Pelsser L.M.,Research Center |
Frankena K.,Wageningen University |
Toorman J.,Catharina Hospital |
Savelkoul H.F.,Wageningen University |
And 5 more authors.
The Lancet | Year: 2011
The effects of a restricted elimination diet in children with attention-deficit hyperactivity disorder (ADHD) have mainly been investigated in selected subgroups of patients. We aimed to investigate whether there is a connection between diet and behaviour in an unselected group of children. The Impact of Nutrition on Children with ADHD (INCA) study was a randomised controlled trial that consisted of an open-label phase with masked measurements followed by a double-blind crossover phase. Patients in the Netherlands and Belgium were enrolled via announcements in medical health centres and through media announcements. Randomisation in both phases was individually done by random sampling. In the open-label phase (first phase), children aged 4-8 years who were diagnosed with ADHD were randomly assigned to 5 weeks of a restricted elimination diet (diet group) or to instructions for a healthy diet (control group). Thereafter, the clinical responders (those with an improvement of at least 40 on the ADHD rating scale [ARS]) from the diet group proceeded with a 4-week double-blind crossover food challenge phase (second phase), in which high-IgG or low-IgG foods (classified on the basis of every child's individual IgG blood test results) were added to the diet. During the first phase, only the assessing paediatrician was masked to group allocation. During the second phase (challenge phase), all persons involved were masked to challenge allocation. Primary endpoints were the change in ARS score between baseline and the end of the first phase (masked paediatrician) and between the end of the first phase and the second phase (double-blind), and the abbreviated Conners' scale (ACS) score (unmasked) between the same timepoints. Secondary endpoints included food-specific IgG levels at baseline related to the behaviour of the diet group responders after IgG-based food challenges. The primary analyses were intention to treat for the first phase and per protocol for the second phase. INCA is registered as an International Standard Randomised Controlled Trial, number ISRCTN 76063113. Between Nov 4, 2008, and Sept 29, 2009, 100 children were enrolled and randomly assigned to the control group (n=50) or the diet group (n=50). Between baseline and the end of the first phase, the difference between the diet group and the control group in the mean ARS total score was 23·7 (95 CI 18·6-28·8; p<0·0001) according to the masked ratings. The difference between groups in the mean ACS score between the same timepoints was 11·8 (95 CI 9·2-14·5; p<0·0001). The ARS total score increased in clinical responders after the challenge by 20·8 (95 CI 14·3-27·3; p<0·0001) and the ACS score increased by 11·6 (7·7-15·4; p<0·0001). In the challenge phase, after challenges with either high-IgG or low-IgG foods, relapse of ADHD symptoms occurred in 19 of 30 (63) children, independent of the IgG blood levels. There were no harms or adverse events reported in both phases. A strictly supervised restricted elimination diet is a valuable instrument to assess whether ADHD is induced by food. The prescription of diets on the basis of IgG blood tests should be discouraged. Foundation of Child and Behaviour, Foundation Nuts Ohra, Foundation for Children's Welfare Stamps Netherlands, and the KF Hein Foundation. © 2011 Elsevier Ltd.
Arits A.H.M.M.,Maastricht University |
Mosterd K.,Maastricht University |
Essers B.A.B.,Maastricht University |
Spoorenberg E.,Maastricht University |
And 12 more authors.
The Lancet Oncology | Year: 2013
Background: Superficial basal-cell carcinoma is most commonly treated with topical non-surgical treatments, such as photodynamic therapy or topical creams. Photodynamic therapy is considered the preferable treatment, although this has not been previously tested in a randomised control trial. We assessed the effectiveness of photodynamic therapy compared with imiquimod or fluorouracil in patients with superficial basal-cell carcinoma. Methods: In this single blind, non-inferiority, randomised controlled multicentre trial, we enrolled patients with a histologically proven superficial basal-cell carcinoma at seven hospitals in the Netherlands. Patients were randomly assigned to receive treatment with methylaminolevulinate photodynamic therapy (MAL-PDT; two sessions with an interval of 1 week), imiquimod cream (once daily, five times a week for 6 weeks), or fluorouracil cream (twice daily for 4 weeks). Follow-up was at 3 and 12 months post-treatment. Data were collected by one observer who was blinded to the assigned treatment. The primary outcome was the proportion of patients free of tumour at both 3 and 12 month follow up. A pre-specified non-inferiority margin of 10% was used and modified intention-to-treat analyses were done. This trial is registered as an International Standard Randomised controlled trial (ISRCTN 79701845). Findings: 601 patients were randomised: 202 to receive MAL-PDT, 198 to receive imiquimod, and 201 to receive fluorouracil. A year after treatment, 52 of 196 patients treated with MAL-PDT, 31 of 189 treated with imiquimod, and 39 of 198 treated with fluorouracil had tumour residue or recurrence. The proportion of patients tumour-free at both 3 and 12 month follow-up was 72·8% (95% CI 66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream, and 80·1% (74·7-85·9) for fluorouracil cream. The difference between imiquimod and MAL-PDT was 10·6% (95% CI 1·5-19·5; p=0·021) and 7·3% (-1·9 to 16·5; p=0·120) between fluorouracil and MAL-PDT, and between fluorouracil and imiquimod was -3·3% (-11·6 to 5·0; p=0·435. For patients treated with MAL-PDT, moderate to severe pain and burning sensation were reported most often during the actual MAL-PDT session. For other local adverse reactions, local skin redness was most often reported as moderate or severe in all treatment groups. Patients treated with creams more often reported moderate to severe local swelling, erosion, crust formation, and itching of the skin than patients treated with MAL-PDT. In the MAL-PDT group no serious adverse events were reported. One patient treated with imiquimod and two patients treated with fluorouracil developed a local wound infection and needed additional treatment in the outpatient setting. Interpretation: Topical fluorouracil was non-inferior and imiquimod was superior to MAL-PDT for treatment of superficial basal-cell carcinoma. On the basis of these findings, imiquimod can be considered the preferred treatment, but all aspects affecting treatment choice should be weighted to select the best treatment for patients. Funding: Grant of the Netherlands Organization for Scientific Research ZONMW (08-82310-98-08626). © 2013 Elsevier Ltd.
Vaessen T.J.A.,VieCuri Medical Center |
Vaessen T.J.A.,University of Tilburg |
Overeem S.,Sleep Medicine Center Kempenhaeghe |
Overeem S.,Radboud University Nijmegen |
Sitskoorn M.M.,University of Tilburg
Sleep Medicine Reviews | Year: 2015
Obstructive sleep apnea (OSA) is associated with impairments in cognitive functioning. Although cognitive complaints are related to quality of life, work productivity and health care expenditures, most research and all reviews have focused exclusively on objective cognitive functioning so far. In this systematic review, we assessed the available literature on subjective measures of cognition in adult OSA patients. Concentration complaints were consistently found to be more severe in untreated OSA patients as compared to primary snorers and healthy controls. The same seems to be true for memory and executive function problems, but firm conclusions cannot be made as of yet, due to methodological limitations of the available studies. Cognitive complaints appear to be at least partially related to subjective sleepiness. Importantly, they are not necessarily a sign of objective cognitive impairment. Additional research is needed to explore the relation between cognitive complaints, sleepiness and mood problems using validated and norm-referenced questionnaires for cognitive complaints. In addition, the impact of continuous positive airway pressure (CPAP) treatment on cognitive complaints in OSA warrants further study. © 2014 Elsevier Ltd.
Koopmans S.M.,Maastricht University |
van Marion A.M.W.,VieCuri Medical Center |
Schouten H.C.,Maastricht University
Netherlands Journal of Medicine | Year: 2012
Essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (PMF) belong to the group of Philadelphia chromosome-negative myeloproliferative neoplasia (Ph-MPN). MPNs are clonal bone marrow stem cell disorders characterised by a proliferation of one or more of the myeloid, erythroid or megakaryocytic cell lines. Due to the different affected cell lines, MPNs show typical clinical and histological features. In 2005, a mutation in the JAK2 gene was discovered which generated more insight into the pathogenetic working mechanism of MPNs. However, the treatment of MPN patients is still mainly only palliative, although progress in reducing the symptoms of MPN patients has been made. This review will give a general overview of MPN patients for internal medicine physicians. © Van Zuiden Communications B.V. All rights reserved.
Boonen B.,Viecuri Medical Center |
Schotanus M.G.M.,Orbis Medical Center |
Kerens B.,AZ Monica |
van der Weegen W.,St Anna Hospital |
And 2 more authors.
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2013
Purpose: This prospective, double-blind, randomised controlled trial was designed to address the following research questions: firstly, is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA. Secondly, is there a significant difference in operation time, blood loss and length of hospital stay between the two techniques. We hypothesise that there will be fewer outliers with PSG TKA and that operation time, blood loss and length of hospital stay can be significantly reduced with PSG. Methods: A total of 180 patients were randomised for PSG TKA (group 1) or conventional TKA (group 2) in two centres. Patients were stratified per hospital. Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital, standing, long-leg and standard lateral radiographs by two independent outcome assessors in both centres. Percentages of outliers (>3°) were determined. We compared blood loss, operation time and length of hospital stay. Results: There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups. No statistically significant difference was found for the alignment of the individual components in the frontal plane nor for the percentages of outliers. There was a statistically significant difference in outliers for the femoral component in the sagittal plane, with a higher percentage of outliers in the group 1 (p = 0.017). No such significant result was found for the tibial component in that plane. All interclass correlation coefficients were good. Blood loss was 100 mL less in group 1 (p < 0.001). Operation time was 5 min shorter in group 1 (p < 0.001). Length of hospital stay was identical with a mean of 3.6 days (p = 0.657). Conclusions: The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups. A small reduction in operation time and blood loss was found with the PSG system. Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA. Level of evidence: I. © 2013 Springer-Verlag Berlin Heidelberg.
Janssen L.,Radboud University Nijmegen |
Janssen L.,VieCuri Medical Center |
Steenbergen B.,Radboud University Nijmegen |
Carson R.G.,Trinity College Dublin |
Carson R.G.,Queen's University of Belfast
Cerebral Cortex | Year: 2015
It has been argued that the variation in brain activity that occurs when observing another person reflects a representation of actions that is indivisible, and which plays out in full once the intent of the actor can be discerned. We used transcranial magnetic stimulation to probe the excitability of corticospinal projections to 2 intrinsic hand muscles while motions to reach and grasp an object were observed. A symbolic cue either faithfully indicated the required final orientation of the object and thus the nature of the grasp that was required, or was in conflict with the movement subsequently displayed. When the cue was veridical, modulation of excitability was in accordance with the functional role of the muscles in the action observed. If however the cue had indicated that the alternative grasp would be required, modulation of output to first dorsal interosseus was consistent with the action specified, rather than the action observed - until the terminal phase of the motion sequence during which the object was seen lifted. Modulation of corticospinal output during observation is thus segmented - it progresses initially in accordance with the action anticipated, and if discrepancies are revealed by visual input, coincides thereafter with that of the action seen. © 2013 The Author.
Van Berlo C.L.H.,VieCuri Medical Center
European Journal of Surgical Oncology | Year: 2013
From 2000 onwards many papers were published regarding the technique of sentinel lymph node biopsy in early breast cancer under local anaesthesia. This technique enabled a solid base for definitive breast surgery in one session under general anaesthesia, contributing to a better preparation of the patient undergoing definite breast cancer treatment and saving operating time. All papers agreed in safety of the concept, quality and patient satisfaction. As we will more and more waive a complete axillary dissection even after positive sentinel nodes, because there is no proof of gain in survival and local control, there is nowadays less place for the knowledge of the sentinel node status prior to definite breast surgery. © 2013 Elsevier Ltd. All rights reserved.
Kerens B.,AZ Monica |
Schotanus M.G.M.,Orbis Medisch Centrum |
Boonen B.,VieCuri Medical Center |
Kort N.P.,Orbis Medisch Centrum
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2014
Purpose: Implant position is an important factor in unicompartmental knee arthroplasty (UKA) surgery. Results on conventional UKA alignment are commonly described in literature. Patient-specific guiding (PSG) is a new technique for positioning the Oxford UKA. Our hypothesis is that PSG improves component position without affecting the HKA angle. Methods: This prospective study compares the results of our first thirty cases of cementless Oxford UKA using PSG with thirty cases using conventional outlining. Baseline characteristics for both groups were identical. Details on handling of the guide, estimated blood loss and operation time were recorded. Postoperative screened radiographs and standing long-leg radiographs of both groups were compared. Results: Median AP position of the femoral component was 3 degrees varus (-5 to 9) using PSG versus 2 degrees varus (-10 to 8) for the conventional group. For the femoral flexion, this was 9 degrees flexion (0-16) using PSG versus 12 degrees flexion (0-20). The tibial median AP position was 1 degree varus (-3 to 7) using PSG versus 2 degrees varus (-5 to 10). The median tibial posterior slope was 5 degrees (1-10) using PSG versus 5 degrees (0-12). All guides aligned well. No conversion to conventional outlining was performed, and no significant changes had to be made to the original approved plan. Operation time, estimated blood loss and postoperative haemoglobin drop were not significantly different between both groups. Discussion: Implant position was not different between both groups, even in the early phase of the learning curve. Perioperative results were not different between both groups. Level of evidence: III. © 2014 Springer-Verlag Berlin Heidelberg.
Michielsen E.C.H.J.,VieCuri Medical Center |
Bisschops P.G.T.,VieCuri Medical Center |
Janssen M.J.W.,VieCuri Medical Center
Clinical Chemistry and Laboratory Medicine | Year: 2011
Background: A 35-year-old female presented with complaints of tiredness, shortness of breath and recent onset of chest pain. The cardiac troponin I (cTnI) concentration was elevated at 6.4 μg/L (Abbott Architect reference value: <0.03 μg/L) with a normal ECG. Physical examination, radiological imaging and routine laboratory investigations did not provide an explanation for the elevated cTnI concentration. Methods: Use of different troponin assays, dilutions with assay diluent, addition of mouse serum, polyethylene glycol (PEG) precipitation and gel filtration chromatography (GFC) were used to investigate possible interference. Results: Troponin concentrations were below the level of detection when measured using all other troponin immunoassays. Serial dilutions of sample and addition of mouse serum did not alter the results. However, PEG precipitation and GFC showed the presence of a high molecular weight immunoreactive protein. Using GFC and protein-A IgG precipitation, the interference could be identified as a macrocomplex containing IgG and (fragments of) cTnI. Conclusions: We report a false positive cTnI result caused by a true macrotroponin, containing IgG and (fragments of) cTnI. This macrotroponin was only immunoreactive in the Abbott Architect cTnI immunoassay. Clinicians should be aware of analytical interference when troponin results are constantly elevated in the absence of (non)coronary causes of an increased troponin. © 2011 by Walter de Gruyter Berlin New York.
Verstraelen F.U.,Viecuri Medical Center |
In Den Kleef N.J.H.M.,Viecuri Medical Center |
Jansen L.,Viecuri Medical Center |
Morrenhof J.W.,Viecuri Medical Center
Clinical Orthopaedics and Related Research | Year: 2014
Background: There are several treatment options for calcifying tendinitis of the shoulder. The next step treatment after conservative treatment fails is still a matter of dispute. Extracorporeal shock wave therapy (ESWT) has been shown to be a good alternative to surgery, but the best treatment intensity remains unknown. High-energy ESWT is much more painful, more expensive, and usually is done in an inpatient setting, whereas low-energy ESWT can be performed in an outpatient setting by a physical therapist. Questions/purposes: A systematic review and meta-analysis of randomized trials was performed to answer two clear research questions: (1) Is there a greater increase in the Constant-Murley score in patients treated with high-energy ESWT compared with those treated with low-energy ESWT by 3 months and by 6 months? (2) Is there a greater chance of complete resorption of the calcifications in patients treated with high-energy ESWT compared with those treated with low-energy ESWT by 3 months and by 6 months? Methods: Five relevant electronic online databases, Medline (through PubMed), EMBASE (through OVID), Cinahl (through EBSCO), Web of Science, and the Cochrane Central Register of Controlled Trials, were systematically searched. We also crosschecked the reference lists of articles and reviews for possible relevant studies. Eligible for inclusion were all randomized controlled trials (RCTs) that compared high-energy ESWT (> 0.28 mJ/mm2) with low-energy ESWT (< 0.08 mJ/mm2). One author examined titles and abstracts of each identified study to assess study eligibility. Two reviewers independently extracted data and assessed the risk of bias and study quality. The primary outcome measure, the Constant-Murley score, was assessed by comparing mean functional outcome scores between the groups. Secondary outcomes were assessed using odds ratios, when appropriate data were pooled. Based on this process, five RCTs (359 participants) were included. Results: All five RCTs showed greater improvement in functional outcome (Constant-Murley score) in patients treated with high-energy ESWT compared with patients treated with low-energy ESWT at 3 and 6 months. The 3-month mean difference was 9.88 (95% CI, 9.04-10.72, p < 0.001; 6-month data could not be pooled). Furthermore, high-energy ESWT more often resulted in complete resorption of the deposits at 3 months. The corresponding odds ratio was 3.40 (95% CI, 1.35-8.58) and p = 0.009 (6-month data could not be pooled). Conclusion: When shock wave therapy is chosen, high-energy shock wave therapy is more likely to result in improved Constant-Murley score and resorption of the deposits compared with low-energy therapy. Level of Evidence: Level I, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence. © 2014 The Association of Bone and Joint Surgeons®.