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Almere Stad, Netherlands

Vaessen-Verberne A.A.P.H.,Amphia Hospital | Van Den Berg N.J.,Flevo Hospital | Brackel H.J.L.,Catharina Hospital | Gerrits G.P.J.M.,Canisius Wilhelmina Hospital | And 2 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).

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.

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).

Fens M.,Maastricht University | Van Heugten C.M.,Maastricht University | Beusmans G.H.M.I.,Maastricht University | Limburg M.,Flevo Hospital | And 3 more authors.
European Journal of General Practice | Year: 2013

Background: Patients with transient ischaemic attack (TIA) or minor stroke generally receive, besides secondary prevention, no regular follow up care after discharge directly home from the Emergency Room or TIA outpatient clinic; because it is believed that they will experience no consequences. Objectives: To explore whether the TIA and minor stroke patients have persistent problems due to the event. Methods: This study has a cross-sectional, comparative non-randomized, exploratory design. Patients with TIA or minor stroke, not requiring hospital admission, and a control group of stroke patients, recently discharged home, were selected and interviewed with a questionnaire by telephone or home visit, between one and eight months after the event. Patients with angina pectoris (AP) were recruited as a second control group. Results: Data showed that 51% of the TIA and minor stroke patients and 71% of the stroke patients experienced five or more problems, as opposed to 32% of patients with AP. Between 39 and 49% of the TIA, minor stroke and the stroke patients reported cognitive and communicative difficulties. Moreover, the TIA and minor stroke patients had more cognitive deficits (n = 27, 49%) and communicative limitations (n = 23, 42%) than the AP group (n = 7, 10% and n = 4, 6%, respectively). Conclusion: About half of the TIA and minor stroke patients experienced problems regarding cognition and communication, which were specific to the event. General practitioners should be aware of these potential problems and monitor patients regularly. Future research should focus on prognostic indicators to identify patients at risk. © 2013 Informa Healthcare.

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.

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