Woerden, Netherlands
Woerden, Netherlands

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Vermeer M.,University of Twente | Vermeer M.,Spectrum | Kievit W.,Radboud University Nijmegen | Kuper H.H.,Spectrum | And 8 more authors.
BMC Musculoskeletal Disorders | Year: 2013

Background: Where health economic studies are frequently performed using modelling, with input from randomized controlled trials and best guesses, we used real-life data to analyse the cost-effectiveness and cost-utility of a treatment strategy aiming to the target of remission compared to usual care in early rheumatoid arthritis (RA). Methods. We used real-life data from comparable cohorts in the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry: the DREAM remission induction cohort (treat-to-target, T2T) and the Nijmegen early RA inception cohort (usual care, UC). Both cohorts were followed prospectively using the DREAM registry methodology. All patients fulfilled the American College of Rheumatology criteria for RA and were included in the cohort at the time of diagnosis. The T2T cohort was treated according to a protocolised strategy aiming at remission (Disease Activity Score in 28 joints (DAS28) < 2.6). The UC cohort was treated without DAS28-guided treatment decisions. EuroQol-5D utility scores were estimated from the Health Assessment Questionnaire. A health care perspective was adopted and direct medical costs were collected. The incremental cost effectiveness ratio (ICER) per patient in remission and incremental cost utility ratio (ICUR) per quality-adjusted life year (QALY) gained were calculated over two and three years of follow-up. Results: Two year data were available for 261 T2T patients and 213 UC patients; an extended follow-up of three years was available for 127 and 180 patients, respectively. T2T produced higher remission percentages and a larger gain in QALYs than UC. The ICER was 3,591 per patient in remission after two years and T2T was dominant after three years. The ICUR was 19,410 per QALY after two years and T2T was dominant after three years. Conclusions: We can conclude that treating to the target of remission in early RA is cost-effective compared with UC. The data suggest that in the third year, T2T becomes cost-saving. © 2013 Vermeer et al.; licensee BioMed Central Ltd.


Fransen J.,Radboud University Nijmegen | Popa-Diaconu D.,Radboud University Nijmegen | Hesselstrand R.,Lund University | Carreira P.,Hospital Of 12 Octobre | And 17 more authors.
Annals of the Rheumatic Diseases | Year: 2011

Objective: Systemic sclerosis (SSc) is associated with a signifi cant reduction in life expectancy. A simple prognostic model to predict 5-year survival in SSc was developed in 1999 in 280 patients, but it has not been validated in other patients. The predictions of a prognostic model are usually less accurate in other patients, especially from other centres or countries. A study was undertaken to validate the prognostic model to predict 5-year survival in SSc in other centres throughout Europe. Methods: A European multicentre cohort of patients with SSc diagnosed before 2002 was established. Patients with SSc according to the preliminary American College of Rheumatology classifi cation criteria were eligible for the study when they were followed for at least 5 years or shorter if they died. The primary outcome was 5-year survival after diagnosis of SSc. The predefi ned prognostic model uses the following baseline variables: age, gender, presence of urine protein, erythrocyte sedimentation rate (ESR) and carbon monoxide diffusing capacity (DLCO). Results: Data were available for 1049 patients, 119 (11%) of whom died within 5 years after diagnosis. Of the patients, 85% were female, the mean (SD) age at diagnosis was 50 (14) years and 30% were classifi ed as having diffuse cutaneous SSc. The prognostic model with age (OR 1.03), male gender (OR 1.93), urine protein (OR 2.29), elevated ESR (1.89) and low DLCO (OR 1.94) had an area under the receiver operating characteristic curve of 0.78. Death occurred in 12 (2.2%) of 509 patients with no risk factors, 45 (13%) of 349 patients with one risk factor, 55 (33%) of 168 patients with two risk factors and 7 (30%) of 23 patients with three risk factors. Conclusion: A simple prognostic model using three disease factors to predict 5-year survival at diagnosis in SSc showed reasonable performance upon validation in a European multicentre study.


Tsoi K.L.,University Utrecht | Custers M.,Maartenskliniek | Bij De Vaate L.,Zuwe Hofpoort Ziekenhuis | Jacobs J.W.G.,University Utrecht
BMJ Case Reports | Year: 2012

A 57-year-old woman presented with malaise and heaviness in her extremities. At first there were no clues of an infammatory disease, but the patient developed slowly progressive oedema of her arms and legs with induration of the skin. Blood tests showed eosinophilia. Additional analysis revealed generalised lymphadenopathy. After excluding an infectious or malignant cause, the clinical diagnosis of eosinophilic fasciitis was made, this was confirmed by the results of a full thickness skin biopsy. Copyright 2012 BMJ Publishing Group. All rights reserved.


Hoogeboom T.J.,Sint Maartenskliniek | Hoogeboom T.J.,Maastricht University | Kwakkenbos L.,Sint Maartenskliniek | Rietveld L.,Maartenskliniek | And 3 more authors.
BMJ Open | Year: 2012

Objectives: To evaluate the feasibility and potential effectiveness of a 12-week, non-pharmacological multidisciplinary intervention in patients with generalised osteoarthritis (GOA). Design: A randomised, concurrent, multiple-baseline single-case design. During the baseline period, the intervention period and the postintervention period, all participants completed several health outcomes twice a week on Visual Analogue Scales. Setting: Rheumatology outpatient department of a specialised hospital in the Netherlands. Participants: 1 man and four women (aged 51-76 years) diagnosed with GOA. Primary outcome measures: To assess feasibility, the authors assessed the number of dropouts and adverse events, adherence rates and patients' satisfaction. Secondary outcome measures: To assess the potential effectiveness, the authors assessed pain and self-efficacy using visual data inspection and randomisation tests. Results: The intervention was feasible in terms of adverse events (none) and adherence rate but not in terms of participants' satisfaction with the intervention. Visual inspection of the data and randomisation testing demonstrated no effects on pain (p=0.93) or self-efficacy (p=0.85). Conclusions: The results of the present study indicate that the proposed intervention for patients with GOA was insufficiently feasible and effective. The data obtained through this multiple-baseline study have highlighted several areas in which the therapy programme can be optimised.


Schipper L.G.,Radboud University Nijmegen | Vermeer M.,University of Twente | Kuper H.H.,University of Twente | Hoekstra M.O.,Isala Klinieken | And 5 more authors.
Annals of the Rheumatic Diseases | Year: 2012

There is strong evidence from clinical trials that a 'treat to target' strategy is effective in reaching remission in rheumatoid arthritis (RA). However, the question is whether these results can be translated into daily clinical practice and clinical remission is a reachable target indeed. Objective: The study aims to investigate whether in early RA a treatment strategy aiming at Disease Activity Score (DAS) 28 <2.6 is more effective than 'usual care'treatment for reaching clinical remission after 1 year. Methods: Two early RA inception cohorts from two different regions including patients who fulfilled the American College of Rheumatology criteria for RA were compared. Patients in the tight-control cohort (n=126) were treated according to a DAS28-driven step-up treatment strategy starting with methotrexate, addition of sulphasalazine (SSZ) and exchange of SSZ by anti-tumour necrosis factor in case of failure. Patients in the usual-care cohort (n=126) were treated with methotrexate or SSZ, without DAS28-guided treatment decisions. The primary outcome was the percentage remission (DAS28<2.6) at 1 year. Time to first remission and change in DAS28 were secondary outcomes. Results: After 1 year, 55% of tight-control patients had a DAS28<2.6 versus 30% of usual care patients (OR 3.1, 95% CI 1.8 to 5.2). The median time to first remission was 25 weeks for tight control and more than 52 weeks for usual care (p<0.0001). The DAS28 decreased with -2.5 in tight control and -1.5 in usual care (p<0.0001). Conclusion: In early RA, a tight control treatment strategy aiming for remission leads to more rapid DAS28 remission and higher percentages of remission after 1 year than does a usual care treatment.


Arts E.E.A.,Radboud University Nijmegen | Popa C.,Radboud University Nijmegen | Den Broeder A.A.,Maartenskliniek | Semb A.G.,Diakonhjemmet Hospital | And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objective: This study was undertaken to assess the predictive ability of 4 established cardiovascular (CV) risk models for the 10-year risk of fatal and non-fatal CV diseases in European patients with rheumatoid arthritis. Methods: Prospectively collected data from the Nijmegen early rheumatoid arthritis (RA) inception cohort was used. Discriminatory ability for CV risk prediction was estimated by the area under the receiver operating characteristic curve. Calibration was assessed by comparing the observed versus expected number of events using Hosmer-Lemeshov tests and calibration plots. Sensitivity and specificity were calculated for the cut-offvalues of 10% and 20% predicted risk. Results: Areas under the receiver operating characteristic curve were 0.78-0.80, indicating moderate to good discrimination between patients with and without a CV event. The CV risk models Systematic Coronary Risk Evaluation (SCORE), Framingham risk score (FRS) and Reynolds risk score (RRS) primarily underestimated CV risk at low and middle observed risk levels, and mostly overestimated CV risk at higher observed risk levels. The QRisk II primarily overestimated observed CV risk. For the 10% and 20% cut-offvalues used as indicators for CV preventive treatment, sensitivity ranged from 68-87% and 40-65%, respectively and specificity ranged from 55-76% and 77-88%, respectively. Depending on the model, up to 32% of observed CV events occurred in patients with RA who were classified as low risk (<10%) for CV disease. Conclusions: Established risk models generally underestimate (Systematic Coronary Risk Evaluation score, Framingham Risk Score, Reynolds risk score) or overestimate (QRisk II) CV risk in patients with RA. © 2014 BMJ Publishing Group Ltd & European League Against Rheumatism.


Van Laar J.M.,Northumbria University | Farge D.,University Paris Diderot | Sont J.K.,Leiden University | Naraghi K.,Ames Cook University Hospital | And 41 more authors.
JAMA - Journal of the American Medical Association | Year: 2014

IMPORTANCE: High-dose immunosuppressive therapy and autologous hematopoietic stem cell transplantation (HSCT) have shown efficacy in systemic sclerosis in phase 1 and small phase 2 trials. OBJECTIVE: To compare efficacy and safety of HSCT vs 12 successive monthly intravenous pulses of cyclophosphamide. DESIGN, SETTING, AND PARTICIPANTS: The Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial, a phase 3, multicenter, randomized (1:1), open-label, parallel-group, clinical trial conducted in 10 countries at 29 centers with access to a European Group for Blood and Marrow Transplantation-registered transplant facility. From March 2001 to October 2009, 156 patients with early diffuse cutaneous systemic sclerosis were recruited and followed up until October 31, 2013. INTERVENTIONS: HSCT vs intravenous pulse cyclophosphamide. MAIN OUTCOMES AND MEASURES: The primary end pointwas event-free survival, defined as time from randomization until the occurrence of death or persistent major organ failure. RESULTS: A total of 156 patients were randomly assigned to receive HSCT (n = 79) or cyclophosphamide (n = 77). During a median follow-up of 5.8 years, 53 events occurred: 22 in the HSCT group (19 deaths and 3 irreversible organ failures) and 31 in the control group (23 deaths and 8 irreversible organ failures). During the first year, there were more events in the HSCT group (13 events [16.5%], including 8 treatment-related deaths) than in the control group (8 events [10.4%], with no treatment-related deaths). At 2 years, 14 events (17.7%) had occurred cumulatively in the HSCT group vs 14 events (18.2%) in the control group; at 4 years, 15 events (19%) had occurred cumulatively in the HSCT group vs 20 events (26%) in the control group. Time-varying hazard ratios (modeled with treatment x time interaction) for event-free survival were 0.35 (95% CI, 0.16-0.74) at 2 years and 0.34 (95% CI, 0.16-0.74) at 4 years. CONCLUSIONS AND RELEVANCE: Among patients with early diffuse cutaneous systemic sclerosis, HSCT was associated with increased treatment-related mortality in the first year after treatment. However, HCST conferred a significant long-term event-free survival benefit. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN54371254 Copyright 2014 American Medical Association. All rights reserved.


Fransen J.,Radboud University Nijmegen | Johnson S.R.,University of Toronto | Van Den Hoogen F.,Maartenskliniek | Baron M.,McGill University | And 33 more authors.
Arthritis Care and Research | Year: 2012

Objective. Classification criteria for systemic sclerosis (SSc; scleroderma) are being updated. Our objective was to select a set of items potentially useful for the classification of SSc using consensus procedures, including the Delphi and nominal group techniques (NGT). Methods. Items were identified through 2 independent consensus exercises performed by the Scleroderma Clinical Trials Consortium and the European League Against Rheumatism Scleroderma Trials and Research Group. The first-round items from both exercises were collated and redundancies were removed, leaving 168 items. A 3-round Delphi exercise was performed using a 1-9 scale (where 1 = completely inappropriate and 9 = completely appropriate) and a consensus meeting using NGT was conducted. During the last Delphi round, the items were ranked on a 1-10 scale. Results. In round 1, 106 experts rated the 168 items. Those with a median score of <4 were removed, resulting in a list of 102 items. In round 2, the items were again rated for appropriateness and subjected to a consensus meeting using NGT by European and North American SSc experts (n = 16), resulting in 23 items. In round 3, SSc experts (n = 26) then individually scored each of the 23 items in a last Delphi round using an appropriateness score (1-9) and ranking their 10 most appropriate items for the classification of SSc. Presence of skin thickening, SSc-specific autoantibodies, abnormal nailfold capillary pattern, and Raynaud's phenomenon ranked highest in the final list that also included items indicating internal organ involvement. Conclusion. The Delphi exercise and NGT resulted in a set of 23 items for the classification of SSc that will be assessed for their discriminative properties in a prospective study. © 2012, American College of Rheumatology.


PubMed | Dudley NHS Hospital Group, Maartenskliniek, Diakonhjemmet Hospital and Radboud University Nijmegen
Type: Journal Article | Journal: Annals of the rheumatic diseases | Year: 2015

This study was undertaken to assess the predictive ability of 4 established cardiovascular (CV) risk models for the 10-year risk of fatal and non-fatal CV diseases in European patients with rheumatoid arthritis.Prospectively collected data from the Nijmegen early rheumatoid arthritis (RA) inception cohort was used. Discriminatory ability for CV risk prediction was estimated by the area under the receiver operating characteristic curve. Calibration was assessed by comparing the observed versus expected number of events using Hosmer-Lemeshov tests and calibration plots. Sensitivity and specificity were calculated for the cut-off values of 10% and 20% predicted risk.Areas under the receiver operating characteristic curve were 0.78-0.80, indicating moderate to good discrimination between patients with and without a CV event. The CV risk models Systematic Coronary Risk Evaluation (SCORE), Framingham risk score (FRS) and Reynolds risk score (RRS) primarily underestimated CV risk at low and middle observed risk levels, and mostly overestimated CV risk at higher observed risk levels. The QRisk II primarily overestimated observed CV risk. For the 10% and 20% cut-off values used as indicators for CV preventive treatment, sensitivity ranged from 68-87% and 40-65%, respectively and specificity ranged from 55-76% and 77-88%, respectively. Depending on the model, up to 32% of observed CV events occurred in patients with RA who were classified as low risk (<10%) for CV disease.Established risk models generally underestimate (Systematic Coronary Risk Evaluation score, Framingham Risk Score, Reynolds risk score) or overestimate (QRisk II) CV risk in patients with RA.


Van Bragt P.J.,Rotterdam Neurorehabilitation Research | Van Ginneken B.T.,Maartenskliniek | Westendorp T.,Rotterdam Neurorehabilitation Research | Heijenbrok-Kal M.H.,Rotterdam Neurorehabilitation Research | And 4 more authors.
International Journal of Rehabilitation Research | Year: 2014

This study aims to evaluate and predict outcome as part of routine quality assessment of an inpatient stroke rehabilitation programme. By relating functional outcome to patient characteristics, including variables from the quality of life domain, we aim to find a set of variables that can be useful for prognosis, stratification and programme improvement. Data were collected, before and after rehabilitation, from a prospective quality registration database. Included were 250 patients in inpatient stroke rehabilitation after sustaining a first or recurrent ischemic or haemorrhagic stroke. Functional status was measured with the Barthel Index and the Academic Medical Centre Linear Disability Score. Health-related quality of life (HrQoL) was measured with the COOP/WONCA and the Nottingham Health Profile. Significant improvements were found on all outcome measures. A lower functional admission score, older age, more severe stroke, more pain and more negative emotional reactions on admission were found to be independent predictors of a lower outcome score, explaining 39.5% of its variance. Subjective (HrQoL) factors such as negative emotion and pain have an adverse effect on outcome of stroke rehabilitation, in addition to stroke severity, age and functional status at admission. These factors need to be taken into account in screening, clinical decision making and treatment design. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.

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