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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.

Den Uil C.A.,Erasmus Medical Center | Van Der Ent M.,Erasmus Medical Center | Jewbali L.S.D.,Erasmus Medical Center | Cheng J.M.,Erasmus Medical Center | And 2 more authors.
European Heart Journal | Year: 2010

Aims We investigated the relationship between sublingual perfused capillary density (PCD) as a measure of tissue perfusion and outcome (i.e. occurrence of organ failure and mortality) in patients with cardiogenic shock from acute myocardial infarction. Methods and results We performed a prospective study in 68 patients. Using Sidestream Dark Field imaging, PCD was measured after hospital admission (T0, baseline) and 24 h later (T1). We compared patients with baseline PCD ≤ median to patients with baseline PCD > median. Sequential organ failure assessment (SOFA) scores were calculated at both time points. The Kaplan-Meier 30-day survival analyses were performed and predictors of 30-day mortality were identified. The baseline PCD was a predictor of the change in the SOFA score between T0 and T1 (SOFA; ρ = -0.25, P = 0.04). Organ failure recovered more frequently in patients with PCD > median (>10.3 mm mm -2; n = 33) than in patients with PCD ≤ median (n = 35; 52 vs. 29, P < 0.05). Twenty-two patients (32) died: 17 patients (49) with PCD ≤ median vs. 5 patients (15) with PCD > median (P = 0.004). After adjustment, the cardiac power index [odds ratio (OR): 0.48, 95 CI: 0.24-0.94) and PCD (OR: 0.65, 95 CI: 0.45-0.92) remained significant predictors of 30-day outcome. Patients with baseline sublingual PCD ≤ median that improved at T1 had a considerable better prognosis relative to patients who had a persistently low PCD. Conclusion Diminished sublingual PCD, at baseline or following treatment, is associated with development of multi-organ failure and is a predictor of poor outcome in patients with acute myocardial infarction complicated by cardiogenic shock. © 2010 The Author.

Introduction: Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. Methods: The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results: Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function restrictions was noted in 51%. One-third of the studies that excluded older patients based on age allowed inclusion of younger patients with poor performance status; 8% did not place any restrictions on organ function. Over time, there was a shift from exclusion based on age (p value for trend < 001) toward exclusion based on organ function (p = 2). Industrysponsored studies were least likely to exclude older patients (p<001).Conclusion. Notably, 27% of currently recruiting clinical trials for hematological malignancies use age-based exclusion criteria. Although physiological reserves diminish with age, the heterogeneity of the elderly population does not legitimize exclusion based on chronological age alone. Investigators should critically review whether sufficient justification exists for every exclusion criterion before incorporating it in trial protocols. ©AlphaMed Press 2014.

Hamaker M.E.,Diakonessenhuis Hospital | Jonker J.M.,Slotervaart Hospital | Vos A.G.,Diakonessenhuis Hospital | Smorenburg C.H.,Medical Center Alkmaar | van Munster B.C.,Gelre Hospitals
The Lancet Oncology | Year: 2012

Comprehensive geriatric assessment (CGA) is done to detect vulnerability in elderly patients with cancer so that treatment can be adjusted accordingly; however, this process is time-consuming and pre-screening is often used to identify fit patients who are able to receive standard treatment versus those in whom a full CGA should be done. We aimed to assess which of the frailty screening methods available show the best sensitivity and specificity for predicting the presence of impairments on CGA in elderly patients with cancer. We did a systematic search of Medline and Embase, and a hand-search of conference abstracts, for studies on the association between frailty screening outcome and results of CGA in elderly patients with cancer. Our search identified 4440 reports, of which 22 publications from 14 studies, were included in this Review. Seven different frailty screening methods were assessed. The median sensitivity and specificity of each screening method for predicting frailty on CGA were as follows: Vulnerable Elders Survey-13 (VES-13), 68% and 78%; Geriatric 8 (G8), 87% and 61%; Triage Risk Screening Tool (TRST 1+; patient considered frail if one or more impairments present), 92% and 47%, Groningen Frailty Index (GFI) 57% and 86%, Fried frailty criteria 31% and 91%, Barber 59% and 79%, and abbreviated CGA (aCGA) 51% and 97%. However, even in case of the highest sensitivity, the negative predictive value was only roughly 60%. G8 and TRST 1+ had the highest sensitivity for frailty, but both had poor specificity and negative predictive value. These findings suggest that, for now, it might be beneficial for all elderly patients with cancer to receive a complete geriatric assessment, since available frailty screening methods have insufficient discriminative power to select patients for further assessment. © 2012 Elsevier Ltd.

Mangoni A.A.,Section of Translational Medical science | Mangoni A.A.,Woodend Hospital | Munster B.C.V.,University of Amsterdam | Munster B.C.V.,Gelre Hospitals | And 2 more authors.
American Journal of Geriatric Psychiatry | Year: 2013

Objectives: To assess possible associations between anticholinergic drug exposure and serum anticholinergic activity (SAA) and their capacities to predict all-cause mortality in older hospitalized patients. Setting: Academic medical center. Participants and Measurements: Data on clinical characteristics, full medication exposure, SAA, and 4 anticholinergic drug scoring systems (ADSSs: Anticholinergic Risk Scale [ARS], Anticholinergic Drug Scale, Anticholinergic Burden scale, and anticholinergic component of the Drug Burden Index) were collected in 71 older hospitalized patients (age 84 ± 6 years) awaiting surgical repair after hip fractures. Results: The median (range) SAA was 2.8 (1.1-4.9) pmol/mL. Age (ρ = 0.25, p = 0.03), Katz Index of Independence in Activities of Daily Living score (ρ = 0.39, p = 0.001), in-hospital delirium (ρ = 0.29, p = 0.01), preadmission cognitive impairment (r = 0.31, p = 0.01), and the number of nonanticholinergic drugs (n-NA, ρ = -0.27, p = 0.02) were associated with SAA. No significant associations were detected between ADSSs and SAA. Cognitive impairment (β = 2.1, 95% confidence interval [CI]: 0.7 to 2.5, p = 0.005) and n-NA (β = -0.3, 95% CI: -0.5 to -0.03, p = 0.03) were independently associated with SAA. Cognitive impairment (hazard ratio [HR]: 6.7, 95% CI: 1.1 to 40.3, p = 0.04) and higher ARS scores (HR: 2.2, 95% CI: 1.2 to 3.7, p = 0.006) independently predicted 3-month mortality whereas in-hospital delirium (HR: 3.6, 95% CI: 1.3 to 10.3, p = 0.02), living at home (HR: 0.2, 95% CI: 0.0 to 0.9, p = 0.03), and length of hospital stay (HR: 1.1, 95% CI: 1.0 to 1.2, p = 0.004) independently predicted 1-year mortality after adjustment for age, gender, and Charlson comorbidity index. Conclusions: Cognitive impairment and n-NA, but not ADSSs, are independently associated with SAA in olderhospitalized patients. The ARS score, together with cognitive impairment, in-hospital delirium, place of residence, and length of hospital stay, predicts all-cause mortality in this group. © 2013 American Association for Geriatric Psychiatry.

Hamaker M.E.,Diakonessenhuis Utrecht Zeist Doorn | Schaar C.,Gelre Hospitals | Van Munster B.C.,Gelre Hospitals
Acta Oncologica | Year: 2014

Aim. The aim of this systematic review is to summarise all available data on the effect of a geriatric evaluation on the multidisciplinary treatment of older cancer patients, focussing on oncologic treatment decisions and the implementation of non-oncologic interventions. Methods. A systematic search in MEDLINE and EMBASE for studies on the effect of a geriatric evaluation on oncologic and non-oncologic treatment for older cancer patients. Results. Literature search identified 1654 reports (624 from Medline and 1030 from Embase), of which 10 studies were included in the review. Three studies used a geriatric consultation while seven used a geriatric assessment performed by a cancer specialist, healthcare worker or (research) nurse. Six studies addressed a change in oncologic treatment, the initial treatment plan was modified in a median of 39% of patients after geriatric evaluation, of which two thirds resulted in less intensive treatment. Seven studies focused on the implementation of non-oncologic interventions based on the results of the geriatric evaluation; all but one reported that interventions were suggested for over 70% of patients, even in studies that did not focus specifically on frail older patients. In the other study, implementation of non-oncologic interventions was left to the cancer specialist's discretion. Conclusion. A geriatric evaluation has significant impact on oncologic and non-oncologic treatment decisions in older cancer patients and deserves consideration in the oncologic work-up for these patients. © 2014 Informa Healthcare.

Gratama J.W.C.,Gelre Hospitals | Van Leeuwen R.B.,Gelre Hospitals
Abdominal Imaging | Year: 2010

Death resulting from a ruptured abdominal aortic aneurysm (AAA) is potentially preventable. Screening for AAA is cost-effective, reducing risk of AAA-related death by 50%. For various reasons screening programs have not been implemented widely. Therefore, the need to identify subgroups with increased prevalence of AAA remains. Recently, men over 59 years of age presenting with stroke or a transient ischemic attack (TIA) at the neurology department were found to have a doubled prevalence of AAA. This confirmed data of another study (SMART), which included broader inclusion criteria (either manifest atherosclerotic disease or only risk factors for atherosclerosis). Incorporation of an aortic ultrasonography into the neurological work up of these patients could result in an effective screening program. However, before that, several cost-effectiveness issues need to be resolved, such as growth rate of the detected aneurysms, risk of death by AAA rupture in this patient group with increased co-morbidity and decreased life expectancy, peri-operative risk of open or endovascular repair. © 2009 Springer Science+Business Media, LLC.

De Rooij S.E.,University of Amsterdam | Van Munster B.C.,University of Amsterdam | Van Munster B.C.,Gelre Hospitals
Rejuvenation Research | Year: 2013

The pineal hormone melatonin plays a major role in circadian sleep-wake rhythm in many mammals, including humans. Patients with acute confusional state or delirium, especially those with underlying cognitive impairment, frequently suffer from sleep disturbances and disturbed circadian rhythm. In this review, an overview is given of delirium and delirium symptoms that correspond with symptoms in dementia, such as sundowning, followed by a presentation of the circadian rhythm disorders in delirium in relation to melatonin deficiency. Finally, this review examines the therapeutic benefit of melatonin treatment in disorders related to delirium and dementia, including the placebo-controlled randomized clinical trials addressing this topic. © Mary Ann Liebert, Inc.

Schultz M.J.,University of Amsterdam | Harmsen R.E.,University of Amsterdam | Spronk P.E.,University of Amsterdam | Spronk P.E.,Gelre Hospitals
Critical Care | Year: 2010

Glycemic control aiming at normoglycemia, frequently referred to as 'strict glycemic control' (SGC), decreased mortality and morbidity of adult critically ill patients in two randomized controlled trials (RCTs). Five successive RCTs, however, failed to show benefit of SGC with one trial even reporting an unexpected higher mortality. Consequently, enthusiasm for the implementation of SGC has declined, hampering translation of SGC into daily ICU practice. In this manuscript we attempt to explain the variances in outcomes of the RCTs of SGC, and point out other limitations of the current literature on glycemic control in ICU patients. There are several alternative explanations for why the five negative RCTs showed no beneficial effects of SGC, apart from the possibility that SGC may indeed not benefit ICU patients. These include, but are not restricted to, variability in the performance of SGC, differences among trial designs, changes in standard of care, differences in timing (that is, initiation) of SGC, and the convergence between the intervention groups and control groups with respect to achieved blood glucose levels in the successive RCTs. Additional factors that may hamper translation of SGC into daily ICU practice include the feared risk of severe hypoglycemia, additional labor associated with SGC, and uncertainties about who the primarily responsible caregiver should be for the implementation of SGC. © 2010 BioMed Central Ltd.

van Sonsbeek S.,Gelre Hospitals | Pullens B.,Gelre Hospitals | van Benthem P.P.,Gelre Hospitals
The Cochrane database of systematic reviews | Year: 2015

BACKGROUND: Ménière's disease is an incapacitating disease in which recurrent attacks of vertigo are accompanied by hearing loss, tinnitus and/or aural fullness, all of which are discontinuous and variable in intensity. A number of different therapies have been identified for patients with this disease, ranging from dietary measures (e.g. a low-salt diet) and medication (e.g. betahistine (Serc®), diuretics) to extensive surgery (e.g. endolymphatic sac surgery). The Meniett® low-pressure pulse generator (Medtronic ENT, 1999) is a device that is designed to generate a computer-controlled sequence of low-pressure (micro-pressure) pulses, which are thought to be transmitted to the vestibular system of the inner ear. The pressure pulse passes via a tympanostomy tube (grommet) to the middle ear, and hence to the inner ear via the round and/or oval window. The hypothesis is that these low-pressure pulses reduce endolymphatic hydrops.OBJECTIVES: To assess the effects of positive pressure therapy (e.g. the Meniett device) on the symptoms of Ménière's disease or syndrome.SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 6 June 2014.SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing positive pressure therapy (using the Meniett or a similar device) with placebo in patients with Ménière's disease. The primary outcome was control of vertigo; secondary outcomes were loss or gain of hearing, severity of tinnitus, perception of aural fullness, functional level, complications or adverse effects, and sick days.DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed risk of bias and extracted data. We contacted authors for additional data. Where possible, we pooled study results using a fixed-effect, mean difference (MD) meta-analysis and tested for statistical heterogeneity using both the Chi² test and I² statistic. This was only possible for the secondary outcomes loss or gain of hearing and sick days. We presented results using forest plots with 95% confidence intervals (Cl).MAIN RESULTS: We included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. Control of vertigo For the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100). Secondary outcomes For the secondary outcomes, we carried out two pooled analyses. We found statistically significant results for loss or gain of hearing . Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level , it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, we included sick days as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. We did not find a statistically significant difference in sick days. No complications or adverse effects were noted by any study.AUTHORS' CONCLUSIONS: There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies.

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