Zwolle, Netherlands
Zwolle, Netherlands

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Berkhof F.F.,Isala | Hertog N.E.D.,Isala | Uil S.M.,Isala | Kerstjens H.A.M.,University of Groningen | van den Berg J.W.K.,Isala
Respiratory Research | Year: 2013

Background: Macrolides reduce exacerbations in patients with COPD. Their effects on health status has not been assessed as primary outcome and is less clear. This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough.Methods: In this randomised controlled trial 84 patients met the eligibility criteria: age of ≥40 years, COPD GOLD stage ≥2 and chronic productive cough. The intervention-group (n = 42) received azithromycin 250 mg 3 times a week and the control-group (n = 42) received a placebo. Primary outcome was cough-specific health status at 12 weeks, measured with the Leicester Cough Questionnaire (LCQ). Secondary outcomes included generic and COPD-specific health status and exacerbations. Changes in adverse events and microbiology were monitored.Results: Mean age of participants was 68 ± 10 years and mean FEV1 was 1.36 ± 0.47 L. The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin (difference 1.3 ± 0.5, 95% CI 0.3;2.3, p = 0.01) and met the minimal clinically important difference. Similar results were found for the domain scores, and COPD-specific and generic health status questionnaires. Other secondary endpoints were non-significant. No imbalances in adverse events were found.Conclusions: Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree. Trial registration: ClinicalTrials.gov NCT01071161. © 2013 Berkhof et al.; licensee BioMed Central Ltd.


Berkhof F.F.,Isala | Van Den Berg J.W.K.,Isala | Uil S.M.,Isala | Kerstjens H.A.M.,University of Groningen
Respirology | Year: 2015

Background and objective Telemedicine, care provided by electronic communication, may serve as an alternative or extension to traditional outpatient visits. This pilot study determined the effects of telemedicine on health-care utilization and health status of chronic obstructive pulmonary disease (COPD) patients. Methods One hundred and one patients were randomized, 52 patients received telemedicine care and 49 had traditional outpatient visits. The primary outcome was COPD-specific health status, measured with the Clinical COPD Questionnaire (CCQ). Secondary outcomes included St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36) and resource use in primary and secondary care. Results The mean age of the participants was 68 ± 9 years and the mean per cent of predicted forced expiratory volume in 1 s was 40.4 ± 12.5. The CCQ total score deteriorated by 0.14 ± 0.13 in the telemedicine group, and improved by -0.03 ± 0.14 in the control group (difference 0.17 ± 0.19, 95% confidence interval (CI): -0.21-0.55, P = 0.38). The CCQ symptom domain showed a significant and clinically relevant difference in favour of the control group, 0.52 ± 0.24 (95% CI: 0.04-0.10, P = 0.03). Similar results were found for the SGRQ, whereas results for SF-36 were inconsistent. Patients in the control group had significantly fewer visits to the pulmonologist in comparison to patients in the telemedicine group (P = 0.05). The same trend, although not significant, was found for exacerbations after 6 months. Conclusions This telemedicine model of initiated phone calls by a health-care provider had a negative effect on health status and resource use in primary and secondary care, in comparison with usual care and therefore cannot be recommended in COPD patients in its current form. Telemedicine has the potential to improve continuity of care, increase efficiency of outpatient management and prevent deterioration of health status in COPD patients. However, the effectiveness of telemedicine is still under debate. This study demonstrated that telemedicine alone, without any form of education, pulmonary rehabilitation or training, had no benefits for COPD patients at all. © 2014 Asian Pacific Society of Respirology.


Gieteling E.,Isala | van de Leur J.J.C.M.,Isala | Stegeman C.A.,University of Groningen | Groeneveld P.H.P.,Isala
Netherlands Journal of Medicine | Year: 2014

Background: The urine dipstick that detects nitrite and leukocyte esterase, and urine sediment is commonly used to diagnose or exclude urinary tract infections (UTIs) as the source of infection in febrile patients admitted to the emergency department of Dutch hospitals. However, the diagnostic accuracy of the urine dipstick and urine sediment has never been studied in this specific situation.Methods: Urinary samples of 104 febrile consecutive patients were examined. Urine culture with ≥ 105 colonies/ ml of one or two known uropathogen was used as the gold standard. The diagnostic value of the urine dipstick, urine sediment and Gram stain at various cut-off points was determined and used to develop a new diagnostic algorithm. This algorithm was validated in a new group of sepsis patients based on systemic inflammatory response syndrome (SIRS) criteria. Results: A positive nitrite on the urine dipstick (specificity 99%) rules in UTI. This is the first step of our diagnostic algorithm. The second step is to exclude UTI by absence of bacteria in the urine sediment (sensitivity 94%). The thirdand last step is the number of leucocytes/high-power field (hpf) in the urine sediment. Less than 10 leucocytes/hpfmakes UTI unlikely whereas ≥ 10 leucocytes/hpf indicates UTI. In contrast to urine dipstick and/or urine sediment results alone, our algorithm showed both a high sensitivity (92%) and specificity (92%) and was validated in a new sepsis population. Conclusion: Our accurate and fast diagnostic algorithm, which combines the selective results of urine dipstick and urine sediment, can be easily used to diagnose UTI in febrile patients at the emergency department of Dutch hospitals. © Van Zuiden Communications B.V. All rights reserved.


Balci A.,Isala | Balci A.,University of Groningen | Sollie-Szarynska K.M.,University of Groningen | Van Der Bijl A.G.L.,University of Groningen | And 11 more authors.
Heart | Year: 2014

Objectives: Adequate prepregnancy prediction of maternal cardiovascular and offspring risk is important for counselling and management of pregnancy in women with congenital heart disease (CHD). Therefore we performed a study to identify the optimal assessment strategy for estimating the risk of pregnancy in women with CHD. Methods: In this prospective study, we determined the outcomes of 213 pregnancies in 203 women with CHD. The ZAHARA I (Zwangerschap bij Aangeboren HARtAfwijkingen I) and CARPREG (CARdiac disease in PREGnancy) risk scores were calculated for each pregnancy, as was the total number of cardiovascular (TPc) or offspring risk predictors (TPo) from these and other studies combined. Pregnancies were also classified according to the modified WHO classification of maternal cardiovascular risk and according to disease complexity (DC). Results: Maternal cardiovascular events occurred during 22 pregnancies (10.3%). Offspring events occurred during 77 pregnancies in 81 children (37.3%). Cardiovascular and offspring event rates increased with higher risk scores, higher TPc or TPo, higher WHO class and greater DC. The highest area under the curve (AUC) for maternal cardiovascular risk was achieved by the WHO class (AUC: 0.77, p<0.0001). AUC for the ZAHARA I risk score was 0.71 (p=0.001), and for the CARPREG risk score 0.57 ( p=0.32). All models performed insufficiently in predicting offspring events (AUC≤0.6). Conclusions: The WHO classification is the best available risk assessment model for estimating cardiovascular risk in pregnant women with CHD. None of the offspring prediction models perform adequately in our cohort.


Detollenaere R.J.,Isala | Detollenaere R.J.,Radboud University Nijmegen | Den Boon J.,Isala | Stekelenburg J.,Medical Center Leeuwarden | And 4 more authors.
BMJ (Online) | Year: 2015

Objective To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse. Design Multicentre randomised controlled non-blinded non-inferiority trial. Setting 4 non-university teaching hospitals, the Netherlands. Participants 208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery. Interventions Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments. The predefined non-inferiority margin was an increase in surgical failure rate of 7%. Main outcom e measures Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault (apical compartment) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months' follow-up. Secondary outcomes were overall anatomical recurrences, including recurrent anterior compartment (bladder) and/or posterior compartment (bowel) prolapse, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning. Results Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery (n=0, 0%) compared with vaginal hysterectomy with suspension of the uterosacral ligaments (n=4, 4.0%, difference ?3.9%, 95% confidence interval for difference ?8.6% to 0.7%). At 12 months, overall anatomical recurrences, functional outcome, quality of life, complications, hospital stay, measures on postoperative recovery, and sexual functioning did not differ between the two groups. Five serious adverse events were reported during hospital stay. None was considered to be related to the type of surgery. Conclusions Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months' follow-up. © 2015 BMJ Publishing Group Ltd.


Bertholee D.,Isala | Maring J.G.,Isala | van Kuilenburg A.B.P.,University of Amsterdam
Clinical Pharmacokinetics | Year: 2016

Cancer treatment is becoming more and more individually based as a result of the large inter-individual differences that exist in treatment outcome and toxicity when patients are treated using population-based drug doses. Polymorphisms in genes encoding drug-metabolizing enzymes and transporters can significantly influence uptake, metabolism, and elimination of anticancer drugs. As a result, the altered pharmacokinetics can greatly influence drug efficacy and toxicity. Pharmacogenetic screening and/or drug-specific phenotyping of cancer patients eligible for treatment with chemotherapeutic drugs, prior to the start of anticancer treatment, can identify patients with tumors that are likely to be responsive or resistant to the proposed drugs. Similarly, the identification of patients with an increased risk of developing toxicity would allow either dose adaptation or the application of other targeted therapies. This review focuses on the role of genetic polymorphisms significantly altering the pharmacokinetics of anticancer drugs. Polymorphisms in DPYD, TPMT, and UGT1A1 have been described that have a major impact on the pharmacokinetics of 5-fluorouracil, mercaptopurine, and irinotecan, respectively. For other drugs, however, the association of polymorphisms with pharmacokinetics is less clear. To date, the influence of genetic variations on the pharmacokinetics of the increasingly used monoclonal antibodies has hardly been investigated. Some studies indicate that genes encoding the Fcγ-receptor family are of interest, but more research is needed to establish if screening before the start of therapy is beneficial. Considering the profound impact of polymorphisms in drug transporters and drug-metabolizing enzymes on the pharmacokinetics of chemotherapeutic drugs and hence, their toxicity and efficacy, pharmacogenetic and pharmacokinetic profiling should become the standard of care. © 2016 The Author(s)


With the introduction of more sensitive markers of myocardial necrosis, it was shown that the diagnosis of (acute) myocardial infarction could be improved. However, many patients without myocardial infarction have elevated troponin levels (low sensitivity), resulting in additional diagnostic testing and longer admission times to find the cause of the troponin rise. Elevated troponin levels in these patients were found to have limited diagnostic but strong prognostic value. This led to studies assessing the value of high-sensitivity troponin in patients with stable disease, e.g. coronary artery disease, or even in patients without apparent (clinical) disease. These studies consistently showed a strong association with long-term (cardiac) mortality. What is the value for the general physician in daily practice? Although troponin levels may help in finding (healthy?) patients at higher risk, it remains unclear whether interventions (medication, lifestyle) are more (cost-)effective in this high-risk subgroup. The role of troponin levels as a prognostic marker in stable patients therefore remains to be determined.


Boesveld M.,Isala | Hemels M.A.C.,Isala
Journal of Pediatric Hematology/Oncology | Year: 2016

Although a leukemoid reaction is a well-recognized phenomenon in the neonatal intensive care unit, transient extreme hyperleukocytosis in premature infants is rare. The exact mechanism is still unclear and several hypotheses are documented in the literature. In this case report, we describe 2 dichorionic diamniotic premature twins, of whom the 2 girls had extreme hyperleukocytosis, whereas their siblings did not, emphasizing the potentially important role of the sex in this phenomena. © 2016 Wolters Kluwer Health, Inc. All rights reserved.


Objective: To investigate whether clinical signs and symptoms can predict intracranial bleeding (ICB) in children with mild traumatic brain injury. Design: Retrospective chart review. Method: We analysed clinical records from all children (0-18 years) who presented at the Emergency Department or were admitted to the paediatric ward of Isala, a regional trauma centre in Zwolle, the Netherlands, with mild traumatic brain injury between 2011 and 2013. We investigated the predictive value of vomiting, drowsiness, headache, periorbital haematoma, change in behaviour, seizures, amnesia, loss of consciousness and mild neurological symptoms for the presence of ICB by calculating sensitivity, specificity, odds ratio and likelihood ratio. Results: We analysed data from 410 patients (248 boys; mean [SD] age 4.5 [5.1] years). Most (n = 381, 93%) had normal consciousness on presentation. A CT scan was performed on admission in 84 patients (20.5%); 282 children (68.8%) were admitted for clinical observation (with or without head CT scan) and 51 children (12.4%) were discharged home immediately without imaging or observation. We found ICB in 10 patients (2.4%), only one of whom required neurosurgical intervention. None of the investigated clinical signs and symptoms showed a statistically significant association with bleeding or skull fractures on head CT scan. Conclusion: In this study, no clinical sign or symptom could predict the risk of ICB in children with mild traumatic brain injury. Taking the low likelihood of ICB and the radiation damage associated with CT scanning into account, we conclude that a wait-and-see approach without initial imaging is justified and safe in children with mild traumatic brain injury without serious neurological symptoms. © 2015, Bohn Stafleu van Loghum. All rights reserved.


Baas E.M.,Isala | Bierenbroodspot F.,Isala | De Lange J.,Isala | De Lange J.,University of Amsterdam
International Journal of Oral and Maxillofacial Surgery | Year: 2015

A randomized clinical trial was performed to evaluate differences in postoperative neurosensory disturbance (NSD) between two methods of mandibular advancement surgery. A total of 66 non-syndromal class II patients with mandibular hypoplasia were randomized for either distraction osteogenesis (DO) or bilateral sagittal split osteotomy (BSSO). Twenty-nine patients in the BSSO group and 34 patients in the DO group were available for evaluation. Objective assessment was performed by Semmes-Weinstein (SW) monofilament testing preoperatively and at least 1 year after surgery. Six of the 34 patients (17.6%) in the DO group experienced objective NSD, compared to 5/29 patients (17.2%) in the BSSO group. In the evaluation of nerve function by individual nerves, 8/68 nerves (11.8%) revealed objective NSD in the DO group, compared to 7/58 nerves (12.1%) in the BSSO group. A subjective NSD was reported in 11/34 patients (32.4%) in the DO group, compared to 9/29 patients (31.0%) in the BSSO group. In the evaluation of nerve function by individual nerves, a subjective NSD was reported for 13/68 nerves (19.1%) in the DO group, compared to 13/58 nerves (22.4%) in the BSSO group. None of the differences was significant. No differences in neurosensory disturbance could be found between the two study groups. Objective WS monofilament testing appeared to underestimate NSD compared to subjective patient report. © 2014 International Association of Oral and Maxillofacial Surgeons.

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