Woltz S.,Leiden University |
Stegeman S.A.,Leiden University |
Krijnen P.,Leiden University |
Van Dijkman B.A.,Flevo Hospital |
And 5 more authors.
Journal of Bone and Joint Surgery - American Volume | Year: 2017
Background: The use of operative treatment for clavicular fractures is increasing, despite varying results in previous studies. The aim of this study was to compare plate fixation and nonoperative treatment for displaced midshaft clavicular fractures with respect to nonunion, adverse events, and shoulder function. Methods: In this multicenter, prospective, randomized controlled trial, patients between 18 and 60 years old with a displaced midshaft clavicular fracture were randomized between nonoperative treatment and open reduction with internal plate fixation. The primary outcome was evidence of nonunion at 1 year. Other outcomes were secondary operations, arm function as measured with the Constant shoulder score and Disabilities of the Arm, Shoulder and Hand (DASH) score, pain, cosmetic results, and general health status. Outcomes were recorded at 6 weeks, 3 months, and 1 year following trauma. Results: One hundred and sixty patients were randomized. The rate of nonunion was significantly higher in the nonoperatively treated group than in the operatively treated group (23.1% compared with 2.4%; p > 0.0001), as was the rate of nonunion for which secondary plate fixation was performed (12.9% compared with 1.2%; p = 0.006). The rate of secondary operations was 27.4% in the operatively treated group (16.7% for elective plate removal) and 17.1% in the nonoperatively treated group (p = 0.18). Nineteen percent of the patients in the operatively treated group had persistent loss of sensation around the scar. No difference was found between the groups with respect to the Constant and DASH scores at all time points. Conclusions: For patients with a diaphyseal fracture of the clavicle displaced at least 1 shaft width, plate fixation improves the chances that the bone will heal; however, the rate of patients who need a second operation is considerable. In addition, the procedure does not improve shoulder function or general symptoms, and it does not decrease limitations compared with nonoperative treatment in a sling. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. © 2017 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED.
Vleming M.,Flevo Hospital
Trials | Year: 2017
Background: Chronic rhinosinusitis with nasal polyps is a chronic disease frequently seen in otorhinolaryngological practice. Along with its chronic disease burden it creates high societal costs. Therapy consists of long-term use of medication and, if insufficient, endoscopic sinus surgery. No consensus exists on the right timing and extent of disease that warrants surgery. Furthermore, there is lack of clinical knowledge about the benefit of surgery over medication only. The current trial evaluates the clinical effectiveness and cost-effectiveness of endoscopic sinus surgery in addition to drug treatment versus medication exclusively in the adult patient group with nasal polyps. Methods: A prospective, multicentre, superiority, randomised controlled (PolypESS) trial in 238 patients aged 18 years or older selected for primary or revision endoscopic sinus surgery by the otorhinolaryngologist was designed. Patients will be randomised to either endoscopic sinus surgery in addition to medication or medical therapy only. Relevant data will be collected prior to randomisation, at baseline and 3, 6, 12, 18 and 24months after start of treatment. Complete follow-up will be 24months. Primary outcome is disease-specific Health-related Quality of Life quantified by the SNOT-22 after 12-month follow-up. Secondary outcomes are generic Health-related Quality of Life, cost-effectiveness, objective signs of disease and adverse effects of treatment. Subgroup analyses will be performed to verify whether treatment effects differ among patient phenotypes. Discussion: The PolypESS trial will investigate tailored care in adult patients with chronic rhinosinusitis with nasal polyps and will result in improved clinical pathways to help to determine in which circumstances to perform surgery. Trial registration: Dutch Trial Register, NTR4978. Registered on 27 November 2014. © 2016 The Author(s).
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.
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.
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.