Almere Stad, Netherlands
Almere Stad, Netherlands

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Van Deelen B.A.,Flevo Hospital | De Haan R.J.,Clinical Research Unit
BMC Health Services Research | Year: 2010

Background. Older patients are at high risk for poor outcomes after acute hospital admission. The mortality rate in these patients is approximately 20%, whereas 30% of the survivors decline in their level of activities of daily living (ADL) functioning three months after hospital discharge. Most diseases and geriatric conditions that contribute to poor outcomes could be subject to pro-active intervention; not only during hospitalization, but also after discharge. This paper presents the design of a randomised controlled clinical trial concerning the effect of a pro-active, multi-component, nurse-led transitional care program following patients for six months after hospital admission. Methods/Design. Three hospitals in the Netherlands will participate in the multi-centre, double-blind, randomised clinical trial comparing a pro-active multi-component nurse-led transitional care program to usual care after discharge. All patients acutely admitted to the Department of Internal Medicine who are 65 years and older, hospitalised for at least 48 hours and are at risk for functional decline are invited to participate in the study. All patients will receive integrated geriatric care by a geriatric consultation team during hospital admission. Randomization, which will be stratified by study site and cognitive impairment, will be conducted during admission. The intervention group will receive the transitional care bridge program, consisting of a handover moment with a community care Care Nurse (CN) during hospital admission and five home visits after discharge. The control group will receive 'care as usual' after discharge. The main outcome is the level of ADL functioning six months after discharge compared to premorbid functioning measured with the Katz ADL index. Secondary outcomes include; survival, cognitive functioning, quality of life, and health care utilization, satisfaction of the patient and primary care giver with the transitional care bridge program. All outcomes will be measured at three, six and twelve months after discharge. Approximately 674 patients will be enrolled to either the intervention or control group. Discussion. The study will provide new knowledge on a combined intervention of integrated care during hospital admission, a proactive handover moment before discharge and intensive home visits after discharge. Trial registration. Trial registration number: NTR 2384. © 2010 Buurman et al; licensee BioMed Central Ltd.


Hakvoort R.A.,Spaarne Hospital | Thijs S.D.,Maxima Medical Center | Bouwmeester F.W.,Waterland Hospital | Broekman A.M.,Twee Steden Hospital | And 3 more authors.
BJOG: An International Journal of Obstetrics and Gynaecology | Year: 2011

Objective To compare clean intermittent catheterisation with transurethral indwelling catheterisation for the treatment of abnormal post-void residual bladder volume (PVR) following vaginal prolapse surgery. Design Multicentre randomised controlled trial. Setting Five teaching hospitals and one non-teaching hospital in the Netherlands. Population All patients older than 18 years experiencing abnormal PVR following vaginal prolapse surgery, with or without the use of mesh. Exclusion criteria were: any neurological or anxiety disorder, or the need for combined anti-incontinence surgery. Methods All patients were given an indwelling catheter directly after surgery, which was removed on the first postoperative day. Patients with a PVR of more than 150 ml after their first void were randomised for clean intermittent catheterisation (CIC), performed by nursing staff, or for transurethral indwelling catheterisation (TIC) for 3 days. Main outcome measure Bacteriuria rate at end of treatment. Results A total of 87 patients were included in the study. Compared with the TIC group (n = 42), there was a lower risk of developing bacteriuria (14 versus 38%; P = 0.02) or urinary tract infection (UTI; 12 versus 33%; P = 0.03) in the CIC group (n = 45); moreover, a shorter period of catheterisation was required (18 hours CIC versus 72 hours TIC; P < 0.001). Patient satisfaction was similar in the two groups, and no adverse events occurred. Conclusion Clean intermittent catheterisation is preferable over indwelling catheterisation for 3 days in the treatment of abnormal PVR following vaginal prolapse surgery. © 2011 RCOG.


Boersma A.A.,Breedestraat O 33 35 boven | Meyboom-De Jong B.,University of Groningen | Kleiverda G.,Flevo Hospital
European Journal of Contraception and Reproductive Health Care | Year: 2011

Objective?To evaluate the efficacy and safety of home administration of buccal misoprostol after mifepristone for medical abortion up to 70 days' gestation in a general practice in Curaçao, where induced abortion is severely restricted by law. Methods?In a prospective study 330 women received 200 mg mifepristone and were instructed to take four tablets (800 μg) of misoprostol via the buccal route 24-36 h later, at home. One week later, follow-up took place. Results?The outcome could be evaluated in 307 of the 330 women. The efficacy of the mifepristone-buccal misoprostol procedure was 97.7% (300/307). In seven women vacuum aspirations for continuing pregnancy or incomplete abortion following treatment were required. Success rates at 64-70 days' gestation were the same as for gestations of less than 64 days duration. The main adverse effects were nausea and diarrhoea. Conclusion?Home administration of buccal misoprostol 24-36 h after mifepristone is a safe and effective method of medical abortion up to 70 days. It could be applied in a general practice in Curaçao, where induced abortion is legally restricted. © 2011 The European Society of Contraception and Reproductive Health.


Vaessen-Verberne A.A.P.H.,Amphia Hospital | Van Den Berg N.J.,Flevo Hospital | Van Nierop J.C.,Emmas Childrens Hospital | Brackel H.J.L.,Catharina Hospital | And 3 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2010

Rationale: For children with symptomatic asthma despite low to moderate doses of inhaled corticosteroids, evidence is still lacking whether to add a long-acting bronchodilator or to increase the dose of inhaled corticosteroids. Objective: To evaluate whether salmeterol/fluticasone propionate (SFP), 50/100 μg twice a day, is noninferior regarding symptom control compared with fluticasone propionate (FP), 200 μg twice a day Diskus in children with symptomatic asthma. Methods: A multicenter, randomized, parallel-group, double-blind study was performed comparing SFP and FP treatment during 26 weeks on asthma control and lung function. Measurements and Main Results: A total of 158 children, 6-16 years old, still symptomatic on FP, 100 μg twice a day, during a 4-week runin period, were included. Percentage of symptom-free days during the last 10 weeks of the treatment period did not differ between treatment groups (per protocol analysis: adjusted mean difference [FP minus SFP] 2.6%; 95% confidence interval, -8.1 to 13.4). Both groups showed substantial improvements of about 25 percent points in symptom-free days (both P < 0.001 from baseline). Lung function measurements (FEV1, FVC, PEF rate, and maximal expiratory flow) did not differ between groups except for a slight advantage in maximal expiratory flow in the SFP group at 1 week. No differences were found between FP and SFP regarding exacerbation rates, adverse events, or growth. Conclusions: In our study the efficacy on symptom control and lung function of the combination of a long-acting bronchodilator with inhaled corticosteroid is equal to doubling the dose of the inhaled corticosteroid in children still symptomatic on a moderate dose of inhaled corticosteroid. Clinical trial registered with www.clinicaltrials.gov (NCT 00197106).


Zwiers I.,Maastricht University | Hoogland C.M.T.,Flevo Hospital | Mackaay A.J.C.,Meander Medical Center Amersfoort
European Journal of Vascular and Endovascular Surgery | Year: 2016

Background In this study the intra- and inter-observer variability of ultrasound measurements of the diameter of the popliteal artery were tested in a group of patients under surveillance for a small (diameter 10-20 mm), asymptomatic popliteal artery aneurysm (PAA). Methods From a group of patients under ultrasound surveillance for bilateral, asymptomatic PAAs, 13 consecutive patients agreed to participate in the study and provided informed consent. The maximum diameter of the popliteal arteries was assessed by a vascular technologist. The same assessment was repeated by a second vascular technologist, unaware of the results of the first measurement. After a week, this protocol was repeated. The intra- and inter-observer reliability of this measurement was calculated using intra-class correlation coefficients (ICCs) and Bland and Altman plots. Results Of the 10 patients with bilateral and three patients with unilateral PAA, 12 completed the 2 week protocol. A total of 86 measurements were analyzed. The mean diameter of the popliteal arteries was 13.5 ± 3.4 mm. The ICC for the intra-observer reliability of observer 1 was 0.96 (95% CI 0.92-0.99), p <.001 and of observer 2 was 0.98 (95% CI 0.95-0.99), p <.001. The ICC for the inter-observer reliability for the first measurements was 0.96 (95% CI 0.90-0.98), p <.001 and for the second measurements 0.97 (95% CI 0.94-0.99), p <.001. The Bland-Altman plots showed random error, while 95% of the variation was between 0.016 and 0.16, p >.47. The absolute magnitude of the systematic error of both observers was less than 0.135 mm (median 0.00). Conclusion Ultrasound measurement of the maximum diameter of the popliteal artery is reproducible; hence, it is suitable for making a clinical treatment decision. Its use for surveillance of small, asymptomatic PAAs is justified. © 2015 European Society for Vascular Surgery.


Koolen B.B.,Amphia Hospital | Pijnenburg M.W.H.,Erasmus Medical Center | Brackel H.J.L.,Catharina Hospital | Landstra A.M.,Rijnstate Hospital | And 4 more authors.
European Respiratory Journal | Year: 2011

Several tools are useful in detecting uncontrolled asthma in children. The aim of this study was to compare Global Initiative for Asthma (GINA) guidelines with the Childhood Asthma Control Test (C-ACT) and the Asthma Control Test (ACT) in detecting uncontrolled asthma in children. 145 children with asthma filled in a web-based daily diary card for 4 weeks on symptoms, use of rescue medication and limitations of activities, followed by either the C-ACT or ACT. For predicting uncontrolled asthma, score cut-off points of 19 were used for C-ACT and ACT. According to GINA guidelines, asthma was uncontrolled in 71 (51%) children and completely controlled in 19 (14%) children. The area under the curve in the receiver operating characteristic curves for C-ACT and ACT versus GINA guidelines were 0.89 and 0.92, respectively. Cut-off points of 19 for C-ACT and ACT resulted in a sensitivity of 33% and 66% in predicting uncontrolled asthma, respectively. C-ACT and ACT correlate well with GINA criteria in predicting uncontrolled asthma, but commonly used cut-off points for C-ACT and ACT seem to underestimate the proportion of children with uncontrolled asthma as defined by GINA. Copyright©ERS 2011.


Van De Vlekkert J.,University of Amsterdam | Van De Vlekkert J.,Flevo Hospital | Hoogendijk J.E.,University Utrecht | De Visser M.,University of Amsterdam
Journal of Neurology | Year: 2014

The aim of this work is to evaluate disease-related mortality and the course of the disease including functional outcome and quality of life. We did a follow-up study on a large prospective cohort of 62 patients with subacute-onset idiopathic inflammatory myopathy (IIM) (dermatomyositis (n = 24), nonspecific myositis (n = 34), necrotizing autoimmune myopathy (n = 4)) after treatment with corticosteroids only (randomized controlled trial comparing daily high-dosage prednisone with pulse therapy of dexamethasone). Development of connective tissue disease (CTD) or malignancy, disease course and mortality, functional outcome and quality of life were evaluated. After a mean follow-up of 3 years (SD 1.5), 22 % had developed a CTD and 17 % a malignancy. Disease-related mortality was 15 %. A monophasic disease course was found in 27 %. Most patients had a chronic (35 %) or polyphasic disease (35 %) course and experienced single or multiple relapses. Sixteen patients (33 %) were off medication after a mean of 1 year of treatment. Disability scores improved particularly in the first 18 months. At follow-up, 68 % still perceived disabilities. Quality of life scores as measured by the short-form (SF)-36 improved in the first 18 months. After 18 months, scores remained stable during the next years of follow-up and remained low compared to a normal population. (1) Two-thirds of the patients with an IIM have a polyphasic or chronic disease course and need maintenance treatment. (2) The impact on functional outcome and quality of life is considerable and does not improve further after 18 months. © 2014 Springer-Verlag.


Schreuder H.W.R.,University Utrecht | Pattij T.O.S.,University Utrecht | Zweemer R.P.,University Utrecht | Van Baal M.W.,Flevo Hospital | Verheijen R.H.M.,University Utrecht
Gynecological Surgery | Year: 2012

We assessed the effect of increasing experience of a single surgeon (learning curve) in the laparoscopic staging procedure for women with early ovarian cancer and compared the results with the literature. We retrospectively analysed a total of 25 women with apparent early-stage ovarian cancer who underwent a laparoscopic staging procedure by the same surgeon. Three time periods, based on date of surgery, were compared with respect to operating time, amount of lymph nodes harvested and surgical outcome. There was no significant difference in operation time, estimated blood loss and hospital stay between the three periods. There was, however, a significant increase in the median number of pelvic and para-aortal lymph nodes harvested (group1=6.5, group 2=8.0 and group 3=21.0; P<0.005). For the total period, median operation time was 235 min and median estimated blood loss was 100 ml. The median length of hospital stay was 4.0 days. Two intraoperative and two postoperative complications occurred. The upstaging rate was 32%. The mean interval between initial surgery and laparoscopic staging was 51.2 days. Mean duration of follow-up was 43 months, range (1-116 months). Five (20%) patients had recurrences, and two (8%) patients died of the disease. In conclusion, there is a significant learning curve for the laparoscopic full staging procedure in ovarian cancer. In our study this is mainly reflected in the amount of lymph nodes harvested and not in the total operating time. © 2011 The Author(s).


Vrijkotte T.G.M.,University of Amsterdam | Krukziener N.,University of Amsterdam | Hutten B.A.,University of Amsterdam | Vollebregt K.C.,Flevo Hospital | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: Elevated lipid levels during late pregnancy are associated with complications and adverse outcome for both mother and newborn. However, it is inconclusive whether a disturbed lipid profile during early pregnancy has similar negative associations. Objective: Our objective was to investigate whether nonfasting maternal total cholesterol and triglyceride levels during early pregnancy are associated with six major adverse pregnancy outcomes. Methods: Data were derived from the Amsterdam Born Children and Their Development (ABCD) cohort study. Random blood samples of nonfasting total cholesterol and triglyceride levels were determined during early gestation (median = 13, interquartile range = 12-14 wk). Outcome measures were pregnancy-induced hypertension (PIH), preeclampsia, preterm birth, small/large for gestational age (SGA/LGA), and child loss. Only nondiabetic women with singleton deliveries were included; the baseline sample consisted of 4008 women. Analysis for PIH and preeclampsia were performed in nulliparous women only (n = 2037). Results: Mean (SD) triglyceride and total cholesterol levels were 1.33 (0.55) and 4.98 (0.87) mmol/liter, respectively. The incidence of pregnancy complications and perinatal outcomes were as follows: PIH, 4.9%; preeclampsia, 3.7%; preterm birth, 5.3%; SGA, 9.3%; LGA, 9.3%; and child loss, 1.4%. After adjustments, every unit increase in triglycerides was linearly associated with an increased risk of PIH [odds ratio (OR) = 1.60, P = 0.021], preeclampsia (OR = 1.69, P = 0.018), LGA (OR = 1.48, P < 0.001), and induced preterm delivery (OR = 1.69, P = 0.006). No associations were found for SGA or child loss. Total cholesterol was not associated with any of the outcome measures. Conclusions: Elevated maternal triglyceride levels measured during early pregnancy are associated with pregnancy complications and adverse pregnancy outcomes. These results suggest that future lifestyle programs in women of reproductive age with a focus on lowering triglyceride levels (i.e. diet, weight reduction, and physical activity) may help to prevent hypertensive complications during pregnancy and adverse birth outcomes. Copyright © 2012 by The Endocrine Society.


van de Vlekkert J.,University of Amsterdam | van de Vlekkert J.,Flevo Hospital | Hoogendijk J.E.,University Utrecht | de Visser M.,University of Amsterdam
Neuromuscular Disorders | Year: 2015

The objective of this study was to investigate if patients with endomysial mononuclear cell infiltrates invading non-necrotic fibers have a disease course consistent with inclusion body myositis (IBM), irrespective of other histopathological and clinical characteristics. All patients with a muscle biopsy showing endomysial inflammation with invasion of non-necrotic muscle fibers during the period 1979-2006 in two tertiary neuromuscular referral centers were classified into three groups: 1) patients whose biopsies also showed rimmed vacuoles; 2) patients whose biopsies showed no vacuoles but fulfilled clinical criteria for IBM, and 3) patients whose biopsies showed no vacuoles, and also did not fulfill clinical criteria for IBM (unclassified patients). These groups were compared with regard to age, gender, clinical features, and disease course including response to immunosuppressive treatment. Eighty-one individuals (41 men) were included. Rimmed vacuoles were found in 49 patients (60.5%). Fourteen patients (17.3%) fulfilled clinical criteria for IBM and 18 patients (22.2%) were unclassified at presentation. At follow up (mean duration 9 years) three women remained unclassified (4%). There were no differences in disease course or effect of treatment between the three groups. Men had more often rimmed vacuoles than women (73% vs 48%; p = 0.018), and women more often than men were unclassified. Women tended to show more often temporary improvement if treated (p = 0.07), but none had sustained improvement. In conclusion, patients with a muscle biopsy showing endomysial cell infiltration with invasion of non-necrotic muscle fibers most probably have IBM, regardless of clinical and other pathological features. Women lack typical features more often than men. © 2015 Elsevier B.V.

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