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Utrecht, Netherlands

Hamaker M.E.,Diakonessenhuis Utrecht | Stauder R.,Innsbruck Medical University
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.

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.

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.

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.

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.

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