mellitus among tuberculosis patients in Southern Nigeria: a multi-centre implementation study under programme settings

    Science.gov (United States)

    Ekeke, Ngozi; Ukwaja, Kingsley N.; Chukwu, Joseph N.; Nwafor, Charles C.; Meka, Anthony O.; Egbagbe, Eruke E.; Soyinka, Festus O.; Alobu, Isaac; Agujiobi, Ifeanyi; Akingbesote, Samuel; Igbinigie, Osagie; Offor, Job B.; Madichie, Nelson O.; Alphonsus, Chukwuka; Anyim, Moses C.; Mbah, Obinna K.; Oshi, Daniel C.

    2017-01-01

    Implementation studies are recommended to assess the feasibility and effectiveness of programmes. In Nigeria, little is known about the burden of diabetes mellitus (DM) among tuberculosis (TB) patients. The objective of this study was to determine screening efficacy, prevalence of DM and determinants of DM among TB patients. We report on a multi-centre implementation study carried-out in 13 health facilities in six States of Southern Nigeria. All newly diagnosed TB patients registered from March to October 2015 were screened for DM using current World Health Organisation guidelines. Overall, 2094 TB patients were evaluated, 196 (9.4%) were found to have DM. The prevalence of newly diagnosed DM was 5.5% (115/2094). DM prevalence varied according to age group; occurring in 2.2% of patients aged ≤ 25 years and 16.9% in patients aged (56–65) years. The additional yield of DM was 59% while the number needed to screen to detect a new case of DM was 18. Factors associated with DM were; age >40 years (aOR2.8, CI 2.1–3.9), rural residence (aOR2.3, 1.6–3.2), private health facility care (aOR2.0, 1.4–2.7), and having an occupation that engages in vigorous activity (aOR0.6, 0.4–0.9). The burden of DM among TB patients is high. Prioritization of DM screening for TB patients is indicated. PMID:28281682

  19. Corifollitropin α followed by menotropin for poor ovarian responders’ trial (COMPORT): a protocol of a multicentre randomised trial

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    Polyzos, Nikolaos P; Camus, Michel; Llacer, Joaquin; Pantos, Konstantinos; Tournaye, Herman

    2013-01-01

    Background Poor response to ovarian stimulation affects a significant proportion of infertile couples undergoing in vitro fertilisation (IVF) treatment. Recently, the European Society of Human Reproduction and Embryology developed new criteria to define poor ovarian response, the so-called Bologna criteria. Although preliminary studies in these patients demonstrated very low pregnancy rates, a recent pilot study has shown promising results in women <40 years old fulfilling the criteria, after treatment with corifollitropin α followed by highly purified menotropin (hpHMG) in a gonadotropin-releasing hormone (GnRH) antagonist setting. Corifollitropin α followed by menotropin for poor ovarian responders’ trial (COMPORT) is a randomised trial aiming to investigate whether this novel protocol is superior to treatment with recombinant follicle-stimulating hormone (FSH) in an antagonist setting for young poor responders. Methods/design COMPORT is a multicentre, open label, phase III randomised trial using a parallel two-arm design. 150 patients <40 years old fulfilling the ‘Bologna criteria’ will be randomised to corifollitropin α followed by hpHMG (group A) or recombinant FSH (group B) in a GnRH antagonist protocol for IVF/intracytoplasmic sperm injection (ICSI). The primary outcome is the ongoing pregnancy rate (defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9–10 weeks of gestation). Secondary outcomes are clinical and biochemical pregnancy rates and number of oocytes retrieved. Central randomisation will be performed using a computer-generated list and allocation concealment will be secured with the use of sealed-opaque envelopes. A sample size of 150 women is essential to detect a difference of 19.5% in ongoing pregnancy rates between group A (28%) and group B (8.5%) with a power of 85% and a level of significance at 0.05 using a two-sided Fisher's exact test. PMID:23794545

  20. The Australian Multiple Sclerosis (MS immunotherapy study: a prospective, multicentre study of drug utilisation using the MSBase platform.

    Directory of Open Access Journals (Sweden)

    Vilija G Jokubaitis

    Full Text Available OBJECTIVE: To prospectively characterise treatment persistence and predictors of treatment discontinuation in an Australian relapsing-remitting multiple sclerosis (RRMS population. METHODS: Tertiary MS treatment centres participating in the MSBase registry prospectively assessed treatment utilisation, persistence, predictors of treatment discontinuation and switch rates. Multivariable survival analyses were used to compare treatment persistence between drugs and to identify predictors of treatment discontinuation. RESULTS: 1113 RRMS patients were studied. Patients persisted on their first disease-modifying therapy (DMT for a median of 2.5 years. Treatment persistence on GA was shorter than on all IFNβ products (p<0.03. Younger age at treatment initiation and higher EDSS were predictive of DMT discontinuation. Patients persisted on subsequent DMTs, for 2.3 years. Patients receiving natalizumab (NAT as a subsequent DMT persisted longer on treatment than those on IFNβ or GA (p<0.000. The primary reason for treatment discontinuation for any drug class was poor tolerability. Annualised switch or cessation rates were 9.5-12.5% for individual IFNβ products, 11.6% for GA and 4.4% for NAT. CONCLUSION: This multicentre MS cohort study is the first to directly compare treatment persistence on IFNβ and GA to NAT. We report that treatment persistence in our Australian RRMS population is short, although patients receiving IFNβ as a first DMT persisted longer on treatment than those on GA. Additionally, patients receiving NAT as a subsequent DMT were more likely to persist on treatment than those switched to IFNβ or GA. EDSS and age at DMT initiation were predictive of DMT discontinuation. Treatment intolerance was the principal reason for treatment cessation.

  1. Can a management pathway for chronic cough in children improve clinical outcomes: protocol for a multicentre evaluation

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    Masters IB

    2010-11-01

    Full Text Available Abstract Background Chronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. Evidence shows that the management of chronic cough in children needs to be improved. Our study tests the hypothesis that the management of chronic cough in children with an evidence-based management pathway is feasible and reliable, and improves clinical outcomes. Methods/Design We are conducting a multicentre randomised controlled trial based in respiratory clinics in 5 major Australian cities. Children (n = 250 fulfilling inclusion criteria (new patients with chronic cough are randomised (allocation concealed to the standardised clinical management pathway (specialist starts clinical pathway within 2 weeks or usual care (existing care until review by specialist at 6 weeks. Cough diary, cough-specific quality of life (QOL and generic QOL are collected at baseline and at 6, 10, 14, 26, and 52 weeks. Children are followed-up for 6 months after diagnosis and cough resolution (with at least monthly contact from study nurses. A random sample from each site will be independently examined to determine adherence to the pathway. Primary outcomes are group differences in QOL and proportion of children that are cough free at week 6. Discussion The clinical management pathway is based on data from Cochrane Reviews combined with collective clinical experience (250 doctor years. This study will provide additional evidence on the optimal management of chronic cough in children. Trial registration ACTRN12607000526471

  2. A multicomponent approach to identify predictors of hospital outcomes in older in-patients: a multicentre, observational study.

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    Stefanie L De Buyser

    Full Text Available BACKGROUND: The identification of older patients at risk of poor hospital outcomes (e.g. longer hospital stay, in-hospital mortality, and institutionalisation is important to provide an effective healthcare service. OBJECTIVE: To identify factors related to older patients' clinical, nutritional, functional and socio-demographic profiles at admission to an acute care ward that can predict poor hospital outcomes. DESIGN AND SETTING: The CRiteria to assess appropriate Medication use among Elderly complex patients project was a multicentre, observational study performed in geriatric and internal medicine acute care wards of seven Italian hospitals. SUBJECTS: One thousand one hundred twenty-three consecutively admitted patients aged 65 years or older. METHODS: Hospital outcomes were length of stay, in-hospital mortality, and institutionalisation. RESULTS: Mean age of participants was 81 years, 56% were women. Median length of stay was 10 (7-14 days, 41 patients died during hospital stay and 37 were newly institutionalised. Number of drugs before admission, metastasized cancer, renal failure or dialysis, infection, falls at home during the last year, pain, and walking speed were independent predictors of LoS. Total dependency in activities of daily living and inability to perform grip strength test were independent predictors of in-hospital mortality. Malnutrition and total dependency in activities of daily living were independent predictors of institutionalisation. CONCLUSIONS: Our results confirm that not only diseases, but also multifaceted aspects of ageing such as physical function and malnutrition are strong predictors of hospital outcomes and suggest that these variables should be systematically recorded.

  3. Determinants of Attrition to Follow-Up in a Multicentre Cohort Study in Children-Results from the IDEFICS Study

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    Sabrina Hense

    2013-01-01

    Full Text Available Cohort participant retention is a crucial element and may depend on several factors. Based on data from a multicentre cohort of European children, the effect of baseline participation on attrition and the association with and the impact of single determinants in relation to the extent of attrition were investigated. Data was available for 16,225 children from the IDEFICS baseline survey (2007/2008. Attrition was defined as nonparticipation in the first follow-up examination (2009/2010. Determinants of attrition were analysed by logistic regression. The statistical significance level was set at α=0.01 to account for the large sample size. The strongest associations were seen for baseline item non-response, especially when information on migration background (odds ratio (OR = 1.55; 99% confidence interval (CI: 1.04, 2.31, single parenthood (OR = 1.37; 99% CI: 1.12, 1.67, or well-being (OR = 1.46; 99% CI: 1.19, 1.79 was lacking. Drop-out proportion rose with the number of missing items. Overweight, low education, single parenthood and low well-being scores were independent determinants of attrition. Baseline participation, and the individual determinant effects seemed unrelated to the variation of the extent of attrition between study centres. A high level of item nonresponse as well as overweight and disadvantageous sociodemographic conditions were identified as main attrition determinants, suggesting the consideration of these aspects in conduct and analysis of cohort studies in childhood obesity research.

  4. Is lesional stability in vitiligo more important than disease stability for performing surgical interventions? results from a multicentric study

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    Imran Majid

    2016-01-01

    Full Text Available Background: Ensuring stability of the disease process is essential for undertaking surgical intervention in vitiligo. However, there is no consensus regarding the minimum duration of stability or the relative importance of disease and lesional stability in selecting patients for vitiligo grafting. Aim: This multicentric study aims to assess the relative importance of lesional and disease stability on selecting patients for vitiligo grafting. Materials and Methods: One hundred seventy patients were recruited into the study and divided into two groups: Group A with lesional stability of >1 year but overall disease stability of only 6-11 months and Group B with overall disease stability of >1 year. Patients underwent either tissue or cellular vitiligo grafting on the selected lesions and the repigmentation achieved was scored from 0 (no repigmentation to 6 (100% repigmentation. Repigmentation achieved on different sites of the body was compared between the two groups. Adverse effects at both the donor and the recipient sites were also compared. Results: Of the 170 patients who were enrolled, 82 patients were placed in Group A and 88 patients in Group B. Average repigmentation achieved (on scale of 0 to 6 was 3.8 and 4.04 in Group A and Group B, respectively. In Group A, ≥90% repigmentation was achieved in 36.6% (30/82 patients, while 37.5% (33/88 achieved similar results in Group B. Additionally, 47.6% (39/82 and 53.4% (47/88 of cases achieved partial repigmentation in Group A and Group B, respectively. Perigraft halo was the commonest adverse effect observed in both groups. Statistical analysis revealed no significant differences between the two groups with respect to the repigmentation achieved or adverse effects observed. Repigmentation achieved was the best on the face and neck area, while acral areas responded the least. Conclusions: Lesional stability seems to be as relevant as the overall disease stability in selecting patients for

  5. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial

    Science.gov (United States)

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; D'Incecco, Carmine; Fusilli, Paola; Perri, Paolo Francesco; Tubaldi, Lucia; Barlafante, Gina

    2013-01-01

    Introduction Neonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns’ length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs). Methods and analysis 690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation. The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique. Ethics and dissemination Written informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n°22/int./CEI/27239) and it is under review by the other regional ethics committees. Results Dissemination of results from this trial will be through scientific medical journals and conferences. Trial registration This trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137). PMID:23430598

  6. Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study.

    Science.gov (United States)

    Sterling, Michele; Hendrikz, Joan; Kenardy, Justin; Kristjansson, Eythor; Dumas, Jean-Pierre; Niere, Ken; Cote, Julie; Deserres, Sophie; Rivest, Karine; Jull, Gwendolen

    2012-08-01

    Uncertainty surrounds prognostic factors after whiplash injury. Previously we identified a prognostic model for 6-month pain-related disability in a cohort of 80 participants with acute whiplash. Predictors included initial disability, older age, decreased cold pain thresholds, decreased neck rotation movement, posttraumatic stress symptoms and decreased sympathetic vasoconstriction. The objective of this study was to externally validate this model. In a multicentre inception cohort study, 286 participants with acute whiplash (I, II or III) were assessed at <3 weeks and 12 months after injury. The Neck Disability Index (NDI) was the outcome. Observed and predicted NDI scores were generated using the published equation of the original model. Model discrimination between participants with no or mild disability from those with moderate to severe disability was examined by receiver operating characteristic curves. Initial NDI and cold pain threshold predicted current observed 12-month NDI scores (r(2) = 0.50, 95% confidence interval 0.42 to 0.58). There was a significant site effect, and the estimated marginal mean ± SE of 12-month NDI for Iceland (27.6 ± 1.79%) was higher than the other 3 sites (Melbourne 11.2 ± 5.03%, Canada 16.4 ± 2.36%, Brisbane 16.8 ± 1.17%). After adjusting for site, age and Impact of Events Scale scores regained significance (r(2) = 0.56, 95% confidence interval 0.48 to 0.64). The tested model was not precise in predicting NDI as a continuous variable. However, it found good accuracy to discriminate participants with moderate to severe disability at 12 months (area under the receiver operating characteristic curve 0.89 [95% confidence interval 0.84-0.94], P<.001) which is clinically useful.

  7. Multicentre study highlighting clinical relevance of new high-throughput methodologies in molecular epidemiology of Pneumocystis jirovecii pneumonia.

    Science.gov (United States)

    Esteves, F; de Sousa, B; Calderón, E J; Huang, L; Badura, R; Maltez, F; Bassat, Q; de Armas, Y; Antunes, F; Matos, O

    2016-06-01

    Pneumocystis jirovecii causes severe interstitial pneumonia (PcP) in immunosuppressed patients. This multicentre study assessed the distribution frequencies of epidemiologically relevant genetic markers of P. jirovecii in different geographic populations from Portugal, the USA, Spain, Cuba and Mozambique, and the relationship between the molecular data and the geographical and clinical information, based on a multifactorial approach. The high-throughput typing strategy for P. jirovecii characterization consisted of DNA pooling using quantitative real-time PCR followed by multiplex-PCR/single base extension. The frequencies of relevant P. jirovecii single nucleotide polymorphisms (mt85, SOD110, SOD215, DHFR312, DHPS165 and DHPS171) encoded at four loci were estimated in ten DNA pooled samples representing a total of 182 individual samples. Putative multilocus genotypes of P. jirovecii were shown to be clustered due to geographic differences but were also dependent on clinical characteristics of the populations studied. The haplotype DHFR312T/SOD110C/SOD215T was associated with severe AIDS-related PcP and high P. jirovecii burdens. The frequencies of this genetic variant of P. jirovecii were significantly higher in patients with AIDS-related PcP from Portugal and the USA than in the colonized patients from Portugal, and Spain, and children infected with P. jirovecii from Cuba or Mozambique, highlighting the importance of this haplotype, apparently associated with the severity of the disease and specific clinical groups. Patients from the USA and Mozambique showed higher rates of DHPS mutants, which may suggest the circulation of P. jirovecii organisms potentially related with trimethoprim-sulfamethoxazole resistance in those geographical regions. This report assessed the worldwide distribution of P. jirovecii haplotypes and their epidemiological impact in distinct geographic and clinical populations.

  8. FDG-PET/CT imaging in the management of HIV-associated multicentric Castleman's disease

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    Barker, Rob; Kazmi, Fahrad; Stebbing, Justin; Chinn, Roger [Imperial College School of Medicine, The Chelsea and Westminster Hospital, Department of Radiology, London (United Kingdom); Ngan, Sarah; Bower, Mark [Imperial College School of Medicine, The Chelsea and Westminster Hospital, Department of Oncology, London (United Kingdom); Nelson, Mark [Imperial College School of Medicine, The Chelsea and Westminster Hospital, Department of HIV Medicine, London (United Kingdom); O' Doherty, Michael [St. Thomas' Hospital, Clinical PET Centre, Guys and St. Thomas Hospital Trust, London (United Kingdom)

    2009-04-15

    To evaluate the role of FDG-PET/CT scanning in the management of HIV-associated multicentric Castleman's disease (MCD) a rare lymphoproliferative disorder associated with infection by human herpesvirus 8 (HHV8). Nine patients with histologically confirmed MCD underwent fused FDG-PET/CT scans at initial MCD diagnosis (n = 3), at MCD relapse (n = 4), or during remission (n = 2). All seven patients with active MCD had markedly elevated plasma HHV8 viral loads, but the patients in remission had no HHV8 viraemia. The three patients with newly diagnosed MCD were not on antiretroviral therapy at the time of imaging, but the other six were all on fully suppressive antiretroviral regimens. In the seven patients with active MCD (newly diagnosed or relapse) 33/91 lymph node groups (36%) included radiologically enlarged nodes on the CT scan, whilst 57/91 lymph node groups (63%) showed enhanced FDG uptake on the PET scan. In scans from patients in remission, there were no enlarged lymph nodes on the CT scan but 3 lymph nodes (11%) demonstrated enhanced FDG uptake. The median SUV recorded for the seven patients with active MCD was 4.8 (range 2.6-9.3) which was significantly higher than the median value of 2.5 recorded for the patients in remission (Mann-Whitney U test, p = 0.011). Despite the small number of patients, in HIV-positive individuals with active MCD, FDG-PET scans more frequently detected abnormal uptake than CT scans detected enlarged lymph nodes. FDG-PET scanning has a useful role in the management of HIV-associated MCD in selecting appropriate sites for biopsy, and in staging and monitoring these lymphoproliferations. (orig.)

  9. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

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    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  10. Parental height and child growth from birth to 2 years in the WHO Multicentre Growth Reference Study.

    Science.gov (United States)

    Garza, Cutberto; Borghi, Elaine; Onyango, Adelheid W; de Onis, Mercedes

    2013-09-01

    Linear growth from birth to 2 years of children enrolled in the World Health Organization Multicentre Growth Reference Study was similar despite substantial parental height differences among the six study sites. Within-site variability in child length attributable to parental height was estimated by repeated measures analysis of variance using generalized linear models. This approach was also used to examine relationships among selected traits (e.g. breastfeeding duration and child morbidity) and linear growth between 6 and 24 months of age. Differences in intergenerational adult heights were evaluated within sites by comparing mid-parental heights (average of the mother's and father's heights) to the children's predicted adult height. Mid-parental height consistently accounted for greater proportions of observed variability in attained child length than did either paternal or maternal height alone. The proportion of variability explained by mid-parental height ranged from 11% in Ghana to 21% in India. The average proportion of between-child variability accounted for by mid-parental height was 16% and the analogous within-child estimate was 6%. In the Norwegian and US samples, no significant differences were observed between mid-parental and children's predicted adult heights. For the other sites, predicted adult heights exceeded mid-parental heights by 6.2-7.8 cm. To the extent that adult height is predicted by height at age 2 years, these results support the expectation that significant community-wide advances in stature are attainable within one generation when care and nutrition approximate international recommendations, notwithstanding adverse conditions likely experienced by the previous generation.

  11. Antidepressant use and 10-year incident fracture risk: the population-based Canadian Multicentre Osteoporosis Study (CaMoS)

    Science.gov (United States)

    Bernatsky, S.; Abrahamowicz, M.; Papaioannou, A.; Bessette, L.; Adachi, J.; Goltzman, D.; Prior, J.; Kreiger, N.; Towheed, T.; Leslie, W. D.; Kaiser, S.; Ioannidis, G.; Pickard, L.; Fraser, L.-A.; Rahme, E.

    2016-01-01

    Summary We used data from a large, prospective Canadian cohort to assess the association between selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) and fracture. We found an increased risk of fractures in individuals who used SSRI or SNRI, even after controlling for multiple risk factors. Introduction Previous studies have suggested an association between SSRIs and increasing risk of fragility fractures. However, the majority of these studies were not long-term analyses or were performed using administrative data and, thus, could not fully control for potential confounders. We sought to determine whether the use of SSRIs and SNRIs is associated with increased risk of fragility fracture, in adults aged 50+. Methods We used data from the Canadian Multicentre Osteoporosis Study (CaMos), a prospective randomly selected population-based community cohort; our analyses focused on subjects aged 50+. Time to event methodology was used to assess the association between SSRI/SNRI use, modeled time-dependently, and fragility fracture. Results Among 6,645 subjects, 192 (2.9 %) were using SSRIs or/and SNRIs at baseline. During the 10-year study period, 978 (14.7 %) participants experienced at least one fragility fracture. In our main analysis, SSRI/SNRI use was associated with increased risk of fragility fracture (hazard ratio (HR), 1.88; 95 % confidence intervals (CI), 1.48–2.39). After controlling for multiple risk factors, including Charlson score, previous falls, and bone mineral density hip and lumbar bone density, the adjusted HR for current SSRI/SNRI use remained elevated (HR, 1.68; 95 % CI, 1.32–2.14). Conclusions Our results lend additional support to an association between SSRI/SNRI use and fragility fractures. Given the high prevalence of antidepressants use, and the impact of fractures on health, our findings may have a significant clinical impact. PMID:24566587

  12. A multicentre study of 513 Danish patients with systemic lupus erythematosus. I. Disease manifestations and analyses of clinical subsets

    DEFF Research Database (Denmark)

    Jacobsen, S; Petersen, J; Ullman, S

    1998-01-01

    cluster (25%) all had malar rash and half were photosensitive. Follow-up showed that the patients of cluster 2 developed azotaemia, large proteinuria, arterial hypertension and myositis significantly more often than did the rest of the patients, but the mortality was not increased. The risk of developing...

  13. Calibration of gamma camera systems for a multicentre European ¹²³I-FP-CIT SPECT normal database

    DEFF Research Database (Denmark)

    Tossici-Bolt, Livia; Dickson, John C; Sera, Terez

    2011-01-01

    A joint initiative of the European Association of Nuclear Medicine (EANM) Neuroimaging Committee and EANM Research Ltd. aimed to generate a European database of [(123)I]FP-CIT single photon emission computed tomography (SPECT) scans of healthy controls. This study describes the characterization...

  14. A multicentre study of 513 Danish patients with systemic lupus erythematosus. I. Disease manifestations and analyses of clinical subsets

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Petersen, J; Ullman, S

    1998-01-01

    duration of follow-up was 8.2 years from diagnosis and 12.8 years from first symptom. This paper describes the most common clinical and laboratory manifestations and their relationship to sex and age at the time of onset and diagnosis. Cluster analysis revealed three clinically defined clusters at the time...... of disease onset. Cluster 1 (57% of patients) consisted of relatively elderly patients without nephropathy or malar rash, but with a high prevalence of discoid lesions. Cluster 2 (18%) consisted of patients with nephropathy, a third of whom also developed serositis and lymphopenia. The patients of the third...

  15. Interactive multicentre teleconferences using open source software in a team of thoracic surgeons.

    Science.gov (United States)

    Ito, Kazuhiro; Shimada, Junichi; Katoh, Daishiro; Nishimura, Motohiro; Yanada, Masashi; Okada, Satoru; Ishihara, Shunta; Ichise, Kaori

    2012-12-01

    Real-time consultation between a team of thoracic surgeons is important for the management of difficult cases. We established a system for interactive teleconsultation between multiple sites, based on open-source software. The graphical desktop-sharing system VNC (virtual network computing) was used for remotely controlling another computer. An image-processing package (OsiriX) was installed on the server to share the medical images. We set up a voice communication system using Voice Chatter, a free, cross-platform voice communication application. Four hospitals participated in the trials. One was connected by gigabit ethernet, one by WiMAX and one by ADSL. Surgeons at three of the sites found that it was comfortable to view images and consult with each other using the teleconferencing system. However, it was not comfortable using the client that connected via WiMAX, because of dropped frames. Apart from the WiMAX connection, the VNC-based screen-sharing system transferred the clinical images efficiently and in real time. We found the screen-sharing software VNC to be a good application for medical image interpretation, especially for a team of thoracic surgeons using multislice CT scans.

  16. Development of a decision support system for diagnosis and grading of brain tumours using in vivo magnetic resonance single voxel spectra.

    NARCIS (Netherlands)

    Tate, A.R.; Underwood, J.; Acosta, D.M.; Julia-Sape, M.; Majos, C.; Moreno-Torres, A.; Howe, F.A.; Graaf, M. van der; Lefournier, V.; Murphy, M.M.; Loosemore, A.; Ladroue, C.; Wesseling, P.; Luc Bosson, J.; Cabanas, M.E.; Simonetti, A.W.; Gajewicz, W.; Calvar, J.; Capdevila, A.; Wilkins, P.R.; Bell, B.A.; Remy, C.; Heerschap, A.; Watson, D.; Griffiths, J.R.; Arus, C.

    2006-01-01

    A computer-based decision support system to assist radiologists in diagnosing and grading brain tumours has been developed by the multi-centre INTERPRET project. Spectra from a database of 1H single-voxel spectra of different types of brain tumours, acquired in vivo from 334 patients at four differe

  17. Association between CASP8 -652 6N del polymorphism (rs3834129) and colorectal cancer risk: results from a multi-centric study.

    Science.gov (United States)

    Pardini, Barbara; Verderio, Paolo; Pizzamiglio, Sara; Nici, Carmela; Maiorana, Maria Valeria; Naccarati, Alessio; Vodickova, Ludmila; Vymetalkova, Veronika; Veneroni, Silvia; Daidone, Maria Grazia; Ravagnani, Fernando; Bianchi, Tiziana; Bujanda, Luis; Carracedo, Angel; Castells, Antoni; Ruiz-Ponte, Clara; Morreau, Hans; Howarth, Kimberley; Jones, Angela; Castellví-Bel, Sergi; Li, Li; Tomlinson, Ian; Van Wezel, Tom; Vodicka, Pavel; Radice, Paolo; Peterlongo, Paolo

    2014-01-01

    The common -652 6N del variant in the CASP8 promoter (rs3834129) has been described as a putative low-penetrance risk factor for different cancer types. In particular, some studies suggested that the deleted allele (del) was inversely associated with CRC risk while other analyses failed to confirm this. Hence, to better understand the role of this variant in the risk of developing CRC, we performed a multi-centric case-control study. In the study, the variant -652 6N del was genotyped in a total of 6,733 CRC cases and 7,576 controls recruited by six different centers located in Spain, Italy, USA, England, Czech Republic and the Netherlands collaborating to the international consortium COGENT (COlorectal cancer GENeTics). Our analysis indicated that rs3834129 was not associated with CRC risk in the full data set. However, the del allele was under-represented in one set of cases with a family history of CRC (per allele model OR = 0.79, 95% CI = 0.69-0.90) suggesting this allele might be a protective factor versus familial CRC. Since this multi-centric case-control study was performed on a very large sample size, it provided robust clarification of the effect of rs3834129 on the risk of developing CRC in Caucasians.

  18. Association between CASP8 -652 6N del polymorphism (rs3834129 and colorectal cancer risk: results from a multi-centric study.

    Directory of Open Access Journals (Sweden)

    Barbara Pardini

    Full Text Available The common -652 6N del variant in the CASP8 promoter (rs3834129 has been described as a putative low-penetrance risk factor for different cancer types. In particular, some studies suggested that the deleted allele (del was inversely associated with CRC risk while other analyses failed to confirm this. Hence, to better understand the role of this variant in the risk of developing CRC, we performed a multi-centric case-control study. In the study, the variant -652 6N del was genotyped in a total of 6,733 CRC cases and 7,576 controls recruited by six different centers located in Spain, Italy, USA, England, Czech Republic and the Netherlands collaborating to the international consortium COGENT (COlorectal cancer GENeTics. Our analysis indicated that rs3834129 was not associated with CRC risk in the full data set. However, the del allele was under-represented in one set of cases with a family history of CRC (per allele model OR = 0.79, 95% CI = 0.69-0.90 suggesting this allele might be a protective factor versus familial CRC. Since this multi-centric case-control study was performed on a very large sample size, it provided robust clarification of the effect of rs3834129 on the risk of developing CRC in Caucasians.

  19. A surprisingly poor correlation between in vitro and in vivo testing of biomaterials for bone regeneration: results of a multicentre analysis.

    Science.gov (United States)

    Hulsart-Billström, G; Dawson, J I; Hofmann, S; Müller, R; Stoddart, M J; Alini, M; Redl, H; El Haj, A; Brown, R; Salih, V; Hilborn, J; Larsson, S; Oreffo, R O

    2016-05-24

    New regenerative materials and approaches need to be assessed through reliable and comparable methods for rapid translation to the clinic. There is a considerable need for proven in vitro assays that are able to reduce the burden on animal testing, by allowing assessment of biomaterial utility predictive of the results currently obtained through in vivo studies. The purpose of this multicentre review was to investigate the correlation between existing in vitro results with in vivo outcomes observed for a range of biomaterials. Members from the European consortium BioDesign, comprising 8 universities in a European multicentre study, provided data from 36 in vivo studies and 47 in vitro assays testing 93 different biomaterials. The outcomes of the in vitro and in vivo experiments were scored according to commonly recognised measures of success relevant to each experiment. The correlation of in vitro with in vivo scores for each assay alone and in combination was assessed. A surprisingly poor correlation between in vitro and in vivo assessments of biomaterials was revealed indicating a clear need for further development of relevant in vitro assays. There was no significant overall correlation between in vitro and in vivo outcome. The mean in vitro scores revealed a trend of covariance to in vivo score with 58 %. The inadequacies of the current in vitro assessments highlighted here further stress the need for the development of novel approaches to in vitro biomaterial testing and validated pre-clinical pipelines.

  20. Therapies in the Pipeline for Systemic Autoimmune Diseases

    OpenAIRE

    Juan Felipe Betancur; Jose Fernando Molina; Gabriel J. Tobón

    2016-01-01

    The current goals in the development of novel therapeutics of systemic autoimmune diseases are to develop agents more effective than conventional therapies as well as to reduce the risk of organ damage. To achieve this goal, large multicentre randomised controlled trials are needed to confirm the efficacy and safety of novel agents. Whether these novel modalities are synergistic to conventional drugs, the optimal dosages, and duration of treatment, need to be explored. As expected, the dev...

  1. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study

    Science.gov (United States)

    Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

    2016-01-01

    Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. Trial registration number 32017426, pre-results. PMID:27609859

  2. Harmonizing FDG PET quantification while maintaining optimal lesion detection: prospective multicentre validation in 517 oncology patients

    Energy Technology Data Exchange (ETDEWEB)

    Quak, Elske [Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); Le Roux, Pierre-Yves; Robin, Philippe; Bourhis, David; Salaun, Pierre-Yves [University Hospital and EA3878 (GETBO) IFR 148, Nuclear Medicine Department, Brest (France); Hofman, Michael S.; Callahan, Jason; Binns, David; Hicks, Rodney J. [East Melbourne and University of Melbourne, Centre for Molecular Imaging, Peter MacCallum Cancer Centre, Melbourne (Australia); Desmonts, Cedric [University Hospital, Nuclear Medicine Department, Caen (France); Aide, Nicolas [Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); University Hospital, Nuclear Medicine Department, Caen (France); Francois Baclesse Cancer Centre, INSERM 1199, Caen (France); Normandie University, Caen (France)

    2015-12-15

    Point-spread function (PSF) or PSF + time-of-flight (TOF) reconstruction may improve lesion detection in oncologic PET, but can alter quantitation resulting in variable standardized uptake values (SUVs) between different PET systems. This study aims to validate a proprietary software tool (EQ.PET) to harmonize SUVs across different PET systems independent of the reconstruction algorithm used. NEMA NU2 phantom data were used to calculate the appropriate filter for each PSF or PSF+TOF reconstruction from three different PET systems, in order to obtain EANM compliant recovery coefficients. PET data from 517 oncology patients were reconstructed with a PSF or PSF+TOF reconstruction for optimal tumour detection and an ordered subset expectation maximization (OSEM3D) reconstruction known to fulfil EANM guidelines. Post-reconstruction, the proprietary filter was applied to the PSF or PSF+TOF data (PSF{sub EQ} or PSF+TOF{sub EQ}). SUVs for PSF or PSF+TOF and PSF{sub EQ} or PSF+TOF{sub EQ} were compared to SUVs for the OSEM3D reconstruction. The impact of potential confounders on the EQ.PET methodology including lesion and patient characteristics was studied, as was the adherence to imaging guidelines. For the 1380 tumour lesions studied, Bland-Altman analysis showed a mean ratio between PSF or PSF+TOF and OSEM3D of 1.46 (95 %CI: 0.86-2.06) and 1.23 (95 %CI: 0.95-1.51) for SUV{sub max} and SUV{sub peak}, respectively. Application of the proprietary filter improved these ratios to 1.02 (95 %CI: 0.88-1.16) and 1.04 (95 %CI: 0.92-1.17) for SUV{sub max} and SUV{sub peak}, respectively. The influence of the different confounding factors studied (lesion size, location, radial offset and patient's BMI) was less than 5 %. Adherence to the European Association of Nuclear Medicine (EANM) guidelines for tumour imaging was good. These data indicate that it is not necessary to sacrifice the superior lesion detection and image quality achieved by newer reconstruction techniques in

  3. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial

    DEFF Research Database (Denmark)

    Kwon, Eugene D; Drake, Charles G; Scher, Howard I;

    2014-01-01

    chemotherapy. METHODS: We did a multicentre, randomised, double-blind, phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy (8 Gy in one...

  4. Erros de administração de antimicrobianos identificados em estudo multicêntrico brasileiro Antimicrobial drug administration errors identified in Brazilian multicentric study

    Directory of Open Access Journals (Sweden)

    Tatiane Cristina Marques

    2008-06-01

    Full Text Available Erros de administração de antimicrobianos são relevantes, pois podem interferir na segurança do paciente e no desenvolvimento de resistência microbiana. O objetivo desse estudo foi identificar os antimicrobianos associados a erros de administração de medicamentos. Estudo multicêntrico, descritivo e exploratório, realizado em unidades de clínica médica de cinco hospitais por meio de técnica observacional, durante 30 dias. Os erros foram classificados em categorias: dose, medicamento não prescrito, via, paciente e horário. A classificação farmacológica dos antimicrobianos foi realizada segundo o Sistema Anatômico Terapêutico Químico (ATC. Os fármacos de intervalo terapêutico estreito foram identificados. A análise estatística descritiva foi realizada no software SPSS 11.5. Foram identificados 1500 erros, sendo 277 (18,5% com antimicrobianos. Os tipos de erros foram: de horário 87,7%; de dose 6,9%; de medicamento não autorizado 3,2%, de via 1,5% e de paciente 0,7%. Foram identificados 36 antimicrobianos e as classes ATC mais freqüentes foram: fluorquinolonas 13,9%, combinações de penicilinas 13,9%, macrolídeos 8,3% e cefalosporina de terceira geração 5,6%. Os fármacos de intervalo terapêutico estreito corresponderam a 16,7% dos antimicrobianos. Os erros com antimicrobianos analisados podem ser fontes de estudo e melhoria no processo de utilização racional de medicamentos e segurança do paciente.Medication administration errors (MAE are the most frequent kind of medication errors. Errors with antimicrobial drugs (AD are relevant because they may interfere in patient safety and in the development of microbial resistance. The aim of this study is to analyze the AD errors detected in a Brazilian multicentric study of MAE. It was a descriptive and exploratory study carried out in clinical units in five Brazilian teaching hospitals. The hospitals were investigated during 30 days. MAE were detected by observation

  5. A large Italian observational multicentre study on vascular ulcers of the lower limbs (Studio Ulcere Vascolari).

    Science.gov (United States)

    Apollonio, Alessandro; Antignani, Pier L; Di Salvo, Michelangelo; Failla, Giacomo; Guarnera, Giorgio; Mosti, Giovanni; Ricci, Elia

    2016-02-01

    An observational study of 2 years was promoted by the Italian Association for Cutaneous Ulcers (AIUC) in order to monitor the epidemiology of leg ulcers, the trend of healing and the more frequent therapeutic approaches in lower limb ulcers. Fifty-nine sites in 14 different Italian regions involved in the study, with 1333 enrolled patients (1163 patients fully evaluated and followed up for 9 months). A prevalence of females (62%) was observed with a mean age of 70 years and a high rate of hypertension (62%), diabetes (38%) and obesity (29%). Venous ulcer was most frequent (55%), followed by mixed (25%) and diabetic (8·3%) ulcers. Basically, all patients received a local therapy (LT) (compression and advanced local therapies), while 63% of patients have an associated systemic pharmaceutical treatment. Ulcer healing rates progressively increased throughout the study and despite the type of observational study does not allow conclusions on the treatment, it was observed that the patients receiving additional systemic drugs were associated with a more rapid acceleration of healing rates of ulcers compared to LT alone (3 months: 39·7% versus 29·2%; 6 months: 62·0% versus 47·0%; 9 months: 74·7% versus 63·8%). In particular, the Studio Ulcere Vascolari (SUV) study showed that a combination treatment with sulodexide and compression therapy allows for a greater increase in the healing rates in venous ulcers.

  6. EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study

    Science.gov (United States)

    Gutiérrez-Gutiérrez, Belén; Sojo-Dorado, Jesús; Bravo-Ferrer, José; Cuperus, Nienke; de Kraker, Marlieke; Kostyanev, Tomislav; Raka, Lul; Daikos, George; Feifel, Jan; Folgori, Laura; Pascual, Alvaro; Goossens, Herman; O'Brien, Seamus; Bonten, Marc J M; Rodríguez-Baño, Jesús

    2017-01-01

    Introduction The rapid worldwide spread of carbapenem-resistant Enterobacteriaceae (CRE) constitutes a major challenge. The aim of the EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA), which is part of the Innovative Medicines Initiative Joint Undertaking (IMI JU) funded COMBACTE-CARE project, is to investigate risk factors for and outcome determinants of CRE infections to inform randomised clinical trial designs and to provide a historical cohort that could eventually be used for future comparisons with new drugs targeting CRE. Methods A multicentre (50 sites), multinational (11 European countries), analytical observational project was designed, comprising 3 studies. The aims of study 1 (a prospective cohort study) include characterising the features, clinical management and outcomes of hospitalised patients with intra-abdominal infection, pneumonia, complicated urinary tract infections and bloodstream infections caused by CRE (202 patients in each group). The main outcomes will be 30-day all-cause mortality and clinical response. Study 2 (a nested case–control study) will identify the risk factors for target infections caused by CRE; 248 selected patients from study 1 will be matched with patients with carbapenem-susceptible Enterobacteriaceae (1:1) and with hospitalised patients (1:3) and will provide a historical cohort of patients with CRE infections. Study 3 (a matched cohort study) will follow patients in study 2 in order to assess mortality, length of stay and hospital costs associated with CRE. All patients will be followed for 30 days. Different, up-to-date statistical methods will be applied to come to unbiased estimates for all 3 studies. Ethics and dissemination Before-study sites will be initiated, approval will be sought from appropriate regulatory agencies and local Ethics Committees of Research or Institutional Review Boards (IRBs) to conduct the study in accordance with regulatory requirements

  7. Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ali Giuseppa

    2011-01-01

    Full Text Available Abstract Background Evidence regarding the effectiveness of oral vitamin B12 in patients with serum vitamin B12 levels between 125-200 pM/l is lacking. We compared the effectiveness of one-month oral vitamin B12 supplementation in patients with a subtle vitamin B12 deficiency to that of a placebo. Methods This multicentre (13 general practices, two nursing homes, and one primary care center in western Switzerland, parallel, randomised, controlled, closed-label, observer-blind trial included 50 patients with serum vitamin B12 levels between 125-200 pM/l who were randomized to receive either oral vitamin B12 (1000 μg daily, N = 26 or placebo (N = 24 for four weeks. The institution's pharmacist used simple randomisation to generate a table and allocate treatments. The primary outcome was the change in serum methylmalonic acid (MMA levels after one month of treatment. Secondary outcomes were changes in total homocysteine and serum vitamin B12 levels. Blood samples were centralised for analysis and adherence to treatment was verified by an electronic device (MEMS; Aardex Europe, Switzerland. Trial registration: ISRCTN 22063938. Results Baseline characteristics and adherence to treatment were similar in both groups. After one month, one patient in the placebo group was lost to follow-up. Data were evaluated by intention-to-treat analysis. One month of vitamin B12 treatment (N = 26 lowered serum MMA levels by 0.13 μmol/l (95%CI 0.06-0.19 more than the change observed in the placebo group (N = 23. The number of patients needed to treat to detect a metabolic response in MMA after one month was 2.6 (95% CI 1.7-6.4. A significant change was observed for the B12 serum level, but not for the homocysteine level, hematocrit, or mean corpuscular volume. After three months without active treatment (at four months, significant differences in MMA levels were no longer detected. Conclusions Oral vitamin B12 treatment normalised the metabolic markers of vitamin B

  8. Perception and use of massive open online courses among medical students in a developing country: multicentre cross-sectional study

    Science.gov (United States)

    Aboshady, Omar A; Radwan, Ahmed E; Eltaweel, Asmaa R; Azzam, Ahmed; Aboelnaga, Amr A; Hashem, Heba A; Darwish, Salma Y; Salah, Rehab; Kotb, Omar N; Afifi, Ahmed M; Noaman, Aya M; Salem, Dalal S; Hassouna, Ahmed

    2015-01-01

    Objectives To assess the prevalence of awareness and use of massive open online courses (MOOCs) among medical undergraduates in Egypt as a developing country, as well as identifying the limitations and satisfaction of using these courses. Design A multicentre, cross-sectional study using a web-based, pilot-tested and self-administered questionnaire. Settings Ten out of 19 randomly selected medical schools in Egypt. Participants 2700 undergraduate medical students were randomly selected, with an equal allocation of participants in each university and each study year. Primary and secondary outcome measures Primary outcome measures were the percentages of students who knew about MOOCs, students who enrolled and students who obtained a certificate. Secondary outcome measures included the limitations and satisfaction of using MOOCs through five-point Likert scale questions. Results Of 2527 eligible students, 2106 completed the questionnaire (response rate 83.3%). Of these students, 456 (21.7%) knew the term MOOCs or websites providing these courses. Out of the latter, 136 (29.8%) students had enrolled in at least one course, but only 25 (18.4%) had completed courses earning certificates. Clinical year students showed significantly higher rates of knowledge (p=0.009) and enrolment (p<0.001) than academic year students. The primary reasons for the failure of completion of courses included lack of time (105; 77.2%) and slow Internet speed (73; 53.7%). Regarding the 25 students who completed courses, 21 (84%) were satisfied with the overall experience. However, there was less satisfaction regarding student–instructor (8; 32%) and student–student (5; 20%) interactions. Conclusions About one-fifth of Egyptian medical undergraduates have heard about MOOCs with only about 6.5% actively enrolled in courses. Students who actively participated showed a positive attitude towards the experience, but better time-management skills and faster Internet connection speeds are required

  9. Does cataract surgery alleviate poverty? Evidence from a multi-centre intervention study conducted in Kenya, the Philippines and Bangladesh.

    Directory of Open Access Journals (Sweden)

    Hannah Kuper

    Full Text Available BACKGROUND: Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. METHODOLOGY/PRINCIPAL FINDINGS: A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh. Poverty data (household per capita expenditure--PCE, asset ownership and self-rated wealth were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls, of which 263 cases had undergone cataract surgery ("operated cases". At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007, assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68. There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. CONCLUSIONS/SIGNIFICANCE: This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate

  10. Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sietske J Tamminga

    Full Text Available OBJECTIVE: One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. METHODS: Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65 or control group (n = 68. The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial, quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. RESULTS: Return-to-work rates were 86% and 83% (p = 0.6 for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14-435 versus 192 days (range 82-465 (p = 0.90 with a hazard ratio of 1.03 (95% CI 0.64-1.6. Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. CONCLUSION: The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which

  11. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Jennifer

    2012-04-01

    Full Text Available Abstract Background People with Multiple Sclerosis (MS frequently experience balance and mobility impairments, including reduced trunk stability. Pilates-based core stability training, which is aimed at improving control of the body's stabilising muscles, is popular as a form of exercise with people with MS and therapists. A replicated single case series study facilitated by the Therapists in MS Group in the United Kingdom (UK provides preliminary evidence that this approach can improve balance and mobility in ambulant people with MS; further evidence is needed to substantiate these findings to ensure that limited time, energy, finances and resources are used to best effect. This study builds upon the pilot work undertaken in the case series study by implementing a powered randomised controlled study, with the aims of: 1 Establishing the effectiveness of core stability training 2 Comparing core stability training with standardised physiotherapy exercise 3 Exploring underlying mechanisms of change associated with this intervention Methods This is a multi-centre, double blind, block randomised, controlled trial. Eligible participants will be recruited from 4 UK centres. Participants will be randomly allocated to one of three groups: Pilates based core stability training, standardised physiotherapy exercise or contract-relax relaxation sessions (placebo control. All will receive face to face training sessions over a 12 week period; together with a 15 minute daily home programme. All will be assessed by a blinded assessor before training, at the end of the 12 week programme and at 4 week follow-up. The primary outcome measure is the 10 metre timed walk. Secondary outcome measures are the MS walking Scale (MSWS-12, the Functional Reach (forwards and lateral, a 10 point Numerical Rating Scale to determine "Difficulty in carrying a drink when walking", and the Activities-specific Balance Confidence (ABC Scale. In addition, ultrasound imaging of the

  12. MIRU-VNTR Genotyping of Mycobacterium tuberculosis Strains Using QIAxcel Technology: A Multicentre Evaluation Study.

    Directory of Open Access Journals (Sweden)

    Vladyslav Nikolayevskyy

    Full Text Available Molecular genotyping of M.tuberculosis is an important laboratory tool in the context of emerging drug resistant TB. The standard 24-loci MIRU-VNTR typing includes PCR amplification followed by the detection and sizing of PCR fragments using capillary electrophoresis on automated sequencers or using agarose gels. The QIAxcel Advanced system might offer a cost-effective medium-throughput alternative.Performance characteristics of the QIAxcel Advanced platform for the standard 24 VNTR loci panel was evaluated at two centres on a total of 140 DNA specimens using automated capillary electrophoresis as a reference method. Additionally 4 hypervariable MIRU-VNTR loci were evaluated on 53 crude DNA extracts. The sizing accuracy, interlaboratory reproducibility and overall instrument's performance were assessed during the study.An overall concordance with the reference method was high reaching 98.5% and 97.6% for diluted genomic and crude DNA extracts respectively. 91.4% of all discrepancies were observed in fragments longer than 700bp. The concordance for hypervariable loci was lower except for locus 4120 (96.2%. The interlaboratory reproducibility agreement rates were 98.9% and 91.3% for standard and hypervariable loci, respectively. Overall performance of the QIAxcel platform for M.tuberculosis genotyping using a panel of standard loci is comparable to that of established methods for PCR fragments up to 700bp. Inaccuracies in sizing of longer fragments could be resolved through using in-house size markers or introduction of offset values. To conclude, the QiaXcel system could be considered an effective alternative to existing methods in smaller reference and regional laboratories offering good performance and shorter turnaround times.

  13. Alarm Variables for Dengue Outbreaks: A Multi-Centre Study in Asia and Latin America.

    Directory of Open Access Journals (Sweden)

    Leigh R Bowman

    Full Text Available Worldwide, dengue is an unrelenting economic and health burden. Dengue outbreaks have become increasingly common, which place great strain on health infrastructure and services. Early warning models could allow health systems and vector control programmes to respond more cost-effectively and efficiently.The Shewhart method and Endemic Channel were used to identify alarm variables that may predict dengue outbreaks. Five country datasets were compiled by epidemiological week over the years 2007-2013. These data were split between the years 2007-2011 (historic period and 2012-2013 (evaluation period. Associations between alarm/ outbreak variables were analysed using logistic regression during the historic period while alarm and outbreak signals were captured during the evaluation period. These signals were combined to form alarm/ outbreak periods, where 2 signals were equal to 1 period. Alarm periods were quantified and used to predict subsequent outbreak periods. Across Mexico and Dominican Republic, an increase in probable cases predicted outbreaks of hospitalised cases with sensitivities and positive predictive values (PPV of 93%/ 83% and 97%/ 86% respectively, at a lag of 1-12 weeks. An increase in mean temperature ably predicted outbreaks of hospitalised cases in Mexico and Brazil, with sensitivities and PPVs of 79%/ 73% and 81%/ 46% respectively, also at a lag of 1-12 weeks. Mean age was predictive of hospitalised cases at sensitivities and PPVs of 72%/ 74% and 96%/ 45% in Mexico and Malaysia respectively, at a lag of 4-16 weeks.An increase in probable cases was predictive of outbreaks, while meteorological variables, particularly mean temperature, demonstrated predictive potential in some countries, but not all. While it is difficult to define uniform variables applicable in every country context, the use of probable cases and meteorological variables in tailored early warning systems could be used to highlight the occurrence of dengue

  14. EC multicentre study on small area variations in air quality and health (SAVIAH)

    Energy Technology Data Exchange (ETDEWEB)

    Lebret, E. [National Inst. of Public Health and Environmental Protection (Netherlands); Elliott, P. [London School of Hygiene and Tropical Medicine (United Kingdom); Briggs, D. [Huddersfield Univ. (United Kingdom). Inst. of Environmental and Policy Analysis; Gorynski, P. [National Inst. of Hygiene, Warsaw (Poland); Kriz, B. [National Inst. of Public Health, Prague (Czech Republic)

    1995-12-31

    SAVIAH is an EC-funded methodological study coordinated by Dr. Paul Elliott at the LSHTM (London School of Hygiene and Tropical Medicine). The project aims to apply, test and evaluate new and emerging methodologies in the fields of epidemiology, geography, air pollution modelling and small area health statistics, and to bring the data together in a consistent geographic framework. The study was carried out in the U.K., The Netherlands, Poland and the Czech Republic, using the example of childhood wheeze and outdoor air pollution. Specific aims of the study were, in each centre, (1) to carry out a questionnaire survey among parents of guardians of around 4000 to 5000 children aged between 7 and 11, (2) to carry out a series of air pollution surveys for NO{sub 2} as a proxy for the complex of traffic-related pollutants, and SO{sub 2} (PL), using a dense network of passive samplers, (3) to build up a detailed Geographical Information System (GIS) for each of the study areas; (4) to construct an air pollution `map` based on the NO{sub 2} and SO{sub 2} measurements and a health `map` based on `map smoothing` techniques and (5) to explore methods to examine relationships between health, pollution, socio-economic and other data. (author)

  15. Paediatric CT dose: a multicentre audit of subspecialty practice in Australia and New Zealand

    Energy Technology Data Exchange (ETDEWEB)

    Jackson, D.; Atkin, K.; Clark, J. [Monash Health, Diagnostic Imaging, Clayton, VIC (Australia); Bettenay, F. [Princess Margaret Hospital for Children, Perth, Western Australia (Australia); Ditchfield, M.R. [Monash Health, Diagnostic Imaging, Clayton, VIC (Australia); Monash Children' s, Clayton, Victoria (Australia); Monash University, Clayton, Victoria (Australia); Grimm, J.E. [Royal Australian and New Zealand College of Radiologists, Sydney, New South Wales (Australia); Linke, R. [Women' s and Children' s Hospital, Adelaide, South Australia (Australia); Long, G. [Royal Children' s Hospital, Brisbane, Queensland (Australia); Onikul, E. [The Children' s Hospital at Westmead, Westmead, New South Wales (Australia); Pereira, J. [Sydney Children' s Hospital, Randwick, New South Wales (Australia); The University of New South Wales, Kensington, New South Wales (Australia); Phillips, M. [Mater Children' s Hospital, Brisbane, Queensland (Australia); Wilson, F. [Starship Children' s Health, Auckland (New Zealand); Paul, E. [Monash University, School of Public Health and Preventive Medicine, Clayton, Victoria (Australia); Goergen, S.K. [Monash Health, Diagnostic Imaging, Clayton, VIC (Australia); Monash University, Department of Surgery, Southern Clinical School, Clayton, Victoria (Australia)

    2015-11-15

    To evaluate paediatric CT dosimetry in Australia and New Zealand and calculate size-specific dose estimates (SSDEs) for chest and abdominal examinations. Eight hospitals provided data from 12 CT systems for 1462 CTs in children aged 0-15. Imaging data were recorded for eight examinations: head (trauma, shunt), temporal bone, paranasal sinuses, chest (mass) and chest HRCT (high-resolution CT), and abdomen/pelvis (mass/inflammation). Dose data for cranial examinations were categorised by age and SSDEs by lateral dimension. Diagnostic reference ranges (DRRs) were defined by the 25th and 75th percentiles. Centralised image quality assessment was not undertaken. DRRs for 201 abdominopelvic SSDEs were: 2.8-4.7, 3.6-11.5, 8.5-15.0, 7.6-15, and 10.6-16.2 for the <15 cm, 15-19 cm, 20-24 cm, 25-29 cm and >30 cm groups, respectively. For 147 chest examinations using these body width categories, SSDE DRRs were 2.0-4.4, 3.3-7.9, 4.0-9.4, 4.5-12, and 6.5-12. Kilovoltage peak (kVp), but not AEC or IR, was associated with SSDE (parameter estimate [standard error]: 0.12 (0.03); p < 0.0001). Australian and New Zealand paediatric CT DRRs and abdominal SSDEs are comparable to international data. SSDEs for chest examinations are proposed. Dose variations could be reduced by adjusting kVp. (orig.)

  16. Maternal and neonatal outcomes in multiple pregnancy: A multicentre study in the Beijing population

    Institute of Scientific and Technical Information of China (English)

    Ri-Na Su; Wei-Wei Zhu; Yu-Mei Wei; Chen Wang; Hui Feng; Li Lin; Hui-Xia Yang

    2015-01-01

    Objective:To compare the adverse maternal and neonatal outcomes of multiple pregnancy and singleton pregnancy from multiple medical centers in Beijing.Methods:Data concerning maternal and neonatal adverse outcomes in multiple and singleton pregnancies were collected from 15 hospitals in Beijing by a systemic cluster sampling survey conducted from 20 June to 30 November 2013.The SPSS software (version 20.0) was used for data analysis.The x2 test was used tbr statistical analyses.Results:The rate of caesarean deliveries was much higher in women with multiple pregnancies (85.8%) than that in women with singleton pregnancies (42.6%,X2 =190.8,P < 0.001).The incidences of anemia (X2 =40.023,P < 0.001),preterm labor (X2 =1021.172,P < 0.001),gestational diabetes mellitus (X2 =9.311,P < 0.01),hypertensive disorders (X2 =122.708,P < 0.001)and post-partum hemorrhage (X2-48.550,P < 0.001) was significantly increased with multiple pregnancy.In addition,multiple pregnancy was associated with a significantly higher rate of small-for-gestational-age infants (X2 =92.602,P < 0.001),low birth weight (X2 =1141.713,P < 0.001),and neonatal intensive care unit (NICU) admission (X2 =340.129,P< 0.001).Conclusions:Multiple pregnancy is a significant risk factor for adverse maternal and neonatal outcomes in Beijing.Improving obstetric care for multiple pregnancy,particularly in reducing preterm labor,is required to reduce the risk to mothers and infants.

  17. Radiation therapy of thymoma. A multicentric retrospective review of 149 cases; Radiotherapie des thymomes. Etude de la litterature a propos d`une serie retrospective et multicentrique de 149 cas

    Energy Technology Data Exchange (ETDEWEB)

    Resbeut, M.; Mornex, F.; Richaud, P.; Bachelot, T.; Jung, G.; Mirabel, X.; Marchal, C.; Lagrange, J.P.; Rambert, P.; Chaplain, G.; N`Guyen, T.D.; Gastaut, J.A. [Federation Nationale des Centres de Lutte contre le Cancer, 75 - Paris (France)

    1995-12-31

    Thymomas is a rare disease. Staging systems and surgical adjuvant treatments remain controversial. We reviewed the outcome and the prognostic factors in a series of 149 patients with non metastatic thymomas treated in ten French cancer centers between 1979 and 1990. Patients were staged according to the ``GETT`` classification derived from that of Masaoka. There were 13 stage I patients, 46 stage II, 58 stage III and 32 stage IV. Surgery consisted of complete resection in 63 patients, partial resection in 31 patients and biopsy alone in 55 patients. All patients received postoperative radiation therapy and 74 were given postoperative chemotherapy. Median follow-up was 7,7 years. Local control was obtained in 117 patients (78,5%) and was influenced by the extent of surgery (p < 0,0001). Metastases occurred in 26 patients. Seven patients developed grade 3-4 pulmonary and heart complications. One patient developed a malignant lymphoma after 24 cycles of chemotherapy. Disease-free survival (DFS) rates were of five years 92%, 75%, 60%, 39% and 48% in stage I, II, IIA, IIIB and IVA patients, respectively. After complete resection, partial resection and biopsy alone, these rates were 74%, 60% and 38%, respectively. With a multivariate analysis, DFS rates were influenced by the extent of surgery (p < 0,001) and by chemotherapy (p < 0,001). Three other factors could predict a worse DFS: young age (p < 0,006), stages III-IV (p < 0,04) and mediastinal symptoms (p < 0,001). ``GETT`` staging correlated well with local control and survival. After complete resection, a 50 Gy postoperative radiation therapy can be recommended in patients with invasive thymomas. Despite a 65% local control rate after partial resection or biopsy alone in this series, a higher dose of radiation (> 60 Gy) must be evaluated. Despite the benefit of the chemotherapy in this retrospective and multicentric study, the role of this treatment remains to be assessed. 43 refs., 5 figs., 7 tabs.

  18. Use of deferred consent for severely ill children in a multi-centre phase III trial

    Directory of Open Access Journals (Sweden)

    Boga Mwamvua

    2011-03-01

    modified system of deferred consent in an emergency intervention trial in children. Although approved by all relevant ethics committees and operational in 3 countries in Africa, formal research is now necessary to explore the perceptions and experiences of parents, health workers, researchers and ethics committees of the modified method of deferred consent.

  19. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling), informant, and centres on sample homogeneity in psychopathological measures. Methods Conners\\' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are used. These

  20. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling, informant, and centres on sample homogeneity in psychopathological measures. Methods Conners' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are

  1. Multicentric performance analysis of HCV quantification assays and its potential relevance for HCV treatment.

    Science.gov (United States)

    Wiesmann, F; Naeth, G; Berger, A; Hirsch, H H; Regenass, S; Ross, R S; Sarrazin, C; Wedemeyer, H; Knechten, H; Braun, P

    2016-06-01

    An accurate quantification of low viremic HCV RNA plasma samples has gained importance since the approval of direct acting antivirals and since only one single measurement predicts the necessity of a prolonged or shortened therapy. As reported previously, HCV quantification assays such as Abbott RealTime HCV and Roche COBAS AmpliPrep/COBAS TaqMan HCV version 2 (CTM v2) may vary in sensitivity and precision particularly in low-level viremia. Importantly, substantial variations were previously demonstrated between some of these assays compared to the Roche High Pure System/COBAS TaqMan assay (HPS) reference assay, which was used to establish the clinical decision points in clinical studies. In this study, the reproducibility of assay performances across several laboratories was assessed by analysing quantification results generated by six independent laboratories (3× RealTime, 3× CTM v2) in comparison with one HPS reference laboratory. The 4th WHO Standard was diluted to 100, 25 and 10 IU/ml, and aliquots were tested in triplicates in 5 independent runs by each assay in the different laboratories to assess assay precision and detection rates. In a second approach, 2 clinical samples (GT 1a & GT 1b) were diluted to 100 and 25 IU/ml and tested as described above. While the result range for WHO 100 IU/ml replicates across all laboratories was similar in this analysis, the CVs of each laboratory ranged from 19.3 to 25.6 % for RealTime laboratories and were lower than CVs of CTM v2 laboratories with a range of 26.1-47.3 %, respectively, and also in comparison with the CV of the HPS reference laboratory (34.9 %). At WHO standard dilution of 25 IU/ml, 24 replicates were quantified by RealTime compared to 8 replicates with CTM v2. Results of clinical samples again revealed a higher variation of CTM v2 results as compared to RealTime values. (CVs at 100 IU/ml: RealTime: 13.1-21.0 % and CTM v2: 15.0-32.3 %; CVs at 25 IU/ml: RealTime 17.6-34.9 % and CTM v2 28

  2. Meeting the privacy requirements for the development of a multi-centre patient registry in Canada: the Rick Hansen Spinal Cord Injury Registry.

    Science.gov (United States)

    Noonan, Vanessa K; Thorogood, Nancy P; Joshi, Phalgun B; Fehlings, Michael G; Craven, B Catharine; Linassi, Gary; Fourney, Daryl R; Kwon, Brian K; Bailey, Christopher S; Tsai, Eve C; Drew, Brian M; Ahn, Henry; Tsui, Deborah; Dvorak, Marcel F

    2013-05-01

    Privacy legislation addresses concerns regarding the privacy of personal information; however, its interpretation by research ethics boards has resulted in significant challenges to the collection, management, use and disclosure of personal health information for multi-centre research studies. This paper describes the strategy used to develop the national Rick Hansen Spinal Cord Injury Registry (RHSCIR) in accordance with privacy statutes and benchmarked against best practices. An analysis of the regional and national privacy legislation was conducted to determine the requirements for each of the 31 local RHSCIR sites and the national RHSCIR office. A national privacy and security framework was created for RHSCIR that includes a governance structure, standard operating procedures, training processes, physical and technical security and privacy impact assessments. The framework meets a high-water mark in ensuring privacy and security of personal health information nationally and may assist in the development of other national or international research initiatives.

  3. Nutritional support in patients undergoing haematopoietic stem cell transplantation: a multicentre survey of the Gruppo Italiano Trapianto Midollo Osseo (GITMO) transplant programmes.

    Science.gov (United States)

    Botti, Stefano; Liptrott, Sarah Jayne; Gargiulo, Gianpaolo; Orlando, Laura

    2015-01-01

    A survey within Italian haematopoietic stem cell transplant (HSCT) programmes was performed, in order to obtain a snapshot of nutritional support (NS) in patients undergoing HSCT. The primary objective was to verify whether an evidence-based practice (EBP) approach to NS was implemented in HSCT centres. A multicentre survey was performed by questionnaire, covering the main areas of NS (screening, treatment planning, monitoring, nutritional counselling, and methods of nutritional support). The results indicated a significant variation between clinical practice and evidence-based guidelines in terms of clinical pathways, decision-making, and care provision regarding NS. Further research is required to identify reasons for the limited application of EBP and measures that may be undertaken to address such issues. Development of a multidisciplinary educational programme in order to raise awareness of the issue should be undertaken.

  4. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian;

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...... anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome...... was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459...

  5. Human Herpesvirus-8 Infection Associated with Kaposi Sarcoma, Multicentric Castleman's Disease, and Plasmablastic Microlymphoma in a Man with AIDS: A Case Report with Review of Pathophysiologic Processes

    Directory of Open Access Journals (Sweden)

    Christian Eaton

    2011-01-01

    Full Text Available Kaposi sarcoma (KS, multicentric Castleman's disease (MCD, and plasmablastic microlymphoma, are all linked to human herpesvirus-8 (HHV-8 infection and HIV-induced immunodeficiency. Herein, we describe the case of a Kenyan man diagnosed with HIV in 2000. He deferred highly active antiretroviral therapy (HAART and remained in good health until his CD4+ count declined in 2006. He was hospitalized with bacterial pneumonia in 2008, after which he agreed to take HAART but did so sporadically. In 2010, he was hospitalized with fever, lymphadenopathy, pancytopenia, and an elevated HHV-8 viral load. A lymph node biopsy showed findings consistent with KS, MCD, and plasmablastic microlymphoma. Eight months after starting liposomal doxorubicin, Rituximab, and a new HAART regimen, he has improved clinically, and his HIV and HHV-8 viral loads are suppressed. These three conditions, found in the same lymph node, underscore the inflammatory and malignant potential of HHV-8, particularly in the milieu of HIV-induced immunodeficiency.

  6. Compliance with the minimum dataset of the British Orthodontic Society/British Association of Oral and Maxillofacial Surgeons for record keeping for orthognathic patients: retrospective comparative multicentre audit.

    Science.gov (United States)

    Dewi, F; Jones, S D; Ghaly, G A; Cronin, A J

    2013-10-01

    Accurate and timely collection of clinical records is of utmost importance in planning, evaluating, and auditing orthognathic operations. The minimum dataset guidelines of the British Orthodontic Society (BOS) and the British Association of Oral and Maxillofacial Surgeons (BAOMS) were published in an attempt to standardise the collection of clinical records of patients having orthognathic operations. This multicentre retrospective audit aimed to assess and compare compliance with the guidelines in 3 maxillofacial units over a 1-year period. A total of 105 cases were reviewed. Compliance varied. Documentation of altered sensation was consistently poor and too many unnecessary radiographs were taken. There may be a need to circulate the guidelines again to increase awareness and reduce variability between centres.

  7. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

    DEFF Research Database (Denmark)

    Jørgensen, Anette; Stengaard-Pedersen, Kristian; Simonsen, Lars Ole;

    2010-01-01

    Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee...... efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention...... to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol...

  8. Los implantes MG-OSSEOUS: Estudio multicéntrico retrospectivo MG-OSSEOUS implants: A multicentric retrospective study

    Directory of Open Access Journals (Sweden)

    E. Serrano Caturla

    2006-12-01

    commercial implants. Material and methodology. This is a retrospective multicentric study coordinated by a company called Scientific Management in O&SS (Barcelona, Spain. 1001 dental implants were placed in 247 patients and 328 prostheses were designed between 2004 and 2005, with a follow-up of two years. All implants were loaded with prostheses. We detail and analyze each implant, according to the diameter, length, position, surgical timing, loadings, design and types of prostheses and complementary surgical procedures, either synchronic or metachronic. Results. After the statistical method was homogenized, we were able to report an overall implant survival rate of 97.8% with monitoring of two years. The failures depending on the peculiarities of each clinical case are provided. No prosthetic failures are reported. Discussion. The criteria and indications applied by the professionals to the MG-OSSEOUS implants are standardized depending on the clinical case. Our results are compared with the international scientific literature, past and present, with these procedures totally agreeing with those found in the history of implantology. Finally, our survey is compared with those published by the Branemark team. Conclusion. The mixture between the quality of the MGOSSEOUS implants and the scientifically supported criteria regarding the implants, reveals an implant failure of 2.2% over two years, with a survival of 100% of both the replaced implants and the loaded prostheses.

  9. Commentary: the 1944 patulin trial: the first properly controlled multicentre trial conducted under the aegis of the British Medical Research Council.

    Science.gov (United States)

    Chalmers, Iain; Clarke, Mike

    2004-04-01

    The 1948 report of the British Medical Research Council's randomized trial of streptomycin for pulmonary tuberculosis is widely regarded as marking the beginning of the modern history of controlled clinical trials. Four years earlier, however, a methodologically sophisticated multicentre trial conducted under the aegis of the Medical Research Council was reported, which assessed the effects of the antibiotic patulin on the course of common colds. Philip D'Arcy Hart and Joan Faulkner (later Joan Doll) were the secretary and assistant secretary, respectively, to the committee overseeing the trial, and they clearly recognized the importance of preventing foreknowledge of allocations from those admitting patients to the study. To do this and to 'muddle people up', they and Ruth D'Arcy Hart devised a scheme involving the use of two patulin groups and two placebo groups, allocating patients to one of these four groups using strict rotation. Philip D'Arcy Hart believes that this study has been overshadowed by the celebrated streptomycin trial (for which he was also secretary to the oversight committee) because no beneficial effect of patulin was detected, and because the report of the streptomycin trial referred to the use of random sampling numbers to generate the allocation schedule. This article makes clear why we agree with Philip D'Arcy Hart that the 1944 patulin trial deserves wider recognition as the first well controlled, multicentre clinical trial to have been conducted under the aegis of the British Medical Research Council. This status is reflected in the International Journal of Epidemiology's reproduction of the full text of the trial report in this issue of the journal.

  10. Diagnostic accuracy of MRI in adults with suspect brachial plexus lesions: A multicentre retrospective study with surgical findings and clinical follow-up as reference standard

    Energy Technology Data Exchange (ETDEWEB)

    Tagliafico, Alberto, E-mail: alberto.tagliafico@unige.it [Institute of Anatomy, Department of Experimental Medicine, University of Genoa, Largo Rosanna Benzi 8, 16132 Genoa (Italy); Succio, Giulia; Serafini, Giovanni [Department of Radiology, Santa Corona Hospital, Pietra Ligure, Italy via XXV Aprile, 38- Pietra Ligure, 17027 Savona (Italy); Martinoli, Carlo [Radiology Department, DISC, Università di Genova, Largo Rosanna Benzi 8, 16138 Genova (Italy)

    2012-10-15

    Objective: To evaluate brachial plexus MRI accuracy with surgical findings and clinical follow-up as reference standard in a large multicentre study. Materials and methods: The research was approved by the Institutional Review Boards, and all patients provided their written informed consent. A multicentre retrospective trial that included three centres was performed between March 2006 and April 2011. A total of 157 patients (men/women: 81/76; age range, 18–84 years) were evaluated: surgical findings and clinical follow-up of at least 12 months were used as the reference standard. MR imaging was performed with different equipment at 1.5 T and 3.0 T. The patient group was divided in five subgroups: mass lesion, traumatic injury, entrapment syndromes, post-treatment evaluation, and other. Sensitivity, specificity with 95% confidence intervals (CIs), positive predictive value (PPV), pre-test-probability (the prevalence), negative predictive value (NPV), pre- and post-test odds (OR), likelihood ratio for positive results (LH+), likelihood ratio for negative results (LH−), accuracy and post-test probability (post-P) were reported on a per-patient basis. Results: The overall sensitivity and specificity with 95% CIs were: 0.810/0.914; (0.697–0.904). Overall PPV, pre-test probability, NPV, LH+, LH−, and accuracy: 0.823, 0.331, 0.905, 9.432, 0.210, 0.878. Conclusions: The overall diagnostic accuracy of brachial plexus MRI calculated on a per-patient base is relatively high. The specificity of brachial plexus MRI in patients suspected of having a space-occupying mass is very high. The sensitivity is also high, but there are false-positive interpretations as well.

  11. Surface-induced intramolecular electron transfer in multi-centre redox metalloproteins: the di-haem protein cytochrome c4 in homogeneous solution and at electrochemical surfaces

    Science.gov (United States)

    Chi, Qijin; Zhang, Jingdong; Jensen, Palle S.; Nazmudtinov, Renat R.; Ulstrup, Jens

    2008-09-01

    Intramolecular electron transfer (ET) between transition metal centres is a core feature of biological ET and redox enzyme function. The number of microscopic redox potentials and ET rate constants is, however, mostly prohibitive for experimental mapping, but two-centre proteins offer simple enough communication networks for complete mapping to be within reach. At the same time, multi-centre redox proteins operate in a membrane environment where conformational dynamics and ET patterns are quite different from the conditions in a homogeneous solution. The bacterial respiratory di-haem protein Pseudomonas stutzeri cytochrome c4 offers a prototype target for environmental gating of intra-haem ET. ET between P. stutzeri cyt c4 and small molecular reaction partners in solution appears completely dominated by intermolecular ET of each haem group/protein domain, with no competing intra-haem ET, for which accompanying propionate-mediated proton transfer is a further barrier. The protein can, however, be immobilized on single-crystal, modified Au(111) electrode surfaces with either the low-potential N terminal or the high-potential C terminal domain facing the surface, clearly with fast intramolecular ET as a key feature in the electrochemical two-ET process. This dual behaviour suggests a pattern for multi-centre redox metalloprotein function. In a homogeneous solution, which is not the natural environment of cyt c4, the two haem group domains operate largely independently with conformations prohibitive for intramolecular ET. Binding to a membrane or electrochemical surface, however, triggers conformational opening of intramolecular ET channels. The haem group orientation in P. stutzeri cyt c4 is finally noted to offer a case for orientation dependent electronic rectification between a substrate and a tip in electrochemical in situ scanning tunnelling microscopy or nanoscale electrode configurations.

  12. Knowledge and Awareness among Parents and General Dental Practitioners regarding Rehabilitation with Full Coverage Restoration in Children: A Multi-centric Trial

    Science.gov (United States)

    Saroj, Gyanendra; Sharma, Swati; Gupta, Basant

    2016-01-01

    ABSTRACT Aims: The aim of this study was to evaluate the knowledge and awareness among parents and general dental practitioners regarding rehabilitation with full coverage restoration in children following pulp therapy. Materials and methods: A multiple choice questionnaire was given to 1,000 parents and 400 general practitioners in this multicentric trial. The questionnaire assessed their beliefs, knowledge regarding care of primary teeth, assessment of treating children, and knowledge regarding importance of primary teeth. All the questionnaires were then compiled and statistically analyzed using Statistical Package for Social Sciences (SPSS) software. Results and discussion: 53% parents did not know the importance of primary teeth and 73% parents also thought that no treatment is possible for pulpally involved primary teeth. 20% parents believed that root canal treatment can be possible for children and only 10% knew about full coverage restorations. 40% of the general dentists felt that the best treatment in the case of primary necrotic teeth is extraction and only 13% knew about stainless steel crowns. 62% of general dental practitioners pointed out patients’ noninterest in providing crowns whereas 68% parents reported non-information by dentists. Conclusion: Both parents and general dental practitioners have incomplete and inadequate knowledge regarding full coverage restorations, and we need to improve the knowledge and dental awareness of the parents and the general dental practitioners. How to cite this article: Moda A, Saroj G, Sharma S, Gupta B. Knowledge and Awareness among Parents and General Dental Practitioners regarding Rehabilitation with Full Coverage Restoration in Children: A Multi-centric Trial. Int J Clin Pediatr Dent 2016;9(2):177-180. PMID:27365944

  13. Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis

    DEFF Research Database (Denmark)

    Denton, Christopher P; Krieg, Thomas; Guillevin, Loic;

    2012-01-01

    OBJECTIVES: The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). METHODS: The DUO Registry is a European, prospective, multicentre......, observational, registry of SSc patients with ongoing digital ulcer disease, irrespective of treatment regimen. Data collected included demographics, SSc duration, SSc subset, internal organ manifestations, autoantibodies, previous and ongoing interventions and complications related to digital ulcers. RESULTS...

  14. Early 2016/17 vaccine effectiveness estimates against influenza A(H3N2): I-MOVE multicentre case control studies at primary care and hospital levels in Europe.

    NARCIS (Netherlands)

    Kissling, E.; Rondy, M.

    2017-01-01

    We measured early 2016/17 season influenza vaccine effectiveness (IVE) against influenza A(H3N2) in Europe using multicentre case control studies at primary care and hospital levels. IVE at primary care level was 44.1%, 46.9% and 23.4% among 0–14, 15–64 and ≥ 65 year-olds, and 25.7% in the influenza

  15. BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35–60 kg/m2 – a multi-centre randomized patient and observer blind non-inferiority trial

    OpenAIRE

    2015-01-01

    Background: Roux-en-Ygastric bypass (RYGB) and sleeve gastrectomy (SG) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation. A systematic review revealed a similar excess weight loss (EWL) 2 years postoperatively between SG and RYGB. However, there is a lack of randomized controlled multi-centre trials comparing SG and RYGB, not only concerning EWL, but also in terms of remission of obesity-related co-morbidities, gastroesophagea...

  16. Randomized, multicentre assessment of the efficacy and safety of ASAQ – a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria

    Directory of Open Access Journals (Sweden)

    Diallo Mouctar

    2009-06-01

    Full Text Available Abstract Background The use of artemisinin derivative-based combination therapy (ACT such as artesunate plus amodiaquine is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. Fixed-dose combinations are more adapted to patients than regimens involving multiple tablets and improve treatment compliance. A fixed-dose combination of artesunate + amodiaquine (ASAQ was recently developed. To assess the efficacy and safety of this new combination and to define its optimum dosage regimen (once or twice daily in the treatment of uncomplicated P. falciparum malaria, a multicentre clinical study was conducted. Methods A multicentre, randomized, controlled, investigator-blinded, parallel-group study was conducted in five African centers in Cameroon, Madagascar, Mali and Senegal from March to December 2006. Efficacy and safety of ASAQ were assessed compared to those of artemether + lumefantrine (AL. The WHO protocol with a 28-day follow-up for assessing the drug therapeutic efficacy was used. Patients suffering from uncomplicated P. falciparum malaria were randomized to receive ASAQ orally once daily (ASAQ1, ASAQ twice daily (ASAQ2 or AL twice daily (AL for three days. The primary outcome was PCR-corrected parasitological cure rate and clinical response. Results Of 941 patients initially randomized and stratified into two age groups ( Conclusion The non-inferiority of ASAQ compared with AL was demonstrated. The fixed-dose combination artesunate + amodiaquine (ASAQ is safe and efficacious even in young children under 5 years of age. Whilst administration on a twice-a-day basis does not improve the efficacy of ASAQ significantly, a once-a-day intake of this new combination clearly appears as an effective and safe therapy in the treatment of uncomplicated P. falciparum malaria both in adults and children. Implications of such findings are of primary importance in terms of public health especially in African countries. As

  17. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit\\/hyperactivity disorder (ADHD-CT) and 1446 \\'unselected\\' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners\\' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband\\/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  18. SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

    Directory of Open Access Journals (Sweden)

    Staffurth John N

    2011-10-01

    Full Text Available Abstract Background Chemoradiotherapy is the standard of care for patients with oesophageal cancer unsuitable for surgery due to the presence of co-morbidity or extent of disease, and is a standard treatment option for patients with squamous cell carcinoma of the oesophagus. Modern regimens of chemoradiotherapy can lead to significant long-term survival. However the majority of patients will die of their disease, most commonly with local progression/recurrence of their tumours. Cetuximab may overcome one of the principal mechanisms of tumour radio-resistance, namely tumour repopulation, in patients treated with chemoradiotherapy. The purpose of this research is first to determine whether the addition of cetuximab to definitive chemoradiotherapy for treatment of patients with non-metastatic carcinoma of the oesophagus is active (in terms of failure-free rate, safe, and feasible within the context of a multi-centre randomised controlled trial in the UK. If the first stage is successful then the trial will continue to accrue sufficient patients to establish whether the addition of cetuximab to the standard treatment improves overall survival. Methods/Design SCOPE1 is a two arm, open, randomised multicentre Phase II/III trial. Eligible patients will have histologically confirmed carcinoma of the oesophagus and have been chosen to receive definitive chemoradiotherapy by an accredited multidisciplinary team including a specialist Upper GI surgeon. 420 patients will be randomised to receive definitive chemoradiotherapy with or without cetuximab using a 1:1 allocation ratio. During Phase II of the study, the trial will assess safety (toxicity, activity (failure-free rate and feasibility (recruitment rate and protocol dose modifications/delays in 90 patients in the experimental arm. If the experimental arm is found to be active, safe, and feasible by the Independent Data Monitoring Committee then recruitment will continue into Phase III. This second

  19. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit/hyperactivity disorder (ADHD-CT and 1446 'unselected' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities. A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS interview and the DSM-IV items of the Conners' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  20. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

    Directory of Open Access Journals (Sweden)

    Thompson Simon

    2002-01-01

    Full Text Available Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT, unparalleled in telemedicine research in either scale or range of outcomes. The study investigated the effectiveness and cost implications in rural and inner-city settings of using videoconferencing to perform joint tele-consultations as an alternative to general practitioner referral to the hospital specialist in the outpatient clinic. Methods Joint tele-consultation services were established in both the Royal Free Hampstead NHS Trust in inner London, and the Royal Shrewsbury Hospitals Trust, in Shropshire. All the patients who gave consent to participate were randomised either to joint tele-consultation or to a routine outpatients appointment. The principal outcome measures included the frequency of decision by the specialist to offer a follow-up outpatient appointment, patient satisfaction (Ware Specific Questionnaire, wellbeing (SF12 and enablement (PEI, numbers of tests, investigations, procedures and treatments. Results A total of 134 general practitioners operating from 29 practices participated in the trial, referring a total of 3170 patients to 20 specialists in ENT medicine, general medicine (including endocrinology, and rheumatology, gastroenterology, orthopaedics, neurology and urology. Of these, 2094 patients consented to participate in the study and were correctly randomised. There was a 91% response rate to the initial assessment questionnaires, and analysis showed equivalence for all key characteristics between the treatment and control groups. Conclusion We have designed and

  1. RADAR – A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis

    Directory of Open Access Journals (Sweden)

    Hauk Michael

    2009-07-01

    Full Text Available Abstract Background Prospective, international, multi-centre, randomised (1:1 trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS on the impaired renal function measured by the estimated glomerular filtration rate (eGFR in patients with haemodynamically significant atherosclerotic renal artery stenosis. Methods Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or post procedure (for PTRAS arm only, and adjusted as needed at all visits. Best medical treatment is defined as optimal drug therapy for control of the major risk factors (blood pressure ≤ 125/80 mmHg, LDL cholesterol ≤ 100 mg/dL, HbA1c ≤ 6.5%. Data recordings include serum creatinine values, eGFR, brain natriuretic peptide, patients' medical history and concomitant medication, clinical events, quality of life questionnaire (SF-12v2™, 24 hour ambulatory blood pressure measurement, renal artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 12 and 36 months following randomisation. The primary endpoint is the difference between treatments in change of eGFR over 12 months. Major secondary endpoints are technical success, change of renal function based on the eGFR slope change between pre-treatment and post-treatment (i.e. improvement, stabilisation, failure, clinical events overall such as renal or cardiac death, stroke, myocardial infarction, hospitalisation for congestive heart failure, progressive renal insufficiency (i.e. need for dialysis, need of target vessel revascularisation or target lesion revascularisation, change in

  2. Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Inmaculada Lupiañez-Perez

    Full Text Available Pressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances.Main objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain. Sample: 831 immobilised patients at risk of suffering pressure ulcers.The follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55% vs HOFA 8 (3.08%, ARR 0.53 (-2.2 to 3.26 Right heel: Olive Oil 4 (1.27% vs HOFA 5 (1.92%, ARR0.65 (-1.43 to 2.73. Left heel: Olive Oil 3 (0.96% vs HOFA 3 (1.15%, ARR0.2 (-1.49 to 1.88. Right trochanter: Olive Oil 0 (0% vs HOFA 4 (1.54%, ARR1.54 (0.04 to 3.03. Left trochanter: Olive Oil 1 (0.32% vs HOFA 1 (0.38%, ARR0.07 (-0.91 to 1.04. In the intention to treat analysis the lower limit of the established confidence interval was never exceeded.The results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome.Clinicaltrials.gov NCT01595347.

  3. Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: A randomized, open label, active-controlled, multicentric, phase IV clinical trial

    Directory of Open Access Journals (Sweden)

    Siva Prasad

    2012-01-01

    Full Text Available Background: Acne vulgaris is a very common skin disease with a significant detrimental effect on the quality of life of the patients. Aims: To assess the comparative efficacy and safety of a nano-emulsion gel formulation of adapalene and clindamycin combination with its conventional formulation in the treatment of acne vulgaris of the face. It was a prospective, randomized, open label, active-controlled, multicentric, clinical trial. Methods: Eligible patients suffering from acne vulgaris of the face were randomized to receive once-daily treatment with a nano-emulsion gel or conventional gel formulation of adapalene 0.1% and clindamycin (as phosphate 1% combination for 12 weeks. Total, inflammatory and noninflammatory lesion counts, with grading of acne severity were carried out on a monthly basis. Safety assessments were done to determine the comparative local and systemic tolerability. Two-tailed significance testing was carried out with appropriate statistical tests, and P-values < 0.05 were considered as significant. Results: 209/212 patients enrolled in the study were eligible for efficacy and safety assessments in both nano-emulsion gel (118/119 patients and conventional gel (91/93 patients groups. Significantly better reductions in total (79.7% vs. 62.7%, inflammatory (88.7% vs. 71.4% and noninflammatory (74.9% vs. 58.4% lesions were reported with the nano-emulsion gel as compared to the conventional gel (P < 0.001 for all. Mean acne severity score also reduced significantly more with the nano-emulsion formulation (1.9 ± 0.9 vs. 1.4 ± 1.0; P < 0.001 than the comparator. Significantly lower incidence and lesser intensity of adverse events like local irritation (4.2% vs. 19.8%; P < 0.05 and erythema (0.8% vs. 9.9%; P < 0.05 were recorded with the nano-emulsion gel. Conclusions: The nano-emulsion gel formulation of adapalene and clindamycin combination appears to be more efficacious and better tolerated than the conventional formulation

  4. Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Maria; Honey, Ian [Trust, Medical Physics Department, Guy' s and St. Thomas' NHS Foundation, London (United Kingdom); Goh, Vicky [King' s College London, St Thomas' Hospital, Division of Imaging Sciences and Biomedical Engineering, London (United Kingdom); Beggs, Shaun [Bradford Teaching Hospitals NHS Foundation Trust, Radiation Physics Services, Bradford (United Kingdom); Bridges, Andrew; Wayte, Sarah [Radiology Physics University Hospitals Coventry and Warwickshire NHS Trust, Coventry (United Kingdom); Clewer, Philip [Medical Physics Department, University Hospital Southampton NHS Foundation Trust, Southampton (United Kingdom); Davis, Anne [Portsmouth Hospitals NHS Trust, Medical Physics Department, Portsmouth (United Kingdom); Foy, Trevelyan [Royal Cornwall Hospital NHS Trust, Medical Physics Department, Truro (United Kingdom); Fuller, Karen [Sheffield Teaching Hospitals NHS Foundation Trust, Medical Physics Department, Sheffield (United Kingdom); George, Jennifer [University Hospital of North Staffordshire NHS Trust, Medical Physics Department, Stoke-on-Trent (United Kingdom); Higginson, Antony [Portsmouth Hospitals NHS Trust, Department of Radiology, Portsmouth (United Kingdom); Iball, Gareth [Leeds Teaching Hospitals NHS Trust, Department of Medical Physics and Engineering, Leeds (United Kingdom); Mutch, Steve [Oxford University Hospitals NHS Trust, Radiation Physics and Protection Department, Oxford (United Kingdom); Neil, Shellagh; Sutton, David [NHS Tayside, Medical Physics Department, Dundee, Scotland (United Kingdom); Rivett, Cat [Plymouth Hospitals NHS Trust, Clinical and Radiation Physics, Plymouth (United Kingdom); Slater, Andrew [Oxford University Hospitals NHS Trust, Department of Radiology, Oxford (United Kingdom); Weir, Nick [Queen' s Medical Research Institute, Clinical Research Imaging Centre, Edinburgh, Scotland (United Kingdom); Collaboration: on behalf of the PROSPeCT Investigators

    2014-09-15

    To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI{sub vol}, DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml{sup -1} and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

  5. The effect of two cognitive aid designs on team functioning during intra-operative anaphylaxis emergencies: a multi-centre simulation study.

    Science.gov (United States)

    Marshall, S D; Sanderson, P; McIntosh, C A; Kolawole, H

    2016-04-01

    This multi-centre repeated measures study was undertaken to determine how contrasting designs of cognitive aids affect team performance during simulated intra-operative anaphylaxis crises. A total of 24 teams consisting of a consultant anaesthetist, an anaesthetic trainee and anaesthetic assistant managed three simulated intra-operative anaphylaxis emergencies. Each team was assigned at random to a counterbalanced order of: no cognitive aid; a linear cognitive aid; and a branched cognitive aid, and scored for team functioning. Scores were significantly higher with a linear compared with either a branched version of the cognitive aid or no cognitive aid for 'Team Overall Behavioural Performance', difference between study groups (F-value) 5.8, p = 0.01. Aggregate scores were higher with the linear compared with the branched aid design (p = 0.03). Cognitive aids improve co-ordination of the team's activities and support team members to verbalise their actions. A linear design of cognitive aid improves team functioning more than a branched design.

  6. High-dose zidovudine plus valganciclovir for Kaposi sarcoma herpesvirus-associated multicentric Castleman disease: a pilot study of virus-activated cytotoxic therapy

    Science.gov (United States)

    Uldrick, Thomas S.; Polizzotto, Mark N.; Aleman, Karen; O'Mahony, Deirdre; Wyvill, Kathleen M.; Wang, Victoria; Marshall, Vickie; Pittaluga, Stefania; Steinberg, Seth M.; Tosato, Giovanna; Whitby, Denise; Little, Richard F.

    2011-01-01

    Kaposi sarcoma herpesvirus (KSHV)–associated multicentric Castleman disease (MCD) is a lymphoproliferative disorder most commonly observed in HIV-infected patients. It is characterized by KSHV-infected plasmablasts that frequently express lytic genes. Patients manifest inflammatory symptoms attributed to overproduction of KSHV viral IL-6, human IL-6, and human IL-6. There is no standard therapy and no established response criteria. We investigated an approach targeting 2 KSHV lytic genes, ORF36 and ORF21, the protein of which, respectively, phosphorylate ganciclovir and zidovudine to toxic moieties. In a pilot study, 14 HIV-infected patients with symptomatic KSHV-MCD received high-dose zidovudine (600 mg orally every 6 hours) and the oral prodrug, valganciclovir (900 mg orally every 12 hours). Responses were evaluated using new response criteria. A total of 86% of patients attained major clinical responses and 50% attained major biochemical responses. Median progression-free survival was 6 months. With 43 months of median follow-up, overall survival was 86% at 12 months and beyond. At the time of best response, the patients showed significant improvements in C-reactive protein, albumin, platelets, human IL-6, IL-10, and KSHV viral load. The most common toxicities were hematologic. These observations provide evidence that therapy designed to target cells with lytic KSHV replication has activity in KSHV-MCD. This trial was registered at www.clinicaltrials.gov as #NCT00099073. PMID:21487108

  7. Sequence Analysis of Kaposi Sarcoma–Associated Herpesvirus (KSHV) MicroRNAs in Patients with Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome

    Science.gov (United States)

    Ray, Alex; Marshall, Vickie; Uldrick, Thomas; Leighty, Robert; Labo, Nazzarena; Wyvill, Kathy; Aleman, Karen; Polizzotto, Mark N.; Little, Richard F.; Yarchoan, Robert; Whitby, Denise

    2012-01-01

    Background Kaposi sarcoma–associated herpesvirus (KSHV) encodes 12 pre-microRNAs that yield 25 mature microRNAs. We previously reported phylogenetic analysis of the microRNA-coding region of KSHV from Kaposi sarcoma (KS), primary effusion lymphoma (PEL), and multicentric Castleman disease (MCD) patients. We observed a high level of conservation for most sequences but also a divergent cluster of 5 KSHV sequences, including 2 from MCD patients. Methods KSHV microRNA sequences from 23 MCD patients and 7 patients with a newly described KSHV-associated inflammatory cytokine syndrome (KICS) were examined by amplification, cloning, and sequencing of a 646-bp fragment of K12/T0.7 encoding microRNA-K12-10 and microRNA-K12-12 and a 2.8-kbp fragment containing the remaining 10 pre-microRNAs. Results Phylogenetic analysis showed a distinct variant cluster consisting exclusively of MCD and KICS patients in all trees. Pearson χ2 analysis revealed that 40 single-nucleotide polymorphisms (SNPs) at various loci were significantly associated with MCD and KICS risk. Cluster analysis of these SNPs generated several combinations of 3 SNPs as putative indicators of MCD and KICS risk. Conclusions These findings show that MCD and KICS patients frequently have unusual KSHV microRNA sequences and suggest an association between the observed sequence variation and risk of MCD and KICS. PMID:22448005

  8. Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study.

    Science.gov (United States)

    Kaku, K; Katou, M; Igeta, M; Ohira, T; Sano, H

    2015-12-01

    A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings.

  9. Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial.

    Science.gov (United States)

    Tembe, D V; Dhavale, A; Desai, H; Mane, D N; Raut, S K; Dhingra, G; Sardesai, U; Saoji, S; Rohra, M; Shinde, V G; Padsalge, M; Paliwal, A; Abbasi, K; Devnani, P; Papinwar, S; Phadke, S; Mehta, H; Bhailume, V

    2011-01-01

    Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD). Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg) or modafinil (200 mg) one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS) by at least 2 grades (responder) and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (P armodafinil (72.12%) and modafinil (74.29%) were comparable (P = .76). Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.

  10. Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial

    Directory of Open Access Journals (Sweden)

    D. V. Tembe

    2011-01-01

    Full Text Available Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD. Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg or modafinil (200 mg one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS by at least 2 grades (responder and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (<.0001. Responder rates with armodafinil (72.12% and modafinil (74.29% were comparable (=.76. Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.

  11. Minimal Access Spinal Technologies (Mast Fusion Procedures For The Treatment Of The Degenerative Lumbar Spine (A Part Of Multicentral Prospective Study

    Directory of Open Access Journals (Sweden)

    Khoshab A.H.

    2014-05-01

    Full Text Available A prospective multicentral observational study of minimally invasive fusion to treat degenerative lumbar disorders, and to report outcomes of one or two level minimally invasive posterior lumbar interbody fusion (MLIF for degenerative lumbar disorders in a multi-center 1-year prospective study. We prospectively studied a group of 32 patients, mostly female 24 ( 75% female , and 8 males ( 25%. They underwent minimally invasive transforaminal lumbar interbody fusion (mTLIF, 21 of them monosegmental and 11 bisegmental. Patients demographics, intraoperative data and complications were recorded. Time to first ambulation, time to study-defined recovery, surgical duration, blood loss, fluoroscopy time and adverse events were recorded. Visual analogue scale (VAS of back and legs pain, Oswestry disability index (ODI and health-related questionnaire (EQ-5D were assessed preoperatively and at defined time points through 12 months postoperatively. Mean surgical duration, blood loss and intraoperative fluoroscopy time were 125 vs.175 minutes, 150 vs. 170 ml, and 105 vs. 145 seconds in one- and twolevel segments, respectively. Mean preoperative VAS back (6.5 and VAS leg (7.9 scores dropped significantly (p<0.0001 to 3.5 (2.6 and 2.1 (2.0 at discharge (6 weeks. At the end, this is the largest prospective multi-center observational study of MLIF to date, following routine local standard of practice and, MLIF demonstrated favourable clinical results with early and sustained improvement in patient reported outcomes and low major perioperative morbidity.

  12. The addition of sirolimus to the graft-versus-host disease prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicentre randomized trial.

    Science.gov (United States)

    Armand, Philippe; Kim, Haesook T; Sainvil, Marie-Michele; Lange, Paulina B; Giardino, Angela A; Bachanova, Veronika; Devine, Steven M; Waller, Edmund K; Jagirdar, Neera; Herrera, Alex F; Cutler, Corey; Ho, Vincent T; Koreth, John; Alyea, Edwin P; McAfee, Steven L; Soiffer, Robert J; Chen, Yi-Bin; Antin, Joseph H

    2016-04-01

    Inhibition of the mechanistic target of rapamycin (mTOR) pathway has clinical activity in lymphoma. The mTOR inhibitor sirolimus has been used in the prevention and treatment of graft-versus-host disease (GVHD) after allogeneic haematopoietic stem cell transplantation (HSCT). A retrospective study suggested that patients with lymphoma undergoing reduced intensity conditioning (RIC) HSCT who received sirolimus as part of their GVHD prophylaxis regimen had a lower rate of relapse. We therefore performed a multicentre randomized trial comparing tacrolimus, sirolimus and methotrexate to standard regimens in adult patients undergoing RIC HSCT for lymphoma in order to assess the possible benefit of sirolimus on HSCT outcome. 139 patients were randomized. There was no difference overall in 2-year overall survival, progression-free survival, relapse, non-relapse mortality or chronic GVHD. However, the sirolimus-containing arm had a significantly lower incidence of grade II-IV acute GVHD (9% vs. 25%, P = 0·015), which was more marked for unrelated donor grafts. In conclusion, the addition of sirolimus for GVHD prophylaxis in RIC HSCT is associated with no increased overall toxicity and a lower risk of acute GVHD, although it does not improve survival; this regimen is an acceptable option for GVHD prevention in RIC HSCT. This trial is registered at clinicaltrials.gov (NCT00928018).

  13. Combination goserelin and tamoxifen therapy in premenopausal advanced breast cancer: a multicentre study by the ITMO group. Italian Trials in Medical Oncology.

    Science.gov (United States)

    Buzzoni, R.; Biganzoli, L.; Bajetta, E.; Celio, L.; Fornasiero, A.; Mariani, L.; Zilembo, N.; Di Bartolomeo, M.; Di Leo, A.; Arcangeli, G.

    1995-01-01

    It has been suggested that tamoxifen may improve the efficacy of medical castration with luteinising hormone-releasing hormone analogues, but very few data have so far been published concerning the clinical and endocrinological activity of this therapeutic modality. In this phase II multicentre trial conducted by the Italian Trials in Medical Oncology group (ITMO), 64 premenopausal patients with hormone receptor-positive or unknown breast cancer were treated with monthly s.c. injections of goserelin 3.6 mg, in association with a tamoxifen daily dose of 20 mg, as first-line therapy for their advanced disease. All of the patients were evaluable for efficacy and there was an overall response rate of 41% (95% confidence interval 28-52%), with 7 of the 26 responders achieving complete remission. The median time to response was 4 months (range 2-17), and the median response duration was 13 months (range 6-37 +). Better responses were observed in soft tissues (51%); the response in visceral and bone metastases was respectively 19% and 37%. Serum concentrations of gonadotrophins and oestradiol were significantly decreased by the treatment, oestrogen levels being constantly suppressed to within the range observed in post-menopausal women. No significant change was detected in serum testosterone levels. In our experience, although it was not associated with any increased clinical efficacy, the concurrent use of goserelin and tamoxifen proved to be a feasible approach in the management of premenopausal advanced breast cancer. PMID:7734310

  14. A multi-centre, prospective, clinical in-market evaluation to assess the performance of Opsite™ Post-Op Visible dressings.

    LENUS (Irish Health Repository)

    O'Brien, Gillian

    2010-10-01

    The aim of this study was to assess the performance of Opsite™ Post-Op Visible as a post-surgical dressing in a typical clinical setting. In this multi-centre clinical evaluation, patients who underwent clean surgery were treated with Opsite Post-Op Visible dressing. Duration of dressing wear, visibility through the dressing and ability to handle exudate were assessed and the product was rated in comparison with those normally used. A total of 64 patients were recruited. Mean wear time was 4·5 days. Exudate management was rated very good or good at 96% of assessments. Visibility of the incision site was rated as very good or good at 72%, and as acceptable at 24%, of assessments. Patient comfort was rated very comfortable (63%) or comfortable (37%) at all assessments. Dressings were generally rated as satisfactory or exceeding expectations with clinicians stating that the Opsite Post-Op Visible dressing was better than the dressing they routinely used for 92% of patients. Opsite Post-Op Visible dressing is an innovative dressing combining good visibility with exudate management and patient comfort. It was found to have adequate wear time, visibility and exudate management properties making it suitable for use on a variety of surgical incision sites.

  15. Early oesophageal cancer: results of a European multicentre survey. Group Européen pour l'Etude des Maladies de l'Oesophage.

    Science.gov (United States)

    Bonavina, L

    1995-01-01

    Early oesophageal cancer has been extensively studied in Far-Eastern countries, where its prevalence is high. A multicentre survey was conducted within the Groupe Européen pour l'Etude des Maladies de l'Oesophage to analyse results of surgical treatment in patients with disease staged as pTis-T1 N0 M0 according to the tumour node metastasis classification. Of 9743 patients with squamous cell oesophageal carcinoma observed since 1980, 4663 underwent resection; 253 (5.4 per cent) of these fulfilled the criteria for inclusion in the study. The overall mortality rate was 9.1 per cent (23 patients), and was higher after transthoracic than transhiatal oesophagectomy (10.7 versus 6 per cent, P not significant). Pathological examination showed an intraepithelial tumour in 46 patients (18.2 per cent), intramucosal carcinoma in 64 (25.3 per cent) and a submucosal lesion in 143 (56.5 per cent). The overall 5-year survival rate for patients with intraepithelial, intramucosal and submucosal tumours was 92.8, 72.8 and 44.3 per cent respectively. The 5-year survival rate was higher after transthoracic than transhiatal oesophagectomy (66 versus 52 per cent). No survival advantage was observed after either operation in patients with mucosal tumours. Of 21 patients with recurrent disease, 20 had a submucosal lesion. The 5-year survival rate in patients with submucosal tumour was higher after transthoracic than transhiatal oesophagectomy (54.2 versus 25.5 per cent).

  16. Image acquisition and interpretation criteria for {sup 99m}Tc-HMPAO-labelled white blood cell scintigraphy: results of a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Erba, Paola A. [University of Pisa Medical School (Italy). Regional Center of Nuclear Medicine; Glaudemans, Andor W.J.M.; Dierckx, Rudi A.J.O. [University Medical Center Groningen (Netherlands). Dept. of Nuclear Medicine and Molecular Imaging; Veltman, Niels C. [Jeroen Bosch Hospital, ' s-Hertogenbosch (Netherlands). Dept. of Nuclear Medicine; Sollini, Martina [Arcisprdale S. Maria Nuova - IRCCS, Reggio Emilia (Italy). Nuclear Medicine Unit; Pacilio, Marta; Galli, Filippo [Sapienza Univ., Rome (Italy). Nuclear Medicine Unit; Signore, Alberto [University Medical Center Groningen (Netherlands). Dept. of Nuclear Medicine and Molecular Imaging; Sapienza Univ., Rome (Italy). Nuclear Medicine Unit; Sapienza Univ., Rome (Italy). Ospedale S. Andrea Medicina Nucleare

    2014-04-15

    There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. This was a multicentre retrospective study analysing 235 WBC scans divided into two groups. The first group of scans (105 patients) were acquired with a fixed-time acquisition protocol and the second group (130 patients) were acquired with a decay time-corrected acquisition protocol. Planar images were interpreted both qualitatively and semiquantitatively. Three blinded readers analysed the images. The most accurate imaging acquisition protocol comprised image acquisition at 3 - 4 h and at 20 - 24 h in time mode with acquisition times corrected for isotope decay. Using this protocol, visual analysis had high sensitivity and specificity in the diagnosis of infection. Semiquantitative analysis could be used in doubtful cases, with no cut-off for the percentage increase in radiolabelled WBC over time, as a criterion to define a positive scan. (orig.)

  17. Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

  18. Validation of the German version of the patient activation measure 13 (PAM13-D in an international multicentre study of primary care patients.

    Directory of Open Access Journals (Sweden)

    Katja Brenk-Franz

    Full Text Available The patients' active participation in their medical care is important for patients with chronic diseases. Measurements of patient activation are needed for studies and in clinical practice. This study aims to validate the Patient Activation Measure 13 (PAM13-D in German-speaking primary care patients. This international cross-sectional multicentre study enrolled consecutively patients from primary care practices in three German-speaking countries: Germany, Austria, and Switzerland. Patients completed the PAM13-D questionnaire. General Self-Efficacy scale (GSE was used to assess convergent validity. Furthermore Cronbach's alpha was performed to assess internal consistency. Exploratory factor analysis was used to evaluate the underlying factor structure of the items. We included 508 patients from 16 primary care practices in the final analysis. Results were internally consistent, with a Cronbach's alpha of 0.84. Factor analysis revealed one major underlying factor. The mean values of the PAM13-D correlated significantly (r = 0.43 with those of the GSE. The German PAM13 is a reliable and valid measure of patient activation. Thus, it may be useful in primary care clinical practice and research.

  19. A prospective, randomized, multicentre trial for the treatment of refractory status epilepticus; experiences from evaluating the effect of the novel drug candidate, NS1209.

    Science.gov (United States)

    Sabers, Anne; Wolf, Peter; Møller, Arne; Rysgaard, Karen; Ben-Menachem, Elinor

    2013-09-01

    Refractory status epilepticus (RSE) is a life-threatening condition that requires immediate and aggressive treatment. Unfortunately, sometimes standard antiepileptic treatment is insufficient. Furthermore, alternative therapeutic options are limited by low evidence of efficacy. The primary objective of this study was to evaluate the effects of the novel drug candidate, NS1209 versus third-line standard treatment (phenytoin/valproate) for RSE. Having not reached the study end-points, the purpose of this paper is to discuss the challenges that are encountered in conducting a controlled study of RSE. This was a phase II, prospective, multicentre, single-blinded, randomized clinical trial and included patients to two separate protocols for convulsive and non-convulsive RSE (NS1209-006 and NS1209-007). In total, 28 patients were included and 14 patients were exposed to NS1209. At study conclusion, the study was insufficiently powered to detect any statistically significant difference between the two treatment groups. This was especially true for the convulsive RSE protocol. We conclude that high-quality studies in RSE are difficult to conduct owing to a number of ethical and practical problems associated with this critical illness. Challenges for further studies are discussed.

  20. Orgaran (Org 10172) or heparin for preventing venous thrombosis after elective surgery for malignant disease? A double-blind, randomised, multicentre comparison. ANZ-Organon Investigators' Group.

    Science.gov (United States)

    Gallus, A; Cade, J; Ockelford, P; Hepburn, S; Maas, M; Magnani, H; Bucknall, T; Stevens, J; Porteous, F

    1993-10-18

    This double-blind, randomised, multicentre trial in 513 patients having elective surgery for intra-abdominal or intrathoracic malignancy compared the efficacy and safety of venous thrombosis (VT) prophylaxis using 750 anti-factor Xa units of Orgaran (a mixture of low molecular weight heparinoids) given subcutaneously (sc) twice-daily with that of twice-daily injections of 5,000 units standard heparin. The main study endpoints were the development of postoperative VT detected by 125I-fibrinogen leg scanning, and the onset of clinically significant venous thromboembolism or bleeding. "Intent to treat" analysis showed a statistically non-significant trend towards less VT during Orgaran prophylaxis (10.4%) than after heparin (14.9%) and there was no difference in bleeding complications between the two study groups. Results remained similar if only patients who completed the intended course of therapy ("compliant patients") were analysed. Other trials have shown that Orgaran prevents VT after hip surgery and stroke. We now show it is also safe and effective in patients having major surgery for cancer.

  1. The influence of sample volume applied to the Makler sperm counting chamber upon the measured concentration of latex beads:A multi-centre study

    Institute of Scientific and Technical Information of China (English)

    Melanie Walls; Cherise Mooy; Patrick Mohan; Sally Catt; Matthew Wiltshire; Hassan W Bakos; Mary Whyte; Phillip Matson; Emily Zuvela; Cheryl Ayres; Deborah Sherrin; Asma Chhotani; Liz Butler; Kelli Peirce; Jenny Krapez; Renae Parker

    2012-01-01

    Objective:To undertake a multi-centre study to maximize the number ofMakler chambers used.Methods:A total of15 laboratories participated with31Makler chambers.A suspension of latex beads was prepared to a concentration of20 millions per milliliter, and0.5 mL aliquots distributed to each participating laboratory.They measured the concentration on theirMakler chamber(s) used for routine semen analysis by adding3,4,5,7 and10µL volumes of bead suspension to the chamber.Results:There was no difference in within-chamber analysis of the bead concentration according to the volume of bead suspension applied within the range of 3-10µL(F4,14=2.634,P=0.056).However, the between-chamber effects were significantly different (F30,124=4.937,P=0.000), and24/31(77.5%) chambers tested had an average bias>10% compared to the target bead concentration.Conclusions:A volume of3-10µL added toMakler counting chambers does not influence the concentration measured of latex beads, but the between-chamber variability and positive bias seen would suggest that other sources of error are present which are yet to be identified.

  2. Pregnancies in women with systemic lupus erythematosus and antiphospholipid antibodies

    DEFF Research Database (Denmark)

    Schreiber, K

    2016-01-01

    Systemic lupus erythematosus (SLE) has preponderance in women in their childbearing years; consequently pregnancy has always been an important issue of concern for the patient and the treating physician. Based upon numerous reports on successful pregnancy outcomes in the past decades, the initial...... of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE) study, so far the largest multicentre cohort study of pregnant women with underlying stable SLE, has given some important answers to long-discussed questions. Future studies on data collected from...

  3. Aplicação multicêntrica informatizada da coleta de dados clínicos na apendicite aguda Computerized multicentric application of data collection on acute appendicitis

    Directory of Open Access Journals (Sweden)

    Crhistiano Coleto Druszcz

    2007-09-01

    êutica das infecções. As complicações pós-operatórias estiveram presentes em 10,32% dos pacientes, correspondendo principalmente às infecções de parede abdominal (64,28%. CONCLUSÃO: O protocolo informatizado de dados clínicos das doenças do cólon, especificamente em sua parte das doenças do apêndice cecal, é viável e eficaz na manipulação de informações clínicas para produção de estudos científicos uni ou multicêntricos.BACKGROUND: A clinical database allows a better way to collect and, consequently, search and cross information to scientific researches. Multicentric studies can be easily created by using this mechanism. AIM: a To analyze the functionality of the computerized database of the appendix diseases; b to show the results of the analyzed data to validate the computerized database of the colon diseases incorporated to SINPE® (Computerized Database Integrated System - INPI 00051543. METHODS: Information provided by 862 patients with acute appendicitis has been collected into the specific protocol of the appendiceal diseases, from three university centers: Hospital de Clínicas of the Universidade Federal do Paraná, Hospital Universitário Evangélico de Curitiba and Hospital do Trabalhador of the Universidade Federal do Paraná. SINPE© was the software used to store, to select and to search information thereby compared to general literature. RESULTS: The Hospital de Clínicas supported 53,83% of the patients, meanwhile, the other two included 31,32% e 14,85%, respectively. Abdominal pain was the most common and characteristic symptom in patients who had confirmation of acute appendicitis. Infectious hemogram (in 77, 81% and abdominal ultrasound showing parietal abnormalities of the appendix (in 67, 40% were the diagnostic exams more frequently adopted to prove the referred diagnosis. Appendectomy, applied in 98, 43% of the patients, was the standard therapeutic proceeding. The MacBurney incision, applied in 74, 55% of all conventional

  4. A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial

    OpenAIRE

    Foster, Claire; Grimmett, Chloe; May, Christine M.; Ewings, Sean; Myall, Michelle; Hulme, Claire; Smith, Peter W.; Powers, Cassandra; Calman, Lynn; Armes, Jo; Breckons, Matthew; Corner, Jessica; Fenlon, Deborah; Batehup, Lynn; Lennan, Elaine

    2015-01-01

    Purpose: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial.\\ud \\ud Methods: A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed ...

  5. The European I-MOVE Multicentre 2013-2014 Case-Control Study. Homogeneous moderate influenza vaccine effectiveness against A(H1N1)pdm09 and heterogenous results by country against A(H3N2).

    LENUS (Irish Health Repository)

    Valenciano, Marta

    2015-06-04

    In the first five I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe) influenza seasons vaccine effectiveness (VE) results were relatively homogenous among participating study sites. In 2013-2014, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in six European Union (EU) countries to measure 2013-2014 influenza VE against medically-attended influenza-like illness (ILI) laboratory-confirmed as influenza. Influenza A(H3N2) and A(H1N1)pdm09 viruses co-circulated during the season.

  6. Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial

    Science.gov (United States)

    Bergström, M; Kieler, H; Waldenström, U

    2009-01-01

    Objective To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers. Design Randomised controlled multicentre trial. Setting Fifteen antenatal clinics in Sweden between January 2006 and May 2007. Sample A total of 1087 nulliparous women and 1064 of their partners. Methods Natural group: Antenatal education focussing on natural childbirth preparation with training in breathing and relaxation techniques (psychoprophylaxis). Standard care group: Standard antenatal education focussing on both childbirth and parenthood, without psychoprophylactic training. Both groups: Four 2-hour sessions in groups of 12 participants during third trimester of pregnancy and one follow-up after delivery. Main outcome measures Epidural analgesia during labour, experience of childbirth as measured by the Wijma Delivery Experience Questionnaire (B), and parental stress measured by the Swedish Parenthood Stress Questionnaire. Results The epidural rate was 52% in both groups. There were no statistically significant differences in the experience of childbirth or parental stress between the randomised groups, either in women or men. Seventy percent of the women in the Natural group reported having used psychoprophylaxis during labour. A minority in the Standard care group (37%) had also used this method, but subgroup analysis where these women were excluded did not change the principal findings. Conclusion Natural childbirth preparation including training in breathing and relaxation did not decrease the use of epidural analgesia during labour, nor did it improve the birth experience or affect parental stress in early parenthood in nulliparous women and men, compared with a standard form of antenatal education. PMID:19538406

  7. SCCA-IC serum levels are predictive of clinical response in HCV chronic hepatitis to antiviral therapy: a multicentric prospective study.

    Science.gov (United States)

    Fransvea, E; Trerotoli, P; Sacco, R; Bernabucci, V; Milella, M; Napoli, N; Mazzocca, A; Renna, E; Quaranta, M; Angarano, G; Villa, E; Antonaci, S; Giannelli, G

    2012-10-01

    The combination of pegylated interferon (Peg-IFN) and ribavirin is currently the gold standard therapy in patients with HCV chronic infection. The duration of therapy, as well as the therapeutic dosage, depend on the genotype. Identification of the genotype and rapid virological response (RVR) are widely accepted as the most important predictors of clinical outcome during antiviral therapy but to optimize cost-benefits and to reduce possible side effects, further prognostic factors are needed. Squamous cell carcinoma antigens immunocomplex (SCCA-IC) has been reported to be increased in the serum of patients with liver cancer. In this multicentric prospective study, we investigated the serum levels of SCCA-IC in 103 patients with HCV chronic infection. Serum HCV-RNA was detected before the beginning of treatment, after 4, 12, 24 or 48 weeks, and at week 24 during follow-up. RVR, early virological response and sustained virological response (SVR) were assessed following the international guidelines. SCCA-IC levels were higher in responders (238 AU, interquartile difference 130-556 AU) and decreased significantly to 125 AU (70-290 AU). The mean baseline value in nonresponders was 149 AU (86.5-306.5 AU), but after 4 weeks of treatment the serum levels decreased to 115 AU (80-280 AU): the profile of reduction was different between patients with or without a positive SVR. Logistic regression with SVR as dependent variable identified as significant independent variables: the reduction in SCCA-IC after 1 month (OR = 4.82; 95% CI 1.39-16.67; P = 0.131) and a genotype other than 1 (OR = 0.094; 95% CI 0.21-0.42; P = 0.002); sex and age were also significant factors influencing SVR. SCCA-IC seems to be a reliable independent prognostic marker of therapeutic effectiveness in anti-HCV positive patients undergoing antiviral therapy.

  8. Visceral leishmaniasis on the Indian sub-continent: a multi-centre study of the costs of three interventions for the control of the sandfly vector, Phlebotomus argentipes.

    Science.gov (United States)

    Das, M; Banjara, M; Chowdhury, R; Kumar, V; Rijal, S; Joshi, A; Akhter, S; Das, P; Kroeger, A

    2008-12-01

    The sandflies that transmit the parasites causing human visceral leishmaniasis (VL) can be controlled by several methods, including indoor residual spraying (IRS), the use of long-lasting insecticidal nets (LLIN) and ecological vector management (EVM). The financial costs of each of these three methods of sandfly control have recently been assessed and compared, in a multi-centre study based on the Indian sub-continent. In each of the four study sites (two in Nepal and one each in India and Bangladesh), 24 neighbourhoods were randomly selected in districts with high incidences of VL. The costs of the three interventions were then prospectively assessed in each study neighbourhood, in the local currency, and then converted to U.S. dollars at the prevailing exchange rate in the country concerned. The costs of IRS, which ranged from U.S.$2.4-11.7 (mean = U.S.$5.9) per household-year, were greater than those of LLIN (U.S.$3.5-5.1/household-year, with a mean of U. S.$4.5) but less than those of EVM (U. S.$5.0- 14.0/household-year, with a mean of U.S.$8.7). These results indicate that LLIN and IRS may be the cheaper options for the control of sandflies on the Indian sub-continent, and that EVM should perhaps only be taken up as a complimentary and voluntary method. Various combinations of these interventions (based on country-specific social and economic factors) may, however, be the best and most cost-effective choice.

  9. 18F-fluorodeoxyglucose Positron Emission Tomography in Kaposi Sarcoma Herpesvirus–Associated Multicentric Castleman Disease: Correlation With Activity, Severity, Inflammatory and Virologic Parameters

    Science.gov (United States)

    Polizzotto, Mark N.; Millo, Corina; Uldrick, Thomas S.; Aleman, Karen; Whatley, Millie; Wyvill, Kathleen M.; O'Mahony, Deirdre; Marshall, Vickie; Whitby, Denise; Maass-Moreno, Roberto; Steinberg, Seth M.; Little, Richard F.; Yarchoan, Robert

    2015-01-01

    Background. Kaposi sarcoma herpesvirus (KSHV)-associated multicentric Castleman disease (MCD) is a lymphoproliferative inflammatory disorder commonly associated with human immunodeficiency virus (HIV). Its presentation may be difficult to distinguish from HIV and its complications, including lymphoma. Novel imaging strategies could address these problems. Methods. We prospectively characterized 18F-fluorodeoxyglucose positron emission tomography (PET) findings in 27 patients with KSHV-MCD. Patients were imaged with disease activity and at remission with scans evaluated blind to clinical status. Symptoms, C-reactive protein level, and HIV and KSHV loads were assessed in relation to imaging findings. Results. KSHV-MCD activity was associated with hypermetabolic symmetric lymphadenopathy (median maximal standardized uptake value [SUVmax], 6.0; range, 2.0–8.0) and splenomegaly (3.4; 1.2–11.0), with increased metabolism also noted in the marrow (2.1; range, 1.0–3.5) and salivary glands (3.0; range, 2.0–6.0). The 18F-fluorodeoxyglucose PET abnormalities improved at remission, with significant SUVmax decreases in the lymph nodes (P = .004), spleen (P = .008), marrow (P = .004), and salivary glands (P = .004). Nodal SUVmax correlated with symptom severity (P = .005), C-reactive protein level (R = 0.62; P = .004), and KSHV load (R = 0.54; P = .02) but not HIV load (P = .52). Conclusions. KSHV-MCD activity is associated with 18F-FDG PET abnormalities of the lymph nodes, spleen, marrow, and salivary glands. These findings have clinical implications for the diagnosis and monitoring of KSHV-MCD and shed light on its pathobiologic mechanism. PMID:25828248

  10. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  11. The Prevalence and Characteristics of Primary Headache and Dream-Enacting Behaviour in Japanese Patients with Narcolepsy or Idiopathic Hypersomnia: A Multi-Centre Cross-Sectional Study.

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    Keisuke Suzuki

    Full Text Available Because the prevalence and characteristics of primary headache have yet to be thoroughly studied in patients with hypersomnia disorders, including narcolepsy and idiopathic hypersomnia, we examined these parameters in the Japanese population.In a multicentre cross-sectional survey, among 576 consecutive outpatients with sleep disorders, 68 narcolepsy patients and 35 idiopathic hypersomnia patients were included. Additionally, 61 healthy control subjects participated. Semi-structured headache questionnaires were administered to all participants.The patients with narcolepsy (52.9% and idiopathic hypersomnia (77.1% more frequently experienced headache than the healthy controls (24.6%; p<0.0001. The prevalence rates were 23.5%, 41.2% and 4.9% for migraine (p<0.0001 and 16.2%, 23.5% and 14.8% (p = 0.58 for tension-type headache among the narcolepsy patients, the idiopathic hypersomnia patients and the control subjects, respectively. Those who experienced migraine more frequently experienced excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of ≥10, than those who did not experience headache among the patients with narcolepsy (93.8% vs. 65.6%, p = 0.040 and idiopathic hypersomnia (86.7% vs. 37.5%, p = 0.026. Dream-enacting behaviour (DEB, as evaluated by the rapid eye movement sleep disorders questionnaire, was more frequently observed in the narcolepsy patients than in the idiopathic hypersomnia patients and the control subjects. An increased DEB frequency was observed in the narcolepsy patients with migraines compared to those without headache.Migraines were frequently observed in patients with narcolepsy and idiopathic hypersomnia. DEB is a characteristic of narcolepsy patients. Further studies are required to assess the factors that contribute to migraines in narcolepsy and idiopathic hypersomnia patients.

  12. Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study.

    Science.gov (United States)

    Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

    2015-02-01

    This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS) and DNA sequence analysis. Susceptibility testing was performed using the European Committee for Antimicrobial Susceptibility Testing (EUCAST) method and breakpoints. The yeasts originated from superficial infections (SUP, 51.5 %), bloodstream infections (BSI, 31.6 %) and deep-seated infections (DEEP, 16.9 %), from patients of all ages. Nine genera and 30 species were identified. The 20 Candida species accounted for 94.6 % of all isolates. C. albicans was the overall leading pathogen (50.5 %). Lodderomyces elongisporus is reported for the first time as a fungaemia cause in Europe. C. glabrata and Saccharomyces cerevisiae, as well as the non-Candida spp. and non-albicans Candida spp. groups, showed decreased fluconazole susceptibility (fluconazole resistance was 10.2 %. C. krusei accounted for 27 of the 56 fluconazole-resistant isolates. The overall voriconazole resistance was 2.5 % and was due mainly to C. glabrata and C. tropicalis isolates. Fluconazole resistance rates for the three categories of infection were similar to the overall value; voriconazole resistance rates differed: 4 % for BSI, 3.2 % for DEEP and 1.4 % for SUP. The antifungal activity of MXP-4509 was superior to voriconazole against C. glabrata and many fluconazole-resistant isolates. There was a large percentage of non-albicans Candida isolates. A large part of the high fluconazole resistance was not acquired but intrinsic, resulting from the high percentage of C. krusei.

  13. Assessment of ventricular function with first-pass radionuclide angiography using technetium 99m hexakis-2-methoxyisobutylisonitrile: A European multicentre study

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    Bisi, G.; Sciagra, R. (Florence Univ. (Italy). Dipt. di Fisiopatologia Clinica); Buell, U. (Technische Hochschule Aachen (Germany, F.R.). Medizinische Fakultaet); Britton, K.E. (Saint Bartholomew' s Hospital, London (UK). Dept. of Nuclear Medicine); Eilles, C. (Luitpoldkrankenhaus, Wuerzburg (Germany, F.R.)); Eissner, D.; Hahn, K. (Mainz Univ. (Germany, F.R.). Klinikum); Hoeffken, H.; Joseph, K. (Marburg Univ. (Germany, F.R.). Klinikum); McKillop, J.H. (Royal Infirmary, Glasgow (UK). Dept. of Medicine); Larock, M.P.; Rigo, P. (Centre Hospitalier Universitaire Sart-Tilman, Tilman (Belgium). Service de Medecine Nucleaire); Mueller, S.P.; Reiners, C. (Essen Univ. (Gesamthochschule) (Germany, F.R.). Klinikum)

    1991-03-01

    In the context of a multicentre study on the use of technetium 99m hexakis-2-methoxyisobutylisonitrile ({sup 99m}Tc-Sestamibi), we evaluated the accuracy of the ventricular function assessed at rest by means of first-pass radionuclide angiocardiography acquired during the injection of the tracer for myocardial perfursion scintigraphy. The results were compared with first-pass studies performed using reference tracers sodium pertechnetate Tc 99m or technetium 99m diethylene triamine penta-acetic acid or with gated radionuclide angiocardiography. A total of 66 patients of the 105 enrolled in the study could be evaluated. The comparison of the first-pass studies was possible in 33 subjects with regard to the left ventricular ejection fraction, yielding r=0.909 (P<10{sup -6}), and in 22 cases with regard to the right ventricular ejection fraction, yielding r=0.712 (P<0.001). The comparison between the first-pass study using {sup 99m}Tc-Sestamibi and the equilibrium gated radionuclide angiocardiography was possible for the left ventricular ejection fraction in 26 cases, with r = 0.937 (P<10{sup -6}), and for the right ventricular ejection fraction in 15 subjects, with r=0.783 (P<0.001). In conclusion, the assessment of ventricular function performed by acquiring a first-pass radionuclide angiocardiograph during the injection of {sup 99m}Tc-Sestamibi for perfusion myocardial scintigraphy can be considered reliable and accurate, when compared with the usually employed techniques. This result confirms the feasibility of a combined evaluation of perfusion and function at rest and during stress testing, which represents one of the most interesting advantages offered by the use of {sup 99m}Tc-Sestamibi. (orig.).

  14. Patterns and predictors of sitting time over ten years in a large population-based Canadian sample: Findings from the Canadian Multicentre Osteoporosis Study (CaMos).

    Science.gov (United States)

    Gebel, Klaus; Pont, Sarah; Ding, Ding; Bauman, Adrian E; Chau, Josephine Y; Berger, Claudie; Prior, Jerilynn C

    2017-03-01

    Our objective was to describe patterns and predictors of sedentary behavior (sitting time) over 10 years among a large Canadian cohort. Data are from the Canadian Multicentre Osteoporosis Study, a prospective study of women and men randomly selected from the general population. Respondents reported socio-demographics, lifestyle behaviors and health outcomes in interviewer-administered questionnaires; weight and height were measured. Baseline data were collected between 1995 and 1997 (n = 9418; participation rate = 42%), and at 5- (n = 7648) and 10-year follow-ups (n = 5567). Total sitting time was summed across domain-specific questions at three time points and dichotomized into "low" (≤ 7 h/day) and "high" (> 7 h/day), based on recent meta-analytic evidence on time sitting and all-cause mortality. Ten-year sitting patterns were classified as "consistently high", "consistently low", "increased", "decreased", and "mixed". Predictors of sedentary behavior patterns were explored using chi-square tests, ANOVA and logistic regression. At baseline (mean age = 62.1 years ± 13.4) average sitting was 6.9 h/day; it was 7.0 at 5- and 10-year follow-ups (p for trend = 0.12). Overall 23% reported consistently high sitting time, 22% consistently low sitting, 14% decreased sitting, 17% increased sitting with 24% mixed patterns. Consistently high sitters were more likely to be men, university educated, full-time employed, obese, and to report consistently low physical activity levels. This is one of the first population-based studies to explore patterns of sedentary behavior (multi-domain sitting) within men and women over years. Risk classification of sitting among many adults changed during follow-up. Thus, studies of sitting and health would benefit from multiple measures of sitting over time.

  15. Multicentre, randomized, open-label study of on-demand treatment with two prophylaxis regimens of recombinant coagulation factor IX in haemophilia B subjects.

    Science.gov (United States)

    Valentino, L A; Rusen, L; Elezovic, I; Smith, L M; Korth-Bradley, J M; Rendo, P

    2014-05-01

    Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on-demand therapy. Male subjects aged 6-65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open-label, four-period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on-demand therapy. In the intent-to-treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on-demand period, the 50 IU kg(-1) twice-weekly period, and the 100 IU kg(-1) once-weekly period respectively. Differences in ABR between the first on-demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg(-1) twice weekly or 100 IU kg(-1) once weekly reduced ABR by 89.4% relative to on-demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B.

  16. Tolerability and efficacy of paliperidone ER compared to olanzapine in the treatment of schizophrenia: A randomized, double-blind, multicentric trial

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    Sandip Shah

    2011-01-01

    Full Text Available Background: Paliperidone is an active metabolite of risperidone and actss through a combination of central dopamine Type 2 (D2 and serotonin Type 2 (5HT2A receptor antagonism. Aim: The present randomized, double-blind, multicentric trial was designed to determine the safety and efficacy of paliperidone extended release (ER compared to olanzapine in the treatment of acute schizophrenia. Materials and Methods: A total of 214 patients with diagnosis of schizophrenia were randomized to paliperidone ER (n=109 and olanzapine (n=106 treatment groups. Totally 206 patients were evaluated for efficacy parameters using Positive and negative syndrome scale (PANSS score and Clinical Global Impression-severity of illness (CGI-S and Clinical Global Impression-improvement of illness (CGI-I scales. Safety was assessed by treatment-emergent adverse events and movement disorders. Results: All patients showed significant reduction in PANSS scores at the end of treatment. However, the results were comparable and there was no significant difference at the end of the trial between paliperidone ER group and olanzapine group. Both the treatment groups showed decrease in the severity of illness and improvement in symptomatology. The most common adverse events reported in paliperidone ER versus olanzapine group were Extra Pyramidal Syndrome (EPS (13.7% vs. 15.6%, headache (12.7% vs. 8.9%, increased appetite (8.8% vs. 10.0% and drowsiness (4.9% vs. 303%. There was no clinically relevant difference in change from baseline to the end of the trial in abnormal involuntary movement scale (AIMS and barnes akathisia rating scale (BARS total scores between both the groups. Conclusion: Paliperidone ER is effective in controlling schizophrenic symptoms as well as exhibits comparable tolerability profile. Thus, paliperidone ER has the potential to be a useful new treatment option for patients with schizophrenia.

  17. SIMBOSPROST: Prevalence of metabolic syndrome and osteoporosis in prostate cancer patients treated with radiotherapy and androgen deprivation therapy: A multicentre, cross-sectional study

    Science.gov (United States)

    Samper Ots, Pilar Ma; Muñoz García, Julia Luisa; Ríos Kavadoy, Yesika; Couselo Paniagua, Ma Luz; Villafranca Iturre, Elena; Rodríguez Liñán, Milagrosa; Pérez Casas, Ana María; Soria, Rodrigo Muelas; Martínez, Blanca Ludeña; Torrecilla, José López; Giner, Manuel Casaña; Laborda, Almudena Zapatero; García-Salazar, Ma Magdalena Márquez

    2015-01-01

    Aim To assess the prevalence of metabolic syndrome (MetS) and osteoporosis in patients with prostate cancer (PCa) treated with radical radiotherapy (RT) with or without androgen deprivation therapy (ADT). Background Worldwide, the prevalence of MetS is estimated to range from 20% to 25% of the adult population. However, prevalence rates are much higher in PCa patients (pts) who undergo ADT. Materials and methods Multicentre cross-sectional study of 270 pts in Spain with PCa. Patients were divided into 3 groups based on the duration of ADT (6, 12–18, ≥24 months) and compared to a control group without ADT. MetS was defined according to NCEP ATP III criteria. Osteoporosis was assessed by DEXA. Results A total of 270 pts, treated from November 2011 to October 2012, were included. Of these, 122 pts (47%) fulfilled the criteria for MetS. The median age of this group was significantly higher (71.3 vs. 69.38 years, p = 0.028). MetS prevalence was 50% in the control group. In pts who received ADT, prevalence was 44.8% after 6 months of ADT, 45.3% after 12–18 months, and 50% after ≥24 months (pns). Most pts (168/270; 62%) underwent DEXA. Of those tested, 78 (46.4%) had osteopenia and only 11 (6.5%) had osteoporosis. Conclusions The prevalence of MetS in pts with PCa treated with radical RT was higher (47%) than in the general population. However, there were no significant differences in the duration of ADT administration. The prevalence of osteoporosis was low. These findings suggest that the prevalence of MetS in PCa patients may be higher than previously reported. PMID:26549995

  18. The effect of using NHS number as the unique identifier for patients who self-harm: a multi-centre descriptive study

    Directory of Open Access Journals (Sweden)

    Lilley Rachael

    2007-09-01

    Full Text Available Abstract Background Processing personal data for research purposes and the requirement of anonymity has been the subject of recent debate. We aimed to determine the proportion of individuals who present to emergency departments with non-fatal suicidal behavior where an NHS number has been successfully traced and to investigate the characteristics of patients associated with non-capture. Method This was a descriptive study of people attending after self-harm using allocation of NHS numbers as main outcome measurement. Data from the Multicentre Monitoring of Self-Harm Project from 3 centres in England were used to identify consecutive patients (N = 3000 who were treated in six emergency departments in Oxford, Manchester and Leeds in 2004 and 2005 following self-harm. Results NHS number was available between 55–73% of individuals across centres. Characteristics associated with non-recording of NHS number in more than one centre included those from ethnic minority groups (Oxford: chi-squared statistic = 13.6, df = 3, p = 0.004; Manchester: chi-squared statistic = 13.6, df = 3, p ≤0.001 and the homeless or living in a hostel or other institution (Oxford: chi-squared statistic = 40.9, df = 7, p = Conclusion Basing research studies on NHS number as the unique identifier, as suggested by the Data Protection Act 1998 and the Patient Information Advisory Group, would exclude some of the most vulnerable groups for further self-harm or suicide. This bias may also affect other research registers.

  19. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: Results of an open label, non-comparative, multi-centric, post marketing observational study

    Science.gov (United States)

    Kumbla, D.K.; Kumar, S.; Reddy, Y.V.; Trailokya, A.; Naik, M.

    2014-01-01

    Background Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. Objective To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. Material and methods An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. Results A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Conclusion Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

  20. Coexistence of IgM antihepatitis A virus and IgM antihepatitis E virus in acute viral hepatitis: a prospective, multicentre study in Korea.

    Science.gov (United States)

    Jang, J-H; Jung, Y M; Kim, J S; Lee, S H; Kim, J-W; Hwang, S G; Rim, K S; Park, S J; Park, Y M; Kang, S-K; Lee, H S; Yun, H; Kim, J-H; Jeong, S-H

    2011-10-01

    This study investigated the clinical, serological and molecular characteristics of coexistence of both immunoglobulin M (IgM) antihepatitis A virus (HAV) and IgM antihepatitis E virus (HEV) in acute viral hepatitis using a prospective, multicentre design. Among a total of 771 symptomatic cases with acute viral hepatitis enrolled in a Korean city from September 2006 to August 2008, coexistence of IgM anti-HAV and IgM anti-HEV was found in 43 patients (A+E group; 6%), while the existence of IgM anti-HAV alone was found in 595 patients (A group; 77%) and that of IgM anti-HEV alone in 14 patients (E group; 2%). Clinical data analysis and measurement of IgM and IgG anti-HEV were performed using two different commercial kits, and HAV RNA and HEV RNA were detected in available serum or stool samples. The clinical features of the A+E group were similar to those of the A group. HAV RNA detection rates in the A+E and A group were similar, while HEV RNA was detected only in the stool samples of the E group, not in the A+E group. Comparative testing of anti-HEV using two different ELISA kits showed markedly discordant results for IgM anti-HEV positivity and consistently low positivity for IgG anti-HEV in the A+E group. Coexistence of IgM anti-HEV measured by the Genelabs ELISA kit in the setting of hepatitis A appears to yield false-positive results in nonendemic areas of HEV infection. Diagnosis of hepatitis E using IgM anti-HEV should be made with caution.

  1. Five-year comparison of wear using oxidised zirconium and cobalt-chrome femoral heads in total hip arthroplasty: a multicentre randomised controlled trial.

    Science.gov (United States)

    Jassim, S S; Patel, S; Wardle, N; Tahmassebi, J; Middleton, R; Shardlow, D L; Stephen, A; Hutchinson, J; Haddad, F S

    2015-07-01

    Oxidised zirconium (OxZi) has been developed as an alternative bearing surface for femoral heads in total hip arthroplasty (THA). This study has investigated polyethylene wear, functional outcomes and complications, comparing OxZi and cobalt-chrome (CoCr) as part of a three-arm, multicentre randomised controlled trial. Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and highly cross-linked polyethylene (XLPE) liner; Group B received an OxZi femoral head and XLPE liner; Group C received an OxZi femoral head and ultra-high molecular weight polyethylene (UHMWPE) liner. At five years, 368 patients had no statistically significant differences in short-form-36 (p = 0.176 mental, p = 0.756 physical), Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.847), pain scores (p = 0.458) or complications. The mean rate of linear wear was 0.028 mm/year (standard deviation (SD) 0.010) for Group A, 0.023 mm/year (SD 0.010) for Group B, and 0.09 mm/year (SD 0.045) for Group C. Penetration was significantly higher in the UHMWPE liner group compared with both XLPE liner groups (p < 0.001) but no significant difference was noted between CoCr and OxZi when articulating with XLPE (p = 0.153). In this, the largest randomised study of this bearing surface, it appears that using a XLPE acetabular liner is more important in reducing THA component wear than the choice of femoral head bearing, at mid-term follow-up. There is a non-significant trend towards lower wear, coupling OxZi rather than CoCr with XLPE but long-term analysis is required to see if this observation changes with time and becomes significant.

  2. MonitorNet: the Italian multi-centre observational study aimed at estimating the risk/benefit profile of biologic agents in real-world rheumatology practice.

    Science.gov (United States)

    Sfriso, P; Salaffi, F; Montecucco, C M; Bombardieri, S; Todesco, S

    2009-01-01

    MonitorNet is a database established by the Italian Society of Rheumatology (SIR) in January 2007 and funded by the Italian Medicines Agency (AIFA), for the active long-term follow-up of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis treated with biologic agents. All hospital Rheumatology Units in Italy were invited to participate in a non-interventional, observational, epidemiological study. The study is conducted in a routine clinical setting (real-world practice) where biologics are prescribed on the basis of current recommendations. In this report we describe the design, methodology, and present preliminary data of the study. At the time of the analysis (April 2009) the database included 3510 patients: 2469 (70.3%) with established RA, 675 (19.2%) with PsA and 366 (10.4%) with AS. The cumulative follow up period was 8,787 patient-years (RA: 8,388, PsA: 157; AS: 242). There were 1,538 adverse events in 938 (26.7%) patients. Infections were recorded in 630 patients, skin-related adverse events in 142 and post-infusion reactions in 90. A total of 30 malignancies were reported. An interim analysis of efficacy was conducted on 2,148 RA patients. Seven hundred and thirty-one patients (35.8%) achieved EULAR remission (defined as DAS28<2.4). When assessed with the more restrictive CDAI and SDAI criteria, the frequency of remission was lower (17.9% and 14.7% respectively). Availability of funding for this study provided an opportunity to organize a collaborative national network of rheumatology clinics to develop a large multicentre observational study.

  3. Multicentric and contralateral invasive tumors identified with pre-op MRI in patients newly diagnosed with ductal carcinoma in situ of the breast.

    Science.gov (United States)

    Hollingsworth, Alan B; Stough, Rebecca G

    2012-09-01

    Preoperative breast MRI in newly diagnosed cancer patients has several potential benefits. Improved survival for patients with invasive disease as the index lesion is unlikely to be one of these benefits, given what is known from variations in locoregional management in the historic conservation trials. However, this may not be the case for patients with ductal carcinoma in situ (DCIS), as the discovery of unsuspected invasive cancer located elsewhere from the biopsy-proven DCIS could result in decreased survival if left undetected and untreated. In support of this hypothesis, a previous observational study of a large cohort of DCIS patients revealed the development of invasive cancer to be the most common event after unilateral DCIS treatment, occurring in 3.9%, mostly in the opposite breast. These cancers appeared on mammography or clinical exam within a short time frame (median 2.9 years) and were associated with a diminution in survival. Given these second events occurring so soon after DCIS treatment, it must be considered that invasive cancers were present elsewhere, but mammographically occult, at the time of DCIS diagnosis. To examine this possibility, 288 consecutive patients with newly diagnosed DCIS underwent preoperative MRI, with the discovery of separate foci of invasive cancer, either multicentric or contralateral, occurring in 3.5% of patients, a similar incidence to the short-term observational study. These "elsewhere" invasive cancers are presented here with details of pathology such that both Stage I and Stage II disease can be seen as clinically significant, with the usual stage-based survival implications.

  4. Associations of individual and family eating patterns during childhood and early adolescence: a multicentre European study of associated eating disorder factors.

    Science.gov (United States)

    Krug, Isabel; Treasure, Janet; Anderluh, Marija; Bellodi, Laura; Cellini, Elena; Collier, David; Bernardo, Milena di; Granero, Roser; Karwautz, Andreas; Nacmias, Benedetta; Penelo, Eva; Ricca, Valdo; Sorbi, Sandro; Tchanturia, Kate; Wagner, Gudrun; Fernández-Aranda, Fernando

    2009-03-01

    The objective of this study was to examine whether there is an association between individual and family eating patterns during childhood and early adolescence and the likelihood of developing a subsequent eating disorder (ED). A total of 1664 participants took part in the study. The ED cases (n 879) were referred for assessment and treatment to specialized ED units in five different European countries and were compared to a control group of healthy individuals (n 785). Participants completed the Early Eating Environmental Subscale of the Cross-Cultural (Environmental) Questionnaire, a retrospective measure, which has been developed as part of a European multicentre trial in order to detect dimensions associated with ED in different countries. In the control group, also the General Health Questionnaire-28 (GHQ-28), the semi-structured clinical interview (SCID-I) and the Eating Attitudes Test (EAT-26) were used. Five individually Categorical Principal Components Analysis (CatPCA) procedures were adjusted, one for each theoretically expected factor. Logistic regression analyses indicated that the domains with the strongest effects from the CatPCA scores in the total sample were: food used as individualization, and control and rules about food. On the other hand, healthy eating was negatively related to a subsequent ED. When differences between countries were assessed, results indicated that the pattern of associated ED factors did vary between countries. There was very little difference in early eating behaviour on the subtypes of ED. These findings suggest that the fragmentation of meals within the family and an excessive importance given to food by the individual and the family are linked to the later development of an ED.

  5. Effect of Providing Multiple Micronutrients in Powder through Primary Healthcare on Anemia in Young Brazilian Children: A Multicentre Pragmatic Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Marly A Cardoso

    Full Text Available Multiple micronutrients in powder (MNP are recommended by WHO to prevent anemia in young children. However, evidences for its effectiveness in different populations and improvements in other outcomes (e.g. linear growth and vitamin A deficiency are scarce.A multicentre pragmatic controlled trial was carried out in primary health centres. At study baseline, a control group (CG of children aged 10- to 14 months (n = 521 was recruited in the routine healthcare for assessing anemia, anthropometric and micronutrient status. At the same time, an intervention group (IG of infants aged 6- to 8 months (n = 462 was recruited to receive MNP daily in complementary feeding over a period of 60 days. Both study groups were compared when the IG infants reached the age of the CG children at enrolment.In CG, the prevalence of anemia [hemoglobin (Hb 8.3 mg/L, and vitamin A deficiency (VAD, serum retinol < 0.70μmol/L were 23.1%, 37.4%, and 17.4%, respectively. Four to six months after enrolment, when the IG participants had the same age of the controls at the time of testing, the prevalence of anemia, ID and VAD in IG were 14.3%, 30.1% and 7.9%, respectively. Adjusting for city, health centre, maternal education, and age, IG children had a lower likelihood of anemia and VAD [Prevalence Ratio (95% CI = 0.63 (0.45, 0.88 and 0.45 (0.29, 0.69, respectively] when compared with CG children. The adjusted mean distributions of Hb and length-for-age Z-scores improved by 2 SE in the IG compared to CG children.MNP effectively reduced anemia and improved growth and micronutrient status among young Brazilian children.Registro Brasileiro de Ensaios Clinicos RBR-5ktv6b.

  6. Improved detection of chromosomal abnormalities in chronic lymphocytic leukemia by conventional cytogenetics using CpG oligonucleotide and interleukin-2 stimulation: A Belgian multicentric study.

    Science.gov (United States)

    Put, Natalie; Konings, Peter; Rack, Katrina; Jamar, Mauricette; Van Roy, Nadine; Libouton, Jeanne-Marie; Vannuffel, Pascal; Sartenaer, Daniel; Ameye, Geneviève; Speleman, Frank; Herens, Christian; Poirel, Hélène A; Moreau, Yves; Hagemeijer, Anne; Vandenberghe, Peter; Michaux, Lucienne

    2009-10-01

    We performed a multicentric study to assess the impact of two different culture procedures on the detection of chromosomal abnormalities in 217 consecutive unselected cases with chronic lymphocytic leukemia (CLL) referred for routine analysis either at the time of diagnosis (n = 172) or during disease evolution (n = 45). Parallel cultures of peripheral blood or bone marrow were set up with the addition of either the conventional B-cell mitogen 12-O-tetradecanoyl-phorbol-13-acetate (TPA) or a combination of CpG oligonucleotide (CpG) and interleukin-2 (IL-2). Cytogenetic analyses were performed on both cultures. Clonal abnormalities were identified in 116 cases (53%). In 78 cases (36%), the aberrant clone was detected in both cultures. Among these, the percentages of aberrant metaphases were similar in both conditions in 17 cases, higher in the CpG/IL-2 culture in 43 cases, and higher in the TPA culture in 18 cases. Clonal aberrations were detected in only one culture, either in CpG/IL-2 or TPA in 33 (15%) and 5 (2%) cases, respectively. Taken together, abnormal karyotypes were observed in 51% with CpG/IL-2 and 38% with TPA (P cytogenetic analysis in 80 cases: del(13q) (n = 71), del(11q) (n = 5), +12 (n = 2), del(14q) (n = 1), and del(17p) (n = 1). In conclusion, our results confirm that CpG/IL-2 stimulation increases the detection rate of chromosomal abnormalities in CLL compared with TPA and that further improvement can be obtained by FISH. However, neither conventional cytogenetics nor FISH detected all aberrations, demonstrating the complementary nature of these techniques.

  7. Intravesical administration of combined hyaluronic acid (HA) and chondroitin sulfate (CS) for the treatment of female recurrent urinary tract infections: a European multicentre nested case–control study

    Science.gov (United States)

    Ciani, Oriana; Arendsen, Erik; Romancik, Martin; Lunik, Richard; Costantini, Elisabetta; Di Biase, Manuel; Morgia, Giuseppe; Fragalà, Eugenia; Roman, Tomaskin; Bernat, Marian; Guazzoni, Giorgio; Tarricone, Rosanna; Lazzeri, Massimo

    2016-01-01

    Objectives To compare the clinical effectiveness of the intravesical administration of combined hyaluronic acid and chondroitin sulfate (HA+CS) versus current standard management in adult women with recurrent urinary tract infections (RUTIs). Setting A European Union-based multicentre, retrospective nested case–control study. Participants 276 adult women treated for RUTIs starting from 2009 to 2013. Interventions Patients treated with either intravesical administration of HA+CS or standard of care (antimicrobial/immunoactive prophylaxis/probiotics/cranberry). Primary and secondary outcome measures The primary outcome was occurrence of bacteriologically confirmed recurrence within 12 months. Secondary outcomes were time to recurrence, total number of recurrences, health-related quality of life and healthcare resource consumption. Crude and adjusted results for unbalanced characteristics are presented. Results 181 patients treated with HA+CS and 95 patients treated with standard of care from 7 centres were included. The crude and adjusted ORs (95% CI) for the primary end point were 0.77 (0.46 to 1.28) and 0.51 (0.27 to 0.96), respectively. However, no evidence of improvement in terms of total number of recurrences (incidence rate ratio (95% CI), 0.99 (0.69 to 1.43)) or time to first recurrence was seen (HR (95% CI), 0.99 (0.61 to 1.61)). The benefit of intravesical HA+CS therapy improves when the number of instillations is ≥5. Conclusions Our results show that bladder instillations of combined HA+CS reduce the risk of bacteriologically confirmed recurrences compared with the current standard management of RUTIs. Total incidence rates and hazard rates were instead non-significantly different between the 2 groups after adjusting for unbalanced factors. In contrast to what happens with antibiotic prophylaxis, the effectiveness of the HA+CS reinstatement therapy improves over time. Trial registration number NCT02016118. PMID:27033958

  8. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol

    Science.gov (United States)

    Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

    2016-01-01

    Introduction The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Methods and analysis Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. Ethics and dissemination This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of

  9. A randomised, double blind, placebo-controlled, multi-centric parallel arm trial to assess the effects of homoeopathic medicines on chronic rhinosinusitis

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2014-01-01

    Full Text Available Background: Chronic rhinosinusitis (CRS is one of the most common illnesses interfering with patient′s quality of life and work. Observational studies conducted by the Council indicate positive outcome. This protocol has been developed to ascertain the usefulness of homoeopathic intervention in comparison with control group in a randomised control setting. Objectives: Primary objective is to evaluate the changes in TSS (Total Symptoms Score and SNOT-22 (Sino-nasal Outcome Test-22 within the two groups of the study (Homoeopathy + Placebo. Secondary objective is to evaluate changes in SNOT-22 at end of the trial, changes in Lund and Mackay staging of CT scan, rhinoscopy grading, absolute eosinophil count, global assessment by investigator and patient, and number of acute exacerbations of CRS (for frequency, duration and intensity as per TSS scale compared to placebo. Methods/Design: This is a randomised double blind, placebo-controlled, multi-centric parallel arm trial of 6 months (three months treatment and three months observation period with 14 days run-in period. The primary outcome is a composite of the changes in the TSS and SNOT-22 over 3 months from baseline with area under the curve and changes over 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22 from baseline. Prescription shall be made as per the homoeopathic principles. Efficacy data will be analysed in the intention-to-treat population. Discussion: This trial will help to evaluate the efficacy of homoeopathic individualised treatment using LM-potencies versus placebo in patients suffering from CRS as per the homoeopathic dictum.

  10. Lack of relationship between EGFR-1 immunohistochemical expression and prognosis in a multicentre clinical trial of 93 patients with advanced primary ovarian epithelial cancer (GINECO group).

    Science.gov (United States)

    Elie, C; Geay, J F; Morcos, M; Le Tourneau, A; Girre, V; Broët, P; Marmey, B; Chauvenet, L; Audouin, J; Pujade-Lauraine, E; Camilleri-Broët, S

    2004-08-02

    Epidermal growth factor receptor 1 (EGFR-1) overexpression is usually described as linked with a worse prognosis in a variety of tumours of epithelial origin. However, its role in ovarian cancer is still controversial. The aim of the present study was to analyse the prognostic impact of EGFR-1 in a retrospective series of 93 stage III-IV primary ovarian epithelial tumours. All patients, enrolled in a multicentre GINECO prospective clinical trial, were treated with the same platinum-based combination chemotherapy, and were followed up with a median of 69 months. Epidermal growth factor receptor 1 plasma membrane expression, assessed by immunohistochemistry on paraffin-embedded tissues, was correlated with clinical parameters as well as immunohistochemical expression results of HER-2 (c-erbB-2), BAX, BCL-2, p53 and anti-Ki-67, previously studied in the same series of patients. Positive immunostaining for EGFR-1 was seen in 31 of the 93 analysed cases (33%). No correlation was found between EGFR-1 expression and clinical parameters. No correlation was found between EGFR-1 expression and other biological markers, except for HER-2, which was limit for significance. Indeed, among the EGFR-1-negative cases, 10.3% expressed HER-2, whereas the HER-2-expressing tumours accounted for 27.6% of EGFR-1-positive cases (P=0.06). Epidermal growth factor receptor 1 overexpression had no prognostic impact on both overall and progression-free survival through univariate and multivariate analyses. The potential effect of EGFR-1 and HER-2 co-expression on targeted therapy against EGFR-1 and/or HER-2 molecules has to be further analysed.

  11. Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: A multicentre, randomised, double-blind controlled trial.

    Science.gov (United States)

    Beraha, Esther M; Salemink, Elske; Goudriaan, Anna E; Bakker, Abraham; de Jong, David; Smits, Natasha; Zwart, Jan Willem; Geest, Dick van; Bodewits, Pieter; Schiphof, Tom; Defourny, Harma; van Tricht, Mirjam; van den Brink, Wim; Wiers, Reinout W

    2016-12-01

    Previous randomised placebo-controlled trials with low-to-medium doses of baclofen (30-60mg) showed inconsistent results, but case studies suggested a dose-response effect and positive outcomes in patients on high doses of baclofen (up to 270mg). Its prescription was temporary permitted for the treatment of alcohol dependence (AD) in France, and baclofen is now widely prescribed. Recently, a small RCT found a strong effect of a mean dose of 180mg baclofen. In the present study the efficacy and safety of high doses of baclofen was examined in a multicentre, double-blind, placebo-controlled trial. 151 patients were randomly assigned to either six weeks titration and ten weeks high-dose baclofen (N=58; up to 150mg), low-dose baclofen (N=31; 30mg), or placebo (N=62). The primary outcome measure was time to first relapse. Nine of the 58 patients (15.5%) in the high-dose group reached 150mg and the mean baclofen dose in this group was 93.6mg (SD=40.3). No differences between the survival distributions for the three groups were found in the time to first relapse during the ten-weeks high-dose phase (χ(2)=0.41; p=0.813) or the 16-weeks complete medication period (χ(2)=0.04; p=0.982). There were frequent dose-related adverse events in terms of fatigue, sleepiness, and dry mouth. One medication related serious adverse event occurred in the high-dose baclofen group. Neither low nor high doses of baclofen were effective in the treatment of AD. Adverse events were frequent, although generally mild and transient. Therefore, large-scale prescription of baclofen for the treatment of AD seems premature and should be reconsidered.

  12. Impact of attenuation correction and gated acquisition in SPECT myocardial perfusion imaging: results of the multicentre SPAG (SPECT Attenuation Correction vs Gated) study

    Energy Technology Data Exchange (ETDEWEB)

    Genovesi, Dario; Giorgetti, Assuero; Gimelli, Alessia; Kusch, Annette; D' Aragona Tagliavia, Irene; Casagranda, Mirta; Marzullo, Paolo [Fondazione CNR-Regione Toscana ' ' G. Monasterio' ' , Nuclear Medicine, Pisa (Italy); Cannizzaro, Giorgio [A.O.V. Cervello, Nuclear Medicine, Palermo (Italy); Giubbini, Raffaele; Bertagna, Francesco [Spedali Civili, Nuclear Medicine, Brescia (Italy); Fagioli, Giorgio; Rossi, Massimiliano; Romeo, Annadina [Ospedale Maggiore, Nuclear Medicine, Bologna (Italy); Bertolaccini, Pietro; Bonini, Rita [Ospedale SS Giacomo e Cristoforo, Nuclear Medicine, Massa (Italy)

    2011-10-15

    In clinical myocardial single photon emission computed tomography (SPECT), attenuation artefacts may cause a loss of specificity in the identification of diseased vessels that can be corrected by means of gated SPECT (GSPECT) acquisition or CT attenuation correction (AC). The purpose of this multicentre study was to assess the impact of GSPECT and AC on the diagnostic performance of myocardial scintigraphy, according to patient's sex, body mass index (BMI) and site of coronary artery disease (CAD). We studied a group of 104 patients who underwent coronary angiography within 1 month before or after the SPECT study. Patients with a BMI > 27 were considered ''overweight''. Attenuation-corrected and standard GSPECT early images were randomly interpreted by three readers blinded to the clinical data. In the whole group, GSPECT and AC showed a diagnostic accuracy of 86.5% (sensitivity 82%, specificity 93%) and 77% (sensitivity 75.4%, specificity 81.4%), respectively (p < 0.05). In women, when anterior ischaemia was matched with CAD, AC failed to show any increase in specificity (AC 63.6% vs GSPECT 63.6%) with evident loss of sensitivity (AC 72.7% vs GSPECT 90.9%). AC significantly improved SPECT specificity in the identification of right CAD in overweight men (AC 100% vs GSPECT 66.7%, p <0.05). AC improved specificity in the evaluation of right CAD in overweight men. In the other evaluable subgroups specificity was not significantly affected while sensitivity was frequently reduced. (orig.)

  13. Efficacy and safety of telmisartan vs. losartan in control of mild-to-moderate hypertension: a multicentre, randomised, double-blind study.

    Science.gov (United States)

    Zhu, J R; Bai, J; Cai, N S; Tang, B; Fan, W H; Guo, J Z; Ke, Y N; Guo, J X; Sheng, L H; Lu, Z Y; Cheng, N N

    2004-12-01

    This multicentre, randomised, double-blind, double-dummy, parallel-group study compared the efficacy and safety of telmisartan with those of losartan after 8 weeks' treatment. In total, 330 patients with mild-to-moderate hypertension (systolic blood pressure [SBP] mmHg; diastolic blood pressure [DBP] 95-109 mmHg) were randomly assigned to receive once-daily treatment with telmisartan 40 mg (n = 164) or losartan 50 mg (n = 166). After 4 weeks' treatment, if a patient's DBP was > or = 90 mmHg, the dose was increased to telmisartan 80 mg or losartan 100 mg, respectively. The results show that mean trough seated blood pressure was reduced significantly more in the telmisartan group than that in the losartan group (SBP 12.5 mmHg vs. 9.4 mmHg, p = 0.037; DBP 10.9 mmHg vs. 9.3 mmHg, p = 0.030). The overall DBP response rate (reduction from baseline in mean seated DBP > or = 10 mmHg and/or a mean seated DBP mmHg) at the end of the study in the telmisartan group was higher than that in losartan group (70.1% vs. 58.7%, p = 0.020). At both the low and high doses, the DBP response rates for telmisartan were significantly higher than those for losartan (telmisartan 40 mg vs. losartan 50 mg: 46.3% vs. 32.5%, p = 0.010; telmisartan 80 mg vs. losartan 100 mg: 79.3% vs. 65.3%, p = 0.008). Adverse events with the two treatments were comparable (telmisartan vs. losartan 23.2% vs. 22.9%, p = 0.952). Most events were mild in intensity and abated within 72 h. Thus, telmisartan 40 mg or 80 mg administered once daily can reduce SBP and DBP effectively and safely.

  14. Technetium-99m tetrofosmin rest/stress myocardial SPET with a same-day 2-hour protocol: comparison with coronary angiography. A Spanish-Portuguese multicentre clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Montz, R. [Univ. Complutense, Madrid (Spain); Perez-Castejon, M.J. [Univ. Complutense, Madrid (Spain); Jurado, J.A. [Inst. de Cardiologia, Madrid (Spain); Martin-Comin, J. [Hospital de Bellvitge, Hospitalet de Ll./Barcelona (Spain); Esplugues, E. [Hospital de Bellvitge, Hospitalet de Ll./Barcelona (Spain); Salgado, L. [Hospital de Santa Cruz, Carnaxide (Portugal); Ventosa, A. [Hospital de Santa Cruz, Carnaxide (Portugal); Cantinho, G. [Facultad de Medicina, Hospital Santa Maria, Lisbon (Portugal); Sa, E.P. [Facultad de Medicina, Hospital Santa Maria, Lisbon (Portugal); Fonseca, A.T. [Inst. Portugues de Oncologia (IPOFG), Lisbon (Portugal); Vieira, M.R. [Inst. Portugues de Oncologia (IPOFG), Lisbon (Portugal); Ortiz-Berrocal, J. [Universidad Autonoma de Madrid (Spain). Clinica Puerta de Hierro; Tabuenca, M.J. [Universidad Autonoma de Madrid (Spain). Clinica Puerta de Hierro; Garcia, A. [Hospital Clinico y Provincial, Barcelona (Spain); Magrina, J. [Hospital Clinico y Provincial, Barcelona (Spain); Ortega, D. [Hospital Valle de Hebron, Barcelona (Spain); Puente, C. [Hospital Regional Carlos Haya, Malaga (Spain); Ferrer, A.I. [Hospitals da Universidade, Coimbra (Portugal); Pedrosa, J. [Hospitals da Universidade, Coimbra (Portugal); Latre, J.M. [Hospital Reina Sofia, Cordoba (Spain); Carreras, J.L. [Univ. Complutense, Madrid (Spain)

    1996-06-01

    Technetium-99m tetrofosmin (Myoview) has unique properties for myocardial perfusion imaging very early after injection of the tracer. We used a very short same-day rest/stress protocol, to be performed within 2 h and evaluated its diagnostic accuracy. The study included 144 patients from seven Spanish and four Portuguese centres with a diagnosis of uncomplicated coronary artery disease (CAD); 78 patients (54%) had no history of prior myocardial infarction. Patients were injected with {<=}300 MBq {sup 99m}Tc-tetrofosmin at rest and {<=}900 MBq approximately 1 h later at peak exercise. Single-photon emission tomographic (SPET) acquisitions were initiated within 5-30 min post injection. The results were compared with those of coronary angiography (CA). The data of 142 patients were completely evaluable (two with non-evaluable images were excluded). The quality of rest images was excellent or good in 86%, regionally problematic in 7%, poor but well interpretable in 5% and non-evaluable in 2%. The overall sensitivity for the detection of CAD was 93%, the specificity 38% and the accuracy 85%. The localization of defects by SPET in relation the perfusion territories of stenosed vessels ({>=}=50%) was achieved with a sensitivity of 64% for the left anterior descending artery, 49% for the left circumflex artery and 86% for the right coronary artery, and an accuracy of 71%, 72% and 73% respectively. Concordance of SPET and CA was 62% for single-vessel disease and 68% for multivessel disease. In conclusion, this Spanish-Portuguese multicentre clinical trial confirmed, in a considerable number of patients who underwent coronary angiography, the feasibility of {sup 99m}Tc terofosmin (Myoview) rest/stress myocardial SPET using a very short protocol (2 h). (orig.)

  15. Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY)

    DEFF Research Database (Denmark)

    Lindhardt, Morten; Persson, Frederik; Currie, Gemma

    2016-01-01

    INTRODUCTION: Diabetes mellitus affects 9% of the European population and accounts for 15% of healthcare expenditure, in particular, due to excess costs related to complications. Clinical trials aiming for earlier prevention of diabetic nephropathy by renin angiotensin system blocking treatment...... to this high-risk population will increase power. We aim to confirm performance of CKD273 in a prospective multicentre clinical trial and test the ability of spironolactone to delay progression of early diabetic nephropathy. METHODS AND ANALYSIS: Investigator-initiated, prospective multicentre clinical trial......, with randomised double-masked placebo-controlled intervention and a prospective observational study. We aim to include 3280 type 2 diabetic participants with normoalbuminuria. The CKD273 classifier will be assessed in all participants. Participants with high-risk pattern are randomised to treatment...

  16. Multicentre prospective validation of a urinary peptidome-based classifier for the diagnosis of type 2 diabetic nephropathy

    NARCIS (Netherlands)

    Siwy, Justyna; Schanstra, Joost P.; Argiles, Angel; Bakker, Stephan J. L.; Beige, Joachim; Boucek, Petr; Brand, Korbinian; Delles, Christian; Duranton, Flore; Fernandez-Fernandez, Beatriz; Jankowski, Marie-Luise; Al Khatib, Mohammad; Kunt, Thomas; Lajer, Maria; Lichtinghagen, Ralf; Lindhardt, Morten; Maahs, David M.; Mischak, Harald; Mullen, William; Navis, Gerarda; Noutsou, Marina; Ortiz, Alberto; Persson, Frederik; Petrie, John R.; Roob, Johannes M.; Rossing, Peter; Ruggenenti, Piero; Rychlik, Ivan; Serra, Andreas L.; Snell-Bergeon, Janet; Spasovski, Goce; Stojceva-Taneva, Olivera; Trillini, Matias; von der Leyen, Heiko; Winklhofer-Roob, Brigitte M.; Zuerbig, Petra; Jankowski, Joachim

    2014-01-01

    Diabetic nephropathy (DN) is one of the major late complications of diabetes. Treatment aimed at slowing down the progression of DN is available but methods for early and definitive detection of DN progression are currently lacking. The 'Proteomic prediction and Renin angiotensin aldosterone system

  17. The feasibility of using 'bring your own device' (BYOD) technology for electronic data capture in multicentre medical audit and research.

    Science.gov (United States)

    Faulds, M C; Bauchmuller, K; Miller, D; Rosser, J H; Shuker, K; Wrench, I; Wilson, P; Mills, G H

    2016-01-01

    Large-scale audit and research projects demand robust, efficient systems for accurate data collection, handling and analysis. We utilised a multiplatform 'bring your own device' (BYOD) electronic data collection app to capture observational audit data on theatre efficiency across seven hospital Trusts in South Yorkshire in June-August 2013. None of the participating hospitals had a dedicated information governance policy for bring your own device. Data were collected by 17 investigators for 392 individual theatre lists, capturing 14,148 individual data points, 12, 852 (91%) of which were transmitted to a central database on the day of collection without any loss of data. BYOD technology enabled accurate collection of a large volume of secure data across multiple NHS organisations over a short period of time. Bring your own device technology provides a method for collecting real-time audit, research and quality improvement data within healthcare systems without compromising patient data protection.

  18. Direct evidence of a multicentre halogen bond: unexpected contraction of the P-XXX-P fragment in triphenylphosphine dihalides.

    Science.gov (United States)

    Nikitin, Kirill; Müller-Bunz, Helge; Gilheany, Declan

    2013-02-18

    Triphenylhalophosphonium halides, Ph(3)PX(2), form crystals comprising bridged linear cations [Ph(3)P-X-X-X-PPh(3)](+) where the X(3) bridge is shortened from 6.56 Å in Cl-Cl-Cl to 6.37 Å in the Br-Br-Br system. It is proposed that this structure is stabilised by five-centre/six-electron (5c-6e) hypervalent interactions.

  19. Design and implementation of a hospital information system for the Palestine Red Crescent Society in Lebanon.

    Science.gov (United States)

    Rossi, L; Materia, E; Hourani, A; Yousef, H; Racalbuto, V; Venier, C; Osman, M

    2009-01-01

    A case-mix hospital information system was designed and implemented in Palestine Red Crescent Society hospitals in order to support the network of Palestinian hospitals in Lebanon and to improve the health of refugees in the country. The system is based on routine collection of essential administrative and clinical data for each episode of hospitalization, relying on internationally accepted diagnostic codes. It is a computerized, user-friendly information system that is a stepping-stone towards better hospital management and evaluation of quality of care. It is also a useful model for the development of hospital information systems in Lebanon and in the Near East.

  20. Selegiline transdermal system: in the treatment of major depressive disorder.

    Science.gov (United States)

    Frampton, James E; Plosker, Greg L

    2007-01-01

    The monamine oxidase (MAO) inhibitor selegiline is selective for MAO-B at the low oral dosages used in the treatment of Parkinson's disease. However, MAO-A is also inhibited at the high oral dosages needed to effectively treat depression (not an approved indication), necessitating a tyramine-restricted diet. The selegiline transdermal system was designed to deliver antidepressant drug concentrations to the CNS, without substantially impairing small intestine MAO-A activity. At the target dose of 6 mg/24 hours, tyramine dietary restrictions are not needed. Short-term treatment with fixed (6 mg/24 hours) or flexible (6, 9 or 12 mg/24 hours) doses of selegiline transdermal system was superior to placebo on most measures of antidepressant activity in 6- or 8-week, randomised, double-blind, multicentre studies in adult outpatients with major depressive disorder (MDD). Likewise, long-term treatment with a fixed dose of selegiline transdermal system 6 mg/24 hours was superior to placebo as maintenance therapy in a 52-week, randomised, double-blind, multicentre, relapse-prevention trial in patients with MDD. Selegiline transdermal system therapy was generally well tolerated in placebo-controlled studies; application site reactions, mostly of mild to moderate severity, were the most commonly reported adverse events. The incidence of sexual adverse effects and weight gain was low and similar to that with placebo.

  1. Complicaciones de la nutrición enteral domiciliaria: Resultados de un estudio multicéntrico Complications of enteral nutrition at home: Results of a multi-centre trial

    Directory of Open Access Journals (Sweden)

    C. Gómez Candela

    2003-06-01

    Full Text Available Objetivo: A pesar del número creciente de nutrición enteral domiciliaria (NED, sólo algunos artículos recogen la frecuencia de sus complicaciones. Este estudio multicéntrico analiza estas complicaciones en relación a la vía de acceso y la duración del soporte nutricional. Método: Seleccionamos aleatoriamente 92 pacientes con NED de 8 hospitales y se distribuyeron en relación a la duración del soporte y a la vía de acceso: sonda nasogástrica (SNG y gastrostomías percutánea o quirúrgica. Tras un programa educativo, los pacientes completaron un cuestionario inicial que se repitió en los días 15 y 30. Recibieron una media de 1.650 kcal de fórmula enteral. Se analizaron un total de 2.760 días prospectivos de NED. Resultados: En la fase prospectiva, el 42% de los pacientes tuvo alguna complicación (112 episodios. Los más frecuentes fueron digestivos (55% y mecánicos (29%; se registraron 0,16 complicaciones por paciente-año. Las complicaciones más comunes fueron: extracción (15%, estreñimiento (13%, vómitos (12% y diarrea (10%. El grupo de gastrostomía tuvo más complicaciones digestivas. En el análisis retrospectivo, el grupo de gastrostomía percutánea tuvo menos complicaciones y el de SNG requirió más recambios de sondas (4 frente a 2 y tuvieron 1,96 complicaciones/paciente (grupo de gastrostomía percutánea 1,85 y quirúrgica 3,1. Conclusión: La NED es segura y presenta una baja incidencia de complicaciones. Un programa educativo adecuado es muy útil y esperamos, en el futuro, contribuir a un mejor sistema de atención domiciliaria.Aim: In spite of the increasing number of home enteral nutrition (HEN patients, only few articles had reported the frequency of complications related to this treatment. Our multicentric study analyzes the HEN complications in relation to access device and time of treatment. Method: 92 HEN patients from 8 hospitals were randomly selected. Patients were distributed in relation to the

  2. Moral imperialism and multi-centric clinical trials in peripheral countries Imperialismo moral e ensaios clínicos multicêntricos em países periféricos

    Directory of Open Access Journals (Sweden)

    Volnei Garrafa

    2008-10-01

    Full Text Available Moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. Examples of Direct Moral Imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central countries in poor and developing (peripheral countries, particularly projects related to the theory of double standards in research. After the WMA General Assembly refused to change the Helsinki Declaration - which would have given moral recognition to the above mentioned theory - the USA abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect America's best interests. Individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of Indirect Moral Imperialism. The paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.Imperialismo moral é a intenção de impor padrões morais de determinadas culturas, regiões geopolíticas e países a outras culturas, regiões ou países. O Imperialismo Moral Direto pode ser exemplificado com diversos episódios recorrentes de ensaios clínicos multicêntricos promovidos por países desenvolvidos (centrais em países pobres e em desenvolvimento (periféricos, especialmente projetos relacionados com a teoria do "double standard" de pesquisas. Com a recusa da Assembléia Geral da Associação Médica Mundial em alterar a Declaração de Helsinki, que significaria o reconhecimento moral da referida teoria, os Estados Unidos abandonaram a declaração, passando a promover

  3. Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for diagnosis of colonic cancer in older symptomatic patients: The SIGGAR study

    Directory of Open Access Journals (Sweden)

    Edwards Rob

    2007-10-01

    Full Text Available Abstract Background and Aims The standard whole-colon tests used to investigate patients with symptoms of colorectal cancer are barium enema and colonoscopy. Colonoscopy is the reference test but is technically difficult, resource intensive, and associated with adverse events, especially in the elderly. Barium enema is safer but has reduced sensitivity for cancer. CT colonography ("virtual colonoscopy" is a newer alternative that may combine high sensitivity for cancer with safety and patient acceptability. The SIGGAR trial aims to determine the diagnostic efficacy, acceptability, and economic costs associated with this new technology. Methods The SIGGAR trial is a multi-centre randomised comparison of CT colonography versus standard investigation (barium enema or colonoscopy, the latter determined by individual clinician preference. Diagnostic efficacy for colorectal cancer and colonic polyps measuring 1 cm or larger will be determined, as will the physical and psychological morbidity associated with each diagnostic test, the latter via questionnaires developed from qualitative interviews. The economic costs of making or excluding a diagnosis will be determined for each diagnostic test and information from the trial and other data from the literature will be used to populate models framed to summarise the health effects and costs of alternative approaches to detection of significant colonic neoplasia in patients of different ages, prior risks and preferences. This analysis will focus particularly on the frequency, clinical relevance, costs, and psychological and physical morbidity associated with detection of extracolonic lesions by CT colonography. Results Recruitment commenced in March 2004 and at the time of writing (July 2007 5025 patients have been randomised. A lower than expected prevalence of end-points in the barium enema sub-trial has caused an increase in sample size. In addition to the study protocol, we describe our approach to

  4. A Prospective, Multicentre, Open-Label Single-Arm Exploratory Study to Evaluate Efficacy and Safety of Saroglitazar on Hypertriglyceridemia in HIV Associated Lipodystrophy.

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    Alka Deshpande

    Full Text Available This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy.During this 12-week prospective, multi-centric, open-label, single arm exploratory study, 50 patients were enrolled to receive saroglitazar 4 mg orally once daily in the morning before breakfast. The primary efficacy endpoint was the percent change in triglyceride (TG levels from baseline to Week 6 and Week 12. The secondary efficacy endpoints were assessment of low-density-lipoprotein (LDL, very-low-density-lipoprotein (VLDL, high-density-lipoprotein (HDL, non-HDL cholesterol, total cholesterol, apo-lipoprotein (Apo A1, Apo B, and C-peptide and fasting insulin for HOMA beta and HOMA IR. Safety assessment was performed during the study.Saroglitazar 4 mg significantly decreased the serum TG levels from baseline at Week 6 (percent change: -40.98; 95% CI: -50.82, -31.15 and Week 12 (percent change -45.11; 95% CI: -52.37, -37.86. Reduction in VLDL cholesterol (percent change: -46.33; 95% CI: -52.89, -39.76 and total cholesterol (percent change: 7.37; 95% CI: 1.96, 12.78 was observed at week 12 from baseline. Saroglitazar increased HDL cholesterol (percent change: 34.56, 95% CI: 22.22, 46.90, Apo A1 (percent change: 33.16; 95% CI: 18.69, 47.63 and Apo B (percent change: 10.55, 95% CI: 2.86, 18.25 levels at week 12 from baseline. Saroglitazar treatment led to increase in the C-peptide (percent change: 59.42, 95% CI: 48.78, 70.06, fasting insulin levels (percent change: 47.10; 95% CI: 38.63, 55.57, HOMA of beta cell function for C-peptide (percent change: 71.67; 95% CI: 39.09, 104.26 and HOMA of insulin resistance for C-peptide (percent change: 58.29, 95% CI: 46.74, 69.83 at week 12 from baseline. Saroglitazar treatment was safe and well tolerated in this study.Overall, the observed changes in lipid profile after 12 weeks of saroglitazar treatment were in the direction of improvement in patients with HIV

  5. Breast density as indicator for the use of mammography or MRI to screen women with familial risk for breast cancer (FaMRIsc: a multicentre randomized controlled trial

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    Saadatmand Sepideh

    2012-10-01

    Full Text Available Abstract Background To reduce mortality, women with a family history of breast cancer often start mammography screening at a younger age than the general population. Breast density is high in over 50% of women younger than 50 years. With high breast density, breast cancer incidence increases, but sensitivity of mammography decreases. Therefore, mammography might not be the optimal method for breast cancer screening in young women. Adding MRI increases sensitivity, but also the risk of false-positive results. The limitation of all previous MRI screening studies is that they do not contain a comparison group; all participants received both MRI and mammography. Therefore, we cannot empirically assess in which stage tumours would have been detected by either test. The aim of the Familial MRI Screening Study (FaMRIsc is to compare the efficacy of MRI screening to mammography for women with a familial risk. Furthermore, we will assess the influence of breast density. Methods/Design This Dutch multicentre, randomized controlled trial, with balanced randomisation (1:1 has a parallel grouped design. Women with a cumulative lifetime risk for breast cancer due to their family history of ≥20%, aged 30–55 years are eligible. Identified BRCA1/2 mutation carriers or women with 50% risk of carrying a mutation are excluded. Group 1 receives yearly mammography and clinical breast examination (n = 1000, and group 2 yearly MRI and clinical breast examination, and mammography biennially (n = 1000. Primary endpoints are the number and stage of the detected breast cancers in each arm. Secondary endpoints are the number of false-positive results in both screening arms. Furthermore, sensitivity and positive predictive value of both screening strategies will be assessed. Cost-effectiveness of both strategies will be assessed. Analyses will also be performed with mammographic density as stratification factor. Discussion Personalized breast cancer screening

  6. Estimates of pandemic influenza vaccine effectiveness in Europe, 2009-2010: results of Influenza Monitoring Vaccine Effectiveness in Europe (I-MOVE multicentre case-control study.

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    Marta Valenciano

    2011-01-01

    Full Text Available BACKGROUND: A multicentre case-control study based on sentinel practitioner surveillance networks from seven European countries was undertaken to estimate the effectiveness of 2009-2010 pandemic and seasonal influenza vaccines against medically attended influenza-like illness (ILI laboratory-confirmed as pandemic influenza A (H1N1 (pH1N1. METHODS AND FINDINGS: Sentinel practitioners swabbed ILI patients using systematic sampling. We included in the study patients meeting the European ILI case definition with onset of symptoms >14 days after the start of national pandemic vaccination campaigns. We compared pH1N1 cases to influenza laboratory-negative controls. A valid vaccination corresponded to >14 days between receiving a dose of vaccine and symptom onset. We estimated pooled vaccine effectiveness (VE as 1 minus the odds ratio with the study site as a fixed effect. Using logistic regression, we adjusted VE for potential confounding factors (age group, sex, month of onset, chronic diseases and related hospitalizations, smoking history, seasonal influenza vaccinations, practitioner visits in previous year. We conducted a complete case analysis excluding individuals with missing values and a multiple multivariate imputation to estimate missing values. The multivariate imputation (n = 2902 adjusted pandemic VE (PIVE estimates were 71.9% (95% confidence interval [CI] 45.6-85.5 overall; 78.4% (95% CI 54.4-89.8 in patients <65 years; and 72.9% (95% CI 39.8-87.8 in individuals without chronic disease. The complete case (n = 1,502 adjusted PIVE were 66.0% (95% CI 23.9-84.8, 71.3% (95% CI 29.1-88.4, and 70.2% (95% CI 19.4-89.0, respectively. The adjusted PIVE was 66.0% (95% CI -69.9 to 93.2 if vaccinated 8-14 days before ILI onset. The adjusted 2009-2010 seasonal influenza VE was 9.9% (95% CI -65.2 to 50.9. CONCLUSIONS: Our results suggest good protection of the pandemic monovalent vaccine against medically attended pH1N1 and no effect of the

  7. Particulate matter air pollution and respiratory symptoms in individuals having either asthma or chronic obstructive pulmonary disease: a European multicentre panel study

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    Karakatsani Anna

    2012-10-01

    Full Text Available Abstract Background Particulate matter air pollution has been associated with adverse health effects. The fraction of ambient particles that are mainly responsible for the observed health effects is still a matter of controversy. Better characterization of the health relevant particle fraction will have major implications for air quality policy since it will determine which sources should be controlled. The RUPIOH study, an EU-funded multicentre study, was designed to examine the distribution of various ambient particle metrics in four European cities (Amsterdam, Athens, Birmingham, Helsinki and assess their health effects in participants with asthma or COPD, based on a detailed exposure assessment. In this paper the association of central site measurements with respiratory symptoms and restriction of activities is examined. Methods At each centre a panel of participants with either asthma or COPD recorded respiratory symptoms and restriction of activities in a diary for six months. Exposure assessment included simultaneous measurements of coarse, fine and ultrafine particles at a central site. Data on gaseous pollutants were also collected. The associations of the 24-hour average concentrations of air pollution indices with the health outcomes were assessed in a hierarchical modelling approach. A city specific analysis controlling for potential confounders was followed by a meta-analysis to provide overall effect estimates. Results A 10 μg/m3 increase in previous day coarse particles concentrations was positively associated with most symptoms (an increase of 0.6 to 0.7% in average and limitation in walking (OR= 1.076, 95% CI: 1.026-1.128. Same day, previous day and previous two days ozone concentrations were positively associated with cough (OR= 1.061, 95% CI: 1.013-1.111; OR= 1.049, 95% CI: 1.016-1.083 and OR= 1.059, 95% CI: 1.027-1.091, respectively. No consistent associations were observed between fine particle concentrations, nitrogen

  8. Virtual patients design and its effect on clinical reasoning and student experience: a protocol for a randomised factorial multi-centre study

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    Bateman James

    2012-08-01

    Full Text Available Abstract Background Virtual Patients (VPs are web-based representations of realistic clinical cases. They are proposed as being an optimal method for teaching clinical reasoning skills. International standards exist which define precisely what constitutes a VP. There are multiple design possibilities for VPs, however there is little formal evidence to support individual design features. The purpose of this trial is to explore the effect of two different potentially important design features on clinical reasoning skills and the student experience. These are the branching case pathways (present or absent and structured clinical reasoning feedback (present or absent. Methods/Design This is a multi-centre randomised 2x2 factorial design study evaluating two independent variables of VP design, branching (present or absent, and structured clinical reasoning feedback (present or absent.The study will be carried out in medical student volunteers in one year group from three university medical schools in the United Kingdom, Warwick, Keele and Birmingham. There are four core musculoskeletal topics. Each case can be designed in four different ways, equating to 16 VPs required for the research. Students will be randomised to four groups, completing the four VP topics in the same order, but with each group exposed to a different VP design sequentially. All students will be exposed to the four designs. Primary outcomes are performance for each case design in a standardized fifteen item clinical reasoning assessment, integrated into each VP, which is identical for each topic. Additionally a 15-item self-reported evaluation is completed for each VP, based on a widely used EViP tool. Student patterns of use of the VPs will be recorded. In one centre, formative clinical and examination performance will be recorded, along with a self reported pre and post-intervention reasoning score, the DTI. Our power calculations indicate a sample size of 112 is required for

  9. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

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    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  10. Long-term effects of interprofessional biopsychosocial rehabilitation for adults with chronic non-specific low back pain: a multicentre, quasi-experimental study.

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    Jana Semrau

    Full Text Available Improvement of the long-term effectiveness of multidisciplinary ortho-paedic rehabilitation (MOR in the management of chronic non-specific low back pain (CLBP remains a central issue for health care in Germany. We developed an interprofessional and interdisciplinary, biopsychosocial rehabilitation concept named "PASTOR" to promote self-management in adults with CLBP and compared its effectiveness with the current model of MOR.A multicentre quasi-experimental study with three measurement time points was implemented. 680 adults aged 18 to 65 with CLBP were assed for eligibil-ity in three inpatient rehabilitation centres in Germany. At first the effects of the MOR, with a total extent of 48 hours (control group, were assessed. Thereafter, PASTOR was implemented and evaluated in the same centres (intervention group. It consisted of six interprofessional modules, which were provided on 12 days in fixed groups, with a total extent of 48 hours. Participants were assessed with self-report measures at baseline, discharge, and 12 months for functional ability (primary outcome using the Hannover Functional Ability Questionnaire (FFbH-R and vari-ous secondary outcomes (e.g. pain, health status, physical activity, pain coping, pain-related cognitions.In total 536 participants were consecutively assigned to PASTOR (n=266 or MOR (n=270. At 12 months, complete data of 368 participants was available. The adjusted between-group difference in the FFbH-R at 12 months was 6.58 (95% CI 3.38 to 9.78 using complete data and 3.56 (95% CI 0.45 to 6.67 using available da-ta, corresponding to significant small-to-medium effect sizes of d=0.42 (p<0.001 and d=0.10 (p=0.025 in favour of PASTOR. Further improvements in secondary out-comes were also observed in favour of PASTOR.The interprofessional and interdisciplinary, biopsychosocial rehabilita-tion program PASTOR shows some improvements of the long-term effectiveness of inpatient rehabilitation in the management of adults

  11. Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571

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    Perrin Catherine

    2009-03-01

    Full Text Available Abstract Background Constipation is a frustrating symptom affecting 3% of children worldwide. Randomised controlled trials show that both polyethylene glycol and lactulose are effective in increasing defecation frequency in children with constipation. However, in 30–50%, these children reported abdominal pain, bloating, flatulence, diarrhoea, nausea and bad taste of the medication. Two recent studies have shown that the fermented dairy product containing Bifidobacterium lactis strain DN-173 010 is effective in increasing stool frequency in constipation-predominant irritable bowel syndrome patients with a defecation frequency Methods/design It is a two nation (The Netherlands and Poland double-blind, placebo-controlled randomised multicentre trial in which 160 constipated children (age 3–16 years with a defecation frequency Bifidobacterium lactis DN-173 010 or a control product, twice a day, for 3 weeks. During the study all children are instructed to try to defecate on the toilet for 5–10 minutes after each meal (3 times a day and daily complete a standardized bowel diary. Primary endpoint is stool frequency. Secondary endpoints are stool consistency, faecal incontinence frequency, pain during defecation, digestive symptoms (abdominal pain, flatulence, adverse effects (nausea, diarrhoea, bad taste and intake of rescue medication (Bisacodyl. Rate of success and rate of responders are also evaluated, with success defined as ≥ 3 bowel movements per week and ≤1 faecal incontinence episode over the last 2 weeks of product consumption and responder defined as a subject reporting a stool frequency ≥ 3 on the last week of product consumption. To demonstrate that the success percentage in the intervention group will be 35% and the success percentage in the control group (acidified milk without ferments, toilet training, bowel diary will be 15%, with alpha 0.05 and power 80%, a total sample size of 160 patients was calculated. Conclusion This

  12. Multicentre studies of insecticide-treated durable wall lining in Africa and South-East Asia: entomological efficacy and household acceptability during one year of field use

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    Messenger Louisa A

    2012-10-01

    Full Text Available Abstract Background Indoor residual spraying (IRS is a primary method of malaria vector control, but its potential impact is constrained by several inherent limitations: spraying must be repeated when insecticide residues decay, householders can tire of the annual imposition and campaign costs are recurrent. Durable lining (DL can be considered an advanced form of long-lasting IRS where insecticide is gradually released from an aesthetically attractive wall lining material to provide vector control for several years. A multicentre trial was carried out in Equatorial Guinea, Ghana, Mali, South Africa and Vietnam to assess the feasibility, durability, bioefficacy and household acceptability of DL, compared to conventional IRS or insecticide-treated curtains (LLITCs, in a variety of operational settings. Methods This study was conducted in 220 households in traditional rural villages over 12-15 months. In all sites, rolls of DL were cut to fit house dimensions and fixed to interior wall surfaces (usually with nails and caps by trained teams. Acceptability was assessed using a standardized questionnaire covering such topics as installation, exposure reactions, entomology, indoor environment, aesthetics and durability. Bioefficacy of interventions was evaluated using WHO cone bioassay tests at regular intervals throughout the year. Results The deltamethrin DL demonstrated little to no decline in bioefficacy over 12-15 months, supported by minimal loss of insecticide content. By contrast, IRS displayed a significant decrease in bioactivity by 6 months and full loss after 12 months. The majority of participants in DL households perceived reductions in mosquito density (93% and biting (82%, but no changes in indoor temperature (83%. Among those households that wanted to retain the DL, 73% cited protective reasons, 20% expressed a desire to keep theirs for decoration and 7% valued both qualities equally. In Equatorial Guinea, when offered a choice of

  13. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: a multicentre randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    Collaborative Research Group of Noninvasive Mechan

    2005-01-01

    Background Respiratory muscle fatigue plays an important role in acute exacerbations of chronic obstructive pulmonary disease (AECOPD). In previous clinical studies, non-invasive positive pressure ventilation (NPPV) was proved to be successful only for AECOPD patients with severe respiratory failure. We hypothesized that, the outcomes of AECOPD would be improved if NPPV is early (within 24 to 48 hours of admission) administered in those patients with respiratory muscle fatigue and mild respiratory insufficiency, especially in patients without fulfilling the conventional criteria of mechanical ventilatory support. Methods A prospective multicentre randomized controlled trial was conducted in 19 hospitals in China over 16 months. Three hundred and forty-two AECOPD patients with pH≥7.25 and PaCO2>45 mmHg were recruited on general ward and randomly assigned to standard medical treatment (control group) or early administration of additional NPPV (NPPV group).Results The characteristics of two groups on admission were similar. The number of AECOPD patients requiring intubations in NPPV group was much fewer than that of the control group (8/171 vs 26/71, P=0.002). Subgroup analysis showed the needs for intubation in mildly (pH≥7.35) and severe (pH<7.30) acidotic patients in NPPV group were both decreased (9/80 vs 2/71, P=0.047 and 8/30 vs 3/43, P=0.048, respectively). The mortality in hospital was reduced slightly by NPPV but with no significant difference (7/171 vs 12/171, P=0.345). Respiratory rate (RR),scale for accessory muscle use and arterial pH improved rapidly at the first 2 hours only in patients of NPPV group. After 24 hours, the differences of pH, PaO2, scale for accessory muscle use and RR in NPPV group [(7.36±0.06) mmHg, (72±22) mmHg, (2.5±0.9)/min, (22±4)/min] were statistically significant compared with control group (7.37±0.05) mmHg, (85±34) mmHg, (2.3±1.1)/min, (21±4)/min, P<0.01 for all comparisons].Conclusions The early use of NPPV on

  14. Patterns and predictors of sitting time over ten years in a large population-based Canadian sample: Findings from the Canadian Multicentre Osteoporosis Study (CaMos

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    Klaus Gebel

    2017-03-01

    Full Text Available Our objective was to describe patterns and predictors of sedentary behavior (sitting time over 10 years among a large Canadian cohort. Data are from the Canadian Multicentre Osteoporosis Study, a prospective study of women and men randomly selected from the general population. Respondents reported socio-demographics, lifestyle behaviors and health outcomes in interviewer-administered questionnaires; weight and height were measured. Baseline data were collected between 1995 and 1997 (n = 9418; participation rate = 42%, and at 5- (n = 7648 and 10-year follow-ups (n = 5567. Total sitting time was summed across domain-specific questions at three time points and dichotomized into “low” (≤7 h/day and “high” (>7 h/day, based on recent meta-analytic evidence on time sitting and all-cause mortality. Ten-year sitting patterns were classified as “consistently high”, “consistently low”, “increased”, “decreased”, and “mixed”. Predictors of sedentary behavior patterns were explored using chi-square tests, ANOVA and logistic regression. At baseline (mean age = 62.1 years ± 13.4 average sitting was 6.9 h/day; it was 7.0 at 5- and 10-year follow-ups (p for trend = 0.12. Overall 23% reported consistently high sitting time, 22% consistently low sitting, 14% decreased sitting, 17% increased sitting with 24% mixed patterns. Consistently high sitters were more likely to be men, university educated, full-time employed, obese, and to report consistently low physical activity levels. This is one of the first population-based studies to explore patterns of sedentary behavior (multi-domain sitting within men and women over years. Risk classification of sitting among many adults changed during follow-up. Thus, studies of sitting and health would benefit from multiple measures of sitting over time.

  15. Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial

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    Larson Debbie

    2011-06-01

    Full Text Available Abstract Background Dupuytren's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function. Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting, however the evidence supporting night splinting is of low quality and equivocal. Methods A multi-centre, pragmatic, open, randomised controlled trial was conducted to evaluate the effect of night splinting on self-reported function, finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy. 154 patients from 5 regional hospitals were randomised after surgery to receive hand therapy only (n = 77 or hand therapy with night-splinting (n = 77. Primary outcome was self-reported function using the Disabilities of the Arm, Shoulder and Hand (DASH questionnaire. Secondary outcomes were finger range of motion and patient satisfaction. Primary analysis was by intention to treat. Results 148 (96% patients completed follow-up at 12 months. No statistically significant differences were observed on the DASH questionnaire (0-100 scale: adjusted mean diff. 0.66, 95%CI - 2.79 to 4.11, p = 0.703, total extension deficit of operated digits (degrees: adjusted mean diff 5.11, 95%CI -2.33 to 12.55, p = 0.172 or patient satisfaction (0-10 numerical rating scale: adjusted mean diff -0.35, 95%CI -1.04 to 0.34, p = 0.315 at 1 year post surgery. Similarly, in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes. Conclusions No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred. Given the added expense of therapists' time, thermoplastic materials and the potential inconvenience to

  16. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels

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    Nieder Ulrike

    2009-11-01

    Full Text Available Abstract Background There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL, the organisational-institutional level (OIL and the political-cultural level (PCL. Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. Methods The intervention consisted of (a two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL, (b a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL, (c informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL. Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL, number of groups continued without external financial

  17. FDG PET during radiochemotherapy is predictive of outcome at 1 year in non-small-cell lung cancer patients: a prospective multicentre study (RTEP2)

    Energy Technology Data Exchange (ETDEWEB)

    Vera, Pierre; Edet-Sanson, Agathe; Modzelewski, Romain [Henri Becquerel Center and QuantIF - Litis EA-Equipe d' Accueil-4108 and Rouen University Hospital, Department of Nuclear Medicine, Henri Becquerel Cancer Center, Rouen (France); Mezzani-Saillard, Sandrine; Thureau, Sebastien; Dubray, Bernard [Henri Becquerel Center and QuantIF - Litis ' ' EA (Equipe d' Accueil) 4108' ' and Rouen University Hospital, Department of Radiation Oncology and Medical Physics, Henri Becquerel Cancer Center, Rouen (France); Menard, Jean-Francois [Rouen University Hospital and University of Rouen, Department of Biostatistics, Rouen (France); Meyer, Marc-Etienne [Amiens University Hospital, Department of Nuclear Medicine, Amiens (France); Jalali, Khadija [Amiens University Hospital, Department of Radiation Oncology, Amiens (France); Bardet, Stephane [Francois Baclesse Cancer Center, Department of Nuclear Medicine, Caen (France); Lerouge, Delphine [Francois Baclesse Cancer Center, Department of Radiation Oncology, Caen (France); Houzard, Claire [Hospices Civils de Lyon, Department of Nuclear Medicine, Lyon (France); Mornex, Francoise [Hospices Civils de Lyon, Department of Radiation Oncology, Lyon (France); Olivier, Pierre [Brabois University Hospital, Department of Nuclear Medicine, Nancy (France); Faure, Guillaume [Centre prive de Radiotherapie de Metz, Department of Radiation Oncology, Metz (France); Rousseau, Caroline [Renee Gauducheau Cancer Center, Department of Nuclear Medicine, Nantes (France); Mahe, Marc-Andre [Institut de Cancerologie-Rene Gauducheau, Department of Radiation Oncology, Nantes (France); Gomez, Philippe [Centre Frederic Joliot, Radiation Oncology, Rouen (France); Clinique Saint-Hilaire, Rouen (France); Brenot-Rossi, Isabelle [Institut Paoli Calmette, Department of Nuclear Medicine, Marseille (France); Salem, Naji [Institut Paoli Calmette, Department of Radiation Oncology, Marseille (France)

    2014-06-15

    To assess prospectively the prognostic value of FDG PET/CT during curative-intent radiotherapy (RT) with or without concomitant chemotherapy in patients with non-small-cell lung cancer (NSCLC). Patients with histological proof of invasive localized NSCLC and evaluable tumour, and who were candidates for curative-intent radiochemotherapy (RCT) or RT were preincluded after providing written informed consent. Definitive inclusion was conditional upon significant FDG uptake before RT (PET{sub 1}). All included patients had a FDG PET/CT scan during RT (PET{sub 2}, mean dose 43 Gy) and were evaluated by FDG PET/CT at 3 months and 1 year after RT. The main endpoint was death (from whatever cause) or tumour progression at 1 year. Of 77 patients preincluded, 52 were evaluable. Among the evaluable patients, 77 % received RT with induction chemotherapy and 73 % RT with concomitant chemotherapy. At 1 year, 40 patients (77 %) had died or had tumour progression. No statistically significant association was found between stage (IIIB vs. other), histology (squamous cell carcinoma vs. other), induction or concomitant chemotherapy, and death/tumour progression at 1 year. The SUV{sub max} in the PET{sub 2} scan was the single variable predictive of death or tumour progression at 1 year (odds ratio 1.97, 95 % CI 1.25 - 3.09, p = 0.003) in multivariate analysis. The area under the receiver operating characteristic curve was 0.85 (95 % CI 0.73 - 0.94, p < 10{sup -4}). A SUV{sub max} value of 5.3 in the PET{sub 2} scan yielded a sensitivity of 70 % and a specificity of 92 % for predicting tumour progression or death at 1 year. This prospective multicentre study demonstrated the prognostic value in terms of disease-free survival of SUV{sub max} assessed during the 5th week of curative-intent RT or RCT in NSCLC patients (NCT01261598; RTEP2 study). (orig.)

  18. Respiratory gated PET/CT in a European multicentre retrospective study: added diagnostic value in detection and characterization of lung lesions

    Energy Technology Data Exchange (ETDEWEB)

    Guerra, Luca; Elisei, Federica [San Gerardo Hospital, Nuclear Medicine, Monza (Italy); De Ponti, Elena [San Gerardo Hospital, Medical Physics, Monza (Italy); Bettinardi, Valentino; Picchio, Maria [San Raffaele Scientific Institute, Nuclear Medicine, Milan (Italy); National Research Council, Institute for Bioimaging and Molecular Physiology, Milan (Italy); Landoni, Claudio [San Raffaele Scientific Institute, Nuclear Medicine, Milan (Italy); University of Milano-Bicocca, Milan (Italy); Gilardi, Maria Carla [San Raffaele Scientific Institute, Nuclear Medicine, Milan (Italy); National Research Council, Institute for Bioimaging and Molecular Physiology, Milan (Italy); University of Milano-Bicocca, Tecnomed Foundation, Milan (Italy); Versari, Annibale [Scientific Institute Santa Maria Nuova Hospital, Nuclear Medicine, Reggio Emilia (Italy); Fioroni, Federica [Scientific Institute Santa Maria Nuova Hospital, Medical Physics, Reggio Emilia (Italy); Dziuk, Miroslaw [Masovian PET-CT Centre, Department of Nuclear Medicine, Military Institute of Medicine, Warsaw (Poland); Koza, Magdalena [Masovian PET-CT Centre, Euromedic Diagnostic, Warsaw (Poland); Ahond-Vionnet, Renee; Collin, Bertrand [Hopital Pierre Beregovoy, Service de Medecine Nucleaire, Nevers (France); Messa, Cristina [San Gerardo Hospital, Nuclear Medicine, Monza (Italy); National Research Council, Institute for Bioimaging and Molecular Physiology, Milan (Italy); University of Milano-Bicocca, Tecnomed Foundation, Milan (Italy)

    2012-09-15

    The aim of our work is to evaluate the added diagnostic value of respiratory gated (4-D) positron emission tomography/computed tomography (PET/CT) in lung lesion detection/characterization in a large patient population of a multicentre retrospective study. The data of 155 patients (89 men, 66 women, mean age 63.9 {+-} 11.1 years) from 5 European centres and submitted to standard (3-D) and 4-D PET/CT were retrospectively analysed. Overall, 206 lung lesions were considered for the analysis (mean {+-} SD lesions dimension 14.7 {+-} 11.8 mm). Maximum standardized uptake values (SUV{sub max}) and lesion detectability were assessed for both 3-D and 4-D PET/CT studies; 3-D and 4-D PET/CT findings were compared to clinical follow-up as standard reference. Mean {+-} SD 3-D and 4-D SUV{sub max} values were 5.2 {+-} 5.1 and 6.8 {+-} 6.1 (p < 0.0001), respectively, with an average percentage increase of 30.8 %. In 3-D PET/CT, 86 of 206 (41.7 %) lesions were considered positive, 70 of 206 (34 %) negative and 50 of 206 (24.3 %) equivocal, while in 4-D PET/CT 117 of 206 (56.8 %) lesions were defined as positive, 80 of 206 (38.8 %) negative and 9 of 206 (4.4 %) equivocal. In 34 of 50 (68 %) 3-D equivocal lesions follow-up data were available and the presence of malignancy was confirmed in 21 of 34 (61.8 %) lesions, while in 13 of 34 (38.2 %) was excluded. In 31 of these 34 controlled lesions, 20 of 34 (58.8 %) and 11 of 34 (32.4 %) were correctly classified by 4-D PET/CT as positive and negative, respectively; 3 of 34 (8.8 %) remained equivocal. With equivocal lesions classified as positive, the overall accuracy of 3-D and 4-D was 85.7 and 92.8 %, respectively, while the same figures were 80.5 and 94.2 % when equivocal lesions were classified as negative. The respiratory gated PET/CT technique is a valuable clinical tool in diagnosing lung lesions, improving quantification and confidence in reporting, reducing 3-D undetermined findings and increasing the overall accuracy in lung

  19. A toolbox for tuberculosis (TB diagnosis: an Indian multicentric study (2006-2008. Evaluation of QuantiFERON-TB gold in tube for TB diagnosis.

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    Philippe H Lagrange

    Full Text Available BACKGROUND: The aim of this multicentric prospective study in India was to assess the performance of the QuantiFERON TB-Gold in tube (QFT-GIT, Tuberculin Skin Test (TST and microbiological results as additional tools for diagnosing active tuberculosis (TB and latent infection (LTBI according to Human Immunodeficiency Virus (HIV status. METHODS: Individuals with and without active TB and HIV infection were enrolled between 2006-2008. QFT-GIT and TST results were analyzed per se and in combination with microbiological data. RESULTS: Among the 276 individuals (96 active pulmonary TB and 180 no active TB tested by QFT-GIT, 18 indeterminate results (6.5% were found, more significantly numerous in the HIV-infected (15/92; 16.3% than the HIV-uninfected (3/184; 1.6%(p<0.0001. QFT-GIT sensitivity for active TB was 82.3% and 92.9% respectively after including or excluding indeterminate results. Clinical sensitivity was significantly lower in the HIV-infected (68.4% than the HIV-uninfected (91.4% patients (p = 0.0059. LTBI was detected in 49.3% of subjects without active TB but varied according to TB exposure. When the TST and QFT-GIT were concomitantly performed, the respective sensitivity for active TB diagnosis was 95.0% and 85.0% in the HIV-uninfected (p = 0.60, and 66.7% and 51.5% in the HIV-infected patients (p = 0.32. QFT-GIT and TST respective specificity for active TB in the HIV-uninfected was 25.0% and 57.1% (p = 0.028, and 64.8% and 83.3% in the HIV-infected (p = 0.047. In those with active TB, QFT-GIT results were not associated with microbiological parameters (smear grade, liquid culture status, time-to-positivity of culture or clinical suspicion of active TB score (provided by the clinicians at enrollment. Combining microbiological tests with both immunological tests significantly increased sensitivity for active TB diagnosis (p = 0.0002, especially in the HIV-infected individuals (p = 0.0016. CONCLUSION: QFT

  20. Association of tobacco use and other determinants with pregnancy outcomes: a multicentre hospital-based case–control study in Karachi, Pakistan

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    Rozi, Shafquat; Butt, Zahid Ahmad; Zahid, Nida; Wasim, Saba; Shafique, Kashif

    2016-01-01

    Objectives The study aimed to identify the effects of maternal tobacco consumption during pregnancy and other factors on birth outcomes and obstetric complications in Karachi, Pakistan. Design A multicentre hospital-based case–control study. Setting Four leading maternity hospitals of Karachi. Participants A random sample of 1275 women coming to the gynaecology and obstetric department of selected hospitals for delivery was interviewed within 48 hours of delivery from wards. Cases were women with adverse birth outcomes and obstetric complications, while controls were women who had normal uncomplicated delivery. Primary and secondary outcome measures Adverse birth outcomes (preterm delivery, low birth weight, stillbirth, low Apgar score) and obstetric complications (antepartum haemorrhage, caesarean section, etc). Results Final multiple logistic regression analysis revealed that with every 1 year increase in age the odds of being a case was 1.03 times as compared with being a control. Tobacco use (adjusted OR (aOR): 2.24; 95% CI 1.56 to 3.23), having no slits in the kitchen (proxy indicator for indoor air pollution) (aOR=1.90; 95% CI 1.05 to 3.43), gravidity (aOR=0.83; 95% CI 0.73 to 0.93), non-booked hospital cases (aOR=1.87; 95% CI 1.38 to 2.74), history of stillbirth (aOR=4.06; 95% CI 2.36 to 6.97), miscarriages (aOR=1.91; 95% CI 1.27 to 2.85) and preterm delivery (aOR=6.04; 95% CI 2.52 to 14.48) were significantly associated with being a case as compared with control. Conclusions This study suggests that women who had adverse pregnancy outcomes were more likely to have exposure to tobacco, previous history of adverse birth outcomes and were non-booked cases. Engagement of stakeholders in tobacco control for providing health education, incorporating tobacco use in women in the tobacco control policy and designing interventions for tobacco use cessation is warranted. Prenatal care and health education might help in preventing such adverse events. PMID

  1. Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE study protocol

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    Barasinski, Chloé; Vendittelli, Françoise

    2016-01-01

    Introduction The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum. Methods and analysis This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs. Ethics and dissemination This study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be

  2. Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL. A multicentre randomised controlled trial

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    Vos Dagmar I

    2011-08-01

    Full Text Available Abstract Background The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries. Aim A prospective, multicentre randomised controlled trial (RCT will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. Methods/design A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view. Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2. Furthermore, the health-related Quality of Life score (ShortForm-36 and the Disabilities of Arm, Shoulder and Hand (DASH Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year. After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses. Discussion This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised

  3. Influence of social support on cognitive change and mortality in old age: results from the prospective multicentre cohort study AgeCoDe

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    Eisele Marion

    2012-03-01

    Full Text Available Abstract Background Social support has been suggested to positively influence cognition and mortality in old age. However, this suggestion has been questioned due to inconsistent operationalisations of social support among studies and the small number of longitudinal studies available. This study aims to investigate the influence of perceived social support, understood as the emotional component of social support, on cognition and mortality in old age as part of a prospective longitudinal multicentre study in Germany. Methods A national subsample of 2,367 primary care patients was assessed twice over an observation period of 18 months regarding the influence of social support on cognitive function and mortality. Perceived social support was assessed using the 14-item version of the FSozU, which is a standardised and validated questionnaire of social support. Cognition was tested by the neuropsychological test battery of the Structured Interview for the Diagnosis of Dementia (SIDAM. The influence of perceived support on cognitive change was analysed by multivariate ANCOVA; mortality was analysed by multivariate logistic and cox regression. Results Sample cognitive change (N = 1,869: Mean age was 82.4 years (SD 3.3 at the beginning of the observation period, 65.9% were female, mean cognition was 49 (SD 4.4 in the SIDAM. Over the observation period cognitive function declined in 47.2% by a mean of 3.4 points. Sample mortality (N = 2,367: Mean age was 82.5 years (SD 3.4, 65.7% were female and 185 patients died during the observation period. Perceived social support showed no longitudinal association with cognitive change (F = 2.235; p = 0.135 and mortality (p = 0.332; CI 0.829-1.743. Conclusions Perceived social support did not influence cognition and mortality over an 18 months observation period. However, previous studies using different operationalisations of social support and longer observation periods indicate that such an influence may exist

  4. Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467

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    Martinez Barquin Dulce

    2006-04-01

    Full Text Available Abstract Background Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60–70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. Methods/Design Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points, placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. Discussion This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain

  5. Body mass index and the prevalence, severity, and risk of coronary artery disease: an international multicentre study of 13 874 patients

    Science.gov (United States)

    Labounty, Troy M.; Gomez, Millie J.; Achenbach, Stephan; Al-Mallah, Mouaz; Berman, Daniel S.; Budoff, Matthew J.; Cademartiri, Filippo; Callister, Tracy Q.; Chang, Hyuk-Jae; Cheng, Victor; Chinnaiyan, Kavitha M.; Chow, Benjamin; Cury, Ricardo; Delago, Augustin; Dunning, Allison; Feuchtner, Gudrun; Hadamitzky, Martin; Hausleiter, Jorg; Kaufmann, Philipp; Kim, Yong-Jin; Leipsic, Jonathon; Lin, Fay Y.; Maffei, Erica; Raff, Gilbert; Shaw, Leslee J.; Villines, Todd C.; Min, James K.

    2013-01-01

    Aims Obesity is associated with the presence of coronary artery disease (CAD) risk factors and cardiovascular events. We examined the relationship between body mass index (BMI) and the presence, extent, severity, and risk of CAD in patients referred for coronary computed tomographic angiography (CCTA). Methods and results We evaluated 13 874 patients from a prospective, international, multicentre registry of individuals without known CAD undergoing CCTA. We compared risk factors, CAD findings, and risk of all-cause mortality and non-fatal myocardial infarction (MI) amongst individuals with underweight (18.5–20.0 kg/m2), normal (20.1–24.9 kg/m2), overweight (25–29.9 kg/m2), and obese (≥30 kg/m2) BMI. The mean follow-up was 2.4 ± 1.2 years with 143 deaths and 193 MIs. Among underweight, normal weight, overweight, and obese individuals, there was increasing prevalence of diabetes (7 vs.10% vs. 12 vs. 19%), hypertension (37 vs. 40% vs. 46 vs. 59%), and hyperlipidaemia (48 vs. 52% vs. 56 vs. 56%; P < 0.001 for trend). After multivariable adjustment, BMI was positively associated with the prevalence of any CAD [odds ratio (OR) 1.25 per +5 kg/m2, 95% confidence interval (CI): 1.20–1.30, P < 0.001] and obstructive (≥50% stenosis) CAD (OR: 1.13 per +5 kg/m2, 95% CI: 1.08–1.19, P < 0.001); a higher BMI was also associated with an increased number of segments with plaque (+0.26 segments per +5 kg/m2, 95% CI: 0.22–0.30, P < 0.001). Larger BMI categories were associated with an increase in all-cause mortality (P = 0.004), but no difference in non-fatal MI. After multivariable adjustment, a higher BMI was independently associated with increased risk of MI (hazards ratio: 1.28 per +5 kg/m2, 95% CI: 1.12–1.45, P < 0.001). Conclusions Amongst patients with suspected CAD referred for CCTA, individuals with increased BMI have greater prevalence, extent, and severity of CAD that is not fully explained by the presence of traditional risk factors. A higher BMI is

  6. Differential Item Functioning in the SF-36 Physical Functioning and Mental Health Sub-Scales: A Population-Based Investigation in the Canadian Multicentre Osteoporosis Study.

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    Lisa M Lix

    Full Text Available Self-reported health status measures, like the Short Form 36-item Health Survey (SF-36, can provide rich information about the overall health of a population and its components, such as physical, mental, and social health. However, differential item functioning (DIF, which arises when population sub-groups with the same underlying (i.e., latent level of health have different measured item response probabilities, may compromise the comparability of these measures. The purpose of this study was to test for DIF on the SF-36 physical functioning (PF and mental health (MH sub-scale items in a Canadian population-based sample.Study data were from the prospective Canadian Multicentre Osteoporosis Study (CaMos, which collected baseline data in 1996-1997. DIF was tested using a multiple indicators multiple causes (MIMIC method. Confirmatory factor analysis defined the latent variable measurement model for the item responses and latent variable regression with demographic and health status covariates (i.e., sex, age group, body weight, self-perceived general health produced estimates of the magnitude of DIF effects.The CaMos cohort consisted of 9423 respondents; 69.4% were female and 51.7% were less than 65 years. Eight of 10 items on the PF sub-scale and four of five items on the MH sub-scale exhibited DIF. Large DIF effects were observed on PF sub-scale items about vigorous and moderate activities, lifting and carrying groceries, walking one block, and bathing or dressing. On the MH sub-scale items, all DIF effects were small or moderate in size.SF-36 PF and MH sub-scale scores were not comparable across population sub-groups defined by demographic and health status variables due to the effects of DIF, although the magnitude of this bias was not large for most items. We recommend testing and adjusting for DIF to ensure comparability of the SF-36 in population-based investigations.

  7. ENLIST 1: An International Multi-centre Cross-sectional Study of the Clinical Features of Erythema Nodosum Leprosum.

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    Stephen L Walker

    Full Text Available Erythema nodosum leprosum (ENL is a severe multisystem immune mediated complication of borderline lepromatous leprosy and lepromatous leprosy. ENL is associated with skin lesions, neuritis, arthritis, dactylitis, eye inflammation, osteitis, orchitis, lymphadenitis and nephritis. The treatment of ENL requires immunosuppression, which is often required for prolonged periods of time and may lead to serious adverse effects. ENL and its treatment is associated with increased mortality and economic hardship. Improved, evidence-based treatments for ENL are needed; however, defining the severity of ENL and outcome measures for treatment studies is difficult because of the multiple organ systems involved. A cross-sectional study was performed, by the members of the Erythema Nodosum Leprosum International STudy (ENLIST Group, of patients with ENL attending seven leprosy referral centres in Brazil, Ethiopia, India, Nepal, the Philippines and the United Kingdom. We systematically documented the clinical features and type of ENL, its severity and the drugs used to treat it. Patients with chronic ENL were more likely to be assessed as having severe ENL. Pain, the most frequent symptom, assessed using a semi-quantitative scale was significantly worse in individuals with "severe" ENL. Our findings will determine the items to be included in a severity scale of ENL which we are developing and validating. The study also provides data on the clinical features of ENL, which can be incorporated into a definition of ENL and used for outcome measures in treatment studies.

  8. A multicentre observational study for early diagnosis of Gaucher disease in patients with Splenomegaly and/or Thrombocytopenia.

    Science.gov (United States)

    Motta, Irene; Filocamo, Mirella; Poggiali, Erika; Stroppiano, Marina; Dragani, Alfredo; Consonni, Dario; Barcellini, Wilma; Gaidano, Gianluca; Facchini, Luca; Specchia, Giorgina; Cappellini, Maria Domenica

    2016-04-01

    Gaucher disease (GD) is the most common lysosomal disorder resulting from deficient activity of the β-glucosidase enzyme that causes accumulation of glucosylceramide in the macrophage-monocyte system. Notably, because of non-specific symptoms and a lack of awareness, patients with GD experience long diagnostic delays. The aim of this study was to apply a diagnostic algorithm to identify GD type 1 among adults subjects referred to Italian haematology outpatient units because of splenomegaly and/or thrombocytopenia and, eventually, to estimate the prevalence of GD in this selected population. One hundred and ninety-six subjects (61 females, 135 males; mean age 47.8 ± 18.2 years) have been enrolled in the study and tested for β-glucosidase enzyme activity on dried blood spot (DBS). Seven of 196 patients have been diagnosed with GD, (5 females and 2 males) with mean age 31.8 ± 8.2 years, with a prevalence of 3.6% (with a prevalence of 3.6% (I95% CI 1.4-7.2; 1/28 patients) in this population. These results show that the use of an appropriate diagnostic algorithm and a simple diagnostic method, such as DBS, are important tools to facilitate the diagnosis of a rare disease even for not disease-expert physicians.

  9. The INDUS knee prosthesis - Prospective multicentric trial of a posteriorly stabilized high-flex design: 2 years follow-up

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    Sancheti Kantilal

    2009-01-01

    Full Text Available Background: The anatomical and morphological differences and high-flexion daily activities in the Asian population have since ever prompted for development of customized knee replacement systems. INDUS knee system has advantages both of high-flex designs and is developed by keeping the anatomical variations of the native population in mind. The purpose of this study is to analyze the 2-year follow-up results using the INDUS prosthesis. Materials and Methods: Two hundred and ninety-seven knees in 276 patients were prospectively analyzed. There were 65 men (72 knees and 211 (225 knees women with a mean age of 64.56 years. Two hundred and forty-five knees had primary osteoarthritis, 48 knees had rheumatoid arthritis, and four knees had post-traumatic arthritis. Clinical parameters, including the Knee Society scores (knee score and function score, range of motion, post-operative anterior knee pain, and complications were recorded. Pre- and post-operative serial radiographs were analyzed for limb alignment, component positioning, and evidence of loosening. Results: The patients were followed-up for an average of 2.59 years (range, 2-3.3 years. The mean knee score and the mean function score were significantly improved from a pre-operative value of 39.4 points and 46.7 points to a post-operative value of 87 points and 86 points, respectively (P value < 0.05. Two hundred and thirty four knees had no anterior knee pain while 63 knees had mild to moderate pain, but none of the patients requested any intervention for the same. Of the 276 patients (297 knees, 79 knees had flexion above 140°, 167 had a flexion range of 130-140°, 27 had a flexion range of 100-130°, and 24 knees had a flexion < 100°, with the mean range of movement being 132.9°. Improvements in the range of movement were retained over time and a total of 205 patients (224 knees, 75.7% could squat or sit cross-legged at the final follow-up. The mean tibiofemoral angle was 8.5°± 6.9º of

  10. Treatment strategies and pregnancy outcomes in antiphospholipid syndrome patients with thrombosis and triple antiphospholipid positivity. A European multicentre retrospective study.

    Science.gov (United States)

    Ruffatti, Amelia; Salvan, Elisa; Del Ross, Teresa; Gerosa, Maria; Andreoli, Laura; Maina, Aldo; Alijotas-Reig, Jaume; De Carolis, Sara; Mekinian, Arsene; Bertero, Maria Tiziana; Canti, Valentina; Brucato, Antonio; Bremme, Katarina; Ramoni, Véronique; Mosca, Marta; Di Poi, Emma; Caramaschi, Paola; Galeazzi, Mauro; Tincani, Angela; Trespidi, Laura; Meroni, Pier Luigi

    2014-10-01

    Previous thrombosis, diagnosis of systemic lupus erythematosus (SLE) and triple antiphospholipid (aPL) antibody positivity have recently been found to be independent factors associated to pregnancy failure during conventional therapy in women with antiphospholipid syndrome (APS). This study aimed to assess the effect of various treatment strategies on pregnancy outcomes in women with APS and the risk factors for pregnancy failure. One hundred ninety-six pregnancies of 156 patients diagnosed with APS were analysed: 118 (60.2%) of these had previous thrombosis, 81 (41.3%) were diagnosed with SLE, and 107 (54.6%) had triple aPL positivity. One hundred seventy-five (89.3%) were treated with conventional therapies (low-dose aspirin [LDA] or prophylactic doses of heparin + LDA or therapeutic doses of heparin + LDA), while 21 (10.7%) were prescribed other treatments in addition to conventional therapy. The pregnancies were classified into seven risk profiles depending on the patients' risk factors - thrombosis, SLE, and triple aPL positivity - and their single, double or triple combinations. It was possible to find significant difference in outcomes correlated to treatments only in the thrombosis plus triple aPL positivity subset, and logistic regression analysis showed that additional treatments were the only independent factor associated to a favourable pregnancy outcome (odds ratio=9.7, 95% confidence interval=1.1-88.9, p-value<0.05). On the basis of this retrospective study, we found that APS pregnant patients with thrombosis and triple aPL positivity treated with additional therapy had a significant higher live-birth rate with respect to those receiving conventional therapy alone.

  11. Pediatrician’s cough and cold medication prescription for hypothetical cases – A cross-sectional multi-centric study

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    Sudha Chandelia

    2016-03-01

    Full Text Available Background: Concerns over inappropriate use of cough and cold medication (CCM in children have been raised. In addition to being ineffective, these are now considered toxic for young children. Despite this fact studies from some regions have shown high use of these medications by physicians. However data on pediatricians and from India are negligible. Aim: To study the burden and patterns of cough and cold medications use by pediatricians for hypothetical cases. Methods: In this cross-sectional study; 172 pediatricians of various hospitals of Delhi and Haryana were enrolled from February 15 to March 15, 2012. They were contacted personally by authors and asked to write their prescriptions for two hypothetical case scenarios [having cough and cold] of two different age groups; (1 less than 2 years and (2 2–5 years. We made two categories as recommendations exist for children less than 2 years while recommendations for the second category are underway. Results were summarized as percentages, counts and; presented in tables and figures. Chi square test was used to establish association between categorical variables of subgroups. Results: Response rate was 93%. The most used CCM was antihistaminics (82% and systemic sympathomimetics (48%. The use of CCM was significantly less in teaching hospitals as compared to non-teaching (77% vs. 95%; p-value – 0.025. However there was no statistical difference in the practice of post graduates and more senior pediatricians (p value-0.895. No difference in CCM use in two age groups {(82% (less than 2 years vs. 85% (2–5 years; p-value – 0.531} was observed. Conclusion: Overall use of CCM is still high irrespective of patient age, pediatrician’s seniority or hospital setting. Efforts should be made to create awareness among the pediatricians regarding cautious use of these medications.

  12. A multicentre study of acute kidney injury in severe sepsis and septic shock: association with inflammatory phenotype and HLA genotype.

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    Didier Payen

    Full Text Available BACKGROUND: To investigate the association between severity of acute kidney injury (AKI and outcome, systemic inflammatory phenotype and HLA genotype in severe sepsis. METHODOLOGY/PRINCIPAL FINDINGS: Prospective multicenter observational study done in 4 intensive care units in two university hospitals. Severe sepsis and septic shock patients with at least 2 organ failures based on the SOFA score were classified: 1 "no AKI", 2 "mild AKI" (grouping stage 1 and 2 of AKIN score and 3 "severe AKI" (stage 3 of AKIN score. Sequential measurements: The vasopressor dependency index (VDI; dose and types of drugs to evaluate the association between hemodynamic status and the development of early AKI; plasma levels of IL-10, macrophage migration inhibitory factor (MIF, IL-6 and HLA-DR monocyte expression. Genotyping of the 13 HLA-DRB1 alleles with deduction of presence of HLA-DRB3, -DRB4 and -DRB5 genes. We used multivariate analysis with competitive risk model to study associations. Overall, 176 study patients (146 with septic shock were classified from AKIN score as "no AKI" (n = 43, "mild AKI" (n = 74 or "severe AKI" (n = 59. The VDI did not differ between groups of AKI. After adjustment, "mild and severe AKI" were an independent risk factor for mortality (HR 2.42 95%CI[1.01-5.83], p = 0.048 and HR 1.99 95%CI[1.30-3.03], p = 0.001 respectively. "Severe AKI" had higher levels of plasma IL-10, MIF and IL-6 compared to "no AKI" and mild AKI (p<0.05 for each, with no difference in mHLA-DR at day 0. HLA-DRB genotyping showed a significantly lower proportion of 4 HLA-DRB alleles among patients requiring renal replacement therapy (RRT (58% than in patients with severe AKI who did not receive RRT (84% (p = 0.004. CONCLUSIONS: AKI severity is independently associated with mortality and plasma IL-10, MIF or IL-6 levels. Presence of 4 alleles of HLA-DRB in severe AKI patients seems associated with a lower need of RRT.

  13. Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. Final rule.

    Science.gov (United States)

    2015-11-01

    This final rule will update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this rule implements the 3rd year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provides a clarification regarding the use of the "initial encounter'' seventh character applicable to certain ICD-10-CM code categories. This final rule will also finalize reductions to the national, standardized 60-day episode payment rate in CY 2016, CY 2017, and CY 2018 of 0.97 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014. In addition, this rule implements a HH value-based purchasing (HHVBP) model, beginning January 1, 2016, in which all Medicare-certified HHAs in selected states will be required to participate. Finally, this rule finalizes minor changes to the home health quality reporting program and minor technical regulations text changes.

  14. A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomized Danish Alzheimer Intervention Study (DAISY)

    DEFF Research Database (Denmark)

    Phung, K.T.T.; Waldorff, F.B.; Buss, D.V.

    2013-01-01

    OBJECTIVES: To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8-12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. DESIGN: Multicentre, randomised, controlled, rater-blinded trial...... groups had follow-up visits at 3, 6, 12 and 36 months. MAIN OUTCOME MEASURES: Primary outcomes for the patients assessed at 36-month follow-up were changes from baseline in global cognitive function (Mini-Mental State Examination), depressive symptoms (Cornell Depression Scale) and proxy-rated Euro...... of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. RESULTS: At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer...

  15. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial

    DEFF Research Database (Denmark)

    Ravnborg, Mads; Sørensen, Per Soelberg; Andersson, Magnus;

    2010-01-01

    BACKGROUND: Interferon beta is commonly used to treat patients with relapsing-remitting multiple sclerosis; however, the treatment is only partially effective in reducing relapses and progression of disability. Corticosteroids are used to treat relapses in patients with multiple sclerosis. We...... therefore aimed to investigate the combination of cyclic methylprednisolone and interferon beta for the treatment of relapsing-remitting multiple sclerosis. METHODS: In 2001, we designed a multicentre, double-blind, randomised, parallel-group trial, termed the methylprednisolone in combination...... with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN) study. Patients were recruited between October, 2002, and March, 2005 from 50 neurology departments in eight countries. We included treatment-naive patients with relapsing-remitting multiple sclerosis who had an expanded disability...

  16. Radio-isotopic assays of vitamin B12: interest of Kappa index in a multicentric study. Dosages radio-isotopiques de la vitamine B12: interet du test Kappa dans une evaluation multicentrique

    Energy Technology Data Exchange (ETDEWEB)

    Fourre, C. (Hopital de Bicetre, 94 - le Kremlin-Bicetre (France)); Guiraud-Vitaux, F. (Hopital de Montfermeil, 93 (France)); Labriolle-Vaylet, C. de (Hopital Saint-Antoine, 75 - Paris (France)); Colas-Linhart, N. (Hopital Beaujon, 92 - Clichy (France))

    1993-12-01

    Owing to the lack of a reference technique and of an international cobalamin (vitamin B12) standard, and the large discrepancy between laboratory norms, the authors performed a multicentric study to compare five RIA kits usually used. First, classical tests were used to evaluate the analytical performances of each kit. Results did not demonstrate any superiority of one kit over another. Secondly, B12 values were classified among three categories (low, normal and high) characterized by laboratory and then manufacturer norms. The concordance between these two ''judgments'' was evaluated with the Kappa coefficient. In addition, the Kappa index proved that the norms supplied by the manufacturer were better than those of laboratories. But mean Kappa coefficient established for each norm gave us an insatisfactory result. Third, clinical informations allowed to improve the classification of the patients. New limits were defined for each technique and should be tested further, routinely in each laboratory. (author).

  17. Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study)

    Science.gov (United States)

    Birring, S S; Brew, J; Kilbourn, A; Edwards, V; Wilson, R; Morice, A H

    2017-01-01

    Objectives To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent. Design A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough. Setting 4 general practitioner (GP) surgeries and 14 pharmacies in the UK. Participants Participants aged ≥18 years who self-referred to a GP or pharmacist with acute cough of <7 days' duration. Participant inclusion criterion was cough severity ≥60 mm on a 0–100 mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12 months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38 years, 57% females). Interventions Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7 days or until resolution of cough. Main outcome measures The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3 days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed. Results At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was −5.9 mm (−14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was −4.2 mm (−12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference −11.6 mm (−20.6 to 2.7), p=0.01) and cough frequency (mean difference −8.1 mm (−16.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean

  18. Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

    Science.gov (United States)

    Xu, Jane; Liu, Yingrui Cyril; Adams, Susan; Karpelowsky, Jonathan

    2016-01-01

    Introduction This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention. Design A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals. Participants Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients. Interventions Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. Analysis Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05. Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. Trial

  19. Surface-induced intramolecular electron transfer in multi-centre redox metalloproteins: the di-haem protein cytochrome c{sub 4} in homogeneous solution and at electrochemical surfaces

    Energy Technology Data Exchange (ETDEWEB)

    Chi Qijin; Zhang Jingdong; Jensen, Palle S; Ulstrup, Jens [Department of Chemistry, Technical University of Denmark, Building 207, DK-2800 Kongens Lyngby (Denmark); Nazmudtinov, Renat R [Kazan State Technological University, 420015 Kazan, Republic of Tatarstan (Russian Federation)

    2008-09-17

    Intramolecular electron transfer (ET) between transition metal centres is a core feature of biological ET and redox enzyme function. The number of microscopic redox potentials and ET rate constants is, however, mostly prohibitive for experimental mapping, but two-centre proteins offer simple enough communication networks for complete mapping to be within reach. At the same time, multi-centre redox proteins operate in a membrane environment where conformational dynamics and ET patterns are quite different from the conditions in a homogeneous solution. The bacterial respiratory di-haem protein Pseudomonas stutzeri cytochrome c{sub 4} offers a prototype target for environmental gating of intra-haem ET. ET between P. stutzeri cyt c{sub 4} and small molecular reaction partners in solution appears completely dominated by intermolecular ET of each haem group/protein domain, with no competing intra-haem ET, for which accompanying propionate-mediated proton transfer is a further barrier. The protein can, however, be immobilized on single-crystal, modified Au(111) electrode surfaces with either the low-potential N terminal or the high-potential C terminal domain facing the surface, clearly with fast intramolecular ET as a key feature in the electrochemical two-ET process. This dual behaviour suggests a pattern for multi-centre redox metalloprotein function. In a homogeneous solution, which is not the natural environment of cyt c{sub 4}, the two haem group domains operate largely independently with conformations prohibitive for intramolecular ET. Binding to a membrane or electrochemical surface, however, triggers conformational opening of intramolecular ET channels. The haem group orientation in P. stutzeri cyt c{sub 4} is finally noted to offer a case for orientation dependent electronic rectification between a substrate and a tip in electrochemical in situ scanning tunnelling microscopy or nanoscale electrode configurations.

  20. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    Directory of Open Access Journals (Sweden)

    Freitag Christine M

    2013-01-01

    Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological s