Zwolle, Netherlands
Zwolle, Netherlands
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Dubois J.A.,Nova Biomedical | Slingerland R.J.,Isala | Fokkert M.,Isala | Roman A.,Free University of Colombia | And 5 more authors.
Critical Care Medicine | Year: 2017

Objectives: New data have emerged from ambulatory and acute care settings about adverse patient events, including death, attributable to erroneous blood glucose meter measurements and leading to questions over their use in critically ill patients. The U.S. Food and Drug Administration published new, more stringent guidelines for glucose meter manufacturers to evaluate the performance of blood glucose meters in critically ill patient settings. The primary objective of this international, multicenter, multidisciplinary clinical study was to develop and apply a rigorous clinical accuracy assessment algorithm, using four distinct statistical tools, to evaluate the clinical accuracy of a blood glucose monitoring system in critically ill patients. Design: Observational study. Setting: Five international medical and surgical ICUs. Patients: All patients admitted to critical care settings in the centers. Interventions: None. Measurements and Main Results: Glucose measurements were performed on 1,698 critically ill patients with 257 different clinical conditions and complex treatment regimens. The clinical accuracy assessment algorithm comprised four statistical tools to assess the performance of the study blood glucose monitoring system compared with laboratory reference methods traceable to a definitive standard. Based on POCT12-A3, the Clinical Laboratory Standards Institute standard for hospitals about hospital glucose meter procedures and performance, and Parkes error grid clinical accuracy performance criteria, no clinically significant differences were observed due to patient condition or therapy, with 96.1% and 99.3% glucose results meeting the respective criteria. Stratified sensitivity and specificity analysis (10 mg/dL glucose intervals, 50-150 mg/dL) demonstrated high sensitivity (mean = 95.2%, sd = ± 0.02) and specificity (mean = 95. 8%, sd = ± 0.03). Monte Carlo simulation modeling of the study blood glucose monitoring system showed low probability of category 2 and category 3 insulin dosing error, category 2 = 2.3% (41/1,815) and category 3 = 1.8% (32/1,815), respectively. Patient trend analysis demonstrated 99.1% (223/225) concordance in characterizing hypoglycemic patients. Conclusions: The multicomponent, clinical accuracy assessment algorithm demonstrated that the blood glucose monitoring system was acceptable for use in critically ill patient settings when compared to the central laboratory reference method. This clinical accuracy assessment algorithm is an effective tool for comprehensively assessing the validity of whole blood glucose measurement in critically ill patient care settings. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc.

OBJECTIVES: Three commonly used techniques for localization of nonpalpable breast cancer are radioactive seed localization (RSL), wire-guided localization (WGL) and radioguided occult lesion localization (ROLL). In this study, we analysed the surgical margins of these three techniques. METHODS: Women diagnosed with nonpalpable breast cancer undergoing breast-conserving surgery with one of the above-mentioned techniques were retrospectively included. The primary outcome parameter was tumour-free margin rate. Secondary outcomes were re-excision rate, recurrence of disease and volume of removed tissue. RESULTS: In total, 272 women were included in whom RSL (n=69), WGL (n=76) or ROLL (n=137) was performed. RSL showed a higher tumour-free margin rate [64 (92.8%)] compared with WGL [51 (67.1%)] and ROLL [113 (82.5%)] (P=0.001). In our multivariable analysis, RSL showed a higher tumour-free margin rate as well compared with WGL (P=0.036) and ROLL (P=0.049). Also, fewer re-excisions were encountered using RSL [5 (7.2%)] compared with WGL [13 (17.1%)] and ROLL [15 (10.9%)] (P=0.171). In 11 patients (WGL n=2, ROLL n=9), recurrence of disease occurred, despite a radical excision. The mean resection volumes were comparable within the three groups. CONCLUSION: RSL results in a higher tumour-free margin rate in nonpalpable breast tumours compared with WGL and ROLL. Therefore, we prefer using RSL in nonpalpable breast tumours. Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.

Steenbruggen I.,Isala | de Jongh F.,Spectrum
Respiratory Physiology and Neurobiology | Year: 2017

DL,CO measurements are often used to evaluate and monitor lung diseases as well as cardiovascular diseases. Whether the combination of DL,CO and DL,NO will improve the management of cardiovascular diseases needs to be investigated.It is hoped that the standardization of the DL,NO measurement will facilitate research. Scientific evidence that DL,NO can provide more accurate information than DL,CO alone, can take away the barriers that prevents DL,NO to become a routine test in pulmonology. © 2017 Elsevier B.V.

Lenters-Westra E.,Isala | Lenters-Westra E.,European Reference Laboratory for Glycohemoglobin | English E.,University of East Anglia
Clinical Chemistry and Laboratory Medicine | Year: 2017

As a reference laboratory for HbA1c, it is essential to have accurate and precise HbA1c methods covering a range of measurement principles. We report an evaluation of the Abbott Enzymatic (Architect c4000), Roche Gen.3 HbA1c (Cobas c513) and Tosoh G11 using different quality targets. The effect of hemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) reference systems was assessed using certified evaluation protocols. Each of the evaluated HbA1c methods had CVs <3% in SI units and <2% in NGSP units at 46 mmol/mol (6.4%) and 72 mmol/mol (8.7%) and passed the NGSP criteria when compared with six secondary reference measurement procedures (SRMPs). Sigma was 8.6 for Abbott Enzymatic, 3.3 for Roche Cobas c513 and 6.9 for Tosoh G11. No clinically significant interference was detected for the common Hb variants for the three methods. All three methods performed well and are suitable for clinical application in the analysis of HbA1c. Partly based on the result of this study, the Abbott Enzymatic method on the Architect c4000 and the Roche Gen.3 HbA1c on the Cobas c513 are now official, certified IFCC and NGSP SRMPs in the IFCC and NGSP networks. Sigma metrics quality criteria presented in a graph distinguish between good and excellent performance. © 2017 Walter de Gruyter GmbH, Berlin/Boston.

Leicher L.W.,PO Box 10400 | De Vos Tot Nederveen Cappel W.H.,PO Box 10400 | Van Westreenen H.L.,Isala
Diseases of the Colon and Rectum | Year: 2017

Background: Combined endoscopic laparoscopic surgical removal is used for polyps in the colon that are not suitable for endoscopic removal because of size, location, or scarring. However, the placement of a linear stapler can be challenging. Currently a wedge resection is mostly documented in the cecum or ascending colon. Objective: We report on our experience with limited endoscopy-assisted wedge resections in the entire colon. Design: A retrospective study was performed. Settings: This was a single-center study. Patients: Eight patients were included between March 2015 and April 2016. Interventions: The laparoscopic surgical technique consisted of placing a suture under endoscopic view through the base of the polyp into the lumen. Subsequently, traction was given on the suture to enable stapling of a wedge of the colon. Main Outcome Measures: Medical data were collected (ie, indication for referral for surgery, location and size of the polyp, duration of surgical procedure, length of hospital stay, and perioperative and postoperative complications). Operative time was defined as the total time of general anesthesia. Results: Eight patients, with a mean age of 74.5 years (range, 68.0-82.0 years), were treated. The main indications for laparoscopic resection were the size and difficult location of the polyp. There were no complications. Mean operative time was 132 minutes. Five patients were discharged the day after surgery, and the other 3 patients were admitted for a total of 2 days. Limitations: The study was limited by its small sample size. Conclusions: Our study found that limited endoscopy-assisted wedge resection is a feasible and easy technique for the removal of colon polyps and residual adenomatous tissue in scars that are not accessible for endoscopic removal. Because of traction given on the suture through the base of the polyp, the linear stapler is easily used for wedge resections of polyps, even for those that are not in favorable positions. © The ASCRS 2016.

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: 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.

Witteveen H.,Isala | van den Berg P.,Isala | Vermeulen G.,Isala
Journal of Headache and Pain | Year: 2017

Background: The aim of this study was to compare a multidisciplinary approach of menstrual (related) migraine, combining the neurological and gynaecological consultation, to a mono-disciplinary approach involving neurological treatment. There is a clear relationship between the menstruation cycle and the occurrence of migraine (menstrual migraine). Nowadays the treatment of menstrual (related) migraine is performed by a neurologist. A treatment with attention to hormonal treatment seems more convenient. Methods: This retrospective study was performed in a cohort using data of 88 women with menstrual (related) migraine who visited the menstrual migraine clinic between 2012 and 2014 (intervention group). The results were compared to a historical control group, which consisted of women with menstrual (related) migraine who were treated before 2012 and received a mono-disciplinary approach. Results: In the intervention group the Headache Impact (HIT) score significantly improved (65 to 59 points). The mean headache days per month declined significantly (from 6 to 3.83 days) and these women needed less use of pain medication. In the control group the decline in HIT score was less striking (65 to 63.5 points) and the mean headache days per month increased (6 to 6,5 days). It appeared that 20 out of 27 patients in the control group required a gynaecological consultation in course of time. Conclusion: A multidisicplinary treatment of women with menstrual (related) migraine gives better results compared to a mono-disciplinary approach. These results should be interpreted with caution as we performed a retrospective study with a relative small control group. © 2017, 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.

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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