Van Hooft J.E.,University of Amsterdam |
Van Hooft J.E.,Spectrum |
Bemelman W.A.,University of Amsterdam |
Oldenburg B.,University Utrecht |
And 6 more authors.
The Lancet Oncology | Year: 2011
Background: Colonic stenting as a bridge to elective surgery is an alternative for emergency surgery in patients with acute malignant colonic obstruction, but its benefits are uncertain. We aimed to establish whether colonic stenting has better health outcomes than does emergency surgery. Methods: Patients with acute obstructive left-sided colorectal cancer were enrolled from 25 hospitals in the Netherlands and randomly assigned (1:1 ratio) to receive colonic stenting as a bridge to elective surgery or emergency surgery. The randomisation sequence was computer generated with permuted blocks and was stratified by centre; treatment allocation was concealed by use of a web-based application. Investigators and patients were unmasked to treatment assignment. The primary outcome was mean global health status during a 6-month follow-up, which was assessed with the QL2 subscale of the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30). Analysis was by intention to treat. This study is registered, number ISRCTN46462267. Findings: Between March 9, 2007, and Aug 27, 2009, 98 patients were assigned to receive colonic stenting (n=47 patients) or emergency surgery (n=51). Two successive interim analyses showed increased 30-day morbidity in the colonic stenting group, with an absolute risk increase of 0·19 (95% CI -0·06 to 0·41) in analysis of the first 60 patients (14 of 28 patients receiving colonic stenting vs 10 of 32 receiving emergency surgery), and an absolute risk increase of 0·19 (-0·01 to 0·37) in analysis of the first 90 patients (23 of 47 patients vs 13 of 43). In accordance with the advice of the data safety monitoring committee, the study was suspended on Sept 18, 2009, and ended on March 12, 2010. At the final analysis of 98 patients, mean global health status during follow-up was 63·0 (SD 23·8) in the colonic stenting group and 61·4 (SD 21·9) in the emergency surgery group; after adjustment for baseline values, mean global health status did not differ between treatment groups (-4·7, 95% CI -14·8 to 5·5, p=0·36). No difference was recorded between treatment groups in 30-day mortality (absolute risk difference -0·01, 95% CI -0·14 to 0·12, p=0·89), overall mortality (-0·02, -0·17 to 0·14, p=0·84), morbidity (-0·08, -0·27 to 0·11, p=0·43), and stoma rates at latest follow-up (0·09, -0·10 to 0·27, p=0·35). However, the emergency surgery group had an increased stoma rate directly after initial intervention (0·23, 0·04 to 0·40, p=0·016) and a reduced frequency of stoma-related problems (between-group difference -12·0, -23·7 to -0·2, p=0·046). The most common serious adverse events were abscess (three in the colonic stenting group vs four in the emergency surgery group), perforations (six vs none), and anastomotic leakage (five vs one), and the most common adverse events were pneumonia (three vs one) and wound infection (one vs three). Interpretation: Colonic stenting has no decisive clinical advantages to emergency surgery. It could be used as an alternative treatment in as yet undefined subsets of patients, although with caution because of concerns about tumour spread caused by perforations. Funding: None. © 2011 Elsevier Ltd.
Berkhemer O.A.,Erasmus Medical Center |
Fransen P.S.S.,Erasmus Medical Center |
Beumer D.,Erasmus Medical Center |
Van Den Berg L.A.,Erasmus Medical Center |
And 29 more authors.
New England Journal of Medicine | Year: 2015
Background In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. Methods We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). Results We enrolled 500 patients at 16 medical centers in the Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. Conclusions In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. © 2015 Massachusetts Medical Society.
Nur E.,Slotervaart Hospital Amsterdam |
Otten H.-M.,Slotervaart Hospital Amsterdam |
Brandjes D.P.,Slotervaart Hospital Amsterdam |
Schnog J.-J.B.,Slotervaart Hospital Amsterdam |
Schnog J.-J.B.,Sint Elisabeth Hospital
American Journal of Hematology | Year: 2011
Sickle cell disease (SCD) is a hemoglobinopathy characterized by hemolytic anemia, increased susceptibility to infections and vaso-occlusion leading to a reduced quality of life and life expectancy. Oxidative stress is an important feature of SCD and plays a significant role in the pathophysiology of hemolysis, vaso-occlusion and ensuing organ damage in sickle cell patients. Reactive oxygen species (ROS) and the (end-)products of their oxidative reactions are potential markers of disease severity and could be targets for antioxidant therapies. This review will summarize the role of ROS in SCD and their potential implication for SCD management. © 2011 Wiley-Liss, Inc.
Beekman R.,Atrium Medical |
Visser L.H.,Sint Elisabeth Hospital |
Verhagen W.I.,Canisius Wilhelmina Hospital Nijmegen
Muscle and Nerve | Year: 2011
Introduction: Ultrasonography of the ulnar nerve has been recommended as a useful additional test in ulnar neuropathy at the elbow (UNE). Methods: We searched the literature and systemically reviewed all clinical trials in UNE. We also looked for articles about the normal sonoanatomy and specific causes of UNE. Results: Seven of 14 clinical trials in UNE were suitable for further analysis. Ultrasonographic ulnar nerve size measurement appears to be a test with good diagnostic accuracy. The most frequently reported abnormality was an increased cross-sectional area of the ulnar nerve at the elbow. However, several studies had methodological flaws. In addition, the ultrasonographic techniques and study designs differed among the studies. There were a few other uncontrolled studies about the underlying causes of UNE. Discussion: The role of ultrasonography in UNE seems promising but could not be firmly established. More prospective studies are needed, and we make several recommendations for further research. © 2011 Wiley Periodicals, Inc.
Ebben R.H.A.,HAN University of Applied Sciences |
Vloet L.C.M.,HAN University of Applied Sciences |
Vloet L.C.M.,Canisius Wilhelmina Hospital |
Verhofstad M.H.J.,Sint Elisabeth Hospital |
And 3 more authors.
Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine | Year: 2013
A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals' adherence to (inter)national guidelines and protocols in the emergency medical dispatch, prehospital and emergency department (ED) settings, and (2) to explore which factors influencing adherence were described in studies reporting on adherence. PubMed (including MEDLINE), CINAHL, EMBASE and the Cochrane database for systematic reviews were systematically searched. Reference lists of included studies were also searched for eligible studies. Identified articles were screened on title, abstract and year of publication (≥1990) and were included when reporting on adherence in the eligible settings. Following the initial selection, articles were screened full text and included if they concerned adherence to a (inter)national guideline or protocol, and if the time interval between data collection and publication date was <10 years. Finally, articles were assessed on reporting quality. Each step was undertaken by two independent researchers. Thirty-five articles met the criteria, none of these addressed the emergency medical dispatch setting or protocols. Median adherence ranged from 7.8-95% in the prehospital setting, and from 0-98% in the ED setting. In the prehospital setting, recommendations on monitoring came with higher median adherence percentages than treatment recommendations. For both settings, cardiology treatment recommendations came with relatively low median adherence percentages. Eight studies identified patient and organisational factors influencing adherence. The results showed that professionals' adherence to (inter)national prehospital and emergency department guidelines shows a wide variation, while adherence in the emergency medical dispatch setting is not reported. As insight in influencing factors for adherence in the emergency care settings is minimal, future research should identify such factors to allow the development of strategies to improve adherence and thus improve quality of care. © 2013 Ebben et al; licensee BioMed Central Ltd.
Van Velzen G.A.J.,Leiden University |
Perez R.S.G.M.,Knowledge Consortium TREND |
Perez R.S.G.M.,VU University Amsterdam |
Perez R.S.G.M.,Institute for Extramural Medicine EMGO |
And 12 more authors.
Pain | Year: 2014
There are limited data available on health-related quality of life (QoL) in patients with complex regional pain syndrome (CRPS). In the present study we examined QoL in 975 CRPS patients attending 6 different clinics in the Netherlands. QoL was assessed using the MOS 36-Item Short-Form Health Survey (SF-36) with the Mental Health Summary Score (MHS) and the Physical Health Summary Score (PHS) as dependent variables. The influences of gender, type of affected limb, disease duration, pain scores, CRPS severity and set of diagnostic criteria used were investigated. We found the lowest scores of QoL in the physical domains of the SF-36, with lower-limb CRPS patients reporting poorer results than patients with an affected upper limb. Influence of gender on QoL was not observed, and correlations of QoL with disease duration and the CRPS severity score were weak. Pain correlated moderately with QoL. In addition, patients fulfilling stricter diagnostic criteria (ie, the Budapest criteria) had lower QoL scores than patients fulfilling less strict criteria (ie, the Orlando criteria). We conclude that loss of QoL in CRPS patients is due mainly to reduced physical health. A comparison with data available from the literature shows that CRPS patients generally report poorer QoL than patients with other chronic pain conditions, particularly in the physical domains. Pain correlated moderately with QoL and therefore deserves ongoing attention by physicians. Finally, patients meeting the diagnostic Budapest criteria have lower QoL scores than patients meeting the Orlando criteria, highlighting the impact of different sets of criteria on population characteristics. © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
Multicenter phase II randomized trial evaluating antiangiogenic therapy with sunitinib as consolidation after objective response to taxane chemotherapy in women with HER2-negative metastatic breast cancer
Wildiers H.,University Hospitals Leuven |
Fontaine C.,Oncologisch Centrum |
Vuylsteke P.,Sint Elisabeth Hospital |
Martens M.,Sint Elisabeth Hospital |
And 6 more authors.
Breast Cancer Research and Treatment | Year: 2010
The aim of this study is to test the hypothesis that antiangiogenic treatment with sunitinib consolidation can prolong remissions induced by taxane-based chemotherapy in women with metastatic breast cancer. The method involves a two-arm open-label (2:1 randomization) multicenter, randomized phase II trial evaluating the efficacy of sunitinib (arm A) versus no therapy (arm B) in patients with HER-2-negative metastatic breast cancer who achieved an objective response to taxane-based chemotherapy. The results of this study indicates that the primary endpoint of progression-free survival (PFS) ≥5 months was achieved in 10 of 36 patients (28%) in arm A and 4 of 19 patients (21%) in arm B. The median PFS was 2.8 and 3.1 months, respectively. A protocol amendment to the sunitinib dosing schedule was made because 53% (17/32) of patients treated at a starting dose of 50 mg (4 weeks on/2 weeks off) required dose reduction. Changing the starting dose to sunitinib 37.5 mg continuously resulted in dose reductions in 44% (7/16) of patients. Grades III-IV toxicity occurred in 69% of patients in arm A (fatigue 31%, musculoskeletal pain 11%, neutropenia and thrombopenia 8%) and 11% in arm B. The proof-of-principle study does not confirm the hypothesis that sunitinib consolidation therapy can lead to a predefined clinically relevant proportion of patients with PFS of ≥5 months after an objective response to taxanes. Furthermore, toxicity was significant. © 2010 Springer Science+Business Media, LLC.
Willemsen I.,Amphia Hospital |
Overdevest I.,Sint Elisabeth Hospital |
Al Naiemi N.,VU University Amsterdam |
Rijnsburger M.,VU University Amsterdam |
And 4 more authors.
Journal of Clinical Microbiology | Year: 2011
The performance of a microarray for the detection of extended-spectrum beta-lactamases was determined on a collection of 638 highly resistant members of the family Enterobacteriaceae collected from patients in 18 hospitals in The Netherlands. The microarray had a significantly higher specificity than the phenotypic assays. It also detects carbapenemases and characterizes the resistance genes, providing epidemiological insight. Copyright © 2011, American Society for Microbiology. All Rights Reserved.
Voogt M.J.,University Utrecht |
Arntz M.J.,University Medical Center Nijmegen |
Lohle P.N.M.,Sint Elisabeth Hospital |
Mali W.P.T.M.,University Utrecht |
Lampmann L.E.H.,Sint Elisabeth Hospital
CardioVascular and Interventional Radiology | Year: 2011
Purpose: To assess current uterine fibroid embolisation (UFE) practice in European countries and determine the clinical environment for UFE in different hospitals. Material and Methods: In May 2009, an invitation for an online survey was sent by e-mail to all members of the Cardiovascular and Interventional Radiologic Society of Europe, representing a total number of 1,250 different candidate European treatment centres. The survey covered 21 questions concerning local UFE practice. Results: A total of 282 respondents completed the questionnaire. Fifteen questionnaires were excluded because they were doubles from centres that had already returned a questionnaire. The response rate was 267 of 1,250 centres (21.4%). Ninety-four respondents (33%) did not perform UFE and were excluded, and six centres were excluded because demographic data were missing. The remaining 167 respondents from different UFE centres were included in the study. Twenty-six percent of the respondents were from the United Kingdom (n = 43); 16% were from Germany (n = 27); 11% were from France (n = 18); and the remaining 47% (n = 79) were from other European countries. Most centres (48%, n = 80) had 5 to 10 years experience with UFE and performed 10 to 50 procedures annually (53% [n = 88]) of respondents). Additional demographic data, as well as specific data on referral of patients, UFE techniques used, and periprocedural and postprocedural, care will be provided. Conclusion: Although UFE as an alternative treatment for hysterectomy or myomectomy is widespread in Europe, its impact on the management of the patient with symptomatic fibroids seems, according to the overall numbers of UFE procedures, somewhat disappointing. Multiple factors might be responsible for this observation. © 2010 The Author(s).