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Sample records for european multicenter study

  1. Toric phakic intraocular lens: European multicenter study.

    Science.gov (United States)

    Dick, H Burkhard; Alió, Jorge; Bianchetti, Marco; Budo, Camille; Christiaans, Bern Jurriën; El-Danasoury, M Alaa; Güell, José L; Krumeich, Jörg; Landesz, Monika; Loureiro, Fransico; Luyten, Gregorius P M; Marinho, Antonio; Rahhal, Mohamed Saleh; Schwenn, Oliver; Spirig, Raimund; Thomann, Urs; Venter, Jan

    2003-01-01

    To evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after implantation of Artisan toric phakic intraocular lenses (TPIOLs) for the correction of myopia or hyperopia with astigmatism. Prospective, nonrandomized, comparative (self-controlled) multicenter trial. Seventy eyes of 53 patients (mean, 35 years; range, 22-59 years) with preoperative spherical equivalent between +6.50 and -21.25 diopters (D) and cylinder between 1.50 and 7.25 D. Seventy eyes underwent implantation of a TPIOL with an optical zone of 5.0 mm (Artisan, Ophtec, Groningen, The Netherlands). The dioptric power of the intraocular lens was calculated by considering refraction, keratometry, and anterior chamber depth. The follow-up was 6 months in all cases. Lenses were available in powers ranging from +12.0 D to -23.5 D (spherical equivalent) in 0.5-D increments, with additional cylinder from 1.0 D to 7.0 D, also in 0.5-D increments. The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, endothelial cell count (ECC), intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, subjective complaints, and patient satisfaction. Eyes were divided into group A, myopia (n = 48), with an average preoperative spherical equivalent of -8.90 +/- 4.52 D, and group B, hyperopia (n = 22), with an average preoperative spherical equivalent of +3.25 +/- 1.98 D. No eyes in either group experienced a loss in BSCVA, and 46 eyes gained 1 or more lines of their preoperative BSCVA. In 62 eyes (88.6%), UCVA was 20/40 or better. There was a significant reduction in spherical errors and astigmatism in all cases after surgery. All eyes of both groups were within +/-1.00 D of target refraction, and 51 eyes (72.9%) were within +/-0.50 D of target refraction. There was a 4.5% mean total loss of ECC during the first 6 months. No serious complications were observed. Overall patient satisfaction was very

  2. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study

    DEFF Research Database (Denmark)

    Nielsen, T L; Eeftinck Schattenkerk, J K; Jensen, B N

    1992-01-01

    Fifty-nine human immunodeficiency virus type-1-infected patients with a microscopically proven first episode of moderate to severe Pneumocystis carinii pneumonia (PCP) were enrolled into a randomized European multicenter study. The effect of adjunctive corticosteroid (CS) therapy was assessed on (a...... (10%) in the CS group; p = 0.01. The 90-day survival was 69% in controls versus 87% in CS patients; p = 0.07. Based on these data we conclude that adjunctive CS therapy for moderate to severe PCP in AIDS patients reduces the acute mortality and the need for mechanical ventilation....

  3. Day-Case Treatment of Peripheral Arterial Disease: Results from a Multi-Center European Study

    Energy Technology Data Exchange (ETDEWEB)

    Spiliopoulos, Stavros, E-mail: stavspiliop@med.uoa.gr, E-mail: stavspiliop@upatras.gr; Karnabatidis, Dimitrios, E-mail: karnaby@med.upatras.gr [Patras University Hospital, Department of Interventional Radiology (Greece); Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Diamantopoulos, Athanasios, E-mail: adiamantopoulos@gmail.com [Guy’s and St Thomas’ Hospitals, NHS Foundation Trust, King’s Health Partners, Department of Interventional Radiology (United Kingdom); Ali, Tariq, E-mail: tariq.ali@addenbrookes.nhs.uk [Addenbrooke’s University Hospital, NHS Foundation Trust, Department of Interventional Radiology (United Kingdom); Kitrou, Panagiotis, E-mail: panoskitrou@gmail.com [Patras University Hospital, Department of Interventional Radiology (Greece); Cannavale, Alessandro, E-mail: alessandro.cannavale@hotmail.com; Krokidis, Miltiadis, E-mail: miltiadis.krokidis@addenbrookes.nhs.uk [Addenbrooke’s University Hospital, NHS Foundation Trust, Department of Interventional Radiology (United Kingdom)

    2016-12-15

    PurposeThe purpose of the study was to investigate safety and feasibility of day-case endovascular procedures for the management of peripheral arterial disease.Materials and MethodsThis was a multi-center, retrospective study including all patients treated over a 30-month period with endovascular angioplasty or stenting for intermittent claudication (IC) or critical limb ischemia (CLI) on a day-case basis, in Interventional Radiology (IR) departments of three European tertiary hospitals. Exclusion criteria were not related to the type of lesion and included unavailability of an adult able to take care of patient overnight; high bleeding risk and ASA score ≥4. Primary efficacy outcome was the rate of procedures performed on an outpatient basis requiring no further hospitalization and primary safety outcome was freedom from 30-day major complications’ rate.ResultsThe study included 652 patients (male 75 %; mean age 68 ± 10 years; range: 27–93), 24.6 % treated for CLI. In 53.3 % of the cases a 6Fr sheath was used. Technical success was 97.1 %. Haemostasis was obtained by manual compression in 52.4 % of the accesses. The primary efficacy outcome occurred in 95.4 % (622/652 patients) and primary safety outcome in 98.6 % (643/652 patients). Major complications included five (0.7 %) retroperitoneal hematomas requiring transfusion; one (0.1 %) common femoral artery pseudoaneurysm successfully treated with US-guided thrombin injection, two cases of intra-procedural distal embolization treated with catheter-directed local thrombolysis and one on-table cardiac arrest necessitating >24 h recovery. No major complication was noted after same-day discharge.ConclusionsDay-case endovascular procedures for the treatment of IC or CLI can be safely and efficiently performed in experienced IR departments of large tertiary hospitals.

  4. European multicenter study on antimicrobial resistance in bacteria isolated from companion animal urinary tract infections

    NARCIS (Netherlands)

    Marques, Cátia; Gama, Luís Telo; Belas, Adriana; Bergström, Karin; Beurlet, Stéphanie; Briend-Marchal, Alexandra; Broens, Els M; Costa, Marta; Criel, Delphine; Damborg, Peter; van Dijk, Marloes A M; van Dongen, A.M.; Dorsch, Roswitha; Espada, Carmen Martin; Gerber, Bernhard; Kritsepi-Konstantinou, Maria; Loncaric, Igor; Mion, Domenico; Misic, Dusan; Movilla, Rebeca; Overesch, Gudrun; Perreten, Vincent; Roura, Xavier; Steenbergen, Joachim; Timofte, Dorina; Wolf, Georg; Zanoni, Renato Giulio; Schmitt, Sarah; Guardabassi, Luca; Pomba, Constança

    2016-01-01

    BACKGROUND: There is a growing concern regarding the increase of antimicrobial resistant bacteria in companion animals. Yet, there are no studies comparing the resistance levels of these organisms in European countries. The aim of this study was to investigate geographical and temporal trends of

  5. Artiflex Toric foldable phakic intraocular lens: short-term results of a prospective European multicenter study.

    Science.gov (United States)

    Doors, Muriël; Budo, Camille J; Christiaans, Ben J; Luger, Michiel; Marinho, Antonio A P; Dick, H Burkhard; Güell, Jose L; Nuijts, Rudy M M A

    2012-10-01

    To evaluate the short-term efficacy, predictability, stability, and safety of the foldable Artiflex Toric phakic intraocular lens (pIOL; Ophtec) for the correction of myopia with astigmatism. Prospective, nonrandomized multicenter study. One hundred fifteen eyes of 73 patients were implanted with an Artiflex Toric pIOL. Mean implanted spherical and cylindrical powers were -7.10 ± 2.70 diopters (D) and -2.14 ± 0.80 D, respectively. Total follow-up was 6 months. Outcome parameters included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), subjective manifest refraction (used for vector analysis), intraocular pressure, and endothelial cell density (ECD). At 6 months, 99.0% of eyes had a UCVA of ≥20/40, and 81.8% of eyes were ±0.5 D of the intended refraction. In 74.5% postoperative UCVA was equal to or better than preoperative BSCVA; 2 eyes lost 2 or more lines of BSCVA postoperatively because of the development of synechiae. In 75.5% of eyes the remaining cylinder was ±0.5 D. There was a significant decrease in ECD after 3 months (4.8% ± 11.9%), with no additional decline between 3 and 6 months. There were few complications, except for the incidence of pigment and nonpigment precipitates (14.8% and 12.2%, respectively at 6 months). Mean misalignment was 0.6 ± 1.5 degrees (range 0-8). The Artiflex Toric pIOL effectively and safely corrects myopia and astigmatism in the short term, with stable and predictable visual results after 6 months, when strict inclusion criteria are applied. Deposition of pigment and nonpigment precipitates on the pIOL warrants further investigation. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group

    NARCIS (Netherlands)

    Ruzicka, T.; Bieber, T.; Schöpf, E.; Rubins, A.; Dobozy, A.; Bos, J. D.; Jablonska, S.; Ahmed, I.; Thestrup-Pedersen, K.; Daniel, F.; Finzi, A.; Reitamo, S.

    1997-01-01

    Tacrolimus (FK 506) is an effective immunosuppressant drug for the prevention of rejection after organ transplantation, and preliminary studies suggest that topical application of tacrolimus is effective in the treatment of atopic dermatitis. We conducted a randomized, doubleblind, multicenter study

  7. A prospective multicenter European study on flexible ureterorenoscopy for the management of renal stone

    Directory of Open Access Journals (Sweden)

    Francesco Berardinelli

    2016-06-01

    Full Text Available ABSTRACT Purpose The aim of this study was to describe the outcomes and the complications of retrograde intrarenal surgery (RIRS for renal stones in a multi-institutional working group. Materials and Methods From 2012 to 2014, we conducted a prospective study including all RIRS performed for kidney stones in 4 European centers. Demographic information, disease characteristics, and perioperative and postoperative data were gathered. Patients and stone data, procedure characteristics, results and safety outcomes were analyzed and compared by descriptive statistics. Complications were reported using the standardized Clavien system. Results Three hundred and fifty-six patients underwent 377 RIRS with holmium laser lithotripsy for renal stones. The RIRS was completed in all patients with a mean operative time of 63.5 min. The stone-free status was confirmed endoscopically and through fluoroscopic imaging after the first procedure in 73.6%. The second procedure was performed in twenty patients (5.6% achieving an overall stone free rate of 78.9%. The overall complication rate was 15.1%. Intra-operative and post-operative complications were seen in 24 (6.7% and 30 (8.4% cases, respectively. Conclusions RIRS is a minimally invasive procedure with good results in terms of stone-free and complications rate.

  8. Sexual behavior of gender-dysphoric individuals before gender-confirming interventions: a European multicenter study.

    Science.gov (United States)

    Cerwenka, Susanne; Nieder, Timo O; Cohen-Kettenis, Peggy; De Cuypere, Griet; Haraldsen, Ira R Hebold; Kreukels, Baudewijntje P C; Richter-Appelt, Hertha

    2014-01-01

    A transsexual course of development that starts before puberty (early onset) or during or after puberty, respectively (late onset), may lead to diverse challenges in coping with sexual activity. The authors explored the sexual behavior of 380 adult male-to-female and female-to-male individuals diagnosed according to DSM-IV-TR criteria who had not yet undergone gender-confirming interventions. Data originated from the European Network for the Investigation of Gender Incongruence Initiative, conducted in Belgium, Germany, The Netherlands, and Norway. Information on outcome variables was collected using self-administered questionnaires at first clinical presentation. Compared with late-onset male-to-females, early-onset individuals tended to show sexual attraction toward males more frequently (50.5%), involve genitals less frequently in partner-related sexual activity, and consider penile sensations and orgasm as more negative. Early-onset female-to-males predominantly reported sexual attraction toward females (84.0%), whereas those with a late-onset more frequently showed other sexual attractions (41.7%). The study (a) shows that early- and late-onset male-to-females differ considerably with regard to coping strategies involving their body during sexual relations and (b) reveals initial insights into developmental pathways of late-onset female-to-males.

  9. Family adaptation to cerebral palsy in adolescents: A European multicenter study.

    Science.gov (United States)

    Guyard, Audrey; Michelsen, Susan I; Arnaud, Catherine; Fauconnier, Jerome

    2017-02-01

    Factors promoting family adaptation to child's disability are poorly studied together. The aim of the study was to describe the family adaptation to disability and to identify determinants associated with using a global theoretical model. 286 families of teenagers [13-17 years] with cerebral palsy (CP) from 4 European disability registers were included and visited at home. Face to face interviews were performed in order to measure parental distress, perceived impact in various dimensions of family life, family resources and stressors. Relationships were modelled with structural equations. 31.8% of parents living with an adolescent with CP showed clinically significant high stress requiring professional assistance. The main stressors were the level of motor impairment and behavioural disorders in adolescent. A good family functioning was the best protective factor. Respite in care and a parents' positive attitude were significantly related to less parental distress. Material support, socioeconomical level, marital status or parental qualifications did not appear to be significant protector factors. Particular attention must be paid not only on physical condition but also on adolescent psychological problems to improve family adaptation. Families at risk of experiencing severe distress should be targeted early and proactive caregiver interventions on the whole family should be performed. Family is a dynamic system: facing disability, it tries to recover its balance with available resources and its perception of the situation. Literature highlights potential stressors and protecting factors that could affect the disabled child's family adaptation but few papers study a global model including most of these factors. This study validated a global theoretical model of family adaptation to disability at adolescence. It identified behaviour disorders and motor impairment level as main stressors, family functioning as the largest protecting factors, and equipment and

  10. Family adaptation to cerebral palsy in adolescents: A European multicenter study

    Science.gov (United States)

    Guyard, Audrey; Michelsen, Susan I.; Arnaud, Catherine; Fauconnier, Jerome

    2017-01-01

    Background and aim Factors promoting family adaptation to child’s disability are poorly studied together. The aim of the study was to describe the family adaptation to disability and to identify determinants associated with using a global theoretical model. Materials and methods 286 families of teenagers [13–17 years] with cerebral palsy (CP) from 4 European disability registers were included and visited at home. Face to face interviews were performed in order to measure parental distress, perceived impact in various dimensions of family life, family resources and stressors. Relationships were modelled with structural equations. Results 31.8% of parents living with an adolescent with CP showed clinically significant high stress requiring professional assistance. The main stressors were the level of motor impairment and behavioural disorders in adolescent. A good family functioning was the best protective factor. Respite in care and a parents’ positive attitude were significantly related to less parental distress. Material support, socioeconomical level, marital status or parental qualifications did not appear to be significant protector factors. Conclusions Particular attention must be paid not only on physical condition but also on adolescent psychological problems to improve family adaptation. Families at risk of experiencing severe distress should be targeted early and proactive caregiver interventions on the whole family should be performed. What this paper adds Family is a dynamic system: facing disability, it tries to recover its balance with available resources and its perception of the situation. Literature highlights potential stressors and protecting factors that could affect the disabled child’s family adaptation but few papers study a global model including most of these factors. This study validated a global theoretical model of family adaptation to disability at adolescence. It identified behaviour disorders and motor impairment level as main

  11. Progress in implantable gastric stimulation: summary of results of the European multi-center study.

    Science.gov (United States)

    De Luca, Maurizio; Segato, Gianni; Busetto, Luca; Favretti, Franco; Aigner, Franz; Weiss, Helmut; de Gheldere, Charles; Gaggiotti, Giorgio; Himpens, Jacques; Limao, Jorge; Scheyer, Matthias; Toppino, Mauro; Zurmeyer, Ernst L; Bottani, Giorgio; Penthaler, Heinrich

    2004-09-01

    The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed. Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed. The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase. IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.

  12. European multicenter study on antimicrobial resistance in bacteria isolated from companion animal urinary tract infections

    DEFF Research Database (Denmark)

    Marques, Cátia; Gama, Luís Telo; Belas, Adriana

    2016-01-01

    of antimicrobial resistant bacteria causing urinary tract infection (UTI) in companion animals in Europe. The antimicrobial susceptibility of 22 256 bacteria isolated from dogs and cats with UTI was determined. Samples were collected between 2008 and 2013 from 16 laboratories of 14 European countries....... The prevalence of antimicrobial resistance of the most common bacteria was determined for each country individually in the years 2012-2013 and temporal trends of bacteria resistance were established by logistic regression. RESULTS: The aetiology of uropathogenic bacteria differed between dogs and cats. For all...

  13. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects

    NARCIS (Netherlands)

    Tack, C.J.; Pohlmeier, H.; Behnke, T.; Schmid, V.; Grenningloh, M.; Forst, T.; Pfutzner, A.

    2012-01-01

    BACKGROUND: This multicenter study was conducted to evaluate the performance of five recently introduced blood glucose (BG) monitoring (BGM) devices under daily routine conditions in comparison with the YSI (Yellow Springs, OH) 2300 Stat Plus glucose analyzer. METHODS: Five hundred one diabetes

  14. European non-invasive trisomy evaluation (EU-NITE) study: a multicenter prospective cohort study for non-invasive fetal trisomy 21 testing.

    Science.gov (United States)

    Verweij, E J; Jacobsson, B; van Scheltema, P A; de Boer, M A; Hoffer, M J V; Hollemon, D; Westgren, M; Song, K; Oepkes, D

    2013-10-01

    To evaluate the performance of a directed non-invasive prenatal testing method of cell-free DNA analysis for fetal trisomy 21 (T21) by shipping the whole blood samples from Europe to a laboratory in the USA. A European multicenter prospective, consecutive cohort study was performed enrolling pregnant women from Sweden and the Netherlands. Blood samples were drawn just prior to a planned of invasive diagnostic procedure in a population at increased risk for fetal T21 and then shipped to the USA without any blood processing. Chromosome-selective sequencing was carried out on chromosome 21 with reporting high risk or low risk of T21. Karyotyping or rapid aneuploidy detection was used as the clinical reference standard. Of the 520 eligible study subjects, a T21 test result was obtained in 504/520 (96.9%). Risk assessment was accurate in 503/504 subjects (99.8%). There was one false negative result for T21 (sensitivity 17/18, 94.4%, and specificity 100%). This is the first prospective European multicenter study showing that non-invasive prenatal testing using directed sequencing of cell-free DNA applied to blood samples shipped across the Atlantic Ocean, is highly accurate for assessing risk of fetal T21. © 2013 John Wiley & Sons, Ltd.

  15. Left-Sided Reoperations After Arterial Switch Operation: A European Multicenter Study.

    Science.gov (United States)

    Vida, Vladimiro L; Zanotto, Lorenza; Zanotto, Lucia; Stellin, Giovanni; Padalino, Massimo; Sarris, Georges; Protopapas, Eleftherios; Prospero, Carol; Pizarro, Christian; Woodford, Edward; Tlaskal, Thomas; Berggren, Hakan; Kostolny, Martin; Omeje, Ikenna; Asfour, Boulos; Kadner, Alexander; Carrel, Thierry; Schoof, Paul H; Nosal, Matej; Fragata, Josè; Kozłowski, Michał; Maruszewski, Bohdan; Vricella, Luca A; Cameron, Duke E; Sojak, Vladimir; Hazekamp, Mark; Salminen, Jukka; Mattila, Ilkka P; Cleuziou, Julie; Myers, Patrick O; Hraska, Viktor

    2017-09-01

    We sought to report the frequency, types, and outcomes of left-sided reoperations (LSRs) after an arterial switch operation (ASO) for patients with D-transposition of the great arteries (D-TGA) and double-outlet right ventricle (DORV) TGA-type. Seventeen centers belonging to the European Congenital Heart Surgeons Association (ECHSA) contributed to data collection. We included 111 patients who underwent LSRs after 7,951 ASOs (1.4%) between January 1975 and December 2010. Original diagnoses included D-TGA (n = 99) and DORV TGA-type (n = 12). Main indications for LSR were neoaortic valve insufficiency (n = 52 [47%]) and coronary artery problems (CAPs) (n = 21 [19%]). Median age at reoperation was 8.2 years (interquartile range [IQR], 2.9-14 years). Seven patients died early after LSRs (6.3%); 4 patients with D-TGA (5.9%) and 3 patients with DORV TGA-type (25%) (p = 0.02). Median age at last follow-up was 16.1 years (IQR, 9.9-21.8 years). Seventeen patients (16%) required another reoperation, which was more frequent in patients with DORV- TGA type (4 of 9 [45%]) than in patients with D-TGA (13 of 95 [14%]). Late death occurred in 4 patients (4 of 104 [3.8%]). The majority of survivors were asymptomatic at last clinical examination (84 of 100 [84%]). Reoperations for residual LSRs are infrequent but may become necessary late after an ASO, predominantly for neoaortic valve insufficiency and CAPs. Risk at reoperation is not negligible, and DORV TGA-type anatomy, as well as procedures on the coronary arteries, were significantly associated with a higher morbidity and a lower overall survival. Recurrent reoperations after LSRs may be required. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  16. Preliminary Results From the C-Pulse? OPTIONS HF European Multicenter Post-Market Study

    OpenAIRE

    Schulz, Antonia; Krabatsch, Thomas; Schmitto, Jan D.; Hetzer, Roland; Seidel, Mirko; Dohmen, Pascal M.; Hotz, Holger

    2016-01-01

    Background The C-Pulse? System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV. Material/Methods We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study. Results Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6?9.3 years. Four had ...

  17. A European multicenter study on systematic ethics work in nursing homes.

    Science.gov (United States)

    Bollig, Georg; Rosland, Jan Henrik; Gjengedal, Eva; Schmidt, Gerda; May, Arnd T; Heller, Andreas

    2017-09-01

    There are many existing ethical challenges in nursing homes. Although different methods and approaches to discussing the ethical challenges have been established, systematic ethics work is not yet a standard in all nursing homes. The aim of the present study was to explore ethical challenges and approaches to implementing systematic ethics work in nursing homes. Data from five institutions in Austria, Germany and Norway were collected, and a mixed-methods two-tiered study approach was chosen. Documentation of ethics discussions was combined with qualitative focus group interviews with staff members regarding the implementation of systematic ethics work in nursing homes. One hundred and five ethics meetings were documented. The main topics were advance care planning, ethical challenges associated with artificial nutrition, hospitalisation and end-of-life decision-making. Of the meetings, 33% focused mainly on everyday ethical challenges. In 76% of prospective case discussions, agreements about a solution were reached; however, in 29% of these no residents or relatives participated. The advantages of systematic ethics work described by the staff were enhanced openness and dialogue, overall, and a greater ethical awareness. Many voiced a need for structure and support from the administration. Systematic ethics work is greatly appreciated by the staff and helps to reach a consensus in the majority of case discussions. It should be implemented in all nursing homes. Attention to everyday ethical challenges is important. The participation of relatives and physicians could be improved. The participation of the residents' in ethics discussions should be encouraged to strengthen their autonomy and dignity. © 2016 The Authors. Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.

  18. Retrospective analysis of laser vs other therapeutic modalities for laryngeal papillomatosis: European multicenter study.

    Science.gov (United States)

    Papaspyrou, Giorgos; Schick, Bernhard; Papaspyrou, Spyros; Eivazi, Behfar; Al Kadah, Basel

    2016-01-01

    Laryngeal papillomatosis can be an aggressive and potentially life-threatening disease, affecting both children and adults. Local excision is the gold standard of treatment, but recurrences are frequently inevitable. The purpose of this study was to present the experience of three institutions with different therapeutic modalities and discuss them in relation with the relevant literature. Sixty patients underwent papilloma resection during the last decade in three institutions (Homburg/Saar and Marburg, Germany and Athens,Greece). Patient data were retrospectively analyzed for therapeutic modalities applied, rate of complications and synechia formation, necessary operations and need for tracheostomy. Carbon dioxide laser therapy was the most common modality applied alone or combined with other treatment modalities. No major complication was observed, while glottic synechia was the most common minor complication in 5 (8.3%) patients. Of the patient cohort 55.6% required reoperation, while no patient required tracheostomy. Surgical debulking with or without adjuvant treatment remains the mainstay of treatment, which mainly aims to reduce the number and frequency of recurrences since no definitive curative therapy is known so far.

  19. Predicting sickness impact profile at six months after stroke: further results from the European multi-center CERISE study

    NARCIS (Netherlands)

    Stummer, C.A.; Verheyden, G.; Putman, K.; Jenni, W.; Schupp, W.; Wit, L. De

    2015-01-01

    PURPOSE: To develop prognostic models and equations for predicting participation at six months after stroke. METHODS: This European prospective cohort study recruited 532 consecutive patients from four rehabilitation centers. Participation was assessed at six months after stroke with the Sickness

  20. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  1. Gender-specific differences in carotid intima-media thickness and its progression over three years: A multicenter European study

    NARCIS (Netherlands)

    Kozakova, M.; Palombo, C.; Morizzo, C.; Nolan, J.J.; Konrad, T.; Dekker, J.M.; Balkau, B.; Nilsson, P.M.

    2013-01-01

    This multicentre European study evaluated, in a young-to-middle-aged healthy population without carotid atherosclerosis, the gender-related differences in carotid intima-media thickness (IMT) and its short-term (3-year) progression, and whether these differences are related to different vascular

  2. Multi-center study on the characteristics and treatment strategies of patients with Graves' orbitopathy: the first European Group on Graves' Orbitopathy experience

    NARCIS (Netherlands)

    Prummel, Mark F.; Bakker, Annemieke; Wiersinga, Wilmar M.; Baldeschi, Lelio; Mourits, Maarten P.; Kendall-Taylor, Pat; Perros, Petros; Neoh, Chris; Dickinson, A. Jane; Lazarus, John H.; Lane, Carol M.; Heufelder, Armin E.; Kahaly, George J.; Pitz, Suzanne; Orgiazzi, Jacques; Hullo, Alain; Pinchera, Aldo; Marcocci, Claudio; Sartini, Maria S.; Rocchi, Roberto; Nardi, Marco; Krassas, Gerry E.; Halkias, A.

    2003-01-01

    To improve management of patients with Graves' orbitopathy, a multi-center collaborative approach is necessary in order to have large enough sample sizes for meaningful randomized clinical trials. This is hampered by a lack of consensus on how to investigate the eye condition. The European Group on

  3. Risk of upper aerodigestive tract cancer and type of alcoholic beverage: a European multicenter case-control study.

    LENUS (Irish Health Repository)

    Marron, Manuela

    2012-07-01

    The general relationship between cancers of the upper aerodigestive tract (UADT) and alcohol drinking is established. Nevertheless, it is uncertain whether different types of alcoholic beverages (wine, beer and liquor) carry different UADT cancer risks. Our study included 2,001 UADT cancer cases and 2,125 controls from 14 centres in 10 European countries. All cases were histologically or cytologically confirmed squamous cell carcinomas. Controls were frequency matched by sex, age and centre. Logistic regression models were used to estimate odds ratios (OR) and 95 % confidence intervals (95 %CI) adjusted for age, sex, centre, education level, vegetable and fruit intake, tobacco smoking and alcohol drinking, where appropriate. Risk of beverage-specific alcohol consumption were calculated among \\'pure drinker\\' who consumed one beverage type exclusively, among \\'predominant drinkers\\' who consumed one beverage type to more than 66 % and among \\'mixed drinkers\\' who consumed more than one beverage type to similar proportions. Compared to never drinkers and adjusted for cumulative alcohol consumption, the OR and 95 %CI for wine, beer and liquor drinking, respectively, were 1.24 (0.86, 1.78), 1.54 (1.05, 2.27) and 0.94 (0.53, 1.64) among \\'pure drinkers\\' (p value for heterogeneity across beverage types = 0.306), 1.05 (0.76,1.47), 1.25 (0.87,1.79) and 1.43 (0.95, 2.16) among \\'predominant drinkers\\' (p value = 0.456), and 1.09 (0.79, 1.50), 1.20 (0.88, 1.63) and 1.12 (0.82, 1.53) among \\'mixed drinkers\\' (p value = 0.889). Risk of UADT cancer increased with increasing consumption of all three alcohol beverage types. Our findings underscore the strong and comparable carcinogenic effect of ethanol in wine, beer and liquor on organs of the UADT.

  4. Clinical characteristics and treatment outcomes of patients with major depressive disorder and comorbid anxiety disorders - results from a European multicenter study.

    Science.gov (United States)

    Dold, Markus; Bartova, Lucie; Souery, Daniel; Mendlewicz, Julien; Serretti, Alessandro; Porcelli, Stefano; Zohar, Joseph; Montgomery, Stuart; Kasper, Siegfried

    2017-08-01

    This naturalistic European multicenter study aimed to elucidate the association between major depressive disorder (MDD) and comorbid anxiety disorders. Demographic and clinical information of 1346 MDD patients were compared between those with and without concurrent anxiety disorders. The association between explanatory variables and the presence of comorbid anxiety disorders was examined using binary logistic regression analyses. 286 (21.2%) of the participants exhibited comorbid anxiety disorders, 10.8% generalized anxiety disorder (GAD), 8.3% panic disorder, 8.1% agoraphobia, and 3.3% social phobia. MDD patients with comorbid anxiety disorders were characterized by younger age (social phobia), outpatient status (agoraphobia), suicide risk (any anxiety disorder, panic disorder, agoraphobia, social phobia), higher depressive symptom severity (GAD), polypsychopharmacy (panic disorder, agoraphobia), and a higher proportion receiving augmentation treatment with benzodiazepines (any anxiety disorder, GAD, panic disorder, agoraphobia, social phobia) and pregabalin (any anxiety disorder, GAD, panic disorder). The results in terms of treatment response were conflicting (better response for panic disorder and poorer for GAD). The logistic regression analyses revealed younger age (any anxiety disorder, social phobia), outpatient status (agoraphobia), suicide risk (agoraphobia), severe depressive symptoms (any anxiety disorder, GAD, social phobia), poorer treatment response (GAD), and increased administration of benzodiazepines (any anxiety disorder, agoraphobia, social phobia) and pregabalin (any anxiety disorder, GAD, panic disorder) to be associated with comorbid anxiety disorders. Our findings suggest that the various anxiety disorders subtypes display divergent clinical characteristics and are associated with different variables. Especially comorbid GAD appears to be characterized by high symptom severity and poor treatment response. Copyright © 2017 Elsevier Ltd. All

  5. Histological and clinical findings in patients with post-transplantation and classical encapsulating peritoneal sclerosis: A European multicenter study

    NARCIS (Netherlands)

    J. Latus (Joerg); S.M. Habib (Meelad); D. Kitterer (Daniel); M.R. Korte (Mario); C. Ulmer (Christoph); P. Fritz (Peter); S. Davies (Simon); M. Lambie (Mark); M.D. Alscher (M. Dominik); M.G.H. Betjes (Michiel); S. Segerer (Stephan); N. Braun (Niko)

    2014-01-01

    textabstractBackground: Encapsulating peritoneal sclerosis (EPS) commonly presents after peritoneal dialysis has been stopped, either post-transplantation (PT-EPS) or after switching to hemodialysis (classical EPS, cEPS). The aim of the present study was to investigate whether PT-EPS and cEPS differ

  6. Dietary Polyphenols in the Aetiology of Crohn's Disease and Ulcerative Colitis-A Multicenter European Prospective Cohort Study (EPIC)

    DEFF Research Database (Denmark)

    Lu, Yunxia; Zamora-Ros, Raul; Chan, Simon

    2017-01-01

    .02). No significant associations between subtypes of polyphenols and UC were found. Effect modification by smoking in CD was documented with borderline statistical significance. CONCLUSIONS: The data supports a potential role of flavones and resveratrol in the risk of developing CD; future aetiological studies should...

  7. Ross Procedure in Neonates and Infants: A European Multicenter Experience.

    NARCIS (Netherlands)

    Schoof, PH

    2015-01-01

    BACKGROUND: Infants and neonates with severe left ventricular outflow tract obstruction may require pulmonary autograft replacement of the aortic root. In this retrospective multicenter cohort study, we present our experience with the Ross procedure in neonates and infants with a focus on midterm

  8. Ross procedure in neonates and infants: A european multicenter experience

    NARCIS (Netherlands)

    A. Mookhoek (Aart); E.I. Charitos (Efstratios); M.G. Hazekamp (Mark); A.J.J.C. Bogers (Ad); J. Hörer (Jürgen); R. Lange (Rüdiger); R. Hetzer (Roland); J. Sachweh (Jörg); A. Riso (Arlindo); U. Stierle (Ulrich); J.J.M. Takkenberg (Hanneke); P.H. Schoof (Paul)

    2015-01-01

    textabstractBackground Infants and neonates with severe left ventricular outflow tract obstruction may require pulmonary autograft replacement of the aortic root. In this retrospective multicenter cohort study, we present our experience with the Ross procedure in neonates and infants with a focus on

  9. Multicenter pin care study.

    Science.gov (United States)

    Patterson, Miki M

    2005-01-01

    Pin-site infection is a common complication of external fixation. Because few studies have compared methods of pin care that reduce infection rate, there is a need for evidence-based practice guidelines for pin-site care. Two of 10 original clinical centers completed a prospective, randomized pin-care study between May 2000 and May 2002 to determine which of seven methods for caring for skeletal pins (external fixator, traction, or halo) resulted in the fewest pin-site infections. The 92 subjects had an average infection rate of 34%, and the 527 pins had a rate of 20%. Thirty patients (98 pins) had stage II infections, two patients (12 pins) had stage III infections, and none had deep infection or osteomyelitis. The protocols were (1) half-strength peroxide cleansing and gauze wraps (45%), (2) half-strength peroxide cleansing and Xeroform wraps (9%), (3) saline cleansing and gauze wraps (33%), (4) saline cleansing and Xeroform wraps (26%), (5) antibacterial soap-and-water cleansing and gauze (38%), (6) antibacterial soap-and-water cleansing and Xeroform gauze (50%), and (7) stable dressings with no pin cleansing (36%). Logistic regression analysis demonstrated significant inverse relationships (p = .05) between infection rate and age, as well as fixator type; the latter may be related to exposed threads. Results suggest that other factors outside the realm of this study may affect children's pin-site infection rate and that half-strength peroxide and Xeroform dressings were superior to soap-and-water cleansing. This pilot study indicates a need for further research with a larger sample size and for exploring factors in a younger population.

  10. Evolving patterns in the diagnosis of reactive gastropathy: data from a prospective Central European multicenter study with proposal of a new histologic scoring system.

    Science.gov (United States)

    Wolf, Eva-Maria; Plieschnegger, Wolfgang; Schmack, Bertram; Bordel, Hartmut; Höfler, Bernd; Eherer, Andreas; Schulz, Tilman; Vieth, Michael; Langner, Cord

    2014-12-01

    Histologic examination of gastric biopsies is crucial for determining the cause of gastritis. This prospective multicenter study was undertaken to investigate different histologic parameters arguing in favor or against the diagnosis of reactive gastropathy and to correlate findings with patient's symptoms and endoscopic findings. A total of 1123 individuals aged 15-93 years participated in a prospective multicenter study (histoGERD trial). Diagnosis of Helicobacter gastritis was made following the Updated Sydney System. Diagnosis of reactive gastropathy was based upon Dixon's parameters of foveolar hyperplasia, smooth muscle fibers in the lamina propria and vasodilatation and congestion of mucosal capillaries. Including paucity of acute and chronic inflammatory cells in analysis, a new score with visual analog scales for the diagnosis of reactive gastropathy was developed. All three histologic parameters in favor of the diagnosis of reactive gastropathy were positively associated with the endoscopic diagnosis of gastritis (p acute and chronic inflammatory cells in lamina propria was positively associated with Helicobacter infection (p gastritis. Our score demonstrated strong association between histologic and endoscopic diagnoses (p < 0.001), yet not with patient's symptoms. In conclusion, our data prove foveolar hyperplasia, smooth muscle fibers and vasodilatation and congestion as key histologic parameters for the diagnosis of reactive gastropathy. The proposed score may enhance the diagnostic accuracy. It should be validated in future studies. Copyright © 2014 Elsevier GmbH. All rights reserved.

  11. Self-Care Practices for Common Colds by Primary Care Patients: Study Protocol of a European Multicenter Survey—The COCO Study

    Directory of Open Access Journals (Sweden)

    Birgitta M. Weltermann

    2015-01-01

    Full Text Available Background. Self-care for common colds is frequent, yet little is known about the spectrum, regional differences, and potential risks of self-care practices in patients from various European regions. Methods/Design. We describe the study protocol for a cross-sectional survey in 27 primary care centers from 14 European countries. At all sites, 120 consecutive adult patients, who visit their general practitioner for any reason, filled in a self-administered 27-item questionnaire. This addresses patients’ self-care practices for common colds. Separately, the subjective level of discomfort when having a common cold, knowing about the diseases’ self-limited nature, and medical and sociodemographic data are requested. Additionally, physicians are surveyed on their use of and recommendations for self-care practices. We are interested in investigating which self-care practices for common colds are used, whether the number of self-care practices used is influenced by knowledge about the self-limited nature of the disease, and the subjective level of discomfort when having a cold and to identify potential adverse interactions with chronic physician-prescribed medications. Further factors that will be considered are, for example, demographic characteristics, chronic conditions, and sources of information for self-care practices. All descriptive and analytical statistics will be performed on the pooled dataset and stratified by country and site. Discussion. To our knowledge, COCO is the first European survey on the use of self-care practices for common colds. The study will provide new insight into patients’ and general practitioners’ self-care measures for common colds across Europe.

  12. European experience of the convergent atrial fibrillation procedure: multicenter outcomes in consecutive patients.

    Science.gov (United States)

    Geršak, Borut; Zembala, Michael O; Müller, Dirk; Folliguet, Thierry; Jan, Matevz; Kowalski, Oskar; Erler, Stefan; Bars, Clement; Robic, Boris; Filipiak, Krzysztof; Wimmer-Greinecker, Gerhard

    2014-04-01

    The objective of this collaborative, multicenter, European effort was to evaluate the outcomes of the convergent procedure for the treatment of persistent and long-standing persistent atrial fibrillation (AF) in consecutive patients at 4 European centers. Outcomes of consecutive patients, undergoing the convergent procedure at 4 European centers, were evaluated in this study. Epicardial ablation was performed before endocardial ablation. Convergent procedure outcomes were recorded by interrogation of implanted loop recorders or Holter monitors. Rhythm status and required interventions (antiarrhythmic drugs, cardioversions, and repeat ablations) were quantified 6 and 12 months after the procedure. Outcomes, monitoring type, and patient baseline characteristics were analyzed and reported. Seventy-three consecutive patients presenting with persistent AF (30.1%) or long-standing persistent AF (69.9%) underwent the convergent procedure between January 2010 and December 2011. At 6 months, 82% (56/68) were in sinus rhythm. At 12 months, 80% (53/66) were in sinus rhythm; single-procedure maintenance of sinus rhythm without postblanking period interventions was 76% (50/66); 52% (34/66) were in sinus rhythm and not receiving antiarrhythmic drugs. This multicenter European collaborative effort demonstrated that the convergent procedure is a safe and efficacious treatment option for persistent and long-standing persistent AF. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  13. Self-Care Practices for Common Colds by Primary Care Patients: Study Protocol of a European Multicenter Survey—The COCO Study

    National Research Council Canada - National Science Library

    Weltermann, Birgitta M; Gerasimovska-Kitanovska, Biljana; Thielmann, Anika; Chambe, Juliette; Lingner, Heidrun; Pirrotta, Enzo; Buczkowski, Krzysztof; Tekiner, Selda; Czachowski, Slawomir; Edirne, Tamer; Zielinski, Andrzej; Yikilkan, Hülya; Koskela, Tuomas; Petrazzuoli, Ferdinando; Hoffman, Robert D; Petek Šter, Marija; Guede Fernández, Clara; Uludağ, Ayşegül; Hoffmann, Kathryn; Mevsim, Vildan; Kreitmayer Pestic, Sanda

    2015-01-01

    Background. Self-care for common colds is frequent, yet little is known about the spectrum, regional differences, and potential risks of self-care practices in patients from various European regions. Methods/Design...

  14. Association between participation in life situations of children with cerebral palsy and their physical, social, and attitudinal environment: a cross-sectional multicenter European study.

    Science.gov (United States)

    Colver, Allan; Thyen, Ute; Arnaud, Catherine; Beckung, Eva; Fauconnier, Jerome; Marcelli, Marco; McManus, Vicki; Michelsen, Susan I; Parkes, Jackie; Parkinson, Kathryn; Dickinson, Heather O

    2012-12-01

    To evaluate how participation of children with cerebral palsy (CP) varied with their environment. Home visits to children. Administration of Assessment of Life Habits and European Child Environment Questionnaires. Structural equation modeling of putative associations between specific domains of participation and environment, while allowing for severity of child's impairments and pain. European regions with population-based registries of children with CP. Children (n=1174) aged 8 to 12 years were randomly selected from 8 population-based registries of children with CP in 6 European countries. Of these, 743 (63%) agreed to participate; 1 further region recruited 75 children from multiple sources. Thus, there were 818 children in the study. Not applicable. Participation in life situations. For the hypothesized associations, the models confirmed that higher participation was associated with better availability of environmental items. Higher participation in daily activities-mealtimes, health hygiene, personal care, and home life-was significantly associated with a better physical environment at home (Penvironment in the community. Participation in social roles (responsibilities, relationships, recreation) was associated with attitudes of classmates and social support at home. School participation was associated with attitudes of teachers and therapists. Environment explained between 14% and 52% of the variation in participation. The findings confirmed the social model of disability. The physical, social, and attitudinal environment of disabled children influences their participation in everyday activities and social roles. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  15. Clinical effectiveness of hymenoptera venom immunotherapy: a prospective observational multicenter study of the European academy of allergology and clinical immunology interest group on insect venom hypersensitivity.

    Directory of Open Access Journals (Sweden)

    Franziska Ruëff

    Full Text Available BACKGROUND: Treatment failure during venom immunotherapy (VIT may be associated with a variety of risk factors. OBJECTIVE: Our aim was to evaluate the association of baseline serum tryptase concentration (BTC and of other parameters with the frequency of VIT failure during the maintenance phase. METHODS: In this observational prospective multicenter study, we followed 357 patients with established honey bee or vespid venom allergy after the maintenance dose of VIT had been reached. In all patients, VIT effectiveness was either verified by sting challenge (n = 154 or patient self-reporting of the outcome of a field sting (n = 203. Data were collected on BTC, age, gender, preventive use of anti-allergic drugs (oral antihistamines and/or corticosteroids right after a field sting, venom dose, antihypertensive medication, type of venom, side effects during VIT, severity of index sting reaction preceding VIT, and duration of VIT. Relative rates were calculated with generalized additive models. RESULTS: 22 patients (6.2% developed generalized symptoms during sting challenge or after a field sting. A strong association between the frequency of VIT failure and BTC could be excluded. Due to wide confidence bands, however, weaker effects (odds ratios <3 of BTC were still possible, and were also suggested by a selective analysis of patients who had a sting challenge. The most important factor associated with VIT failure was a honey bee venom allergy. Preventive use of anti-allergic drugs may be associated with a higher protection rate. INTERPRETATION: It is unlikely that an elevated BTC has a strong negative effect on the rate of treatment failures. The magnitude of the latter, however, may depend on the method of effectiveness assessment. Failure rate is higher in patients suffering from bee venom allergy.

  16. Clinical effectiveness of hymenoptera venom immunotherapy: a prospective observational multicenter study of the European academy of allergology and clinical immunology interest group on insect venom hypersensitivity.

    Science.gov (United States)

    Ruëff, Franziska; Przybilla, Bernhard; Biló, Maria Beatrice; Müller, Ulrich; Scheipl, Fabian; Seitz, Michael J; Aberer, Werner; Bodzenta-Lukaszyk, Anna; Bonifazi, Floriano; Campi, Paolo; Darsow, Ulf; Haeberli, Gabrielle; Hawranek, Thomas; Küchenhoff, Helmut; Lang, Roland; Quercia, Oliviero; Reider, Norbert; Schmid-Grendelmeier, Peter; Severino, Maurizio; Sturm, Gunter Johannes; Treudler, Regina; Wüthrich, Brunello

    2013-01-01

    Treatment failure during venom immunotherapy (VIT) may be associated with a variety of risk factors. Our aim was to evaluate the association of baseline serum tryptase concentration (BTC) and of other parameters with the frequency of VIT failure during the maintenance phase. In this observational prospective multicenter study, we followed 357 patients with established honey bee or vespid venom allergy after the maintenance dose of VIT had been reached. In all patients, VIT effectiveness was either verified by sting challenge (n = 154) or patient self-reporting of the outcome of a field sting (n = 203). Data were collected on BTC, age, gender, preventive use of anti-allergic drugs (oral antihistamines and/or corticosteroids) right after a field sting, venom dose, antihypertensive medication, type of venom, side effects during VIT, severity of index sting reaction preceding VIT, and duration of VIT. Relative rates were calculated with generalized additive models. 22 patients (6.2%) developed generalized symptoms during sting challenge or after a field sting. A strong association between the frequency of VIT failure and BTC could be excluded. Due to wide confidence bands, however, weaker effects (odds ratios honey bee venom allergy. Preventive use of anti-allergic drugs may be associated with a higher protection rate. It is unlikely that an elevated BTC has a strong negative effect on the rate of treatment failures. The magnitude of the latter, however, may depend on the method of effectiveness assessment. Failure rate is higher in patients suffering from bee venom allergy.

  17. Ross Procedure in Neonates and Infants: A European Multicenter Experience.

    Science.gov (United States)

    Mookhoek, Aart; Charitos, Efstratios I; Hazekamp, Mark G; Bogers, Ad J J C; Hörer, Jürgen; Lange, Rüdiger; Hetzer, Roland; Sachweh, Joerg S; Riso, Arlindo; Stierle, Ulrich; Takkenberg, Johanna J M; Schoof, Paul H

    2015-12-01

    Infants and neonates with severe left ventricular outflow tract obstruction may require pulmonary autograft replacement of the aortic root. In this retrospective multicenter cohort study, we present our experience with the Ross procedure in neonates and infants with a focus on midterm survival and pulmonary autograft durability. A retrospective observational study was performed in 76 infants (aged less than 1 year) operated on in six congenital cardiac centers in The Netherlands and Germany between 1990 and 2013. Patients had a pulmonary autograft replacement of the aortic valve with (68%) or without (32%) septal myectomy. Median patient age was 85 days (range, 6 to 347). Early mortality (n = 13, 17%) was associated with neonatal age, preoperative use of intravenous inotropic drugs, and congenital aortic arch defects. Five patients (9%) died during follow-up. Freedom from autograft reintervention was 98% at 10 years. Echocardiography demonstrated good valve function, with no or trace regurgitation in 73% of patients. Freedom from right ventricular outflow tract reintervention was 51% at 10 years. Univariable analysis demonstrated superior freedom from reintervention of pulmonary homografts compared with aortic homografts or xenografts. Pulmonary autograft replacement of the aortic valve in neonates and infants is a high-risk operation but offers a durable neoaortic valve. Midterm durability reflects successful adaptation of the autograft to the systemic circulation. Late mortality associated with heart failure was an unexpected finding. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  18. European Studies

    Directory of Open Access Journals (Sweden)

    V. O. Pechatnov

    2014-01-01

    Full Text Available The study of Western countries and teaching courses on the related subjects have longstanding and established tradition at MGIMO-University. The basis of this brilliant research and teaching tradition was laid down by such academicians as E.V. Tarle and V.G. Trukhanovsky, Professor L.I. Clove, Y. Borisov, F.I. Notovitch, G.L. Rozanov. Their work in 1940-1960's at the Department of World History at MGIMO-University progressed in following directions: France studies, German studies, American studies. The work resulted in a number of monographs and textbooks on modern history and foreign policy of the studied countries and regions. The aim of the publications was dictated by the goal of the Institute - to prepare the specialists in international affairs primarily for practical work. A close relationship with the Foreign Ministry was "binding advantage" sometimes limiting researchers in choosing periods and subjects for the study. At the same time the undisputed advantage and quality of regional studies at MGIMO were strengthened by the practical relevance of research, making it a vital and interesting not only for specialists but also for students and researchers from other research centers. Another characteristic of the tradition is the analysis of foreign policy and diplomacy in a close relationship with the socio-economic and political processes. Such an integrated approach to regional geography also formed largely under the influence of institutional profile designed to train highly skilled and versatile specialists in specific countries and regions with a good knowledge of their languages, history, economics, politics, law and culture. Therefore, scientific and educational-methodical work at MGIMO-University has always relied on a wealth of empirical data and has been focused on the analysis of real-world phenomena and processes, acute problems of foreign countries. Scientific research at MGIMO-University traditionally intertwined with

  19. Self-Care for Common Colds by Primary Care Patients: A European Multicenter Survey on the Prevalence and Patterns of Practices—The COCO Study

    Directory of Open Access Journals (Sweden)

    Anika Thielmann

    2016-01-01

    Full Text Available Background. Patients use self-care to relieve symptoms of common colds, yet little is known about the prevalence and patterns across Europe. Methods/Design. In a cross-sectional study 27 primary care practices from 14 countries distributed 120 questionnaires to consecutive patients (≥18 years, any reason for consultation. A 27-item questionnaire asked for patients’ self-care for their last common cold. Results. 3,074 patients from 27 European sites participated. Their mean age was 46.7 years, and 62.5% were females. 99% of the participants used ≥1 self-care practice. In total, 527 different practices were reported; the age-standardized mean was 11.5 (±SD 6.0 per participant. The most frequent self-care categories were foodstuffs (95%, extras at home (81%, preparations for intestinal absorption (81%, and intranasal applications (53%. Patterns were similar across all sites, while the number of practices varied between and within countries. The most frequent single practices were water (43%, honey (42%, paracetamol (38%, oranges/orange juice (38%, and staying in bed (38%. Participants used 9 times more nonpharmaceutical items than pharmaceutical items. The majority (69% combined self-care with and without proof of evidence, while ≤1% used only evidence-based items. Discussion. This first cross-national study on self-care for common colds showed a similar pattern across sites but quantitative differences.

  20. Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study.

    Science.gov (United States)

    Nyström, Max; Machytka, Evzen; Norén, Erik; Testoni, Pier Alberto; Janssen, Ignace; Turró Homedes, Jesus; Espinos Perez, Jorge Carlos; Turro Arau, Roman

    2018-02-01

    The objective of this post-market study was to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics. The AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is an endoscopic weight loss therapy utilizing a customized percutaneous endoscopic gastrostomy tube and an external device to aspirate approximately 30% of ingested calories after a meal, in conjunction with lifestyle counseling. A total of 201 participants, with body mass index (BMI) of 35.0-70.0 kg/m2, were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m2. Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30), where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up. Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were observed. For participants with diabetes, HbA1C decreased by 1% (P < 0.0001) from 7.8% at baseline to 6.8% at 1 year. The only serious complications were buried bumpers, experienced by seven participants and resolved by removal/replacement of the A-Tube, and a single case of peritonitis, resolved with a 2-day course of intravenous antibiotics. This study establishes that aspiration therapy is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting. ISRCTN 49958132.

  1. Foldable Artiflex phakic intraocular lens for the correction of myopia: two-year follow-up results of a prospective European multicenter study.

    Science.gov (United States)

    Dick, H Burkhard; Budo, Camille; Malecaze, Francois; Güell, Josep L; Marinho, Antonio A P; Nuijts, Rudy M M A; Luyten, Gregorius P M; Menezo, Jose L; Kohnen, Thomas

    2009-04-01

    To evaluate the safety, efficacy, predictability, stability, and complications of the foldable Artiflex iris-fixated intraocular lens (Ophtec BV, Groningen, The Netherlands) for the correction of myopia in phakic eyes. Prospective, nonrandomized, open-label, multicenter trial. Two hundred ninety eyes of 191 patients aged 18 to 60 years with average spherical equivalent of -7.33+/-2.60 diopters (D; range, -12.63 to -1.5 D) were analyzed. All eyes underwent implantation of the foldable iris-fixated Artiflex phakic intraocular lens (PIOL) with an optic zone of 6 mm. The follow-up was 2 years. Phakic intraocular lenses were implanted in powers ranging from -2.0 to -12.0 D. The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, and endothelial cell count. After 2 years, a UCVA of 20/40 or better was observed in 97.2% of eyes. The BSCVA was 20/40 or better in all eyes. A gain of 1 line or more of BSCVA was found in 49.9% of eyes, and 0.8% lost 2 or more lines. The mean endothelial cell change was -0.05%, 1.79%, and -1.07% at 6 months, 1 year, and 2 years, respectively. Complications were comparable with complications that have been reported previously of the Artisan PIOL, the only exception being a higher incidence of iris pigment precipitates (4.8% at 2 years after surgery). After 2 years of follow-up, the implantation of the foldable iris-fixated Artiflex intraocular lens proved to be effective and predictable for the correction of myopia in phakic eyes.

  2. Occupational noise, smoking, and a high body mass index are risk factors for age-related hearing impairment and moderate alcohol consumption is protective: A European population-based multicenter study

    DEFF Research Database (Denmark)

    Fransen, E.; Topsakal, V.; Hendrickx, J.J.

    2008-01-01

    A multicenter study was set up to elucidate the environmental and medical risk factors contributing to age-related hearing impairment (ARHI). Nine subsamples, collected by nine audiological centers across Europe, added up to a total of 4,083 subjects between 53 and 67 years. Audiometric data (pur...

  3. Occupational noise, smoking, and a high body mass index are risk factors for age-related hearing impairment and moderate alcohol consumption is protective: a European population-based multicenter study.

    NARCIS (Netherlands)

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

    2008-01-01

    A multicenter study was set up to elucidate the environmental and medical risk factors contributing to age-related hearing impairment (ARHI). Nine subsamples, collected by nine audiological centers across Europe, added up to a total of 4,083 subjects between 53 and 67 years. Audiometric data

  4. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument.

    Science.gov (United States)

    Muysoms, Filip E; Vanlander, Aude; Ceulemans, Robrecht; Kyle-Leinhase, Iris; Michiels, Maarten; Jacobs, Ivo; Pletinckx, Pieter; Berrevoet, Frederik

    2016-11-01

    There is an increasing interest in patient-reported outcome measurement to evaluate hernia operations. Several hernia-specific quality of life (QoL) scales have been proposed, but none are constructed for preoperative assessment. The European Registry for Abdominal Wall Hernias (EuraHS) proposed the short, 9-question EuraHS-QoL instrument for assessment pre- and postoperatively. The EuraHS-QoL was evaluated in a prospective, multicenter validation study alongside the Visual Analogue Scale, Verbal Rating Scale, and Carolina Comfort Scale (https://clinicaltrials.gov; NCT01936584). We included 101 patients undergoing unilateral laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh. Clinical follow-up at 12 months was 87% complete. The EuraHS-QoL score shows good internal consistency (Cronbach's α ≥ .90), good test-retest reliability (Spearman correlation coefficient r ≥ 0.72), and high correlation for pain with the Visual Analogue Scale, the Verbal Rating Scale, the Carolina Comfort Scale pain scale (r between 0.64 and 0.86), and for restriction of activity with the Carolina Comfort Scale movement scale (r between 0.65 and 0.79). Our results show significant improvement in quality of life at 3 weeks compared with preoperative and further significant improvement at 12 months (P 75%) or with a 95%) in the majority of the patients. The EuraHS-QoL instrument is a short and valid patient-reported outcome measurement following groin hernia repair. Laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh results in a favorable outcome and significant improvement of quality of life compared with the preoperative assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Responsiveness and clinically meaningful improvement, according to disability level, of five walking measures after rehabilitation in multiple sclerosis: a European multicenter study.

    Science.gov (United States)

    Baert, Ilse; Freeman, Jennifer; Smedal, Tori; Dalgas, Ulrik; Romberg, Anders; Kalron, Alon; Conyers, Helen; Elorriaga, Iratxe; Gebara, Benoit; Gumse, Johanna; Heric, Adnan; Jensen, Ellen; Jones, Kari; Knuts, Kathy; Maertens de Noordhout, Benoît; Martic, Andrej; Normann, Britt; Eijnde, Bert O; Rasova, Kamila; Santoyo Medina, Carmen; Truyens, Veronik; Wens, Inez; Feys, Peter

    2014-09-01

    Evaluation of treatment effects on walking requires appropriate and responsive outcome measures. To determine responsiveness of 5 walking measures and provide reference values for clinically meaningful improvements, according to disability level, in persons with multiple sclerosis (pwMS). Walking tests were measured pre- and postrehabilitation in 290 pwMS from 17 European centers. Combined anchor- and distribution-based methods determined responsiveness of objective short and long walking capacity tests (Timed 25-Foot Walk [T25FW] and 2- and 6-Minute Walk Tests [2MWT and 6MWT] and of the patient-reported Multiple Sclerosis Walking Scale-12 [MSWS-12]). A global rating of change scale, from patients' and therapists' perspective, was used as external criteria to determine the area under the receiver operating characteristic curve (AUC), minimally important change (MIC), and smallest real change (SRC). Patients were stratified into disability subgroups (Expanded Disability Status Scale score ≤4 [n = 98], >4 [n = 186]). MSWS-12, 2MWT, and 6MWT were more responsive (AUC 0.64-0.73) than T25FW (0.50-0.63), especially in moderate to severely disabled pwMS. Clinically meaningful changes (MICs) from patient and therapist perspective were -10.4 and -11.4 for MSWS-12 (P < .01), 9.6 m and 6.8 m for 2MWT (P < .05), and 21.6 m (P < .05) and 9.1 m (P = .3) for 6MWT. In subgroups, MIC was significant from patient perspective for 2MWT (10.8 m) and from therapist perspective for MSWS-12 (-10.7) in mildly disabled pwMS. In moderate to severely disabled pwMS, MIC was significant for MSWS-12 (-14.1 and -11.9). Long walking tests and patient-reported MSWS-12 were more appropriate than short walking tests in detecting clinically meaningful improvement after physical rehabilitation, particularly the MSWS-12 for moderate to severely disabled pwMS. © The Author(s) 2014.

  6. Comparison between zofenopril and ramipril in combination with acetylsalicylic acid in patients with left ventricular systolic dysfunction after acute myocardial infarction: results of a randomized, double-blind, parallel-group, multicenter, European study (SMILE-4).

    Science.gov (United States)

    Borghi, Claudio; Ambrosioni, Ettore; Novo, Salvatore; Vinereanu, Dragos; Ambrosio, Giuseppe

    2012-01-01

    Angiotensin-converting enzyme inhibitors (ACEIs) are largely employed for treating patients with left ventricular dysfunction (LVD), but their efficacy may be negatively affected by concomitant administration of acetylsalicylic acid (ASA), with some difference among the different compounds. The interaction between ASA and the two ACEIs zofenopril and ramipril may result in a different impact on survival of cardiac patients, due to differences in the pharmacological properties of the two ACEIs. This phase IIIb, randomized, double-blind, parallel-group, multicenter, European study compared the safety and efficacy of zofenopril (60 mg/day) and ramipril (10 mg/day) plus ASA (100 mg/day), in 771 patients with LVD (clinical signs of heart failure or a left ventricular ejection fraction <45%) following acute myocardial infarction (AMI). The primary study end point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. In the intention-to-treat population, the primary outcome was significantly reduced by zofenopril (n = 365) vs ramipril (n = 351) (odds ratio [OR]: 0.70, and 95% confidence interval [CI]: 0.51-0.96; P = 0.028) as a result of a decrease in cardiovascular hospitalization (OR: 0.64,95% CI: 0.46-0.88; P = 0.006). Mortality rate was not significantly different between the 2 treatments (OR: 1.51, 95% CI: 0.70-3.27; P = 0.293). Blood pressure values did not significantly change during the 1-year follow-up. N-terminal pro-brain natriuretic peptide levels were progressively reduced during the study, with no statistically significant between-treatment differences. Proportion of patients with deterioration of renal function during the study was similar between the 2 groups. Drug safety profile was comparable between treatments. In patients with LVD following AMI, the efficacy of zofenopril associated with ASA was superior to that of ramipril plus ASA, indicating some important clinical implications for the future use of ACEIs in patients

  7. A multicenter study confirms CD226 gene association with systemic sclerosis-related pulmonary fibrosis

    NARCIS (Netherlands)

    Bossini-Castillo, L.; Simeon, C.P.; Beretta, L.; Broen, J.C.A.; Vonk, M.C.; Rios-Fernandez, R.; Espinosa, G.; Carreira, P.; Camps, M.T.; Castillo, M.J.; Gonzalez-Gay, M.A.; Beltran, E.; Carmen Freire, M.; Narvaez, J.; Tolosa, C.; Witte, T.; Kreuter, A.; Schuerwegh, A.J.; Hoffmann-Vold, A.M.; Hesselstrand, R.; Lunardi, C.; Laar, J.M. van; Chee, M.M.; Herrick, A.; Koeleman, B.P.; Denton, C.P.; Fonseca, C.; Radstake, T.R.D.J.; Martin, J.; Spanish Scleroderma, G.

    2012-01-01

    INTRODUCTION: CD226 genetic variants have been associated with a number of autoimmune diseases and recently with systemic sclerosis (SSc). The aim of this study was to test the influence of CD226 loci in SSc susceptibility, clinical phenotypes and autoantibody status in a large multicenter European

  8. Oral cancer: A multicenter study

    Science.gov (United States)

    Rojanawatsirivej, Somsri; Thosaporn, Watcharaporn; Kintarak, Sompid; Subarnbhesaj, Ajiravudh; Darling, Mark; Kryshtalskyj, Eugene; Chiang, Chun-Pin; Shin, Hong-In; Choi, So-Young; Lee, Sang-shin; Shakib, Pouyan-Amini

    2018-01-01

    Background To determine the prevalence and clinicopathologic features of the oral cancer patients. Material and Methods Biopsy records of the participating institutions were reviewed for oral cancer cases diagnosed from 2005 to 2014. Demographic data and site of the lesions were collected. Sites of the lesion were subdivided into lip, tongue, floor of the mouth, gingiva, alveolar mucosa, palate, buccal/labial mucosa, maxilla and mandible. Oral cancer was subdivided into 7 categories: epithelial tumors, salivary gland tumors, hematologic tumors, bone tumors, mesenchymal tumors, odontogenic tumors, and others. Data were analyzed by descriptive statistics using SPSS software version 17.0. Results Of the 474,851 accessioned cases, 6,151 cases (1.30%) were diagnosed in the category of oral cancer. The mean age of the patients was 58.37±15.77 years. A total of 4,238 cases (68.90%) were diagnosed in males, whereas 1911 cases (31.07%) were diagnosed in females. The male-to-female ratio was 2.22:1. The sites of predilection for oral cancer were tongue, labial/buccal mucosa, gingiva, palate, and alveolar mucosa, respectively. The three most common oral cancer in the descending order of frequency were squamous cell carcinoma, non-Hodgkin lymphoma and mucoepidermoid carcinoma. Conclusions Although the prevalence of oral cancer is not high compared to other entities, oral cancer pose significant mortality and morbidity in the patients, especially when discovered late in the course of the disease. This study highlights some anatomical locations where oral cancers are frequently encountered. As a result, clinicians should pay attention to not only teeth, but oral mucosa especially in the high prevalence area as well since early detection of precancerous lesions or cancers in the early stage increase the chance of patient being cured and greatly reduce the mortality and morbidity. This study also shows some differences between pediatric and elderly oral cancer patients as well as

  9. A modular informatics platform for effective support of collaborative and multicenter studies in cardiology.

    Science.gov (United States)

    Marinelli, Martina; Positano, Vincenzo; Lorenzoni, Valentina; Caselli, Chiara; Mangione, Maurizio; Marcheschi, Paolo; Puzzuoli, Stefano; Esposito, Natalia; L'Abbate, Giuseppe Andrea; Neglia, Danilo

    2016-12-01

    Collaborative and multicenter studies permit a large number of patients to be enrolled within a reasonable time and providing the opportunity to collect different data. Informatics platforms play an important role in management, storage, and exchange of data between the participants involved in the study. In this article, we describe a modular informatics platform designed and developed to support collaborative and multicenter studies in cardiology. In each developed module, data management is implemented following local defined protocols. The modular characteristic of the developed platform allows independent transfer of different kinds of data, such as biological samples, imaging raw data, and patients' digital information. Moreover, it offers safe central storage of the data collected during the study. The developed platform was successfully tested during a European collaborative and multicenter study, focused on evaluating multimodal non-invasive imaging to diagnose and characterize ischemic heart disease. © The Author(s) 2015.

  10. European multicenter experience with valve-sparing reoperations after the Ross procedure

    NARCIS (Netherlands)

    A. Mookhoek (Aart); L. De Kerchove (Laurent); G. El Khoury (Gebrine); T. Weimar (Timo); G.B. Luciani (Giovanni Battista); A. Mazzucco (Alessandro); A.J.J.C. Bogers (Ad); D. Aicher (Diana); H.J. Schäfers (Hans J.); E.I. Charitos (Efstratios); U. Stierle (Ulrich); J.J.M. Takkenberg (Hanneke)

    2015-01-01

    textabstractBackground Autograft valve preservation at reoperation may conserve some of the advantages of the Ross procedure. However, results of long-term follow-up are lacking. In this retrospective multicenter study, we present our experience with valve-sparing reoperations after the Ross

  11. European multicenter experience with valve-sparing reoperations after the Ross procedure.

    Science.gov (United States)

    Mookhoek, Aart; de Kerchove, Laurent; El Khoury, Gebrine; Weimar, Timo; Luciani, Giovanni Battista; Mazzucco, Alessandro; Bogers, Ad J J C; Aicher, Diana; Schäfers, Hans-Joachim; Charitos, Efstratios I; Stierle, Ulrich; Takkenberg, Johanna J M

    2015-11-01

    Autograft valve preservation at reoperation may conserve some of the advantages of the Ross procedure. However, results of long-term follow-up are lacking. In this retrospective multicenter study, we present our experience with valve-sparing reoperations after the Ross procedure, with a focus on long-term outcome. A total of 86 patients from 6 European centers, who underwent valve-sparing reoperation after the Ross procedure between 1997 and 2013, were included in the study. Reoperation was performed a median of 9.1 years after the Ross procedure in patients with a median age of 38.4 years (interquartile range: 27.1-51.6 years). Preoperative severe autograft regurgitation (grade ≥3) was present in 46% of patients. In-hospital mortality was 1%. During a median follow-up of 4.3 years, 3 more patients died of noncardiac causes, resulting in a cumulative survival at 8 years of 89% (95% confidence interval: 65%-97%). Fifteen patients required a reintervention after valve-sparing reoperation, mostly owing to prolapse or retraction of autograft cusps. Freedom from reintervention was 76% (95% confidence interval: 57%-87%) at 8 years. The reintervention hazard was increased in patients who had isolated and/or severe aortic regurgitation at valve-sparing reoperation. In patients without reintervention after valve-sparing autograft reoperation (n = 63), severe aortic regurgitation was present in 3% at last follow-up. Valve-sparing autograft reoperations after the Ross procedure carry a low operative risk, with acceptable reintervention rates in the first postoperative decade. Patients with isolated and/or severe autograft regurgitation have an increased hazard of reintervention after valve-sparing reoperation; for these patients, careful preoperative weighing of surgical options is required. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  12. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay.

    Science.gov (United States)

    Krintus, Magdalena; Kozinski, Marek; Boudry, Pascal; Capell, Nuria Estañ; Köller, Ursula; Lackner, Karl; Lefèvre, Guillaume; Lennartz, Lieselotte; Lotz, Johannes; Herranz, Antonio Mora; Nybo, Mads; Plebani, Mario; Sandberg, Maria B; Schratzberger, Wolfgang; Shih, Jessie; Skadberg, Øyvind; Chargui, Ahmed Taoufik; Zaninotto, Martina; Sypniewska, Grazyna

    2014-11-01

    International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac troponin I (hs-cTnI) assay and its 99th percentile upper reference limit (URL). Laboratories from nine European countries evaluated the ARCHITECT STAT high sensitive troponin I (hs-TnI) immunoassay on the ARCHITECT i2000SR/i1000SR immunoanalyzers. Imprecision, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ) linearity of dilution, interferences, sample type, method comparisons, and 99th percentile URLs were evaluated in this study. Total imprecision of 3.3%-8.9%, 2.0%-3.5% and 1.5%-5.2% was determined for the low, medium and high controls, respectively. The lowest cTnI concentration corresponding to a total CV of 10% was 5.6 ng/L. Common interferences, sample dilution and carryover did not affect the hs-cTnI results. Slight, but statistically significant, differences with sample type were found. Concordance between the investigated hs-cTnI assay and contemporary cTnI assay at 99th percentile cut-off was found to be 95%. TnI was detectable in 75% and 57% of the apparently healthy population using the lower (1.1 ng/L) and upper (1.9 ng/L) limit of the LoD range provided by the ARCHITECT STAT hs-TnI package insert, respectively. The 99th percentile values were gender dependent. The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool.

  13. Invasive aspergillosis: results of multicenter study

    Directory of Open Access Journals (Sweden)

    N. N. Klimko

    2014-09-01

    Full Text Available We present the results of a multicenter study of 445 patients with “proven” and “probable” invasive aspergillosis (EORTC/MSG, 2008. Invasive aspergillosis usually occurs in patients with hematological malignancies (88 %, main underlying diseases were acute myeloid and acute lymphoblastic leukemia. The risk factors: prolonged agranulocytosis (64 %, cytostatic chemotherapy (57 %, corticosteroid treatment (45 %, and allogeneic hematopoietic stem cells transplantation (29 %. The pathogens – A. fumigatus (42 %, A. niger (33 %, and A. flavus (21 %. The main site of infection were lungs (86 %. 12 week overall survival was 83 %. Bronchoscopy use for the early diagnosis (p = 0.01, adequatetherapy with voriconazole (p = 0.002 and secondary antifungal prophylaxis (p = 0.0003 were positive prognostic factors for survival of patients with invasive aspergillosis.

  14. Extraskeletal osteosarcoma : A European Musculoskeletal Oncology Society study on 266 patients

    NARCIS (Netherlands)

    Longhi, A.; Bielack, S.; Grimer, R.; Whelan, J.; Windhager, R; Leithner, Andreas; Gronchi, A.; Biau, David J.; Jutte, P.; Krieg, A. H.; Klenke, Frank M.; Grignani, G.; Donati, D. M.; Capanna, R.; Casanova, Jose; Gerrand, Craig; Bisogno, G.; Hecker-Nolting, Stefanie; De Lisa, M.; D'Ambrosio, Lia; Willegger, M.; Scoccianti, G.; FERRARI, S

    Purpose: Prognosis of extraskeletal osteosarcoma (ESOS) is reported to be poorer than that of skeletal osteosarcoma. This multicenter retrospective study aimed to evaluate factors influencing ESOS prognosis. Patients and methods: Members of the European Musculoskeletal Oncology Society (EMSOS)

  15. Pirating European Studies

    Directory of Open Access Journals (Sweden)

    Natalia Timus

    2016-08-01

    Full Text Available Open Science has gained a lot of attention not only within the academic community but also among policy-makers. Some international publishers have been active in moving towards open access publications and research data, but, overall, modest results have been achieved so far. In this context, the digital piracy engines emerge as vital actors in disseminating and determining the impact of research. This study examines the Sci-Hub downloads data in order to uncover patterns of piracy in European Studies research. We identify journals and the subjects of articles that have been pirated the most. We also study the geographical distribution of download requests. The analysis reveals that the readers are mostly interested in subjects reflecting the current major European challenges, specifically populism and the economic crisis. Both developing countries as well as the ‘old’ EU members are active in illegal downloads.

  16. European and Integration Studies

    Directory of Open Access Journals (Sweden)

    N. Yu. Kaveshnikov

    2014-01-01

    Full Text Available Soviet scientific school of pan-European integration studies began to emerge in the 1960s at the Institute of World Economy and International Relations (Russian Academy of Science. Among the leading scientists who have developed methodological approaches of Soviet integration studies were M.M. Maximova, Y.A. Borko, Y. Shishkov, L.I. Capercaillie. Later, a new center for integration studies became the Institute of Europe, created in 1987. It was led by such renowned scientists as Academicians V.V. Zhurkin and N.P. Shmelev. In the 1980s the subject of the integration process in Europe attracted attention of experts from MGIMO. An important role in the development of school of integration research in the USSR was played by a MGIMO professor, head of the chair of history of international relations and foreign policy of the USSR V.B. Knyazhinskiy. His work contributed to the deliverance of the national scientific community from skepticism about the prospects for European integration. Ideas of V.B. Knyazhinsky are developed today in MGIMO by his followers A.V. Mal'gin and T.V. Ur'eva. In the mid-1990s, having retired from diplomatic service, professor Yu. Matveevskiy started to work at MGIMO. With a considerable practical experience in the field, he produced a series of monographs on the history of European integration. In his works, he analyses the development of integration processes in Western Europe from their inception to the present day, showing the gradual maturation of the necessary spiritual and material prerequisites for the start of integration and traces the various stages of the "integration". In the late 1990s, the growing demand from the domestic business and government for professionals who are capable of interacting with the European Union, has produced the necessary supply in the form of educational programs based on accumulated scientific knowledge. Setting up a discipline "European Integration" was a major step in the development

  17. Patient, lesion, and procedural variables as risk factors for luminal re-narrowing after successful coronary angioplasty: a quantitative analysis in 653 patients with 778 lesions. Multicenter European Research Trial with Cilazapril after Angioplasty to prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group

    NARCIS (Netherlands)

    Hermans, W. R.; Rensing, B. J.; Foley, D. P.; Tijssen, J. G.; Rutsch, W.; Emanuelsson, H.; Danchin, N.; Wijns, W.; Chappuis, F.; Serruys, P. W.

    1993-01-01

    Follow-up angiography at 6 months was obtained in 94% of the 693 patients (778 successfully dilated coronary lesions) enrolled in the Multicenter European Research trial with Cilazapril after Angioplasty to prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) trial--a double-blind,

  18. [Inguinofemoral hernia: multicenter study of surgical techniques].

    Science.gov (United States)

    Porrero, José L; Sánchez-Cabezudo, Carlos; Bonachía, Oscar; López-Buenadicha, Adolfo; Sanjuánbenito, Alfonso; Hidalgo, Manuel

    2005-07-01

    The present study was performed by the Spanish Association of surgeons through its abdominal wall and sutures section. The aim was to determine the current situation of inguinofemoral hernias in Spain and was based on an anonymous multicenter study with the participation of various national hospitals. Fifty general surgery departments in distinct surgical centers throughout Spain responded to an anonymous survey in 2000. The survey gathered data on anesthetic features, surgical techniques and complications in the treatment of inguinofemoral hernias. Sixty-six percent of hospital centers had a specific abdominal wall unit and 24% performed laparoscopic hernia surgery. Prosthetic techniques (especially Lichtenstein) were the most frequently used in the treatment of primary inguinal hernia (72%) and recurrent hernia (100%). The most frequently used prosthetic material was polypropylene mesh (76%). Only 28% of the departments surveyed performed anatomic techniques in the repair of primary inguinal hernia (Shouldice and Bassini). The most frequent treatment for femoral hernia was the Lichtenstein "plug" (78%). Sixty-eight percent of the centers surveyed performed regional anesthesia, 18% used general anesthesia and only 14% used local anesthesia with sedation. Severe complications were found in 20% of departments. Clinical postoperative follow-up was performed in 96% of the centers and telephone follow-up was used in 4%. The recurrence rate was 1.2% for primary inguinal hernia, 2.7% for recurrent inguinal hernia and 0.3% for femoral hernia. In Spain the most commonly used surgical technique in the treatment of inguinal hernia is Lichtenstein hernioplasty under spinal anesthesia and with polypropylene prosthesis. The Lichtenstein plug is the most commonly used technique in the treatment of femoral hernia.

  19. Underweight and malnutrition in home care: A multicenter study.

    Science.gov (United States)

    Lahmann, Nils A; Tannen, Antje; Suhr, Ralf

    2016-10-01

    This study aimed to provide representative figures about the prevalence of underweight and malnutrition among home care clients, and to determine the associated risk factors and the provided nutritional nursing interventions. In 2012, a multicenter point prevalence study was conducted among 878 randomly selected clients from 100 randomly selected home care services across Germany. Following a standardized study protocol, demographics, nutritional assessments (Body Mass Index, Malnutrition Universal Screening Tool (MUST), Mini nutritional Assessment - short form (MNA-sf), nurses' clinical judgment on nutritional status) and interventions were assessed. Common nutritional risk factors for underweight and malnutrition were analyzed in a logistic regression model. Malnutrition figures varied between 4.8% (MNA-sf) and 6.8% (MUST), underweight between 8.7% (BMI nutritional status. Mental overload (OR 8.1/4.4), needs help with feeding (OR 5.0/2.8) and loss of appetite (OR 3.6/3.9) were highly associated with malnutrition/underweight. Malnutrition and underweight are important issues in home care clients. Regular weighing should be performed in all home care clients so that a potential weight loss can be detected in time. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  20. Multicenter observational prehospital resuscitation on helicopter study.

    Science.gov (United States)

    Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

    2017-07-01

    at any time point, although only 10% of the high-risk sample were able to be matched. Because of the unexpected imbalance in systolic blood pressure, Glasgow Coma Scale, and Injury Severity Score between systems with and without blood products on helicopters, matching was limited, and the results of this study are inconclusive. With few units transfused to each patient and small outcome differences between groups, it is likely large, multicenter, randomized studies will be required to detect survival differences in this important population. Level II.

  1. Infliximab-induced autoantibodies: a multicenter study.

    Science.gov (United States)

    Vaz, João Luiz Pereira; Fernandes, Vander; Nogueira, Felipe; Arnóbio, Adriano; Levy, Roger A

    2016-02-01

    The purpose of this study was to assess autoantibody incidence in patients treated with infliximab for various diseases, and the development of autoimmune diseases using a multicenter, longitudinal, open-label, phase IV observational study. All patients received anti-tumor necrosis factor (anti-TNF) according to local treatment guidelines. The autoantibodies assessed before and after infliximab treatment were ANA, anti-Sm, anti-dsDNA, anticardiolipin IgM/IgG, anti-Scl70, anti-centromere B, anti-chromatin, anti-ribosomal P, anti-Sm-RNP, anti-RNP A, anti-RNP 68 kD, anti-La/SSB, anti-Ro/SSA 52 kD and 60 kD, and anti-Jo1. ANA was determined by indirect immunofluorescence on HEp-2 cells (INOVA); the remaining was assessed using BioPlexTM 2200. The Fisher exact test, Wilcoxon test, and the McNemar were used when appropriate.Two hundred eighty-six patients were included (139 with rheumatoid arthritis, 77 with ankylosing spondylitis, 29 with inflammatory bowel disease, 27 with psoriatic arthritis, and 14 with psoriasis), 167 females and 119 males, with mean age of 46.3 years. Subjects received at least five infusions of infliximab (6-month treatment). A significant difference was observed in antinuclear antibody (ANA) detection between samplings (p = 0.001). Among patients that had ANA before treatment (n = 92), six became ANA-negative, 48 had increased titers, 29 maintained, and nine decreased titers after treatment; a total of 186 patients had a positive ANA after treatment. Fine speckled nuclear pattern was most commonly observed (both before and after infliximab treatment). The number of patients with anti-dsDNA had a statistically significant increase (p = 0.003). No significant differences were noted for anticardiolipin and the remaining autoantibodies tested. Among the 286 patients included in the study, only one (0.35 %) showed clinical signs of drug-induced lupus, presenting elevated ANA and anti-dsDNA titers that normalized once treatment was

  2. Allogeneic stem cell transplantation after reduced-intensity conditioning in patients with myelofibrosis: a prospective, multicenter study of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.

    Science.gov (United States)

    Kröger, Nicolaus; Holler, Ernst; Kobbe, Guido; Bornhäuser, Martin; Schwerdtfeger, Rainer; Baurmann, Herrad; Nagler, Arnon; Bethge, Wolfgang; Stelljes, Matthias; Uharek, Lutz; Wandt, Hannes; Burchert, Andreas; Corradini, Paolo; Schubert, Jörg; Kaufmann, Martin; Dreger, Peter; Wulf, Gerald G; Einsele, Hermann; Zabelina, Tatjana; Kvasnicka, Hans Michael; Thiele, Jürgen; Brand, Ronald; Zander, Axel R; Niederwieser, Dietger; de Witte, Theo M

    2009-12-17

    From 2002 to 2007, 103 patients with primary myelofibrosis or postessential thrombocythemia and polycythemia vera myelofibrosis and a median age of 55 years (range, 32-68 years) were included in a prospective multicenter phase 2 trial to determine efficacy of a busulfan (10 mg/kg)/fludarabine (180 mg/m(2))-based reduced-intensity conditioning regimen followed by allogeneic stem cell transplantation from related (n = 33) or unrelated donors (n = 70). All but 2 patients (2%) showed leukocyte and platelet engraftment after a median of 18 and 22 days, respectively. Acute graft-versus-host disease grade 2 to 4 occurred in 27% and chronic graft-versus-host disease in 43% of the patients. Cumulative incidence of nonrelapse mortality at 1 year was 16% (95% confidence interval, 9%-23%) and significantly lower for patients with a completely matched donor (12% vs 38%; P = .003). The cumulative incidence of relapse at 3 years was 22% (95% confidence interval, 13%-31%) and was influenced by Lille risk profile (low, 14%; intermediate, 22%; and high, 34%; P = .02). The estimated 5-year event-free and overall survival was 51% and 67%, respectively. In a multivariate analysis, age older than 55 years (hazard ratio = 2.70; P = .02) and human leukocyte antigen-mismatched donor (hazard ratio = 3.04; P = .006) remained significant factors for survival. The study was registered at www.clinicaltrials.gov as #NCT 00599547.

  3. Allogeneic stem cell transplantation after reduced-intensity conditioning in patients with myelofibrosis: a prospective, multicenter study of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.

    NARCIS (Netherlands)

    Kroger, N.; Holler, E.; Kobbe, G.; Bornhauser, M.; Schwerdtfeger, R.; Baurmann, H.; Nagler, A.; Bethge, W.; Stelljes, M.; Uharek, L.; Wandt, H.; Burchert, A.; Corradini, P.; Schubert, J.; Kaufmann, Martin; Dreger, P.; Wulf, G.G.; Einsele, H.; Zabelina, T.; Kvasnicka, H.M.; Thiele, J.; Brand, R.; Zander, A.R.; Niederwieser, D.; Witte, T.J.M. de

    2009-01-01

    From 2002 to 2007, 103 patients with primary myelofibrosis or postessential thrombocythemia and polycythemia vera myelofibrosis and a median age of 55 years (range, 32-68 years) were included in a prospective multicenter phase 2 trial to determine efficacy of a busulfan (10 mg/kg)/fludarabine (180

  4. Multicenter study of the Artisan phakic intraocular lens.

    Science.gov (United States)

    Budo, C; Hessloehl, J C; Izak, M; Luyten, G P; Menezo, J L; Sener, B A; Tassignon, M J; Termote, H; Worst, J G

    2000-08-01

    To assess the Artisan intraocular lens to correct myopia in phakic eyes. European multicenter study sponsored by Ophtec BV, Groningen, The Netherlands. In this prospective multicenter clinical study, the Artisan lens was implanted in 518 eyes between September 1991 and October 1999. The power of the lenses ranged from -5.0 to -20.0 diopters (D). Follow-up examinations were performed at 6 months and 1, 2, and 3 years. Follow-up ranged from 6 months (n = 454) to 3 years (n = 249). The preoperative uncorrected visual acuity (UCVA) was not recorded but was estimated to be worse than 0.1. The preoperative mean best spectacle-corrected visual acuity (BSCVA) was 0.67 +/- 0.26 (SD). Endothelial cell counts were done at 6 months and 1, 2, and 3 years in a subgroup of 129 eyes. A UCVA of 20/40 or better was observed in 76.8% of eyes regardless of the postoperative goal. A BSCVA of 20/40 or better was observed in 93.9% of eyes and remained stable throughout the follow-up. Of the eyes with extremely high myopia (>-15.0 D), 63.3% gained 2 or more lines of BSCVA; of those with moderate myopia (-5.0 to -10.0 D), 23.5% gained 2 or more lines. The mean endothelial cell density change was 4.8% at 6 months, 2.4% at 1 year, 1.7% at 2 years, and 0.7% at 3 years. The incidence of persistent adverse events at 3 years was relatively low. Secondary surgical interventions included repositioning of the lens because of poor initial placement and lens exchange because of preoperative power calculation errors. Glare and halo effects during night driving were noted and were related to large pupils in young patients. The Artisan lens is a safe, stable, efficacious, and predictable method to correct -5.0 to -20.0 D of myopia. This study suggests that the corneal endothelial cell loss is stabilized to the physiologically normal level after 3 years.

  5. Improving the manchester triage system for pediatric emergency care: An international multicenter study

    NARCIS (Netherlands)

    N. Seiger (Nienke); M. van Veen (Mirjam); H. Almeida (Helena); E.W. Steyerberg (Ewout); A.H.J. van Meurs (Alfred); R. Carneiro (Rita); C.F. Alves (Claudio); I.K. MacOnochie (Ian); J. van der Lei (Johan); H.A. Moll (Henriëtte)

    2014-01-01

    textabstractObjectives: This multicenter study examines the performance of the Manchester Triage System (MTS) after changing discriminators, and with the addition use of abnormal vital sign in patients presenting to pediatric emergency departments (EDs). Design: International multicenter study

  6. Lateralization in cluster headache: a Nordic multicenter study

    DEFF Research Database (Denmark)

    Meyer, Eva Laudon; Laurell, Katarina; Artto, Ville

    2009-01-01

    A slight predominance of cluster pain on the right side has been reported in several studies. The aim of this large retrospective Nordic multicenter study was to estimate the prevalence of right- and left-sided pain in cluster headache (CH) patients with side-locked pain, the prevalence of side...

  7. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study

    Science.gov (United States)

    Halbach, Nicky; Julu, Peter; Witt‐Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F.; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-01-01

    Many studies have attempted to establish the genotype–phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well‐defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype–phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non‐invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence‐based management in RTT. © 2016 The Authors. American Journal of Medical Genetics Part A published by Wiley Periodicals, Inc. PMID:27354166

  8. Oral cancer in the UAE: a multicenter, retrospective study | Anis ...

    African Journals Online (AJOL)

    Aim: To determine the prevalence of various malignant oral lesions in the UAE and correlate cases of squamous cell carcinomas with age, gender, site, grade, clinical presentations at the time of diagnosis, and the prevalence of neck metastasis. Materials and methods: A multicenter, retrospective study was conducted at ...

  9. Multicenter study on antibiotic susceptibility/resistance trends in the ...

    African Journals Online (AJOL)

    Multicenter study on antibiotic susceptibility/resistance trends in the western region of Cameroon. Reine Flaviette Tchapdie Ngassam, Megne Tantse, Pierre René Fotsing Kwetche, Dorice Pascale Noukela Noumi, Jonas Kouamouo, Josué Simo Louokdom, Sandrine Gamwo Dongmo, Serge Honoré Tchoukoua, Blandine ...

  10. Prevalence of smell loss in Parkinson's disease - A multicenter study

    NARCIS (Netherlands)

    Haehner, A.; Boesveldt, S.; Berendse, H.W.; Mackay-Sim, A.; Fleischman, J.; Silburn, P.A.; Johnston, A.N.; Mellick, G.D.; Herting, B.; Reichmann, H.; Hummel, T.

    2009-01-01

    Previous data on the prevalence of olfactory dysfunction in Parkinson's disease (PD) range from 45% to 90%. The present multicenter study aimed to provide data on the prevalence of smell loss in a large sample of PD patients from three independent populations. Olfactory sensitivity was tested in 400

  11. Cabergoline for Cushing's disease: a large retrospective multicenter study.

    Science.gov (United States)

    Ferriere, A; Cortet, C; Chanson, P; Delemer, B; Caron, P; Chabre, O; Reznik, Y; Bertherat, J; Rohmer, V; Briet, C; Raingeard, I; Castinetti, F; Beckers, A; Vroonen, L; Maiter, D; Cephise-Velayoudom, F L; Nunes, M L; Haissaguerre, M; Tabarin, A

    2017-03-01

    The efficacy of cabergoline in Cushing's disease (CD) is controversial. The aim of this study was to assess the efficacy and tolerability of cabergoline in a large contemporary cohort of patients with CD. We conducted a retrospective multicenter study from thirteen French and Belgian university hospitals. Sixty-two patients with CD received cabergoline monotherapy or add-on therapy. Symptom score, biological markers of hypercortisolism and adverse effects were recorded. Twenty-one (40%) of 53 patients who received cabergoline monotherapy had normal urinary free cortisol (UFC) values within 12 months (complete responders), and five of these patients developed corticotropic insufficiency. The fall in UFC was associated with significant reductions in midnight cortisol and plasma ACTH, and with clinical improvement. Compared to other patients, complete responders had similar median baseline UFC (2.0 vs 2.5xULN) and plasma prolactin concentrations but received lower doses of cabergoline (1.5 vs 3.5 mg/week, P 12 months), cabergoline was withdrawn in 28% of complete responders because of treatment escape or intolerance. Overall, sustained control of hypercortisolism was obtained in 23% of patients for 32.5 months (19-105). Nine patients on steroidogenesis inhibitors received cabergoline add-on therapy for 19 months (1-240). Hypercortisolism was controlled in 56% of these patients during the first year of treatment with cabergoline at 1.0 mg/week (0.5-3.5). About 20-25% of CD patients are good responders to cabergoline therapy allowing long-term control of hypercortisolism at relatively low dosages and with acceptable tolerability. No single parameter, including the baseline UFC and prolactin levels, predicted the response to cabergoline. © 2017 European Society of Endocrinology.

  12. Segmentation of age-related white matter changes in a clinical multi-center study

    DEFF Research Database (Denmark)

    Dyrby, Tim B.; Rostrup, E.; Baare, W.F.C.

    2008-01-01

    Leukoaraiosis And Disability (LADIS). Semi-manually delineated WMC were used for validating the segmentation produced by the neural networks. The neural network segmentation demonstrated high consistency between subjects and centers, making it a promising technique for large studies. For WMC volumes less than......) pruning method in the training stage. Six optimized neural networks were produced to investigate the impact of different input information on WMC segmentation. The automatic segmentation method was applied to MR scans of 362 non-demented elderly subjects from 11 centers in the European multi-center study...

  13. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years.

    LENUS (Irish Health Repository)

    Rolfs, Arndt

    2011-01-01

    Stroke in the young has not been thoroughly investigated with most previous studies based on a small number of patients from single centers. Furthermore, recent reports indicate that Fabry disease may be a significant cause for young stroke. The primary aim of our study was to determine the prevalence of Fabry disease in young stroke patients, while the secondary aim was to describe patterns of stroke in young patients.

  14. SDHB/SDHA immunohistochemistry in pheochromocytomas and paragangliomas: a multicenter interobserver variation analysis using virtual microscopy: a Multinational Study of the European Network for the Study of Adrenal Tumors (ENS@T)

    NARCIS (Netherlands)

    Papathomas, T.G.; Oudijk, L.; Persu, A.; Gill, A.J.; Nederveen, F. van; Tischler, A.S.; Tissier, F.; Volante, M; Matias-Guiu, X.; Smid, M.; Favier, J.; Rapizzi, E.; Libe, R.; Curras-Freixes, M.; Aydin, S.; Huynh, T.; Lichtenauer, U.; Berkel, A van; Canu, L.; Domingues, R.; Clifton-Bligh, R.J.; Bialas, M.; Vikkula, M.; Baretton, G.; Papotti, M.; Nesi, G.; Badoual, C.; Pacak, K.; Eisenhofer, G.; Timmers, H.J.L.M.; Beuschlein, F.; Bertherat, J.; Mannelli, M.; Robledo, M.; Gimenez-Roqueplo, A.P.; Dinjens, W.N.; Korpershoek, E.; Krijger, R.R. de

    2015-01-01

    Despite the established role of SDHB/SDHA immunohistochemistry as a valuable tool to identify patients at risk for familial succinate dehydrogenase-related pheochromocytoma/paraganglioma syndromes, the reproducibility of the assessment methods has not as yet been determined. The aim of this study

  15. SDHB/SDHA immunohistochemistry in pheochromocytomas and paragangliomas : A multicenter interobserver variation analysis using virtual microscopy: A Multinational Study of the European Network for the Study of Adrenal Tumors (ENS@T)

    NARCIS (Netherlands)

    Papathomas, Thomas G.; Oudijk, Lindsey; Persu, Alexandre; Gill, Anthony J.; Van Nederveen, Francien; Tischler, Arthur S.; Tissier, Frédérique; Volante, Marco; Matias-Guiu, Xavier; Smid, Marcel; Favier, Judith; Rapizzi, Elena; Libe, Rosella; Currás-Freixes, Maria; Aydin, Selda; Huynh, Thanh; Lichtenauer, Urs; Van Berkel, Anouk; Canu, Letizia; Domingues, Rita; Clifton-Bligh, Roderick J.; Bialas, Magdalena; Vikkula, Miikka; Baretton, Gustavo; Papotti, Mauro; Nesi, Gabriella; Badoual, Cécile; Pacak, Karel; Eisenhofer, Graeme; Timmers, Henri J.; Beuschlein, Felix; Bertherat, Jérôme; Mannelli, Massimo; Robledo, Mercedes; Gimenez-Roqueplo, Anne Paule; Dinjens, Winand N M; Korpershoek, Esther; De Krijger, Ronald R.

    2015-01-01

    Despite the established role of SDHB/SDHA immunohistochemistry as a valuable tool to identify patients at risk for familial succinate dehydrogenase-related pheochromocytoma/paraganglioma syndromes, the reproducibility of the assessment methods has not as yet been determined. The aim of this study

  16. State of the art of aldosterone immunoassays. A multicenter collaborative study on the behalf of the Cardiovascular Biomarkers Study Group of the Italian Section of European Society of Ligand Assay (ELAS) and Società Italiana di Biochimica Clinica (SIBIOC).

    Science.gov (United States)

    Fortunato, Antonio; Prontera, Concetta; Masotti, Silvia; Franzini, Maria; Marchetti, Cristina; Giovannini, Stefania; Zucchelli, Gian Carlo; Emdin, Michele; Passino, Claudio; Clerico, Aldo

    2015-04-15

    Two new immunoassay methods for aldosterone assay using automated platforms recently became available into market. The main aim of the present study is to evaluate the analytical performance of these automated direct immunoassay methods, and also to compare their analytical characteristics to those of the most popular RIA and EIA methods used in an Italian External Quality Assessment (EQA) study. In this study analytical performances of two aldosterone immunoassays using the IDS iSYS and DiaSorin LIAISON fully automated platforms, were evaluated. Results obtained with the two platforms in EDTA plasma samples of healthy subjects and patients were compared with those obtained by RIA and EIA methods used in the Italian EQA scheme, named Immunocheck study. The two automated methods showed similar analytical performances: LoD 83.9 vs 92.2 pmol/L, LoQ 104.4 vs 111.1 pmol/L, respectively; moreover, the within-run and total imprecision values showed CV% between 8.1 and 14.1 for samples with 180.8 and 387.2 pmol/L concentration for both methods. There was a close linear regression between methods, however we found a significant proportional bias between LIAISON and iSYS methods. The EQA samples results obtained with these two methods were highly correlated to the consensus mean values. Our data indicate that aldosterone values measured with the two automated methods actually show better reproducibility, shorter laboratory Turn Around Time (TAT) and require less "hands on labor" compared to RIA and EIA immunoassays. However, in our study significant bias was observed in result comparison, this means that translating aldosterone concentration in clinical information an appropriate definition of reference ranges for each method is mandatory. Copyright © 2015 Elsevier B.V. All rights reserved.

  17. Design effect in multicenter studies: gain or loss of power?

    Directory of Open Access Journals (Sweden)

    Vierron Emilie

    2009-06-01

    Full Text Available Abstract Background In a multicenter trial, responses for subjects belonging to a common center are correlated. Such a clustering is usually assessed through the design effect, defined as a ratio of two variances. The aim of this work was to describe and understand situations where the design effect involves a gain or a loss of power. Methods We developed a design effect formula for a multicenter study aimed at testing the effect of a binary factor (which thus defines two groups on a continuous outcome, and explored this design effect for several designs (from individually stratified randomized trials to cluster randomized trials, and for other designs such as matched pair designs or observational multicenter studies. Results The design effect depends on the intraclass correlation coefficient (ICC (which assesses the correlation between data for two subjects from the same center but also on a statistic S, which quantifies the heterogeneity of the group distributions among centers (thus the level of association between the binary factor and the center and on the degree of global imbalance (the number of subjects are then different between the two groups. This design effect may induce either a loss or a gain in power, depending on whether the S statistic is respectively higher or lower than 1. Conclusion We provided a global design effect formula applying for any multicenter study and allowing identifying factors – the ICC and the distribution of the group proportions among centers – that are associated with a gain or a loss of power in such studies.

  18. The Clinical Outcome Study for dysferlinopathy: An international multicenter study.

    Science.gov (United States)

    Harris, Elizabeth; Bladen, Catherine L; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X; Blamire, Andrew M; Bravver, Elena; Carlier, Pierre G; Day, John W; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J; Lochmüller, Hanns; Mendell, Jerry R; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M C; Bushby, Kate

    2016-08-01

    To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design.

  19. RANDOMIZED EUROPEAN MULTICENTER TRIAL OF SURFACTANT REPLACEMENT THERAPY FOR SEVERE NEONATAL RESPIRATORY-DISTRESS SYNDROME - SINGLE VERSUS MULTIPLE DOSES OF CUROSURF

    NARCIS (Netherlands)

    SPEER, CP; ROBERTSON, B; CURSTEDT, T; HALLIDAY, HL; COMPAGNONE, D; GEFELLER, O; HARMS, K; HERTING, E; MCCLURE, G; REID, M; TUBMAN, R; HERIN, P; NOACK, G; KOK, J; KOPPE, J; VANSONDEREN, L; LAUFKOTTER, E; KOHLER, W; BOENISCH, H; ALBRECHT, K; HANSSLER, L; HAIM, M; OETOMO, SB; Okken, Albert; ALTFELD, PC; GRONECK, P; KACHEL, W; RELIER, JP; WALTI, H

    There is now convincing evidence that the severity of neonatal respiratory distress syndrome can be reduced by surfactant replacement therapy; however, the optimal therapeutic regimen has not been defined. This randomized European multicenter trial was designed to determine whether the beneficial

  20. A multicenter study on Leigh syndrome

    DEFF Research Database (Denmark)

    Sofou, Kalliopi; De Coo, Irenaeus F M; Isohanni, Pirjo

    2014-01-01

    BACKGROUND: Leigh syndrome is a progressive neurodegenerative disorder, associated with primary or secondary dysfunction of the mitochondrial oxidative phosphorylation. Despite the fact that Leigh syndrome is the most common phenotype of mitochondrial disorders in children, longitudinal natural...... history data is missing. This study was undertaken to assess the phenotypic and genotypic spectrum of patients with Leigh syndrome, characterise the clinical course and identify predictors of survival in a large cohort of patients. METHODS: This is a retrospective study of patients with Leigh syndrome...... was significantly correlated to a more severe disease course, characterised by early onset before 6 months of age, acute exacerbations and/or relapses, as well as brainstem involvement. 39% of patients had died by the age of 21 years, at a median age of 2.4 years. Disease onset before 6 months of age, failure...

  1. The pediatric heart network: meeting the challenges to multicenter studies in pediatric heart disease.

    Science.gov (United States)

    Burns, Kristin M; Pemberton, Victoria L; Pearson, Gail D

    2015-10-01

    Because of the relatively small numbers of pediatric patients with congenital heart disease cared for in any individual center, there is a significant need for multicenter clinical studies to validate new medical or surgical therapies. The Pediatric Heart Network (PHN), with 15 years of experience in multicenter clinical research, has tackled numerous challenges when conducting multicenter studies. This review describes the challenges encountered and the strategies employed to conduct high-quality, collaborative research in pediatric cardiovascular disease. Sharing lessons learned from the PHN can provide guidance to investigators interested in conducting pediatric multicenter studies.

  2. The representativeness of a European multi-center network for influenza-like-illness participatory surveillance.

    Science.gov (United States)

    Cantarelli, Pietro; Debin, Marion; Turbelin, Clément; Poletto, Chiara; Blanchon, Thierry; Falchi, Alessandra; Hanslik, Thomas; Bonmarin, Isabelle; Levy-Bruhl, Daniel; Micheletti, Alessandra; Paolotti, Daniela; Vespignani, Alessandro; Edmunds, John; Eames, Ken; Smallenburg, Ronald; Koppeschaar, Carl; Franco, Ana O; Faustino, Vitor; Carnahan, AnnaSara; Rehn, Moa; Colizza, Vittoria

    2014-09-20

    The Internet is becoming more commonly used as a tool for disease surveillance. Similarly to other surveillance systems and to studies using online data collection, Internet-based surveillance will have biases in participation, affecting the generalizability of the results. Here we quantify the participation biases of Influenzanet, an ongoing European-wide network of Internet-based participatory surveillance systems for influenza-like-illness. In 2011/2012 Influenzanet launched a standardized common framework for data collection applied to seven European countries. Influenzanet participants were compared to the general population of the participating countries to assess the representativeness of the sample in terms of a set of demographic, geographic, socio-economic and health indicators. More than 30,000 European residents registered to the system in the 2011/2012 season, and a subset of 25,481 participants were selected for this study. All age classes (10 years brackets) were represented in the cohort, including under 10 and over 70 years old. The Influenzanet population was not representative of the general population in terms of age distribution, underrepresenting the youngest and oldest age classes. The gender imbalance differed between countries. A counterbalance between gender-specific information-seeking behavior (more prominent in women) and Internet usage (with higher rates in male populations) may be at the origin of this difference. Once adjusted by demographic indicators, a similar propensity to commute was observed for each country, and the same top three transportation modes were used for six countries out of seven. Smokers were underrepresented in the majority of countries, as were individuals with diabetes; the representativeness of asthma prevalence and vaccination coverage for 65+ individuals in two successive seasons (2010/2011 and 2011/2012) varied between countries. Existing demographic and national datasets allowed the quantification of the

  3. Functional correlates of cognitive dysfunction in multiple sclerosis: A multicenter fMRI Study.

    Science.gov (United States)

    Rocca, Maria A; Valsasina, Paola; Hulst, Hanneke E; Abdel-Aziz, Khaled; Enzinger, Christian; Gallo, Antonio; Pareto, Debora; Riccitelli, Gianna; Muhlert, Nils; Ciccarelli, Olga; Barkhof, Frederik; Fazekas, Franz; Tedeschi, Gioacchino; Arévalo, Maria J; Filippi, Massimo

    2014-12-01

    In this multicenter study, we applied functional magnetic resonance imaging (fMRI) to define the functional correlates of cognitive dysfunction in patients with multiple sclerosis (MS). fMRI scans during the performance of the N-back task were acquired from 42 right-handed relapsing remitting (RR) MS patients and 52 sex-matched right-handed healthy controls, studied at six European sites using 3.0 Tesla scanners. Patients with at least two abnormal (function of increasing task difficulty, CI MS patients had reduced activations of several areas located in the fronto-parieto-temporal lobes as well as reduced deactivations of regions which are part of the default mode network compared to the other two groups. Significant correlations were found between abnormal fMRI patterns of activations and deactivations and behavioral measures, cognitive performance, and brain T2 and T1 lesion volumes. This multicenter study supports the theory that a preserved fMRI activity of the frontal lobe is associated with a better cognitive profile in MS patients. It also indicates the feasibility of fMRI to monitor disease evolution and treatment effects in future studies. © 2014 Wiley Periodicals, Inc.

  4. Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access BR Monitor assay on the UniCel Dxl 800 Immunoassay System.

    Science.gov (United States)

    Molina, Rafael; Gion, Massimo; Gressner, Axel; Troalen, Frédéric; Auge, Jose Maria; Holdenrieder, Stefan; Zancan, Matelda; Wycislo, Matthias; Stieber, Petra

    2008-01-01

    Cancer antigen CA15-3 antigen is known as a valuable marker for the management of breast cancer. The analytical and clinical performance of the Access BR Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA15-3 on the Elecsys System (Roche Diagnostics). Total imprecision (% CV) of the BR Monitor ranged between 5.5% and 11.7%, and inter-laboratory reproducibility between 3.4% and 5.1%. Linearity upon dilution showed a mean recovery of 98.5% (SD + 9.1%). Endogenous interferents had no influence on BR Monitor levels (mean recoveries: hemoglobin 112%, bilirubin 111%, triglycerides 108%). There was no high-dose hook effect up to 13,540 kU/L. Clinical performance investigated in sera from individuals showed a general correlation between the Access BR Monitor and Elecsys CA15-3 (R = 0.797), with a slope of 1.383. CA15-3 serum levels, as measured by the BR Monitor, were low in healthy individuals (n = 267, median = 11.9 kU/L, 95th percentile = 23.5 kU/L), higher in individuals with various benign diseases (n = 549, medians = 11.3-15.6 kU/L, 95th percentiles = 21.6-54.6 kU/L) and even higher in individuals suffering from various cancers (n = 995, medians = 11.2-22.8 kU/L, 95th percentiles = 30.0-429.7 kU/L). Best diagnostic accuracy for cancer detection against the relevant benign control group by the BR Monitor was found for locoregional and metastatic breast cancer, as well as for ovarian cancer [area under the curve (AUC) 0.619, 0.897 and 0.774]. Results for the reference CA15-3 assay were comparable (AUC 0.611, 0.887 and 0.818). The Access BR Monitor provides accurate methodological characteristics and demonstrates an analytical and clinical correlation with Elecsys CA15-3. Best diagnostic accuracy for the BR Monitor was found in breast and ovarian cancer. Our results also suggest a clinical value of the BR Monitor in other cancers.

  5. Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access GI Monitor assay on the UniCel Dxl 800 Immunoassay System.

    Science.gov (United States)

    Stieber, Petra; Molina, Rafael; Gion, Massimo; Gressner, Axel; Troalen, Frédéric; Holdenrieder, Stefan; Auge, Jose Maria; Zancan, Matelda; Wycislo, Matthias; Jarrige, Véronique

    2008-01-01

    Gastrointestinal cancer antigen CA19-9 is known as a valuable marker for the management of patients with pancreatic cancer. The analytical and clinical performance of the Access GI Monitor assay (Beckman Coulter) was evaluated on the UniCel Dxl 800 Immunoassay System at five different European sites and compared with a reference method, defined as CA19-9 on the Elecsys System (Roche Diagnostics). Total imprecision (%CV) of the GI Monitor ranged between 3.4% and 7.7%, and inter-laboratory reproducibility between 3.6% and 4.0%. Linearity upon dilution showed a mean recovery of 97.4% (SD + 7.2%). Endogenous interferents had no influence on GI Monitor levels (mean recoveries: hemoglobin 103%, bilirubin 106%, triglycerides 106%). There was no high-dose hook effect up to 115,000 kU/L. Clinical performance investigated in sera from 1811 individuals showed a good correlation between the Access GI Monitor and Elecsys CA19-9 (R = 0.959, slope = 1.004, intercept = +0.17). GI Monitor serum levels were low in healthy individuals (n = 267, median = 6.0 kU/L, 95th percentile=23.1 kU/L), higher in individuals with various benign diseases (n = 550, medians = 5.8-13.4 kU/L, 95th percentiles = 30.1-195.5 kU/L) and even higher in individuals suffering from various cancers (n = 995, medians = 8.4-233.8 kU/L, 95th percentiles = 53.7-13,902 kU/L). Optimal diagnostic accuracy for cancer detection against the relevant benign control group by the GI Monitor was found for pancreatic cancer [area under the curve (AUC) 0.83]. Results for the reference CA19-9 assay were comparable (AUC 0.85). The Access GI Monitor provides very good methodological characteristics and demonstrates an excellent analytical and clinical correlation with the Elecsys CA19-9. The GI Monitor shows the best diagnostic accuracy in pancreatic cancer. Our results also suggest a clinical value of the GI Monitor in other cancers.

  6. Alternative antibody for the detection of CA125 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access OV Monitor assay on the UniCel Dxl 800 Immunoassay System.

    Science.gov (United States)

    Holdenrieder, Stefan; Molina, Rafael; Gion, Massimo; Gressner, Axel; Troalen, Frédéric; Auge, Jose Maria; Zancan, Matelda; Wycislo, Matthias; Stieber, Petra

    2008-01-01

    Cancer antigen CA125 is known as a valuable marker for the management of ovarian cancer. The analytical and clinical performance of the Access OV Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA125 on the Elecsys System (Roche Diagnostics). Total imprecision (% CV) of the OV Monitor ranged between 3.1% and 8.8%, and inter-laboratory reproducibility between 4.7% and 5.0%. Linearity upon dilution showed a mean recovery of 100% (SD + 8.1%). Endogenous interferents had no influence on OV Monitor levels (mean recoveries: hemoglobin 107%, bilirubin 103%, triglycerides 103%). There was no high-dose hook effect up to 27,193 kU/L. Clinical performance investigated in sera from 1811 individuals showed a good correlation between the Access OV Monitor and Elecsys CA125 (R = 0.982, slope = 0.921, intercept = +1.951). OV Monitor serum levels were low in healthy individuals (n = 267, median = 9.7 kU/L, 95th percentile = 30.8 kU/L), higher in individuals with various benign diseases (n = 549, medians = 10.9-16.4 kU/L, 95th percentiles = 44.2-355 kU/L) and even higher in individuals suffering from various cancers (n = 995, medians = 12.4-445 kU/L; 95th percentiles = 53.4-4664 kU/L). Optimal diagnostic accuracy for cancer detection against the relevant benign control group by the OV Monitor was found for ovarian cancer [area under the curve (AUC) 0.898]. Results for the reference CA125 assay were comparable (AUC 0.899). The Access OV Monitor provides very good methodological characteristics and demonstrates an excellent analytical and clinical correlation with Elecsys CA125. The best diagnostic accuracy for the OV Monitor was found in ovarian cancer. Our results also suggest a clinical value of the OV Monitor in other cancers.

  7. Factors predicting survival in ALS: a multicenter Italian study.

    Science.gov (United States)

    Calvo, Andrea; Moglia, Cristina; Lunetta, Christian; Marinou, Kalliopi; Ticozzi, Nicola; Ferrante, Gianluca Drago; Scialo, Carlo; Sorarù, Gianni; Trojsi, Francesca; Conte, Amelia; Falzone, Yuri M; Tortelli, Rosanna; Russo, Massimo; Chiò, Adriano; Sansone, Valeria Ada; Mora, Gabriele; Silani, Vincenzo; Volanti, Paolo; Caponnetto, Claudia; Querin, Giorgia; Monsurrò, Maria Rosaria; Sabatelli, Mario; Riva, Nilo; Logroscino, Giancarlo; Messina, Sonia; Fini, Nicola; Mandrioli, Jessica

    2017-01-01

    The aim of this multicenter, retrospective study is to investigate the role of clinical characteristics and therapeutic intervention on ALS prognosis. The study included patients diagnosed from January 1, 2009 to December 31, 2013 in 13 Italian referral centers for ALS located in 10 Italian regions. Caring neurologists collected a detailed phenotypic profile and follow-up data until death into an electronic database. One center collected also data from a population-based registry for ALS. 2648 incident cases were collected. The median survival time from onset to death/tracheostomy was 44 months (SE 1.18, CI 42-46). According to univariate analysis, factors related to survival from onset to death/tracheostomy were: age at onset, diagnostic delay, site of onset, phenotype, degree of certainty at diagnosis according to revised El Escorial criteria (R-EEC), presence/absence of dementia, BMI at diagnosis, patients' provenance. In the multivariate analysis, age at onset, diagnostic delay, phenotypes but not site of onset, presence/absence of dementia, BMI, riluzole use, R-EEC criteria were independent prognostic factors of survival in ALS. We compared patients from an ALS Registry with patients from tertiary centers; the latter ones were younger, less frequently bulbar, but more frequently familial and definite at diagnosis. Our large, multicenter study demonstrated the role of some clinical and demographic factors on ALS survival, and showed some interesting differences between referral centers' patients and the general ALS population. These results can be helpful for clinical practice, in clinical trial design and to validate new tools to predict disease progression.

  8. The early European lithium studies.

    Science.gov (United States)

    Schou, M

    1999-12-01

    Cade's discovery of lithium's antimanic effect soon became known in Europe and was confirmed by a Danish controlled trial. The same investigators discovered a prophylactic action of lithium against both manic and depressive recurrences, which was confirmed by a Swiss-Czech-Danish cooperative trial. The evidence of these studies was met with skepticism based on methodological speculations, but a Danish randomised, placebo-controlled, double-blind trial of discontinuation design established the prophylactic action of lithium, as did a number of European controlled trials of start design and discontinuation design. The review ends with personal memories of John Cade.

  9. Lactobacillus GG administered in oral rehydration solution to children with acute diarrhea: a multicenter European trial.

    Science.gov (United States)

    Guandalini, S; Pensabene, L; Zikri, M A; Dias, J A; Casali, L G; Hoekstra, H; Kolacek, S; Massar, K; Micetic-Turk, D; Papadopoulou, A; de Sousa, J S; Sandhu, B; Szajewska, H; Weizman, Z

    2000-01-01

    The probiotic Lactobacillus GG is effective in promoting a more rapid recovery of acute, watery diarrhea in children with rotavirus enteritis. Very limited information is available, however, on the potential role of such agents in non-rotaviral diarrheal episodes. Furthermore, no evidence is available concerning the efficacy of Lactobacillus GG administered in the oral rehydration solution during oral rehydration therapy. A multicenter trial was conducted to evaluate the efficacy of Lactobacillus GG administered in the oral rehydration solution to patients with acute-onset diarrhea of all causes. Children 1 month to 3 years of age with acute-onset diarrhea were enrolled in a double-blind, placebo-controlled investigation. Patients were randomly allocated to group A, receiving oral rehydration solution plus placebo, or group B, receiving the same preparation but with a live preparation of Lactobacillus GG (at least 10(10) CFU/250 ml). After rehydration in the first 4 to 6 hours, patients were offered their usual feedings plus free access to the same solution until diarrhea stopped. One hundred forty children were enrolled in group A, and 147 in group B. There were no differences at admission between the groups in age, sex, previous types of feeding, previous duration of diarrhea, use of antibiotics, weight, height, weight-height percentile, prevalence of fever, overall status, degree of dehydration, and percentage of in- versus outpatients. Duration of diarrhea after enrollment was 71.9 +/- 35.8 hours in group A versus 58.3 +/- 27.6 hours in group B (mean +/- SD; P = 0.03). In rotavirus-positive children, diarrhea lasted 76.6 +/- 41.6 hours in group A versus 56.2 +/- 16.9 hours in groups B (P children with acute diarrhea is safe and results in shorter duration of diarrhea, less chance of a protracted course, and faster discharge from the hospital.

  10. Idiopathic cardiomyopathies in Korean children. - 9-Year Korean Multicenter Study-.

    Science.gov (United States)

    Oh, Jin Hee; Hong, Young Mi; Choi, Jae Young; Kim, Soo Jin; Jung, Jo Won; Sohn, Sejung; Hyun, Myung Chul; Noh, Chung Il; Lee, Joo Won; Park, In Sook

    2011-01-01

    Idiopathic cardiomyopathies (CMPs) are an important heterogeneous group of diseases. With the advance of therapeutic strategies, epidemiologic data on CMP have become very important, but only a few have been reported in Asian children. We conducted a retrospective epidemiologic study of primary CMP in Korean children. Using a multicenter survey, we studied primary CMP among Korean children from January 1998 to December 2006 based on classification (2006) of CMP by the American Heart Association. A total of 277 primary CMP patients were reported from 17 cardiovascular centers. The average annual occurrence of new cases of primary CMP was 0.28 per 100,000 Korean children younger than 15 years of age (95% confidence interval (CI) 0.24-0.31). Dilated CMP (DCMP) was 66.43%, hypertrophic CMP (HCMP) 23.47%, restrictive CMP (RCMP) 6.50% and others 3.61%. The point prevalence of primary CMP at the end of the study was estimated as 2.11/100,000 (95%CI 1.83-2.43), DCMP 1.39/100,000, HCMP 0.51/100,000, RCMP 0.16/100,000 and others 0.04/100,000. Survival rates over 9 years were 69.8% in DCMP, 90.3% in HCMP, and 47.2% in RCMP. Recent point prevalence of childhood primary CMP in Korea was estimated as 2.11/100,000. Further epidemiologic study with a nationwide survey is necessary.

  11. Multicenter Study of Voriconazole Pharmacokinetics and Therapeutic Drug Monitoring

    Science.gov (United States)

    Dolton, Michael J.; Ray, John E.; Chen, Sharon C.-A.; Ng, Kingsley; Pont, Lisa G.

    2012-01-01

    Voriconazole is a first-line agent in the treatment of many invasive fungal infections and is known to display highly variable pharmacokinetics. Previous studies of voriconazole therapeutic drug monitoring (TDM) have suggested concentration monitoring to be clinically useful but have been limited by small patient samples at a single institution. This multicenter retrospective study aimed to investigate relationships between voriconazole concentration and clinical outcomes and adverse events and to assess clinical factors and drug interactions that may affect voriconazole concentration. Medical records were reviewed for patients who received voriconazole and had at least 1 concentration measured at seven hospitals in Australia. The study included 201 patients with 783 voriconazole trough concentrations. Voriconazole concentrations of voriconazole concentrations of >5 mg/liter (10/31 patients [32%]) than at concentrations of ≤5 mg/liter (2/170 patients [1.2%]) (P voriconazole concentration identified associations between increasing patient weight, oral administration of voriconazole, and coadministration of phenytoin or rifampin and significantly reduced concentrations, and associations between increasing patient age and coadministration of proton pump inhibitors and increased concentrations. Coadministration of glucocorticoids was found to significantly reduce voriconazole concentrations, inferring a previously unreported drug interaction between glucocorticoids and voriconazole. PMID:22751544

  12. Safety and efficacy of the long-term adjuvant treatment of primary intermediate- to high-risk malignant melanoma (UICC/AJCC stage II and III) with a standardized fermented European mistletoe (Viscum album L.) extract. Results from a multicenter, comparative, epidemiological cohort study in Germany and Switzerland.

    Science.gov (United States)

    Augustin, Matthias; Bock, Paul R; Hanisch, Jürgen; Karasmann, Marita; Schneider, Berthold

    2005-01-01

    Mistletoe therapy is the most frequently used complementary treatment in cancer patients in Germany and Switzerland. However, its safety and efficacy were controversially discussed, also in case of malignant melanoma (MM). The present study should evaluate the therapeutic safety and efficacy of a long-term therapy with a standardized fermented European mistletoe (Viscum album L.) extract Iscador (FME) during post-surgical aftercare of primary intermediate to high-risk MM (UICC/AJCC stage II-III) patients and compare it with an untreated parallel control group from the same cohort. The study was designed as a multicenter, comparative, retrolective, epidemiological cohort study with parallel groups, carried out according to the guidelines of Good Epidemiological Practice (GEP). All patients suffered from surgically treated and histopathologically confirmed primary MM in UICC/AJCC stage II-III without distant metastases. In the study group, FME was administered subcutaneously 2-3 times weekly for at least three months, while the untreated control group was merely observed ("watchful waiting"). In both groups some patients also received radio-, chemo-, and/or immunotherapy. The patients were followed until the last visit or until death. Unselected, chronologically ordered, and standardized anonymous data from medical records that satisfied the predefined eligibility criteria were included for the "per protocol" analysis. Safety was assessed by the number of patients with FME-associated adverse drug reactions (ADRs) and by the search for tumor enhancement. The primary endpoint of efficacy was the adjusted tumor-related survival. Secondary end-points were the overall-, the disease-free- and the brain metastasis-free survival. The survival results were analyzed after adjustment for baseline imbalances, treatment regimens and other potential confounders by the Cox proportional hazard regression method. 686 eligible patients (329 FME vs. 357 controls) from 35 centers were

  13. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder

    NARCIS (Netherlands)

    Chouinard, G; Saxena, B; Belanger, MC; Ravindran, A; Bakish, D; Beauclair, L; Morris, P; Nair, NPV; Manchanda, R; Reesal, R; Remick, R; O'Neill, MC

    Background: Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors. In a 12-week randomized, multicenter, double-blind trial, the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in

  14. Voriconazole and squamous cell carcinoma after lung transplantation : A multicenter study

    NARCIS (Netherlands)

    Hamandi, B.; Fegbeutel, C.; Silveira, F. P.; Verschuuren, E. A.; Younus, M.; Mo, J.; Yan, J.; Ussetti, P.; Chin-Hong, P. V.; Sole, A.; Holmes-Liew, C. L.; Billaud, E. M.; Grossi, P. A.; Manuel, O.; Levine, D. J.; Barbers, R. G.; Hadjiliadis, D.; Aram, J.; Singer, L. G.; Husain, S.

    This study evaluated the independent contribution of voriconazole to the development of squamous cell carcinoma (SCC) in lung transplant recipients, by attempting to account for important confounding factors, particularly immunosuppression. This international, multicenter, retrospective, cohort

  15. Sports activity level after surgical treatment for chronic anterolateral ankle instability - A multicenter study

    NARCIS (Netherlands)

    Krips, Rover; van Dijk, C. Niek; Lehtonen, Hannu; Halasi, Tamas; Moyen, Bernard; Karlsson, Jon

    2002-01-01

    The objective of this retrospective multicenter study was to determine whether anatomic reconstruction or tenodesis produces better results in athletic patients with lateral ankle instability. Forty-one patients who underwent anatomic reconstruction and 36 patients who underwent tenodesis were

  16. Consensus strategy to quantitate malignant cells in myeloma patients is validated in a multicenter study

    NARCIS (Netherlands)

    Willems, P; Verhagen, O; Segeren, C; Veenhuizen, P; Guikema, J; Wiemer, E; Groothuis, L; Buitenweg-de Jong, T; Kok, H; Bloem, A; Bos, N; Vellenga, E; Mensink, E; Sonneveld, P; van der Schoot, HLE; Raymakers, R

    2000-01-01

    Recently the Belgium-Dutch Hematology-Oncology group initiated a multicenter study to evaluate whether myeloma patients treated with intensive chemotherapy benefit from additional peripheral stem cell transplantation. To determine treatment response accurately, we decided to quantitate malignant

  17. The filtering, clear-cornea diathermal keratostomy: a minor Danish multicenter study

    DEFF Research Database (Denmark)

    Kessing, S.V.; Nissen, O.I.; Thygesen, J.

    2008-01-01

    PURPOSE: Is the new micropenetrating, clear-cornea procedure, intrastromal diathermal keratostomy (IDK), an alternative to the intricate "modern trabeculectomy"? METHODS: Prospective multicenter study. Four surgeons from 4 Danish eye departments attended an IDK course and subsequently decided when...

  18. Brain SPECT in subtypes of mild cognitive impairment Findings from the DESCRIPA multicenter study

    NARCIS (Netherlands)

    Nobili, F.; Frisoni, G. B.; Portet, F.; Verhey, F.; Rodriguez, G.; Caroli, A.; Touchon, J.; Calvini, P.; Morbelli, S.; De Carli, F.; Guerra, U.P.; van de Pol, L.A.; Visser, P.J.

    2008-01-01

    The Development of Screening Guidelines and Clinical Criteria of Predementia Alzheimer's Disease (DESCRIPA) multicenter study enrolled patients with MCI or subjective cognitive complaints (SUBJ), a part of whom underwent optional brain perfusion SPECT. These patients were classified as SUBJ (n =

  19. Colorectal carcinoma in childhood: a retrospective multicenter study.

    Science.gov (United States)

    Kravarusic, Dragan; Feigin, Elad; Dlugy, Elena; Steinberg, Ran; Baazov, Arthur; Erez, Ilan; Lazar, Ludvig; Kapuller, Vadim; Grunspan, Moshe; Ash, Shifra; Freud, Enrique

    2007-02-01

    Colorectal carcinoma, a common adult malignancy, has an estimated childhood incidence of 0.3 to 1.5/million in Western countries and 0.2/million in Israel. Diagnosis is difficult because adult screening measures are unfeasible in children. The tumor is frequently associated with predisposing genetic factors, aggressive biological behavior, and poor prognosis. The aim of this multicenter study was to document the clinical profile, treatment and prognosis of colorectal carcinoma in children in Israel. The clinical, laboratory, therapeutic, and prognostic parameters of all 7 children from 4 medical centers in Israel who were diagnosed with colorectal carcinoma over a 25-y period were reviewed. Patients presented with rectal bleeding (4 of 7), abdominal pain (2 of 7), and abdominal distension (2 of 7). Average time to diagnosis was 6 months. Six patients underwent surgery (1 refused), and 5 received chemotherapy. Histopathological studies showed poorly differentiated mucinous adenocarcinoma, signet-ring type, in 4 cases, moderately differentiated adenocarcinoma in 2, and well-differentiated carcinoma in 1. Three patients died of the disease, 2 shortly after diagnosis. One patient with recurrent metastatic disease was lost to follow-up. Colorectal carcinoma in children is characterized by aggressive tumor behavior and delayed diagnosis, resulting in a worse prognosis than in adults. Heightened physician awareness of the possibility of this disease in children, with special attention to adolescents with predisposing factors and rectal bleeding, could help to improve outcome.

  20. Multicenter study of principles-based waveforms for external defibrillation.

    Science.gov (United States)

    Bain, A C; Swerdlow, C D; Love, C J; Ellenbogen, K A; Deering, T F; Brewer, J E; Augostini, R S; Tchou, P J

    2001-01-01

    The efficacy of a shock waveform for external defibrillation depends on the waveform characteristics. Recently, design principles based on cardiac electrophysiology have been developed to determine optimal waveform characteristics. The objective of this clinical trial was to evaluate the efficacy of principles-based monophasic and biphasic waveforms for external defibrillation. A prospective, randomized, blinded, multicenter study of 118 patients undergoing electrophysiologic testing or receiving an implantable defibrillator was conducted. Ventricular fibrillation was induced, and defibrillation was attempted in each patient with a biphasic and a monophasic waveform. Patients were randomly placed into 2 groups: group 1 received shocks of escalating energy, and group 2 received only high-energy shocks. The biphasic waveform achieved a first-shock success rate of 100% in group 1 (95% confidence interval [CI] 95.1% to 100%) and group 2 (95% CI 94.6% to 100%), with average delivered energies of 201+/-17 J and 295+/-28 J, respectively. The monophasic waveform demonstrated a 96.7% (95% CI 89.1% to 100%) first-shock success rate and average delivered energy of 215+/-12 J for group 1 and a 98.2% (95% CI 91.7% to 100%) first-shock success rate and average delivered energy of 352+/-13 J for group 2. Using principles of electrophysiology, it is possible to design both biphasic and monophasic waveforms for external defibrillation that achieve a high first-shock efficacy.

  1. Toilet training age and influencing factors: a multicenter study.

    Science.gov (United States)

    Tarhan, Hüseyin; Çakmak, Özgür; Akarken, İlker; Ekin, Rahmi Gökhan; Ün, Sıtkı; Uzelli, Derya; Helvacı, Mehmet; Aksu, Nejat; Yavaşcan, Önder; Mutlubaş Özsan, Fatma; Cun, Selma; Koç, Feyza; Özkarakaş, Özlem; İlbey, Yusuf Özlem; Zorlu, Ferruh

    2015-01-01

    To determine toilet training age and the factors influencing this in our country, 1500 children who had completed toilet training were evaluated in a multicenter study. The mean age of toilet training was 22.32 ± 6.57 months. The duration it took to complete toilet training was 6.60 ± 2.20 months on the average. In univariant analysis, toilet training age increased as the parental education level, specifically that of the mother, increased. The training age of children whose mothers had over 12 years of education differed significantly from that of children of mothers with less education. There was no significant difference in toilet training age with regard to the education level of the father, or the employment status of the mother. We also found significant differences with respect to family income level, toilet type and training method. In multivariant analysis, family income >5000 TL and use of a potty chair were determined to be factors affecting toilet training age. In conclusion, toilet training age in Turkey, a developing country, was found to be lower than that in developed countries.

  2. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay

    DEFF Research Database (Denmark)

    Krintus, Magdalena; Kozinski, Marek; Boudry, Pascal

    2014-01-01

    high sensitive cardiac troponin I (hs-cTnI) assay and its 99th percentile upper reference limit (URL). METHODS: Laboratories from nine European countries evaluated the ARCHITECT STAT high sensitive troponin I (hs-TnI) immunoassay on the ARCHITECT i2000SR/i1000SR immunoanalyzers. Imprecision, limit...... hs-cTnI assay and contemporary cTnI assay at 99th percentile cut-off was found to be 95%. TnI was detectable in 75% and 57% of the apparently healthy population using the lower (1.1 ng/L) and upper (1.9 ng/L) limit of the LoD range provided by the ARCHITECT STAT hs-TnI package insert, respectively....... The 99th percentile values were gender dependent. CONCLUSIONS: The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool....

  3. Blunt abdominal aortic injury: a Western Trauma Association multicenter study.

    Science.gov (United States)

    Shalhub, Sherene; Starnes, Benjamin W; Brenner, Megan L; Biffl, Walter L; Azizzadeh, Ali; Inaba, Kenji; Skiada, Dimitra; Zarzaur, Ben; Nawaf, Cayce; Eriksson, Evert A; Fakhry, Samir M; Paul, Jasmeet S; Kaups, Krista L; Ciesla, David J; Todd, S Rob; Seamon, Mark J; Capano-Wehrle, Lisa M; Jurkovich, Gregory J; Kozar, Rosemary A

    2014-12-01

    Blunt abdominal aortic injury (BAAI) is a rare injury. The objective of the current study was to examine the presentation and management of BAAI at a multi-institutional level. The Western Trauma Association Multi-Center Trials conducted a study of BAAI from 1996 to 2011. Data collected included demographics, injury mechanism, associated injuries, interventions, and complications. Of 392,315 blunt trauma patients, 113 (0.03%) presented with BAAI at 12 major trauma centers (67% male; median age, 38 years; range, 6-88; median Injury Severity Score [ISS], 34; range, 16-75). The leading cause of injury was motor vehicle collisions (60%). Hypotension was documented in 47% of the cases. The most commonly associated injuries were spine fractures (44%) and pneumothorax/hemothorax (42%). Solid organ, small bowel, and large bowel injuries occurred in 38%, 35%, and 28% respectively. BAAI presented as free aortic rupture (32%), pseudoaneurysm (16%), and injuries without aortic external contour abnormality on computed tomography such as large intimal flaps (34%) or intimal tears (18%). Open and endovascular repairs were undertaken as first-choice therapy in 43% and 15% of cases, respectively. Choice of management varied by type of BAAI: 89% of intimal tears were managed nonoperatively, and 96% of aortic ruptures were treated with open repair. Overall mortality was 39%, the majority (68%) occurring in the first 24 hours because of hemorrhage or cardiac arrest. The highest mortality was associated with Zone II aortic ruptures (92%). Follow-up was documented in 38% of live discharges. This is the largest BAAI series reported to date. BAAI presents as a spectrum of injury ranging from minimal aortic injury to aortic rupture. Nonoperative management is successful in uncomplicated cases without external aortic contour abnormality on computed tomography. Highest mortality occurred in free aortic ruptures, suggesting that alternative measures of early noncompressible torso hemorrhage

  4. Enumeration of antigen-specific CD8+ T lymphocytes by single-platform, HLA tetramer-based flow cytometry: a European multicenter evaluation.

    Science.gov (United States)

    Heijnen, Ingmar A F M; Barnett, David; Arroz, Maria J; Barry, Simon M; Bonneville, Marc; Brando, Bruno; D'hautcourt, Jean-Luc; Kern, Florian; Tötterman, Thomas H; Marijt, Erik W A; Bossy, David; Preijers, Frank W M B; Rothe, Gregor; Gratama, Jan W

    2004-11-01

    HLA class I peptide tetramers represent powerful diagnostic tools for detection and monitoring of antigen-specific CD8(+) T cells. The impetus for the current multicenter study is the critical need to standardize tetramer flow cytometry if it is to be implemented as a routine diagnostic assay. Hence, the European Working Group on Clinical Cell Analysis set out to develop and evaluate a single-platform tetramer-based method that used cytomegalovirus (CMV) as the antigenic model. Absolute numbers of CMV-specific CD8(+) T cells were obtained by combining the percentage of tetramer-binding cells with the absolute CD8(+) T-cell count. Six send-outs of stabilized blood from healthy individuals or CMV-carrying donors with CMV-specific CD8(+) T-cell counts of 3 to 10 cells/microl were distributed to 7 to 16 clinical sites. These sites were requested to enumerate CD8(+) T cells and, in the case of CMV-positive donors, CMV-specific subsets on three separate occasions using the standard method. Between-site coefficients of variation of less than 10% (absolute CD8(+) T-cell counts) and approximately 30% (percentage and absolute numbers of CMV-specific CD8(+) T cells) were achieved. Within-site coefficients of variation were approximately 5% (absolute CD8(+) T-cell counts), approximately 9% (percentage CMV-specific CD8(+) T cells), and approximately 17% (absolute CMV-specific CD8(+) T-cell counts). The degree of variation tended to correlate inversely with the proportion of CMV-specific CD8(+) T-cell subsets. The single-platform MHC tetramer-based method for antigen-specific CD8(+) T-cell counting has been evaluated by a European group of laboratories and can be considered a reproducible assay for routine enumeration of antigen-specific CD8(+) T cells. (c) 2004 Wiley-Liss, Inc.

  5. Postnatal Outcomes of Fetal Supraventricular Tachycardia: a Multicenter Study.

    Science.gov (United States)

    Hinkle, Kevin A; Peyvandi, Shabnam; Stiver, Corey; Killen, Stacy A S; Weng, Hsin Yi; Etheridge, Susan P; Puchalski, Michael D

    2017-10-01

    Supraventricular tachycardia (SVT), the most common fetal tachycardia, can be difficult to manage in utero. We sought to better understand predictors of the postnatal clinical course in neonates who experienced fetal SVT. We hypothesized that fetuses with hydrops or those with refractory SVT (failure of first-line SVT therapy) are more likely to experience postnatal SVT. This was a retrospective multicenter cohort study of subjects diagnosed with fetal SVT between 2006 and 2014. Fetuses with structural heart disease were excluded. Descriptive comparative statistics and univariate analysis with logistic regression were utilized to determine factors that most strongly predicted postnatal SVT and preterm delivery. The cohort consisted of 103 subjects. Refractory SVT was found in 37% (N = 38) of the cohort with this group more likely to be delivered prematurely (median = 36 vs. 37.5 weeks, p = 0.04). Refractory SVT did not increase the risk of postnatal SVT (p = 0.09). Postnatal SVT was seen in 61% (N = 63). Of those, 68% (N = 43) had postnatal SVT at ≤2 days of age. Postnatal SVT was associated with a later fetal SVT diagnosis (median = 30 vs. 27.5 weeks, p = 0.006). We found a strong correlation between postnatal SVT and later gestational age at fetal SVT diagnosis. Subjects with refractory SVT or hydrops did not have a higher risk of postnatal SVT. We propose strong consideration for term delivery in the absence of significant clinical compromise. Further studies to assess whether outcomes vary for preterm delivery versus expectant management in those with refractory SVT should be performed.

  6. Divorce and Severity of Coronary Artery Disease: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Amin Daoulah

    2017-01-01

    Full Text Available The association between marital status and coronary artery disease (CAD is supported by numerous epidemiological studies. While divorce may have an adverse effect on cardiac outcomes, the relationship between divorce and severe CAD is unclear. We conducted a multicenter, observational study of consecutive patients undergoing coronary angiography during the period between April 1, 2013, and March 30, 2014. Of 1,068 patients, 124 (12% were divorced. Divorce was more frequent among women (27% compared to men (6%. Most divorced patients had been divorced only once (49%, but a subset had been divorced 2 (38% or ≥3 (12% times. After adjusting for baseline differences, there was no significant association between divorce and severe CAD in men. In women, there was a significant adjusted association between divorce and severe MVD (OR 2.31 [1.16, 4.59] or LMD (OR 5.91 [2.19, 15.99]. The modification of the association between divorce and severe CAD by gender was statistically significant for severe LMD (Pinteraction 0.0008 and marginally significant for CAD (Pinteraction 0.05. Among women, there was a significant adjusted association between number of divorces and severe CAD (OR 2.4 [95% CI 1.2, 4.5], MVD (OR 2.0 [95% CI 1.4, 3.0], and LMD (OR 3.4 [95% CI 1.9, 5.9]. In conclusion, divorce, particularly multiple divorces, is associated with severe CAD, MVD, and LMD in women but not in men.

  7. NUT carcinoma in children and adults: A multicenter retrospective study.

    Science.gov (United States)

    Lemelle, Lauriane; Pierron, Gaëlle; Fréneaux, Paul; Huybrechts, Sophie; Spiegel, Alexandra; Plantaz, Dominique; Julieron, Morbize; Dumoucel, Sophie; Italiano, Antoine; Millot, Fréderic; Le Tourneau, Christophe; Leverger, Guy; Chastagner, Pascal; Carton, Matthieu; Orbach, Daniel

    2017-12-01

    Nuclear protein of the testis (NUT) carcinoma (formerly NUT midline carcinoma) is an aggressive tumor defined by the presence of NUT rearrangement with a poor prognosis. This rare cancer is underdiagnosed and poorly treated. The primary objective of this study was to describe the clinical, radiologic, and biological features of NUT carcinoma. The secondary objective was to describe the various treatments and assess their efficacy. This retrospective multicenter study was based on review of the medical records of children and adults with NUT carcinoma with specific rearrangement or positive anti-NUT nuclear staining (>50%). This series of 12 patients had a median age of 18.1 years (ranges: 12.3-49.7 years). The primary tumor was located in the chest in eight patients, the head and neck in three patients, and one patient had a multifocal tumor. Nine patients presented regional lymph node involvement and eight distant metastases. One-half of patients were initially misdiagnosed. Specific NUT antibody was positive in all cases tested. A transient response to chemotherapy was observed in four of 11 patients. Only two patients were treated by surgery and five received radiotherapy with curative intent. At the end of follow-up, only one patient was still in remission more than 12 years after the diagnosis. Median overall survival was 4.7 months (95% confidence interval [CI]: 2.1-17.7). NUT carcinoma is an aggressive disease refractory to conventional therapy. Early diagnosis by NUT-specific antibody immunostaining in cases of undifferentiated or poorly differentiated carcinoma to identify the specific rearrangement of NUT gene is useful to propose the optimal therapeutic strategy. © 2017 Wiley Periodicals, Inc.

  8. Burnout Among Otolaryngology Residents in Saudi Arabia: A Multicenter Study.

    Science.gov (United States)

    Aldrees, Turki; Badri, Motasim; Islam, Tahera; Alqahtani, Khalid

    2015-01-01

    Determine the prevalence of, and associated risk factors for, burnout among otolaryngologist residents in Saudi Arabia. A cross-section study of multicenter hospitals in Saudi Arabia conducted in March 2013. Registered residents in Saudi Otolaryngology Board Program. The Maslach Burnout Inventory was used to measure burnout status. Questions supplementary to the Maslach Burnout Inventory were also included to identify associated potential risk factors such as demographic data, resident satisfaction, and work conditions. Of the initial 123 questionnaires that were distributed, 85 yielded responses, a rate of 69%. The mean age (standard deviation [SD]) of respondents was 29 (2.3) years. Of those, 67% (57/85) were men and 66% (55/85) were married. Resident levels were delineated: level 2, 19%; level 3, 33%; level 4, 29%; and level 5, 19%. The mean number of on-call days/month (SD) was 7 (2), clinics/week (SD) was 3 (1), sleep hours/day (SD) was 6 (1), and operations/week (SD) was 2 (1). The mean emotional exhaustion (EE) and depersonalization scores were high at 29.5 (SD = 9.6) and 10.7 (SD = 6), respectively. The mean personal accomplishment was low at 32.33 (SD = 6). The mean of all subscales did not differ by sex (EE p = 0.5; depersonalization p = 0.09; personal accomplishment p = 0.4). Mean EE differed by marital status, which was 31.2, 31.3, and 25.6 for married, divorced, and single, respectively, analysis of variance test p = 0.045. Burnout prevalence was found to be high among otolaryngologist residents in Saudi Arabia. The associated variables examined in this study should be addressed to decrease this level of burnout and provide residents with a less stressful work environment. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  9. Bronchopulmonary infection-colonization patterns in Spanish cystic fibrosis patients: Results from a national multicenter study.

    Science.gov (United States)

    de Dios Caballero, Juan; Del Campo, Rosa; Royuela, Ana; Solé, Amparo; Máiz, Luis; Olveira, Casilda; Quintana-Gallego, Esther; de Gracia, Javier; Cobo, Marta; de la Pedrosa, Elia Gómez G; Oliver, Antonio; Cantón, Rafael

    2016-05-01

    Clinical and demographical knowledge on Spanish cystic fibrosis (CF) patients is incomplete as no national registry exists. CF-microbiology has not been studied at national level. The results of the first Spanish multicenter study on CF microbiology are presented. 24 CF-Units for adult (n=12) and pediatric (n=12) patients from 17 hospitals provided sputa and clinical data from 15 consecutive patients. Cultures and susceptibility testing were performed. Colonization impact on pulmonary function was assessed. 341 patients [mean (SD) age 21 (11) years, 180≥18years, mean (SD) FEV1=68 (25)%] were included. Pseudomonas aeruginosa was reported as chronic, intermittent or absent in 46%, 22% and 32% of patients, respectively. The annual prevalence was 62%. Positive P. aeruginosa and methicillin-resistant Staphylococcus aureus cultures were significantly associated with lower FEV1 (pSpanish CF-population which has been clinically, demographically and microbiologically characterized will serve as a reference for future CF studies in Spain. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  10. Efficiency of a clinical prediction model for selective rapid testing in children with pharyngitis: A prospective, multicenter study

    National Research Council Canada - National Science Library

    Cohen, Jérémie F; Cohen, Robert; Bidet, Philippe; Elbez, Annie; Levy, Corinne; Bossuyt, Patrick M; Chalumeau, Martin

    2017-01-01

    .... Materials and methods In this multicenter, prospective, cross-sectional study, French primary care physicians collected clinical data and double throat swabs from 676 consecutive children with pharyngitis...

  11. Results of cryopreserved parathyroid autografts: a retrospective multicenter study.

    Science.gov (United States)

    Borot, Sophie; Lapierre, Valérie; Carnaille, Bruno; Goudet, Pierre; Penfornis, Alfred

    2010-04-01

    The functionality of cryopreserved parathyroid autotransplantation (CPAT) has been evaluated in few studies, mostly conducted by experienced single-institution centers that have reported different success rates ranging from 17% to 83%. In France, CPAT are rare and their functionality has never been evaluated. Moreover, French tissue banks are facing an accumulation of ungrafted samples. The aim of our work was to evaluate the implantation rate of cryopreserved parathyroid samples and the functionality of CPAT in a multicenter study. Data from 9 French tissue banks were analyzed. CPAT functionality was defined as fully functional (normal parathyroid hormone [PTH] and calcium levels without treatment), partially functional (normal PTH levels but need for treatment to maintain normocalcemia), and nonfunctional (low PTH levels and need for treatment). For dialyzed patients, CPAT was considered nonfunctional if the PTH level in the nongrafted arm was less than 20 pg/mL, partially functional if the PTH level was between 20 and 50 pg/mL, and fully functional if the PTH level was between 50 and 300 pg/mL. The 9 centers had cryopreserved 1376 samples of parathyroid tissue and only 22 (1.6%) had been autografted in 20 patients (65% renal hyperparathyroidism, 20% multiple endocrine neoplasia type 1, 15% "other") by 12 different surgical teams. The median duration of storage was 11.1 months (range, 0.4-28.5). Only 2 autografts (10%) were fully functional, 2 (10%) were partially functional, and 17 (80%) were nonfunctional at 26 months median follow-up. The reimplantation rate is low, and the functionality of CPAT is less than those published by experienced centers. Logistical and technical problems occurring in less experienced centers are probably the main reasons for nonfunctioning implants. Considering the results of this study, we suggest that cryopreservation of parathyroid glands should be abandoned when not performed in very large experimented centers, that CPAT should

  12. European Values Study 1981-2017

    NARCIS (Netherlands)

    Luijkx, A.R.C.M.; Halman, L.C.J.M.

    2017-01-01

    The European Values Study is a large-scale, cross-national, and longitudinal survey research program on basic human values providing insight into the ideas, beliefs, preferences, attitudes, values and opinions of citizens all over Europe. It is a unique research project on how Europeans think about

  13. Acetate-free biofiltration reduces intradialytic hypotension: a European multicenter randomized controlled trial.

    Science.gov (United States)

    Tessitore, Nicola; Santoro, Antonio; Panzetta, Giovanni Oliviero; Wizemann, Volker; Perez-Garcia, Rafael; Martinez Ara, Jorge; Perrone, Bruno; Mantovani, William; Poli, Albino

    2012-01-01

    Intradialytic hypotension (IH) is a common complication of bicarbonate hemodialysis (BD) and contributes to the intolerance of dialysis and the high cardiovascular morbidity and mortality among dialysis patients, the risk of which can be contained by convective therapies. To assess whether acetate-free biofiltration (AFB), a hemodiafiltration technique found to improve intradialytic cardiovascular stability in short-term studies, can influence long-term IH rates, predialysis systolic blood pressure (SBP), cardiovascular morbidity and mortality by comparison with BD, we analyzed data from a randomized controlled trial enrolling 371 new-to-dialysis patients, 194 on BD and 177 on AFB. During a 3-year follow-up, AFB carried a significantly lower risk of IH (incidence rate ratio 0.60 (95% CI 0.53-0.68), p < 0.0001). SBP dropped on AFB (p = 0.01), while it did not change on BD. Cardiovascular morbidity and mortality were similar between AFB and BD. AFB carries a lower long-term IH rate and reduces SBP by comparison with BD. Copyright © 2013 S. Karger AG, Basel.

  14. Ocular adnexal follicular lymphoma: a multicenter international study.

    Science.gov (United States)

    Rasmussen, Peter K; Coupland, Sarah E; Finger, Paul T; Graue, Gerardo F; Grossniklaus, Hans E; Honavar, Santosh G; McKelvie, Penny; Mulay, Kaustubh; Prause, Jan U; Ralfkiaer, Elisabeth; Sjö, Lene D; Heegaard, Steffen

    2014-07-01

    The clinical features of the follicular subtype of ocular adnexal lymphoma (OAL) have not been previously evaluated in a large cohort. To characterize the clinical features of follicular OAL. We performed a retrospective multicenter study that involved 6 eye cancer centers from January 1, 1980, through December 31, 2010. A total of 105 patients with follicular OAL were identified, of which 7 patients were excluded because of missing clinical data. The median follow-up time was 52 months (range, 13-118 months). Overall survival, disease-specific, and progression-free survivals were the primary end points. Ninety-eight eligible patients with follicular OAL were included; 60 (61%) were women. The median patient age was 63 years (range, 32-96 years). Sixty-nine patients (70%) had primary OAL, 19 (19%) had OAL in conjunction with a concurrent systemic lymphoma, and 10 (10%) presented with an ocular adnexal relapse. The lacrimal gland (28%), conjunctiva (28%), and orbit (28%) were the most frequently involved sites. Of the 69 patients with primary follicular lymphoma, 38 (55%) presented with Ann Arbor stage IE lymphoma, and 31 (45%) had stage IIE lymphoma. Patients with disseminated lymphoma had stage IIIE (9 of 19 [47%]) and stage IV (10 of 19 [53%]) disease, whereas patients with a relapse of systemic lymphoma presented with stage IE (8 of 10 [80%]), stage IIE (1 of 10 [10%]), and stage IIIE (1 of 10 [10%]) disease. Patients with primary follicular lymphoma (n = 69) and those with isolated ocular relapse (n = 9) were treated with external beam radiation therapy (EBRT) (35 of 78 [45%]) or EBRT plus chemotherapy (22 of 78 [28%]). Patients presenting with stage IIIE-IV follicular lymphoma (n = 20) most frequently received chemotherapy (9 of 20 [45%]) or EBRT plus chemotherapy (4 of 20 [20%]). The 10-year overall survival for the entire study cohort was 60%. Primary patients treated with EBRT had a better disease-specific survival compared with patients

  15. Minimally invasive flapless implant surgery: a prospective multicenter study.

    Science.gov (United States)

    Becker, William; Goldstein, Moshe; Becker, Burton E; Sennerby, Lars

    2005-01-01

    Placement of implants with a minimally invasive flapless approach has the potential to minimize crestal bone loss, soft tissue inflammation, and probing depth adjacent to implants and to minimize surgical time. The aim of this multicenter study was to evaluate implant placement using a minimally invasive one-stage flapless technique up to 2 years. Fifty-seven patients ranging in age from 24 to 86 years were recruited from three clinical centers (Tucson, AZ, USA; Tel Aviv, Israel; Göteborg, Sweden). Seventy-nine implants were placed. A small, sharp-tipped guiding drill was used to create a precise, minimally invasive initial penetration through the mucosa and into bone (Nobel Biocare, Yorba, Linda, CA, USA). Implants were placed according to the manufacturer's instructions, with minimal countersinking. The parameters evaluated were total surgical time, implant survival, bone quality and quantity, implant position by tooth type, depth from mucosal margin to bone crest, implant length, probing depth, inflammation, and crestal bone changes. At 2 years, for 79 implants placed in 57 patients, the cumulative success rate using a minimally invasive flapless method was 98.7%, indicating the loss of 1 implant. Changes in crestal bone for 77 baseline and follow-up measurements were insignificant (radiograph 1: mean 0.7 mm, SD 0.5 mm, range 2.8 mm, minimum 0.2 mm, maximum 3.0 mm; radiograph 2: mean 0.8 mm, SD 0.5 mm, range 3.4 mm, minimum 0.12 mm, maximum 3.5 mm). Using descriptive statistics for 78 patients (one implant lost), mean changes for probing depth and inflammation were clinically insignificant. The average time for implant placement was 28 minutes (minimum 10 minutes, maximum 60 minutes, SD 13.1 minutes). Average depth from mucosal margin to bone was 3.3 mm ( SD 0.7 mm, minimum 2 mm, maximum 5 mm, range 3 mm). Thirty-two implants were placed in maxillae and 47 in mandibles. The results of this study demonstrate that following diagnostic treatment planning criteria

  16. [Enterococcal endocarditis: a multicenter study of 76 cases].

    Science.gov (United States)

    Martínez-Marcos, Francisco Javier; Lomas-Cabezas, José Manuel; Hidalgo-Tenorio, Carmen; de la Torre-Lima, Javier; Plata-Ciézar, Antonio; Reguera-Iglesias, José María; Ruiz-Morales, Josefa; Márquez-Solero, Manuel; Gálvez-Acebal, Juan; de Alarcón-González, Arístides

    2009-12-01

    Although enterococci occupy the third position among microorganisms producing infectious endocarditis (IE) following streptococci and Staphylococcus aureus, few multicenter studies have provided an in-depth analysis of enterococcal IE. Description of the characteristics of 76 cases of enterococcal left-sided infectious endocarditis (LSIE) (native: 59, prosthetic: 17) retrieved from the database of the Cardiovascular Infections Study Group of the Andalusian Society of Infectious Diseases, with emphasis on the comparison with non-enterococcal LSIE. Enterococci were the causal agent in 76 of the 696 episodes of LSIE (11%). Compared with non-enterococcal LSIE, enterococcal LSIE was more commonly seen in patients older than 65 (47.4% vs. 27.6%, P<0.0005), and those with chronic diseases (75% vs. 54.6%, P<0.001), calcified valves (18.6% vs. 10%, P<0.05), and previous urinary (30.3% vs. 2.1%, P<0.00001) or abdominal (10.5% vs. 3.1%, P<0.01) infections, and produced a higher rate of relapses (6.6% vs. 2.3%, P<0.05). Enterococcal LSIE was associated with fewer peripheral vascular or skin manifestations (14.5% vs. 27.1%, P<0.05) and fewer immunological phenomena (10.5% vs. 24%, P<0.01). Among the total of patients with enterococcal LSIE, 36.8% underwent valve surgery during hospitalization. In-hospital mortality was 32.9% for enterococcal LSIE, 9.3% for viridans group streptococci (VGS) LSIE and 48.6% for S. aureus LSIE (enterococci vs VGS: P<0.0001; enterococci vs S. aureus: P=0.02). Enterococcal LSIE patients treated with the combination of a penicillin or vancomycin plus an aminoglycoside (n=60) and those treated with ampicillin plus ceftriaxone (n=6) showed similar in-hospital mortality (26.7% vs 33.3%, P=0.66). High-level resistance to gentamicin was detected in 5 of 38 episodes of enterococcal LSIE (13.1%). Enterococcal LSIE appears in patients with well-defined clinical characteristics, and causes few peripheral vascular or skin manifestations and few immunological

  17. Aortoiliac reconstruction and kidney transplantation: a multicenter study.

    Science.gov (United States)

    Pittaluga, P; Hassen-Khodja, R; Cassuto-Viguier, E; Batt, M; Declemy, S; Bariseel, H; Toubol, J; Le Bas, P

    1998-11-01

    The occurrence of aortoiliac lesions with renal transplantation is an increasingly common combination that causes problems regarding operative strategy and indications for aortoiliac reconstruction and renal transplantation. To gain greater insight into these problems we undertook a retrospective multicenter study based on data from 24 kidney transplantation centers in France. A total of 83 patients who underwent both aortoiliac reconstruction and kidney transplantation were enrolled. Patients were divided into two groups according to the order in which the two procedures were performed. Group I included 36 patients in whom aortoiliac reconstruction was performed before kidney transplantation-either during the same procedure (6 patients) or as separate procedures (30 patients). Group II included 47 patients in whom aortoiliac reconstruction was performed after kidney transplantation. The mean age was 49.9 years. There were 43 abdominal aortic aneurysms (51.8%), 36 occlusive aortoiliac lesions (43.4%), and 4 aortoiliac dissections (4.8%). Prosthetic bypass grafting was performed in 72 cases (86.8%), transluminal angioplasty in 6 cases (7.2%), endarterectomy in 3 cases (3.6%), and arterial autograft bypass in 1 case. Renal transplant protection was used during aortoiliac clamping in only 3 patients in group II (7.3%). One month after the second procedure (i.e., kidney transplantation in group I and aortoiliac reconstruction in group II), creatinemia was <200 micromol/L in 27 patients (87.1%) in group I and in 37 patients (88.1%) in group II. The graft survival rate was 86.1% in group I and 89.3% in group II. The overall postoperative morbidity rate was 36.1% (13 cases) in group I and 36.1% (17 cases) in group II. One year after the second procedure creatinemia was <200 micromol/L in 29 patients (93.5%) in group I and 36 patients (93%) in group II. The graft survival rate was 86.1% in group I and 85.1% in group II. The outcome of kidney transplantation is comparable

  18. A European multi-center trial investigating the anti-restenotic effect of intravascular sonotherapy after stenting of de novo lesions (EUROSPAH: EUROpean Sonotherapy Prevention of Arterial Hyperplasia).

    Science.gov (United States)

    Serruys, P W; Hoye, A; Grollier, G; Colombo, A; Symons, J; Mudra, H

    2004-01-01

    Intravascular sonotherapy (IST) reduces neointimal hyperplasia post-stenting in animal studies. Euro-SPAH is a multi-center, double blind, randomized trial investigating the efficacy of IST to reduce in-stent late loss. Patients with angina or silent ischaemia with stented de novo lesions were randomised to sham or IST. The sample size had a 90% power to detect a late loss difference of 0.21 mm at 6 months. The secondary endpoints were MACE at 1, 6, 12 months and neo-intimal hyperplasia on IVUS at 6 months. At 23 sites in Europe, 403 patients were randomized, with successful treatment with sham or IST in 95.6%. There were no significant differences between the groups in terms of baseline demographics or lesion characteristics. Angiographic follow-up was obtained in 89%. In-stent late loss was not significantly different. The restenosis rate at 6 months was 23% in the IST group versus 25% in the sham group. The IVUS measurements confirm the absence of effect of IST on neointimal hyperplasia. At one year, the event-free survival did not significantly differ between the two groups. The use of sonotherapy following stent implantation in de novo lesions does not reduce intra-stent neointimal hyperplasia, or effect the angiographic restenosis rate compared to sham treatment.

  19. Enumeration of antigen-specific CD8+ T lymphocytes by single-platform, HLA tetramer-based flow cytometry: a European multicenter evaluation.

    NARCIS (Netherlands)

    Heijnen, I.; Barnett, D.; Arroz, M.J.; Barry, S.M.; Bonneville, M.; Brando, B.; D'Hautcourt, J.L.; Kern, F.; Totterman, T.H.; Marijt, E.W.; Bossy, D.; Preijers, F.W.M.B.; Rothe, G.; Gratama, J.W.

    2004-01-01

    BACKGROUND: HLA class I peptide tetramers represent powerful diagnostic tools for detection and monitoring of antigen-specific CD8(+) T cells. The impetus for the current multicenter study is the critical need to standardize tetramer flow cytometry if it is to be implemented as a routine diagnostic

  20. Use of maraviroc in clinical practice: a multicenter observational study

    Directory of Open Access Journals (Sweden)

    C Dentone

    2012-11-01

    Full Text Available Purpose of the study: Promising research suggest that maraviroc (MVC has favourable clinical outcome in HIV-infected patients (pts. Aim of the study is to assess: durability, safety profile and immunovirological recovery in a large MVC-based cohort. Methods: All HIV pts treated with antiretroviral therapy (ART containing MVC for at least 6 months (all viruses CCR-5 tropic analyzed by genotypic and phenotypic test were recruited in an observational multicenter study. Eight Infectious Diseases Centers in Liguria and Piedmont (Italy collected at baseline and every 3 months demographics, clinical and immunovirological data on a web-based system (by MedinfoDist, University of Genoa. We used SPSS for Pearson Chi square test and for generalized estimating equation (GEE; in this model for longitudinal data and frequency analysis we considered altered: TCD4+≤350/mmc, HIVRNA>50 cp/ml, total cholesterol >200 mg/dl, triglycerides >160 mg/dl, transaminase>40 mg/dl, creatinine>1.3 mg/dl and we divided data in 5 time periods: baseline, 1–6, 9–12, 15–24 and 24–45 months. Summary of results: We enrolled 55 pts: 36 (65% males, median age 49.6 years (yrs (range [r] 18.2–76.6, IQR 44.5–53.3, 11 (20% HCVRNA-positive, 4 (7% HBsAg-positive, 1 both infection. Twenty-four (44% pts were classified as CDC C stage, median nadir TCD4+ was 219/mmc (r 11-529, IQR 125–317, median duration of ART was 15.3 yrs (r 1.3–27.3, IQR 12–16.8, median duration of treatment with MVC was 23 months (r 6–47, IQR 14–36. At baseline 42 (76% pts had HIVRNA >50 cp/ml, 11 (20% HIVRNA≤50 cp/ml, 2 (4% pts no data; on treatment at the last examination 53 pts (96% had HIVRNA≤50 cp/ml, 2 pts still had HIVRNA>50 cp/ml (CCR5 tropic and median TCD4+ count was 469/mmc (r 73–1802, IQR 302–592. One pt died and only 2 pts shifted to X4. Chi square test at 9–12 months showed p=0.0001 and the 80% of pts had TCD4+>350/mmc; at the same observation time 83.3% of pts had HIVRNA

  1. Conjunctival Lymphoma--An International Multicenter Retrospective Study.

    Science.gov (United States)

    Kirkegaard, Marina M; Rasmussen, Peter K; Coupland, Sarah E; Esmaeli, Bita; Finger, Paul T; Graue, Gerardo F; Grossniklaus, Hans E; Honavar, Santosh G; Khong, Jwu J; McKelvie, Penny A; Mulay, Kaustubh; Prause, Jan U; Ralfkiaer, Elisabeth; Sjö, Lene D; Toft, Peter B; Vemuganti, Geeta K; Thuro, Bradley A; Curtin, Jeremy; Heegaard, Steffen

    2016-04-01

    To date, the clinical features of the various subtypes of conjunctival lymphoma (CL) have not been previously evaluated in a large cohort. To characterize subtype-specific clinical features of CL and their effect on patient outcome. A retrospective multicenter study was performed. Patient data were collected from January 1, 1980, through December 31, 2010. The dates of the analysis were May 15, 2015, to August 20, 2015. The median follow-up period was 43 months. Seven eye cancer centers were involved in the study. In total, 268 patients with CL were identified, 5 of whom were excluded because of missing clinical data. Overall survival, disease-specific survival, and progression-free survival were the primary end points. Two hundred sixty-three patients with CL were included in the study. Their mean age was 61.3 years, and 55.1% (145 of 263) were female. All lymphomas were of B-cell type. The most frequent subtype was extranodal marginal zone lymphoma (EMZL) (68.4% [180 of 263]), followed by follicular lymphoma (FL) (16.3% [43 of 263]), mantle cell lymphoma (MCL) (6.8% [18 of 263]), and diffuse large B-cell lymphoma (DLBCL) (4.6% [12 of 263). Conjunctival lymphoma commonly manifested in elderly individuals (age range, 60-70 years old), with EMZL having a female predilection (57.8% [104 of 180]) and MCL having a marked male predominance (77.8% [14 of 18]). Unlike EMZL and FL, DLBCL and MCL were frequently secondary diseases (41.7% [5 of 12] and 88.9% [16 of 18], respectively), with MCL showing a frequent occurrence of stage IVE lymphoma (61.1% [11 of 18]) and bilateral manifestation (77.8% [14 of 18]). Localized disease (stage IE or IIE) was commonly treated with external beam radiation therapy (EBRT) with or without chemotherapy, while widespread lymphoma (stage IIIE or IVE) and MCL of any stage were managed with chemotherapy with or without EBRT. Diffuse large B-cell lymphoma and MCL had a poor prognosis, with 5-year disease-specific survival of 55.0% and 9

  2. Performance of Ultrasound in the Diagnosis of Gout in a Multi-Center Study

    DEFF Research Database (Denmark)

    Ogdie, Alexis; Taylor, William J; Neogi, Tuhina

    2017-01-01

    OBJECTIVES: To examine the performance of ultrasound for the diagnosis of gout using presence of monosodium urate (MSU) crystals as the gold standard. METHODS: We analyzed data from the Study for Updated Gout Classification Criteria (SUGAR), a large, multi-center observational cross-sectional study...

  3. Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

    LENUS (Irish Health Repository)

    Unterscheider, Julia

    2013-04-01

    The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

  4. Simplified Therapeutic Intervention Scoring System : The TISS-28 items - Results from a multicenter study

    NARCIS (Netherlands)

    Miranda, DR; deRijk, A; Schaufeli, W

    Objectives: To validate a simplified version of the Therapeutic Intervention Scoring System, the TISS-28, and to determine the association of TISS-28 with the time spent on scored and nonscored nursing activities. Design: Prospective, multicenter study. Setting: Twenty-two adult medical, surgical,

  5. Long-term results of a multicenter study on subthalamic and pallidal stimulation in Parkinson's disease

    NARCIS (Netherlands)

    Moro, Elena; Lozano, Andres M.; Pollak, Pierre; Agid, Yves; Rehncrona, Stig; Volkmann, Jens; Kulisevsky, Jaime; Obeso, Jose A.; Albanese, Alberto; Hariz, Marwan I.; Quinn, Niall P.; Speelman, Jans D.; Benabid, Alim L.; Fraix, Valerie; Mendes, Alexandre; Welter, Marie-Laure; Houeto, Jean-Luc; Cornu, Philippe; Dormont, Didier; Tornqvist, Annalena L.; Ekberg, Ron; Schnitzler, Alfons; Timmermann, Lars; Wojtecki, Lars; Gironell, Andres; Rodriguez-Oroz, Maria C.; Guridi, Jorge; Bentivoglio, Anna R.; Contarino, Maria F.; Romito, Luigi; Scerrati, Massimo; Janssens, Marc; Lang, Anthony E.

    2010-01-01

    We report the 5 to 6 year follow-up of a multicenter study of bilateral subthalamic nucleus (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) in advanced Parkinson's disease (PD) patients. Thirty-five STN patients and 16 GPi patients were assessed at 5 to 6 years after DBS

  6. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  7. Predicting progression in primary progressive multiple sclerosis: a 10-year multicenter study

    NARCIS (Netherlands)

    Khaleeli, Z.; Ciccarelli, O.; Manfredonia, F.; Barkhof, F.; Brochet, B.; Cercignani, M.; Dousset, V.; Filippi, M.; Montalban, X.; Polman, C.H.; Rovaris, M.; Rovira, A.; Sastre-Garriga, J.; Vellinga, M.M.; Miller, D.; Thompson, A.

    2008-01-01

    Rates of progression vary widely in primary progressive multiple sclerosis. This multicenter study aimed to identify predictors of progression over 10 years. A total of 101 patients who had been imaged at baseline and 2 years were scored on the expanded disability status scale after 10 years.

  8. LDL oxidative modification and carotid atherosclerosis : Results of a multicenter study

    NARCIS (Netherlands)

    Nyyssonen, K.; Kurl, S.; Karppi, J.; Nurmi, T.; Baldassarre, D.; Veglia, F.; Rauramaa, R.; de Faire, U.; Hamsten, A.; Smit, A. J.; Mannarino, E.; Humphries, S. E.; Giral, P.; Grossi, E.; Tremoli, E.

    2012-01-01

    Objective: Serum LDL conjugated diene concentration is a marker of oxidative modification of LDL. We investigated the relationship between LDL conjugated dienes and cross-sectional subclinical atherosclerosis assessed by carotid IMT in high-risk subjects of a multicenter study. Methods: Serum LDL

  9. Multicenter, randomized, placebo-controlled phase III study of pyridoxalated hemoglobin polyoxyethylene in distributive shock (PHOENIX).

    Science.gov (United States)

    Vincent, Jean-Louis; Privalle, Christopher T; Singer, Mervyn; Lorente, José A; Boehm, Erwin; Meier-Hellmann, Andreas; Darius, Harald; Ferrer, Ricard; Sirvent, Josep-Maria; Marx, Gernot; DeAngelo, Joseph

    2015-01-01

    To compare the effectiveness and safety of the hemoglobin-based nitric oxide scavenger, pyridoxalated hemoglobin polyoxyethylene, against placebo in patients with vasopressor-dependent distributive shock. Multicenter, randomized, placebo-controlled, open-label study. Sixty-one participating ICUs in six European countries (Austria, Belgium, Germany, the Netherlands, Spain, and United Kingdom). All patients admitted with distributive shock, defined as the presence of at least two systemic inflammatory response syndrome criteria, persisting norepinephrine dependence and evidence of organ dysfunction/hypoperfusion despite adequate fluid resuscitation. Patients were randomized to receive 0.25 mL/kg/hr pyridoxalated hemoglobin polyoxyethylene (20 mg Hb/kg/hr) or an equal volume of placebo, infused for up to 150 hours, in addition to conventional vasopressor therapy. The study was stopped after interim analysis showed higher mortality in the pyridoxalated hemoglobin polyoxyethylene group and an increased prevalence of adverse events. At this time, 377 patients had been randomized to pyridoxalated hemoglobin polyoxyethylene (n = 183) or placebo (n = 194). Age, gender, type of patient (medical/surgical), and Acute Physiology and Chronic Health Evaluation II scores were similar between groups. Twenty-eight-day mortality rate was 44.3% in the pyridoxalated hemoglobin polyoxyethylene group versus 37.6% in the placebo group (OR, 1.29; 95% CI, 0.85-1.95; p = 0.227). In patients with higher organ dysfunction scores (Sepsis-related Organ Failure Assessment > 13), mortality rates were significantly higher in the pyridoxalated hemoglobin polyoxyethylene group when compared with those in placebo-treated patients (60.9% vs 39.2%; p = 0.014). Survivors who received pyridoxalated hemoglobin polyoxyethylene had a longer vasopressor-free time (21.3 vs 19.7 d; p = 0.035). In this randomized, controlled phase III trial in patients with vasopressor-dependent distributive shock

  10. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus: The DALI Lifestyle Pilot.

    Science.gov (United States)

    Simmons, David; Jelsma, Judith G M; Galjaard, Sander; Devlieger, Roland; van Assche, Andre; Jans, Goele; Corcoy, Rosa; Adelantado, Juan M; Dunne, Fidelma; Desoye, Gernot; Harreiter, Jürgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Lise Lotte; Lapolla, Annunziata; Dalfra, Maria; Bertolotto, Alessandra; Wender-Ozegowska, Ewa; Zawiejska, Agnieszka; Hill, David; Rebollo, Pablo; Snoek, Frank J; van Poppel, Mireille N M

    2015-09-01

    Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. Pregnant women at risk for GDM (BMI ≥29 kg/m2) from nine European countries were invited to undertake a 75-g oral glucose tolerance test before 20 weeks' gestation. Those without GDM were randomized to HE, PA, or HE+PA. Women received five face-to-face and four optional telephone coaching sessions, based on the principles of motivational interviewing. A gestational weight gain (GWG) Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  11. Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

    Directory of Open Access Journals (Sweden)

    Concetta Dagostino

    Full Text Available Chronic low back pain (CLBP is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on the Global Burden of Disease 2010 study. Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine. Multicentre studies are needed for such an effort, and a standardized and homogeneous approach is vital for recruitment of large numbers of participants among different centres (clinical and laboratories to obtain robust and reproducible results. To date, no validated standard operating procedures (SOPs for genetic/-omics studies in chronic pain have been developed. In this study, we validated an SOP model that will be used in the multicentre (5 centres retrospective "PainOmics" study, funded by the European Community in the 7th Framework Programme, which aims to develop new biomarkers for CLBP through three different -omics approaches: genomics, glycomics and activomics. The SOPs describe the specific procedures for (1 blood collection, (2 sample processing and storage, (3 shipping details and (4 cross-check testing and validation before assays that all the centres involved in the study have to follow. Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses. The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.

  12. Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain

    Science.gov (United States)

    De Gregori, Manuela; Gieger, Christian; Manz, Judith; Gudelj, Ivan; Lauc, Gordan; Divizia, Laura; Wang, Wei; Sim, Moira; Pemberton, Iain K.; MacDougall, Jane; Williams, Frances; Van Zundert, Jan; Primorac, Dragan; Aulchenko, Yurii; Kapural, Leonardo; Allegri, Massimo

    2017-01-01

    Chronic low back pain (CLBP) is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on the Global Burden of Disease 2010 study. Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine). Multicentre studies are needed for such an effort, and a standardized and homogeneous approach is vital for recruitment of large numbers of participants among different centres (clinical and laboratories) to obtain robust and reproducible results. To date, no validated standard operating procedures (SOPs) for genetic/-omics studies in chronic pain have been developed. In this study, we validated an SOP model that will be used in the multicentre (5 centres) retrospective “PainOmics” study, funded by the European Community in the 7th Framework Programme, which aims to develop new biomarkers for CLBP through three different -omics approaches: genomics, glycomics and activomics. The SOPs describe the specific procedures for (1) blood collection, (2) sample processing and storage, (3) shipping details and (4) cross-check testing and validation before assays that all the centres involved in the study have to follow. Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses. The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies. PMID:28459826

  13. Crossroads in European Union Studies

    DEFF Research Database (Denmark)

    Lynggaard, Kennet; Löfgren, Karl; Manners, Ian James

    2015-01-01

    Over the past two decades the educational practices within EU studies have been challenged by the lack of comprehensive texts on research strategy, design and method useful for study programmes. Since the ‘comparative turn’ of the 1990s, where we saw a shift towards applying theories, analytical ...

  14. Intellectual development of childhood ALL patients: a multicenter longitudinal study.

    Science.gov (United States)

    Sleurs, Charlotte; Lemiere, Jurgen; Vercruysse, Trui; Nolf, Nathalie; Van Calster, Ben; Deprez, Sabine; Renard, Marleen; Vandecruys, Els; Benoit, Yves; Uyttebroeck, Anne

    2017-04-01

    In childhood acute lymphoblastic leukemia (ALL), radiotherapy for CNS prophylaxis is not used in frontline therapy anymore. Standard treatment for ALL nowadays consists of polychemotherapy. Therefore, assessment of potential chemotherapy-induced cognitive side effects becomes important. Although neurotoxicity was demonstrated in cross-sectional studies, longitudinal studies remain scarce. We evaluated intellectual development of 94 pediatric ALL patients between 1990 and 1997, diagnosed before the age of 12 years, treated according to the European Organisation for Research and Treatment of Cancer Children's Leukemia Group 58881 protocol. Three assessments of the Wechsler Intelligence Scale for Children Revised were performed since diagnosis, according to age. Using repeated measures regression analysis, we investigated the effect of gender (low versus increased) risk group, parents' education, age at diagnosis, intelligence quotient (IQ) subscale (verbal (VIQ) versus performance (PIQ) intelligence), and test session. PIQ scores were lower than VIQ at baseline (-5.3 points on average, p = 0.0032), yet PIQ increased more strongly (PIQ: +3.9 points per test session; VIQ: +0.8, p = 0.0079), so this baseline difference disappeared (p = 0.0079). There were no clear effects of gender (girls: +0.6 points; p = 0.78) or risk group (low risk: +1.5 points; p = 0.49), but IQ scores were higher when one parent had followed higher education (+9.5 points, p < 0.0001). Finally, diagnosis at younger age predicted lower IQ scores (-1.3 points per year, p = 0.0009). Given that IQ scores did not decline, our findings demonstrate a stable pattern. However, the lower PIQ scores at baseline may indicate that performance functioning is vulnerable to acute neurotoxicity. Also, lower scores for younger patients highlight the stronger impact of the disease and/or treatment at younger age.Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons

  15. Multi-center comparison of medial temporal atrophy in patients with Alzheimer's disease--data from the ICTUS study.

    Science.gov (United States)

    Galluzzi, Samantha; Talassi, Erika; Belussi, Michela; Scheltens, Philip; van de Pol, Laura; Nobili, Flavio; Rodriguez, Guido; Froelich, Lutz; Damian, Marinella; Martinez-Lage, Pablo; Gomez-Isla, Teresa; Reynish, Emma; Ousset, Pierre Jean; Vellas, Bruno; Frisoni, Giovanni B

    2008-01-01

    To study multi-center variability of medial temporal lobe atrophy (MTA) in patients with Alzheimer's disease (AD) recruited in a European observational study of AD. 117 mild to moderate AD patients from 5 European centers (Amsterdam, The Netherlands; Brescia and Genova, Italy; Mannheim, Germany; Pamplona, Spain) had magnetic resonance imaging scans performed as part of the routine diagnostic examination. MTA was assessed with the visual Scheltens scale. AD patients from Brescia, Genova, Pamplona, and Mannheim had a mean 32% prevalence of no or borderline MTA vs. 62% of patients from Amsterdam (p = 0.002 for the difference between Amsterdam and all the other centers). The peculiar distribution of MTA in the Amsterdam patients may be attributable to younger age (70.7 +/- 8.4 vs. 75.3 +/- 6.8 years, p = 0.002), milder dementia severity (score 0.5 on the clinical dementia rating scale: 52 vs. 23%, p = 0.003), and less frequent depression (14 vs. 49%, p < 0.0005 in Amsterdam vs. all the other centers, respectively). Patients with probable AD recruited in different centers of Europe generally have similar MTA distribution, even if peculiar demographic and clinical findings might explain occasional differences. These results have implications for clinical trials in AD with biological markers as outcome measures. Copyright 2008 S. Karger AG, Basel.

  16. Epidemiology and outcomes of acute respiratory distress syndrome in children according to the Berlin definition: a multicenter prospective study.

    Science.gov (United States)

    Barreira, Eliane R; Munoz, Gabriela O C; Cavalheiro, Priscilla O; Suzuki, Adriana S; Degaspare, Natalia V; Shieh, Huei H; Martines, João A D S; Ferreira, Juliana C; Lane, Christianne; Carvalho, Werther B; Gilio, Alfredo E; Precioso, Alexander R

    2015-05-01

    In 2012, a new acute respiratory distress syndrome definition was proposed for adult patients. It was later validated for infants and toddlers. Our objective was to evaluate the prevalence, outcomes, and risk factors associated with acute respiratory distress syndrome in children up to 15 years according to the Berlin definition. A prospective, multicenter observational study from March to September 2013. Seventy-seven PICU beds in eight centers: two private hospitals and six public academic hospitals in Brazil. All children aged 1 month to 15 years admitted to the participating PICUs in the study period. None. All children admitted to the PICUs were daily evaluated for the presence of acute respiratory distress syndrome according to the American-European Consensus Conference and Berlin definitions. Of the 562 patients included, acute respiratory distress syndrome developed in 57 patients (10%) and 58 patients (10.3%) according to the Berlin definition and the American-European Consensus Conference definition, respectively. Among patients with acute respiratory distress syndrome according to the Berlin definition, nine patients (16%) were mild, 21 (37%) were moderate, and 27 (47%) were severe. Compared with patients without acute respiratory distress syndrome, patients with acute respiratory distress syndrome had significantly higher severity scores, longer PICU and hospital length of stay, longer duration of mechanical ventilation, and higher mortality (p definition can identify a subgroup of patients with distinctly worse outcomes, as shown by the increased mortality and reduced number of ventilator-free days in pediatric patients with severe acute respiratory distress syndrome.

  17. Intracluster correlation coefficients for the Brazilian Multicenter Study on Preterm Birth (EMIP): methodological and practical implications

    Science.gov (United States)

    2014-01-01

    Background Cluster-based studies in health research are increasing. An important characteristic of such studies is the presence of intracluster correlation, typically quantified by the intracluster correlation coefficient (ICC), that indicate the proportion of data variability that is explained by the way of clustering. The purpose of this manuscript was to evaluate ICC of variables studied in the Brazilian Multicenter Study on Preterm Birth. Methods This was a multicenter cross-sectional study on preterm births involving 20 referral hospitals in different regions of Brazil plus a nested case–control study to assess associated factors with spontaneous preterm births. Estimated prevalence rates or means, ICC with 95% confidence intervals, design effects and mean cluster sizes were presented for more than 250 maternal and newborn variables. Results Overall, 5296 cases were included in the study (4,150 preterm births and 1,146 term births). ICC ranged from 0.3 was found in some clinical management aspects well defined in literature such as use of corticosteroids, indicating there was homogeneity in clusters for these variables. Conclusions Clusters selected for Brazilian Multicenter Study on Preterm Birth had mainly heterogeneous findings and these results can help researchers estimate the required sample size for future studies on maternal and perinatal health. PMID:24755392

  18. The reliability of echocardiographic left ventricular wall motion index to identify high-risk patients for multicenter studies

    DEFF Research Database (Denmark)

    Gislason, Gunnar H; Gadsbøll, Niels; Quinones, Miguel A

    2006-01-01

    OBJECTIVE: To study whether the use of echocardiographic left ventricular (LV) wall motion index (WMI) is a dependable parameter for identifying patients with LV dysfunction to be enrolled in multicenter trials. METHODS: Videotaped echocardiographic examinations from 200 randomly selected patient...

  19. Small-bowel capsule endoscopy with panoramic view: results of the first multicenter, observational study (with videos).

    Science.gov (United States)

    Tontini, Gian Eugenio; Wiedbrauck, Felix; Cavallaro, Flaminia; Koulaouzidis, Anastasios; Marino, Roberta; Pastorelli, Luca; Spina, Luisa; McAlindon, Mark E; Leoni, Piera; Vitagliano, Pasquale; Cadoni, Sergio; Rondonotti, Emanuele; Vecchi, Maurizio

    2017-02-01

    The first small-bowel video-capsule endoscopy (VCE) with 360° panoramic view has been developed recently. This new capsule has wire-free technology, 4 high-frame-rate cameras, and a long-lasting battery life. The aim of the present study was to assess the performance and safety profile of the 360° panoramic-view capsule in a large series of patients from a multicenter clinical practice setting. Consecutive patients undergoing a 360° panoramic-view capsule procedure in 7 European Institutions between January 2011 and November 2015 were included. Both technical (ie, technical failures, completion rate) and clinical (ie, indication, findings, retention rate) data were collected by means of a structured questionnaire. VCE findings were classified according to the likelihood of explaining the reason for referral: P0, low; P1, intermediate; P2, high. Of the 172 patients (94 men; median age, 68 years; interquartile range, 53-75), 142 underwent VCE for obscure (32 overt, 110 occult) GI bleeding (OGIB), and 28 for suspected (17) or established (2) Crohn's disease (CD). Overall, 560 findings were detected; 252 were classified as P2. The overall diagnostic yield was 40.1%; 42.2% and 30.0% in patients with OGIB and CD, respectively. The rate of complete enteroscopy was 90.2%. All patients but one, who experienced capsule retention (1/172, 0.6%), excreted and retrieved the capsule. VCE failure occurred in 4 of 172 (2.3%) patients because of technical problems. This multicenter study, conducted in the clinical practice setting and based on a large consecutive series of patients, showed that the diagnostic yield and safety profile of the 360° panoramic-view capsule are similar to those of forward-view VCEs. Copyright © 2017 American Society for Gastrointestinal Endoscopy. All rights reserved.

  20. Continuous versus Intermittent Infusion of Vancomycin in Severe Staphylococcal Infections: Prospective Multicenter Randomized Study

    OpenAIRE

    Wysocki, Marc; Delatour, Frederique; Faurisson, François; Rauss, Alain; Pean, Yves; Misset, Benoit; Thomas, Frank; Timsit, Jean-François; Similowski, Thomas; Mentec, Herve; Mier, Laurence; Dreyfuss, Didier

    2001-01-01

    A continuous infusion of vancomycin (CIV) may provide an alternative mode of infusion in severe hospital-acquired methicillin-resistant staphylococcal (MRS) infections. A multicenter, prospective, randomized study was designed to compare CIV (targeted plateau drug serum concentrations of 20 to 25 mg/liter) and intermittent infusions of vancomycin (IIV; targeted trough drug serum concentrations of 10 to 15 mg/liter) in 119 critically ill patients with MRS infections (bacteremic infections, 35%...

  1. An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence

    DEFF Research Database (Denmark)

    Lose, Gunnar; Sørensen, Helle Christina; Axelsen, Susanne Maigaard

    2010-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence.......Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence....

  2. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - a multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Tabor, Ann

    The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC).......The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC)....

  3. LORIS: A web-based data management system for multi-center studies.

    Directory of Open Access Journals (Sweden)

    Samir eDas

    2012-01-01

    Full Text Available LORIS (Longitudinal Online Research and Imaging System is a modular and extensible web-based data management system that integrates all aspects of a multi-center study: from heterogeneous data acquisition (imaging, clinical, behavior, genetics to storage, processing and ultimately dissemination. It provides a secure, user-friendly, and streamlined platform to automate the flow of clinical trials and complex multi-center studies. A subject-centric internal organization allows researchers to capture and subsequently extract all information, longitudinal or cross-sectional, from any subset of the study cohort. Extensive error-checking and quality control procedures, security, data management, data querying and administrative functions provide LORIS with a triple capability (i continuous project coordination and monitoring of data acquisition (ii data storage/cleaning/querying, (iii interface with arbitrary external data processing pipelines. LORIS is a complete solution that has been thoroughly tested through the full life cycle of a multi-center longitudinal project# and is now supporting numerous neurodevelopment and neurodegeneration research projects internationally.

  4. OnWARD: ontology-driven web-based framework for multi-center clinical studies.

    Science.gov (United States)

    Tran, Van-Anh; Johnson, Nathan; Redline, Susan; Zhang, Guo-Qiang

    2011-12-01

    With a large percentage of clinical trials still using paper forms as the primary data collection tool, there is much potential for increasing efficiency through web-based data collection systems, especially for large-scale multi-center trials. This paper presents OnWARD, an ontology-driven, secure, rapidly-deployed, web-based framework supporting data capture for large-scale multi-center clinical research. Our approach is developed using the agile methodology to provide a flexible, user-centered dynamic form generator, which can be quickly deployed and customized for any clinical study without the need of deep technical expertise. Because of the flexible framework, the data management system can be extended to accommodate a large variety of data types, including genetic, genomic and proteomic data. In this paper, we demonstrate the initial deployment of OnWARD for a Phase II multi-center clinical trial after a development period of merely three months. The study utilizes 23 clinical report forms containing more than 1500 data points. Preliminary evaluation results show that OnWARD exceeded expectations of the clinical investigators in efficiency, flexibility and ease in setting up. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. Efficacy and safety of bilastine in Japanese patients with chronic spontaneous urticaria: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II/III study

    OpenAIRE

    Michihiro Hide; Akiko Yagami; Michinori Togawa; Akihiro Saito; Masutaka Furue

    2017-01-01

    Background: Bilastine, a novel non-sedating second-generation H1-antihistamine, has been widely used in the treatment of allergic rhinoconjunctivitis and urticaria with a recommended dose of 20 mg once daily in most European countries since 2010. We evaluated its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU). Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled phase II/III study (trial registration No. JapicCTI-142574). Pati...

  6. Video-game epilepsy: a European study.

    OpenAIRE

    KASTELEIJN‐NOLST TRENITÉ, D.G.; Da Silva, A. M.; Ricci, S; Binnie, C D; Rubboli, G; Tassinari, C A; SEGERS, J.P.

    1999-01-01

    Epilepsia. 1999;40 Suppl 4:70-4. Video-game epilepsy: a European study. Kasteleijn-Nolst Trenité DG, da Silva AM, Ricci S, Binnie CD, Rubboli G, Tassinari CA, Segers JP. Stichting Epilepsie Instellingen Nederland, Heemstede, The Netherlands. Abstract With the introduction of Nintendo video-games on a large scale, reports of children having seizures while playing suggested a possible specific, provocative factor. Although 50% of the photosensitive patients are al...

  7. Evaluation of 5-year-old children with complete cleft lip and palate: Multicenter study. Part 2: Functional results.

    Science.gov (United States)

    Dissaux, Caroline; Grollemund, Bruno; Bodin, Frédéric; Picard, Arnaud; Vazquez, Marie-Paule; Morand, Béatrice; James, Isabelle; Kauffmann, Isabelle; Bruant-Rodier, Catherine

    2016-02-01

    Cleft surgery is marked by all the controversies and the multiplication of protocols, as it has been shown by the Eurocleft study. The objective of this pilot study is to start a comparison and analyzing procedure between primary surgical protocols in French centers. Four French centers with different primary surgical protocols for cleft lip and palate repair, have accepted to be involved in this retrospective study. In each center, 20 consecutive patients with complete cleft lip and palate (10 UCLP, 10 BCLP per center), non syndromic, have been evaluated at a mean age of 5 [range, 4-6]. In this second part, maxillary growth and palatine morphology were assessed on clinical examination and on dental casts (Goslon score). Speech was also evaluated clinically (Borel-maisonny classification) and by Aerophonoscope. Veau-Wardill-Killner palatoplasty involves a higher rate of transversal maxillary deficiency and retromaxillary. The fistula rate is statistically lower with tibial periosteum graft hard palate closure but this technique seems to give retromaxillary. Malek and Talmant two-stage-palatoplasty techniques reach Goslon scores of 1 or 2. Considering speech, Sommerlad intravelar veloplasty got higher outcomes. Primary results. Extension to other centers required. The two-stage palatoplasty, including a Sommerlad intravelar veloplasty seems to have the less negative impact on maxillary growth, and to give good speech outcomes. Therapeutic study. Level III/retrospective multicenter comparative study. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  8. Standardization and performance evaluation of mononuclear cell cytokine secretion assays in a multicenter study

    Directory of Open Access Journals (Sweden)

    Grindle Kristine

    2006-12-01

    Full Text Available Abstract Background Cryopreservation of peripheral blood mononuclear cells has been used to preserve and standardize immunologic measurements for multicenter studies, however, effects of cryopreservation on cytokine responses are incompletely understood. In designing immunologic studies for a new multicenter birth cohort study of childhood asthma, we performed a series of experiments to determine the effects of two different methods of cryopreservation on the cytokine responses of cord and peripheral blood mononuclear cells. Results Paired samples of PBMC were processed freshly, or after cryopreservation in a Nalgene container (NC or a controlled-rate freezer (CRF. Although there were some differences between the methods, cryopreservation inhibited PHA-induced IL-10 secretion and Der f 1-induced IL-2 secretion, and augmented PHA-induced IL-2 secretion and spontaneous secretion of TNF-α. In separate experiments, NC cryopreservation inhibited secretion of several cytokines (IL-13, IL-10, IFN-γ, TNF-α by PHA-stimulated cord blood mononuclear cells. With the exception of PHA-induced IL-13, results from fresh and cryopreserved cord blood samples were not significantly correlated. Finally, in reproducibility studies involving processing of identical cell samples in up to 4 separate laboratories, variances in cytokine responses of fresh cells stimulated at separate sites did not exceed those in cryopreserved cells stimulated at a central site. Conclusion Collectively, these studies indicate that cryopreservation can affect mononuclear cell cytokine response profiles, and that IL-10 secretion and antigen-induced responses may be especially vulnerable. These studies also demonstrate that mononuclear cell responses can be standardized for performance in a small number of laboratories for multicenter studies, and underscore the importance of measuring reproducibility and of testing whether cryopreservation techniques alter specific immunologic outcomes.

  9. Open, multicenter study to evaluate the tolerability and efficacy of Echinaforce Forte tablets in athletes.

    Science.gov (United States)

    Schoop, Ronald; Büechi, Samuel; Suter, Andy

    2006-01-01

    This open, multicenter study investigated the tolerability and efficacy of a new tablet formulation of Echinacea purpurea extract (Echinaforce Forte; A. Vogel, Bioforce AG, Roggwil, Switzerland) in 80 subjects actively involved in sports. Most investigators (97.5%) rated the treatment as having "very good" or "good" tolerability. About 75% of patients and investigators rated its efficacy during a common cold as "very good" or "good," and 71% of subjects were free of cold episodes. This study is the first to suggest that Echinaforce is effective in the prophylaxis, as well as the treatment, of the common cold in persons who actively participate in sports.

  10. Candidacy for Bilateral Hearing Aids: A Retrospective Multicenter Study

    NARCIS (Netherlands)

    Boymans, M.; Goverts, S.T.; Kramer, S.E.; Festen, J.M.; Dreschler, W.A.

    2009-01-01

    Purpose: The goal of this study was to find factors for refining candidacy criteria for bilateral hearing aid fittings. Clinical files of 1,000 consecutive hearing aid fittings were analyzed. Method: Case history, audiometric, and rehabilitation data were collected from clinical files, and an

  11. Oral cancer in the UAE: a multicenter, retrospective study

    African Journals Online (AJOL)

    2013-08-27

    Aug 27, 2013 ... 23. Note: OSCC, oral squamous cell carcinoma. Table 2. Distribution of the various histopathological diagnosis of malignant lesions in the UAE for the studied time periods. Diagnosis. Frequency. Percentage of malignant tumors (%). Malignant neoplasms of epithelial origin. Squamous cell carcinoma. 103.

  12. Geriatric rehabilitation of lower limb amputees : a multicenter study

    NARCIS (Netherlands)

    Eijk, Monica Spruit-van; van der Linde, Harmen; Buijck, Bianca I; Zuidema, Sytse U; Koopmans, Raymond T C M

    2012-01-01

    PURPOSE: The aim of this study was to determine factors independently associated with successful rehabilitation of patients with lower limb amputation in skilled nursing facilities (SNFs). METHODS: All patients admitted to one of the 11 participating SNFs were eligible. Multidisciplinary teams

  13. Serious gaming and voluntary laparoscopic skills training: a multicenter study

    NARCIS (Netherlands)

    Verdaasdonk, E. G. G.; Dankelman, J.; Schijven, M. P.; Lange, J. F.; Wentink, M.; Stassen, L. P. S.

    2009-01-01

    This study assesses the issue of voluntary training of a standardized online competition (serious gaming) between surgical residents. Surgical residents were invited to join a competition on a virtual reality (VR) simulator for laparoscopic motor skills. A final score was calculated based on the

  14. Serious gaming and voluntary laparoscopic skills training : A multicenter study

    NARCIS (Netherlands)

    Verdaasdonk, E.; Dankelman, J.; Schijven, M.P.; Lange, J.F.; Wentink, M.; Stassen, L.P.S.

    2009-01-01

    This study assesses the issue of voluntary training of a standardized online competition (serious gaming) between surgical residents. Surgical residents were invited to join a competition on a virtual reality (VR) simulator for laparoscopic motor skills. A final score was calculated based on the

  15. BCG status in children with tuberculosis: A multicenter study in ...

    African Journals Online (AJOL)

    Background: Bacille Calmette.Guerin (BCG) vaccine has been in use since 1921, yet childhood TB is still very prevalent in Nigeria. Since BCG efficacy depends in part on appropriate vaccine utilization, this study was designed to investigate the current practice of BCG administration through determination of BCG status.

  16. Candidacy for Bilateral Hearing Aids: A Retrospective Multicenter Study

    Science.gov (United States)

    Boymans, Monique; Goverts, S. Theo; Kramer, Sophia E.; Festen, Joost M.; Dreschler, Wouter A.

    2009-01-01

    Purpose: The goal of this study was to find factors for refining candidacy criteria for bilateral hearing aid fittings. Clinical files of 1,000 consecutive hearing aid fittings were analyzed. Method: Case history, audiometric, and rehabilitation data were collected from clinical files, and an extensive questionnaire on long-term outcome measures…

  17. Adult prostatic sarcoma: A contemporary multicenter Rare Cancer Network study

    NARCIS (Netherlands)

    Bari, B. De; Stish, B.; Ball, M.W.; Habboush, Y.; Sargos, P.; Krengli, M.; Bossi, A.; Stabile, A.; Pesutic, C. Sole; Lestrade, L.; Smeenk, R.J.; Jereczek-Fossa, B.A.; Zilli, T.; Crehange, G.; Alongi, F.; Zaorsky, N.; Ozsahin, M.

    2017-01-01

    INTRODUCTION: Adult prostatic sarcoma (PS) is a rare disease. While surgery is considered the standard approach, the role of other therapies is not completely established. We report results of the largest multicentric contemporary cohort of PS patients. MATERIALS AND METHODS: This study included 61

  18. Sexual functioning of people with rheumatoid arthritis: a multicenter study

    NARCIS (Netherlands)

    van Berlo, Willy T.M.; van de Wiel, Harry B.M.; Taal, Erik; Rasker, Johannes J.; Weijmar Schultz, Willibrord C.M.; van Rijswijk, Martin H.

    2007-01-01

    The objective of this study is to compare men and women with rheumatoid arthritis (RA) to controls regarding sexual motivation, activity, satisfaction, and specific sexual problems, and to determine the correlation of physical aspects of the disease with sexual functioning. Questionnaire for

  19. Sexual functioning of people with rheumatoid arthritis : a multicenter study

    NARCIS (Netherlands)

    van Berlo, W.T.M.; van de Wiel, H.B.M.; Taal, E.; Rasker, J.J.; Schultz, W.C.M.W.; van Rijswijk, M.H.

    The objective of this study is to compare men and women with rheumatoid arthritis (RA) to controls regarding sexual motivation, activity, satisfaction, and specific sexual problems, and to determine the correlation of physical aspects of the disease with sexual functioning. Questionnaire for

  20. Dialectical Effects on Nasalance: A Multicenter, Cross-Continental Study

    Science.gov (United States)

    Awan, Shaheen N.; Bressmann, Tim; Poburka, Bruce; Roy, Nelson; Sharp, Helen; Watts, Christopher

    2015-01-01

    Purpose: This study investigated nasalance in speakers from six different dialectal regions across North America using recent versions of the Nasometer. It was hypothesized that many of the sound changes observed in regional dialects of North American English would have a significant impact on measures of nasalance. Method: Samples of the Zoo…

  1. Establishing a multicenter longitudinal clinical cohort Study in ...

    African Journals Online (AJOL)

    Conclusions: A comprehensive and resourceful mechanism for scientific inquiry was established to support the national HIV/ART program. With meaningful involvement and defined roles, establishment of a study, which involved multiple institutions and investigators, was possible. Since ACM is the largest multi-site clinical ...

  2. Mass Spectrometry Imaging of Biological Tissue: An Approach for Multicenter Studies

    Energy Technology Data Exchange (ETDEWEB)

    Rompp, Andreas; Both, Jean-Pierre; Brunelle, Alain; Heeren, Ronald M.; Laprevote, Olivier; Prideaux, Brendan; Seyer, Alexandre; Spengler, Bernhard; Stoeckli, Markus; Smith, Donald F.

    2015-03-01

    Mass spectrometry imaging has become a popular tool for probing the chemical complexity of biological surfaces. This led to the development of a wide range of instrumentation and preparation protocols. It is thus desirable to evaluate and compare the data output from different methodologies and mass spectrometers. Here, we present an approach for the comparison of mass spectrometry imaging data from different laboratories (often referred to as multicenter studies). This is exemplified by the analysis of mouse brain sections in five laboratories in Europe and the USA. The instrumentation includes matrix-assisted laser desorption/ionization (MALDI)-time-of-flight (TOF), MALDI-QTOF, MALDIFourier transform ion cyclotron resonance (FTICR), atmospheric-pressure (AP)-MALDI-Orbitrap, and cluster TOF-secondary ion mass spectrometry (SIMS). Experimental parameters such as measurement speed, imaging bin width, and mass spectrometric parameters are discussed. All datasets were converted to the standard data format imzML and displayed in a common open-source software with identical parameters for visualization, which facilitates direct comparison of MS images. The imzML conversion also allowed exchange of fully functional MS imaging datasets between the different laboratories. The experiments ranged from overview measurements of the full mouse brain to detailed analysis of smaller features (depending on spatial resolution settings), but common histological features such as the corpus callosum were visible in all measurements. High spatial resolution measurements of AP-MALDI-Orbitrap and TOF-SIMS showed comparable structures in the low-micrometer range. We discuss general considerations for planning and performing multicenter studies in mass spectrometry imaging. This includes details on the selection, distribution, and preparation of tissue samples as well as on data handling. Such multicenter studies in combination with ongoing activities for reporting guidelines, a common

  3. Mass spectrometry imaging of biological tissue: an approach for multicenter studies.

    Science.gov (United States)

    Römpp, Andreas; Both, Jean-Pierre; Brunelle, Alain; Heeren, Ron M A; Laprévote, Olivier; Prideaux, Brendan; Seyer, Alexandre; Spengler, Bernhard; Stoeckli, Markus; Smith, Donald F

    2015-03-01

    Mass spectrometry imaging has become a popular tool for probing the chemical complexity of biological surfaces. This led to the development of a wide range of instrumentation and preparation protocols. It is thus desirable to evaluate and compare the data output from different methodologies and mass spectrometers. Here, we present an approach for the comparison of mass spectrometry imaging data from different laboratories (often referred to as multicenter studies). This is exemplified by the analysis of mouse brain sections in five laboratories in Europe and the USA. The instrumentation includes matrix-assisted laser desorption/ionization (MALDI)-time-of-flight (TOF), MALDI-QTOF, MALDI-Fourier transform ion cyclotron resonance (FTICR), atmospheric-pressure (AP)-MALDI-Orbitrap, and cluster TOF-secondary ion mass spectrometry (SIMS). Experimental parameters such as measurement speed, imaging bin width, and mass spectrometric parameters are discussed. All datasets were converted to the standard data format imzML and displayed in a common open-source software with identical parameters for visualization, which facilitates direct comparison of MS images. The imzML conversion also allowed exchange of fully functional MS imaging datasets between the different laboratories. The experiments ranged from overview measurements of the full mouse brain to detailed analysis of smaller features (depending on spatial resolution settings), but common histological features such as the corpus callosum were visible in all measurements. High spatial resolution measurements of AP-MALDI-Orbitrap and TOF-SIMS showed comparable structures in the low-micrometer range. We discuss general considerations for planning and performing multicenter studies in mass spectrometry imaging. This includes details on the selection, distribution, and preparation of tissue samples as well as on data handling. Such multicenter studies in combination with ongoing activities for reporting guidelines, a common

  4. Insomnia in hemodialysis patients: A multicenter study from morocco

    Directory of Open Access Journals (Sweden)

    Mohamed Amine Hamzi

    2017-01-01

    Full Text Available Previous studies have shown that insomnia is a common sleep disorder in patients with end-stage renal disease. This study aims to determine the prevalence and risk factors of insomnia in our chronic hemodialysis (HD patients. This is a cross-sectional study conducted in three HD units in Morocco. To assess the prevalence of insomnia, we used a specific questionnaire. Patients complaining of difficulty in falling asleep and/or nocturnal awakenings occurring seven nights a week during the last month were included in the group “insomnia;” the other patients were used as controls. Clinical, biological, and dialysis data were recorded for each patient. Sleep disorders and their subjective causes were also identified. Eighty-nine percent of questioned patients admitted to having sleep disturbances of different degrees. Insomnia was significantly associated with female gender and time of dialysis. Age, body mass index, inter-dialytic weight gain, and blood pressure were similar between the two groups, as well as dialytic parameters and drug use. There was no significant difference in the values of plasma creatinine, urea, hemoglobin, parathyroid hormone, calcium, phosphorus, C-reactive protein, and albumin between the groups. Disorders most frequently encountered in patients with insomnia were waking up at night (90%, difficulty falling asleep (60%, and daytime sleepiness (60%. The restless legs syndrome was seen in half of these patients. The main reported causes of insomnia were anxiety and/or depression (70% and bone pain (67%. Insomnia is common in HD patients and is frequently associated with other disorders of sleep. Female sex and duration on dialysis are the two risk factors found in our study. Insomnia does not appear related to any biochemical or dialysis parameters. Increased attention should be given to the management of dialysis patients regarding the diagnosis and management of insomnia and associated sleep disorders.

  5. [HCV and HBV prevalence in hemodialyzed pediatric patients. Multicenter study].

    Science.gov (United States)

    Cañero-Velasco, M C; Mutti, J E; Gonzalez, J E; Alonso, A; Otegui, L; Adragna, M; Antonuccio, M; Laso, M; Montenegro, M; Repetto, L; Brandi, M; Canepa, J; Baimberg, E

    1998-01-01

    Hemodialized pediatric patients are a risk population for the hepatitis B and C virus infection. The aim of this paper was to study the serum prevalence of HBV and HCV infection in hemodialized children. We study 61 pediatric patients at hemodialisis, 12 on renal transplant, range between 2 and 20 years old (mean: 12.9 years), 23 male and 38 female. The specific anti-HCV IgC were measured by enzyme immunoassay (ELISA Abbott) and confirmed by LIA-TEK (Organon). The anti-HBV were measured by ELISA Abbott and transaminases by cinetic method (ASAT: 29 UI/L and ALT: 33 UI/L). The 19.7% of studied children were HCV (+) and 29.5% were HBV (+), 38.9% of them were HbsAg (+) and 50% anti-HBs (+). The HCV and HBV infection was more elevated in relation to the transfusion number and the hemodilisis time. The elevation of ALT/ASAT activity isn't a right infection index for HCV and HBV in this children.

  6. Estimated cognitive decline in patients with schizophrenia: A multicenter study.

    Science.gov (United States)

    Fujino, Haruo; Sumiyoshi, Chika; Yasuda, Yuka; Yamamori, Hidenaga; Fujimoto, Michiko; Fukunaga, Masaki; Miura, Kenichiro; Takebayashi, Yuto; Okada, Naohiro; Isomura, Shuichi; Kawano, Naoko; Toyomaki, Atsuhito; Kuga, Hironori; Isobe, Masanori; Oya, Kazuto; Okahisa, Yuko; Takaki, Manabu; Hashimoto, Naoki; Kato, Masaki; Onitsuka, Toshiaki; Ueno, Takefumi; Ohnuma, Tohru; Kasai, Kiyoto; Ozaki, Norio; Sumiyoshi, Tomiki; Imura, Osamu; Hashimoto, Ryota

    2017-05-01

    Studies have reported that cognitive decline occurs after the onset of schizophrenia despite heterogeneity in cognitive function among patients. The aim of this study was to investigate the degree of estimated cognitive decline in patients with schizophrenia by comparing estimated premorbid intellectual functioning and current intellectual functioning. A total of 446 patients with schizophrenia (228 male, 218 female), consisting of three sample sets obtained from 11 psychiatric facilities, and 686 healthy controls participated in this study. The Wechsler Adult Intelligence Scale-III (WAIS-III) was used to measure the participants' current full-scale IQ (FSIQ). The premorbid IQ was estimated using the Japanese Adult Reading Test-25. Estimated cognitive decline (difference score) was defined as the difference between the estimated premorbid IQ and the current FSIQ. Patients with schizophrenia showed greater estimated cognitive decline, a lower FSIQ, and a lower premorbid IQ compared with the healthy controls. The mean difference score, FSIQ, and estimated premorbid IQ were -16.3, 84.2, and 100.5, respectively, in patients with schizophrenia. Furthermore, 39.7% of the patients had a difference score of 20 points or greater decline. A discriminant analysis showed that the difference score accurately predicted 81.6% of the patients and healthy controls. These results show the distribution of difference score in patients with schizophrenia. These findings may contribute to assessing the severity of estimated cognitive decline and identifying patients with schizophrenia who suffer from cognitive decline. © 2016 The Authors. Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.

  7. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile.

    Science.gov (United States)

    Wahabi, Hayfaa; Fayed, Amel; Esmaeil, Samia; Alzeidan, Rasmieh; Elawad, Mamoun; Tabassum, Rabeena; Hansoti, Shehnaz; Magzoup, Mohie Edein; Al-Kadri, Hanan; Elsherif, Elham; Al-Mandil, Hazim; Al-Shaikh, Ghadeer; Zakaria, Nasria

    2016-01-01

    To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant. A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated. The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%. Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world.

  8. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile.

    Directory of Open Access Journals (Sweden)

    Hayfaa Wahabi

    Full Text Available To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant.A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated.The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%.Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world.

  9. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p .... With larger patient samples, it is possible, however, that a significant difference might have been achieved. The running costs for APD treatment were US $75 per day and for CAPD treatment US $61 per day. CONCLUSION: If APD treatment can help to keep selected patients vocationally or socially active, paying...

  10. A large multicenter outcome study of female genital plastic surgery.

    Science.gov (United States)

    Goodman, Michael P; Placik, Otto J; Benson, Royal H; Miklos, John R; Moore, Robert D; Jason, Robert A; Matlock, David L; Simopoulos, Alex F; Stern, Bernard H; Stanton, Ryan A; Kolb, Susan E; Gonzalez, Federico

    2010-04-01

    Female Genital Plastic Surgery, a relatively new entry in the field of Cosmetic and Plastic Surgery, has promised sexual enhancement and functional and cosmetic improvement for women. Are the vulvovaginal aesthetic procedures of Labiaplasty, Vaginoplasty/Perineoplasty ("Vaginal Rejuvenation") and Clitoral Hood Reduction effective, and do they deliver on that promise? For what reason do women seek these procedures? What complications are evident, and what effects are noted regarding sexual function for women and their partners? Who should be performing these procedures, what training should they have, and what are the ethical considerations? This study was designed to produce objective, utilizable outcome data regarding FGPS. 1) Reasons for considering surgery from both patient's and physician's perspective; 2) Pre-operative sexual functioning per procedure; 3) Overall patient satisfaction per procedure; 4) Effect of procedure on patient's sexual enjoyment, per procedure; 5) Patient's perception of effect on her partner's sexual enjoyment, per procedure; 6) Complications. This cross-sectional study, including 258 women and encompassing 341 separate procedures, comes from a group of twelve gynecologists, gynecologic urologists and plastic surgeons from ten centers in eight states nationwide. 104 labiaplasties, 24 clitoral hood reductions, 49 combined labiaplasty/clitoral hood reductions, 47 vaginoplasties and/or perineoplasties, and 34 combined labiaplasty and/or reduction of the clitoral hood plus vaginoplasty/perineoplasty procedures were studied retrospectively, analyzing both patient's and physician's perception of surgical rationale, pre-operative sexual function and several outcome criteria. Combining the three groups, 91.6% of patients were satisfied with the results of their surgery after a 6-42 month follow-up. Significant subjective enhancement in sexual functioning for both women and their sexual partners was noted (p = 0.0078), especially in patients

  11. Rapid HIV-1 testing during labor: a multicenter study.

    Science.gov (United States)

    Bulterys, Marc; Jamieson, Denise J; O'Sullivan, Mary Jo; Cohen, Mardge H; Maupin, Robert; Nesheim, Steven; Webber, Mayris P; Van Dyke, Russell; Wiener, Jeffrey; Branson, Bernard M

    2004-07-14

    Timely testing of women in labor with undocumented human immunodeficiency virus (HIV) status could enable immediate provision of antiretroviral prophylaxis. To determine the feasibility and acceptance of rapid HIV testing among women in labor and to assess rapid HIV assay performance. The Mother-Infant Rapid Intervention At Delivery (MIRIAD) study implemented 24-hour counseling and voluntary rapid HIV testing for women in labor at 16 US hospitals from November 16, 2001, through November 15, 2003. A rapid HIV-1 antibody test for whole blood was used. Acceptance of HIV testing; sensitivity, specificity, and predictive value of the rapid test; time from blood collection to patient notification of results. There were 91,707 visits to the labor and delivery units in the study, 7381 of which were by eligible women without documentation of HIV testing. Of these, 5744 (78%) women were approached for rapid HIV testing and 4849 (84%) consented. HIV-1 test results were positive for 34 women (prevalence = 7/1000). Sensitivity and specificity of the rapid test were 100% and 99.9%, respectively; positive predictive value was 90% compared with 76% for enzyme immunoassay (EIA). Factors independently associated with higher test acceptance included younger age, being black or Hispanic, gestational age less than 32 weeks, and having had no prenatal care. Lower acceptance was associated with being admitted between 4 pm and midnight, particularly on Friday nights, but this may be explained in part by fewer available personnel. Median time from blood collection to patient notification of result was 66 minutes (interquartile range, 45-120 minutes), compared with 28 hours for EIA (PHIV testing is feasible and delivers accurate and timely test results for women in labor. It provides HIV-positive women prompt access to intrapartum and neonatal antiretroviral prophylaxis, proven to reduce perinatal HIV transmission, and may be particularly applicable to higher-risk populations.

  12. Pigmented villonodular synovitis: a retrospective multicenter study of 237 cases.

    Directory of Open Access Journals (Sweden)

    Guo-ping Xie

    Full Text Available To review clinical characteristics of pigmented villonodular synovitis (PVNS in China.Electronic medical records (EMR of four Chinese institutes were queried for patients with histologically proven PVNS between January 2005 and February 2014. Their data were collected including gender, age at diagnosis, clinical presentation, affected site, symptom duration, comorbidities, treatment strategy, recurrence and routine laboratories.A total of 237 patients with biopsy-proven PVNS were investigated. The gender ratio was 1.35 for a female predominance (101 males and 136 females. The average age was 36 years (range, 2 to 83 years. The median delay from initial clinical symptom to diagnosis was 18 months. Main affected areas were the knee (73.84% and the hip (18.14%. Forty patients had a clear history of joint trauma. Six patients were concurrently diagnosed with PVNS and avascular necrosis (AVN. Five patients suffered from PVNS following implantation of orthopaedic devices including artificial prosthesis, plate and wire. One hundred and twenty-nine patients underwent arthroscopic synovectomy and 108 open synovectomy. Altogether 48 patients (26 males and 22 females had recurrence of disease. The relapse rate was 24% (knee and 6.98% (hip, 20.93% (open surgery and 19.44% (arthroscopy, respectively. Erythrocyte sedimentation rate (ESR and C-reactive protein (CRP rate were elevated in 45.83% and 38.41% of the patients respectively.To our knowledge, this study is the largest sample size of PVNS patients reported as well as the largest sample of PVNS with concurrent AVN reported to date. Our outcomes suggest that PVNS shows a female predominance, occurs mostly between 20-40 years and favors the knee and hip. Recurrence is frequent, particularly in the knee. Serum ESR and CRP may be elevated in some patients. Additionally, the present study supports the theory of an association between PVNS and orthopedic surgery, which is not limited to joint replacement.

  13. Retention of the Boston keratoprosthesis type 1: multicenter study results.

    Science.gov (United States)

    Ciolino, Joseph B; Belin, Michael W; Todani, Amit; Al-Arfaj, Khalid; Rudnisky, Christopher J

    2013-06-01

    To report the retention rate of the Boston keratoprosthesis type 1 and to identify risk factors for keratoprosthesis loss. Cohort study. A total of 300 eyes of 300 patients who underwent implantation of the Boston keratoprosthesis type I device between January 2003 and July 2008 by 19 surgeons at 18 medical centers. Forms reporting preoperative, intraoperative, and postoperative parameters were prospectively collected and subsequently analyzed at a central data collection site. Keratoprosthesis retention. A total cumulative number of 422 life-years of device implantation are included in this analysis. The average duration of follow-up was 17.1 ± 14.8 months, with a range of 1 week to >6.1 years. Ninety-three percent of the 300 Boston keratoprosthesis implants were retained at their last follow-up, corresponding to a retention time of 396 patient-years or 1.42 years/keratoprosthesis. The probability of retention after 1 year and 2 years was 94% and 89%, respectively. During the study period, 21 (7%) eyes failed to retain the device; the reasons for keratoprosthesis loss include sterile keratolysis (9), fungal infections (8), dense retroprosthetic membranes (3), and bacterial endophthalmitis (1). Multivariate analysis demonstrated 3 independent risk factors for keratoprosthesis loss: autoimmune cause (hazard ratio [HR], 11.94; 95% confidence interval [CI], 3.31-43.11), ocular surface exposure requiring a concomitant tarsorrhaphy (HR, 3.43; 95% CI, 1.05-11.22), and number of prior failed penetrating keratoplasties (HR, 1.64; 95% CI, 1.18-2.28). The Boston keratoprosthesis type 1 seems to be a viable option for eyes that are not candidates for penetrating keratoplasty (PK). Ocular surface disease due to an autoimmune cause demonstrated the lowest retention rate. The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  14. EBM in primary care: a qualitative multicenter study in Spain

    Directory of Open Access Journals (Sweden)

    Calderón Carlos

    2011-08-01

    Full Text Available Abstract Background Evidence based medicine (EBM has made a substantial impact on primary care in Spain over the last few years. However, little research has been done into family physicians (FPs' attitudes related to EBM. The present study investigates FPs' perceptions of EBM in the primary care context. Methods This study used qualitative methodology. Information was obtained from 8 focus groups composed of 67 FPs from 47 health centers in 4 autonomous regions in Spain. Intentional sampling considered participants' previous education in EBM, and their experience as tutors in family medicine or working groups' members of the Spanish Society of Family Practice. Sociological discourse analysis was used with the support of the MAXqda software. Results were validated by means of triangulation among researchers and contrast with participants. Results Findings were grouped into three main areas: 1 The tug-of-war between the "science" of EBM and "experience" in the search for good clinical practice in primary care; 2 The development of EBM sensemaking as a reaction to contextual factors and interests; 3 The paradox of doubt and trust in the new EBM experts. The meaning of EBM was dynamically constructed within the primary care context. FPs did not consider good clinical practice was limited to the vision of science that EBM represents. Its use appeared to be conditioned by several factors that transcended the common concept of barriers. Along with concerns about its objectivity, participants showed a tendency to see EBM as the use of simplified guidelines developed by EBM experts. Conclusions The identification of science with EBM and its recognition as a useful but insufficient tool for the good clinical practice requires rethinking new meanings of evidence within the primary care reality. Beyond the barriers related to accessing and putting into practice the EBM, its reactive use can determine FPs' questions and EBM development in a direction not

  15. Secured web-based video repository for multicenter studies

    Science.gov (United States)

    Yan, Ling; Hicks, Matt; Winslow, Korey; Comella, Cynthia; Ludlow, Christy; Jinnah, H. A; Rosen, Ami R; Wright, Laura; Galpern, Wendy R; Perlmutter, Joel S

    2015-01-01

    Background We developed a novel secured web-based dystonia video repository for the Dystonia Coalition, part of the Rare Disease Clinical Research network funded by the Office of Rare Diseases Research and the National Institute of Neurological Disorders and Stroke. A critical component of phenotypic data collection for all projects of the Dystonia Coalition includes a standardized video of each participant. We now describe our method for collecting, serving and securing these videos that is widely applicable to other studies. Methods Each recruiting site uploads standardized videos to a centralized secured server for processing to permit website posting. The streaming technology used to view the videos from the website does not allow downloading of video files. With appropriate institutional review board approval and agreement with the hosting institution, users can search and view selected videos on the website using customizable, permissions-based access that maintains security yet facilitates research and quality control. Results This approach provides a convenient platform for researchers across institutions to evaluate and analyze shared video data. We have applied this methodology for quality control, confirmation of diagnoses, validation of rating scales, and implementation of new research projects. Conclusions We believe our system can be a model for similar projects that require access to common video resources. PMID:25630890

  16. Secured web-based video repository for multicenter studies.

    Science.gov (United States)

    Yan, Ling; Hicks, Matt; Winslow, Korey; Comella, Cynthia; Ludlow, Christy; Jinnah, H A; Rosen, Ami R; Wright, Laura; Galpern, Wendy R; Perlmutter, Joel S

    2015-04-01

    We developed a novel secured web-based dystonia video repository for the Dystonia Coalition, part of the Rare Disease Clinical Research network funded by the Office of Rare Diseases Research and the National Institute of Neurological Disorders and Stroke. A critical component of phenotypic data collection for all projects of the Dystonia Coalition includes a standardized video of each participant. We now describe our method for collecting, serving and securing these videos that is widely applicable to other studies. Each recruiting site uploads standardized videos to a centralized secured server for processing to permit website posting. The streaming technology used to view the videos from the website does not allow downloading of video files. With appropriate institutional review board approval and agreement with the hosting institution, users can search and view selected videos on the website using customizable, permissions-based access that maintains security yet facilitates research and quality control. This approach provides a convenient platform for researchers across institutions to evaluate and analyze shared video data. We have applied this methodology for quality control, confirmation of diagnoses, validation of rating scales, and implementation of new research projects. We believe our system can be a model for similar projects that require access to common video resources. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Factors affecting breastfeeding adherence among Chinese mothers: A multicenter study.

    Science.gov (United States)

    Huang, Pan; Ren, Jianhua; Liu, Yi; Luo, Biru; Zhao, Xiufang

    2017-09-01

    Breastfeeding is beneficial for both infant and mother, but discontinuation of breastfeeding is very common.To investigate maternal breastfeeding intention and the rate of breastfeeding based on the theory of reasoned action, and analyze the predominant factors associated with breastfeeding and breastfeeding problems.This observational study was conducted in 3 hospitals. Three researchers recruited women at 3 time points in the hospitals: initial documentation of pregnancy at the outpatient department, prenatal admission, and postpartum discharge. SPSS version 21 was used for statistical analyses. Significance was set at P breastfeeding problems. The multivariate analysis showed that nonsuccessful breastfeeding was associated with neonatal birth length, food intake before breastfeeding, infrequent sucking, the intention of breastfeeding, understanding level of the benefits of breastfeeding and that breastfeeding problems were related with the understanding level of the benefits of breastfeeding, neonatal birth length, normal vaginal delivery, breast size, the experience of breastfeeding, use of pacifier and the needs of family member's support in breastfeeding.Most mothers who intended to practice exclusive breastfeeding initially chose to add formula and had breastfeeding problems when discharged from hospital. Successful breastfeeding depends on antenatal and postnatal breastfeeding education and on support provided by healthcare professionals.

  18. Dense deposit disease in Korean children: a multicenter clinicopathologic study.

    Science.gov (United States)

    Park, Se Jin; Kim, Yong-Jin; Ha, Tae-Sun; Lim, Beom Jin; Jeong, Hyeon Joo; Park, Yong Hoon; Lee, Dae Yeol; Kim, Pyung Kil; Kim, Kyo Sun; Chung, Woo Yeong; Shin, Jae Il

    2012-10-01

    The purpose of this study was to investigate the clinical, laboratory, and pathologic characteristics of dense deposit disease (DDD) in Korean children and to determine whether these characteristics differ between Korean and American children with DDD. In 2010, we sent a structured protocol about DDD to pediatric nephrologists throughout Korea. The data collected were compared with previously published data on 14 American children with DDD. Korean children had lower 24-hr urine protein excretion and higher serum albumin levels than American children. The light microscopic findings revealed that a higher percentage of Korean children had membranoproliferative glomerulonephritis patterns (Korean, 77.8%; American, 28.6%, P = 0.036), whereas a higher percentage of American children had crescents (Korean, 0%; American, 78.6%, P deposits in the lamina densa of the glomerular basement membrane (Korean, 100%; American, 28.6%, P = 0.002); mesangial deposit was more frequent in American children (Korean, 66.7%; American, 100%, P = 0.047). The histological findings revealed that Korean children with DDD were more likely to show membranoproliferative glomerulonephritis patterns than American children. The degree of proteinuria and hypoalbuminemia was milder in Korean children than American children.

  19. Italian multicenter study on complications of laparoscopic myomectomy.

    Science.gov (United States)

    Sizzi, Ornella; Rossetti, Alfonso; Malzoni, Mario; Minelli, Luca; La Grotta, Francesco; Soranna, Liberato; Panunzi, Simona; Spagnolo, Rocco; Imperato, Fabio; Landi, Stefano; Fiaccamento, Andrea; Stola, Emilio

    2007-01-01

    To study intraoperative and postoperative complications of laparoscopic myomectomy and patients' characteristics influencing this risk. Prospective study, with a review of the patient records by the first author (Canadian Task Force classification II-2). Four Italian referral centers. The incidence and type of complications occurring in 2050 laparoscopic myomectomies undertaken from January 1998 through December 2004 were recorded. The surgical technique, as well as the expertise of the operators, was the same for the 4 centers. Injection of vasoconstrictive agents was used in 37%. The serosa was always incised in a vertical fashion; mechanical enucleation of the myoma was completed whenever possible; suture was performed in 1 or 2 layers with deep and large stitches swaged to 1 or 0 polyglactin sutures that were tied intracorporeally or extracorporeally. Single or multiple myomectomies (n = 2050) for symptomatic myomas measuring at least 4 cm in diameter were performed. Most patients (48%) had more than 1 myoma, with a maximum of 15 per patient (myomas removed for patients: 2.26 +/- 1.8, mean +/- SD). Myoma size ranged from 1 to 20 cm (mean 6.40 +/- 2.6 SD). Myomas smaller than 4 cm were removed during myomectomy for larger ones. Total complication rate was 11.1% (225/2050 cases). Minor complications accounted for 9.1% (187/2050 cases) and major complications for 2.02% (38/2050 cases). The most serious events were hemorrhages (14 cases, 0.68%) requiring blood transfusions in 3 cases (0.14%); 10 postoperative hematomas (0.48%, one in the broad ligament and 9 in the myomectomy scar); 1 bowel injury (0.04%); 1 postoperative acute kidney failure (0.04%); and 2 unexpected sarcomas (0.09%). Failure to complete planned surgery occurred in 7 cases (0.34%). Two patients were readmitted for surgery (0.09%): 1 had a laparoscopic hysterectomy because of a severe blood loss, and the other had drainage of a hematoma in the broad ligament. After a follow-up period of 41

  20. Recognition of Delirium in Postoperative Elderly Patients: A Multicenter Study.

    Science.gov (United States)

    Numan, Tianne; van den Boogaard, Mark; Kamper, Adriaan M; Rood, Paul J T; Peelen, Linda M; Slooter, Arjen J C

    2017-09-01

    To evaluate to what extent delirium experts agree on the diagnosis of delirium when independently assessing exactly the same information and to evaluate the sensitivity of delirium screening tools in routine daily practice of clinical nurses. Prospective observational longitudinal study. Three medical centers in the Netherlands. Elderly postoperative adults (n = 167). A researcher examined participants daily (Postoperative Day 1-3) for delirium using a standardized cognitive assessment and interview including the Delirium Rating Scale Revised-98 as global impression without any cut-off values that was recorded on video. Two delirium experts independently evaluated the videos and clinical information from the last 24 hours in the participants' record and classified each assessment as delirious, possibly delirious, or not delirious. Interrater agreement between the delirium experts was determined using weighted Cohen's kappa. When there was no consensus, a third expert was consulted. Final classification was based on median score and compared with the results of the Confusion Assessment Method for Intensive Care Unit and Delirium Observation Scale that clinical nurses administered. Four hundred twenty-four postoperative assessments of 167 participants were included. The overall kappa was 0.61 (95% confidence interval = 0.53-0.68). There was no agreement between the experts for 89 (21.0%) assessments and a third delirium expert was needed for the final classification. Delirium screening that nurses performed detected 32% of the assessments that the experts diagnosed as (possibly) delirious. There was considerable disagreement in classification of delirium by experts who independently assessed exactly the same information, showing the difficulty of delirium diagnosis. Furthermore, the sensitivity of daily delirium screening by clinical nurses was poor. Future research should focus on development of objective instruments to diagnose delirium. © 2017, Copyright the

  1. Congenital heart disease in Nigerian children: a multicenter echocardiographic study.

    Science.gov (United States)

    Sadoh, Wilson E; Uzodimma, Chinyere C; Daniels, Queennette

    2013-04-01

    Congenital heart disease (CHD) is among the leading causes of morbidity and mortality in childhood. We report on the spectrum of echocardiographically diagnosed CHD from three different centers across Nigeria. Over a period of 42 months, children who were referred for echocardiographic evaluation in the centers located in three large metropolitan cities were consecutively recruited if they were confirmed to have identifiable CHD. Data were collected on age, gender, and types of CHD and analyzed using SPSS 16 (Chicago, Illinois,). A total of 605 children were recruited, their mean age was 2.1 ± 3.5 (range 0-17) years, and 296 (48.9%) were males. Nearly half (42.5%) had echocardiographic diagnosis of their CHD within the first year of life. Only 17% of the diagnoses were made in the neonatal age group. Acyanotic CHDs were more common than the cyanotic heart diseases (82.8% vs 17.2%). The most common CHD was ventricular septal defect (VSD; 46.6%) followed by patent ductus arteriosus (12.1%), atrial septal defect (8.7%), atrioventricular septal defect (8.2%), and tetralogy of Fallot (7.8%). More than half of the VSDs were perimembranous (55.1%) followed by outlet VSD (23.8%), muscular (10.7%), and inlet VSD (9.6%). Only 42 (6.9%) of the entire study population had definitive intervention. The VSD is the most prevalent CHD in Nigerian children. There is increasing awareness, availability, and use of diagnostic facilities as mirrored in the age distribution of the children. However, access to definitive surgery is poor and draws attention to the urgent need for affordable surgical facilities in the country.

  2. Pediatric palliative care patients: a prospective multicenter cohort study.

    Science.gov (United States)

    Feudtner, Chris; Kang, Tammy I; Hexem, Kari R; Friedrichsdorf, Stefan J; Osenga, Kaci; Siden, Harold; Friebert, Sarah E; Hays, Ross M; Dussel, Veronica; Wolfe, Joanne

    2011-06-01

    To describe demographic and clinical characteristics and outcomes of patients who received hospital-based pediatric palliative care (PPC) consultations. Prospective observational cohort study of all patients served by 6 hospital-based PPC teams in the United States and Canada from January to March 2008. There were 515 new (35.7%) or established (64.3%) patients who received care from the 6 programs during the 3-month enrollment interval. Of these, 54.0% were male, and 69.5% were identified as white and 8.1% as Hispanic. Patient age ranged from less than one month (4.7%) to 19 years or older (15.5%). Of the patients, 60.4% lived with both parents, and 72.6% had siblings. The predominant primary clinical conditions were genetic/congenital (40.8%), neuromuscular (39.2%), cancer (19.8%), respiratory (12.8%), and gastrointestinal (10.7%). Most patients had chronic use of some form of medical technology, with gastrostomy tubes (48.5%) being the most common. At the time of consultation, 47.2% of the patients had cognitive impairment; 30.9% of the cohort experienced pain. Patients were receiving many medications (mean: 9.1). During the 12-month follow-up, 30.3% of the cohort died; the median time from consult to death was 107 days. Patients who died within 30 days of cohort entry were more likely to be infants and have cancer or cardiovascular conditions. PPC teams currently serve a diverse cohort of children and young adults with life-threatening conditions. In contrast to the reported experience of adult-oriented palliative care teams, most PPC patients are alive for more than a year after initiating PPC.

  3. Better organized care via care pathways: A multicenter study.

    Directory of Open Access Journals (Sweden)

    Deborah Seys

    Full Text Available An increased need for efficiency and effectiveness in today's healthcare system urges professionals to improve the organization of care. Care pathways are an important tool to achieve this. The overall aim of this study was to analyze if care pathways lead to better organization of care processes. For this, the Care Process Self-Evaluation tool (CPSET was used to evaluate how healthcare professionals perceive the organization of care processes. Based on information from 2692 health care professionals gathered between November 2007 and October 2011 we audited 261 care processes in 108 organizations. Multilevel analysis was used to compare care processes without and with care pathways and analyze if care pathways led to better organization of care processes. A significant difference between care processes with and without care pathways was found. A care pathway in use led to significant better scores on the overall CPSET scale (p<0.001 and its subscales, "coordination of care" (p<0.001 and "follow-up of care" (p<0.001. Physicians had the highest score on the overall CPSET scale and the five subscales. Care processes organized by care pathways had a 2.6 times higher probability that the care process was well-organized. In around 75% of the cases a care pathway led to better organized care processes. Care processes supported by care pathways were better organized, but not all care pathways were well-organized. Managers can use care pathways to make healthcare professionals more aware of their role in the organization of the care process.

  4. Impact of the revised International Prognostic Scoring System, cytogenetics and monosomal karyotype on outcome after allogeneic stem cell transplantation for myelodysplastic syndromes and secondary acute myeloid leukemia evolving from myelodysplastic syndromes: a retrospective multicenter study of the European Society of Blood and Marrow Transplantation.

    Science.gov (United States)

    Koenecke, Christian; Göhring, Gudrun; de Wreede, Liesbeth C; van Biezen, Anja; Scheid, Christof; Volin, Liisa; Maertens, Johan; Finke, Jürgen; Schaap, Nicolaas; Robin, Marie; Passweg, Jakob; Cornelissen, Jan; Beelen, Dietrich; Heuser, Michael; de Witte, Theo; Kröger, Nicolaus

    2015-03-01

    The aim of this study was to determine the impact of the revised 5-group International Prognostic Scoring System cytogenetic classification on outcome after allogeneic stem cell transplantation in patients with myelodysplastic syndromes or secondary acute myeloid leukemia who were reported to the European Society for Blood and Marrow Transplantation database. A total of 903 patients had sufficient cytogenetic information available at stem cell transplantation to be classified according to the 5-group classification. Poor and very poor risk according to this classification was an independent predictor of shorter relapse-free survival (hazard ratio 1.40 and 2.14), overall survival (hazard ratio 1.38 and 2.14), and significantly higher cumulative incidence of relapse (hazard ratio 1.64 and 2.76), compared to patients with very good, good or intermediate risk. When comparing the predictive performance of a series of Cox models both for relapse-free survival and for overall survival, a model with simplified 5-group cytogenetics (merging very good, good and intermediate cytogenetics) performed best. Furthermore, monosomal karyotype is an additional negative predictor for outcome within patients of the poor, but not the very poor risk group of the 5-group classification. The revised International Prognostic Scoring System cytogenetic classification allows patients with myelodysplastic syndromes to be separated into three groups with clearly different outcomes after stem cell transplantation. Poor and very poor risk cytogenetics were strong predictors of poor patient outcome. The new cytogenetic classification added value to prediction of patient outcome compared to prediction models using only traditional risk factors or the 3-group International Prognostic Scoring System cytogenetic classification. Copyright© Ferrata Storti Foundation.

  5. Delayed Diagnoses in Children with Constipation: Multicenter Retrospective Cohort Study.

    Science.gov (United States)

    Freedman, Stephen B; Rodean, Jonathan; Hall, Matthew; Alpern, Elizabeth R; Aronson, Paul L; Simon, Harold K; Shah, Samir S; Marin, Jennifer R; Cohen, Eyal; Morse, Rustin B; Katsogridakis, Yiannis; Berry, Jay G; Neuman, Mark I

    2017-07-01

    The use of abdominal radiographs contributes to increased healthcare costs, radiation exposure, and potentially to misdiagnoses. We evaluated the association between abdominal radiograph performance and emergency department (ED) revisits with important alternate diagnosis among children with constipation. Retrospective cohort study of children aged constipation at one of 23 EDs from 2004 to 2015. The primary exposure was abdominal radiograph performance. The primary outcome was a 3-day ED revisit with a clinically important alternate diagnosis. RAND/University of California, Los Angeles methodology was used to define whether the revisit was related to the index visit and due to a clinically important condition other than constipation. Regression analysis was performed to identify exposures independently related to the primary outcome. A total of 65.7% (185 439/282 225) of children with constipation had an index ED visit abdominal radiograph performed. Three-day revisits occurred in 3.7% (10 566/282 225) of children, and 0.28% (784/282 225) returned with a clinically important alternate related diagnosis. Appendicitis was the most common such revisit, accounting for 34.1% of all 3-day clinically important related revisits. Children who had an abdominal radiograph performed were more likely to have a 3-day revisit with a clinically important alternate related diagnosis (0.33% vs 0.17%; difference 0.17%; 95% CI 0.13-0.20). Following adjustment for covariates, abdominal radiograph performance was associated with a 3-day revisit with a clinically important alternate diagnosis (aOR: 1.39; 95% CI 1.15-1.67). Additional characteristics associated with the primary outcome included narcotic (aOR: 2.63) and antiemetic (aOR: 2.35) administration and underlying comorbidities (aOR: 2.52). Among children diagnosed with constipation, abdominal radiograph performance is associated with an increased risk of a revisit with a clinically important alternate related diagnosis

  6. Severe varicella-zoster virus pneumonia: a multicenter cohort study.

    Science.gov (United States)

    Mirouse, Adrien; Vignon, Philippe; Piron, Prescillia; Robert, René; Papazian, Laurent; Géri, Guillaume; Blanc, Pascal; Guitton, Christophe; Guérin, Claude; Bigé, Naïke; Rabbat, Antoine; Lefebvre, Aurélie; Razazi, Keyvan; Fartoukh, Muriel; Mariotte, Eric; Bouadma, Lila; Ricard, Jean-Damien; Seguin, Amélie; Souweine, Bertrand; Moreau, Anne-Sophie; Faguer, Stanislas; Mari, Arnaud; Mayaux, Julien; Schneider, Francis; Stoclin, Annabelle; Perez, Pierre; Maizel, Julien; Lafon, Charles; Ganster, Frédérique; Argaud, Laurent; Girault, Christophe; Barbier, François; Lecuyer, Lucien; Lambert, Jérôme; Canet, Emmanuel

    2017-06-07

    Pneumonia is a dreaded complication of varicella-zoster virus (VZV) infection in adults; however, the data are limited. Our objective was to investigate the clinical features, management, and outcomes of critically ill patients with VZV-related community-acquired pneumonia (VZV-CAP). This was an observational study of patients with VZV-CAP admitted to 29 intensive care units (ICUs) from January 1996 to January 2015. One hundred and two patients with VZV-CAP were included. Patients were young (age 39 years (interquartile range 32-51)) and 53 (52%) were immunocompromised. Time since respiratory symptom onset was 2 (1-3) days. There was a seasonal distribution of the disease, with more cases during spring and winter time. All but four patients presented with typical skin rash on ICU admission. Half the patients received mechanical ventilation within 1 (1-2) day following ICU admission (the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO 2 /FiO 2 ) = 150 (80-284), 80% with acute respiratory distress syndrome (ARDS)). Sequential Organ Failure Assessment (SOFA) score on day 1 (odds ratio (OR) 1.90 (1.33-2.70); p < 0.001), oxygen flow at ICU admission (OR 1.25 (1.08-1.45); p = 0.004), and early bacterial co-infection (OR 14.94 (2.00-111.8); p = 0.009) were independently associated with the need for mechanical ventilation. Duration of mechanical ventilation was 14 (7-21) days. ICU and hospital mortality rates were 17% and 24%, respectively. All patients were treated with aciclovir and 10 received adjunctive therapy with steroids. Compared to 60 matched steroid-free controls, patients treated with steroids had a longer mechanical ventilation duration, ICU length of stay, and a similar hospital mortality, but experienced more ICU-acquired infections. Severe VZV-CAP is responsible for an acute pulmonary involvement associated with a significant morbidity and mortality. Steroid therapy did not influence mortality, but increased the

  7. Reliability of Radiographic Assessments of Adolescent Midshaft Clavicle Fractures by the FACTS Multicenter Study Group.

    Science.gov (United States)

    Li, Ying; Donohue, Kyna S; Robbins, Christopher B; Pennock, Andrew T; Ellis, Henry B; Nepple, Jeffrey J; Pandya, Nirav; Spence, David D; Willimon, Samuel Clifton; Heyworth, Benton E

    2017-09-01

    There is a recent trend toward increased surgical treatment of displaced midshaft clavicle fractures in adolescents. The primary purpose of this study was to evaluate the intrarater and interrater reliability of clavicle fracture classification systems and measurements of displacement, shortening, and angulation in adolescents. The secondary purpose was to compare 2 different measurement methods for fracture shortening. This study was performed by a multicenter study group conducting a prospective, comparative, observational cohort study of adolescent clavicle fractures. Eight raters evaluated 24 deidentified anteroposterior clavicle radiographs selected from patients 10-18 years of age with midshaft clavicle fractures. Two clavicle fracture classification systems were used, and 2 measurements for shortening, 1 measurement for superior-inferior displacement, and 2 measurements for fracture angulation were performed. A minimum of 2 weeks after the first round, the process was repeated. Intraclass correlation coefficients were calculated. Good to excellent intrarater and interrater agreement was achieved for the descriptive classification system of fracture displacement, direction of angulation, presence of comminution, and all continuous variables, including both measurements of shortening, superior-inferior displacement, and degrees of angulation. Moderate agreement was achieved for the Arbeitsgemeinschaft für Osteosynthesefragen classification system overall. Mean shortening by 2 different methods were significantly different from each other (P < 0.0001). Most radiographic measurements performed by investigators in a multicenter, prospective cohort study of adolescent clavicle fractures demonstrated good-to-excellent intrarater and interrater reliability. Future consensus on the most accurate and clinically appropriate measurement method for fracture shortening is critical.

  8. Risk Factors for Contact Lens-Related Microbial Keratitis: A Case-Control Multicenter Study.

    Science.gov (United States)

    Sauer, Arnaud; Meyer, Nicolas; Bourcier, Tristan

    2016-05-01

    The most feared complication of contact lens (CL) wear is microbial keratitis (MK), even though its incidence remains low. This study aimed to identify the risk factors of CL-related MK in a large, prospective, multicenter case-control study. A multicenter case-control study was designed. The CL-related MK subpopulation (Case) was compared with healthy CL wearers (Control) using a 52-item anonymous questionnaire designed to determine subject demographics and lens wear history. Univariate and multivariate logistic regression analyses were performed to compare both groups. The study enrolled 499 cases and 508 controls. The risk factors associated with the greatest increased odds of CL-related MK were as follows: using disinfecting solution more than 3 months (odds ratio [OR]=1.94), cosmetic CL wear and use of multipurpose disinfection solution (1.37 each), overnight wear, and soft lens use (OR=1.24 each). The protective factors associated with the greatest reduction in OR were fitting by an ophthalmologist (OR=0.73) and hyperopia versus myopia (OR=0.75). The infectious determinants were linked to the type of lenses, hygiene routine, CL handling, disinfecting solution, and storage case. This study aimed to highlight the increasingly CL-related MK, which likely occurs because of lack of patient information regarding basic rules of hygiene and CL care and handling.

  9. A cross-sectional multicenter study of cognitive and behavioural features in multiple system atrophy patients of the parkinsonian and cerebellar type.

    Science.gov (United States)

    Siri, C; Duerr, S; Canesi, M; Delazer, M; Esselink, R; Bloem, B R; Gurevich, T; Balas, M; Giladi, N; Santacruz, P; Marti, F; Tolosa, E; Rubino, A; Meco, G; Poewe, W; Pezzoli, G; Wenning, G; Antonini, A

    2013-04-01

    Imaging and neuropathology studies have demonstrated significant abnormalities not only in subcortical, but also in cortical regions of patients with multiple system atrophy (MSA). This raises the possibility that cognitive dysfunction may contribute to the clinical spectrum of this disorder to a greater extent than it is currently not widely appreciated. In this cross-sectional multicenter study from the European multiple system atrophy study group ( http://www.emsa-sg.org ), we applied an extensive neuropsychological test battery in a series of 61 clinically diagnosed probable MSA patients. The results demonstrated that general cognitive decline as assessed by MMSE was uncommon (2 out of 61 patients system atrophy and this involves primarily frontal-executive functions. Their contribution to clinical disability and disease progression needs to be addressed in larger prospective studies.

  10. Persistence in the treatment of overactive bladder syndrome (OAB) with mirabegron in a multicenter clinical study.

    Science.gov (United States)

    Martan, Alois; Masata, Jaromir; Krhut, Jan; Zachoval, Roman; Hanus, Tomas; Svabik, Kamil

    2017-03-01

    The objective of this project was to evaluate treatment persistence in patients being treated for overactive bladder syndrome (OAB) with mirabegron, employing clinical follow-up in a prospective, multicenter study. This is an analysis of patients who started treatment with mirabegron between May and September 2014 and were evaluated 1year after treatment commenced. During this evaluation we determined how many patients stopped treatment and established their reasons for discontinuation. 206 patients being treated for OAB with mirabegron were evaluated a year after starting treatment. It emerged that 60 patients (29.1%) had discontinued the treatment, citing the following reasons: 24/60 insufficient treatment efficacy, 26/60 other reasons, while 10 members of the group discontinued treatment because of side effects. 75 out of 206 patients were ≤60 years old and 28% terminated the study prematurely: 131 out of 206 were >60years old and 29.2% terminated the study prematurely. In the group of patients without previous OAB treatment 35.7% discontinued treatment with mirabegron, while 28.1% of patients with previous anticholinergic treatment discontinued treatment. In our clinical prospective multicenter study, persistence in treatment with mirabegron reached a figure of 71%. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. [Risk factors for contact lens-related microbial keratitis: A multicenter case-control study].

    Science.gov (United States)

    Becmeur, P H; Abry, F; Bourcier, T; Meyer, N; Sauer, A

    2017-03-01

    Currently, the most feared complication by ophthalmologists of contact lens (CL) wear is microbial keratitis (MK), even though its incidence remains low. It is also a significant financial burden for society. This study aimed to identify the risk factors for CL-related MK especially with regard to hygiene and pattern of use, in a large, prospective, multicenter, case-control study. A multicenter retrospective case-control study was designed. The CL-related MK subpopulation (case) was compared with healthy CL wearers (control) using a 52-item anonymous questionnaire designed to determine subject demographics, lens wear history, lens type and disinfection solution, fitting, patient education, hygiene and maintenance of contact lenses, and patient history. Univariate logistic regression analysis was performed to compare both groups. The study included 497 cases and 364 controls. The risk factors associated with the greatest increased odds of CL-related MK were as follows: extended wear (OR=2.96 [1.65-5.33], Plens use (OR=6.37 [4,55-8.90], Pcontact lens (OR=4.47 [2.27-8.77], Pcontact lens wear, fitting by an ophthalmologist, written and verbal instruction, and daily case maintenance. The knowledge of these risks factors incentivizes action at all levels to reduce the incidence of MK, from the prescriber to the patient, including the type of CL, case and contact lens solution. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  12. Survey on treatments for primary headaches in 13 specialized juvenile Headache Centers: The first multicenter Italian study.

    Science.gov (United States)

    Toldo, Irene; Rattin, Martina; Perissinotto, Egle; De Carlo, Debora; Bolzonella, Barbara; Nosadini, Margherita; Rossi, Livia Nicoletta; Vecchio, Angelo; Simonati, Alessandro; Carotenuto, Marco; Scalas, Cinzia; Sciruicchio, Vittorio; Raieli, Vincenzo; Mazzotta, Giovanni; Tozzi, Elisabetta; Valeriani, Massimiliano; Cianchetti, Carlo; Balottin, Umberto; Guidetti, Vincenzo; Sartori, Stefano; Battistella, Pier Antonio

    2017-05-01

    could be used more frequently as first or almost second choice for treating migraine attack in adolescents. Non-pharmacological preventive treatments are recommended by some pediatric guidelines as first-line interventions for primary headaches and their use should be implemented in clinical practice. Prospective multicenter studies based on larger series are warranted to better understand the best treatment strategies for young people with primary headaches. Copyright © 2016 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  13. Multicenter validation study of the sentinel lymph node concept in cervical cancer: AGO Study Group.

    Science.gov (United States)

    Altgassen, Christopher; Hertel, Hermann; Brandstädt, Antje; Köhler, Christhardt; Dürst, Matthias; Schneider, Achim

    2008-06-20

    Single-institution case series have demonstrated the feasibility of the sentinel concept in cervical cancer. However, the diagnostic accuracy remains to be validated. We evaluated detection rate and diagnostic accuracy to predict the histopathologic pelvic nodal status in patients with cervical cancer of all stages. In a hypothesis-based, prospective, multicenter cohort study, patients underwent lymph node detection after labeling with technetium, patent blue, or both. After systematic pelvic and, if indicated, para-aortic node dissection, all lymph nodes were histopathologically examined. Detection rate, sensitivity, and negative predictive value (NPV) were calculated. According to the protocol, 590 patients were eligible. Detection rate of pelvic sentinel nodes was 88.6% (95% CI, 85.8% to 91.1%) and was significantly higher for the combination of technetium and patent blue (93.5%; 95% CI, 90.3% to 96.0%). Of 106 patients with pelvic lymph node metastases, 82 had pelvic sentinel node metastases. The overall sensitivity was 77.4% (95% CI, 68.2% to 85.0%), which was lower than 90%, the predefined noninferiority margin (P concept was low. However, patients with tumor diameter concept.

  14. Test–Retest and Between-Site Reliability in a Multicenter fMRI Study

    Science.gov (United States)

    Friedman, Lee; Stern, Hal; Brown, Gregory G.; Mathalon, Daniel H.; Turner, Jessica; Glover, Gary H.; Gollub, Randy L.; Lauriello, John; Lim, Kelvin O.; Cannon, Tyrone; Greve, Douglas N.; Bockholt, Henry Jeremy; Belger, Aysenil; Mueller, Bryon; Doty, Michael J.; He, Jianchun; Wells, William; Smyth, Padhraic; Pieper, Steve; Kim, Seyoung; Kubicki, Marek; Vangel, Mark; Potkin, Steven G.

    2013-01-01

    In the present report, estimates of test–retest and between-site reliability of fMRI assessments were produced in the context of a multicenter fMRI reliability study (FBIRN Phase 1, www.nbirn.net). Five subjects were scanned on 10 MRI scanners on two occasions. The fMRI task was a simple block design sensorimotor task. The impulse response functions to the stimulation block were derived using an FIR-deconvolution analysis with FMRISTAT. Six functionally-derived ROIs covering the visual, auditory and motor cortices, created from a prior analysis, were used. Two dependent variables were compared: percent signal change and contrast-to-noise-ratio. Reliability was assessed with intraclass correlation coefficients derived from a variance components analysis. Test–retest reliability was high, but initially, between-site reliability was low, indicating a strong contribution from site and site-by-subject variance. However, a number of factors that can markedly improve between-site reliability were uncovered, including increasing the size of the ROIs, adjusting for smoothness differences, and inclusion of additional runs. By employing multiple steps, between-site reliability for 3T scanners was increased by 123%. Dropping one site at a time and assessing reliability can be a useful method of assessing the sensitivity of the results to particular sites. These findings should provide guidance to others on the best practices for future multicenter studies. PMID:17636563

  15. Test-retest and between-site reliability in a multicenter fMRI study.

    Science.gov (United States)

    Friedman, Lee; Stern, Hal; Brown, Gregory G; Mathalon, Daniel H; Turner, Jessica; Glover, Gary H; Gollub, Randy L; Lauriello, John; Lim, Kelvin O; Cannon, Tyrone; Greve, Douglas N; Bockholt, Henry Jeremy; Belger, Aysenil; Mueller, Bryon; Doty, Michael J; He, Jianchun; Wells, William; Smyth, Padhraic; Pieper, Steve; Kim, Seyoung; Kubicki, Marek; Vangel, Mark; Potkin, Steven G

    2008-08-01

    In the present report, estimates of test-retest and between-site reliability of fMRI assessments were produced in the context of a multicenter fMRI reliability study (FBIRN Phase 1, www.nbirn.net). Five subjects were scanned on 10 MRI scanners on two occasions. The fMRI task was a simple block design sensorimotor task. The impulse response functions to the stimulation block were derived using an FIR-deconvolution analysis with FMRISTAT. Six functionally-derived ROIs covering the visual, auditory and motor cortices, created from a prior analysis, were used. Two dependent variables were compared: percent signal change and contrast-to-noise-ratio. Reliability was assessed with intraclass correlation coefficients derived from a variance components analysis. Test-retest reliability was high, but initially, between-site reliability was low, indicating a strong contribution from site and site-by-subject variance. However, a number of factors that can markedly improve between-site reliability were uncovered, including increasing the size of the ROIs, adjusting for smoothness differences, and inclusion of additional runs. By employing multiple steps, between-site reliability for 3T scanners was increased by 123%. Dropping one site at a time and assessing reliability can be a useful method of assessing the sensitivity of the results to particular sites. These findings should provide guidance toothers on the best practices for future multicenter studies.

  16. Outlook for the development of European forest resources; a study prepared for the European Forest Sector Outlook Study (EFSOS)

    NARCIS (Netherlands)

    Schelhaas, M.J.; Brusselen, van J.; Pussinen, A.; Pesonen, E.; Schuck, A.; Nabuurs, G.J.; Sasse, V.

    2006-01-01

    This Outlook for the Development of European Forest Resources provides the methodologies, data, scenarios, and results of the outlook on the European forest resources from 2000 to 2040. The aim of this forest resource study was to analyse the impacts on the European forest resources under the level

  17. Teaching European Studies: A Blended Learning Approach

    Directory of Open Access Journals (Sweden)

    Alina Christova

    2011-12-01

    Full Text Available This paper will be looking into the teaching method developed by the Institute for European Studies in Brussels, combining an e-learning tool- the E-modules- with face-to-face training sessions and webinars. The main aim is to analyse the three different components of this “blended learning” pedagogical approach, as well as the way they complement each other and to address a few of the challenges that have emerged from the experience of working with them so far. The E-modules are an e-learning platform that has been designed with the purpose of offering a structured and interactive way of learning how the European Union functions. The face-to-face training component currently takes the form of three days in-house seminars, covering in an intensive manner the most important areas of the curriculum. The lectures are held by a mix of academics and practitioners, hereby ensuring a balanced approach, in which theory and practice come together to facilitate the learning experience. The third element of the “blended learning” method is placed in-between online and face-to-face learning: interactive seminars and debates are held online, giving the participants the chance to deepen their knowledge in certain fields of interest and to discuss the content of the course with specialists and among themselves. The mixture of delivery and interaction methods was chosen in order to accommodate a large variety of target groups, ranging from students to professionals working with EU-related issues, with different backgrounds and geographical origins. One of the main challenges is to use each medium for the functionalities it is best designed for and to ensure that the various pieces of the pedagogical puzzle fit together perfectly, while allowing the learners the flexibility that had initially directed them towards “blended learning” instead of a classical classroom approach.

  18. Prospective validation of a prognostic model for respiratory syncytial virus bronchiolitis in late preterm infants: a multicenter birth cohort study

    NARCIS (Netherlands)

    Blanken, M.O.; Koffijberg, H.; Nibbelke, E.E.; Rovers, M.M.; Bont, L.; Liem, K.D.

    2013-01-01

    OBJECTIVES: This study aimed to update and validate a prediction rule for respiratory syncytial virus (RSV) hospitalization in preterm infants 33-35 weeks gestational age (WGA). STUDY DESIGN: The RISK study consisted of 2 multicenter prospective birth cohorts in 41 hospitals. Risk factors were

  19. Group level validation of protein intakes estimated by 24-hour diet recall and dietary questionnaires against 24-hour urinary nitrogen in the European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study

    NARCIS (Netherlands)

    Slimani, N.; Bingham, S.; Runswick, S.; Ferrari, P.; Day, N.E.; Welch, A.A.; Key, T.J.; Miller, A.B.; Boeing, H.; Sieri, S.; Veglia, F.; Palli, D.; Panico, S.; Tumino, R.; Bueno de Mesquita, B.; Ocké, M.C.; Clavel-Chapelon, F.; Trichopoulou, A.; Staveren, van W.A.; Riboli, E.

    2003-01-01

    A calibration approach was developed to correct for systematic between-cohort dietary measurement errors in the European Prospective Investigation into Cancer and Nutrition (EPIC), a large multicenter cohort study. To validate the 24-h diet recalls (24-HDRs) as reference measurements for

  20. Automated telecommunication to obtain longitudinal follow-up in a multicenter cross-sectional COPD study.

    Science.gov (United States)

    Stewart, Jeffrey I; Moyle, Sarah; Criner, Gerard J; Wilson, Carla; Tanner, Ron; Bowler, Russell P; Crapo, James D; Zeldin, Robert K; Make, Barry J; Regan, Elizabeth A; For The Copdgene Investigators

    2012-08-01

    It can be challenging to maintain longitudinal follow-up of subjects in clinical studies. COPDGene is a multicenter, observational study designed to identify genetic factors associated with COPD and to characterize COPD-related phenotypes. To obtain follow-up data on patient's vital status and outcomes, the COPDGene Longitudinal Follow-up (LFU) Program was developed to supplement its parent study. We used a telecommunication system that employed automated telephone contact or web-based questions to obtain longitudinal follow-up data in our subjects. A branching questionnaire asked about exacerbations, new therapies, smoking status, development of co-morbid conditions, and general health status. Study coordinators contacted subjects who did not respond to one of the automated methods. We enrolled 10,383 subjects in the COPDGene study. As of August 29, 2011, 7,959 subjects completed 19,955 surveys. On the first survey, 68.8% of subjects who completed their survey did so by electronic means, while 31.3% required coordinator phone follow-up. On each subsequent survey the number of subjects who completed their survey by electronic means increased, while the number of subjects who required coordinator follow-up decreased. Despite many of the patients in the cohort being chronically ill and elderly, there was broad acceptance of the system with over half the cohort using electronic response methods. The COPDGene LFU Study demonstrated that telecommunications was an effective way to obtain longitudinal follow-up of subjects in a large multicenter study. Web-based and automated phone contacts are accepted by research subjects and could serve as a model for LFU in future studies.

  1. The timing of discharge from the intensive care unit and subsequent mortality. A prospective, multicenter study.

    Science.gov (United States)

    Santamaria, John D; Duke, Graeme J; Pilcher, David V; Cooper, D James; Moran, John; Bellomo, Rinaldo

    2015-05-01

    Previous studies suggested an association between after-hours intensive care unit (ICU) discharge and increased hospital mortality. Their retrospective design and lack of correction for patient factors present at the time of discharge make this association problematic. To determine factors independently associated with mortality after ICU discharge. This was a prospective, multicenter, binational observational study involving 40 ICUs in Australia and New Zealand. Participants were consecutive adult patients discharged alive from the ICU between September 2009 and February 2010. We studied 10,211 patients discharged alive from the ICU. Median age was 63 years (interquartile range, 49-74), 6,224 (61%) were male, 5,707 (56%) required mechanical ventilation, and their median Acute Physiology and Chronic Health Evaluation III risk of death was 9% (interquartile range, 3-25%). A total of 8,539 (83.6%) patients were discharged in-hours (06:00-18:00) and 1,672 (16.4%) after-hours (18:00-06:00). Of these, 408 (4.8%) and 124 (7.4%), respectively, subsequently died in hospital (P time of ICU discharge including limitations of medical therapy (LOMT) orders, the time of discharge was no longer a significant predictor of mortality. The presence of a LOMT order was the strongest predictor of death (odds ratio, 35.4; 95% confidence interval, 27.5-45.6). In this large, prospective, multicenter, binational observational study, we found that patient status at ICU discharge, particularly the presence of LOMT orders, was the chief predictor of hospital survival. In contrast to previous studies, the timing of discharge did not have an independent association with mortality.

  2. Myocardial Infarct Size and Mortality Depend on the Time of Day—A Large Multicenter Study

    Science.gov (United States)

    Fournier, Stephane; Taffé, Patrick; Radovanovic, Dragana; Von Elm, Erik; Morawiec, Beata; Stauffer, Jean-Christophe; Erne, Paul; Beggah, Ahmed; Monney, Pierre; Pascale, Patrizio; Iglesias, Juan-Fernando; Eeckhout, Eric; Muller, Olivier

    2015-01-01

    Background Different studies have shown circadian variation of ischemic burden among patients with ST-Elevation Myocardial Infarction (STEMI), but with controversial results. The aim of this study was to analyze circadian variation of myocardial infarction size and in-hospital mortality in a large multicenter registry. Methods This retrospective, registry-based study was based on data from AMIS Plus, a large multicenter Swiss registry of patients who suffered myocardial infarction between 1999 and 2013. Peak creatine kinase (CK) was used as a proxy measure for myocardial infarction size. Associations between peak CK, in-hospital mortality, and the time of day at symptom onset were modelled using polynomial-harmonic regression methods. Results 6,223 STEMI patients were admitted to 82 acute-care hospitals in Switzerland and treated with primary angioplasty within six hours of symptom onset. Only the 24-hour harmonic was significantly associated with peak CK (p = 0.0001). The maximum average peak CK value (2,315 U/L) was for patients with symptom onset at 23:00, whereas the minimum average (2,017 U/L) was for onset at 11:00. The amplitude of variation was 298 U/L. In addition, no correlation was observed between ischemic time and circadian peak CK variation. Of the 6,223 patients, 223 (3.58%) died during index hospitalization. Remarkably, only the 24-hour harmonic was significantly associated with in-hospital mortality. The risk of death from STEMI was highest for patients with symptom onset at 00:00 and lowest for those with onset at 12:00. Discussion As a part of this first large study of STEMI patients treated with primary angioplasty in Swiss hospitals, investigations confirmed a circadian pattern to both peak CK and in-hospital mortality which were independent of total ischemic time. Accordingly, this study proposes that symptom onset time be incorporated as a prognosis factor in patients with myocardial infarction. PMID:25760988

  3. Myocardial infarct size and mortality depend on the time of day-a large multicenter study.

    Directory of Open Access Journals (Sweden)

    Stephane Fournier

    Full Text Available Different studies have shown circadian variation of ischemic burden among patients with ST-Elevation Myocardial Infarction (STEMI, but with controversial results. The aim of this study was to analyze circadian variation of myocardial infarction size and in-hospital mortality in a large multicenter registry.This retrospective, registry-based study was based on data from AMIS Plus, a large multicenter Swiss registry of patients who suffered myocardial infarction between 1999 and 2013. Peak creatine kinase (CK was used as a proxy measure for myocardial infarction size. Associations between peak CK, in-hospital mortality, and the time of day at symptom onset were modelled using polynomial-harmonic regression methods.6,223 STEMI patients were admitted to 82 acute-care hospitals in Switzerland and treated with primary angioplasty within six hours of symptom onset. Only the 24-hour harmonic was significantly associated with peak CK (p = 0.0001. The maximum average peak CK value (2,315 U/L was for patients with symptom onset at 23:00, whereas the minimum average (2,017 U/L was for onset at 11:00. The amplitude of variation was 298 U/L. In addition, no correlation was observed between ischemic time and circadian peak CK variation. Of the 6,223 patients, 223 (3.58% died during index hospitalization. Remarkably, only the 24-hour harmonic was significantly associated with in-hospital mortality. The risk of death from STEMI was highest for patients with symptom onset at 00:00 and lowest for those with onset at 12:00.As a part of this first large study of STEMI patients treated with primary angioplasty in Swiss hospitals, investigations confirmed a circadian pattern to both peak CK and in-hospital mortality which were independent of total ischemic time. Accordingly, this study proposes that symptom onset time be incorporated as a prognosis factor in patients with myocardial infarction.

  4. Myocardial infarct size and mortality depend on the time of day-a large multicenter study.

    Science.gov (United States)

    Fournier, Stephane; Taffé, Patrick; Radovanovic, Dragana; Von Elm, Erik; Morawiec, Beata; Stauffer, Jean-Christophe; Erne, Paul; Beggah, Ahmed; Monney, Pierre; Pascale, Patrizio; Iglesias, Juan-Fernando; Eeckhout, Eric; Muller, Olivier

    2015-01-01

    Different studies have shown circadian variation of ischemic burden among patients with ST-Elevation Myocardial Infarction (STEMI), but with controversial results. The aim of this study was to analyze circadian variation of myocardial infarction size and in-hospital mortality in a large multicenter registry. This retrospective, registry-based study was based on data from AMIS Plus, a large multicenter Swiss registry of patients who suffered myocardial infarction between 1999 and 2013. Peak creatine kinase (CK) was used as a proxy measure for myocardial infarction size. Associations between peak CK, in-hospital mortality, and the time of day at symptom onset were modelled using polynomial-harmonic regression methods. 6,223 STEMI patients were admitted to 82 acute-care hospitals in Switzerland and treated with primary angioplasty within six hours of symptom onset. Only the 24-hour harmonic was significantly associated with peak CK (p = 0.0001). The maximum average peak CK value (2,315 U/L) was for patients with symptom onset at 23:00, whereas the minimum average (2,017 U/L) was for onset at 11:00. The amplitude of variation was 298 U/L. In addition, no correlation was observed between ischemic time and circadian peak CK variation. Of the 6,223 patients, 223 (3.58%) died during index hospitalization. Remarkably, only the 24-hour harmonic was significantly associated with in-hospital mortality. The risk of death from STEMI was highest for patients with symptom onset at 00:00 and lowest for those with onset at 12:00. As a part of this first large study of STEMI patients treated with primary angioplasty in Swiss hospitals, investigations confirmed a circadian pattern to both peak CK and in-hospital mortality which were independent of total ischemic time. Accordingly, this study proposes that symptom onset time be incorporated as a prognosis factor in patients with myocardial infarction.

  5. Motor impairment after severe traumatic brain injury: A longitudinal multicenter study.

    Science.gov (United States)

    Walker, William C; Pickett, Treven C

    2007-01-01

    Neuromotor impairment is a common sequela of severe traumatic brain injury (TBI) but has been understudied relative to neurocognitive outcomes. This multicenter cohort study describes the longitudinal course of neurological examination-based motor abnormalities after severe TBI. Subjects were enrolled from the four lead Department of Veterans Affairs and Defense and Veterans Brain Injury Center sites. The study cohort consisted of 102 consecutive patients (active duty, veteran, or military dependent) with severe TBI who consented during acute rehabilitation for data collection and completed all follow-up evaluations. Paresis, ataxia, and postural instability measures showed a pattern of improvement over time, with the greatest improvement occurring between the inpatient (baseline) and 6-month follow-up assessments. Involuntary movement disorders were rare at all time points. Two years following acute rehabilitation, more than one-third of subjects continued to display a neuromotor abnormality on basic neurological examination. Persistence of tandem gait abnormality was particularly common.

  6. Effect of women's age on embryo morphology, cleavage rate and competence-A multicenter cohort study

    DEFF Research Database (Denmark)

    Grøndahl, Marie Louise; Christiansen, Sofie Lindgren; Kesmodel, Ulrik Schiøler

    2017-01-01

    .0001) with increasing age. Maternal age had no effect on cleavage parameters or on the morphology of the embryo day 2 post insemination. Interestingly, initial hCG value after single embryo transfer followed by ongoing pregnancy was increased with age in both IVF (p = 0.007) and ICSI (p = 0.001) cycles. For the first...... time, we show that a woman's age does impose a significant footprint on early embryo morphological development (3PN). In addition, the developmentally competent embryos were associated with increased initial hCG values as the age of the women increased. Further studies are needed to elucidate......This multicenter cohort study on embryo assessment and outcome data from 11,744 IVF/ICSI cycles with 104,830 oocytes and 42,074 embryos, presents the effect of women's age on oocyte, zygote, embryo morphology and cleavage parameters, as well as cycle outcome measures corrected for confounding...

  7. Immune reconstitution inflammatory syndrome associated with toxoplasmic encephalitis in hiv-infected patients : a multicenter cohort study

    NARCIS (Netherlands)

    van Bilsen, Ward P H; van den Berg, Charlotte H S B; Rijnders, Bart J A; Brinkman, Kees; Mulder, Jan W.; Gelinck, Luc B S; Hoepelman, Andy I M|info:eu-repo/dai/nl/074382160; Wit, Ferdinand W N M; van de Beek, Diederik; Prins, Jan M.

    OBJECTIVES:: To investigate the incidence and risk factors of immune reconstitution inflammatory syndrome (IRIS) associated with toxoplasmic encephalitis (TE) in patients starting cART. DESIGN:: A historical multicenter cohort study. METHODS:: We included all HIV-infected patients diagnosed with TE

  8. Risk Factors for Borderline Personality Disorder in Treatment Seeking Patients with a Substance Use Disorder : An International Multicenter Study

    NARCIS (Netherlands)

    Wapp, Manuela; van de Glind, Geurt; van Emmerik-van Oortmerssen, Katelijne; Dom, Geert; Verspreet, Sofie; Carpentier, Pieter Jan; Ramos-Quiroga, Josep Antoni; Skutle, Arvid; Bu, Eli-Torlid; Franck, Johan; Konstenius, Maija; Kaye, Sharlene; Demetrovics, Zsolt; Barta, Csaba; Fatseas, Melina; Auriacombe, Marc; Johnson, Brian; Faraone, Stephen V.; Levin, Frances R.; Allsop, Steve; Carruthers, Susan; Schoevers, Robert A.; Koeter, Maarten W. J.; van den Brink, Wim; Moggi, Franz

    2015-01-01

    Borderline personality disorder (BPD) and substance use disorders (SUDs) often co-occur, partly because they share risk factors. In this international multicenter study, risk factors for BPD were examined for SUD patients. In total, 1,205 patients were comprehensively examined by standardized

  9. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - A multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Loft, Annika

    2013-01-01

    OBJECTIVES: The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC). METHODS: 318 consecutive women with EC were included when...

  10. SEROPREVALENCE OF ANTIBODIES TO THE HUMAN-IMMUNODEFICIENCY-VIRUS IN DIALYSIS WORKERS - RESULTS OF A MULTICENTER STUDY

    NARCIS (Netherlands)

    BERLYNE, G; KACZMAREK, RG; HAMBURGER, S; HAMILTON, P; MOORE, RM; CHARNEY, AN; KAHN, T; GRUBER, M; KAUFMAN, CE; GOFFINET, J; BERNARD, MA

    1992-01-01

    The Center for Devices and Radiological Health, in collaboration with the Department of Veterans Affairs Medical Center, Brooklyn, N.Y., conducted a multi-center, multi-institutional study of the seroprevalence of antibodies to the human immunodeficiency virus (HIV) among dialysis workers. Seven

  11. Sentinel node biopsy in head and neck squamous cell cancer: 5-year follow-up of a European multicenter trial

    DEFF Research Database (Denmark)

    Alkureishi, Lee W T; Ross, Gary L; Shoaib, Taimur

    2010-01-01

    Sentinel node biopsy (SNB) may represent an alternative to elective neck dissection for the staging of patients with early head and neck squamous cell carcinoma (HNSCC). To date, the technique has been successfully described in a number of small single-institution studies. This report describes t...

  12. Antibiotic prescription patterns in Spanish cystic fibrosis patients: results from a national multicenter study

    Directory of Open Access Journals (Sweden)

    Concepción Prados

    2017-05-01

    Full Text Available Objective: Information about antibiotic prescription patterns for cystic fibrosis (CF patients and, specifically, about inhaled treatment strategies for their management is lacking in Spain due to the absence of a national patient registry. In this study we present data about antibiotic prescription in the Spanish CF context that were obtained in a multicenter study, being inhaled treatment strategies the special focus of this work.Methods: Twenty-four specialized CF units (12 adult, 12 pediatric from 17 tertiary- care hospitals covering all Spanish Autonomous Communities provided sputa and clinical data from 15 consecutive patients. Data about antibiotic and non-antibiotic therapies prescribed to these patients during the year prior inclusion (2013 were retrospectively collected.Results: The multicenter study included 341 CF patients from all age groups and clinical status. The prevalence of oral, inhaled and intravenous therapies was 89% (n = 302, 80% (n = 273 and 31% (n = 105, respectively. The most prevalent oral agents were ciprofloxacin (n = 177, 59%, cotrimoxazole (n = 109, 36% and amoxicillin-clavulanate (n = 99, 33%, whereas ceftazidime (n = 53, 50%, tobramycin (n = 43, 41% and meropenem (n = 41, 49% were the most prevalent intravenous ones. Two or more different inhaled antibiotics were administered to 67 patients (24%, 51 of them receiving 2 drugs continuously in alternating schemes. Nebulization of intravenous specific antibiotics was common (n = 39 and, in some cases, was used for maintenance purposes.Conclusions: These results show that the treatment of CF patients is evolving more rapidly than clinical consensus guidelines. Clinical trials evaluating new specific inhaled combinations and new alternative treatment regimes of the existing ones are needed.

  13. Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads.

    Science.gov (United States)

    Abdelhadi, Raed H; Saba, Samir F; Ellis, Christopher R; Mason, Pamela K; Kramer, Daniel B; Friedman, Paul A; Gura, Melanie T; DiMarco, John P; Mugglin, Andrew S; Reynolds, Matthew R; Bazaz, Raveen R; Retel, Linda Kallinen; Hayes, David L; Hauser, Robert G

    2013-03-01

    Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance. To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers. The study included adults who received St Jude Medical Riata or Riata ST leads. Data for Quattro Secure leads were obtained from an earlier study. From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2 ± 2.4 years vs 3.3 ± 1.7 years; Pleads failed (6.2%), including 62 of 774 Riata (8.0%) and 5 of 307 Riata ST (1.6%) leads. Forty-seven of 67 lead failures (70.1%) were caused by electrical malfunction, and 20 lead failures (29.9%) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32%) and 1 of 29 Riata ST (3.4%) leads. Of 26 Riata leads with ECs, 7 (27%) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (Plead survival was not different (P = .422). The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate. Copyright © 2013. Published by Elsevier Inc.

  14. Clinical Characteristics of Microscopic Colitis in Korea: Prospective Multicenter Study by KASID

    Science.gov (United States)

    Baek, Dae Hyun; Kim, Won Ho; Kim, Joo Sung; Yang, Suk-Kyun; Jung, Sung-Ae; Jang, Byung Ik; Choi, Chnag Hwan; Han, Dong Soo; Kim, Young-Ho; Chung, Yong Woo; Kim, Sang Woo; Kim, You Sun

    2011-01-01

    Background/Aims Microscopic colitis (MC) encompasses collagenous and lymphocytic colitis and is characterized by chronic diarrhea. In cases of MC, colonic mucosae are macroscopically normal, and diagnostic histopathological features are observed only upon microscopic examination. We designed a prospective multicenter study to determine the clinical features, pathological distribution in the colon and prevalence of MC in Korea. Methods We prospectively enrolled patients having watery diarrhea no more than 3 times a day between March 2008 and February 2009. We obtained patient histories and performed colonoscopies with random biopsies at each colon segment. Results A total of 100 patients with chronic diarrhea were enrolled for a normal colonoscopy and stool exam. MC was observed in 22 patients (22%) (M:F 1.2:1; mean age, 47.5 years). Of those 22 patients, 18 had lymphocytic colitis and 4 had collagenous colitis. The entire colon was affected in only 3 cases (13.6%), the ascending colon in 6 cases (27.2%), the transverse colon in 3 cases (13.6%), and the left colon in 3 cases (13.6%). More than 2 segments were affected in 7 cases (31.8%). Nonsteroidal anti-inflammatory drug-associated MCs were observed in 4 cases (18.2%), 3 of which showed improved diarrhea symptoms following discontinuation of the medication. Frequently associated symptoms were abdominal pain and weight loss. Autoimmune diseases were observed in 4 cases (18.2%). Half of the 22 patients with MC improved with conservative care by loperamide or probiotics. Conclusions In a prospective multicenter study of Korean patients with chronic diarrhea, the frequency of MC was found to be approximately 20%, similar to the percentage observed in Western countries. Therefore, the identification of MC is important for the adequate management of Korean patients with chronic diarrhea. PMID:21814598

  15. The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF

    Directory of Open Access Journals (Sweden)

    Birkenmaier Christof

    2010-09-01

    Full Text Available Abstract Background Because of the implant-related problems with pedicle screw-based spinal instrumentations, other types of fixation have been tried in spinal arthrodesis. One such technique is the direct trans-pedicular, trans-discal screw fixation, pioneered by Grob for spondylolisthesis. The newly developed GO-LIF procedure expands the scope of the Grob technique in several important ways and adds security by means of robotic-assisted navigation. This is the first clinical trial on the GO-LIF procedure and it will assess safety and efficacy. Methods/Design Multicentric prospective study with n = 40 patients to undergo single level instrumented spinal arthrodesis of the lumbar or the lumbosacral spine, based on a diagnosis of: painful disc degeneration, painful erosive osteochondrosis, segmental instability, recurrent disc herniation, spinal canal stenosis or foraminal stenosis. The primary target criteria with regards to safety are: The number, severity and cause of intra- and perioperative complications. The number of significant penetrations of the cortical layer of the vertebral body by the implant as recognized on postoperative CT. The primary target parameters with regards to feasibility are: Performance of the procedure according to the preoperative plan. The planned follow-up is 12 months and the following scores will be evaluated as secondary target parameters with regards to clinical improvement: VAS back pain, VAS leg pain, Oswestry Disability Index, short form - 12 health questionnaire and the Swiss spinal stenosis questionnaire for patients with spinal claudication. The secondary parameters with regards to construct stability are visible fusion or lack thereof and signs of implant loosening, implant migration or pseudarthrosis on plain and functional radiographs. Discussion This trial will for the first time assess the safety and efficacy of guided oblique lumbar interbody fusion. There is no control group, but the results, the

  16. Profile of Nigerians with diabetes mellitus - Diabcare Nigeria study group (2008: Results of a multicenter study

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    Sunday Chinenye

    2012-01-01

    Full Text Available Background: Diabetes Mellitus is the commonest endocrine-metabolic disorder in Nigeria similar to the experience in other parts of the world. The aim was to assess the clinical and laboratory profile, and evaluate the quality of care of Nigerian diabetics with a view to planning improved diabetes care. Materials and Methods: In a multicenter study across seven tertiary health centers in Nigeria, the clinical and laboratory parameters of diabetic out-patients were evaluated. Clinical parameters studied include type of diabetes, anthropometry, and blood pressure (BP status, chronic complications of diabetes, and treatment types. Laboratory data assessed included fasting plasma glucose (FPG, 2-h post-prandial (2-HrPP glucose, glycated hemoglobin (HbA1c, urinalysis, serum lipids, electrolytes, urea, and creatinine. Results: A total of 531 patients, 209 (39.4% males and 322 (60.6% females enrolled. The mean age of the patients was 57.1 ± 12.3 years with the mean duration of diabetes of 8.8 ± 6.6 years. Majority (95.4% had type 2 diabetes mellitus (DM compared to type 1 DM (4.6%, with P < 0.001. The mean FPG, 2-HrPP glucose, and HbA1c were 8.1 ± 3.9 mmol/L, 10.6 ± 4.6 mmol/L, and 8.3 ± 2.2%, respectively. Only 170 (32.4% and 100 (20.4% patients achieved the ADA and IDF glycemic targets, respectively. Most patients (72.8% did not practice self-monitoring of blood glucose. Hypertension was found in 322 (60.9%, with mean systolic BP 142.0 ± 23.7 mmHg, and mean diastolic BP 80.7 ± 12.7 mmHg. Diabetic complications found were peripheral neuropathy (59.2%, retinopathy (35.5%, cataracts (25.2%, cerebrovascular disease (4.7%, diabetic foot ulcers (16.0%, and nephropathy (3.2%. Conclusion: Most Nigerian diabetics have suboptimal glycemic control, are hypertensives, and have chronic complications of DM. Improved quality of care and treatment to target is recommended to reduce diabetes-related morbidity and mortality.

  17. Relationship between Nutritional Status and the Severity of Huntington’s Disease. A Spanish Multicenter Dietary Intake Study.

    Science.gov (United States)

    Cubo, Esther; Rivadeneyra, Jéssica; Armesto, Diana; Mariscal, Natividad; Martinez, Asunción; Camara, Rafael J

    2015-01-01

    Little is known about the impact of nutrition status on Huntington’s disease (HD) severity. To analyze the association of nutritional factors with HD severity. Observational, cross-sectional, national multicenter study. Participants were selected from a Spanish cohort of patients who participate in the European Huntington Disease Network (EHDN). The frequency of food consumption, caloric and nutrients intake in patients with HD were assessed using validated questionnaires for the Spanish population, and calculated using Alimentaci´on and Salud, version 2.0, and the Spanish Dietary Recommended Intakes were used as the gold standard. Disease severity was assessed using the Unified HD Rating Scale (UHDRS) and Total Functional Capacity (TFC). Logistic regression models were performed using the TFC as the dependent variable, and the macro-micronutrients as the independent variables, adjusted for age, gender, education, physical activity, and intake of supplements. Two hundred and twenty four patients with HD were included (59% women), mean age of 47.41±14.26 years, median TFC 9 (3–13), median UHDRS motor score of 33.5 (3.75–56), 75.8% with normal-high caloric intake, 55.4% normal BMI, and 54.4% with medium-high adherence to the Mediterranean diet. Compared to patients with mild-moderate HD, patients with severe HD had higher caloric intake (p = 0.02), and similar BMI (p = 0.33). Advanced HD was associated with higher intake of water-soluble vitamins (OR = 2.08; 95% CI = 1.12–3.85, p = 0.02), and minerals (OR = 1.86; 95% CI = 1.09– 3.19, p = 0.02). An adequate dietary intake prevents against weight loss in patients with advanced HD, but it is not associated with better functional state.

  18. Childhood Graves' ophthalmopathy: results of a European questionnaire study

    NARCIS (Netherlands)

    Krassas, G. E.; Segni, M.; Wiersinga, W. M.

    2005-01-01

    Objective: Evaluation of the frequency of Graves' ophthalmopathy (GO) and its management in children and adolescents up to 18 years old with Graves' hyperthyroidism. Study design: This was a questionnaire study (QS) among members of the European Thyroid Association and the European Society for

  19. Video-game epilepsy: a European study.

    Science.gov (United States)

    Kasteleijn-Nolst Trenité, D G; da Silva, A M; Ricci, S; Binnie, C D; Rubboli, G; Tassinari, C A; Segers, J P

    1999-01-01

    With the introduction of Nintendo video-games on a large scale, reports of children having seizures while playing suggested a possible specific, provocative factor. Although 50% of the photosensitive patients are also sensitive to a 50-Hz television, nonphotosensitive patients with a history of video-game seizures were described as well. The question arises whether this is a mere coincidence, provoked by fatigue and stress, is related to the reaction to the television screen itself, or depends on the movement and color of the pictures of this specific game. A European study was performed in four countries and five sites. All patients were selected because of a history of television, video- or computer-game seizures, with a history of sun-light-, discotheque-, or black and white pattern-evoked seizures, or were already known to be sensitive to intermittent photic stimulation. A total of 387 patients were investigated; 220 (75%) were female and 214 (55%) of those were Super Mario World and a standard relatively nonprovocative TV program, both on a 50- and 100-Hz television. Regardless of the distance, Super Mario World proved to be more provocative than the standard program (Wilcoxon, p computer-game seizure, were significantly more sensitive to pattern and to the 50-Hz television (chi square, p Super Mario, compared with the standard program (Wilcoxon, p = 0.001) and more sensitive with playing versus viewing (p = 0.016). Of the patients who were referred because of seizures in front of the television, or evoked by a video- or computer game, 14% proved not to be photosensitive. Although no difference in age or use of medication was found, twice as many men were found in this nonphotosensitive group.

  20. How to study the history of European law?

    DEFF Research Database (Denmark)

    Rasmussen, Morten

    the emerging academic field of European law was deeply involved in legitimating the jurisprudence of the Court of Justice in the 1960s. In the second part of the article, the starting point is to place mainstream legal and political science studies of European law in a historical perspective in order...... of the development of European law. To historians, mainstream legal and political science scholarship rather seems to be part of the research object....... constituted by the Commission’s legal service, transnationally organised pro-European jurists and the European Parliament. When the Court of Justice in the two key judgments, Van Gend en Loos (1963) and Costa V. ENEL (1964), took the decisive steps to transform European law into a semi-federal legal order...

  1. European contribution to the study of ROS

    DEFF Research Database (Denmark)

    Egea, Javier; Fabregat, Isabel; Frapart, Yves M

    2017-01-01

    The European Cooperation in Science and Technology (COST) provides an ideal framework to establish multi-disciplinary research networks. COST Action BM1203 (EU-ROS) represents a consortium of researchers from different disciplines who are dedicated to providing new insights and tools for better u...

  2. Accuracy of immunodiagnostic tests for active tuberculosis using single and combined results: a multicenter TBNET-Study.

    Directory of Open Access Journals (Sweden)

    Delia Goletti

    Full Text Available BACKGROUND: The clinical application of IFN-gamma release assays (IGRAs has recently improved the diagnosis of latent tuberculosis infection. In a multicenter study of the Tuberculosis Network European Trialsgroup (TBNET we aimed to ascertain in routine clinical practice the accuracy of a novel assay using selected peptides encoded in the mycobacterial genomic region of difference (RD 1 for the diagnosis of active tuberculosis in comparison with tuberculin skin test (TST, QuantiFERON-TB GOLD In-Tube (Cellestis Ltd., Carnegie, Australia and T-SPOT.TB (Oxfordimmunotec, Abingdon, UK. PRINCIPAL FINDINGS: 425 individuals from 6 different European centres were prospectively enrolled. We found that sensitivity of the novel test, TST, QuantiFERON-TB GOLD In-Tube and T-SPOT.TB was respectively 73.1%, 85.3%, 78.1%, and 85.2%; specificity was respectively 70.6%, 48.0%, 61.9% and 44.3%; positive likelihood ratios were respectively 2.48, 1.64, 2.05, and 1.53; negative likelihood ratios were respectively 0.38, 0.31, 0.35, 0.33. Sensitivity of TST combined with the novel test, QuantiFERON-TB GOLD In-Tube and T-SPOT.TB increased up to 92.4%, 97.7% and 97.1%, respectively. The likelihood ratios of combined negative results of TST with, respectively, the novel test, QuantiFERON-TB GOLD In-Tube and T-SPOT.TB were 0.19, 0.07 and 0.10. CONCLUSIONS: The assay based on RD1 selected peptides has similar accuracy for active tuberculosis compared with TST and commercial IGRAs. Then, independently of the spectrum of antigens used in the assays to elicit mycobacterial specific immune responses, the novel test, IGRAs, and the TST do not allow an accurate identification of active tuberculosis in clinical practice. However, the combined use of the novel assay or commercial IGRAs with TST may allow exclusion of tuberculosis.

  3. Linking Public Administration and Law Studies within European Union

    Directory of Open Access Journals (Sweden)

    Mihaela V. Cărăuşan

    2012-05-01

    Full Text Available The year 1987 represented for us, scholars, the turning point for the Europeanization of highdegree studies. The European Region Action Scheme for the Mobility of University Students (ERASMUS isa European Union student exchange program which has proved its utility in the last two decade. The publicadministration and law studies are two of the fields of studies which have benefited from the ERASMUSProgramme. In this respect we will try to learn the lesson of internationalization from the European contactthrough ERASMUS programme. The ‘win win’ for students is not just in the increase of knowledge in thearea of administrative sciences and law, but also in the share of cultures. The ERASMUS gives students abetter sense of what it means to be a European citizen. In addition, many employers highly value such aperiod abroad, which increases the students’ employability and job prospects.

  4. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus: The DALI Lifestyle Pilot

    NARCIS (Netherlands)

    Simmons, D.; Jelsma, J.G.M.; Galjaard, S.; Devlieger, R.; van Assche, A.; Jans, G.; Corcoy, R.; Adelantado, J.M.; Dunne, F.; Desoye, G.; Harreiter, J.; Kautzky-Willer, A.; Damm, P.; Mathiesen, E.R.; Jensen, D.M.; Andersen, L.L.; Lapolla, A.; Dalfra, M.; Bertolotto, A.; Wender-Ozegowska, E.; Zawiejska, A.; Hill, D.; Rebollo, P.; Snoek, F.J.; van Poppel, M.N.M.

    2015-01-01

    OBJECTIVE Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS Pregnant

  5. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus

    DEFF Research Database (Denmark)

    Simmons, David; Jelsma, Judith G M; Galjaard, Sander

    2015-01-01

    OBJECTIVE: Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS...

  6. Cognitive dysfunction is associated with poor socioeconomic status in patients with cirrhosis: an international multicenter study.

    Science.gov (United States)

    Bajaj, Jasmohan S; Riggio, Oliviero; Allampati, Sanath; Prakash, Ravi; Gioia, Stefania; Onori, Eugenia; Piazza, Nicole; Noble, Nicole A; White, Melanie B; Mullen, Kevin D

    2013-11-01

    In patients with cirrhosis, cognitive dysfunction most often results from covert hepatic encephalopathy (HE). These patients are not tested routinely for cognitive dysfunction despite single-center evidence that it could be associated with poor socioeconomic status (SES). We investigated the association between SES and cognition in a multicenter study of cirrhosis. In a cross-sectional study, 236 cirrhotic patients from 3 centers (84 subjects from Virginia, 102 from Ohio, and 50 from Rome, Italy; age 57.7 ± 8.6 y; 14% with prior overt HE) were given recommended cognitive tests and a validated SES questionnaire that included questions about employment, personal and family income, and overall financial security. Comparisons were made among centers and between subjects who were employed or not. Regression analysis was performed using employment and personal income as outcomes. Only 37% of subjects had been employed in the past year. Subjects had substantial financial insecurity-their yearly personal income ranged from $16,000 to $24,999, and their family income ranged from $25,000 to $49,999. They would be able to maintain a residence for only 3 to 6 months if their income stopped, and their current liquid assets were $500 to $4999 (<$500 if debt was subtracted). Cognition and SES were worst in Ohio and best in Virginia. Cognition correlated with personal and family income, within and between centers. On regression analysis, cognitive performance (digit symbol, lures, and line tracing) was associated with personal yearly income, after controlling for demographics, country, employment, and overt HE. Unemployed subjects had a higher rate of overt HE, worse cognition, and lower personal income than employed subjects. On regression analysis, performance on digit symbol, line tracing, inhibitory control test lures, and serial dotting tests remained associated with employment, similar to income. In an international multicenter study of patients with cirrhosis

  7. Anti-ribosomal P antibody: a multicenter study in childhood-onset systemic lupus erythematosus patients.

    Science.gov (United States)

    Valões, C C M; Molinari, B C; Pitta, A C G; Gormezano, N W S; Farhat, S C L; Kozu, K; Sallum, A M E; Appenzeller, S; Sakamoto, A P; Terreri, M T; Pereira, R M R; Magalhães, C S; Ferreira, J C O A; Barbosa, C M; Gomes, F H; Bonfá, E; Silva, C A

    2017-04-01

    Objectives Anti-ribosomal P protein (anti-P) autoantibodies are highly specific for systemic lupus erythematosus (SLE). However, the evaluation of this autoantibody in childhood-onset SLE (cSLE) populations has been limited to a few small series, hampering the interpretation of the clinical and laboratorial associations. Therefore, the objective of this multicenter cohort study was to evaluate demographic, clinical/laboratorial features, and disease damage score in cSLE patients with and without the presence of anti-P antibody. Methods This was a retrospective multicenter study performed in 10 pediatric rheumatology services of São Paulo state, Brazil. Anti-P antibodies were measured by ELISA in 228 cSLE patients. Results Anti-P antibodies were observed in 61/228 (27%) cSLE patients. Frequencies of cumulative lymphadenopathy (29% vs. 15%, p = 0.014), acute confusional state (13% vs. 5%, p = 0.041), mood disorder (18% vs. 8%, p = 0.041), autoimmune hemolytic anemia (34% vs. 15%, p = 0.001), as well as presence of anti-Sm (67% vs. 40%, p = 0.001), anti-RNP (39% vs. 21%, p = 0.012) and anti-Ro/SSA antibodies (43% vs. 25%, p = 0.016) were significantly higher in cSLE patients with anti-P antibodies compared to those without these autoantibodies. A multiple regression model revealed that anti-P antibodies were associated with autoimmune hemolytic anemia (odds ratio (OR) = 2.758, 95% confidence interval (CI): 1.304-5.833, p = 0.008) and anti-Sm antibody (OR = 2.719, 95% CI: 1.365-5.418, p = 0.004). The SLICC/ACR damage index was comparable in patients with and without anti-P antibodies ( p = 0.780). Conclusions The novel association of anti-P antibodies and autoimmune hemolytic anemia was evidenced in cSLE patients and further studies are necessary to determine if anti-P titers may vary with this hematological manifestation.

  8. Predictors of wound infection in elective colorectal surgery. Multicenter observational case-control study.

    Science.gov (United States)

    Fraccalvieri, Doménico; Kreisler Moreno, Esther; Flor Lorente, Blas; Torres García, Antonio; Muñoz Calero, Alberto; Mateo Vallejo, Francisco; Biondo, Sebastiano

    2014-01-01

    The aim of this study is to evaluate the usefulness of Vicryl Plus(®) suture in reducing the rate of postoperative wound infection in elective colorectal surgery. A prospective case-control multicenter study with 480 patients undergoing elective colorectal surgery was performed between 2006 and 2007. Patients were divided in 2 groups of equal sample size: group 1, closure of the abdominal wall using Vicryl Plus(®) and group 2 where PDS II(®) was used. The study involved 5 hospitals in the Spanish State. Wound infection was classified into superficial and deep. All patients diagnosed of wound infection during the hospital stay and up to 30 days after discharge were studied. For the statistical analysis Chi-square test and Fisher exact were used for bivariate analysis and logistic regression model for multivariate analysis. Wound infection rates were significantly lower in group 1: 14.6 vs. 29.2. Multivariate analysis showed that risk of wound infection was higher in patients with cancer, lung disease, anemia, operative time greater than 2 h, lack of second dose intra-operative prophylactic antibiotic and laparotomy closure with PDS suture II(®). The use of suture coated with triclosan can be an effective prophylactic tool in reducing wound infection rate in patients undergoing elective colorectal surgery. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  9. Apathy and Leukoaraiosis in Mild Cognitive Impairment and Alzheimer's Disease: Multicenter Diagnostic Criteria according to the Latest Studies

    Directory of Open Access Journals (Sweden)

    Carmen María Sarabia-Cobo

    2014-07-01

    Full Text Available Aims: The aim is to study the prevalence and possible relationship of apathy and leukoaraiosis in cases of cognitive impairment of varying severity in Spain. Methods: We conducted a cross-sectional, descriptive, multicenter study involving 109 patients with Alzheimer's disease (AD and 59 with mild cognitive impairment (MCI. Results: The older group with AD had a higher prevalence of leukoaraiosis and apathy, with significant differences compared to the MCI group. Conclusions: To our knowledge, this is the first multicenter study in our country that jointly analyzes the presence of apathy and leukoaraiosis in the institutionalized elderly with varying degrees of cognitive impairment according to the most recent criteria for detecting apathy in dementia.

  10. Herpes zoster infection in childhood-onset systemic lupus erythematosus patients: a large multicenter study.

    Science.gov (United States)

    Ferreira, J C O A; Marques, H H; Ferriani, M P L; Gormezano, N W S; Terreri, M T; Pereira, R M; Magalhães, C S; Campos, L M; Bugni, V; Okuda, E M; Marini, R; Pileggi, G S; Barbosa, C M; Bonfá, E; Silva, C A

    2016-06-01

    The aim of this multicenter study in a large childhood-onset systemic lupus erythematosus (cSLE) population was to assess the herpes zoster infection (HZI) prevalence, demographic data, clinical manifestations, laboratory findings, treatment, and outcome. A retrospective multicenter cohort study (Brazilian cSLE group) was performed in ten Pediatric Rheumatology services in São Paulo State, Brazil, and included 852 cSLE patients. HZI was defined according to the presence of acute vesicular-bullous lesions on erythematous/edematous base, in a dermatomal distribution. Post-herpetic neuralgia was defined as persistent pain after one month of resolution of lesions in the same dermatome. Patients were divided in two groups for the assessment of current lupus manifestations, laboratory findings, and treatment: patients with HZI (evaluated at the first HZI) and patients without HZI (evaluated at the last visit). The frequency of HZI in cSLE patients was 120/852 (14%). Hospitalization occurred in 73 (61%) and overlap bacterial infection in 16 (13%). Intravenous or oral aciclovir was administered in 113/120 (94%) cSLE patients at HZI diagnosis. None of them had ophthalmic complication or death. Post-herpetic neuralgia occurred in 6/120 (5%). After Holm-Bonferroni correction for multiple comparisons, disease duration (1.58 vs 4.41 years, p < 0.0001) was significantly lower in HZI cSLE patients compared to those without HZI. Nephritis (37% vs 18%, p < 0.0001), lymphopenia (32% vs 17%, p < 0.0001) prednisone (97% vs 77%, p < 0.0001), cyclophosphamide (20% vs 5%, p < 0.0001) and SLE Disease Activity Index 2000 (6.0 (0-35) vs 2 (0-45), p < 0.0001) were significantly higher in the former group. The logistic regression model showed that four independent variables were associated with HZI: disease duration < 1 year (OR 2.893 (CI 1.821-4.597), p < 0.0001), lymphopenia <1500/mm(3) (OR 1.931 (CI 1.183-3.153), p = 0.009), prednisone (OR 6.723 (CI 2

  11. Nationwide, Multicenter, Retrospective Study on High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Yoshioka, Yasuo, E-mail: yoshioka@radonc.med.osaka-u.ac.jp [Department of Radiation Oncology, Osaka University Graduate School of Medicine, Osaka (Japan); Kotsuma, Tadayuki [Department of Radiation Oncology, Osaka National Hospital, Osaka (Japan); Komiya, Akira [Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama (Japan); Department of Urology, Chiba University Hospital, Chiba (Japan); Kariya, Shinji [Department of Radiology, Kochi Medical School, Kochi (Japan); Konishi, Koji [Department of Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan); Nonomura, Norio [Department of Urology, Osaka University Graduate School of Medicine, Osaka (Japan); Ogawa, Kazuhiko [Department of Radiation Oncology, Osaka University Graduate School of Medicine, Osaka (Japan); Tanaka, Eiichi [Department of Radiation Oncology, Osaka National Hospital, Osaka (Japan); Nishimura, Kensaku [Department of Urology, Osaka National Hospital, Osaka (Japan); Fujiuchi, Yasuyoshi; Kitamura, Hiroshi [Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama (Japan); Yamagami, Takuji [Department of Radiology, Kochi Medical School, Kochi (Japan); Yamasaki, Ichiro [Department of Urology, Kochi Medical School, Kochi (Japan); Nishimura, Kazuo [Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan); Teshima, Teruki [Department of Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan); Nakamura, Katsumasa [Department of Radiation Oncology, Hamamatsu University School of Medicine, Shizuoka (Japan); Itami, Jun [Department of Radiation Oncology, National Cancer Center Hospital, Tokyo (Japan)

    2017-04-01

    Purpose: To present, analyze, and discuss results of a nationwide, multicenter, retrospective study on high-dose-rate brachytherapy (HDR-BT) as monotherapy for low-, intermediate-, and high-risk prostate cancer. Methods and Materials: From 1995 through 2013, 524 patients, 73 (14%) with low-risk, 207 (40%) with intermediate-risk, and 244 (47%) with high-risk prostate cancer, were treated with HDR-BT as monotherapy at 5 institutions in Japan. Dose fractionations were 27 Gy/2 fractions for 69 patients (13%), 45.5 Gy/7 fractions for 168 (32%), 49 Gy/7 fractions for 149 (28%), 54 Gy/9 fractions for 130 (25%), and others for 8 (2%). Of these patients, 156 (30%) did not receive androgen deprivation therapy, and 202 patients (39%) did receive androgen deprivation therapy <1 year, 112 (21%) for 1-3 years, and 54 (10%) for >3 years. Median follow-up time was 5.9 years (range, 0.4-18.1 years), with a minimum of 2 years for surviving patients. Results: After 5 years, respective actuarial rates of no biochemical evidence of disease, overall survival, cause-specific survival, and metastasis-free survival for all patients were 92%, 97%, 99%, and 94%. For low/intermediate/high-risk patients, the 5-year no biochemical evidence of disease rates were 95%/94%/89%, the 5-year overall survival rates were 98%/98%/94%, the 5-year cause-specific survival rates were 98%/100%/98%, and the 5-year metastasis-free survival rates were 98%/95%/90%, respectively. The cumulative incidence of late grade 2 to 3 genitourinary toxicity at 5 years was 19%, and that of late grade 3 was 1%. The corresponding incidences of gastrointestinal toxicity were 3% and 0% (0.2%). No grade 4 or 5 of either type of toxicity was detected. Conclusions: The findings of this nationwide, multicenter, retrospective study demonstrate that HDR-BT as monotherapy was safe and effective for all patients with low-, intermediate-, and high-risk prostate cancer.

  12. German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients.

    Science.gov (United States)

    Rahbar, Kambiz; Ahmadzadehfar, Hojjat; Kratochwil, Clemens; Haberkorn, Uwe; Schäfers, Michael; Essler, Markus; Baum, Richard P; Kulkarni, Harshad R; Schmidt, Matthias; Drzezga, Alexander; Bartenstein, Peter; Pfestroff, Andreas; Luster, Markus; Lützen, Ulf; Marx, Marlies; Prasad, Vikas; Brenner, Winfried; Heinzel, Alexander; Mottaghy, Felix M; Ruf, Juri; Meyer, Philipp Tobias; Heuschkel, Martin; Eveslage, Maria; Bögemann, Martin; Fendler, Wolfgang Peter; Krause, Bernd Joachim

    2017-01-01

    177Lu-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). Initiated by the German Society of Nuclear Medicine, a retrospective multicenter data analysis was started in 2015 to evaluate efficacy and safety of 177Lu-PSMA-617 in a large cohort of patients. One hundred forty-five patients (median age, 73 y; range, 43-88 y) with mCRPC were treated with 177Lu-PSMA-617 in 12 therapy centers between February 2014 and July 2015 with 1-4 therapy cycles and an activity range of 2-8 GBq per cycle. Toxicity was categorized by the common toxicity criteria for adverse events (version 4.0) on the basis of serial blood tests and the attending physician's report. The primary endpoint for efficacy was biochemical response as defined by a prostate-specific antigen decline ≥ 50% from baseline to at least 2 wk after the start of RLT. A total of 248 therapy cycles were performed in 145 patients. Data for biochemical response in 99 patients as well as data for physician-reported and laboratory-based toxicity in 145 and 121 patients, respectively, were available. The median follow-up was 16 wk (range, 2-30 wk). Nineteen patients died during the observation period. Grade 3-4 hematotoxicity occurred in 18 patients: 10%, 4%, and 3% of the patients experienced anemia, thrombocytopenia, and leukopenia, respectively. Xerostomia occurred in 8%. The overall biochemical response rate was 45% after all therapy cycles, whereas 40% of patients already responded after a single cycle. Elevated alkaline phosphatase and the presence of visceral metastases were negative predictors and the total number of therapy cycles positive predictors of biochemical response. The present retrospective multicenter study of 177Lu-PSMA-617 RLT demonstrates favorable safety and high efficacy exceeding those of other third-line systemic therapies in mCRPC patients. Future phase II/III studies are warranted to

  13. Does lung cancer surgery cause circulating tumor cells?-A multicenter, prospective study.

    Science.gov (United States)

    Matsutani, Noriyuki; Sawabata, Noriyoshi; Yamaguchi, Masafumi; Woo, Tetsukan; Kudo, Yujin; Kawase, Akikazu; Shiono, Satoshi; Iinuma, Hisae; Morita, Shigeki; Kawamura, Masafumi

    2017-08-01

    Cancer relapse is caused by residual isolated tumor cells (ITCs) remaining in the body after surgery. It is speculated that surgical manipulation may cause circulating tumor cells (CTCs) which are the origin of ITCs in the body. The occurrence of CTCs in surgical patients with non-small cell lung cancer (NSCLC) has been shown in retrospective observation, but not prospectively, thus we conducted a multicenter prospective study regarding the occurrence of CTCs by surgical manipulation. Patients with T1b-2N0M0 lung cancer were studied. Blood samples were collected from the peripheral artery in the operating room at both pre- and post-lobectomy to extract CTCs by a size selection method. The CTCs detection rate, pathological findings, and background of each patient were studied. The histological diagnosis of 29 patients were adenocarcinoma in 24 patients, squamous cell carcinoma in 3 patients, and other types in 2 patients. The number of pre-CTCs positive patients was 13 and the number of post CTCs positive patients was 17. Among the 16 patients who were pre-CTCs negative, 4 patients showed post CTCs positive, while all pre-CTCs positive patients remained post-CTCs positive. The likelihood of CTC dislodgement by surgical manipulation is indicated based on the result that CTCs were detected after lung cancer surgery, where there were no cases of pre-CTCs positive and post CTCs negative.

  14. Acceptance of living liver donation among medical students: A multicenter stratified study from Spain

    Science.gov (United States)

    Ríos, Antonio; López-Navas, Ana Isabel; López-López, Ana Isabel; Gómez, Francisco Javier; Iriarte, Jorge; Herruzo, Rafael; Blanco, Gerardo; Llorca, Francisco Javier; Asunsolo, Angel; Sánchez-Gallegos, Pilar; Gutiérrez, Pedro Ramón; Fernández, Ana; de Jesús, María Teresa; Martínez-Alarcón, Laura; Lana, Alberto; Fuentes, Lorena; Hernández, Juan Ramón; Virseda, Julio; Yelamos, José; Bondía, José Antonio; Hernández, Antonio Miguel; Ayala, Marco Antonio; Ramírez, Pablo; Parrilla, Pascual

    2016-01-01

    AIM: To analyze the attitude of Spanish medical students toward living liver donation (LLD) and to establish which factors have an influence on this attitude. METHODS: Study type: A sociological, interdisciplinary, multicenter and observational study. Study population: Medical students enrolled in Spain (n = 34000) in the university academic year 2010-2011. Sample size: A sample of 9598 students stratified by geographical area and academic year. Instrument used to measure attitude: A validated questionnaire (PCID-DVH RIOS) was self-administered and completed anonymously. Data collection procedure: Randomly selected medical schools. The questionnaire was applied to each academic year at compulsory sessions. Statistical analysis: Student´s t test, χ2 test and logistic regression analysis. RESULTS: The completion rate was 95.7% (n = 9275). 89% (n = 8258) were in favor of related LLD, and 32% (n = 2937) supported unrelated LLD. The following variables were associated with having a more favorable attitude: (1) age (P = 0.008); (2) sex (P donation (P donation (P donated liver segment from a family member if one were needed (P donation (P < 0.001). CONCLUSION: Spanish medical students have a favorable attitude toward LLD. PMID:27433093

  15. A Multi-Center, Cross-Sectional Study on the Burden of Infectious Keratitis in China

    Science.gov (United States)

    Song, Xiusheng; Xie, Lixin; Tan, Xiaodong; Wang, Zhichong; Yang, Yanning; Yuan, Yuansheng; Deng, Yingping; Fu, Shaoying; Xu, Jianjiang; Sun, Xuguang; Sheng, Xunlun; Wang, Qing

    2014-01-01

    Objective To understand the prevalence and demographic characteristics of infectious keratitis and infectious corneal blindness. Methods A multi-center, population-based cross-sectional study was conducted from January 1 to August 31, 2010. A total of 191,242 individuals of all age groups from 10 geographically representative provinces were sampled using stratified, multi-stage, random and systematic sampling procedures. A majority, 168,673 (88.2%), of those sampled participated in the study. The examination protocol included a structured interview, visual acuity testing, an external eye examination, and an anterior segment examination using a slit lamp. The causes and sequelae of corneal disease were identified using uniform customized protocols. Blindness in one eye caused by infectious keratitis was defined as infectious corneal blindness. Results The prevalence of past and active infectious keratitis was 0.192% (95% confidence interval [CI], 0.171–0.213%), and the prevalence of viral, bacterial, and fungal keratitis was 0.11%, 0.075%, and 0.007%, respectively. There were 138 cases of infectious corneal blindness in at least one eye in the study population (prevalence of 0.082% [95%CI, 0.068%–0.095%]). Statistical analysis suggested that ocular trauma, alcoholic consumption, low socioeconomic levels, advanced age, and poor education were risk factors for infectious corneal blindness. Conclusions Infectious keratitis is the leading cause of corneal blindness in China. Eye care strategies should focus on the prevention and rehabilitation of infectious corneal blindness. PMID:25438169

  16. Prospective multicenter study of bronchiolitis: predicting safe discharges from the emergency department.

    Science.gov (United States)

    Mansbach, Jonathan M; Clark, Sunday; Christopher, Norman C; LoVecchio, Frank; Kunz, Sarah; Acholonu, Uchechi; Camargo, Carlos A

    2008-04-01

    Bronchiolitis is the leading cause of hospitalization for infants. Our objective was to identify factors associated with safe discharge to home from the emergency department. We conducted a prospective cohort study during 2 consecutive bronchiolitis seasons, from 2004 to 2006. Thirty US emergency departments contributed data. All patients were or = 2 months, no history of intubation, a history of eczema, age-specific respiratory rates ( or = 94%, fewer albuterol or epinephrine treatments in the first hour, and adequate oral intake. The importance of each factor varied slightly according to age, but the comprehensive model (developed and validated for all children < 2 years of age) yielded an area under the receiver operating characteristic curve of 0.81, with a good fit of the data. This large multicenter study of children presenting to the emergency department with bronchiolitis identified several factors associated with safe discharge, including cut points for respiratory rate and oxygen saturation. Although the low-risk model requires further study, we believe that it will assist clinicians evaluating children with bronchiolitis and may help reduce some unnecessary hospitalizations.

  17. Factors associated with nursing students' academic success or failure: a retrospective Italian multicenter study.

    Science.gov (United States)

    Dante, A; Valoppi, G; Saiani, L; Palese, A

    2011-01-01

    With the increasing standardization of nursing education in Europe under the Bologna Process Declaration (1999), there is a growing interest in defining a common concept of academic success and/or failure, measuring associated factors and comparing differences and similarities between different countries. While there is literature available on these issues from other countries, the phenomenon has not been studied in Italy. The aim of this study was to define the factors associated with academic success or failure in an Italian cohort of nursing students on a bachelor's degree course. A retrospective multicenter study design was adopted. All students enrolling in the academic year 2004-05 on two different bachelor's courses in the north of Italy were interviewed. Only 81 of the 117 students considered (69.2%) concluded their course in three years. Multivariate analysis identified two factors determining academic success/failure: good results in the entry examination for the bachelor's degree in nursing sciences were associated with academic success (OR 4.217, IC(95%) 1.501-11.84), while family commitments, e.g. caring for children or elderly people were associated with academic failure (OR 0.120, IC(95%) 0.03-0.471). Academic failure has a strong impact on students, their families, the teaching faculties and the community, and its prevention is a challenge in the countries with a shortage of nurses. Copyright © 2010 Elsevier Ltd. All rights reserved.

  18. Effectiveness of Robot Paro in Intramural Psychogeriatric Care: A Multicenter Quasi-Experimental Study.

    Science.gov (United States)

    Bemelmans, Roger; Gelderblom, Gert Jan; Jonker, Pieter; de Witte, Luc

    2015-11-01

    Together with care professionals, specific psychogeriatric care applications were developed for the seal robot Paro. This study aims to evaluate the outcomes of the developed Paro interventions, applying the robot in psychogeriatric care. A multicenter quasi-experimental time series ABAB study (n = 91) with within-subject comparison was conducted to assess both the short-term effects of the Paro interventions for therapeutic applications, and the facilitation of daily care activities by care providers. Small-scale care units (8-10 residents each), spread over 6 different locations, in 3 Dutch care institutions for intramural psychogeriatric care. A total of 91 patients with dementia, in all stages of dementia. Two user-centered intervention types were applied, one for therapeutic purposes and one for the facilitation of daily care activities. Effectiveness was measured with a goal attainment scale (IPPA) and a mood scale (Coop/Wonca), by means of a registration form. A total of 106 user-specific interventions were defined for 91 participants; 71 participants completed the study, 14 were men and 57 were women. All interventions combined show a significant effect (P < .001). Paro should be seen as a tool for care staff and not as a replacement of care. Successful implementation of Paro in daily intramural psychogeriatric care practice can increase the quality of care and the quality of life for the elderly. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  19. Natural history of relapsed myeloma, refractory to immunomodulatory drugs and proteasome inhibitors: a multicenter IMWG study.

    Science.gov (United States)

    Kumar, S K; Dimopoulos, M A; Kastritis, E; Terpos, E; Nahi, H; Goldschmidt, H; Hillengass, J; Leleu, X; Beksac, M; Alsina, M; Oriol, A; Cavo, M; Ocio, E M; Mateos, M V; O'Donnell, E K; Vij, R; Lokhorst, H M; van de Donk, N W C J; Min, C; Mark, T; Turesson, I; Hansson, M; Ludwig, H; Jagannath, S; Delforge, M; Kyriakou, C; Hari, P; Mellqvist, U; Usmani, S Z; Dytfeld, D; Badros, A Z; Moreau, P; Kim, K; Otero, P R; Lee, J H; Shustik, C; Waller, D; Chng, W J; Ozaki, S; Lee, J-J; de la Rubia, J; Eom, H S; Rosinol, L; Lahuerta, J J; Sureda, A; Kim, J S; Durie, B G M

    2017-11-01

    Introduction of new myeloma therapies offers new options for patients refractory to immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). In this multicenter study, patients with relapsed multiple myeloma, who have received at least three prior lines of therapy, are refractory to both an IMiD (lenalidomide or pomalidomide) and a PI (bortezomib or carfilzomib), and have been exposed to an alkylating agent were identified. The time patients met the above criteria was defined as time zero (T0). Five hundred and forty-three patients diagnosed between 2006 and 2014 were enrolled in this study. Median age at T0 was 62 years (range 31-87); 61% were males. The median duration between diagnosis and T0 was 3.1 years. The median number of lines of therapy before T0 was 4 (range 3-13). The median overall survival (OS) from T0 for the entire cohort was 13 (95% confidence interval (CI) 11, 15) months. At least one regimen recorded after T0 in 462 (85%) patients, with a median (95% CI) progression-free survival and OS from T0 of 5 (4, 6), and 15.2 (13, 17) months, respectively. The study provides the expected outcome of relapsed multiple myeloma that is refractory to a PI and an IMiD, a benchmark for comparison of new therapies being evaluated.

  20. Prevalence of genital Chlamydia trachomatis infections in Russia: systematic literature review and multicenter study.

    Science.gov (United States)

    Smelov, Vitaly; Thomas, Pierre; Ouburg, Sander; Morré, Servaas A

    2017-09-29

    A reliable overview of data on the prevalence of Chlamydia trachomatis (CT) in Russia is lacking and needed. All the available data on CT prevalence were analyzed in a systematic literature review on CT prevalence in Russia, strengthened with data from the multicenter study among 1263 people in the second-largest Russian megalopolis, St. Petersburg, testing for CT DNA in urethral, anal, cervical and prostate samples. A total of 10 articles met the inclusion criteria. The overall average prevalence of genital CT infections in Russian populations ranged from 2.9% to 33%. Risk factors included being symptomatic (P = 0.004; in men P < 0.001), being younger than 30 years (P = 0.001) and being a man who has sex with men (MSM) (P = 0.0084). Main limitations included the lack of studies in MSM. CT prevalence was higher in the groups where urethral and prostate secretion samples were pooled (5.2%-7.3% vs 3.2% in the urethra only). The data on CT prevalence in a range of Russian populations are analyzed and reported. Prostate secretions represent an additional sampling material for the study of CT infection in men. CT detection in some settings in St. Petersburg yielded levels of reliability comparable with internationally available tests. The initiation of screening programs for Chlamydia infections in Russia should be considered. © FEMS 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  1. ADALIMUMAB FOR ULCERATIVE COLITIS: RESULTS OF A BRAZILIAN MULTICENTER OBSERVATIONAL STUDY

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    Patrícia ZACHARIAS

    2017-10-01

    Full Text Available ABSTRACT BACKGROUND: Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce. OBJECTIVE: To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. METHODS: Observational, multicenter and retrospective study on a case series of patients with moderate-to-severe ulcerative colitis under adalimumab therapy. The variables analyzed were: demographic data, previous infliximab status, concomitant drugs, the Montreal Classification, disease activity (Mayo score at weeks 0, 8, 26 and 52, or until the last follow-up. Clinical remission was defined as a partial Mayo score ≤2 and Last observation carried forward (LOCF and Non responder imputation (NRI analysis were used. RESULTS: Thirty-six patients were included in the study. With LOCF analysis, remission rates at weeks 8, 26 e 52 were of 41.7%, 47.2% and 47.2%, respectively. With NRI analysis, remission rates at weeks 8, 26 and 52 were of 41.7%, 41.7% and 27.8%, respectively. CONCLUSION: Adalimumab was effective in the treatment of moderate-to-severe ulcerative colitis. Clinical remission was observed in approximately 40% of the patients at weeks 8 and 26, and in almost a quarter of the patients after 1 year of follow up.

  2. Acupuncture for Smoking Cessation in Hong Kong: A Prospective Multicenter Observational Study

    Directory of Open Access Journals (Sweden)

    Ying-ying Wang

    2016-01-01

    Full Text Available This was a prospective multicenter observational study, aiming to explore the effects of acupuncture on smoking cessation in Hong Kong. From March of 2010 to August of 2015, a total of 5202 smokers were recruited based on inclusion criteria and treated with acupuncture for 8 weeks. As a result, 2940 subjects finished the study with a drop-out rate of 43.48%. The self-reported 7-day point abstinence rate was 34.00% in Week 8 and 18.40% in Week 52. The exhaled carbon monoxide level and the number of cigarettes smoked per day were reduced significantly after treatment. The time to relapse was calculated to be 38.71 days. In addition, “cigarettes smoked per day,” “Fagerstrom Test for Nicotine Dependence,” “total sessions of acupuncture,” “whether finished 8 acupuncture treatments in the first month,” and “total sessions of acupuncture” were believed to be essential factors for abstinence success. It was concluded that acupuncture was a safe method for smoking cessation and was effective in helping smokers to quit; therefore, acupuncture could be considered as one of the methods to help smokers quit. Further studies regarding the effect differences between acupuncture and medications were needed to clarify the overall benefits of acupuncture.

  3. Evolution of adolescent idiopathic scoliosis: results of a multicenter study at 20 years' follow-up.

    Science.gov (United States)

    Pesenti, S; Jouve, J-L; Morin, C; Wolff, S; Sales de Gauzy, J; Chalopin, A; Ibnoulkhatib, A; Polirsztok, E; Walter, A; Schuller, S; Abelin-Genevois, K; Leroux, J; Lechevallier, J; Kabaj, R; Mary, P; Fuentes, S; Parent, H; Garin, C; Bin, K; Peltier, E; Blondel, B; Chopin, D

    2015-09-01

    To date there is no consensus on therapeutic indications in adolescent idiopathic scoliosis (AIS) with curvature between 30° and 60° at the end of growth. The objective of this study was to assess outcome in patients with moderate AIS. A multicenter retrospective study was conducted. Inclusion criteria were: Cobb angle, 30-60° at end of growth; and follow-up > 20 years. The data collected were angular values in adolescence and at last follow-up, and quality of life scores at follow-up. A total of 258 patients were enrolled: 100 operated on in adolescence, 116 never operated on, and 42 operated on in adulthood. Mean follow-up was 27.8 years. Cobb angle progression significantly differed between the 3 groups: 3.2° versus 8.8° versus 23.6°, respectively; P scoliosis, the risk of progression to ≥ 20° was significantly higher for initial Cobb angle > 35° (OR=4.278, P=0.002). There were no significant differences in quality of life scores. Patients operated on in adolescence showed little radiological progression, demonstrating the efficacy of surgical treatment for curvature greater than 50°. Curvature greater than 40° was progressive and may require surgery in adulthood. Lumbar scoliosis showed greater potential progression than thoracic scoliosis in adulthood, requiring fusion as of 35° angulation. IV, retrospective study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  4. Clinical features of idiopathic restrictive cardiomyopathy: A retrospective multicenter cohort study over 2 decades.

    Science.gov (United States)

    Hong, Jung Ae; Kim, Min-Seok; Cho, Min-Su; Choi, Hyo In; Kang, Duk-Hyun; Lee, Sang-Eun; Lee, Ga-Yeon; Jeon, Eun-Seok; Cho, Jae-Yeong; Kim, Kye-Hun; Yoo, Byung-Su; Lee, Jong-Young; Kim, Won-Jang; Kim, Kyung-Hee; Chung, Wook-Jin; Lee, Ju-Hee; Cho, Myeong-Chan; Kim, Jae-Joong

    2017-09-01

    Idiopathic restrictive cardiomyopathy (RCMP) has not been fully understood because this disease is difficult to diagnose. The present study aimed to assess the clinical profile and outcome of idiopathic RCMP from a multicenter cohort.This investigation is a retrospective study of consecutive patients with idiopathic RCMP at 10 centers in Korea between 1990 and 2010. We evaluated the clinical characteristics of the patients and prognostic factors associated with mortality using multivariate Cox proportional hazards regression analyses.The study included 53 patients (26 men, 49.1%). During a median follow-up of 1.7 years, 17 patients (32.1%) died and 5 patients (9.4%) received a heart transplant. The 5-year survival rate of the overall patients was 64.4% ± 7.8%. In multivariable analyses, the predictors of mortality were tricuspid regurgitation (TR) ≥ moderate (hazard ratio [HR] 32.55, P RCMP showed unfavorable prognosis. Advanced TR and lower LVEDD are independent adverse predictors of mortality in patients with idiopathic RCMP.

  5. Assessing patient safety culture in Tunisian operating rooms: A multicenter study.

    Science.gov (United States)

    Mallouli, Manel; Tlili, Mohamed Ayoub; Aouicha, Wiem; Ben Rejeb, Mohamed; Zedini, Chekib; Salwa, Amrani; Mtiraoui, Ali; Ben Dhiab, Mohamed; Ajmi, Thouraya

    2017-04-01

    To assess the patient safety culture (PSC) in operating rooms (ORs) and to determine influencing factors. A cross-sectional descriptive multicenter study which was conducted over a period of 7 months (October 2014-April 2015) using the French validated version of the Hospital Survey On Patient Safety Culture questionnaire. Of the note, 15 ORs of public and private healthcare institutions. In total, there were 368 participants including surgeons, anesthesiologists, surgical and anesthesia technicians, nurses and caregivers, divided into 316 professionals exercising in public sector and 52 working in private one. A self-administrated questionnaire investigating 10 dimensions of PSC (including 45 items), two items examining the staff perception of patient safety quality and reporting events, and five items regarding demographic characteristics of respondents. The participation rate in the study was 70.8%. All 10 dimensions were to be improved. The overall perception of patient safety had a score of 34.9%. The dimension that had the lowest score (20.5%) was the non-punitive response to error, and the one that had the highest score (41.67%) was teamwork in the ORs. Three dimensions were developed in private sector, and none in public hospitals. This study showed that the level of the PSC needs to be improved not only in public hospitals but also in private ones. The obtained results highlight the importance of implementing quality management systems and developing PSC.

  6. Neutrophil Gelatinase Associated Lipocalin (NGAL) in Leptospirosis Acute Kidney Injury: A Multicenter Study in Thailand.

    Science.gov (United States)

    Srisawat, Nattachai; Praditpornsilpa, Kearkiat; Patarakul, Kanitha; Techapornrung, Malee; Daraswang, Tinnapop; Sukmark, Theerapon; Khositrangsikun, Kamol; Fakthongyoo, Apinya; Oranrigsupak, Petchdee; Praderm, Laksamon; Suwattanasilpa, Ummarit; Peerapornratana, Sadudee; Loahaveeravat, Passisd; Suwachittanont, Nattachai; Wirotwan, Thaksa-on; Phonork, Chayanat; Kumpunya, Sarinya; Tiranathanagul, Khajohn; Chirathaworn, Chintana; Eiam-ong, Somchai; Tungsanga, Kriang; Sitprija, Visith; Kellum, John A; Townamchai, Natavudh

    2015-01-01

    AKI is one of the most serious complications of leptospirosis, an important zoonosis in the tropics. Recently, NGAL, one of the novel AKI biomarkers, is extensively studied in various specific settings such as sepsis, cardiac surgery, and radiocontrast nephropathy. In this multicenter study, we aimed to study the role of NGAL as an early marker and an outcome predictor of leptospirosis associated AKI. Patients who presented with clinical suspiciousness of leptospirosis were prospectively enrolled in 9 centers from August 2012 to November 2014. The first day of enrollment was the first day of clinical suspicious leptospirosis. Blood and urine samples were serially collected on the first three days and day 7 after enrollment. We used three standard techniques (microscopic agglutination test, direct culture, and PCR technique) to confirm the diagnosis of leptospirosis. KDIGO criteria were used for AKI diagnosis. Recovery was defined as alive and not requiring dialysis during hospitalization or maintaining maximum KDIGO stage at hospital discharge. Of the 221 recruited cases, 113 cases were leptospirosis confirmed cases. Thirty seven percent developed AKI. Median uNGAL and pNGAL levels in those developing AKI were significantly higher than in patients not developing AKI [253.8 (631.4) vs 24.1 (49.6) ng/ml, p leptospirosis associated AKI. However, both of them did not show the potential role to be the predictor of renal recovery in this specific setting.

  7. Fibromyalgia as a cause of uncontrolled asthma: a case-control multicenter study.

    Science.gov (United States)

    Martinez-Moragon, Eva; Plaza, Vicente; Torres, Isabel; Rosado, Ana; Urrutia, Isabel; Casas, Xavier; Hinojosa, Belen; Blanco-Aparicio, Marina; Delgado, Julio; Quirce, Santiago; Sabadell, Carles; Cebollero, Pilar; Muñoz-Fernández, Ana

    2017-12-01

    Fibromyalgia can affect the control of asthma when both diseases are present in a single patient. To characterize asthma in patients with concomitant fibromyalgia to assess whether fibromyalgia is an independent factor of asthma severity that influences poor asthma control. We also evaluated how dyspnea is perceived by patients in order to demonstrate that alterations in the perception of airway obstruction may be responsible for poor asthma control. This was a cross-sectional case-control multicenter study, in which 56 patients in the asthma and fibromyalgia group were matched to 36 asthmatics by sex, approximate age, and asthma severity level. All patients were women. Study variables included the Asthma Control Test (ACT), the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), the Nijmegen hyperventilation syndrome questionnaire, the Hospital Anxiety and Depression Scale, and perception of dyspnea after acute bronchoconstriction. Although patients in both study groups showed similar asthma severity and use of anti-asthmatic drugs, patients in the asthma and fibromyalgia group showed lower scores on the ACT and MiniAQLQ questionnaires, and higher scores of anxiety and depression as well as hyperventilation compared to asthma patients without fibromyalgia. All these differences were statistically significant. Fibromyalgia in patients with asthma influences poor control of the respiratory disease and is associated with altered perception of dyspnea, hyperventilation syndrome, high prevalence of depression and anxiety, and impaired quality of life. Fibromyalgia may be considered a risk factor for uncontrolled asthma in patients suffering from asthma and fibromyalgia concomitantly.

  8. The Anti-Osteoporotic Drug Preferences of Physiatrists: A Multicenter Descriptive Study

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    Yeşim Gökçe Kutsal

    2012-08-01

    Full Text Available Aim: The purpose of this multicenter descriptive study is to determine the preferences of physiatrists in our country for anti-osteoporotic drugs in patients with primary and secondary osteoporosis. Materials and Methods: This study was carried out in 10 provinces of Turkey. The diagnosis of osteoporosis was based on World Health Organization criteria using dual-energy x-ray absorptiometry. Patients with a spine and/or hip T-score ≤-2.5 were considered as osteoporotic. 714 patients over 18 years old with primary or secondary osteoporosis were included in the study. In addition to socio-demographic characteristics and chronic use of medications and/or additional systemic diseases that cause secondary osteoporosis were questioned and antiosteoporotic drugs that are recommended by their physicians were recorded.Results: The physicians’ preferred vitamin D and calcium as the prior treatment both in primary and secondary osteoporosis. The most commonly used anti-osteoporotic agent was alendronate from the biphosphonate group. It was followed by ibandronate, risedronate, strontium ranelate, calcitonin, zoledronate, raloxifene, parathyroid hormone (PTH and hormone replacement therapy (HRT in the primary osteoporosis and risedronate, ibandronate, calcitonin, strontium ranelate, zoledronate, PTH, HRT and raloxifene in the secondary osteoporosis, respectively. Conclusion: The physician should choose the most suitable treatment for the patient based on fracture risk, medical history, previous treatments for osteoporosis, concomitant diseases, treatment-induced risks and benefits, and the relation between financial cost and potential benefit. (Turkish Journal of Osteoporosis 2012;18: 42-6

  9. The Cases of the European Values Study and the European Social Survey

    DEFF Research Database (Denmark)

    Kropp, Kristoffer

    2017-01-01

    This article is a comparative analysis of the European Values Study (EVS) and the European Social Survey (ESS) using five analytical dimensions: agents, ideas, methods, institutions and context. From the outset, both surveys were closely connected to national and European social science...... institutions, had ties to the EU, and used survey techniques to address urgent contemporary political and social problems. Despite their similarities, the surveys represent two rather different constellations of social science knowledge production. The EVS emerged from a coalition of Catholic-oriented agents...... from a diverse set of social institutions driven by political and ethical concerns about social change in the 1960s and 1970s. The EVS used its links to various social institutions to set up and run the survey, and its ethical and political concerns and connections to Catholic Church organisations...

  10. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

    DEFF Research Database (Denmark)

    Toozs-Hobson, Philip; Al-Singary, Waleed; Fynes, Michelle

    2012-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence....

  11. Delay in the administration of appropriate antimicrobial therapy in Staphylococcus aureus bloodstream infection : A prospective multicenter hospital-based cohort study

    NARCIS (Netherlands)

    Kaasch, A. J.; Rieg, S.; Kuetscher, J.; Brodt, H. -R.; Widmann, T.; Herrmann, M.; Meyer, C.; Welte, T.; Kern, P.; Haars, U.; Reuter, S.; Huebner, I.; Strauss, R.; Sinha, B.; Brunkhorst, F. M.; Hellmich, M.; Faetkenheuer, G.; Kern, W. V.; Seifert, H.

    2013-01-01

    Early broad-spectrum antimicrobial treatment reduces mortality in patients with septic shock. In a multicenter, prospective observational study, we explored whether delayed appropriate antimicrobial therapy (AAT) influences outcome in Staphylococcus aureus bloodstream infection (SAB). Two hundred

  12. Undernutrition, risk of malnutrition and obesity in gastroenterological patients: A multicenter study

    Science.gov (United States)

    Rizzi, Massimiliano; Mazzuoli, Silvia; Regano, Nunzia; Inguaggiato, Rosa; Bianco, Margherita; Leandro, Gioacchino; Bugianesi, Elisabetta; Noè, Donatella; Orzes, Nicoletta; Pallini, Paolo; Petroni, Maria Letizia; Testino, Gianni; Guglielmi, Francesco William

    2016-01-01

    AIM: To investigate the prevalence of undernutrition, risk of malnutrition and obesity in the Italian gastroenterological population. METHODS: The Italian Hospital Gastroenterology Association conducted an observational, cross-sectional multicenter study. Weight, weight loss, and body mass index were evaluated. Undernutrition was defined as unintentional weight loss > 10% in the last three-six months. Values of Malnutrition Universal Screening Tool (MUST) > 2, NRS-2002 > 3, and Mini Nutritional Assessment (MNA) from 17 to 25 identified risk of malnutrition in outpatients, inpatients and elderly patients, respectively. A body mass index ≥ 30 indicated obesity. Gastrointestinal pathologies were categorized into acute, chronic and neoplastic diseases. RESULTS: A total of 513 patients participated in the study. The prevalence of undernutrition was 4.6% in outpatients and 19.6% in inpatients. Moreover, undernutrition was present in 4.3% of the gastrointestinal patients with chronic disease, 11.0% of those with acute disease, and 17.6% of those with cancer. The risk of malnutrition increased progressively and significantly in chronic, acute and neoplastic gastrointestinal diseases in inpatients and the elderly population. Logistical regression analysis confirmed that cancer was a risk factor for undernutrition (OR = 2.7; 95%CI: 1.2-6.44, P = 0.02). Obesity and overweight were more frequent in outpatients. CONCLUSION: More than 63% of outpatients and 80% of inpatients in gastroenterological centers suffered from significant changes in body composition and required specific nutritional competence and treatment. PMID:27559436

  13. A Multicenter Comparative Study of Impulse Control Disorder in Latin American Patients With Parkinson Disease.

    Science.gov (United States)

    Ramírez Gómez, Carolina Candelaria; Serrano Dueñas, Marcos; Bernal, Oscar; Araoz, Natalia; Sáenz Farret, Michel; Aldinio, Victoria; Montilla, Verónica; Micheli, Federico

    Impulse control disorder (ICD) is a common adverse effect in patients with Parkinson disease who receive dopamine agonists; however, other factors are involved in its manifestations. To study the frequency and factors involved in the development of this adverse effect in a Latin American population, we conducted a cross-sectional multicenter study. Two hundred fifty-five patients in 3 Latin American centers were evaluated by examination and application of scales (Unified Parkinson's Disease Rating Scale, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale, Hoehn and Yahr, Clinical Impression of Severity Index for Parkinson's Disease). Of the patients, 27.4% had ICD, most of whom were on dopamine agonists. Other associated risk factors included a younger age at onset of Parkinson disease, moderate symptoms, a shorter evolution of the clinical manifestations, rapid eye movement (REM) sleep disorder behavior, and the consumption of tea, mate, and alcohol. The frequency of ICD is higher in Latin America than in Anglo-Saxon populations. Consuming tea and mate, in addition to the use of dopamine agonists, is a factor that may demonstrate a genetic link that predisposes patients to the establishment of an ICD.

  14. Molecular Profiling-Selected Therapy for Treatment of Advanced Pancreaticobiliary Cancer: A Retrospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Ron Epelbaum

    2015-01-01

    Full Text Available This multicenter cohort study assessed the impact of molecular profiling (MP on advanced pancreaticobiliary cancer (PBC. The study included 30 patients treated with MP-guided therapy after failing ≥1 therapy for advanced PBC. Treatment was considered as having benefit for the patient if the ratio between the longest progression-free survival (PFS on MP-guided therapy and the PFS on the last therapy before MP was ≥1.3. The null hypothesis was that ≤15% of patients gain such benefit. Overall, ≥1 actionable (i.e., predictive of response to specific therapies biomarker was identified/patient. Immunohistochemistry (the most commonly used method for guiding treatment decisions identified 1–6 (median: 4 actionable biomarkers per patient. After MP, patients received 1–4 (median: 1 regimens/patient (most commonly, FOLFIRI/XELIRI. In a decision-impact analysis, of the 27 patients for whom treatment decisions before MP were available, 74.1% experienced a treatment decision change in the first line after MP. Twenty-four patients were evaluable for clinical outcome analysis; in 37.5%, the PFS ratio was ≥1.3. In one-sided exact binomial test versus the null hypothesis, P = 0.0015; therefore, the null hypothesis was rejected. In conclusion, our analysis demonstrated the feasibility, clinical decision impact, and potential clinical benefits of MP-guided therapy in advanced PBC.

  15. A multicenter study on experience of 13 tertiary hospitals in Turkey in patients with infective endocarditis.

    Science.gov (United States)

    Elbey, Mehmet Ali; Akdağ, Serkan; Kalkan, Mehmet Emin; Kaya, Mehmet G; Sayın, M Raşit; Karapınar, Hekim; Bulur, Serkan; Ulus, Taner; Akıl, M Ata; Elbey, Hatice Köprü; Akyüz, Abdurrahman

    2013-09-01

    The aim of this retrospective multicenter study was to investigate the clinical manifestations, microbiological profile, echocardiographic findings and management strategies of infective endocarditis (IE) in Turkey. The study population consisted of 248 Turkish patients with IE treated at 13 major hospitals in Turkey from 2005 to 2012 retrospectively. All hospitals are tertiary referral centers, which receive patients from surrounding hospitals. Data were collected from the medical files of all patients hospitalized with IE diagnosed according to modified Duke Criteria. One hundred thirty seven of the patients were males. Native valves were involved in 158 patients while in 75 participants there was prosthetic valve endocarditis. Vegetations were detected in 223 patients (89%) and 52 patients had multiple vegetations. Mitral valve was the most common site of vegetation (43%). The most common valvular pathology was mitral regurgitation. The most common predisposing factor was rheumatic valvular disease (28%). Positive culture rate was 65%. Staphylococci were the most frequent causative microorganisms isolated (29%) followed by enterococci (11%). In-hospital mortality rate was 33%. Compared to IE in developed countries younger age, higher prevalence of rheumatic heart disease, more frequent enterococci infection and higher rates of culture negativity were other important aspects of IE epidemiology in Turkey.

  16. Quadriceps Weakness, Patella Alta and Structural Features of Patellofemoral Osteoarthritis: The Multicenter Osteoarthritis Study

    Science.gov (United States)

    Stefanik, Joshua J.; Guermazi, Ali; Zhu, Yanyan; Zumwalt, Ann C.; Gross, K. Douglas; Clancy, Margaret; Lynch, John A.; Segal, Neil A.; Lewis, Cora E.; Roemer, Frank W.; Powers, Christopher M.; Felson, David T.

    2011-01-01

    Objective To determine the relationship between quadriceps weakness and cartilage damage and bone marrow lesions (BMLs) in the patellofemoral joint (PFJ), and if this relationship is modified by patella alta. Methods The Multicenter Osteoarthritis (MOST) Study is a cohort study of persons aged 50–79 years with or at risk for knee OA. Concentric knee extensor strength was measured using an isokinetic dynamometer. Patella alta was measured using the Insall-Salvati ratio (ISR) on the lateral radiograph, and cartilage damage and bone marrow lesions (BMLs) were graded on MRI in the PFJ. We determined the association between quadriceps weakness with cartilage damage and BMLs in the PFJ among those knees with (ISR≥1.2) and without patella alta (ISRpatella alta in the lateral PFJ. Conclusion Quadriceps weakness was associated with PFJ cartilage damage and BMLs. While both patella alta and quadriceps weakness are associated with PFJ damage, the combination of the two was not associated with more damage than either of these factors alone. PMID:21702087

  17. Transcutaneous Bone-anchored Hearing Aids Versus Percutaneous Ones: Multicenter Comparative Clinical Study.

    Science.gov (United States)

    Iseri, Mete; Orhan, Kadir Serkan; Tuncer, Ulku; Kara, Ahmet; Durgut, Merve; Guldiken, Yahya; Surmelioglu, Ozgur

    2015-06-01

    The aim of this study is to compare the clinical audiological outcomes as well as patient satisfaction of bone-anchored, hearing aid surgery between the percutaneous Dermalock and the transcutaneous Attract systems. This is a multicenter, retrospective clinical study. The patients who underwent Baha Dermalock and Baha Attract surgery were analyzed for hearing results, surgical complications, and postoperative follow-up specifications for both systems. Speech reception thresholds and bone conduction thresholds with and without aided conditions were evaluated. Patient satisfactions were also determined for both groups by Glasgow Benefit Inventory questionnaire. Both of the groups had some minor complications such as skin irritations around the abutment and skin erythema over the magnet. Both of the groups benefit from the devices audiologically; however, when the groups were compared, better results were observed in the percutaneous, bone-conduction group. We can confirm that both transcutaneous and percutaneous techniques are effective in the rehabilitation of conductive hearing loss when conventional hearing aids cannot be used. However, both of the systems have some advantages and limitations in terms of audiological and surgical perspectives.

  18. Factors associated to depression and anxiety in medical students: a multicenter study.

    Science.gov (United States)

    Brenneisen Mayer, Fernanda; Souza Santos, Itamar; Silveira, Paulo S P; Itaqui Lopes, Maria Helena; de Souza, Alicia Regina Navarro Dias; Campos, Eugenio Paes; de Abreu, Benedita Andrade Leal; Hoffman Ii, Itágores; Magalhães, Cleidilene Ramos; Lima, Maria Cristina P; Almeida, Raitany; Spinardi, Mateus; Tempski, Patricia

    2016-10-26

    To evaluate personal and institutional factors related to depression and anxiety prevalence of students from 22 Brazilian medical schools. The authors performed a multicenter study (August 2011 to August 2012), examining personal factors (age, sex, housing, tuition scholarship) and institutional factors (year of the medical training, school legal status, location and support service) in association with scores of Beck Depression Inventory (BDI) and State Trait Anxiety Inventory (STAI). Of 1,650 randomly selected students, 1,350 (81.8 %) completed the study. The depressive symptoms prevalence was 41 % (BDI > 9), state-anxiety 81.7 % and trait-anxiety in 85.6 % (STAI > 33). There was a positive relationship between levels of state (r = 0,591, p anxiety and depression scores. All three symptoms were positively associated with female sex and students from medical schools located in capital cities of both sexes. Tuition scholarship students had higher state-anxiety but not trait-anxiety or depression scores. Medical students with higher levels of depression and anxiety symptoms disagree more than their peers with the statements "I have adequate access to psychological support" and "There is a good support system for students who get stressed". The factors associated with the increase of medical students' depression and anxiety symptoms were female sex, school location and tuition scholarship. It is interesting that tuition scholarship students showed state-anxiety, but not depression and trait-anxiety symptoms.

  19. Multicenter validation study of a prognostic index for portal vein tumor thrombosis in hepatocellular carcinoma.

    Science.gov (United States)

    Yu, Jeong Il; Yoon, Sang Min; Park, Hee Chul; Kim, Jong Hoon; Kim, Tae Hyun; Park, Joong-Won; Seong, Jinsil; Lee, Ik Jae; Jang, Hong Seok; Kay, Chul Seung; Kim, Chul Yong; Chie, Eui Kyu; Kim, Jin Hee; Kim, Mi-Sook; Choi, Young Min

    2014-10-01

    We previously reported on a staging system and prognostic index (PITH) for portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients treated with radiotherapy (RT) at a single institution. The aim of this study is to validate the PITH staging system using data from patients at other institutions and to compare it with other published staging systems. A total of 994 HCC patients with PVTT who were treated with RT between 1998 and 2011 by the Korean Radiation Oncology Group were analyzed retrospectively. All patients were staged using the Cancer of the Liver Italian Program (CLIP), Japanese Integrated Staging (JIS), Okuda, and PITH staging systems, and survival data were analyzed. The likelihood ratio, Akaike information criteria (AIC), time-dependent receiver operating characteristics, and prediction error curve analysis were used to determine discriminatory ability for comparison of staging systems. The median survival was 9.2 months. Compared with the other staging systems, the PITH score gave the highest values for likelihood ratio and lowest AIC values, demonstrating that PITH may be a better prognostic model. Although the values were not significant and differences were not exceptional, the PITH score showed slightly better performance with respect to time-dependent area under curve and integrated Brier score of prediction error curve. The PITH staging system was validated in this multicenter retrospective study and showed better stratification ability in HCC patients with PVTT than other systems.

  20. Immediate Loading of Single Implants: A 2-Year Prospective Multicenter Study.

    Science.gov (United States)

    Mangano, Carlo; Raes, Filiep; Lenzi, Carolina; Eccellente, Tammaro; Ortolani, Michele; Luongo, Giuseppe; Mangano, Francesco

    The aim of this prospective multicenter study was to evaluate the outcomes of single implants subjected to immediate functional loading. Inclusion criteria were single-tooth placement in postextraction sockets or fully healed sites, and sufficient bone height and width to place an implant of at least 3.5 × 10.0 mm. All implants were functionally loaded immediately after placement and followed for 2 years. Outcome measures were implant survival, complications, and peri-implant marginal bone loss (MBL). A total of 57 implants (38 maxilla, 19 mandible) were placed in 46 patients (23 men, 23 women, aged 18-73 years). Of these, 10 implants were placed in postextraction sockets. One implant failed, in a healed site, giving a patient-based overall 2-year survival rate of 97.6%. The incidence of biologic complications was 1.8%; prosthetic complications amounted to 7.5%. The peri-implant MBL was 0.37 ± 0.22 mm (healed sites: 0.4 mm ± 0.22; postextraction sockets: 0.3 mm ± 0.22). The immediate functional loading of single implants seems to represent a safe and successful procedure. Long-term follow-up studies on a larger sample of patients are needed to confirm these results.

  1. Possible risk factors associated with greater damage in systemic lupus erythematosus patients: an Egyptian multicenter study.

    Science.gov (United States)

    Hammad, M; Eissa, M; Fathi, S

    2016-08-01

    Systemic lupus erythematosus (SLE) is a prototypic multisystem autoimmune disorder. The total damage in a patient with SLE may result from SLE itself or from any other pathologic process. The aim of this study was to assess risk factors of greater damage in a sample of Egyptian SLE patients. This Egyptian multicenter retrospective study included 100 SLE patients: 64 patients from Cairo University Hospitals and 36 patients from Zagazig University Hospitals. The Systemic Lupus International Collaborative Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (ACR-DI) was used to document the damage in each patient. The total SLICC/ACR-DI score ranged from 0 to 8. A higher DI score was found in hypertensive patients, compared to normotensive patients; and among those with positive anti-phospholipid antibodies, compared to those with negative anti-phospholipid antibodies. This difference was statistically significant (p seizures, compared to those without; and the difference was statistically significant (p < 0.05). There was a significant positive correlation between the DI and patient age (p < 0.05). Damage in SLE cannot be prevented completely, as SLE disease is considered an aggressive disease treated by aggressive medications, but rheumatologists should try to minimize damage as much as possible to maintain the patients' health, functioning and general wellbeing. © The Author(s) 2016.

  2. Clinicopathological features of invasive lobular carcinoma of the breast: A nationwide multicenter study in China.

    Science.gov (United States)

    Zhu, M Z; Yu, X F; He, X M; Feng, W L; Fan, J H; Li, J; Xu, F; Tang, Z H; Zhang, B N; Qiao, Y L; Zheng, S; Yang, H J

    2015-08-01

    To analyze the clinicopathological features of invasive lobular carcinoma (ILC) and compare them with invasive ductal carcinoma (IDC), hoping to find the fact of ILC in China and assist the decision makers with proper individualized treatment. A nationwide multicenter retrospective study was performed. A total of 4211 primary breast cancer cases were randomly selected from 1999 to 2008 in seven regions of China. ILC cases were compared with IDC by clinicopathological features and molecular subtypes. A total of 135 (3.2%) ILC and 3471 (82.4%) IDC cases were included for analysis. The age, tumor size, menopausal state, family history, nodal status, and stage of ILC were similar to that of IDC. ILC was more likely to be positive for estrogen receptor (65.5% vs. 57.7%) and progesterone receptor (64.7% vs. 58.5%), and less likely to overexpress human epidermal growth factor receptor-2 (17.3% vs. 23.6%). Even though, these differences are not significant, the proportion of luminal A type of ILC is significantly larger than that of IDC (54.8% vs. 42.7%; P < 0.05). ILC has a larger proportion of luminal A type compared with IDC. Larger sample size study for better known of molecular subtypes of ILC is needed in future to individualize the treatment decision.

  3. Risk Factors for Malnutrition among Older Adults in the Emergency Department: A Multicenter Study.

    Science.gov (United States)

    Burks, Collin E; Jones, Christopher W; Braz, Valerie A; Swor, Robert A; Richmond, Natalie L; Hwang, Kay S; Hollowell, Allison G; Weaver, Mark A; Platts-Mills, Timothy F

    2017-08-01

    Among older adults, malnutrition is common, often missed by healthcare providers, and influences recovery from illness or injury. To identify modifiable risk factors associated with malnutrition in older patients. Prospective cross-sectional multicenter study. 3 EDs in the South, Northeast, and Midwest. Non-critically ill, English-speaking adults aged ≥65 years. Random time block sampling was used to enroll patients. The ED interview assessed malnutrition using the Mini Nutritional Assessment Short-Form. Food insecurity and poor oral health were assessed using validated measures. Other risk factors examined included depressive symptoms, limited mobility, lack of transportation, loneliness, and medication side effects, qualified by whether the patient reported the risk factor affected their diet. The population attributable risk proportion (PARP) for malnutrition was estimated for each risk factor. In our sample (n = 252), the prevalence of malnutrition was 12%. Patient characteristics associated with malnutrition included not having a college degree, being admitted to the hospital, and residence in an assisted living facility. Of the risk factors examined, the PARPs for malnutrition were highest for poor oral health (54%; 95% CI 16%, 78%), food insecurity (14%; 95% CI 3%, 31%), and lack of transportation affecting diet (12%; 95% CI 3%, 28%). Results of this observational study identify multiple modifiable factors associated with the problem of malnutrition in older adults. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  4. Reliability of Semiautomated Computational Methods for Estimating Tibiofemoral Contact Stress in the Multicenter Osteoarthritis Study

    Directory of Open Access Journals (Sweden)

    Donald D. Anderson

    2012-01-01

    Full Text Available Recent findings suggest that contact stress is a potent predictor of subsequent symptomatic osteoarthritis development in the knee. However, much larger numbers of knees (likely on the order of hundreds, if not thousands need to be reliably analyzed to achieve the statistical power necessary to clarify this relationship. This study assessed the reliability of new semiautomated computational methods for estimating contact stress in knees from large population-based cohorts. Ten knees of subjects from the Multicenter Osteoarthritis Study were included. Bone surfaces were manually segmented from sequential 1.0 Tesla magnetic resonance imaging slices by three individuals on two nonconsecutive days. Four individuals then registered the resulting bone surfaces to corresponding bone edges on weight-bearing radiographs, using a semi-automated algorithm. Discrete element analysis methods were used to estimate contact stress distributions for each knee. Segmentation and registration reliabilities (day-to-day and interrater for peak and mean medial and lateral tibiofemoral contact stress were assessed with Shrout-Fleiss intraclass correlation coefficients (ICCs. The segmentation and registration steps of the modeling approach were found to have excellent day-to-day (ICC 0.93–0.99 and good inter-rater reliability (0.84–0.97. This approach for estimating compartment-specific tibiofemoral contact stress appears to be sufficiently reliable for use in large population-based cohorts.

  5. Complications of Microwave Ablation for Liver Tumors: Results of a Multicenter Study

    Energy Technology Data Exchange (ETDEWEB)

    Livraghi, Tito, E-mail: lalivra@tin.it [IRCCS Istituto Clinico Humanitas, Department of Interventional Radiology (Italy); Meloni, Franca, E-mail: meloni@yahoo.it [San Gerardo Hospital, Department of Radiology (Italy); Solbiati, Luigi, E-mail: lusolbia@tin.it [Azienda Ospedaliera di Busto Arsizio, Department of Interventional Radiology (Italy); Zanus, Giorgio, E-mail: zanus@unipd.it [Azienda Universita di Padova, General Surgery and Organ Transplantation (Italy); Collaboration: For the Collaborative Italian Group using AMICA system

    2012-08-15

    Purpose: New technologies for microwave ablation (MWA) have been conceived, designed to achieve larger areas of necrosis compared with radiofrequency ablation (RFA). The purpose of this study was to report complications by using this technique in patients with focal liver cancer. Methods: Members of 14 Italian centers used a 2.45-GMHz generator delivering energy through a cooled miniature-choke MW antenna and a standardized protocol for follow-up. They completed a questionnaire regarding number and type of deaths, major and minor complications and side effects, and likelihood of their relationship to the procedure. Enrollment included 736 patients with 1.037 lesions: 522 had hepatocellular carcinoma with cirrhosis, 187 had metastases predominantly from colorectal cancer, and 27 had cholangiocellular carcinoma. Tumor size ranged from 0.5 to 10 cm. In 13 centers, the approach used was percutaneous, in 4 videolaparoscopic, and in 3 laparotomic. Results: No deaths were reported. Major complications occurred in 22 cases (2.9%), and minor complications in 54 patients (7.3%). Complications of MWA do not differ from those RFA, both being based on the heat damage. Conclusion: Results of this multicenter study confirmed those of single-center experiences, indicating that MWA is a safe procedure, with no mortality and a low rate of major complications. The low rate of complications was probably due to precautions adopted, knowing in advance possible risk conditions, on the basis of prior RFA experience.

  6. Efficacy, safety and drug survival of conventional agents in pediatric psoriasis: A multicenter, cohort study.

    Science.gov (United States)

    Ergun, Tulin; Seckin Gencosmanoglu, Dilek; Alpsoy, Erkan; Bulbul-Baskan, Emel; Saricam, Merve Hatun; Salman, Andac; Onsun, Nahide; Sarioz, Abdullah

    2017-06-01

    The data on long-term efficacy, safety and drug survival rates of conventional systemic therapeutics in pediatric psoriasis is lacking. The primary aim of this study is to investigate acitretin, methotrexate, cyclosporin efficacy, safety and drug survival rates in pediatric patients as well as predictors of drug survival. This is a multicenter study including 289 pediatric cases being treated with acitretin, methotrexate and cyclosporin in four academic referral centers. Efficacy, adverse events, reasons for discontinuation, 1, 2- and 3-year drug survival rates, and determinants of drug survival were analyzed. A 75% reduction of Psoriasis Area and Severity Index score or better response rate was obtained in 47.5%, 34.1% and 40% of the patients who were treated with acitretin, methotrexate and cyclosporin, respectively. One-year drug survival rates for acitretin, methotrexate and cyclosporin were 36.3%, 21.1% and 15.1%, respectively. The most significant determinant of drug survival, which diminished over time, was treatment response whereas arthritis, body mass index and sex had no influence. Although all three medications are effective and relatively safe in children, drug survival rates are low due to safety concerns at this age group. Effective disease control through their rational use can be expected to improve survival rates. © 2016 Japanese Dermatological Association.

  7. Diagnostic accuracy of placental growth factor in women with suspected preeclampsia: a prospective multicenter study.

    Science.gov (United States)

    Chappell, Lucy C; Duckworth, Suzy; Seed, Paul T; Griffin, Melanie; Myers, Jenny; Mackillop, Lucy; Simpson, Nigel; Waugh, Jason; Anumba, Dilly; Kenny, Louise C; Redman, Christopher W G; Shennan, Andrew H

    2013-11-05

    Hypertensive disorders of pregnancy are a major contributor to death and disability for pregnant women and their infants. The diagnosis of preeclampsia by using blood pressure and proteinuria is of limited use because they are tertiary, downstream features of the disease. Placental growth factor (PlGF) is an angiogenic factor, a secondary marker of associated placental dysfunction in preeclampsia, with known low plasma concentrations in the disease. In a prospective multicenter study, we studied the diagnostic accuracy of low plasma PlGF concentration (preeclampsia between 20 and 35 weeks' gestation (and up to 41 weeks' gestation as a secondary analysis). The outcome was delivery for confirmed preeclampsia within 14 days. Of 625 women, 346 (55%) developed confirmed preeclampsia. In 287 women enrolled before 35 weeks' gestation, PlGF preeclampsia within 14 days; specificity was lower (0.55; 0.48-0.61). Area under the receiver operating characteristic curve for low PlGF (0.87, standard error 0.03) for predicting preeclampsia within 14 days was greater than all other commonly used tests, singly or in combination (range, 0.58-0.76), in women presenting with suspected preeclampsia (Ppreeclampsia, low PlGF has high sensitivity and negative predictive value for preeclampsia within 14 days, is better than other currently used tests, and presents an innovative adjunct to management of such women.

  8. Multicenter cohort study on association of genotypes with prospective sports concussion: methods, lessons learned, and recommendations.

    Science.gov (United States)

    Terrell, Thomas R; Bostick, Roberd; Barth, Jeffrey; Sloane, Richard; Cantu, Robert C; Bennett, Ellen; Galloway, Leslie; Laskowitz, Daniel; Erlanger, Dave; McKeag, Doug; Valentine, Verle; Nichols, Gregory

    2017-01-01

    Approximately 3.8 million sports related TBIs occur per year. Genetic variation may affect both TBI risk and post-TBI clinical outcome. Limited research has focused on genetic risk for concussion among athletes. We describe the design, methods, and baseline characteristics of this prospective cohort study designed to investigate a potential association between genetic polymorphisms of apolipoprotein E gene, APOE promoter G-219T, and Tau gene exon 6 polymorphisms (Ser53 Pro and Hist47Tyr) with: 1) the risk of prospective concussion; 2) concussion severity; and 3) postconcussion neurocognitive recovery. The prospective cohort study included a final population of 2947 college, high school, and professional athletes. Baseline data collection included a concussion/medical history questionnaire, neuropsychological (NP) testing, and genetic sampling for the genetic polymorphisms. Data collection on new concussions experienced utilized post-concussion history/mental status form, Lovell post-concussion symptom score, Standardized Assessment of Concussion (SAC) and/or the Sports Concussion Assessment Tool (SCAT)-1/SCAT-2, and post-concussion NP testing. This paper is focused on discussing the important methodological considerations, organizational challenges and lessons learned in the completion of a multi-center prospective cohort study. A total of 3740 subjects enrolled, with a total of 335 concussions experienced. Of critical importance to the success of a study of this type is to successfully recruit committed institutions with qualified local study personnel, obtain "buy-in" from study sites, and cultivate strong working relationships with study sites. The use of approved incentives may improve study site recruitment, enhance retention, and enhance compliance with study protocols. Future publications will detail the specific findings of this study. Collaborative research is very likely needed given the nature of this study population.

  9. Fraser syndrome : epidemiological study in a European population

    NARCIS (Netherlands)

    Barisic, Ingeborg; Odak, Ljubica; Loane, Maria; Garne, Ester; Wellesley, Diana; Calzolari, Elisa; Dolk, Helen; Addor, Marie-Claude; Arriola, Larraitz; Bergman, Jorieke; Bianca, Sebastiano; Boyd, Patricia A; Draper, Elizabeth S; Gatt, Miriam; Haeusler, Martin; Khoshnood, Babak; Latos-Bielenska, Anna; McDonnell, Bob; Pierini, Anna; Rankin, Judith; Rissmann, Anke; Queisser-Luft, Annette; Verellen-Dumoulin, Christine; Stone, David; Tenconi, Romano

    Fraser syndrome is a rare autosomal recessive disorder characterized by cryptophthalmos, cutaneous syndactyly, laryngeal, and urogenital malformations. We present a population-based epidemiological study using data provided by the European Surveillance of Congenital Anomalies (EUROCAT) network of

  10. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  11. Multicenter European Prevalence Study of Neurocognitive Impairment and Associated Factors in HIV Positive Patients

    DEFF Research Database (Denmark)

    Haddow, Lewis J; Laverick, Rosanna; Daskalopoulou, Marina

    2017-01-01

    ≤-1 in at least 2 out of 5 cognitive domains. Participants' mean age was 45.8 years; 84% male; 87% white; 56% university educated; median CD4 count 550 cells/mm(3); 89% on antiretroviral therapy. 156 (35%) participants had NCI, among whom 26 (17%; 5.8% overall) reported a decline in activities...... of daily living. Prevalence of NCI was lower in those always able to afford basic needs (adjusted prevalence ratio [aPR] 0.71, 95% confidence interval [CI] 0.54-0.94) or with a university education (aPR 0.72, 95% CI 0.54-0.97) and higher in those with severe depressive symptoms (aPR 1.53, 95% CI 1...

  12. Sexual Behavior of Gender-Dysphoric Individuals Before Gender-Confirming Interventions: A European Multicenter Study

    NARCIS (Netherlands)

    Cerwenka, S.; Nieder, T.O.; Cohen-Kettenis, P.T.; De Cuypere, G.; Haraldsen, I.R.H.; Kreukels, B.P.C.; Richter-Appelt, H.

    2014-01-01

    A transsexual course of development that starts before puberty (early onset) or during or after puberty, respectively (late onset), may lead to diverse challenges in coping with sexual activity. The authors explored the sexual behavior of 380 adult male-to-female and female-to-male individuals

  13. Health care providers underestimate symptom intensities of cancer patients: A multicenter European study

    NARCIS (Netherlands)

    Laugsand, E.A.; Sprangers, M.A.G.; Bjordal, K.; Skorpen, F.; Kaasa, S.; Klepstad, P.

    2010-01-01

    ABSTRACT: BACKGROUND: Many patients with advanced cancer depend upon health care providers for symptom assessment. The extent of agreement between patient and provider symptom assessments and the association of agreement with demographic- and disease-related factors was examined. METHODS: This

  14. IncobotulinumtoxinA use in aesthetic indications in daily practice: a European multicenter, noninterventional, retrospective study

    Directory of Open Access Journals (Sweden)

    Pavicic T

    2015-03-01

    Full Text Available Tatjana Pavicic,1 Welf Prager,2 Markus Klöppel,3 Simon Ravichandran,4 Olivier Galatoire5 1Private Practice, Munich, Germany; 2Dr. Prager & Partner, Derma-Hamburg, Hamburg, Germany; 3Private Practice Clinic of Esthetic Surgery, MediCenter Munich-Solln, Munich, Germany; 4Clinetix Rejuvenation, Glasgow, Scotland, UK; 5Department of Ophthalmology, Adolphe Rothschild Ophthalmological Foundation, Paris, France Purpose: To characterize utilization patterns and treatment satisfaction with incobotulinumtoxinA for aesthetic indications and assess adherence to the Summary of Product Characteristics. Patients and methods: Data were collected retrospectively from physicians in Germany, France, and the UK regarding patients (n=638 treated with incobotulinumtoxinA for aesthetic indications. Data on indication, treatment interval, dose injected, physician and patient satisfaction, and adverse drug reactions were recorded according to routine daily practice. Results: Most patients (76.0% received incobotulinumtoxinA for glabellar frown lines (GFL and were given doses of ≤20 U. The majority of treatment intervals were 5 months or longer. Overall, 64.1% of patients were treated for off-label indications, sometimes in combination with treatment for GFL. The most frequently treated off-label indications were horizontal forehead lines (38.6% and/or crow's feet (CF; 31.7%; for CF, >95% of injected doses were ≤24 U. In Germany, a smaller proportion of patients were given incobotulinumtoxinA treatment for CF (27.6%, compared with France (40.4% and the UK (33.2%, although country-specific differences were less prominent when treatment cycle data for CF were examined. Treatment satisfaction among physicians and patients (overall, and for GFL specifically was very high, with excellent tolerability and only one mild adverse drug reaction reported. Conclusion: In daily practice, incobotulinumtoxinA is mainly used for GFL; however, its use for CF and horizontal forehead lines (often in combination with GFL is relatively common. Treatment satisfaction across aesthetic indications is high, and incobotulinumtoxinA is well tolerated, with time intervals of 5 months or longer between injections in the majority of cases. When considering factors such as dose and treatment interval, adherence to the Summary of Product Characteristics when treating GFL in daily practice is good. These results support previous reports that incobotulinumtoxinA is an effective treatment for GFL, with an excellent safety profile. Furthermore, incobotulinumtoxinA may display efficacy and tolerability in other indications. Keywords: incobotulinumtoxinA, Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™, NT 201; free from complexing proteins, retrospective, daily practice, glabellar frown lines, crow's feet

  15. [A MULTICENTER STUDY ON CHILDHOOD ALLERGIC RHINITIS TREATMENT IN THE TOHOKU REGION].

    Science.gov (United States)

    Matsubara, Atsushi; Ogawa, Hiroshi; Ohta, Nobuo; Oshima, Takeshi; Honda, Kohei; Satoh, Morito; Ichikawa, Yoko; Shimizu, Yukitoshi; Morikawa, Miki; Komatsu, Masaki; Yoshida, Shinichi; Tsuruta, Yasushi; Tamura, Gen

    2015-08-01

    We performed a multicenter study in order to clarify the present conditions of the childhood allergic rhinitis treatment in many departments of otorhinolaryngology and pediatrics/internal medicine in the Tohoku region, northern Japan. We performed a questionnaire survey about patient backgrounds, nasal symptoms, QOL disturbance, and treatment agents, for childhood allergic rhinitis patients under age 12. The total number of cases was 814, the mean age of the patients seen in pediatrics/internal medicine departments was significantly lower than that in otorhinolaryngology. The merger rate of bronchial asthma of the patients seen in pediatrics/internal medicine was significantly higher, and nasal symptoms and QOL disturbance of the patients seen in otorhinolaryngology were significantly more severe. For therapeutic agents, antihistamines were most prescribed, and the combination of LT receptor antagonist and intranasal steroids was used for the cases in which nasal symptoms were severe. The nasal symptoms in the combination group were significantly improved compared with the antihistamine monotherapy group. It was indicated that the combination therapy was useful in the severe cases of childhood allergic rhinitis.

  16. Possible relation of Tunisian pemphigus with traditional cosmetics: a multicenter case-control study.

    Science.gov (United States)

    Bastuji-Garin, Sylvie; Turki, Hamida; Mokhtar, Inçaf; Nouira, Rafia; Fazaa, Bassima; Jomaa, Bechir; Zahaf, Abdelmajid; Osman, Amel Ben; Souissi, Rafika; Hémon, Denis; Roujeau, Jean-Claude; Kamoun, Mohamed R

    2002-02-01

    Pemphigus is a severe, autoimmune, blistering disorder with a high incidence among young women in rural Tunisia. The authors investigated explanatory environmental factors. A multicenter case-control study was conducted prospectively from 1992 to 1996 in Tunisia. Sixty-eight incident female cases of pemphigus and 166 controls matched on age, hospital, and geographic area were included. Data collected concerned socioeconomic status, medical history, drug intakes, lifestyle, and environment. Several factors were significantly associated with pemphigus in multivariate logistic regression analyses: traditional cosmetics (odds ratio (OR) = 4.0, 95% confidence interval (CI): 1.1, 14.8); Turkish baths (OR = 3.2, 95% CI: 1.4, 7.3); cutting up raw poultry (OR = 5.1, 95% CI: 1.3, 19.4); contact with ruminants (OR = 2.7, 95% CI: 1.3, 5.8); and wasp, bee, and spider stings (OR = 3.1, 95% CI: 1.5, 6.4). A dose-dependent relation was observed for traditional cosmetics. All risks except insect bites were higher when analysis was restricted to younger women, the demographic group with higher incidence. The strength of the associations, the dose-dependent relation for traditional cosmetics, and the increase of risk estimates for younger women support a causal relation. Traditional cosmetics widely used by Tunisian women could play a major role in excess of cases of pemphigus.

  17. A multicenter study on amidolytic factor X evaluation in oral anticoagulant therapy.

    Science.gov (United States)

    Berthier, A M; Pommereuil, M; Scarabin, P Y; Conard, J

    1985-06-24

    For laboratory control of oral anticoagulation, amidolytic factor X (F X) determination may offer an alternative to standardization difficulties of prothrombin time (PT). In order to validate this amidolytic assay on a large scale, a multicenter study was undertaken in 6 French laboratories using the same chromogenic substrate (Stachrom X Stago) and different automated instruments. Intra and between laboratory reproducibility of factor X was estimated on fresh and lyophilized patients plasmas and was found to be highly satisfactory. Standardization of the method did not seem to depend on the chromogenic substrate used, as investigated in two different centers. Results of PT and factor X were compared in over 500 patients on a long-term stabilized oral anticoagulant treatment: there was a strong positive correlation between the 2 tests in each center. The therapeutic range for factor X was evaluated from therapeutic PT values reported by Duckert and Marbet for the different thromboplastin reagents: the estimated mean range was 21 to 32%. Pooling the results of the six different centers a concordant information for prothrombin time and factor X amidolytic assay was found in 76% of patients and a fully discordant response was present in 0.6%. The results suggest that amidolytic factor X may be suitable for monitoring long-term anticoagulation. However, prospective trials are needed to evaluate its usefulness as compared to conventional methods.

  18. Continuous versus intermittent infusion of vancomycin in severe Staphylococcal infections: prospective multicenter randomized study.

    Science.gov (United States)

    Wysocki, M; Delatour, F; Faurisson, F; Rauss, A; Pean, Y; Misset, B; Thomas, F; Timsit, J F; Similowski, T; Mentec, H; Mier, L; Dreyfuss, D

    2001-09-01

    A continuous infusion of vancomycin (CIV) may provide an alternative mode of infusion in severe hospital-acquired methicillin-resistant staphylococcal (MRS) infections. A multicenter, prospective, randomized study was designed to compare CIV (targeted plateau drug serum concentrations of 20 to 25 mg/liter) and intermittent infusions of vancomycin (IIV; targeted trough drug serum concentrations of 10 to 15 mg/liter) in 119 critically ill patients with MRS infections (bacteremic infections, 35%; pneumonia, 45%). Microbiological and clinical outcomes, safety, pharmacokinetics, ease of treatment adjustment, and cost were compared. Microbiological and clinical outcomes and safety were similar. CIV patients reached the targeted concentrations faster (36 +/- 31 versus 51 +/- 39 h, P = 0.029) and fewer samples were required for treatment monitoring than with IIV patients (7.7 +/- 2.2 versus 11.8 +/- 3.9 per treatment, P < 0.0001). The variability between patients in both the area under the serum concentration-time curve (AUC(24h)) and the daily dose given over 10 days of treatment was lower with CIV than with IIV (variances, 14,621 versus 53,975 mg(2)/liter(2)/h(2) [P = 0.026] and 414 versus 818 g(2) [P = 0.057], respectively). The 10-day treatment cost per patient was $454 +/- 137 in the IIV group and was 23% lower in the CIV group ($321 +/- 81: P < 0.0001). In summary, for comparable efficacy and tolerance, CIV may be a cost-effective alternative to IIV.

  19. Recurrence after cystectomy for borderline ovarian tumors: results of a French multicenter study.

    Science.gov (United States)

    Poncelet, Christophe; Fauvet, Raffaèle; Boccara, Joëlle; Daraï, Emile

    2006-04-01

    Fertility-sparing surgery for borderline ovarian tumors (BOT) is feasible and effective and does not seem to have a negative effect on survival. Specific data on the effect of cystectomy, and notably on recurrence, are lacking. This was a French retrospective multicenter study of 313 women with stage I BOT treated from 1990 to 2000 in 13 specialized gynecological units and 1 cancer center. Diagnosis and staging were based on International Federation of Gynecology and Obstetrics (1989) criteria. Surgery consisted of cystectomy, unilateral salpingo-oophorectomy (USO), or bilateral salpingo-oophorectomy (BSO). After cystectomy, persistent BOT and benign ovarian cysts on the operated ovary were observed in 15% and 65% of patients, respectively. Mean follow-up did not differ among patients receiving the three types of surgery. The recurrences after cystectomy, USO, and BSO treatment were 30.3%, 11%, and 1.7%, respectively (PBOT is associated with a high risk of intraoperative cyst rupture and of recurrence compared with USO or BSO.

  20. The Association of Obesity with Walking Independent of Knee Pain: The Multicenter Osteoarthritis Study

    Directory of Open Access Journals (Sweden)

    Daniel K. White

    2012-01-01

    Full Text Available Practice guidelines recommend addressing obesity for people with knee OA, however, the association of obesity with walking independent of pain is not known. We investigated this association within the Multicenter Osteoarthritis Study, a cohort of older adults who have or are at high risk of knee OA. Subjects wore a StepWatch to record steps taken over 7 days. We measured knee pain from a visual analogue scale and obesity by BMI. We examined the association of obesity with walking using linear regression adjusting for pain and covariates. Of 1788 subjects, the mean steps/day taken was 8872.9±3543.4. Subjects with a BMI ≥35 took 3355 fewer steps per day independent of knee pain compared with those with a BMI ≤25 (95% CI −3899, −2811. BMI accounted for 9.7% of the variability of walking while knee pain accounted for 2.9%. BMI was associated with walking independent of knee pain.

  1. Alveolar Ridge Reconstruction with Titanium Meshes and Simultaneous Implant Placement: A Retrospective, Multicenter Clinical Study

    Science.gov (United States)

    Paraud Freixas, Andres; Han, Chang-Hun; Bechara, Sohueil; Tawil, Isaac

    2016-01-01

    Objective. To evaluate horizontal bone gain and implant survival and complication rates in patients treated with titanium meshes placed simultaneously with dental implants and fixed over them. Methods. Twenty-five patients treated with 40 implants and simultaneous guided bone regeneration with titanium meshes (i–Gen®, MegaGen, Gyeongbuk, Republic of Korea) were selected for inclusion in the present retrospective multicenter study. Primary outcomes were horizontal bone gain and implant survival; secondary outcomes were biological and prosthetic complications. Results. After the removal of titanium meshes, the CBCT evaluation revealed a mean horizontal bone gain of 3.67 mm (±0.89). The most frequent complications were mild postoperative edema (12/25 patients: 48%) and discomfort after surgery (10/25 patients: 40%); these complications were resolved within one week. Titanium mesh exposure occurred in 6 patients (6/25 : 24%): one of these suffered partial loss of the graft and another experienced complete graft loss and implant failure. An implant survival rate of 97.5% (implant-based) and a peri-implant marginal bone loss of 0.43 mm (±0.15) were recorded after 1 year. Conclusions. The horizontal ridge reconstruction with titanium meshes placed simultaneously with dental implants achieved predictable satisfactory results. Prospective randomized controlled trials on a larger sample of patients are required to validate these positive outcomes. PMID:27999799

  2. Multicenter study on adult growth hormone level in postoperative pituitary tumor patients.

    Science.gov (United States)

    Cheng, Jing-min; Gu, Jian-wen; Kuang, Yong-qin; Ma, Yuan; Xia, Xun; Yang, Tao; Lu, Min; He, Wei-qi; Sun, Zhi-yong; Zhang, Yan-chao

    2015-03-01

    The objective of this study is to observe the adult growth hormone level in postoperative pituitary tumor patients of multi-centers, and explore the change of hypophyseal hormones in postoperative pituitary tumor patients. Sixty patients with pituitary tumor admitted during March, 2011-March, 2012 were selected. Postoperative hypophyseal hormone deficiency and the change of preoperative, intraoperative, and postoperative growth hormone levels were recorded. Growth hormone hypofunction was the most common hormonal hypofunction, which took up to 85.0 %. Adrenocortical hormone hypofunction was next to it and accounted for 58.33 %. GH + ACTH + TSH + Gn deficiency was the most common in postoperative hormone deficiency, which took up to 40.00 %, and GH + ACTH + TSH + Gn + AVP and GH deficiencies were next to it and accounted for 23.33 and 16.67 %, respectively. The hormone levels in patients after total pituitary tumor resection were significantly lower than those after partial pituitary tumor resection, and the difference was statistically significant; growth hormone and serum prolactin levels after surgery in two groups were decreased, and the difference was statistically significant. The incidence rate of growth hormone deficiency in postoperative pituitary tumor patients is high, which is usually complicated with deficiency of various hypophyseal hormones. In clinical, we should pay attention to the levels of the hypopnyseal hormones, and take timely measures to avoid postoperative complications.

  3. Value of Chest Radiographic Pattern in RSV Disease of the Newborn: A Multicenter Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Américo Gonçalves

    2012-01-01

    Full Text Available Respiratory syncytial virus (RSV lower respiratory tract infection is the most common viral respiratory infection in infants. Several authors have sought to determine which risk factors are the best predictors for severe RSV disease. Our aim was to evaluate if a specific chest radiographic pattern in RSV disease can predict the disease severity. We conducted a multicenter retrospective cohort study in term and preterm neonates with confirmed lower respiratory tract RSV infection, admitted to neonatal intensive care units (NICU from 2000 to 2010. To determine which factors independently predicted the outcomes, multivariate logistic regression analysis was performed. A total of 259 term and preterm neonates were enrolled. Patients with a consolidation pattern on the chest radiograph at admission (n=101 had greater need for invasive mechanical ventilation (OR: 2.5; P=.015, respiratory support (OR: 2.3; P=.005, supplemental oxygen (OR: 3.0; P=.008, and prolonged stay in the NICU (>7 days (OR: 1.8; P=.025. Newborns with a consolidation pattern on admission chest radiograph had a more severe disease course, with greater risk of invasive mechanical ventilation, respiratory support, supplemental oxygen, and prolonged hospitalization.

  4. Rheumatic fever: a multicenter study in the State of São Paulo

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    Silva Carlos Henrique Martins da

    1999-01-01

    Full Text Available Rheumatic fever is still the most commonly seen rheumatic disease in Brazilian pediatric rheumatology clinics. It remains a significant health problem since subsequent cardiac sequelae represent one of the most important causes of chronic heart disease in children. We reviewed the clinical manifestations of rheumatic fever in 786 patients, followed at seven pediatric rheumatology clinics in the state of São Paulo, Brazil. All patients were diagnosed according to revised Jones' criteria. Regarding major criteria, 396 (50.4% children exhibited carditis, 453 (57.6% polyarthritis, 274 (34.8% chorea, 13 (1.6% erythema marginatum, and 12 (1.5% subcutaneous nodules. Valvular lesions documented by echocardiography in the absence of accompanying auscultatory findings were found in 144 (18.3% patients. Migratory polyarthritis was observed in 290 (64.0% patients with articular involvement. Documented previous streptococcal infection assessed by serum antistreptolysin (ASO titers occurred in 531 (67.5% patients. Even though prophylaxis with benzathine penicillin was recommended to all patients, recurrent attacks were observed in 147 (18.7%. We emphasize the high frequency of chorea, silent carditis and recurrences in our series as well as the variable clinical presentation of arthritis in rheumatic fever. Multicenter studies should be encouraged to improve our understanding of the clinical features of rheumatic diseases in children and adolescents.

  5. Factors Associated With Domestic Violence Against Women in Iran: An Exploratory Multicenter Community-Based Study.

    Science.gov (United States)

    Saffari, Mohsen; Arslan, Syed Asadullah; Yekaninejad, Mir Saeid; Pakpour, Amir H; Zaben, Faten Al; Koenig, Harold G

    2017-06-01

    Domestic violence against women committed by intimate partners is a worldwide concern especially in developing countries. The aim of this study was to assess the problem among Iranian women and identify associated risk factors. Using a cross-sectional multicenter design, 1,600 women in six different areas of Iran were surveyed. A measure of domestic violence against women was administered and demographic information collected. Logistic regression models were used to identify factors associated with domestic violence. The prevalence of domestic violence among participants were emotional (64%), physical (28%), and sexual (18%). Higher education (both women and their partners), employment status of partner (being employed), and lower number of children lowered the risk, whereas history of previous marriage (for either women or their partners), unstable marriage, substance abuse, crowded family situation, and lower socioeconomic status increased the risk of domestic violence. There is a high prevalence of domestic violence, particularly emotional, against women by their partners. Preventive measures are recommended such as increasing public awareness, improving in socioeconomic status of families, educating women about what they can do, and encouraging counseling for the couple or the woman alone.

  6. The safety of omeprazole during pregnancy: a multicenter prospective controlled study.

    Science.gov (United States)

    Lalkin, A; Loebstein, R; Addis, A; Ramezani-Namin, F; Mastroiacovo, P; Mazzone, T; Vial, T; Bonati, M; Koren, G

    1998-09-01

    Our purpose was to determine whether omeprazole use during pregnancy is associated with an increased risk of malformations, spontaneous abortions, decreased birth weight, or perinatal complications. In a multicenter, prospective controlled study, pregnant women exposed to omeprazole during gestation were matched with controls exposed to nonteratogens and with disease-paired controls who used histamine blockers for similar indications. The primary end point was the incidence of major malformations. One hundred thirteen pregnant women were exposed to omeprazole during pregnancy. Rates of major malformations in the omeprazole group (4%) did not differ from controls exposed to nonteratogens (2%) (P = .68, relative risk = 1.94, 95% confidence interval 0.36 to 10.36) and disease-paired controls (2.8%). Birth weight, gestational age at delivery, preterm deliveries, and neonatal complications were comparable among the three groups. No association was found between exposure to omeprazole during the period of organogenesis and increased risk for major malformations. Exposure throughout pregnancy is not associated with increased risk of spontaneous abortions, decreased birth weight, or perinatal complications.

  7. [Participatory education and the development of critical reading in teachers theoretical texts. Multicenter study].

    Science.gov (United States)

    Leyva-González, Félix Arturo; Leo-Amador, Guillermo Enrique; Viniegra-Velázquez, Leonardo; Degollado-Bardales, Lilia; Zavala-Arenas, Jesús Arturo; González-Cobos, Roberto Palemón; Valencia-Sánchez, Jesús Salvador; Leyva-Salas, César Arturo; Angulo-Bernal, Sonia Elizabeth; Gómez-Arteaga, Gress Marissell

    2010-01-01

    Determine what the relationship between participation in classroom of students attending courses at the Educational Research and Teacher Education (CIEFD's) and the development of proficiency in critical reading of theoretical texts in education. Intervention study, multicenter students (medical specialist) level Diploma in teaching methodology (DMDN) 1 and 2 (n=46 n=29) of the six CIEFD's (DF Siglo XXI, Mexico City La Raza, Nuevo Leon, Sonora, Puebla and Veracruz), period: March to August 2007 and a Masters in education (n=9, generation 2007-2008). Two instruments were constructed that evaluated the participation variables and critical reading of theoretical texts in education, conceptual validity; content and reliability were assessed by experts in education research. The educational intervention was in the form of seminars (three times a week in DMDN 1 and twice weekly in DMDN 2 and Masters). Participation was assessed halfway through the course and on completion, critical reading at the beginning as well as the end. Statistically significant associations were observed in DMDN 1 (four Centers) and the Masters, but not DMDN 2. In this investigation some of the theoretical proposals of the participatory education were recreated, starting from the analysis of our results. In some centers and in the masters, strengthening participation in this educational intervention is related to the development of critical reading of theoretical texts in education.

  8. Pressure ulcer incidence in Dutch and German nursing homes: design of a prospective multicenter cohort study

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    Lohrmann Christa

    2011-04-01

    Full Text Available Abstract Background Pressure ulcers are a common and serious health care problem in all health care settings. Results from annual national pressure ulcer prevalence surveys in the Netherlands and Germany reveal large differences in prevalence rates between both countries over the past ten years, especially in nursing homes. When examining differences in prevalence and incidence rates, it is important to take into account all factors associated with the development of pressure ulcers. Numerous studies have identified patient related factors, as well as nursing related interventions as risk factors for the development of pressure ulcers. Next to these more process oriented factors, also structural factors such as staffing levels and staff quality play a role in the development of pressure ulcers. This study has been designed to investigate the incidence of pressure ulcers in nursing homes in the Netherlands and Germany and to identify patient related factors, nursing related factors and structural factors associated with pressure ulcer development. The present article describes the protocol for this study. Methods/design A prospective multicenter study is designed in which a cohort of newly admitted nursing home residents in 10 Dutch and 11 German nursing homes will be followed for a period of 12 weeks. Data will be collected by research assistants using questionnaires on four different levels: resident, staff, ward, and nursing home. Discussion The results of the study will provide information on the incidence of pressure ulcers in Dutch and German nursing homes. Furthermore, information will be gathered on the influence of patient related factors, nursing related factors and structural factors on the incidence of pressure ulcers. The present article describes the study design and addresses the study's strengths and weaknesses.

  9. Characteristics of pediatric ulcerative colitis in Saudi Arabia: a multicenter national study.

    Science.gov (United States)

    AlSaleem, Khalid; El Mouzan, Mohammad Issa; Saadah, Omar I; AlSaleem, Bader; Al-Hussaini, Abdulrahman; Hassosa, Mohammed; Ali, Al-Mehaidib; Banemai, Mohammed Othman; Halaby, Hana; El Edreesi, Mohammed

    2015-01-01

    Despite the extensive reporting of pediatric ulcerative colitis (UC) from industrialized developed countries, reports from developing countries are limited to small-case series from single centers. The objective of our large multicenter study was to determine the clinical, laboratory, endoscopic characteristics of UC in children from a developing country, Saudi Arabia. A retrospective study of children diagnosed with UC under the age of 18 years during the period from 2003 to 2012. Patients enrolled from 15 medical centers from different regions in Saudi Arabia. A unified database collection form specifically designed for this study was completed by all participating centers. A total of 188 children were diagnosed with UC during the study period (97 males [51.6%] and 91 females [48.4%]). The mean age at diagnosis was 9.1 years, and the mean duration of symptoms before diagnosis was 8.7 months. Consanguinity was present in 57 cases (32.6%), and the family history of inflammatory bowel disease (IBD) was noted in 16 cases (9%). The most common clinical presentation was blood in stool (90%), followed by diarrhea (86%) and abdominal pain (62%). Laboratory investigations revealed elevated erythrocyte sedimentation rate (82%), anemia (75%), thrombocytosis (72%), and hypoalbuminemia (33%). The extent of the disease was pan colonic in 46.1%, and confined to left side of colon and rectum in 23% and 9.6% of the cases, respectively. This demographically pediatric IBD retrospective study revealed age-related variation in the distribution of IBD. Clinical presentation, with a high prevalence of positive consanguinity and positive family history, was noted in young patients with UC. The data from this study indicate that UC is increasingly recognized in Saudi Arabia and show many similarities to data from North America and Europe.

  10. Estimating relative risks in multicenter studies with a small number of centers - which methods to use? A simulation study.

    Science.gov (United States)

    Pedroza, Claudia; Truong, Van Thi Thanh

    2017-11-02

    Analyses of multicenter studies often need to account for center clustering to ensure valid inference. For binary outcomes, it is particularly challenging to properly adjust for center when the number of centers or total sample size is small, or when there are few events per center. Our objective was to evaluate the performance of generalized estimating equation (GEE) log-binomial and Poisson models, generalized linear mixed models (GLMMs) assuming binomial and Poisson distributions, and a Bayesian binomial GLMM to account for center effect in these scenarios. We conducted a simulation study with few centers (≤30) and 50 or fewer subjects per center, using both a randomized controlled trial and an observational study design to estimate relative risk. We compared the GEE and GLMM models with a log-binomial model without adjustment for clustering in terms of bias, root mean square error (RMSE), and coverage. For the Bayesian GLMM, we used informative neutral priors that are skeptical of large treatment effects that are almost never observed in studies of medical interventions. All frequentist methods exhibited little bias, and the RMSE was very similar across the models. The binomial GLMM had poor convergence rates, ranging from 27% to 85%, but performed well otherwise. The results show that both GEE models need to use small sample corrections for robust SEs to achieve proper coverage of 95% CIs. The Bayesian GLMM had similar convergence rates but resulted in slightly more biased estimates for the smallest sample sizes. However, it had the smallest RMSE and good coverage across all scenarios. These results were very similar for both study designs. For the analyses of multicenter studies with a binary outcome and few centers, we recommend adjustment for center with either a GEE log-binomial or Poisson model with appropriate small sample corrections or a Bayesian binomial GLMM with informative priors.

  11. Digital pathology evaluation in the multicenter Nephrotic Syndrome Study Network (NEPTUNE).

    Science.gov (United States)

    Barisoni, Laura; Nast, Cynthia C; Jennette, J Charles; Hodgin, Jeffrey B; Herzenberg, Andrew M; Lemley, Kevin V; Conway, Catherine M; Kopp, Jeffrey B; Kretzler, Matthias; Lienczewski, Christa; Avila-Casado, Carmen; Bagnasco, Serena; Sethi, Sanjeev; Tomaszewski, John; Gasim, Adil H; Hewitt, Stephen M

    2013-08-01

    Pathology consensus review for clinical trials and disease classification has historically been performed by manual light microscopy with sequential section review by study pathologists, or multi-headed microscope review. Limitations of this approach include high intra- and inter-reader variability, costs, and delays for slide mailing and consensus reviews. To improve this, the Nephrotic Syndrome Study Network (NEPTUNE) is systematically applying digital pathology review in a multicenter study using renal biopsy whole slide imaging (WSI) for observation-based data collection. Study pathology materials are acquired, scanned, uploaded, and stored in a web-based information system that is accessed through a web-browser interface. Quality control includes metadata and image quality review. Initially, digital slides are annotated, with each glomerulus identified, given a unique number, and maintained in all levels until the glomerulus disappears or sections end. The software allows viewing and annotation of multiple slide sections concurrently. Analysis utilizes "descriptors" for patterns of injury, rather than diagnoses, in renal parenchymal compartments. This multidimensional representation via WSI, allows more accurate glomerular counting and identification of all lesions in each glomerulus, with data available in a searchable database. The use of WSI brings about efficiency critical to pathology review in a clinical trial setting, including independent review by multiple pathologists, improved intraobserver and interobserver reproducibility, efficiencies and risk reduction in slide circulation and mailing, centralized management of data integrity and slide images for current or future studies, and web-based consensus meetings. The overall effect is improved incorporation of pathology review in a budget neutral approach.

  12. Validation of the Spanish version of the Hip Outcome Score: a multicenter study.

    Science.gov (United States)

    Seijas, Roberto; Sallent, Andrea; Ruiz-Ibán, Miguel Angel; Ares, Oscar; Marín-Peña, Oliver; Cuéllar, Ricardo; Muriel, Alfonso

    2014-05-13

    The Hip Outcome Score (HOS) is a self-reported questionnaire evaluating the outcomes of treatment interventions for hip pathologies, divided in 19 items of activities of daily life (ADL) and 9 sports' items. The aim of the present study is to translate and validate HOS into Spanish. A prospective and multicenter study with 100 patients undergoing hip arthroscopy was performed between June 2012 and January 2013. Crosscultural adaptation was used to translate HOS into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 45.05 years old. 36 women and 64 men were included. Feasibility: 13% had at least one missing item within the ADL subscale and 17% within the sport subscale. Reliability: the translated version of HOS was highly reproducible with intraclass correlation coefficient of 0.95 for ADL and 0.94 for the sports subscale. Internal consistency was confirmed with Cronbach's alpha >0.90 in both subscales. Construct validity showed statistically significant correlation with WOMAC. Ceiling effect was observed in 6% and 12% for ADL and sports subscale, respectively. Floor effect was found in 3% and 37% ADL and sports subscale, respectively. Large sensitivity to change was shown in both subscales. The translated version of HOS into Spanish has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of HOS allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

  13. European Studies and Public Engagement: A Conceptual Toolbox

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    Andreas Müllerleile

    2014-11-01

    Full Text Available Journal of Contemporary European Research User Username Password Remember me Subscribe... Sign up for issue alerts Follow JCER on Twitter Font Size Make font size smaller Make font size default Make font size larger Journal Content Search Search Scope Browse By Issue By Author By Title Information For Readers For Authors For Librarians Journal Help Keywords CFSP Communication ESDP EU EU enlargement EU trade policy Energy, EU, External Policy Europe European Commission European Parliament European Union European integration Europeanisation First Enlargement Germany Liberty Lisbon Treaty Poland Russia Security teaching European studies The UACES Blog The Commission after the 2014 EP... Power shift? The EU’s pivot to Asia 100 Books on Europe to be Remembered For a Global European Studies? EU Member State Building in the... Open Journal Systems Home About Login Register Search Current Archives Announcements UACES Home > Vol 10, No 4 (2014 > Müllerleile European Studies and Public Engagement: A Conceptual Toolbox Andreas Müllerleile Abstract This article examines public engagement strategies for academics working in the field of European Studies. Should academics engage with the public? What are the most effective outreach strategies? And what are the implications for universities and departments? The article argues that engaging with the public should be considered an integral part for academics working on topics that relate to the European Union or European politics. The article has a theoretical and a practical dimension. The first part of the paper deals with the nature of public engagement, explaining why it is an important issue and how it differs from the mainstream understanding of public engagement. The practical part of the paper presents the idea of building an online presence through which academics can engage with the public debate both during periods of low issue salience and high issue salience. The final section includes a toolbox

  14. Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: a multicenter retrospective study.

    Science.gov (United States)

    Anchala, Praveen R; Irving, Winston D; Hillen, Travis J; Friedman, Michael V; Georgy, Bassem A; Coldwell, Douglass M; Tran, Nam D; Vrionis, Frank D; Brook, Allan; Jennings, Jack W

    2014-01-01

    Spinal metastatic lesions are a common occurrence among oncology patients and contribute to significant morbidity. Treatment options have been limited in their effectiveness and scope to this point. This study aims to report the safety and efficacy of radiofrequency ablation (RFA) of malignant spinal lesions using a novel RFA bipolar tumor ablation system which includes a navigational electrode containing 2 active thermocouples. IRB approved multicenter retrospective review of patients receiving RFA as a treatment of metastatic osseous lesions between March 2012 and March 2013. This study consists of patients from 5 large academic centers. One hundred twenty-eight metastatic lesions were identified in 92 patients who underwent a total of 96 procedures. Cement augmentation was performed when the vertebral body was at risk or had a pathological fracture. Visual analogue scale (VAS) scores were obtained preoperatively as well as postoperatively at the one week, one month, and 6 month time points. Interval change in the patients' pain medications was recorded. Postoperative imaging was used to assess tumor burden at the treated level when available. RFA was technically successful in all of the lesions without complication or thermal injury. Our study demonstrated significant (P postoperatively. In our largest center, 54% of our patients experienced a decrease and 30% had no change in their pain medications postoperatively. Sixty-two percent of the spinal lesions in this largest institution were located in the posterior vertebral body. Post-ablation imaging confirmed size of ablation zones consistent with that measured by the thermocouples. The main limitations of this study are the heterogeneous patient population, data set, and potential confounding variable of concurrent cement augmentation. The STAR System is an RFA device that was safely and effectively used in the treatment of spine metastatic osseous lesions. This new device allows RFA treatment of previously

  15. A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

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    Verleisdonk Egbert JMM

    2011-06-01

    Full Text Available Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF, or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. Methods/Design The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36. Discussion The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are

  16. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

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    Oliveira Sérgio A

    2007-01-01

    Full Text Available Abstract Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum. For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271

  17. Career Choices of Medical doctors at Graduate level - A Multicenter Study.

    Science.gov (United States)

    Zia, Sadaf; Abbas, Maisam; Sulaiman, Mehreen; Sheikh, Salman Matiullah

    2017-01-01

    To find out the specialty choices being taken by Final year Medical students and graduate Doctors. This is a cross sectional survey study which was conducted over two months from 1st November to 31st December 2016. Final year students and house job doctors were asked for the filling of Performa, after filling the consent form. A self-developed, anonymous questionnaire was used to conduct the study using close ended type of questions. This was a multi-center study conducted at Dow International Medical College and Jinnah Medical and Dental College. An IRB approval was taken for the study. A total of 317 individuals completed the Performa. Demaographic data included information regarding the year of passing, number of family members already in the medical profession, then specific questions were asked regarding their future career choice and the reason for choosing that particular speciality. After collection of data from both the centers a single operator entered the Data on SPSS 16 version. Frequencies and chi-square test were performed and p-valves were tabulated. A total of 317 individuals completed the Performa. Two hundred and nine participants (65.9%) were females and one hundred and eight (34.1%) were male participants. The age ranged from 22-29 years mean of 25.15 and SD of 1.348. One hundred and twenty one (38%) had a family member as a doctor in the family. Medicine and allied was the most sought after specialty 184(58%), followed by surgery and allied in 108(34%). Non-Clinical Specialty such as radiology, basic sciences was taken up by 27(7.9%). The working hours followed by passion for the chosen field were the important reasons for selecting any specialty. The next most important reason was higher income and other family responsibilities of an individual. The ladies are opting more for fields with a controllable life style.

  18. Who Donates Their Body to Science? An International, Multicenter, Prospective Study

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    Cornwall, Jon; Perry, Gary F.; Louw, Graham; Stringer, Mark D.

    2012-01-01

    The altruistic act of body donation provides a precious resource for both teaching and researching human anatomy. However, relatively little is known about individuals who donate their bodies to science (donors), and in particular whether donors in different geographical locations share similar characteristics. A multicenter prospective survey of…

  19. Topical corticosteroid abuse on the face: A prospective, multicenter study of dermatology outpatients

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    Abir Saraswat

    2011-01-01

    Full Text Available Background: Abuse of topical corticosteroids (TC, especially over the face, is prevalent worldwide, including in India. Data about the magnitude of this problem in our country is lacking. Aims: The aims of this study were to ascertain the demographics, magnitude and clinical features of TC misuse on the face in the dermatology outpatient department (OPD attendees in order to raise awareness about this problem and to analyze its causes. Methods: This was a prospective multicenter questionnaire-based clinical study conducted at 12 dermatology centers nationwide. Patients with relevant facial dermatoses reporting to the investigator were asked about their current use of over-the-counter topical formulations and a structured questionnaire applied in case the same was confirmed to be TC. Results: A total of 2926 patients with facial dermatoses were screened, of which 433 (14.8% were using TC. TC was used as a fairness/general purpose cream or aftershave in 126 (29% and in 104 (24% for acne. Steroid combinations were used by 258 (59.6%. Potent and super-potent TC were significantly (P = 0.05 more frequently used by the rural/suburban population. The younger age groups used more potent formulations. A non-physician recommendation for TC use was obtainable in 257 (59.3% patients. Of these, 232 (90.3% were for potent/super-potent steroids. Among 176 physician prescriptions, 78 (44.3% were from non-dermatologists. All non-physician prescriptions and 146 (83% physician prescriptions for TC were inappropriately refilled. Adverse effects were seen in 392 (90.5% TC users. Acne/exacerbation of acne was the most common adverse effect. Conclusions: TC misuse in patients with facial dermatoses is quite common, and most of this use is unwarranted. Use as a fairness cream is the most common indication in this cohort. Limitations: This was an OPD-based study and, therefore, it may or may not accurately reflect the community data.

  20. Hours of television viewing and sleep duration in children: a multicenter birth cohort study.

    Science.gov (United States)

    Marinelli, Marcella; Sunyer, Jordi; Alvarez-Pedrerol, Mar; Iñiguez, Carmen; Torrent, Maties; Vioque, Jesús; Turner, Michelle C; Julvez, Jordi

    2014-05-01

    This study used longitudinal data to examine potential associations between hours of television viewing and sleep duration in children. To examine the association between hours of television viewing and sleep duration in preschool and school-aged children. Longitudinal, multicenter study among birth cohorts in Menorca, Sabadell, and Valencia from the Spanish Infancia y Medio Ambiente (environment and childhood) project. The study sample included 1713 children (468 from Menorca, 560 from Sabadell, and 685 from Valencia). Parent-reported child television viewing duration measured in hours per day at 2 and 4 years of age in Sabadell and Valencia and at 6 and 9 years of age in Menorca. Parent-reported child sleep duration measured in hours per day at 2 and 4 years of age in Sabadell and Valencia and at 6 and 9 years of age in Menorca. In cross-sectional analysis, children with longer periods of television viewing reported at baseline (≥ 1.5 hours per day) had shorter sleep duration. Longitudinally, children with reported increases in television viewing duration over time (from <1.5 to ≥ 1.5 hours per day) had a reduction in sleep duration at follow-up visits. Results were similar when examining television viewing duration as a continuous variable, with each 1 hour per day of increased viewing decreasing sleep duration at follow-up visits (β = -0.11; 95% CI, -0.18 to -0.05). Associations were similar when television viewing duration was assessed during weekends and after adjusting for potential intermediate factors (child executive function and attention-deficit/hyperactivity disorder symptoms) and confounders (child physical activity level, parental mental health status, maternal IQ, and maternal marital status). Children spending longer periods watching television had shorter sleep duration. Changes in television viewing duration were inversely associated with changes in sleep duration in longitudinal analysis. Parents should consider avoiding long periods of

  1. Multicenter Study of Viral Etiology and Relapse in Hospitalized Children with Bronchiolitis

    Science.gov (United States)

    Hasegawa, Kohei; Mansbach, Jonathan M.; Teach, Stephen J.; Fisher, Erin S.; Hershey, Daniel; Koh, Joyce Y.; Clark, Sunday; Piedra, Pedro A.; Sullivan, Ashley F.; Camargo, Carlos A.

    2014-01-01

    Background It is unclear whether the infectious etiology of severe bronchiolitis affects short-term outcomes, such as post-hospitalization relapse. We tested the hypothesis that children hospitalized with rhinovirus (RV) bronchiolitis, either as a sole pathogen or in combination with respiratory syncytial virus (RSV), are at increased risk of relapse. Methods We performed a 16-center, prospective cohort study of hospitalized children age bronchiolitis. During the winters of 2007 to 2010, researchers collected clinical data and nasopharyngeal aspirates from study participants; the aspirates were tested using real-time polymerase chain reaction. The primary outcome was bronchiolitis relapse (urgent bronchiolitis visit or scheduled visit at which additions to the bronchiolitis medications were made) during the 2 weeks after hospital discharge. Results Among 1836 enrolled children with 2-week follow-up data, the median age was 4 months and 60% were male. Overall, 48% had sole RSV infection, 8% had sole RV infection, and 13% had RSV/RV co-infection. Compared with children with sole RSV infection, and adjusting for 10 demographic and clinical characteristics and clustering of patients within hospitals, children with sole RV infection did not differ in their likelihood of relapse (OR, 0.99; 95%CI, 0.52–1.90; P=0.98), whereas those with RSV/RV co-infection were more likely to have relapse (OR, 1.54; 95%CI, 1.03–2.30; P=0.03). Conclusions In this prospective, multicenter, multiyear study of children hospitalized with bronchiolitis, we found that RSV/RV co-infection was independently associated with a higher likelihood of bronchiolitis relapse. Present data support the concept that the infectious etiology of severe bronchiolitis affects short-term outcomes. PMID:24577039

  2. The Association Between Depressive Symptoms and Age in Cancer Patients: A Multicenter Cross-Sectional Study.

    Science.gov (United States)

    Wada, Saho; Shimizu, Ken; Inoguchi, Hironobu; Shimoda, Haruki; Yoshiuchi, Kazuhiro; Akechi, Tatsuo; Uchida, Megumi; Ogawa, Asao; Fujisawa, Daisuke; Inoue, Shinichirou; Uchitomi, Yosuke; Matsushima, Eisuke

    2015-12-01

    There is controversy around the association between depressive symptoms and age in adult cancer patients. The aim of this study was to evaluate the following hypotheses: 1) cancer patients' depressive symptoms decrease with age, and 2) in individuals aged 65 years or older, depressive symptoms increase because of the effect of somatic symptoms. We retrospectively analyzed a database of 356 cancer patients who were consecutively recruited in a previous multicenter cross-sectional study. Depressive symptoms were assessed by the Patient Health Questionnaire-9 (PHQ-9), and correlations with age and other factors were assessed by hierarchical multivariate regression analysis. Age was entered as the dependent variable in the first step, patient characteristics and cancer-related variables were entered in the second step, and somatic symptoms were entered in the last step. We analyzed this model for both the total sample and the subpopulation aged 65 years or older. In the total sample, the PHQ-9 score was significantly associated with lower age, fatigue, and shortness of breath (adjusted R(2) 14.2%). In the subpopulation aged 65 years or older, no factor was associated with the PHQ-9 score (adjusted R(2) 7.3%). The finding that depressive symptoms in cancer patients decreased with age was concordant with our first hypothesis, but the second hypothesis was not supported. Younger cancer patients were vulnerable to depressive symptoms and should be monitored carefully. Further studies using more representative samples are needed to examine in detail the association between depressive symptoms and age in older cancer patients. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  3. Predictors of responses to corticosteroids for anorexia in advanced cancer patients: a multicenter prospective observational study.

    Science.gov (United States)

    Matsuo, Naoki; Morita, Tatsuya; Matsuda, Yoshinobu; Okamoto, Kenichiro; Matsumoto, Yoshihisa; Kaneishi, Keisuke; Odagiri, Takuya; Sakurai, Hiroki; Katayama, Hideki; Mori, Ichiro; Yamada, Hirohide; Watanabe, Hiroaki; Yokoyama, Taro; Yamaguchi, Takashi; Nishi, Tomohiro; Shirado, Akemi; Hiramoto, Shuji; Watanabe, Toshio; Kohara, Hiroyuki; Shimoyama, Satofumi; Aruga, Etsuko; Baba, Mika; Sumita, Koki; Iwase, Satoru

    2017-01-01

    Although corticosteroids are widely used to relieve anorexia, information regarding the factors predicting responses to corticosteroids remains limited. The purpose of the study is to identify potential factors predicting responses to corticosteroids for anorexia in advanced cancer patients. Inclusion criteria for this multicenter prospective observational study were patients who had metastatic or locally advanced cancer and had an anorexia intensity score of 4 or more on a 0-10 Numerical Rating Scale (NRS). Univariate and multivariate analyses were conducted to identify the factors predicting ≥2-point reduction in NRS on day 3. Among 180 patients who received corticosteroids, 99 (55 %; 95 % confidence interval [CI], 47-62 %) had a response with ≥2-point reduction. Factors that significantly predicted responses were Palliative Performance Scale (PPS) > 40 and absence of drowsiness. In addition, factors that tended to be associated with ≥2-point reduction in NRS included PS 0-3, absence of diabetes mellitus, absence of peripheral edema, presence of lung metastasis, absence of peritoneal metastasis, baseline anorexia NRS of >6, presence of pain, and presence of constipation. A multivariate analysis showed that the independent factors predicting responses were PPS of >40 (odds ratio = 2.7 [95 % CI = 1.4-5.2]), absence of drowsiness (2.6 [1.3-5.0]), and baseline NRS of >6 (2.4 [1.1-4.8]). Treatment responses to corticosteroids for anorexia may be predicted by PPS, drowsiness, and baseline symptom intensity. Larger prospective studies are needed to confirm these results.

  4. Prospective multicenter study of bone scintigraphy in consecutive patients with newly diagnosed prostate cancer.

    Science.gov (United States)

    Zacho, Helle Damgaard; Barsi, Tamás; Mortensen, Jesper C; Mogensen, Maureen K; Bertelsen, Henrik; Josephsen, Norah; Petersen, Lars J

    2014-01-01

    International guidelines uniformly suggest no routine staging of bone metastasis in patients with bone scintigraphy (BS) in low-risk prostate cancer (PCa). These recommendations are based on retrospective investigations only. In addition, BS has most often been reported as a definitive investigation with no room for equivocal cases. The objective of this study was to determine the diagnostic value of BS in a large cohort of consecutive patients with newly diagnosed PCa. Over a period of 1.5 years in 2008 to 2009, consecutive patients with newly diagnosed PCa were enrolled in a noninterventional, multicenter, observational study. All patients had a whole-body, planar BS. Clinical history and clinical, pathological, and biochemical data were obtained from electronic patient files and questionnaires. Bone scintigraphy was classified into 4 categories as nonmalignant, equivocal, likely malignant, or multiple metastasis. The primary end point was final imaging, which was a composite end point of BS and additional CT and MRI investigations. A total of 635 eligible patients were recruited. Their median prostate-specific antigen (PSA) was 15 ng/mL, median Gleason was 7, and 80% of patients had local disease (T1 or T2). The proportion of nonmalignant BS was 61%, equivocal scans 26%, and likely or definitive metastasis 13%. A total of 154 patients had additional CT or MRI investigations. The final imaging diagnosis showed a prevalence of bone metastases in 87 (13.7%) of 635 patients. No bone metastases were observed in (1) patients with PSA of less than 10 ng/mL, independently of the clinical Tstage and Gleason score (n = 212) and (2) PSA of less than 20 ng/mL if Tstage is less than T3 and Gleason score is less than 8 (n = 97). Approximately 50% of the patients enrolled in this study met these criteria. This is the first prospective trial to demonstrate that BS can be avoided in patients with low-risk PCa.

  5. Physical inactivity in patients with COPD, a controlled multi-center pilot-study.

    Science.gov (United States)

    Troosters, Thierry; Sciurba, Frank; Battaglia, Salvatore; Langer, Daniel; Valluri, Srinivas Rao; Martino, Lavinia; Benzo, Roberto; Andre, David; Weisman, Idelle; Decramer, Marc

    2010-07-01

    Physical activity (PA) has been reported to be reduced in severe chronic obstructive pulmonary disease (COPD). Studies in moderate COPD are currently scarce. The aim of the present study was to investigate physical activity in daily life in patients with COPD (n=70) and controls (n=30). A multi-center controlled study was conducted. PA was assessed using a multisensor armband device (SenseWear, BodyMedia, Pittsburgh, PA) and is reported as the average number of steps per day, and the time spent in mild and moderate physical activity. Patients suffered from mild (n=9), moderate (n=28), severe (n=23) and very severe (n=10) COPD. The time spent in activities with mild (80 + or - 69 min vs 160 + or - 89 min, p<0.0001) and moderate intensity (24 + or - 29 min vs 65 + or - 70 min; p<0.0036) was reduced in patients compared to controls. The number of steps reached 87 + or - 34%, 71 + or - 32%, 49 + or - 34% and 29 + or - 20% of control values in GOLD-stages I to IV respectively. The time spent in activities at moderate intensity was 53 + or - 47%, 41 + or - 45%, 31 + or - 47% and 22 + or - 34% of the values obtained in controls respectively with increasing GOLD-stage. These differences reached statistical significance as of GOLD stage II (p<0.05). No differences were observed among centers. Physical activity is reduced early in the disease progression (as of GOLD-stage II). Reductions in physical activities at moderate intensity seem to precede the reduction in the amount of physical activities at lower intensity. Copyright 2010 Elsevier Ltd. All rights reserved.

  6. Intravenous Vitamin C in the treatment of shingles: Results of a multicenter prospective cohort study

    Science.gov (United States)

    Schencking, Martin; Vollbracht, Claudia; Weiss, Gabriele; Lebert, Jennifer; Biller, Andreas; Goyvaerts, Birgit; Kraft, Karin

    2012-01-01

    Summary Background Vitamin C is an immune-relevant micronutrient, which is depleted in viral infections and this deficiency seems to play a critical role in the pathogenesis of herpes infections and in the development of postherpetic neuralgia. The objective of this observational multicenter study was to evaluate the utilization, safety and efficacy of intravenously administrated vitamin C in patients with shingles. Material/Methods Between April 2009 and December 2010 16 general practitioners recorded data of 67 participants with symptomatic herpes zoster who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment. The assessment of pain (VAS) and the dermatologic symptoms of shingles such as hemorrhagic lesions and the number of efflorescences were investigated in a follow-up observation phase of up to 12 weeks. Results Mean declines of pain scores (VAS), number of affected dermatomes and efflorescences, and the presence of hemorrhagic vesicles between the baseline and follow-up assessments at 2 and 12 weeks were statistically significant. Overall, 6.4% of the participants experienced post-herpetic neuralgia. Common complaints such as general fatigue and impaired concentration also improved during the study. The effects and the tolerability of the treatment were evaluated positively by the physicians. The risk of developing PHN was reduced. Conclusions The data presented here provide evidence that concomitant use of intravenously administered ascorbic acid may have beneficial effects on herpes zoster-associated pain, dermatologic findings and accompanying common complaints. To confirm our findings, randomized, placebo-controlled clinical studies are necessary. PMID:22460093

  7. The impact of skin diseases on quality of life: A multicenter study.

    Science.gov (United States)

    Sanclemente, G; Burgos, C; Nova, J; Hernández, F; González, C; Reyes, M I; Córdoba, N; Arévalo, Á; Meléndez, E; Colmenares, J; Ariza, S; Hernández, G

    2017-04-01

    To date, no formal study has been published regarding how Colombian patients with skin disorders could be affected according to their perception of disease. To determine the impact in quality of life of skin diseases in a Colombian population. This multicenter study included patients with skin disease from almost the whole country. Individuals >18 years old; of any gender; with any skin disease and who signed informed consent, were included. We applied the Colombian validated version of the Skindex-29 instrument. A total of 1896 questionnaires had sufficient information for the analyses. No significant differences in sociodemographic characteristics of patients who returned the questionnaire incomplete vs. complete, were found. Participants mean age was 41.5 years. There were no statistical differences in men vs. women regarding the global (p=0.37), symptoms (p=0.71) and emotions (p=0.32) domains, whereas statistical differences were found in the function domain (p=0.04; Mann-Whitney U test). Psoriasis, contact dermatitis, atopic dermatitis, urticaria, hair disorders, Hansen's disease, scars, hyperhidrosis and genital human papillomavirus disease scored the highest. Skindex-29 score variability as a result of differences in the location of the skin lesions, their inflammatory or non-inflammatory nature, and the start of therapy. Even the most localized or asymptomatic skin lesion in our population leads to a disruption at some level of patient's wellness. This study adds well supported scientific data of the burden of skin diseases worldwide. Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Prospective multicenter study of the viral etiology of bronchiolitis in the emergency department.

    Science.gov (United States)

    Mansbach, Jonathan M; McAdam, Alexander J; Clark, Sunday; Hain, Paul D; Flood, Robert G; Acholonu, Uchechi; Camargo, Carlos A

    2008-02-01

    To determine the viral etiology of bronchiolitis and clinical characteristics of children age < 2 years presenting to the emergency department (ED) with bronchiolitis. The authors conducted a 14-center prospective cohort study during 2005-2006 of ED patients age < 2 years with bronchiolitis. The study was conducted in 10 states as part of the Emergency Medicine Network. Researchers collected nasopharyngeal aspirates and conducted structured interviews, medical record reviews, and 2-week follow-up telephone calls. Samples were tested using reverse transcription polymerase chain reaction for respiratory syncytial virus (RSV), rhinovirus (RV), human metapneumovirus (hMPV), and influenza viruses (Flu). Testing of 277 samples revealed 176 (64%) positive for RSV, 44 (16%) for RV, 26 (9%) for hMPV, 17 (6%) for Flu A, and none for Flu B. When children were categorized as RSV only, RV only, RV and RSV, and all others (hMPV, Flu, no identified virus), children with RV only were more likely to be African American (19, 62, 14, and 40%, respectively; p < 0.001) and have a history of wheezing (23, 52, 21, and 15%, respectively; p = 0.01). In multivariate models, children with RV were more likely to receive corticosteroids (odds ratio [OR] 3.5; 95% confidence interval [CI] = 1.5 to 8.15). The duration of illness may be shorter for children with RV (Days 8, 3, 6, and 8; p = 0.07). In this multicenter study, RSV was the most frequent cause of bronchiolitis (64%). RV was present in 16%, and these children have a distinct profile in terms of demographics, medical history, and ED treatment.

  9. Medical students and controversial ethical issues: results from the multicenter study SBRAME.

    Science.gov (United States)

    Lucchetti, Giancarlo; de Oliveira, Leandro Romani; Leite, José Roberto; Lucchetti, Alessandra Lamas Granero

    2014-12-15

    Medical students(MS) will face ethical issues throughout their lives as doctors. The present study aims to investigate medical students' opinions on controversial ethical issues and factors associated with these opinions. SBRAME (Spirituality and Brazilian Medical Education) is a multicenter study involving 12 Brazilian medical schools with 5950 MS. Participants completed a questionnaire that collected information on socio-demographic data, medical schools characteristics, religious beliefs and opinions on controversial ethical issues. Of all MS, 3630 participated in the survey (61.0%). The sample was 53.8% women and the mean age was 22.5 years. In general, most MS have no objections to prescription of birth control (90.8%), adult stem cell use (87.5%), embryonic stem cell use (82.0%) and abortion for genetic reasons (51.2%). Approximately half of students have no objections to human cloning (47.3%), 45.7% to withdrawal of artificial life support, 41.4% to euthanasia and 23.3% to abortion for failed contraception. Socio-demographic data such as age, gender and income had little influence on MS opinions. On the other hand, medical schools characteristics (number of medical students in the university, year of medical school foundation, location of the university and type of university) and religious aspects (religious affiliation, religious attendance, non-organizational religiousness and intrinsic religiousness) were highly correlated with their opinions. In general, MS with more supportive opinions on controversial ethical issues were less religious and from non-traditional (newer), urban, public and bigger universities. The current study reveals MS have different opinions regarding controversial ethical issues. Noteworthy, these opinions seem to be shaped more by university characteristics and religious beliefs than socio-demographic data.

  10. Pediatric drug-related problems: a multicenter study in four French-speaking countries.

    Science.gov (United States)

    Prot-Labarthe, Sonia; Di Paolo, Ermindo R; Lavoie, Annie; Quennery, Stefanie; Bussières, Jean-François; Brion, Françoise; Bourdon, Olivier

    2013-04-01

    Pediatric intensive care patients represent a population at high risk for drug-related problems. There are few studies that compare the activity of clinical pharmacists between countries. To describe the drug-related problems identified and interventions by four pharmacists in a pediatric cardiac and intensive care unit. Four pediatric centers in France, Quebec, Switzerland and Belgium. This was a six-month multicenter, descriptive and prospective study conducted from August 1, 2009 to January 31, 2010. Drug-related problems and clinical interventions were compiled from four pediatric centers in France, Quebec, Switzerland and Belgium. Data on patients, drugs, intervention, documentation, approval and estimated impact were compiled. Number and type of drug-related problems encountered in a large pediatric inpatient population. A total of 996 interventions were recorded: 238 (24 %) in France, 278 (28 %) in Quebec, 351 (35 %) in Switzerland and 129 (13 %) in Belgium. These interventions targeted 270 patients (median 21 months old, 53 % male): 88 (33 %) in France, 56 (21 %) in Quebec, 57 (21 %) in Switzerland and 69 (26 %) in Belgium. The main drug-related problems were inappropriate administration technique (29 %), untreated indication (25 %) and supra-therapeutic dose (11 %). The pharmacists' interventions were mostly optimizing the mode of administration (22 %), dose adjustment (20 %) and therapeutic monitoring (16 %). The two major drug classes that led to interventions were anti-infectives for systemic use (23 %) and digestive system and metabolism drugs (22 %). Interventions mainly involved residents and all clinical staff (21 %). Among the 878 (88 %) proposed interventions requiring physician approval, 860 (98 %) were accepted. This descriptive study illustrates drug-related problems and the ability of clinical pharmacists to identify and resolve them in pediatric intensive care units in four French-speaking countries.

  11. Bismuth-based quadruple therapy following H. pylori eradication failures: a multicenter study in clinical practice.

    Science.gov (United States)

    Zullo, Angelo; De Francesco, Vincenzo; Bellesia, Annamaria; Vassallo, Roberto; D'Angelo, Audenzio; Scaccianoce, Giuseppe; Sacco, Rodolfo; Bresci, Giampaolo; Eramo, Annarita; Tanzilli, Anna; Ridola, Lorenzo; Alvaro, Domenico; Londoni, Claudio; Brambilla, Gianfranco; Manta, Raffaele; Di Ciaula, Agostino; Portincasa, Piero

    2017-09-01

    Helicobacter pylori (H. pylori) eradication in patients who failed one or more therapeutic attempts remains challenging. This study aimed to assess the efficacy of three-in-one capsules bismuth-based quadruple therapy (Pylera®) in these patients managed in clinical practice. This was a prospective, open-label, multicenter study enrolling consecutive, adult patients with persistent H. pylori infection following at least one standard therapy. All patients received a rescue quadruple therapy with Pylera (3 capsules four times daily) and esomeprazole 20 mg (1 tablet twice daily) for 10 days. H. pylori eradication was assessed by using Urea Breath Test 4-6 weeks following therapy ending. H. pylori eradication rates, compliance, and side-effects were calculated. A total of 208 patients in the 9 participating centres were enrolled. Overall, 180 patients were successfully cured from the infection, accounting for 86.5% (95% CI 81.9-91.2) and 92.3% (95% CI 88.6-96.1) eradication rates at intention-to-treat analysis and at per protocol analysis, respectively. Cure rates were similar across patients who failed one to three previous therapy attempts, but the success rate fell to 67% after 4 or more therapy failures. Compliance to therapy was good in 198 (95.2%) patients, whilst in 7 (5.3%) cases the therapy was interrupted within 5 days due to side effects. A total of 97 (46.6%) patients complained of at least one side effect; nausea, diarrhea and vomiting were the most frequently reported. Our study found that this bismuth-based quadruple therapy is highly effective as second-line and rescue therapy for H. pylori eradication in clinical practice.

  12. A multicenter study on Leigh syndrome: disease course and predictors of survival.

    Science.gov (United States)

    Sofou, Kalliopi; De Coo, Irenaeus F M; Isohanni, Pirjo; Ostergaard, Elsebet; Naess, Karin; De Meirleir, Linda; Tzoulis, Charalampos; Uusimaa, Johanna; De Angst, Isabell B; Lönnqvist, Tuula; Pihko, Helena; Mankinen, Katariina; Bindoff, Laurence A; Tulinius, Már; Darin, Niklas

    2014-04-15

    Leigh syndrome is a progressive neurodegenerative disorder, associated with primary or secondary dysfunction of the mitochondrial oxidative phosphorylation. Despite the fact that Leigh syndrome is the most common phenotype of mitochondrial disorders in children, longitudinal natural history data is missing. This study was undertaken to assess the phenotypic and genotypic spectrum of patients with Leigh syndrome, characterise the clinical course and identify predictors of survival in a large cohort of patients. This is a retrospective study of patients with Leigh syndrome that have been followed at eight centers specialising in mitochondrial diseases in Europe; Gothenburg, Rotterdam, Helsinki, Copenhagen, Stockholm, Brussels, Bergen and Oulu. A total of 130 patients were included (78 males; 52 females), of whom 77 patients had identified pathogenic mutations. The median age of disease onset was 7 months, with 80.8% of patients presenting by the age of 2 years. The most common clinical features were abnormal motor findings, followed by abnormal ocular findings. Epileptic seizures were reported in 40% of patients. Approximately 44% of patients experienced acute exacerbations requiring hospitalisation during the previous year, mainly due to infections. The presence of pathological signs at birth and a history of epileptic seizures were associated with higher occurrence of acute exacerbations and/or relapses. Increased lactate in the cerebrospinal fluid was significantly correlated to a more severe disease course, characterised by early onset before 6 months of age, acute exacerbations and/or relapses, as well as brainstem involvement. 39% of patients had died by the age of 21 years, at a median age of 2.4 years. Disease onset before 6 months of age, failure to thrive, brainstem lesions on neuroimaging and intensive care treatment were significantly associated with poorer survival. This is a multicenter study performed in a large cohort of patients with Leigh syndrome

  13. Efficacy of a ketogenic diet in resistant myoclono-astatic epilepsy: A French multicenter retrospective study.

    Science.gov (United States)

    Stenger, Elodie; Schaeffer, Mickael; Cances, Claude; Motte, Jacques; Auvin, Stéphane; Ville, Dorothée; Maurey, Hélène; Nabbout, Rima; de Saint-Martin, Anne

    2017-03-01

    Recent studies have suggested that the early introduction of a ketogenic diet (KD) could improve seizure control in myoclono-astatic epilepsy (MAE). This multicenter study sought to identify the benefits of KD use on seizure control and epilepsy and on developmental outcomes in children with resistant MAE. Fifty children who were diagnosed with severe MAE in the French network of Reference Centers for Rare Epilepsies and who were treated with KD between 2000 and 2013 were included in this study. The seizure frequency and EEG recordings were assessed two weeks before KD introduction, 2 and 6 months after, and during the last follow-up, which also included an assessment of developmental outcome. Patients had a median follow up of 52 months (range 13-136) and received 4.3 antiepileptic drugs [2-9] before KD introduction. Fifty-four percent (54%) of our patients were seizure-free after 6 months of KD or more, and 86% experienced more than a 70% seizure reduction after 2 months of KD. Forty-four percent (44%) of them had a clear benefit of early KD treatment (after four AEDs failed). Early KD treatment did not result in a greater seizure reduction (p=0.055), but significantly resulted in remission (p<0.028). Fifty percent of patients with resistant MAE had normal development outcomes. Earlier KD treatment, after three AEDs failed, was correlated with a better cognitive outcome (p<0.01). Early introduction of KD treatment in resistant MAE has a strong, persistent anticonvulsant effect with long-term remission and better cognitive outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  15. Primary total hip arthroplasty revision due to dislocation: prospective French multicenter study.

    Science.gov (United States)

    Girard, J; Kern, G; Migaud, H; Delaunay, C; Ramdane, N; Hamadouche, M

    2013-09-01

    Dislocation following total hip arthroplasty (THA) may require surgical revision, and is one of the most frequent causes for revision in national registers. The goals of this study were to determine the characteristics of revision THA for dislocation and identify the typical features of hips revised due to dislocation. A prospective multicenter study (30 centers) was performed in first revision THA performed between January 1, 2010 and December 31, 2011 (multiple revisions were excluded). Two hundred nineteen (10.4%) of all first revisions (2153 cases in 2107 patients) were for dislocation, which was the fifth cause of revision. There were 135 men and 84 women, mean age 65.9 years old (24.3-92.4) at primary THA and 72.9 years old (31.9-98.8) at revision. Revision surgery was performed a mean 7.1 years (± 7.1) after primary THA. The predictive risk factors for dislocation were: a 22.2mm diameter femoral head (risk × 2.4), a posterolateral approach (risk × 1.7), older age (risk × 1.1), an elevated rim liner for primary THA (risk × 6.6). The use of a dual mobility cup did not influence the rate of revision for dislocation (8.8%) compared to the use of a flat rim liner (9.1%). The 10.4% rate of revision of THA for dislocation seems markedly lower than the results in the literature both for frequency and ranking. The use of elevated rim or constrained liners designed to decrease the risk of dislocation does not improve results compared to standard liners. Level IV, prospective prognostic study without a control group. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  16. HER2 status in ovarian carcinomas: a multicenter GINECO study of 320 patients.

    Directory of Open Access Journals (Sweden)

    Marianne Tuefferd

    Full Text Available BACKGROUND: Despite a typically good response to first-line combination chemotherapy, the prognosis for patients with advanced ovarian cancer remains poor because of acquired chemoresistance. The use of targeted therapies such as trastuzumab may potentially improve outcomes for patients with ovarian cancer. HER2 overexpression/amplification has been reported in ovarian cancer, but the exact percentage of HER2-positive tumors varies widely in the literature. In this study, HER2 gene status was evaluated in a large, multicentric series of 320 patients with advanced ovarian cancer, including 243 patients enrolled in a multicenter prospective clinical trial of paclitaxel/carboplatin-based chemotherapy. METHODOLOGY/PRINCIPAL FINDINGS: The HER2 status of primary tumors and metastases was evaluated by both immunohistochemistry (IHC and fluorescence in situ hybridization (FISH analysis of paraffin-embedded tissue on conventional slides. The prognostic impact of HER2 expression was analyzed. HER2 gene was overexpressed and amplified in 6.6% of analyzed tumors. Despite frequent intratumoral heterogeneity, no statistically significant difference was detected between primary tumors and corresponding metastases. CONCLUSIONS/SIGNIFICANCE: Our results show that the decision algorithm usually used in breast cancer (IHC as a screening test, with equivocal results confirmed by FISH is appropriate in ovarian cancer. In contrast to previous series, HER2-positive status did not influence outcome in the present study, possibly due to the fact that patients in our study received paclitaxel/carboplatin-based chemotherapy. This raises the question of whether HER2 status and paclitaxel sensitively are linked.

  17. Assessment of thromboprophylaxis in medical patients hospitalized in Andalusia. A multicenter study.

    Science.gov (United States)

    Navarro Puerto, M A; Medrano Ortega, F J; Izquierdo Guerrero, R; Calderón Sandubete, E; Buzón-Barrera, M L; Marín-León, I

    2015-04-01

    Hospitalized patients are a population at risk for venous thromboembolism (VTE). The PRETEMED-2007 clinical practice guidelines help identify high-risk medical patients who are suited to thromboprophylaxis. These guidelines therefore provide a standard for prophylaxis in such patients. We evaluated the risk of VTE and the adjustment of thromboprophylaxis to the standards of the PRETEMED-2007 guidelines in patients hospitalized in internal medicine departments. An observational, cross-sectional multicenter study was performed in 2010 in 16 hospitals in Andalusia and included 20 consecutive patients per center. The study variables were age, sex, risk factors for VTE and hemorrhage, the risk-adjusted PRETEMED of VTE, adjustment of thromboembolic prophylaxis at admission and at discharge and hospital mortality. The study included 293 patients (57.8% men) with a mean age of 69 (±15) years. The most common triggers for VTE were acute severe infection (27.3%) and neoplasia (16.4%). Some 43.4% of the patients presented a risk of hemorrhage. The risk of VTE at admission and discharge was high in 47.8% and 31% and moderate in 8.2% and 10.6%, respectively. A total of 91.7% and 17.3% of the patients underwent prophylaxis with low-molecular-weight heparin on admission and at discharge, respectively. The prescription was appropriate for 59.9% of the patients at admission (overutilization 38.4%, underutilization 1.7%) and for 74.7% at discharge (overutilization 5.4%, underutilization 19.9%). The adjustment was greater in patients older than 60 years and with greater hemorrhagic risk. For 60% of the patients admitted to the departments of internal medicine in Andalusia, the thromboprophylaxis was appropriate. The inadequacy of thromboprophylaxis (40%) is mostly due to overutilization. These results suggest significant space for improvement. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  18. Association of tattooing and hepatitis C virus infection: a multicenter case-control study.

    Science.gov (United States)

    Carney, Kerrilynn; Dhalla, Sameer; Aytaman, Ayse; Tenner, Craig T; Francois, Fritz

    2013-06-01

    Although injection drug use (IDU) and blood transfusions prior to 1992 are well-accepted risk factors for hepatitis C virus (HCV) infection, many studies that evaluated tattooing as a risk factor for HCV infection did not control for a history of IDU or transfusion prior to 1992. In this large, multicenter, case-control study, we analyzed demographic and HCV risk factor exposure history data from 3,871 patients, including 1,930 with chronic HCV infection (HCV RNA-positive) and 1,941 HCV-negative (HCV antibody-negative) controls. Crude and fully adjusted odds ratios (ORs) of tattoo exposure by multivariate logistic regression in HCV-infected versus controls were determined. As expected, IDU (65.9% versus 17.8%; P history of having one or more tattoos (OR, 3.81; 95% CI, 3.23-4.49; P history of ever injecting drugs and those who had a blood transfusion prior to 1992, a total of 1,886 subjects remained for analysis (465 HCV-positive patients and 1,421 controls). Among these individuals without traditional risk factors, HCV-positive patients remained significantly more likely to have a history of one or more tattoos after adjustment for age, sex, and race/ethnicity (OR, 5.17; 95% CI, 3.75-7.11; P Tattooing is associated with HCV infection, even among those without traditional HCV risk factors such as IDU and blood transfusion prior to 1992. Copyright © 2013 American Association for the Study of Liver Diseases.

  19. Prospective multicenter study of viral etiology and hospital length of stay in children with severe bronchiolitis.

    Science.gov (United States)

    Mansbach, Jonathan M; Piedra, Pedro A; Teach, Stephen J; Sullivan, Ashley F; Forgey, Tate; Clark, Sunday; Espinola, Janice A; Camargo, Carlos A

    2012-08-01

    To determine whether hospital length of stay(LOS) for acute bronchiolitis is influenced by the infecting pathogen. A prospective observational cohort study was performed during 3 consecutive years. Sixteen US hospitals participated in the study. Children younger than 2 years hospitalized with bronchiolitis were included. The results of nasopharyngeal aspirate polymerase chain reaction pathogen testing served as the main exposure. Hospital LOS was determined. Of 2207 participants, 72.0% had respiratory syncytial virus (RSV) and 25.6% had human rhinovirus(HRV); the incidence of each of the other viruses and bacteria was 7.8% or less. Multiple pathogen infections were present in 29.8% of the children. There were 1866 children(84.5%) with RSV and/or HRV. Among these 1866 children, the median age was 4 months and 59.5% were male. The median LOS was 2 days (interquartile range,1-4 days). Compared with children who had only RSV,an LOS of 3 or more days was less likely among children with HRV alone (adjusted odds ratio [AOR], 0.36; 95%CI, 0.20-0.63; P.001) and those with HRV plus non-RSV pathogens (AOR, 0.39; 95% CI, 0.23-0.66; P.001)but more likely among children with RSV plus HRV(AOR,1.33; 95% CI, 1.02-1.73; P=.04), controlling for 15 demographic and clinical factors. In this multicenter study of children hospitalized with bronchiolitis, RSV was the most common virus detected, but HRV was detected in one-quarter of the children. Since 1 in 3 children had multiple virus infections and HRV was associated with LOS, these data challenge the effectiveness of current RSV-based cohorting practices, the sporadic testing for HRV in bronchiolitis research, and current thinking that the infectious etiology of severe bronchiolitis does not affect short-term outcomes.

  20. Air contamination for predicting wound contamination in clean surgery: A large multicenter study.

    Science.gov (United States)

    Birgand, Gabriel; Toupet, Gaëlle; Rukly, Stephane; Antoniotti, Gilles; Deschamps, Marie-Noelle; Lepelletier, Didier; Pornet, Carole; Stern, Jean Baptiste; Vandamme, Yves-Marie; van der Mee-Marquet, Nathalie; Timsit, Jean-François; Lucet, Jean-Christophe

    2015-05-01

    The best method to quantify air contamination in the operating room (OR) is debated, and studies in the field are controversial. We assessed the correlation between 2 types of air sampling and wound contaminations before closing and the factors affecting air contamination. This multicenter observational study included 13 ORs of cardiac and orthopedic surgery in 10 health care facilities. For each surgical procedure, 3 microbiologic air counts, 3 particles counts of 0.3, 0.5, and 5 μm particles, and 1 bacteriologic sample of the wound before skin closure were performed. We collected data on surgical procedures and environmental characteristics. Of 180 particle counts during 60 procedures, the median log10 of 0.3, 0.5, and 5 μm particles was 7 (interquartile range [IQR], 6.2-7.9), 6.1 (IQR, 5.4-7), and 4.6 (IQR, 0-5.2), respectively. Of 180 air samples, 50 (28%) were sterile, 90 (50%) had 1-10 colony forming units (CFU)/m(3) and 40 (22%) >10 CFU/m(3). In orthopedic and cardiac surgery, wound cultures at closure were sterile for 24 and 9 patients, 10 and 11 had 1-10 CFU/100 cm(2), and 0 and 6 had >10 CFU/100 cm(2), respectively (P air microbial counts (P contamination (P = .22). This study suggests that particle counting is a good surrogate of airborne microbiologic contamination in the OR. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  1. Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

    Directory of Open Access Journals (Sweden)

    Frank Ana

    2006-04-01

    Full Text Available Abstract Background Available screening tests for dementia are of limited usefulness because they are influenced by the patient's culture and educational level. The Eurotest, an instrument based on the knowledge and handling of money, was designed to overcome these limitations. The objective of this study was to evaluate the diagnostic accuracy of the Eurotest in identifying dementia in customary clinical practice. Methods A cross-sectional, multi-center, naturalistic phase II study was conducted. The Eurotest was administered to consecutive patients, older than 60 years, in general neurology clinics. The patients' condition was classified as dementia or no dementia according to DSM-IV diagnostic criteria. We calculated sensitivity (Sn, specificity (Sp and area under the ROC curves (aROC with 95% confidence intervals. The influence of social and educational factors on scores was evaluated with multiple linear regression analysis, and the influence of these factors on diagnostic accuracy was evaluated with logistic regression. Results Sixteen neurologists recruited a total of 516 participants: 101 with dementia, 380 without dementia, and 35 who were excluded. Of the 481 participants who took the Eurotest, 38.7% were totally or functionally illiterate and 45.5% had received no formal education. Mean time needed to administer the test was 8.2+/-2.0 minutes. The best cut-off point was 20/21, with Sn = 0.91 (0.84–0.96, Sp = 0.82 (0.77–0.85, and aROC = 0.93 (0.91–0.95. Neither the scores on the Eurotest nor its diagnostic accuracy were influenced by social or educational factors. Conclusion This naturalistic and pragmatic study shows that the Eurotest is a rapid, simple and useful screening instrument, which is free from educational influences, and has appropriate internal and external validity.

  2. Antecedents of organizational citizenship behavior among Iranian nurses: a multicenter study.

    Science.gov (United States)

    Taghinezhad, Fakhredin; Safavi, Mahboobe; Raiesifar, Afsaneh; Yahyavi, Sayed Hossein

    2015-10-08

    Organizational citizenship behavior (OCB) improves efficiency and employees' participation and generally provides a good ambiance. This study was conducted to determine the role of job satisfaction (JS), organizational commitment (OC) and procedural justice (PJ) in explaining OCB among nurses working in fifteen educational-treatment centers in Tehran-Iran, to provide guidelines for health care managers' further understanding of how to encourage citizenship behavior among nurses. In this multi-center descriptive-correlational study 373 nurses were evaluated through a Multi-stage cluster sampling method after obtaining approval from the Ethics Committee of Islamic Azad University, Tehran Medical Branch and Tehran University of Medical Sciences Research Deputy. Nurses who signed the informed consent and holding a bachelor or master degree, having a minimum one year of job experience and not having organizational management position during the questionnaire distribution were included in the study. In order to collect data, Demographic questionnaire, Podsakoff et al. (Leadersh Q 1(2):107-142, 1990) OCB questionnaire, OC questionnaire, Aelterman et al. (Educ Stud 33(3):285-297, 2007) JS questionnaire and PJ questionnaire were used. These questionnaires were translated into Persian and content validity was confirmed by an expert group; their reliability was calculated by the internal consistency Cronbach alpha coefficient and it was satisfied. Data were analyzed by descriptive statistics, Comparative mean tests, correlation coefficient and multiple-regression in the SPSS software version 11. The general mean and all five aspects of OCB that ranked higher than 3 were evaluated in a "quite desired" state. The mean for perceived procedural justice, the general mean for JS and the mean of general grade for OC from the nurses' was in "quite desired" state. Finding from multiple regression indicated that OC and PJ exhibit about 19 % of OCB variance totally which is

  3. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Exercise 5: an international multicenter reliability study using computerized MRI erosion volume measurements

    DEFF Research Database (Denmark)

    Bird, P; Ejbjerg, B; McQueen, F

    2003-01-01

    . The volume estimation method was more time consuming, taking roughly 5 times as long as the scoring method. Computerized MRI erosion volume measurements are feasible, with high intra-observer and inter-occasion reliabilities. Despite high ICC, the inter-observer reliability is not sufficient for multicenter......Scoring erosions on magnetic resonance imaging (MRI) is one method of estimating damage in patients with rheumatoid arthritis (RA), but it has limitations. The aim of this pilot study was to assess the feasibility and inter-reader reliability of computer assisted erosion volume estimation...... in patients with RA. Intra-reader and inter-occasion reliability was also assessed, and different slice thicknesses were compared in terms of erosion volume estimation. A 3 mm slice thickness 3D gradient-echo sequence followed by a 1 mm sequence was performed at baseline and repeated within 24 h...

  4. Evaluation of 5-year-old children with complete cleft lip and palate: Multicenter study. Part 1: Lip and nose aesthetic results.

    Science.gov (United States)

    Dissaux, Caroline; Bodin, Frédéric; Grollemund, Bruno; Picard, Arnaud; Vazquez, Marie-Paule; Morand, Béatrice; James, Isabelle; Kauffmann, Isabelle; Bruant-Rodier, Catherine

    2015-12-01

    Cleft surgery is marked by all the controversies and the multiplication of protocols, as it has been shown by the Eurocleft study. The objective of this pilot study is to start a comparison and analyzing procedure between primary surgical protocols in French centers. Four French centers with different primary surgical protocols for cleft lip and palate repair, have accepted to be involved in this retrospective study. In each center, 20 consecutive patients with complete cleft lip and palate (10 UCLP and 10 BCLP per center), non syndromic, have been evaluated at a mean age of 5 [4,6]. In this first part, the aesthetic results of nose and lip repair were assessed based on the scale established by Mortier et al. (1997). Considering nose outcome, primary cleft repair surgery including a nasal dissection gives a statistically significant benefit in terms of septum deviation. Considering lip result, muscular dehiscence rate is significantly higher in BCLP patients with a two-stage lip closure. The centers using Millard one-stage lip closure do not have uniform results. For UCLP patients, the quality of scar is not statistically different between Skoog and Millard techniques. Primary results based on a simple, reproducible evaluation protocol. Extension to other centers required. Therapeutic study. Level III/retrospective multicenter comparative study. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  5. Immediate transmucosal implant placement in molar extraction sites: a 12-month prospective multicenter cohort study.

    Science.gov (United States)

    Cafiero, C; Annibali, S; Gherlone, E; Grassi, F R; Gualini, F; Magliano, A; Romeo, E; Tonelli, P; Lang, N P; Salvi, G E

    2008-05-01

    To assess the clinical and radiographic outcomes of immediate transmucosal placement of implants into molar extraction sockets. Twelve-month multicenter prospective cohort study. Following molar extraction, tapered implants with an endosseous diameter of 4.8 mm and a shoulder diameter of 6.5 mm were immediately placed into the sockets. Molars with evidence of acute periapical pathology were excluded. After implant placement and achievement of primary stability, flaps were repositioned and sutured allowing a non-submerged, transmucosal healing. Peri-implant marginal defects were treated according to the principles of guided bone regeneration (GBR) by means of deproteinized bovine bone mineral particles in conjunction with a bioresrobable collagen membrane. Standardized radiographs were obtained at baseline and 12 months thereafter. Changes in depth and width of the distance from the implant shoulder (IS) and from the alveolar crest (AC) to the bottom of the defect (BD) were assessed. Eighty-two patients (42 males and 40 females) were enrolled and followed for 12 months. They contributed with 82 tapered implants. Extraction sites displayed sufficient residual bone volume to allow primary stability of all implants. Sixty-four percent of the implants were placed in the areas of 36 and 46. GBR was used in conjunction with the placement of all implants. No post-surgical complications were observed. All implants healed uneventfully yielding a survival rate of 100% and healthy soft tissue conditions after 12 months. Radiographically, statistically significant changes (Pcrestal bone levels were observed from baseline to the 12-month follow-up. The findings of this 12-month prospective cohort study showed that immediate transmucosal implant placement represented a predictable treatment option for the replacement of mandibular and maxillary molars lost due to reasons other than periodontitis including vertical root fractures, endodontic failures and caries.

  6. Phase I/II multicenter ketogenic diet study for adult superrefractory status epilepticus.

    Science.gov (United States)

    Cervenka, Mackenzie C; Hocker, Sara; Koenig, Matthew; Bar, Barak; Henry-Barron, Bobbie; Kossoff, Eric H; Hartman, Adam L; Probasco, John C; Benavides, David R; Venkatesan, Arun; Hagen, Eliza C; Dittrich, Denise; Stern, Tracy; Radzik, Batya; Depew, Marie; Caserta, Filissa M; Nyquist, Paul; Kaplan, Peter W; Geocadin, Romergryko G

    2017-03-07

    To investigate the feasibility, safety, and efficacy of a ketogenic diet (KD) for superrefractory status epilepticus (SRSE) in adults. We performed a prospective multicenter study of patients 18 to 80 years of age with SRSE treated with a KD treatment algorithm. The primary outcome measure was significant urine and serum ketone body production as a biomarker of feasibility. Secondary measures included resolution of SRSE, disposition at discharge, KD-related side effects, and long-term outcomes. Twenty-four adults were screened for participation at 5 medical centers, and 15 were enrolled and treated with a classic KD via gastrostomy tube for SRSE. Median age was 47 years (interquartile range [IQR] 30 years), and 5 (33%) were male. Median number of antiseizure drugs used before KD was 8 (IQR 7), and median duration of SRSE before KD initiation was 10 days (IQR 7 days). KD treatment delays resulted from intravenous propofol use, ileus, and initial care received at a nonparticipating center. All patients achieved ketosis in a median of 2 days (IQR 1 day) on KD. Fourteen patients completed KD treatment, and SRSE resolved in 11 (79%; 73% of all patients enrolled). Side effects included metabolic acidosis, hyperlipidemia, constipation, hypoglycemia, hyponatremia, and weight loss. Five patients (33%) ultimately died. KD is feasible in adults with SRSE and may be safe and effective. Comparative safety and efficacy must be established with randomized placebo-controlled trials. This study provides Class IV evidence that in adults with SRSE, a KD is effective in inducing ketosis. © 2017 American Academy of Neurology.

  7. Healthcare-associated infections and Shanghai clinicians: a multicenter cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Yunfang Zhou

    Full Text Available Literature about healthcare-associated infection (HCAI in China is scarce. A cross-sectional anonymous survey was conducted on 647 clinicians (199 physicians and 448 nurses from six Shanghai hospitals (grades A-C to investigate their cognizance, knowledge, attitude, self-reported practice, and risks regarding HCAI with emphasis on precautions. The mean overall score of HCAI knowledge was 40.89±11.4 (mean±SD; range, 13∼72 out of 100 for physicians and 43.48±9.9 (10∼70 for nurses. The respondents generally received high scores in hand hygiene, HCAI core concept, and healthcare worker safety but low scores in HCAI pathogen identification and isolation precautions. There were substantial variations in the knowledge scores of various demographic groups across individual hospitals and within hospital grades (ps<0.05. Within-hospital comparisons showed that the nurses were better than physicians particularly in hand hygiene knowledge in 4 hospitals (ps<0.05. Multiple linear regression analysis showed that longer work experience was inversely and independently associated with the overall and categorical knowledge of nurses, whereas independent associations between older age or higher education and categorical knowledge were noted for physicians. The respondents' self-reported practices and adherence to standard precautions were less than satisfactory. This multi-center study reports a high level of cognizance, patchy knowledge, suboptimal adherence to infection control precautions, and self-protective attitudes among the practicing clinicians regarding HCAI, with potential safety risk to patients and healthcare providers. Providing quality learning resources, enforcing knowledge-informed practice, and promoting a healthcare safety culture are recommended as interventions. Future studies are warranted for social and behavioral aspects of healthcare safety with emphasis on infection control.

  8. Sarcopenia in patients with hip fracture: A multicenter cross-sectional study.

    Science.gov (United States)

    Steihaug, Ole Martin; Gjesdal, Clara Gram; Bogen, Bård; Kristoffersen, Målfrid Holen; Lien, Gunhild; Ranhoff, Anette Hylen

    2017-01-01

    Sarcopenia is prevalent in older persons and is a risk factor for falls, fractures, and mortality. The aim of this study was to determine a) the feasibility of determining sarcopenia in patients with acute hip fracture, b) the prevalence of sarcopenia and c) associations of sarcopenia with nutritional status and comorbidities. A multicenter cross-sectional study on sarcopenia in male and female patients with acute hip fracture. Participants were previously ambulatory and living in the community. Sarcopenia was assessed postoperatively with muscle mass estimated by anthropometry using triceps skinfold, arm circumference, height, weight and sex. Grip strength was measured by Jamar dynamometer and pre-fracture mobility was by self-report using the New Mobility Score. Out of 282 patients, 202 were assessed for sarcopenia of whom 74 (37%) were diagnosed as sarcopenic. Sarcopenia was associated with age, odds ratio (OR) 1.4 per 5 years, 95% confidence interval (CI) [1.1, 1.8], ASA Physical Status Classification System score, OR 2.3 per point, 95% CI [1.3, 4.3] and number of medications at discharge, OR 1.2 per medication, 95% CI [1.0, 1.3] and inversely associated with BMI, OR 0.8, 95% CI [0.7, 0.9] and serum albumin, OR 0.9, 95% CI [0.8,1.0]. Thirty-seven percent of assessed subjects were diagnosed with sarcopenia. Our data demonstrates that the prevalence of sarcopenia is associated with older age, malnutrition and comorbidities. Determining sarcopenia at the bedside was feasible in postoperative hip fracture patients by using grip strength, estimation of muscle mass by anthropometry and self-reported mobility.

  9. Hospital Admissions for Hypertensive Crisis in the Emergency Departments: A Large Multicenter Italian Study

    Science.gov (United States)

    Pinna, Giuliano; Pascale, Claudio; Fornengo, Paolo; Arras, Sebastiana; Piras, Carmela; Panzarasa, Pietro; Carmosino, Gianpaolo; Franza, Orietta; Semeraro, Vincenzo; Lenti, Salvatore; Pietrelli, Susanna; Panzone, Sergio; Bracco, Christian; Fiorini, Roberto; Rastelli, Giovanni; Bergandi, Daniela; Zampaglione, Bruno; Musso, Roberto; Marengo, Claudio; Santoro, Giancarlo; Zamboni, Sergio; Traversa, Barbara; Barattini, Maddalena; Bruno, Graziella

    2014-01-01

    Epidemiological data on the impact of hypertensive crises (emergencies and urgencies) on referral to the Emergency Departments (EDs) are lacking, in spite of the evidence that they may be life-threatening conditions. We performed a multicenter study to identify all patients aged 18 years and over who were admitted to 10 Italian EDs during 2009 for hypertensive crises (systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg). We classified patients as affected by either hypertensive emergencies or hypertensive urgencies depending on the presence or the absence of progressive target organ damage, respectively. Logistic regression analysis was then performed to assess variables independently associated with hypertensive emergencies with respect to hypertensive urgencies. Of 333,407 patients admitted to the EDs over the one-year period, 1,546 had hypertensive crises (4.6/1,000, 95% CI 4.4–4.9), and 23% of them had unknown hypertension. Hypertensive emergencies (n = 391, 25.3% of hypertensive crises) were acute pulmonary edema (30.9%), stroke (22.0%,), myocardial infarction (17.9%), acute aortic dissection (7.9%), acute renal failure (5.9%) and hypertensive encephalopathy (4.9%). Men had higher frequency than women of unknown hypertension (27.9% vs 18.5%, phypertensive patients, a larger proportion of men than women reported not taking anti-hypertensive drug (12.6% among men and 9.4% among women (phypertensive emergencies than urgencies (OR = 1.34, 95% CI 1.06–1.70), independently of presenting symptoms, creatinine, smoking habit and known hypertension. This study shows that hypertensive crises involved almost 5 out of 1,000 patients-year admitted to EDs. Sex differences in frequencies of unknown hypertension, compliance to treatment and risk of hypertensive emergencies might have implications for public health programs. PMID:24695800

  10. Prediction of ineffective elective cardioversion of atrial fibrillation: a retrospective multi-center patient cohort study.

    Science.gov (United States)

    Hellman, Tapio; Kiviniemi, Tuomas; Vasankari, Tuija; Nuotio, Ilpo; Biancari, Fausto; Bah, Aissa; Hartikainen, Juha; Mäkäräinen, Marianne; Airaksinen, K E Juhani

    2017-01-18

    Elective cardioversion (ECV) of atrial fibrillation (AF) is a standard procedure to restore sinus rhythm. However, predictors for ineffective ECV (failure of ECV or recurrence of AF within 30 days) are unknown. We investigated 1998 ECVs performed for AF lasting >48 h in 1,342 patients in a retrospective multi-center study. Follow-up data were collected from 30 days after ECV. Median number of cardioversions was one per patient with a range of 1-10. Altogether 303/1998 (15.2%) ECVs failed. Long (>5 years) AF history and over 30 days duration of the index AF episode were independent predictors for ECV failure and low (ECV. In patients with successful ECVs an early recurrence of AF was detected in 549 (32.4%) cases. Female gender, high (>60/min) ventricular rate, renal failure and antiarrhythmic agents at discharge were the independent predictors for recurrence. In total ECV was ineffective in 852 (42.6%) cases. Female gender (OR 1.44, CI95% 1.15-1.80, p 60/min (OR 1.92, CI95% 1.08-3.41, p = 0.03), antiarrhythmic medication at discharge (OR 1.48, CI95% 1.14-1.93, p ECV. Female gender, use of antiarrhythmic drug therapy and renal failure predicted both recurrence of AF and the composite end point. For the first time in a large real-life study several clinical predictors for clinically ineffective ECV were identified.

  11. A prospective multi-center study of intramedullary nailing vs casting of stable tibial shaft fractures.

    Science.gov (United States)

    Obremskey, William T; Cutrera, Norele; Kidd, Christopher M

    2017-03-01

    The purpose of this study was to determine optimal treatment of stable tibial shaft fractures using intramedullary nailing (IMN) or casting. We performed a multi-center prospective study cohort. Patients with stable tibia shaft fractures meeting Sarmiento's criteria (isolated closed fractures with less than 12 mm of shortening and 10° of angulation) were enrolled prospectively and treated with either a reamed IMN with static interlocking screws or closed reduction followed by long-leg casting. Both groups were weight bearing following surgery. Radiographs were taken until union, and range of motion of knee and ankle joints was assessed. Malalignment (>5°) and malunion (>10°) were determined. Functional outcome measures using short musculoskeletal assessment scores (SMFA) and a knee pain score were scheduled at 6 weeks, 3 months and 6 months. At 3 months, differences between the casting and IMN groups were noted in return to work (6/15 vs 3/17, P casting group and in 1/17 in the IMN group (P = 0.02). Malunion was present in 1/15 in the cast group. One fracture in the casting group went on to nonunion and required late IMN placement at 7 months and eventually healed. There were no differences in ankle motion, SMFA scores, or return to work. There was no difference in knee pain between the groups as measured by VAS and Court-Brown pain scale at 6 months. Patients with stable tibia fractures treated with intramedullary nailing have improved clinical and functional outcomes at 3 months compared with those treated with casting, but there are no differences in any other outcome measure. Patients treated in a cast may have a higher incidence of malalignment or malunion. Level-II prognostic.

  12. VEPTR to treat nonsyndromic congenital scoliosis: a multicenter, mid-term follow-up study.

    Science.gov (United States)

    Flynn, John M; Emans, John B; Smith, John T; Betz, Randal R; Deeney, Vincent F; Patel, Neeraj M; Campbell, Robert M

    2013-01-01

    Traditional surgical management of multiple congenital vertebral anomalies in young children, including fusion in situ and hemiepiphyseodesis, do not promote spinal growth nor address the associated thoracic insufficiency syndrome. We hypothesize that vertical expandable prosthetic titanium rib (VEPTR) with expansion thoracoplasty may control spinal deformity, allow spinal growth, and address thoracic insufficiency syndrome in children with nonsyndromic complex congenital spinal deformities. Eight pediatric spine centers prospectively entered clinical and radiographic data into a database on every congenital spinal deformity treated with VEPTR as part of an Food and Drug Administration study. We retrospectively reviewed these data and excluded patients with spina bifida, Jarcho-Levin, or other syndromes. Data analysis focused on surgical technique and expansion frequency, change in Cobb angle and thoracic heights, and adverse events for a consecutive series of patients with at least 2 years of follow-up. Twenty-four children with an average age at surgery of 3.3 years (range, 1.0 to 12.5 y) were treated with VEPTR insertion and expansion thoracostomy and were followed for an average of 40.7 months (range, 25 to 78 mo). Twenty-three (95.8%) had associated rib fusions. All patients had subsequent expansion surgery; 50% had 5 or more expansions. Twenty patients (83.3%) had an improvement in Cobb angle during treatment with an average improvement of 8.9 degrees. All had an increase in thoracic height, with a mean increase of 3.41 cm. The most common adverse events were device migration in 7 patients and infection or skin problems in 6 patients. VEPTR insertion with expansion thoracoplasty represents a successful treatment paradigm for nonsyndromic congenital spinal deformities. We report multicenter data with midterm follow-up of children without syndromic diagnoses, in which the vast majority had an improvement in Cobb angle and thoracic height over the treatment

  13. Clinical manifestations of pediatric psoriasis: Results of a multi-center study in the United States

    Science.gov (United States)

    Mercy, Katherine; Kwasny, Mary; Cordoro, Kelly M.; Menter, Alan; Tom, Wynnis L.; Korman, Neil; Belazarian, Leah; Armstrong, April W.; Levy, Moise L.; Paller, Amy S.

    2012-01-01

    Background/Objectives The clinical features of pediatric psoriasis warrant further attention. A national study was completed to determine the prevalence of scalp and nail involvement, and history of guttate psoriasis at onset, according to age, sex, and disease severity. Materials and Methods 181 children, ages 5 to 17 years, with plaque psoriasis were enrolled in a multi-center, cross-sectional study. Subjects/guardians were asked about a history of scalp and nail involvement and whether the initial presentation was guttate. Peak psoriasis severity was assessed and defined historically as mild psoriasis (MP) or severe psoriasis (SP) according to Physician Global Assessment and Body Surface Area measures. Results 79.0% (n=143) of subjects reported a history of scalp involvement and 39.2% (n=71) described a history of nail involvement. Boys were less likely than girls to report a history of scalp involvement (OR= 0.40 (0.19-0.84)), but were more likely to have had nail involvement (OR=3.01 (1.62-5.60)). Scalp and nail involvement was not related to psoriasis severity. In contrast, SP subjects (35.9%) more often reported a history of guttate lesions than did MP subjects (21.8%) (p=0.017). Antecedent streptococcal infection was more common in children with guttate vs. plaque psoriasis at onset (p=0.02), but did not correlate with severity. Conclusions Gender-related differences in scalp and nail involvement suggest koebnerization. Preceding streptococcal infection predicts guttate morphology but not severity, and initial guttate morphology is associated with eventual greater severity of disease More aggressive monitoring and management should be considered for guttate psoriasis, given its later association with more severe disease. PMID:23360462

  14. [Nosocomial risk factors of hepatitis C infection. A multicenter study in a hospital-based population].

    Science.gov (United States)

    Maugat, S; Astagneau, P; Thibault, V; Desruennes, E; Baffoy, N; Desenclos, J-C; Brücker, G

    2003-06-01

    Drug abuse and blood transfusion are well known risk factors for hepatitis C virus (HCV) infection. However, the route of transmission remains undetermined for 30% of HCV infections. The potential for nosocomial transmission of HCV in health care settings has been suggested but remains poorly estimated. The aim of the study was to assess the prevalence and to identify risk factors for hepatitis C virus (HCV) infection in hospitalized patients frequently exposed to invasive procedures. A multi-center sero-prevalence study was conducted in hospitalized patients who underwent invasive procedures in interventional radiology wards in 6 University hospitals in Paris between 1998 and 1999. Each patient presenting in the ward was consecutively interviewed by a medical investigator. Data were collected on a standardized questionnaire including items on socio-demographic characteristics, past exposure to intravenous drug use, blood transfusions, underlying diseases and type and number of previous invasive procedures. Before procedure, HCV antibody testing (ELISA) was performed in all patients after informed consent. In all HCV-positive patients, HCV viremia was detected using polymerase chain reaction. Overall, 91 of 944 (9.7%) patients were HCV-positive, of whom 90% had positive viremia and 10 were identified HCV positive by the screening. HCV prevalence decreased with age and ranged from 4.5% to 22% according to center. Logistic regression analysis showed that intravenous drug use, history of blood transfusions and endoscopy were found as independent risk factors for HCV infection (odds ratio [CI95%]: 77.3 [23.3-256.3], 4.7 [2.7-8.2] et 1.20 [1.01-1.44]). No other risk factor for nosocomial or iatrogenic transmission was identified. The results suggest that, except for blood transfusions, other healthcare-related procedures may partly explain HCV transmission. This emphasizes the need to reinforce compliance with standard precautions of hygiene.

  15. Risk factors for the development of retroprosthetic membranes with Boston keratoprosthesis type 1: multicenter study results.

    Science.gov (United States)

    Rudnisky, Christopher J; Belin, Michael W; Todani, Amit; Al-Arfaj, Khalid; Ament, Jared D; Zerbe, Brian J; Ciolino, Joseph B

    2012-05-01

    The purpose of this study was to identify possible risk factors for retroprosthetic membrane (RPM) development in a large, multicenter cohort of patients receiving a Boston type 1 keratoprosthesis. Cohort study. The final analysis included 265 eyes of 265 patients who underwent implantation of a Boston keratoprosthesis type I device between January 2003 and July 2008 by 1 of 19 surgeons at 18 medical centers. Forms reporting preoperative, intraoperative, and postoperative parameters were prospectively collected and subsequently analyzed at a central data collection site. The primary outcome was the presence or absence of an RPM during the follow-up period. The average age of patients was 63.3±19.1 years, 48.5% of the patients were female, and 52.5% of procedures were performed on the right eye. The mean follow-up time was 17.8±14.9 months. The majority (85.4%; n = 222) had undergone an average of 2.2±1.2 (range, 1-8) penetrating keratoplasties before keratoprosthesis implantation, and 38 eyes (14.6%) received a primary keratoprosthesis. The overall RPM formation rate was 31.7% (n = 84). The most significant risk factor for RPM development was infectious keratitis (as a surgical indication for keratoprosthesis surgery itself), resulting in a rate of RPM formation of 70.6%. As an independent risk factor, the hazard ratio (HR) of RPM development in these eyes was 3.20 (95% confidence interval, 1.66-6.17). Aniridia was also an independent risk factor for RPM development (HR, 3.13; 95% confidence interval, 1.10-8.89). Formation of RPM is a common complication of keratoprosthesis surgery, occurring in approximately one-third of cases. Eyes at the highest risk of RPM development are those receiving corneal replacement for infectious keratitis and aniridia. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  16. Feasibility and safety of dilatational tracheotomy using the rigid endoscope: a multicenter study.

    Science.gov (United States)

    Nowak, Andreas; Kern, Peter; Koscielny, Sven; Usichenko, Taras I; Hahnenkamp, Klaus; Jungehülsing, Markus; Tittel, Matthias; Oeken, Jens; Klemm, Eckart

    2017-01-14

    Fiberoptic tracheo-bronchoscopy is the most commonly used procedure for percutaneous dilational tracheotomy (PDT). However, PDT can be associated with major complications, including death. Furthermore it is unclear, whether the tracheal ring fractures may contribute to the development of tracheal stenosis after PDT nor whether tracheal ring fractures can be prevented by using a rigid endoscope for this procedure. The purpose of this study was to evaluate the feasibility of and the incidence of complications for PDT using the rigid tracheotomy endoscope (TED). In a prospective multicenter observational study from 2006 to 2010, 180 adult patients in intensive care and those scheduled for ear, nose and throat surgery underwent PDT using TED. Data collection was performed using a structured protocol. The patients were observed according to PDT phase (phase 1: puncture, phase 2: dilatation and phase 3: cannula insertion). The descriptive data are given as the number (percent) of cases and the mean ± standard deviation (SD) where appropriate. The relationships between dichotomous and categorical parameters were analyzed using the chi-square test. P values ≤ 0.05 were considered significant. PDT was performed in 179 patients. The procedure time was 14.8 ± 6.2 (mean ± SD) minutes. Pneumothorax or procedure-related lethal complications did not occur. Other adverse events included tracheal ring fractures (17.1%), desaturations (6.8%), special incidents (6.2%), bleeding (5.5%), anesthesia complications (4.5%) and posterior tracheal wall injuries (1.1%). The use of TED in PDT is feasible, and the incidence of complications and adverse events was comparable with that of PDT using the flexible endoscope. Tracheal ring fractures in PDT cannot be avoided by the use of a rigid endoscope. With TED, the airway always remains open thus the use of jet ventilation via the TED during PDT is possible.

  17. Hospital admissions for hypertensive crisis in the emergency departments: a large multicenter Italian study.

    Science.gov (United States)

    Pinna, Giuliano; Pascale, Claudio; Fornengo, Paolo; Arras, Sebastiana; Piras, Carmela; Panzarasa, Pietro; Carmosino, Gianpaolo; Franza, Orietta; Semeraro, Vincenzo; Lenti, Salvatore; Pietrelli, Susanna; Panzone, Sergio; Bracco, Christian; Fiorini, Roberto; Rastelli, Giovanni; Bergandi, Daniela; Zampaglione, Bruno; Musso, Roberto; Marengo, Claudio; Santoro, Giancarlo; Zamboni, Sergio; Traversa, Barbara; Barattini, Maddalena; Bruno, Graziella

    2014-01-01

    Epidemiological data on the impact of hypertensive crises (emergencies and urgencies) on referral to the Emergency Departments (EDs) are lacking, in spite of the evidence that they may be life-threatening conditions. We performed a multicenter study to identify all patients aged 18 years and over who were admitted to 10 Italian EDs during 2009 for hypertensive crises (systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg). We classified patients as affected by either hypertensive emergencies or hypertensive urgencies depending on the presence or the absence of progressive target organ damage, respectively. Logistic regression analysis was then performed to assess variables independently associated with hypertensive emergencies with respect to hypertensive urgencies. Of 333,407 patients admitted to the EDs over the one-year period, 1,546 had hypertensive crises (4.6/1,000, 95% CI 4.4-4.9), and 23% of them had unknown hypertension. Hypertensive emergencies (n = 391, 25.3% of hypertensive crises) were acute pulmonary edema (30.9%), stroke (22.0%,), myocardial infarction (17.9%), acute aortic dissection (7.9%), acute renal failure (5.9%) and hypertensive encephalopathy (4.9%). Men had higher frequency than women of unknown hypertension (27.9% vs 18.5%, phypertensive patients, a larger proportion of men than women reported not taking anti-hypertensive drug (12.6% among men and 9.4% among women (phypertensive emergencies than urgencies (OR = 1.34, 95% CI 1.06-1.70), independently of presenting symptoms, creatinine, smoking habit and known hypertension. This study shows that hypertensive crises involved almost 5 out of 1,000 patients-year admitted to EDs. Sex differences in frequencies of unknown hypertension, compliance to treatment and risk of hypertensive emergencies might have implications for public health programs.

  18. A multicenter, cross-platform clinical validation study of cancer cytogenomic arrays.

    Science.gov (United States)

    Li, Marilyn M; Monzon, Federico A; Biegel, Jaclyn A; Jobanputra, Vaidehi; Laffin, Jennifer J; Levy, Brynn; Leon, Annette; Miron, Patricia; Rossi, Michael R; Toruner, Gokce; Alvarez, Karla; Doho, Gregory; Dougherty, Margaret J; Hu, Xiaofeng; Kash, Shera; Streck, Deanna; Znoyko, Iya; Hagenkord, Jill M; Wolff, Daynna J

    2015-11-01

    Cytogenomic microarray analysis (CMA) offers high resolution, genome-wide copy number information and is widely used in clinical laboratories for diagnosis of constitutional abnormalities. The Cancer Genomics Consortium (CGC) conducted a multiplatform, multicenter clinical validation project to compare the reliability and inter- and intralaboratory reproducibility of this technology for clinical oncology applications. Four specimen types were processed on three different microarray platforms-from Affymetrix, Agilent, and Illumina. Each microarray platform was employed at two independent test sites. The results were compared in a blinded manner with current standard methods, including karyotype, FISH, or morphology. Twenty-nine chronic lymphocytic leukemia blood, 34 myelodysplastic syndrome bone marrow, and 30 fresh frozen renal epithelial tumor samples were assessed by all six laboratories. Thirty formalin fixed paraffin embedded renal tumor samples were analyzed at the Affymetrix and Agilent test sites only. All study samples were initial diagnostic samples. Array data were analyzed at each participating site and were submitted to caArray for central analysis. Laboratory interpretive results were submitted to the central analysis team for comparison with the standard-of-care assays and for calculation of intraplatform reproducibility and cross-platform concordance. The results demonstrated that the three microarray platforms 1) detect clinically actionable genomic changes in cancer compatible to standard-of-care methods; 2) further define cytogenetic aberrations; 3) identify submicroscopic alterations and loss of heterozygosity (LOH); and 4) yield consistent results within and between laboratories. Based on this study, the CGC concludes that CMA is a sensitive and reliable technique for copy number and LOH assessment that may be used for clinical oncology genomic analysis. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Frailty and subclinical coronary atherosclerosis: The Multicenter AIDS Cohort Study (MACS).

    Science.gov (United States)

    Korada, Sai Krishna C; Zhao, Di; Tibuakuu, Martin; Brown, Todd T; Jacobson, Lisa P; Guallar, Eliseo; Bolan, Robert K; Palella, Frank J; Margolick, Joseph B; Martinson, Jeremy J; Budoff, Matthew J; Post, Wendy S; Michos, Erin D

    2017-11-01

    Frailty and cardiovascular disease share many risk factors. We evaluated whether frailty is independently associated with subclinical coronary atherosclerosis and whether any relationships differ by HIV-serostatus. We studied 976 [62% HIV-infected] male participants of the Multicenter AIDS Cohort Study who underwent assessment of frailty and non-contrast cardiac CT scanning; of these, 747 men also underwent coronary CT angiography (CCTA). Frailty was defined as having ≥3 of 5 of the following: weakness, slowness, weight loss, exhaustion, and low physical activity. Coronary artery calcium (CAC) was assessed by non-contrast CT, and total plaque score (TPS), mixed plaque score (MPS), and non-calcified plaque score (NCPS) by CCTA. Multivariable-adjusted regression was used to assess the cross-sectional associations between frailty and subclinical coronary atherosclerosis. Mean (SD) age of participants was 54 (7) years; 31% were black. Frailty existed in 7.5% and 14.3% of HIV-uninfected and HIV-infected men, respectively. After adjustment for demographics, frailty was significantly associated with prevalence of any CAC (CAC>0), any plaque (TPS>0), and mixed plaque (MPS>0) in HIV-uninfected but not in HIV-infected men (p-interactionHIVfrailty was significantly associated only with CAC>0 [Prevalence Ratio 1.27 (95%CI 1.02, 1.59)] and TPS>0 [1.19 (1.06, 1.35)]. No association was found for NCPS. Frailty was independently associated with subclinical coronary atherosclerosis among HIV-uninfected men, but not among HIV-infected men. Further work is needed to ascertain mechanisms underlying these differences and whether interventions that improve frailty (i.e. strength training) can improve cardiovascular outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease--A Prospective, Multicenter Noninterventional Study.

    Science.gov (United States)

    Steven, Philipp; Scherer, Dieter; Krösser, Sonja; Beckert, Michael; Cursiefen, Claus; Kaercher, Thomas

    2015-10-01

    Evaporation of the tear film is heavily discussed as one core reason for dry eye disease (DED). Subsequently, new artificial tear products are developed that specifically target this pathomechanism. Perfluorohexyloctane (F6H8, NovaTears(®)) from the family of semifluorinated alkanes is a novel substance that has been approved as a medical device, as a nonblurring wetting agent for the ocular surface. Thirty patients with hyperevaporative dry eye received F6H8 during a prospective, multicenter, observational 6-week study. Patients were advised to apply 1 drop 4 times daily in both eyes. Parameters assessed included best corrected visual acuity, intraocular pressure, Schirmer I test, tear fluid, tear film breakup time (TFBUT), corneal staining, meibum secretion, and Ocular Surface Disease Index (OSDI(©)). From the 30 patients recruited, 25 completed the trial per protocol. Four patients discontinued F6H8 and 1 patient did not present for follow-up. F6H8 treatment led to significant reduction of corneal staining and significant increase of Schirmer I and TFBUT. In addition, OSDI score dropped significantly from a mean of 55 (± 23.0) to 34 (± 22.4). Visual acuity and ocular pressure did not change. This prospective observational study shows significant beneficial effects in patients suffering from evaporative DED, using F6H8 in all the relevant parameters tested. The decrease of the OSDI by a mean of 21 points was particularly remarkable and clearly exceeds minimal, clinical important differences for mild or moderate and severe disease. Overall, F6H8 (NovaTears) seems to be safe and effective in treating mild to moderate hyperevaporative DED.

  1. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease—A Prospective, Multicenter Noninterventional Study

    Science.gov (United States)

    Scherer, Dieter; Krösser, Sonja; Beckert, Michael; Cursiefen, Claus; Kaercher, Thomas

    2015-01-01

    Abstract Purpose: Evaporation of the tear film is heavily discussed as one core reason for dry eye disease (DED). Subsequently, new artificial tear products are developed that specifically target this pathomechanism. Perfluorohexyloctane (F6H8, NovaTears®) from the family of semifluorinated alkanes is a novel substance that has been approved as a medical device, as a nonblurring wetting agent for the ocular surface. Methods: Thirty patients with hyperevaporative dry eye received F6H8 during a prospective, multicenter, observational 6-week study. Patients were advised to apply 1 drop 4 times daily in both eyes. Parameters assessed included best corrected visual acuity, intraocular pressure, Schirmer I test, tear fluid, tear film breakup time (TFBUT), corneal staining, meibum secretion, and Ocular Surface Disease Index (OSDI©). Results: From the 30 patients recruited, 25 completed the trial per protocol. Four patients discontinued F6H8 and 1 patient did not present for follow-up. F6H8 treatment led to significant reduction of corneal staining and significant increase of Schirmer I and TFBUT. In addition, OSDI score dropped significantly from a mean of 55 (±23.0) to 34 (±22.4). Visual acuity and ocular pressure did not change. Conclusions: This prospective observational study shows significant beneficial effects in patients suffering from evaporative DED, using F6H8 in all the relevant parameters tested. The decrease of the OSDI by a mean of 21 points was particularly remarkable and clearly exceeds minimal, clinical important differences for mild or moderate and severe disease. Overall, F6H8 (NovaTears) seems to be safe and effective in treating mild to moderate hyperevaporative DED. PMID:26296040

  2. Risk factor analysis following maxillary sinus augmentation: a retrospective multicenter study.

    Science.gov (United States)

    Testori, Tiziano; Weinstein, Roberto L; Taschieri, Silvio; Del Fabbro, Massimo

    2012-01-01

    Implant-supported rehabilitation of the atrophic posterior maxilla often necessitates maxillary sinus surgery to augment existing bone volumes. Recent systematic reviews have reported implant survival rates above 90% following sinus elevation. However, statistical assessment of the effect of anatomic factors, implant design and surface, individual risk factors, and complications related to sinus floor elevation procedures on implant survival through analyzing patient data has not yet been performed. The aim of this study is to identify risk factors that might affect implant survival following sinus elevation. Three centers were involved in this retrospective multicenter study; 106 patients were treated with 144 sinus elevation procedures and received 328 implants. The mean follow-up was 48.4 months, and the longest follow-up period was 72 months. The analysis considered patient age, gender, health status, and smoking habit; implant size, shape, and surface; residual ridge height; timing of implant placement with respect to grafting; graft material; and the occurrence of surgical complications. For quantitative variables, the Pearson correlation was used. The chi-square test and Fisher exact test (for samples smaller than five units) were used for qualitative variables. The cumulative implant survival rate was 93.0% up to 5 years. Complications occurred in 41 patients. Intraoperative sinus membrane perforation occurred in 40 sinuses (28%) and was not a significant risk factor for implant survival. Six patients experienced postoperative infection leading to graft failure, and two patients had considerable intraoperative bleeding. Smoking more than 15 cigarettes/day and a residual ridge height < 4 mm were significantly associated with reduced implant survival. Smoking habits and residual ridge height should be evaluated carefully prior to sinus elevation procedures.

  3. Factors associated to depression and anxiety in medical students: a multicenter study

    Directory of Open Access Journals (Sweden)

    Fernanda Brenneisen Mayer

    2016-10-01

    Full Text Available Abstract Background To evaluate personal and institutional factors related to depression and anxiety prevalence of students from 22 Brazilian medical schools. Methods The authors performed a multicenter study (August 2011 to August 2012, examining personal factors (age, sex, housing, tuition scholarship and institutional factors (year of the medical training, school legal status, location and support service in association with scores of Beck Depression Inventory (BDI and State Trait Anxiety Inventory (STAI. Results Of 1,650 randomly selected students, 1,350 (81.8 % completed the study. The depressive symptoms prevalence was 41 % (BDI > 9, state-anxiety 81.7 % and trait-anxiety in 85.6 % (STAI > 33. There was a positive relationship between levels of state (r = 0,591, p < 0.001 and trait (r = 0,718, p < 0.001 anxiety and depression scores. All three symptoms were positively associated with female sex and students from medical schools located in capital cities of both sexes. Tuition scholarship students had higher state-anxiety but not trait-anxiety or depression scores. Medical students with higher levels of depression and anxiety symptoms disagree more than their peers with the statements “I have adequate access to psychological support” and “There is a good support system for students who get stressed”. Conclusions The factors associated with the increase of medical students’ depression and anxiety symptoms were female sex, school location and tuition scholarship. It is interesting that tuition scholarship students showed state-anxiety, but not depression and trait-anxiety symptoms.

  4. Latarjet Procedure for Anterior Shoulder Instability Due to Tramadol-Induced Seizures: A Multicenter Study.

    Science.gov (United States)

    Khater, Ahmad Hany; Sobhy, Mohamed H; Said, Hatem G; Kandil, Ahmed; Reda, Walid; Seifeldin, Ahmed Fouad; Moustafa, Ramez; Elassal, Maher A; Kamel, Ezzat M

    2016-04-01

    Seizures, commonly due to epilepsy, are known to cause shoulder instability. Tramadol addiction has recently been found to induce seizures in patients who exceed the recommended dose. Because of the easy accessibility and low cost of tramadol, an increasingly alarming phenomenon of tramadol abuse has been demonstrated in recent years. The purpose of this multicenter study was to investigate shoulder instability resulting from tramadol-induced seizure (TIS) as well as to recommended management for such shoulder instability. The hypothesis was that TIS leads to anterior shoulder dislocations with major bony defects, which favors bony reconstructive procedures as a suitable method of treatment. Case series; Level of evidence, 4. This prospective case series study was conducted on 73 patients (78 shoulders) who presented with anterior shoulder dislocations and a clear history of tramadol abuse. The mean age of the patients was 26.8 years, and the mean number of dislocations was 14. The mean duration of addiction was 17 months, with a mean dose of 752 mg of tramadol hydrochloride per day. Glenoid and humeral bone loss ranged from 15% to 35% and from 15% to 40%, respectively. The mean follow-up period was 28 months. All patients underwent an open Latarjet procedure. Postoperative mean Rowe score and American Shoulder and Elbow Surgeons score at final follow-up (24 months) improved significantly from 20 to 84 and from 44 to 91, respectively (P shoulder dislocation. Anterior shoulder instability with TIS occurs mainly with higher levels of addiction and results in significant humeral and/or glenoid bone defects. The Latarjet procedure is recommended for these patients, after control of addiction, and provides 95% satisfaction at midterm follow-up. © 2016 The Author(s).

  5. Noncutaneous malignant melanoma: a prognostic model from a retrospective multicenter study

    Directory of Open Access Journals (Sweden)

    Kim Jung Han

    2010-04-01

    Full Text Available Abstract Background We performed multicenter study to define clinical characteristics of noncutaneous melanomas and to establish prognostic factors patients who received curative resection. Methods Of the 141 patients who were diagnosed of non-cutaneous melanoma at 4 institutions in Korea between June 1992 and May 2005, 129 (91.5% satisfied the selection criteria. Results Of the 129 noncutaneous melanoma patients, 14 patients had ocular melanoma and 115 patients had mucosal melanoma. For mucosal melanoma, anorectum was the most common anatomic site (n = 39, 30.2% which was followed by nasal cavity (n = 30, 23.3%, genitourinary (n = 21, 16.3%, oral cavity (n = 14, 10.9%, upper gastrointestinal tract (n = 6, 4.7% and maxillary sinus (n = 5, 3.9% in the order of frequency. With the median 64.5 (range 4.3-213.0 months follow-up, the median overall survival were 24.4 months (95% CI 13.2-35.5 for all patients, and 34.6 (95% CI 24.5-44.7 months for curatively resected mucosal melanoma patients. Adverse prognostic factors of survival for 87 curatively resected mucosal melanoma patients were complete resection (R1 resection margin, and age > 50 years. For 14 ocular melanoma, Survival outcome was much better than mucosal melanoma with 73.3% of 2 year OS and 51.2 months of median OS (P = .04. Conclusion Prognosis differed according to primary sites of noncutaneous melanoma. Based on our study, noncutaneous melanoma patients should be treated differently to improve survival outcome.

  6. Repeated nipple fluid aspiration: compliance and feasibility results from a prospective multicenter study.

    Directory of Open Access Journals (Sweden)

    J S de Groot

    Full Text Available Despite intensive surveillance, a high rate of interval malignancies is still seen in women at increased breast cancer risk. Therefore, novel screening modalities aiming at early detection remain needed. The intraductal approach offers the possibility to directly sample fluid containing cells, DNA and proteins from the mammary ductal system where, in the majority of cases, breast cancer originates. Fluid from the breast can non-invasively be obtained by oxytocin-assisted vacuum aspiration, called nipple fluid aspiration (NFA. The goal of this feasibility study was to evaluate the potential of repeated NFA, which is a critical and essential step to evaluate its possible value as a breast cancer screening method.In this multicenter, prospective study, we annually collected nipple fluid for up to 5 consecutive years from women at increased breast cancer risk, and performed a questionnaire-based survey regarding discomfort of the aspiration. Endpoints of the current interim analyses were the feasibility and results of 994 NFA procedures in 451 women with total follow-up of 560 person years of observation.In this large group of women at increased risk of breast cancer, repetitive NFA appeared to be feasible and safe. In 66.4% of aspirated breasts, nipple fluid was successfully obtained. Independent predictive factors for successful NFA were premenopausal status, spontaneous nipple discharge, smaller breast size, bilateral oophorectomy and previous use of hormone replacement therapy or anti-hormonal treatment. The procedure was well tolerated with low discomfort. Drop-out rate was 20%, which was mainly due to repeated unsuccessful aspiration attempts. Only 1.6% of women prematurely declined further participation because of side effects.Repeated NFA in women at increased breast cancer risk is feasible and safe. Therefore, NFA is a promising method to non-invasively obtain a valuable source of potential breast cancer specific biomarkers.

  7. Good prognosis for pericarditis with and without myocardial involvement: results from a multicenter, prospective cohort study.

    Science.gov (United States)

    Imazio, Massimo; Brucato, Antonio; Barbieri, Andrea; Ferroni, Francesca; Maestroni, Silvia; Ligabue, Guido; Chinaglia, Alessandra; Cumetti, Davide; Della Casa, Giovanni; Bonomi, Federica; Mantovani, Francesca; Di Corato, Paola; Lugli, Roberta; Faletti, Riccardo; Leuzzi, Stefano; Bonamini, Rodolfo; Modena, Maria Grazia; Belli, Riccardo

    2013-07-02

    The natural history of myopericarditis/perimyocarditis is poorly known, and recently published studies have presented contrasting data on their outcomes. The aim of the present article is to assess the prognosis of myopericarditis/perimyocarditis in a multicenter, prospective cohort study. A total of 486 patients (median age, 39 years; range, 18-83 years; 300 men) with acute pericarditis or a myopericardial inflammatory syndrome (myopericarditis/perimyocarditis; 85% idiopathic, 11% connective tissue disease or inflammatory bowel disease, 5% infective) were prospectively evaluated from January 2007 to December 2011. The diagnosis of acute pericarditis was based on the presence of 2 of 4 clinical criteria (chest pain, pericardial rubs, widespread ST-segment elevation or PR depression, and new or worsening pericardial effusion). Myopericardial inflammatory involvement was suspected with atypical ECG changes for pericarditis, arrhythmias, and cardiac troponin elevation or new or worsening ventricular dysfunction on echocardiography and confirmed by cardiac magnetic resonance. After a median follow-up of 36 months, normalization of left ventricular function was achieved in >90% of patients with myopericarditis/perimyocarditis. No deaths were recorded, as well as evolution to heart failure or symptomatic left ventricular dysfunction. Recurrences (mainly as recurrent pericarditis) were the most common complication during follow-up and were recorded more frequently in patients with acute pericarditis (32%) than in those with myopericarditis (11%) or perimyocarditis (12%; P<0.001). Troponin elevation was not associated with an increase in complications. The outcome of myopericardial inflammatory syndromes is good. Unlike acute coronary syndromes, troponin elevation is not a negative prognostic marker in this setting.

  8. Surgical and Patient Reported Outcomes of Artificial Urinary Sphincter Implantation: A Multicenter, Prospective, Observational Study.

    Science.gov (United States)

    Kaiho, Yasuhiro; Masuda, Hitoshi; Takei, Mineo; Hirayama, Takahiro; Mitsui, Takahiko; Yokoyama, Minato; Kitta, Takeya; Kawamorita, Naoki; Nakagawa, Haruo; Iwamura, Masatsugu; Arai, Yoichi

    2018-01-01

    We performed a multicenter, prospective, observational study to assess outcomes, including changes in continence status and quality of life, after artificial urinary sphincter implantation. Prospectively enrolled in this study were 135 patients who underwent primary AMS 800™ implantation between 2011 and 2014 at 1 of 5 institutions. Perioperative complications were categorized according to the Clavien-Dindo classification. We estimated the revision-free rate, that is the incidence of patients who did not undergo artificial urinary sphincter revision surgery. Cox regression analysis was performed to identify patient risk factors for revision surgery. The number of pads needed per day, ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form) and KHQ (King's Health Questionnaire) were used to estimate continence status and quality of life preoperatively, and 1, 3 and 12 months postoperatively. The artificial urinary sphincter was implanted without major complications. The revision-free rate 1, 2 and 3 years after implantation was 94%, 88% and 81%, respectively. Diabetes mellitus and poor preoperative American Society of Anesthesiologists® physical status were significant risk factors for revision surgery. Continence status and quality of life were markedly improved after surgery. However, ICIQ-SF and some KHQ items showed slight but significant deterioration at 12 months compared with scores 1 month after surgery. Artificial urinary sphincter implantation is a safe and durable procedure that substantially improves patient continence status and quality of life soon after surgery. Our results indicate that patients start to experience slight but noticeable deterioration in continence status and quality of life relatively early (within 1 year) after surgery. This finding might be helpful with appropriately counseling patients who undergo artificial urinary sphincter implantation. Copyright © 2018 American Urological Association Education and

  9. Need for a European approach to the effects of extremely low-frequency electromagnetic fields on cancer. ELF-EMF European Feasibility Study Group.

    Science.gov (United States)

    1997-02-01

    A European feasibility study on environmental exposure to extremely low-frequency electromagnetic fields (ELF-EMF) and cancer was conducted. The study was motivated by public health concern about possible adverse health effects associated with ELF-EMF exposure. A review of completed research in Europe was conducted. Information on the methods and accessibility of new epidemiologic studies were requested and reviewed. Eight studies on environmental ELF-EMF exposure have been completed in Europe while 15 large studies are in progress. Although there is no known mechanism by which electric or magnetic fields of this frequency could play a role in the development of cancer or other adverse health effects, the results of the studies conducted so far provide some support for the hypothesis that they are associated with the incidence of childhood leukemia. The best use of available data will be made through a pooled re-analysis of data, particularly those on childhood tumors. It is recommended to apply multiple methods for exposure assessment in view of the heterogeneity in the methods used in different studies. New multicenter case-referent studies should not be initiated until the results of the large on-going studies have been reported. Prospective cohort studies will have to be very large to identify moderate excess risks resulting from environmental exposure to ELF-EMF, and their feasibility should be discussed after the results of the on-going case-referent studies have been reported. A European collaborative approach will lead to greater statistical power and will assess the exposure-effect association under differing exposure patterns and distributions of potential confounding factors.

  10. Solid organ transplantation after allogeneic hematopoietic stem cell transplantation: a retrospective, multicenter study of the EBMT

    DEFF Research Database (Denmark)

    Koenecke, C; Hertenstein, B; Schetelig, J

    2010-01-01

    To analyze the outcome of solid organ transplantation (SOT) in patients who had undergone allogeneic hematopoietic stem cell transplantation (HSCT), a questionnaire survey was carried out within 107 European Group of Blood and Marrow Transplantation centers. This study covered HSCT between 1984...... for underlying malignant diseases was 4% at 5 years (95% CI, 0% to 12%). In summary, this study shows that selected patients receiving SOT after HSCT have a remarkably good overall and organ survival. These data indicate that SOT should be considered in selected patients with single organ failure after HSCT....

  11. Medical students, spirituality and religiosity-results from the multicenter study SBRAME

    Science.gov (United States)

    2013-01-01

    Background To evaluate the relationship between spirituality/religiosity (S/R) and the attitudes, beliefs and experiences of medical students in Brazil with respect to S/R in their undergraduate training and clinical practice. Methods SBRAME (Spirituality and Brazilian Medical Education) is a multicenter study involving 12 Brazilian medical schools with 5950 medical students (MS). Participants completed a questionnaire that collected information on socio-demographic data and S/R in their undergraduate training and practice. Results Of all MS, 3630 participated in the survey (61.0%). The sample was 53.8% women and the mean age was 22.5 years. The majority of MS believed that spirituality has an impact on patients’ health (71.2%) and that this impact was positive (68.2%). The majority also wanted to address S/R in their clinical practice (58.0%) and considered it relevant (75.3%), although nearly one-half (48.7%) felt unprepared to do so. Concerning their training, most MS reported that they had never participated in a “spirituality and health” activity (81.0%) and that their medical instructors had never or rarely addressed this issue (78.3%). The majority also believed that they should be prepared to address spiritual issues related to the health of their patients (61.6%) and that this content should be included in the medical curriculum (62.6%). Conclusion There is a large gap between MS attitudes and expectations and the S/R training that they are receiving during their undergraduate training. The majority of MS surveyed believe that patients should have their beliefs addressed and that these beliefs could have important effects on their health and the doctor-patient relationship. These results should stimulate discussion about the place that S/R training should have in the medical curriculum. PMID:24314327

  12. Etiology of bronchiolitis in a hospitalized pediatric population: prospective multicenter study.

    Science.gov (United States)

    Antunes, H; Rodrigues, H; Silva, N; Ferreira, C; Carvalho, F; Ramalho, H; Gonçalves, A; Branca, F

    2010-06-01

    In 2006, bronchiolitis due to adenovirus nosocomial infections resulted in the closure of a pediatric department in northern Portugal. To determine the etiology of bronchiolitis in northern Portugal. It was a prospective multicenter study on the etiology of bronchiolitis during the respiratory syncytial virus (RSV) season (November-April). Children first wheezing episode were included. Nasopharyngeal specimens were analyzed by an indirect immunofluorescent-antibody assay (IFA) for RSV, adenovirus (HAdV), parainfluenza (PIV) 1-3 and influenza (IV) A and B and by polymerase chain reaction (PCR) or reverse transcription-PCR for the same viruses and for human metapneumovirus (hMPV), bocavirus (HBoV), rhinovirus (HRV), coronaviruses (229/E; NL63; OC43; HKU1) and enterovirus. During this period, 253 children were included, 249 IFA analyses and 207 PCRs were performed. IFA detected RSV in 58.1%; PCR increased it to 66.7%. IFA detected HAdV in 3.2%, PCR 10.0%. PCR detected IV A in 5; IV B in 2; PIV 1 in 6, PIV 2 in 4 and PIV 3 in 11 cases. HBoV, as single agent in 2 cases, and HRV were positive in 8 samples and hMPV in 11. With this virus panel, 19.7% remained without etiology. The most frequent agent was RSV, followed by HAdV. PCR can be cost-effective and more accurate than IFA, which is crucial for HAdV that may be associated with significant mortality (IFA alone did not detect 2/3 of the cases). Copyright 2010 Elsevier B.V. All rights reserved.

  13. Adherence to confidentiality principles from the viewpoint of Iranian dental students: A multicenter study.

    Science.gov (United States)

    Ghodousi, A; Abedzadeh, M; Ketabi, M; Zarean, Parichehr; Zarean, Paridokht

    2017-03-09

    Confidentiality is a basic ethical principle appreciating human autonomy, relationships, and dignity and in medical research has a long history. In dental practice, it has the same importance as medical field. Therefore, providing patients with information about the confidentiality will promote their confidence in dental professionals and prevent legal conflicts. The present study sought to evaluate the knowledge and viewpoints of dental students about patient confidentiality. In this multicenter applied research, the participants were recruited from schools of dentistry of Isfahan, Tehran, Tabriz, Shiraz, and Mashhad Universities of Medical Sciences and Isfahan Islamic Azad University during 2013. Ultimately, data were collected randomly with a researcher-made questionnaire from 180 dental students of fifth-sixth-year. The collected data were entered into SPSS 20.0. Independent t-tests and one-way analysis of variance (ANOVA) were performed to analyze the data. Overall, 60.3% of the participating students were concerned about acquiring adequate knowledge on the concept of patient confidentiality and 59.0% felt obliged to participate in related educational courses. Most students (66.5%) were careful not to share patient information with their friends. According to one-way ANOVA, students of Tehran University of Medical Sciences scored significantly higher than other participants. However, no significant differences were detected between the students of other schools. The confidentiality laws imposed by the Ministry of Health and Medical Education seem to adequate details, but needs more education for dentists. Also it should be accentuated, due to state of confidentiality in patients' rights guidline and courses on ethics should be tailored based on the specific subjects raised in each field of dentistry. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Body mass index and mortality in Korean intensive care units: a prospective multicenter cohort study.

    Directory of Open Access Journals (Sweden)

    So Yeon Lim

    Full Text Available BACKGROUND: The level of body mass index (BMI that is associated with the lowest mortality in critically ill patients in Asian populations is uncertain. We aimed to examine the association of BMI with hospital mortality in critically ill patients in Korea. METHODS: We conducted a prospective multicenter cohort study of 3,655 critically ill patients in 22 intensive care units (ICUs in Korea. BMI was categorized into five groups: <18.5, 18.5 to 22.9, 23.0 to 24.9 (the reference category, 25.0 to 29.9, and ≥30.0 kg/m2. RESULTS: The median BMI was 22.6 (IQR 20.3 to 25.1. The percentages of patients with BMI<18.5, 18.5 to 22.9, 23.0 to 24.9, 25.0 to 29.9, and ≥30.0 were 12, 42.3, 19.9, 22.4, and 3.3%, respectively. The Cox-proportional hazard ratios with exact partial likelihood to handle tied failures for hospital mortality comparing the BMI categories <18.5, 18.5 to 22.9, 25.0 to 29.9, and ≥30.0 with the reference category were 1.13 (0.88 to 1.44, 1.03 (0.84 to 1.26, 0.96 (0.76 to 1.22, and 0.68 (0.43 to 1.08, respectively, with a highly significant test for trend (p = 0.02. CONCLUSIONS: A graded inverse association between BMI and hospital mortality with a strong significant trend was found in critically ill patients in Korea.

  15. Estimating cardiovascular risk in patients with type 2 diabetes: a national multicenter study in Brazil

    Directory of Open Access Journals (Sweden)

    Gomes Marilia B

    2009-10-01

    Full Text Available Abstract According to Brazilian National Data Survey diabetes is the fifth cause for hospitalization and is one of the ten major causes of mortality in this country. Aims to stratify the estimated cardiovascular risk (eCVR in a population of type 2 diabetics (T2DM according to the Framingham prediction equations as well as to determine the association between eCVR with metabolic and clinical control of the disease. Methods From 2000 to 2001 a cross-sectional multicenter study was conducted in 13 public out-patients diabetes/endocrinology clinics from 8 Brazilian cities. The 10-year risk of developing coronary heart disease (CHD was estimated by the prediction equations described by Wilson et al (Circulation 1998. LDL equations were preferably used; when patients missed LDL data we used total cholesterol equations instead. Results Data from 1382 patients (59.0% female were analyzed. Median and inter-quartile range (IQ of age and duration of diabetes were 57.4 (51-65 and 8.8 (3-13 years, respectively without differences according to the gender. Forty-two percent of these patients were overweight and 35.4% were obese (the prevalence of higher BMI and obesity in this T2DM group was significantly higher in women than in men; p 20% in 738 (53.4%, intermediate in 202 (14.6% and low in 442 (32% patients. Men [25.1(15.4-37.3] showed a higher eCVR than women [18.8 (12.4-27.9 p

  16. Esophageal polyps in pediatric patients undergoing routine diagnostic upper gastrointestinal endoscopy: a multicenter study.

    Science.gov (United States)

    Septer, S; Cuffari, C; Attard, T M

    2014-01-01

    Esophageal polyps are uncommon findings in pediatric patients, and reports have been limited to case reports. Esophageal polyps have been previously ascribed to esophagitis secondary to gastroesophageal reflux, medications, infections and recurrent vomiting. They have been associated with underlying conditions such as hiatal hernia, Barrett's esophagus, eosinophilic esophagitis and Crohn's disease. Presenting complaints of children with esophageal polyps have included vomiting, dysphagia, hematemesis and abdominal pain. The aim of this paper is to characterize the incidence, clinical presentation and progression, histologic subtypes and associated mucosal abnormalities in children with esophageal polyps. A retrospective multicenter study was performed at four institutions identifying diagnosis of esophageal polyps in pediatric patients (polyps were identified in 13 patients (9 M) from 9438 esophagogastroduodenoscopies (0.14%). Mean age of subjects was 9.2 years. Vomiting was the most common indication for endoscopy. Polyp location was at the gastroesophageal junction in 7 of the 13 cases. Most polyps were inflammatory (n = 7). Esophagitis was noted in 69% of those with esophageal polyps. Repeat endoscopies in six patients at a mean interval of 8 months noted persistence of polyps in all six patients. This paper is the first to characterize esophageal polyps in pediatrics. These polyps are rare in children and often are associated with esophagitis. Presenting complaints seem to vary by age. Polyps did not consistently change with either time or acid suppression. The optimal management strategy has yet to be defined and likely depends on the underlying pathophysiologic process. © 2013 Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

  17. Developmental outcomes of children with congenital diaphragmatic hernia: a multicenter prospective study

    Science.gov (United States)

    Wynn, Julia; Aspelund, Gudrun; Zygmunt, Annette; Stolar, Charles JH.; Mychaliska, George; Butcher, Jennifer; Lim, Foong-Yen; Gratton, Teresa; Potoka, Douglas; Brennan, Kate; Azarow, Ken; Jackson, Barbara; Needelman, Howard; Crombleholme, Timothy; Zhang, Yuan; Duong, Jimmy; Arkovitz, Marc S.; Chung, Wendy K.; Farkouh, Christiana

    2013-01-01

    Purpose To determine developmental outcomes and associated factors in patients with congenital diaphragmatic hernia (CDH) at two years of age. Methods This is a multicenter prospective study of a CDH birth cohort. Clinical and socioeconomic data were collected. Bayley Scales of Infant Development (BSID-III) and Vineland Adaptive Behavior Scales (VABS-II) were performed at two years of age. Results BSID-III and VABS-II assessments were completed on 48 and 49 children, respectively. The BSID-III mean cognitive, language, and motor scores were significantly below the norm mean with average scores of 93 +/− 15, 95 +/−16, and 95 +/− 11. Ten percent (5/47) scored more than two standard deviations below the norm on one or more domains. VABS-II scores were similar to BSID-III scores with mean communication, daily living skills, social, motor, adaptive behavior scores of 97 +/−14, 94+/−16, 93 +/− 13, 97+/− 10, and 94 +/− 14. For the BSID-III, supplemental oxygen at 28 days, a prenatal diagnosis, need for extracorporeal membrane oxygenation (ECMO) and exclusive tube feeds at time of discharge were associated with lower scores. At two years of age, history of hospital readmission and need for tube feeds were associated with lower scores. Lower socioeconomic status correlated with lower developmental scores when adjusted for significant health factors. Conclusion CDH patients on average have lower developmental scores at two years of age compared to the norm. A need for ECMO, oxygen at 28 days of life, ongoing health issues and lower socioeconomic status are factors associated with developmental delays. PMID:24094947

  18. Developmental outcomes of children with congenital diaphragmatic hernia: a multicenter prospective study.

    Science.gov (United States)

    Wynn, Julia; Aspelund, Gudrun; Zygmunt, Annette; Stolar, Charles J H; Mychaliska, George; Butcher, Jennifer; Lim, Foong-Yen; Gratton, Teresa; Potoka, Douglas; Brennan, Kate; Azarow, Ken; Jackson, Barbara; Needelman, Howard; Crombleholme, Timothy; Zhang, Yuan; Duong, Jimmy; Arkovitz, Marc S; Chung, Wendy K; Farkouh, Christiana

    2013-10-01

    To determine developmental outcomes and associated factors in patients with congenital diaphragmatic hernia (CDH) at 2 years of age. This is a multicenter prospective study of a CDH birth cohort. Clinical and socioeconomic data were collected. Bayley Scales of Infant Development (BSID-III) and Vineland Adaptive Behavior Scales (VABS-II) were performed at 2 years of age. BSID-III and VABS-II assessments were completed on 48 and 49 children, respectively. The BSID-III mean cognitive, language, and motor scores were significantly below the norm mean with average scores of 93 ± 15, 95 ± 16, and 95 ± 11. Ten percent (5/47) scored more than 2 standard deviations below the norm on one or more domains. VABS-II scores were similar to BSID-III scores with mean communication, daily living skills, social, motor, adaptive behavior scores of 97 ± 14, 94 ± 16, 93 ± 13, 97 ± 10, and 94 ± 14. For the BSID-III, supplemental oxygen at 28 days, a prenatal diagnosis, need for extracorporeal membrane oxygenation (ECMO) and exclusive tube feeds at time of discharge were associated with lower scores. At 2 years of age, history of hospital readmission and need for tube feeds were associated with lower scores. Lower socioeconomic status correlated with lower developmental scores when adjusted for significant health factors. CDH patients on average have lower developmental scores at 2 years of age compared to the norm. A need for ECMO, oxygen at 28 days of life, ongoing health issues and lower socioeconomic status are factors associated with developmental delays. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III).

    Science.gov (United States)

    Stein, Paul D; Chenevert, Thomas L; Fowler, Sarah E; Goodman, Lawrence R; Gottschalk, Alexander; Hales, Charles A; Hull, Russell D; Jablonski, Kathleen A; Leeper, Kenneth V; Naidich, David P; Sak, Daniel J; Sostman, H Dirk; Tapson, Victor F; Weg, John G; Woodard, Pamela K

    2010-04-06

    The accuracy of gadolinium-enhanced magnetic resonance pulmonary angiography and magnetic resonance venography for diagnosing pulmonary embolism has not been determined conclusively. To investigate performance characteristics of magnetic resonance angiography, with or without magnetic resonance venography, for diagnosing pulmonary embolism. Prospective, multicenter study from 10 April 2006 to 30 September 2008. 7 hospitals and their emergency services. 371 adults with diagnosed or excluded pulmonary embolism. Sensitivity, specificity, and likelihood ratios were measured by comparing independently read magnetic resonance imaging with the reference standard for diagnosing pulmonary embolism. Reference standard diagnosis or exclusion was made by using various tests, including computed tomographic angiography and venography, ventilation-perfusion lung scan, venous ultrasonography, d-dimer assay, and clinical assessment. Magnetic resonance angiography, averaged across centers, was technically inadequate in 25% of patients (92 of 371). The proportion of technically inadequate images ranged from 11% to 52% at various centers. Including patients with technically inadequate images, magnetic resonance angiography identified 57% (59 of 104) with pulmonary embolism. Technically adequate magnetic resonance angiography had a sensitivity of 78% and a specificity of 99%. Technically adequate magnetic resonance angiography and venography had a sensitivity of 92% and a specificity of 96%, but 52% of patients (194 of 370) had technically inadequate results. A high proportion of patients with suspected embolism was not eligible or declined to participate. Magnetic resonance pulmonary angiography should be considered only at centers that routinely perform it well and only for patients for whom standard tests are contraindicated. Magnetic resonance pulmonary angiography and magnetic resonance venography combined have a higher sensitivity than magnetic resonance pulmonary angiography

  20. Analysis of platelet-derived extracellular vesicles in plateletpheresis concentrates: a multicenter study.

    Science.gov (United States)

    Black, Anne; Orsó, Evelyn; Kelsch, Reinhard; Pereira, Melanie; Kamhieh-Milz, Julian; Salama, Abdulgabar; Fischer, Michael B; Meyer, Eduardo; Frey, Beat M; Schmitz, Gerd

    2017-06-01

    Routine quantification of platelet-derived extracellular vesicles (PL-EVs) may be useful in the quality control (QC) of platelet concentrates (PCs). The aim of this multicenter study was to establish and validate a consensus protocol for the standardized PL-EV quantification using conventional flow cytometers. Eighty-six PCs were investigated in five blood transfusion centers (A-E) on Days 0 and 5. The centers used different apheresis instruments: Trima Accel (n = 56) and/or Amicus (n = 30). PCs were prepared using standard methods (sd-PCs; n = 73; A-D) or with pathogen inactivation (PI [PI-PCs]; n = 13; E). Platelet (PLT) count was determined using conventional hematology analyzers. PLT degranulation (P-selectin expression in response to thrombin receptor PAR1 activation) and PL-EVs were analyzed by flow cytometry. During storage, PLT count remained stable in 58 PCs (A, C, E), whereas a decrease was observed in 12 PCs (B). PLT degranulation declined in all PCs (p < 0.001) and PL-EVs increased in 74 PCs (A, C-E; p < 0.001). Certain donor variables (e.g., plasma cholesterol, immature PLT fraction) were associated with lower PL-EVs. In Trima-produced PCs, PL-EVs were significantly lower (D) and PLT degranulation was superior compared to PCs prepared with the Amicus (A, D). PL-EVs were 10-fold lower in PI-PCs, compared to sd-PCs. However, similar QC trends were demonstrated for both PC groups during storage. PL-EV analysis in a QC program of PCs was successfully performed with results comparable among the different centers. PLT degranulation and vesiculation were primarily affected by preparation techniques. © 2017 AABB.

  1. Acute renal failure according to the RIFLE and AKIN criteria: a multicenter study.

    Science.gov (United States)

    Salgado, G; Landa, M; Masevicius, D; Gianassi, S; San-Román, J E; Silva, L; Gimenez, M; Tejerina, O; Díaz-Cisneros, P; Ciccioli, F; do Pico, J L

    2014-01-01

    To determine the incidence of acute renal failure (ARF) in critically ill patients using the RIFLE and AKIN criteria. A prospective, multicenter observational study with a duration of one year from February 2010 was carried out. RIFLE and AKIN were employed using the urinary (UC) and creatinine criteria (CC) jointly and separately. Nine polyvalent Critical Care Units (CCUs) in Argentina. A total of 627 critical patients over 18 years of age were admitted to the CCU for more than 48h. inability to quantify diuresis, surgical instrumentation of the urinary tract, and need for renal support therapy (RST). Calculated hourly diuresis (CHD) was used to apply the UC. The incidence of ARF was 69.4% and 51.8% according to RIFLE and AKIN, respectively. UC detected ARF in 59.5% of cases, while CC identified ARF in 34.7% (RIFLE) and 25.3% (AKIN). The mortality rate was 40.9% and 44.6% according to RIFLE and AKIN respectively, was significantly higher than in patients without ARF, and increased with disease severity (Data processing: Excel, SQL and SPSS. Levene test, comparison of means with Student t and chi-squared, with 95% confidence interval). RIFLE identified more cases of ARF. UC proved more effective than CC. The presence of ARF and severity levels were correlated to mortality but not to days of stay in the CCU. Implementation of the unified CHD was useful for implementing UC and achieving comparable results. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

  2. Shigella isolates from the global enteric multicenter study inform vaccine development.

    Science.gov (United States)

    Livio, Sofie; Strockbine, Nancy A; Panchalingam, Sandra; Tennant, Sharon M; Barry, Eileen M; Marohn, Mark E; Antonio, Martin; Hossain, Anowar; Mandomando, Inacio; Ochieng, John B; Oundo, Joseph O; Qureshi, Shahida; Ramamurthy, Thandavarayan; Tamboura, Boubou; Adegbola, Richard A; Hossain, Mohammed Jahangir; Saha, Debasish; Sen, Sunil; Faruque, Abu Syed Golam; Alonso, Pedro L; Breiman, Robert F; Zaidi, Anita K M; Sur, Dipika; Sow, Samba O; Berkeley, Lynette Y; O'Reilly, Ciara E; Mintz, Eric D; Biswas, Kousick; Cohen, Dani; Farag, Tamer H; Nasrin, Dilruba; Wu, Yukun; Blackwelder, William C; Kotloff, Karen L; Nataro, James P; Levine, Myron M

    2014-10-01

    Shigella, a major diarrheal disease pathogen worldwide, is the target of vaccine development. The Global Enteric Multicenter Study (GEMS) investigated burden and etiology of moderate-to-severe diarrheal disease in children aged Shigella was 1 of the 4 most common pathogens across sites and age strata. GEMS Shigella serotypes are reviewed to guide vaccine development. Subjects' stool specimens/rectal swabs were transported to site laboratories in transport media and plated onto xylose lysine desoxycholate and MacConkey agar. Suspect Shigella colonies were identified by biochemical tests and agglutination with antisera. Shigella isolates were shipped to the GEMS Reference Laboratory (Baltimore, MD) for confirmation and serotyping of S. flexneri; one-third of isolates were sent to the Centers for Disease Control and Prevention for quality control. Shigella dysenteriae and S. boydii accounted for 5.0% and 5.4%, respectively, of 1130 Shigella case isolates; S. flexneri comprised 65.9% and S. sonnei 23.7%. Five serotypes/subserotypes comprised 89.4% of S. flexneri, including S. flexneri 2a, S. flexneri 6, S. flexneri 3a, S. flexneri 2b, and S. flexneri 1b. A broad-spectrum Shigella vaccine must protect against S. sonnei and 15 S. flexneri serotypes/subserotypes. A quadrivalent vaccine with O antigens from S. sonnei, S. flexneri 2a, S. flexneri 3a, and S. flexneri 6 can provide broad direct coverage against these most common serotypes and indirect coverage against all but 1 (rare) remaining subserotype through shared S. flexneri group antigens. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

  3. Safety and Efficacy of Defibrillator Charging During Ongoing Chest Compressions: A Multicenter Study

    Science.gov (United States)

    Edelson, Dana P.; Robertson-Dick, Brian J.; Yuen, Trevor C.; Eilevstjønn, Joar; Walsh, Deborah; Bareis, Charles J.; Vanden Hoek, Terry L.; Abella, Benjamin S.

    2013-01-01

    BACKGROUND Pauses in chest compressions during cardiopulmonary resuscitation have been shown to correlate with poor outcomes. In an attempt to minimize these pauses, the American Heart Association recommends charging the defibrillator during chest compressions. While simulation work suggests decreased pause times using this technique, little is known about its use in clinical practice. METHODS We conducted a multicenter, retrospective study of defibrillator charging at three US academic teaching hospitals between April 2006 and April 2009. Data were abstracted from CPR-sensing defibrillator transcripts. Pre-shock pauses and total hands- off time preceding the defibrillation attempts were compared among techniques. RESULTS A total of 680 charge-cycles from 244 cardiac arrests were analyzed. The defibrillator was charged during ongoing chest compressions in 448 (65.9%) instances with wide variability across the three sites. Charging during compressions correlated with a decrease in median pre-shock pause [2.6 (IQR 1.9–3.8) vs 13.3 (IQR 8.6–19.5) s; p defibrillation [10.3 (IQR 6.4–13.8) vs 14.8 (IQR 11.0–19.6) s; p defibrillator in anticipation of the pause, prior to any rhythm analysis. There was no difference in inappropriate shocks when charging during chest compressions (20.0 vs 20.1%; p=0.97) and there was only one instance noted of inadvertent shock administration during compressions, which went unnoticed by the compressor. CONCLUSIONS Charging during compressions is underutilized in clinical practice. The technique is associated with decreased hands-off time preceding defibrillation, with minimal risk to patients or rescuers. PMID:20807672

  4. Acute disseminated encephalomyelitis in 228 patients: A retrospective, multicenter US study.

    Science.gov (United States)

    Koelman, Diederik L H; Chahin, Salim; Mar, Soe S; Venkatesan, Arun; Hoganson, George M; Yeshokumar, Anusha K; Barreras, Paula; Majmudar, Bittu; Klein, Joshua P; Chitnis, Tanuja; Benkeser, David C; Carone, Marco; Mateen, Farrah J

    2016-05-31

    To analyze the range of demographic, clinical, MRI, and CSF features of acute disseminated encephalomyelitis (ADEM), a rare, typically monophasic demyelinating disorder, and analyze long-term outcomes including time and risk factors for subsequent clinical events as well as competing diagnoses. We performed a retrospective, multicenter study in 4 US academic medical centers of all patients clinically diagnosed with ADEM. Initial presentation of pediatric and adult ADEM and monophasic and multiphasic disease were compared. The Aalen-Johansen estimator was used to produce estimates of the probability of transitioning to a multiphasic diagnosis as a function of time since initial diagnosis, treating death and alternative diagnoses as competing risks. Of 228 patients (122 children, age range 1-72 years, 106 male, median follow-up 24 months [25th-75th percentile 6-67], 7 deaths), approximately one quarter (n = 55, 24%) experienced at least one relapse. Relapsing disease in children was more often diagnosed as multiphasic ADEM than in adults (58% vs 21%, p = 0.007), in whom MS was diagnosed more often. Encephalopathy at initial presentation (hazard ratio [HR] 0.383, p = 0.001), male sex (HR 0.394, p = 0.002), and increasing age at onset (HR 0.984, p = 0.035) were independently associated with a longer time to a demyelinating disease relapse in a multivariable model. In 17 patients, diagnoses other than demyelinating disease were concluded in long-term follow-up. Relapsing disease after ADEM is fairly common and associated with a few potentially predictive features at initial presentation. Age-specific guidelines for ADEM diagnosis and treatment may be valuable, and vigilance for other, mostly rare, diseases is imperative. © 2016 American Academy of Neurology.

  5. The effects of celebrity suicide on copycat suicide attempt: a multi-center observational study.

    Science.gov (United States)

    Jeong, Joo; Shin, Sang Do; Kim, Ho; Hong, Yun Chul; Hwang, Seung Sik; Lee, Eui Jung

    2012-06-01

    The effect of celebrity suicides on copycat suicide attempts is not well known. Our objective was to determine the association between celebrity suicide and copycat suicide attempts. We conducted a retrospective multicenter observational time series analysis. Celebrity suicides were selected by an operational definition via three nationwide television news internet sites from January 2005 to December 2008. The reference week was defined as the week preceding date of suicide notification to the public. Then two pre-event weeks and four post-event weeks were analyzed for suicide attempts. We derived a prediction model for suicide attempt visits for each ED for these seven observational weeks using a General Additive Model with data from the National Emergency Department Information System (NEDIS) database. We calculated the mean excess visit (EV = observed visit - expected visit) and mean excess visit ratio (EVR = EV/expected visit). We tested the mean EV and EVR between reference weeks versus the observational weeks using independent t test and repeated measures ANOVA. Five celebrity suicides occurred during the study period. Total number of ED visits was 5,453,441 in the 85 EDs over the 4-year period, and suicide attempt or self-injury occurred in 27,605. The mean excess visit for each observational interval per ED was less than 0.1 during pre-event periods but increased to 0.695 in the second post-event week. EVs were significantly higher in the first to the third post-event weeks (p = 0.02, p suicide attempts or self injury increased following the announcements of celebrity suicides.

  6. [Critical reading of reports of educational research in teachers of IMSS. Multicenter study].

    Science.gov (United States)

    Leyva-González, Félix Arturo; Cacho-Salazar, Julio M; Degollado-Bardales, Lilia; Zavala-Arenas, Jesús Arturo; Angulo-Bernal, Sonia Elizabeth; Leyva-Salas, César Arturo; Orozco-Bisson, Gisele Victorine

    2011-01-01

    To determine the effect of an educational strategy promoting participation in the development of critical reading of educational research reports on professors of Educational Research and Teacher Education (CIEFD's). We performed an intervention study, multicenter professors (medical specialists) who enrolled in the courses: Diploma in teaching methodological level 1 and 2 (n = 46, n = 29, respectively) in the six CIEFD's (D.F. Siglo XXI, DF. La Raza, Nuevo León, Sonora, Puebla and Jalisco), in the period March to August 2007. A tool was built that assessed the variables critical appraisal of educational research reports, the construct validity, content and reliability was assessed by experts in education research. The educational strategy developed in the form of seminars, which were held three times a week in the Certification in teaching methodological level 1 and twice per week in the Certification Level 2 in teaching methodology duration per session: 6 h. The instrument was applied at the beginning and end of the course. In the two Graduates it was observed in the total group, an advance in the three indicators of critical reading, which was expressed with statistically significant differences; in the global score of the Diploma level 1 (final vs. initial measurement) the following mediums were observed: 36-67 (p = 0.0001); in the Diploma level 2, it was observed in its overall rating: 42-78 (p = 0.0001). This inquiry from the results observed some of theoretical approaches to mainstreaming participatory. An educational strategy promoting participation produced a breakthrough in the three indicators (to interpret, to judge and to formulate proposals) for critical reading of educational research reports.

  7. The Effectiveness and Efficiency of Inpatient Rehabilitation Services in Thailand: A Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Vilai Kuptniratsaikul

    2016-01-01

    Full Text Available Objective To investigate the effectiveness and efficiency of inpatient rehabilitation. Methods A total of 2,081 patients across 14 hospitals were recruited in this prospective, multicenter cohort study. Data on the diagnoses, types of admission, length of stay (LOS, and functional ability score based on a modified Barthel index (BI at admission (BIa and at discharge (BId were collected. Effectiveness was defined as the difference of BI (ΔBI and efficiency as ΔBI divided by LOS. Results The majority of patients were diagnosed with spinal cord injury and stroke (41.8% and 37.5%, respectively. The mean age was 52.4 ± 18.6 years with a mean LOS of 23.9 ± 19.9 days, BIa of 9.4 ± 6.1, and BId of 12.3 ± 5.7. The overall effectiveness and efficiency were 2.9 ± 3.4 and 0.16 ± 0.30 scores/day, respectively; stroke rehabilitation provided the most effective and efficient BI improvement compared with rehabilitation for other diseases. Most patients (54.5% received intensive functional rehabilitation, which was the most effective and efficient program (4.4 ± 3.6 and 0.23 ± 0.32 scores/day, respectively; the efficiency of the intensive program was not different among various diseases (P = 0.726. Conclusion Stroke rehabilitation had the highest efficiency compared with rehabilitation for other neurological diseases. The most efficient type of admission was intensive rehabilitation, regardless of the disease being treated.

  8. Ideal cardiovascular health and inflammation in European adolescents: The HELENA study.

    Science.gov (United States)

    González-Gil, E M; Santabárbara, J; Ruiz, J R; Bel-Serrat, S; Huybrechts, I; Pedrero-Chamizo, R; de la O, A; Gottrand, F; Kafatos, A; Widhalm, K; Manios, Y; Molnar, D; De Henauw, S; Plada, M; Ferrari, M; Palacios Le Blé, G; Siani, A; González-Gross, M; Gómez-Martínez, S; Marcos, A; Moreno Aznar, L A

    2017-05-01

    Inflammation plays a key role in atherosclerosis and this process seems to appear in childhood. The ideal cardiovascular health index (ICHI) has been inversely related to atherosclerotic plaque in adults. However, evidence regarding inflammation and ICHI in adolescents is scarce. The aim is to assess the association between ICHI and inflammation in European adolescents. As many as 543 adolescents (251 boys and 292 girls) from the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) study, a cross-sectional multi-center study including 9 European countries, were measured. C-reactive protein (CRP), complement factors C3 and C4, leptin and white blood cell counts were used to compute an inflammatory score. Multilevel linear models and multilevel logistic regression were used to assess the association between ICHI and inflammation controlling by covariates. Higher ICHI was associated with a lower inflammatory score, as well as with several individual components, both in boys and girls (p < 0.01). In addition, adolescents with at least 4 ideal components of the ICHI had significantly lower inflammatory score and lower levels of the study biomarkers, except CRP. Finally, the multilevel logistic regression showed that for every unit increase in the ICHI, the probability of having an inflammatory profile decreased by 28.1% in girls. Results from this study suggest that a better ICHI is associated with a lower inflammatory profile already in adolescence. Improving these health behaviors, and health factors included in the ICHI, could play an important role in CVD prevention. Copyright © 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  9. New oral anticoagulants-TURKey (NOAC-TURK): Multicenter cross-sectional study.

    Science.gov (United States)

    Altay, Servet; Yıldırımtürk, Özlem; Çakmak, Hüseyin Altuğ; Aşkın, Lütfü; Sinan, Ümit Yaşar; Beşli, Feyzullah; Gedikli, Ömer; Özden Tok, Özge

    2017-05-01

    New oral anticoagulants (NOACs) are increasingly used both for prevention of stroke in non-valvular atrial fibrillation (NVAF) and the treatment of venous thromboembolism (VTE). In this study, we aimed to evaluate the current patterns of NOACs treatment in Turkey. Moreover, demographic and clinical parameters and bleeding and/or embolic events under NOACs treatment were analyzed. The New Oral Anticoagulants-TURKey (NOAC-TURK) study was designed as a multicenter cross-sectional study. A total of 2,862 patients from 21 different centers of Turkey under the treatment of NOACs for at least three months were included in this study. Demographic, clinical, and laboratory characteristics of study participants with their medications used were obtained through the NOAC-TURK survey database. Additional necessary medical records were obtained from electronic health records of participating centers. Of the 2. 862 patients, 1.131 (39.5%) were male and the mean age was 70.3±10.2 years. Hypertension was found as the most frequent comorbidity (81%). The most common indication for NOACs was permanent atrial fibrillation (83.3%). NOACs were mainly preferred because of inadequate therapeutic range or overdose during warfarin usage. The most frequent complication was bleeding (n=217, 7.6%), and major bleeding was observed in 1.1% of the patients. Embolic events were observed in 37 patients (1.3%). Rivaroxaban and dabigatran were both more preferred than apixaban. Almost half of the patients (47.6%) were using lower doses of NOACs, which is definitely much more than expected. The NOAC-TURK study showed an important overview of the current NOACs treatment regimens in Turkey. Although embolic and bleeding complications were lower than or similar to previous studies, increased utilization of low-dose NOACs in this study should be considered carefully. According to the results of this study, NOACs treatment should be guided through CHA2DS2-VASc and HASBLED scores to ensure more benefit and

  10. Pre-fracture nutritional status is predictive of functional status at discharge during the acute phase with hip fracture patients: A multicenter prospective cohort study.

    Science.gov (United States)

    Inoue, Tatsuro; Misu, Syogo; Tanaka, Toshiaki; Sakamoto, Hiroki; Iwata, Kentaro; Chuman, Yuki; Ono, Rei

    2017-10-01

    Malnutrition is common in patients with hip fractures, and elderly patients with hip fractures lose functional independence and often fail to recover previous functional status. The aim of this study was to determine whether pre-fracture nutritional status predicts functional status of patients with hip fracture at discharge from acute hospitals. In the present multicenter prospective cohort study, pre-fracture nutritional status was assessed using the Mini Nutritional Assessment Short-Form (MNA-SF). At discharge from acute hospitals, functional status was evaluated using a functional independent measurement instrument (FIM). Subsequently, multiple regression analyses were performed using FIM as the dependent variable and MNA-SF as the independent variable. Among the 204 patients analyzed in the present study, the mean length of hospital stay was 26.2 ± 12.6 days, and according to MNA-SF assessments, 51 (25.0%) patients were malnourished, 98 (48.0%) were at risk of malnutrition, and 55 (27.0%) were well-nourished before fracture. At discharge, FIM scores were higher in patients who were well-nourished than in those who were malnourished or were at risk of malnutrition (p nutritional status was a significant independent predictor for functional status at discharge during the acute phase, warranting early assessment of nutritional status and early intervention for successful postoperative rehabilitation. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  11. Functional Impairment Is a Risk Factor for Knee Replacement in the Multicenter Osteoarthritis Study.

    Science.gov (United States)

    Wise, Barton L; Niu, Jingbo; Felson, David T; Hietpas, Jean; Sadosky, Alesia; Torner, James; Lewis, Cora E; Nevitt, Michael

    2015-08-01

    Debilitating pain associated with knee osteoarthritis (OA) often leads patients to seek and complete total knee arthroplasty (TKA). To date, few studies have evaluated the relation of functional impairment to the risk of TKA, despite the fact that OA is associated with functional impairment. The purpose of our study was to (1) evaluate whether function as measured by WOMAC physical function subscale was associated with undergoing TKA; and (2) whether any such association varied by sex. The National Institutes of Health-funded Multicenter Osteoarthritis Study (MOST) is an observational cohort study of persons aged 50 to 79 years with or at high risk of symptomatic knee OA who were recruited from the community. All eligible subjects with complete data were included in this analysis. Our study population sample consisted of 2946 patients with 5796 knees; 1776 (60%) of patients were women. We performed a repeated-measures analysis using baseline WOMAC physical function score to predict the risk of TKA from baseline to 30 months and WOMAC score at 30 months to predict risk of incident TKA from 30 months to 60 months. We used generalized estimating equations to account for the correlation between two knees within an individual and across the two periods. We calculated relative risk (RR) of TKA over 30 months by WOMAC function using a score of 0 to 5 as the referent in multiple binomial regressions with log link. Those with the greatest functional impairment (WOMAC scores 40-68; 62 TKAs in 462 knee periods) had 15.5 times (95% confidence interval [CI], 7.6-31.8; prisk of undergoing TKA over 30 months compared with the referent group (12 TKAs in 3604 knee periods), adjusting for basic covariates, and 5.9 times (95% CI, 2.8-12.5; prisk after further adjusting for knee pain severity. At every level of functional limitation, the RR for TKA for women was higher than for men, but interaction with sex did not reach significance after adjustment for covariates including

  12. Internet based multicenter study for thoracolumbar injuries: a new concept and preliminary results.

    Science.gov (United States)

    Knop, Christian; Reinhold, Maximilian; Roeder, Christoph; Staub, Lukas; Schmid, Rene; Beisse, Rudolf; Bühren, Volker; Blauth, Michael

    2006-11-01

    This article reports about the internet based, second multicenter study (MCS II) of the spine study group (AG WS) of the German trauma association (DGU). It represents a continuation of the first study conducted between the years 1994 and 1996 (MCS I). For the purpose of one common, centralised data capture methodology, a newly developed internet-based data collection system ( http://www.memdoc.org ) of the Institute for Evaluative Research in Orthopaedic Surgery of the University of Bern was used. The aim of this first publication on the MCS II was to describe in detail the new method of data collection and the structure of the developed data base system, via internet. The goal of the study was the assessment of the current state of treatment for fresh traumatic injuries of the thoracolumbar spine in the German speaking part of Europe. For that reason, we intended to collect large number of cases and representative, valid information about the radiographic, clinical and subjective treatment outcomes. Thanks to the new study design of MCS II, not only the common surgical treatment concepts, but also the new and constantly broadening spectrum of spine surgery, i.e. vertebro-/kyphoplasty, computer assisted surgery and navigation, minimal-invasive, and endoscopic techniques, documented and evaluated. We present a first statistical overview and preliminary analysis of 18 centers from Germany and Austria that participated in MCS II. A real time data capture at source was made possible by the constant availability of the data collection system via internet access. Following the principle of an application service provider, software, questionnaires and validation routines are located on a central server, which is accessed from the periphery (hospitals) by means of standard Internet browsers. By that, costly and time consuming software installation and maintenance of local data repositories are avoided and, more importantly, cumbersome migration of data into one integrated

  13. Accuracy of cotinine serum test to detect the smoking habit and its association with periodontal disease in a multicenter study.

    Science.gov (United States)

    Duque, A; Martínez, P-J; Giraldo, A; Gualtero, D-F; Ardila, C-M; Contreras, A; Duarte, S; Lafaurie, G-I

    2017-07-01

    The validity of the surveys on self-reported smoking status is often questioned because smokers underestimate cigarette use and deny the habit. It has been suggested that self-report should be accompanied by cotinine test. This report evaluates the usefulness of serum cotinine test to assess the association between smoking and periodontal status in a study with a large sample population to be used in studies with other serum markers in epidemiologic and periodontal medicine researches. 578 patients who were part of a multicenter study on blood biomarkers were evaluated about smoking and its relation to periodontal disease. Severity of periodontal disease was determinate using clinical attachment loss (CAL). Smoking was assessed by a questionnaire and a blood sample drawn for serum cotinine determination. The optimal cut-off point for serum cotinine was 10 ng/ml. Serum cotinine showed greater association with severity of CAL than self-report for mild-moderate CAL [OR 2.03 (CI95% 1.16-3.53) vs. OR 1.08 (CI95% 0.62-1.87) ] advanced periodontitis [OR 2.36 (CI95% 1.30- 4.31) vs. OR 2.06 (CI95% 0.97-4.38) ] and extension of CAL > 3 mm [ OR 1.78 (CI95% 1.16-1.71) vs. 1.37 (CI95% 0.89-2.11)]. When the two tests were evaluated together were not shown to be better than serum cotinine test. Self-reported smoking and serum cotinine test ≥ 10ng/ml are accurate ,complementary and more reliable methods to assess the patient's smoking status and could be used in studies evaluating serum samples in large population and multicenter studies. The serum cotinine level is more reliable to make associations with the patient's periodontal status than self-report questionnaire and could be used in multicenter and periodontal medicine studies.

  14. Research Strategies in European Union Studies

    DEFF Research Database (Denmark)

    Manners, Ian James; Lynggaard, Kennet; Löfgren, Karl

    2015-01-01

    The contributing chapters of this book all illustrate the richness and diversity of problem-driven research in EU studies. This concluding chapter draws together the insights of this rich diversity in order to move the study of research strategies beyond the dichotomies of the past towards a new ...

  15. RESULTS OF MULTICENTER STUDY OF PIDOTIMOD FOR THE PROPHYLAXIS OF ACUTE RESPIRATORY INFECTIONS IN FREQUENTLY AILING CHILDREN

    Directory of Open Access Journals (Sweden)

    L.S. Namazova-Baranova

    2010-01-01

    Full Text Available The article describes actual pediatric problem — frequent development of respiratory infections in children. Authors present the results of Russian multicenter study of effectiveness and safety of pidotimod (Imunorix in frequently ailing children. It was shown that treatment with pidotimod during 30 days resulted in decreased rate of acute respiratory infections and their complications including ones with necessity of antibacterial therapy compared to children from control group. The dynamics of immunological rates in blood serum was studied.Key words: frequently ailing children, acute respiratory infections, prophylaxis, pidotimod.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2010;9(2:40-44

  16. Severe Obesity Impacts Recurrence-Free Survival of Women with High-Risk Endometrial Cancer: Results of a French Multicenter Study.

    Science.gov (United States)

    Canlorbe, Geoffroy; Bendifallah, Sofiane; Raimond, Emilie; Graesslin, Olivier; Hudry, Delphine; Coutant, Charles; Touboul, Cyril; Bleu, Géraldine; Collinet, Pierre; Darai, Emile; Ballester, Marcos

    2015-08-01

    Studies focusing on the impact of obesity on survival in endometrial cancer (EC) have reported controversial results and few data exist on the impact of obesity on recurrence rate and recurrence-free survival (RFS). The aim of this study was to assess the impact of obesity on surgical staging and RFS in EC according to the European Society of Medical Oncology (ESMO) risk groups. Data of 729 women with EC who received primary surgical treatment between January 2000 and December 2012 were abstracted from a multicenter database. RFS distributions according to body mass index (BMI) in each ESMO risk group were estimated using the Kaplan-Meier method. Survival was evaluated using the log-rank test, and the Cox proportional hazards model was used to determine influence of multiple variables. Distribution of the 729 women with EC according to BMI was BMI obese women in the low-/intermediate-risk groups, but a BMI ≥ 35 was independently correlated to a poorer RFS (hazard ratio 12.5; 95 % confidence interval 3.1-51.3) for women in the high-risk group. Severe obesity negatively impacts RFS in women with high-risk EC, underlining the importance of complete surgical staging and adapted adjuvant therapies in this subgroup of women.

  17. Energy and Protein in Critically Ill Patients with AKI: A Prospective, Multicenter Observational Study Using Indirect Calorimetry and Protein Catabolic Rate

    Directory of Open Access Journals (Sweden)

    Alice Sabatino

    2017-07-01

    Full Text Available The optimal nutritional support in Acute Kidney Injury (AKI still remains an open issue. The present study was aimed at evaluating the validity of conventional predictive formulas for the calculation of both energy expenditure and protein needs in critically ill patients with AKI. A prospective, multicenter, observational study was conducted on adult patients hospitalized with AKI in three different intensive care units (ICU. Nutrient needs were estimated by different methods: the Guidelines of the European Society of Parenteral and Enteral Nutrition (ESPEN for both calories and proteins, the Harris-Benedict equation, the Penn-State and Faisy-Fagon equations for energy. Actual energy and protein needs were repeatedly measured by indirect calorimetry (IC and protein catabolic rate (PCR until oral nutrition start, hospital discharge or renal function recovery. Forty-two patients with AKI were enrolled, with 130 IC and 123 PCR measurements obtained over 654 days of artificial nutrition. No predictive formula was precise enough, and Bland-Altman plots wide limits of agreement for all equations highlight the potential to under- or overfeed individual patients. Conventional predictive formulas may frequently lead to incorrect energy and protein need estimation. In critically ill patients with AKI an increased risk for under- or overfeeding is likely when nutrient needs are estimated instead of measured.

  18. Research Methods in European Union Studies

    DEFF Research Database (Denmark)

    Research methods and designs from the social sciences and beyond can, and should, be applied in research directed at EU affairs. The purpose of this edited collection is twofold: (1) to provide a state-of-the-art examination of social science research methods in EU studies and (2) to provide...... innovative guidelines to the advancement of more inclusive and empirically sensitive research methods in EU studies....

  19. Multicenter study of subjective acceptance during magnetic resonance imaging at 7 and 9.4 T.

    Science.gov (United States)

    Rauschenberg, Jaane; Nagel, Armin M; Ladd, Susanne C; Theysohn, Jens M; Ladd, Mark E; Möller, Harald E; Trampel, Robert; Turner, Robert; Pohmann, Rolf; Scheffler, Klaus; Brechmann, André; Stadler, Jörg; Felder, Jörg; Shah, N Jon; Semmler, Wolfhard

    2014-05-01

    The aims of this study were to investigate the subjective discomfort and sensory side effects during ultrahigh field (UHF) magnetic resonance imaging (MRI) examinations in a large-scale study and to evaluate differences between magnetic resonance (MR) sites. Four MR sites with a 7-T MR system and 2 MR sites with a 9.4-T MR system participated in this multicenter study with a total number of 3457 completed questionnaires on causes of discomfort and sensations during the examination. For a pooled retrospective analysis of the results from the partially different questionnaires, all data were adapted to an answer option with a 4-point scale (0 = no discomfort/side effect, 3 = very unpleasant/very strong sensation). To differentiate effects evoked by the low-frequency time-varying magnetic fields due to movement through the static magnetic field, most questionnaires separated the manifestation of sensory side effects during movement on the patient table from manifestation while lying still in the isocenter. In general, a high acceptance of UHF examinations was found, where in 82% of the completed questionnaires, the subjects stated the examination to be at least tolerable. Although in 7.6% of the questionnaires, subjects felt discomfort during the examination, only 0.9% of the image acquisitions had to be terminated prematurely. No adverse events occurred in any of the examinations. Only 1% of the subjects were unwilling to undergo further UHF MRI examinations. Examination duration was the most complained cause of discomfort, followed by acoustic noise and lying still. All magnetic-field-related sensations were more pronounced when moving the patient table versus the isocenter position (19%/2% of the subjects felt unpleasant vertigo during the moving/stationary state). In general, vertigo was the most often stated sensory side effect and was more pronounced at 9.4 T compared with 7 T. However, the results varied substantially among the different sites. The high levels

  20. Early rehabilitation for severe acquired brain injury in intensive care unit: multicenter observational study.

    Science.gov (United States)

    Bartolo, Michelangelo; Bargellesi, Stefano; Castioni, Carlo A; Bonaiuti, Donatella; Antenucci, Roberto; Benedetti, Angelo; Capuzzo, Valeria; Gamna, Federica; Radeschi, Giulio; Citerio, Giuseppe; Colombo, Carolina; Del Casale, Laura; Recubini, Elena; Toska, Saimir; Zanello, Marco; D'Aurizio, Carlo; Spina, Tullio; Del Gaudio, Alredo; Di Rienzo, Filomena; Intiso, Domenico; Dallocchio, Giulia; Felisatti, Giovanna; Lavezzi, Susanna; Zoppellari, Roberto; Gariboldi, Valentina; Lorini, Luca; Melizza, Giovanni; Molinero, Guido; Mandalà, Giorgio; Pignataro, Amedeo; Montis, Andrea; Napoleone, Alessandro; Pilia, Felicita; Pisu, Marina; Semerjian, Monica; Pagliaro, Giuseppina; Nardin, Lorella; Scarponi, Federico; Zampolini, Mauro; Zava, Raffaele; Massetti, Maria A; Piccolini, Carlo; Aloj, Fulvio; Antonelli, Sergio; Zucchella, Chiara

    2016-02-01

    The increased survival after a severe acquired brain injury (sABI) raise the problem of making most effective the treatments in Intensive Care Unit (ICU)/Neurointensive Care Unit (NICU), also integrating rehabilitation care. Despite previous studies reported that early mobilization in ICU was effective in preventing complications and reducing hospital stay, few studies addressed the rehabilitative management of sABI patients in ICU/NICU. To collect clinical and functional data about the early rehabilitative management of sABI patients during ICU/NICU stay. Prospective, observational, multicenter study. Fourteen facilities supplied by intensive neurorehabilitation units and ICU/NICUs. Consecutive sABI patients admitted to ICU/NICU. Patients were evaluated at admission and then every 3-5 days. Clinical, functional and rehabilitative data, including Glasgow Coma Scale (GCS), Disability Rating Scale (DRS), The Rancho Los Amigos Levels of Cognitive Functioning Scale (LCF), Early Rehabilitation Barthel Index (ERBI), Glasgow Outcome scale (GOS) and Functional Independence Measure (FIM) were collected. One hundred and two patients (F/M 44/58) were enrolled. The mean duration of ICU stay was 24.7±13.9 days and the first rehabilitative evaluation occurred after 8.7±8.8 days. Regular postural changes and multijoint mobilization were prescribed in 63.7% and 64.7% cases, respectively. The mean session duration was 38±11.5 minutes. Swallowing evaluation was performed in 14.7% patients, psychological support was provided to 12.7% of patients' caregivers, while 17.6% received a psycho-educational intervention, and 28.4% were involved in interdisciplinary team meetings. The main discharge destinations were Severe Acquired Brain Injury rehabilitation units for 43.7%, intensive neurorehabilitation units for 20.7%. Data showed that early rehabilitation was not diffusely performed in sABI subjects in ICU/NICU and rehabilitative interventions were variable; one-third of subjects were

  1. Multicenter study on the asymmetry of skin temperature in complex regional pain syndrome

    Science.gov (United States)

    Cho, Chan Woo; Nahm, Francis Sahngun; Choi, Eunjoo; Lee, Pyung-Bok; Jang, In-Ki; Lee, Chul Joong; Kim, Yong Chul; Lee, Sang Chul

    2016-01-01

    Abstract According to the International Association for the Study of Pain (IASP) and American Medical Association (AMA), the diagnostic criteria for complex regional pain syndrome (CRPS) require the presence of skin temperature asymmetry. In CRPS, it is generally accepted that the temperature of skin of affected limbs changes from warm to cold; however, in our clinical practice, we have experienced many cases with different thermographic characteristics. Therefore, we conducted a retrospective multicenter study that examined the distribution of skin temperature in patients with CRPS and skin temperature asymmetry versus symptom duration. Patients diagnosed with type 1 or 2 CRPS were recruited. After confirming CRPS according to the IASP diagnostic criteria, infrared thermographic images were evaluated for skin temperature differences (ΔT) between the affected and unaffected limbs. A total of 296 patients with CRPS were included in this study. The median duration of symptoms was 6 months and the mean ± standard deviation of ΔT was –0.72 ± 1.65°C. A skin temperature difference between bilateral limbs (|ΔT|) of 1°C or less was seen in 131 patients (44.3%); thus, these 131 patients did not meet the IASP criteria for CRPS. Further, cool skin temperature was not observed in 88 patients (29.7%), meaning that these patients did not meet the AMA criteria for CRPS. There was no correlation between the symptom duration and ΔT (Spearman's rho = –0.075, P = 0.196) and there was no significant difference in the average ΔT among the 4 symptom duration groups (0–3 months, 4–6 months, 7–12 months, >12 months, P = 0.08). In conclusion, a considerable proportion of the patients that participated in this study did not meet the thermal criteria set forth by the IASP and AMA. Further, there was no correlation between symptom duration and skin temperature difference. PMID:28033251

  2. A Prospective, Multicentered Study to Assess Social Adjustment in Patients With an Intestinal Stoma in Turkey.

    Science.gov (United States)

    Karadağ, Ayişe; Karabulut, Hatice; Baykara, Zehra G; Harputlu, Deniz; Toyluk, Eylem; Ulusoy, Birgül; Karadağ, Sercan; Kahraman, Aysel; Hin, Aysel Ören; Altinsoy, Meral; Akıl, Yasemin; Leventoğlu, Sezai

    2015-10-01

    with planned stoma operations and persons with permanent stomas increased significantly (P less than 0.05) between assessments. Significant increases in OAI-23 scores also were noted among persons who did not receive information before the operation, patients whose stoma site was not marked, and patients who had experienced a complication (P less than 0.05). Postoperatively, it is important to consider sociodemographic and stoma characteristics as well as preoperative variables that may influence adaptation to stoma. Additional larger, multicentered studies with extended patient follow-up are warranted.

  3. Occupation and skin cancer: the results of the HELIOS-I multicenter case-control study

    Directory of Open Access Journals (Sweden)

    Gafà Lorenzo

    2007-07-01

    Full Text Available Abstract Background Non-melanoma skin cancer (NMSC is the most frequent tumour among Caucasian populations worldwide. Among the risk factors associated with this tumour, there are host-related factors and several environmental agents. A greater likelihood of high exposure to physical agents (with the exception of solar radiation and chemical agents depends on the work setting. Our objective is to evaluate the role of occupational exposures in NMSC, with special emphasis on risk factors other than solar radiation and skin type. Methods We analysed 1585 cases (1333 basal cell carcinoma (BCC and 183 squamous cell carcinoma (SCC and 1507 controls drawn from the Helios-I multicenter study. Odds ratios (OR and 95% confidence intervals (CI were estimated using logistic regression mixed models. Results For NMSC as a whole (both histological types, miners and quarrymen, secondary education teachers, and masons registered excess risk, regardless of exposure to solar radiation and skin type (OR 7.04, 95% CI 2.44–20.31; OR 1.75, 95% CI 1.05–2.89 and OR 1.54, 95% CI 1.04–2.27, respectively. Frequency of BCC proved higher among railway engine drivers and firemen (OR 4.55; 95% CI 0.96–21.57, specialised farmers (OR 1.65; 95% CI 1.05–2.59 and salesmen (OR 3.02; 95% CI 1.05–2.86, in addition to miners and quarrymen and secondary education teachers (OR 7.96; 95% CI 2.72–23.23 and OR 1.76; 95% CI 1.05–2.94 respectively. The occupations that registered a higher risk of SCC (though not of BCC were those involving direct contact with livestock, construction workers not elsewhere classified (OR 2.95, 95% CI 1.12–7.74, stationary engine and related equipment operators not elsewhere classified (OR 5.31, 95% CI 1.13–21.04 and masons (OR 2.55, 95% CI 1.36–4.78. Conclusion Exposure to hazardous air pollutants, arsenic, ionizing radiations and burns may explain a good part of the associations observed in this study. The Helios study affords an

  4. Are Teachers Ready for CLIL? Evidence from a European Study

    Science.gov (United States)

    Pérez Cañado, María Luisa

    2016-01-01

    This article presents the outcomes of a European study on the main training needs which pre- and in-service teachers, teacher trainers, and coordinators consider they have in order to adapt to a bilingual education model. The macro-study has designed, validated and administered four sets of questionnaires to 706 informants across the whole of…

  5. Entrepreneurial Training: A Comparative Study across Fifteen European Countries

    Science.gov (United States)

    Matricano, Diego

    2014-01-01

    This paper arises from the contents of the Lisbon Strategy, a set of cooperation policies stressing the role of education and training. The findings from a comparative study of the influence that entrepreneurial training--classified as formal or informal--can have on start-up expectations are analysed. The study covers fifteen European countries…

  6. Diagnostic accuracy of 123I-meta-iodobenzylguanidine myocardial scintigraphy in dementia with Lewy bodies: a multicenter study.

    Directory of Open Access Journals (Sweden)

    Mitsuhiro Yoshita

    Full Text Available Dementia with Lewy bodies (DLB needs to be distinguished from Alzheimer's disease (AD because of important differences in patient management and outcome. Severe cardiac sympathetic degeneration occurs in DLB, but not in AD, offering a potential system for a biological diagnostic marker. The primary aim of this study was to investigate the diagnostic accuracy, in the ante-mortem differentiation of probable DLB from probable AD, of cardiac imaging with the ligand 123I-meta-iodobenzylguanidine (MIBG which binds to the noradrenaline reuptake site, in the first multicenter study.We performed a multicenter study in which we used 123I-MIBG scans to assess 133 patients with clinical diagnoses of probable (n = 61 or possible (n = 26 DLB or probable AD (n = 46 established by a consensus panel. Three readers, unaware of the clinical diagnosis, classified the images as either normal or abnormal by visual inspection. The heart-to-mediastinum ratios of 123I-MIBG uptake were also calculated using an automated region-of-interest based system.Using the heart-to-mediastinum ratio calculated with the automated system, the sensitivity was 68.9% and the specificity was 89.1% to differentiate probable DLB from probable AD in both early and delayed images. By visual assessment, the sensitivity and specificity were 68.9% and 87.0%, respectively. In a subpopulation of patients with mild dementia (MMSE ≥ 22, n = 47, the sensitivity and specificity were 77.4% and 93.8%, respectively, with the delayed heart-to-mediastinum ratio.Our first multicenter study confirmed the high correlation between abnormal cardiac sympathetic activity evaluated with 123I-MIBG myocardial scintigraphy and a clinical diagnosis of probable DLB. The diagnostic accuracy is sufficiently high for this technique to be clinically useful in distinguishing DLB from AD, especially in patients with mild dementia.

  7. Two-Nation Comparison of Classification and Treatment of Thoracolumbar Fractures: An Internet-Based Multicenter Study Among Spine Surgeons.

    Science.gov (United States)

    Pishnamaz, Miguel; Curfs, Inez; Balosu, Stephan; Willems, Paul; van Hemert, Wouter; Pape, Hans-Christoph; Kobbe, Philipp

    2015-11-01

    Web-based multicenter study. The aim of the study was to assess and compare the management strategy for traumatic thoracolumbar fractures between German and Dutch spine surgeons. To date, there is no evidence-based treatment algorithm for thoracolumbar spine fractures, thereby an international controversy concerning optimal treatment exists. In this web-based multicenter study (www.spine.hostei.com), computed tomography scans of traumatic thoracolumbar fractures (T12-L2) were evaluated by German and Dutch spine surgeons. Supplementary case-specific information such as age, sex, height, weight, neurological status, and injury mechanism were provided.By using a questionnaire, fractures were classified according to the AO-Magerl Classification, followed by 6 questions concerning the treatment algorithm. Data were analyzed using SPSS (Version 21, 76, Chicago, IL). The interobserver agreement was determined by using Cohen κ. Statistical significance was defined as P spine surgeons was found. Overall German spine surgeons had a lower threshold concerning the indication for surgical treatment (Ger 87% vs. NL 30%; P < 0.05). There was a consensus about operative stabilization of AO Type B and C injuries and injuries with neurologic deficit, whereas a discrepancy in the therapeutic algorithm for AO Type A fractures was observed. This difference was most pronounced regarding the indication for posterior (Ger 96.6%; NL 41.2%; P < 0.05) and circumferential stabilization (Ger 53.4%; NL 0%; P < 0.05) for burst fractures. There is a consensus to stabilize AO Type B and C fractures, whereas country-specific differences in the treatment of Type A fractures, especially in case of burst fractures, occur. Prospective, controlled multicenter outcome studies may provide more evidence in optimal treatment for thoracolumbar fractures. 2.

  8. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  9. Diagnostic Accuracy of 123I-Meta-Iodobenzylguanidine Myocardial Scintigraphy in Dementia with Lewy Bodies: A Multicenter Study

    Science.gov (United States)

    Yoshita, Mitsuhiro; Arai, Heii; Arai, Hiroyuki; Arai, Tetsuaki; Asada, Takashi; Fujishiro, Hiroshige; Hanyu, Haruo; Iizuka, Osamu; Iseki, Eizo; Kashihara, Kenichi; Kosaka, Kenji; Maruno, Hirotaka; Mizukami, Katsuyoshi; Mizuno, Yoshikuni; Mori, Etsuro; Nakajima, Kenichi; Nakamura, Hiroyuki; Nakano, Seigo; Nakashima, Kenji; Nishio, Yoshiyuki; Orimo, Satoshi; Samuraki, Miharu; Takahashi, Akira; Taki, Junichi; Tokuda, Takahiko; Urakami, Katsuya; Utsumi, Kumiko; Wada, Kenji; Washimi, Yukihiko; Yamasaki, Junichi; Yamashina, Shouhei; Yamada, Masahito

    2015-01-01

    Background and Purpose Dementia with Lewy bodies (DLB) needs to be distinguished from Alzheimer’s disease (AD) because of important differences in patient management and outcome. Severe cardiac sympathetic degeneration occurs in DLB, but not in AD, offering a potential system for a biological diagnostic marker. The primary aim of this study was to investigate the diagnostic accuracy, in the ante-mortem differentiation of probable DLB from probable AD, of cardiac imaging with the ligand 123I-meta-iodobenzylguanidine (MIBG) which binds to the noradrenaline reuptake site, in the first multicenter study. Methods We performed a multicenter study in which we used 123I-MIBG scans to assess 133 patients with clinical diagnoses of probable (n = 61) or possible (n = 26) DLB or probable AD (n = 46) established by a consensus panel. Three readers, unaware of the clinical diagnosis, classified the images as either normal or abnormal by visual inspection. The heart-to-mediastinum ratios of 123I-MIBG uptake were also calculated using an automated region-of-interest based system. Results Using the heart-to-mediastinum ratio calculated with the automated system, the sensitivity was 68.9% and the specificity was 89.1% to differentiate probable DLB from probable AD in both early and delayed images. By visual assessment, the sensitivity and specificity were 68.9% and 87.0%, respectively. In a subpopulation of patients with mild dementia (MMSE ≥ 22, n = 47), the sensitivity and specificity were 77.4% and 93.8%, respectively, with the delayed heart-to-mediastinum ratio. Conclusions Our first multicenter study confirmed the high correlation between abnormal cardiac sympathetic activity evaluated with 123I-MIBG myocardial scintigraphy and a clinical diagnosis of probable DLB. The diagnostic accuracy is sufficiently high for this technique to be clinically useful in distinguishing DLB from AD, especially in patients with mild dementia. PMID:25793585

  10. EFFICIENCY OF DYNAMIC ELECTRONEUROSTIMULATION IN KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    O. M. Lesnyak

    2015-01-01

    Full Text Available Dynamic electroneurostimulation (DENS is a type of percutaneous electroneurostimulation with a differentiation approach to choosing exposure areas and to optimizing electrocutaneous therapeutic action on the reflexogenic areas and acupuncture points for analgesia and for the treatment of functional disorders.Objective: to study the clinical efficiency and safety of therapy using a DiaDENS-PC apparatus in the treatment of knee osteoarthritis (OA.Subjects and methods. A multicenter randomized double-blind placebo-controlled study was conducted in 132 knee OA patients with pain value above 40 mm on visual analogue scale (VAS and Lequesne’s index of 4–12. In a study group (n = 66, DENS was carried outwith a DiaDENS-PC apparatus using a trailing electrode applicator to the knee target in a Therapy stimulation mode at a frequency 77 Hz, a power of 15 units. In the placebo group, the similar procedure was performed with a switched-on placebo apparatus that did not differ in appearance from the working apparatus; but produced no electrical pulses. The treatment cycle consisted of 10 sessions lasting 30 min. Changes in Lequesne’s algofunctional index were primary end point. The results of the Get-Up to Go test (in seconds and changes pain on VAS and WOMAC were used as secondary end points.Results and discussion. Both groups showed a statistically significant reduction of painand improvement of Get-Up and to Go test results by the end of the treatment course (p < 0.0001. Therewas a statistically significant difference in pain in the compared groups after a treatment session during the first (p = 0.037 and second (p = 0.010 visits. The analgesic effect of therapy was observed to persist in the DENS group 2 weeks (p = 0.006 and 1 month (p = 0.070 after treatment termination. After 10 sessions, there was a statistically significant difference between the groups in the Get-Up and Go test (p = 0.033 and Lequesne’s index (p = 0.022. Both

  11. Outcomes of stereotactic radiosurgery for foramen magnum meningiomas: an international multicenter study.

    Science.gov (United States)

    Mehta, Gautam U; Zenonos, Georgios; Patibandla, Mohana Rao; Lin, Chung Jung; Wolf, Amparo; Grills, Inga; Mathieu, David; McShane, Brendan; Lee, John Y; Blas, Kevin; Kondziolka, Douglas; Lee, Cheng-Chia; Lunsford, L Dade; Sheehan, Jason P

    2017-09-01

    OBJECTIVE Meningiomas are the most common benign extramedullary lesions of the foramen magnum; however, their optimal management remains undefined. Given their location, foramen magnum meningiomas (FMMs) can cause significant morbidity, and complete microsurgical removal can be challenging. Anterior and anterolateral FMMs carry greater risks with surgery, but they comprise the majority of these lesions. As an alternative to resection, stereotactic radiosurgery (SRS) has been used to treat FMMs in small case series. To more clearly define the outcomes of SRS and to delineate a rational management paradigm for these lesions, the authors analyzed the safety and efficacy of SRS for FMM in an international multicenter trial. METHODS Seven medical centers participating in the International Gamma Knife Research Foundation (IGKRF) provided data for this retrospective cohort study. Patients who were treated with Gamma Knife radiosurgery and whose clinical and radiological follow-up was longer than 6 months were eligible for study inclusion. Data from pre- and post-SRS radiological and clinical evaluations were analyzed. Stereotactic radiosurgery treatment variables were recorded. RESULTS Fifty-seven patients (39 females and 18 males, with a median age of 64 years) met the study inclusion criteria. Thirty-two percent had undergone prior microsurgical resection. Patients most frequently presented with cranial neuropathy (39%), headache (35%), numbness (32%), and ataxia (30%). Median pre-SRS tumor volume was 2.9 cm3. Median SRS margin dose was 12.5 Gy (range 10-16 Gy). At the last follow-up after SRS, 49% of tumors were stable, 44% had regressed, and 7% had progressed. Progression-free survival rates at 5 and 10 years were each 92%. A greater margin dose was associated with a significantly increased likelihood of tumor regression, with 53% of tumors treated with > 12 Gy regressing. Fifty-two percent of symptomatic patients noted some clinical improvement. Adverse radiation

  12. Retrospective review of epidemic viral pneumonia cases in Turkey: A multicenter study.

    Science.gov (United States)

    Çörtük, Mustafa; Acat, Murat; Yazici, Onur; Yasar, Zehra; Kiraz, Kemal; Ataman, Sena Yapicioglu; Tanriverdi, Elif; Zitouni, Burcak; Kirakli, Cenk; Ediboglu, Ozlem; Tuksavul, Fevziye; Dirican, Adem; Celik, Hale Kefeli; Ozkaya, Sevket; Cetinkaya, Erdogan

    2017-04-01

    Influenza A (H1N1) caused its first pandemic in 2009 in USA and Mexico. Since then, clinicians have exercised great care in order to make an early diagnosis of viral pneumonias. This is due in part to pandemic influenza A infection having greater impact on populations <65 years old than other viral strains, including seasonal influenza. Chest radiographies of those affected displayed a rapid progression of patchy infiltrates, and a large proportion of individuals required admission to intensive care units (ICU). Despite efforts, patients infected with the virus had a high mortality rate. The present multicenter study aimed to retrospectively evaluate the clinical, demographic and prognostic characteristics of patients diagnosed with epidemic viral pneumonia in Turkey. A total of 92 patients were included in the study. The Student's t-test and Chi-square tests were performed to analyze quantitative data, assuming a normal distribution, and to analyze qualitative data, respectively. Stepwise logistic regression was used to evaluate the effects of demographic variables and laboratory values on the virus mortality rate. The male/female ratio was 42/50 and the mean age was 48.74±16.65 years. A total of 69 (75%) patients were unvaccinated against influenza. The most common symptoms were cough (87%) and fever (63%). Chest computed tomography showed peripheral patchy areas of the lungs of ground glass density in 38 patients (41.3%). A total of 22 (59.4%) patients had H1N1, 5 (12.5%) patients had influenza B, and 38 (41.3%) patients met the criteria for admission to the ICU. Of these patients, 20 (52.63%) were monitored with a mechanical ventilator, with a noninvasive ventilator being adequate for 10 (26.32%) of patients. The length of stay in the ICU was 6.45±5.97 days and the duration of mechanical ventilation was 5.06±4.69 days. A total of 12 (13.04%) patients in the ICU succumbed. Logistic regression analysis revealed that among the parameters possibly associated

  13. Evaluation of multidetector computed tomography for penetrating neck injury: a prospective multicenter study.

    Science.gov (United States)

    Inaba, Kenji; Branco, Bernardino C; Menaker, Jay; Scalea, Thomas M; Crane, Sean; DuBose, Joseph J; Tung, Lily; Reddy, Sravanthi; Demetriades, Demetrios

    2012-03-01

    The purpose of this prospective multicenter study was to evaluate a clinical protocol integrating multidetector computed tomographic angiography (MDCTA) as the initial screening examination for the work-up of penetrating neck injury. All penetrating neck injuries assessed at two Level I trauma centers (January 2009-July 2011) prospectively underwent a structured clinical examination. Those with hard signs of injury (active bleed, instability, expanding/pulsatile hematoma, bruit/thrill, hemoptysis, hematemesis, and air bubbling) underwent exploration, those who were asymptomatic were observed. The remainder, with soft signs underwent MDCTA. Sensitivity and specificity were tested against an aggregate gold standard of operative intervention, clinical follow-up, and when obtained, conventional angiography, bronchoscopy, esophagogram, and esophagoscopy. Four hundred fifty-three penetrating neck injuries were evaluated. Hard signs of vascular or aerodigestive tract injury were observed in 8.6% with an 89.7% incidence of clinically significant injury. 41.7% had no signs of injury and were observed with no missed injuries (follow-up, 2.6 days ± 1.1 days [1-58 days]). The remaining 225 (49.7%) underwent MDCTA (stab wound, 61.3%; gunshot wound, 37.8%; shotgun, 0.9%). The external wounds were in zone II (38.2%), multiple (28.9%), zone I (16.9%), and zone III (16.0%). Twenty-eight injuries were found in 22 patients (5 internal jugular-V, 2 external jugular-V, 1 vertebral-A, 7 common carotid-A, 2 internal carotid-A, 3 external carotid-A, 2 subclavian-A, 3 esophagus, and 3 tracheas). Five patients had false-positive findings (2 vascular and 3 aerodigestive tract). The 194 negative studies (follow-up, 5.5 days ± 7.5 days [1-27 days]) had no delayed diagnosis of injury. MDCTA was nondiagnostic in four patients (1.8%), secondary to artifact. One of these had a vertebral-A injury diagnosed at angiography. MDCTA achieved 100% sensitivity and 97.5% specificity in detecting all

  14. The costs in provision of haemodialysis in a developing country: A multi-centered study

    Directory of Open Access Journals (Sweden)

    Wijesinghe Aruna

    2011-09-01

    % reduction. Conclusions This multi-centered study demonstrated that the costs of haemodialysis in a developing country remained significantly lower compared to developed countries. However, it still places a significant burden on the health care sector, whilst possibility of further cost reduction exists.

  15. Research Methods in European Union Studies

    DEFF Research Database (Denmark)

    Research methods and designs from the social sciences and beyond can, and should, be applied in research directed at EU affairs. The purpose of this edited collection is twofold: (1) to provide a state-of-the-art examination of social science research methods in EU studies and (2) to provide inno...

  16. [In vitro activity of ceftaroline against Spanish isolates of Staphylococcus aureus: a multicenter study].

    Science.gov (United States)

    Tenorio-Abreu, Alberto; Gil Tomás, Jesús; Bratos Pérez, Miguel Ángel; de la Iglesia Salgado, Alberto; Borrás Máñez, María; Ortiz de Lejarazu Leonardo, Raúl; Ávila Alonso, Ana; Colomina Rodríguez, Javier; Pérez Cáceres, Juan Antonio; Saavedra Martín, José María; Márquez Sanabria, Adriana; Domínguez Castaño, Ana; de la Iglesia Salgado, Matilde

    2015-02-01

    Ceftaroline fosamil is a new-generation antimicrobial agent of cephalosporins subgroup. It is the first commercially available beta-lactam antibiotic that exhibits activity against methicillin-resistant Staphylococcus aureus (MRSA). The aim of this study is to determine the in vitro Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) values of ceftaroline against S.aureus strains (including MRSA). A multicenter study involving four hospitals representative of the Spanish geography was performed. MIC and MBC values against both the methicillin-resistant and sensitive strains of S.aureus (MRSA and methicillin-sensitive S.aureus [MSSA]) were determined using a broth microdilution method. A total of 266 S.aureus strains were analyzed (95 MRSA and 171 MSSA). Ceftaroline bacterial sensitivity showed a mean MIC of 0.227 μg/ml (SD=0.146; range, 0.06 to 1 μg/ml). All MIC values of the 266 strains tested belonged to the sensitive category (value ≤ 1 μg/ml). Intermediate or resistant strains were not detected. MIC50 and MIC90 values for MRSA were 0.25 and 0.5 μg/ml, respectively (range=0.125-1 μg/ml). MSSA strains showed MIC50 and MIC90 values of 0.125 and 0.25 μg/ml, respectively (range=0.125-0.5 μg/ml). MBC50 and MBC90 values for MRSA were 0.5 and 1 μg/ml, respectively (range=0.125-1 μg/ml). MSSA strains showed MBC50 and MBC90 values of 0.25 and 0.25 μg/ml, respectively (range=0.125-0.5 μg/ml). Ceftaroline shows excellent in vitro activity against S.aureus, including MRSA strains. Therefore, this antibiotic may be a promising alternative for the treatment of infections caused by this bacterium. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  17. Spanish Multicenter Study of the Epidemiology and Mechanisms of Amoxicillin-Clavulanate Resistance in Escherichia coli

    Science.gov (United States)

    Ortega, Adriana; Aranzamendi-Zaldumbide, Maitane; Bartolomé, Rosa M.; Bou, Germán; Cercenado, Emilia; Conejo, M. Carmen; González-López, Juan José; Marín, Mercedes; Martínez-Martínez, Luis; Merino, María; Navarro, Ferran; Oliver, Antonio; Pascual, Álvaro; Rivera, Alba; Rodríguez-Baño, Jesús; Weber, Irene; Aracil, Belén; Campos, José

    2012-01-01

    We conducted a prospective multicenter study in Spain to characterize the mechanisms of resistance to amoxicillin-clavulanate (AMC) in Escherichia coli. Up to 44 AMC-resistant E. coli isolates (MIC ≥ 32/16 μg/ml) were collected at each of the seven participant hospitals. Resistance mechanisms were characterized by PCR and sequencing. Molecular epidemiology was studied by pulsed-field gel electrophoresis (PFGE) and by multilocus sequence typing. Overall AMC resistance was 9.3%. The resistance mechanisms detected in the 257 AMC-resistant isolates were OXA-1 production (26.1%), hyperproduction of penicillinase (22.6%), production of plasmidic AmpC (19.5%), hyperproduction of chromosomic AmpC (18.3%), and production of inhibitor-resistant TEM (IRT) (17.5%). The IRTs identified were TEM-40 (33.3%), TEM-30 (28.9%), TEM-33 (11.1%), TEM-32 (4.4%), TEM-34 (4.4%), TEM-35 (2.2%), TEM-54 (2.2%), TEM-76 (2.2%), TEM-79 (2.2%), and the new TEM-185 (8.8%). By PFGE, a high degree of genetic diversity was observed although two well-defined clusters were detected in the OXA-1-producing isolates: the C1 cluster consisting of 19 phylogroup A/sequence type 88 [ST88] isolates and the C2 cluster consisting of 19 phylogroup B2/ST131 isolates (16 of them producing CTX-M-15). Each of the clusters was detected in six different hospitals. In total, 21.8% of the isolates were serotype O25b/phylogroup B2 (O25b/B2). AMC resistance in E. coli is widespread in Spain at the hospital and community levels. A high prevalence of OXA-1 was found. Although resistant isolates were genetically diverse, clonality was linked to OXA-1-producing isolates of the STs 88 and 131. Dissemination of IRTs was frequent, and the epidemic O25b/B2/ST131 clone carried many different mechanisms of AMC resistance. PMID:22491692

  18. Restaging surgery for women with borderline ovarian tumors: results of a French multicenter study.

    Science.gov (United States)

    Fauvet, Raffaèle; Boccara, Joëlle; Dufournet, Charlotte; David-Montefiore, Emmanuel; Poncelet, Christophe; Daraï, Emile

    2004-03-15

    The purpose of the current study was to examine the surgical management of women with borderline ovarian tumors and the adequacy of initial staging according to the guidelines of the International Federation of Gynecology and Obstetrics; to evaluate the impact of restaging operations; and to identify risk factors for initial understaging. In a retrospective French multicenter study, 54 of 360 women with borderline ovarian tumors underwent a restaging operation. After excluding women with initial complete staging (n = 62), epidemiologic, surgical, and histologic parameters and risk of recurrence were compared between women who underwent restaging (n = 54) and those who did not (n = 244). One hundred fifty (41.6%) of 360 women underwent intraoperative histologic examination, which led to the diagnosis of a borderline tumor in 97 cases (64.7%). Thirty-seven (38.1%) of these 97 women had undergone complete initial staging procedures. A restaging operation was performed for 54 women. A lower median age and a higher rate of conservative treatment were noted in the group that underwent restaging. Eight (14.8%) of the 54 women who underwent restaging had their tumors upstaged: 7 of the 41 cases initially diagnosed as Stage IA tumors were upstaged to Stage IB (n = 3) or to Stage IIA, IIB, IIIA, or IIIC (n = 1 for each); in the eighth case, a Stage IC tumor was upstaged to Stage IIIA. Upstaging tended to be more common in women with serous borderline tumors (P = 0.06) and in women who underwent cystectomy (P = 0.08). There was no difference in recurrence rates according to whether a restaging operation was performed. The recurrence rates after conservative and radical treatment were 15.6% (25 of 160) and 4.5% (9 of 200), respectively (P < 0.001). Women who initially were diagnosed with Stage IA disease and who had serous borderline tumors or underwent cystectomy appeared to derive the most benefit from restaging surgery. Nonetheless, the indications for restaging surgery

  19. Stereotactic radiosurgery for Spetzler-Martin Grade IV and V arteriovenous malformations: an international multicenter study.

    Science.gov (United States)

    Patibandla, Mohana Rao; Ding, Dale; Kano, Hideyuki; Xu, Zhiyuan; Lee, John Y K; Mathieu, David; Whitesell, Jamie; Pierce, John T; Huang, Paul P; Kondziolka, Douglas; Feliciano, Caleb; Rodriguez-Mercado, Rafael; Almodovar, Luis; Grills, Inga S; Silva, Danilo; Abbassy, Mahmoud; Missios, Symeon; Barnett, Gene H; Lunsford, L Dade; Sheehan, Jason P

    2017-09-08

    OBJECTIVE Due to the complexity of Spetzler-Martin (SM) Grade IV-V arteriovenous malformations (AVMs), the management of these lesions remains controversial. The aims of this multicenter, retrospective cohort study were to evaluate the outcomes after single-session stereotactic radiosurgery (SRS) for SM Grade IV-V AVMs and determine predictive factors. METHODS The authors retrospectively pooled data from 233 patients (mean age 33 years) with SM Grade IV (94.4%) or V AVMs (5.6%) treated with single-session SRS at 8 participating centers in the International Gamma Knife Research Foundation. Pre-SRS embolization was performed in 71 AVMs (30.5%). The mean nidus volume, SRS margin dose, and follow-up duration were 9.7 cm3, 17.3 Gy, and 84.5 months, respectively. Statistical analyses were performed to identify factors associated with post-SRS outcomes. RESULTS At a mean follow-up interval of 84.5 months, favorable outcome was defined as AVM obliteration, no post-SRS hemorrhage, and no permanently symptomatic radiation-induced changes (RIC) and was achieved in 26.2% of patients. The actuarial obliteration rates at 3, 7, 10, and 12 years were 15%, 34%, 37%, and 42%, respectively. The annual post-SRS hemorrhage rate was 3.0%. Symptomatic and permanent RIC occurred in 10.7% and 4% of the patients, respectively. Only larger AVM diameter (p = 0.04) was found to be an independent predictor of unfavorable outcome in the multivariate logistic regression analysis. The rate of favorable outcome was significantly lower for unruptured SM Grade IV-V AVMs compared with ruptured ones (p = 0.042). Prior embolization was a negative independent predictor of AVM obliteration (p = 0.024) and radiologically evident RIC (p = 0.05) in the respective multivariate analyses. CONCLUSIONS In this multi-institutional study, single-session SRS had limited efficacy in the management of SM Grade IV-V AVMs. Favorable outcome was only achieved in a minority of unruptured SM Grade IV-V AVMs, which supports

  20. EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques.

    Science.gov (United States)

    Chen, Yen-I; Kunda, Rastislav; Storm, Andrew C; Aridi, Hanaa Dakour; Thompson, Christopher C; Nieto, Jose; Siddiqui, Ali A; James, Theodore; Irani, Shayan; Bukhari, Majidah; Gutierrez, Olaya Brewer; Agarwal, Amol; Fayad, Lea; Moran, Robert; Alammar, Nuha; Sanaei, Omid; Canto, Marcia I; Singh, Vikesh K; Baron, Todd H; Khashab, Mouen A

    2017-07-24

    Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a developing modality in the management of gastric outlet obstruction (GOO) with several technical approaches including the direct and balloon-assisted techniques. The aim of this study is to compare the direct with the balloon-assisted modality while further defining the role of EUS-GE in GOO. Multicenter, retrospective study involving consecutive patients who underwent EUS gastroenterostomy with the direct or balloon-assisted technique for GOO (January 2014-October 2016). The primary outcome is technical success. Secondary outcomes include clinical success (ability to tolerate at least a full fluid diet), procedure time, and rate/severity of adverse events (AE). Seventy-seven patients (42.9% female; mean age 63.2 ± 11.5 years) underwent EUS gastroenterostomy for GOO (n=55 DGE and n=22 BAGE). GOO was of malignant and benign etiology in 67.5% and 32.5% of the patients, respectively. Technical success was achieved in 94.5% of the direct and 90.9% of the balloon-assisted approach (p=0.62). Mean procedure time was shorter with the direct technique (35.1±31.2 minutes vs 89.9±33.3 minutes, p<0.001). Clinical success rate was 92.7% for the direct and 90.9% for balloon-assisted modality (p=0.79), with a mean time to oral intake of 1.41±2.75 days. The AE rate was 6.5% with only one severe AE noted. Rate of AE, postprocedure length of stay, need for re-intervention, and survival were similar between the 2 groups. EUS gastroenterostomy is effective and safe in the management of GOO. The direct technique may be the preferred method given its shorter procedure time when compared with balloon-assisted approach. Prospective trials are needed to confirm these findings. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  1. Outcomes of Geriatric Trauma Patients on Preinjury Anticoagulation: A Multicenter Study.

    Science.gov (United States)

    Ang, Darwin; Kurek, Stan; McKenney, Mark; Norwood, Scott; Kimbrell, Brian; Barquist, Erik; Liu, Huazhi; O'Dell, Annette; Ziglar, Michele; Hurst, James

    2017-06-01

    Outpatient anticoagulation in the geriatric trauma patient is a challenging clinical problem. The aim of this study is to determine clinical outcomes associated with class of preinjury anticoagulants (PA) used by this population. This is a multicenter retrospective cohort study among four Level II trauma centers. A total of 1642 patients were evaluated; 684 patients were on anticoagulation and 958 patients were not. Patients on PA were compared with those who were not. Drug classes were divided into thromboxane A2 inhibitors, vitamin K factor-dependent inhibitors, antithrombin III activation, platelet P2Y12 inhibitors, and thrombin inhibitors. Multivariate regression was used to adjust for age, gender, race, mechanism of injury, and Injury Severity Score. No single or combination of anticoagulation agents had a significant association with mortality; however, there were positive trends toward increased mortality were noted for all antiplatelet groups involving thromboxane A2 inhibitors and platelet P2Y12 inhibitors classes. The likelihood of complications was significantly higher with platelet P2Y12 inhibitors adjusted odds ratio (aOR) 2.39 [95% confidence interval (CI) 1.32, 4.3]. The likelihood of blood transfusion was increased with vitamin K inhibitors aOR 2.89 (95% CI 1.3, 6.5), P2Y12 inhibitors aOR 2.76 (95% CI 1.12, 6.76), and combined thromboxane A2 and P2Y12 inhibitors aOR 2.89 (95% CI 1.13, 7.46). P2Y12 inhibitors were also more likely associated with traumatic brain injury aOR 2.16 (95% CI 1.01, 4.6). All classes of PA were associated with solid organ injury. There were no significant differences in the use of antiplatelet agents between patients with major indications for PA and those without major indications. Geriatric trauma patients on outpatient anticoagulants have a higher likelihood of developing complications, packed red blood cell transfusions, traumatic brain injury, and solid organ injury. Attention should be paid to patients on platelet P2Y

  2. Multicenter epidemiological and clinical study on imported Chagas diseases in Alicante, Spain.

    Science.gov (United States)

    Ramos, José M; Torrús, Diego; Amador, Concepción; Jover, Francisco; Pérez-Chacón, Fabiola; Ponce, Yamileth; Arjona, Francisco J; Caro, Elena; Martínez-Peinado, Concepción; Gallegos, Ingrid; Cuadrado, José M; Tello, Antonio; Gutiérrez, Felix

    2012-10-01

    Recently, there has been an increase in the number of patients with Chagas disease outside of areas that are generally considered endemic. The aim of this investigation is to describe the clinical profile of a series of patients with Chagas disease in Alicante, Spain, which is a province located on the coast of the Mediterranean Sea. This study was performed at four general hospitals in Alicante between January 2002 and May 2011. A total of 128 patients from seven countries were diagnosed with Trypanosoma cruzi. The main country of origin of these patients was Bolivia (n5101; 78.9%), and the median of age of these patients was 35 years (range: 0–72 years). Four (3.3%) patients were children under 14 years of age, and 81 (63.3%) were female. Polymerase chain reaction (PCR) was used to analyze 106 patients, 66.0% of whom demonstrated positive PCR results. Visceral involvement was diagnosed in 26.8%: 24.1% demonstrated cardiac involvement, 0.9% demonstrated gastrointestinal involvement, 0.9% demonstrated cardiac and gastrointestinal involvement, and 0.9% demonstrated involvement of the central nervous system. Syncope was found to be associated with cardiomyopathy (28.0% versus 5.2%) (odds ratio: 6.5; 95% confidence interval: 1.5–27.1). Seventy-six patients received treatment with benznidazole, of whom 57 (75.0%) completed the treatment course without significant adverse events and 17.1% discontinued benznidazole due to adverse events. In total, 50% of patients experienced documented adverse reactions. Among patients with positive PCR results before treatment, all demonstrated negative PCR results following treatment. In conclusion, majority of our patients were female Bolivians immigrants, one of four of our patients demonstrated cardiac involvement, and treatment tolerance was poor. It is important to improve the clinical and epidemiological knowledge of Chagas disease in nonendemic with additional multicenter studies in order to determine the magnitude of this

  3. Hospital admissions for hypertensive crisis in the emergency departments: a large multicenter Italian study.

    Directory of Open Access Journals (Sweden)

    Giuliano Pinna

    Full Text Available Epidemiological data on the impact of hypertensive crises (emergencies and urgencies on referral to the Emergency Departments (EDs are lacking, in spite of the evidence that they may be life-threatening conditions. We performed a multicenter study to identify all patients aged 18 years and over who were admitted to 10 Italian EDs during 2009 for hypertensive crises (systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg. We classified patients as affected by either hypertensive emergencies or hypertensive urgencies depending on the presence or the absence of progressive target organ damage, respectively. Logistic regression analysis was then performed to assess variables independently associated with hypertensive emergencies with respect to hypertensive urgencies. Of 333,407 patients admitted to the EDs over the one-year period, 1,546 had hypertensive crises (4.6/1,000, 95% CI 4.4-4.9, and 23% of them had unknown hypertension. Hypertensive emergencies (n = 391, 25.3% of hypertensive crises were acute pulmonary edema (30.9%, stroke (22.0%,, myocardial infarction (17.9%, acute aortic dissection (7.9%, acute renal failure (5.9% and hypertensive encephalopathy (4.9%. Men had higher frequency than women of unknown hypertension (27.9% vs 18.5%, p<0.001. Even among known hypertensive patients, a larger proportion of men than women reported not taking anti-hypertensive drug (12.6% among men and 9.4% among women (p<0.001. Compared to women of similar age, men had higher likelihood of having hypertensive emergencies than urgencies (OR = 1.34, 95% CI 1.06-1.70, independently of presenting symptoms, creatinine, smoking habit and known hypertension. This study shows that hypertensive crises involved almost 5 out of 1,000 patients-year admitted to EDs. Sex differences in frequencies of unknown hypertension, compliance to treatment and risk of hypertensive emergencies might have implications for public health programs.

  4. [Multicenter Ozurdex® assessment for diabetic macular edema: MOZART study].

    Science.gov (United States)

    Guigou, S; Hajjar, C; Parrat, E; Merite, P Y; Pommier, S; Matonti, F; Prost-Magnin, O; Meyer, F

    2014-06-01

    To evaluate the efficiency and safety of intravitreal implant of 0.7mg dexamathasone in visual impairment due to diabetic macular edema (DME). This was a retrospective, multicenter, study. Seventy-four patients, with a mean age of 65 years, followed for at least 6 months (mean follow-up: 9.8 months) were included in 5 French eye clinics (P 1.5 collective). The mean systolic blood pressure was 138mmHg and the mean HbA1c was 7.2%. We monitored 2 systemic parameters: blood pressure and glycemic balance. Best-corrected visual acuity (BCVA), central retinal thickness (CRT, Spectralis OCT), intraocular pressure (IOP) and cataract progression are studied at baseline and then at 1, 2, 4 and 6 months. The average CRT decrease was: 239μm at month 2 (M2) and 135μm at month 6 (M6). The mean improvement from baseline of BCVA is 8.5 letters at M2 and 7.6 letters at M6. A gain greater than 15 letters is found in 27% of patients at M6. For naive patients the BCVA is 71 letters versus 60 letters (P<0.05). Patients with a baseline CRT <500mmHg have a BCVA of 66 letters versus 57 letters (P<0.05). The mean rate injections was 1.2 at 6 months with an average of 5.4 months for reinjection. Ocular hypertension greater than 25mmHg, managed by topical treatment, is observed in 13.4% of patients. No glaucoma surgery was necessary. Dexamethasone has an anatomical and functional effectiveness in the treatment of DME. Outcomes for naive patients and lower CRT suggest that the duration of diabetes mellitus and previous treatments are negative factors of recovery. Side effects are rare and manageable. Ozurdex(®) seems to be a treatment for visual impairment due to DME with a favorable safety profile. Patient follow-up must be adapted to half-life of the product with a control before M1 (intraocular pressure) and before M5 (DME recurrence, BCVA). Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  5. A self-adhering mesh for inguinal hernia repair: preliminary results of a prospective, multicenter study.

    Science.gov (United States)

    Champault, G; Torcivia, A; Paolino, L; Chaddad, W; Lacaine, F; Barrat, C

    2011-12-01

    Prosthetic reinforcement is the gold standard treatment for inguinal hernia and reduces the risk of recurrence. Yet up to one-third of patients complain of post-surgical pain due to irritation and inflammation caused by the mesh and the fixation materials. Of these patients, 3-4% will experience severe and disabling chronic pain. We performed a prospective multicenter clinical study of a self-adhering prosthesis, consisting of a lightweight polypropylene mesh (40 g/m²) coated on each side with synthetic glue, to evaluate early postoperative complications and patient outcomes. Between August 2008 and June 2010, 186 patients underwent hernia repair using the Lichtenstein technique and the self-adhering prosthesis. Primary endpoints were the frequency of disabling complications and quality of life (QoL) at 3-month follow-up. Pain, numbness, and groin discomfort were evaluated pre- and postoperatively (1 week, 1 and 3 months) using a visual analogue scale (VAS). Patients' pre- and postoperative QoL were measured using the SF12 questionnaire. Secondary endpoints were number of complications and recurrence rate, use of analgesic drugs, length of hospital stay, delay to return to normal activities, and patient satisfaction. The quality of the self-adhering mesh and its clinical utility were also evaluated by the participating surgeons. A total of 186 patients were enrolled and followed for at least 3 months after inguinal hernia repair. A total of 174 (95%) primary hernias and 12 (5%) recurrent hernias were treated. There were no intraoperative complications, no recurrences, and no repeat interventions performed during the study. The post-surgical complication rate was 4.5%. The mean delay to recover normal physical activity was 4 days. For the primary endpoint of pain, a VAS of zero was reported by 93/184 (50.5%) patients at 1 week, 130/171 (76.0%) patients at 1 month and 119/132 (90.2%) patients at 3 months' follow-up (P post-surgical complications or pain, a

  6. Occurrence and Duration of Interruptions During Nurses' Work in Surgical Wards: Findings From a Multicenter Observational Study.

    Science.gov (United States)

    Dante, Angelo; Andrigo, Isabella; Barone, Francesca; Bonamico, Rossella; De Chiara, Antonio; Nait, Michela; Toci, Ergyseda; Palese, Alvisa

    2016-01-01

    This was an observational multicenter study of 50 registered nurses, randomly selected, on 5 surgical wards in 5 Italian hospitals. There were on average 5.6 interruptions per hour. Interruptions occurred more frequently during the afternoon shift (n = 1061; 52.8%), were caused mainly by the staff members (n = 978; 48.7%) during medication administration (n = 1075; 53.5%), and were managed directly by the nurses (n = 1639; 81.6%). The average duration of an interruption was 32.7 seconds (95% confidence interval, 30.7-34.7).

  7. Species distribution and susceptibility profile of yeasts isolated from blood cultures: results of a multicenter active laboratory-based surveillance study in Argentina.

    Science.gov (United States)

    Córdoba, Susana; Vivot, Walter; Bosco-Borgeat, Maria E; Taverna, Constanza; Szusz, Wanda; Murisengo, Omar; Isla, Guillermina; Davel, Graciela

    2011-01-01

    The Mycology Department of the Instituto Nacional de Enfermedades Infecciosas "Dr. C. Malbrán", conducted the Second National Multicenter Survey on Fungemia due to Yeasts in Argentina. The aim was to obtain updated data of the frequency of the causative species encountered and their in vitro susceptibility to seven antifungal agents. Yeast species were identified by micromorphological and biochemical studies. Antifungal susceptibility testing was performed by the reference microdilution method E.Def 7.1 of the European Committee on Antibiotic Susceptibility Testing (EUCAST). A total of 461 viable yeasts were identified. The most frequent species were: Candida albicans (38.4 %), Candida parapsilosis (26 %), Candida tropicalis (15.4 %) and Candida glabrata (4.3 %). Other uncommon species, such as Candida viswanathii (0.6 %), Candida haemulonii (0.4 %), Candida inconspicua (0.2 %) and Candida fermentati (0.2 %) were also isolated. Among the Candida spp., 5.4 % and 1.6 % were resistant to fluconazole and voriconazole, respectively. Itraconazole and caspofungin were the most efficient agents against all Candida spp. tested (MIC 8 mg/l), 75 % of Trichosporon spp., and 100 % of Rhodotorula spp., Geotrichum candidum, Saccharomyces cerevisiae. The global percentage of mortality was 20 %. The presence of uncommon species reinforces the need for performing continuous laboratory surveillance in order to monitor possible changes, not only in the epidemiological distribution of species, but also in the resistance to antifungal drugs.

  8. A Multicenter Study Evaluating the Effect of Ulipristal Acetate during Myomectomy.

    Science.gov (United States)

    Murji, Ally; Wais, Marta; Lee, Sabrina; Pham, Alice; Tai, Melissa; Liu, Grace

    2017-10-24

    To compare surgical experience at myomectomy between patients with myomas pretreated with ulipristal acetate versus no pretreatment. A prospective, observational, multicenter study of myomectomy procedures by any route (hysteroscopic, laparoscopic, or laparotomy) (Canadian Task Force classification II-2). Five university-affiliated hospitals including tertiary care and community sites. Any patient who underwent hysteroscopic, laparotomic, or laparoscopic myomectomy regardless of medical pretreatment. Surgeons completed a Web-based questionnaire after each myomectomy procedure. Surgeons evaluated visualization, the myoma-myometrium relationship, extrusion, fluid deficit, blood loss, and overall ease of hysteroscopic myomectomies. For laparotomic/laparoscopic myomectomies, plane delineation, myoma separation, blood loss, and overall ease were assessed. The total surgical experience score was calculated by summing the values for each subscale. A total of 309 myomectomies were evaluated by 52 surgeons (response rate = 83%) at 5 institutions. Of 140 hysteroscopic myomectomies, 84 (60%) were performed without pretreatment, 29 (21%) after ulipristal acetate pretreatment, and 27 (19%) after pretreatment with gonadotropin-releasing hormone agonist/other. Of 169 laparotomic/laparoscopic myomectomies, 104 (62%) were performed without pretreatment, 46 (27%) after ulipristal acetate, and 19 (11%) after gonadotropin-releasing hormone agonist/other. The mean surgical experience score (±standard deviation) was comparable between the no pretreatment and ulipristal acetate groups for hysteroscopic myomectomies (13.8 ± 2.2 vs 13.3 ± 2.2, p = .35) and laparotomic/laparoscopic myomectomies (12.9 ± 4.1 vs 12.1 ± 4.2, p = .30). Compared with no pretreatment, more laparotomic/laparoscopic myomectomies after ulipristal acetate pretreatment were associated with difficult delineation of surgical planes (22 [47.8%] vs 23 [22.1%], p = .002) and difficult

  9. A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation.

    Science.gov (United States)

    Lansaat, L; de Kleijn, B J; Hilgers, F J M; van der Laan, B F A M; van den Brekel, M W M

    2017-02-01

    Evaluation of short- and long-term clinical feasibility and exploration of limitations and advantages of a new automatic speaking valve (ASV) for laryngectomized patients with integrated HME, the Provox FreeHands FlexiVoice (FlexiVoice). This ASV not only enables automatic, but also manual closure of the valve. A multicenter, prospective clinical study in 40 laryngectomized patients was conducted. Participants were asked to use the FlexiVoice for 26 weeks. The primary outcome measure was long-term compliance. Secondary outcome measures were: patient preference, hours of FlexiVoice use, device life of adhesive, voice and speech quality, and quality of life. After 26 weeks, 15 patients (37.5 %) were using the FlexiVoice on a daily basis, for a mean of 12.64 h/day (SD ± 5.03). Ten patients (25 %) were using the device on a non-daily basis, for a mean of 3.76 h/day (SD ± 2.07). The remaining 15 patients (37.5 %) discontinued using the FlexiVoice. Sixty percent of the 25 long-term users applied both automatic and manual closure of the valve. Unpredictable fixation of the adhesive was the main reason for discontinuing or not using the FlexiVoice on a daily basis. Overall, 18 patients (45 %) preferred the FlexiVoice, 16 patients (40 %) their usual HME, 3 patients (7.5 %) their usual ASV, 1 patient (2.5 %) preferred no device at all, and in 2 patients preference was not recorded. The minor technical issues identified could be corrected. The Provox FreeHands FlexiVoice appears to be a useful ASV, which allows for hands-free speech in a larger proportion of laryngectomized patients in the present cohort. The additional manual closure option of the device is beneficial for maintaining the adhesive seal longer.

  10. Full title: peripheral venous catheter complications in children: predisposing factors in a multicenter prospective cohort study.

    Science.gov (United States)

    Ben Abdelaziz, Rim; Hafsi, Habiba; Hajji, Hela; Boudabous, Hela; Ben Chehida, Amel; Mrabet, Ali; Boussetta, Khadija; Barsaoui, Sihem; Sammoud, Azza; Hamzaoui, Mourad; Azzouz, Hatem; Tebib, Néji

    2017-12-19

    Peripheral venous catheterization (PVC) is frequently used in children. This procedure is not free from potential complications. Our purpose was to identify the types and incidences of PVC complications in children and their predisposing factors in a developing country. We conducted a prospective observational multicenter study in five pediatric and pediatric surgery departments over a period of 2 months. Two hundred fifteen PVC procedures were conducted in 98 children. The times of insertion and removal and the reasons for termination were noted, and the lifespan was calculated. Descriptive data were expressed as percentages, means, standard deviations, medians and interquartile ranges. The Chi2 test or the Fisher test, with hazard ratios and 95% confidence intervals (CI95%), as well as Student's t test or the Mann-Whitney U test were used to compare categorical and quantitative variables, respectively, in groups with and without complications. The Spearman test was used to determine correlations between the lifespan and the quantitative variables. The Kruskal Wallis test was used to test for differences in the median lifespan within 3 or more subgroups of a variable. Linear regression and logistic binary regression were used for multivariate analysis. A p-value <0.05 was considered significant. The mean lifespan was 68.82 ± 35.71 h. A local complication occurred in 111 PIVC (51.9%) cases. The risk factors identified were a small catheter gauge (24-gauge) (p = 0.023), the use of a volume-controlled burette (p = 0.036), a longer duration of intravenous therapy (p < 0.001), a medical diagnosis of respiratory or infectious disease (p = 0.047), the use of antibiotics (p = 0.005), including cefotaxime (p = 0.024) and vancomycin (p = 0.031), and the use of proton pump inhibitors (p = 0.004).The lifespan of the catheters was reduced with the occurrence of a complication (p < 0.001), including the use of 24-gauge catheters (p = 0

  11. The sexuality and quality of life of hemodialyzed patients--ASED multicenter study.

    Science.gov (United States)

    Lew-Starowicz, Michal; Gellert, Ryszard

    2009-04-01

    Chronic kidney disease (CKD) strongly affects sexual function (SF) and quality of life (QoL). The relations between CKD, SF, mental health, and QoL remain poorly understood in dialyzed patients. To correlate sexuality to QoL in hemodialysis patients. One hundred twelve patients (69 males and 43 females) aged 20-60 years at six dialysis units were interviewed, and their medical records were reinvestigated and supplemented with completed Beck's Depression Inventory, Self-Evaluation Questionnaire, Mell-Krat Scale, International Index of Erectile Function-5, Arizona Sexual Experience Scale, and health-related Quality of Life (Short Form [SF]-36) questionnaires. Prevalence of different levels of measurable aspects of sexual life, mental health, QoL, as well as their correlations, was assessed. Only 55.4% of the patients were sexually active (79% in the age-matched general population) and 24.1% has ever before spoken to a doctor about their sexual life. The patients perceived sexual activity as important and were not satisfied with the performance. The predominant sexual dysfunctions were loss or diminished sexual needs (84.7% males and 48.8% females); in men, also erectile dysfunction (44.5%) and inhibited or lack of ejaculation (51.5%); in women, arousal dysfunction and anorgasmia (67.8% and 80.7%, respectively). The rate of depression was extremely high (80.5%). The patients self-assessed their QoL as low in both the physical and the mental health domains. Multiple regression analysis revealed that anxiety in men and depression in women independently predicted the lower quality of sexual life (P = 0.017 and 0.04, respectively). The general QoL, mental health, and physical health negatively correlated with the presence of depressive symptoms (P = 0.011, 0.013, and 0.011, respectively). This pilot study is the first to present, in a multicenter design, the complex relations of sexuality and QoL in hemodialyzed patients, which are strongly underevaluated by medical

  12. [Predictive value of hour-specific transcutaneous bilirubin nomogram for neonatal hyperbilirubinemia: a national multicenter study].

    Science.gov (United States)

    2015-11-01

    To assess the predictive value of hour-specific transcutaneous bilirubin (TcB) nomogram for subsequent neonatal hyperbilirubinemia. Thirteen tertiary class-A hospitals (including two hospitals respectively in the northeastern, northern, eastern, south, northwest, southwestern regions of China, and one in central region) participated in this multicenter study between January 1 and December 31, 2013. All TcB measurements were obtained from healthy term and near-term newborns (gestational age ≥ 35 weeks, birth weight ≥ 2 000 g) by the JM-103 bilirubinometer between 0 and 168 postnatal hours.Developed an hour-specific TcB bilirubin nomogram with these data.Newborns were divided into 4 groups based on the predischarge bilirubin "risk zone" (≤ P40, >P40-P75, >P75-P95, and > P95 as low, low-intermediate, high-intermediate and high risk zones on the hour-specific bilirubin nomogram) to predict subsequent hyperbilirubinemia.Selected bilirubin measurements of three time quantums (25-48 h, 49-72 h, 73-96 h) as a predictor for the respective danger zone, and adopted ROC curve to assess the predictive ability of the TcB nomogram. Data from 19 601 healthy term and near-term newborns, and 2 673 cases with neonatal hyperbilirubinemia were collected. The prevalence was 13.6%. The P40, P75, and P95 peak percentile value of the hour-specific TcB nomogram was 167, 206, 253 µmol/L, respectively. The rate of rise in TcB was highest during the first 24 h of age, and the 95(th) percentile curve was faster than the P40 and P75 percentile curves. The areas under the ROC curves of 25-48 h, 49-72 h and 73-96 h were respectively 0.752 0, 0.834 4, 0.856 1. During 25-48 h, 49-72 h and 73-96 h after birth, the TcB before discharge were in the high-risk zone, its prevalence was 49.4%, 67.3%, 80.4%, its likelihood ratio was 6.20, 13.0, and 27.8, respectively. The constructed TcB nomogram shows a good predictivity for hyperbilirubinemia.

  13. Tumor budding in colorectal cancer revisited: results of a multicenter interobserver study.

    Science.gov (United States)

    Koelzer, Viktor H; Zlobec, Inti; Berger, Martin D; Cathomas, Gieri; Dawson, Heather; Dirschmid, Klaus; Hädrich, Marion; Inderbitzin, Daniel; Offner, Felix; Puppa, Giacomo; Seelentag, Walter; Schnüriger, Beat; Tornillo, Luigi; Lugli, Alessandro

    2015-05-01

    Tumor budding in colorectal cancer (CRC) is recognized as a valuable prognostic factor but its translation into daily histopathology practice has been delayed by lack of agreement on the optimal method of assessment. Within the context of the Swiss Association of Gastrointestinal Pathology (SAGIP), we performed a multicenter interobserver study on tumor budding, comparing hematoxylin and eosin (H&E) with pan-cytokeratin staining using a 10 high power field (10HPF) and hotspot (1HPF) method. Two serial sections of 50 TNM stage II-IV surgically treated CRC were stained for H&E and pan-cytokeratin. Tumor buds were scored by independent observers at six participating centers in Switzerland and Austria using the 10HPF and 1HPF method on a digital pathology platform. Pearson correlation (r) and intra-class correlation coefficients (ICC) comparing scores between centers were calculated. Three to four times more tumor buds were detected in pan-cytokeratin compared to H&E slides. Correlation coefficients for tumor budding counts between centers ranged from r = 0.46 to r = 0.91 for H&E and from r = 0.73 to r = 0.95 for pan-cytokeratin slides. Interobserver agreement across all centers was excellent for pan-cytokeratin [10HPF: ICC = 0.83 and 1HPF: ICC = 0.8]. In contrast, assessment of tumor budding on H&E slides reached only moderate agreement [10HPF: ICC = 0.58 and 1HPF: ICC = 0.49]. Based on previous literature and our findings, we recommend (1) pan-cytokeratin staining whenever possible, (2) 10HPF method for resection specimens, and (3) 1HPF method for limited material (preoperative biopsy or pT1). Since tumor budding counts can be used to determine probabilities of relevant outcomes and as such more optimally complement clinical decision making, we advocate the avoidance of cutoff scores.

  14. Analysis of Down syndrome failed to be diagnosed after prenatal screening: A multicenter study.

    Science.gov (United States)

    Jiang, Tao; Ding, Jie; Zhang, Xiao-Qing; Zhang, Xiao-Juan; Zhang, Bin; Wang, Ting; Yu, Bin

    2017-06-01

    To analyze the characters of Down syndrome (DS) who failed to be diagnosed after prenatal screening and hope to be able to improve the programs of prenatal screening and reduce the missed diagnosis of DS. In this multicenter study, we collected the missed cases from 3 prenatal diagnosis centers and analyzed their characters. A total of 126 DS babies failed to be diagnosed after prenatal screening. Their mothers accepted the prenatal screening in second trimester. We collected the mothers' blood and detected the levels of alpha-fetoprotein (AFP) and the free beta subunit of human chorionic gonadotropin (fβhCG) by time-resolved fluoroimmunoassay. The values were also presented as multiples of the median (MoM) and determined the risk of carrying a fetus with DS by Wallace LifeCycle Elipse analysis software. Compared with normal control group, the level of fβhCG and hCG MoM were dramatically increased, while AFP and AFP MoM were decreased. The area under the receiver-operating-characteristic curve of trisomy 21 was 0.8387 for hCG-MoM and AFP-MoM testing. The sensitivity, specificity, positive predictive value, and negative predictive value were 84.6%, 74.8%, 75.4%, and 83.6%, respectively. Meanwhile, the prediction mode was "0.39957 + 1.90897HCG-MOM -3.32713AFP-MOM". It was worthwhile noting that the risk of 65.9% DS missed diagnosis group were higher than 1/1000, 92.9% higher than 1/3000. However, 72.5% cases in normal control group were lower than 1/3000. Only 9.2% mothers would be higher than the value of risk in 1/1000. The prediction mode of hCG MoM and AFP MoM might be able to help us reduce the missed diagnosis. It is also necessary to adjust more reasonable range of noninvasive prenatal testing with further clinical researches.

  15. Nosocomial acquisition of methicillin-resistant Staphyloccocus aureus (MRSA and extended-spectrum beta-lactamase (ESBL Enterobacteriaceae in hospitalised patients: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    De Angelis Giulia

    2012-03-01

    Full Text Available Abstract Background The risk of acquisition of antibiotic resistant-bacteria during or shortly after antibiotic therapy is still unclear and it is often confounded by scarce data on antibiotic usage. Primary objective of the study is to compare rates of acquisition of methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae in hospitalised patients, after starting antibiotic therapy. Methods/Design The study, running in three European hospitals, is a multicenter, prospective, longitudinal, observational cohort study funded from the European Community's Seventh Framework Programme [FP7/2007-2013] within the project 'Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria' (acronym SATURN. Nasal and rectal screening for methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae will be obtained at hospital admission, discharge, at antibiotic start (t0, within one hour and at the following intervals: day 3 (t1, 7 (t2, 15 (t3, and 30 (t4. Two nested case-control studies will be performed. The objective of the first study will be to define individual level of risk related to specific antibiotics. Patients acquiring methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae (cases will be compared with patients not acquiring antibiotic-resistant strains after starting antibiotic therapy (controls; ratio 1:4. To define the impact of antibiotics on new acquisition of target antibiotic-resistant bacteria, a second nested case-control study will be done (ratio 1:4. Control group will be selected among patients not receiving antibiotics, admitted in the same ward on the day of the corresponding case, with negative cultures at admission. Epidemiological, clinical and microbiological data will be prospective collected. Discussion The rationale of this study is to better

  16. Teacher Behavior and Student Outcomes : Results of a European Study

    NARCIS (Netherlands)

    Panayiotou, A.; Kyriakides, L.; Creemers, B.P.M.; McMahon, L.; Vanlaar, G.; Pfeifer, M.; Rekalidou, G.; Bren, M.

    This study investigates the extent to which the factors included in the dynamic model of educational effectiveness are associated with student achievement gains in six different European countries. At classroom level, the dynamic model refers to eight factors relating to teacher behavior in the

  17. Ethnic Heritage Studies: Northern European Foods. Experimental Unit.

    Science.gov (United States)

    Freepartner, Susan

    This teaching guide focuses on the Northern European food heritage. It is part of the Louisville Area Ethnic Heritage Studies Project described in ED 150 043. The materials are designed to foster communication across intercultural/ethnic lines. The objective of this unit is to gain familiarity with and appreciate foods from Scandinavia, the Soviet…

  18. Ethnic Heritage Studies: Southern European Foods. Experimental Unit.

    Science.gov (United States)

    Freepartner, Susan

    This teaching guide focuses on the Southern European food heritage. It is part of the Louisville Area Ethnic Heritage Studies Project described in ED 150 043. The project materials are designed to foster communication across intercultural/ethnic lines. The objective of this unit is to gain familiarity with and appreciate foods from Spain, France,…

  19. Central Nervous System Idiopathic Inflammatory Demyelinating Disorders in South Americans: A Descriptive, Multicenter, Cross-Sectional Study.

    Directory of Open Access Journals (Sweden)

    Regina Maria Papais-Alvarenga

    Full Text Available The idiopathic inflammatory demyelinating disease (IIDD spectrum has been investigated among different populations, and the results have indicated a low relative frequency of neuromyelitis optica (NMO among multiple sclerosis (MS cases in whites (1.2%-1.5%, increasing in Mestizos (8% and Africans (15.4%-27.5% living in areas of low MS prevalence. South America (SA was colonized by Europeans from the Iberian Peninsula, and their miscegenation with natives and Africans slaves resulted in significant racial mixing. The current study analyzed the IIDD spectrum in SA after accounting for the ethnic heterogeneity of its population. A cross-sectional multicenter study was performed. Only individuals followed in 2011 with a confirmed diagnosis of IIDD using new diagnostic criteria were considered eligible. Patients' demographic, clinical and laboratory data were collected. In all, 1,917 individuals from 22 MS centers were included (73.7% female, 63.0% white, 28.0% African, 7.0% Mestizo, and 0.2% Asian. The main disease categories and their associated frequencies were MS (76.9%, NMO (11.8%, other NMO syndromes (6.5%, CIS (3.5%, ADEM (1.0%, and acute encephalopathy (0.4%. Females predominated in all main categories. The white ethnicity also predominated, except in NMO. Except in ADEM, the disease onset occurred between 20 and 39 years old, early onset in 8.2% of all cases, and late onset occurred in 8.9%. The long-term morbidity after a mean disease time of 9.28±7.7 years was characterized by mild disability in all categories except in NMO, which was scored as moderate. Disease time among those with MS was positively correlated with the expanded disability status scale (EDSS score (r=0.374; p=<0.001. This correlation was not observed in people with NMO or those with other NMO spectrum disorders (NMOSDs. Among patients with NMO, 83.2% showed a relapsing-remitting course, and 16.8% showed a monophasic course. The NMO-IgG antibody tested using indirect

  20. Central Nervous System Idiopathic Inflammatory Demyelinating Disorders in South Americans: A Descriptive, Multicenter, Cross-Sectional Study.

    Science.gov (United States)

    Papais-Alvarenga, Regina Maria; Vasconcelos, Claudia Cristina Ferreira; Carra, Adriana; de Castillo, Ibis Soto; Florentin, Sara; Diaz de Bedoya, Fernando Hamuy; Mandler, Raul; de Siervi, Luiza Campanella; Pimentel, Maria Lúcia Vellutini; Alvarenga, Marina Papais; Alvarenga, Marcos Papais; Grzesiuk, Anderson Kuntz; Gama Pereira, Ana Beatriz Calmon; Gomes Neto, Antonio Pereira; Velasquez, Carolina; Soublette, Carlos; Fleitas, Cynthia Veronica; Diniz, Denise Sisteroli; Armas, Elizabeth; Batista, Elizabeth; Hernandez, Freda; Pereira, Fernanda Ferreira Chaves da Costa; Siqueira, Heloise Helena; Cabeça, Hideraldo; Sanchez, Jose; Brooks, Joseph Bruno Bidin; Gonçalves, Marcus Vinicius; Barroso, Maria Cristina Del Negro; Ravelo, Maria Elena; Castillo, Maria Carlota; Ferreira, Maria Lúcia Brito; Rocha, Maria Sheila Guimarães; Parolin, Monica Koncke Fiuza; Molina, Omaira; Marinho, Patricia Beatriz Christino; Christo, Paulo Pereira; Brant de Souza, Renata; Pessanha Neto, Silvio; Camargo, Solange Maria das Graças; Machado, Suzana Costa; Neri, Vanderson Carvalho; Fragoso, Yara Dadalti; Alvarenga, Helcio; Thuler, Luiz Claudio Santos

    2015-01-01

    The idiopathic inflammatory demyelinating disease (IIDD) spectrum has been investigated among different populations, and the results have indicated a low relative frequency of neuromyelitis optica (NMO) among multiple sclerosis (MS) cases in whites (1.2%-1.5%), increasing in Mestizos (8%) and Africans (15.4%-27.5%) living in areas of low MS prevalence. South America (SA) was colonized by Europeans from the Iberian Peninsula, and their miscegenation with natives and Africans slaves resulted in significant racial mixing. The current study analyzed the IIDD spectrum in SA after accounting for the ethnic heterogeneity of its population. A cross-sectional multicenter study was performed. Only individuals followed in 2011 with a confirmed diagnosis of IIDD using new diagnostic criteria were considered eligible. Patients' demographic, clinical and laboratory data were collected. In all, 1,917 individuals from 22 MS centers were included (73.7% female, 63.0% white, 28.0% African, 7.0% Mestizo, and 0.2% Asian). The main disease categories and their associated frequencies were MS (76.9%), NMO (11.8%), other NMO syndromes (6.5%), CIS (3.5%), ADEM (1.0%), and acute encephalopathy (0.4%). Females predominated in all main categories. The white ethnicity also predominated, except in NMO. Except in ADEM, the disease onset occurred between 20 and 39 years old, early onset in 8.2% of all cases, and late onset occurred in 8.9%. The long-term morbidity after a mean disease time of 9.28±7.7 years was characterized by mild disability in all categories except in NMO, which was scored as moderate. Disease time among those with MS was positively correlated with the expanded disability status scale (EDSS) score (r=0.374; p=course, and 16.8% showed a monophasic course. The NMO-IgG antibody tested using indirect immunofluorescence (IIF) with a composite substrate of mouse tissues in 200 NMOSD cases was positive in people with NMO (95/162; 58.6%), longitudinally extensive transverse myelitis

  1. Photodynamic therapy of necrobiosis lipoidica--a multicenter study of 18 patients

    DEFF Research Database (Denmark)

    Berking, C; Hegyi, J; Arenberger, P

    2008-01-01

    BACKGROUND: Necrobiosis lipoidica (NL) is a granulomatous skin disease of unknown origin, and no reliably effective treatment option exists to handle this often disfiguring disease. Recently, a patient with long-lasting NL was reported to be cured by topical photodynamic therapy (PDT). OBJECTIVE......: To evaluate the overall potential of PDT in the treatment of NL on the lower legs. METHODS: Retrospective study of 18 patients (aged 16-62 years) from 3 European university departments of dermatology treated with PDT for NL. Methyl aminolevulinate or 5-aminolevulinic acid were used as topically applied...... photosensitizers. Illumination followed with red light-emitting diode light. RESULTS: Complete response was seen in 1/18 patients after 9 PDT cycles, and partial response in 6/18 patients (2-14 PDT cycles) giving an overall response rate of 39% (7/18). CONCLUSION: Although almost 40% of the cases showed some...

  2. Solid organ transplantation after allogeneic hematopoietic stem cell transplantation: a retrospective, multicenter study of the EBMT

    DEFF Research Database (Denmark)

    Koenecke, C; Hertenstein, B; Schetelig, J

    2010-01-01

    To analyze the outcome of solid organ transplantation (SOT) in patients who had undergone allogeneic hematopoietic stem cell transplantation (HSCT), a questionnaire survey was carried out within 107 European Group of Blood and Marrow Transplantation centers. This study covered HSCT between 1984...... and 2007 in Europe. Forty-five SOT in 40 patients were reported. Fifteen liver, 15 renal, 13 lung, 1 heart and 1 skin transplantations were performed in 28 centers. Overall survival (OS) of patients after SOT was 78% at 5 years (95% confidence interval [CI], 64% to 92%). OS at 5 years was 100% for renal......, 71% (95% CI, 46% to 96%) for liver and 63% (95% CI, 23% to 100%) for lung transplant recipients. The 2-year-incidence of SOT failure was 20% (95% CI, 4% to 36%) in patients with graft-versus-host disease (GvHD) and 7% (95% CI, 0% to 21%) in patients without GvHD before SOT. The relapse incidence...

  3. Effect of prehospital notification on acute stroke care: a multicenter study.

    Science.gov (United States)

    Hsieh, Ming-Ju; Tang, Sung-Chun; Chiang, Wen-Chu; Tsai, Li-Kai; Jeng, Jiann-Shing; Ma, Matthew Huei-Ming

    2016-04-27

    within 3 hours of symptom onset. Such a close collaboration between hospitals and the EMS system gives citizens an in-time emergency care network. Our study revealed that, like in other countries, prehospital notification for stroke patients improved in-hospital stroke care in Taiwan. Our study showed that the sensitivity and PPV of prenotification decisions according to our CPSS-based criteria was comparable with those in other studies. Our study also found that DTN time was shorter in the hospital that treated a greater volume of patients with thrombolytic therapy. A multicenter collaboration program is needed to help those hospitals with relatively lower stroke patient volume to set up interventions that have been proven to improve stroke care. Prehospital notification of stroke can significantly shorten door-to-CT time and improve acute stroke care in Taiwan.

  4. European birth cohort studies on asthma and atopic diseases I

    DEFF Research Database (Denmark)

    Keil, T; Kulig, M; Simpson, A

    2006-01-01

    BACKGROUND: The reasons for the rise in asthma and allergies remain unclear. To identify risk or protective factors, it is essential to carry out longitudinal epidemiological studies, preferably birth cohort studies. In Europe, several birth cohort studies on asthma and atopic diseases have been...... initiated over the last two decades. AIM: One of the work packages within the Global Allergy and Asthma European Network (GA(2)LEN) project was designed to identify and compare European birth cohorts on asthma and atopic diseases. The present review (part I) describes their objectives, study settings......, recruitment process and follow-up rates. A subsequent review (part II) will compare outcome and exposure parameters. METHODS: For each birth cohort, we collected detailed information regarding recruitment process, study setting, baseline data (pregnancy, birth, parents/siblings) as well as follow-up rates...

  5. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    Energy Technology Data Exchange (ETDEWEB)

    Zaknun, John J. [University Hospital of Innsbruck, Department of Nuclear Medicine, Innsbruck (Austria); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria); IAEA, Nuclear Medicine Section, Division of Human Health, Wagramer Strasse 5, P.O. Box 100, Wien (Austria); Bal, Chandrasekhar [All India Institute of Medical Sciences, Department of Nuclear Medicine, New Delhi (India); Maes, Alex [Katholieke Universiteit Leuven, Leuven (Belgium); AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); Tepmongkol, Supatporn [Chulalongkorn University, Nuclear Medicine Division, Department of Radiology, Bangkok (Thailand); Vazquez, Silvia [Instituto de Investigaciones Neurologicas, FLENI, Department of Radiology, Buenos Aires (Argentina); Dupont, Patrick [Katholieke Universiteit Leuven, Leuven (Belgium); Dondi, Maurizio [Ospedale Maggiore, Department of Nuclear Medicine, Bologna (Italy); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria)

    2008-01-15

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  6. Ureteral Involvement Is Associated with Poor Prognosis in Upper Urinary Tract Urothelial Carcinoma Patients Treated by Nephroureterectomy: A Multicenter Database Study.

    Science.gov (United States)

    Waseda, Yuma; Saito, Kazutaka; Ishioka, Junichiro; Matsuoka, Yoh; Numao, Noboru; Fujii, Yasuhisa; Sakai, Yasuyuki; Koga, Fumitaka; Okuno, Tetsuo; Arisawa, Chizuru; Kamata, Shigeyoshi; Nagahama, Katsuji; Masuda, Hitoshi; Yonese, Junji; Kageyama, Yukio; Noro, Akira; Tsujii, Toshihiko; Morimoto, Shinji; Gotoh, Shuichi; Kihara, Kazunori

    2016-08-01

    The prognostic significance of tumor location for patients with upper urinary tract urothelial carcinoma (UUT-UC) has been disputed. Several papers have reported that ureteral cancer is associated with worse prognosis. To investigate the prognostic significance of the presence of ureteral tumors in UUT-UC patients who underwent radical nephroureterectomy (RNU). In this multicenter retrospective study, 1068 eligible patients (median follow-up: 40 mo [interquartile range: 17-77 mo]) were divided into three groups based on tumor location: renal pelvic, ureteral, and both-regional (having both renal pelvic and ureteral tumors). The ureteral and both-regional groups were subsequently integrated into the ureteral involvement group to evaluate its prognostic impact. All patients underwent RNU. The prognostic impact of tumor location on survival was analyzed. The renal pelvic, ureteral, and both-regional groups consisted of 507 (47.5%), 430 (40.3%), and 131 (12.3%) patients, respectively. The ureteral and both-regional groups had a higher rate of lymphovascular invasion and lymph node metastasis compared with the renal pelvic group. The renal pelvic and both-regional tumors presented more frequently with locally advanced stages (pT3/T4) compared with the ureteral tumors. The 5-yr cancer-specific survival (CSS) and progression-free survival (PFS) rates of patients in the ureteral (70.5% and 66.7%, respectively) and both-regional groups (64.8% and 57.8%, respectively) were significantly worse than those in the renal pelvic group (81.9% and 78.1%, respectively). In a multivariate analysis, the presence of ureteral involvement was a significant prognostic factor for CSS (hazard ratio [HR]: 1.50; p=0.006) and PFS (HR: 1.35; p=0.023). This study is inherently limited by the biases associated with its retrospective and multicenter design. The presence of ureteral involvement had a significant impact on the survival of surgically treated UUT-UC patients associated with a poor

  7. A 10-year follow-up of the European multicenter trial of interferon beta-1b in secondary-progressive multiple sclerosis

    NARCIS (Netherlands)

    Kuhle, J.; Hardmeier, M.; Disanto, G.; Gugleta, K.; Ecsedi, M.; Lienert, C.; Amato, M. P.; Baum, K.; Buttmann, M.; Bayas, A.; Brassat, D.; Brochet, B.; Confavreux, C.; Edan, G.; Farkkila, M.; Fredrikson, S.; Frontoni, M.; D'Hooghe, M.; Hutchinson, M.; De Keyser, J.; Kieseier, B. C.; Kuempfel, T.; Rio, J.; Polman, C.; Roullet, E.; Stolz, C.; Vass, K.; Wandinger, K. P.; Kappos, L.

    Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded

  8. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

  9. Use of social media by Western European hospitals: longitudinal study.

    Science.gov (United States)

    Van de Belt, Tom H; Berben, Sivera A A; Samsom, Melvin; Engelen, Lucien J L P G; Schoonhoven, Lisette

    2012-05-01

    Patients increasingly use social media to communicate. Their stories could support quality improvements in participatory health care and could support patient-centered care. Active use of social media by health care institutions could also speed up communication and information provision to patients and their families, thus increasing quality even more. Hospitals seem to be becoming aware of the benefits social media could offer. Data from the United States show that hospitals increasingly use social media, but it is unknown whether and how Western European hospitals use social media. To identify to what extent Western European hospitals use social media. In this longitudinal study, we explored the use of social media by hospitals in 12 Western European countries through an Internet search. We collected data for each country during the following three time periods: April to August 2009, August to December 2010, and April to July 2011. We included 873 hospitals from 12 Western European countries, of which 732 were general hospitals and 141 were university hospitals. The number of included hospitals per country ranged from 6 in Luxembourg to 347 in Germany. We found hospitals using social media in all countries. The use of social media increased significantly over time, especially for YouTube (n = 19, 2% to n = 172, 19.7%), LinkedIn (n =179, 20.5% to n = 278, 31.8%), and Facebook (n = 85, 10% to n = 585, 67.0%). Differences in social media usage between the included countries were significant. Social media awareness in Western European hospitals is growing, as well as its use. Social media usage differs significantly between countries. Except for the Netherlands and the United Kingdom, the group of hospitals that is using social media remains small. Usage of LinkedIn for recruitment shows the awareness of the potential of social media. Future research is needed to investigate how social media lead to improved health care.

  10. Contraceptive Use and the Risk of Ectopic Pregnancy: A Multi-Center Case-Control Study.

    Science.gov (United States)

    Li, Cheng; Zhao, Wei-Hong; Meng, Chun-Xia; Ping, Hua; Qin, Guo-Juan; Cao, Shu-Jun; Xi, Xiaowei; Zhu, Qian; Li, Xiao-Cui; Zhang, Jian

    2014-01-01

    To evaluate the association between the risk of ectopic pregnancy (EP) and the use of common contraceptives during the previous and current conception/menstrual cycle. A multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n = 2,411). Women with intrauterine pregnancy (IUP) (n = 2,416) and non-pregnant women (n = 2,419) were matched as controls at a ratio of 1∶1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs) and the corresponding 95% confidential intervals (CIs). Previous use of intrauterine devices (IUDs) was associated with a slight risk of ectopic pregnancy (AOR1 = 1.87 [95% CI: 1.48-2.37]; AOR2 = 1.84 [1.49-2.27]), and the risk increased with the duration of previous use (P1 for trend contraceptives reduced the risk of both unwanted IUP (condom: AOR = 0.04 [0.03-0.05]; withdrawal method: AOR = 0.10 [0.07-0.13]; calendar rhythm method: AOR = 0.54 [0.40-0.73]; oral contraceptive pills [OCPs]: AOR = 0.03 [0.02-0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR = 0.22 [0.16-0.30]; IUDs: AOR = 0.01 [0.005-0.012]; tubal sterilization: AOR = 0.01 [0.001-0.022]) and unwanted EP (condom: AOR1 = 0.05 [0.04-0.06]; withdrawal method: AOR1 = 0.13 [0.09-0.19]; calendar rhythm method: AOR1 = 0.66 [0.48-0.91]; OCPs: AOR1 = 0.14 [0.07-0.26]; IUDs: AOR1 = 0.17 [0.13-0.22]; tubal sterilization: AOR1 = 0.04 [0.02-0.08]). However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2 = 4.06 [1.64-10.07]), LNG-EC (AOR2 = 4.87 [3.88-6.10]), IUDs (AOR2 = 21.08 [13.44-33.07]), and tubal sterilization (AOR2 = 7.68 [1.69-34.80]) increased the risk of EP compared with the non-use of contraceptives. Current use of most contraceptives reduce the risk of both IUP and EP. However, if the

  11. Contraceptive Use and the Risk of Ectopic Pregnancy: A Multi-Center Case-Control Study.

    Directory of Open Access Journals (Sweden)

    Cheng Li

    Full Text Available To evaluate the association between the risk of ectopic pregnancy (EP and the use of common contraceptives during the previous and current conception/menstrual cycle.A multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n = 2,411. Women with intrauterine pregnancy (IUP (n = 2,416 and non-pregnant women (n = 2,419 were matched as controls at a ratio of 1∶1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs and the corresponding 95% confidential intervals (CIs.Previous use of intrauterine devices (IUDs was associated with a slight risk of ectopic pregnancy (AOR1 = 1.87 [95% CI: 1.48-2.37]; AOR2 = 1.84 [1.49-2.27], and the risk increased with the duration of previous use (P1 for trend <10-4, P2 for trend <10-4. The current use of most contraceptives reduced the risk of both unwanted IUP (condom: AOR = 0.04 [0.03-0.05]; withdrawal method: AOR = 0.10 [0.07-0.13]; calendar rhythm method: AOR = 0.54 [0.40-0.73]; oral contraceptive pills [OCPs]: AOR = 0.03 [0.02-0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR = 0.22 [0.16-0.30]; IUDs: AOR = 0.01 [0.005-0.012]; tubal sterilization: AOR = 0.01 [0.001-0.022] and unwanted EP (condom: AOR1 = 0.05 [0.04-0.06]; withdrawal method: AOR1 = 0.13 [0.09-0.19]; calendar rhythm method: AOR1 = 0.66 [0.48-0.91]; OCPs: AOR1 = 0.14 [0.07-0.26]; IUDs: AOR1 = 0.17 [0.13-0.22]; tubal sterilization: AOR1 = 0.04 [0.02-0.08]. However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2 = 4.06 [1.64-10.07], LNG-EC (AOR2 = 4.87 [3.88-6.10], IUDs (AOR2 = 21.08 [13.44-33.07], and tubal sterilization (AOR2 = 7.68 [1.69-34.80] increased the risk of EP compared with the non-use of contraceptives.Current use of most

  12. Lung cancer and occupation in nonsmokers: a multicenter case-control study in Europe.

    Science.gov (United States)

    Zeka, Ariana; Mannetje, Andrea't; Zaridze, David; Szeszenia-Dabrowska, Neonila; Rudnai, Peter; Lissowska, Jolanta; Fabiánová, Eleonóra; Mates, Dana; Bencko, Vladimir; Navratilova, Marie; Cassidy, Adrian; Janout, Vladimir; Travier, Noemie; Fevotte, Joelle; Fletcher, Tony; Brennan, Paul; Boffetta, Paolo

    2006-11-01

    Tobacco smoking is the main cause for lung cancer worldwide, making it difficult to examine the carcinogenic role of other risk factors because of possible confounding by smoking. Therefore, the present study aimed to investigate the association between lung cancer and occupation independent of smoking. A case-control study of lung cancer was carried out between March 1998 and January 2002 in 16 centers from 7 European countries, including 223 never-smoking cases and 1039 controls. Information on lifestyle and occupation was obtained through detailed questionnaires. Job and industries were classified as entailing exposure to known or suspected carcinogens; in addition, expert assessment provided exposure estimates to specific agents. The odds ratio of lung cancer among women employed for more than 12 years in suspected high-risk occupations was 1.75 (95% confidence interval = 0.63-4.85). A comparable increase in risk was not detected for employment in established high-risk occupations or among men. Increased risk of lung cancer was suggested among individuals exposed to nonferrous metal dust and fumes, crystalline silica, and organic solvents. Occupations were found to play a limited role in lung cancer risk among never-smokers. Jobs entailing exposure to suspected lung carcinogens should receive priority in future studies among women. Nonferrous metal dust and fumes and silica may exert a carcinogenic effect independently from smoking.

  13. OPTIMIZATION OF SKIN TESTING .2. EVALUATION OF CONCENTRATION AND CUTOFF VALUES, AS COMPARED WITH RAST AND CLINICAL HISTORY, IN A MULTICENTER STUDY

    NARCIS (Netherlands)

    NIEMEIJER, NR; FLUKS, AF; DEMONCHY, JGR

    1993-01-01

    In this multicenter study we evaluated the results of a previous study (part I) in a relatively large Dutch patient population, using the two previously tested allergens (house-dust mite and grass pollen) and two other standardized allergens (tree pollen and cat dander). The obtained skin test

  14. A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group

    NARCIS (Netherlands)

    Wolffenbuttel, B H; Landgraf, R

    OBJECTIVE: Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type

  15. HIV-1 variation before seroconversion in men who have sex with men: analysis of acute/early HIV infection in the multicenter AIDS cohort study

    NARCIS (Netherlands)

    Gottlieb, Geoffrey S.; Heath, Laura; Nickle, David C.; Wong, Kim G.; Leach, Stephanie E.; Jacobs, Benjamin; Gezahegne, Surafel; van 't Wout, Angélique B.; Jacobson, Lisa P.; Margolick, Joseph B.; Mullins, James I.

    2008-01-01

    Understanding the characteristics of human immunodeficiency virus (HIV) necessary for infection in a new host is a critical goal for acquired immunodeficiency syndrome (AIDS) research. We studied the characteristics of HIV-1 envelope genes in 38 men in the Multicenter AIDS Cohort Study cohort before

  16. A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch

    DEFF Research Database (Denmark)

    Berrevoet, Frederik; Doerhoff, Carl; Muysoms, Filip

    2017-01-01

    PURPOSE: This study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]). PATIENTS AND METHODS: A single-arm, multicenter prospective study of 126 patients undergoing...

  17. A multicenter study on the audiometric findings of styrene-exposed workers.

    Science.gov (United States)

    Morata, Thais C; Sliwinska-Kowalska, Mariola; Johnson, Ann-Christin; Starck, Jukka; Pawlas, Krystyna; Zamyslowska-Szmytke, Ewa; Nylen, Per; Toppila, Esko; Krieg, Edward; Pawlas, Natalia; Prasher, Deepak

    2011-10-01

    The objective of this study was to evaluate hearing loss among workers exposed to styrene, alone or with noise. This cross-sectional study was conducted as part of NoiseChem, a European Commission 5th Framework Programme research project, by occupational health institutes in Finland, Sweden, and Poland. Participants' ages ranged from 18-72 years (n = 1620 workers). Participants exposed to styrene, alone or with noise, were from reinforced fiberglass products manufacturing plants (n = 862). Comparison groups were comprised of workers noise-exposed (n = 400) or controls (n = 358). Current styrene exposures ranged from 0 to 309 mg/m(3), while mean current noise levels ranged from 70-84 dB(A). Hearing thresholds of styrene-exposed participants were compared with Annexes A and B from ANSI S3.44, 1996. The audiometric thresholds of styrene exposed workers were significantly poorer than those in published standards. Age, gender, and styrene exposure met the significance level criterion in the multiple logistic regression for the binary outcome 'hearing loss' (P = 0.0000). Exposure to noise (risk factor for hearing loss, and styrene-exposed workers should be included in hearing loss prevention programs.

  18. In vivo field dependence of proton relaxation times in human brain, liver and skeletal muscle: a multicenter study

    DEFF Research Database (Denmark)

    Henriksen, O; de Certaines, J D; Spisni, A

    1993-01-01

    and MRS, the in vivo field dispersion of T1 and T2 has been measured in order to evaluate whether ex vivo data are representative for the in vivo situation. Brain, skeletal muscle, and liver of healthy human volunteers were studied. Fifteen MR units with a field strength ranging from 0.08 T to 1.5 T took......T1 and T2 relaxation times are fundamental parameters for signal contrast behaviour in MRI. A number of ex vivo relaxometry studies have dealt with the magnetic field dispersion of T1. By means of multicenter study within the frame of the COMAC BME Concerted Action on Tissue Characterization by MRI...... part in the trial, which comprised 218 volunteers. All the MR systems were tested for measurement accuracy using the Eurospin TO5 test object. The measured relaxation data were subsequently corrected according to the obtained calibration curves. The results showed a clear field dispersion of T1...

  19. Prevalence of age-related maculopathy in older Europeans: The European Eye Study (EUREYE)

    NARCIS (Netherlands)

    C. Augood (Cristina); J.R. Vingerling (Hans); P.T.V.M. de Jong (Paulus); U. Chakravarthy (Usha); J.H. Seland (Johan ); G. Soubrane; L. Tomazzoli (Laura); F. Topouzis (Fotis); G.C. Bentham (Graham ); M. Rahu; J. Vioque (Jesus); I.S. Young (Ian ); A.E. Fletcher (Astrid E.)

    2006-01-01

    textabstractObjective: To estimate the prevalence of age-related maculopathy in an older population from 7 European countries. Methods: Randomly sampled people 65 years and older were invited to an eye examination in centers across 7 European countries (Norway, Estonia, United Kingdom, France,

  20. Consulting Communities When Patients Cannot Consent: A Multi-Center Study of Community Consultation for Research in Emergency Settings

    Science.gov (United States)

    Dickert, Neal W; Mah, Victoria A; Biros, Michelle H; Harney, Deneil M; Silbergleit, Robert; Sugarman, Jeremy; Veledar, Emir; Weinfurt, Kevin P; Wright, David W; Pentz, Rebecca D

    2013-01-01

    Objective To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent (EFIC) research and understanding of the proposed study. Design A cognitively pre-tested survey instrument was administered to 2,612 community consultation participants at 12 US centers participating in a multi-center trial of treatment for acute traumatic brain injury (TBI). Setting Survey nested within community consultation for a Phase III, randomized controlled trial of treatment for acute TBI conducted within a multi-center trial network and using EFIC. Subjects Adult participants in community consultation events. Interventions Community consultation efforts at participating sites. Measurements and Main Results Acceptance of EFIC in general, attitude toward personal EFIC enrollment, and understanding of the study content were assessed. 54% of participants agreed EFIC was acceptable in the proposed study; 71% were accepting of personal EFIC enrollment. Participants in interactive versus non-interactive community consultation events were more accepting of EFIC in general (63% vs. 49%) and personal EFIC inclusion (77% vs. 67%). Interactive community consultation participants had high-level recall of study content significantly more often than non-interactive consultation participants (77% vs. 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs. 45%) but less likely to recall potential risks (56% vs. 69%). Conclusions Interactive community consultation methods were associated with increased acceptance of EFIC and greater overall recall of study information but lower recall of risks. There was also significant variability in EFIC acceptance among different interactive consultation events. These findings have important implications for IRBs and investigators conducting EFIC research and for community

  1. [Multicenter study on incidence of total parenteral nutrition complications in the critically-ill patient. ICOMEP study. Part I].

    Science.gov (United States)

    Bonet, A; Grau, T

    2005-01-01

    To assess parenteral nutrition complications in a prospective cohort of patients admitted to the ICU. Prospective, multicenter study of patients admitted to the ICU and that received total parenteral nutrition (TPN). A 14-item questionnaire was done. Total number of admissions and TPN-treated patients were recorded. Demographical data, diagnosis, APACHE II, multiorgan dysfunction index and TPN indications were included. Each complication was previously defined and was related to the route, administration, serum electrolytes unbalances, active ingredients, liver dysfunction, and nosocomial infections. An independent group managed the databases. Data were expressed in absolute values or by their median and percentile (25-75). The rate and incidence density of complications are determined. The number of admissions during the study period was 3409. Three hundred and seventy (11%) were valid cases that were treated with PN. Two hundred and thirty seven were men, 142 patients were admitted for medical causes, 195 for surgical causes and 33 for trauma. One hundred and twenty patients were moderately or severely underfed, 181 received PN for 7 days (3-11), and 189 received PN and EN. The main indication for PN was paralytic ileus, in 145 patients. TPN was withdrawn for switching to EN in 121 cases and for complications in 5 cases. PN summed up 3220 days. The incidence of complications was: access route 9.32%, maintenance 19.7% and 0.8 per 100 days. Administration, 5.6% and 6.4 per 100 days. Nutrients, 94.3% and 10.8 per 100 days. Catheter-induced sepsis, 54.6% and 0.44 bacteriemias per 100 days with catheter. Nosocomial infection, 54.6% and 6.27 per 100 days on TPN. hyperglycemia and liver dysfunction have a greater incidence. Hyperglycemia, electrolyte unbalances and catheter complications have a greater number of therapeutic interventions, but does not mean that TPN should be withdrawn.

  2. A multicenter prospective study to assess the effect of early cleavage on embryo quality, implantation, and live-birth rate.

    Science.gov (United States)

    de los Santos, Maria José; Arroyo, Gemma; Busquet, Ana; Calderón, Gloria; Cuadros, Jorge; Hurtado de Mendoza, Maria Victoria; Moragas, Marta; Herrer, Raquel; Ortiz, Agueda; Pons, Carme; Ten, Jorge; Vilches, Miguel Angel; Figueroa, Maria José

    2014-04-01

    To investigate the impact of early cleavage (EC) on embryo quality, implantation, and live-birth rates. Prospective cross-sectional study. Multicenter study. Seven hundred embryo transfers and 1,028 early-stage human embryos. None. Implantation according to the presence of EC and embryo quality. The presence of EC is associated with embryo quality, especially in cycles with autologous oocytes. However, the use of EC as an additional criterion for selecting an embryo for transfer does not appear to significantly improve likelihood of implantation. Furthermore, embryos that presented EC had live-birth rates per implanted embryo similar to those that did not show any sign of cleavage. At least for conventional embryo culture and morphologic evaluations, the additional evaluation of EC in embryos may not be valuable to improve embryo implantation. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  3. “Remotion” Total Wrist Arthroplasty: Preliminary Results of a Prospective International Multicenter Study of 215 Cases

    DEFF Research Database (Denmark)

    Herzberg, Guillaume; Boeckstyns, Michel Ernest Henri; Sorensen, Allan Ibsen

    2012-01-01

    This study reports the current results of an international multicenter study of one last generation total wrist arthroplasty (TWA) ("ReMotion," Small Bone Innovation, Morristown, PA). The two first authors (G.H. and M.B.) built a Web-based prospective database including clinical and radiological...... preoperative and postoperative reports of "ReMotion" TWA at regular intervals. The cases of 7 centers with more than 15 inclusions were considered for this article. A total of 215 wrists were included. In the rheumatoid arthritis (RA; 129 wrists) and nonrheumatoid arthritis (non-RA; 86 wrists) groups......, there were respectively 5 and 6% complications requiring implant revision with a survival rate of 96 and 92%, respectively, at an average follow-up of 4 years. Within the whole series, only one dislocation was observed in one non-RA wrist. A total of 112 wrists (75 rheumatoid and 37 nonrheumatoid) had more...

  4. A multicenter study on objective and subjective benefits with a transcutaneous bone-anchored hearing aid device

    DEFF Research Database (Denmark)

    Hougaard, Dan Dupont; Boldsen, Soren Kjaergaard; Jensen, Anne Marie

    2017-01-01

    Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive