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Sample records for multicenter association studies

  1. 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

  2. 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

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

    OpenAIRE

    White, Daniel K.; Tuhina Neogi; Yuqing Zhang; David Felson; Michael LaValley; Jingbo Niu; Michael Nevitt; Cora E Lewis; James Torner; K. Douglas Gross

    2012-01-01

    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 lin...

  4. Multicenter study of Blount disease in Japan by the Japanese Pediatric Orthopaedic Association.

    Science.gov (United States)

    Inaba, Yutaka; Saito, Tomoyuki; Takamura, Kazuyuki

    2014-01-01

    In order to investigate the epidemiology and features of Blount disease in Japan, the Japanese Pediatric Orthopaedic Association conducted a multicenter study on Blount disease in 2003. Questionnaires were sent to 1,350 training hospitals of the Japanese Orthopaedic Association. This study included those with stage I or II diagnosed between 1990 and 2002 and those with stage III or higher diagnosed between 1980 and 2002 based on the Langenskiöld classification. The questionnaire items included age at diagnosis, sex, presence or absence of a family history of bowlegs, past history of trauma, birthplace, age when starting to walk, height and weight at the initial presentation, laterality of the affected knee, disease types (infantile or adolescent), treatments, and plain radiographic findings. The results for 212 patients with 296 affected knees were obtained. The disease types were infantile in 190 patients with 270 affected knees and adolescent in 22 patients with 26 affected knees. There were more girls among cases with both types. Among the infantile-type cases, there were more patients with bilaterally affected knees; however, in the adolescent-type cases, there were more patients with unilaterally affected knees. Patients with either type tended to be obese at diagnosis. There was little difference in age at which patients with either type started to walk, compared with the mean age for the general population. Conservative treatment was applied to most infantile-type cases in stage I or II, whereas surgery was performed in all but one of those with stage III or IV of the disease. Most adolescent-type cases underwent surgery. This was the first multicenter study on Blount disease in Japan. Among 296 knees, the majority of these knees had stage I or II Blount disease. Very few cases had stage III or higher disease, and there were 35 knees with the infantile type and 19 with the adolescent type in the 23 years from 1980 through 2002.

  5. 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.

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

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    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. Association between 24-h urinary sodium excretion and obesity in Korean adults: A multicenter study.

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    Nam, Ga Eun; Kim, Seon Mee; Choi, Mi-Kyeong; Heo, Young-Ran; Hyun, Tai-Sun; Lyu, Eun-Soon; Oh, Se-Young; Park, Hae-Ryun; Ro, Hee-Kyong; Han, Kyungdo; Lee, Yeon Kyung

    2017-09-01

    The aim of this study was to explore the association between sodium intake, as assessed by 24-h urinary sodium excretion, and various obesity parameters among South Korean adults. The associations of 24-h urinary sodium excretion and sodium intake calculated from the dietary questionnaire with obesity parameters also were compared. This multicenter, cross-sectional study analyzed data of 640 healthy adults from eight provinces in South Korea. Obesity was assessed by body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR). Mean 24-h urinary sodium excretion was calculated from repeatedly collected 24-h urine samples. Participants' dietary intake was assessed by 24-h dietary recall interview on the days before 24-h urine collection. In both sexes, the means of all anthropometric measurements tended to increase proportionally with 24-h urinary sodium excretion quartiles, regardless of adjustment. Men in the highest quartile (Q4) of 24-h urinary sodium excretion had increased odds of obesity (as assessed by BMI, WC, WHR, and WHtR) compared with men in the three lower quartiles (Q1-Q3) of 24-h urinary sodium excretion. Women in Q4 of 24-h urinary sodium excretion exhibited a higher chance of general obesity and abdominal obesity. Sodium intake calculated from the dietary questionnaire was not significantly associated with obesity in either sex. In Korean adults, there was a positive association between higher sodium intake as assessed by 24-h urinary sodium excretion and obesity independent of energy intake. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Lumbar spinal stenosis associated with peripheral arterial disease: a prospective multicenter observational study.

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    Uesugi, Kazuhide; Sekiguchi, Miho; Kikuchi, Shin-ichi; Kanayama, Masahiro; Takahashi, Kazuhisa; Chiba, Kazuhiro; Doita, Minoru; Toribatake, Yasumitsu; Matsuo, Hiroshi; Yonenobu, Kazuo; Matsuyama, Yukihiro; Konno, Shin-Ichi

    2012-11-01

    Intermittent claudication is a common symptom of both lumbar spinal stenosis (LSS) and peripheral arterial disease (PAD) in middle-aged and elderly people. However, the prevalence and clinical characteristics of LSS with PAD (LSSPAD) have not been investigated in a multicenter study. The aim of this study was to investigate the prevalence and clinical characteristics of LSS associated with PAD. 570 patients diagnosed with LSS using a clinical diagnostic support tool and MRI at 64 facilities were enrolled. We evaluated each patient's medical history, physical findings, ankle brachial index, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) score, and the Short Form 36 (SF-36) score. Statistical analyses were performed to compare LSSPAD patients and LSS patients without PAD using the t test, Mann-Whitney's U test, and multivariate recurrence analysis. p values of <0.05 were considered statistically significant. The LSSPAD group comprised 38 patients (6.7 %); 20 (3.5 %) had pre-diagnosised PAD while 18 (3.2 %) had undetected PAD. The clinical characteristics of these patients were advanced age, diabetes, and a history of ischemic heart disease and cerebrovascular disorder. 570 patients enrolled, and 448 (78.6 %) of those patients were followed up at three months after enrollment. Pain in buttocks and legs improved less in the LSSPAD group than in the LSS group (p < 0.05). Improvements in the "general health" score in SF-36 were lower in the LSSPAD group than in the LSS group (p < 0.05). Advanced age, diabetes, and a history of cerebrovascular disorder and ischemic heart disease were associated with LSSPAD. Because LSSPAD patients show less improvement in QOL than patients with LSS but without PAD do, clinicians should consider the coexistence of PAD in LSS patients.

  9. [French multicenter prospective epidemiologic study (ORLI Group) of allergic and lung diseases associated with nasal polyposis].

    Science.gov (United States)

    Crampette, L; Serrano, E; Klossek, J M; Rugina, M; Rouvier, P; Peynègre, R; Bébéar, J P; Stoll, D

    2001-01-01

    224 patients presenting with nasal polyposis (NP) were included in a french prospective multicenter study. NP was evaluated by nasal endoscopy and computed tomography. Allergic status was documented using skin prick-tests and/or specific IgE. Pneumologic assessment included spirometry with carbamyl-choline hyper-reactivity test or beta 2 mimetic broncho-dilation test. Minimal follow up period was 1 year. 45% of the whole population were considered as asthmatic. Asthma onset occurred before and after the NP onset in respectively 45.7%, 22.3% and 32% of cases; these two conditions started simultaneously in 32% of patients. Skin prick-tests and/or specific IgE were positive in 32.5% of cases. In most of the cases (80%), patients were polysensitized to house dust mite and/or pollens and/or animal danders and/or fungi. 31% of the population had idiosyncrasy, caused by drugs in general and especially aspirin in 44% of cases. The global population could be divided in two groups according to the occurrence of previous polypectomy or not. The group "polypectomy" and the group "no polypectomy" were similar regarding the frequency, the age of onset, the course and the severity of associated asthma. Familial history (parents, children, brothers and sisters) was of great interest: 58.7% of the patients had one (or more) relative suffering from NP, 43.6% of the patients had one (or more) relative suffering from asthma and 12.2% of the patients had one (or more) relative suffering from idiosyncrasy. These results support a genetic etiology for NP.

  10. Brazilian multicenter study on prevalence of preterm birth and associated factors

    Directory of Open Access Journals (Sweden)

    Guinsburg Ruth

    2010-05-01

    Full Text Available Abstract Background The occurrence of preterm birth remains a complex public health condition. It is considered the main cause of neonatal morbidity and mortality, resulting in a high likelihood of sequelae in surviving children. With variable incidence in several countries, it has grown markedly in the last decades. In Brazil, however, there are still difficulties to estimate its real occurrence. Therefore, it is essential to establish the prevalence and causes of this condition in order to propose prevention actions. This study intend to collect information from hospitals nationwide on the prevalence of preterm births, their associated socioeconomic and environmental factors, diagnostic and treatment methods resulting from causes such as spontaneous preterm labor, prelabor rupture of membranes, and therapeutic preterm birth, as well as neonatal results. Methods/Design This proposal is a multicenter cross-sectional study plus a nested case-control study, to be implemented in 27 reference obstetric centers in several regions of Brazil (North: 1; Northeast: 10; Central-west: 1; Southeast: 13; South: 2. For the cross sectional component, the participating centers should perform, during a period of six months, a prospective surveillance of all patients hospitalized to give birth, in order to identify preterm birth cases and their main causes. In the first three months of the study, an analysis of the factors associated with preterm birth will also be carried out, comparing women who have preterm birth with those who deliver at term. For the prevalence study, 37,000 births will be evaluated (at term and preterm, corresponding to approximately half the deliveries of all participating centers in 12 months. For the case-control study component, the estimated sample size is 1,055 women in each group (cases and controls. The total number of preterm births estimated to be followed in both components of the study is around 3,600. Data will be collected

  11. Association of ADH4 genetic variants with alcohol dependence risk and related phenotypes: results from a larger multicenter association study.

    Science.gov (United States)

    Preuss, Ulrich W; Ridinger, Monika; Rujescu, Dan; Samochowiec, Jerzy; Fehr, Christoph; Wurst, Friedrich M; Koller, Gabriele; Bondy, Brigitta; Wodarz, Norbert; Debniak, Tadeusz; Grzywacz, Anna; Soyka, Michael; Zill, Peter

    2011-04-01

    Genetic variants of the alcohol-metabolizing enzyme ADH4, located on chromosome 4q22-4q23, have been related to alcohol dependence (AD) risk in previous research. The aim of this association study in a large multicenter sample of alcohol-dependent individuals and controls is to confirm ADH4 single nucleotide polymorphism (SNP) and haplotype association with AD and relevant related phenotypes. One thousand, six hundred and twenty-two (1622) inpatient subjects and 1469 control subjects with DSM-IV. AD from four addiction treatment centres were included. Characteristics of AD and related phenotypes including alcohol withdrawal, Cloninger's type I and II and first ages of drinking, regular drinking and AD onset were obtained using standardized structured interviews. After subjects were genotyped for 2 ADH4 polymorphisms, single SNP case-control and haplotype analyses were conducted. Both variants--rs1800759 and rs1042364--and the A-A and C-G haplotypes were significantly related to AD across samples. Furthermore, associations with AD-related phenotypes and subtypes revealed a potential protective influence of this haplotype. This study confirms the significant relationship of ADH4 variants with AD and related phenotypes. While the rs1800759 and rs1042364 A-A haplotype had a potential protective influence on the risk for several AD-related phenotypes, this effect is rather small compared to functional variants of other alcohol or acetaldehyde-metabolizing enzymes like ALDH2*2 or ADH1B*2.

  12. Clinicopathological study of glomerular diseases associated with sarcoidosis: a multicenter study

    Science.gov (United States)

    2013-01-01

    Background The association between sarcoidosis and glomerular diseases has not been extensively investigated in a large series and the potential features of this uncommon association remain to be determined. Methods We retrospectively identified 26 patients with biopsy-proven glomerular lesions that occurred in a sarcoidosis context. Potential remission of glomerular disease and sarcoidosis under specific treatment (steroid and/or immunosuppressive agents) was recorded for all patients. Demographic, clinical and biological characteristics were assessed at the time of kidney biopsy for each patient. Therapeutic data were analyzed for all patients. Results Glomerular disease occurred after the diagnosis of sarcoidosis in 11 of 26 cases (42%) (mean delay of 9.7 years). In six patients (23%), the glomerulopathy preceded the sarcoidosis diagnosis (mean delay 8 years). In the last nine patients (35%), both conditions occurred simultaneously. The most frequent glomerular disease occurring in sarcoidosis patients was membranous nephropathy in eleven cases. Other glomerular lesions included IgA nephropathy in six cases, focal segmental glomerulosclerosis in four patients, minimal change nephrotic syndrome for three patients and proliferative lupus nephritis in two patients. Granulomatous interstitial nephritis was associated with glomerular disease in six patients and was exclusively found in patients in whom the both disease occurred simultaneously. In nine patients with simultaneous glomerular and sarcoidosis diseases, we observed a strong dissociation between glomerular disease and sarcoidosis in terms of steroid responsiveness. At the end of the follow-up (mean of 8.4 years), six patients had reached end-stage renal disease and three patients had died. Conclusions A wide spectrum of glomerular lesions is associated with sarcoidosis. The close temporal relationship observed in some patients suggests common causative molecular mechanisms of glomerular injury but

  13. Factors associated to temporal artery biopsy result in suspects of giant cell arteritis: a retrospective, multicenter, case-control study.

    Science.gov (United States)

    González-López, Julio J; González-Moraleja, Julio; Burdaspal-Moratilla, Ana; Rebolleda, Gema; Núñez-Gómez-Álvarez, María T; Muñoz-Negrete, Francisco J

    2013-12-01

    To evaluate the positivity rate of temporal artery biopsies (TAB) performed in suspects of giant cell arteritis (GCA) and to study the epidemiological and clinical factors associated to the biopsy result. A retrospective, multicenter, case-control study was performed, including three hundred and thirty-five patients who underwent TAB for a suspicion of GCA from 2001 to 2010. Clinical, epidemiological and pathology data were recovered from the patients' clinical records. Histologic diagnosis of GCA was made when active inflammation or giant cells were found in the arterial wall. Eighty-one biopsies (24.2%) were considered positive for GCA. Clinical factors independently associated to TAB result in a logistic regression analysis were temporal cutaneous hyperalgesia (OR = 10.8; p result and number of days of previous systemic corticosteroid treatment (p = 0.146). However, an association was observed between TAB result and the total accumulated dose of previous systemic corticotherapy (p = 0.043). Exhaustive anamnesis and clinical examination remain of paramount importance in the diagnosis of GCA. To improve the yield of TAB, it should be performed specially in older patients with GCA-compatible clinic. TAB could be avoided in patients with an isolated elevation of acute phase reactants, without GCA-compatible clinic. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  14. Serotonin transporter 5HTTLPR polymorphism and affective disorders: no evidence of association in a large European multicenter study.

    Science.gov (United States)

    Mendlewicz, Julien; Massat, Isabelle; Souery, Daniel; Del-Favero, Jurgen; Oruc, Lilijana; Nöthen, Markus M; Blackwood, Douglas; Muir, Walter; Battersby, Sharon; Lerer, Beny; Segman, Ronen H; Kaneva, Radka; Serretti, Alessandro; Lilli, Roberta; Lorenzi, Christian; Jakovljevic, Miro; Ivezic, Sladana; Rietschel, Marcella; Milanova, Vihra; Van Broeckhoven, Christine

    2004-05-01

    The available data from preclinical and pharmacological studies on the role of the serotonin transporter (5-HTT) support the hypothesis that a dysfunction in brain serotonergic system activity contributes to the vulnerability to affective disorders (AD). 5-HTT is the major site of serotonin reuptake into the presynaptic neuron, and it has been shown that the polymorphic repeat polymorphism in the 5-HTT promotor region (5-HTTLPR) may affect gene-transcription activity. 5-HTT maps to chromosome 17 at position 17q11.17-q12, and the 5-HTTLPR polymorphisms have been extensively investigated in AD with conflicting results. The present study tested the genetic contribution of the 5-HTTLPR polymorphism in a large European multicenter case-control sample, including 539 unipolar (UPAD), 572 bipolar patients (BPAD), and 821 controls (C). Our European collaboration has led to efforts to optimize a methodology that attenuates some of the major limitations of the case-control association approach. No association was found with primary psychiatric diagnosis (UPAD and BPAD) and with phenotypic traits (family history of AD, suicidal attempt, and presence of psychotic features). Our negative findings are not attributable to the lack of statistical power, and may contribute to clarify the role of 5-HTTLPR polymorphism in AD.

  15. Microorganisms Associated With Pneumonia in Children Emerging Countries: The GABRIEL Pneumonia Multicenter, Prospective, Case-Control Study.

    Science.gov (United States)

    Bénet, Thomas; Sánchez Picot, Valentina; Messaoudi, Mélina; Chou, Monidarin; Eap, Tekchheng; Wang, Jianwei; Shen, Kunling; Pape, Jean-William; Rouzier, Vanessa; Awasthi, Shally; Pandey, Nitin; Bavdekar, Ashish; Sanghavi, Sonali; Robinson, Annick; Rakoto-Andrianarivelo, Mala; Sylla, Maryam; Diallo, Souleymane; Nymadawa, Pagbajabyn; Naranbat, Nymadawaagiin; Russomando, Graciela; Basualdo, Wilma; Komurian-Pradel, Florence; Endtz, Hubert; Vanhems, Philippe; Paranhos-Baccalà, Gláucia

    2017-06-12

    Pneumonia, the leading infectious cause of child mortality globally, mainly afflicts developing countries. This prospective observational study aimed to assess the microorganisms associated with pneumonia in children aged emerging countries. A multicenter, case-control study by the GABRIEL (Global Approach to Biological Research, Infectious diseases and Epidemics in Low-income countries) network was conducted between 2010 and 2014 in Cambodia, China, Haiti, India (2 sites), Madagascar, Mali, Mongolia, and Paraguay. Cases were hospitalized children with radiologically confirmed pneumonia; controls were children from the same setting without any features suggestive of pneumonia. Nasopharyngeal swabs were collected from all subjects; 19 viruses and 5 bacteria were identified by reverse-transcription polymerase chain reaction. Associations between microorganisms and pneumonia were quantified by calculating the adjusted population attributable fraction (aPAF) after multivariate logistic regression analysis adjusted for sex, age, time period, other pathogens, and site. Overall, 888 cases and 870 controls were analyzed; ≥1 microorganism was detected in respiratory samples in 93.0% of cases and 74.4% of controls (P emerging countries. Increasing S. pneumoniae vaccination coverage may substantially reduce the burden of pneumonia among children in developing countries.

  16. 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

    We conducted a cross-sectional study in 448 HIV positive patients attending five European outpatient clinics to determine prevalence of and factors associated with neurocognitive impairment (NCI) using computerized and pen-and-paper neuropsychological tests. NCI was defined as a normalized Z score...

  17. Factors associated with hospitalization after suicide spectrum behaviors: results from a multicenter study in Spain.

    Science.gov (United States)

    Jiménez-Treviño, Luis; Saiz, Pilar Alejandra; Corcoran, Paul; Burón, Patricia; García-Portilla, Ma Paz; Chinea, Eugenio Ramón; Navio, Mercedes; Fernández, Vanessa; Jimenez-Arriero, Miguel Angel; Gracia, Ramón; Bobes, Julio

    2015-01-01

    The objective of this study was to identify factors associated with hospital admission after suicide spectrum behaviors. Patients' characteristics, the nature of the suicidal behavior, admission rates between centers, and factors associated with admission have been examined in suicide spectrum presentations to emergency departments in 3 Spanish cities. The intent of the suicidal behavior had the greatest impact on hospitalization. Older age, living alone, self-harm method not involving drug overdose, previous history of suicide spectrum behaviors, and psychiatric diagnosis of schizophrenia, mood, or personality disorder were independently associated with being admitted. There was a 3-fold between-center difference in the rate of hospitalization. Widespread differences in the rate of hospitalization were primarily accounted for by characteristics of the individual patients and their suicidal behavior.

  18. Assessment of the Asian Neurogastroenterology and Motility Association Chronic Constipation Criteria: An Asian Multicenter Cross-sectional Study.

    Science.gov (United States)

    Gwee, Kok-Ann; Bergmans, Paul; Kim, JinYong; Coudsy, Bogdana; Sim, Angelia; Chen, Minhu; Lin, Lin; Hou, Xiaohua; Wang, Huahong; Goh, Khean-Lee; Pangilinan, John A; Kim, Nayoung; Varannes, Stanislas Bruley des

    2017-04-30

    There is a need for a simple and practical tool adapted for the diagnosis of chronic constipation (CC) in the Asian population. This study compared the Asian Neurogastroenterology and Motility Association (ANMA) CC tool and Rome III criteria for the diagnosis of CC in Asian subjects. This multicenter, cross-sectional study included subjects presenting at outpatient gastrointestinal clinics across Asia. Subjects with CC alert symptoms completed a combination Diagnosis Questionnaire to obtain a diagnosis based on 4 different diagnostic methods: self-defined, investigator's judgment, ANMA CC tool, and Rome III criteria. The primary endpoint was the level of agreement/disagreement between the ANMA CC diagnostic tool and Rome III criteria for the diagnosis of CC. The primary analysis comprised of 449 subjects, 414 of whom had a positive diagnosis according to the ANMA CC tool. Rome III positive/ANMA positive and Rome III negative/ANMA negative diagnoses were reported in 76.8% and 7.8% of subjects, respectively, resulting in an overall percentage agreement of 84.6% between the 2 diagnostic methods. The overall percentage disagreement between these 2 diagnostic methods was 15.4%. A higher level of agreement was seen between the ANMA CC tool and self-defined (374 subjects [90.3%]) or investigator's judgment criteria (388 subjects [93.7%]) compared with the Rome III criteria. This study demonstrates that the ANMA CC tool can be a useful for Asian patients with CC.

  19. Geriatrics education is associated with positive attitudes toward older people in internal medicine residents: a multicenter study.

    Science.gov (United States)

    Tufan, Fatih; Yuruyen, Mehmet; Kizilarslanoglu, Muhammet Cemal; Akpinar, Timur; Emiksiye, Sirhan; Yesil, Yusuf; Ozturk, Zeynel Abidin; Bozbulut, Utku Burak; Bolayir, Basak; Tasar, Pinar Tosun; Yavuzer, Hakan; Sahin, Sevnaz; Ulger, Zekeriya; Ozturk, Gulistan Bahat; Halil, Meltem; Akcicek, Fehmi; Doventas, Alper; Kepekci, Yalcin; Ince, Nurhan; Karan, Mehmet Akif

    2015-01-01

    The number of older people is growing fast in Turkey. In this context, internal medicine residents and specialists contact older people more frequently. Thus, healthcare providers' knowledge and attitudes toward older people is becoming more important. Studies that specifically investigate internal medicine residents' attitudes toward the elderly are scarce. We aimed to investigate the attitudes of internal medicine residents toward older people. This cross-sectional multicenter study was undertaken in the internal medicine clinics of six university state hospitals that provide education in geriatric care. All internal medicine residents working in these hospitals were invited to participate in this questionnaire study between March 2013 and December 2013. We recorded the participants' age, sex, duration of internal medicine residency, existence of relatives older than 65 years, history of geriatrics course in medical school, geriatrics rotation in internal medicine residency, and nursing home visits. A total of 274 (82.3%) of the residents participated in this study, and 83.6% of them had positive attitudes toward older people. A geriatrics rotation during internal medicine residency was the only independent factor associated with positive attitudes toward the elderly in this multivariate analysis. A geriatrics course during medical school was associated with positive attitudes in the univariate analysis, but only tended to be so in the multivariate analysis. Geriatrics rotation during internal medicine residency was independently associated with positive attitudes toward older people. Generalization of geriatrics education in developing countries may translate into a better understanding and improved care for older patients. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  20. Excess intraoperative fluid volume administration is associated with pancreatic fistula after pancreaticoduodenectomy: A retrospective multicenter study.

    Science.gov (United States)

    Han, In Woong; Kim, Hongbeom; Heo, JinSeok; Oh, Min Gu; Choi, Yoo Shin; Lee, Seung Eun; Lim, Chang-Sup

    2017-06-01

    Recent studies on perioperative fluid administration in patients undergoing pancreaticoduodenectomy (PD) have suggested that increased fluid loads are associated with worse perioperative outcomes. The purpose of this study was to investigate the relationship between intraoperative fluid (IOF) administration and postoperative pancreatic fistula (POPF), and to determine additional risk factors affecting pancreatic fistula in patients undergoing PD.From 2005 to 2014, a total of 182 patients with various periampullary diseases after PD were reviewed retrospectively at Dongguk University Ilsan Hospital, Chung-Ang University Hospital, and Dongnam Institute of Radiological and Medical Sciences. Patients were assigned to high or low IOF groups based on more or less fluid administration for supplementation of estimated blood loss and maintenance volume (12.5 mL/kg/h) than planned, respectively. The associations between IOF administration, pancreatic fistula development, and perioperative outcomes were evaluated.A total of 98 patients were assigned to the high-IOF group, and 84 to the low-IOF group. Risk factors for pancreatic fistula after univariate analysis were assignment to the high-IOF group, higher preoperative serum hemoglobin level, ampullary or bile duct cancer, pylorus preserving PD, small pancreatic duct, duct-to-mucosa pancreatojejunostomy, use of a stent, and mesh application to pancreatojejunal anastomosis. Among these, assignment to the high-IOF group (hazard ratio [HR] = 5.501, 95% CI 1.624-18.632, P = .006) and a small (fistula after multivariate analysis. However, long-term survival rate did not differ according to IOF group or duct size.Excessive IOF volume administration is associated with an increased incidence of pancreatic fistula after pancreaticoduodenectomy.

  1. Adult female acne and associated risk factors: Results of a multicenter case-control study in Italy.

    Science.gov (United States)

    Di Landro, Anna; Cazzaniga, Simone; Cusano, Francesco; Bonci, Angela; Carla, Cardinali; Musumeci, Maria Letizia; Patrizi, Annalisa; Bettoli, Vincenzo; Pezzarossa, Enrico; Caproni, Marzia; Fortina, Anna Belloni; Campione, Elena; Ingordo, Vito; Naldi, Luigi

    2016-12-01

    The reasons for the appearance of acne in adulthood are largely unknown. We explored the role of personal and environmental factors in adult female acne. We conducted a multicenter case-control study in the outpatient departments of 12 Italian cities. Cases (n = 248) were consecutive women ≥25 years of age with newly diagnosed acne of any grade. Controls (n = 270) were females diagnosed with conditions other than acne. In multivariate analysis, a history of acne in parents (odds ratio [OR] = 3.02) or siblings (OR = 2.40), history of acne during adolescence (OR = 5.44), having no previous pregnancies (OR = 1.71), having hirsutism (OR = 3.50), being an office worker versus being unemployed or being a housewife (OR = 2.24), and having a high level of reported psychological stress (OR = 2.95) were all associated with acne. A low weekly intake of fruits or vegetables (OR = 2.33) and low consumption of fresh fish (OR = 2.76) were also associated with acne. We did not establish an onset date for acne. Some of our associations may reflect consequences of established acne. Lifestyle factors may play an important role for acne development in adulthood, but their role should be further assessed in prospective studies. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  2. Association between family members of dialysis patients and chronic kidney disease: a multicenter study in China

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    Kong Xianglei

    2013-01-01

    Full Text Available Abstract Background Family members of patients with end stage renal disease were reported to have an increased prevalence of chronic kidney disease (CKD. However, studies differentiated genetic and non-genetic family members are limited. We sought to investigate the prevalence of CKD among fist-degree relatives and spouses of dialysis patients in China. Methods Seventeen dialysis facilities from 4 cities of China including 1062 first-degree relatives and 450 spouses of dialysis patients were enrolled. Sex- and age- matched controls were randomly selected from a representative sample of general population in Beijing. CKD was defined as decreased estimated glomerular (eGFR 2 or albuminuria. Results The prevalence of eGFR less than 60 mL/min/1.73 m2, albuminuria and the overall prevalence of CKD in dialysis spouses were compared with their counterpart controls, which was 3.8% vs. 7.8% (P 2, albuminuria and the overall prevalence of CKD in dialysis relatives were also compared with their counterpart controls, which was 1.5% vs. 2.4% (P = 0.12, 14.4% vs. 8.4% (P  Conclusions The association between being family members of dialysis patients and presence of CKD is different between first-degree relatives and spouses. The underlying mechanisms deserve further investigation.

  3. Acute Middle Gastrointestinal Bleeding Risk Associated with NSAIDs, Antithrombotic Drugs, and PPIs: A Multicenter Case-Control Study.

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    Naoyoshi Nagata

    Full Text Available Middle gastrointestinal bleeding (MGIB risk has not been fully investigated due to its extremely rare occurrence and the need for multiple endoscopies to exclude upper and lower gastrointestinal bleeding. This study investigated whether MGIB is associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs, low-dose aspirin (LDA, thienopyridines, anticoagulants, and proton-pump inhibitors (PPIs, and whether PPI use affects the interactions between MGIB and antithrombotic drugs.In this multicenter, hospital-based, case-control study, 400 patients underwent upper and lower endoscopy, 80 had acute overt MGIB and 320 had no bleeding and were matched for age and sex as controls (1:4. MGIB was additionally evaluated by capsule and/or double-balloon endoscopy, after excluding upper and lower GI bleeding. Adjusted odds ratios (AOR for MGIB risk were calculated using conditional logistic regression. To estimate the propensity score, we employed a logistic regression model for PPI use.In patients with MGIB, mean hemoglobin level was 9.4 g/dL, and 28 patients (35% received blood transfusions. Factors significantly associated with MGIB were chronic kidney disease (p<0.001, liver cirrhosis (p = 0.034, NSAIDs (p<0.001, thienopyridines (p<0.001, anticoagulants (p = 0.002, and PPIs (p<0.001. After adjusting for these factors, NSAIDs (AOR, 2.5; p = 0.018, thienopyridines (AOR, 3.2; p = 0.015, anticoagulants (AOR, 4.3; p = 0.028, and PPIs (AOR; 2.0; p = 0.021 were independently associated with MGIB. After adjusting for propensity score, the use of PPIs remained an independent risk factors for MGIB (AOR, 1.94; p = 0.034. No significant interactions were observed between PPIs and NSAIDs (AOR, 0.7; p = 0.637, LDA (AOR, 0.3; p = 0.112, thienopyridine (AOR, 0.7, p = 0.671, or anticoagulants (AOR, 0.5; p = 0.545.One-third of patients with acute small intestinal bleeding required blood transfusion. NSAIDs, thienopyridines, anticoagulants, and PPIs increased

  4. Acute Middle Gastrointestinal Bleeding Risk Associated with NSAIDs, Antithrombotic Drugs, and PPIs: A Multicenter Case-Control Study.

    Science.gov (United States)

    Nagata, Naoyoshi; Niikura, Ryota; Yamada, Atsuo; Sakurai, Toshiyuki; Shimbo, Takuro; Kobayashi, Yuka; Okamoto, Makoto; Mitsuno, Yuzo; Ogura, Keiji; Hirata, Yoshihiro; Fujimoto, Kazuma; Akiyama, Junichi; Uemura, Naomi; Koike, Kazuhiko

    2016-01-01

    Middle gastrointestinal bleeding (MGIB) risk has not been fully investigated due to its extremely rare occurrence and the need for multiple endoscopies to exclude upper and lower gastrointestinal bleeding. This study investigated whether MGIB is associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), low-dose aspirin (LDA), thienopyridines, anticoagulants, and proton-pump inhibitors (PPIs), and whether PPI use affects the interactions between MGIB and antithrombotic drugs. In this multicenter, hospital-based, case-control study, 400 patients underwent upper and lower endoscopy, 80 had acute overt MGIB and 320 had no bleeding and were matched for age and sex as controls (1:4). MGIB was additionally evaluated by capsule and/or double-balloon endoscopy, after excluding upper and lower GI bleeding. Adjusted odds ratios (AOR) for MGIB risk were calculated using conditional logistic regression. To estimate the propensity score, we employed a logistic regression model for PPI use. In patients with MGIB, mean hemoglobin level was 9.4 g/dL, and 28 patients (35%) received blood transfusions. Factors significantly associated with MGIB were chronic kidney disease (pfactors, NSAIDs (AOR, 2.5; p = 0.018), thienopyridines (AOR, 3.2; p = 0.015), anticoagulants (AOR, 4.3; p = 0.028), and PPIs (AOR; 2.0; p = 0.021) were independently associated with MGIB. After adjusting for propensity score, the use of PPIs remained an independent risk factors for MGIB (AOR, 1.94; p = 0.034). No significant interactions were observed between PPIs and NSAIDs (AOR, 0.7; p = 0.637), LDA (AOR, 0.3; p = 0.112), thienopyridine (AOR, 0.7, p = 0.671), or anticoagulants (AOR, 0.5; p = 0.545). One-third of patients with acute small intestinal bleeding required blood transfusion. NSAIDs, thienopyridines, anticoagulants, and PPIs increased the risk of acute small intestinal bleeding. However, there were no significant interactions found between antithrombotic drugs and PPI use for bleeding

  5. Semantic Integration of Cervical Cancer Data Repositories to Facilitate Multicenter Association Studies: The ASSIST Approach

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    Theodoros Agorastos

    2009-02-01

    Full Text Available The current work addresses the unification of Electronic Health Records related to cervical cancer into a single medical knowledge source, in the context of the EU-funded ASSIST research project. The project aims to facilitate the research for cervical precancer and cancer through a system that virtually unifies multiple patient record repositories, physically located in different medical centers/hospitals, thus, increasing flexibility by allowing the formation of study groups “on demand” and by recycling patient records in new studies. To this end, ASSIST uses semantic technologies to translate all medical entities (such as patient examination results, history, habits, genetic profile and represent them in a common form, encoded in the ASSIST Cervical Cancer Ontology. The current paper presents the knowledge elicitation approach followed, towards the definition and representation of the disease’s medical concepts and rules that constitute the basis for the ASSIST Cervical Cancer Ontology. The proposed approach constitutes a paradigm for semantic integration of heterogeneous clinical data that may be applicable to other biomedical application domains.

  6. Original Paper Multicenter study on antibiotic susceptibility ...

    African Journals Online (AJOL)

    Multicenter study on antibiotic susceptibility/resistance trends in the western region of Cameroon ... This would be achieved with State support to public and private institutions. ... because of lack or insufficient knowledge on microbial life and ...

  7. Prospective Multicenter Study of Community-Associated Skin and Skin Structure Infections due to Methicillin-Resistant Staphylococcus aureus in Buenos Aires, Argentina

    Science.gov (United States)

    López Furst, María José; de Vedia, Lautaro; Fernández, Silvina; Gardella, Noella; Ganaha, María Cristina; Prieto, Sergio; Carbone, Edith; Lista, Nicolás; Rotryng, Flavio; Morera, Graciana I.; Mollerach, Marta; Stryjewski, Martín E.

    2013-01-01

    Background Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) is now the most common cause of skin and skin structure infections (SSSI) in several world regions. In Argentina prospective, multicenter clinical studies have only been conducted in pediatric populations. Objective Primary: describe the prevalence, clinical and demographic characteristics of adult patients with community acquired SSSI due to MRSA; secondary: molecular evaluation of CA-MRSA strains. Patients with MRSA were compared to those without MRSA. Materials and Methods Prospective, observational, multicenter, epidemiologic study, with molecular analysis, conducted at 19 sites in Argentina (18 in Buenos Aires) between March 2010 and October 2011. Patients were included if they were ≥14 years, were diagnosed with SSSI, a culture was obtained, and there had no significant healthcare contact identified. A logistic regression model was used to identify factors associated with CA-MRSA. Pulse field types, SCCmec, and PVL status were also determined. Results A total of 311 patients were included. CA-MRSA was isolated in 70% (218/311) of patients. Clinical variables independently associated with CA-MRSA were: presence of purulent lesion (OR 3.29; 95%CI 1.67, 6.49) and age <50 years (OR 2.39; 95%CI 1.22, 4.70). The vast majority of CA-MRSA strains causing SSSI carried PVL genes (95%) and were SCCmec type IV. The sequence type CA-MRSA ST30 spa t019 was the predominant clone. Conclusions CA-MRSA is now the most common cause of SSSI in our adult patients without healthcare contact. ST30, SCCmec IV, PVL+, spa t019 is the predominant clone in Buenos Aires, Argentina. PMID:24324543

  8. Multicenter study of street foods in 13 towns on four continents by the food and environmental hygiene study group of the international network of pasteur and associated institutes.

    Science.gov (United States)

    Garin, B; Aïdara, A; Spiegel, A; Arrive, P; Bastaraud, A; Cartel, J L; Aissa, R Ben; Duval, P; Gay, M; Gherardi, C; Gouali, M; Karou, T G; Kruy, S L; Soares, J L; Mouffok, F; Ravaonindrina, N; Rasolofonirina, N; Pham, M T; Wouafo, M; Catteau, M; Mathiot, C; Mauclere, P; Rocourt, J

    2002-01-01

    An international multicenter study of ready-to-eat foods, sandwiches, and ice creams or sorbets sold in the streets and their vendors was carried out to assess the microbiological quality of these foods and to identify characteristics of the vendors possibly associated with pathogens. Thirteen towns in Africa, America, Asia, and Oceania were involved in the study. A single protocol was used in all 13 centers: representative sampling was by random selection of vendors and a sample of foods bought from each of these vendors at a time and date selected at random. Microbiological analyses were carried out using standardized Association Française de Normalisation methods, and the use of a standardized questionnaire to collect data concerning the characteristics of the vendors. Fifteen surveys were carried out, with 3,003 food samples from 1,268 vendors. The proportion of unsatisfactory food samples was between 12.7 and 82.9% for ice creams and sorbets and between 11.3 and 92% for sandwiches. For ice creams and sorbets, the sale of a large number of units (>80 per day) increased the risk of unsatisfactory food by a factor of 2.8 (95% confidence interval [CI]: 1.5 to 5.1), lack of training in food hygiene by 6.6 (95% CI: 1.1 to 50). and by a factor of 2.8 (95% CI: 1.4 to 5.4) for mobile vendors. These risk factors were not identified for sandwiches, this difference may be due to the presence of a cooking step in their preparation. These results show that the poor microbiological quality of these street foods constitutes a potential hazard to public health, that the extent of this hazard varies between the cities studied, and that vendors' health education in food safety is a crucial factor in the prevention of foodborne infections.

  9. Acute necrotizing pancreatitis: a multicenter study.

    Science.gov (United States)

    Fernández-Cruz, L; Navarro, S; Valderrama, R; Sáenz, A; Guarner, L; Aparisi, L; Espi, A; Jaurietta, E; Marruecos, L; Gener, J

    1994-04-01

    A multicenter study of acute necrotizing pancreatitis (ANP) classified in accordance with the Balthazar criteria (grades D and E), has been performed in 12 teaching hospitals. A total of 233 patients were reviewed, and the mortality rate was 26.6%. The most common etiology was biliary pancreatitis (45.5%). Among the complications, shock, renal insufficiency, pulmonary insufficiency and hemorrhagic gastritis were associated with a mortality rate of 51-66%. Diffuse fluid collections were associated with a higher mortality rate (26.8%) than localized fluid collections (14.5%). In 106 patients with gallstone pancreatitis, early surgery was performed in 17, and 5 patients (29.4%) died. No mortality was observed in 32 patients with delayed surgery. Sphincterotomy was performed in 13 patients, and 4 (30.7%) died. Early surgery (necrosectomy and closed peritoneal lavage) was undertaken in 75 patients, with a mortality rate of 39%. In conclusion, the morbidity and mortality rates of ANP can be improved with proper monitoring, adequate supportive care and the judicious use of surgery based on clinical and morphological findings.

  10. Association between severe disease course and nephritis with Q222R polymorphism in DNAse I gene among lupus patients: An Argentine multicenter study

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    Gabriela Camicia

    2016-04-01

    Full Text Available Abstract Objetives: Systemic lupus erythematosus is a multifactorial autoimmune disease and the glomerulonephritis is one of the most severe complications, which leads to severe persistent proteinuria, chronic renal failure, and end-stage renal disease. This multicenter study investigated the genetic associations of a non-synonymous single-nucleotide polymorphism in DNase I with the risk of lupus and its influence on development of nephropathy in an Argentinean population. Methods: Using the Polymerase chain reaction restriction fragment length polymorphism method, the Q222R (+2373A→G; Gln244Arg DNase I polymorphism was studied in 156 systemic lupus erythematosus patients and 170 healthy controls. Results: Although no significant association between Q222R polymorphism and the risk of systemic lupus erythematosus was found, the presence of the A allele was associated with an increased risk for the development of nephropathy (p=0.019, Odd Ratio=2.196, 95 % confidence interval [1.135-4.247] and a worse disease course [moderate disease course: p=0.006, Odd Ratio=3.250, 95% confidence interval (1.401-7.539; severe disease course: p=0.040, Odd Ratio=2.339, 95% confidence interval (1.040-5.260]. Conclusions: A better understanding of the genetic basis of systemic lupus erythematosus will help in the development of new and more effectives strategies for the treatment of the disease in the future.

  11. Associations between Tobacco, Alcohol, and Drug Use with Coronary Artery Plaque among HIV-Infected and Uninfected Men in the Multicenter AIDS Cohort Study.

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    Sean G Kelly

    Full Text Available We characterized associations between smoking, alcohol, and recreational drug use and coronary plaque by HIV serostatus within the Multicenter AIDS Cohort Study (MACS.MACS participants (N = 1005, 621 HIV+ and 384 HIV- underwent non-contrast CT scanning to measure coronary artery calcium; 764 underwent coronary CT angiograms to evaluate plaque type and extent. Self-reported use of alcohol, tobacco, smoked/inhaled cocaine, methamphetamine, ecstasy, marijuana, inhaled nitrites, and erectile dysfunction drugs was obtained at semi-annual visits beginning 10 years prior to CT scanning. Multivariable logistic and linear regression models were performed, stratified by HIV serostatus.Among HIV+ men, current smoking, former smoking, and cumulative pack years of smoking were positively associated with multiple coronary plaque measures (coronary artery calcium presence and extent, total plaque presence and extent, calcified plaque presence, and stenosis >50%. Smoking was significantly associated with fewer plaque measures of comparable effect size among HIV- men; current smoking and calcified plaque extent was the only such association. Heavy alcohol use (>14 drinks/week was associated with stenosis >50% among HIV+ men. Among HIV- men, low/moderate (1-14 drinks/week and heavy alcohol use were inversely associated with coronary artery calcium and calcified plaque extent. Few significant associations between other recreational drug use and plaque measures were observed.Smoking is strongly associated with coronary plaque among HIV+ men, underscoring the value of smoking cessation for HIV+ persons. Alcohol use may protect against coronary artery calcium and calcified plaque progression in HIV- (but not HIV+ men. Few positive associations were observed between recreational drug use and coronary plaque measures.

  12. The Burden of Provider-Initiated Preterm Birth and Associated Factors: Evidence from the Brazilian Multicenter Study on Preterm Birth (EMIP.

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    Renato T Souza

    Full Text Available About 15 million children are born under 37 weeks of gestation worldwide. Prematurity is the leading cause of neonatal deaths and short/long term morbidities, entailing consequences not only for the individual, but also their family, health agencies, facilities and all community. The provider-initiated preterm birth is currently one of the most important obstetric conditions related to preterm births, particularly in middle and high income countries, thus decreasing the need for therapeutic preterm birth is essential to reduce global prematurity. Therefore detailed knowledge on the factors associated with provider-initiated preterm birth is essential for the efforts to reduce preterm birth rates and its consequences. In this current analysis we aimed to assess the proportion of provider-initiated (pi-PTB among preterm births in Brazil and identify associated factors.This is an analysis of a multicenter cross-sectional study with a nested case-control component called Brazilian Multicenter Study on Preterm Birth (EMIP. EMIP was conducted in 20 referral obstetric hospitals located in the three most populated of the five Brazilian regions. We analysed data of women with pi-PTB, defined as childbirth occurring at less than 37 weeks, medically indicated for maternal/fetal compromise or both; and women with term birth, childbirth at or after 37 weeks. Maternal, sociodemographic, obstetric, prenatal care, delivery, and postnatal characteristics were assessed as possible factors associated with pi-PTB, compared to term births. The overall prevalence of preterm births was 12.3%. Of these, approximately one-third of cases were initiated by the provider. Hypertensive disorders, placental abruption, and diabetes were the main maternal conditions leading to pi-PTB. Caesarean section was the most common mode of delivery. Chronic hypertension (OR 7.47; 95%CI 4.02-13.88, preeclampsia/eclampsia/HELLP syndrome (OR 15.35; 6.57-35.88, multiple pregnancy (OR 12

  13. Parenteral nutrition-associated hyperglycemia in non-critically ill inpatients increases the risk of in-hospital mortality (multicenter study).

    Science.gov (United States)

    Olveira, Gabriel; Tapia, María José; Ocón, Julia; Cabrejas-Gómez, Carmen; Ballesteros-Pomar, María D; Vidal-Casariego, Alfonso; Arraiza-Irigoyen, Carmen; Olivares, Josefina; Conde-García, Maria Del Carmen; García-Manzanares, Alvaro; Botella-Romero, Francisco; Quílez-Toboso, Rosa P; Cabrerizo, Lucio; Matia, Pilar; Chicharro, Luisa; Burgos, Rosa; Pujante, Pedro; Ferrer, Mercedes; Zugasti, Ana; Prieto, Javier; Diéguez, Marta; Carrera, María José; Vila-Bundo, Anna; Urgelés, Juan Ramón; Aragón-Valera, Carmen; Rovira, Adela; Bretón, Irene; García-Peris, Pilar; Muñoz-Garach, Araceli; Márquez, Efren; Del Olmo, Dolores; Pereira, José Luis; Tous, María C

    2013-05-01

    Hyperglycemia may increase mortality in patients who receive total parenteral nutrition (TPN). However, this has not been well studied in noncritically ill patients (i.e., patients in the nonintensive care unit setting). The aim of this study was to determine whether mean blood glucose level during TPN infusion is associated with increased mortality in noncritically ill hospitalized patients. This prospective multicenter study involved 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included prospectively, and data were collected on demographic, clinical, and laboratory variables as well as on in-hospital mortality. The study included 605 patients (mean age 63.2 ± 15.7 years). The daily mean TPN values were 1.630 ± 323 kcal, 3.2 ± 0.7 g carbohydrates/kg, 1.26 ± 0.3 g amino acids/kg, and 0.9 ± 0.2 g lipids/kg. Multiple logistic regression analysis showed that the patients who had mean blood glucose levels >180 mg/dL during the TPN infusion had a risk of mortality that was 5.6 times greater than those with mean blood glucose levels 180 mg/dL) in noncritically ill patients who receive TPN is associated with a higher risk of in-hospital mortality.

  14. Parenteral Nutrition–Associated Hyperglycemia in Non–Critically Ill Inpatients Increases the Risk of In-Hospital Mortality (Multicenter Study)

    Science.gov (United States)

    Olveira, Gabriel; Tapia, María José; Ocón, Julia; Cabrejas-Gómez, Carmen; Ballesteros-Pomar, María D.; Vidal-Casariego, Alfonso; Arraiza-Irigoyen, Carmen; Olivares, Josefina; Conde-García, Maria del Carmen; García-Manzanares, Álvaro; Botella-Romero, Francisco; Quílez-Toboso, Rosa P.; Cabrerizo, Lucio; Matia, Pilar; Chicharro, Luisa; Burgos, Rosa; Pujante, Pedro; Ferrer, Mercedes; Zugasti, Ana; Prieto, Javier; Diéguez, Marta; Carrera, María José; Vila-Bundo, Anna; Urgelés, Juan Ramón; Aragón-Valera, Carmen; Rovira, Adela; Bretón, Irene; García-Peris, Pilar; Muñoz-Garach, Araceli; Márquez, Efren; del Olmo, Dolores; Pereira, José Luis; Tous, María C.

    2013-01-01

    OBJECTIVE Hyperglycemia may increase mortality in patients who receive total parenteral nutrition (TPN). However, this has not been well studied in noncritically ill patients (i.e., patients in the nonintensive care unit setting). The aim of this study was to determine whether mean blood glucose level during TPN infusion is associated with increased mortality in noncritically ill hospitalized patients. RESEARCH DESIGN AND METHODS This prospective multicenter study involved 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included prospectively, and data were collected on demographic, clinical, and laboratory variables as well as on in-hospital mortality. RESULTS The study included 605 patients (mean age 63.2 ± 15.7 years). The daily mean TPN values were 1.630 ± 323 kcal, 3.2 ± 0.7 g carbohydrates/kg, 1.26 ± 0.3 g amino acids/kg, and 0.9 ± 0.2 g lipids/kg. Multiple logistic regression analysis showed that the patients who had mean blood glucose levels >180 mg/dL during the TPN infusion had a risk of mortality that was 5.6 times greater than those with mean blood glucose levels 180 mg/dL) in noncritically ill patients who receive TPN is associated with a higher risk of in-hospital mortality. PMID:23223407

  15. Epicardial Fat is Associated with Duration of Antiretroviral Therapy and Coronary Atherosclerosis: The Multicenter AIDS Cohort Study

    Science.gov (United States)

    Brener, Michael; Ketlogetswe, Kerunne; Budoff, Matthew; Jacobson, Lisa P.; Li, Xiuhong; Rezaeian, Panteha; Razipour, Aryabod; Palella, Frank J; Kingsley, Lawrence; Witt, Mallory D; George, Richard T; Post, Wendy S

    2014-01-01

    Objective Cytokines released by epicardial fat are implicated in the pathogenesis of atherosclerosis. HIV infection and anti-retroviral therapy have been associated with changes in body fat distribution and coronary artery disease. We sought to determine if HIV infection is associated with greater epicardial fat and if epicardial fat is associated with subclinical coronary atherosclerosis. Design We studied 579 HIV-infected and 353 HIV-uninfected men age 40 to 70 years with non-contrast computed tomography (CT) to measure epicardial adipose tissue volume (EAT) and coronary artery calcium (CAC). Total plaque score (TPS), and plaque subtypes (non-calcified, calcified and mixed) were measured by coronary CT angiography in 706 men. Methods We evaluated the association between EAT and HIV serostatus, and the association of EAT with subclinical atherosclerosis, adjusting for age, race and serostatus and with additional cardiovascular (CV) risk factors and tested for modifying effects of HIV serostatus. Results HIV-infected men had greater EAT than HIV-uninfected men (p=0.001). EAT was positively associated with duration of antiretroviral therapy (p=0.02), specifically AZT (p<0.05). EAT was associated with presence of any coronary artery plaque (p=0.006) and non-calcified plaque (p=0.001), adjusting for age, race, serostatus and CV risk factors. Among men with CAC, EAT was associated with CAC extent (p=0.006). HIV serostatus did not modify associations between EAT and either CAC extent or presence of plaque. Conclusions Greater epicardial fat volume in HIV-infected men and its association with coronary plaque and antiretroviral therapy duration suggest potential mechanisms that might lead to increased risk for cardiovascular disease in HIV. PMID:24809732

  16. [Multicenter paragliding accident study 1990].

    Science.gov (United States)

    Lautenschlager, S; Karli, U; Matter, P

    1992-01-01

    During the period from 1.1.90 until 31.12.90, 86 injuries associated with paragliding were analyzed in a prospective study in 12 different Swiss hospitals with reference to causes, patterns, and frequencies. The injuries showed a mean score of over 2 and were classified as severe. Most frequent spine injuries (36%) and lesions of the lower extremity (35%) with a high risk of the ankles were diagnosed. One accident was fatal. 60% of the accidents happened during landing, 26% during launching and 14% during flight. Half of the pilots were affected during their primary training course. Most accidents were caused by inflight error of judgement--especially incorrect estimation of wind conditions--and further the choice of unfavourable landing sites. In contrast to previous injury-reports, only one equipment failure could be noted, but often the equipment was not corresponding with the experience and the weight of the pilot. To reduce the frequency of paragliding-injuries an accurate choice of equipment and an increased attention to environmental factors is mandatory. Furthermore an education-program regarding the attitude and intelligence of the pilot should be included in training courses.

  17. Polymicrogyria-associated epilepsy: a multi-center phenotypic study from the Epilepsy Phenome/Genome Project

    Science.gov (United States)

    Shain, Catherine; Ramgopal, Sriram; Fallil, Zianka; Parulkar, Isha; Alongi, Richard; Knowlton, Robert; Poduri, Annapurna

    2013-01-01

    Purpose Polymicrogyria (PMG) is an epileptogenic malformation of cortical development. We describe the clinical epilepsy and imaging features of a large cohort with PMG-related epilepsy. Methods Participants were recruited through the Epilepsy Phenome/Genome Project, a multi-center collaborative effort to collect detailed phenotypic data on individuals with epilepsy. We reviewed phenotypic data from participants with epilepsy and PMG. Key Findings We identified 87 participants, 43 female and 44 male, with PMG and epilepsy. Median age of seizure onset was 3 years (range <1 month-37 years). Most presented with focal epilepsy (87.4%), some in combination with seizures generalized from onset (23.0%). Focal seizures with dyscognitive features were most common (54.3%). Of those presenting with generalized seizure types, infantile spasms were most prevalent (45.2%). The most common topographic pattern was perisylvian PMG (77.0%), of which the majority was bilateral (56.7%). Generalized PMG presented with an earlier age of seizure onset (median age of 8 months) and an increased prevalence of developmental delay prior to seizure onset (57.1%). Of the focal, unilateral and asymmetric bilateral groups where PMG was more involved in one hemisphere, the majority (71.4%) of participants had seizures that lateralized to the same hemisphere as the PMG or the hemisphere with greater involvement. Significance Participants with PMG had both focal and generalized onset of seizures. Our data confirm the involvement of known topographic patterns of PMG and suggest that more extensive distributions of PMG present with an earlier age of seizure onset and increased prevalence of developmental delay prior to seizure onset. PMID:23750890

  18. Are frailty components associated with disability in specific activities of daily living in community-dwelling older adults? A multicenter Canadian study.

    Science.gov (United States)

    Provencher, Véronique; Béland, François; Demers, Louise; Desrosiers, Johanne; Bier, Nathalie; Ávila-Funes, José Alberto; Galand, Claude; Julien, Dominic; Fletcher, John D; Trottier, Lise; Hami, Benyahia

    2017-11-01

    Current studies show the relevance of geriatric prevention and rehabilitation programs to slow down the development of disability in community-dwelling older adults who are becoming frail. This evidence reveals the importance of improving knowledge on how individual components of frailty and specific disability in basic and instrumental activities of daily living (ADL) are related, to offer early, targeted, and tailored interventions. The objective was to examine the association between each of the five frailty phenotype components (weakness, slowness, exhaustion, low physical activity, weight loss) and disability in specific ADL pertaining to physical aspects (bathing, dressing, cutting toe nails, transportation, shopping, housekeeping, food purchasing, food preparation) and cognitive aspects (finances, telephone, medication). A cross-sectional design involving 1643 community-dwelling older adults (65+) from the longitudinal multi-center FRéLE study was used. Disability was defined as needing help or being unable to perform specific ADL. Multiple logistic regressions were adjusted for socio-demographic characteristics, clinical variables, and for 4 other frailty components. Results showed that low physical activity and slowness were significantly linked to disability in all physical and cognitive aspects of ADL (OR: 1.71-9.42; pdisability in the physical aspects of instrumental ADL (transportation, shopping, housekeeping, food purchasing, food preparation) (OR: 1.73-9.42; pdisability. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Histoplasmosis in patients with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS): multicenter study of outcomes and factors associated with relapse.

    Science.gov (United States)

    Myint, Thein; Anderson, Albert M; Sanchez, Alejandro; Farabi, Alireza; Hage, Chadi; Baddley, John W; Jhaveri, Malhar; Greenberg, Richard N; Bamberger, David M; Rodgers, Mark; Crawford, Timothy N; Wheat, L Joseph

    2014-01-01

    Although discontinuation of suppressive antifungal therapy for acquired immunodeficiency syndrome (AIDS)-associated histoplasmosis is accepted for patients with immunologic recovery, there have been no published studies of this approach in clinical practice, and minimal characterization of individuals who relapse with this disease. We performed a multicenter retrospective cohort study to determine the outcome in AIDS patients following discontinuation of suppressive antifungal therapy for histoplasmosis. Ninety-seven patients were divided into a physician-discontinued suppressive therapy group (PD) (38 patients) and a physician-continued suppressive therapy group (PC) (59 patients). The 2 groups were not statistically different at baseline, but at discontinuation of therapy and at the most recent follow-up there were significant differences in adherence to therapy, human immunodeficiency virus (HIV) RNA, and urinary Histoplasma antigen concentration. There was no relapse or death attributed to histoplasmosis in the PD group compared with 36% relapse (p 150 cells/mL, HIV RNA <400 c/mL, Histoplasma antigenuria <2 ng/mL (equivalent to <4.0 units in second-generation method), and no CNS histoplasmosis.

  20. [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.

  1. Increasing incidence of hospital-acquired and healthcare-associated bacteremia in northeast Thailand: a multicenter surveillance study.

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    Maliwan Hongsuwan

    Full Text Available BACKGROUND: Little is known about the epidemiology of nosocomial bloodstream infections in public hospitals in developing countries. We evaluated trends in incidence of hospital-acquired bacteremia (HAB and healthcare-associated bacteremia (HCAB and associated mortality in a developing country using routinely available databases. METHODS: Information from the microbiology and hospital databases of 10 provincial hospitals in northeast Thailand was linked with the national death registry for 2004-2010. Bacteremia was considered hospital-acquired if detected after the first two days of hospital admission, and healthcare-associated if detected within two days of hospital admission with a prior inpatient episode in the preceding 30 days. RESULTS: A total of 3,424 patients out of 1,069,443 at risk developed HAB and 2,184 out of 119,286 at risk had HCAB. Of these 1,559 (45.5% and 913 (41.8% died within 30 days, respectively. Between 2004 and 2010, the incidence rate of HAB increased from 0.6 to 0.8 per 1,000 patient-days at risk (p<0.001, and the cumulative incidence of HCAB increased from 1.2 to 2.0 per 100 readmissions (p<0.001. The most common causes of HAB were Acinetobacter spp. (16.2%, Klebsiella pneumoniae (13.9%, and Staphylococcus aureus (13.9%, while those of HCAB were Escherichia coli (26.3%, S. aureus (14.0%, and K. pneumoniae (9.7%. There was an overall increase over time in the proportions of ESBL-producing E. coli causing HAB and HCAB. CONCLUSIONS: This study demonstrates a high and increasing incidence of HAB and HCAB in provincial hospitals in northeast Thailand, increasing proportions of ESBL-producing isolates, and very high associated mortality.

  2. Association between anxiety and severe quality-of-life impairment in postmenopausal women: analysis of a multicenter Latin American cross-sectional study.

    Science.gov (United States)

    Núñez-Pizarro, Jorge L; González-Luna, Alejandro; Mezones-Holguín, Edward; Blümel, Juan E; Barón, Germán; Bencosme, Ascanio; Benítez, Zully; Bravo, Luz M; Calle, Andrés; Flores, Daniel; Espinoza, María T; Gómez, Gustavo; Hernández-Bueno, José A; Martino, Mabel; Lima, Selva; Monterrosa, Alvaro; Mostajo, Desiree; Ojeda, Eliana; Onatra, William; Sánchez, Hugo; Tserotas, Konstantinos; Vallejo, María S; Witis, Silvina; Zúñiga, María C; Chedraui, Peter

    2017-06-01

    To evaluate associations between anxiety and severe impairment of quality of life (QoL) in Latin American postmenopausal women. This was a secondary analysis of a multicenter cross-sectional study among postmenopausal women aged 40 to 59 from 11 Latin American countries. We evaluated anxiety (The Goldberg Depression and Anxiety Scale), and QoL (Menopause Rating Scale [MRS]), and included sociodemographic, clinical, lifestyle, and anthropometric variables in the analysis. Poisson family generalized linear models with robust standard errors were used to estimate prevalence ratios (PRs) and 95% CIs. There were two adjusted models: a statistical model that included variables associated with the outcomes in bivariate analyses, and an epidemiologic model that included potentially confounding variables from literature review. Data from 3,503 women were included; 61.9% had anxiety (Goldberg). Severe QoL impairment (total MRS score ≥17) was present in 13.7% of women, as well as severe symptoms (MRS subscales): urogenital (25.5%), psychological (18.5%), and somatic (4.5%). Anxiety was independently associated with severe QoL impairment and severe symptoms in the epidemiological (MRS total score: PR 3.6, 95% CI, 2.6-5.0; somatic: 5.1, 95% CI, 2.6-10.1; psychological: 2.8, 95% CI, 2.2-3.6; and urogenital: 1.4, 95% CI, 1.2-1.6) and the statistical model (MRS total score: PR 3.5, 95% CI, 2.6-4.9; somatic: 5.0, 95% CI, 2.5-9.9; psychological: 2.9, 95% CI, 2.2-3.7; and urogenital: 1.4; 95% CI, 1.2-1.6). In this postmenopausal Latin American sample, anxiety was independently associated with severe QoL impairment. Hence, screening for anxiety in this population is important.

  3. Epidemiology, microbiology and mortality associated with community-acquired bacteremia in northeast Thailand: a multicenter surveillance study.

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    Manas Kanoksil

    Full Text Available BACKGROUND: National statistics in developing countries are likely to underestimate deaths due to bacterial infections. Here, we calculated mortality associated with community-acquired bacteremia (CAB in a developing country using routinely available databases. METHODS/PRINCIPAL FINDINGS: Information was obtained from the microbiology and hospital database of 10 provincial hospitals in northeast Thailand, and compared with the national death registry from the Ministry of Interior, Thailand for the period between 2004 and 2010. CAB was defined in patients who had pathogenic organisms isolated from blood taken within 2 days of hospital admission without a prior inpatient episode in the preceding 30 days. A total of 15,251 CAB patients identified, of which 5,722 (37.5% died within 30 days of admission. The incidence rate of CAB between 2004 and 2010 increased from 16.7 to 38.1 per 100,000 people per year, and the mortality rate associated with CAB increased from 6.9 to 13.7 per 100,000 people per year. In 2010, the mortality rate associated with CAB was lower than that from respiratory tract infection, but higher than HIV disease or tuberculosis. The most common causes of CAB were Escherichia coli (23.1%, Burkholderia pseudomallei (19.3%, and Staphylococcus aureus (8.2%. There was an increase in the proportion of Extended-Spectrum Beta-Lactamases (ESBL producing E. coli and Klebsiella pneumoniae over time. CONCLUSIONS: This study has demonstrated that national statistics on causes of death in developing countries could be improved by integrating information from readily available databases. CAB is neglected as an important cause of death, and specific prevention and intervention is urgently required to reduce its incidence and mortality.

  4. Concomitant pulmonary tuberculosis in hospitalized healthcare-associated pneumonia in a tuberculosis endemic area: a multi-center retrospective study.

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    Jia-Yih Feng

    Full Text Available BACKGROUND: In tuberculosis (TB endemic areas, Mycobacterium tuberculosis is an important but easily misdiagnosed pathogen in community-acquired pneumonia (CAP. However, the occurrence of concomitant pulmonary tuberculosis (PTB in hospitalized healthcare-associated pneumonia (HCAP has never been investigated. METHODS AND FINDINGS: Seven hundred and one hospitalized HCAP and 934 hospitalized CAP patients from six medical centers in Taiwan were included in this nationwide retrospective study. Concomitant PTB was defined as active PTB diagnosed within 60 days of admission due to HCAP or CAP. The predictors for concomitant PTB and the impact of PTB on the outcomes of pneumonia were investigated. Among the enrolled subjects, 21/701 (3% of the HCAP patients and 25/934 (2.7% of the CAP patients were documented to have concomitant PTB. In multivariate analysis, a history of previous anti-TB treatment (OR = 5.84, 95% CI: 2.29-20.37 in HCAP; OR = 3.33, 95% CI: 1.09-10.22 in CAP and escalated pneumonia severity index (PSI scores (OR = 1.014, 95% CI: 1.002-1.026, in HCAP; OR = 1.013, 95% CI: 1.001-1.026, in CAP were independent predictors for concomitant PTB in both CAP and HCAP patients. Regarding treatment outcomes, HCAP patients with concomitant PTB were associated with more acute respiratory failure within 48 hours of admission (47.6% vs. 22.6%, p = 0.008, higher intensive care unit admission rate (61.9% vs. 35.7%, p = 0.014, longer hospitalization (39.6±34.1 vs. 23.7±27 days, p = 0.009, and higher in-hospital mortality (47.6% vs. 26.3%, p = 0.03 than those without concomitant PTB. Exposure to certain groups of antibiotics for the treatment of pneumonia was not associated with the occurrence of concomitant PTB. CONCLUSIONS: In HCAP patients, the occurrence of concomitant PTB is comparable with that in CAP patients and associated with higher PSI scores, more acute respiratory failure, and higher in-hospital mortality.

  5. The association between patella alta and the prevalence and worsening of structural features of patellofemoral joint osteoarthritis: The Multicenter Osteoarthritis Study

    Science.gov (United States)

    Stefanik, J.J.; Zhu, Y.; Zumwalt, A.C.; Gross, K.D.; Clancy, M.; Lynch, J. A.; Frey Law, L.A.; Lewis, C.E.; Roemer, F.W.; Powers, C.M.; Guermazi, A.; Felson, D.T.

    2010-01-01

    Objective To examine the relationship between patella alta and the prevalence and worsening at follow-up of structural features of patellofemoral joint (PFJ) osteoarthritis (OA) on MRI. Methods The Multicenter Osteoarthritis (MOST) Study is a cohort study of persons aged 50-79 years with or at risk for knee OA. Patella alta was measured using the Insall-Salvati ratio (ISR) on the baseline lateral radiograph and cartilage damage, bone marrow lesions (BMLs), and subchondral bone attrition (SBA) were graded on MRI at baseline and at 30 months follow-up in the PFJ. We examined the association of the ISR with the prevalence and worsening of cartilage damage, BMLs, and SBA in the PFJ using logistic regression. Results 907 knees were studied (mean age 62, BMI 30, ISR 1.10), 63% from female subjects. Compared with knees in the lowest ISR quartile at baseline, those in the highest had 2.4 (95% CI 1.7, 3.3), 2.9 (2.0, 4.3), and 3.5 (2.3, 5.5) times the odds of having lateral PFJ cartilage damage, BMLs, and SBA respectively, and 1.5 (95% CI 1.1, 2.0), 1.3 (0.9, 1.8), and 2.2 (1.4, 3.4) times the odds of having medial PFJ cartilage damage, BMLs, and SBA respectively. Similarly, those with high ISRs were also at risk for worsening of cartilage damage and BMLs over time than those with low ISRs. Conclusion A high ISR, indicative of patella alta, is associated with structural features of OA in the PFJ. Additionally, the same knees have increased risk of worsening of these same features over time. PMID:20506169

  6. 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

    Earlier use of in-hospital plasma, platelets, and red blood cells (RBCs) has improved survival in trauma patients with severe hemorrhage. Retrospective studies have associated improved early survival with prehospital blood product transfusion (PHT). We hypothesized that PHT of plasma and/or RBCs would result in improved survival after injury in patients transported by helicopter. Adult trauma patients transported by helicopter from the scene to nine Level 1 trauma centers were prospectively observed from January to November 2015. Five helicopter systems had plasma and/or RBCs, whereas the other four helicopter systems used only crystalloid resuscitation. All patients meeting predetermined high-risk criteria were analyzed. Patients receiving PHT were compared with patients not receiving PHT. Our primary analysis compared mortality at 3 hours, 24 hours, and 30 days, using logistic regression to adjust for confounders and site heterogeneity to model patients who were matched on propensity scores. Twenty-five thousand one hundred eighteen trauma patients were admitted, 2,341 (9%) were transported by helicopter, of which 1,058 (45%) met the highest-risk criteria. Five hundred eighty-five of 1,058 patients were flown on helicopters carrying blood products. In the systems with blood available, prehospital median systolic blood pressure (125 vs 128) and Glasgow Coma Scale (7 vs 14) was significantly lower, whereas median Injury Severity Score was significantly higher (21 vs 14). Unadjusted mortality was significantly higher in the systems with blood products available, at 3 hours (8.4% vs 3.6%), 24 hours (12.6% vs 8.9%), and 30 days (19.3% vs 13.3%). Twenty-four percent of eligible patients received a PHT. A median of 1 unit of RBCs and plasma were transfused prehospital. Of patients receiving PHT, 24% received only plasma, 7% received only RBCs, and 69% received both. In the propensity score matching analysis (n = 109), PHT was not significantly associated with mortality

  7. Diagnosis of asymptomatic common bile duct stones: preoperative endoscopic ultrasonography versus intraoperative cholangiography--a multicenter, prospective controlled study. French Associations for Surgical Research.

    Science.gov (United States)

    Montariol, T; Msika, S; Charlier, A; Rey, C; Bataille, N; Hay, J M; Lacaine, F; Fingerhut, A

    1998-07-01

    In patients with symptomatic cholelithiasis, preoperative diagnosis of common bile duct (CBD) stones can modify the therapeutic strategy. The aims of this prospective, controlled multicenter study were to assess the feasibility, concordance, discordance, and indexes such as sensitivity, specificity, positive and negative predictive values, and accuracy of preoperative endoscopic ultrasonography compared with those of intraoperative cholangiography (IOC) in the diagnosis of asymptomatic CBD stones (i.e., patients undergoing cholecystectomy with no clinical or biologic evidence of CBD stones). From October 1993 to October 1995, 240 consecutive patients with symptomatic cholelithiasis, scheduled for cholecystectomy in 14 surgical centers, were enrolled in this study. All patients were selected for this study according to a preoperative high-risk CBD stone predictive score. Each patient underwent both endoscopic ultrasonography and IOC, as well as surgical exploration of the CBD when stones were detected during one or both preoperative investigations. All patients were seen 1 months and 1 year after operation to check for residual stones. The feasibility of endoscopic ultrasonography was significantly higher overall than that of IOC (99% vs 90%; p stones of 19%, positive and negative predictive values of IOC were significantly higher than those of endoscopic ultrasonography (0.93 and 1.00 vs 0.75 and 0.96, respectively). Although endoscopic ultrasonography is feasible more often than IOC, IOC is associated with a slightly lower degree of discordance and better information indexes and remains an efficient method of investigation for CBD stones. Endoscopic ultrasonography can be suggested in preference to endoscopic retrograde cholangiography when postoperative residual stones are suspected but need not be performed routinely before cholecystectomy.

  8. Coordination of international multicenter studies: governance and administrative structure

    Directory of Open Access Journals (Sweden)

    Bangdiwala Shrikant I.

    2003-01-01

    Full Text Available A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (WorldSAFE, illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.

  9. Primary Mucosa-Associated Lymphoid Tissue Lymphoma of the Salivary Glands: A Multicenter Rare Cancer Network Study

    Energy Technology Data Exchange (ETDEWEB)

    Anacak, Yavuz, E-mail: yavuz.anacak@ege.edu.tr [Department of Radiation Oncology, Ege University Medical School, Izmir (Turkey); Miller, Robert C. [Department of Radiation Oncology, Mayo Clinic, Rochester, MN (United States); Constantinou, Nikos [Department of Hematology, Theagenion Cancer Center, Thessaloniki (Greece); Mamusa, Angela M. [Division of Hematology, Armando Businco Cancer Center, Cagliari (Italy); Epelbaum, Ron [Department of Oncology, Rambam Medical Center, Haifa (Israel); Li Yexiong [Department of Radiation Oncology, Cancer Hospital of Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (China); Calduch, Anna Lucas [Servicio de Oncologia Radioterapica, Institut Catala d' Oncologia, Barcelona (Spain); Kowalczyk, Anna [Department of Oncology and Radiotherapy, Medical University of Gdansk (Poland); Weber, Damien C. [Department of Radiation Oncology, Geneva University Hospital (Switzerland); Kadish, Sidney P. [Department of Radiation Oncology, University of Massachusetts Medical School/Center, North Worcester, MA (United States); Bese, Nuran [Department of Radiation Oncology, Istanbul University Cerrahpasa Medical School, Istanbul (Turkey); Poortmans, Philip [Institute Verbeeten, Tilburg (Netherlands); Kamer, Serra [Department of Radiation Oncology, Ege University Medical School, Izmir (Turkey); Ozsahin, Mahmut [Department of Radiation Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne (Switzerland)

    2012-01-01

    Purpose: Involvement of salivary glands with mucosa-associated lymphoid tissue (MALT) lymphoma is rare. This retrospective study was performed to assess the clinical profile, treatment outcome, and prognostic factors of MALT lymphoma of the salivary glands. Methods and Materials: Thirteen member centers of the Rare Cancer Network from 10 countries participated, providing data on 63 patients. The median age was 58 years; 47 patients were female and 16 were male. The parotid glands were involved in 49 cases, submandibular in 15, and minor glands in 3. Multiple glands were involved in 9 patients. Staging was as follows: IE in 34, IIE in 12, IIIE in 2, and IV in 15 patients. Results: Surgery (S) alone was performed in 9, radiotherapy (RT) alone in 8, and chemotherapy (CT) alone in 4 patients. Forty-one patients received combined modality treatment (S + RT in 23, S + CT in 8, RT + CT in 4, and all three modalities in 6 patients). No active treatment was given in one case. After initial treatment there was no tumor in 57 patients and residual tumor in 5. Tumor progression was observed in 23 (36.5%) (local in 1, other salivary glands in 10, lymph nodes in 11, and elsewhere in 6). Five patients died of disease progression and the other 5 of other causes. The 5-year disease-free survival, disease-specific survival, and overall survival were 54.4%, 93.2%, and 81.7%, respectively. Factors influencing disease-free survival were use of RT, stage, and residual tumor (p < 0.01). Factors influencing disease-specific survival were stage, recurrence, and residual tumor (p < 0.01). Conclusions: To our knowledge, this report represents the largest series of MALT lymphomas of the salivary glands published to date. This disease may involve all salivary glands either initially or subsequently in 30% of patients. Recurrences may occur in up to 35% of patients at 5 years; however, survival is not affected. Radiotherapy is the only treatment modality that improves disease-free survival.

  10. Association study of PDE4B gene variants in Scandinavian schizophrenia and bipolar disorder multicenter case-control samples

    DEFF Research Database (Denmark)

    Kähler, Anna K; Otnaess, Mona K; Wirgenes, Katrine V;

    2010-01-01

    The phosphodiesterase 4B (PDE4B), which is involved in cognitive function in animal models, is a candidate susceptibility gene for schizophrenia (SZ) and bipolar disorder (BP). Variations in PDE4B have previously been associated with SZ, with a suggested gender-specific effect. We have genotyped...

  11. Association between the location of diverticular disease and the irritable bowel syndrome: a multicenter study in Japan.

    Science.gov (United States)

    Yamada, Eiji; Inamori, Masahiko; Uchida, Eri; Tanida, Emiko; Izumi, Motoyoshi; Takeshita, Kimiya; Fujii, Tetsuro; Komatsu, Kazuto; Hamanaka, Jun; Maeda, Shin; Kanesaki, Akira; Matsuhashi, Nobuyuki; Nakajima, Atsushi

    2014-12-01

    No previous reports have shown an association between location of diverticular disease (DD) and the irritable bowel syndrome (IBS). We included 1,009 consecutive patients undergoing total colonoscopy in seven centers in Japan from June 2013 to September 2013. IBS was diagnosed using Rome III criteria, and diverticulosis was diagnosed by colonoscopy with transparent soft-short-hood. Left-sided colon was defined as sigmoid colon, descending colon, and rectum. Right-sided colon was defined as cecum, ascending colon, and transverse colon. We divided the patients into IBS and non-IBS groups and compared characteristics. Patient characteristics included mean age, 64.2±12.9 years and male:female ratio, 1.62:1. Right-sided DD was identified in 21.6% of subjects. Left-sided and bilateral DD was identified in 6.6 and 12.0% of subjects, respectively. IBS was observed in 7.5% of subjects. Multiple logistic regression analysis showed left-sided DD (odds ratio, 3.1; 95% confidence interval (CI): 1.4-7.1; P=0.0060) and bilateral DD (odds ratio, 2.6; 95% CI, 1.3-5.2; P=0.0070) were independent risk factors for IBS. Right-sided DD was not a risk factor for IBS. Our data showed that the presence of left-sided and bilateral DD, but not right-sided disease, was associated with a higher risk of IBS, indicating that differences in pathological factors caused by the location of the DD are important in the development of IBS. Clarifying the specific changes associated with left-sided DD could provide a better understanding of the pathogenic mechanisms of IBS (Trial registration # R000012739).

  12. Clinical predictors of methicillin-resistant Staphylococcus aureus in nosocomial and healthcare-associated pneumonia: a multicenter, matched case-control study.

    Science.gov (United States)

    Torre-Cisneros, J; Natera, C; Mesa, F; Trikic, M; Rodríguez-Baño, J

    2017-09-08

    The situations in which coverage for methicillin-resistant Staphylococcus aureus (MRSA) in the empirical treatment of nosocomial pneumonia (NP) or severe healthcare-associated pneumonia (HCAP) is needed are poorly defined, particularly outside intensive care units (ICUs). Our aim was to characterize if the risk of MRSA NP/HCAP can be defined by clinical variables. We designed an observational, retrospective, multicenter, case-control study to analyze the association between defined clinical variables and risk of MRSA NP/HCAP in non-ICU patients using conditional multivariable logistic regression. Cases and controls (1:2) with microbiological diagnosis were included. Controls were matched for hospital, type of pneumonia (NP or HCAP), and date of isolation. A total of 140 cases (77 NP and 63 HCAP) and 280 controls were studied. The variables associated with the risk of MRSA pneumonia were: (i) respiratory infection/colonization caused by MRSA in the previous year [odds ratio (OR) 14.81, 95% confidence interval (CI) 4.13-53.13, p < 0.001]; (ii) hospitalization in the previous 90 days (OR 2.41, 95% CI 1.21-4.81, p = 0.012); and (iii) age (OR 1.02, 95% CI 1.001-1.05, p = 0.040). The area under the receiver operating characteristic (ROC) curve for the multivariable model was 0.72 (95% CI 0.66-0.78). The multivariate model had a sensitivity of 74.5% (95% CI 65.3-83.6), a specificity of 63.3% (95% CI 56.0-70.6), a positive predictive value of 52.5% (95% CI 43.9-61.2), and a negative predictive value of 82.0% (95% CI 75.3-88.8) for the observed data. Clinical predictors of MRSA NP/HCAP can be used to define a low-risk population in whom coverage against MRSA may not be needed.

  13. Prospective assessment of clinical symptoms associated with enterovirus and parechovirus genotypes in a multicenter study in Dutch children

    NARCIS (Netherlands)

    de Crom, S. C. M.; Rossen, J. W. A.; de Moor, R. A.; Veldkamp, E. J. M.; van Furth, A. M.; Obihara, C. C.

    2016-01-01

    Background: Human non-polio enterovirus (EV) and human parechovirus (HPeV) are important pathogens viral infection and aseptic meningitis in children. The aim of this study is to prospectively compare the incidence, clinical signs, blood and cerebrospinal fluid in EV and HPeV infected children. Obje

  14. 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.

  15. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study

    Directory of Open Access Journals (Sweden)

    Hurwitz Eric L

    2011-10-01

    Full Text Available Abstract Background Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes. Methods Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1 Neck pain disability index (100-point scale, 2 Oswestry back pain index (100-point scale, 3 11-point numerical rating scale (NRS for neck, headache, midback, and low back pain, 4 treatment satisfaction, and 5 Symptomatic Reactions (SR. Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score 30% based on an 11-point numeric rating scale occurring Results A total of 1,090 patients completed the study having 4,920 (4.5 per patient office visits requiring 2,653 (2.4 per patient upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0% patients had SRs meeting the accepted definition. Intense SR (NRS ≥8 occurred in 56 patients (5.1%. Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p 5 million career upper cervical adjustments without a reported incidence of serious adverse event. Conclusions Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs short in duration (

  16. A multicenter prospective study of neonatal outcomes at less than 32 weeks associated with indications for maternal admission and delivery.

    Science.gov (United States)

    Garite, Thomas J; Combs, C Andrew; Maurel, Kimberly; Das, Anita; Huls, Kevin; Porreco, Richard; Reisner, Dale; Lu, George; Bush, Melissa; Morris, Bruce; Bleich, April

    2017-07-01

    Counseling for patients with impending premature delivery traditionally has been based primarily on the projected gestational age at delivery. There are limited data regarding how the indications for the preterm birth affect the neonatal outcome and whether this issue should be taken into account in decisions regarding management and patient counseling. We performed a prospective study of pregnancies resulting in premature delivery at less than 32 weeks to determine the influence of both the indications for admission and their associated indications for delivery on neonatal mortality and complications of prematurity. This is a multicenter, prospective study in 10 hospitals where all data from the neonatal intensive care unit routinely was imported to a deidentified data warehouse. Maternal data were collected prospectively at or near the time of delivery. Eligible subjects included singleton deliveries in these hospitals between 23 0/7 and 31 6/7 weeks. The primary hypothesis of the study was to determine whether there was a difference in the primary outcome, which was defined as neonatal composite morbidity, between those neonates delivered after admission for premature labor vs premature rupture of membranes, because these were expected to be the 2 most frequent diagnoses leading to premature birth. The sample size was calculated based on a 10% difference in outcomes for these 2 entities. We based this hypothesis on the knowledge that premature rupture of membranes has a greater incidence of intra-amniotic infection and inflammation than premature labor and that outcomes for premature neonates are worse when delivery is associated with intra-amniotic infection. Additional outcomes were analyzed for all other indications for admission and delivery. Composite morbidity was defined as ≥1 of the following: respiratory distress syndrome (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen

  17. [A multicenter randomized controlled study of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea in infants and young children].

    Science.gov (United States)

    Wan, C M; Yu, H; Liu, G; Xu, H M; Mao, Z Q; Xu, Y; Jin, Y; Luo, R P; Wang, W J; Fang, F

    2017-05-04

    Objective: To evaluate the efficacy and safety of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea (AAD) in infants and young children. Method: From November 2012 to September 2013, ten research units of large teaching hospitals or children's hospitals participated in this multicenter randomized controlled clinical trial. Hospitalized young children aged between 1 month and 3 years (nongastrointestinal infection and antibiotic therapy required)were involved in our study. The children were randomly divided into control group and prevention group by means of block random allocation method. The control group received antibiotic therapy and other conventional treatment. The prevention group was given additional Saccharomyces boulardii (250 mg/d) orally. Diarrhea rates of two groups were compared both during the usage of antibiotics and within 14 days after the antibiotics withdrawal. The adverse reactions of Saccharomyces boulardii were observed all through this study. The results were analyzed by χ(2) test or Kruskal-Wallis test or t test. Result: Totally 408 cases (213 cases in prevention group and 195 cases in control group) were enrolled. The age ranged from 1 month to 3 years, with an average age of 1.14 years. The basic diseases were parenteral infections: 368 cases with different kinds of respiratory tract infections or pneumonia, 10 cases of bacterial meningitis, 9 cases with septicemia or sepsis, 6 cases with pertussis or pertussis like syndrome, 5 cases with urinary infection, 5 cases with skin or subcutaneous tissue infections, 3 cases of Kawasaki disease, one with scarlet fever and one with congenital syphilis. During the administration of antibiotics, the incidence of AAD in prevention group was 10.3% (22 cases), which was significantly lower than that of control group (57 cases, 29.2%, χ(2)=23.296, Pantibiotics, the percent of new diarrhea cases in prevention group (2.4%, 5/213) was also significantly lower than that in

  18. Microscopic examination of intracellular organisms in bronchoalveolar lavage fluid for the diagnosis of ventilator-associated pneumonia:a prospective multi-center study

    Institute of Scientific and Technical Information of China (English)

    Liu Chang; Du Zhaohui; Zhou Qing; Hu Bo; Li Zhifeng; Yu Li; Xu Tao

    2014-01-01

    Background The presence of intracellular organisms (ICOs) in polymorphonuclear leukocytes obtained from bronchoalveolar lavage fluid (BALF) is a possible method for rapid diagnosis of ventilator-associated pneumonia (VAP).However,the validity of this diagnostic method remains controversial and the diagnostic thresholds reported by investigators were different.Our objective was to evaluate the accuracy of quantification of ICOs in BALF for the diagnosis of VAP,and to detect the best cutoff percentage of PMNs containing ICOs (PIC) in the microscopic examination of BALF for the diagnosis of VAP.Methods This was a prospective multi-center study conducted in 4 ICUs in Wuhan,China,which involved 181 patients suspected of first episode of VAP.BALF was obtained from all enrolled patients.The BALF samples underwent quantitative culture,cytological and bacteriological analysis to detect the culture results,PIC values and the morphological features of microorganisms.Definite diagnosis of VAP was based on pre-set criteria.The receiver-operating characteristic curve was used to detect the best cutoff point for PIG to diagnose VAP,and the diagnostic accuracy was calculated.Moreover,quantitative culture and Gram's stain of BALF were adopted to diagnose VAP,and their diagnostic accuracy was evaluated as well.Results There were 102 patients definitely diagnosed with VAP (VAP group),and 60 patients definitely diagnosed without VAP (no VAP group).We found that ICOs were present in 96.08% (98 out of 102) of VAP patients and 20.00% (12 out of 60) of no VAP patients.The PICs were significantly higher ((9.53±6.65)% vs.(0.52±1.33)%,P<0.01) in VAP group.In our study,the best cutoff point for PIC to diagnose VAP was 1.5%,which had a sensitivity of 94.12%,a specificity of 88.33%,a positive predictive value (PPV) of 93.20% and a negative predictive value (NPV) of 89.83%.The area under the receiveroperating characteristic curve was 0.956 (95% confidence interval,0

  19. Effect of probiotic Lactobacillus (Lacidofil® cap) for the prevention of antibiotic-associated diarrhea: a prospective, randomized, double-blind, multicenter study.

    Science.gov (United States)

    Song, Hyun Joo; Kim, Jin-Yong; Jung, Sung-Ae; Kim, Seong-Eun; Park, Hye-Sook; Jeong, Yoolwon; Hong, Sung Pil; Cheon, Jae Hee; Kim, Won Ho; Kim, Hyo-Jong; Ye, Byong Duk; Yang, Suk-Kyun; Kim, Sang-Woo; Shin, Sung-Jae; Kim, Hyun-Soo; Sung, Jae-Kyu; Kim, Eun Young

    2010-12-01

    Antibiotic-associated diarrhea (AAD) is a common complication of antibiotic use. There is growing interest in probiotics for the treatment of AAD and Clostridium difficile infection because of the wide availability of probiotics. The aim of this multicenter, randomized, placebo-controlled, double-blind trial was to assess the efficacy of probiotic Lactobacillus (Lacidofil® cap) for the prevention of AAD in adults. From September 2008 to November 2009, a total of 214 patients with respiratory tract infection who had begun receiving antibiotics were randomized to receive Lactobacillus (Lacidofil® cap) or placebo for 14 days. Patients recorded bowel frequency and stool consistency daily for 14 days. The primary outcome was the proportion of patients who developed AAD within 14 days of enrollment. AAD developed in 4 (3.9%) of 103 patients in the Lactobacillus group and in 8 (7.2%) of 111 patients in the placebo group (P=0.44). However, the Lactobacillus group showed lower change in bowel frequency and consistency (50/103, 48.5%) than the placebo group (35/111, 31.5%) (P=0.01). Although the Lacidofil® cap does not reduce the rate of occurrence of AAD in adult patients with respiratory tract infection who have taken antibiotics, the Lactobacillus group maintains their bowel habits to a greater extent than the placebo group.

  20. 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

  1. 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.

  2. Multicenter study with a direct acoustic cochlear implant

    NARCIS (Netherlands)

    Lenarz, T.; Zwartenkot, J.W.; Stieger, C.; Schwab, B.; Mylanus, E.A.M.; Caversaccio, M.; Kompis, M.; Snik, A.F.M.; D'Hondt, C.; Mojallal, H.

    2013-01-01

    OBJECTIVE: To confirm the clinical efficacy and safety of a direct acoustic cochlear implant. STUDY DESIGN: Prospective multicenter study. SETTING: The study was performed at 3 university hospitals in Europe (Germany, The Netherlands, and Switzerland). PATIENTS: Fifteen patients with severe-to-profo

  3. 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...

  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. Evaluation of possible associated factors for early childhood caries and severe early childhood caries: a multicenter cross-sectional survey

    NARCIS (Netherlands)

    Özen, B.; van Strijp, A.J.P.; Özer, L.; Olmus, H.; Genc, A.; Cehreli, S.B.

    2016-01-01

    Objectives: The present study evaluated associated factors for developing early childhood caries (ECC) and Severe-ECC (S-ECC) in a group of children aged 24–71 months. Potential positive effects of early dental visit on formation of ECC is investigated as well. Study Design: This was a multicenter,

  6. Evaluation of possible associated factors for early childhood caries and severe early childhood caries: a multicenter cross-sectional survey

    NARCIS (Netherlands)

    Özen, B.; van Strijp, A.J.P.; Özer, L.; Olmus, H.; Genc, A.; Cehreli, S.B.

    2016-01-01

    Objectives: The present study evaluated associated factors for developing early childhood caries (ECC) and Severe-ECC (S-ECC) in a group of children aged 24–71 months. Potential positive effects of early dental visit on formation of ECC is investigated as well. Study Design: This was a multicenter,

  7. 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

  8. 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.

  9. Serum calcium concentration and prostate cancer risk: a multicenter study.

    Science.gov (United States)

    Salem, Sepehr; Hosseini, Mostafa; Allameh, Farzad; Babakoohi, Shahab; Mehrsai, Abdolrasoul; Pourmand, Gholamreza

    2013-01-01

    This study sought to further evaluate the possible effects of serum calcium level on prostate cancer (PC) risk, with considering the age, body mass index (BMI), and sex steroid hormones. Using data from a prospective multicenter study, serum calcium concentration, as well as thorough demographic and medical characteristics, were determined in 194 cases with newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Serum total and ionized calcium levels were categorized into tertiles. Multivariate logistic regression model was used to estimate odds ratios (OR) and corresponding 95% confidence intervals (CI) after adjustment for major potential confounders, including age, BMI, smoking, alcohol, education, occupation, marital status, family history of PC, and sex hormones level. The mean serum calcium level (±SD) in case and control groups was 9.22 (±0.46) mg/dl and 9.48 (±0.51) mg/dl, respectively (P < 0.001). After adjustment for mentioned confounders, a significant trend of decreasing risk was found for serum total calcium concentration (OR = 0.27, 95% CI = 0.12-0.59, comparing the highest with the lowest tertile) and ionized calcium (OR = 0.25, 95% CI = 0.10-0.58). An increase of 1 mg/dl in serum calcium level was associated with a significant decrease in PC risk (OR = 0.52; 95% CI = 0.34-0.76). Our findings reveal the inverse association between serum total and ionized concentrations and PC risk, which supports the hypothesis that calcium may protect against PC. Furthermore, no evidence was found regarding age, BMI, and sex steroid hormones to modify the association between serum calcium and PC risk.

  10. The association between change in body mass index and upper aerodigestive tract cancers in the ARCAGE project: multicenter case-control study.

    LENUS (Irish Health Repository)

    Park, Sungshim Lani

    2011-03-15

    Previous studies reported an inverse relationship between body mass index (BMI) and upper aerodigestive tract (UADT) cancers. Examining change in BMI over time may clarify these previous observations. We used data from 2,048 cases and 2,173 hospital- and population-based controls from ten European countries (alcohol-related cancers and genetic susceptibility in Europe study) to investigate the relationship with BMI and adult change in BMI on UADT cancer risk. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated for associations between BMI at three time intervals and BMI change on UADT cancer development, adjusting for center, age, sex, education, fruit and vegetable intake, smoking and alcohol consumption. We found an inverse relationship between UADT cancers and BMI at time of interview and 2 years before interview. No association was found with BMI at 30 years of age. Regarding BMI change between age 30 and 2 years before interview, BMI decrease (BMI change <-5%) vs. BMI stability (-5% ≤ BMI change <5%) showed no overall association with UADT cancers (OR = 1.15; 95% CI = 0.89, 1.49). An increase in BMI (BMI change ≥+5%) was inversely associated with UADT cancers (OR = 0.74; 95% CI = 0.62, 0.89). BMI gain remained inversely associated across all subsites except for esophageal cancer. When stratified by smoking or by drinking, association with BMI gain was detected only in drinkers and smokers. In conclusion, BMI gain is inversely associated with UADT cancers. These findings may be influenced by smoking and\\/or drinking behaviors and\\/or the development of preclinical UADT cancers and should be corroborated in studies of a prospective nature.

  11. Elderly donor liver grafts are not associated with a higher incidence of biliary complications after liver transplantation : results of a national multicenter study

    NARCIS (Netherlands)

    Westerkamp, Andrie C.; Korkmaz, Kerem S.; Bottema, Jan T.; Ringers, Jan; Polak, Wojciech G.; van den Berg, Aad P.; van Hoek, Bart; Metselaar, Herold J.; Porte, Robert J.

    2015-01-01

    Background: Liver transplantation with livers grafts from elderly donors has been associated with a higher risk of biliary complications. The aim of this study was to examine whether our national protocol could contribute to a lower incidence of biliary complications. Methods: All adult recipients i

  12. A Multicenter Trial Defining a Serum Protein Signature Associated with Pancreatic Ductal Adenocarcinoma

    Directory of Open Access Journals (Sweden)

    Anna S. Gerdtsson

    2015-01-01

    Full Text Available Background. Pancreatic ductal adenocarcinoma (PDAC is an aggressive disease with rapid tumor progression and poor prognosis. This study was motivated by the lack of sensitive and specific PDAC biomarkers and aimed to identify a diagnostic, serum protein signature for PDAC. Methods. To mimic a real life test situation, a multicenter trial comprising a serum sample cohort, including 338 patients with either PDAC or other pancreatic diseases (OPD and controls with nonpancreatic conditions (NPC, was analyzed on 293-plex recombinant antibody microarrays targeting immunoregulatory and cancer-associated antigens. Results. Serum samples collected from different hospitals were analyzed and showed that (i sampling from five different hospitals could not be identified as a preanalytical variable and (ii a multiplexed biomarker signature could be identified, utilizing up to 10 serum markers that could discriminate PDAC from controls, with sensitivities and specificities in the 91–100% range. The first protein profiles associated with the location of the primary tumor in the pancreas could also be identified. Conclusions. The results demonstrate that robust enough serum signatures could be identified in a multicenter trial, potentially contributing to the development of a multiplexed biomarker immunoassay for improved PDAC diagnosis.

  13. EEG Abnormalities Are Associated With Poorer Depressive Symptom Outcomes With Escitalopram and Venlafaxine-XR, but Not Sertraline: Results From the Multicenter Randomized iSPOT-D Study.

    Science.gov (United States)

    Arns, Martijn; Gordon, Evian; Boutros, Nash N

    2017-01-01

    Rationale Limited research is available on electrophysiological abnormalities such as epileptiform EEG or EEG slowing in depression and its association with antidepressant treatment response. Objectives We investigated the association between EEG abnormalities and antidepressant treatment response in the international Study to Predict Optimized Treatment in Depression (iSPOT-D). Methods Of 1008 participants with major depressive disorder randomized to escitalopram, sertraline, or venlafaxine-XR, 622 completed 8 weeks of treatment per protocol. The study also recruited 336 healthy controls. Treatment response was established after 8 weeks using the 17-item Hamilton Rating Scale for Depression (HRSD17). The resting-state EEG was assessed at baseline with eyes closed. EEG abnormalities including epileptiform activity, EEG slowing, and alpha peak frequency (APF) were scored for all subjects, blind to treatment outcome. Results Patients and controls did not differ in the occurrence of EEG abnormalities. Furthermore, in the per protocol sample the occurrence of epileptiform EEG and EEG slowing (as a combined marker) were associated with a reduced likelihood of responding to escitalopram (P = .019; odds ratio [OR] = 3.56) and venlafaxine-XR (P = .043; OR = 2.76), but not sertraline (OR = 0.73). The response rates for this "any EEG abnormality" groups versus the "no-abnormality" group were 33% and 64% for escitalopram and 41% and 66% for venlafaxine-XR, respectively. A slow APF was associated with treatment response only in the sertraline group (P = .21; d = .027). Conclusions EEG abnormalities are associated with nonresponse to escitalopram and venlafaxine-XR, but not sertraline, whereas a slow APF is associated to response for sertraline only.

  14. Does Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Use in Adult Spinal Deformity (ASD) Increase Complications and Are Complications Associated With Location of rhBMP-2 Use?: A Prospective, Multicenter Study of 279 Consecutive Patients.

    Science.gov (United States)

    Bess, Shay; Line, Breton G; Lafarge, Virginie; Schwab, Frank; Shaffrey, Christopher I; Hart, Robert A; Boachie-Adjei, Oheneba; Akbarnia, Behrooz A; Ames, Christopher P; Burton, Douglas C; Deverin, Vedat; Fu, Kai-Ming G; Gupta, Munish; Hostin, Richard; Kebaish, Khaled; Klineberg, Eric; Mundis, Gregory; O'Brien, Michael; Shelokov, Alexis; Smith, Justin S

    2013-11-18

    Study Design. Multi-center, prospective analysis of consecutive ASD patients.Objective. Evaluate complications associated with rhBMP-2 use in ASDSummary of Background Data. Off-label rhBMP-2 use is common, however under-reporting of rhBMP-2 associated complications has been recently scrutinized.Methods. ASD patients consecutively enrolled into a prospective, multicenter database, were evaluated for type and timing of acute perioperative complications. Inclusion criteria: age ≥ 18 years, ASD, spinal arthrodesis >4 levels, and ≥3 months follow-up. Patients divided into those receiving rhBMP-2 (BMP) or no rhBMP-2 (NOBMP). BMP divided into location of use: posterior (PBMP), interbody (IBMP), and interbody + posterior spine (I+PBMP). Correlations between acute perioperative complications and rhBMP-2 use including total dose, dose/level and location of use were evaluated.Results. 279 patients (mean age 57 years, mean spinal levels fused 12.0, mean follow-up 28.8 months) met inclusion criteria. BMP (n = 172; average posterior dose = 2.5 mg/level, average interbody dose = 5 mg/level) had similar age, smoking history, previous spine surgery, total spinal levels fused, estimated blood loss, and duration of hospital stay as NOBMP (n = 107; p>0.05). BMP had greater Charlson Comorbidity Index (1.9 vs. 1.2), greater scoliosis (43° vs. 38°), longer operative time (488.2 vs. 414.6 minutes), more osteotomies/patient (4.0 vs. 1.6) and greater percentage of anteroposterior fusion (APSF; 20.9% vs. 8.4%) than NOBMP, respectively (p0.05). Multivariate analysis demonstrated small to non-existent correlations between rhBMP-2 use and complications.Conclusions. RhBMP-2 use and location of rhBMP-2 use in ASD surgery, at reported doses, does not increase acute major, neurological or wound complications. Research is needed for higher rhBMP-2 dosing and long-term follow-up.

  15. Multicenter prospective study on device-associated infection rates and bacterial resistance in intensive care units of Venezuela: International Nosocomial Infection Control Consortium (INICC) findings.

    Science.gov (United States)

    Empaire, Gabriel D; Guzman Siritt, Maria E; Rosenthal, Victor D; Pérez, Fernando; Ruiz, Yvis; Díaz, Claudia; Di Silvestre, Gabriela; Salinas, Evelyn; Orozco, Nelva

    2017-01-01

    Device-associated healthcare-acquired infections (DA-HAI) pose a threat to patient safety in the intensive care unit (ICU). A DA-HAI surveillance study was conducted by the International Nosocomial Infection Control Consortium (INICC) in two adult medical/surgical ICUs at two hospitals in Caracas, Venezuela, in different periods from March 2008 to April 2015, using the US Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC/NHSN) definitions and criteria, and INICC methods. We followed 1041 ICU patients for 4632 bed days. Central line-associated bloodstream infection (CLABSI) rate was 5.1 per 1000 central line days, ventilator-associated pneumonia (VAP) rate was 7.2 per 1000 mechanical ventilator days, and catheter-associated urinary tract infection (CAUTI) rate was 3.9 per 1000 urinary catheter days, all similar to or lower than INICC rates (4.9 [CLABSI]; 16.5 [VAP]; 5.3 [CAUTI]), and higher than CDC/NHSN rates (0.8 [CLABSI]; 1.1 [VAP]; and 1.3 [CAUTI]). Device utilization ratios were higher than INICC and CDC/NHSN rates, except for urinary catheter, which was similar to INICC. Extra length of stay was 8 days for patients with CLABSI, 9.6 for VAP and 5.7 days for CAUTI. Additional crude mortality was 3.0% for CLABSI, 4.4% for VAP, and 16.9% for CAUTI. DA-HAI rates in our ICUs are higher than CDC/NSHN's and similar to or lower than INICC international rates. © The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.

  16. 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.

  17. Incompatible type A plasma transfusion in patients requiring massive transfusion protocol: Outcomes of an Eastern Association for the Surgery of Trauma multicenter study.

    Science.gov (United States)

    Stevens, W Tait; Morse, Bryan C; Bernard, Andrew; Davenport, Daniel L; Sams, Valerie G; Goodman, Michael D; Dumire, Russell; Carrick, Matthew M; McCarthy, Patrick; Stubbs, James R; Pritts, Timothy A; Dente, Christopher J; Luo-Owen, Xian; Gregory, Jason A; Turay, David; Gomaa, Dina; Quispe, Juan C; Fitzgerald, Caitlin A; Haddad, Nadeem N; Choudhry, Asad; Quesada, Jose F; Zielinski, Martin D

    2017-07-01

    With a relative shortage of type AB plasma, many centers have converted to type A plasma for resuscitation of patients whose blood type is unknown. The goal of this study is to determine outcomes for trauma patients who received incompatible plasma transfusions as part of a massive transfusion protocol (MTP). As part of an Eastern Association for the Surgery of Trauma multi-institutional trial, registry and blood bank data were collected from eight trauma centers for trauma patients (age, ≥ 15 years) receiving emergency release plasma transfusions as part of MTPs from January 2012 to August 2016. Incompatible type A plasma was defined as transfusion to patient blood type B or type AB. Of the 1,536 patients identified, 92% received compatible plasma transfusions and 8% received incompatible type A plasma. Patient characteristics were similar except for greater penetrating injuries (48% vs 36%; p = 0.01) in the incompatible group. In the incompatible group, patients were transfused more plasma units at 4 hours (median, 9 vs. 5; p plasma to patients with blood groups B and AB as part of a MTP does not appear to be associated with significant increases in morbidity or mortality. Therapeutic study, level IV.

  18. Fatty replacement of rotator cuff in brain-injured patients is associated with hemiplegic arm function, but not with tendon tear: A multicenter study.

    Science.gov (United States)

    Beom, Jaewon; Jang, Hye Jin; Han, Tai Ryoon; Oh, Byung-Mo; Paik, Nam-Jong; Yang, Eun Joo; Lee, Shi-Uk

    2015-01-01

    The association between fatty replacement of rotator cuff and hemiplegic upper extremity function has not been defined yet. Moreover, the relationships among rotator cuff tears, shoulder pain, spasticity, and fatty replacement were not clearly studied. We investigated the association of fatty replacement of the supraspinatus and infraspinatus muscles with tendon tear in stroke or brain-injured patients. A total of 72 hemiplegic patients were enrolled in 3 hospitals, and ultrasonography of both shoulders was performed once. Fatty replacement of the supraspinatus and infraspinatus was graded by the visibility of outer contours, pennate pattern, central tendon, and echogenicity. Fatty replacement was observed in 22 (30.6%) out of the 72 patients (in 18 supraspinatus muscles and 12 infraspinatus). Inter-rater agreement (kappa value) between the 2 physiatrists was 0.530 for the supraspinatus, and 0.411 for the infraspinatus. The Fugl-Meyer assessment score, Brunnstrom stage, and modified Barthel index were significantly lower in patients with fatty replacement of the supraspinatus or infraspinatus (group 1) than in those without (group 2). The motor power of both shoulders, the pain-free range of motion, spasticity, and hemiplegic shoulder pain were comparable between the two groups. The tear rate of the supraspinatus, infraspinatus, or subscapularis tendon at the hemiplegic side was higher than that at the contralesional side in each group, although there was no significant difference between group 1 and group 2. Disuse leading to muscle atrophy rather than rotator cuff tear might be the cause of fatty replacement of these muscles, which may be associated with decreased function of the hemiplegic upper extremities.

  19. Prevalence of Chlamydia trachomatis and Neisseria gonorrhea and associated factors among women living with Human Immunodeficiency Virus in Brazil: a multicenter study

    Directory of Open Access Journals (Sweden)

    Angelica E. Miranda

    Full Text Available Abstract Background: Chlamydia trachomatis (CT and Neisseria gonorrhoeae (GC cause infections in the female genital tract, increasing susceptibility to and infectiousness of HIV. The objectives of the present study were to determine the prevalence and associated factors of CT and GC infection among HIV-infected women in Brazil. Methods: Cross-sectional study conducted from March to December 2015, including HIV-infected women attending referral centers in nine states of Brazil, aged 18-49 years, nonpregnant. An interview was conducted including socio-demographic, epidemiological and clinical characteristics. After the interview, gynecological examination was conducted to collect cervical cytology and vaginal secretion to C. trachomatis and N. gonorrhoeae tests through molecular biology. Results: A total of 802 (89.1% women participated. The prevalence of CT was 2.1% (17/802 and CG was 0.9% (7/802. The prevalence of a positive test for both CT and/or GC was 2.7%. The factors associated with positive CT/GC test in the multivariate logistic regression analysis were abnormal Papanicolau smear (OR 4.1; 95% CI: 1.54-11.09 and the presence of abnormal cervical discharge (OR 2.6; 95% CI: 1.02-6.71. Among 377 women who reported previous STI 245 (65.0% reported using condom more frequently after being diagnosed. 62 (16.4% discovered the STI after the partner told he was infected; 157 (41.6% had STI symptoms and looked for care, and 158 (41.9% discovered it in a routine consultation for another reason. Conclusions: The control of STI represents a unique opportunity to improve reproductive health of women living with HIV. STI diagnosis can change their behavior and reduce the sexual transmission of HIV and bacterial STI.

  20. Prevalence of Chlamydia trachomatis and Neisseria gonorrhea and associated factors among women living with Human Immunodeficiency Virus in Brazil: a multicenter study.

    Science.gov (United States)

    Miranda, Angelica E; Silveira, Mariangela F; Travassos, Ana Gabriela; Tenório, Teresinha; Val, Isabel Cristina Chulvis do; Lannoy, Leonor de; Junior, Hortensio Simões de Mattos; Carvalho, Newton Sergio de

    Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) cause infections in the female genital tract, increasing susceptibility to and infectiousness of HIV. The objectives of the present study were to determine the prevalence and associated factors of CT and GC infection among HIV-infected women in Brazil. Cross-sectional study conducted from March to December 2015, including HIV-infected women attending referral centers in nine states of Brazil, aged 18-49 years, nonpregnant. An interview was conducted including socio-demographic, epidemiological and clinical characteristics. After the interview, gynecological examination was conducted to collect cervical cytology and vaginal secretion to C. trachomatis and N. gonorrhoeae tests through molecular biology. A total of 802 (89.1%) women participated. The prevalence of CT was 2.1% (17/802) and CG was 0.9% (7/802). The prevalence of a positive test for both CT and/or GC was 2.7%. The factors associated with positive CT/GC test in the multivariate logistic regression analysis were abnormal Papanicolau smear (OR 4.1; 95% CI: 1.54-11.09) and the presence of abnormal cervical discharge (OR 2.6; 95% CI: 1.02-6.71). Among 377 women who reported previous STI 245 (65.0%) reported using condom more frequently after being diagnosed. 62 (16.4%) discovered the STI after the partner told he was infected; 157 (41.6%) had STI symptoms and looked for care, and 158 (41.9%) discovered it in a routine consultation for another reason. The control of STI represents a unique opportunity to improve reproductive health of women living with HIV. STI diagnosis can change their behavior and reduce the sexual transmission of HIV and bacterial STI. Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

  1. Factors associated with HIV/AIDS diagnostic disclosure to HIV infected children receiving HAART: a multi-center study in Addis Ababa, Ethiopia.

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    Sibhatu Biadgilign

    Full Text Available BACKGROUND: Diagnostic disclosure of HIV/AIDS to a child is becoming an increasingly common issue in clinical practice. Nevertheless, some parents and health care professionals are reluctant to inform children about their HIV infection status. The objective of this study was to identify the proportion of children who have knowledge of their serostatus and factors associated with disclosure in HIV-infected children receiving HAART in Addis Ababa, Ethiopia. METHODS: A cross-sectional study was conducted in five hospitals in Addis Ababa from February 18, 2008-April 28, 2008. The study populations were parents/caretakers and children living with HIV/AIDS who were receiving Highly Active Antiretroviral Therapy (HAART in selected hospitals in Addis Ababa. Univariate and multivariate logistic regression analysis were carried out using SPSS 12.0.1 statistical software. RESULTS: A total of 390 children/caretaker pairs were included in the study. Two hundred forty three children (62.3% were between 6-9 years of age. HIV/AIDS status was known by 68 (17.4% children, 93 (29% caretakers reported knowing the child's serostatus two years prior to our survey, 180 (46.2% respondents said that the child should be told about his/her HIV/AIDS status when he/she is older than 14 years of age. Children less than 9 years of age and those living with educated caregivers are less likely to know their results than their counterparts. Children referred from hospital's in-patient ward before attending the HIV clinic and private clinic were more likely to know their results than those from community clinic. CONCLUSION: The proportion of disclosure of HIV/AIDS diagnosis to HIV-infected children is low. Strengthening referral linkage and health education tailored to educated caregivers are recommended to increase the rate of disclosure.

  2. A multicenter study to quantify systematic variations and associated uncertainties in source positioning with commonly used HDR afterloaders and ring applicators for the treatment of cervical carcinomas

    Energy Technology Data Exchange (ETDEWEB)

    Awunor, O., E-mail: onuora.awunor@stees.nhs.uk [The Medical Physics Department, The James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW, England (United Kingdom); Berger, D. [Department of Radiotherapy, General Hospital of Vienna, Vienna A-1090 (Austria); Kirisits, C. [Department of Radiotherapy, Comprehensive Cancer Center, Medical University of Vienna, Vienna A-1090 (Austria)

    2015-08-15

    Purpose: The reconstruction of radiation source position in the treatment planning system is a key part of the applicator reconstruction process in high dose rate (HDR) brachytherapy treatment of cervical carcinomas. The steep dose gradients, of as much as 12%/mm, associated with typical cervix treatments emphasize the importance of accurate and precise determination of source positions. However, a variety of methodologies with a range in associated measurement uncertainties, of up to ±2.5 mm, are currently employed by various centers to do this. In addition, a recent pilot study by Awunor et al. [“Direct reconstruction and associated uncertainties of {sup 192}Ir source dwell positions in ring applicators using gafchromic film in the treatment planning of HDR brachytherapy cervix patients,” Phys. Med. Biol. 58, 3207–3225 (2013)] reported source positional differences of up to 2.6 mm between ring sets of the same type and geometry. This suggests a need for a comprehensive study to assess and quantify systematic source position variations between commonly used ring applicators and HDR afterloaders across multiple centers. Methods: Eighty-six rings from 20 European brachytherapy centers were audited in the form of a postal audit with each center collecting the data independently. The data were collected by setting up the rings using a bespoke jig and irradiating gafchromic films at predetermined dwell positions using four afterloader types, MicroSelectron, Flexitron, GammaMed, and MultiSource, from three manufacturers, Nucletron, Varian, and Eckert & Ziegler BEBIG. Five different ring types in six sizes (Ø25–Ø35 mm) and two angles (45° and 60°) were used. Coordinates of irradiated positions relative to the ring center were determined and collated, and source position differences quantified by ring type, size, and angle. Results: The mean expanded measurement uncertainty (k = 2) along the direction of source travel was ±1.4 mm. The standard deviation

  3. Update on Anti-Saccharomyces cerevisiae antibodies, anti-nuclear associated anti-neutrophil antibodies and antibodies to exocrine pancreas detected by indirect immunofluorescence as biomarkers in chronic inflammatory bowel diseases: Results of a multicenter study

    Institute of Scientific and Technical Information of China (English)

    S Desplat-Jégo; JC Grimaud; M Veyrac; P Chamouard; RL Humbel; C Johanet; A Escande; J Goetz; N Fabien; N Olsson; E Ballot; J Sarles; JJ Baudon

    2007-01-01

    AIM:Anti-Saccharomyces cerevisiae antibodies (ASCA), anti-nuclear associated anti-neutrophil antibodies (NANA) and antibodies to exocrine pancreas (PAB), are serological tools for discriminating Crohn's disease (CrD) and ulcerative colitis (DC). Like CrD, coeliac disease (CoD) is an inflammatory bowel disease (IBD) associated with (auto) antibodies. Performing a multicenter study we primarily aimed to determine the performance of ASCA, NANA and PAB tests for IBD diagnosis in children and adults, and secondarily to evaluate the prevalence of these markers in CoD.METHODS: Sera of 109 patients with CrD, 78 with UC, 45 with CoD and 50 healthy blood donors were retrospectively included. ASCA, NANA and PAB were detected by indirect immunofluorescence (IIF).RESULTS: ASCA+/NANA- profile displayed a positive predictive value of 94.2% for CrD. Detection of ASCA was correlated with a more severe clinical profile of CrD and treatment of the disease did not influence their serum levels. ASCA positivity was found in 37.9% of active CoD.PAB were found in 36.7% CrD and 13.3% CoD patients and were not correlated with clinical features of CrD, except with an early onset of the disease. Fifteen CrD patients were ASCA negative and PAB positive.CONCLUSION: ASCA and PAB detected by IIF are specific markers for CrD although their presence does not rule out a possible active CoD. The combination of ASCA, NANA and PAB tests improves the sensitivity of immunological markers for CrD. Repeating ASCA, NANA, and PAB testing during the course of CrD has no clinical value.

  4. Primary hepatic lymphoma: a retrospective, multicenter Rare Cancer Network study

    Directory of Open Access Journals (Sweden)

    Gamze Ugurluer

    2016-10-01

    Full Text Available Primary hepatic lymphoma (PHL is a rare malignancy. We aimed to assess the clinical profile, outcome and prognostic factors in PHL through the Rare Cancer Network (RCN. A retrospective analysis of 41 patients was performed. Median age was 62 years (range, 23- 86 years with a male-to-female ratio of 1.9:1.0. Abdominal pain or discomfort was the most common presenting symptom. Regarding B-symptoms, 19.5% of patients had fever, 17.1% weight loss, and 9.8% night sweats. The most common radiological presentation was multiple lesions. Liver function tests were elevated in 56.1% of patients. The most common histopathological diagnosis was diffuse large B-cell lymphoma (65.9%. Most of the patients received Chop-like (cyclophosphamide, doxorubicin, vincristine, and prednisone regimens; 4 patients received radiotherapy (dose range, 30.6-40.0 Gy. Median survival was 163 months, and 5- and 10-year overall survival rates were 77 and 59%, respectively. The 5- and 10-year disease-free and lymphoma-specific survival rates were 69, 56, 87 and 70%, respectively. Multivariate analysis revealed that fever, weight loss, and normal hemoglobin level were the independent factors influencing the outcome. In this retrospective multicenter RCN study, patients with PHL had a relatively better prognosis than that reported elsewhere. Multicenter prospective studies are still warranted to establish treatment guidelines, outcome, and prognostic factors.

  5. Primary Hepatic Lymphoma: A Retrospective, Multicenter Rare Cancer Network Study

    Science.gov (United States)

    Ugurluer, Gamze; Miller, Robert C.; Li, Yexiong; Thariat, Juliette; Ghadjar, Pirus; Schick, Ulrike; Ozsahin, Mahmut

    2016-01-01

    Primary hepatic lymphoma (PHL) is a rare malignancy. We aimed to assess the clinical profile, outcome and prognostic factors in PHL through the Rare Cancer Network (RCN). A retrospective analysis of 41 patients was performed. Median age was 62 years (range, 23-86 years) with a male-to-female ratio of 1.9:1.0. Abdominal pain or discomfort was the most common presenting symptom. Regarding B-symptoms, 19.5% of patients had fever, 17.1% weight loss, and 9.8% night sweats. The most common radiological presentation was multiple lesions. Liver function tests were elevated in 56.1% of patients. The most common histopathological diagnosis was diffuse large B-cell lymphoma (65.9%). Most of the patients received Chop-like (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimens; 4 patients received radiotherapy (dose range, 30.6-40.0 Gy). Median survival was 163 months, and 5- and 10-year overall survival rates were 77 and 59%, respectively. The 5- and 10-year disease-free and lymphoma-specific survival rates were 69, 56, 87 and 70%, respectively. Multivariate analysis revealed that fever, weight loss, and normal hemoglobin level were the independent factors influencing the outcome. In this retrospective multicenter RCN study, patients with PHL had a relatively better prognosis than that reported elsewhere. Multicenter prospective studies are still warranted to establish treatment guidelines, outcome, and prognostic factors. PMID:27746888

  6. Factors Associated with the Duration of Moderate-to-Severe Diarrhea among Children in Rural Western Kenya Enrolled in the Global Enteric Multicenter Study, 2008-2012.

    Science.gov (United States)

    Schilling, Katharine A; Omore, Richard; Derado, Gordana; Ayers, Tracy; Ochieng, John B; Farag, Tamer H; Nasrin, Dilruba; Panchalingam, Sandra; Nataro, James P; Kotloff, Karen L; Levine, Myron M; Oundo, Joseph; Parsons, Michelle B; Bopp, Cheryl; Laserson, Kayla; Stauber, Christine E; Rothenberg, Richard; Breiman, Robert F; O'Reilly, Ciara E; Mintz, Eric D

    2017-07-01

    Diarrheal disease is a leading cause of death among young children worldwide. As rates of acute diarrhea (AD; 1-6 days duration) have decreased, persistent diarrhea (PD; > 14 days duration) accounts for a greater proportion of the diarrheal disease burden. We describe factors associated with the duration of moderate-to-severe diarrhea in Kenyan children diarrhea (ProAD; 7-13 days duration), and 73 (7%) had PD. We constructed a Cox proportional hazards model to identify factors associated with diarrheal duration. Risk factors independently associated with longer diarrheal duration included infection with Cryptosporidium (hazard ratio [HR]: 0.868, P = 0.035), using an unimproved drinking water source (HR: 0.87, P = 0.035), and being stunted at enrollment (HR: 0.026, P improve drinking water are imperative, and nutrition should be improved through exclusive breastfeeding in infants ≤ 6 months and appropriate continued feeding practices for ill children.

  7. A Multicenter Study of Volumetric Computed Tomography for Staging Malignant Pleural Mesothelioma.

    Science.gov (United States)

    Rusch, Valerie W; Gill, Ritu; Mitchell, Alan; Naidich, David; Rice, David C; Pass, Harvey I; Kindler, Hedy L; De Perrot, Marc; Friedberg, Joseph

    2016-10-01

    Standard imaging modalities are inaccurate in staging malignant pleural mesothelioma (MPM). Single-institution studies suggest that volumetric computed tomography (CT) is more accurate but labor intensive. We established a multicenter network to test interobserver variability, accuracy (relative to pathologic stage), and the prognostic significance of semiautomated volumetric CT. Six institutions electronically submitted to an established multicenter database clinical and pathologic data for patients with MPM who had operations. Institutional radiologists reviewed preoperative CT scans for quality and then submitted by electronic network (AG Mednet, www.agmednet.com) to the biostatistical center. Two reference radiologists blinded to clinical data performed semiautomated tumor volume calculations using Vitrea Enterprise 6.0 software (Vital Images, Minnetonka, MN) and then submitted readings to the biostatistical center. Study end points included feasibility of the network, interobserver variability for volumetric CT, correlation of tumor volume to pTN stages, and overall survival (OS). Of 164 patients, the CT scans for 129 were analyzable and read by reference radiologists. Most tumors were less than 500 cm(3). A small bias was observed between readers because one provided consistently larger measurements than the other (mean difference, 47.9; p = .0027), but for 80%, the absolute difference was 200 cm(3) or less. Spearman correlation between readers was 0.822. Volume correlated with pTN stages and OS, best defined by three groups with average volumes of 91.2, 245.3, and 511.3 cm(3) associated with median OS of 37, 18, and 8 months, respectively. For the first time, a multicenter network was established and initial correlations of tumor volume with pTN stages and OS are shown. A larger multicenter international study is planned to confirm the results and refine correlations. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights

  8. Naturally Acquired Binding-Inhibitory Antibodies to Plasmodium vivax Duffy Binding Protein in Pregnant Women Are Associated with Higher Birth Weight in a Multicenter Study

    Science.gov (United States)

    Requena, Pilar; Arévalo-Herrera, Myriam; Menegon, Michela; Martínez-Espinosa, Flor E.; Padilla, Norma; Bôtto-Menezes, Camila; Malheiro, Adriana; Hans, Dhiraj; Castellanos, Maria Eugenia; Robinson, Leanne; Samol, Paula; Kochar, Swati; Kochar, Sanjay K.; Kochar, Dhanpat K.; Desai, Meghna; Sanz, Sergi; Quintó, Llorenç; Mayor, Alfredo; Rogerson, Stephen; Mueller, Ivo; Severini, Carlo; del Portillo, Hernando A.; Bardají, Azucena; Chitnis, Chetan C.; Menéndez, Clara; Dobaño, Carlota

    2017-01-01

    A vaccine to eliminate malaria would need a multi-stage and multi-species composition to achieve robust protection, but the lack of knowledge about antigen targets and mechanisms of protection precludes the development of fully efficacious malaria vaccines, especially for Plasmodium vivax (Pv). Pregnant women constitute a risk population who would greatly benefit from a vaccine preventing the adverse events of Plasmodium infection during gestation. We hypothesized that functional immune responses against putative targets of naturally acquired immunity to malaria and vaccine candidates will be associated with protection against malaria infection and/or poor outcomes during pregnancy. We measured (i) IgG responses to a large panel of Pv and Plasmodium falciparum (Pf) antigens, (ii) the capacity of anti-Pv ligand Duffy binding protein (PvDBP) antibodies to inhibit binding to Duffy antigen, and (iii) cellular immune responses to two Pv antigens, in a subset of 1,056 pregnant women from Brazil, Colombia, Guatemala, India, and Papua New Guinea (PNG). There were significant intraspecies and interspecies correlations for most antibody responses (e.g., PfMSP119 versus PfAMA1, Spearman’s rho = 0.81). Women from PNG and Colombia had the highest levels of IgG overall. Submicroscopic infections seemed sufficient to boost antibody responses in Guatemala but not antigen-specific cellular responses in PNG. Brazil had the highest percentage of Duffy binding inhibition (p-values versus Colombia: 0.040; Guatemala: 0.047; India: 0.003, and PNG: 0.153) despite having low anti-PvDBP IgG levels. Almost all antibodies had a positive association with present infection, and coinfection with the other species increased this association. Anti-PvDBP, anti-PfMSP1, and anti-PfAMA1 IgG levels at recruitment were positively associated with infection at delivery (p-values: 0.010, 0.003, and 0.023, respectively), suggesting that they are markers of malaria exposure. Peripheral blood

  9. [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

  10. Alcohol Consumption among University Students in North Rhine-Westphalia, Germany--Results from a Multicenter Cross-Sectional Study

    Science.gov (United States)

    Akmatov, Manas K.; Mikolajczyk, Rafael T.; Meier, Sabine; Kramer, Alexander

    2011-01-01

    Objective: To assess alcohol use and problem drinking among university students in the German Federal State of North Rhine-Westphalia (NRW) and to examine the associated factors. Method: A multicenter cross-sectional study was conducted in 16 universities in 2006-2007 in NRW by a standardized questionnaire and 3,306 students provided information…

  11. Alcohol Consumption among University Students in North Rhine-Westphalia, Germany--Results from a Multicenter Cross-Sectional Study

    Science.gov (United States)

    Akmatov, Manas K.; Mikolajczyk, Rafael T.; Meier, Sabine; Kramer, Alexander

    2011-01-01

    Objective: To assess alcohol use and problem drinking among university students in the German Federal State of North Rhine-Westphalia (NRW) and to examine the associated factors. Method: A multicenter cross-sectional study was conducted in 16 universities in 2006-2007 in NRW by a standardized questionnaire and 3,306 students provided information…

  12. Epidemiology, Seasonality and Factors Associated with Rotavirus Infection among Children with Moderate-to-Severe Diarrhea in Rural Western Kenya, 2008–2012: The Global Enteric Multicenter Study (GEMS)

    Science.gov (United States)

    Omore, Richard; Tate, Jacqueline E.; O’Reilly, Ciara E.; Ayers, Tracy; Williamson, John; Moke, Feny; Schilling, Katie A.; Awuor, Alex O.; Jaron, Peter; Ochieng, John B.; Oundo, Joseph; Parashar, Umesh D.; Parsons, Michele B.; Bopp, Cheryl C.; Nasrin, Dilruba; Farag, Tamer H.; Kotloff, Karen L.; Nataro, James P.; Panchalingam, Sandra; Levine, Myron M.; Laserson, Kayla F.; Nuorti, J. Pekka; Mintz, Eric D.; Breiman, Robert F.

    2016-01-01

    Objective To evaluate factors associated with rotavirus diarrhea and to describe severity of illness among children <5 years old with non-dysenteric, moderate-to-severe diarrhea (MSD) in rural western Kenya. Methods We analyzed data from children <5 years old with non-dysenteric MSD enrolled as cases in the Global Enteric Multicenter Study (GEMS) in Kenya. A non-dysenteric MSD case was defined as a child with ≥3 loose stools in 24 hrs. and one or more of the following: sunken eyes, skin tenting, intravenous rehydration, or hospitalization, who sought care at a sentinel health center within 7 days of illness onset. Rotavirus antigens in stool samples were detected by ELISA. Demographic and clinical information was collected at enrollment and during a single follow-up home visit at approximately 60 days. We analyzed diarrhea severity using a GEMS 17 point numerical scoring system adapted from the Vesikari score. We used logistic regression to evaluate factors associated with rotavirus infection. Results From January 31, 2008 to September 30, 2012, among 1,637 (92%) non-dysenteric MSD cases, rotavirus was detected in stools of 245 (15.0%). Rotavirus-positive compared with negative cases were: younger (median age, 8 vs. 13 months; p<0.0001), had more severe illness (median severity score, 9 vs 8; p<0.0001) and had to be hospitalized more frequently (37/245 [15.1%] vs. 134/1,392 [9.6%]), p <0.013). Independent factors associated with rotavirus infection included age 0–11 months old (aOR = 5.29, 95% CI 3.14–8.89) and presenting with vomiting ≥3 times/24hrs (aOR = 2.58, 95% CI [1.91–3.48]). Rotavirus was detected more commonly in warm and dry months than in the cool and rainy months (142/691 [20%] vs 70/673 [10%]) p<0.0001). Conclusions Diarrhea caused by rotavirus is associated with severe symptoms leading to hospitalization. Consistent with other settings, infants had the greatest burden of disease. PMID:27494517

  13. Mycobacterium tuberculosis pyrazinamide resistance determinants: a multicenter study.

    Science.gov (United States)

    Miotto, Paolo; Cabibbe, Andrea M; Feuerriegel, Silke; Casali, Nicola; Drobniewski, Francis; Rodionova, Yulia; Bakonyte, Daiva; Stakenas, Petras; Pimkina, Edita; Augustynowicz-Kopeć, Ewa; Degano, Massimo; Ambrosi, Alessandro; Hoffner, Sven; Mansjö, Mikael; Werngren, Jim; Rüsch-Gerdes, Sabine; Niemann, Stefan; Cirillo, Daniela M

    2014-10-21

    Pyrazinamide (PZA) is a prodrug that is converted to pyrazinoic acid by the enzyme pyrazinamidase, encoded by the pncA gene in Mycobacterium tuberculosis. Molecular identification of mutations in pncA offers the potential for rapid detection of pyrazinamide resistance (PZA(r)). However, the genetic variants are highly variable and scattered over the full length of pncA, complicating the development of a molecular test. We performed a large multicenter study assessing pncA sequence variations in 1,950 clinical isolates, including 1,142 multidrug-resistant (MDR) strains and 483 fully susceptible strains. The results of pncA sequencing were correlated with phenotype, enzymatic activity, and structural and phylogenetic data. We identified 280 genetic variants which were divided into four classes: (i) very high confidence resistance mutations that were found only in PZA(r) strains (85%), (ii) high-confidence resistance mutations found in more than 70% of PZA(r) strains, (iii) mutations with an unclear role found in less than 70% of PZA(r) strains, and (iv) mutations not associated with phenotypic resistance (10%). Any future molecular diagnostic assay should be able to target and identify at least the very high and high-confidence genetic variant markers of PZA(r); the diagnostic accuracy of such an assay would be in the range of 89.5 to 98.8%. Importance: Conventional phenotypic testing for pyrazinamide resistance in Mycobacterium tuberculosis is technically challenging and often unreliable. The development of a molecular assay for detecting pyrazinamide resistance would be a breakthrough, directly overcoming both the limitations of conventional testing and its related biosafety issues. Although the main mechanism of pyrazinamide resistance involves mutations inactivating the pncA enzyme, the highly diverse genetic variants scattered over the full length of the pncA gene and the lack of a reliable phenotypic gold standard hamper the development of molecular diagnostic

  14. Implementation of departmental quality strategies is positively associated with clinical practice: results of a multicenter study in 73 hospitals in 7 European countries.

    NARCIS (Netherlands)

    Suñol, R.; Wagner, C.; Arah, O.A.; Kristensen, S.; Pfaff, H.; Klazinga, N.; Thompson, C.A.; Wang, A.; DerSarkissian, M.; Bartels, P.; Michel, P.; Groene, O.

    2015-01-01

    Background: Given the amount of time and resources invested in implementing quality programs in hospitals, few studies have investigated their clinical impact and what strategies could be recommended to enhance its effectiveness. Objective: To assess variations in clinical practice and explore

  15. IL1RL1 Gene Variants and Nasopharyngeal IL1RL-a Levels Are Associated with Severe RSV Bronchiolitis : A Multicenter Cohort Study

    NARCIS (Netherlands)

    Faber, Tina E.; Schuurhof, Annemieke; Vonk, Annelies; Koppelman, Gerard H.; Hennus, Marije P.; Kimpen, Jan L. L.; Janssen, Riny; Bont, Louis J.

    2012-01-01

    Background: Targets for intervention are required for respiratory syncytial virus (RSV) bronchiolitis, a common disease during infancy for which no effective treatment exists. Clinical and genetic studies indicate that IL1RL1 plays an important role in the development and exacerbations of asthma. Hu

  16. IL1RL1 Gene Variants and Nasopharyngeal IL1RL-a Levels Are Associated with Severe RSV Bronchiolitis : A Multicenter Cohort Study

    NARCIS (Netherlands)

    Faber, Tina E.; Schuurhof, Annemieke; Vonk, Annelies; Koppelman, Gerard H.; Hennus, Marije P.; Kimpen, Jan L. L.; Janssen, Riny; Bont, Louis J.

    2012-01-01

    Background: Targets for intervention are required for respiratory syncytial virus (RSV) bronchiolitis, a common disease during infancy for which no effective treatment exists. Clinical and genetic studies indicate that IL1RL1 plays an important role in the development and exacerbations of asthma.

  17. Should we use laparoscopic adrenalectomy for metastases? Scandinavian multicenter study

    DEFF Research Database (Denmark)

    Marangos, Irina Pavlik; Kazaryan, Airazat M; Rosseland, Arne R;

    2009-01-01

    carcinoma, 5 lung carcinoma, 4 melanoma, and 1 hepatocellular metastases. The resection margin was not free in one case (3.7%). The median hospital stay was 2 (1-21) days. The median length of survival was 29 +/- 2.1 months for all patients. CONCLUSION: Laparoscopic adrenalectomy for metastases is feasible......INTRODUCTION: Laparoscopic adrenalectomy for metastases is considered controversial. Multicenter retrospective study was performed to gain new knowledge in this issue. MATERIALS AND METHODS: From January 1997 till November 2008, 41 adrenalectomies were performed during follow-up of the patients...... operated for malignant tumors. The median age was 64 (52-77) years. Metastases were confirmed in 31/41 cases. Metastatic lesions were further studied and to define factors influencing on survival, patients were divided to sub-groups of metachronous/synchronous, tumor origin and tumor size. RESULTS...

  18. Efficacy and Safety of Danshen Compound Tablets in Preventing Thalidomide-Associated Thromboembolism in Patients with Multiple Myeloma: A Multicenter Retrospective Study

    Science.gov (United States)

    Yin, Qing-song; Chen, Lin; Mi, Rui-hua; Ai, Hao; Yin, Jun-jie; Liu, Xiao-juan; Wei, Xu-dong

    2016-01-01

    Background Currently available antithrombotic prophylaxis is not perfectly reliable in elderly patients. The aim of this retrospective study was to evaluate the efficacy and safety of Compound Danshen Tablet (CDT) in preventing thromboembolism in multiple myeloma (MM) patients treated with thalidomide-based regimens. Material/Methods MM patients treated with thalidomide-based regimens were retrospectively reviewed between January 2008 and March 2015. Patients were categorized into 3 cohorts based on thromboembolic prophylaxis used: CDT, Warfarin Tablet, and no prophylaxis. Venous thromboembolism (VTE), other adverse effects (AEs), and the changes of D-dimer and fibrinogen levels were monitored. Results Seven out of 313 MM patients (2.24%) developed venous thrombosis events (VTE) in this retrospective study, all clustering in the no prophylaxis cohort. Three patients of the Warfarin cohort (3.19%) experienced hemorrhage. Neither VTE events nor serious AEs were observed in the CDT cohort. Following Compound Danshen or Warfarin treatment for 3 months, the D-dimer and fibrinogen levels (in particular the D-dimer level) (all Pthalidomide-based regimens, and is well tolerated in long-term use. PMID:27760978

  19. Anti-Interleukin-6 Receptor Tocilizumab for Severe Juvenile Idiopathic Arthritis-Associated Uveitis Refractory to Anti-Tumor Necrosis Factor Therapy: A Multicenter Study of Twenty-Five Patients.

    Science.gov (United States)

    Calvo-Río, Vanesa; Santos-Gómez, Montserrat; Calvo, Inmaculada; González-Fernández, M Isabel; López-Montesinos, Berta; Mesquida, Marina; Adán, Alfredo; Hernández, María Victoria; Maíz, Olga; Atanes, Antonio; Bravo, Beatriz; Modesto, Consuelo; Díaz-Cordovés, Gisela; Palmou-Fontana, Natalia; Loricera, Javier; González-Vela, M C; Demetrio-Pablo, Rosalía; Hernández, J L; González-Gay, Miguel A; Blanco, Ricardo

    2017-03-01

    To assess the efficacy of tocilizumab (TCZ) for the treatment of juvenile idiopathic arthritis (JIA)-associated uveitis. We conducted a multicenter study of patients with JIA-associated uveitis that was refractory to conventional immunosuppressive drugs and anti-tumor necrosis factor (anti-TNF) agents. We assessed 25 patients (21 female; 47 affected eyes) with a mean ± SD age of 18.5 ± 8.3 years. Uveitis was bilateral in 22 patients. Cystoid macular edema was present in 9 patients. Ocular sequelae found at initiation of TCZ included cataracts (n = 13), glaucoma (n = 7), synechiae (n = 10), band keratopathy (n = 12), maculopathy (n = 9), and amblyopia (n = 5). Before TCZ, patients had received corticosteroids, conventional immunosuppressive drugs, and biologic agents (median 2 [range 1-5]), including adalimumab (n = 24), etanercept (n = 8), infliximab (n = 7), abatacept (n = 6), rituximab (n = 2), anakinra (n = 1), and golimumab (n = 1). Patients received 8 mg/kg TCZ intravenously every 4 weeks in most cases. TCZ yielded rapid and maintained improvement in all ocular parameters. After 6 months of therapy, 79.2% of patients showed improvement in anterior chamber cell numbers, and 88.2% showed improvement after 1 year. Central macular thickness measured by optical coherence tomography in patients with cystoid macular edema decreased from a mean ± SD of 401.7 ± 86.8 μm to 259.1 ± 39.5 μm after 6 months of TCZ (P = 0.012). The best-corrected visual acuity increased from 0.56 ± 0.35 to 0.64 ± 0.32 (P uveitis was observed in 19 of 25 patients. Significant reduction in the prednisone dosage was also achieved. The main adverse effects were severe autoimmune thrombocytopenia in 1 patient, pneumonia and then autoimmune anemia and thrombocytopenia in 1 patient, and viral conjunctivitis and bullous impetigo in 1 patient. TCZ appears to be a useful therapy for severe refractory JIA-associated

  20. Routine Cine-CMR for Prosthesis Associated Mitral Regurgitation – A Multicenter Comparison to Echocardiography

    Science.gov (United States)

    Simprini, Lauren A.; Afroz, Anika; Cooper, Mitchell A.; Klem, Igor; Jensen, Christoph; Kim, Raymond J.; Srichai, Monvadi B.; Heitner, John F.; Sood, Michael; Chandy, Elizabeth; Shah, Dipan J.; Lopez-Mattei, Juan; Biederman, Robert W.; Grizzard, John D.; Fuisz, Anthon; Ghafourian, Kambiz; Farzaneh-Far, Afshin; Weinsaft, Jonathan

    2016-01-01

    Background/Aim MR is an important complication after PMV. Transthoracic echocardiography is widely used to screen for native MR, but can be limited with PMV. Cine-CMR holds potential to non-invasively assess regurgitant severity based on MR-induced inter-voxel dephasing. This study evaluated routine cine-CMR for visual assessment of prosthetic mitral valve (PMV) associated mitral regurgitation (MR). Methods Routine cine-CMR was performed at 9 sites. A uniform protocol was used to grade MR based on jet size in relation to the left atrium (mild 2/3): MR was graded in each long axis orientation, with overall severity based on cumulative grade. Cine-CMR was also scored for MR density and pulmonary vein systolic flow reversal (PSFR). Visual interpretation was compared to quantitative analysis in a single center (derivation) cohort, and to transesophageal echocardiography (TEE) in a multicenter (validation) cohort. Results The population comprised 85 PMV patients (59% mechanical, 41% bioprosthetic). Among the derivation cohort (n=25), quantitative indices paralleled visual scores, with stepwise increases in jet size and density in relation to visually graded MR severity (both p=0.001): Patients with severe MR had nearly a 3-fold increase in quantitative jet area (p=0.002), and 2-fold increase in density (p=0.04) than did others. Among the multicenter cohort, cine-CMR and TEE (Δ=2±3 days) demonstrated moderate agreement (κ=0.44); 64% of discordances differed by ≤ 1 grade (Δ=1.2±0.5). Using a TEE reference, cine-CMR yielded excellent diagnostic performance for severe MR (sensitivity, negative predictive value=100%). Patients with visually graded severe MR also had more frequent PVSFR (pcine-CMR. Conclusions Cine-CMR is useful for assessment of PMV-associated MR, which manifests concordant quantitative and qualitative changes in size and density of inter-voxel dephasing. Visual MR assessment based on jet size provides an accurate non-invasive means of screening for

  1. Routine cine-CMR for prosthesis-associated mitral regurgitation: a multicenter comparison to echocardiography.

    Science.gov (United States)

    Simprini, Lauren A; Afroz, Anika; Cooper, Mitchell A; Klem, Igor; Jensen, Christoph; Kim, Raymond J; Srichai, Monvadi B; Heitner, John F; Sood, Michael; Chandy, Elizabeth; Shah, Dipan J; Lopez-Mattei, Juan; Biederman, Robert W; Grizzard, John D; Fuisz, Anthon; Ghafourian, Kambiz; Farzaneh-Far, Afshin; Weinsaft, Jonathan

    2014-09-01

    Mitral regurgitation (MR) is an important complication after prosthetic mitral valve (PMV) implantation. Transthoracic echocardiography is widely used to screen for native MR, but can be limited with PMV. Cine-cardiac magnetic resonance (CMR) holds the potential for the non-invasive assessment of regurgitant severity based on MR-induced inter-voxel dephasing. The study aim was to evaluate routine cine-CMR for the visual assessment of PMV-associated MR. Routine cine-CMR was performed at nine sites. A uniform protocol was used to grade MR based on jet size in relation to the left atrium (mild 2/3). MR was graded in each long-axis orientation, with overall severity based on cumulative grade. Cine-CMR was also scored for MR density and pulmonary vein systolic flow reversal (PVSFR). Visual interpretation was compared to quantitative analysis in a single-center (derivation) cohort, and to transesophageal echocardiography (TEE) in a multicenter (validation) cohort. The population comprised 85 PMV patients (59% mechanical valves, 41% bioprostheses). Among the derivation cohort (n = 25), quantitative indices paralleled visual scores, with stepwise increases in jet size and density in relation to visually graded MR severity (both p = 0.001). Patients with severe MR had an almost three-fold increase in quantitative jet area (p = 0.002), and a two-fold increase in density (p = 0.04) than did other patients. Among the multicenter cohort, cine-CMR and TEE (Δ =. 2 ± 3 days) demonstrated moderate agreement (κ = 0.44); 64% of discordances differed by ≤ 1 grade (Δ = 1.2 ± 0.5). Using a TEE reference, cine-CMR yielded excellent diagnostic performance for severe MR (sensitivity, negative predictive value = 100%). Patients with visually graded severe MR also had more frequent PVSFR (p cine-CMR. Cine-CMR is useful for the assessment of PMV-associated MR, which manifests concordant quantitative and qualitative changes in size and density of inter-voxel dephasing. Visual MR

  2. Epidemiology, severity classification, and outcome of moderate and severe traumatic brain injury: a prospective multicenter study

    NARCIS (Netherlands)

    Andriessen, T.M.J.C.; Horn, J.; Franschman, G.; Naalt, J. van der; Haitsma, I.; Jacobs, B.; Steyerberg, E.W.; Vos, P.E.

    2011-01-01

    Changes in the demographics, approach, and treatment of traumatic brain injury (TBI) patients require regular evaluation of epidemiological profiles, injury severity classification, and outcomes. This prospective multicenter study provides detailed information on TBI-related variables of 508 moderat

  3. Epidemiology, Severity Classification, and Outcome of Moderate and Severe Traumatic Brain Injury: A Prospective Multicenter Study

    NARCIS (Netherlands)

    T.M.J.C. Andriessen; J. Horn; G. Franschman; J. van der Naalt; I. Haitsma; B. Jacobs; E.W. Steyerberg; P.E. Vos

    2011-01-01

    Changes in the demographics, approach, and treatment of traumatic brain injury (TBI) patients require regular evaluation of epidemiological profiles, injury severity classification, and outcomes. This prospective multicenter study provides detailed information on TBI-related variables of 508 moderat

  4. 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

    1999-01-01

    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

  5. 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 cel

  6. Epidemiology, Severity Classification, and Outcome of Moderate and Severe Traumatic Brain Injury : A Prospective Multicenter Study

    NARCIS (Netherlands)

    Andriessen, Teuntje M. J. C.; Horn, Janneke; Franschman, Gaby; van der Naalt, Joukje; Haitsma, Iain; Jacobs, Bram; Steyerberg, Ewout W.; Vos, Pieter E.

    2011-01-01

    Changes in the demographics, approach, and treatment of traumatic brain injury (TBI) patients require regular evaluation of epidemiological profiles, injury severity classification, and outcomes. This prospective multicenter study provides detailed information on TBI-related variables of 508 moderat

  7. New Predictive Hematologic Parameters in Chronic Rhinosinusitis: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Beyhan Yilmaz

    2016-12-01

    Full Text Available INTRODUCTION: Our aim was to investigate whether Neutrophil-Lymphocyte Ratio (NLR, Platelet-Lymphocyte Ratio (PLR and Mean Platelet Volume parameters (MPV may be utilized as inflammatory markers of chronic rhinosinusitis with nasal polyps (CRSwNP and without nasal polyps (CRSsNP. METHODS: This retrospective multicenter study was performed on 647 patients who were underwent endoscopic sinus surgery. Clinical and preoperative laboratory data of patients were screened retrospectively. The study and control groups were compared for the parameters NLR, PLR, MPV, neutrophils, lymphocytes, and platelets. RESULTS: Of the 647 patients, 313 were in the CRSwNP group, 334 were in the CRSsNP group. There were 93 individuals in the control group. NLR and PLR levels were significantly higher in study groups compared to control group (p < 0.001. But no statistically significant differences were identified between CRSwNP group and CRSsNP group in terms of NLR, PLR, MPV levels. DISCUSSION AND CONCLUSION: We speculate that high NLR and PLR values may be useful inflammatory indicator for CRSwNP and CRSsNP groups. We believe these parameters will have increasing clinical use in the future on treatment options and prognosis.

  8. Multicenter Case-Control Study on Restless Legs Syndrome in Multiple Sclerosis: the REMS Study

    Science.gov (United States)

    Manconi, Mauro; Ferini-Strambi, Luigi; Filippi, Massimo; Bonanni, Enrica; Iudice, Alfonso; Murri, Luigi; Gigli, Gian Luigi; Fratticci, Lara; Merlino, Giovanni; Terzano, Giovanni; Granella, Franco; Parrino, Liborio; Silvestri, Rosalia; Aricò, Irene; Dattola, Vincenzo; Russo, Giovanna; Luongo, Carmela; Cicolin, Alessandro; Tribolo, Antonella; Cavalla, Paola; Savarese, Mariantonietta; Trojano, Maria; Ottaviano, Salvatore; Cirignotta, Fabio; Simioni, Valentina; Salvi, Fabrizio; Mondino, Fiorella; Perla, Franco; Chinaglia, Giorgia; Zuliani, Cristina; Cesnik, Edward; Granieri, Enrico; Placidi, Fabio; Palmieri, Maria Giuseppina; Manni, Raffaele; Terzaghi, Michele; Bergamaschi, Roberto; Rocchi, Raffaele; Ulivelli, Monica; Bartalini, Sabina; Ferri, Raffaele; Fermo, Salvatore Lo; Ubiali, Emilio; Viscardi, Massimo; Rottoli, Mariarosa; Nobili, Lino; Protti, Alessandra; Ferrillo, Franco; Allena, Marta; Mancardi, Gianluigi; Guarnieri, Biancamaria; Londrillo, Francesco

    2008-01-01

    Study objectives: To verify the existence of a symptomatic form of restless legs syndrome (RLS) secondary to multiple sclerosis (MS) and to identify possible associated risk factors. Design: Prospective, multicenter, case-control epidemiologic survey. Settings: Twenty sleep centers certified by the Italian Association of Sleep Medicine. Patients: Eight hundred and sixty-one patients affected by MS and 649 control subjects. Interventions: N/A. Measures and results: Data regarding demographic and clinical factors, presence and severity of RLS, the results of hematologic tests, and visual analysis of cerebrospinal magnetic resonance imaging studies were collected. The prevalence of RLS was 19% in MS and 4.2% in control subjects, with a risk to be affected by RLS of 5.4 (95%confidence interval: 3.56–8.26) times greater for patients with MS than for control subjects. In patients with MS, the following risk factors for RLS were significant: older age; longer MS duration; the primary progressive MS form; higher global, pyramidal, and sensory disability; and the presence of leg jerks before sleep onset. Patients with MS and RLS more often had sleep complaints and a higher intake of hypnotic medications than patients with MS without RLS. RLS associated with MS was more severe than that of control subjects. Conclusions: RLS is significantly associated with MS, especially in patients with severe pyramidal and sensory disability. These results strengthen the idea that the inflammatory damage correlated with MS may induce a secondary form of RLS. As it does in idiopathic cases, RLS has a significant impact on sleep quality in patients with MS; therefore, it should be always searched for, particularly in the presence of insomnia unresponsive to treatment with common hypnotic drugs. Citation: Manconi M; Ferini-Strambi L; Filippi M; Bonanni E; Iudice A; Murri L; Gigli GL; Fratticci L; Merlino G; Terzano G; Granella F; Parrino L; Silvestri R; Aricò I; Dattola V; Russo G; Luongo

  9. [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], Pcase replacement (OR=3.95 [2.28-6.82] Pcase 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.

  10. Tree-structured survival analysis of patients with Pseudomonas aeruginosa bacteremia: A multicenter observational cohort study.

    Science.gov (United States)

    Yoon, Young Kyung; Kim, Hyun Ah; Ryu, Seong Yeol; Lee, Eun Jung; Lee, Mi Suk; Kim, Jieun; Park, Seong Yeon; Yang, Kyung Sook; Kim, Shin Woo

    2017-02-01

    This study aimed to construct a prediction algorithm, which is readily applicable in the clinical setting, to determine the mortality rate for patients with P. aeruginosa bacteremia. A multicenter observational cohort study was performed retrospectively in seven university-affiliated hospitals in Korea from March 2012 to February 2015. In total, 264 adult patients with monomicrobial P. aeruginosa bacteremia were included in the analyses. Among the predictors independently associated with 30-day mortality in the Cox regression model, Pitt bacteremia score >2 and high-risk source of bacteremia were identified as critical nodes in the tree-structured survival analysis. Particularly, the empirical combination therapy was not associated with any survival benefit in the Cox regression model compared to the empirical monotherapy. This study suggests that determining the infection source and evaluating the clinical severity are critical to predict the clinical outcome in patients with P. aeruginosa bacteremia.

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

    Science.gov (United States)

    Halbach, Nicky; Smeets, Eric E; 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

    2016-09-01

    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 Wiley Periodicals, Inc.

  12. 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.

  13. Ras-Association Domain Family 1 Isoform A (RASSF1A) Gene Polymorphism rs1989839 is Associated with Risk and Metastatic Potential of Osteosarcoma in Young Chinese Individuals: A Multi-Center, Case-Control Study.

    Science.gov (United States)

    Xu, Hongwei; Zhan, Wang; Chen, Zhiyuan

    2016-11-23

    BACKGROUND The ras-association domain family 1 isoform A (RASSF1A) gene serves as a bona fide tumor suppressor gene. The polymorphisms in RASSF1A were previously reported to be associated with the risk of solid malignant tumors. We hypothesized herein that RASSF1A gene polymorphisms are involved in the risk and prognosis of osteosarcoma (OS). MATERIAL AND METHODS We recruited 279 young OS cases and 286 tumor-free controls from the east Chinese population. Five tagSNPs of RASSF1A gene (rs2236947A/C, rs2073497A/C, rs1989839C/T, rs72932987C/T, and rs4688728G/T) were genotyped. DNA was isolated from blood samples and then underwent PCR analysis for genotyping. RESULTS rs1989839C/T is an important predictor of osteosarcoma risk and outcome. The CT genotype of rs1989839 is highly related to elevated risk of osteosarcoma. Furthermore, rs1989839C/T is also associated with the Enneking stage of osteosarcoma and risk of lung metastasis. One of the other 4 SNPs, rs2236947A/C, shows a borderline significance in predicting osteosarcoma risk. CONCLUSIONS Our study is the first to prove that RASSF1A gene polymorphisms may potentially be predictive for osteosarcoma risk and prognosis.

  14. 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

    Age-related white matter changes (WMC) are thought to be a marker of vascular pathology, and have been associated with motor and cognitive deficits. In the present study, an optimized artificial neural network was used as an automatic segmentation method to produce probabilistic maps of WMC......) 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...... 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...

  15. Multicenter follow-up study of ankle fracture surgery

    Institute of Scientific and Technical Information of China (English)

    XU Hai-lin; WANG Gang; WANG Guang-lin; WU Xin-bao; LIU Li-min; LI Xuan; ZHANG Dian-ying; FU Zhong-guo; WANG Tian-bing; ZHANG Pei-xun; JIANG Bao-guo; SHEN Hui-liang

    2012-01-01

    Background Few data on ankle fractures in China from large multicenter epidemiological and clinical studies are available.The aim of this research was to evaluate the epidemiological features and surgical outcomes of ankle fractures by reviewing 235 patients who underwent ankle fracture surgery at five hospitals in China.Methods This study included patients who underwent ankle fracture surgery at five Chinese hospitals from January 2000 to July 2009.Age,gender,mechanism of injury,Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture type,fracture pattern,length of hospital stay and treatment outcome were recorded.Statistical analyses were conducted using SPSS software.The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale,visual analogue scale (VAS),and arthritis scale were used to evaluate outcome.Results Of 235 patients with ankle fractures,105 were male with an average age of 37.8 years and 130 were female with an average age of 47.3 years.The average follow-up period was 55.7 months.There were significant differences in the ratios of patients in different age groups between males and females,and in mechanisms of injury among different age groups.There were also significant differences in the length of hospital stay among different fracture types and mechanisms of injury.In healed fractures,the average AOFAS ankle-hindfoot score was 95.5,with an excellence rate of 99.6%,the average VAS score was 0.17,and the average arthritis score was 0.18.Movement of the injured ankle was significantly different to that of the uninjured ankle.There were no significant differences between AO fracture types,fracture patterns or follow-up periods and AOFAS score,but there were some significant differences between these parameters and ankle joint movements,pain VAS score and arthritis score.Conclusions Ankle fractures occur most commonly in middle-aged and young males aged 20-39 years and in elderly females aged 50-69 years.The most common mechanisms of

  16. 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.

  17. Cancer in Crohn's Disease patients treated with infliximab: a long-term multicenter matched pair study.

    Science.gov (United States)

    Biancone, Livia; Petruzziello, Carmelina; Orlando, Ambrogio; Kohn, Anna; Ardizzone, Sandro; Daperno, Marco; Angelucci, Erika; Castiglione, Fabiana; D'Incà, Renata; Zorzi, Francesca; Papi, Claudio; Meucci, Gianmichele; Riegler, Gabriele; Sica, Giuseppe; Rizzello, Fernando; Mocciaro, Filippo; Onali, Sara; Calabrese, Emma; Cottone, Mario; Pallone, Francesco

    2011-03-01

    The long-term risk of neoplasia in Crohn's disease (CD) patients treated with infliximab is undefined. The aim was to assess, in a multicenter, matched-pair study, whether infliximab use in CD is associated with an increased frequency of neoplasia in the long term. A multicenter, long-term, matched-pair study was conducted in 12 referral inflammatory bowel disease (IBD) centers. An initial cohort of 808 CD patients, including 404 infliximab-treated (CD-IFX) and 404 matched CD controls never treated with infliximab (CD-C) studied from 1999 to 2004, was followed up for an additional 4 years (2004-2008). Cases and controls were matched for: sex, age (±5 years), CD site, follow-up (±5 years), immunosuppressant use, and CD duration (±5 years). From 1999 to 2008 the frequency and characteristics of neoplasia were compared between CD-IFX and CD-C. In 2008, 591 patients (304 CD-IFX, 287 CD-C) were in follow-up. Matched couples included 442 patients: 221 CD-IFX and 221 CD-C (median follow-up, months: 72, range 48-114 versus 75, range 44-114). From 1999 to 2008 the frequency of neoplasia among the 591 patients did not differ between CD-IFX (12/304; 3.94%) and CD-C (12/287; 4.19%; P = 0.95). A comparable frequency of neoplasia was also observed between the 221 matched couples (CD-IFX: 8/221; 3.61% versus CD-C: 9/221; 4.07%; P = 1). No specific histotype of cancer appeared associated with infliximab use. The frequency of neoplasia was comparable in an adult population of CD patients treated or not with infliximab, matched for clinical variables and followed up for a median of 6 years. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.

  18. Multicenter case-control study on restless legs syndrome in multiple sclerosis: the REMS study.

    Science.gov (United States)

    Manconi, Mauro; Ferini-Strambi, Luigi; Filippi, Massimo; Bonanni, Enrica; Iudice, Alfonso; Murri, Luigi; Gigli, Gian Luigi; Fratticci, Lara; Merlino, Giovanni; Terzano, Giovanni; Granella, Franco; Parrino, Liborio; Silvestri, Rosalia; Aricò, Irene; Dattola, Vincenzo; Russo, Giovanna; Luongo, Carmela; Cicolin, Alessandro; Tribolo, Antonella; Cavalla, Paola; Savarese, Mariantonietta; Trojano, Maria; Ottaviano, Salvatore; Cirignotta, Fabio; Simioni, Valentina; Salvi, Fabrizio; Mondino, Fiorella; Perla, Franco; Chinaglia, Giorgia; Zuliani, Cristina; Cesnik, Edward; Granieri, Enrico; Placidi, Fabio; Palmieri, Maria Giuseppina; Manni, Raffaele; Terzaghi, Michele; Bergamaschi, Roberto; Rocchi, Raffaele; Ulivelli, Monica; Bartalini, Sabina; Ferri, Raffaele; Lo Fermo, Salvatore; Ubiali, Emilio; Viscardi, Massimo; Rottoli, Mariarosa; Nobili, Lino; Protti, Alessandra; Ferrillo, Franco; Allena, Marta; Mancardi, Gianluigi; Guarnieri, Biancamaria; Londrillo, Francesco

    2008-07-01

    To verify the existence of a symptomatic form of restless legs syndrome (RLS) secondary to multiple sclerosis (MS) and to identify possible associated risk factors. Prospective, multicenter, case-control epidemiologic survey. Twenty sleep centers certified by the Italian Association of Sleep Medicine. Eight hundred and sixty-one patients affected by MS and 649 control subjects. N/A. Data regarding demographic and clinical factors, presence and severity of RLS, the results of hematologic tests, and visual analysis of cerebrospinal magnetic resonance imaging studies were collected. The prevalence of RLS was 19% in MS and 4.2% in control subjects, with a risk to be affected by RLS of 5.4 (95%confidence interval: 3.56-8.26) times greater for patients with MS than for control subjects. In patients with MS, the following risk factors for RLS were significant: older age; longer MS duration; the primary progressive MS form; higher global, pyramidal, and sensory disability; and the presence of leg jerks before sleep onset. Patients with MS and RLS more often had sleep complaints and a higher intake of hypnotic medications than patients with MS without RLS. RLS associated with MS was more severe than that of control subjects. RLS is significantly associated with MS, especially in patients with severe pyramidal and sensory disability. These results strengthen the idea that the inflammatory damage correlated with MS may induce a secondary form of RLS. As it does in idiopathic cases, RLS has a significant impact on sleep quality in patients with MS; therefore, it should be always searched for, particularly in the presence of insomnia unresponsive to treatment with common hypnotic drugs.

  19. 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

  20. 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 (<2 standard deviations from the normative values) neuropsychological tests at a standardized evaluation were considered cognitively impaired (CI). FMRI data were analyzed using the SPM8 software, modeling regions showing load-dependent activations/deactivations with increasing task difficulty. Twenty (47%) MS patients were CI. During the N-back load condition, compared to controls and CI patients, cognitively preserved (CP) patients had increased recruitment of the right dorsolateral prefrontal cortex. As a 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.

  1. ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics.

    Science.gov (United States)

    Mitsumoto, Hiroshi; Factor-Litvak, Pam; Andrews, Howard; Goetz, Raymond R; Andrews, Leslie; Rabkin, Judith G; McElhiney, Martin; Nieves, Jeri; Santella, Regina M; Murphy, Jennifer; Hupf, Jonathan; Singleton, Jess; Merle, David; Kilty, Mary; Heitzman, Daragh; Bedlack, Richard S; Miller, Robert G; Katz, Jonathan S; Forshew, Dallas; Barohn, Richard J; Sorenson, Eric J; Oskarsson, Bjorn; Fernandes Filho, J Americo M; Kasarskis, Edward J; Lomen-Hoerth, Catherine; Mozaffar, Tahseen; Rollins, Yvonne D; Nations, Sharon P; Swenson, Andrea J; Shefner, Jeremy M; Andrews, Jinsy A; Koczon-Jaremko, Boguslawa A

    2014-06-01

    Abstract In a multicenter study of newly diagnosed ALS patients without a reported family history of ALS, we are prospectively investigating whether markers of oxidative stress (OS) are associated with disease progression. Methods utilize an extensive structured telephone interview ascertaining environmental, lifestyle, dietary and psychological risk factors associated with OS. Detailed assessments were performed at baseline and at 3-6 month intervals during the ensuing 30 months. Our biorepository includes DNA, plasma, urine, and skin. Three hundred and fifty-five patients were recruited. Subjects were enrolled over a 36-month period at 16 sites. To meet the target number of subjects, the recruitment period was prolonged and additional sites were included. Results showed that demographic and disease characteristics were similar between 477 eligible/non-enrolled and enrolled patients, the only difference being type of health insurance among enrolled patients. Sites were divided into three groups by the number of enrolled subjects. Comparing these three groups, the Columbia site had fewer 'definite ALS' diagnoses. This is the first prospective, interdisciplinary, in-depth, multicenter epidemiological investigation of OS related to ALS progression and has been accomplished by an aggressive recruitment process. The baseline demographic and disease features of the study sample are now fully characterized.

  2. Chasing the Effects of Pre-Analytical Confounders - A Multicenter Study on CSF-AD Biomarkers

    DEFF Research Database (Denmark)

    Leitão, Maria João; Baldeiras, Inês; Herukka, Sanna-Kaisa

    2015-01-01

    play an important role in the reliable measurement of these biomarkers across laboratories. AIM: In this study, we aim to surpass the efforts from previous studies, by employing a multicenter approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification...

  3. Prospective Multicenter Assessment of Early Complication Rates Associated With Adult Cervical Deformity Surgery in 78 Patients.

    Science.gov (United States)

    Smith, Justin S; Ramchandran, Subaraman; Lafage, Virginie; Shaffrey, Christopher I; Ailon, Tamir; Klineberg, Eric; Protopsaltis, Themistocles; Schwab, Frank J; OʼBrien, Michael; Hostin, Richard; Gupta, Munish; Mundis, Gregory; Hart, Robert; Kim, Han Jo; Passias, Peter G; Scheer, Justin K; Deviren, Vedat; Burton, Douglas C; Eastlack, Robert; Bess, Shay; Albert, Todd J; Riew, K Daniel; Ames, Christopher P

    2016-09-01

    Few reports have focused on treatment of adult cervical deformity (ACD). To present early complication rates associated with ACD surgery. A prospective multicenter database of consecutive operative ACD patients was reviewed for early (≤30 days from surgery) complications. Enrollment required at least 1 of the following: cervical kyphosis >10 degrees, cervical scoliosis >10 degrees, C2-7 sagittal vertical axis >4 cm, or chin-brow vertical angle >25 degrees. Seventy-eight patients underwent surgical treatment for ACD (mean age, 60.8 years). Surgical approaches included anterior-only (14%), posterior-only (49%), anterior-posterior (35%), and posterior-anterior-posterior (3%). Mean numbers of fused anterior and posterior vertebral levels were 4.7 and 9.4, respectively. A total of 52 early complications were reported, including 26 minor and 26 major. Twenty-two (28.2%) patients had at least 1 minor complication, and 19 (24.4%) had at least 1 major complication. Overall, 34 (43.6%) patients had at least 1 complication. The most common complications included dysphagia (11.5%), deep wound infection (6.4%), new C5 motor deficit (6.4%), and respiratory failure (5.1%). One (1.3%) mortality occurred. Early complication rates differed significantly by surgical approach: anterior-only (27.3%), posterior-only (68.4%), and anterior-posterior/posterior-anterior-posterior (79.3%) (P = .007). This report provides benchmark rates for overall and specific ACD surgery complications. Although the surgical approach(es) used were likely driven by the type and complexity of deformity, there were significantly higher complication rates associated with combined and posterior-only approaches compared with anterior-only approaches. These findings may prove useful in treatment planning, patient counseling, and ongoing efforts to improve safety of care. 3CO, 3-column osteotomiesACD, adult cervical deformityEBL, estimated blood lossISSG, International Spine Study groupSVA, sagittal vertical axis.

  4. Multicenter Study of Posaconazole Therapeutic Drug Monitoring: Exposure-Response Relationship and Factors Affecting Concentration

    OpenAIRE

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

    2012-01-01

    Posaconazole has an important role in the prophylaxis and salvage treatment of invasive fungal infections (IFIs), although poor and variable bioavailability remains an important clinical concern. Therapeutic drug monitoring of posaconazole concentrations has remained contentious, with the use of relatively small patient cohorts in previous studies hindering the assessment of exposure-response relationships. This multicenter retrospective study aimed to investigate relationships between posaco...

  5. 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...

  6. 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

  7. Outcomes and demostration of cranial firearm injuries: A multicenter retrospective study.

    Science.gov (United States)

    Çınar, Kadir; Seçer, Mehmet; Alagöz, Fatih; Ulutaş, Murat; Uçkun, Özhan Merzuk; Yıldırım, Ali Erdem; Gürçay, Ahmet Gürhan; Güvenç, Yahya; Çelik, Haydar; Narin, Fırat

    2015-07-01

    Cranial firearm injuries (CFAI) are associated with significant morbidity and mortality.This study was aimed to determine the factors affecting mortality of CFAI cases managed in our institution by a retrospective analysis of CT scans and clinical data. This multicenter retrospective study examined two hundred and nineteen patients presenting to neurosurgery clinics after CFAI between January 2012 and November 2014. Age, sex, Glasgow Coma Score (GCS), CT findings, and mortality and morbidity rates of the patients were analyzed to determine the factors affecting mortality. Mean age of the study population was 24.19±12.25 years, 85.8% of them were male. The most common CT findings were fracture (100%), intracranial hemorrhage (61.2%), and an intracranially located foreign body (44.3%). A cranial operation was performed in 64.8% of the victims. Mean GCS on admission was 8±3.9, which increased in survivors (p<0.05). CFAIs are associated with increased mortality and morbidity. We determined that many factors affected morbidity and mortality rates, and patient age, presence of intracranial hemorrhage, GCS, and treatment protocols were significantly associated with mortality.

  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 co

  9. Outcome of HCV/HIV-coinfected liver transplant recipients: a prospective and multicenter cohort study.

    NARCIS (Netherlands)

    Miro, J.M.; Montejo, M.; Castells, L.; Rafecas, A.; Moreno, S.; Aguero, F.; Abradelo, M.; Miralles, P.; Torre-Cisneros, J.; Pedreira, J.D.; Cordero, E.; Rosa, G. De; Moyano, B.; Moreno, A.; Perez, I.; Rimola, A.; Barrera, P.

    2012-01-01

    Eighty-four HCV/HIV-coinfected and 252-matched HCV-monoinfected liver transplant recipients were included in a prospective multicenter study. Thirty-six (43%) HCV/HIV-coinfected and 75 (30%) HCV-monoinfected patients died, with a survival rate at 5 years of 54% (95% CI, 42-64) and 71% (95% CI, 66 to

  10. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study

    DEFF Research Database (Denmark)

    Giovannini, Marc; Thomas, Botelberge; Erwan, Bories

    2009-01-01

    AIM: To evaluate the ability of endoscopic ultrasound (EUS) elastography to distinguish benign from malignant pancreatic masses and lymph nodes. METHODS: A multicenter study was conducted and included 222 patients who underwent EUS examination with assessment of a pancreatic mass (n = 121) or lym...

  11. 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...

  12. 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

  13. 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.

  14. Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery.

    Science.gov (United States)

    Smith, Justin S; Klineberg, Eric; Lafage, Virginie; Shaffrey, Christopher I; Schwab, Frank; Lafage, Renaud; Hostin, Richard; Mundis, Gregory M; Errico, Thomas J; Kim, Han Jo; Protopsaltis, Themistocles S; Hamilton, D Kojo; Scheer, Justin K; Soroceanu, Alex; Kelly, Michael P; Line, Breton; Gupta, Munish; Deviren, Vedat; Hart, Robert; Burton, Douglas C; Bess, Shay; Ames, Christopher P

    2016-07-01

    OBJECTIVE Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. METHODS As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. RESULTS Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82

  15. 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.

  16. Italian Multicenter Cross-Sectional Study (AISAG) on light smoking and allergic diseases in adults.

    Science.gov (United States)

    Lombardi, C; Passalacqua, G

    2016-03-01

    Allergic rhinitis, allergic dermatitis, and food allergy are extremely common diseases and are frequently associated to each other and to asthma. Smoking is a potential risk factor for these conditions, but so far, results from individual studies have been conflicting. On the basis of these contradictory data in the literature we have carried out a multicenter cross-sectional study to evaluate the relationship between some allergic conditions and exposure or not to active light smoking. The study was carried out between May 2013 and November 2013 in 22 different Italian hospitals. Patients with respiratory and/or food allergy, and aged 18 years and over, visited at Allergy Outpatient Clinics, were invited to participate. A total of 1586 allergic patients (21.6% smokers) with a mean age of 39.2 years (standard deviation, SD = 15.1) were included. We demonstrated that the prevalence of tobacco smoking was higher in patients with food allergy and in asthmatic patients in stage III-IV. But no other statistical differences were found at univariate analysis. The sensitization patterns of non-smokers and smokers were similar. Furthermore, tobacco smoking was associated with higher risk of food allergy and lower risk of asthma. Moreover, tobacco smoking was an independent risk factor for persistent respect to intermittent rhinitis, and for asthma GINA stage III-IV with respect to stage I-II.

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

    NARCIS (Netherlands)

    Eijk, M.S. van; Linde, H. van der; Buijck, B.I.; Zuidema, S.U.; Koopmans, R.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 colle

  18. 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 colle

  19. Outcomes of Second Combination Antiretroviral Therapy Regimens Among HIV-Infected Persons in Clinical Care: A Multicenter Cohort Study

    OpenAIRE

    2013-01-01

    Data on the effectiveness of second-line combination antiretroviral therapy (cART) are limited. We evaluated virologic outcomes of second cART in a multicenter cohort collaboration. The study population initiated first and second modern cART between 1996 and 2010. The second cART required a switch in at least the anchor agent of first cART. We evaluated time to virologic failure of second cART and factors associated with greater risk of failure using multivariable Cox proportional hazards mod...

  20. Incidence of Malignancy after Living Kidney Transplantation: A Multicenter Study from Iran

    Science.gov (United States)

    Einollahi, Behzad; Rostami, Zohreh; Nourbala, Mohammad Hossein; Lessan-Pezeshki, Mahboob; Simforoosh, Naser; Nemati, Eghlim; Pourfarziani, Vahid; Beiraghdar, Fatemeh; Nafar, Mohsen; Pour-Reza-Gholi, Fatemeh; Mazdeh, Mitra Mahdavi; Amini, Manochehr; Ahmadpour, Pedram; Makhdoomi, Khadijeh; Ghafari, Ali; Ardalan, Mohammad Reza; Khosroshahi, Hamid Taebi; Oliaei, Farshid; Shahidi, Shahrzad; Abbaszadeh, Shahin; Fatahi, Mohammad Reza; Hiedari, Fatemeh; Makhlogh, Atehieh; Azmandian, Jalal; Samimagham, Hamid Reza; Shahbazian, Heshmatollah; Nazemian, Fatemeh; Naghibi, Massih; Khosravi, Masoud; Monfared, Ali; Mosavi, Seyed Majid; Ahmadi, Javad; Jalalzadeh, Mojgan

    2012-01-01

    Malignancy is a common complication after renal transplantation. However, limited data are available on post-transplant malignancy in living kidney transplantation. Therefore, we made a plan to evaluate the incidence and types of malignancies, association with the main risk factors and patient survival in a large population of living kidney transplantation. We conducted a large retrospective multicenter study on 12525 renal recipients, accounting for up to 59% of all kidney transplantation in Iran during 22 years follow up period. All information was collected from observation of individual notes or computerized records for transplant patients. Two hundred and sixty-six biopsy-proven malignancies were collected from 16 Transplant Centers in Iran; 26 different type of malignancy categorized in 5 groups were detected. The mean age of patients was 46.2±12.9 years, mean age at tumor diagnosis was 50.8±13.2 years and average time between transplantation and detection of malignancy was 50.0±48.4 months. Overall tumor incidence in recipients was 2%. Kaposis' sarcoma was the most common type of tumor. The overall mean survival time was 117.1 months (95% CI: 104.9-129.3). In multivariate analysis, the only independent risk factor associated with mortality was type of malignancy. This study revealed the lowest malignancy incidence in living unrelated kidney transplantation. PMID:22712025

  1. Incidence of Malignancy after Living Kidney Transplantation: A Multicenter Study from Iran

    Directory of Open Access Journals (Sweden)

    Behzad Einollahi, Zohreh Rostami, Mohammad Hossein Nourbala, Mahboob Lessan-Pezeshki, Naser Simforoosh, Eghlim Nemati, Vahid Pourfarziani, Fatemeh Beiraghdar, Mohsen Nafar, Fatemeh Pour-Reza-Gholi, Mitra Mahdavi Mazdeh, Manochehr Amini, Pedram Ahmadpour,

    2012-01-01

    Full Text Available Malignancy is a common complication after renal transplantation. However, limited data are available on post-transplant malignancy in living kidney transplantation. Therefore, we made a plan to evaluate the incidence and types of malignancies, association with the main risk factors and patient survival in a large population of living kidney transplantation. We conducted a large retrospective multicenter study on 12525 renal recipients, accounting for up to 59% of all kidney transplantation in Iran during 22 years follow up period. All information was collected from observation of individual notes or computerized records for transplant patients. Two hundred and sixty-six biopsy-proven malignancies were collected from 16 Transplant Centers in Iran; 26 different type of malignancy categorized in 5 groups were detected. The mean age of patients was 46.2±12.9 years, mean age at tumor diagnosis was 50.8±13.2 years and average time between transplantation and detection of malignancy was 50.0±48.4 months. Overall tumor incidence in recipients was 2%. Kaposis' sarcoma was the most common type of tumor. The overall mean survival time was 117.1 months (95% CI: 104.9-129.3. In multivariate analysis, the only independent risk factor associated with mortality was type of malignancy. This study revealed the lowest malignancy incidence in living unrelated kidney transplantation.

  2. Kinetic and Related Determinants of Plasma Triglyceride Concentration in Abdominal Obesity: Multicenter Tracer Kinetic Study.

    Science.gov (United States)

    Borén, Jan; Watts, Gerald F; Adiels, Martin; Söderlund, Sanni; Chan, Dick C; Hakkarainen, Antti; Lundbom, Nina; Matikainen, Niina; Kahri, Juhani; Vergès, Bruno; Barrett, P Hugh R; Taskinen, Marja-Riitta

    2015-10-01

    Patients with obesity and diabetes mellitus have increased risk of cardiovascular disease. A major cause is an atherogenic dyslipidemia related primarily to elevated plasma concentrations of triglyceride-rich lipoproteins. The aim of this study was to clarify determinants of plasma triglyceride concentration. We focused on factors that predict the kinetics of very-low density lipoprotein 1 (VLDL1) triglycerides. A multicenter study using dual stable isotopes (deuterated leucine and glycerol) and multicompartmental modeling was performed to elucidate the kinetics of triglycerides and apoB in VLDL1 in 46 subjects with abdominal obesity and additional cardiometabolic risk factors. Results showed that plasma triglyceride concentrations were dependent on both the secretion rate (r=0.44, Ptriglycerides and VLDL1-apoB. Liver fat mass was independently and directly associated with secretion rates of VLDL1-triglycerides (r=0.56, Ptriglycerides (r=0.48, Ptriglyceride concentrations in abdominal obesity are determined by the kinetics of VLDL1 subspecies, catabolism being mainly dependent on apoC-III concentration and secretion on liver fat content. Reduction in liver fat and targeting apoC-III may be an effective approach for correcting triglyceride metabolism atherogenic dyslipidemia in obesity. © 2015 American Heart Association, Inc.

  3. Extra-coronary calcification (aortic valve calcification, mitral annular calcification, aortic valve ring calcification and thoracic aortic calcification) in HIV seropositive and seronegative men: Multicenter AIDS Cohort Study.

    OpenAIRE

    Rezaeian, P.; Miller, PE; Haberlen, SA; Razipour, A; Bahrami, H; Castillo, R.; Witt, MD; Kingsley, L; Palella, FJ; Nakanishi, R; Matsumoto, S.; Alani, A; Jacobson, LP; Post, WS; Budoff, MJ

    2016-01-01

    Previous studies have demonstrated an association between HIV infection and coronary artery disease (CAD); little is known about potential associations between HIV infection and extra-coronary calcification (ECC).We analyzed 621 HIV infected (HIV+) and 384 HIV uninfected (HIV-) men from the Multicenter AIDS Cohort Study who underwent non-contrast computed tomography (CT) from 2010-2013. Agatston scores were calculated for mitral annular calcification (MAC), aortic valve calcification (AVC), a...

  4. Pegaferon in hepatitis C: Results of a Multicenter Study

    OpenAIRE

    Jabbari, Hossain; Zamani, Farhad; Hatami, Khadijeh; Sheikholeslami, Arghavan; Fakharzadeh, Elham; Shahzamani, Kiana; Zamini, Hedye; Merat, Shahin; Malekzadeh, Reza; Sharfi, Amir Houshang

    2011-01-01

    BACKGROUND Chronic hepatitis C (CHC) is a major contributor to cirrhosis and hepatocellular carcinoma and major global public health problem that causes mortality in both developed and developing countries.For the past decade, treatment with pegylated interferon (peg interferon α) and ribavirin (RBV) has been associated with rates of sustained virologic response of ≤ 66% among patients with hepatitis C virus (HCV) infection. In this study, we report the response rate of Iranian treatment-naïv...

  5. "Burnout in Medical Oncology Fellows: a Prospective Multicenter Cohort Study in Brazilian Institutions".

    Science.gov (United States)

    Cubero, Daniel I G; Fumis, Renata Rego Lins; de Sá, Thiago Hérick; Dettino, Aldo; Costa, Felipe Osório; Van Eyll, Brigitte M R H Adam; Beato, Carlos; Peria, Fernanda Maris; Mota, Augusto; Altino, José; Azevedo, Sérgio Jobim; da Rocha Filho, Duílio Reis; Moura, Melba; Lessa, Álvaro Edson Ramos; Del Giglio, Auro

    2016-09-01

    Burnout syndrome is a common occurrence among oncologists. Doctors enrolled in residency programs in clinical oncology are exposed to similar risk factors; however, few data are available in this population. This study assessed the occurrence of burnout and associated factors among first-year residents at Brazilian institutions. The present prospective, multicenter, cohort study was conducted with doctors enrolled in residency programs in clinical oncology at Brazilian institutions affiliated with the public health system. The participants answered a sociodemographic questionnaire, the Maslach Burnout Inventory (MBI), Lipp's Stress Inventory, and the Beck Depression Inventory (BDI), upon admission to the program and 6 and 12 months later. Of 37 eligible residency programs in 2009, 11 (30.6 %) agreed to participate in the study. Fifty-four residents, representing 100 % of new admissions to the participating institutions, were included. Most of the participants met the criteria for severe burnout upon admission to the residency programs (emotional exhaustion in 49.0 % and depersonalization in 64.7 %). The scores on MBI domains emotional exhaustion and depersonalization increased significantly (p burnout increased to 88 % at the end of that first year. The present study found a high prevalence of burnout among doctors enrolled in residency programs in clinical oncology at Brazilian institutions. A large fraction of the participants met the criteria for burnout syndrome upon admission to the program, which suggests that the problem began during the course of the previous residency program in internal medicine.

  6. Multicenter study of posaconazole therapeutic drug monitoring: exposure-response relationship and factors affecting concentration.

    Science.gov (United States)

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

    2012-11-01

    Posaconazole has an important role in the prophylaxis and salvage treatment of invasive fungal infections (IFIs), although poor and variable bioavailability remains an important clinical concern. Therapeutic drug monitoring of posaconazole concentrations has remained contentious, with the use of relatively small patient cohorts in previous studies hindering the assessment of exposure-response relationships. This multicenter retrospective study aimed to investigate relationships between posaconazole concentration and clinical outcomes and adverse events and to assess clinical factors and drug interactions that may affect posaconazole concentrations. Medical records were reviewed for patients who received posaconazole and had ≥1 concentration measured at six hospitals in Australia. Data from 86 patients with 541 posaconazole concentrations were included in the study. Among 72 patients taking posaconazole for prophylaxis against IFIs, 12 patients (17%) developed a breakthrough fungal infection; median posaconazole concentrations were significantly lower than in those who did not develop fungal infection (median [range], 289 [50 to 471] ng/ml versus 485 [0 to 2,035] ng/ml; P posaconazole concentration was a significant predictor of breakthrough fungal infection via binary logistic regression (P posaconazole exposure, including coadministration with proton pump inhibitors, metoclopramide, phenytoin or rifampin, and the H(2) antagonist ranitidine (P posaconazole exposure (P posaconazole concentrations are common and are associated with breakthrough fungal infection, supporting the utility of monitoring posaconazole concentrations to ensure optimal systemic exposure.

  7. 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 mutilation of the body after donation (P < 0.001). CONCLUSION: Spanish medical students have a favorable attitude toward LLD. PMID:27433093

  8. 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

  9. Cytomegalovirus Infection following Kidney Transplantation: a Multicenter Study of 3065 Cases

    OpenAIRE

    2012-01-01

    Background: Cytomegalovirus (CMV) infection is a common complication following kidney transplantation. Objective: To assess the incidence and risk factors of CMV infection among renal transplant recipients. Methods: In a retrospective multicenter study, 3065 renal transplant recipients from 17 transplant centers of Iran were studied between April 2008 and January 2011. Kidney transplant patients were routinely monitored by sequential blood samples drawn for use in the CMV-pp65 antigenemia ass...

  10. 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

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

    Institute of Scientific and Technical Information of China (English)

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

    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 threesix 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.

  12. Health care utilization in patients with gout: a prospective multicenter cohort study.

    Science.gov (United States)

    Singh, Jasvinder A; Bharat, Aseem; Khanna, Dinesh; Aquino-Beaton, Cleopatra; Persselin, Jay E; Duffy, Erin; Elashoff, David; Khanna, Puja P

    2017-05-31

    All published studies of health care utilization in gout have been cross-sectional to date, and most used a patient-reported diagnosis of gout. Our objective was to assess health care utilization and its predictors in patients with physician-confirmed gout in a prospective cohort study. In a multi-center prospective cohort study of U.S. veterans with rheumatologist-confirmed gout (N = 186; two centers), we assessed patient self-reported overall and gout-specific health care utilization with the Gout Assessment Questionnaire (GAQ) every 3-months for a 9-month period. Comparisons were made using the student's t test or the chi-square, Wilcoxon rank sum test or Fisher exact test, as appropriate. Mixed effects Poisson regression was used to assess potential correlates of gout-related health care utilization. Mean age was 64.6 years, 98% were men, 13% Hispanic or Latino, 32% were African-American, 6% did not graduate high school, mean serum urate was 8.3 and mean Deyo-Charlson score was 3.1. During the past year, mean gout-related visits were as follows: rheumatologist, 1.5; primary care physician, 2 visits; ≥1 inpatient visits, 7%; ≥1 ER visits, 26%; and urgent care/walk-in visit, 33%. In longitudinal analyses, African-American race and gout flares in the last 3 months were associated with significantly higher rate ratio of gout-related outpatient visits. African-American race and lack of college education were associated with significantly higher rate ratio for gout-related urgent visits and overnight stays. African-American race and recent gout flares were associated with higher outpatient utilization and African-American race and no college education with higher urgent or inpatient utilization. Future studies should examine whether modifiable predictors of utilization can be targeted to reduce healthcare utilization in patients with gout.

  13. 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....

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

    Directory of Open Access Journals (Sweden)

    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.

  15. Effectiveness and predictors of success of noninvasive ventilation during H1N1 pandemics: a multicenter study.

    Science.gov (United States)

    Nicolini, A; Tonveronachi, E; Navalesi, P; Antonelli, M; Valentini, I; Melotti, R M; Pigna, A; Carrassi, A; Righini, P; Ferrari Bravo, M; Pelosi, P; Nicoli, F; Cosentini, R; Vaschetto, R; Faenza, S; Nava, S

    2012-12-01

    The use of non-invasive ventilation (NIV) in acute hypoxemic respiratory failure (AHRF) due to H1N1 virus infection is controversial. In this multicenter study we aimed to assess the efficacy of NIV in avoiding endotracheal intubation (ETI) and to identify predictors of success or failure. In this prospective multicenter study, 98 patients with new pulmonary infiltrate(s) sustained by H1N1 virus and a PaO(2)/FiO2intubated after 5.8+5.5 hours from enrolment. The remaining 47/60 patients were successfully ventilated with NIV. Hospital mortality was significantly higher in those patients who failed NIV vs. those who succeeded (53.8% vs. 2.1%; OR=0.52, P29 and a PaO(2)/FIO(2)≤127 at admission and PaO2/FIO(2)≤149 after 1 hr of NIV were independently associated with the need for ETI. The early application of NIV, with the aim to avoid invasive ventilation, during the H1N1 pandemics was associated with an overall success rate of 47/98 (48%). Patients presenting at admission with an high SAPS II score and a low PaO(2)/FiO(2) ratio and/or unable to promptly correct gas exchange are at high risk of intubation and mortality.

  16. Participation of a coordinating center pharmacy in a multicenter international study.

    Science.gov (United States)

    Jeon, Jihyun Esther; Mighty, Janet; Lane, Karen; McBee, Nichol; Majkowski, Ryan; Mayo, Steven; Hanley, Daniel

    2016-11-15

    The activities of a coordinating center pharmacy (CCP) supporting a multicenter, international clinical trial are described. Serving in a research support role comparable to that of a commercial clinical trial supply company, a CCP within the Johns Hopkins Hospital Investigational Drug Service (JHH IDS) uses its management expertise and infrastructure to support multicenter trials, such as the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III) trial. The role of the CCP staff in supporting the CLEAR III trial was overall investigational product (IP) management through coordination of IP-related operations to ensure high-quality care for study participants at study sites in the United States and abroad. For the CLEAR III trial, the CCP coordinated IP supply activities; provided education to site pharmacists; developed study-specific documents, including pharmacy manuals; communicated with trial stakeholders, including third-party IP distributors; monitored treatment assignments; and performed quality assurance monitoring to ensure compliance with institutional, state, federal, and international regulations regarding IP procurement and storage. Acting as a CCP for a multicenter international study poses a number of operational challenges while providing opportunities for the CCP to contribute to research of global importance and enrich the skill sets of its personnel. The development and implementation of the CCP at JHH IDS for the CLEAR III trial included several responsibilities, such as IP supply management, communication, and database, regulatory, and finance management. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  17. Prospective Multicenter Study of the Impact of Carbapenem Resistance on Mortality in Pseudomonas aeruginosa Bloodstream Infections

    OpenAIRE

    2012-01-01

    The impact of antimicrobial resistance on clinical outcomes is the subject of ongoing investigations, although uncertainty remains about its contribution to mortality. We investigated the impact of carbapenem resistance on mortality in Pseudomonas aeruginosa bacteremia in a prospective multicenter (10 teaching hospitals) observational study of patients with monomicrobial bacteremia followed up for 30 days after the onset of bacteremia. The adjusted influence of carbapenem resistance on mortal...

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

    OpenAIRE

    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 ...

  19. Multicenter Study of Prevalence of Nontuberculous Mycobacteria in Patients with Cystic Fibrosis in France ▿

    Science.gov (United States)

    Roux, Anne-Laure; Catherinot, Emilie; Ripoll, Fabienne; Soismier, Nathalie; Macheras, Edouard; Ravilly, Sophie; Bellis, Gil; Vibet, Marie-Anne; Le Roux, Evelyne; Lemonnier, Lydie; Gutierrez, Cristina; Vincent, Véronique; Fauroux, Brigitte; Rottman, Martin; Guillemot, Didier; Gaillard, Jean-Louis

    2009-01-01

    We performed a multicenter prevalence study of nontuberculous mycobacteria (NTM) involving 1,582 patients (mean age, 18.9 years; male/female ratio, 1.06) with cystic fibrosis in France. The overall NTM prevalence (percentage of patients with at least one positive culture) was 6.6% (104/1,582 patients), with prevalences ranging from 3.7% (in the east of France) to 9.6% (in the greater Paris area). Mycobacterium abscessus complex (MABSC; 50 patients) and Mycobacterium avium complex (MAC; 23 patients) species were the most common NTM, and the only ones associated with fulfillment of the American Thoracic Society bacteriological criteria for NTM lung disease. The “new” species, Mycobacterium bolletii and Mycobacterium massiliense, accounted for 40% of MABSC isolates. MABSC species were isolated at all ages, with a prevalence peak between 11 and 15 years of age (5.8%), while MAC species reached their highest prevalence value among patients over 25 years of age (2.2%). PMID:19846643

  20. Arthroscopic repair of peripheral avulsions of the triangular fibrocartilage complex of the wrist: a multicenter study.

    Science.gov (United States)

    Corso, S J; Savoie, F H; Geissler, W B; Whipple, T L; Jiminez, W; Jenkins, N

    1997-02-01

    A multicenter study to assess arthroscopic reconstruction of the peripheral attachment of the triangular fibrocartilage complex was undertaken. A total of 44 patients (45 wrists) from three institutions were reviewed. Twenty-seven of the 45 wrists had associated injuries, including distal radius fracture (4), partial or complete rupture of the scapholunate (7), lunotriquetral (9), ulnocarpal (2), or radiocarpal (2) ligaments. There were two fractured ulnar styloids and one scapholunate accelerated collapse (SLAC) wrist deformity. The peripheral tears were repaired using a zone-specific repair kit. The patients were immobilized in a munster cast, allowing elbow flexion and extension, but no pronation or supination for 4 weeks, followed by 2 to 4 weeks in a short arm cast or VersaWrist splint. All patients were reexamined independently 1 to 3 years postoperatively by a physician, therapist, and registered nurse. The results were graded according to the Mayo modified wrist score. Twenty-nine of the 45 wrists were rated excellent. 12 good, 1 fair, and 3 poor. Overall, 42 of the 45 patients (93%) rated as satisfactory and returned to sports or work activities. One patient had chronic pain, and two patients had ulnar nerve symptoms, although motion was normal in all, and their grip strength was at least 75% of the opposite hand. Arthroscopic repair of peripheral tears of the triangular fibrocartilage complex (TFCC) is a satisfactory method of repairing these injuries.

  1. [Trauma-related disorders in patients with borderline personality disorders. Results of a multicenter study].

    Science.gov (United States)

    Sack, M; Sachsse, U; Overkamp, B; Dulz, B

    2013-05-01

    There is current controversy about the diagnostic overlap between personality disorders and trauma-related disorders. Applying a multicenter study design, trauma-related disorders were investigated via interview assessment in 136 patients with borderline personality disorder (BPD) in 5 specialized treatment centers. Additionally a spectrum of psychological symptoms and prevalence of lifetime traumatic experiences were assessed by questionnaire measures. Diagnostic overlap between BPD and PTSD was found to be high (79%) as well as the overlap of BPD with complex PTSD (55%) and severe dissociative disorders (41%). Including neglect and emotional violence as trauma categories, an extremely high prevalence of lifetime traumatic experiences was reported (96%). Experiences of sexual violence were reported by 48% of all female and 28% of all male patients. Severe forms of physical violence were reported by 65% of all patients. BPD patients with severe psychopathology show a high comorbidity with trauma-related disorders including dissociative disorders. This association has to be taken into account when planning psychological treatment.

  2. 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.

  3. The morbidity and associated risk factors of cancer in chronic liver disease patients with diabetes mellitus: a multicenter field survey.

    Science.gov (United States)

    Kawaguchi, Takumi; Kohjima, Motoyuki; Ichikawa, Tatsuki; Seike, Masataka; Ide, Yasushi; Mizuta, Toshihiko; Honda, Koichi; Nakao, Kazuhiko; Nakamuta, Makoto; Sata, Michio

    2015-03-01

    Diabetes mellitus is associated with various cancers; however, little is known of the relationship between cancer and diabetes in chronic liver disease (CLD) patients. The aim of this study is to investigate the morbidity and associated factors of cancer, including the use of anti-diabetics, in CLD patients with diabetes. We performed a multicenter survey in 2012 and 478 CLD patients with diabetes were enrolled (age 64.3 ± 12.1 years, female/male 187/291). A frequency analysis of cancer and antidiabetic use was performed. Independent factors for cancer were analyzed using logistic regression and decision-tree analysis. The morbidity of cancer was 33.3%. Hepatocellular carcinoma (HCC) and extra-hepatic cancer were diagnosed in 24.7 and 11.3% of enrolled patients, respectively. The frequency of antidiabetic use was 66.5%. Of prescribed antidiabetics, 39% were dipeptidyl-peptidase 4 inhibitors; however, their use was not significantly associated with cancer. In contrast, the use of exogenous insulin (OR 2.21; 95% CI 1.16-4.21, P = 0.0165) and sulfonylurea (OR 2.08; 95% CI 1.05-3.97, P = 0.0353) were independently associated with HCC and extra-hepatic cancer, respectively. In decision-tree analysis, exogenous insulin and sulfonylurea were also identified as a divergence factor for HCC and extra-hepatic cancer, respectively. We found a high morbidity of not only HCC, but also extra-hepatic cancer in CLD patients with diabetes. We also showed a possible association between the use of antidiabetics and the morbidity of cancer. Thus, a large-scale cohort study is needed to establish a therapeutic strategy for diabetes to suppress carcinogenesis in CLD patients.

  4. 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.

  5. LORIS: a web-based data management system for multi-center studies.

    Science.gov (United States)

    Das, Samir; Zijdenbos, Alex P; Harlap, Jonathan; Vins, Dario; Evans, Alan C

    2011-01-01

    Longitudinal Online Research and Imaging System (LORIS) 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, and 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 (1) continuous project coordination and monitoring of data acquisition (2) data storage/cleaning/querying, (3) interface with arbitrary external data processing "pipelines." LORIS is a complete solution that has been thoroughly tested through a full 10 year life cycle of a multi-center longitudinal project and is now supporting numerous international neurodevelopment and neurodegeneration research projects.

  6. Over- and undersupply in home care: a representative multicenter correlational study.

    Science.gov (United States)

    Lahmann, Nils A; Suhr, Ralf; Kuntz, Simone; Kottner, Jan

    2015-04-01

    Quality assurance and funding of care become a major challenge against the background of demographic changes in western societies. The primary aim of the study was to identify possible misclassification, respectively over and undersupply of care by comparing the Barthel Index of clients of home care service with the level of care (Stage 0, I, II, III) according to the statutory German long-term care insurance. In 2012, a multi-center point prevalence study of 878 randomly selected clients of 100 randomly selected home care services across Germany was conducted. According to a standardized study protocol, demographics, the Barthel Index and the nurses' professional judgment-whether a client requires more nursing care-were assessed. Associations of the Barthel items and professional judgment were analyzed using univariate (Chi-square) and multivariate (logistic regression and classification-regression-tree-models) statistics. In each level of care, the Barthel Index showed large variability e.g. in level II ranging from 0 to 100 points. Multivariate logistic regression regarding possible under- and oversupply revealed occasionally fecal incontinence (2.1; 95 % CI 1.2-3.7), urinary incontinence (2.0; 95 % CI 1.1-3.6), feeding (1.7; 95 % CI 1.0-2.9), immobility (0.2; 95 % CI 0.1-0.6) and to be female (1.8; 95 % CI 1.2-2.6) to be statistically significantly associated. The variability in Barthel Index in each level of care found in this study indicated a large general misclassification of home care clients according to their actual need of care. Professional caregivers identified occasional incontinence, help with eating and drinking and mobility (especially in female clients) as areas of possible under- and oversupply of care. The statutory German long-term care insurance classification should be modified according to the above finding to increase the quality of care in home care clients.

  7. The Burden of Spine Fractures in India: A Prospective Multicenter Study.

    Science.gov (United States)

    Aleem, Ilyas S; DeMarco, Dylan; Drew, Brian; Sancheti, Parag; Shetty, Vijay; Dhillon, Mandeep; Foote, Clary J; Bhandari, Mohit

    2017-06-01

    Prospective cohort study. The objectives of this study were (1) to determine the characteristics of patients sustaining spinal trauma in India and (2) to explore the association between patient or injury characteristics and outcomes after spinal trauma. In affiliation with the ongoing INternational ORthopaedic MUlticentre Study (INORMUS), 192 patients with spinal injuries were recruited during an 8-week period (November 2011 to June 2012) from 14 hospitals in India and followed for 30-days. The primary outcome was a composite of mortality, complications, and reoperation. This was regressed on a set of 13 predictors in a multiple logistic regression model. Most patients were middle-aged (mean age = 51.0 years; median age = 55.5 years; range = 18.0 to 72.0 years), male (60.4%), injured from falls (72.4%), and treated in a private setting (59.9%). Fractures in the lumbar region (51.0%) were most common, followed by thoracic (30.7%) and cervical (18.2%). More than 1 in 5 (21.6%) patients experienced a treatment delay greater than 24 hours, and 36.5% arrived by ambulance. Thirty-day mortality and complication rates were 2.6% and 10.0%, respectively. Care in the public hospital system (odds ratio [OR] = 6.7, 95% CI = 1.1-41.6), chest injury (OR = 11.1, 95% CI = 1.8-66.9), and surgical intervention (OR = 4.8, 95% CI = 1.2-19.6) were independent predictors of major complications. Treatment in the public health care system, increased severity of injury, and surgical intervention were associated with increased risk of major complications following spinal trauma. The need for a large-scale, prospective, multicenter study taking into account spinal stability and neurologic status is feasible and warranted.

  8. Critical Pertussis Illness in Children, A Multicenter Prospective Cohort Study

    Science.gov (United States)

    Berger, John T.; Carcillo, Joseph A.; Shanley, Thomas P.; Wessel, David L.; Clark, Amy; Holubkov, Richard; Meert, Kathleen L.; Newth, Christopher J.L.; Berg, Robert A.; Heidemann, Sabrina; Harrison, Rick; Pollack, Murray; Dalton, Heidi; Harvill, Eric; Karanikas, Alexia; Liu, Teresa; Burr, Jeri S.; Doctor, Allan; Dean, J. Michael; Jenkins, Tammara L.; Nicholson, Carol E.

    2013-01-01

    Objective Pertussis persists in the United States despite high immunization rates. The present report characterizes the presentation and acute course of critical pertussis by quantifying demographic data, laboratory findings, clinical complications, and critical care therapies required among children requiring admission to the pediatric intensive care unit (PICU). Design Prospective cohort study. Setting Eight PICUs comprising the Eunice Kennedy Shriver National Institute for Child Health and Human Development Collaborative Pediatric Critical Care Research Network and 17 additional PICUs across the United States. Patients Eligible patients had laboratory confirmation of pertussis infection, were < 18 years of age, and died in the PICU or were admitted to the PICU for at least 24 hours between June 2008 and August 2011. Interventions None. Measurements and Main Results 127 patients were identified. Median age was 49 days, and 105 (83%) patients were < 3 months of age. Fifty-five (43%) required mechanical ventilation. Twelve (9.4%) died during initial hospitalization. Pulmonary hypertension was found in 16 patients (12.5%), and was present in 75% of patients who died, compared with 6% of survivors (p< 0.001). Median white blood cell count (WBC) was significantly higher in those requiring mechanical ventilation (p<0.001), those with pulmonary hypertension (p<0.001) and non-survivors (p<0.001). Age, sex and immunization status did not differ between survivors and non-survivors. Fourteen patients received leukoreduction therapy (exchange transfusion (12), leukopheresis (1) or both (1)). Survival benefit was not apparent. Conclusions Pulmonary hypertension may be associated with mortality in pertussis critical illness. Elevated WBC is associated with the need for mechanical ventilation, pulmonary hypertension, and mortality risk. Research is indicated to elucidate how pulmonary hypertension, immune responsiveness, and elevated WBC contribute to morbidity and mortality

  9. Major dietary factors and prostate cancer risk: a prospective multicenter case-control study.

    Science.gov (United States)

    Salem, Sepehr; Salahi, Mona; Mohseni, Mona; Ahmadi, Hamed; Mehrsai, Abdolrasoul; Jahani, Yunes; Pourmand, Gholamreza

    2011-01-01

    The association between diet and prostate cancer (PC) risk, although suggestive, still remains largely elusive particularly in the Asian population. This study sought to further evaluate the possible effects of different dietary factors on risk of PC in Iran. Using data from a prospective hospital-based multicenter case-control study, dietary intakes of red meat, fat, garlic, and tomato/tomato products, as well as thorough demographic and medical characteristics, were determined in 194 cases with the newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were obtained after adjustment for major potential confounders, including age, body mass index, smoking, alcohol, education, occupation, family history of PC, and total dietary calories. Comparing the highest with the lowest tertile, a significant trend of increasing risk with more frequent consumption was found for dietary fat (OR: 1.79, 95% CI: 1.71-4.51), whereas inverse association was observed for tomato/tomato products (OR: 0.33, 95% CI: 0.16-0.65). A nonsignificant increase in PC risk was revealed for dietary red meat (OR: 1.69, 95% CI: 0.93-3.06). For garlic consumption, a borderline reduction in risk was observed (OR: 0.58, 95% CI: 0.32-1.01; P = 0.05). In conclusion, our study supports the hypothesis that total fat may increase PC risk and tomatoes/tomato products and garlic may protect patients against PC.

  10. Anatomical Location of Pathology Is Predictive of Prolonged Fluoroscopy Time During ERCP: A Multicenter American Study.

    Science.gov (United States)

    Alkhatib, Amer A; Abdel Jalil, Ala A; Faigel, Douglas O; Pannala, Rahul; Crowell, Michael; Harrison, M E

    2015-06-01

    Different factors have been associated with prolonged fluoroscopy time (FT) during endoscopic retrograde cholangiopancreatography (ERCP). We hypothesize that FT depends on both the anatomical location of the pathology managed during ERCP and the complexity of the ERCP. Three centers participated in a retrospective multi-center cohort study. Data on patient demographics, ERCP complexity, and the location of pathology were collected. The relationships between FT and the location of pathology, ERCP complexity, patient demographics, and ERCP maneuvers, respectively, were analyzed. Prolonged FT was defined as a FT > 10 min. A total of 442 cases underwent ERCP in three different centers (301 cases, 76 cases, and 65 cases in centers A, B, and C, respectively) by six endoscopists. The median FT for all cases was 282 (range 8-3,516) s. Mean FT increased progressively according to anatomical location in the order extrahepatic cases {n = 298; mean FT 292 [95 % confidence interval (CI) 263-322] s}, pancreatic cases [n = 27; mean FT 359 (95 % CI 200-517) s], and intrahepatic cases [n = 117; mean FT 736 s (95 % CI 635-836) s]. Mean FT increased progressively with the complexity scale, with mean FT for Grade I, 218 (95 % CI 138-299) s; Grade II, 295 (95 % 261-329) s; Grade III, 586 (95 % CI 508-663) s; Grade IV, 636 (95 % CI 437-834) s. Multivariable analysis confirmed that prolonged FT was independently associated with anatomical location of the targeted pathology during ERCP-but not with ERCP complexity and endoscopy center. Prolonged FT during ERCP is associated most strongly with intrahepatic cases. FT can be used most effectively as a quality measure if it is stratified according to presence or absence of intrahepatic cases.

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

    Science.gov (United States)

    Xie, Guo-ping; Jiang, Nan; Liang, Chang-xiang; Zeng, Jian-chun; Chen, Zhi-yuan; Xu, Qian; Qi, Rui-zhen; Chen, Yi-rong; Yu, Bin

    2015-01-01

    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.

  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. Epidemiology of acute kidney injury in Hungarian intensive care units: a multicenter, prospective, observational study

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    Bencsik Gabor

    2011-09-01

    Full Text Available Abstract Background Despite the substantial progress in the quality of critical care, the incidence and mortality of acute kidney injury (AKI continues to rise during hospital admissions. We conducted a national, multicenter, prospective, epidemiological survey to evaluate the importance of AKI in intensive care units (ICUs in Hungary. The objectives of this study were to determine the incidence of AKI in ICU patients; to characterize the differences in aetiology, illness severity and clinical practice; and to determine the influencing factors of the development of AKI and the patients' outcomes. Methods We analysed the demographic, morbidity, treatment modality and outcome data of patients (n = 459 admitted to ICUs between October 1st, 2009 and November 30th, 2009 using a prospectively filled in electronic survey form in 7 representative ICUs. Results The major reason for ICU admission was surgical in 64.3% of patients and medical in the remaining 35.7%. One-hundred-twelve patients (24.4% had AKI. By AKIN criteria 11.5% had Stage 1, 5.4% had Stage 2 and 7.4% had Stage 3. In 44.0% of patients, AKI was associated with septic shock. Vasopressor treatment, SAPS II score, serum creatinine on ICU admission and sepsis were the independent risk factors for development of any stage of AKI. Among the Stage 3 patients (34 50% received renal replacement therapy. The overall utilization of intermittent renal replacement therapy was high (64.8%. The overall in-hospital mortality rate of AKI was 49% (55/112. The ICU mortality rate was 39.3% (44/112. The independent risk factors for ICU mortality were age, mechanical ventilation, SOFA score and AKI Stage 3. Conclusions For the first time we have established the incidence of AKI using the AKIN criteria in Hungarian ICUs. Results of the present study confirm that AKI has a high incidence and is associated with high ICU and in-hospital mortality.

  14. Unmasking Glucose Metabolism Alterations in Stable Renal Transplant Recipients: A Multicenter Study

    Science.gov (United States)

    Delgado, Patricia; Diaz, Juan Manuel; Silva, Irene; Osorio, José M.; Osuna, Antonio; Bayés, Beatriz; Lauzurica, Ricardo; Arellano, Edgar; Campistol, Jose Maria; Dominguez, Rosa; Gómez-Alamillo, Carlos; Ibernon, Meritxell; Moreso, Francisco; Benitez, Rocio; Lampreave, Ildefonso; Porrini, Esteban; Torres, Armando

    2008-01-01

    Background and objectives: Emerging information indicates that glucose metabolism alterations are common after renal transplantation and are associated with carotid atheromatosis. The aims of this study were to investigate the prevalence of different glucose metabolism alterations in stable recipients as well as the factors related to the condition. Design, setting, participants, & measurements: A multicenter, cross-sectional study was conducted of 374 renal transplant recipients without pre- or posttransplantation diabetes. A standard 75-g oral glucose tolerance test was performed. Results: Glucose metabolism alterations were present in 119 (31.8%) recipients: 92 (24.6%) with an abnormal oral glucose tolerance test and 27 (7.2%) with isolated impaired fasting glucose. The most common disorder was impaired glucose tolerance (17.9%), and an abnormal oral glucose tolerance test was observed for 21.5% of recipients with a normal fasting glucose. By multivariate analysis, age, prednisone dosage, triglyceride/high-density lipoprotein cholesterol ratio, and β blocker use were shown to be factors related to glucose metabolism alterations. Remarkably, triglyceride levels, triglyceride/high-density lipoprotein cholesterol ratio, and the proportion of recipients with impaired fasting glucose were already higher throughout the first posttransplantation year in recipients with a current glucose metabolism alteration as compared with those without the condition. Conclusions: Glucose metabolism alterations are common in stable renal transplant recipients, and an oral glucose tolerance test is required for its detection. They are associated with a worse metabolic profile, which is already present during the first posttransplantation year. These findings may help planning strategies for early detection and intervention. PMID:18322043

  15. CONSCIOUSNESS, CONNECTEDNESS AND INTRAOPERATIVE UNRESPONSIVENESS STUDY (CONSCIOUS) : A PROSPECTIVE INTERNATIONAL MULTICENTER COHORT STUDY OF THE ISOLATED FOREARM TECHNIQUE FOLLOWING INTUBATION

    NARCIS (Netherlands)

    Sanders, Robert; Raz, A; Absalom, Anthony; Mashour, George; Bonhomme, V.; Coburn, Marc; Sleigh, J. W.

    2016-01-01

    BACKGROUND: Prior data from the isolated forearm technique (IFT) following noxious stimuli suggest that the incidence of response to command may approach 40% under anesthesia 1,2 . We conducted an international, multicenter, pragmatic study of the IFT to establish the incidence of responsiveness fol

  16. Liver retransplantation in adults: the largest multicenter Italian study.

    Directory of Open Access Journals (Sweden)

    Umberto Maggi

    Full Text Available This study is the largest Italian survey on liver retransplantations (RET. Data report on 167 adult patients who received 2 grafts, 16 who received 3 grafts, and one who received 4 grafts over a 11 yr period.There was no statistically significant difference in graft survival after the first or the second RET (52, 40, and 29% vs 44, 36, and 18% at 1,5,and 10 yr, respectively: Log-Rank test, p = 0.30.Survivals at 1, 5, and 10 years of patients who underwent 2 (n = 151 or 3 (n = 15 RETs, were 65, 48,and 39% vs 59, 44, and 30%, respectively (p = 0.59.Multivariate analysis of survival showed that only the type of graft (whole vs reduced was associated with a statistically significant difference (HR = 3.77, Wald test p = 0. 05; the donor age appeared to be a relevant factor as well, although the difference was not statistically significant (HR = 1.91, Wald test p = 0.08.Though late RETs have better results on long term survival relative to early RETs, no statistically significant difference can be found in early results, till three years after RET.Considering late first RETs (interval>30 days from previous transplantation with whole grafts the difference in graft survival in RETs due to HCV recurrence (n = 17 was not significantly different from RETs due to other causes (n = 53 (65-58 and 31% vs 66-57 and 28% respectively at 1-5 and 10 years, p = 0.66.

  17. Extrahepatic manifestations associated with hepatitis C virus infection. A prospective multicenter study of 321 patients. The GERMIVIC. Groupe d'Etude et de Recherche en Medecine Interne et Maladies Infectieuses sur le Virus de l'Hepatite C.

    Science.gov (United States)

    Cacoub, P; Renou, C; Rosenthal, E; Cohen, P; Loury, I; Loustaud-Ratti, V; Yamamoto, A M; Camproux, A C; Hausfater, P; Musset, L; Veyssier, P; Raguin, G; Piette, J C

    2000-01-01

    From January 1996 to January 1997, 321 patients with an average age of 46 +/- 16 years and chronically infected with hepatitis C virus (HCV) were prospectively enrolled in a study designed to determine the prevalence of extrahepatic manifestations associated with HCV infection in a large cohort of HCV patients, to identify associations between clinical and biologic manifestations, and to compare the results obtained in human immunodeficiency virus (HIV)-positive versus HIV-negative subsets. In a cross-sectional study, clinical extrahepatic manifestations, viral coinfections with HIV and/or hepatitis B virus, connective tissue diseases, and a wide panel of autoantibodies were assessed. Thirty-eight percent (122/321) of patients presented at least 1 clinical extrahepatic manifestation including arthralgia (60/321, 19%), skin manifestations (55/321, 17%), xerostomia (40/321, 12%), xerophthalmia (32/321, 10%), and sensory neuropathy (28/321, 9%). Main biologic abnormalities were mixed cryoglobulins (110/196, 56%), thrombocytopenia (50/291, 17%), and the presence of the following autoantibodies: antinuclear (123/302, 41%), rheumatoid factor (107/280, 38%), anticardiolipin (79/298, 27%), antithyroglobulin (36/287, 13%) and antismooth muscle cell (27/288, 9%). At least 1 autoantibody was present in 210/302 (70%) of sera. By multivariate logistic regression analysis, 4 parameters were significantly associated with cryoglobulin positivity: systemic vasculitis (p = 0.01, odds ratio OR[ = 17.3), HIV positivity (p = 0.0006, OR = 10.2), rheumatoid factor positivity (p = 0.01, OR = 2.8), and sicca syndrome (p = 0.03, OR = 0.27). A definite connective tissue disease was noted in 44 patients (14%), mainly symptomatic mixed cryoglobulinemia and systemic vasculitis, HIV coinfection (23%) was associated with 3 parameters: anticardiolipin (p = 0.003, OR = 4.18), thrombocytopenia (p = 0.01, OR = 3.56), and arthralgia or myalgia (p = 0.017, OR = 0.23). HIV-positive patients presented

  18. 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

  19. Determinants of mortality for adults with cystic fibrosis admitted in Intensive Care Unit: a multicenter study

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    Rabbat Antoine

    2006-01-01

    Full Text Available Abstract Background Intensive care unit (ICU admission of adults with cystic fibrosis (CF is controversial because of poor outcome. This appraisal needs re-evaluation following recent changes in both CF management and ICU daily practice. Objectives were to determine long-term outcome of adults with CF admitted in ICU and to identify prognostic factors. Methods Retrospective multicenter study of 60 ICU hospitalizations for 42 adult CF patients admitted between 2000 and 2003. Reason for ICU admission, ventilatory support provided and one-year survival were recorded. Multiple logistic analysis was used to determine predictors of mortality. Results Prior to ICU admission, all patients (mean age 28.1 ± 8 yr had a severe lung disease (mean FEV1 28 ± 12% predicted; mean PaCO2 47 ± 9 mmHg. Main reason for ICU hospitalization was pulmonary infective exacerbation (40/60. At admission, noninvasive ventilation was used in 57% of cases and was successful in 67% of patients. Endotracheal intubation was implemented in 19 episodes. Overall ICU mortality rate was 14%. One year after ICU discharge, 10 of the 28 survivors have been lung transplanted. Among recognized markers of CF disease severity, only the annual FEV1 loss was associated with a poor outcome (HR = 1.47 [1.18–1.85], p = 0.001. SAPSII (HR = 1.08 [1.03–1.12], p Conclusion Despite advanced lung disease, adult patients with CF admitted in ICU have high survival rate. Endotracheal intubation is associated with a poor prognosis and should be used as the last alternative. Although efforts have to be made in selecting patients with CF likely to benefit from ICU resources, ICU admission of these patients should be considered.

  20. Therapy response evaluation of malignant lymphoma in a multicenter study. Comparison of manual and semiautomatic measurements in CT

    Energy Technology Data Exchange (ETDEWEB)

    Wessling, J.; Schuelke, C. [Muenster Univ. (Germany). Dept. of Clinical Radiology; Koch, R. [Muenster Univ. (Germany). Dept. of Medical Informatics and Biomathematics; and others

    2014-08-15

    Purpose: Comparison of manual one-/bi-dimensional measurements versus semi-automatically derived one-/bi-dimensional and volumetric measurements for therapy response evaluation of malignant lymphoma during CT follow-up examinations in a multicenter setting. Materials and Methods: MSCT data sets of patients with malignant lymphoma were evaluated before (baseline) and after two cycles of chemotherapy (follow-up) at radiological centers of five university hospitals. The long axis diameter (LAD), the short axis diameter (SAD) and the bi-dimensional WHO of 307 target lymph nodes were measured manually and semi-automatically using dedicated software. Lymph node volumetry was performed semi-automatically only. The therapeutic response was evaluated according to lymphoma-adapted RECIST. Results: Based on a single lymph node, semi-automatically derived multidimensional parameters allowed for significantly more accurate therapy response classification than the manual or the semi-automatic unidimensional parameters. Incorrect classifications were reduced by up to 9.6%. Compared to the manual approach, the influence of the study center on correct therapy classification is significantly less relevant when using semi-automatic measurements. Conclusion: Semi-automatic volumetry and bi-dimensional WHO significantly reduce the number of incorrectly classified lymphoma patients by approximately 9.6% in the multicenter setting in comparison to linear parameters. Semi-automatic quantitative software tools may help to significantly reduce wrong classifications that are associated with the manual assessment approach. (orig.)

  1. Prognostic power of abnormal cytogenetics for multiple myeloma:a multicenter study in China

    Institute of Scientific and Technical Information of China (English)

    LAI Yue-yun; FU Wei-ling; GUO Hai-ying; HOU Ming; HOU Jian; HU Yu; HU Xiao-tong; HU Xiao-mei; HUANG Li-qiang; JIN Jie; LI Jian-yong; HUANG Xiao-jun; LI Juan; Li Wei; LIANG Ying-min; LIU Ting; LIU Qi-fa; LIU Yan-hui; MAO Ping; OUYANG Jian; QIU Lu-gui; QIU Lin; CAI Zhen; SHAO Chun-kui; SHI Bin; SONG Yong-ping; SUN Zi-min; WANG Qi-shan; WANG Chun; WANG Jian-ming; WANG Yun-shan; WANG Zhao; WU Jian-bo; CAO Xiang-shan; WU Yin-xia; XIA Rui-xiang; XUE Yong-quan; YANG Bao-zhen; YANG Guang; YANG Zheng-lin; YU Li; YUAN Zhong; ZHANG Sheng; ZHANG Yin; CHEN Fang-ping; ZHAO Hong-guo; ZHAO Li; ZHOU Dao-bin; ZOU Shan-hua; ZHU Yun-feng; CHEN Xie-qun; CHEN Bao-an; FANG Mei-yun; FENG Jia-fu

    2012-01-01

    Background Chromosomal abnormalities have been shown to play an important prognostic role in multiple myeloma (MM).tnterphase fluorescence in situ hybridization (i-FISH) has been much more effective to identify cytogenetic aberrations in MM than conventional cytogenetic technique (CC).To clearly determine the cytogenetic features of Chinese MM patients and identify their prognostic implications,we designed a multicenter study based on i-FISH including 672 patients from 52 hospitals in China.Methods All 672 patients were systematically screened for the following genomic aberrations:del(13q).lgHrearrangement,del(p53) and 1q21 amplifications.Results The analysis showed that the chromosomal changes were detected in 22.1% patients by CC and in 82.3%patients by i-FISH.The most common abnormalities by CC were chromosome 1 aberrations (48.4%),-13/13q- (37.6%),hyperdiploidy (36.6%),hypodiploidy (30.1%) and lgH rearrangements (23.7%).The most frequent abnormalities by FISH was del(13q),which was found in 60.4% patients.whereas IgH rearrangement,1q21 amplification and p53 deletions were detected in 57.6%,49.0% and 34.7% cases.respectively.By statistical analysis.-13/13q- by CC was associated with low level of platelet (P=0.015).hyperdiploidy was associated with low level of serum albumin (P=0.028),and lgH rearrangement by FISH was associated with high level of β32 microglobulin (P=0.019).Moreover,1q21 amplification and del(p53) by FlSH conferred a high incidence of progressive disease (PD) after initial therapy.Metaphase detection of lgH rearrangements and chromosome 1 aberrations concurrently was associated with a short progression free survival (PFS)(P=0.036).No significant prognostic implications of other cytogenetic abnormalities were found associated with overall survival and PFS.Conclusions Chinese MM patients had similar cytogenetic abnormalities compared with the previous reported studies.However,the prognostic significance of FISH aberrations

  2. Early-Stage Primary Bone Lymphoma: A Retrospective, Multicenter Rare Cancer Network (RCN) Study

    Energy Technology Data Exchange (ETDEWEB)

    Cai Ling [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland); Sun Yat-sen University Cancer Center, Guangzhou, Guangdong (China); Stauder, Michael C. [Mayo Clinic, Rochester, MN (United States); Zhang Yujing [Sun Yat-sen University Cancer Center, Guangzhou, Guangdong (China); Poortmans, Philip [Verbeeten Institute, Tilburg (Netherlands); Li Yexiong [Cancer Hospital, Chinese Academy of Medical Sciences, Beijing (China); Constantinou, Nicolaos [Theagenio Cancer Hospital, Thessaloniki, Macedonia (Greece); Thariat, Juliette [Centre Anti-Cancereux Antoine-Lacassagne, Nice, Cote d' Azur (France); Kadish, Sidney P. [University of Massachusetts Medical School, Worcester, MA (United States); Nguyen, Tan Dat [Institut Jean-Godinot, Reims, Champagne-Ardenne (France); Kirova, Youlia M. [Institut Curie, Paris (France); Ghadjar, Pirus [Inselspital, Bern University Hospital, and University of Bern (Switzerland); Weber, Damien C. [Hopitaux Universitaires de Geneve (Switzerland); Bertran, Victoria Tuset [Hospital Universitari Germans Trias i Pujol, Barcelona (Spain); Ozsahin, Mahmut [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland); Mirimanoff, Rene-Olivier, E-mail: Rene-Olivier.Mirimanoff@chuv.ch [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland)

    2012-05-01

    Purpose: Primary bone lymphoma (PBL) represents less than 1% of all malignant lymphomas. In this study, we assessed the disease profile, outcome, and prognostic factors in patients with Stages I and II PBL. Patients and Methods: Thirteen Rare Cancer Network (RCN) institutions enrolled 116 consecutive patients with PBL treated between 1987 and 2008 in this study. Eighty-seven patients underwent chemoradiotherapy (CXRT) without (78) or with (9) surgery, 15 radiotherapy (RT) without (13) or with (2) surgery, and 14 chemotherapy (CXT) without (9) or with (5) surgery. Median RT dose was 40 Gy (range, 4-60). The median number of CXT cycles was six (range, 2-8). Median follow-up was 41 months (range, 6-242). Results: The overall response rate at the end of treatment was 91% (complete response [CR] 74%, partial response [PR] 17%). Local recurrence or progression was observed in 12 (10%) patients and systemic recurrence in 17 (15%). The 5-year overall survival (OS), lymphoma-specific survival (LSS), and local control (LC) were 76%, 78%, and 92%, respectively. In univariate analyses (log-rank test), favorable prognostic factors for OS and LSS were International Prognostic Index (IPI) score {<=}1 (p = 0.009), high-grade histology (p = 0.04), CXRT (p = 0.05), CXT (p = 0.0004), CR (p < 0.0001), and RT dose >40 Gy (p = 0.005). For LC, only CR and Stage I were favorable factors. In multivariate analysis, IPI score, RT dose, CR, and CXT were independently influencing the outcome (OS and LSS). CR was the only predicting factor for LC. Conclusion: This large multicenter retrospective study confirms the good prognosis of early-stage PBL treated with combined CXRT. An adequate dose of RT and complete CXT regime were associated with better outcome.

  3. Cytomegalovirus Infection following Kidney Transplantation: a Multicenter Study of 3065 Cases

    Science.gov (United States)

    Einollahi, B.

    2012-01-01

    Background: Cytomegalovirus (CMV) infection is a common complication following kidney transplantation. Objective: To assess the incidence and risk factors of CMV infection among renal transplant recipients. Methods: In a retrospective multicenter study, 3065 renal transplant recipients from 17 transplant centers of Iran were studied between April 2008 and January 2011. Kidney transplant patients were routinely monitored by sequential blood samples drawn for use in the CMV-pp65 antigenemia assay, and for hematological and biochemistry tests. Results: 63% of studied patients were males; the mean±SD age of participants was 38±15 years. The majority of cases (81%) received a kidney from a living unrelated donor (LURD), 9% from living related donor (LRD), and 10% from deceased donors. 671 patients experienced CMV viremia. The incidence of CMV infection was 21.9% (95% CI: 20.4%–23.4%). The rate was higher in the first 6 months after transplantation (p<0.001); in recipients with higher level of cyclosporine (p<0.001); in those with lower hemoglobin concentration (p=0.02); patients with elevated ALT (p<0.001); those with increased fasting blood sugar (p=0.005); recipients with dyslipidemia (p<0.05); deceased kidney recipients (p=0.006); and patients with kidney graft impairment (p=0.01). In multivariate regression analysis, time since kidney transplantation (p<0.001) and renal allograft failure (p<0.001) were the only risk factors associated with CMV infection. Conclusions: CMV infection was a common complication in the first 6 months of kidney transplantation, particularly among patients with kidney graft impairment. PMID:25013626

  4. 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

  5. Differential diagnosis of fetal hyperechogenic cystic kidneys unrelated to renal tract anomalies: A multicenter study.

    Science.gov (United States)

    Chaumoitre, K; Brun, M; Cassart, M; Maugey-Laulom, B; Eurin, D; Didier, F; Avni, E F

    2006-12-01

    To identify important factors in the differential diagnosis of renal cysts associated with hyperechogenic kidneys. This was a retrospective multicenter study. We identified 93 fetuses presenting between 1990 and 2002 with hyperechogenic kidneys and which had a diagnosis of nephropathy confirmed later. We analyzed retrospectively the prenatal ultrasound findings of those fetuses which were found sonographically to have renal cysts. Of the 93 fetuses presenting with hyperechogenic kidneys and with a later diagnosis of nephropathy, there were 28 with autosomal dominant polycystic kidney disease (ADPKD), 31 with autosomal recessive polycystic kidney disease (ARPKD), 11 with Bardet-Biedl syndrome, nine with Meckel-Gruber syndrome, six with Ivemark II syndrome, one with Jarcho-Levin syndrome, one with Beemer syndrome and one with Meckel-like syndrome. One third of the fetuses (30/93) had renal cysts. Cystic characteristics (size, location, number) were not very useful for diagnosis; more useful was diagnosis of an associated malformation. Three (11%) of the fetuses with ADPKD had cysts, as did nine (29%) of those with ARPKD, three (27%) of those with Bardet-Biedl syndrome, all (100%) of those with Meckel-Gruber syndrome, three (50%) of those with Ivemark II syndrome, and each of the three cases with other syndromes (Jarcho-Levin, Beemer and Meckel-like syndromes). None of the cases with trisomy 13 had cysts. There were no associated malformations in the 12 cases with renal cysts and polycystic kidney disease; the other 18 cases with renal cysts were associated with malformations that were often specific, such as polydactyly in Bardet-Biedl and Beemer syndromes, occipital defect and Dandy-Walker malformation in Meckel-Gruber or Meckel-Gruber-like syndromes, and thoracic and/or vertebral abnormalities in Jarcho-Levin and Beemer syndromes. Renal cysts associated with hyperechogenic kidneys are not rare. The clue to diagnosis is the demonstration of an associated

  6. Multicenter study of endoscopic preoperative biliary drainage for malignant distal biliary obstruction

    Science.gov (United States)

    Sasahira, Naoki; Hamada, Tsuyoshi; Togawa, Osamu; Yamamoto, Ryuichi; Iwai, Tomohisa; Tamada, Kiichi; Kawaguchi, Yoshiaki; Shimura, Kenji; Koike, Takero; Yoshida, Yu; Sugimori, Kazuya; Ryozawa, Shomei; Kakimoto, Toshiharu; Nishikawa, Ko; Kitamura, Katsuya; Imamura, Tsunao; Mizuide, Masafumi; Toda, Nobuo; Maetani, Iruru; Sakai, Yuji; Itoi, Takao; Nagahama, Masatsugu; Nakai, Yousuke; Isayama, Hiroyuki

    2016-01-01

    AIM: To determine the optimal method of endoscopic preoperative biliary drainage for malignant distal biliary obstruction. METHODS: Multicenter retrospective study was conducted in patients who underwent plastic stent (PS) or nasobiliary catheter (NBC) placement for resectable malignant distal biliary obstruction followed by surgery between January 2010 and March 2012. Procedure-related adverse events, stent/catheter dysfunction (occlusion or migration of PS/NBC, development of cholangitis, or other conditions that required repeat endoscopic biliary intervention), and jaundice resolution (bilirubin level < 3.0 mg/dL) were evaluated. Cumulative incidence of jaundice resolution and dysfunction of PS/NBC were estimated using competing risk analysis. Patient characteristics and preoperative biliary drainage were also evaluated for association with the time to jaundice resolution and PS/NBC dysfunction using competing risk regression analysis. RESULTS: In total, 419 patients were included in the study (PS, 253 and NBC, 166). Primary cancers included pancreatic cancer in 194 patients (46%), bile duct cancer in 172 (41%), gallbladder cancer in three (1%), and ampullary cancer in 50 (12%). The median serum total bilirubin was 7.8 mg/dL and 324 patients (77%) had ≥ 3.0 mg/dL. During the median time to surgery of 29 d [interquartile range (IQR), 30-39 d]. PS/NBC dysfunction rate was 35% for PS and 18% for NBC [Subdistribution hazard ratio (SHR) = 4.76; 95%CI: 2.44-10.0, P < 0.001]; the pig-tailed tip was a risk factor for PS dysfunction. Jaundice resolution was achieved in 85% of patients and did not depend on the drainage method (PS or NBC). CONCLUSION: PS has insufficient patency for preoperative biliary drainage. Given the drawbacks of external drainage via NBC, an alternative method of internal drainage should be explored. PMID:27076764

  7. 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.

  8. Outcomes after operations for anal fistula: results of a prospective, multicenter, regional study.

    Science.gov (United States)

    Hall, Jason F; Bordeianou, Liliana; Hyman, Neil; Read, Thomas; Bartus, Christine; Schoetz, David; Marcello, Peter W

    2014-11-01

    There are various surgical techniques used treat anal fistulas. The adoption and success rates of newer techniques have not been clearly established. The purpose of this study was to determine the healing rate after operations for anal fistulas in New England colorectal surgery practices. We conducted a retrospective review of a prospectively collected database. The study was conducted at colorectal surgery practices in New England. A prospective, multicenter registry was created by the New England Society of Colon and Rectal Surgeons. Surgeons were invited to collect data prospectively regarding patients operated on for anal fistulas between January 1, 2011, and August 1, 2013. Fistula classification, surgical intervention, continence scores, and healing were determined by the treating surgeon. Operation for anal fistula was performed. We measured the proportion of patients with healed fistulas at 3 months. Sixteen surgeons submitted data regarding 240 operations for fistula with curative intent. Mean patient age was 45 ± 14 years. A total of 158 patients (66%) were men, and 110 (46%) had undergone an anorectal operation. Twenty-nine (12%) had Crohn's disease. The healing rates of fistulotomy, advancement flap, and fistula plugs at 3 months were 94% (95% CI, 89-97), 60% (95% CI, 33-77), and 20% (95% CI, 5-50). The healing rate of the ligation of intersphincteric fistula tract procedure at 3 months was 79% (95% CI, 65-88). Hospital site was the only variable associated with healing (p fistula tract procedures had higher healing rates at 3 months (p anal fistulas in our region. Fistulotomy continues to have excellent results. There has been enthusiastic early adoption of the ligation of intersphincteric fistula tract technique. Early healing rates after the ligation of intersphincteric fistula tract procedure appear to be excellent.

  9. The ratio of serum n-3 to n-6 polyunsaturated fatty acids is associated with diabetes mellitus in patients with prior myocardial infarction: a multicenter cross-sectional study.

    Science.gov (United States)

    Takahashi, Masao; Ando, Jiro; Shimada, Kazunori; Nishizaki, Yuji; Tani, Shigemasa; Ogawa, Takayuki; Yamamoto, Masato; Nagao, Ken; Hirayama, Atsushi; Yoshimura, Michihiro; Daida, Hiroyuki; Nagai, Ryozo; Komuro, Issei

    2017-01-26

    In prior myocardial infarction (PMI) patients, diabetes mellitus (DM), dyslipidemia, and hypertension increase the risk of secondary cardiovascular events. Although a decreased ratio of serum eicosapentaenoic acid (EPA) to arachidonic acid (AA; EPA/AA) has been shown to significantly correlate with the onset of acute coronary syndrome, the associations between polyunsaturated fatty acid (PUFA) levels and coronary risk factors in PMI patients have not been evaluated thoroughly. This study aimed to assess the associations between PUFAs levels and the risk factors in PMI patients. We enrolled 1733 patients with known PUFA levels who were treated in five divisions of cardiology in a metropolitan area of Japan, including 303 patients with PMI. EPA/AA and docosahexaenoic acid (DHA) to AA level ratio (DHA/AA) in patients with and without PMI were analyzed according to presence of coronary risk factors. Diabetes patients with PMI had significantly lower EPA/AA and DHA/AA than diabetes patients without PMI (EPA/AA: P levels (>0.1 mg/dL), EPA/AA was low in individuals who also had PMI, whereas DHA/AA was not (EPA/AA, with PMI: 0.43 ± 0.24; without PMI: 0.53 ± 0.30, P level in DM patients with PMI. Statin use can potentially affect DHA/AA but not EPA/AA, and therefore EPA/AA ratio is a better marker of assessment for cardiovascular events.

  10. Therapy-associated late effects after irradiation of malignant diseases in childhood and adolescence. Feasibility analyses of a prospective multicenter register study; Behandlungsassoziierte Spaetfolgen nach Strahlentherapie maligner Erkrankungen im Kindes- und Jugendalter. Machbarkeitsanalyse einer prospektiven multizentrischen Registerstudie

    Energy Technology Data Exchange (ETDEWEB)

    Boelling, T.; Schuck, A.; Hesselmann, S.; Willich, N. [Klinik fuer Strahlentherapie, Universitaetsklinikum Muenster (Germany); Ruebe, C.; Speiser-Held, I. [Klinik fuer Strahlentherapie, Universitaetsklinikum Homburg/Saar (Germany); Pape, H. [Klinik fuer Strahlentherapie, Universitaetsklinikum Duesseldorf (Germany); Dieckmann, K. [Klinik fuer Strahlentherapie, Universitaetsklinikum Wien (Austria); Poellinger, B. [Klinik fuer Strahlentherapie, Universitaetsklinikum Muenchen (Germany); Kortmann, R.D. [Klinik fuer Strahlentherapie, Universitaetsklinikum Leipzig (Germany); Meyer, F.M. [Klinik fuer Strahlentherapie, Klinikum Augsburg (Germany); Martini, C. [Klinik fuer Strahlentherapie, Universitaetsklinikum Freiburg (Germany); Asadpour, B. [Klinik fuer Strahlentherapie, Universitaetsklinikum Aachen (Germany); Timmermann, B. [Paul-Scherrer-Inst. Villigen (Switzerland); Beck, J.D.; Langer, T.; Paulides, M. [Abt. fuer Paediatrische Onkologie, LESS-Zentrum, Universitaetskinderklinik Erlangen (Germany); Schmidt, B. [Klinik fuer Strahlentherapie, Katharinenhospital Stuttgart (Germany)

    2006-08-15

    Background and purpose: Radiogenic late effects in children and adolescents have been evaluated retrospectively in most analyses, with small patient numbers. The German Group of Pediatric Radiation Oncology (APRO) has generated a concept for a prospective evaluation of radiation-associated late effects in childhood. The aim of this study was to evaluate the feasibility of a nationwide central database for the documentation of radiation parameters and side effects of all children treated within therapy protocols of the German Society of Pediatric Oncology and Hematology (GPOH). Material and methods: A study center has been implemented in Muenster, the documentation has started in July 2001 in few centers in a pilot phase. Since February 2004 the documentation is done countrywide. Detailed documentation forms have been designed for treatment parameters and for doses applied at organs at risk. Furthermore, a uniform toxicity documentation, according to the RTOG/EORTC criteria, was chosen. Patients were reported from the study centers of the GPOH to the study center. All information was collected and analyzed in the study center. Results: Till July 31, 2205, 438 documentations of radiation and 579 toxicity documentations of side effects have been collected in the study center. 46 centers for radiotherapy in Germany and one center each in Austria and in Switzerland took part in the documentation. The quality of documentation regarding completeness and plausibility fulfilled the expected criteria in most cases. This feasibility analysis showed that important information about organ dose levels and side effects was documented in a large number of patients (Figures 1 and 2). Conclusion: This prospective evaluation of radiotherapy and radiogenic side effects in children and adolescents will allow correlating doses at organs at risk and the incidence of acute and late sequelae in Germany. Further documentations and a longer follow-up are necessary to obtain powerful results

  11. 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.

  12. 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

  13. 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

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD)...

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

    African Journals Online (AJOL)

    ... clinical cohort Study in Ethiopia: Advanced Clinical Monitoring of Antiretroviral Treatment Project. ... Ethiopian Journal of Health Sciences ... Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective ...

  15. Atypical manifestations of hepatitis A infection: a prospective, multicenter study in Korea.

    Science.gov (United States)

    Jung, Youn Mu; Park, Sang Jong; Kim, Jeong Sim; Jang, Je-Hyuck; Lee, Sang Hyub; Kim, Jin-Wook; Park, Young Min; Hwang, Seong Gyu; Rim, Kyu Sung; Kang, Sook-Kyoung; Lee, Hyun Seok; Yun, Hae Sun; Jee, Young Mee; Jeong, Sook-Hyang

    2010-08-01

    The clinical outcome of symptomatic hepatitis A and the incidence and clinical characteristics of atypical presentation of hepatitis A were studied using prospective, multicenter design. The atypical presentation included delayed anti-hepatitis A virus (HAV) immunoglobulin M (IgM) seroconversion defined as positive anti-HAV IgM on the repeated test within 7 days of hospital admission after the initially negative result, prolonged cholestasis, and acute kidney injury (AKI). A total of 595 patients with symptomatic hepatitis A requiring hospital admission were enrolled prospectively from September 2006 to August 2008 in four major hospitals in a Korean city with a population of approximately 1 million. Clinical outcomes of symptomatic hepatitis A showed a case fatality rate of 0.2%, and fulminant hepatitis in 0.5%. Delayed anti-HAV IgM seroconversion was found in 6.4%, and was significantly associated with shorter intervals from symptom onset to hospital admission, higher body mass index, and lower alanine aminotransferase (ALT) level at admission. Prolonged cholestasis was found in 4.7% of patients, and could be predicted by preexisting chronic hepatitis B viral infection, prolonged prothrombin time, and higher total bilirubin level. AKI was complicated in 1.5%, which could be predicted by lower albumin level, higher ALT level, and higher white blood cell (WBC) count. More than half of the patients required hemodialysis. Substantial occurrence of delayed anti-HAV IgM seroconversion, prolonged cholestasis, and AKI was confirmed with various predictable factors, which could be helpful for accurate diagnosis and management of hepatitis A patients. (c) 2010 Wiley-Liss, Inc.

  16. Multicenter study of pectus excavatum, final report: complications, static/exercise pulmonary function, and anatomic outcomes.

    Science.gov (United States)

    Kelly, Robert E; Mellins, Robert B; Shamberger, Robert C; Mitchell, Karen K; Lawson, M Louise; Oldham, Keith T; Azizkhan, Richard G; Hebra, Andre V; Nuss, Donald; Goretsky, Michael J; Sharp, Ronald J; Holcomb, George W; Shim, Walton K T; Megison, Stephen M; Moss, R Lawrence; Fecteau, Annie H; Colombani, Paul M; Cooper, Dan; Bagley, Traci; Quinn, Amy; Moskowitz, Alan B; Paulson, James F

    2013-12-01

    A multicenter study of pectus excavatum was described previously. This report presents our final results. Patients treated surgically at 11 centers were followed prospectively. Each underwent a preoperative evaluation with CT scan, pulmonary function tests, and body image survey. Data were collected about associated conditions, complications, and perioperative pain. One year after treatment, patients underwent repeat chest CT scan, pulmonary function tests, and body image survey. A subset of 50 underwent exercise pulmonary function testing. Of 327 patients, 284 underwent Nuss procedure and 43 underwent open procedure without mortality. Of 182 patients with complete follow-up (56%), 18% had late complications, similarly distributed, including substernal bar displacement in 7% and wound infection in 2%. Mean initial CT scan index of 4.4 improved to 3.0 post operation (severe >3.2, normal = 2.5). Computed tomography index improved at the deepest point (xiphoid) and also upper and middle sternum. Pulmonary function tests improved (forced vital capacity from 88% to 93%, forced expiratory volume in 1 second from 87% to 90%, and total lung capacity from 94% to 100% of predicted (p VO2 max during peak exercise increased by 10.1% (p = 0.015) and O2 pulse by 19% (p = 0.007) in 20 subjects who completed both pre- and postoperative exercise tests. There is significant improvement in lung function at rest and in VO2 max and O2 pulse after surgical correction of pectus excavatum, with CT index >3.2. Operative correction significantly reduces CT index and markedly improves the shape of the entire chest, and can be performed safely in a variety of centers. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  17. Prehospital and en route cricothyrotomy performed in the combat setting: a prospective, multicenter, observational study.

    Science.gov (United States)

    Barnard, Ed B G; Ervin, Alicia T; Mabry, Robert L; Bebarta, Vikhyat S

    2014-01-01

    Airway compromise is the third most common cause of potentially preventable combat death. Surgical cricothyrotomy is an infrequently performed but lifesaving airway intervention. There are limited published data on prehospital cricothyrotomy in civilian or military settings. Our aim was to prospectively describe the survival rate and complications associated with cricothyrotomy performed in the military prehospital and en route setting. The Life-Saving Intervention (LSI) study is a prospective, institutional review board-approved, multicenter trial examining LSIs performed in the prehospital combat setting. We prospectively recorded LSIs performed on patients in theater who were transported to six combat hospitals. Trained site investigators evaluated patients on arrival and recorded demographics, vital signs, and LSIs performed. LSIs were predefined and include cricothyrotomies, chest tubes, intubations, tourniquets, and other procedures. From the large dataset, we analyzed patients who had a cricothyrotomy performed. Hospital outcomes were cross-referenced from the Department of Defense Trauma Registry. Descriptive statistics or Wilcoxon test (nonparametric) were used for data comparisons; statistical significance was set at pcombat medic (pre-evacuation), and 18 by an evacuation helicopter medic. Combat-hospital outcome data were available for 26 patients, 13 (50%) of whom survived to discharge. The cricothyrotomy patients had more LSIs than noncricothyrotomy patients (four versus two LSIs per patient; pcombat, procedural success was higher than previously reported. In addition, the majority of cricothyrotomies were performed by the evacuation helicopter medic rather than the prehospital combat medic. Prehospital military medics should receive training in decision making and be provided with adjuncts to facilitate this lifesaving procedure. 2014.

  18. Outcome of HCV/HIV-coinfected liver transplant recipients: a prospective and multicenter cohort study.

    Science.gov (United States)

    Miro, J M; Montejo, M; Castells, L; Rafecas, A; Moreno, S; Agüero, F; Abradelo, M; Miralles, P; Torre-Cisneros, J; Pedreira, J D; Cordero, E; de la Rosa, G; Moyano, B; Moreno, A; Perez, I; Rimola, A

    2012-07-01

    Eighty-four HCV/HIV-coinfected and 252-matched HCV-monoinfected liver transplant recipients were included in a prospective multicenter study. Thirty-six (43%) HCV/HIV-coinfected and 75 (30%) HCV-monoinfected patients died, with a survival rate at 5 years of 54% (95% CI, 42-64) and 71% (95% CI, 66 to 77; p = 0.008), respectively. When both groups were considered together, HIV infection was an independent predictor of mortality (HR, 2.202; 95% CI, 1.420-3.413 [p < 0.001]). Multivariate analysis of only the HCV/HIV-coinfected recipients, revealed HCV genotype 1 (HR, 2.98; 95% CI, 1.32-6.76), donor risk index (HR, 9.48; 95% CI, 2.75-32.73) and negative plasma HCV RNA (HR, 0.14; 95% CI, 0.03-0.62) to be associated with mortality. When this analysis was restricted to pretransplant variables, we identified three independent factors (HCV genotype 1, pretransplant MELD score and centers with <1 liver transplantation/year in HIV-infected patients) that allowed us to identify a subset of 60 (71%) patients with a similar 5-year prognosis (69%[95% CI, 54-80]) to that of HCV-monoinfected recipients. In conclusion, 5-year survival in HCV/HIV-coinfected liver recipients was lower than in HCV-monoinfected recipients, although an important subset with a favorable prognosis was identified in the former. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

  19. 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

  20. Obesity in the pediatric headache population: a multicenter study.

    Science.gov (United States)

    Hershey, Andrew D; Powers, Scott W; Nelson, Timothy D; Kabbouche, Marielle A; Winner, Paul; Yonker, Marcy; Linder, Steven L; Bicknese, Alma; Sowel, Michael K; McClintock, William

    2009-02-01

    To examine the prevalence of obesity, the relationship between weight compared with headache frequency and disability, and effect of weight change on headache outcomes within a pediatric headache population. Headache and obesity are both common conditions in children and adults. Research in adults has suggested a relationship between the 2 conditions. This relationship has not yet been explored within a pediatric population. The effect of obesity and weight change on headache outcomes may have important implications for clinical care. Data on height, weight, age, and gender, as well as headache frequency and disability, were collected on 913 consecutive patients at 7 pediatric headache centers, the body mass index (BMI) calculated and the BMI percentile determined. The same data were collected on patients seen at 3- (n = 213) and 6-month (n = 174) follow-up for comparative analysis. The prevalence of overweight patients at initial visit did not significantly differ from the general pediatric population. BMI percentile was significantly correlated with headache frequency and disability at initial visit, although the correlations were relatively small. For children who were obese or at risk for overweight as initial visit, change in BMI was significantly positively correlated with change in headache frequency at 3- and 6-month follow-up. Obesity is associated with headache frequency and disability in the pediatric headache population. For children who are overweight, weight loss can contribute to a reduction in headaches over time. Clinicians should consider child weight status in providing care for pediatric headache.

  1. 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.

    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 screeni

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

    NARCIS (Netherlands)

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

  3. [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.

  4. Characteristics of rheumatoid arthritis in Algeria: a multicenter study.

    Science.gov (United States)

    Slimani, Samy; Abbas, Abdelmalek; Ben Ammar, Amina; Kebaili, Djemaa; Ali, El Hadi; Rahal, Fadia; Khamari, Mohamed Choukri; Baltache, Ayada; Khider, Imene; Chiheub, Riad; Khelif, Khireddine; Akbi, Sabrina; Rahmani, Salima; Dahou-Makhloufi, Chafia; Brahimi-Mazouni, Nadjia; Abtroun-Benmadi, Sabira; Ladjouze-Rezig, Aicha

    2014-09-01

    The aim of this study was to compare the epidemiology of rheumatoid arthritis (RA) in North Africa to that of Western countries. We have enrolled in a cross-sectional study all consecutive patients presenting with the diagnosis of RA according to the 1987 ACR criteria, and during a 5-month period, patients were included in 11 centers across northern Algeria. Demographics, clinical data, and health assessment questionnaires (HAQ) were collected for each patient. We have estimated means, standard deviations, and 95 % confidence intervals for all parameters. Of the 249 patients (213 females and 36 males) enrolled in the study, 10 (4 %) had juvenile onset of the disease. The mean age was 50.1 ± 14.5 years, and the mean duration of RA was 8.4 ± 7.8 years. In terms of comorbidities, 18.9 % of patients reported hypertension and 5.2 % had diabetes. The mean DAS28 at inclusion was 4.3 (95 % CI 4.1-4.5); 14.0 % were in remission (DAS28 ≤ 2.6). The mean HAQ score was 0.81 ± 0.82. Rheumatoid factor was positive in 78.5 % of cases, and anti-citrullinated protein/peptide antibodies, when measured, was positive in 69.0 % of cases. Seronegative patients were older and had a relatively less severe disease. For treatment, 89.7 % of patients were taking disease-modifying anti-rheumatic drugs and only 4 % were taking biologics (rituximab); 90.8 % of patients were taking glucocorticoids, and none of the patients satisfied the recommended calcium intake guidelines. RA in Algeria is more common in women. Compared to reports from Western countries, RA in Algeria appears to be less aggressive, with more dominant seronegative oligoarthritis forms. The remission rate is comparable to that of Western populations.

  5. 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.

  6. Temperamental characteristics in childhood migraine without aura: a multicenter study

    Directory of Open Access Journals (Sweden)

    Esposito M

    2013-08-01

    Full Text Available Maria Esposito,1 Rosa Marotta,2 Beatrice Gallai,3 Lucia Parisi,4 Giuseppina Patriciello,1 Serena Marianna Lavano,2 Giovanni Mazzotta,5 Michele Roccella,4 Marco Carotenuto11Center for Childhood Headache, Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Second University of Naples, Naples, Italy; 2Department of Psychiatry, "Magna Graecia" University of Catanzaro, Catanzaro, Italy; 3Unit of Child and Adolescent Neuropsychiatry, University of Perugia, Perugia, Italy; 4Child Neuropsychiatry, Department of Psychology, University of Palermo, Palermo, Italy; 5Unit of Child and Adolescent Neuropsychiatry, AUSL Umbria 2, Terni, ItalyBackground: Children with migraine seem to be more anxious, sensitive, deliberate, cautious, fearful, vulnerable to frustration, tidy, and less physically enduring than comparisons. To the best our knowledge no studies about the temperamental and the characterial dimension aspects in childhood migraine was conducted. Therefore, the aim of the present study was to describe the temperamental and character aspects in a sample of children affected by migraine without aura (MoA and their relationship with clinical aspects of MoA such as frequency, duration, and severity of attacks.Materials and methods: In our study, 486 children affected by MoA (239 male, 247 female aged 7–12 years, (mean 10.04 ± 2.53 years and 518 typical developing children comparable for age (P = 0.227 and sex (P = 0.892 were enrolled to assess their temperamental characteristics. The mothers of all subjects filled out the Junior Temperament and Character Inventory: Parent Version.Results: Children affected by migraine show a higher prevalence of harm avoidance and persistence temperamental domains (P < 0.001 and significantly lower prevalence of the self-directedness character trait (P = 0.023 with respect to the comparisons, according to Cloninger's model. The Spearman rank correlation analysis

  7. Stereotactic radiosurgery for idiopathic glossopharyngeal neuralgia: an international multicenter study.

    Science.gov (United States)

    Kano, Hideyuki; Urgosik, Dusan; Liscak, Roman; Pollock, Bruce E; Cohen-Inbar, Or; Sheehan, Jason P; Sharma, Mayur; Silva, Danilo; Barnett, Gene H; Mathieu, David; Sisterson, Nathaniel D; Lunsford, L Dade

    2016-12-01

    OBJECTIVE The goal of this study was to evaluate the outcomes of Gamma Knife stereotactic radiosurgery (SRS) when used for patients with intractable idiopathic glossopharyngeal neuralgia. METHODS Six participating centers of the International Gamma Knife Research Foundation identified 22 patients who underwent SRS for intractable glossopharyngeal neuralgia between 1998 and 2015. The median patient age was 60 years (range 34-83 years). The median duration of symptoms before SRS was 46 months (range 1-240 months). Three patients had unsuccessful prior surgical procedures, including microvascular decompression (MVD) (n = 2) and balloon compression (n = 1). The radiosurgical target was the glossopharyngeal meatus. The median maximum dose was 80 Gy. RESULTS The median follow-up was 45 months after SRS (range 6-120 months). Twelve patients (55%) had neuralgia provided lasting pain reduction in 55% of patients after 1 or 2 SRS procedures. Patients who had a poor response or pain recurrence may require additional procedures such as repeat SRS, MVD, nerve blocks, or nerve section. No patient developed changes in vocal cord function or swallowing disorders after SRS in this study.

  8. Changes in Physician Decision Making after CT: A Prospective Multicenter Study in Primary Care Settings.

    Science.gov (United States)

    Pandharipande, Pari V; Alabre, Claude I; Coy, David L; Zaheer, Atif; Miller, Chad M; Herring, Maurice S; Tramontano, Angela C; Dowling, Emily C; Eisenberg, Jonathan D; Ashar, Bimal H; Halpern, Elkan F; Donelan, Karen; Gazelle, G Scott

    2016-12-01

    Purpose To determine the effect of computed tomography (CT) results on physician decision making in three common clinical scenarios in primary care. Materials and Methods This research was approved by the institutional review board (IRB) and was HIPAA compliant. All physicians consented to participate with an opt-in or opt-out mechanism; patient consent was waived with IRB approval. In this prospective multicenter observational study, outpatients referred by primary care providers (PCPs) for CT evaluation of abdominal pain, hematuria, or weight loss were identified. Prior to CT, PCPs were surveyed to elicit their leading diagnosis, confidence in that diagnosis (confidence range, 0%-100%), a rule-out diagnosis, and a management plan if CT were not available. Surveys were repeated after CT. Study measures were the proportion of patients in whom leading diagnoses and management changed (PCP management vs specialist referral vs emergency department transfer), median changes in diagnostic confidence, and the proportion of patients in whom CT addressed rule-out diagnoses. Regression analyses were used to identify associations between study measures and site and participant characteristics. Specifically, logistic regression analysis was used for binary study measures (change in leading diagnosis, change in management), and linear regression analysis was used for the continuous study measure (change in diagnostic confidence). Accrual began on September 5, 2012, and ended on June 28, 2014. Results In total, 91 PCPs completed pre- and post-CT surveys in 373 patients. In patients with abdominal pain, hematuria, or weight loss, leading diagnoses changed after CT in 53% (131 of 246), 49% (36 of 73), and 57% (27 of 47) of patients, respectively. Management changed in 35% (86 of 248), 27% (20 of 74), and 54% (26 of 48) of patients, respectively. Median absolute changes in diagnostic confidence were substantial and significant (+20%, +20%, and +19%, respectively; P ≤ .001 for

  9. Pediatric neurofibromatosis 1 and parental stress: a multicenter study

    Directory of Open Access Journals (Sweden)

    Esposito M

    2014-01-01

    Full Text Available Maria Esposito,1 Rosa Marotta,2 Michele Roccella,3 Beatrice Gallai,4 Lucia Parisi,3 Serena Marianna Lavano,2 Marco Carotenuto1 1Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Second University of Naples, Naples, Italy; 2Department of Psychiatry, "Magna Graecia" University of Catanzaro, Catanzaro, Italy; 3Child Neuropsychiatry, Department of Psychology, University of Palermo, Palermo, Italy; 4Unit of Child and Adolescent Neuropsychiatry, University of Perugia, Perugia, Italy Background: Neurofibromatosis 1 (NF1 is a complex and multifaceted neurocutaneous syndrome with many and varied comorbidities. The literature about the prevalence and degree of maternal stress and the impact of NF1 in the parent–child interaction is still scant. The aim of this study was to evaluate the prevalence of maternal stress in a large pediatric sample of individuals affected by NF1. Methods: Thirty-seven children (19 boys, 18 girls of mean age 7.86±2.94 (range 5–11 years affected by typical NF1 and a control group comprising 405 typically developing children (207 boys, 198 girls; mean age 8.54±2.47 years were included in this study. To assess parental stress, the mothers of all individuals (NF1 and comparisons filled out the Parenting Stress Index-Short Form test. Results: The two study groups were comparable for age (P=0.116, gender (P=0.886, and body mass index adjusted for age (P=0.305. Mothers of children affected by NF1 reported higher mean Parenting Stress Index-Short Form scores on the Parental Distress domain (P<0.001, Difficult Child domain (P<0.001, and Total Stress domain than the mothers of typically developing children (controls (P<0.001. No significant differences between the two groups were found for the Parent-Child Dysfunctional Interaction domain (P=0.566 or Defensive Responding domain scores (P=0.160. Conclusion: NF1 is considered a multisystemic and complex disease, with many

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

    Science.gov (United States)

    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 task performance of three exercises and was presented to all the participants through an online database on the Internet. The resident with the best score would win a lap-top computer. During three months, 31 individuals from seven hospitals participated (22 surgical residents, 3 surgeons and six interns). A total of 777 scores were logged in the database. In order to out-perform others some participants scheduled themselves voluntarily for additional training. More attempts correlated with higher scores. The serious gaming concept may enhance voluntary skills training. Online data capturing could facilitate monitoring of skills progression in surgical trainees and enhance (VR) simulator validation.

  11. Late prematurity in twins: a Polish multicenter study.

    Science.gov (United States)

    Kosinska-Kaczynska, Katarzyna; Szymusik, Iwona; Bomba-Opon, Dorota; Madej, Anna; Oleszczuk, Jan; Patro-Malysza, Jolanta; Marciniak, Beata; Breborowicz, Grzegorz; Drews, Krzysztof; Seremak-Mrozikiewicz, Agnieszka; Szymankiewicz, Marta; Zimmer, Mariusz; Pomorski, Michal; Olejek, Anita; Slawska, Helena; Wielgos, Mirosław

    2014-10-01

    The study aimed at investigating the impact of late prematurity (LPT) on neonatal outcome in twins and neonatal morbidity and mortality within LPT with regard to the completed weeks of gestation. The study was conducted in six tertiary obstetric departments from different provinces of Poland (Warsaw, Lublin, Poznan, Wroclaw, Bytom). It included 465 twin deliveries in the above centers in 2012. A comparative analysis of maternal factors, the course of pregnancy and delivery and neonatal outcome between LPT (34 + 0-36 + 6 weeks of gestation) and term groups (completed 37 weeks) was performed. The neonatal outcome included short-term morbidities. The analysis of neonatal complication rates according to completed gestational weeks was carried out. Out of 465 twin deliveries 213 (44.8%) were LPT and 156 (33.55%) were term. There were no neonatal deaths among LPT and term twins. One-third of LPT newborns suffered from respiratory disorders or required antibiotics, 40% had jaundice requiring phototherapy, and 30% were admitted to NICU. The analysis of neonatal morbidity with regard to each gestational week at delivery showed that most analyzed complications occurred less frequently with the advancing gestational age, especially respiratory disorders and NICU admissions. The only two factors with significant influence on neonatal morbidity rate were neonatal birth weight (OR = 0.43, 95% CI = 0.2-0.9, p = .02) and gestational age at delivery (OR = 0.62, 95% CI = 0.5-0.8, p twins. Gestational age and neonatal birth weight seem to play a crucial role in neonatal outcome in twins.

  12. Integrating surgery and radiology in one suite: a multicenter study.

    Science.gov (United States)

    ten Cate, Gerben; Fosse, Erik; Hol, Per Kristian; Samset, Eigil; Bock, Richard W; McKinsey, James F; Pearce, Benjamin J; Lothert, Mark

    2004-09-01

    The study was performed to evaluate the performance of digital fixed-mounted angiographic C-arm systems in the operating room as used by surgeons, cardiologists, and interventional radiologists. An observational study in the operating room was performed, along with a structured questionnaire and semi-structured interviews. Twenty interventions were observed at 5 sites. Workflow was analyzed. Integration of high-end angiographic imaging equipment in the operating room enables image-guided surgery with high-quality images, on-table quality assessment of surgical procedures, and "one-stop shopping" procedures. Integrated suites were run by surgery as well as radiology departments, and are used for a variety of procedures, including vascular, cardiothoracic, open surgical, percutaneous, and combined procedures. Operation of the angiographic system and its user interface design were not considered ideal for operating room use. Limited patient accessibility was observed, sometimes leading to uncomfortable positions for the operating physicians. Certain procedures, such as tibial artery surgery, were difficult to perform, owing to lack of accessories. Patient transfer was considered inadequate. Cleaning of the system was rated as poor. Operating room use puts an even higher demand on reliability of the system. Integration of digital angiographic systems into operating rooms has produced opportunities for new treatments and offers a superior solution for interdisciplinary work among surgeons, cardiologists, and radiologists. However, the context of use differs radically from that in the traditional radiologic examination room; the environment, users, and procedures are all different. Integration of imaging methods into the operating room can be more successful if special operating room conditions are taken into account by medical systems manufacturers.

  13. Giant cell arteritis: a multicenter observational study in Brazil

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    Alexandre Wagner Silva de Souza

    2013-01-01

    Full Text Available OBJECTIVE: To describe demographic features, disease manifestations and therapy in patients with giant cell arteritis from referral centers in Brazil. METHODS: A retrospective cohort study was performed on 45 giant cell arteritis patients from three university hospitals in Brazil. Diagnoses were based on the American College of Rheumatology classification criteria for giant cell arteritis or temporal artery biopsy findings. RESULTS: Most patients were Caucasian, and females were slightly more predominant. The frequencies of disease manifestations were as follows: temporal headache in 82.2%, neuro-ophthalmologic manifestations in 68.9%, jaw claudication in 48.9%, systemic symptoms in 44.4%, polymyalgia rheumatica in 35.6% and extra-cranial vessel involvement in 17.8% of cases. Aortic aneurysms were observed in 6.6% of patients. A comparison between patients with biopsy-proven giant cell arteritis and those without temporal artery biopsies did not yield significant differences in disease manifestations. All patients were treated with oral prednisone, and intravenous methylprednisolone was administered to nearly half of the patients. Methotrexate was the most commonly used immunosuppressive agent, and low-dose aspirin was prescribed to the majority of patients. Relapses occurred in 28.9% of patients, and aspirin had a protective effect against relapses. Females had higher prevalences of polymyalgia rheumatica, systemic manifestations and jaw claudication, while permanent visual loss was more prevalent in men. CONCLUSIONS: Most of the clinical features of Brazilian giant cell arteritis patients were similar to those found in other studies, except for the high prevalence of neuro-ophthalmic manifestations and permanent blindness in the Brazilian patients. Aspirin had a protective effect on relapses.

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

    Science.gov (United States)

    Calderón, Carlos; Sola, Iván; Rotaeche, Rafael; Marzo-Castillejo, Mèrce; Louro-González, Arturo; Carrillo, Ricard; González, Ana-Isabel; Alonso-Coello, Pablo

    2011-08-09

    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. 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. 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. 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 always centred on patients' needs. The questioning of experts

  15. 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

  16. Pain during medical abortion: a multicenter study in France.

    Science.gov (United States)

    Saurel-Cubizolles, Marie-Josèphe; Opatowski, Marion; David, Philippe; Bardy, Françoise; Dunbavand, Annabel

    2015-11-01

    To compare the level of pain reported by women by dose of mifepristone, 200 or 600mg, and describe the main factors related to the pain level in the 5 days after a medical abortion. Observational study in 11 medical centers in France between October 2013 and September 2014. The protocols were 200 or 600mg orally mifepristone on day 1 of the medical abortion and 400, 600 or 800μg orally misoprostol on day 3. Women returned a questionnaire that they completed during 5 days following the abortion; pain was recorded on a visual analog scale (0-10) daily. 453 women were included; the mean age was 29 years (range 18-49 years). Pain was greater with 200 than 600mg mifepristone: 33% of women reported a pain level of ≥8 on day 3 with 200mg as compared with 16% with 600mg. This difference remained after controlling for age, gestational age, gravidity, usual painful menstruation and misoprostol dose. Percentages of symptoms as vomiting or diarrhea were also lower with 600mg mifépristone than 200mg. The mean pain severity experienced by women undergoing medical abortion is high; it is higher with a regimen of 200mg mifepristone. The findings emphasize the need to improve analgesic strategies and invite to opt for a protocol of 600mg instead of 200mg mifepristone. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Management of cholelithiasis in Italian children: A national multicenter study

    Science.gov (United States)

    Corte, Claudia Della; Falchetti, Diego; Nebbia, Gabriella; Calacoci, Marisa; Pastore, Maria; Francavilla, Ruggiero; Marcellini, Matilde; Vajro, Pietro; Iorio, Raffaele

    2008-01-01

    AIM: To evaluate the management of Italian children with cholelithiasis observed at Pediatric and Surgical Departments linked to Italian Society of Pediatric Gastroenterology Hepatology and Nutrition. METHODS: One-hundred-eighty children (90 males, median age at diagnosis 7.3 years; range, 0-18 years) with echographic evidence of cholelithiasis were enrolled in the study; the data were collected by an anonymous questionnaire sent to participating centers. RESULTS: One hundred seventeen patients were treated with ursodeoxycholic acid; in 8 children dissolution of gallstones was observed, but the cholelithiasis recurred in 3 of them. Sixty-five percent of symptomatic children treated became asymptomatic. Sixty-four patients were treated with cholecystectomy and in only 2 cases a postoperative complication was reported. Thirty-four children received no treatment and were followed with clinical and echographic controls; in no case the development of complications was reported. CONCLUSION: The therapeutic strategies were extremely heterogeneous. Ursodeoxycholic acid was ineffective in dissolution of gallstones but it had a positive effect on the symptoms. Laparoscopic cholecystectomy was confirmed to be an efficacy and safe treatment for pediatric gallstones. PMID:18322952

  18. Seizures in Preterm Neonates: A Multicenter Observational Cohort Study.

    Science.gov (United States)

    Glass, Hannah C; Shellhaas, Renée A; Tsuchida, Tammy N; Chang, Taeun; Wusthoff, Courtney J; Chu, Catherine J; Cilio, M Roberta; Bonifacio, Sonia L; Massey, Shavonne L; Abend, Nicholas S; Soul, Janet S

    2017-07-01

    The purpose of this study was to characterize seizures among preterm neonates enrolled in the Neonatal Seizure Registry, a prospective cohort of consecutive neonates with seizures at seven pediatric centers that follow the American Clinical Neurophysiology Society's neonatal electroencephalography monitoring guideline. Of 611 enrolled neonates with seizures, 92 (15%) were born preterm. Seizure characteristics were evaluated by gestational age at birth for extremely preterm (preterm (28 to preterm (32 to preterm neonates. Hypothermia therapy was utilized in 15 moderate to late preterm subjects with encephalopathy. The presence of subclinical seizures, monotherapy treatment failure, and distribution of seizure burden (including status epilepticus) was similar in preterm and term neonates. However, exclusively subclinical seizures occurred more often in preterm than term neonates (24% vs 14%). Phenobarbital was the most common initial medication for all gestational age groups, and failure to respond to an initial loading dose was 63% in both preterm and term neonates. Mortality was similar among the three preterm gestational age groups; however, preterm mortality was more than twice that of term infants (35% vs 15%). Subclinical seizures were more common and mortality was higher for preterm than term neonates. These data underscore the importance of electroencephalographic monitoring and the potential for improved management in preterm neonates. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Multicenter study on caries risk assessment in Japanese adult patients.

    Science.gov (United States)

    Arino, Masumi; Ataru, Ito; Fujiki, Shozo; Sugiyama, Seiichi; Hayashi, Mikako

    2015-10-01

    This study was conducted to identify significant risk factors for the onset and the accumulation of new caries in adult patients undergoing regular preventive therapy. The data of 732 patients from nine Japanese general dental practices were retrospectively analyzed. Classification and regression tree (CART) analysis was applied to develop a caries prediction model using the following patient parameters: age, number of teeth with caries experience (DMFT), levels of mutans streptococci (SM) and lactobacilli (LB), saliva flow rate and buffer capacity, and compliance with a preventive program. Poisson regression analysis was conducted to identify factors affecting caries accumulation within three years. CART analysis identified patients at high risk for primary caries with an odds ratio of 3.08 (95%CI, 1.55-5.79; p=0.0018) according to SM levels and compliance; and those for secondary caries with an odds ratio of 3.69 (95%CI, 2.29-5.91; pcaries was affected by compliance (pcaries was affected by DMFT (pcaries development in individual adult patients. Cariogenic bacteria are important factors for both the onset and accumulation of primary and secondary caries. Participation in a regular preventive program limits the onset and the accumulation of primary caries in adult patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Clinical manifestations of colorectal cancer patients from a large multicenter study in Colombia.

    Science.gov (United States)

    Bohorquez, Mabel; Sahasrabudhe, Ruta; Criollo, Angel; Sanabria-Salas, María Carolina; Vélez, Alejandro; Castro, Jorge Mario; Marquez, Juan Ricardo; Mateus, Gilbert; Bolaños, Fernando; Panqueva, Cesar; Restrepo, Jose Ignacio; Puerta, Juan Dario; Murillo, Raul; Bravo, María Mercedes; Hernández, Gustavo; Rios, Angela; Prieto, Rodrigo; Tomlinson, Ian; Echeverry, Magdalena; Carvajal-Carmona, Luis G

    2016-10-01

    Colorectal cancer (CRC) is a major public health problem, and its incidence is rising in developing countries. However, studies characterizing CRC clinicopathological features in cases from developing countries are still lacking. The goal of this study was to evaluate clinicopathological and demographic features in one of the largest CRC studies in Latin America.The study involved over 1525 CRC cases recruited in a multicenter study in Colombia between 2005 and 2014 as part of ongoing genetic and epidemiological studies. We gathered clinicopathological data such as age at diagnosis, sex, body mass index, tobacco and alcohol consumption, family history of cancer, and tumor features including location, histological type, and stage. Statistical analyses were performed to test the association between age of onset, sex, and clinical manifestations.The average age at CRC diagnosis was 57.4 years, with 26.5% of cases having early-onset CRC (diagnosed by age 50 years). Most cases were women (53.2%; P = 0.009), 49.2% were overweight or obese, 49.1% were regular alcohol drinkers, 52% were smokers/former smokers, and 12.2% reported relatives with cancer. Most tumors in the study were located in the rectum (42.7%), were adenocarcinomas (91.5%), and had advanced stage (T3-T4, 79.8%). Comparisons by sex found that male cases were more likely to be obese (36.5% vs 31.1%; P = 0.001), less likely to have a family history of cancer (9.7% vs 15.3%; P = 0.016), and more likely to have advanced-stage tumors (83.9% vs 76.1%; P = 0.036). Comparisons by age of onset found that early-onset cases were more likely to be women (59.3% vs 51.0%; P = 0.005) and report a family history of cancer (17.4% vs 10.2%; P = 0.001).To our knowledge, our study is the largest report of clinicopathological characterization of Hispanic CRC cases, and we suggest that further studies are needed to understand CRC etiology in diverse Hispanic populations.

  1. 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.

  2. 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

  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. 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

  5. Consulting communities when patients cannot consent: a multicenter 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

    2014-02-01

    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 research and understanding of the proposed study. A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury. Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent. Adult participants in community consultation events. Community consultation efforts at participating sites. Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive 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%). Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed

  6. 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 cm(3). 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

  7. Determinants of Patient-Physician Discordance in Global Assessment in Psoriatic Arthritis: A Multicenter European Study.

    Science.gov (United States)

    Desthieux, Carole; Granger, Benjamin; Balanescu, Andra Rodica; Balint, Peter; Braun, Jürgen; Canete, Juan D; Heiberg, Turid; Helliwell, Philip S; Kalyoncu, Umut; Kvien, Tore K; Kiltz, Uta; Niedermayer, Dora; Otsa, Kati; Scrivo, Rossana; Smolen, Josef; Stamm, Tanja A; Veale, Douglas J; de Vlam, Kurt; de Wit, Maarten; Gossec, Laure

    2016-12-20

    Patient-physician discordance in global assessment of disease activity concerns one-third of patients, but what does it reflect? We aimed to assess patient-physician discordance in psoriatic arthritis (PsA) and patient-reported domains of health (physical and psychological) associated with discordance. We analyzed the PsAID (Psoriatic Arthritis Impact of Disease), a cross-sectional, multicenter European study of patients with PsA according to expert opinion. Patient global assessment (PGA) and physician global assessment (PhGA) were rated on a 0-10 numeric rating scale. Discordance was defined as the difference (PGA-PhGA) and as the absolute difference |PGA-PhGA| ≥3 points. Determinants of PGA-PhGA were assessed by a stepwise multivariate linear regression among 12 physical and psychological aspects of impact: pain, skin problems, fatigue, ability to work/leisure, functional incapacity, feeling of discomfort, sleep disturbance, anxiety/fear, coping, embarrassment/shame, social participation, and depressive affects. In 460 patients (mean ± SD age 50.6 ± 12.9 years, 52.2% female, mean ± SD disease duration 9.5 ± 9.5 years, mean ± SD Disease Activity Index for Psoriatic Arthritis score 30.8 ± 32.4, and 40.4% undergoing treatment with biologic agents), the mean ± SD PGA was higher than the mean PhGA, with a mean absolute difference of 1.9 ± 1.8 points. Discordance defined by |PGA-PhGA| ≥3 of 10 concerned 134 patients (29.1%), and 115 patients (85.8% of the patients with discordance) had PGA>PhGA. Higher fatigue (β = 0.14), lower self-perceived coping (β = 0.23), and impaired social participation (β = 0.16) were independently associated with a higher difference (PGA-PhGA). Discordance concerned 29.1% of these patient/physician dyads, mainly by PGA>PhGA. Factors associated with discordance were psychological rather than physical domains of health. Discordance was more frequent in patients in remission, indicating

  8. A multicenter study of the clinical features of allergic rhinitis in central China.

    Science.gov (United States)

    Chen, Jianjun; Zhao, Yan; Li, Bin; Zhang, Quanming; Wan, Lijia; Liu, Jun; Tian, Xingde; Li, Guoyi; Zhou, Jie; Zhang, Long; Wang, Pengju; Cheng, Qi; Liang, Jianwei; Zhao, Ping; He, Jingpei; Lou, Zhihong; Lu, Haitao; Zhou, Yi; Zhang, Yuanfen; Chen, Xiangjun; Pan, Fangming; Zhang, Zhimao; Zeng, Ligang; He, Benchao; Zeng, Ying; Xu, Xiaoyan; Kong, Weijia

    2014-01-01

    Several epidemiological surveys of allergic rhinitis (AR) have been conducted in China. However, the clinical features of AR are still not clear enough. The aim of the current study was to perform a multicenter investigation to evaluate the clinical features of AR in China. A multicenter investigation was performed in 13 allergy centers in central China. A disease-related questionnaire was completed by each patient themselves or with guardian assistance after the diagnosis of AR. The clinical features of AR and allergen profile were analyzed. Eleven thousand four patients who were diagnosed with AR were recruited in this study. The percentages of classification of AR according to the Allergic Rhinitis and Its Impact on Asthma guidelines were 9.7% intermittent mild (IM), 3.1% persistent mild (PM), 33.9% intermittent moderate-severe (IMS), and 53.3% persistent moderate-severe (PMS). There were 61.6 and 42.2% AR patients who had concomitant ocular or lower respiratory symptoms in clinic. The occurrence of ocular and lower respiratory symptoms was found to be gradually increased from IM, PM, and IMS to PMS. Cold air and temperature change were the two most common factors triggering the nasal symptoms. Dermatophagoides pteronyssinus and Dermatophagoides farinae were the most important allergens of central China. This study has contributed to a better understanding of clinical features of AR in China.

  9. Evaluation of a graphic interface to control a robotic grasping arm: a multicenter study.

    Science.gov (United States)

    Laffont, Isabelle; Biard, Nicolas; Chalubert, Gérard; Delahoche, Laurent; Marhic, Bruno; Boyer, François C; Leroux, Christophe

    2009-10-01

    Laffont I, Biard N, Chalubert G, Delahoche L, Marhic B, Boyer FC, Leroux C. Evaluation of a graphic interface to control a robotic grasping arm: a multicenter study. Grasping robots are still difficult to use for persons with disabilities because of inadequate human-machine interfaces (HMIs). Our purpose was to evaluate the efficacy of a graphic interface enhanced by a panoramic camera to detect out-of-view objects and control a commercialized robotic grasping arm. Multicenter, open-label trial. Four French departments of physical and rehabilitation medicine. Control subjects (N=24; mean age, 33y) and 20 severely impaired patients (mean age, 44y; 5 with muscular dystrophies, 13 with traumatic tetraplegia, and 2 others) completed the study. None of these patients was able to grasp a 50-cL bottle without the robot. Participants were asked to grasp 6 objects scattered around their wheelchair using the robotic arm. They were able to select the desired object through the graphic interface available on their computer screen. Global success rate, time needed to select the object on the screen of the computer, number of clicks on the HMI, and satisfaction among users. We found a significantly lower success rate in patients (81.1% vs 88.7%; chi(2)P=.017). The duration of the task was significantly higher in patients (71.6s vs 39.1s; Probotic arms for disabled people, with numerous potential applications in daily life.

  10. 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

    overall agreement for identifying patients with severe impairment of LV function. This not only underscores the value of LV-WMI as a useful tool for selecting high-risk patients to be included in multicenter studies but also serves to warn against the use of rigid cutoff values for WMI in the treatment......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 patients...

  11. Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

    Directory of Open Access Journals (Sweden)

    Bockelbrink Angelina

    2010-07-01

    Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

  12. Multi-Center Genetic Study of Hypertension: The Family Blood Pressure Program (FBPP)

    National Research Council Canada - National Science Library

    The FBPP Investigators

    2002-01-01

    The Family Blood Pressure Program (FBPP) consists of 4 independently established multicenter networks of investigators who have complementary approaches to the genetics of blood pressure levels and hypertension...

  13. Characterization of chronic arthritis in a multicenter study of 852 childhood-onset systemic lupus erythematosus patients.

    Science.gov (United States)

    Sakamoto, Ana Paula; Silva, Clovis Artur; Ferriani, Mariana Paes Leme; Pereira, Rosa Maria Rodrigues; Bonfá, Eloisa; Saad-Magalhães, Claudia; Okuda, Eunice; Appenzeller, Simone; Gomes, Francisco Hugo; Cunha, Ana Luiza Garcia; Salume, Mirna Henriques Tomich; Piotto, Daniela Petry; Terreri, Maria Teresa

    2016-12-01

    Chronic arthritis (CA) is an unusual condition in childhood-onset systemic lupus erythematosus (cSLE) and data in children is very limited. The aim of the study is to assess CA in a large population of cSLE patients, in a multicenter cross-sectional study including 852 cSLE patients followed in ten Pediatric Rheumatology referral services in state of São Paulo, Brazil. CA was observed in 32/852 (3.7 %) cSLE patients mostly in hands and ankles. Chronic monoarthritis was diagnosed in four cSLE patients, oligoarthritis in nine and polyarthritis in 19. In the latter group, six had rhupus syndrome. Two oligoarticular patients had Jaccoud's arthropathy. CA was an isolated manifestation observed at disease onset in 13/32 (41 %) cSLE patients, and juvenile idiopathic arthritis (JIA) was the first diagnosis in 18/32 (56 %). The comparison of last visit of patients with CA and without this manifestation revealed higher frequency of splenomegaly (28 vs. 11 %, p = 0.002). The median of SLICC/ACR-DI score [1(0-9) vs. 0(0-7), p = 0.003] was significantly higher in CA patients compared to patients without this manifestation, likewise the frequency of musculoskeletal damage (31 vs. 9 % p = 0.001). Frequencies of treatment with nonsteroidal anti-inflammatory drugs (75 vs. 26 %, p < 0.0001), hydroxychloroquine sulfate (87 vs. 59 %, p = 0.001) and methotrexate (47 vs. 22 %, p = 0.001) were significantly higher in CA patients. This large multicenter study allowed us to characterize CA as a rare and early manifestation of cSLE, frequently mimicking JIA at disease onset. It is predominantly polyarticular, involving more often hands and ankles and it is associated with significant musculoskeletal accrual damage.

  14. Multicenter study on risk factors for multidrug-resistant organism health-care-associated pneumonia%多中心多重耐药菌医院感染肺炎危险因素研究

    Institute of Scientific and Technical Information of China (English)

    张越伦; 韩立中; 杨智荣; 肖永红; 林臻; 倪语星; 吴安华; 方任飞; 詹思延

    2014-01-01

    Objective To assess the risk factors of multidrug-resistant organism(MDRO)healthcare-associated pneumonia(HCAP).Methods The case-control study was conducted in patients admitted to 22 hospitals in 4 cities between April 1 ,2013 and December 31 ,2013,patients with HCAP caused by MDRO (MRSA,MDRPA,MDRAB, ESBL KP,ESBL E.coli)(drug-resistant group )and drug-sensitive organisms (MSSA,PA,AB,KP,E.coli)(drug-sensitive group )were surveyed .Univariate and multivariate statistical analysis methods were used to evaluate the risk factors for MDRO HCAP.The prognosis,cost and length of hospital stay between drug-resistant group and drug-sensitive group were compared .Results A total of 1 656 patients were included in the study ,including 43 pa-tients (2.60%)with mixed infection caused by both drug-resistant and drug-sensitive organisms ;there were 927 ca-ses (55.98%)in drug-resistant group and 772 cases(46.62%)in drug-sensitive group .Logistic regression model re-vealed that admission to ICUs (OR 95%CI :1 .55[1 .14-2.11]),mechanical ventilation (OR 95%CI :1 .45[1 .15-1 .84]),arteriovenous catheterization (OR 95%CI :1 .29 [1 .02 - 1 .63 ]),fiberbronchoscopy (OR 95%CI :1 .46 [1 .02-2.09]),antimicrobial use(OR 95%CI :1 .63[1 .20-2.22]),chronic lung diseases (OR 95%CI :1 .54[1 .13-2.10]),and chronic cardiovascular and cerebrovascular diseases (OR 95%CI :1 .42[1 .15-1 .74])were independ-ent risk factors for MDRO HCAP .Compared with drug-sensitive group ,drug-resistant group prolonged length of hospital stay by an average of 5.89 days,increased hospitalization and antimicrobial expense by ¥40 739.30 and¥2 805.80 respectively;prognoses was worse,risk factor was 1 .66-fold of drug-sensitive group(OR 95%CI :1 .16-2.35).Conclusion Admission to ICUs,invasive operations,antimicrobial use,chronic lung diseases and chronic cardiovascular and cerebrovascular diseases can increase the risk of MDRO HCAP .%目的:探索住院患者发生多重耐药菌(MDRO)医院感染肺

  15. Clinical presentation of intralabyrinthine schwannomas: a multicenter study of 110 cases.

    Science.gov (United States)

    Dubernard, Xavier; Somers, Thomas; Veros, Konstantinos; Vincent, Christophe; Franco-Vidal, Valérie; Deguine, Olivier; Bordure, Philippe; Linder, Thomas; Lescanne, Emmanuel; Ayache, Denis; Mondain, Michel; Schmerber, Sébastien; Dahmani-Causse, Myriam; Truy, Eric; Darrouzet, Vincent

    2014-10-01

    To describe the presentation of intralabyrinthine schwannomas (ILSs). Retrospective multicenter study involving 12 European skull base surgery tertiary referral centers. One hundred ten patients with the diagnosis of ILS, either labyrinth confined or extending into the internal auditory meatus for less than 50% of their volume. Data collected were age, sex, nature and timing of presenting symptoms, hearing (according to the AAO-HNS grading system), results of vestibular tests (caloric tests and cervical vestibular-evoked myogenic potentials [c-VEMPs]), and tumor localization. Presenting symptoms and laboratory test results were studied according to the extension of the lesion into the cochlea (C) and vestibule (V), on one hand, and according to unifocal (L1) or plurifocal (L2) extension into the labyrinth, on the other. Intracochlear type was more common (50%) than vestibular (19.1%) and more diffuse forms (30.9%). The mean delay for diagnosis was long (72.5 mo; SD, 76.6). Mean age was 53.9 years (SD, 13.2). Deafness was the most common symptom (77.8 dB HL [SD, 33.6], with only 24.6% of patients keeping viable hearing. Caloric tests (65.5% of patients) were abnormal in 77.8% of cases. c-VEMPs were abnormal in 65.7% of the 36 cases analyzed. In V forms, hearing was significantly better (class A + B in 21.1% in C and 45.8% in V forms) (p = 0.03), and vestibular function was more altered (C: 57%, V: 100%, p = 0.0009*). L2 forms were diagnosed later (L1: 59.1 mo, L2: 104.5 mo; p = 0.004*) and were associated more frequently with a dead ear (L1: 13.1%, L2: 41.2%, p = 0.002*) than L1 forms. This series, which is the largest in the literature, demonstrates that even very small and localized ILSs heavily compromise labyrinthine functions.

  16. Hospital admissions for hypertensive crisis in the emergency departments: a large multicenter Italian study.

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    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.

  17. Gamma Knife radiosurgery for sellar and parasellar meningiomas: a multicenter study.

    Science.gov (United States)

    Sheehan, Jason P; Starke, Robert M; Kano, Hideyuki; Kaufmann, Anthony M; Mathieu, David; Zeiler, Fred A; West, Michael; Chao, Samuel T; Varma, Gandhi; Chiang, Veronica L S; Yu, James B; McBride, Heyoung L; Nakaji, Peter; Youssef, Emad; Honea, Norissa; Rush, Stephen; Kondziolka, Douglas; Lee, John Y K; Bailey, Robert L; Kunwar, Sandeep; Petti, Paula; Lunsford, L Dade

    2014-06-01

    Parasellar and sellar meningiomas are challenging tumors owing in part to their proximity to important neurovascular and endocrine structures. Complete resection can be associated with significant morbidity, and incomplete resections are common. In this study, the authors evaluated the outcomes of parasellar and sellar meningiomas managed with Gamma Knife radiosurgery (GKRS) both as an adjunct to microsurgical removal or conventional radiation therapy and as a primary treatment modality. A multicenter study of patients with benign sellar and parasellar meningiomas was conducted through the North American Gamma Knife Consortium. For the period spanning 1988 to 2011 at 10 centers, the authors identified all patients with sellar and/or parasellar meningiomas treated with GKRS. Patients were also required to have a minimum of 6 months of imaging and clinical follow-up after GKRS. Factors predictive of new neurological deficits following GKRS were assessed via univariate and multivariate analyses. Kaplan-Meier analysis and Cox multivariate regression analysis were used to assess factors predictive of tumor progression. The authors identified 763 patients with sellar and/or parasellar meningiomas treated with GKRS. Patients were assessed clinically and with neuroimaging at routine intervals following GKRS. There were 567 females (74.3%) and 196 males (25.7%) with a median age of 56 years (range 8-90 years). Three hundred fifty-five patients (50.7%) had undergone at least one resection before GKRS, and 3.8% had undergone prior radiation therapy. The median follow-up after GKRS was 66.7 months (range 6-216 months). At the last follow-up, tumor volumes remained stable or decreased in 90.2% of patients. Actuarial progression-free survival rates at 3, 5, 8, and 10 years were 98%, 95%, 88%, and 82%, respectively. More than one prior surgery, prior radiation therapy, or a tumor margin dose Gamma Knife radiosurgery provides a high rate of tumor control for patients with

  18. A multicenter study of neurocognition in children with hypertension: methods, challenges, and solutions.

    Science.gov (United States)

    Lande, Marc B; Adams, Heather R; Kupferman, Juan C; Hooper, Stephen R; Szilagyi, Peter G; Batisky, Donald L

    2013-01-01

    Hypertensive adults demonstrate decreased performance on neurocognitive testing compared with that of normotensive controls. There is now emerging, preliminary evidence that children with hypertension also manifest neurocognitive differences when compared with normotensive controls, findings postulated to potentially represent early signs of hypertensive target organ damage to the brain. However, reports in children to date have been limited to database and single-center studies. We have established an ongoing, prospective, multicenter study of neurocognition in children with primary hypertension. This article outlines the study methods, with particular attention to the unique challenges in this area of clinical research. We highlight aspects of the study design that are specifically designed as solutions to these challenges.

  19. China collaborative study on dialysis: a multi-centers cohort study on cardiovascular diseases in patients on maintenance dialysis

    Directory of Open Access Journals (Sweden)

    Hou Fanfan

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the main cause of death in patients on chronic dialysis. The question whether dialysis modality impacts cardiovascular risk remains to be addressed. China Collaborative Study on Dialysis, a multi-centers cohort study, was performed to evaluate cardiovascular morbidity during maintenance hemodialysis (HD and peritoneal dialysis (PD. Method The cohort consisted of chronic dialysis patients from the database of 9 of the largest dialysis facilities around China. The inclusion period was between January 1, 2005, and December 1, 2010. Cardiovascular morbidity was defined as the presence of clinically diagnosed ischemic heart disease, heart failure, peripheral vascular disease, and/or stroke. The patients who had cardiovascular morbidity before initiation of dialysis were excluded. Data collection was based on review of medical record. Result A total of 2,388 adult patients (1,775 on HD and 613 on PD were enrolled. Cardiovascular morbidity affected 57% patients and was comparable between HD and PD patients. However, clinically diagnosed ischemic heart disease and stroke was more prevalent in PD than HD patients. When the patients were stratified by age or dialysis vintage, the cardiovascular morbidity was significantly higher in PD than HD among those aged 50 years or older, or those receiving dialysis over 36 months. Multivariate analysis revealed that the risk factors for cardiovascular morbidity had different pattern in PD and HD patients. Hyperglycemia was the strongest risk factor for cardiovascular morbidity in PD, but not in HD patients. Hypertriglyceridemia and hypoalbuminemia were independently associated with CVD only in PD patients. Conclusions Cardiovascular morbidity during chronic dialysis was more prevalent in PD than HD patients among those with old age and long-term dialysis. Metabolic disturbance-related risk factors were independently associated with CVD only in PD patients

  20. Structural MRI correlates of cognitive impairment in patients with multiple sclerosis: A Multicenter Study.

    Science.gov (United States)

    Preziosa, Paolo; Rocca, Maria A; Pagani, Elisabetta; Stromillo, Maria Laura; Enzinger, Christian; Gallo, Antonio; Hulst, Hanneke E; Atzori, Matteo; Pareto, Deborah; Riccitelli, Gianna C; Copetti, Massimiliano; De Stefano, Nicola; Fazekas, Franz; Bisecco, Alvino; Barkhof, Frederik; Yousry, Tarek A; Arévalo, Maria J; Filippi, Massimo

    2016-04-01

    In a multicenter setting, we applied voxel-based methods to different structural MR imaging modalities to define the relative contributions of focal lesions, normal-appearing white matter (NAWM), and gray matter (GM) damage and their regional distribution to cognitive deficits as well as impairment of specific cognitive domains in multiple sclerosis (MS) patients. Approval of the institutional review boards was obtained, together with written informed consent from all participants. Standardized neuropsychological assessment and conventional, diffusion tensor and volumetric brain MRI sequences were collected from 61 relapsing-remitting MS patients and 61 healthy controls (HC) from seven centers. Patients with ≥2 abnormal tests were considered cognitively impaired (CI). The distribution of focal lesions, GM and WM atrophy, and microstructural WM damage were assessed using voxel-wise approaches. A random forest analysis identified the best imaging predictors of global cognitive impairment and deficits of specific cognitive domains. Twenty-three (38%) MS patients were CI. Compared with cognitively preserved (CP), CI MS patients had GM atrophy of the left thalamus, right hippocampus and parietal regions. They also showed atrophy of several WM tracts, mainly located in posterior brain regions and widespread WM diffusivity abnormalities. WM diffusivity abnormalities in cognitive-relevant WM tracts followed by atrophy of cognitive-relevant GM regions explained global cognitive impairment. Variable patterns of NAWM and GM damage were associated with deficits in selected cognitive domains. Structural, multiparametric, voxel-wise MRI approaches are feasible in a multicenter setting. The combination of different imaging modalities is needed to assess and monitor cognitive impairment in MS.

  1. Spanish Multicenter Normative Studies (NEURONORMA Project): norms for verbal fluency tests.

    Science.gov (United States)

    Peña-Casanova, Jordi; Quiñones-Ubeda, Sonia; Gramunt-Fombuena, Nina; Quintana-Aparicio, María; Aguilar, Miquel; Badenes, Dolors; Cerulla, Noemí; Molinuevo, José Luis; Ruiz, Eva; Robles, Alfredo; Barquero, Maria Sagrario; Antúnez, Carmen; Martínez-Parra, Carlos; Frank-García, Anna; Fernández, Manuel; Alfonso, Verónica; Sol, Josep M; Blesa, Rafael

    2009-06-01

    Lexical fluency tests are frequently used in clinical practice to assess language and executive function. As part of the Spanish multicenter normative studies (NEURONORMA project), we provide age- and education-adjusted norms for three semantic fluency tasks (animals, fruit and vegetables, and kitchen tools), three formal lexical tasks (words beginning with P, M, and R), and three excluded letter fluency tasks (excluded A, E, and S). The sample consists of 346 participants who are cognitively normal, community dwelling, and ranging in age from 50 to 94 years. Tables are provided to convert raw scores to age-adjusted scaled scores. These were further converted into education-adjusted scaled scores by applying regression-based adjustments. The current norms should provide clinically useful data for evaluating elderly Spanish people. These data may also be of considerable use for comparisons with other international normative studies. Finally, these norms should help improve the interpretation of verbal fluency tasks and allow for greater diagnostic accuracy.

  2. Effect of medication reconciliation on unintentional medication discrepancies in acute hospital admissions of elderly adults: A multicenter study

    NARCIS (Netherlands)

    Bemt, P.M.L.A. van den; Schrieck-De Loos, E.M. van der; Linden, C. van der; Theeuwes, A.M.L.J.; Pol, A.G.

    2013-01-01

    Objectives To investigate the effect of pharmacy-based medication reconciliation on the frequency of unintentional medication discrepancies in acutely admitted individuals aged 65 and older. Design Multicenter intervention study with pre-post design. Setting Twelve Dutch hospitals. Participants One

  3. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers

    NARCIS (Netherlands)

    de Baat, Cees; van 't Hof, Martin; van Zeghbroeck, Lieve; Ozcan, Mutlu; Kalk, Warner

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using

  4. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers.

    NARCIS (Netherlands)

    Baat, C. de; Hof, M.A. van 't; Zeghbroeck, L. van; Ozcan, M.; Kalk, W.

    2007-01-01

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using

  5. Sulfasalazine in the treatment of juvenile chronic arthritis - A randomized, double-blind, placebo-controlled, multicenter study

    NARCIS (Netherlands)

    Fiselier, TJW; Franssen, MJAM; Zwinderman, AH; ten Cate, R; van Suijlekom-Smit, LWA; van Luijk, WHJ; van Soesbergen, RM; Wulffraat, NM; Oostveen, JCM; Kuis, W; Dijkstra, PF; van Ede, CFP; Dijkmans, BAC

    1998-01-01

    Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. we conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticula

  6. 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 interv

  7. Intracranial Aneurysms Treated with Coil Placement: Test Characteristics of Follow-up MR Angiography-Multicenter Study

    NARCIS (Netherlands)

    J.D. Schaafsma; B.K. Velthuis; C.B.L.M. Majoie; R. van den Berg; P.A. Brouwer; F. Barkhof; O. Eshghi; G.A.P. de Kort; R.T.H. Lo; T.D. Witkamp; M.E.S. Sprengers; M.A. van Walderveen; J.C. Bot; E. Sanchez; W.P. Vandertop; J. van Gijn; E. Buskens; Y. van der Graaf; G.J.E. Rinkel

    2010-01-01

    Purpose: To determine the test characteristics of magnetic resonance (MR) angiography in the assessment of occlusion of aneurysms treated with coil placement. Materials and Methods: This was an ethics committee-approved multicenter study. Written informed consent was obtained in 311 patients with 34

  8. Effect of medication reconciliation on unintentional medication discrepancies in acute hospital admissions of elderly adults: A multicenter study

    NARCIS (Netherlands)

    Bemt, P.M.L.A. van den; Schrieck-De Loos, E.M. van der; Linden, C. van der; Theeuwes, A.M.L.J.; Pol, A.G.

    2013-01-01

    Objectives To investigate the effect of pharmacy-based medication reconciliation on the frequency of unintentional medication discrepancies in acutely admitted individuals aged 65 and older. Design Multicenter intervention study with pre-post design. Setting Twelve Dutch hospitals. Participants One

  9. 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 dia

  10. 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.

  11. Use of Standardized, Quantitative Digital Photography in a Multicenter Web-based Study

    Science.gov (United States)

    Molnar, Joseph A.; Lew, Wesley K.; Rapp, Derek A.; Gordon, E. Stanley; Voignier, Denise; Rushing, Scott; Willner, William

    2009-01-01

    Objective: We developed a Web-based, blinded, prospective, randomized, multicenter trial, using standardized digital photography to clinically evaluate hand burn depth and accurately determine wound area with digital planimetry. Methods: Photos in each center were taken with identical digital cameras with standardized settings on a custom backdrop developed at Wake Forest University containing a gray, white, black, and centimeter scale. The images were downloaded, transferred via the Web, and stored on servers at the principal investigator's home institution. Color adjustments to each photo were made using Adobe Photoshop 6.0 (Adobe, San Jose, Calif). In an initial pilot study, model hands marked with circles of known areas were used to determine the accuracy of the planimetry technique. Two-dimensional digital planimetry using SigmaScan Pro 5.0 (SPSS Science, Chicago, Ill) was used to calculate wound area from the digital images. Results: Digital photography is a simple and cost-effective method for quantifying wound size when used in conjunction with digital planimetry (SigmaScan) and photo enhancement (Adobe Photoshop) programs. The accuracy of the SigmaScan program in calculating predetermined areas was within 4.7% (95% CI, 3.4%–5.9%). Dorsal hand burns of the initial 20 patients in a national study involving several centers were evaluated with this technique. Images obtained by individuals denying experience in photography proved reliable and useful for clinical evaluation and quantification of wound area. Conclusion: Standardized digital photography may be used quantitatively in a Web-based, multicenter trial of burn care. This technique could be modified for other medical studies with visual endpoints. PMID:19212431

  12. Restless legs syndrome and multiple sclerosis: a Brazilian multicenter study and meta-analysis of the literature

    Directory of Open Access Journals (Sweden)

    Yára Dadalti Fragoso

    2011-04-01

    Full Text Available OBJECTIVE: The increased prevalence of restless legs syndrome (RLS in multiple sclerosis (MS has recently been the subject of a few papers. The present study investigated the prevalence of RLS symptoms in MS patients and in controls in four Brazilian cities. Additionally, a systematic review and meta-analysis of the literature was carried out on the subject of RLS-MS. METHOD: MS patients and controls were investigated regarding the presence of the four typical symptoms of RLS. A questionnaire assessing RLS severity was also used for patients and controls presenting the four RLS symptoms criteria. The systematic review and meta-analysis on the subject were carried out according to the strict international criteria. RESULTS: In the present report, the RLS-MS association was confirmed as being more than fortuitous in Brazilian MS patients, in a multicenter case-control study. MS patients also presented RLS symptoms of greater severity than did the control population. A systematic review and meta-analysis of the literature showed that MS patients had a fourfold higher chance of presenting RLS than did the controls. CONCLUSION: Although underlying mechanisms to explain the association RLS-MS are still a matter of discussion, there is a clear association of these two neurological conditions.

  13. Evaluation of prenatal corticosteroid use in spontaneous preterm labor in the Brazilian Multicenter Study on Preterm Birth (EMIP).

    Science.gov (United States)

    Dias, Tabata Z; Passini, Renato; Tedesco, Ricardo P; Lajos, Giuliane J; Rehder, Patricia M; Nomura, Marcelo L; Costa, Maria L; Oliveira, Paulo F; Sousa, Maria H; Cecatti, Jose G

    2017-11-01

    To evaluate prenatal corticosteroid use in women experiencing spontaneous preterm labor and preterm delivery. The present cross-sectional multicenter study analyzed interview data from patients attending 20 hospitals in Brazil owing to preterm delivery between April 1, 2011 and July 30, 2012. Patients were stratified based on preterm delivery occurring before 34 weeks or at 34-36(+6)  weeks of pregnancy, and the frequency of prenatal corticosteroid use at admission was compared. Prenatal corticosteroid use, sociodemographic data, obstetric characteristics, and neonatal outcomes were examined. There were 1455 preterm deliveries included in the present study; 527 (36.2%) occurred before 34 weeks of pregnancy and prenatal corticosteroids were used in 285 (54.1%) of these pregnancies. Among neonates delivered at 32-33(+6)  weeks, prenatal corticosteroid use was associated with lower pneumonia (P=0.026) and mortality (P=0.029) rates. Among neonates delivered at 34-36(+6)  weeks, prenatal corticosteroid use was associated with longer neonatal hospital admission (PPreterm labor and late preterm delivery were associated with worse neonatal outcomes following prenatal corticosteroids. This could reflect a sub-optimal interval between administration and delivery. © 2017 International Federation of Gynecology and Obstetrics.

  14. [Results of the multicenter prospective study of cerebrolysin safety and efficacy in acute stroke].

    Science.gov (United States)

    Skwortsova, V I; Stakhovskaia, L V; Shamalov, N A; Kerbikov, O B

    2006-01-01

    The multicenter prospective study of cerebrolysin safety and efficacy included 277 patients with ischemic stroke aged 55-85 years, who received therapy within 12 h from the disease development. Cerebrolysin was used in dosage 10 ml daily along with concomitant standard basic treatment during 10 days after stroke onset in 138 patients. A control group comprised 139 patients who received basic treatment only. A quantitative analysis of the dynamics of neurological deficit revealed the accelerated improvement by NIHSS score, modified Rankin score and Barthel index in the cerebrolysin group on days 10 and 28 (pcerebrolysin within the first 3h after stroke onset comparing to those treated within 6-12h. The trial demonstrated cerebrolysin safety and good tolerability in treatment of ischemic stroke in the carotid artery territory as well as its favorable clinical effect.

  15. [Auranofin in the treatment of chronic polyarthritis. Results of an open multicenter study].

    Science.gov (United States)

    Siegmeth, W

    1984-01-01

    Auranofin (Ridaura SK and F 39 162) was tested in an open multicenter study with regard to its anti-inflammatory effect in 166 patients suffering from rheumatoid arthritis. The time for treatment lasted for one or two years. The therapeutic effect of the drug was judged by its influence on pain, joint swelling, morning stiffness, grip strength, blood-sedimentation rate and rheumatoid factor etc. The serum gold concentration was measured regularly. With Auranofin the majority of the patients achieved a lasting improvement of the condition. The therapeutical effect was observed gradually. Side-effects were frequent but removal from the therapy was rare. Most of the side-effects were diarrhea, rash, pruritus and conjunctivitis. Regular laboratory controls revealed in some cases toxic organic reactions.

  16. Treatment of primary headache in children: a multicenter hospital-based study in France.

    Science.gov (United States)

    Cuvellier, Jean-Christophe; Donnet, Anne; Guégan-Massardier, Evelyne; Nachit-Ouinekh, Fatima; Parain, Dominique; Vallée, Louis

    2009-12-01

    The aim of this 6-month, prospective, multicenter study of 398 children and adolescents with primary headaches was to collect data on headache treatment in neuropediatric departments. Treatments were compared before and after consultation. Prior to consultation, the acute treatments that had been prescribed most frequently were paracetamol (82.2% of children) and non-steroidal anti-inflammatory drugs treatment (53.5%); 10.3% had received a prophylactic treatment. No differences in either acute or prophylactic treatment with respect to headache diagnosis were observed. After the neuropediatric consultation, paracetamol was replaced by a non-steroidal anti-inflammatory drug in about three-quarters of cases and by triptan in about one-quarter of cases. The number of children prescribed a prophylactic treatment nearly doubled, whereas there was a 5-fold and 23-fold increase in psychotherapy and relaxation training, respectively, between pre-referral and referral. We conclude that specific treatments were underused for primary headache.

  17. Sexual function in adult patients with classic bladder exstrophy: A multicenter study.

    Science.gov (United States)

    Park, Weon; Zwink, Nadine; Rösch, Wolfgang H; Schmiedeke, Eberhard; Stein, Raimund; Schmidt, Dominik; Noeker, Meinolf; Jenetzky, Ekkehart; Reutter, Heiko; Ebert, Anne-Karoline

    2015-06-01

    The bladder exstrophy-epispadias complex (BEEC) comprises a spectrum of congenital anomalies that represents the severe end of urorectal malformations, and has a profound impact on continence as well as sexual and renal functions. The relation between severity of BEEC and its associated functional impairments, on one hand, and the resulting restrictions in quality of life and potential psychopathology determine the patients' outcome. It is important for improving further outcome to identify BEEC-related sources of distress in the long term. Genital function and sexuality becomes an important issue for adolescent and adult BEEC individuals. Hence, the present study focused on sexual function and psychological adaption in patients with BEEC. In a multicenter study 52 patients (13 females, 39 males) with classic bladder exstrophy (BE) with their bladders in use were assessed by a self-developed questionnaire about sexual function, and psychosexual and psychosocial outcome. The patients were born between 1948 and 1994 (median age 31 years). Twelve of 13 (92%) females and 25 of 39 (64%) males with classic BE had answered the questions on sexual function. Of these, 50% females and 92% males answered that they masturbated. Females had sexual intercourse more frequently. Six (50%) females affirmed dyspareunia whereas only two (8%) males reported pain during erection. Eight (67%) females specified having orgasms. Eighteen (72%) males were able to ejaculate. Two males and none of the females lived in a committed partnership (Figure). Two (15%) females and 13 (33%) males answered all psychosocial questions. The majority of these patients had concerns about satisfactory sexuality and lasting, happy partnerships. A minority of patients of both sexes were willing to answer psychosocial questions. Sexual activity and relationships of many adult BE patients seems to be impaired. Not surprisingly, sexual activity and awareness were different in males and females even in a multi

  18. Prevalence of Neuropathic Pain in Patients with Traumatic Brachial Plexus Injury: A Multicenter Prospective Hospital-Based Study.

    Science.gov (United States)

    Ciaramitaro, Palma; Padua, Luca; Devigili, Grazia; Rota, Eugenia; Tamburin, Stefano; Eleopra, Roberto; Cruccu, Giorgio; Truini, Andrea

    2017-03-03

    Prevalence and clinical characteristics of neuropathic pain due to traumatic brachial plexus injury. Observational epidemiological study. Hospital-based multicenter study. One hundred seven prospectively enrolled patients with brachial plexus injury. All the patients underwent clinical examination and neurophysiological testing for a definitive diagnosis of the brachial plexus lesion. The DN4 questionnaire was used to identify neuropathic pain, and the Neuropathic Pain Symptom Inventory (NPSI) to evaluate the different symptoms of neuropathic pain. The SF36 questionnaire and the Beck Depression Inventory (BDI) were used to assess quality of life and mood disturbances in patients with neuropathic pain. Of the 107 enrolled patients, 74 had pain (69%); neuropathic pain, as assessed by means of the DN4, was identified in 60 (56%) of these patients. According to the NPSI, the most frequent and severe pain type was the spontaneous burning pain. Clinical and neurophysiological findings showed that pain is unrelated to age but is associated with the severity of peripheral nerve damage. The SF36 questionnaire and BDI showed that neuropathic pain impairs quality of life and causes depression. Our study provides information on the prevalence, characteristics, and variables associated with neuropathic pain due to traumatic brachial plexus injuries that might provide a basis for improving the clinical management of this condition.

  19. Preoperative anemia does not predict complications after single-level lumbar fusion: a propensity score-matched multicenter study.

    Science.gov (United States)

    Kim, Bobby D; Edelstein, Adam I; Patel, Alpesh A; Lovecchio, Francis; Kim, John Y S

    2014-11-01

    Multicenter retrospective cohort study. To estimate the impact of preoperative anemia on 30-day complications in patients undergoing single-level lumbar fusion. Anemia has been widely implicated as a risk factor in various surgical procedures including elective spine surgery. No large-scale study has been performed to examine this relationship in single-level lumbar fusion surgery. The American College of Surgeons National Surgical Quality Improvement Program database was retrospectively reviewed to identify all patients who underwent single-level lumbar fusion procedures during 2006 to 2011. A propensity score-matching algorithm was used to match scores of anemic patients with that of nonanemic patients. Multivariate logistic regression analysis of unadjusted and propensity score-matched cohorts was performed to examine the effect of preoperative anemia on 30-day postoperative complication rates and length of hospital stay. A total of 2960 patients met inclusion criteria. The propensity score-matching procedure yielded scores of 491 pairs of well-matched nonanemic and anemic patients. The multivariate analysis of propensity score-matched population found preoperative anemia to carry no significant association with any of the complications analyzed, including overall complications, medical complications, surgical complications, reoperation, mortality, or length of total hospital stay. For patients undergoing single-level lumbar fusion, preoperative anemia is not independently associated with increased risk of 30-day complications or increased length of stay. Further studies are needed to independently validate this relationship in other spine surgical procedures. 3.

  20. 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.

  1. [Multicenter study on incidence of total parenteral nutrition complications in the critically-ill patient. ICOMEP study. Part II].

    Science.gov (United States)

    Grau, T; Bonet, A

    2005-01-01

    To assess enteral nutrition complications in a prospective cohort of patients admitted to the ICU. Prospective, multicenter study of patients admitted to the ICU and that received enteral nutrition (EN). Demographical data, main diagnosis, and nutritional and severity indexes were included. Complications were previously defined and were categorized as gastrointestinal or infectious. An independent group managed the databases and performed the statistical analysis. Data were expressed in absolute values or by their median and percentile (25-75). The rate and incidence density of complications and the odds ratio for complications were determined. 544 out of 3409 patients received enteral nutrition. Three hundred and three patients were admitted for medical causes, 149 for surgical causes and 92 for trauma. Ninety nine patients were underfed, and the nutritional risk index was 69.7. The incidence of gastrointestinal complications was 6 episodes per 100 days of nutrition, and in 89 patient they resulted in enteral nutrition withdrawal. Early enteral nutrition did not yield more complications than late EN. Vomiting was more frequent in late EN (OR 0.4; 95%CI: 0.2-0.7). Temporary withdrawal of diet in 140 patients was the most used procedure, which resulted in a lower caloric intake (median of 2 kcal/kg/d) than programmed. Nosocomial infection rates were 7.47% for catheter-induced sepsis and 51% for other nosocomial infections, and 35% developed pneumonia. Gastrointestinal complications with enteral nutrition are frequent, result in insufficient caloric intake and definitive withdrawal of diet in a significant number of cases. Early enteral nutrition is not associated with an increased number of complications. Episodes of increase of the gastric residue do not increase the incidence of pneumonia. Other infectious complications are within the range of what has been published and seem to be little modified by the use of enteral nutrition.

  2. Varus thrust during walking and the risk of incident and worsening medial tibiofemoral MRI lesions: the Multicenter Osteoarthritis Study.

    Science.gov (United States)

    Wink, A E; Gross, K D; Brown, C A; Guermazi, A; Roemer, F; Niu, J; Torner, J; Lewis, C E; Nevitt, M C; Tolstykh, I; Sharma, L; Felson, D T

    2017-06-01

    To determine the association of varus thrust during walking to incident and worsening medial tibiofemoral cartilage damage and bone marrow lesions (BMLs) over 2 years in older adults with or at risk for osteoarthritis (OA). Subjects from the Multicenter Osteoarthritis Study (MOST) were studied. Varus thrust was visually assessed from high-speed videos of forward walking trials. Baseline and two-year MRIs were acquired from one knee per subject and read for cartilage loss and BMLs. Logistic regression with generalized estimating equations was used to estimate the odds of incident and worsening cartilage loss and BMLs, adjusting for age, sex, race, body mass index (BMI), and clinic site. The analysis was repeated stratified by varus, neutral, and valgus alignment. 1007 participants contributed one knee each. Varus thrust was observed in 29.9% of knees. Knees with thrust had 2.17 [95% CI: 1.51, 3.11] times the odds of incident medial BML, 2.51 [1.85, 3.40] times the odds of worsening medial BML, and 1.85 [1.35, 2.55] times the odds of worsening medial cartilage loss. When stratified by alignment, varus knees also had significantly increased odds of these outcomes. Varus thrust observed during walking is associated with increased odds of incident and worsening medial BMLs and worsening medial cartilage loss. Increased odds of these outcomes persist in varus-aligned knees. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  3. [Role of the Web on behaviors and health choices in six Italian cities: results of a multicenter study].

    Science.gov (United States)

    Lovato, E; Bert, F; Bruno, S; Ceruti, M; De Vito, E; La Torre, G; Liguori, G; Manzoli, L; Messina, G; Minniti, D; Siliquini, R

    2011-01-01

    A cross-sectional, multicenter study was carried out in 6 Italian cities (Cassino, Chieti, Naples, Rome, Siena, Turin) in order to highlight differences in Web use to find out health information and its related consequences on behavioral choices and to describe the distribution of the phenomenon in Italy. Data were collected from October 2009 to September 2010 on a sample of volunteers recruited from laboratory analysis, with face-to-face interview, including information about socio-demographic, health, and Web use to health. Data analysis shows that e-health use is greater in Northern Italy, in women aged 30-41 years, in chronic patients and those who have been caught up medical malpractice. Behavioral changes are associated with the Region; in particular Rome and Cassino show to choose/change professionals and facilities, engaging in alternative therapies and buy drugs online more frequently. Living in Southern Italy, a lower educational level and the infrequent drugs use are associated with a greater probability of incurring in negative behaviors. Positive results on the behavior are instead low and not significant. Given the regional differences, the potentiality and the risks of e-health use, it will be important to identify strategies for risks containment and implementation of the web in prevention.

  4. Incidence and Risk Factors for Delirium among Mechanically Ventilated Patients in an African Intensive Care Setting: An Observational Multicenter Study

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    Arthur Kwizera

    2015-01-01

    Full Text Available Aim. Delirium is common among mechanically ventilated patients in the intensive care unit (ICU. There are little data regarding delirium among mechanically ventilated patients in Africa. We sought to determine the burden of delirium and associated factors in Uganda. Methods. We conducted a multicenter prospective study among mechanically ventilated patients in Uganda. Eligible patients were screened daily for delirium using the confusional assessment method (CAM-ICU. Comparisons were made using t-test, chi-squares, and Fisher’s exact test. Predictors were assessed using logistic regression. The level of statistical significance was set at P<0.05. Results. Of 160 patients, 81 (51% had delirium. Median time to onset of delirium was 3.7 days. At bivariate analysis, history of mental illness, sedation, multiorgan dysfunction, neurosurgery, tachypnea, low mean arterial pressure, oliguria, fevers, metabolic acidosis, respiratory acidosis, anaemia, physical restraints, marital status, and endotracheal tube use were significant predictors. At multivariable analysis, having a history of mental illness, sedation, respiratory acidosis, higher PEEP, endotracheal tubes, and anaemia predicted delirium. Conclusion. The prevalence of delirium in a young African population is lower than expected considering the high mortality. A history of mental illness, anaemia, sedation, endotracheal tube use, and respiratory acidosis were factors associated with delirium.

  5. The burden and etiology of community-onset pneumonia in the aging Japanese population: a multicenter prospective study.

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    Konosuke Morimoto

    Full Text Available The increasing burden of pneumonia in adults is an emerging health issue in the era of global population aging. This study was conducted to elucidate the burden of community-onset pneumonia (COP and its etiologic fractions in Japan, the world's most aged society.A multicenter prospective surveillance for COP was conducted from September 2011 to January 2013 in Japan. All pneumonia patients aged ≥ 15 years, including those with community-acquired pneumonia (CAP and health care-associated pneumonia (HCAP, were enrolled at four community hospitals on four major islands. The COP burden was estimated based on the surveillance data and national statistics.A total of 1,772 COP episodes out of 932,080 hospital visits were enrolled during the surveillance. The estimated overall incidence rates of adult COP, hospitalization, and in-hospital death were 16.9 (95% confidence interval, 13.6 to 20.9, 5.3 (4.5 to 6.2, and 0.7 (0.6 to 0.8 per 1,000 person-years (PY, respectively. The incidence rates sharply increased with age; the incidence in people aged ≥ 85 years was 10-fold higher than that in people aged 15-64 years. The estimated annual number of adult COP cases in the entire Japanese population was 1,880,000, and 69.4% were aged ≥ 65 years. Aspiration-associated pneumonia (630,000 was the leading etiologic category, followed by Streptococcus pneumoniae-associated pneumonia (530,000, Haemophilus influenzae-associated pneumonia (420,000, and respiratory virus-associated pneumonia (420,000, including influenza-associated pneumonia (30,000.A substantial portion of the COP burden occurs among elderly members of the Japanese adult population. In addition to the introduction of effective vaccines for S. pneumoniae and influenza, multidimensional approaches are needed to reduce the pneumonia burden in an aging society.

  6. A multi-center study of hemodynamic characteristics exhibited by children with unexplained syncope

    Institute of Scientific and Technical Information of China (English)

    CHEN Li; TANG Chao-shu; DU Jun-bao; YANG Yuan-yuan; WANG Cheng; WANG Hong-wei; TIAN Hong; ZHANG Qing-you; CHEN Jian-jun; WANG Yu-li; KANG Yi-long

    2006-01-01

    Background Syncope is common in children and adolescents, with 15% estimated to have had at least one syncopal episode by age 18. In recent years, an increasing number of children, especially girls at their school age,have developed unexplained syncope. The mechanism of an unexplained syncope exhibited by children is incompletely studied; the association between different hemodynamic patterns and clinical features is also not clear. The aim of the study was to investigate the hemodynamic patterns of children with unexplained syncope and to examine the clinical relevance.Methods Two hundred and eight children [87 boys, 121 girls, aged 3-19 years, mean (11.66±2.72) years]were selectively recruited from May 2000 to April 2006 when they presented syncope as their main complaint at the Multi-center Network for Childhood Syncope in Beijing, Hunan Province, Hubei Province, and Shanghai of China. All of the patients underwent head-up tilt tests; data were analyzed using SPSS version 10.0 for Windows.Continuous variables were expressed as the mean±standard deviation. Dichotomous variables were compared through a χ2 test. A value of P<0.05 (two sided) was regarded as statistically significant.Results The age distribution of children with syncope was approximately normal. Head-up tilt tests was positive in 155 children, and the incidence of positive response of the baseline head-up tilt test for diagnosing unexplained syncope was 50.48%. The sensitivity value and diagnostic value of sublingual nitroglycerin head-up tilt test were both 74.52%. The hemodynamic pattern was normal in 53 children. The 155 children, who were positive in head-up tilt tests, showed signs of postural orthostatic tachycardia syndrome (60, 28.8%), the vasoinhibitory pattern (72, 34.6%), the cardioinhibitory pattern (5, 2.4%), and the mixed pattern (18, 8.7%). The gender distribution between the two age groups (age < 12 years vs age ≥ 12 years) was not different (P>0.05).The distribution of

  7. Clinical characteristics and predictors of mortality in cirrhotic patients with candidemia and intra-abdominal candidiasis: a multicenter study.

    Science.gov (United States)

    Bassetti, Matteo; Peghin, Maddalena; Carnelutti, Alessia; Righi, Elda; Merelli, Maria; Ansaldi, Filippo; Trucchi, Cecilia; Alicino, Cristiano; Sartor, Assunta; Toniutto, Pierluigi; Wauters, Joost; Laleman, Wim; Tascini, Carlo; Menichetti, Francesco; Luzzati, Roberto; Brugnaro, Pierluigi; Mesini, Alessio; Raviolo, Stefania; De Rosa, Francesco G; Lagunes, Leonel; Rello, Jordi; Dimopoulos, George; Colombo, Arnaldo L; Nucci, Marcio; Vena, Antonio; Bouza, Emilio; Muñoz, Patricia; Tumbarello, Mario; Losito, Raffaella; Martin-Loeches, Ignacio; Viscoli, Claudio

    2017-04-01

    The aim of the study was to describe the characteristics of cirrhotic patients with candidemia and intra-abdominal candidiasis (IAC) and to evaluate the risk factors associated with 30-day mortality. A multicenter multinational retrospective study including all consecutive episodes of candidemia and IAC in adult patients with liver cirrhosis in 14 European hospitals during the period 2011-2013 was performed. A total of 241 episodes (169 candidemia, 72 IAC) were included. Most Candida infections were acquired in hospital (208, 86.3%), mainly in the intensive care unit (ICU) (121, 50.2%). At clinical presentation, fever was seen in 60.6% of episodes (146/241) and septic shock in 34.9% (84/241). C. albicans was the most common species (found in 131 episodes, 54.4%), followed by C. glabrata (35, 14.5%) and C. parapsilosis (34, 14.1%). Overall, the 30-day mortality was 35.3%. Multivariable analysis identified candidemia (OR 2.2, 95% CI 1.2-4.5) and septic shock (OR 3.2, 95% CI 1.7-6) as independent factors associated with 30-day mortality. Adequate antifungal treatment (OR 0.4, 95% CI 0.3-0.9) was associated with survival benefit. A shift towards increasing prevalence of C. glabrata and C. parapsilosis species in patients with liver disease was documented. Candidemia and IAC were associated with significant mortality in cirrhotic patients. Thirty-day mortality was associated with candidemia and severe clinical presentation, whereas adequate antifungal treatment improved the prognosis.

  8. Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study

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    Enger Shelley M

    2007-06-01

    Full Text Available Abstract Background The choice between paper data collection methods and electronic data collection (EDC methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study. Methods A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859, at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR system was developed using a modified version of the EDC. Results Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites. Conclusion Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.

  9. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study

    Science.gov (United States)

    Lee, Woo Hyun; Kim, Dong-Kyu; Kim, Sung Wan; Kim, Young Hyo; Nam, Jung Gwon; Park, Seok-Won; Park, Chan-Soon; Bae, Woo Yong; Yeo, Nam-Kyung; Won, Tae-Bin; Lee, Seung Hoon; Lee, Tae-Hoon; Lee, Hyoung Joo; Kim, Sang-Wook; Jeong, Sung-Wook; Choi, Jeong-Seok; Han, Doo Hee; Choi, Ji Ho

    2015-01-01

    Background/Objective There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA) with those of power-assisted adenoidectomy. Study Design Prospective multi-institutional study. Methods Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C) or without cauterization (PAA-C) due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated. Results A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females) were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1) CA (n = 116); (2) PAA+C (n = 153); and (3) PAA-C (n = 119). Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001) and degree of intraoperative bleeding was significantly less (P < 0.001) compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016). Conclusions This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding. PMID:26267337

  10. A multicenter study to map genes for Fuchs endothelial corneal dystrophy: baseline characteristics and heritability.

    Science.gov (United States)

    Louttit, Megan D; Kopplin, Laura J; Igo, Robert P; Fondran, Jeremy R; Tagliaferri, Angela; Bardenstein, David; Aldave, Anthony J; Croasdale, Christopher R; Price, Marianne O; Rosenwasser, George O; Lass, Jonathan H; Iyengar, Sudha K

    2012-01-01

    To describe the methods for family and case-control recruitment for a multicenter genetic and associated heritability analyses of Fuchs endothelial corneal dystrophy (FECD). Twenty-nine enrolling sites with 62 trained investigators and coordinators gathered individual and family information, graded the phenotype, and collected blood and/or saliva for genetic analysis on all individuals with and without FECD. The degree of FECD was assessed in a 0 to 6 semiquantitative scale using standardized clinical methods with pathological verification of FECD on at least 1 member of each family. Central corneal thickness was measured by ultrasonic pachymetry. Three hundred twenty-two families with 330 affected sibling pairs with FECD were enrolled and included a total of 650 sibling pairs of all disease grades. Using the entire 7-step FECD grading scale or a dichotomous definition of severe disease, heritability was assessed in families via sib-sib correlations. Both binary indicators of severe disease and semiquantitative measures of disease severity were significantly heritable, with heritability estimates of 30% for severe disease, 37% to 39% for FECD score, and 47% for central corneal thickness. Genetic risk factors have a strong role in the severity of the FECD phenotype and corneal thickness. Genotyping this cohort with high-density genetic markers followed by appropriate statistical analyses should lead to novel loci for disease susceptibility.

  11. Multicenter matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI) identifies proteomic differences in breast-cancer-associated stroma.

    Science.gov (United States)

    Dekker, Tim J A; Balluff, Benjamin D; Jones, Emrys A; Schöne, Cédrik D; Schmitt, Manfred; Aubele, Michaela; Kroep, Judith R; Smit, Vincent T H B M; Tollenaar, Rob A E M; Mesker, Wilma E; Walch, Axel; McDonnell, Liam A

    2014-11-07

    MALDI mass spectrometry imaging (MSI) has rapidly established itself as a powerful biomarker discovery tool. To date, no formal investigation has assessed the center-to-center comparability of MALDI MSI experiments, an essential step for it to develop into a new diagnostic method. To test such capabilities, we have performed a multicenter study focused on biomarkers of stromal activation in breast cancer. MALDI MSI experiments were performed in two centers using independent tissue banks, infrastructure, methods, and practitioners. One of the data sets was used for discovery and the other for validation. Areas of intra- and extratumoral stroma were selected, and their protein signals were compared. Four protein signals were found to be significantly associated with tumor-associated stroma in the discovery data set measured in Munich. Three of these peaks were also detected in the independent validation data set measured in Leiden, all of which were also significantly associated with intratumoral stroma. Hierarchical clustering displayed 100% accuracy in the Munich MSI data set and 80.9% accuracy in the Leiden MSI data set. The association of one of the identified mass signals (PA28) with stromal activation was confirmed with immunohistochemistry performed on 20 breast tumors. Independent and international MALDI MSI investigations could identify validated biomarkers of stromal activation.

  12. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Jeong-Whun Kim

    Full Text Available There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA with those of power-assisted adenoidectomy.Prospective multi-institutional study.Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C or without cauterization (PAA-C due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated.A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1 CA (n = 116; (2 PAA+C (n = 153; and (3 PAA-C (n = 119. Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001 and degree of intraoperative bleeding was significantly less (P < 0.001 compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016.This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding.

  13. Cruciferous vegetables, mushrooms, and gastrointestinal cancer risks in a multicenter, hospital-based case-control study in Japan.

    Science.gov (United States)

    Hara, Megumi; Hanaoka, Tomoyuki; Kobayashi, Minatsu; Otani, Tetsuya; Adachi, Helena Yukari; Montani, Ai; Natsukawa, Syusuke; Shaura, Kozo; Koizumi, Yoichi; Kasuga, Yoshio; Matsuzawa, Tsunetomo; Ikekawa, Tetsuro; Sasaki, Satoshi; Tsugane, Shoichiro

    2003-01-01

    We assessed the possible association of gastrointestinal cancers with cruciferous vegetables and mushrooms in a multicenter, hospital-based case-control study in an agricultural area of Japan. One hundred forty-nine cases and 287 controls for stomach cancer and 115 cases and 230 controls for colorectal cancer were matched by age, sex, and residential area. In stomach cancer, the protective effect of vegetables (consumption of total vegetable) was obscure, but it became clearer when we examined specific kinds of vegetables. Marginal associations were observed in the group of the highest consumption of Chinese cabbage (odds ratio [OR] = 0.61; 95% confidence interval [CI] = 0.35-1.07), broccoli (OR = 0.60; 95% CI = 0.34-1.08), Hypsizigus marmoreus (Bunashimeji) (OR = 0.57; 95% CI = 0.31-1.04) and Pholita nameko (Nameko) (OR = 0.56; 95% CI = 0.30-1.06). In colorectal cancer, we observed decreased risks from the highest tertile of total vegetables (OR = 0.22; 95% CI = 0.08-0.66) and low-carotene-containing vegetables (OR = 0.28; 95% CI = 0.08-0.77), and inverse associations were observed in the group of the highest consumption of broccoli (OR = 0.18; 95% CI = 0.06-0.58). Although the sample size was limited, subgroup analyses showed that the associations differed with the histopathological subtype. These findings suggest that cruciferous vegetables decrease the risk of both stomach and colorectal cancer, and that mushrooms are associated with a decreased risk of stomach cancer.

  14. [Drug resistance in Mycobacterium tuberculosis. A multicenter study of the Barcelona area. Grupo de Trabajo sobre Resistencias en Tuberculosis].

    Science.gov (United States)

    Martin-Casabona, N; Alcaide, F; Coll, P; González, J; Manterola, J M; Salvadó, M; Caylà, J A

    2000-10-21

    The aims of this multicenter study was to establish the level of primary and acquired drug resistance of M. Tuberculosis strains isolated in Barcelona and to identify possible risk groups using clinical data. All tuberculosis patients with isolation and identification of M. tuberculosis strains from October 1995 to September 1997 were included. Susceptibility tests isoniazid, rifampin, ethambutol, streptomycin and pyrazinamide were performed using the Bactec 460 system and the proportions method on solid medium. Logistic progression was used for statistical analysis. The total number of patients included was 1,749 (1,535 non-treated and 214 previously treated). Primary drug resistance was 5.7% (isoniazid 3.8%; rifampin 1.0%, streptomycin 2.1%, ethambutol 0.3% and pyrazinamide 1.0%). Acquired drug resistance was 20.5% (isoniazid 17.3%, rifampin 9.8%, ethambutol 1.9%, streptomycin 4.7% and pyrazinamide 6.5%). Primary drug resistance was associated with people over 60 years old and women. The low level of drug resistance enables antituberculosis treatment of non-treated patients to start with the standardised three-drug regimes except in the case of foreign people from countries with a high level of drug resistance. Susceptibility tests are recommended on all M. tuberculosis strains isolated, together with controlled studies of drug resistance surveillance.

  15. Assessment of risk factors for candidemia in non-neutropenic patients hospitalized in Internal Medicine wards: A multicenter study.

    Science.gov (United States)

    Falcone, M; Tiseo, G; Tascini, C; Russo, A; Sozio, E; Raponi, G; Rosin, C; Pignatelli, P; Carfagna, P; Farcomeni, A; Luzzati, R; Violi, F; Menichetti, F; Venditti, M

    2017-06-01

    An increasing prevalence of candidemia has been reported in Internal Medicine wards (IMWs). The aim of our study was to identify risk factors for candidemia among non-neutropenic patients hospitalized in IMWs. A multicenter case-control study was performed in three hospitals in Italy. Patients developing candidemia (cases) were compared to patients without candidemia (controls) matched by age, time of admission and duration of hospitalization. A logistic regression analysis identified risk factors for candidemia, and a new risk score was developed. Validation was performed on an external cohort of patients. Overall, 951 patients (317 cases of candidemia and 634 controls) were included in the derivation cohort, while 270 patients (90 patients with candidemia and 180 controls) constituted the validation cohort. Severe sepsis or septic shock, recent Clostridium difficile infection, diabetes mellitus, total parenteral nutrition, chronic obstructive pulmonary disease, concomitant intravenous glycopeptide therapy, presence of peripherally inserted central catheter, previous antibiotic therapy and immunosuppressive therapy were factors independently associated with candidemia. The new risk score showed good area under the curve (AUC) values in both derivation (AUC 0.973 95% CI 0.809-0.997, pcandidemia. A new risk score with a good performance could facilitate the identification of candidates to early antifungal therapy. Copyright © 2017 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  16. 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.

  17. Influence of socioeconomic status on community-acquired pneumonia outcomes in elderly patients requiring hospitalization: a multicenter observational study.

    Science.gov (United States)

    Izquierdo, Conchita; Oviedo, Manuel; Ruiz, Laura; Sintes, Xavier; Vera, Isabel; Nebot, Manel; Bayas, Jose-María; Carratalà, Jordi; Varona, Wenceslao; Sousa, Dolores; Celorrio, Jose-Miguel; Salleras, Luis; Domínguez, Angela

    2010-07-15

    The associations between socioeconomic status and community-acquired pneumonia outcomes in adults have been studied although studies did not always document a relationship.The aim of this multicenter observational study was to determine the association between socioeconomic status and community-acquired pneumonia outcomes in the elderly, in the context of a public health system providing universal free care to the whole population. A total of 651 patients aged > or =65 years hospitalized due to community-acquired pneumonia through the emergency departments of five Spanish public hospitals were recruited and followed up between May 2005 and January 2007. The primary outcomes studied were: length of stay, intensive care unit admission, overall mortality and readmission. Socioeconomic status was measured using both individual and community data: occupation [categorized in six social groups (I, II, III, IVa, IVb and V)], educational level ( or = secondary level) and disposable family income of the municipality or district of residence [>12,500 euro (high municipality family income) and income)]. The six social groups were further categorized as upper/middle social class (groups I-IVb) and lower class (group V).Bivariate and multivariate analyses were performed. OR and their 95% confidence intervals were calculated. All statistical tests were two tailed and statistical significance was established as p income and 63.6% were upper/middle social class (I-IVb). Only 15.7% of patients had a secondary education. The adjusted analysis showed no association between pneumonia outcomes and social class, educational level or municipality family income. However, length of stay increased significantly in patients in whom the factors, living alone and being a smoker or ex-smoker coincided (p class, educational level or municipality family income and the variables of pneumonia outcomes. The lack of differences between social classes supports the provision of universal, equitable

  18. Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study

    Directory of Open Access Journals (Sweden)

    Borba HHL

    2017-01-01

    had an influence on the RVR rate (odds ratio [OR] =0.011; 95% confidence interval [CI]: 0.001–0.119; P<0.001/OR =13.004; 95% CI: 1.522–111.115; P=0.019, respectively.Conclusion: In this longitudinal multicenter cohort study conducted from the Brazilian perspective, differences were found in the RVR rates, favoring telaprevir over boceprevir for genotype 1 HCV-infected patients. In addition, the baseline viral load was associated with RVR achievement in both evaluated groups. As RVR is also reported in the literature as a predictor of the sustained virological response (SVR, further analyses of RVR as predictor of SVR outcomes should be further evaluated in Brazil. Keywords: hepatitis C, rapid virological response, protease inhibitors, telaprevir, boceprevir, multicenter

  19. 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....

  20. A Multicenter Phase II Study of Erlotinib and Sorafenib in Chemotherapy-Naive Patients with Advanced Non-Small Cell Lung Cancer

    NARCIS (Netherlands)

    Lind, Joline S. W.; Dingemans, Anne-Marie C.; Groen, Harry J. M.; Thunnissen, Frederik B.; Bekers, Otto; Heideman, Danielle A. M.; Honeywell, Richard J.; Giovannetti, Elisa; Peters, Godefridus J.; Postmus, Pieter E.; van Suylen, Robert Jan; Smit, Egbert F.

    2010-01-01

    Purpose: This multicenter, phase II study evaluates the efficacy and safety of erlotinib, an epidermal growth factor receptor (EGFR) inhibitor, plus sorafenib, a multityrosine kinase inhibitor against vascular endothelial growth factor receptors, in patients with previously untreated advanced

  1. 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 an

  2. Risk factors for death during pulmonary tuberculosis treatment in Korea: a multicenter retrospective cohort study.

    Science.gov (United States)

    Kwon, Yong-Soo; Kim, Yee Hyung; Song, Jae-Uk; Jeon, Kyeongman; Song, Junwhi; Ryu, Yon Ju; Choi, Jae Chol; Kim, Ho Cheol; Koh, Won-Jung

    2014-09-01

    The data regarding risk factors for death during tuberculosis (TB) treatment are inconsistent, and few studies examined this issue in Korea. The purpose of this study was to evaluate baseline prognostic factors for death during treatment of adult patients with pulmonary TB in Korea. A multicenter retrospective cohort study of 2,481 patients who received TB treatment at eight hospitals from January 2009 to December 2010 was performed. Successful treatment included cure (1,129, 45.5%) and treatment completion (1,204, 48.5%) in 2,333 patients (94.0%). Unsuccessful treatment included death (85, 3.4%) and treatment failure (63, 2.5%) occurred in 148 patients (6.0%). In multivariate analysis, male sex, anemia, dyspnea, chronic heart disease, malignancy, and intensive care unit (ICU) admission were significant risk factors for death during TB treatment. Therefore, male sex, anemia, dyspnea, chronic heart disease, malignancy, and ICU admission could be baseline prognostic factors for death during treatment of adult patients with pulmonary TB in Korea.

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

    Directory of Open Access Journals (Sweden)

    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

  5. Predictors for length of hospital stay in patients with community-acquired Pneumonia: Results from a Swiss Multicenter study

    Directory of Open Access Journals (Sweden)

    Suter-Widmer Isabelle

    2012-05-01

    Full Text Available Abstract Background Length of hospital stay (LOS in patients with community-acquired pneumonia (CAP is variable and directly related to medical costs. Accurate estimation of LOS on admission and during follow-up may result in earlier and more efficient discharge strategies. Methods This is a prospective multicenter study including patients in emergency departments of 6 tertiary care hospitals in Switzerland between October 2006 and March 2008. Medical history, clinical data at presentation and health care insurance class were collected. We calculated univariate and multivariate cox regression models to assess the association of different characteristics with LOS. In a split sample analysis, we created two LOS prediction rules, first including only admission data, and second including also additional inpatient information. Results The mean LOS in the 875 included CAP patients was 9.8 days (95%CI 9.3-10.4. Older age, respiratory rate >20 pm, nursing home residence, chronic pulmonary disease, diabetes, multilobar CAP and the pneumonia severity index class were independently associated with longer LOS in the admission prediction model. When also considering follow-up information, low albumin levels, ICU transfer and development of CAP-associated complications were additional independent risk factors for prolonged LOS. Both weighted clinical prediction rules based on these factors showed a high separation of patients in Kaplan Meier Curves (p logrank and a good calibration when comparing predicted and observed results. Conclusions Within this study we identified different baseline and follow-up characteristics to be strong and independent predictors for LOS. If validated in future studies, these factors may help to optimize discharge strategies and thus shorten LOS in CAP patients.

  6. A multicenter study of cellulite treatment with a variable emission radio frequency system.

    Science.gov (United States)

    van der Lugt, Claudia; Romero, Carmen; Ancona, Dvora; Al-Zarouni, Marwan; Perera, Joanet; Trelles, Mario A

    2009-01-01

    Radio frequency (RF) systems have been reported as producing electrothermally mediated and subcutaneous effects. The present study evaluates a new approach to treat cellulite with a bipolar RF device. The buttocks of 50 patients were treated, 10 from each of five multinational centers with a novel bipolar RF technology set at 6 J/cm(3), which changes its frequency between 0.6 and 2.4 MHz according to impedance of tissue. Twelve weekly sessions were given for 12 minutes on each buttock, with a treatment end point of 42 degrees C external skin temperature. Cellulite changes and tissue condition were assessed before and immediately after the first session, before the final 12th session, and 2 months thereafter. The patient Satisfaction Index was recorded. Objective evaluation involved clinical photography, three-dimensional optical skin surface measurement, and histological findings. Almost all patients noted improvement of cellulite and body silhouette at the final session, which slightly decreased at the 2-month assessment. Improved skin appearance was objectively detected. Histological findings following the first session showed reactive edema and lysis of adipocyte membranes, possibly implicated in the final effects achieved. The RF technology used in the present multicenter study improved the general aspect of skin and cellulite, with high patient Satisfaction Index. Maintenance sessions might lead to even better and longer-lasting results.

  7. 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.

  8. 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.

  9. [Multicenter Clinical Study of Vibrant Soundbridge in Japan: Analysis of Subjective Questionnaires].

    Science.gov (United States)

    Kumakawa, Kozo; Kanzaki, Sho; Usami, Shin-ichi; Iwasaki, Satoshi; Yamanaka, Noboru; Doi, Katsumi; Naito, Yasushi; Gyo, Kiyofumi; Tono, Tetsuya; Takahashi, Haruo; Kanda, Yukihiko

    2015-11-01

    The Vibrant Soundbridge (VSB) is an active middle ear implant with the Floating Mass Transducer (FMT). We performed a multicenter study to study the efficacy of the VSB by means of "the 10 Questionnaire on Hearing 2002" and "the APHAB questionnaire" at 13 hospitals between 2011 and 2013. In all, 23 patients with mixed or conductive hearing loss received VSB implantation by the round window placement technique. These individuals were generally unable to use, or gained little from conventional hearing aids or bone conduction hearing aids. Two questionnaires were administrated before the surgery and 20 weeks after the VSB implantation. Scores on every item of "the 10 Questionnaire on Hearing 2002" showed significant improvement under noise after VSB implantation. On the APHAB, the scores for Ease of Communication, Reverberation, and Background subscales improved significantly after the VSB implantation, while the score for the Aversiveness subscale alone failed to show a positive improvement from the inexperience to the new sound. Analysis of the responses to these subjective questionnaires revealed better results after VSB implantation as compared to the preoperative data. In conclusion, RW vibroplasty with the use of VSB provided subjective benefit in patients with conductive and mixed hearing loss.

  10. Multicenter Study of Brain Volume Abnormalities in Children and Adolescent-Onset Psychosis

    Science.gov (United States)

    Reig, Santiago; Parellada, Mara; Castro-Fornieles, Josefina; Janssen, Joost; Moreno, Dolores; Baeza, Inmaculada; Bargalló, Nuria; González-Pinto, Ana; Graell, Montserrat; Ortuño, Felipe; Otero, Soraya; Arango, Celso; Desco, Manuel

    2011-01-01

    The goal of the study is to determine the extent of structural brain abnormalities in a multicenter sample of children and adolescents with a recent-onset first episode of psychosis (FEP), compared with a sample of healthy controls. Total brain and lobar volumes and those of gray matter (GM), white matter, and cerebrospinal fluid (CSF) were measured in 92 patients with a FEP and in 94 controls, matched for age, gender, and years of education. Male patients (n = 64) showed several significant differences when compared with controls (n = 61). GM volume in male patients was reduced in the whole brain and in frontal and parietal lobes compared with controls. Total CSF volume and frontal, temporal, and right parietal CSF volumes were also increased in male patients. Within patients, those with a further diagnosis of “schizophrenia” or “other psychosis” showed a pattern similar to the group of all patients relative to controls. However, bipolar patients showed fewer differences relative to controls. In female patients, only the schizophrenia group showed differences relative to controls, in frontal CSF. GM deficit in male patients with a first episode correlated with negative symptoms. Our study suggests that at least part of the GM deficit in children and adolescent-onset schizophrenia and in other psychosis occurs before onset of the first positive symptoms and that, contrary to what has been shown in children-onset schizophrenia, frontal GM deficits are probably present from the first appearance of positive symptoms in children and adolescents. PMID:20478821

  11. 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.

  12. [Snow board accidents. Multicenter Swiss snow board study 1992/93 with the cooperation of the bfu].

    Science.gov (United States)

    Campell, L; Soklic, P; Ziegler, W; Matter, P; Fenner, A; Noesberger, B; Rigo, M

    1993-01-01

    Snowboarding has become increasingly popular in recent years. A prospective multicenter study was therefore performed during the winter 1992/93. 345 injuries were analysed and compared with 305 healthy snowboarders on the slopes. Preliminary results show predominantly injuries of the upper extremity comparative to those suffered from alpine skiing. Protection of the hand and wrist is recommended as well as an instruction for a special technique for falling as measurements for accident prevention.

  13. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    Institute of Scientific and Technical Information of China (English)

    Elena Ricart; Maria Esteve; Montserrat Andreu; Francesc Casellas; David Monfort; Miquel Sans; Natalia Oudovenko; Raúl Lafuente; Julián Panés

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and L1 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases.Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.

  14. The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

    Science.gov (United States)

    Legro, Richard S; Brzyski, Robert G; Diamond, Michael P; Coutifaris, Christos; Schlaff, William D; Alvero, Ruben; Casson, Peter; Christman, Gregory M; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J; Barnhart, Kurt T; Bates, G Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J C; Krawetz, Stephen A; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2014-01-01

    To summarize baseline characteristics from a large multicenter infertility clinical trial. Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Academic Health Centers throughout the United States. Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. None. Historic, biometric, biochemical, and questionnaire parameters. Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. NCT00719186. Copyright © 2014 American Society for Reproductive Medicine. All rights reserved.

  15. Medical and non-medical expenditure for breast cancer diagnosis and treatment in China: a multicenter cross-sectional study.

    Science.gov (United States)

    Liao, Xian-Zhen; Shi, Ju-Fang; Liu, Jing-Shi; Huang, Hui-Yao; Guo, Lan-Wei; Zhu, Xin-Yu; Xiao, Hai-Fan; Wang, Le; Bai, Ya-Na; Liu, Guo-Xiang; Mao, A-Yan; Ren, Jian-Song; Sun, Xiao-Jie; Mai, Ling; Liu, Yu-Qin; Song, Bing-Bing; Gong, Ji-Yong; Zhou, Jin-Yi; Du, Ling-Bing; Zhou, Qi; Cao, Rong; Zhu, Lin; Ren, Ying; Lou, Pei-An; Lan, Li; Sun, Xiao-Hua; Qi, Xiao; Wang, Yuan-Zheng; Zhang, Kai; He, Jie; Dai, Min

    2017-07-03

    We aimed to assess economic burden of breast cancer (BC) diagnosis and treatment in China through a multicenter cross-sectional study, and to obtain theoretical evidence for policy-making. This survey was conducted in 37 hospital centers across 13 provinces in China from September 2012 to December 2014. We collected information on the subject characteristics. We then assessed the medical and non-medical expenditure for BC diagnosis and treatment, factors influencing the average case expense, variations between medical and non-medical expenditure at different clinical stages, economic impact of overall expenditure in newly diagnosed course after reimbursement to the patient's family, composition of non-medical expenditure and time loss for the patient and family. Among 2746 women with BC (72.6% were admitted to specialized hospitals), the overall average expenditure was US $8450 (medical expenditure: $7527; non-medical expenditure: $922). Significant differences were found among the overall expenditure in the four clinical stages (P < 0.0001); the expenditure was higher in stages III and IV than that in stages I and II, whereas the stage IV was the highest (P < 0.0001). Moreover, a higher self-reported predicted reimbursement ratio was associated with a less economic impact on the patient's family, and the average time lost was estimated as $1529. Early detection and treatment of breast cancer might be effective for decreasing the economic burden, because costs escalate as the degree of malignancy increases. © 2017 John Wiley & Sons Australia, Ltd.

  16. Factors that impact health-related quality of life in adults with celiac disease: A multicenter study

    Institute of Scientific and Technical Information of China (English)

    F Casellas; M Papo; J Gelabert; JR Malagelada; L Rodrigo; J López Vivancos; S Riestra; C Pantiga; JS Baudet; F Junquera; V Puig Diví; C Abadia

    2008-01-01

    AIM:To evaluate the factors involved in the impairment of health-related quality of life (HRQOL) in patients with celiac disease.METHODS: A multicenter, cross-sectional prospective study was performed in patients with celiac disease who completed two HRQOL questionnaires: the gastrointestinal quality of life index (GIQLI) and the EuroQol-SD (EQ).RESULTS: Three hundred and forty patients (163 controlled with a gluten-free diet, and 177 newly diagnosed with a normal diet) were included. The GIQLI score was significantly better in patients on a gluten- free diet (GFD) than in non-treated patients on their usual diet, both in terms of the overall score (3.3 vs 2.7,respectively; P<0.001), as well as on the individual questionnaire dimensions. Both the preference value of the EQ as the visual analogue scale were significantly better in treated than in non-treated patients (0.93 vs 0.72 P<0.001 and 80 vs 70 P<0.001, respectively). Variables significantly associated with a worse HRQOL score were female gender, failure to adhere to a GFD,and symptomatic status.CONCLUSION: In untreated celiac disease, the most important factors that influence patient perception of health are the presence of symptoms and a normal diet.HRQOL improves to levels similar to those described in the general population in celiac disease patients well controlled with a GFD.

  17. Multicenter study to evaluate efficacy and irritation potential of benzoyl peroxide 4% cream in hydrophase base (Brevoxyl in acne vulgaris

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    Sawleshwarkar S

    2003-01-01

    Full Text Available In this multicenter, open, non-comparative study, the efficacy and irritation potential of 4% benzoyl peroxide cream in hydrophase base (Brevoxyl was evaluated for the treatment of acne vulgaris. All evaluable patients (n=567 received treatment with 4% benzoyl peroxide cream in hydrophase base for six weeks. The investigators evaluated the patients at baseline and at 1,2,4 & 6 weeks. Patients also rated their improvement and adverse effects. Doctor′s assessment showed that at the end of 6′h week 85.6% had good to very good effect of the treatment. The profile of side effects observed by doctors revealed that 53.8% of total patients did not have any irritation whereas only 11.6% had moderate to severe irritation. 53.8% of patients did not report any irritation: 41.4% had some irritation whereas only 4.8% patients reported troublesome irritation. A satisfactory response was reported as ear;y as two weeks and most of the patients had a very satisfactory response after six weeks and were willing to continue the treatment. This supports the theory that the hydrophase formulation in ′Brevoxyl helped to enhance efficacy and decrease the irritation associated with use of benzoyl peroxide.

  18. Resective Epilepsy Surgery for Tuberous Sclerosis in Children: Determining Predictors of Seizure Outcomes in a Multicenter Retrospective Cohort Study.

    Science.gov (United States)

    Fallah, Aria; Rodgers, Shaun D; Weil, Alexander G; Vadera, Sumeet; Mansouri, Alireza; Connolly, Mary B; Major, Philippe; Ma, Tracy; Devinsky, Orrin; Weiner, Howard L; Gonzalez-Martinez, Jorge A; Bingaman, William E; Najm, Imad; Gupta, Ajay; Ragheb, John; Bhatia, Sanjiv; Steinbok, Paul; Witiw, Christopher D; Widjaja, Elysa; Snead, O Carter; Rutka, James T

    2015-10-01

    There are no established variables that predict the success of curative resective epilepsy surgery in children with tuberous sclerosis complex (TSC). We performed a multicenter observational study to identify preoperative factors associated with seizure outcome in children with TSC undergoing resective epilepsy surgery. A retrospective chart review was performed in eligible children at New York Medical Center, Miami Children's Hospital, Cleveland Clinic Foundation, BC Children's Hospital, Hospital for Sick Children, and Sainte-Justine Hospital between January 2005 and December 2013. A time-to-event analysis was performed. The "event" was defined as seizures after resective epilepsy surgery. Seventy-four patients (41 male) were included. The median age of the patients at the time of surgery was 120 months (range, 3-216 months). The median time to seizure recurrence was 24.0 ± 12.7 months. Engel Class I outcome was achieved in 48 (65%) and 37 (50%) patients at 1- and 2-year follow-up, respectively. On univariate analyses, younger age at seizure onset (hazard ratio [HR]: 2.03, 95% confidence interval [CI]: 1.03-4.00, P = .04), larger size of predominant tuber (HR: 1.03, 95% CI: 0.99-1.06, P = .12), and resection larger than a tuberectomy (HR: 1.86, 95% CI: 0.92-3.74, P = .084) were associated with a longer duration of seizure freedom. In multivariate analyses, resection larger than a tuberectomy (HR: 2.90, 95% CI: 1.17-7.18, P = .022) was independently associated with a longer duration of seizure freedom. In this large consecutive cohort of children with TSC and medically intractable epilepsy, a greater extent of resection (more than just the tuber) is associated with a greater probability of seizure freedom. This suggests that the epileptogenic zone may include the cortex surrounding the presumed offending tuber.

  19. Viral suppression and adherence among HIV-infected children and adolescents on antiretroviral therapy: results of a multicenter study

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    Maria L.S. Cruz

    2014-12-01

    Full Text Available OBJECTIVE: To evaluate treatment adherence among perinatally-infected pediatric human immunodeficiency virus (HIV patients followed in pediatric centers in Brazil. METHODS: This was a cross-sectional multicenter study. Medical records were reviewed and adherence scale, assessment of caregivers' quality of life (WHOQOL-BREF, anxiety, depression, and alcohol/substances use/abuse were assessed. Outcomes included self-reported 100% adherence in the last three days and HIV viral load (VL < 50 copies/mL. Statistical analyses included contingency tables and respective statistics, and multivariable logistic regression. RESULTS: 260 subjects were enrolled: 78% children and 22% adolescents; 93% of caregivers for the children and 77% of adolescents reported 100% adherence; 57% of children and 49% of adolescents had VL < 50 copies/mL. In the univariate analyses, HIV diagnosis for screening due to maternal infection, lower caregiver scores for anxiety, and higher scores in physical and psychological domains of WHOQOL-BREF were associated with 100% adherence. Shorter intervals between pharmacy visits were associated with VL < 50 copies/mL (p ≤ 0.01. Multivariable regression demonstrated that caregivers who did not abuse alcohol/other drugs (OR = 0.49; 95% CI: 0.27-0.89 and median interval between pharmacy visits < 33 days (OR = 0.97; 95% CI: 0.95-0.98 were independently associated with VL < 50 copies/mL; whereas lower caregiver scores for anxiety (OR = 2.57; 95% CI: 1.27-5.19 and children's HIV diagnosis for screening due to maternal infection (OR = 2.25; 95% CI: 1.12-4.50 were found to be independently associated with 100% adherence. CONCLUSIONS: Pediatric HIV programs should perform routine assessment of caregivers' quality of life, and anxiety and depression symptoms. In this setting, pharmacy records are essential to help identify less-than-optimal adherence.

  20. Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study.

    Science.gov (United States)

    Abo, Masahiro; Kakuda, Wataru; Momosaki, Ryo; Harashima, Hiroaki; Kojima, Miki; Watanabe, Shigeto; Sato, Toshihiro; Yokoi, Aki; Umemori, Takuma; Sasanuma, Jinichi

    2014-07-01

    Many poststroke patients suffer functional motor limitation of the affected upper limb, which is associated with diminished health-related quality of life. The aim of this study is to conduct a randomized, multicenter, comparative study of low-frequency repetitive transcranial magnetic stimulation combined with intensive occupational therapy, NEURO (NovEl intervention Using Repetitive TMS and intensive Occupational therapy) versus constraint-induced movement therapy in poststroke patients with upper limb hemiparesis. In this randomized controlled study of NEURO and constraint-induced movement therapy, 66 poststroke patients with upper limb hemiparesis were randomly assigned at 2:1 ratio to low-frequency repetitive transcranial magnetic stimulation plus occupational therapy (NEURO group) or constraint-induced movement therapy (constraint-induced movement therapy group) for 15 days. Fugl-Meyer Assessment and Wolf Motor Function Test and Functional Ability Score of Wolf Motor Function Test were used for assessment. No differences in patients' characteristics were found between the two groups at baseline. The Fugl-Meyer Assessment score was significantly higher in both groups after the 15-day treatment compared with the baseline. Changes in Fugl-Meyer Assessment scores and Functional Ability Score of Wolf Motor Function Test were significantly higher in the NEURO group than in the constraint-induced movement therapy group, whereas the decrease in the Wolf Motor Function Test log performance time was comparable between the two groups (changes in Fugl-Meyer Assessment score, NEURO: 5·39 ± 4·28, constraint-induced movement therapy: 3·09 ± 4·50 points; mean ± standard error of the mean; P < 0·05) (changes in Functional Ability Score of Wolf Motor Function Test, NEURO: 3·98 ± 2·99, constraint-induced movement therapy: 2·09 ± 2·96 points; P < 0·05). The results of the 15-day rehabilitative protocol showed the superiority of NEURO

  1. Frequency of atrial tachyarrhythmias in patients treated by cardiac resynchronization (from the Prospective, Multicenter Mona Lisa Study).

    Science.gov (United States)

    Marijon, Eloi; Jacob, Sophie; Mouton, Elisabeth; Defaye, Pascal; Piot, Olivier; Delarche, Nicolas; Dennetiere, Stéphane; Galley, Daniel; Le Franc, Pierre; Appl, Ursula; Guyomar, Yves; Albenque, Jean Paul; Chevalier, Philippe; Boveda, Serge

    2010-09-01

    The continuous measurement of sustained atrial tachyarrhythmia (AT) is now possible with some permanently implanted devices. Data on this subject remain controversial. The aim of this study was to evaluate the incidence of sustained AT in patients treated with cardiac resynchronization therapy using pacemakers without backup defibrillators (CRT-P), within the first year after implantation, using strict definition criteria for sustained AT and a systematic review of all high-quality electrographically recorded episodes. The Mona Lisa study was a prospective, multicenter, cohort study carried out from February 2004 to February 2006, with a 12-month follow-up period. Sustained AT was defined as an episode lasting > or =5 minutes; episodes were confirmed by a systematic review of electrograms in the whole study population. Of the 198 patients who underwent CRT-P device implantation and were enrolled in the study, 173 were in stable sinus rhythm at baseline and were included in the analysis (mean age 70 +/- 9 years, 66% men, 91% in New York Heart Association class III, mean QRS duration 164 +/- 26 ms, mean left ventricular ejection fraction 25 +/- 7%). During a mean follow-up period of 9.9 +/- 3.6 months, 34 patients experienced > or =1 episode of sustained AT, for an incidence rate of 27.5% (95% confidence interval 18.2 to 36.7). Only a history of AT was independently associated with the occurrence of sustained AT within the 12 months after CRT-P device implantation (hazard ratio 2.3, 95% confidence interval 1.2 to 4.4, p = 0.02). In conclusion, this first prospective electrogram-based evaluation of AT incidence demonstrated that 27% of patients developed > or =1 episode of sustained AT lasting > or =5 minutes in the 12 months after CRT-P device implantation. 2010 Elsevier Inc. All rights reserved.

  2. Effect of hemodiafiltration with endogenous reinfusion on overt idiopathic chronic inflammation in maintenance hemodialysis patients: a multicenter longitudinal study.

    Science.gov (United States)

    Borrelli, Silvio; Minutolo, Roberto; De Nicola, Luca; De Simone, Emanuele; De Simone, Walter; Zito, Bruno; Guastaferro, Pasquale; Nigro, Filippo; Iulianiello, Giuseppe; Credendino, Olga; Bassi, Antonio; Leone, Luigi; Capuano, Maria; Auricchio, Maria Rita; Conte, Giuseppe

    2014-10-01

    Chronic inflammation is widely diffuse in maintenance hemodialysis (MHD) patients and is associated with poor survival. Hemodiafiltration with endogenous reinfusion (HFR) is a dialysis technique, highly biocompatible, able to adsorb proinflammatory cytokines and to decrease amino acids and antioxidants loss. These features could be helpful in MHD patients affected by idiopathic chronic inflammation, but this issue remains to be elucidated. We performed a multicenter longitudinal study to assess the effect of the switching from bicarbonate HD to HFR in patients with serum C-reactive Protein (CRP) > 5 mg/L coupled with albumin inflammation. At baseline, serum levels of CRP (18.7[7.0-39.4] mg/L) and albumin (3.5[3.3-3.7] g/dL) were significantly correlated (r = -0.49; P = 0.028). The effect on CRP and albumin was almost evident in the first 4 months and remained stable until to eighth month. A strict correlation (R = -0.49; 0.040) between percentage change of CRP (-35%) and albumin (+14%) after 8 months of HFR. These effects were associated with the reduction of IL-6, IL-1β, and TNF-α and the increment of pre-albumin and leptin, whereas the serum levels of Branched Chain Amino Acid (BCAA) remained unchanged. In MHD patients affected by idiopathic chronic inflammation the switching from BHD to HFR is associated with improvement of inflammation. Whether these favorable effects may modify the outcomes of these high-risk patients needs to be confirmed by studies ad hoc.

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

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    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. 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.

  5. 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.

  6. Natural history of splenic vascular abnormalities after blunt injury: A Western Trauma Association multicenter trial.

    Science.gov (United States)

    Zarzaur, Ben L; Dunn, Julie A; Leininger, Brian; Lauerman, Margaret; Shanmuganathan, K; Kaups, Krista; Zamary, Kirellos; Hartwell, Jennifer L; Bhakta, Ankur; Myers, John; Gordy, Stephanie; Todd, Samuel R; Claridge, Jeffrey A; Teicher, Erik; Sperry, Jason; Privette, Alicia; Allawi, Ahmed; Burlew, Clay Cothren; Maung, Adrian A; Davis, Kimberly A; Cogbill, Thomas; Bonne, Stephanie; Livingston, David H; Coimbra, Raul; Kozar, Rosemary A

    2017-05-30

    Following blunt splenic injury (BSI) there is conflicting evidence regarding the natural history and appropriate management of patients with vascular injuries of the spleen such as pseudoaneurysms or blushes. The purpose of this study was to describe the current management and outcomes of patients with PSA or BLUSH. Data was collected on adult (≥18) patients with BSI and a splenic vascular injury from 17 trauma centers. Demographic, physiologic, radiographic, and injury characteristics were gathered. Management and outcomes were collected. Univariate and multivariable analyses were used to determine factors associated with splenectomy. Two hundred patients with a vascular abnormality on CT scan were enrolled. Of those, 14.5% were managed with early splenectomy. Of the remaining, 59% underwent angiography and embolization (ANGIO) and 26.5% were observed. Of those who underwent ANGIO, 5.9% had a repeat ANGIO and 6.8% had splenectomy. Of those observed, 9.4% had a delayed ANGIO and 7.6% underwent splenectomy. There were no statistically significant differences between those observed and those who underwent ANGIO. There were 111 CT scans with splenic vascular injuries available for review by an expert trauma radiologist. The concordance between the original classification of the type of vascular abnormality and the expert radiologist's interpretation was 56.3%. Based on expert review the presence of an actively bleeding vascular injury was associated with a 40.9% risk of splenectomy. This was significantly higher than those with a non-bleeding vascular injury. In this series, the vast majority of patients are managed with ANGIO and usually embolization while splenectomy remains a rare event. However, patients with a bleeding vascular injury of the spleen are at high risk of non-operative failure no matter the strategy used for management. This group may warrant closer observation or an alternative management strategy. Prognostic Level III.

  7. Occupational and Environmental Risk Factors for Idiopathic Pulmonary Fibrosis in Egypt: A Multicenter Case-Control Study

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    RA Elmetwally

    2012-06-01

    Full Text Available Background: Despite the advances in medical therapy and technology, the prognosis of idiopathic pulmonary fibrosis (IPF remains poor and the need for disease prevention based on identifying the risk factors becomes mandatory. Occupational and environmental exposures were studied in several countries and found to play important role in the disease development. However, in Egypt, a little attention has been paid to study the effect of these factors in the disease development. Objective: To identify the occupational and environmental risk factors associated with the development of IPF in Egypt.Methods: A multicenter hospital-based case-control study was carried out in chest hospitals affiliated to three Egyptian cities—Cairo, Tanta and Mansoura. Subjects were 201 patients with confirmed IPF (cases and 205 age-, sex- and residence-matched controls. Data on occupational and environmental factors were obtained from a questionnaire. Multiple logistic regression analysis was used to determine the independent risk factors of IPF in both sexes for single factors with adjustment for age, residence and smoking status.Results: Compared with the controls, the risk of IPF in male workers was observed to increase significantly in chemical and petrochemical industries and carpentry and wood working (OR=2.56, 95% CI: 1.02–7.01, and with occupational exposures to wood dust and wood preservatives. Among female workers, a significant increase was observed in farming (OR=3.34, 95% CI: 1.17–10.12, raising birds and occupational exposures to animal feeds, products and dusts and pesticides. Risk of IPF decreased significantly in male workers and insignificantly among female workers in sales and clerical related activities. The environmental exposures to birds and cats were significantly associated with elevated risk of IPF development in both sexes.Conclusion: In Egypt, farming, raising birds and wood working are important risk factors for the development of IPF.

  8. Occupational and environmental risk factors for idiopathic pulmonary fibrosis in Egypt: a multicenter case-control study.

    Science.gov (United States)

    Awadalla, N J; Hegazy, A; Elmetwally, R A; Wahby, I

    2012-07-01

    Despite the advances in medical therapy and technology, the prognosis of idiopathic pulmonary fibrosis (IPF) remains poor and the need for disease prevention based on identifying the risk factors becomes mandatory. Occupational and environmental exposures were studied in several countries and found to play important role in the disease development. However, in Egypt, a little attention has been paid to study the effect of these factors in the disease development. To identify the occupational and environmental risk factors associated with the development of IPF in Egypt. A multicenter hospital-based case-control study was carried out in chest hospitals affiliated to three Egyptian cities-Cairo, Tanta and Mansoura. Subjects were 201 patients with confirmed IPF (cases) and 205 age-, sex- and residence-matched controls. Data on occupational and environmental factors were obtained from a questionnaire. Multiple logistic regression analysis was used to determine the independent risk factors of IPF in both sexes for single factors with adjustment for age, residence and smoking status. Compared with the controls, the risk of IPF in male workers was observed to increase significantly in chemical and petrochemical industries and carpentry and wood working (OR = 2.56, 95% CI: 1.02-7.01), and with occupational exposures to wood dust and wood preservatives. Among female workers, a significant increase was observed in farming (OR = 3.34, 95% CI: 1.17-10.12), raising birds and occupational exposures to animal feeds, products and dusts and pesticides. Risk of IPF decreased significantly in male workers and insignificantly among female workers in sales and clerical related activities. The environmental exposures to birds and cats were significantly associated with elevated risk of IPF development in both sexes. In Egypt, farming, raising birds and wood working are important risk factors for the development of IPF.

  9. Multicenter study differentiated thyroid carcinoma (MSDS). Diminished acceptance of adjuvant external beam radiotherapy.

    Science.gov (United States)

    Biermann, M; Pixberg, M K; Schuck, A; Heinecke, A; Köpcke, W; Schmid, K W; Dralle, H; Willich, N; Schober, O

    2003-12-01

    The Multicenter Study Differentiated Thyroid Carcinoma (MSDS) is an ongoing study in Germany, Austria, and Switzerland on the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated thyroid carcinoma (DTC) in TNM stages pT4 pN0/1/x M0/x (5th ed. 1997). MSDS was designed as a prospective randomized trial. Patients receive thyroidectomy, radioiodine therapy (RIT) to ablate the thyroid remnant, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical iodine-131 uptake (http://msds-studie.uni-muenster.de). 311 patients were enrolled between January 2000 and March 2003. 279 patients met the trial's inclusion criteria. 45 consented to randomization, of whom 17 were randomized into treatment arm A (RTx) and 18 into arm B (no RTx). Advised by the trial's independent Data Monitoring and Safety Committee, the MSDS steering committee decided to terminate randomization in April 2003 and continue MSDS as a prospective cohort study. 23 of the 234 patients in the observation arm of the trial were prescribed RTx by their physicians. Thus, 14% of the trial cohort were randomized or assigned to receive RTx (in-tention-to-treat analysis). In contrast, at least 44% of all patients with pT4 papillary DTC in Germany in the nation-wide PCES study underwent RTx in 1996 (p <0.001, chi(2)-test). Acceptance of external beam RTx as a treatment modality for DTC has receded to a degree that accrual of a sufficient number of patients for a randomized trial has been impossible. Observation of the trial cohort is continued in order to assess clinical event rates with and without RTx and chronic RTx toxicity.

  10. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

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    Reinaldo Menezes Martins

    2004-12-01

    Full Text Available The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang® were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70% met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566, children 1 to 10 years old (484, adolescents from 11 to 19 years (740, adults from 20 to 30 years (568, and adults from 31 to 40 years (396. Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults or 0, 1, and 7 months (children. Vaccine dose was intramuscular 10 µg (infants, children, and adolescents or 20 µg (adults. Percent seroprotection (assumed when anti-HBs titers were > 10mIU/ml and geometric mean titer (mIU/ml were: newborn infants, 93.7% and 351.1 (Butang® and 97.5% and 1530.6 (Engerix B®; children, 100% and 3600.0 (Butang® and 97.7% and 2753.1 (Engerix B®; adolescents, 95.1% and 746.3 (Butang® and 96% and 1284.3 (Engerix B®; adults 20-30 years old, 91.8% and 453.5 (Butang® and 95.5% and 1369.0 (Engerix B®; and adults 31-40 years old, 79.8% and 122.7 (Butang® and 92.4% and 686.2 (Engerix B®. There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults.

  11. Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

    Science.gov (United States)

    Inoue, Hirosuke; Kusuda, Takeshi; Kang, Dongchon; Ichihara, Kiyoshi; Nakashima, Naoki; Ihara, Kenji; Ohga, Shouichi; Hara, Toshiro

    2016-01-01

    Preterm low-birth-weight infants remain difficult to manage based on adequate laboratory tests. The aim of this study was to establish blood reference intervals (RIs) in those newborns who were admitted to and survived in the neonatal intensive care unit (NICU). A multicenter prospective study was conducted among all infants admitted to 11 affiliated NICUs from 2010 to 2013. The clinical information and laboratory data were registered in a network database designed for this study. The RIs for 26 items were derived using the parametric method after applying the latent abnormal values exclusion method. The influence of birth weight (BW) and gestational age (GA) on the test results was expressed in terms of the standard deviation ratio (SDR), as SDRBW and SDRGA, respectively. A total of 3189 infants were admitted during the study period; 246 were excluded due to a lack of blood sampling data, and 234 were excluded for chromosomal abnormalities (n = 108), congenital anomalies requiring treatment with surgical procedures (n = 76), and death or transfer to another hospital (n = 50). As a result, 2709 infants were enrolled in this study. Both the SDRGA and SDRBW were above 0.4 in the test results for total protein (TP), albumin (ALB), alanine aminotransferase (ALT), and red blood cells (RBC); their values increased in proportion to the BW and GA. We derived 26 blood RIs for infants who were admitted to NICUs. These RIs should help in the performance of proper clinical assessments and research in the field of perinatal-neonatal medicine. PMID:27552225

  12. Differential Effect of Viral Hepatitis Infection on Mortality among Korean Maintenance Dialysis Patients: A Prospective Multicenter Cohort Study.

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    Eugene Kwon

    Full Text Available The role of infection with hepatitis B virus (HBV and hepatitis C virus (HCV in terms of survival among dialysis patients remains incompletely understood. In the present multicenter prospective cohort study, we investigated the prevalences of HBV and HCV infection among 3,321 patients receiving maintenance dialysis in Korea, and assessed the impacts of these infections on survival. All included patients underwent hepatitis B antigen (HBsAg and HCV antibody (Ab testing, which revealed that 236 patients (7.1% were HBsAg-positive, and 123 patients (3.7% were HCV Ab-positive. HBsAg-positive and HCV Ab-positive patients were matched to hepatitis virus-negative patients using a propensity score at a ratio of 1:2. The prevalences of HBV and HCV infection did not significantly differ according to dialysis modality. Linear-by-linear association analysis revealed that hepatitis B prevalence significantly increased with increasing dialysis vintage (p = 0.001, and hepatitis C prevalence tended to be higher with increasing dialysis vintage (p = 0.074. We compared the survival of HBsAg-positive and HCV Ab-positive patients to that of hepatitis virus-negative patients. After propensity score matching, cumulative survival did not differ between HBsAg-positive and HBsAg-negative patients (p = 0.37, while HCV Ab-positive patients showed significantly lower survival than HCV Ab-negative patients (p = 0.03. The main conclusions of the present study are that HBV infection prevalence increased with longer dialysis vintage, and that both HBV and HCV infections were most prevalent among patients with the longest dialysis vintage. Additionally, HCV infection among maintenance dialysis patients is associated with an increased risk of mortality.

  13. The burden of eclampsia: results from a multicenter study on surveillance of severe maternal morbidity in Brazil.

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    Juliana C Giordano

    Full Text Available OBJECTIVE: Maternal mortality (MM is a core indicator of disparities in women's rights. The study of Near Miss cases is strategic to identifying the breakdowns in obstetrical care. In absolute numbers, both MM and occurrence of eclampsia are rare events. We aim to assess the obstetric care indicators and main predictors for severe maternal outcome from eclampsia (SMO: maternal death plus maternal near miss. METHODS: Secondary analysis of a multicenter, cross-sectional study, including 27 centers from all geographic regions of Brazil, from 2009 to 2010. 426 cases of eclampsia were identified and classified according to the outcomes: SMO and non-SMO. We classified facilities as coming from low- and high-income regions and calculated the WHO's obstetric health indicators. SPSS and Stata softwares were used to calculate the prevalence ratios (PR and respective 95% confidence interval (CI to assess maternal characteristics, clinical and obstetrical history, and access to health services as predictors for SMO, subsequently correlating them with the corresponding perinatal outcomes, also applying multiple regression analysis (adjusted for cluster effect. RESULTS: Prevalence of and mortality indexes for eclampsia in higher and lower income regions were 0.2%/0.8% and 8.1%/22%, respectively. Difficulties in access to health care showed that ICU admission (adjPR 3.61; 95% CI 1.77-7.35 and inadequate monitoring (adjPR 2.31; 95% CI 1.48-3.59 were associated with SMO. CONCLUSIONS: Morbidity and mortality associated with eclampsia were high in Brazil, especially in lower income regions. Promoting quality maternal health care and improving the availability of obstetric emergency care are essential actions to relieve the burden of eclampsia.

  14. 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

  15. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas.

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    Stamos, Michael J; Snyder, Michael; Robb, Bruce W; Ky, Alex; Singer, Marc; Stewart, David B; Sonoda, Toyooki; Abcarian, Herand

    2015-03-01

    Although interest in sphincter-sparing treatments for anal fistulas is increasing, few large prospective studies of these approaches have been conducted. The study assessed outcomes after implantation of a synthetic bioabsorbable anal fistula plug. A prospective, multicenter investigation was performed. The study was conducted at 11 colon and rectal centers. Ninety-three patients (71 men; mean age, 47 years) with complex cryptoglandular transsphincteric anal fistulas were enrolled. Exclusion criteria included Crohn's disease, an active infection, a multitract fistula, and an immunocompromised status. Draining setons were used at the surgeon's discretion. Patients had follow-up evaluations at 1, 3, 6, and 12 months postoperatively. The primary end point was healing of the fistula, defined as drainage cessation plus closure of the external opening, at 6 and 12 months. Secondary end points were fecal continence, duration of drainage from the fistula, pain, and adverse events during follow-up. Thirteen patients were lost to follow-up and 21 were withdrawn, primarily to undergo an alternative treatment. The fistula healing rates at 6 and 12 months were 41% (95% CI, 30%-52%; total n = 74) and 49% (95% CI, 38%-61%; total n = 73). Half the patients in whom a previous treatment failed had healing. By 6 months, the mean Wexner score had improved significantly (p = 0.0003). By 12 months, 93% of patients had no or minimal pain. Adverse events included 11 infections/abscesses, 2 new fistulas, and 8 total and 5 partial plug extrusions. The fistula healed in 3 patients with a partial extrusion. The study was nonrandomized and had relatively high rates of loss to follow-up. Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure.

  16. Complication rates associated with 3-column osteotomy in 82 adult spinal deformity patients: retrospective review of a prospectively collected multicenter consecutive series with 2-year follow-up.

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    Smith, Justin S; Shaffrey, Christopher I; Klineberg, Eric; Lafage, Virginie; Schwab, Frank; Lafage, Renaud; Kim, Han Jo; Hostin, Richard; Mundis, Gregory M; Gupta, Munish; Liabaud, Barthelemy; Scheer, Justin K; Diebo, Bassel G; Protopsaltis, Themistocles S; Kelly, Michael P; Deviren, Vedat; Hart, Robert; Burton, Doug; Bess, Shay; Ames, Christopher P

    2017-02-17

    OBJECTIVE Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database. METHODS This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators. RESULTS Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33

  17. 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…

  18. HER2 status in ovarian carcinomas: a multicenter GINECO study of 320 patients.

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    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.

  19. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

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    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

  20. Pediatric drug-related problems: a multicenter study in four French-speaking countries.

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    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.

  1. CEUS Time Intensity Curves in the Differentiation Between Leydig Cell Carcinoma and Seminoma: A Multicenter Study.

    Science.gov (United States)

    Drudi, F M; Valentino, M; Bertolotto, M; Malpassini, F; Maghella, F; Cantisani, V; Liberatore, M; De Felice, C; D'Ambrosio, F

    2016-04-01

    Ultrasound (US) is the main imaging technique in the assessment of testicular masses, as it has proved to be highly accurate in the visualization of these pathologies. Identification of a Leydig cell tumor is essential since the lesion is benign in 90% of cases. The aim of this multicenter study is to assess the effectiveness of contrast-enhanced ultrasound (CEUS) in differentiating Leydig cell tumors from seminoma using qualitative and quantitative features. From February 2011 to December 2013, 31 patients (mean age: 34 years; range: 25 - 52) were recruited for this prospective study. Three of them were monorchid. Therefore, a total of 59 testicles were assessed. All patients underwent grayscale US, color Doppler ultrasound (CDUS), CEUS and orchiectomy. The paired one-tailed Student's t-test was carried out to differentiate between Leydig cell tumors and seminomas. 31 lesions suspicious for malignancy were hypoechoic on grayscale US while they did not show a typical pattern on CDUS. CEUS qualitative analysis, based on contrast enhancement pattern, during the arterial and venous phases, did not allow discrimination of Leydig cell tumors from seminoma. Quantitative analysis of time-intensity curves (TICs) demonstrated that only three parameters presented statistical significance, i. e. wash-in rate (WiR) p = 0.014, peak enhancement (PE) p = 0.001 and time to peak (TTP) p = 0.003. The vascular bed of a Leydig cell tumor is wider and the blood flow velocity is higher than that of a seminoma due to more regular neovascularization. In contrast, a seminoma presents large areas of necrosis due to irregular neovascularization. This explains the different PE and WiR values. Further studies involving larger patient populations are mandatory to confirm these encouraging preliminary results. © Georg Thieme Verlag KG Stuttgart · New York.

  2. Assessment of thromboprophylaxis in medical patients hospitalized in Andalusia. A multicenter study.

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    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.

  3. 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.

  4. Antecedents of organizational citizenship behavior among Iranian nurses: a multicenter study.

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    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

  5. Appropriateness guidelines and predictive rules to select patients for upper endoscopy: a nationwide multicenter study.

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    Buri, Luigi; Hassan, Cesare; Bersani, Gianluca; Anti, Marcello; Bianco, Maria Antonietta; Cipolletta, Livio; Di Giulio, Emilio; Di Matteo, Giovanni; Familiari, Luigi; Ficano, Leonardo; Loriga, Pietro; Morini, Sergio; Pietropaolo, Vincenzo; Zambelli, Alessandro; Grossi, Enzo; Intraligi, Marco; Buscema, Massimo

    2010-06-01

    Selecting patients appropriately for upper endoscopy (EGD) is crucial for efficient use of endoscopy. The objective of this study was to compare different clinical strategies and statistical methods to select patients for EGD, namely appropriateness guidelines, age and/or alarm features, and multivariate and artificial neural network (ANN) models. A nationwide, multicenter, prospective study was undertaken in which consecutive patients referred for EGD during a 1-month period were enrolled. Before EGD, the endoscopist assessed referral appropriateness according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines, also collecting clinical and demographic variables. Outcomes of the study were detection of relevant findings and new diagnosis of malignancy at EGD. The accuracy of the following clinical strategies and predictive rules was compared: (i) ASGE appropriateness guidelines (indicated vs. not indicated), (ii) simplified rule (>or=45 years or alarm features vs. <45 years without alarm features), (iii) logistic regression model, and (iv) ANN models. A total of 8,252 patients were enrolled in 57 centers. Overall, 3,803 (46%) relevant findings and 132 (1.6%) new malignancies were detected. Sensitivity, specificity, and area under the receiver-operating characteristic curve (AUC) of the simplified rule were similar to that of the ASGE guidelines for both relevant findings (82%/26%/0.55 vs. 88%/27%/0.52) and cancer (97%/22%/0.58 vs. 98%/20%/0.58). Both logistic regression and ANN models seemed to be substantially more accurate in predicting new cases of malignancy, with an AUC of 0.82 and 0.87, respectively. A simple predictive rule based on age and alarm features is similarly effective to the more complex ASGE guidelines in selecting patients for EGD. Regression and ANN models may be useful in identifying a relatively small subgroup of patients at higher risk of cancer.

  6. Oral propranolol therapy for infantile hemangiomas beyond the proliferation phase: a multicenter retrospective study.

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    Zvulunov, Alex; McCuaig, Catherine; Frieden, Ilona J; Mancini, Anthony J; Puttgen, Kate B; Dohil, Magdalene; Fischer, Gayle; Powell, Julie; Cohen, Bernard; Ben Amitai, Dan

    2011-01-01

    Pharmacological therapies for infantile hemangiomas were considered effective only during the proliferative phases. Recently reported beneficial effects of propranolol may extend beyond the proliferative phase of infantile hemangiomas. The purpose of the study was to assess the effect of oral propranolol therapy for infantile hemangiomas beyond the proliferative phase of these lesions. Members of the Society for Pediatric Dermatology were invited to participate in a multicenter retrospective study. Only children with infantile hemangiomas with documented cessation of lesions' growth or those older than 12 months of age were eligible for the study. Clinical and demographic information and digital photographs before, at the start, and following the treatment were collected. Scaled panels of photographs were distributed among preselected experienced pediatric dermatologists. Visual analog scale was used to assess photographs for each case. Paired t-test was used for statistical analyses. Data on 49 eligible patients from eight pediatric dermatology centers was collected. Seven cases were excluded because of insufficient photographic documentation. The age of the patients at the start of propranolol therapy ranged 7 to 120 months (mean 28 mos, median 22 mos). The duration of propranolol therapy ranged 1 to 8 months (mean 3.6 mos). The mean visual analog scale score before the treatment was 6.8 ± 2.15, and mean reduction in the visual analog scale score at the assessment was 2.6 ± 1.74 (p < 0.001). The rate of visual analog scale reduction was 0.4 per month before the start of the therapy, while this rate was accelerated to 0.9 per months following the therapy (p < 0.001). No significant side effects were reported. We conclude that propranolol is effective in infantile hemangiomas, including post-proliferative phase, and should be considered as the first-line therapy in that setting.

  7. Clinical evaluation of the use of a multifunctional remotely controlled insulin pump: multicenter observational study.

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    Boizel, Robert; Pinget, Michel; Lachgar, Karim; Parkin, Christopher G; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-11-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system's advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. © 2014 Diabetes Technology Society.

  8. A prospective, multicenter study of pharmacist activities resulting in medication error interception in the emergency department.

    Science.gov (United States)

    Patanwala, Asad E; Sanders, Arthur B; Thomas, Michael C; Acquisto, Nicole M; Weant, Kyle A; Baker, Stephanie N; Merritt, Erica M; Erstad, Brian L

    2012-05-01

    The primary objective of this study is to determine the activities of pharmacists that lead to medication error interception in the emergency department (ED). This was a prospective, multicenter cohort study conducted in 4 geographically diverse academic and community EDs in the United States. Each site had clinical pharmacy services. Pharmacists at each site recorded their medication error interceptions for 250 hours of cumulative time when present in the ED (1,000 hours total for all 4 sites). Items recorded included the activities of the pharmacist that led to medication error interception, type of orders, phase of medication use process, and type of error. Independent evaluators reviewed all medication errors. Descriptive analyses were performed for all variables. A total of 16,446 patients presented to the EDs during the study, resulting in 364 confirmed medication error interceptions by pharmacists. The pharmacists' activities that led to medication error interception were as follows: involvement in consultative activities (n=187; 51.4%), review of medication orders (n=127; 34.9%), and other (n=50; 13.7%). The types of orders resulting in medication error interceptions were written or computerized orders (n=198; 54.4%), verbal orders (n=119; 32.7%), and other (n=47; 12.9%). Most medication error interceptions occurred during the prescribing phase of the medication use process (n=300; 82.4%) and the most common type of error was wrong dose (n=161; 44.2%). Pharmacists' review of written or computerized medication orders accounts for only a third of medication error interceptions. Most medication error interceptions occur during consultative activities. Copyright © 2011. Published by Mosby, Inc.

  9. Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

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    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.

  10. Axial Globe Position Measurement: A Prospective Multicenter Study by the International Thyroid Eye Disease Society.

    Science.gov (United States)

    Bingham, Chad M; Sivak-Callcott, Jennifer A; Gurka, Matthew J; Nguyen, John; Hogg, Jeffery P; Feldon, Steve E; Fay, Aaron; Seah, Lay-Leng; Strianese, Diego; Durairaj, Vikram D; Uddin, Jimmy; Devoto, Martin H; Harris, Matheson; Saunders, Justin; Osaki, Tammy H; Looi, Audrey; Teo, Livia; Davies, Brett W; Elefante, Andrea; Shen, Sunny; Realini, Tony; Fischer, William; Kazim, Michael

    2016-01-01

    Identify a reproducible measure of axial globe position (AGP) for multicenter studies on patients with thyroid eye disease (TED). This is a prospective, international, multicenter, observational study in which 3 types of AGP evaluation were examined: radiologic, clinical, and photographic. In this study, CT was the modality to which all other methods were compared. CT AGP was measured from an orthogonal line between the anterior lateral orbital rims to the cornea. All CT measurements were made at a single institution by 3 individual clinicians. Clinical evaluation was performed with exophthalmometry. Three clinicians from each clinical site assessed AGP with 3 different exophthalmometers and horizontal palpebral width using a ruler. Each physician made 3 separate measurements with each type of exophthalmometer not in succession. All photographic measurements were made at a single institution. AGP was measured from lateral photographs in which a standard marker was placed at the anterior lateral orbital rim. Horizontal and vertical palpebral fissure were measured from frontal photographs. Three trained readers measured 3 separate times not in succession. Exophthalmometry and photography method validity was assessed by agreement with CT (mean differences calculation, intraclass correlation coefficients [ICCs], Bland-Altman figures). Correlation between palpebral fissure and CT AGP was assessed with Pearson correlation. Intraclinician and interclinician reliability was evaluated using ICCs. Sixty-eight patients from 7 centers participated. CT mean AGP was 21.37 mm (15.96-28.90 mm) right and 21.22 mm (15.87-28.70 mm) left (ICC 0.996 and 0.995). Exophthalmometry AGP fell between 18 mm and 25 mm. Intraclinician agreement across exophthalmometers was ideal (ICC 0.948-0.983). Agreement between clinicians was greater than 0.85 for all upright exophthalmometry measurements. Photographic mean AGP was 20.47 mm (10.92-30.88 mm) right and 20.30 mm (8.61-28.72

  11. A multicenter, double-blind, randomized, placebo-controlled comparison of nocturnal roxatidine in the treatment of active duodenal ulcer disease. Multicenter Roxatidine Cooperative Study Group.

    Science.gov (United States)

    Gilinsky, N H; Bright-Asare, P; Cobert, B L; Fitch, D D; Lanza, F L; Kerr, R M; Savitsky, J P

    1992-07-01

    This multicenter randomized, double-blind, 4-wk study compared the new H2-receptor antagonistic roxatidine (R) to placebo (P) for treatment of endoscopically diagnosed active duodenal ulcer disease. Subjects were evaluated after 2 and 4 wk of treatment. Those whose ulcer was unhealed at 2 wk received 2 more weeks of treatment before final evaluation. Ulcer healing (endoscopically determined) with roxatidine was more effective than placebo at both wk 0-2 (R = 33.9%, P = 21.9%, p = 0.018) and wk 2-4 (R = 68.2%, P = 29.7%, p less than 0.001), with an overall 4-wk effectiveness of 78.9% compared to 44.8% (p less than 0.001). At the end of treatment, average maximum ulcer diameter diminished 83% in R and 50% in P (p less than 0.001). Roxatidine was also more effective than placebo in decreasing abdominal pain (p less than 0.001), decreasing the number of antacid tablets taken for pain relief (p less than 0.001), improving dyspeptic symptoms (p less than 0.001), and permitting return to a normal routine for subjects with previous illness-imposed restrictions on work and/or other daily activities. The profile of laboratory values and adverse experiences demonstrated roxatidine to be safe and well-tolerated. The efficacy of roxatidine as evaluated by the healing rate of duodenal ulcer and reduction in abdominal pain emphasize its value as an addition to the family of H2-receptor antagonists.

  12. Inflammatory arthritis in patients with myelodysplastic syndromes: a multicenter retrospective study and literature review of 68 cases.

    Science.gov (United States)

    Mekinian, Arsène; Braun, Thorsten; Decaux, Olivier; Falgarone, Géraldine; Toussirot, Eric; Raffray, Loic; Omouri, Mohamed; Gombert, Bruno; De Wazieres, Benoit; Buchdaul, Anne-Laure; Ziza, Jean-Marc; Launay, David; Denis, Guillaume; Madaule, Serge; Rose, Christian; Grignano, Eric; Fenaux, Pierre; Fain, Olivier

    2014-01-01

    We describe the characteristics and outcome of inflammatory arthritis in patients with myelodysplastic syndrome (MDS) in a French multicenter retrospective study. Twenty-two patients with MDS (median age, 77.5 yr [interquartile range, 69-81]; 10 women) were included. Inflammatory arthritis presented as polyarthritis in 17 cases (77%) and with symmetric involvement in 15 cases (68%). At diagnosis, the median disease activity score 28 based on C-reactive protein (DAS28-CRP) was 4.5 [2-6.5]. Two patients had anti-citrullinated protein antibodies (ACPAs), and 1 had radiologic erosions. The median time between the diagnoses of arthritis and MDS was 10 months [6-42], with a median articular symptom duration of 3 months [2-8]. The diagnosis of both diseases was concomitant in 6 cases (27%); arthritis preceded MDS in 12 cases (55%), and occurred after MDS in 4 (18%). While the number of swollen and tender joints significantly decreased during follow-up, as did the median DAS28-CRP (from 4.3 [3.8-4.6] at baseline to 2.9 [1.75-3.3]; p 20 mg/L) in 8 patients (42%). Nevertheless, radiographic progression and new ACPA positivity were not observed during a median follow-up of 29 months [9-76]. While most of the patients were treated with steroids (n = 16) for arthritis, additional treatment was administered in only 4 patients (hydroxychloroquine, n = 2; sulfasalazine [Salazopyrin] and etanercept, n = 1, respectively). Eleven patients died during follow-up from acute myeloid leukemia (n = 5); infections (n = 3); or cerebral bleeding, cardiorespiratory failure, or undetermined cause (n = 1, respectively). Inflammatory arthritis associated with MDS can have various presentations and is often seronegative and nonerosive. Steroids alone are the most common treatment in MDS-associated arthritis, but that treatment is insufficient to control arthritis. Steroid-sparing strategies need to be identified.

  13. Capturing patients' experiences to change Parkinson's disease care delivery: a multicenter study.

    Science.gov (United States)

    van der Eijk, Martijn; Faber, Marjan J; Post, Bart; Okun, Michael S; Schmidt, Peter; Munneke, Marten; Bloem, Bastiaan R

    2015-11-01

    Capturing patients' perspectives has become an essential part of a quality of care assessment. The patient centeredness questionnaire for PD (PCQ-PD) has been validated in The Netherlands as an instrument to measure patients' experiences. This study aims to assess the level of patient centeredness in North American Parkinson centers and to demonstrate the PCQ-PD's potential as a quality improvement instrument. 20 Parkinson Centers of Excellence participated in a multicenter study. Each center asked 50 consecutive patients to complete the questionnaire. Data analyses included calculating case mix-adjusted scores for overall patient centeredness (scoring range 0-3), six subscales (0-3), and quality improvement (0-9). Each center received a feedback report on their performance. The PCQ-PD was completed by 972 PD patients (median 50 per center, range 37-58). Significant differences between centers were found for all subscales, except for emotional support (p < 0.05). The information subscale (mean 1.62 SD 0.62) and collaboration subscale (mean 2.03 SD 0.58) received the lowest experience ratings. 14 centers (88 %) who returned the evaluation survey claimed that patient experience scores could help to improve the quality of care. Nine centers (56 %) utilized the feedback to change specific elements of their care delivery process. PD patients are under-informed about critical care issues and experience a lack of collaboration between healthcare professionals. Feedback on patients' experiences facilitated Parkinson centers to improve their delivery of care. These findings create a basis for collecting patients' experiences in a repetitive fashion, intertwined with existing quality of care registries.

  14. Long-term outcomes in primary spinal osteochondroma: a multicenter study of 27 patients

    Science.gov (United States)

    Sciubba, Daniel M.; Macki, Mohamed; Bydon, Mohamad; Germscheid, Niccole M.; Wolinsky, Jean-Paul; Boriani, Stefano; Bettegowda, Chetan; Chou, Dean; Luzzati, Alessandro; Reynolds, Jeremy J.; Szövérfi, Zsolt; Zadnik, Patti; Rhines, Laurence D.; Gokaslan, Ziya L.; Fisher, Charles G.; Varga, Peter Paul

    2016-01-01

    OBJECT Clinical outcomes in patients with primary spinal osteochondromas are limited to small series and sporadic case reports. The authors present data on the first long-term investigation of spinal osteochondroma cases. METHODS An international, multicenter ambispective study on primary spinal osteochondroma was performed. Patients were included if they were diagnosed with an osteochondroma of the spine and received surgical treatment between October 1996 and June 2012 with at least 1 follow-up. Perioperative prognostic variables, including patient age, tumor size, spinal level, and resection, were analyzed in reference to long-term local recurrence and survival. Tumor resections were compared using Enneking appropriate (EA) or Enneking inappropriate surgical margins. RESULTS Osteochondromas were diagnosed in 27 patients at an average age of 37 years. Twenty-two lesions were found in the mobile spine (cervical, thoracic, or lumbar) and 5 in the fixed spine (sacrum). Twenty-three cases (88%) were benign tumors (Enneking tumor Stages 1–3), whereas 3 (12%) exhibited malignant changes (Enneking tumor Stages IA–IIB). Sixteen patients (62%) underwent en bloc treatment—that is, wide or marginal resection—and 10 (38%) underwent intralesional resection. Twenty-four operations (92%) followed EA margins. No one received adjuvant therapy. Two patients (8%) experienced recurrences: one in the fixed spine and one in the mobile spine. Both recurrences occurred in latent Stage 1 tumors following en bloc resection. No osteochondroma-related deaths were observed. CONCLUSIONS In the present study, most patients underwent en bloc resection and were treated as EA cases. Both recurrences occurred in the Stage 1 tumor cohort. Therefore, although benign in character, osteochondromas still require careful management and thorough follow-up. PMID:25793467

  15. Reference equations for the six-minute walk distance based on a Brazilian multicenter study.

    Science.gov (United States)

    Britto, Raquel R; Probst, Vanessa S; de Andrade, Armele F Dornelas; Samora, Giane A R; Hernandes, Nidia A; Marinho, Patrícia E M; Karsten, Marlus; Pitta, Fabio; Parreira, Veronica F

    2013-01-01

    It is important to include large sample sizes and different factors that influence the six-minute walking distance (6MWD) in order to propose reference equations for the six-minute walking test (6 MWT). To evaluate the influence of anthropometric, demographic, and physiologic variables on the 6 MWD of healthy subjects from different regions of Brazil to establish a reference equation for the Brazilian population. In a multicenter study, 617 healthy subjects performed two 6 MWTs and had their weight, height, and body mass index (BMI) measured, as well as their physiologic responses to the test. Delta heart rate (∆HR), perceived effort, and peripheral oxygen saturation were calculated by the difference between the respective values at the end of the test minus the baseline value. Walking distance averaged 586 ± 106 m, 54 m greater in male compared to female subjects (p<0.001). No differences were observed among the 6 MWD from different regions. The quadratic regression analysis considering only anthropometric and demographic data explained 46% of the variability in the 6 MWT (p<0.001) and derived the equation: 6 MWD(pred)=890.46-(6.11 × age)+(0.0345 × age(2))+(48.87 × gender)-(4.87 × BMI). A second model of stepwise multiple regression including ∆HR explained 62% of the variability (p<0.0001) and derived the equation: 6 MWD(pred)=356.658-(2.303 × age)+(36.648 × gender)+(1.704 × height)+(1.365×∆HR). The equations proposed in this study, especially the second one, seem adequate to accurately predict the 6 MWD for Brazilians.

  16. 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 Latarjet procedure is recommended for these patients, after control of addiction, and provides 95% satisfaction at midterm follow-up. © 2016 The Author(s).

  17. Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.

    Science.gov (United States)

    Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li'an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

    2016-03-01

    A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box-Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China.

  18. One-step surgical placement of Brånemark implants: a prospective multicenter clinical study.

    Science.gov (United States)

    Becker, W; Becker, B E; Israelson, H; Lucchini, J P; Handelsman, M; Ammons, W; Rosenberg, E; Rose, L; Tucker, L M; Lekholm, U

    1997-01-01

    This prospective longitudinal multicenter study evaluated the clinical outcomes after placement and restoration of one-step Brånemark implants into the maxillae and mandibles of completely and partially edentulous patients. Six surgical treatment centers participated in this study, in which 135 implants were placed into 63 adult patients. All implants were stable after placement. The majority of implants were placed into type B bone with minimal jaw resorption and type 2 bone quality. After implant placement, standard transmucosal healing abutments were firmly placed. The average amount of time between implant placement and prosthetic abutment connection was 170 days in the maxillae and 147 days in the mandibles. To evaluate crestal bone changes caused by implant placement, a periodontal probe was used to measure midbuccally from the top of the implant cylinder to the alveolar crest; in 29 patients, 54 midbuccal bone crest sites were remeasured following prosthetic abutment connection. Crestal bone changes in mandibles and maxillae were statistically and clinically insignificant. Six implants were lost prior to loading and one implant has not been restored. No implants or restorations were lost after loading. At 1 year, the implant success rate was 95.6%. Mesiodistal radiographic measurements from 34 patients were averaged, and changes from prosthetic abutment connection to, on average, 12 months follow-up were compared. The radiographs, which were digitalized, measured from the bottom of the implant cylinder to the most coronal bone in contact with implant thread. For mandibular implants, the mean radiographic bone level at prosthetic abutment connection was 1.07 mm; after loading, it was 1.35 mm. For maxillary implants, the mean radiographic bone height at prosthetic abutment connection was 1.16 mm; after loading, it was 1.36 mm. These changes were not statistically significant. The 1-year outcomes from this patient series indicate that one-step Br

  19. Contrast-induced nephropathy in patients undergoing computed tomography (CONNECT) - a clinical problem in daily practice? A multicenter observational study

    Energy Technology Data Exchange (ETDEWEB)

    Lencioni, Riccardo (Div. of Diagnostic Imaging and Intervention, Dept. of Liver Transplantation, Hepatology, Pisa Univ. Hospital, Pisa (Italy)), e-mail: lencioni@med.unipi.it; Fattori, Rossella (Dept. of Radiology-Cardiovascular Unit, Univ. Hospital S. Orsola, Bologna (Italy)); Morana, Giovanni (Dept. of Radiology, General Hospital ' Ca' Foncello' , Treviso (Italy)); Stacul, Fulvio (Dept. of Radiology, Univ. Hospital of Trieste, Ospedale Maggiore, Trieste (Italy))

    2010-09-15

    Background: Although several studies have examined contrast-induced nephropathy (CIN) following computed tomography (CT) procedures under closely controlled clinical trial conditions, less is known about the incidence of CIN (or its key predictive factors) in a 'real world' clinical setting. Purpose: A multicenter, observational registry study was undertaken in Italian hospital radiology departments to retrospectively assess the incidence of CIN in at-risk patients undergoing iodixanol-enhanced CT procedures. Material and Methods: Each department used center-specific (non standardized) CT protocols. Data were available from 493 at-risk patients; most (76.4%) had 1 risk factor for CIN, 19.8% had 2, and 3.4% had 3. In all, 169 patients (34.3%) had reduced renal function (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73m2). Prophylactic volume expansion was not used in 70.6% of the study population. Results: The overall incidence of CIN (defined as a =44.2 mumol/l [0.5 mg/dl] increase in serum creatinine from baseline 72 h post procedure) was 2.6%; in the subpopulation of patients with renal impairment (with or without other risk factors), CIN incidence was 4.7%. Multivariate analysis identified renal insufficiency as the only risk factor predictive of CIN (relative risk, 3.850; 95% confidence interval, 1.200-12.348; P=0.023). Conclusion: In the clinical setting of hospital CT radiology practice, where guideline-recommended strategies for CIN prevention may not be consistently followed, use of the iso-osmolar agent iodixanol appears to be associated with a low incidence of CIN in at-risk patients. Keywords CT, intravenous contrast agents, kidney, vascular

  20. Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT Study.

    Directory of Open Access Journals (Sweden)

    Sara E Moore

    Full Text Available Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated. We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating

  1. Late outcomes after acute pulmonary embolism: rationale and design of FOCUS, a prospective observational multicenter cohort study.

    Science.gov (United States)

    Konstantinides, Stavros V; Barco, Stefano; Rosenkranz, Stephan; Lankeit, Mareike; Held, Matthias; Gerhardt, Felix; Bruch, Leonard; Ewert, Ralf; Faehling, Martin; Freise, Julia; Ghofrani, Hossein-Ardeschir; Grünig, Ekkehard; Halank, Michael; Heydenreich, Nadine; Hoeper, Marius M; Leuchte, Hanno H; Mayer, Eckhard; Meyer, F Joachim; Neurohr, Claus; Opitz, Christian; Pinto, Antonio; Seyfarth, Hans-Jürgen; Wachter, Rolf; Zäpf, Bianca; Wilkens, Heinrike; Binder, Harald; Wild, Philipp S

    2016-11-01

    Acute pulmonary embolism (PE) is a frequent cause of death and serious disability. The risk of PE-associated mortality and morbidity extends far beyond the acute phase of the disease. In earlier follow-up studies, as many as 30 % of the patients died during a follow-up period of up to 3 years, and up to 50 % of patients continued to complain of dyspnea and/or poor physical performance 6 months to 3 years after the index event. The most feared 'late sequela' of PE is chronic thromboembolic pulmonary hypertension (CTEPH), the true incidence of which remains obscure due to the large margin of error in the rates reported by mostly small, single-center studies. Moreover, the functional and hemodynamic changes corresponding to early, possibly reversible stages of CTEPH, have not been systematically investigated. The ongoing Follow-Up after acute pulmonary embolism (FOCUS) study will prospectively enroll and systematically follow, over a 2-year period and with a standardized comprehensive program of clinical, echocardiographic, functional and laboratory testing, a large multicenter prospective cohort of 1000 unselected patients (all-comers) with acute symptomatic PE. FOCUS will possess adequate power to provide answers to relevant remaining questions regarding the patients' long-term morbidity and mortality, and the temporal pattern of post-PE abnormalities. It will hopefully provide evidence for future guideline recommendations regarding the selection of patients for long-term follow-up after PE, the modalities which this follow-up should include, and the findings that should be interpreted as indicating progressive functional and hemodynamic post-PE impairment, or the development of CTEPH.

  2. Levels of protein C and soluble thrombomodulin in critically ill patients with acute kidney injury: a multicenter prospective observational study.

    Directory of Open Access Journals (Sweden)

    Josée Bouchard

    Full Text Available Endothelial dysfunction contributes to the development of acute kidney injury (AKI in animal models of ischemia reperfusion injury and sepsis. There are limited data on markers of endothelial dysfunction in human AKI. We hypothesized that Protein C (PC and soluble thrombomodulin (sTM levels could predict AKI. We conducted a multicenter prospective study in 80 patients to assess the relationship of PC and sTM levels to AKI, defined by the AKIN creatinine (AKI Scr and urine output criteria (AKI UO. We measured marker levels for up to 10 days from intensive care unit admission. We used area under the curve (AUC and time-dependent multivariable Cox proportional hazard model to predict AKI and logistic regression to predict mortality/non-renal recovery. Protein C and sTM were not different in patients with AKI UO only versus no AKI. On intensive care unit admission, as PC levels are usually lower with AKI Scr, the AUC to predict the absence of AKI was 0.63 (95%CI 0.44-0.78. The AUC using log10 sTM levels to predict AKI was 0.77 (95%CI 0.62-0.89, which predicted AKI Scr better than serum and urine neutrophil gelatinase-associated lipocalin (NGAL and cystatin C, urine kidney injury molecule-1 and liver-fatty acid-binding protein. In multivariable models, PC and urine NGAL levels independently predicted AKI (p=0.04 and 0.02 and PC levels independently predicted mortality/non-renal recovery (p=0.04. In our study, PC and sTM levels can predict AKI Scr but are not modified during AKI UO alone. PC levels could independently predict mortality/non-renal recovery. Additional larger studies are needed to define the relationship between markers of endothelial dysfunction and AKI.

  3. [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.

  4. 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

  5. Osteosarcoma of the spine: prognostic variables for local recurrence and overall survival, a multicenter ambispective study.

    Science.gov (United States)

    Dekutoski, Mark B; Clarke, Michelle J; Rose, Peter; Luzzati, Alessandro; Rhines, Laurence D; Varga, Peter P; Fisher, Charles G; Chou, Dean; Fehlings, Michael G; Reynolds, Jeremy J; Williams, Richard; Quraishi, Nasir A; Germscheid, Niccole M; Sciubba, Daniel M; Gokaslan, Ziya L; Boriani, Stefano

    2016-07-01

    OBJECTIVE Primary spinal osteosarcomas are rare and aggressive neoplasms. Poor outcomes can occur, as obtaining marginal margins is technically demanding; further Enneking-appropriate en bloc resection can have significant morbidity. The goal of this study is to identify prognostic variables for local recurrence and mortality in surgically treated patients diagnosed with a primary osteosarcoma of the spine. METHODS A multicenter ambispective database of surgically treated patients with primary spine osteosarcomas was developed by AOSpine Knowledge Forum Tumor. Patient demographic, diagnosis, treatment, perioperative morbidity, local recurrence, and cross-sectional survival data were collected. Tumors were classified in 2 cohorts: Enneking appropriate (EA) and Enneking inappropriate (EI), as defined by pathology margin matching Enneking-recommended surgical margins. Prognostic variables were analyzed in reference to local recurrence and survival. RESULTS Between 1987 and 2012, 58 patients (32 female patients) underwent surgical treatment for primary spinal osteosarcoma. Patients were followed for a mean period of 3.5 ± 3.5 years (range 0.5 days to 14.3 years). The median survival for the entire cohort was 6.7 years postoperative. Twenty-four (41%) patients died, and 17 (30%) patients suffered a local recurrence, 10 (59%) of whom died. Twenty-nine (53%) patients underwent EA resection while 26 (47%) patients underwent EI resection with a postoperative median survival of 6.8 and 3.7 years, respectively (p = 0.048). EI patients had a higher rate of local recurrence than EA patients (p = 0.001). Patient age, previous surgery, biopsy type, tumor size, spine level, and chemotherapy timing did not significantly influence recurrence and survival. CONCLUSIONS Osteosarcoma of the spine presents a significant challenge, and most patients die in spite of aggressive surgery. There is a significant decrease in recurrence and an increase in survival with en bloc resection (EA

  6. 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.

  7. 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.

  8. Survey on the Treatment of Postherpetic Neuralgia in Korea; Multicenter Study of 1,414 Patients

    Science.gov (United States)

    Nahm, Francis Sahngun; Kim, Sang Hun; Kim, Hong Soon; Shin, Jin Woo; Yoo, Sie Hyeon; Yoon, Myung Ha; Lee, Doo Ik; Lee, Youn Woo; Lee, Jun Hak; Jeon, Young Hoon

    2013-01-01

    Background Postherpetic neuralgia (PHN) is a serious complication resulting from herpes zoster infections, and it can impair the quality of life. In order to relieve pain from PHN, various treatments, including pharmacological and interventional methods have been used. However, little information on the recommendations for the interventional treatment of PHN, along with a lack of nation-wide surveys on the current status of PHN treatment exists. This multicenter study is the first survey on the treatment status of PHN in Korea. Methods Retrospective chart reviews were conducted on the entire patients who visited the pain clinics of 11 teaching hospitals from January to December of 2011. Co-morbid disease, affected site of PHN, routes to pain clinic visits, parenteral/topical medications for treatment, drugs used for nerve block, types and frequency of nerve blocks were investigated. Results A total of 1,414 patients' medical records were reviewed. The most commonly affected site was the thoracic area. The anticonvulsants and interlaminar epidural blocks were the most frequently used pharmacological and interventional methods for PHN treatment. For the interval of epidural block, intervals of 5 or more-weeks were the most popular. The proportion of PHN patients who get information from the mass media or the internet was only 0.8%.The incidence of suspected zoster sine herpete was only 0.1%. Conclusions The treatment methods for PHN vary among hospitals. The establishment of treatment recommendation for PHN treatment is necessary. In addition, public relations activities are required in order to inform the patients of PHN treatments by pain clinicians. PMID:23342203

  9. Influence of socioeconomic status on community-acquired pneumonia outcomes in elderly patients requiring hospitalization: a multicenter observational study

    Directory of Open Access Journals (Sweden)

    Carratalà Jordi

    2010-07-01

    Full Text Available Abstract Background The associations between socioeconomic status and community-acquired pneumonia outcomes in adults have been studied although studies did not always document a relationship. The aim of this multicenter observational study was to determine the association between socioeconomic status and community-acquired pneumonia outcomes in the elderly, in the context of a public health system providing universal free care to the whole population. Methods A total of 651 patients aged ≥65 years hospitalized due to community-acquired pneumonia through the emergency departments of five Spanish public hospitals were recruited and followed up between May 2005 and January 2007. The primary outcomes studied were: length of stay, intensive care unit admission, overall mortality and readmission. Socioeconomic status was measured using both individual and community data: occupation [categorized in six social groups (I, II, III, IVa, IVb and V], educational level (≤ primary level or ≥ secondary level and disposable family income of the municipality or district of residence [>12,500 € (high municipality family income and ≤12,500 € (low municipality family income]. The six social groups were further categorized as upper/middle social class (groups I-IVb and lower class (group V. Bivariate and multivariate analyses were performed. OR and their 95% confidence intervals were calculated. All statistical tests were two tailed and statistical significance was established as p Results 17.7% of patients lived in a municipality or district with a high municipality family income and 63.6% were upper/middle social class (I-IVb. Only 15.7% of patients had a secondary education. The adjusted analysis showed no association between pneumonia outcomes and social class, educational level or municipality family income. However, length of stay increased significantly in patients in whom the factors, living alone and being a smoker or ex-smoker coincided (p

  10. Infections in travellers returning to Turkey from the Arabian peninsula: a retrospective cross-sectional multicenter study.

    Science.gov (United States)

    Erdem, H; Ak, O; Elaldi, N; Demirdal, T; Hargreaves, S; Nemli, S A; Cag, Y; Ulug, M; Naz, H; Gunal, O; Sirmatel, F; Sipahi, O R; Alpat, S N; Ertem-Tuncer, G; Sozen, H; Evlice, O; Meric-Koc, M; Dogru, A; Koksaldi-Motor, V; Tekin, R; Ozdemir, D; Ozturk-Engin, D; Savasci, U; Karagoz, E; Cekli, Y; Inan, A

    2016-06-01

    Mass gatherings pooling people from different parts of the world-the largest of which is to Mecca, Saudi Arabia, for Hajj-may impose risks for acquisition and dissemination of infectious diseases. A substantial number of pilgrims to Hajj and Umrah are Turkish citizens (456,000 in 2014) but data are lacking on scale of the problem. We did a retrospective cross-sectional multicenter study in Turkey to explore the range of infections among inpatients who had recently returned from the Arabian Peninsula. Our inclusion criteria were patients who had acquired an infection during their trip to an Arabian Peninsula country, or who became symptomatic within 1 week of their return. The data were collected retrospectively for January 1, 2013 and March 1, 2015. 185 Turkish patients were recruited to the study across 15 referral centers with travel associated infectious diseases after returning from Arabian Peninsula countries (predominantly Saudi Arabia 163 [88.1 %] for religious purposes 162 [87.5 %]). Seventy four (40.0 %) of them were ≥ 65 years old with numerous comorbidities including diabetes (24.3 %) and COPD (14.1 %). The most common clinical diagnosis was respiratory tract infections (169 [91.5 %]), followed by diarrheal diseases (13 [7 %]), and there was one case of MERS-CoV. Patients spent a median of 5 (3-7) days as hospital inpatients and overall mortality was 1.1 %. Returning travellers from the Arabian Peninsula present as inpatients with a broad range of infectious diseases similar to common community acquired infections frequently seen in daily medical practices in Turkey.

  11. C-reactive protein, an early marker of community-acquired sepsis resolution: a multi-center prospective observational study.

    Science.gov (United States)

    Póvoa, Pedro; Teixeira-Pinto, Armando M; Carneiro, António H

    2011-07-15

    C-reactive protein (CRP) has been shown to be a valuable marker in the diagnosis of infection and in monitoring its response to antibiotics. Our objective was to evaluate serial CRP measurements after prescription of antibiotics to describe the clinical course of Community-Acquired Sepsis admitted to intensive care units (ICU). During a 12-month period a multi-center, prospective, observational study was conducted, segregating adults with Community-Acquired Sepsis. Patients were followed-up during the first five ICU days, day of ICU discharge or death and hospital outcome. CRP-ratio was calculated in relation to Day 1 CRP concentration. Patients were classified according to the pattern of CRP-ratio response to antibiotics: fast response if Day 5 CRP-ratio was 0.8. Comparison between survivors and non-survivors was performed. A total of 891 patients (age 60 ± 17 yrs, hospital mortality 38%) were studied. There were no significant differences between the CRP of survivors and non-survivors until Day 2 of antibiotic therapy. On the following three days, CRP of survivors was significantly lower (P patterns was 23%, 30% and 41%, respectively (P = 0.001). No responders had a significant increase on the odds of death (OR = 2.5, CI95% = (1.6, 4.0), P prescription were useful as early as Day 3 in identification of Community-Acquired Sepsis patients with poor outcome. The rate of CRP decline during the first five ICU days was markedly associated with prognosis. The identification of the pattern of CRP-ratio response was useful in the recognition of the individual clinical course.

  12. Study Design of the Microcirculatory Shock Occurrence in Acutely Ill Patients (microSOAP: an International Multicenter Observational Study of Sublingual Microcirculatory Alterations in Intensive Care Patients

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    Namkje A. R. Vellinga

    2012-01-01

    Full Text Available Objective. Sublingual microcirculatory alterations are associated with an adverse prognosis in several critical illness subgroups. Up to now, single-center studies have reported on sublingual microcirculatory alterations in ICU patient subgroups, but an extensive evaluation of the prevalence of these alterations is lacking. We present the study design of an international multicenter observational study to investigate the prevalence of microcirculatory alterations in critically ill: the Microcirculatory Shock Occurrence in Acutely ill Patients (microSOAP. Methods. 36 ICU’s worldwide have participated in this study aiming for inclusion of over 500 evaluable patients. To enable communication and data collection, a website, an Open Clinica 3.0 database, and image uploading software have been designed. A one-session assessment of the sublingual microcirculation using Sidestream Dark Field imaging and data collection on patient characteristics has been performed in every ICU patient >18 years, regardless of underlying disease. Statistical analysis will provide insight in the prevalence and severity of sublingual alterations, its relation to systemic hemodynamic variables, disease, therapy, and outcome. Conclusion. This study will be the largest microcirculation study ever performed. It is expected that this study will also establish a basis for future studies related to the microcirculation in critically ill.

  13. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine

    OpenAIRE

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D.; Zava, Dario; Pinessi, Lorenzo

    2010-01-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1–3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment pe...

  14. Cytokine signaling pathway polymorphisms and AIDS-related non-Hodgkin lymphoma risk in the Multicenter AIDS Cohort Study

    Science.gov (United States)

    Wong, Hui-Lee; Breen, Elizabeth C.; Pfeiffer, Ruth M.; Aissani, Brahim; Martinson, Jeremy J.; Margolick, Joseph B.; Kaslow, Richard A.; Jacobson, Lisa P.; Ambinder, Richard F.; Chanock, Stephen; Martínez-Maza, Otoniel; Rabkin, Charles S.

    2014-01-01

    Cytokine stimulation of B-cell proliferation may be an important etiologic mechanism for acquired immunodeficiency syndrome (AIDS)-related non-Hodgkin lymphoma (NHL). The Epstein-Barr virus may be a co-factor, particularly for primary central nervous system (CNS) tumors, which are uniformly EBV-positive in the setting of AIDS. Thus, we examined associations of genetic variation in IL10 and related cytokine signaling molecules (IL10RA, CXCL12, IL13, IL4, IL4R, CCL5 and BCL6) with AIDS-related NHL risk and evaluated differences between primary CNS and systemic tumors. We compared 160 Multicenter AIDS Cohort Study (MACS) participants with incident lymphomas, of which 90 followed another AIDS diagnosis, to HIV-1-seropositive controls matched on duration of lymphoma-free survival post-HIV-1 infection (N=160) or post-AIDS diagnosis (N=90). We fit conditional logistic regression models to estimate odds ratios (ORs) and 95 percent confidence intervals (95%CIs). Carriage of at least one copy of the T allele for the IL10 rs1800871 (as compared to no copies) was associated with decreased AIDS-NHL risk specific to lymphomas arising from the CNS (CC vs. CT/TT: OR=0.3; 95%CI: 0.1, 0.7) but not systemically (CC vs. CT/TT: OR=1.0; 95%CI: 0.5, 1.9) (Pheterogeneity=0.03). Carriage of two copies of the “low IL10” haplotype rs1800896_A/rs1800871_T/rs1800872_A was associated with decreased lymphoma risk that varied by number of copies (Ptrend=0.02). None of the ORs for the other studied polymorphisms was significantly different from 1.0. Excessive IL10 response to HIV-1 infection may be associated with increased risk of NHL, particularly in the CNS. IL10 dysregulation may be an important etiologic pathway for EBV-related lymphomagenesis. PMID:20299965

  15. 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

  16. A feasibility dosimetric study on prostate cancer. Are we ready for a multicenter clinical trial on SBRT?

    Energy Technology Data Exchange (ETDEWEB)

    Marino, Carmelo; Bonanno, Elisa [Humanitas C.C.O., Catania (Italy); Villaggi, Elena [AUSL, Piacenza (Italy); Maggi, Giulia; Mancosu, Pietro [IRCCS Humanitas Clinical Research Center, Milan (Italy); Esposito, Marco [Azienda Sanitaria Firenze (Italy); Strigari, Lidia [Regina Elena National Cancer Institute, Rome (Italy). Lab. of Medical Physics and Expert Systems; Borzi, Giusi R. [REM Radioterapia, Catania (Italy); Carbonini, Claudia [A.O. Ospedale Niguarda Ca' Granda, Milan (Italy); Consorti, Rita [ACO S. Filippo Neri, Rome (Italy); Fedele, David [Casa di Cura Privata San Rossore s.r.l., Pisa (Italy); Fiandra, Christian [Torino Univ. (Italy). Radiation Oncology Unit; Ielo, Isidora [A.O.U. Policlinico G. Martino, Messina (Italy); Malatesta, Tiziana [' ' S. Giovanni Calibita' ' Fatebenefratelli, Rome (Italy); Malisan, Maria Rosa [Azienda Ospedaliero-Universitaria di Udine (Italy); Martinotti, Anna [Centro Diagnostico Italiano, Milan (Italy); Moretti, Renzo [Az. Ospedaliera Spedali Civili di Brescia (Italy); Nardiello, Barbara [UPMC San Pietro FBF, Rome (Italy); Oliviero, Caterina; Clemente, Stefania [IRCCS CROB Rieonero in Vulture, Potenza (Italy)

    2015-07-15

    The Italian Association of Medical Physics (AIFM) started a working group dedicated to stereotactic body radiotherapy (SBRT) treatment. In this work, we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals. Fourteen centers were provided the contours of 5 patients. Plans were performed following the dose prescription and constraints for organs at risk (OARs) of a reference paper. The dose prescription was 35 Gy in five fractions for the planning target volume (PTV). Different techniques were used (3D-CRT, fixed-Field IMRT, VMAT, CyberKnife). Plans were compared in terms of dose-volume histogram (DVH) parameters. Furthermore, the median DVH was calculated and one patient was re-planned. A total of 70 plans were compared. The maximum dose to the body was 107.9 ± 4.5 % (range 101.5-116.3 %). Dose at 98 % (D{sub 98} {sub %}) and mean dose to the clinical target volume (CTV) were 102.0 ± 0.9 % (global range 101.1-102.9 %) and 105.1 ± 0.6 % (range 98.6-124.6 %). Similar trends were found for D{sub 95} {sub %} and mean dose to the PTV. Important differences were found in terms of the homogeneity index. Doses to OARs were heterogeneous. The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group. In the re-optimized plans, DVH differences among institutes were reduced and OAR sparing improved. Important dosimetric differences with possible clinical implications, in particular related to OARs, were found. Replanning allowed a reduction in the OAR dose and decreased standard deviations. Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure. (orig.) [German] Der italienische Verband der Medizinphysiker (AIFM) hat eine Arbeitsgruppe gegruendet, die sich mit der Koerperstammstereotaxie (SBRT) befasst. Im Rahmen

  17. The costs in provision of haemodialysis in a developing country: A multi-centered study

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    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.

  18. An international multicenter study on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing.

    Science.gov (United States)

    Simen, Birgitte B; Braverman, Michael S; Abbate, Isabella; Aerssens, Jeroen; Bidet, Yannick; Bouchez, Olivier; Gabriel, Christian; Izopet, Jacques; Kessler, Harald H; Stelzl, Evelyn; Di Giallonardo, Francesca; Schlapbach, Ralph; Radonic, Aleksander; Paredes, Roger; Recordon-Pinson, Patricia; Sakwa, James; St John, Elizabeth P; Schmitz-Agheguian, Gudrun G; Metzner, Karin J; Däumer, Martin P

    2014-08-01

    The detection of mutant spectra within the viral quasispecies is critical for therapeutic management of HIV-1 infections. Routine clinical application of ultrasensitive genotyping requires reproducibility and concordance within and between laboratories. The goal of the study was to evaluate a new protocol on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing (454-UDS) in an international multicenter study. Sixteen blinded HIV-1 subtype B samples were provided for 454-UDS as both RNA and cDNA with viral titers of 88,600-573,000 HIV-1 RNA copies/ml. Eight overlapping amplicons spanning protease (PR) codons 10-99 and reverse transcriptase (RT) codons 1-251 were generated using molecular barcoded primers. 454-UDS was performed using the 454 Life Sciences/Roche GS FLX platform. PR and RT sequences were analyzed using 454 Life Sciences Amplicon Variant Analyzer (AVA) software. Quantified variation data were analyzed for intra-laboratory reproducibility and inter-laboratory concordance. Routine population sequencing was performed using the ViroSeq HIV-1 genotyping system. Eleven laboratories and the reference laboratory 454 Life Sciences sequenced the HIV-1 sample set. Data presented are derived from seven laboratories and the reference laboratory since severe study protocol execution errors occurred in four laboratories leading to exclusion. The median sequencing depth across all sites was 1364 reads per position (IQR=809-2065). 100% of the ViroSeq-reported mutations were also detected by 454-UDS. Minority HIV-1 drug resistance mutations, defined as HIV-1 drug resistance mutations identified at frequencies of 1-25%, were only detected by 454-UDS. Analysis of 10 preselected majority and minority mutations were consistently found across sites. The analysis of drug-resistance mutations detected between 1 and 10% demonstrated high intra- and inter-laboratory consistency in frequency estimates for both RNA and prepared cDNA samples, indicating robustness of the

  19. A Prospective Multi-Center Observational Study of Children Hospitalized with Diarrhea in Ho Chi Minh City, Vietnam.

    OpenAIRE

    Thompson, CN; Phan, MV; Hoang, NV; Minh, PV; Vinh, NT; Thuy, CT; Nga, TT; Rabaa, MA; Duy, PT; Dung, TT; Phat, VV; Nga, TV; Tu, leTP; Tuyen, HT; K. Yoshihara

    2015-01-01

    : We performed a prospective multicenter study to address the lack of data on the etiology, clinical and demographic features of hospitalized pediatric diarrhea in Ho Chi Minh City (HCMC), Vietnam. Over 2,000 (1,419 symptomatic and 609 non-diarrheal control) children were enrolled in three hospitals over a 1-year period in 2009-2010. Aiming to detect a panel of pathogens, we identified a known diarrheal pathogen in stool samples from 1,067/1,419 (75.2%) children with diarrhea and from 81/609 ...

  20. Infliximab Versus Adalimumab in the Treatment of Refractory Inflammatory Uveitis: A Multicenter Study From the French Uveitis Network.

    Science.gov (United States)

    Vallet, Hélène; Seve, Pascal; Biard, Lucie; Baptiste Fraison, Jean; Bielefeld, Philip; Perard, Laurent; Bienvenu, Boris; Abad, Sébastien; Rigolet, Aude; Deroux, Alban; Sene, Damien; Perlat, Antoinette; Marie, Isabelle; Feurer, Elodie; Hachulla, Eric; Fain, Olivier; Clavel, Gaëlle; Riviere, Sophie; Bouche, Pierre-Alban; Gueudry, Julie; Pugnet, Gregory; Le Hoang, Phuc; Resche Rigon, Matthieu; Cacoub, Patrice; Bodaghi, Bahram; Saadoun, David

    2016-06-01

    To analyze the factors associated with response to anti-tumor necrosis factor (anti-TNF) treatment and compare the efficacy and safety of infliximab (IFX) and adalimumab (ADA) in patients with refractory noninfectious uveitis. This was a multicenter observational study of 160 patients (39% men and 61% women; median age 31 years [interquartile range 21-42]) with uveitis that had been refractory to other therapies, who were treated with anti-TNF (IFX 5 mg/kg at weeks 0, 2, 6, and then every 5-6 weeks [n = 98] or ADA 40 mg every 2 weeks [n = 62]). Factors associated with complete response were assessed by multivariate analysis. Efficacy and safety of IFX versus ADA were compared using a propensity score approach with baseline characteristics taken into account. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (95% CIs) were calculated. The main etiologies of uveitis included Behçet's disease (BD) (36%), juvenile idiopathic arthritis (22%), spondyloarthropathy (10%), and sarcoidosis (6%). The overall response rate at 6 and 12 months was 87% (26% with complete response) and 93% (28% with complete response), respectively. The median time to complete response was 2 months. In multivariate analysis, BD and occurrence of >5 uveitis flares before anti-TNF initiation were associated with complete response to anti-TNF (SHR 2.52 [95% CI 1.35-4.71], P = 0.004 and SHR 1.97 [95% CI 1.02-3.84], P = 0.045, respectively). Side effects were reported in 28% of patients, including serious adverse events in 13%. IFX and ADA did not differ significantly in terms of occurrence of complete response (SHR 0.65 [95% CI 0.25-1.71], P = 0.39), serious side effects (SHR 0.22 [95% CI 0.04-1.25], P = 0.089), or event-free survival (SHR 0.55 [95% CI 0.28-1.08], P = 0.083). Anti-TNF treatment is highly effective in refractory inflammatory uveitis. BD is associated with increased odds of response. IFX and ADA appear to be equivalent in terms of efficacy.

  1. Italian multicenter study on low-density lipoprotein apheresis Working Group 2009 survey.

    Science.gov (United States)

    Stefanutti, Claudia; Morozzi, Claudia; Di Giacomo, Serafina

    2013-04-01

    We present results of the second survey of the Italian Multicenter Study on Low-Density Lipoprotein Apheresis (IMSLDLa-WG/2). The study involved 18 centers in 2009, treating 66 males and 35 females, mean age 47 ± 18 years. Mean age for initiation of drug treatment before low-density lipoprotein apheresis (LDLa) was 31 ± 18 years, mean age to the first LDLa was 37 ± 20 years and average duration of treatment was 9 ± 6 years. The techniques used included direct adsorption of lipids, dextran sulfate cellulose adsorption, heparin-mediated low-density lipoprotein (LDL) precipitation, cascade filtration, and plasma exchange. The mean treated plasma/blood volumes/session were 3127 ± 518 mL and 8666 ± 1384 mL, respectively. The average plasma volume substituted was 3500 ± 300 mL. Lipid therapy before LDLa included ezetimibe, statins, ω-3 fatty acids and fenofibrate. Baseline mean LDL cholesterol (LDLC) levels were 386 ± 223 mg/dL. The mean before/after apheresis LDLC level decreased by 67% from 250 ± 108 mg/dL (P = 0.05 vs. baseline) to 83 ± 37 mg/dL (P = 0.001 vs. before). Baseline mean Lipoprotein(a) [Lp(a)] level was 179 ± 136 mg/dL. Mean before/after apheresis Lp(a) level decreased by 71% from 133 ± 120 mg/dL (P = 0.05 vs. baseline) to 39 ± 44 mg/dL (P = 0.001 vs. before). Major and minor side effects occurred in 27 and 62 patients, respectively. Among patients with coronary artery disease (CAD), 62.3% had coronary angiography and 50.4% coronary revascularization before LDLa. Single vessel, double vessel and triple vessel CAD occurred in 19 (30.1%), 15 (23.8%) and 29 (46%) patients, respectively. Both CAD and extra-CAD occurred in 41.5%, 39% had hypertension, 9.9% were smokers, 9.9% consumed alcohol and 42% were physically active. Ischemic cardiovascular events were not observed in any patient over 9 ± 6 years of treatment. Two centers have also treated 34 patients (females: 17/males 17; no. sessions: 36; average plasma volume treated: 3000 mL) for

  2. [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.

  3. Multicenter prospective study of magnetic resonance imaging prior to breast-conserving surgery for breast cancer

    Institute of Scientific and Technical Information of China (English)

    Liu Qian; Liu Yinhua; Xu Ling; Duan Xuening; Li Ting; Qin Naishan; Kang Hua

    2014-01-01

    Background This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer.Methods The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012.The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group).Enhanced MRI was used to measure breast volume,longest diameter of tumor and tumor volume.The correlations between these measurements and those derived from histopathologic findings were assessed.The relationships between the success rate of breast-conserving surgery and MRI-and pathology-based measurement results were statistically analyzed in the breast-conserving group.Results The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group.Allocation to these groups was based on clinical indications and patient preferences.The cut-off for concurrence between MRI-and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm.In the total mastectomy group,the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%.Correlation coefficients for MRI and histopathology-based measurements of breast volume,tumor volume and tumor volume/breast volume ratio were r=0.861,0.569,and 0.600,respectively (all P <0.001).In the breast-conserving group,with 0.30 cm taken as the cut-off for concurrence,the 95% confidence interval for MRI and pathology-based measurements of the longest diameter of tumor was 29.98%-44.01%.The subjective and objective success rates for breast-conserving surgery were 100% and 88.54%,respectively.Conclusions There were significant correlations between dynamic enhanced MRI-and histopathology-based measurements of the longest

  4. Association of Insurance Status with Health Outcomes Following Traumatic Injury: Statewide Multicenter Analysis

    Directory of Open Access Journals (Sweden)

    Chikani, Vatsal

    2015-05-01

    Full Text Available Introduction: Recognizing disparities in definitive care for traumatic injuries created by insurance status may help reduce the higher risk of trauma-related mortality in this population. Our objective was to understand the relationship between patients’ insurance status and trauma outcomes. Methods: We collected data on all patients involved in traumatic injury from eight Level I and 15 Level IV trauma centers, and four non-designated hospitals through Arizona State Trauma Registry between January 1, 2008 and December 31, 2011. Of 109,497 records queried, we excluded 29,062 (26.5% due to missing data on primary payer, sex, race, zip code of residence, injury severity score (ISS, and alcohol or drug use. Of the 80,435 cases analyzed, 13.3% were self-pay, 38.8% were Medicaid, 13% were Medicare, and 35% were private insurance. We evaluated the association between survival and insurance status (private insurance, Medicare, Medicaid, and self-pay using multiple logistic regression analyses after adjusting for race/ethnicity (White, Black/African American, Hispanic, and American Indian/Alaska Native, age, gender, income, ISS and injury type (penetrating or blunt. Results: The self-pay group was more likely to suffer from penetrating trauma (18.2% than the privately insured group (6.0%, p<0.0001. There were more non-White (53% self-pay patients compared to the private insurance group (28.3%, p<0.0001. Additionally, the self-pay group had significantly higher mortality (4.3% as compared to private insurance (1.9%, p<0.0001. A simple logistic regression revealed higher mortality for self-pay patients (crude OR= 2.32, 95% CI [2.07-2.67] as well as Medicare patients (crude OR= 2.35, 95% CI [2.54-3.24] as compared to private insurance. After adjusting for confounding, a multiple logistic regression revealed that mortality was highest for self-pay patients as compared to private insurance (adjusted OR= 2.76, 95% CI [2.30-3.32]. Conclusion: These results

  5. Cutaneous Invasive Aspergillosis: Retrospective Multicenter Study of the French Invasive-Aspergillosis Registry and Literature Review.

    Science.gov (United States)

    Bernardeschi, Céline; Foulet, Francoise; Ingen-Housz-Oro, Saskia; Ortonne, Nicolas; Sitbon, Karine; Quereux, Gaëlle; Lortholary, Olivier; Chosidow, Olivier; Bretagne, Stéphane

    2015-07-01

    Invasive aspergillosis (IA) has poor prognosis in immunocompromised patients. Skin manifestations, when present, should contribute to an early diagnosis. The authors aimed to provide prevalence data and a clinical and histologic description of cutaneous manifestations of primary cutaneous IA (PCIA) and secondary CIA (SCIA) in a unique clinical series of IA and present the results of an exhaustive literature review of CIA. Cases of proven and probable IA with cutaneous manifestations were retrospectively extracted from those registered between 2005 and 2010 in a prospective multicenter aspergillosis database held by the National Reference Center for Invasive Mycoses and Antifungals, Pasteur Institute, France. Patients were classified as having PCIA (i.e., CIA without extracutaneous manifestations) or SCIA (i.e., disseminated IA). Among the 1,410 patients with proven or probable IA, 15 had CIA (1.06%), 5 PCIA, and 10 SCIA. Hematological malignancies were the main underlying condition (12/15). Patients with PCIA presented infiltrated and/or suppurative lesions of various localizations not related to a catheter site (4/5), whereas SCIA was mainly characterized by disseminated papules and nodules but sometimes isolated nodules or cellulitis. Histologic data were available for 11 patients, and for 9, similar for PCIA and SCIA, showed a dense dermal polymorphic inflammatory infiltrate, with the epidermis altered in PCIA only. Periodic acid Schiff and Gomori-Grocott methenamine silver nitrate staining for all but 2 biopsies revealed hyphae compatible with Aspergillus. Aspergillus flavus was isolated in all cases of PCIA, with Aspergillus fumigatus being the most frequent species (6/10) in SCIA. Two out 5 PCIA cases were treated surgically. The 3-month survival rate was 100% and 30% for PCIA and SCIA, respectively. Our study is the largest adult series of CIA and provides complete clinical and histologic data for the disease. Primary cutaneous IA should be recognized early

  6. Clinical presentation and visual status of retinitis pigmentosa patients: a multicenter study in southwestern Nigeria

    Directory of Open Access Journals (Sweden)

    Onakpoya OH

    2016-08-01

    Full Text Available Oluwatoyin Helen Onakpoya,1 Caroline Olufunlayo Adeoti,2 Tunji Sunday Oluleye,3 Iyiade Adeseye Ajayi,4 Timothy Majengbasan,4,5 Olayemi Kolawole Olorundare1 1Department of Ophthalmology, Obafemi Awolowo University Teaching Hospital, Ile-Ife, 2Department of Ophthalmology, Ladoke Akintola University of Technology Teaching Hospital, Osogbo, 3Department of Ophthalmology, University College Hospital, Ibadan, 4Department of Ophthalmology, University Teaching Hospital, Ado-Ekiti, 5Department of Ophthalmology, Federal Medical Centre, Ido-Ekiti, Nigeria Background: To review the visual status and clinical presentation of patients with retinitis pigmentosa (RP.Methodology: Multicenter, retrospective, and analytical review was conducted of the visual status and clinical characteristics of patients with RP at first presentation from January 2007 to December 2011. Main outcome measure was the World Health Organization’s visual status classification in relation to sex and age at presentation. Data analysis by SPSS (version 15 and statistical significance was assumed at P<0.05.Results: One hundred and ninety-two eyes of 96 patients with mean age of 39.08±18.5 years and mode of 25 years constituted the study population; 55 (57.3% were males and 41 (42.7% females. Loss of vision 67 (69.8% and night blindness 56 (58.3% were the leading symptoms. Twenty-one (21.9% patients had a positive family history, with RP present in their siblings 15 (71.4%, grandparents 11 (52.3%, and parents 4 (19.4%. Forty (41.7% were blind at presentation and 23 (24% were visually impaired. Blindness in six (15% patients was secondary to glaucoma. Retinal vascular narrowing and retinal pigmentary changes of varying severity were present in all patients. Thirty-five (36.5% had maculopathy, 36 (37.5% refractive error, 19 (20% lenticular opacities, and eleven (11.5% had glaucoma. RP was typical in 85 patients (88.5%. Older patients had higher rates of blindness at presentation (P=0

  7. Stability of R2* and quantitative susceptibility mapping of the brain tissue in a large scale multi-center study

    Science.gov (United States)

    Wang, Rongpin; Xie, Guangyou; Zhai, Maoxiong; Zhang, Zhongping; Wu, Bing; Zheng, Dandan; Hong, Nan; Jiang, Tao; Wen, Baohong; Cheng, Jingliang

    2017-01-01

    Multi-center studies are advantageous for enrolling participants of varying pathological and demographical conditions, and especially in neurological studies. Hence stability of the obtained quantitative R2* and susceptibility in multicenter studies is a key issue for their widespread applications. In this work, the stabilities of simultaneously obtained R2* and susceptibility are investigated and compared across 10 sites that are equipped with the same scanner and receiver coil, the same post-processing process was used to achieve consistent experiment setup. Two healthy adult volunteers (one male and female) participated in this study. High intraclass correlation coefficient was obtained for both susceptibility (0.94) and R2* (0.96). The coefficients of variance for all measurements obtained were smaller than 0.1, the largest variations of measurements in all the chosen ROIs fall within ±20% from the median value. Higher level of stability was obtained in R2* as compared to susceptibility at 1 mm resolution (P < 0.05) and at 1.5 mm (P < 0.01). PMID:28349957

  8. Multicenter case-control study of the role of lens materials and care products on the development of corneal infiltrates.

    Science.gov (United States)

    Chalmers, Robin L; Keay, Lisa; McNally, John; Kern, Jami

    2012-03-01

    To evaluate the association of symptomatic soft contact lens (SCL)-related corneal infiltrative events (CIEs) with SCL material, lens care products (LCPs), and other risk factors. Cases with symptomatic CIEs were identified in a retrospective, multicenter case-control study at five academic eye care centers. Each case was matched to three controls each who had received eye care near the time of the case's last full examination at that center but were not matched for demographic or other factors. Infiltrate status was established by an expert panel who were masked to sponsor, SCL, and LCP brand. Stratified analyses were conducted removing all daily disposable (DD) and all extended wear (EW) cases. Clinical records from 166 patients with symptomatic CIEs and known EW status were included. Cases used >50 SCL brands and >10 LCP brands. Increased risk in univariate analysis for LCP was not significant after adjustment for other factors. In the multivariate analysis of all cases, use of reusable SCLs (4.03×; 95% C.I. 1.12 to 14.67) and EW (3.98×; 2.32 to 6.84) increased risk and patient age (per year older) was protective (0.96×; 0.94 to 0.98). Among daily wear cases (n = 102 cases), use of reusable SCLs (12.46×; 1.54 to 100.62) and silicone hydrogel (SiHy) (1.99×; 1.06 to 3.75) and age (0.95×: 0.92 to 0.97) were associated. Without DD cases (n = 162), EW (4.42×; 2.53 to 7.70), SiHy use (1.84×; 1.03 to 3.29), and patient age (0.96× 0.94 to 0.98) were significant factors. No specific SCL or LCP brands were associated with increased risk. In this community-based trial, younger patients were at increased risk of infiltrative events. DD lenses were protective relative to reusable lenses. Overnight use increased risk in all analyses and silicone hydrogels increased risk in daily wearers, regardless of LCP brand. Improvements in lens storage case hygiene and environment may be a mechanism for reducing risk of CIEs related to SCL use.

  9. Angioedema Related to Angiotensin-Converting Enzyme Inhibitors: Attack Severity, Treatment, and Hospital Admission in a Prospective Multicenter Study.

    Science.gov (United States)

    Javaud, Nicolas; Achamlal, Jallal; Reuter, Paul-George; Lapostolle, Frédéric; Lekouara, Akim; Youssef, Mustapha; Hamza, Lilia; Karami, Ahmed; Adnet, Frédéric; Fain, Olivier

    2015-11-01

    The number of cases of acquired angioedema related to angiotensin converting enzyme inhibitors induced (ACEI-AAE) is on the increase, with a potential concomitant increase in life-threatening attacks of laryngeal edema. Our objective was to determine the main characteristics of ACEI-AAE attacks and, in doing so, the factors associated with likelihood of hospital admission from the emergency department (ED) after a visit for an attack.A prospective, multicenter, observational study (April 2012-December 2014) was conducted in EDs of 4 French hospitals in collaboration with emergency services (SAMU 93) and a reference center for bradykinin-mediated angioedema. For each patient presenting with an attack, emergency physicians collected demographic and clinical presentation data, treatments, and clinical course. They recorded time intervals from symptom onset to ED arrival and to treatment decision, from ED arrival to specific treatment with plasma-derived C1-inhibitor (C1-INH) or icatibant, and from specific treatment to onset of symptom relief. Attacks requiring hospital admission were compared with those not requiring admission.Sixty-two eligible patients with ACEI-AAE (56% men, median age 63 years) were included. Symptom relief occurred significantly earlier in patients receiving specific treatment than in untreated patients (0.5 [0.5-1.0] versus 3.9 [2.5-7.0] hours; P < 0.0001). Even though icatibant was injected more promptly than plasma-derived C1-INH, there, however, was no significant difference in median time to onset of symptom relief between the 2 drugs (0.5 [0.5-1.3] versus 0.5 [0.4-1.0] hours for C1-INH and icatibant, respectively, P = 0.49). Of the 62 patients, 27 (44%) were admitted to hospital from the ED. In multivariate analysis, laryngeal involvement and progressive swelling at ED arrival were independently associated with admission (Odds ratio [95% confidence interval] = 6.2 [1.3-28.2] and 5.9 [1.3-26.5], respectively). A favorable course

  10. Anti-HMGCR antibodies as a biomarker for immune-mediated necrotizing myopathies: A history of statins and experience from a large international multi-center study.

    Science.gov (United States)

    Musset, Lucile; Allenbach, Yves; Benveniste, Olivier; Boyer, Olivier; Bossuyt, Xavier; Bentow, Chelsea; Phillips, Joe; Mammen, Andrew; Van Damme, Philip; Westhovens, René; Ghirardello, Anna; Doria, Andrea; Choi, May Y; Fritzler, Marvin J; Schmeling, Heinrike; Muro, Yoshinao; García-De La Torre, Ignacio; Ortiz-Villalvazo, Miguel A; Bizzaro, Nicola; Infantino, Maria; Imbastaro, Tiziana; Peng, Qinglin; Wang, Guochun; Vencovský, Jiří; Klein, Martin; Krystufkova, Olga; Franceschini, Franco; Fredi, Micaela; Hue, Sophie; Belmondo, Thibaut; Danko, Katalin; Mahler, Michael

    2016-10-01

    In an effort to find naturally occurring substances that reduce cholesterol by inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), statins were first discovered by Endo in 1972. With the widespread prescription and use of statins to decrease morbidity from myocardial infarction and stroke, it was noted that approximately 5% of all statin users experienced muscle pain and weakness during treatment. In a smaller proportion of patients, the myopathy progressed to severe morbidity marked by proximal weakness and severe muscle wasting. Remarkably, Mammen and colleagues were the first to discover that the molecular target of statins, 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), is an autoantibody target in patients that develop an immune-mediated necrotizing myopathy (IMNM). These observations have been confirmed in a number of studies but, until today, a multi-center, international study of IMNM, related idiopathic inflammatory myopathies (IIM), other auto-inflammatory conditions and controls has not been published. Accordingly, an international, multi-center study investigated the utility of anti-HMGCR antibodies in the diagnosis of statin-associated IMNM in comparison to different forms of IIM and controls. This study included samples from patients with different forms of IIM (n=1250) and patients with other diseases (n=656) that were collected from twelve sites and tested for anti-HMGCR antibodies by ELISA. This study confirmed that anti-HMGCR autoantibodies, when found in conjunction with statin use, characterize a subset of IIM who are older and have necrosis on muscle biopsy. Taken together, the data to date indicates that testing for anti-HMGCR antibodies is important in the differential diagnosis of IIM and might be considered for future classification criteria.

  11. Challenges in the design of antibiotic equivalency studies: the multicenter equivalency study of oral amoxicillin versus injectable penicillin in children aged 3-59 months with severe pneumonia.

    Science.gov (United States)

    Hibberd, Patricia L; Patel, Archana

    2004-08-15

    The World Health Organization (WHO) recommends that children with severe pneumonia (characterized by cough or difficult breathing, as well as lower chest wall indrawing) be hospitalized and treated with parenteral penicillin. Oral amoxicillin, if equally effective for treating severe pneumonia, would address challenges associated with providing parenteral therapy, including risk of transmission of bloodborne pathogens from contaminated needles, exposure to nosocomial pathogens during hospitalization, inadequate access to health care facilities, and cost. The recently completed multicenter international trial of oral amoxicillin versus parenteral penicillin for treatment of severe pneumonia demonstrated the equivalency of these agents in children with severe pneumonia. This article focuses on the challenges of designing an equivalence study and the threats to the validity of the trial results, particularly the implications of the bias toward finding equivalence when subjects are unlikely to respond to either study therapy. These considerations have implications for use of the Amoxicillin Penicillin Pneumonia International Study (APPIS) results in clinical practice and for potential modification of WHO treatment guidelines.

  12. 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)

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    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. PMID:20703765

  13. Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

    Science.gov (United States)

    Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

    2009-11-01

    The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

  14. Lung-protective Ventilation in Patients with Brain Injury: A Multicenter Cross-sectional Study and Questionnaire Survey in China

    Institute of Scientific and Technical Information of China (English)

    Xu-Ying Luo; Ying-Hong Hu; Xiang-Yuan Cao; Yan Kang; Li-Ping Liu; Shou-Hong Wang; Rong-Guo Yu

    2016-01-01

    Background:Over the years,the mechanical ventilation (MV) strategy has changed worldwide.The aim of the present study was to describe the ventilation practices,particularly lung-protective ventilation (LPV),among brain-injured patients in China.Methods:This study was a multicenter,1-day,cross-sectional study in 47 Intensive Care Units (ICUs) across China.Mechanically ventilated patients (18 years and older) with brain injury in a participating ICU during the time of the study,including traumatic brain injury,stroke,postoperation with intracranial tumor,hypoxic-ischemic encephalopathy,intracranial infection,and idiopathic epilepsy,were enrolled.Demographic data,primary diagnoses,indications for MV,MV modes and settings,and prognoses on the 60th day were collected.Multivariable logistic analysis was used to assess factors that might affect the use of LPV.Results:A total of 104 patients were enrolled in the present study,87 (83.7%) of whom were identified with severe brain injury based on a Glasgow Coma Scale <8 points.Synchronized intermittent mandatory ventilation (SIMV) was the most frequent ventilator mode,accounting for 46.2% of the entire cohort.The median tidal volume was set to 8.0 ml/kg (interquartile range [IQR],7.0-8.9 ml/kg) of the predicted body weight;50 (48.1%) patients received LPV.The median positive end-expiratory pressure (PEEP) was set to 5 cmH2O (IQR,5-6 cmH2O).No PEEP values were higher than 10 cmH2O.Compared with partially mandatory ventilation,supportive and spontaneous ventilation practices were associated with LPV.There were no significant differences in mortality and MV duration between patients subjected to LPV and those were not.Conclusions:Among brain-injured patients in China,SIMV was the most frequent ventilation mode.Nearly one-half of the brain-injured patients received LPV.Patients under supportive and spontaneous ventilation were more likely to receive LPV.

  15. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study - PRIME study.

    Science.gov (United States)

    Shah, Kshitij; Chaudhari, Omvijay B; Gupta, Palash; Chaudhuri, R Hom; Kamilya, Ranjan; Kulkarni, Shreedhar S; Subbaiah, S; Sorathia, Zubair H; Billa, Gauri

    2017-01-01

    To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician's routine clinical practice. In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18-60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (pevents of moderate intensity. Two patients developed three adverse reactions (burning sensation in urine, giddiness, and urine retention) other than GI events. No serious adverse drug reactions were reported during the study period. Tramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions.

  16. Trajectories of Marijuana Use among HIV-seropositive and HIV-seronegative MSM in the Multicenter AIDS Cohort Study (MACS), 1984-2013.

    Science.gov (United States)

    Okafor, Chukwuemeka N; Cook, Robert L; Chen, Xinguang; Surkan, Pamela J; Becker, James T; Shoptaw, Steve; Martin, Eileen; Plankey, Michael W

    2017-04-01

    To construct longitudinal trajectories of marijuana use in a sample of men who have sex with men living with or at-risk for HIV infection. We determined factors associated with distinct trajectories of use as well as those that serve to modify the course of the trajectory. Data were from 3658 [1439 HIV-seropositive (HIV+) and 2219 HIV-seronegative (HIV-)] participants of the Multicenter AIDS Cohort Study. Frequency of marijuana use was obtained semiannually over a 29-year period (1984-2013). Group-based trajectory models were used to identify the trajectories and to determine predictors and modifiers of the trajectories over time. Four distinct trajectories of marijuana use were identified: abstainer/infrequent (65 %), decreaser (13 %), increaser (12 %) and chronic high (10 %) use groups. HIV+ status was significantly associated with increased odds of membership in the decreaser, increaser and chronic high use groups. Alcohol, smoking, stimulant and other recreational drug use were associated with increasing marijuana use across all four trajectory groups. Antiretroviral therapy use over time was associated with decreasing marijuana use in the abstainer/infrequent and increaser trajectory groups. Having a detectable HIV viral load was associated with increasing marijuana use in the increaser group only. Future investigations are needed to determine whether long-term patterns of use are associated with adverse consequences especially among HIV+ persons.

  17. The treatment of angina pectoris with nitroglycerin plasters. A multicenter study involving 6,986 patients.

    Science.gov (United States)

    Agabiti Rosei, E; Muiesan, M L; Pollavini, G; Bichisao, E; Muiesan, G

    1987-10-01

    A multicenter study was carried out in order to evaluate the efficacy and tolerability of 2 doses of a nitroglycerin transdermal system (TTS-NG 5 mg/24 h and TTS-NG 10 mg/24 h) on a large population of patients affected by angina pectoris. Nine hundred and seventy three cardiologists enrolled a total of 6,986 patients, 4,290 males and 2,696 females, mean age 61.7 years (range 26-95), 3,283 with effort-angina, 2,062 with mixed angina and 1,641 with angina at rest. Patients whose angina was not satisfactorily controlled by their previous therapy, were given TTS-NG 5 for 1 week in the morning, while continuing their antianginal treatment, with the exception of nitrates which were gradually withdrawn. At the end of this period, patients who responded to the treatment continued taking the same dose for a further 6 weeks, while poor responders were given a double dose of the study medication over the same period. Six thousand two hundred and sixty patients (90%) completed the study. TTS-NG 5 proved to be effective in 2,091 patients (33%) with a reduction in weekly anginal attacks after only 1 week of treatment (from 5.8 +/- 2.9 to 2.4 +/- 2.3). This reduction improved in the following 2 weeks (from 2.4 +/- 2.3 to 1.2 +/- 1.6) and subsequently remained virtually unchanged. Four thousand one hundred and sixty-nine patients (67%), whose angina was not sufficiently controlled by TTS-NG 5 (from 5.0 +/- 2.4 to 4.3 +/- 2.8), received double the dose at the end of the first week. TTS-NG 10 brought about a reduction in weekly anginal symptoms during the 2nd and the 3rd week (from 4.3 +/- 2.8 to 2.0 +/- 2.2), with a further decrease during the following 2 weeks (from 2.0 +/- 2.2 to 1.1 +/- 1.7). The reduction in anginal attacks was of the same extent both during the day and the night, thus suggesting that the drug is effective throughout 24 hours. A similar pattern was observed in the reduction of the number of anginal attacks weighted by their severity, the severity of attacks

  18. Peripheral sub-inflammation is associated with antidepressant consumption in schizophrenia. Results from the multi-center FACE-SZ data set.

    Science.gov (United States)

    Fond, G; Godin, O; Brunel, L; Aouizerate, B; Berna, F; Bulzacka, E; Capdevielle, D; Chereau, I; Dorey, J M; Dubertret, C; Dubreucq, J; Faget, C; Gabayet, F; Le Strat, Y; Micoulaud-Franchi, J A; Misdrahi, D; Rey, R; Richieri, R; Passerieux, C; Schandrin, A; Schürhoff, F; Tronche, A M; Urbach, M; Vidalhet, P; Llorca, P M; Leboyer, M

    2016-02-01

    The relation between C-Reactive Protein (CRP), depression and antidepressant consumption has been well explored in major depressive disorders but not in schizophrenia, which has a high rate of depression comorbidity. The objectives of this study were: (i) to determine the prevalence of abnormal CRP levels, depression and antidepressant consumption in a multicenter community-dwelling sample of subjects with schizophrenia (ii) to determine the association between abnormal CRP levels, depression and antidepressant consumption in schizophrenia. 219 stable patients with schizophrenia (mean age=31.6 years, 75.3% male gender) were systematically included in the multicentre network of FondaMental Expert Center for schizophrenia (FACE-SZ) and assessed with a dedicated electronic medical record including the Structured Clinical Interview for DSM-IV Axis I Disorders and Calgary Depression Scale for depression. High sensitivity CRP (hs-CRP) was measured with an assay using nephelometry (Dade Behring). Abnormal CRP level was defined by levels >3mg/L. Current medication was recorded. Overall, 63 subjects (28.8%) were found to have abnormal CRP levels, 43 (20.1%) received a diagnosis of comorbid current depression, and 51 (31.9%) had ongoing antidepressant treatment. In univariate analysis, abnormal CRP levels were found to be significantly associated with body mass index (BMI) (p0.05). In a multivariate model, abnormal CRP was associated with antidepressant consumption independently of other confounding variables (adjusted Odds Ratio=2.8, 95% confidence interval 1.22-6.62). Metabolic syndrome was also independently associated with abnormal CRP (adjusted Odds Ratio=2.6, 95% confidence interval 1.01-6.71). Abnormal CRP levels in schizophrenia were found to be associated with antidepressant consumption, but not with depression. The potential mechanisms were discussed. Antidepressant consumption should be systematically recorded in future studies exploring inflammation in

  19. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience.

    Science.gov (United States)

    Reddy, Vivek Y; Miller, Marc A; Knops, Reinoud E; Neuzil, Petr; Defaye, Pascal; Jung, Werner; Doshi, Rahul; Castellani, Mark; Strickberger, Adam; Mead, R Hardwin; Doppalapudi, Harish; Lakkireddy, Dhanunjaya; Bennett, Matthew; Sperzel, Johannes

    2016-12-01

    Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (6 weeks) of the leadless cardiac pacemaker in humans. This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for 6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure. This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker. URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244. © 2016 American Heart Association, Inc.

  20. Optimizing imaging in suspected appendicitis (OPTIMAP-study: A multicenter diagnostic accuracy study of MRI in patients with suspected acute appendicitis. Study Protocol

    Directory of Open Access Journals (Sweden)

    Bossuyt Patrick MM

    2010-10-01

    Full Text Available Abstract Background In patients with clinically suspected appendicitis, imaging is needed to substantiate the clinical diagnosis. Imaging accuracy of ultrasonography (US is suboptimal, while the most accurate technique (CT is associated with cancer related deaths through exposure to ionizing radiation. MRI is a potential replacement, without associated ionizing radiation and no need for contrast medium administration. If MRI is proven to be sufficiently accurate, it could be introduced in the diagnostic pathway of patients with suspected appendicitis, increasing diagnostic accuracy and improving clinical outcomes, without the risk of radiation induced cancer or iodinated contrast medium-related drawbacks. The multicenter OPTIMAP study was designed to estimate the diagnostic accuracy of MRI in patients with suspected acute appendicitis in the general population. Methods/Design Eligible for this study are consecutive patients presenting with clinically suspected appendicitis at the emergency department in six centers. All patients will undergo imaging according to the Dutch guideline for acute appendicitis: initial ultrasonography in all and subsequent CT whenever US does not confirm acute appendicitis. Then MRI is performed in all patients, but the results are not used for patient management. A final diagnosis assigned by an expert panel, based on all available information including 3-months follow-up, except MRI findings, is used as the reference standard in estimating accuracy. We will calculate the sensitivity, specificity, predictive values and inter-observer agreement of MRI, and aim to include 230 patients. Patient acceptance and total imaging costs will also be evaluated. Discussion If MRI is found to be sufficiently accurate, it could replace CT in some or all patients. This will limit or obviate the ionizing radiation exposure associated risk of cancer induction and contrast medium induced nephropathy with CT, preventing the burden and

  1. Observational Multicenter Study of a Direct-to-CT Protocol for EMS-transported Patients with Suspected Stroke.

    Science.gov (United States)

    Cone, David C; Cooley, Craig; Ferguson, Jeffrey; Harrell, Andrew J; Luk, Jeffrey H; Martin-Gill, Christian; Marquis, Sean W; Pasichow, Scott

    2017-08-25

    In an effort to decrease door-to-needle times for patients with acute ischemic stroke, some hospitals have begun taking stable EMS patients with suspected stroke directly from the ambulance to the CT scanner, then to an emergency department (ED) bed for evaluation. Minimal data exist regarding the potential for time savings with such a protocol. The study hypothesis was that a direct-to-CT protocol would be associated with decreases in both door-to-CT-ordered and door-to-needle times. An observational, multicenter before/after study was conducted of time/process measures at hospitals that have implemented direct-to-CT protocols for patients transported by EMS with suspected stroke. Participating hospitals submitted data on at least the last 50 "EMS stroke alert" patients before the launch of the direct-to-CT protocol, and at least the first 50 patients after. Time elements studied were arrival at the ED, time the head CT was ordered, and time tPA was started. Data were submitted in blinded fashion (patient and hospital identifiers removed); at the time of data analysis, the lead investigator was unaware of which data came from which hospital. Simple descriptive statistics were used, along with the Mann-Whitney test to compare time medians. Seven hospitals contributed data on 1040 patients (529 "before" and 511 "after"); 512 were male, and 627 had final diagnoses of ischemic stroke, of whom 275 received tPA. The median door-to-CT-ordered time for all patients was 7 minutes in the before phase, and 4 minutes after (difference 3 minutes, p = < 0.0001); similarly, the median door-to-CT-started time was 6 minutes "before" and 10 minutes after (p < 0.0001). The median door-to-needle time for all patients given tPA was 42 minutes before, and 44 minutes after (p = 0.78). Four hospitals had modest decreases in door-to-CT-ordered time (of 2, 4, 2, and 5 minutes), and only one hospital had a decrease in door-to-needle time (32 min vs 26 min, p = 0.012). In this sample from

  2. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Science.gov (United States)

    Shah, Kshitij; Chaudhari, Omvijay B; Gupta, Palash; Chaudhuri, R Hom; Kamilya, Ranjan; Kulkarni, Shreedhar S; Subbaiah, S; Sorathia, Zubair H; Billa, Gauri

    2017-01-01

    Objective To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (pTramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions. PMID:28579825

  3. Cardiac preload responsiveness in children with cardiovascular dysfunction or dilated cardiomyopathy: a multicenter observational study.

    Science.gov (United States)

    de la Oliva, Pedro; Menéndez-Suso, Juan J; Iglesias-Bouzas, Mabel; Álvarez-Rojas, Elena; González-Gómez, José M; Roselló, Patricia; Sánchez-Díaz, Juan I; Jaraba, Susana

    2015-01-01

    To characterize cardiac preload responsiveness in pediatric patients with cardiovascular dysfunction and dilated cardiomyopathy using global end-diastolic volume index, stroke volume index, cardiac index, and extravascular lung water index. Prospective multicenter observational study. Medical/surgical PICUs of seven Spanish University Medical Centers. Seventy-five pediatric patients (42 male, 33 female), median age 36 months (range, 1-207 mo), were divided into three groups: normal cardiovascular status, cardiovascular dysfunction, and dilated cardiomyopathy. All patients received hemodynamic monitoring with PiCCO2 (Pulsion Medical System SE, Munich, Germany). We evaluated 598 transpulmonary thermodilution sets of measurements. In 40 patients, stroke volume index, cardiac index, and global end-diastolic volume index were measured before and after 66 fluid challenges and loadings to test fluid responsiveness at different preload levels. Global end-diastolic volume versus predicted body surface area exhibits a power-law relationship: Global end-diastolic volume = 488.8·predicted body surface area (r = 0.93). Four levels of cardiac preload were established from the resulting "normal" global end-diastolic volume index (= 488.8·predicted body surface area). Stroke volume index and cardiac index versus global end-diastolic volume index/normal global end-diastolic volume index built using a linear mixed model analysis emulated Frank-Starling curves: in cardiovascular dysfunction group, stroke volume index (geometric mean [95% CI]) was 27 mL/m (24-31 mL/m) at "≤ 0.67 times normal global end-diastolic volume index," 37 mL/m (35-40 mL/m) at "> 0.67 ≤ 1.33 times normal global end-diastolic volume index" (Δ stroke volume index = 35%; p 1.33 ≤ 1.51 times normal global end-diastolic volume index" (Δ stroke volume index = 21%; p 1.51 times normal global end-diastolic volume index" (Δ stroke volume index = 4%; p = 1; area under the receiver

  4. Prevalence estimates for primary brain tumors in China: a multi-center cross-sectional study

    Institute of Scientific and Technical Information of China (English)

    JIANG Tao; WU Nai-feng; CHEN Xiao-jun; XING Hou-xun; SU Tong-yong; WANG Zhong-cheng; TANG Gen-fu; LIN Yi; PENG Xiao-xia; ZHANG Xiao; ZHAI Xiu-wei; PENG Xiang; YANG Jin-qing; HUANG Hong-er

    2011-01-01

    Background Although the first leading cause of death in China was malignant neoplasms (mortality,374.1 per 100000 person-years),the full impact of primary brain tumors (PBT) on the healthcare system is not completely described because there are a few well documented reports about the epidemiologic features of brain tumors.This study aimed to report a comprehensive assessment on the prevalence of PBT.Methods A multicenter cross-sectional study on brain tumor (MCSBT) in China was initiated in five regional centers:Daqing (northeast),Puyang (north of China),Shiyan (center of China),Ma'anshan (center of China) and Shanghai (southeast).Prevalence rate was calculated by counting the number of people living with a PBT between October 1,2005 and September 30,2006 and dividing by the total population of the five communities at January 1,2006.Estimates of prevalence were expressed as percentages and grouped according to gender and to age in fifteen-year categories.Within these strata,the rates were estimated with 95% confidence intervals (C/) using the accurate calculation of CI for Poisson distribution.A chi-square test was used to compare the various frequencies with α<0.05.Age-standardized prevalence with the direct method was calculated with the ten-year age-specific prevalence and the age distribution of the Chinese population in 2010,obtained from Worldpopulation prospects:the 2008 revision.Results We estimated that the overall prevalence of PBT was 24.56 per 100 000 (95% CI,14.85 to 34.27),and the overall prevalence of PBT in female population (30.57 per 100 000 and its 95% CI ranged from 19.73 to 41.41 ) was higher than that in male population (18.84 per 100 000 and its 95% CI ranged from 10.33 to 27.35).However,the discrepancy between genders was not statistically significant because the 95% CI overlapped.Of 272 cases of newly diagnosed PBT,the proportion of histological subtypes by age groups,gender was statistically different (χ2=52.6510,P <0.0001).More than

  5. Results of prospective multicenter study on heart failure on Campania Internal Medicine wards: the FASHION study

    Directory of Open Access Journals (Sweden)

    Fernando Gallucci

    2017-06-01

    Full Text Available Heart failure (HF is characterized by a high prevalence and hospitalization rate with considerable health and social impact; the knowledge of its epidemiological features remains the mainstay to assess adequacy of the health care needs. The aim of this study was to evaluate the prevalence of HF in Internal Medicine Units of the Campania region (Italy and patients’ characteristics. We recruited all patients with HF admitted between April 1 and June 30, 2014, in 23 Units of Internal Medicine: 975 patients (19.5% of 5000 admissions, 518 women and 457 men, mean age 76.9±9.9 (range 34-100 with 741 (76% older than 70 years. The mean age was higher in women than men; 35.8% of patients had atrial fibrillation, with higher prevalence in women than in men. Coronary artery disease represented the leading etiology while prevalence of non-ischemic heart failure was higher in women. New York Heart Association class was indicated in 926 patients. Left ventricular ejection fraction (LVEF was measured in 503 patients; 18.4% of patients had a severely reduced LVEF<35%, mostly men (P=0.0001 and 67.4% presented a LVEF>40%. At least one hospital admission in the previous 12 months was registered in 39.6% of patients. One, two and more than two relevant comorbidities were present in 8.6%, 24.7% and 64.8% of patients, respectively. Arterial hypertension and coronary artery disease were more frequent in female. In conclusion, advanced age and clinical complexity were the main characteristics of HF patients hospitalized in the Internal Medicine Units in Campania. Gender differences also emerged from the analysis of demographic parameters and etiopathogenetic features. Some diagnostic and therapeutic aspects not in line with that recommended by the most recent HF international guidelines were registered.

  6. Acute toxicity of adjuvant radiotherapy in locally advanced differentiated thyroid carcinoma. First results of the Multicenter Study Differential Thyroid Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Schuck, A.; Mueller, S.B.; Willich, N. [Dept. of Radiotherapy, Univ. Hospital Muenster (Germany); Biermann, M.; Pixberg, M.K.; Schober, O. [Dept. of Nuclear Medicine, Univ. Hospital Mueunster (Germany); Heinecke, A. [Dept. of Medical Informatics and Biomathematics, Univ. Hospital Muenster (Germany)

    2003-12-01

    Background and Purpose: The indication for adjuvant postoperative radiotherapy in patients with differentiated thyroid carcinoma (DTC) extending beyond the thyroid capsule has been an issue of controversy during the past 2 decades. No randomized studies evaluating the benefit of radiotherapy have been published so far. In the Multicenter Study Differentiated Thyroid Carcinoma (MSDS), a randomization has been performed concerning external-beam radiotherapy in patients with DTC extending beyond the thyroid capsule (pT4 pN0/1/ x cM0, TNM classification, 5th edition, 1997) following surgery and radioiodine therapy. Radiation-associated toxicity has been prospectively evaluated. Patients and Methods: Radiotherapy was performed with 50.4 Gy (pN1) or 54.0 Gy (pN1/x) to the cervical, supraclavicular and upper mediastinal lymph nodes. A total dose of 59.4 Gy (R0 resection) or 66.6 Gy (R1) was used to treat the tumor bed. Conventional fractionation was used with 1.8 Gy/d. At the time of the analysis, 36 patients were randomized or allocated to treatment arm A (with external-beam radiotherapy). Of these, 22 were treated with radiotherapy, and documentation of acute toxicity was available. Toxicity was evaluated prospectively according to the RTOG/EORTC criteria. Results: The maximal acute toxicity observed during radiotherapy was grade I in four patients, grade II in 16 patients, and grade III in two patients (9.1%; 95% confidence interval [95% CI] 1.1-29.2%). Toxicity was mainly observed at the pharynx, larynx, and skin. In 19 patients, residual toxicity within 100 days following radiotherapy was evaluated. No residual toxicity was observed in two patients. Maximal residual toxicity was grade I in 13 patients and grade II in four. No further grade III toxicity could be observed. Conclusion: The majority of patients experience mild to moderate side effects from adjuvant external-beam radiotherapy. At the first follow-up examination, most side effects have subsided. Acute

  7. Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B

    Institute of Scientific and Technical Information of China (English)

    Ping Liu; Mo-Bin Wan; Xiong Cai; Zhi-Qing Zhang; Jun Ye; Ren-Xing Zhou; Jia He; Bao-Zhang Tang; Yi-Yang Hu; Cheng Liu; Lie-Ming Xu; Cheng-Hai Liu; Ke-Wei Sun; De-Chang Hu; You-Kuan Yin; Xia-Qiu Zhou

    2005-01-01

    AIM: To study the efficacy and safety of Fuzhenghuayu capsule (FZHY capsule, a capsule for strengthening body resistance to remove blood stasis) against liver fibrosis due to chronic hepatitis B. METHODS: Multicenter, randomized, double blinded and parallel control experiment was conducted in patients (aged from 18 to 65 years) with liver fibrosis due to chronic hepatitis B. Hepatic histologic changes and HBV markers were examined at wk 0 and 24 during treatment. Serologic parameters (HA, LM, P-Ⅲ-P, Ⅳ-C) were determined and B ultrasound examination of the spleen and liver was performed at wk 0, 12 and 24. Liver function (liver function and serologic parameters for liver fibrosis) was observedat wk 0, 6, 12, 18 and 24. Blood and urine routine test, renal function and ECG were examined before and after treatment. RESULTS: There was no significant difference between experimental group (110 cases) and control group (106 cases) in demographic features, vital signs, course of illness, history for drug anaphylaxis and previous therapy, liver function, serologic parameters for liver fibrosis, liver histologic examination (99 cases in experimental group, 96 cases in control group), HBV markers, and renal function. According to the criteria for liver fibrosis staging, meanscore of fibrotic stage(s) in experimental group after treatment (1.80) decreased significantly compared to the previous treatment (2.33, P<0.05), but there was no significant difference in mean score of fibrotic stage(s) (2.11 and 2.14 respectively). There was a significant difference in reverse rate between experimental group (52%) and control group (23.3%) in liver biopsy. With marked effect on decreasing the mean value of inflammatory activity and score of inflammation (P<0.05), Fuzhenghuayu capsule had rather good effects on inhibiting inflammatory activity and was superior to that of Heluoshugan capsule. Compared to that of pretreatment, there was a significant decrease in HA, LM, P-Ⅲ-P and

  8. 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

    1999-01-01

    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

  9. Toward Developing a Specific Outcome Instrument for Spine Trauma : An Empirical Cross-sectional Multicenter ICF-Based Study by AOSpine Knowledge Forum Trauma

    NARCIS (Netherlands)

    Oner, F. Cumhur|info:eu-repo/dai/nl/188615326; Sadiqi, Said; Lehr, A. Mechteld; Aarabi, Bizhan; Dunn, Robert N.; Dvorak, Marcel F.; Fehlings, Michael G.; Kandziora, Frank; Post, Marcel W.|info:eu-repo/dai/nl/137146426; Rajasekaran, S.; Vialle, Luiz; Vaccaro, Alexander R.

    2015-01-01

    STUDY DESIGN: Empirical cross-sectional multicenter study. OBJECTIVE: To identify the most commonly experienced problems by patients with traumatic spinal column injuries, excluding patients with complete paralysis. SUMMARY OF BACKGROUND DATA: There is no disease or condition-specific outcome instru

  10. Double-blind randomized multicenter dose-comparison study of interferon-beta-1a (AVONEX) : rationale, design and baseline data

    NARCIS (Netherlands)

    Kristoferitsch, W; Seeldrayers, P; Kyriallis, K; Brochet, B; Confavreux, C; Clanet, M; Cesaro, P; Defer, G; Edan, G; Lyon-Caen, O; Pelletier, J; Rumbach, L; Roullet, E; Vermersch, P; Dengler, R; Zschenderlein, R; Storch-Hagenlocher, B; Sailer, M; Hohlfeld, R; Kunze, KP; Heesen, C; Bamborschke, P; Grunwald, F; Hartung, HP; Rieckmann, P; DeKeyser, J; Montalban, [No Value; Fernandez, U; Arbizu, T; Sandberg, M; Kappos, L; Bates, D; Campbell, MJ; Capildeo, R; Compston, A; McLellan, DL; Wroe, S; Young, C; Clanet, M; Hartung, HP; Hohlfeld, R; Kappos, L; Radue, EW; Rieckmann, P; Sandberg, M; Polman, C; Kesselring, J; Thompson, A; Wekerle, H; Whitehead, J; Bains, H; Butler, E; Kooijmans-Coutinho, M; McAllister, A; Simonian, N; White, K; Anderson, D; Liddiard, S; Keane, R

    2001-01-01

    We describe the rationale and design of a double-blind, randomized multicenter, dose-comparison study of interferon-beta-Ia (IFN-beta -Ia: AVONEX(R) in the treatment of relapsing multiple sclerosis (MS). The study is expected to provide quantitative insights on the dose range for optimal clinical be

  11. The morbidity of laparoscopic radical cystectomy: analysis of postoperative complications in a multicenter cohort by the European Association of Urology (EAU)-Section of Uro-Technology.

    Science.gov (United States)

    Albisinni, Simone; Oderda, Marco; Fossion, Laurent; Varca, Virginia; Rassweiler, Jens; Cathelineau, Xavier; Chlosta, Piotr; De la Taille, Alexandre; Gaboardi, Franco; Piechaud, Thierry; Rimington, Peter; Salomon, Laurent; Sanchez-Salas, Rafael; Stolzenburg, Jens-Uwe; Teber, Dogu; Van Velthoven, Roland

    2016-02-01

    To analyze postoperative complications after laparoscopic radical cystectomy (LRC) and evaluate its risk factors in a large prospective cohort built by the ESUT across European centers involved in minimally invasive urology in the last decade. Patients were prospectively enrolled, and data were retrospectively analyzed. Only oncologic cases were included. There were no formal contraindications for LRC: Also patients with locally advanced tumors (pT4a), serious comorbidities, and previous major abdominal surgery were enrolled. All procedures were performed via a standard laparoscopic approach, with no robotic assistance. Early and late postoperative complications were graded according to the modified Clavien-Dindo classification. Multivariate logistic regression was performed to explore possible risk factors for developing complications. A total of 548 patients were available for final analysis, of which 258 (47%) experienced early complications during the first 90 days after LRC. Infectious, gastrointestinal, and genitourinary were, respectively, the most frequent systems involved. Postoperative ileus occurred in 51/548 (9.3%) patients. A total of 65/548 (12%) patients underwent surgical re-operation, and 10/548 (2%) patients died in the early postoperative period. Increased BMI (p = 0.024), blood loss (p = 0.021), and neoadjuvant treatment (p = 0.016) were significantly associated with a greater overall risk of experiencing complications on multivariate logistic regression. Long-term complications were documented in 64/548 (12%), and involved mainly stenosis of the uretero-ileal anastomosis or incisional hernias. In this multicenter, prospective, large database, LRC appears to be a safe but morbid procedure. Standardized complication reporting should be encouraged to evaluate objectively a surgical procedure and permit comparison across studies.

  12. Risk of atrial fibrillation among bisphosphonate users: a multicenter, population-based, Italian study

    NARCIS (Netherlands)

    L. Herrera (Lizbeth); I. Leal (Ingrid); F. Lapi (Francesco); M.J. Schuemie (Martijn); V. Arcoraci (Vincenzo); F. Cipriani (Francesco); E. Sessa (E.); A. Vaccheri (Alberto); C. Piccinni (C.); T. Staniscia (Tommaso); A. Vestri (Annarita); M. Di Bari (M.); G. Corrao (Giovanni); A. Zambon (A.); D Gregori (Dario); F. Carle (F.); M.C.J.M. Sturkenboom (Miriam); G. Mazzaglia (Giampiero); G. Trifirò (Gianluca)

    2015-01-01

    textabstractSummary: Bisphosphonate treatment is used to prevent bone fractures. A controversial association of bisphosphonate use and risk of atrial fibrillation has been reported. In our study, current alendronate users were associated with a higher risk of atrial fibrillation as compared with tho

  13. Interpreting the Global Enteric Multicenter Study (GEMS) Findings on Sanitation, Hygiene, and Diarrhea.

    Science.gov (United States)

    Crocker, Jonny; Bartram, Jamie

    2016-05-01

    In this Perspective on the GEMS study by Kelly Baker and colleagues, Jonny Crocker and Jamie Bartram consider the implications of associations found and not found between diarrheal disease and sanitation and hygiene.

  14. Interpreting the Global Enteric Multicenter Study (GEMS Findings on Sanitation, Hygiene, and Diarrhea.

    Directory of Open Access Journals (Sweden)

    Jonny Crocker

    2016-05-01

    Full Text Available In this Perspective on the GEMS study by Kelly Baker and colleagues, Jonny Crocker and Jamie Bartram consider the implications of associations found and not found between diarrheal disease and sanitation and hygiene.

  15. 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

    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...... 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...... 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...

  16. HIV-1 infection: no evidence of cognitive decline during the asymptomatic stages. The Multicenter AIDS Cohort Study.

    Science.gov (United States)

    Selnes, O A; Miller, E; McArthur, J; Gordon, B; Muñoz, A; Sheridan, K; Fox, R; Saah, A J

    1990-02-01

    Cross-sectional studies have not adequately resolved the question of whether subjects infected with HIV-1 may suffer cognitive decline during the early, asymptomatic stages of the infection. We studied longitudinally 238 asymptomatic healthy HIV-1-infected homosexual/bisexual men (CDC groups 2 and 3) and 170 uninfected controls in the Multicenter AIDS Cohort Study with neuropsychological testing at semiannual intervals. A comparison of change in scores between visits 1 and 4 as well as a multivariate autoregressive analysis revealed no evidence of decline in test performance over time in the HIV-1-infected group compared with the seronegative controls. These findings suggest that a gradual cognitive decline does not occur during the early, asymptomatic stages of HIV infection.

  17. A multicenter phase II study of irinotecan in patients with advanced colorectal cancer previously treated with 5-fluorouracil.

    Science.gov (United States)

    Méndez, Miguel; Salut, Antonieta; García-Girón, Carlos; Navalon, Marta; Diz, Pilar; García López, Maria José; España, Pilar; de la Torre, Ascensión; Martínez del Prado, Purificación; Duarte, Isabel; Pujol, Eduardo; Arizcun, Alberto; Cruz, Juan Jesús

    2003-11-01

    This multicenter, open-label, phase II study was performed to assess the efficacy and toxicity of irinotecan 350 mg/m2 intravenously every 3 weeks in patients with advanced colorectal cancer (CRC) previously treated with 5-fluorouracil (5-FU). The study enrolled 115 patients and a total of 558 cycles (median, 6 per patient) were administered. The overall objective response rate on an intent-to-treat basis was 18% (with 1 complete response and 20 partial responses), whereas 42 patients (37%) showed stable disease. Median time to progression was 4.8 months and median survival was 13.6 months. Grade 3/4 toxicities included delayed diarrhea (19.1%), nausea/vomiting (10.4%), and neutropenia (8.7%). There were 2 toxic deaths, 1 from delayed diarrhea and 1 from hemorrhage and grade 4 mucositis. In conclusion, the present study confirms the antitumor efficacy of irinotecan monotherapy in patients with CRC pretreated with 5-FU.

  18. Sex-based Prognostic Implications of Nonobstructive Coronary Artery Disease: Results from the International Multicenter CONFIRM Study

    Science.gov (United States)

    Taylor, Carolyn M.; Gransar, Heidi; Shaw, Leslee J.; Ahmadi, Amir; Thompson, Angus; Humphries, Karin; Berman, Daniel S.; Hausleiter, Jörg; Achenbach, Stephan; Al-Mallah, Mouaz; Budoff, Matthew J.; Cademartiri, Fillippo; Callister, Tracy Q.; Chang, Hyuk-Jae; Chow, Benjamin J. W.; Cury, Ricardo C.; Delago, Augustin J.; Dunning, Allison L.; Feuchtner, Gudrun M.; Hadamitzky, Martin; Kaufmann, Philipp A.; Lin, Fay Y.; Chinnaiyan, Kavitha M.; Maffei, Erica; Raff, Gilbert L.; Villines, Todd C.; Gomez, Millie J.; Min, James K.

    2014-01-01

    Purpose To determine the clinical outcomes of women and men with nonobstructive coronary artery disease (CADcoronary artery disease) with coronary computed tomographic (CT) angiography data in patients who were similar in terms of CADcoronary artery disease risk factors, angina typicality, and CADcoronary artery disease extent and distribution. Materials and Methods Institutional review board approval was obtained for all participating sites, with either informed consent or waiver of informed consent. In a prospective international multicenter cohort study of 27 125 patients undergoing coronary CT angiography at 12 centers, 18 158 patients with no CADcoronary artery disease or nonobstructive (<50% stenosis) CADcoronary artery disease were examined. Men and women were propensity matched for age, CADcoronary artery disease risk factors, angina typicality, and CADcoronary artery disease extent and distribution, which resulted in a final cohort of 11 462 subjects. Nonobstructive CADcoronary artery disease presence and extent were related to incident major adverse cardiovascular events (MACEmajor adverse cardiovascular events), which were inclusive of death and myocardial infarction and were estimated by using multivariable Cox proportional hazards models. Results At a mean follow-up ± standard deviation of 2.3 years ± 1.1, MACEmajor adverse cardiovascular events occurred in 164 patients (0.6% annual event rate). After matching, women and men experienced identical annualized rates of myocardial infarction (0.2% vs 0.2%, P = .72), death (0.5% vs 0.5%, P = .98), and MACEmajor adverse cardiovascular events (0.6% vs 0.6%, P = .94). In multivariable analysis, nonobstructive CADcoronary artery disease was associated with similarly increased MACEmajor adverse cardiovascular events for both women (hazard ratio: 1.96 [95% confidence interval {CIconfidence interval}: 1.17, 3.28], P = .01) and men (hazard ratio: 1.77 [95% CIconfidence interval: 1.07, 2.93], P = .03). Conclusion

  19. Psoriasis and Diabetes: A Multicenter Study in 222078 Type 2 Diabetes Patients Reveals High Levels of Depression

    Directory of Open Access Journals (Sweden)

    Anke Schwandt

    2015-01-01

    Full Text Available Objective. This study aimed to investigate the association between psoriasis and disease outcome in type 2 diabetes (T2D. Methods. 222078 T2D patients (≥10 years old from the prospective, multicenter diabetes patient registry were analyzed. Specific search items were used to identify psoriasis patients. Multiple regression models were fitted and adjusted for demographic confounder. Results. 232 T2D patients had comorbid psoriasis. After adjusting psoriasis patients revealed a higher BMI (31.8 [31.0; 32.6] versus 30.6 [30.5; 30.6] kg/m2, p=0.004 and HbA1c (64.8 [62.1; 67.6] versus 59.0 [58.9; 59.1] mmol/mol, p<0.0001. Insulin was used more frequently (62.3 [55.7; 68.5] versus 50.9 [50.7; 51.1] %, p=0.001, only OAD/GLP-1 was similar, and nonpharmacological treatment was less common (13.3 [9.5; 18.3] versus 21.9 [21.7; 22.1] %, p=0.002. Severe hypoglycemia (0.31 [0.238; 0.399] versus 0.06 [0.057; 0.060] events per patient-year, p<0.0001, hypertension (86.1 [81.1; 90.0] versus 68.0 [67.8; 68.2] %, p<0.0001, and thyroid disease (14.0 [10.1; 19.2] versus 4.6 [4.5; 4.7] %, p<0.0001 were more prevalent. Depression occurred more often (10.5 [7.1; 15.2] versus 2.8 [2.7; 2.8] %, p<0.0001. Conclusions. Clinical diabetes characteristics in psoriasis T2D patients were clearly worse compared to patients without psoriasis. Comorbid conditions and depression were more prevalent, and more intensive diabetes therapy was required.

  20. Prospective multi-center study of female patients with ST-elevation myocardial infarction in Liaoning province, China

    Institute of Scientific and Technical Information of China (English)

    ZHANG Bo; LI Yu-ze; SHI Jing-pu; QI Guo-xian; JIANG Da-ming; ZHOU Xu-chen; LIU Jun; ZHANG Wei; SUN Yu-jiao; REN Li-na; ZHANG Zhi-hong; GAO Yuan

    2012-01-01

    Background In cardiology,it is controversial whether gender influences prognosis after acute myocardial infarction (MI).We examined the 30-day and 1-year prognosis for female patients with ST-elevation myocardial infarction (STEMI)in Liaoning province,and we analyzed factors that influenced these outcomes.Methods This was a prospective,multicenter,observational study in which patient data were collected by questionnaire at the time of diagnosis and at approximately 30 days and 1 year later by telephone inquiries.Patients were diagnosed with STEMI between June 1,2009 and June 1,2010 at any of the 20 hospitals that gave treatment representative of current STEMI treatment in Liaoning Province.Unified follow-up questionnaire was used to visit the STEMI patients.Results We analyzed data from a total of 1429 consecutive patients with STEMI in Liaoning province.Female patients were older (70.0 vs.60.3,P <0.001) and were less likely to receive emergency reperfusion therapy than male ones (39.2% vs.58.0%,P <0.001).Female gender was associated with higher unadjusted 30-day mortality rates (HR=2.118,95%C/:1.572-2.854,P <0.001) and higher unadjusted 1-year mortality rates (HR=2.174,95%C/:1.659-2.848,P <0.001).Multivariate Cox regression analysis showed that female gender was not an independent predictor of 30-day mortality rates (HR=1.273,95%C/:0.929-1.745,P=0.133) nor of 1-year mortality rates (HR=1.112,95%C/:0.831-1.487,P=0.475).Conclusions Women with STEMI appear to be at increased risk of 30-day and 1-year mortality compared with male STEMI patients,but this difference may be explained by older age and less frequent receipt of reperfusion therapy among the women.

  1. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study.

    Science.gov (United States)

    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

    2010-01-01

    Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing mean displacements of 1.87+/-0.95 mm and rotations of 1.56+/-0.66 degrees . Mean gray matter CBF was 47.4+/-7.5 [ml/100 g/min] with a between-subject standard variation SD(b)=5.5 [ml/100 g/min] and a within-subject standard deviation SD(w)=4.7 [ml/100 g/min]. The corresponding repeatability was 13.0 [ml/100 g/min] and was found to be within the range of previous studies.

  2. Conditions for exercising residents' voting rights in long-term care residences: a prospective multicenter study.

    Science.gov (United States)

    Bosquet, Antoine; El Massioui, Farid; Mahé, Isabelle

    2015-01-01

    To assess voting conditions in long-term care settings, we conducted a multicenter survey after the 2009 European elections in France. A questionnaire about voting procedures and European elections was proposed in 146 out of 884 randomized facilities. Sixty-four percent of facilities answered the questionnaire. Four percent of residents voted (national turnout: 40%), by proxy (58%) or at polling places (42%). Abstention related to procedural issues was reported in 32% of facilities. Sixty-seven percent of establishments had voting procedures, and 53% declared that they assessed residents' capacity to vote. Assistance was proposed to residents for voter registration, for proxy voting, and for voting at polling places, respectively, in 33%, 87%, and 80% of facilities. This survey suggests that residents may be disenfranchised and that more progress should be made to protect the voting rights of residents in long-term care facilities.

  3. 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...... referred to three Danish tertiary gynecological centers for surgical treatment. Preoperatively they were PET/CT-, MRI-, and 2DUS scanned. The imaging results were compared to the final pathological findings. This study was approved by the National Committee on Health Research Ethics. RESULTS......: For predicting myometrial invasion, we found sensitivity, specificity, PPV, NPV, and accuracy for PET/CT to be 93%, 49%, 41%, 95% and 61%, for MRI to be 87%, 57%, 44%, 92%, and 66% and for 2DUS to be 71%, 72%, 51%, 86% and 72%. For predicting cervical invasion, the values were 43%, 94%, 69%, 85% and 83...

  4. A multicenter study of the early detection of synaptic dysfunction in Mild Cognitive Impairment using Magnetoencephalography-derived functional connectivity.

    Science.gov (United States)

    Maestú, Fernando; Peña, Jose-Maria; Garcés, Pilar; González, Santiago; Bajo, Ricardo; Bagic, Anto; Cuesta, Pablo; Funke, Michael; Mäkelä, Jyrki P; Menasalvas, Ernestina; Nakamura, Akinori; Parkkonen, Lauri; López, Maria E; Del Pozo, Francisco; Sudre, Gustavo; Zamrini, Edward; Pekkonen, Eero; Henson, Richard N; Becker, James T

    2015-01-01

    Synaptic disruption is an early pathological sign of the neurodegeneration of Dementia of the Alzheimer's type (DAT). The changes in network synchronization are evident in patients with Mild Cognitive Impairment (MCI) at the group level, but there are very few Magnetoencephalography (MEG) studies regarding discrimination at the individual level. In an international multicenter study, we used MEG and functional connectivity metrics to discriminate MCI from normal aging at the individual person level. A labeled sample of features (links) that distinguished MCI patients from controls in a training dataset was used to classify MCI subjects in two testing datasets from four other MEG centers. We identified a pattern of neuronal hypersynchronization in MCI, in which the features that best discriminated MCI were fronto-parietal and interhemispheric links. The hypersynchronization pattern found in the MCI patients was stable across the five different centers, and may be considered an early sign of synaptic disruption and a possible preclinical biomarker for MCI/DAT.

  5. Topical tretinoin 0.1% for pregnancy-related abdominal striae: an open-label, multicenter, prospective study.

    Science.gov (United States)

    Rangel, O; Arias, I; García, E; Lopez-Padilla, S

    2001-01-01

    In an open-label, multicenter, prospective study, 20 women applied tretinoin (retinoic acid) cream 0.1% daily for 3 months to pregnancy-related stretch marks in the abdominal area. Efficacy was evaluated by analysis of one preselected target lesion, which was rated on a six-point scale (-1 = worse to 4 = cleared). At week 12, significant global improvement was noted from baseline in all stretch marks, and the target lesion decreased in length by 20% (P = .01). Erythema and scaling, the most common adverse events, occurred in 11 patients, decreased in severity after the first month of treatment, and were controlled with continued application of tretinoin and petroleum jelly ointment. In this small study, topical application of tretinoin significantly improved the clinical appearance of pregnancy-related stretch marks.

  6. Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment : a prospective web-based multi-center study in multiple sclerosis patients with a relapse

    NARCIS (Netherlands)

    Jongen, Peter Joseph; Stavrakaki, Ioanna; Voet, Bernard; Hoogervorst, Erwin; van Munster, Erik; Linssen, Wim H.; Sinnige, Ludovicus G.; Verhagen, Wim I.; Visser, Leo H.; van der Kruijk, Ruud; Verheul, Freek; Boringa, Jan; Heerings, Marco; Gladdines, Werner; Lonnqvist, Fredrik; Gaillard, Pieter

    2016-01-01

    In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-repo

  7. No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study.

    NARCIS (Netherlands)

    Meulen, C.G. ter; Riemsdijk, I.C. van; Hene, R.J.; Christiaans, M.H.; Borm, G.F.; Corstens, F.H.M.; Gelder, T. van; Hilbrands, L.B.; Weimar, W.; Hoitsma, A.J.

    2004-01-01

    BACKGROUND: Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal t

  8. Use of the University of California Los Angeles integrated staging system to predict survival in renal cell carcinoma: an international multicenter study.

    NARCIS (Netherlands)

    Patard, J.J.; Kim, H.L.; Lam, J.; Dorey, F.J.; Pantuck, A.J.; Zisman, A.; Ficarra, V.; Han, K.R.; Cindolo, L.; Taille, A. De La; Tostain, J.; Artibani, W.; Dinney, C.P.; Wood, C.G.; Swanson, D.A.; Abbou, C.C.; Lobel, B.; Mulders, P.F.A.; Chopin, D.K.; Figlin, R.A.; Belldegrun, A.S.

    2004-01-01

    PURPOSE: To evaluate ability of the University of California Los Angeles Integrated Staging System (UISS) to stratify patients with localized and metastatic renal cell carcinoma (RCC) into risk groups in an international multicenter study. PATIENTS AND METHODS: 4,202 patients from eight internationa

  9. Real-World Experience with Echinocandin MICs against Candida Species in a Multicenter Study of Hospitals That Routinely Perform Susceptibility Testing of Bloodstream Isolates

    OpenAIRE

    Eschenauer, Gregory A.; Nguyen, M Hong; Shoham, Shmuel; Jose A. Vazquez; Morris, Arthur J.; Pasculle, William A.; Kubin, Christine J.; Klinker, Kenneth P.; Carver, Peggy L.; Hanson, Kimberly E.; Chen, Sharon; Lam, Simon W.; Potoski, Brian A.; Clarke, Lloyd G.; Ryan K Shields

    2014-01-01

    Reference broth microdilution methods of Candida echinocandin susceptibility testing are limited by interlaboratory variability in caspofungin MICs. Recently revised Clinical and Laboratory Standards Institute (CLSI) breakpoint MICs for echinocandin nonsusceptibility may not be valid for commercial tests employed in hospital laboratories. Indeed, there are limited echinocandin susceptibility testing data from hospital laboratories. We conducted a multicenter retrospective study of 9 U.S., Aus...

  10. Blonanserin Augmentation of Atypical Antipsychotics in Patients with Schizophrenia-Who Benefits from Blonanserin Augmentation?: An Open-Label, Prospective, Multicenter Study

    National Research Council Canada - National Science Library

    Woo, Young Sup; Park, Joo Eon; Kim, Do-Hoon; Sohn, Inki; Hwang, Tae-Yeon; Park, Young-Min; Jon, Duk-In; Jeong, Jong-Hyun; Bahk, Won-Myong

    2016-01-01

    ...) with augmentation by blonanserin in schizophrenic patients. aA total of 100 patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP were recruited in this 12-week, open-label, non-comparative, multicenter study...

  11. Risk and timing of biochemical recurrence in pT3aN0/Nx prostate cancer with positive surgical margin - A multicenter study.

    Science.gov (United States)

    Karl, Alexander; Buchner, Alexander; Tympner, Christiane; Kirchner, Thomas; Ganswindt, Ute; Belka, Claus; Ganzer, Roman; Wieland, Wolf; Eder, Fabian; Hofstädter, Ferdinand; Schilling, David; Sievert, Karl-Dietrich; Stenzl, Arnulf; Scharpf, Marcus; Fend, Falko; Vom Dorp, Frank; Rübben, Herbert; Schmid, Kurt Werner; Porres-Knoblauch, Daniel; Heidenreich, Axel; Hangarter, Birgit; Knüchel-Clarke, Ruth; Rogenhofer, Michael; Wullich, Bernd; Hartmann, Arndt; Comploj, Evi; Pycha, Armin; Hanspeter, Esther; Pehrke, Dirk; Sauter, Guido; Graefen, Markus; Gratzke, Christian; Stief, Christian; Wiegel, Thomas; Haese, Alexander

    2015-07-01

    Positive surgical margins (PSM) after radical prostatectomy have been shown to be associated with impaired outcome. In pT3pN0 patients with PSM either immediate radiotherapy or clinical and biological monitoring followed by salvage radiotherapy is recommended by the latest guidelines of the European Association of Urology. A retrospective, multicenter study of eight urological centers was conducted on 536 prostatectomy patients with pT3aN0/NxR1 tumors and no neoadjuvant/adjuvant therapy. A pathological re-review of all prostate specimens was performed. Association of clinical and pathological features with biochemical recurrence (BCR) was analyzed using univariate and multivariate analysis. With 48months median follow-up, BCR occurred in 39.7%. Preoperative PSA value, performance of pelvic lymph node dissection and Gleason score were significantly associated with BCR. In multivariate analysis, Gleason score was the only independent prognostic factor (p<0.001) for BCR. Five-year BCR-free survival rates were 74%, 70%, 38%, and 51% with Gleason score 6, 3+4=7a, 4+3=7b, and 8-10, respectively. In pT3aN0/NxR1 patients with no adjuvant/neoadjuvant treatment, Gleason Score permits independent prediction of the risk for BCR. These findings could help to estimate and discuss the individual risk for BCR with our patients on an individual basis. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. Pharmacokinetics and pharmacodynamics of medication in asphyxiated newborns during controlled hypothermia. The PharmaCool multicenter study

    Directory of Open Access Journals (Sweden)

    de Haan Timo R

    2012-05-01

    Full Text Available Abstract Background In the Netherlands, perinatal asphyxia (severe perinatal oxygen shortage necessitating newborn resuscitation occurs in at least 200 of the 180–185.000 newly born infants per year. International randomized controlled trials have demonstrated an improved neurological outcome with therapeutic hypothermia. During hypothermia neonates receive sedative, analgesic, anti-epileptic and antibiotic drugs. So far little information is available how the pharmacokinetics (PK and pharmacodynamics (PD of these drugs are influenced by post resuscitation multi organ failure and the metabolic effects of the cooling treatment itself. As a result, evidence based dosing guidelines are lacking. This multicenter observational cohort study was designed to answer the question how hypothermia influences the distribution, metabolism and elimination of commonly used drugs in neonatal intensive care. Methods/Design Multicenter cohort study. All term neonates treated with hypothermia for Hypoxic Ischemic Encephalopathy (HIE resulting from perinatal asphyxia in all ten Dutch Neonatal Intensive Care Units (NICUs will be eligible for this study. During hypothermia and rewarming blood samples will be taken from indwelling catheters to investigate blood concentrations of several antibiotics, analgesics, sedatives and anti-epileptic drugs. For each individual drug the population PK will be characterized using Nonlinear Mixed Effects Modelling (NONMEM. It will be investigated how clearance and volume of distribution are influenced by hypothermia also taking maturation of neonate into account. Similarly, integrated PK-PD models will be developed relating the time course of drug concentration to pharmacodynamic parameters such as successful seizure treatment; pain assessment and infection clearance. Discussion On basis of the derived population PK-PD models dosing guidelines will be developed for the application of drugs during neonatal hypothermia treatment. The

  13. Multicenter trial of motion analysis for injury risk prediction: lessons learned from prospective longitudinal large cohort combined biomechanical - epidemiological studies

    Directory of Open Access Journals (Sweden)

    Timothy E. Hewett

    2015-10-01

    Full Text Available ABSTRACTOur biodynamics laboratory group has conducted large cohort biomechanical-epidemiological studies targeted at identifying the complex interactions among biomechanical, biological, hormonal, and psychosocial factors that lead to increased risk of anterior cruciate ligament (ACL injuries. The findings from our studies have revealed highly sensitive and specific predictors for ACL injury. Despite the high incidence of ACL injuries among young athletes, larger cohorts are needed to reveal the underlying mechanistic causes of increased risk for ACL injury. In the current study, we have outlined key factors that contribute to the overall success of multicenter, biomechanical-epidemiological investigations designed to test a larger number of athletes who otherwise could not be recruited, screened, or tested at a single institution. Twenty-five female volleyball players were recruited from a single high school team and tested at three biodynamics laboratories. All athletes underwent three-dimensional motion capture analysis of a drop vertical jump task. Kinematic and kinetic variables were compared within and among laboratories. Reliability of peak kinematic variables was consistently rated good-to-excellent. Reliability of peak kinetic variables was consistently rated goodto-excellent within sites, but greater variability was observed between sites. Variables measured in the sagittal plane were typically more reliable than variables measured in the coronal and transverse planes. This study documents the reliability of biomechanical variables that are key to identification of ACL injury mechanisms and of athletes at high risk. These findings indicate the feasibility of executing multicenter, biomechanical investigations that can yield more robust, reliable, and generalizable findings across larger cohorts of athletes.

  14. Applying the Maternal Near Miss Approach for the Evaluation of Quality of Obstetric Care: A Worked Example from a Multicenter Surveillance Study

    Directory of Open Access Journals (Sweden)

    Samira Maerrawi Haddad

    2014-01-01

    Full Text Available Objective. To assess quality of care of women with severe maternal morbidity and to identify associated factors. Method. This is a national multicenter cross-sectional study performing surveillance for severe maternal morbidity, using the World Health Organization criteria. The expected number of maternal deaths was calculated with the maternal severity index (MSI based on the severity of complication, and the standardized mortality ratio (SMR for each center was estimated. Analyses on the adequacy of care were performed. Results. 17 hospitals were classified as providing adequate and 10 as nonadequate care. Besides almost twofold increase in maternal mortality ratio, the main factors associated with nonadequate performance were geographic difficulty in accessing health services (P<0.001, delays related to quality of medical care (P=0.012, absence of blood derivatives (P=0.013, difficulties of communication between health services (P=0.004, and any delay during the whole process (P=0.039. Conclusions. This is an example of how evaluation of the performance of health services is possible, using a benchmarking tool specific to Obstetrics. In this study the MSI was a useful tool for identifying differences in maternal mortality ratios and factors associated with nonadequate performance of care.

  15. Comparison of Racial Differences in Plaque Composition and Stenosis among HIV Positive and Negative Men from the Multicenter Aids Cohort Study (MACS)

    Science.gov (United States)

    Miller, P Elliott; Budoff, Matthew; Zikusoka, Michelle; Li, Xiuhong; Palella, Frank; Kingsley, Lawrence A; Witt, Mallory D; Sharrett, A Richey; Jacobson, Lisa P; Post, Wendy S

    2014-01-01

    Previous studies demonstrated that blacks have less coronary artery calcification (CAC) than whites. We evaluated racial differences in plaque composition and stenosis in the Multicenter AIDS Cohort Study (MACS). HIV positive and negative men completed non-contrast cardiac CT if they were 40–70 years, weighed 50% on CTA. The association of presence and extent of plaque with race was determined after adjustment for HIV serostatus, cardiovascular risk factors and measures of socioeconomic status. The prevalences of any plaque on CTA and non-calcified plaque were not different between black and white men; however, black men had lower prevalences of CAC (Prevalence ratio (PR)=0.79, p=0.01), calcified plaque (PR=0.69, p=0.002), and stenosis >50% (PR=0.59, p=0.009). There were no associations between black race and extent of plaque in fully adjusted models. Using log-linear regression, black race was associated with a lower extent of any plaque on CTA in HIV positive men (estimate=−0.24, p=0.051) but not in HIV negative men (0.12, p=0.50, HIV interaction p=0.005). In conclusion, a lower prevalence of CAC in black compared to white men appears to reflect less calcification of plaque and stenosis rather than a lower overall prevalence of plaque. PMID:24929623

  16. Management of venous thromboembolism in patients with acute leukemia at high bleeding risk: a multi-center study.

    Science.gov (United States)

    Napolitano, Mariasanta; Valore, Luca; Malato, Alessandra; Saccullo, Giorgia; Vetro, Calogero; Mitra, Maria Enza; Fabbiano, Francesco; Mannina, Donato; Casuccio, Alessandra; Lucchesi, Alessandro; Del Principe, Maria Ilaria; Candoni, Anna; Di Raimondo, Francesco; Siragusa, Sergio

    2016-01-01

    In the last decades, evaluation of clinically relevant thrombotic complications in patients with acute leukemia (AL) has been poorly investigated. The authors performed a multi-center study to evaluate the management of symptomatic venous thromboembolism (VTE) in adult patients with AL. The intention was to find as clinically relevant the following: symptomatic Venous Thrombosis (VT) occurred in typical (lower limbs) and atypical (cerebral, upper limbs, abdominal, etc) sites with or without pulmonary embolism (PE). Over a population of 1461 patients with AL, 22 cases of symptomatic VTE were recorded in hospitalized patients with a mean age of 54.6 years. The absolute incidence of VTE was 1.5%. VTE occurred during chemotherapy in 17/22 (77.2%) cases, mainly (14/17, 82.3%) during the induction phase. Treatment of acute VTE was based on Low Molecular Weight Heparin (LMWH) at full dosage for the first month from diagnosis and reduced dosage (75%) for the following months.

  17. Roxatidine versus ranitidine in the treatment of patients with duodenal ulcer: a randomized, double-masked, multicenter study.

    Science.gov (United States)

    Zuberi, S J; Khan, A Q; Irshad-ul-Haque, I; Hussain, A; Hasnain, S S; Shah, S; Sadick, A; Yusuf, M Z; Reuter, M

    1996-01-01

    The comparative efficacy of roxatidine and ranitidine in the treatment of patients with acute duodenal ulcer was assessed at 4 and 6 weeks in this multicenter study. Ninety-four of 192 patients were given roxatidine in a single nightly dose of 150 mg, and 98 patients were given ranitidine in a single nightly dose of 300 mg. All the patients had endoscopically proven duodenal ulcer. Of the 171 assessable patients, ulcers were healed in 88% of the roxatidine group (73 of 83) and in 84% of the ranitidine group (74 of 88). No serious adverse events were reported in either group. We conclude that roxatidine 150 mg once daily is as effective and safe for the treatment of acute duodenal ulcer as ranitidine 300 mg once daily.

  18. Peri-ictal and inter-ictal headache in children and adolescents with idiopathic epilepsy: a multicenter cross-sectional study.

    Science.gov (United States)

    Verrotti, Alberto; Coppola, Giangennaro; Spalice, Alberto; Di Fonzo, Alessia; Bruschi, Raffaella; Tozzi, Elisabetta; Iannetti, Paola; Villa, Maria Pia; Parisi, Pasquale

    2011-09-01

    Headache in epileptic population ranges from 8% to 15%. The aim of this paper was to study the clinical and temporal characteristics of primary headache comorbidity in idiopathic epileptic children. From June 2006 to June 2009, a cross-sectional multi-center study involving five Italian Child Neurology University Centers (two in Rome, one in Chieti, one in Naples, and one in L'Aquila) was conducted. Among 1,264 consecutively newly diagnosed, idiopathic, partial, or generalized, epileptic children, according to ILAE diagnostic criteria (aged between 5 and 15 years of age), we selected 142 children (11.2%) (130 of whom completed the study) who showed an associated peri-ictal and/or inter-ictal headache diagnosed according to the International Headache Society Criteria. Rare cases of "ictal epileptic headache", in which headache represents the sole ictal epileptic manifestation, were excluded from this study. Post-ictal headaches were most frequent (62%). Pre-ictal headaches were less common (30%). Inter-ictal headaches were described in 57.6%. Clear migrainous features were present in 93% of pre-ictal and 81.4% of post-ictal headaches. Inter-ictal headaches meet criteria for migraines in 87%. The association between partial epilepsy and migraine without aura is most common and reported in 82% of our patients with peri-ictal headache and in 76.5% of patients with post-ictal headache.

  19. What Is the Impact of Center Variability in a Multicenter International Prospective Observational Study on Developmental Dysplasia of the Hip?

    Science.gov (United States)

    Mulpuri, Kishore; Schaeffer, Emily K; Kelley, Simon P; Castañeda, Pablo; Clarke, Nicholas M P; Herrera-Soto, Jose A; Upasani, Vidyadhar; Narayanan, Unni G; Price, Charles T

    2016-05-01

    Little information exists concerning the variability of presentation and differences in treatment methods for developmental dysplasia of the hip (DDH) in children Hip Dysplasia Institute to establish the need to consider the center as a key variable in multicenter studies. (1) How do patient demographics differ across participating centers at presentation? (2) How do patient diagnoses (severity and laterality) differ across centers? (3) How do initial treatment approaches differ across participating centers? A multicenter prospective hip dysplasia study database was analyzed from 2010 to April 2015. Patients younger than 6 months of age at diagnosis were included if at least one hip was completely dislocated, whereas patients between 6 and 18 months of age at diagnosis were included with any form of DDH. Participating centers (academic, urban, tertiary care hospitals) span five countries across three continents. Baseline data (patient demographics, diagnosis, swaddling history, baseline International Hip Dysplasia Institute classification, and initial treatment) were compared among all nine centers. A total of 496 patients were enrolled with site enrolment ranging from 10 to 117. The proportion of eligible patients who were enrolled and followed at the nine participating centers was 98%. Patient enrollment rates were similar across all sites, and data collection/completeness for relevant variables at initial presentation was comparable. In total, 83% of all patients were female (410 of 496), and the median age at presentation was 2.2 months (range, 0-18 months). Breech presentation occurred more often in younger (Hip Dysplasia Institute classification), which included 58% (51 of 88) of all classified dislocated hips. Splintage was the primary initial treatment of choice at 80% (395 of 496), but was far more likely in younger compared with older patients (94% [309 of 328] versus 18% [17 of 93]; p < 0.001). With the lack of strong prognostic indicators for DDH

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