Hamaker M.E.,Diakonessenhuis Utrecht |
Stauder R.,Innsbruck Medical University |
Van Munster B.C.,Gelre Hospitals
Annals of Oncology | Year: 2014
Background: Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. Method: The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results: In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Conclusion: Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Van Der Meijden O.A.,Diakonessenhuis Utrecht |
Marijn Houwert R.,Diakonessenhuis Utrecht |
Hulsmans M.,Diakonessenhuis Utrecht |
Wijdicks F.-J.G.,Diakonessenhuis Utrecht |
And 5 more authors.
Journal of Bone and Joint Surgery - American Volume | Year: 2015
Background: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. Methods: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p < 0.05. Results: No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). Conclusions: The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant removal. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2015 By The Journal of Bone and Joint Surgery, Incorporated.
Buddingh K.T.,Deventer Hospital |
Buddingh K.T.,University of Groningen |
Herngreen T.,Deventer Hospital |
Haringsma J.,Erasmus Medical Center |
And 4 more authors.
American Journal of Gastroenterology | Year: 2011
Objectives: Delayed hemorrhage is an infrequent, but serious complication of colonoscopic polypectomy. Large size is the only polyp-related factor that has been unequivocally proven to increase the risk of delayed bleeding. It has been suggested that location in the right hemi-colon is also a risk factor. The objective of this study was to determine whether polyp location is an independent risk factor for delayed post-polypectomy hemorrhage. Methods: A retrospective case-control study was conducted in two university hospitals and two community hospitals. Results: Thirty-nine cases and 117 controls were identified. In multivariate analysis, size and location were found to be independent polyp-related risk factors for delayed type hemorrhage. The risk increased by 13% for every 1 mm increase in polyp diameter (odds ratio (OR) 1.13, 95% confidence interval (CI) 1.05-1.20, P0.001). Polyps located in the right hemi-colon had an OR of 4.67 (1.88-11.61, P0.001) for delayed hemorrhage. Polyps in the cecum seemed to be especially at high risk in univariate analysis (OR 13.82, 95% CI 2.66-71.73), but this could not be assessed in multivariate analysis as the number of cases was too small. Polyp type (sessile or pedunculated) was not a risk factor. Conclusions: Polyp location in the right hemi-colon seems to be an independent and substantial risk factor for delayed post-polypectomy hemorrhage. A low threshold for preventive hemostatic measures is advised when removing polyps from this region. © 2011 by the American College of Gastroenterology.
Van Eijk M.M.J.,University Utrecht |
Roes K.C.B.,University Utrecht |
Honing M.L.H.,Medical Center Alkmaar |
Kuiper M.A.,Medical Center Leeuwarden |
And 6 more authors.
The Lancet | Year: 2010
Delirium is frequently diagnosed in critically ill patients and is associated with adverse outcome. Impaired cholinergic neurotransmission seems to have an important role in the development of delirium. We aimed to establish the effect of the cholinesterase inhibitor rivastigmine on the duration of delirium in critically ill patients. Patients (aged ≥18 years) who were diagnosed with delirium were enrolled from six intensive care units in the Netherlands, and treated between November, 2008, and January, 2010. Patients were randomised (1:1 ratio) to receive an increasing dose of rivastigmine or placebo, starting at 0·75 mL (1·5 mg rivastigmine) twice daily and increasing in increments to 3 mL (6 mg rivastigmine) twice daily from day 10 onwards, as an adjunct to usual care based on haloperidol. The trial pharmacist generated the randomisation sequence by computer, and consecutively numbered bottles of the study drug according to this sequence to conceal allocation. The primary outcome was the duration of delirium during hospital admission. Analysis was by intention to treat. Duration of delirium was censored for patients who died or were discharged from hospital while delirious. Patients, medical staff, and investigators were masked to treatment allocation. Members of the data safety and monitoring board (DSMB) were unmasked and did interim analyses every 3 months. This trial is registered with ClinicalTrials.gov, number NCT00704301. Although a sample size of 440 patients was planned, after inclusion of 104 patients with delirium who were eligible for the intention-to-treat analysis (n=54 on rivastigmine, n=50 on placebo), the DSMB recommended that the trial be halted because mortality in the rivastigmine group (n=12, 22) was higher than in the placebo group (n=4, 8; p=0·07). Median duration of delirium was longer in the rivastigmine group (5·0 days, IQR 2·7-14·2) than in the placebo group (3·0 days, IQR 1·0-9·3; p=0·06). Rivastigmine did not decrease duration of delirium and might have increased mortality so we do not recommend use of rivastigmine to treat delirium in critically ill patients. ZonMw, the Netherlands Brain Foundation, and Novartis. © 2010 Elsevier Ltd.
Postma D.F.,University Utrecht |
Van Werkhoven C.H.,University Utrecht |
Van Elden L.J.R.,Diakonessenhuis Utrecht |
Thijsen S.F.T.,Diakonessenhuis Utrecht |
And 8 more authors.
New England Journal of Medicine | Year: 2015
Background: The choice of empirical antibiotic treatment for patients with clinically suspected community-acquired pneumonia (CAP) who are admitted to non-intensive care unit (ICU) hospital wards is complicated by the limited availability of evidence. We compared strategies of empirical treatment (allowing deviations for medical reasons) with beta-lactam monotherapy, beta-lactam-macrolide combination therapy, or fluoroquinolone monotherapy. Methods: In a cluster-randomized, crossover trial with strategies rotated in 4-month periods, we tested the noninferiority of the beta-lactam strategy to the beta-lactam-macrolide and fluoroquinolone strategies with respect to 90-day mortality, in an intention- to-treat analysis, using a noninferiority margin of 3 percentage points and a two-sided 90% confidence interval. Results: A total of 656 patients were included during the beta-lactam strategy periods, 739 during the beta-lactam-macrolide strategy periods, and 888 during the fluoroquinolone strategy periods, with rates of adherence to the strategy of 93.0%, 88.0%, and 92.7%, respectively. The median age of the patients was 70 years. The crude 90-day mortality was 9.0% (59 patients), 11.1% (82 patients), and 8.8% (78 patients), respectively, during these strategy periods. In the intention-to-treat analysis, the risk of death was higher by 1.9 percentage points (90% confidence interval [CI], -0.6 to 4.4) with the betalactam- macrolide strategy than with the beta-lactam strategy and lower by 0.6 percentage points (90% CI, -2.8 to 1.9) with the fluoroquinolone strategy than with the beta-lactam strategy. These results indicated noninferiority of the beta-lactam strategy. The median length of hospital stay was 6 days for all strategies, and the median time to starting oral treatment was 3 days (interquartile range, 0 to 4) with the fluoroquinolone strategy and 4 days (interquartile range, 3 to 5) with the other strategies. Conclusions: Among patients with clinically suspected CAP admitted to non-ICU wards, a strategy of preferred empirical treatment with beta-lactam monotherapy was noninferior to strategies with a beta-lactam-macrolide combination or fluoroquinolone monotherapy with regard to 90-day mortality. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
Kool M.B.,University Utrecht |
Van Middendorp H.,University Utrecht |
Lumley M.A.,Wayne State University |
Schenk Y.,Diakonessenhuis Utrecht |
And 3 more authors.
Annals of the Rheumatic Diseases | Year: 2010
Background: Patients with rheumatic diseases may face 'discounting' (denying and patronising) or 'lack of understanding' because of having symptoms without external clinical signs, but instruments to assess such invalidation experiences are lacking. Objectives: To develop and evaluate the Illness Invalidation Inventory (3*I), to compare invalidation experiences of two groups of patients who differ in visual signs and laboratory findings - rheumatoid arthritis (RA) and fibromyalgia - and to examine the association of invalidation with health status. Methods: A questionnaire (eight items with respect to five sources: spouse, family, medical professionals, work environment and social services) was constructed. It was completed by 142 patients with RA and 167 patients with fibromyalgia. Results: Principal axis factoring with oblimin rotation yielded two factors with high internal consistency (α>0.70): 'discounting' (five items) and 'lack of understanding' (three items). Patients with fibromyalgia experienced significantly more discounting and lack of understanding from their family, medical professionals, colleagues and social services than did patients with RA. Both patient groups experienced more invalidation from social services, colleagues and family than from medical professionals and spouses. More discounting and lack of understanding correlated with poorer mental well-being and social functioning in both patient groups. Discounting correlated with more physical disability and pain in patients with RA. Conclusions: The 3*I is a brief, reliable instrument for assessing patients' perceptions of invalidation from different sources, which differ between patient groups and are associated with health status. Future validation research should clarify the clinical impact of invalidation on treatment adherence and outcome.
Hamaker M.E.,Diakonessenhuis Utrecht |
Vos A.G.,Diakonessenhuis Utrecht |
Smorenburg C.H.,Medical Center Alkmaar |
de Rooij S.E.,Academic Medical Center Amsterdam |
Van Munster B.C.,Academic Medical Center Amsterdam
Oncologist | Year: 2012
Background. Awareness of the use of geriatric assessments for older patients with cancer is increasing. The aim of this review is to summarize all available evidence on the association between geriatric assessments and relevant oncologic outcomes. Method. A systematic search was conducted in Medline and Embase of studies on geriatric assessment in oncology, focusing on the association between baseline assessment and outcome. Results. The literature search identified 2008 reports; 51 publications from 37 studies were selected for inclusion in the review. The quality of studies was heterogeneous and generally poor. A median of five geriatric conditions were assessed per study (interquartile range: 4-8). Little consistency was found in the results of the studies. Furthermore, different tools appear to be predictive depending on the outcome measure: frailty, nutritional status, and comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics were predictive for all-cause mortality; frailty was predictive for toxicity of chemotherapy; cognitive impairment and activities of daily living impairment were predictive for chemotherapy completion; and instrumental activities of daily living impairment was predictive for perioperative complications. Conclusion. Although various geriatric conditions appear to be of some value in predicting outcome in elderly patients with cancer, the results are too inconsistent to guide treatment decisions. Further research is needed to elucidate the role of geriatric assessments in the oncologic decision-making process for these patients. © AlphaMed Press.
Houwert R.M.,Diakonessenhuis Utrecht |
Wijdicks F.-J.,Diakonessenhuis Utrecht |
Steins Bisschop C.,University Utrecht |
Verleisdonk E.-J.,Diakonessenhuis Utrecht |
Kruyt M.,University Utrecht
International Orthopaedics | Year: 2012
Purpose: The optimal surgical approach for displaced midshaft clavicle fracture remains controversial. The objective of this systematic review is to compare functional outcome and complications after plate fixation and intramedullary fixation for displaced midshaft clavicle fractures. Methods: A computer aided search of PUBMED and Embase was carried out on January 11th 2011. Every study that was published in the English, German, French or Dutch language was considered for inclusion. A total of four studies could be included of which two compared intramedullary fixation versus plate fixation, and two compared intramedullary fixation and plate fixation versus conservative treatment for displaced midshaft clavicle fractures. Studies that compared plate fixation with intramedullary fixation in patients with fresh unilateral displaced midshaft clavicle fractures were included. Dislocation or displacement had to be mentioned in the inclusion criteria of the study for inclusion in this review. The modified version of the Cochrane Bone, Joint and Muscle Trauma Group's former quality assessment tool was used. Furthermore, the studies included were scored according to the GRADE approach to assess the quality. The chosen studies were summarised in a data-extraction form. Because of the different study designs and characteristics data were summarised separately for each study. Conclusions: High quality evidence from one study and low quality evidence from three studies showed no difference in functional outcome or complications after plate fixation or intramedullary fixation for displaced midshaft clavicle fractures. © 2011 The Author(s).
Hofland R.W.,Diakonessenhuis Utrecht |
Thijsen S.F.T.,Diakonessenhuis Utrecht |
Verhagen M.A.M.T.,Diakonessenhuis Utrecht |
Schenk Y.,Diakonessenhuis Utrecht |
Bossink A.W.J.,Diakonessenhuis Utrecht
Thorax | Year: 2013
As part of a prospective study on the safety of TNF-a inhibitor therapy after screening for and treatment of latent tuberculosis infection (LTBI), we report two patients who developed active tuberculosis (TB) infection during TNF-a inhibitor therapy, despite negative screening for LTBI. The clinical history is suggestive of a primary infection acquired during travelling to TB-endemic countries. In this lesson of the month we would like to highlight the risk of travelling to TBendemic areas in patients treated with TNF-a inhibitor therapy. Screening for latent tuberculosis infection is not enough to prevent tuberculosis in patients treated with TNF-a inhibitor therapy.
de Lau H.,Diakonessenhuis Utrecht
Archives of gynecology and obstetrics | Year: 2011
To determine the risk of uterine rupture for women undergoing trial of labour (TOL) with both a prior caesarean section (CS) and a vaginal delivery. A systematic literature search was performed using keywords for CS and uterine rupture. The results were critically appraised and the data from relevant and valid articles were extracted. Odds ratios were calculated and a pooled estimate was determined using the Mantel-Haenszel method. Five studies were used for final analysis. Three studies showed a significant risk reduction for women with both a previous CS and a prior vaginal delivery (PVD) compared to women with a previous CS only, and two studies showed a trend towards risk reduction. The absolute risk of uterine rupture with a prior vaginal delivery varied from 0.17 to 0.46%. The overall odds ratio for PVD was 0.39 (95% CI 0.29-0.52, P < 0.00001). Women with a history of both a CS and vaginal delivery are at decreased risk of uterine rupture when undergoing TOL compared with women who have only had a CS.