24 results on '"Boers, Maarten"'
Search Results
2. Self-monitoring combined with patient-initiated care in RA patients with low disease activity: cost-effectiveness analysis of an RCT.
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Seppen, Bart F, Greuter, Marjolein J E, Wiegel, Jimmy, Wee, Marieke M ter, Boers, Maarten, Nurmohamed, Michael T, and Bos, Wouter H
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PATIENT aftercare ,LABOR productivity ,CONFIDENCE intervals ,MOBILE apps ,MEDICAL care costs ,SMARTPHONES ,SEVERITY of illness index ,MEDICAL care use ,COMPARATIVE studies ,ANTIRHEUMATIC agents ,RHEUMATOID arthritis ,COST effectiveness ,RESEARCH funding ,DESCRIPTIVE statistics ,PATIENT care ,MEDICAL appointments ,HEALTH self-care ,DISEASE remission ,LONGITUDINAL method - Abstract
Objectives Self-monitoring and patient-initiated care (PIC) leads to fewer outpatient clinic visits in patients with established RA with low disease activity (LDA) while healthcare outcomes are similar. This study assesses the cost-effectiveness of PIC with self-monitoring. Methods A 12-month randomized controlled trial was performed with 49 patients in the PIC with self-monitoring group (app-group) and 53 in usual care. The usual care group continued with preplanned visits. The app group had one planned follow-up visit after 12 months and monitored their RA disease activity in a smartphone app. Both groups could make additional appointments at liberty. We included adult RA patients with a disease duration of over 2 years, a disease activity score 28 (DAS28) below 3.2 that were stable on medication for at least 6 months. The effect measure, the DAS28, was measured at 12 months and healthcare resource usage and productivity losses were measured at 3, 6, 9 and 12 months. Results There was no significant difference in mean change of DAS28 (-0.04 mean difference, 95% CI: -0.39, 0.30), nor a statistically significant difference in total costs (mean difference €514, 95% CI:-€266, €3690) in the app group compared with the usual care group. The probability that the app was cost-effective was 0.37 and 0.57 at a willingness-to-pay threshold of 0 and 50 000 €/point improvement DAS28, respectively. Conclusion Although rheumatic care costs were significantly lower in the app group, total costs and effects of PIC with self-monitoring were not different from usual care in RA patients with LDA. [ABSTRACT FROM AUTHOR]
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- 2023
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3. Safety and efficacy associated with long-term low-dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis.
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Palmowski, Andriko, Nielsen, Sabrina M, Boyadzhieva, Zhivana, Schneider, Abelina, Pankow, Anne, Hartman, Linda, Silva, José A P Da, Kirwan, John, Wassenberg, Siegfried, Dejaco, Christian, Christensen, Robin, Boers, Maarten, and Buttgereit, Frank
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DRUG efficacy ,GLUCOCORTICOIDS ,ONLINE information services ,MEDICAL databases ,META-analysis ,CONFIDENCE intervals ,MEDICAL information storage & retrieval systems ,SYSTEMATIC reviews ,TREATMENT effectiveness ,RHEUMATOID arthritis ,DESCRIPTIVE statistics ,MEDLINE ,PATIENT safety ,EVALUATION - Abstract
Objectives The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. Methods A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE). Results Six trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19–1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: −0.23; −0.43 to −0.03), function (HAQ −0.09; −0.18 to 0.00), and Larsen scores (–4.61; −7.52 to −1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs. Conclusion There is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties. [ABSTRACT FROM AUTHOR]
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- 2023
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4. A machine learning approach reveals features related to clinicians' diagnosis of clinically relevant knee osteoarthritis.
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Wang, Qiuke, Runhaar, Jos, Kloppenburg, Margreet, Boers, Maarten, Bijlsma, Johannes W J, Bacardit, Jaume, Bierma-Zeinstra, Sita M A, and Group, The CREDO Experts
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KNEE osteoarthritis ,KNEE joint ,MACHINE learning ,QUANTITATIVE research ,RANDOM forest algorithms ,COMPARATIVE studies ,DESCRIPTIVE statistics ,RESEARCH funding ,ALGORITHMS ,LONGITUDINAL method - Abstract
Objectives To identify highly ranked features related to clinicians' diagnosis of clinically relevant knee OA. Methods General practitioners (GPs) and secondary care physicians (SPs) were recruited to evaluate 5–10 years follow-up clinical and radiographic data of knees from the CHECK cohort for the presence of clinically relevant OA. GPs and SPs were gathered in pairs; each pair consisted of one GP and one SP, and the paired clinicians independently evaluated the same subset of knees. A diagnosis was made for each knee by the GP and SP before and after viewing radiographic data. Nested 5-fold cross-validation enhanced random forest models were built to identify the top 10 features related to the diagnosis. Results Seventeen clinician pairs evaluated 1106 knees with 139 clinical and 36 radiographic features. GPs diagnosed clinically relevant OA in 42% and 43% knees, before and after viewing radiographic data, respectively. SPs diagnosed in 43% and 51% knees, respectively. Models containing top 10 features had good performance for explaining clinicians' diagnosis with area under the curve ranging from 0.76–0.83. Before viewing radiographic data, quantitative symptomatic features (i.e. WOMAC scores) were the most important ones related to the diagnosis of both GPs and SPs; after viewing radiographic data, radiographic features appeared in the top lists for both, but seemed to be more important for SPs than GPs. Conclusions Random forest models presented good performance in explaining clinicians' diagnosis, which helped to reveal typical features of patients recognized as clinically relevant knee OA by clinicians from two different care settings. [ABSTRACT FROM AUTHOR]
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- 2023
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5. A multidisciplinary lifestyle program for rheumatoid arthritis: the 'Plants for Joints' randomized controlled trial.
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Walrabenstein, Wendy, Wagenaar, Carlijn A, van der Leeden, Marike, Turkstra, Franktien, Twisk, Jos W R, Boers, Maarten, Middendorp, Henriët van, Weijs, Peter J M, and Schaardenburg, Dirkjan van
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LIPOPROTEINS ,EVALUATION of human services programs ,HEALTH outcome assessment ,SEVERITY of illness index ,TREATMENT effectiveness ,PLANT-based diet ,PHYSICAL activity ,RANDOMIZED controlled trials ,HEALTH care teams ,RHEUMATOID arthritis ,HEALTH behavior ,STRESS management ,BODY mass index ,BEHAVIOR modification - Abstract
Objective To determine the effect of a multidisciplinary lifestyle program in patients with RA with low–moderate disease activity. Methods In the 'Plants for Joints' (PFJ) parallel-arm, assessor-blind randomized controlled trial, patients with RA and 28-joint DAS (DAS28) ≥2.6 and ≤5.1 were randomized to the PFJ or control group. The PFJ group followed a 16-week lifestyle program based on a whole-food plant-based diet, physical activity and stress management. The control group received usual care. Medication was kept stable 3 months before and during the trial whenever possible. We hypothesized that PFJ would lower disease activity (DAS28). Secondary outcomes included anthropometric, metabolic and patient-reported measures. An intention-to-treat analysis with a linear mixed model adjusted for baseline values was used to analyse between-group differences. Results Of the 83 people randomized, 77 completed the study. Participants were 92% female with mean (s. d.) age of 55 (12) years, BMI of 26 (4) kg/m
2 and mean DAS28 of 3.8 (0.7). After 16 weeks the PFJ group had a mean 0.9-point greater improvement of DAS28 vs the control group (95% CI 0.4, 1.3; P < 0.0001). The PFJ intervention led to greater decreases in body weight (difference –3.9 kg), fat mass (–2.8 kg), waist circumference (–3 cm), HbA1c (–1.3 mmol/mol) and low-density lipoprotein (–0.32 mmol/l), whereas patient-reported outcome measures, blood pressure, glucose and other lipids did not change. Conclusion The 16-week PFJ multidisciplinary lifestyle program substantially decreased disease activity and improved metabolic status in people with RA with low–moderate disease activity. Trial Registration International Clinical Trials Registry Platform; https://www.who.int/clinical-trials-registry-platform ; NL7800. [ABSTRACT FROM AUTHOR]- Published
- 2023
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6. Favourable effect of a 'second hit' after 13 weeks in early RA non-responders: the Amsterdam COBRA treat-to-target randomized trial.
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Hartman, Linda, Rasch, Linda A, Turk, Samina A, Wee, Marieke M ter, Kerstens, Pit J S M, Laken, Conny J van der, Nurmohamed, Michael T, Schaardenburg, Dirkjan van, Tuyl, Lilian H D van, Voskuyl, Alexandre E, Boers, Maarten, and Lems, Willem F
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RHEUMATOID arthritis risk factors ,COMBINATION drug therapy ,PREDNISOLONE ,CONFIDENCE intervals ,CLASSIFICATION ,PATIENTS ,TREATMENT effectiveness ,METHOTREXATE ,RHEUMATOID arthritis ,DRUG therapy ,RESEARCH funding ,HYDROXYCHLOROQUINE ,STATISTICAL sampling ,ADVERSE health care events ,EARLY medical intervention ,SULFONAMIDES - Abstract
Objective The aim of this study was to investigate the effect of treat-to-target combination therapy with intensification at 13 weeks in early RA. Methods Early RA patients were classified as being at high or low risk of worsening RA based on disease activity and prognostic factors. High-risk patients received COBRA-light (prednisolone 30 mg/day tapered to 7.5 mg/day, MTX increasing to 25 mg/week), and low-risk patients received MTX monotherapy increasing to 25 mg/week. The primary outcome (target) was DAS44 < 1.6 or EULAR good response at 26 weeks. At 13 weeks, non-responders were randomized to (open-label) intensification [high-risk patients: prednisolone 60 mg/day tapered to 7.5 mg/day, addition of SSZ (2 g/day) and HCQ (400 mg/day); low-risk patients: prednisolone 30 mg/day tapered to 7.5 mg/day] or continuation. Results In the high-risk group (n = 150), 110 patients (73%) reached the target at 13 weeks, and 9 dropped out. Non-responders were randomized to intensification (n = 15) or continuation (n = 16), and after 26 weeks, 12 (80%) vs 7 (44%) of these, respectively, reached the target [difference: 36%, (95% CI 2%, 71%); P = 0.04]. In the low-risk group (n = 40), 17 (43%) reached the target. Non-responders were randomized to intensification (n = 8) or continuation (n = 7); 4 vs 3, respectively, reached the target. Adverse event rates were higher in the high-risk group, and higher in the intensification subgroup of that group. Serious adverse events were rare. Protocol violations were frequent and mostly led to mitigation of actual treatment intensification. Conclusion Initial combination therapy was very successful in high-risk RA, and early intensification was beneficial in patients not reaching the strict target. The low-risk group was too small for drawing conclusions. In routine practice, adherence to early intensification based on strict targets is difficult. Trial registration Netherlands Trial Register (NTR), NL4393, https://www.trialregister.nl/. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Development of prediction models to select older RA patients with comorbidities for treatment with chronic low-dose glucocorticoids.
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Hartman, Linda, Silva, José A P da, Buttgereit, Frank, Cutolo, Maurizio, Opris-Belinski, Daniela, Szekanecz, Zoltan, Masaryk, Pavol, Voshaar, Marieke J H, Heymans, Martijn W, Lems, Willem F, Heijde, Désirée M F M van der, and Boers, Maarten
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DISEASE progression ,GLUCOCORTICOIDS ,PREDNISOLONE ,PATIENT selection ,RESEARCH methodology ,REGRESSION analysis ,RHEUMATOID arthritis ,RESEARCH funding ,PREDICTION models ,LOGISTIC regression analysis ,COMORBIDITY ,OLD age - Abstract
Objective To develop prediction models for individual patient harm and benefit outcomes in elderly patients with RA and comorbidities treated with chronic low-dose glucocorticoid therapy or placebo. Methods In the Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis (GLORIA) study, 451 RA patients ≥65 years of age were randomized to 2 years 5 mg/day prednisolone or placebo. Eight prediction models were developed from the dataset in a stepwise procedure based on prior knowledge. The first set of four models disregarded study treatment and examined general predictive factors. The second set of four models was similar but examined the additional role of low-dose prednisolone. In each set, two models focused on harm [the occurrence of one or more adverse events of special interest (AESIs) and the number of AESIs per year) and two on benefit (early clinical response/disease activity and a lack of joint damage progression). Linear and logistic multivariable regression methods with backward selection were used to develop the models. The final models were assessed and internally validated with bootstrapping techniques. Results A few variables were slightly predictive for one of the outcomes in the models, but none were of immediate clinical value. The quality of the prediction models was sufficient and the performance was low to moderate (explained variance 12–15%, area under the curve 0.67–0.69). Conclusion Baseline factors are not helpful in selecting elderly RA patients for treatment with low-dose prednisolone given their low power to predict the chance of benefit or harm. Trial registration https://clinicaltrials.gov ; NCT02585258. [ABSTRACT FROM AUTHOR]
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- 2023
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8. Switching from prednisolone to dexamethasone in difficult-to-treat rheumatoid arthritis.
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Kerstens, Floor, Spijkers, Karin, Wolthuis, David, Boers, Maarten, Herwaarden, Noortje van, and Cate, David ten
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GLUCOCORTICOIDS ,PREDNISOLONE ,GENERIC drug substitution ,DEXAMETHASONE ,BIOAVAILABILITY ,GENETIC variation ,ISOENZYMES ,RHEUMATOID arthritis ,PHARMACODYNAMICS - Abstract
The article reports a response after switching from prednisole to dexamethasone in three D2T-RA patients with active disease despite prednisolone. Topics discussed include possible mechanisms why response to different glucocorticoids (GCs) may vary, pharmacodynamic differences between GCs, and characteristics of 3 ACPA-positive patients switched from prednisolone to dexamethasone.
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- 2024
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9. Paradoxically protective effect of glucocorticoids on bone mass and fragility fracture in a large cohort: a cross-sectional study.
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Bukhari, Marwan, Goodson, Nicola, and Boers, Maarten
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GLUCOCORTICOIDS ,BONE density ,DUAL-energy X-ray absorptiometry - Abstract
Objectives Glucocorticoids (GCs) increase the risk of fracture through reduction in BMD; they may also reduce bone quality, but recent supporting data are scarce. We aimed to confirm these effects in a large population-based cohort. Methods We used data from patients referred for first hip and lumbar spine BMD estimation by the sole DXA scanner in the north-west of England between June 2004 and September 2016. We compared the history of fractures and BMD between patients currently on GCs and patients never exposed to GC. A logistic model adjusted for possible confounders. Results More than 20 000 subjects were included, 82% female, with mean age 63 (s. d. 13) years; 19% were currently on GCs. The patients on GCs were more often male, with higher BMI, but their age was similar to those not exposed to GC. Surprisingly, patients receiving GCs had ∼2% higher BMD at both sites (P < 0.001) and lower prevalence of (history of) fractures (22% vs 34%; P < 0.001). The corresponding odds ratio was 0.53 (95% CI: 0.49, 0.58); adjustment for age, sex, BMI and the number of indications for scanning did not alter the association. Conclusion In this large population-based cohort, current GC use compared with never use was associated with higher bone mass and fewer rather than more fractures after adjusting for confounders. These results might be subject to unmeasured confounding, but for now they do not lend support to a detrimental effect of GCs on bone. [ABSTRACT FROM AUTHOR]
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- 2022
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10. Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE.
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D'Agostino, Maria Antonietta, Schett, Georg, López-Rdz, Alejandra, Šenolt, Ladislav, Fazekas, Katalin, Burgos-Vargas, Ruben, Maldonado-Cocco, Jose, Naredo, Esperanza, Carron, Philippe, Duggan, Anne-Marie, Goyanka, Punit, Boers, Maarten, and Gaillez, Corine
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PSORIATIC arthritis ,INTERLEUKINS ,SYNOVITIS ,MONOCLONAL antibodies ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PLACEBOS ,SEVERITY of illness index ,DOPPLER ultrasonography ,DESCRIPTIVE statistics ,PROSTATE-specific antigen ,STATISTICAL sampling - Abstract
Objectives To investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound. Methods The randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses. Results Of the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [−9 (0.9) vs −6 (0.9), difference (95% CI): −3 (−6, −1); one-sided P= 0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported. Conclusion This unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients. Trial registration ClinicalTrials.gov; NCT02662985. [ABSTRACT FROM AUTHOR]
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- 2022
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11. Diagnostic criteria for early hip osteoarthritis: first steps, based on the CHECK study.
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Runhaar, Jos, Özbulut, Ömer, Kloppenburg, Margreet, Boers, Maarten, Bijlsma, Johannes W J, Bierma-Zeinstra, Sita M A, and group, the CREDO expert
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HIP joint diseases diagnosis ,OSTEOARTHRITIS diagnosis ,OSTEOARTHRITIS treatment ,HIP joint diseases ,PHYSICAL diagnosis ,RADIOGRAPHY ,MEDICAL history taking ,DESCRIPTIVE statistics ,EARLY diagnosis ,LONGITUDINAL method - Abstract
Objectives Although there is a general focus on early diagnosis and treatment of hip OA, there are no validated diagnostic criteria for early-stage hip OA. The current study aimed to take the first steps in developing diagnostic criteria for early-stage hip OA, using factors obtained through history taking, physical examination, radiography and blood testing at the first consultation in individuals presenting with hip pain, suspicious for hip OA, in primary care. Methods Data of the 543 individuals with 735 symptomatic hips at baseline who had any follow-up data available from the prospective CHECK cohort study were used. A group of 26 clinical experts [general practitioners (GPs), rheumatologists and orthopaedic surgeons] evaluated standardized clinical assessment forms of all subjects on the presence of clinically relevant hip OA 5–10 years after baseline. Using the expert-based diagnoses as reference standard, a backward selection method was used to create predictive models based on pre-defined baseline factors from history taking, physical examination, radiography and blood testing. Results Prevalence of clinically relevant hip OA during follow-up was 22%. Created models contained four to eight baseline factors (mainly WOMAC pain items, painful/restricted movements and radiographic features) and obtained area under the curve between 0.62 (0.002) and 0.71 (0.002). Conclusion Based on clinical and radiographic features of hip OA obtained at first consultation at a GP for pain/stiffness of the hip, the prediction of clinically relevant hip OA within 5–10 years was 'poor' to 'fair'. [ABSTRACT FROM AUTHOR]
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- 2021
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12. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials—lessons learned from six large multicentre randomized controlled trials.
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Buttgereit, Thomas, Palmowski, Andriko, Forsat, Noah, Boers, Maarten, Witham, Miles D, Rodondi, Nicolas, Moutzouri, Elisavet, Navidad, Antonio Jesus Quesada, Hof, Arnoud W J van't, van der Worp, Bart, Coll-Planas, Laura, Voshaar, Marieke, Wit, Maarten de, Silva, José da, Stegemann, Sven, Bijlsma, Johannes W, Koeller, Marcus, Mooijaart, Simon, Kearney, Patricia M, and Buttgereit, Frank
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HUMAN research subjects ,PATIENT participation ,CLINICAL trials ,PATIENT selection ,TIME ,CONFERENCES & conventions ,HEALTH status indicators ,RANDOMIZED controlled trials ,BUSINESS networks ,INTERPROFESSIONAL relations ,HEALTH attitudes ,HEALTH ,INFORMATION resources ,PATIENT-professional relations ,EMOTIONS ,COMORBIDITY ,PERSONNEL management ,COMMUNICATION education ,OLD age - Abstract
Background older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients. Objective to identify key barriers and to discuss solutions to specific issues affecting recruitment and retention of older participants in clinical trials based on experience gained from six current European randomised controlled trials (RCTs) focusing on older people. Methods a multidisciplinary group of experts including representatives of the six RCTs held two networking conferences and compiled lists of potential barriers and solutions. Every item was subsequently allocated points by each study team according to how important it was perceived to be for their RCTs. Results the six RCTs enrolled 7,612 older patients. Key barriers to recruitment were impaired health status, comorbidities and diverse health beliefs including priorities within different cultural systems. All trials had to increase the number of recruitment sites. Other measures felt to be effective included the provision of extra time, communication training for the study staff and a re-design of patient information. Key barriers for retention included the presence of severe comorbidities and the occurrence of adverse events. Long study duration, frequent study visits and difficulties accessing the study site were also mentioned. Solutions felt to be effective included spending more time maintaining close contact with the participants, appropriate measures to show appreciation and reimbursement of travel arrangements. Conclusion recruitment and retention of older patients in trials requires special recognition and a targeted approach. Our results provide scientifically-based practical recommendations for optimizing future studies in this population. [ABSTRACT FROM AUTHOR]
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- 2021
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13. Cardiovascular events in anti-neutrophil cytoplasmic antibody-associated vasculitis: a meta-analysis of observational studies.
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Houben, Eline, Penne, Erik L, Voskuyl, Alexandre E, Heijden, Joost W van der, Otten, René H J, Boers, Maarten, and Hoekstra, Tiny
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CARDIOVASCULAR diseases risk factors ,CORONARY disease ,INFORMATION storage & retrieval systems ,MEDICAL databases ,MEDICAL information storage & retrieval systems ,MEDLINE ,META-analysis ,ONLINE information services ,PERIPHERAL vascular diseases ,STROKE ,VASCULITIS ,SYSTEMATIC reviews ,ANTINEUTROPHIL cytoplasmic antibodies - Abstract
Objectives. Several chronic inflammatory diseases are associated with cardiovascular disease, but the risk in ANCA-associated vasculitis is poorly quantified. The aim of the present study was to review the evidence for an increased cardiovascular risk, including ischaemic heart disease, cerebrovascular accidents and peripheral arterial disease, in patients with ANCA-associated vasculitis. Methods. A comprehensive systematic review was conducted in accordance with guidelines of preferred reporting items for systematic reviews and meta-analyses. The databases PubMed, Embase.com and the Cochrane Library (Wiley) were searched for original observational studies comparing vasculitis patients with at least one control group. Summary estimates were derived with a random-effects model and reported as relative risks. Results. One thousand three hundred and seventy-five studies were identified. Seven studies were included, comprising almost 14 000 ANCA-associated vasculitis patients vs general population controls in six studies and chronic kidney disease patients in one study. ANCA-associated vasculitis carried a relative risk of 1.65 (95% CI: 1.23, 2.22) for all cardiovascular events, 1.60 (95% CI: 1.39, 1.84) for ischaemic heart disease and 1.20 (95% CI: 0.98, 1.48) for cerebrovascular accidents. We did not find studies that addressed the risk for peripheral arterial disease separately. No heterogeneity was seen in the estimates. Conclusion. This meta-analysis of observational studies supports an increase in cardiovascular risk in patients with ANCA-associated vasculitis of ~65%, similar to that found in other chronic inflammatory diseases. Hence, there is a clear need for active cardiovascular risk management in patients with ANCA-associated vasculitis. [ABSTRACT FROM AUTHOR]
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- 2018
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14. Similar efficacy and safety of initial COBRA-light and COBRA therapy in rheumatoid arthritis: 4-year results from the COBRA-light trial.
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Konijn, Nicole P. C., van Tuyl, Lilian H. D., Boers, Maarten, den Uyl, Debby, ter Wee, Marieke M., van der Wijden, Lindsey K. M., Bultink, Irene E. M., Kerstens, Pit J. S. M., Voskuyl, Alexandre E., van Schaardenburg, Dirkjan, Nurmohamed, Michael T., and Lems, Willem F.
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ANTIRHEUMATIC agents ,COMBINATION drug therapy ,INTERVIEWING ,MEDICAL needs assessment ,METHOTREXATE ,RESEARCH funding ,RHEUMATOID arthritis ,STATISTICAL sampling ,COMORBIDITY ,DATA analysis software ,DESCRIPTIVE statistics ,PREDNISOLONE - Abstract
Objective. To assess the efficacy and safety of initial COBRA-light vs COBRA therapy in RA patients after a 4-year follow-up period. Methods. In the COBRA-light trial, 162 consecutive patients with recent-onset RA were randomized to either COBRA-light (prednisolone and MTX) or COBRA therapy (prednisolone, MTX and SSZ) for 1 year. After 1 year, treatment was continued without protocol, and adjusted by the treating physician according to clinical judgement, preferably with a treat-to-target strategy. Four years after trial initiation, all patients were invited to participate in the COBRA-light extension study, in which patients were interviewed and physically examined, patient reported outcomes were assessed, radiographs were made and clinical records were examined for comorbidities and medication use. Results. In the extension study, 149 out of 162 (92%) original trial patients participated: 72 COBRA-light and 77 COBRA patients. Initial COBRA-light and COBRA therapy showed similar effect on disease activity, physical functioning, radiological outcome and Boolean remission over the 4-year follow-up period. In addition, both treatment groups showed similar survival and major comorbidities, although the power to detect differences was limited. Besides protocolled differences in prednisolone, MTX and SSZ use, the use of other synthetic and biologic DMARDs and intra-articular and intramuscular glucocorticoid injections was similar in both treatment groups over the 4-year period. Conclusion. Early RA patients initially treated with COBRA-light or COBRA therapy had similar efficacy and safety outcomes over a 4-year follow-up period. [ABSTRACT FROM AUTHOR]
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- 2017
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15. Cardiovascular risk management in rheumatoid arthritis patients still suboptimal: the Implementation of Cardiovascular Risk Management in Rheumatoid Arthritis project.
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van den Oever, Inge A. M., Heslinga, Maaike, Griep, Ed N., Griep-Wentink, Hanneke R. M., Schotsman, Rob, Cambach, Walter, Smulders, Yvo M., Dijkmans, Ben A. C., Lems, Willem F., Boers, Maarten, Voskuyl, Alexandre E., Peters, Mike J. L., van Schaardenburg, Dirkjan, and Nurmohamed, Micheal T.
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CARDIOVASCULAR diseases risk factors ,PREVENTIVE health services ,QUESTIONNAIRES ,RESEARCH funding ,RHEUMATOID arthritis ,RISK management in business ,DATA analysis software ,DESCRIPTIVE statistics - Abstract
Objective. To assess the 10-year cardiovascular (CV) risk score and to identify treatment and undertreatment of CV risk factors in patients with established RA. Methods. Demographics, CV risk factors and prevalence of cardiovascular disease (CVD) were assessed by questionnaire. To calculate the 10-year CV risk score according to the Dutch CV risk management guideline, systolic blood pressure was measured and cholesterol levels were determined from fasting blood samples. Patients were categorized into four groups: indication for treatment but not treated; inadequately treated, so not meeting goals (systolic blood pressure ≤140mmHg and/or low-density lipoprotein ≤2.5mmol/l); adequately treated; or no treatment necessary. Results. A total of 720 consecutive RA patients were included, 375 from Reade and 345 from the Antonius Hospital. The mean age of patients was 59 years (S.D. 12) and 73% were female. Seventeen per cent of the patients had a low 10-year CV risk (<10%), 21% had an intermediate risk (10-19%), 53% a high risk (≥20%) and 9% had CVD. In total, 69% had an indication for preventive treatment (cholesterol-lowering or antihypertensive drugs). Of those, 42% received inadequate treatment and 40% received no treatment at all. Conclusion. Optimal CV risk management remains a major challenge and better awareness and management are urgently needed to reduce the high risk of CVD in the RA population. [ABSTRACT FROM AUTHOR]
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- 2017
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16. Comment on: Paradoxically protective effect of glucocorticoids on bone mass and fragility fracture in a large cohort: a cross-sectional study. Reply.
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Bukhari, Marwan, Goodson, Nicola, and Boers, Maarten
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GLUCOCORTICOIDS ,BONE density - Published
- 2022
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17. Risk of serious adverse effects of biological and targeted drugs in patients with rheumatoid arthritis: a systematic review meta-analysis.
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Tarp, Simon, Furst, Daniel Eric, Boers, Maarten, Luta, George, Bliddal, Henning, Tarp, Ulrik, Heller Asmussen, Karsten, Brock, Birgitte, Dossing, Anna, Schjødt Jørgensen, Tanja, Thirstrup, Steffen, and Christensen, Robin
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ANTIRHEUMATIC agents ,BIOLOGICAL products ,DATABASES ,META-analysis ,MONOCLONAL antibodies ,PIPERIDINE ,RHEUMATOID arthritis ,SYSTEMATIC reviews ,ETANERCEPT ,ABATACEPT ,ADALIMUMAB ,GOLIMUMAB ,TOCILIZUMAB - Abstract
Objectives. To determine possible differences in serious adverse effects among the 10 currently approved biological and targeted synthetic DMARDs (b/ts-DMARDs) for RA. Methods. Systematic review in bibliographic databases, trial registries and websites of regulatory agencies identified randomized trials of approved b/ts-DMARDs for RA. Network meta-analyses using mixed-effects Poisson regression models were conducted to calculate rate ratios for serious adverse events (SAEs) and deaths between each of the 10 drugs and control (i.e. no b/ts-DMARD treatment), based on subjects experiencing an event in relation to person-years. Confidence in the estimates was assessed by applying the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). Results. A total of 117 trials (47 615 patients) were included. SAEs were more common with certolizumab compared with abatacept (rate ratio = 1.58, 95% CI: 1.18, 2.14), adalimumab (1.36, 95% CI: 1.02, 1.81), etanercept (1.60, 95% CI: 1.18, 2.17), golimumab (1.45, 95% CI: 1.00, 2.08), rituximab (1.63, 95% CI: 1.16, 2.30), tofacitinib (1.44, 95% CI: 1.03, 2.02) and control (1.45, 95% CI: 1.13, 1.87); and tocilizumab compared with abatacept (1.30, 95% CI: 1.03, 1.65), etanercept (1.31, 95% CI: 1.04, 1.67) and rituximab (1.34, 95% CI: 1.01, 1.78). No other comparisons were statistically significant. Accounting for study duration confirmed our findings for up to 6 months' treatment but not for longer-term treatment (6-24 months). No differences in mortality between b/ts-DMARDs and control were found. Based on the GRADE approach, confidence in the estimates was low due to lack of head-to-head comparison trials and imprecision in indirect estimates. Conclusion. Despite low confidence in the estimates, our analysis found potential differences in rates of SAEs. Our data suggest caution should be taken when deciding among available drugs. Systematic review registration number. PROSPERO CRD42014014842. [ABSTRACT FROM AUTHOR]
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- 2017
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18. The short-term effects of two high-dose, step-down prednisolone regimens on body composition in early rheumatoid arthritis.
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Konijn, Nicole P. C., van Tuyl, Lilian H. D., Boers, Maarten, van de Ven, Peter M., den Uyl, Debby, ter Wee, Marieke M., Kerstens, Pit, Voskuyl, Alexandre E., van Schaardenburg, Dirkjan, Lems, Willem F., and Nurmohamed, Michael T.
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ACADEMIC medical centers ,ADIPOSE tissues ,BODY composition ,COMBINATION drug therapy ,LONGITUDINAL method ,QUESTIONNAIRES ,RESEARCH funding ,RHEUMATOID arthritis ,STATISTICAL sampling ,SECONDARY analysis ,DATA analysis software ,DESCRIPTIVE statistics ,PREDNISOLONE ,PHOTON absorptiometry ,DYADIC Adjustment Scale - Abstract
Objective. To investigate the effect of two different high-dose, step-down prednisolone regimens on body composition in early RA patients after 26 weeks of treatment. Methods. Prednisolone-naive patients with recent-onset RA (n = 108) were randomized to either COBRA (prednisolone 60 mg/day, tapered to 7.5 mg/day in 6 weeks; MTX and SSZ) or COBRA-light therapy (prednisolone 30 mg/day, tapered to 7.5 mg/day in 8 weeks and MTX). Body composition was assessed at baseline (before or soon after start of treatment) and after 26 weeks with DXA, and recorded as total body mass (TBM), total fat mass (FM), total lean mass (LM) and trunk/peripheral fat ratio. Log-ratio analyses assessed the proportional distribution of TBM (between LM, FM and bone mass) and FM (between trunk, extremities and head). The subgroup of patients with a DXA before start of treatment (n = 38) was analysed separately. Results. In the subgroup of patients with a DXA before start of treatment, TBM increased by 1.6 kg (P < 0.001) and total FM by 1.3 kg (P < 0.001). The trunk/peripheral fat ratio and the proportional distribution of TBM and FM remained stable over time. There were no differences between the treatment groups. Similar results were obtained in the study population as a whole. Conclusion. Both high-dose, step-down prednisolone regimens caused increases in TBM, mainly caused by an increase in FM, but we found no fat redistribution from peripheral to central tissues. This absence in fat redistribution contradicts the widely held assumption of rapid adverse effects of prednisolone on body composition in RA. Trial registration: ISRCTNregistry, http://www.isrctn.com, ISRCTN55552928 [ABSTRACT FROM AUTHOR]
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- 2016
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19. Cohort Profile: Cohort Hip and Cohort Knee (CHECK) study.
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Wesseling, Janet, Boers, Maarten, Viergever, Max A., Hilberdink, Wim K. H. A., Lafeber, Floris P. J. G., Dekker, Joost, Bijlsma, Johannes W. J., Hilberdink, Wim Kha, Lafeber, Floris Pjg, and Bijlsma, Johannes Wj
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KNEE diseases , *OSTEOARTHRITIS , *RADIOGRAPHY , *OSTEOARTHRITIS diagnosis , *HIP joint diseases , *COHORT analysis , *PROGNOSIS , *PAIN diagnosis , *COMPARATIVE studies , *HIP joint , *KNEE , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *PAIN measurement , *SEVERITY of illness index , *DISEASE progression - Abstract
The Cohort Hip and Cohort Knee (CHECK) study included participants with early symptomatic osteoarthritis (OA) of the hip or knee and evaluated clinical, radiographic and biochemical variables in order to establish the course, prognosis and underlying mechanisms of early symptomatic osteoarthritis. A total of 1002 participants aged 45-65 years, with symptomatic OA characterized by pain of knee and/ or hip, entered the cohort in the period October 2002 to September 2005. They were included at or within 6 months of their first visit to the general practitioner for these symptoms. An overview of measures that are included in the study can be found on the website [www.check-research.com]. On the basis of their presenting symptoms, participants were divided into two groups. Participants with mild symptoms visited the research centre at years 0, 2, 5, 8 and 10 (variable visiting group) and participants with more serious symptoms visited the research centre each year (annual visiting group). After 7 years, only 105 participants (10%) had dropped out; their baseline characteristics did not differ significantly from those of other participants. CHECK is a valuable source of information on early symptomatic OA, that allows the examination of high-quality data on clinical, radiographic and biochemical variables. The CHECK steering group welcomes collaboration with national and international colleagues. Requests for collaboration or access to data can be sent to [checkreu@umcutrecht.nl]. [ABSTRACT FROM AUTHOR]
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- 2016
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20. Validity and measurement precision of the PROMIS physical function item bank and a content validity-driven 20-item short form in rheumatoid arthritis compared with traditional measures.
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Oude Voshaar, Martijn A. H., ten Klooster, Peter M., Glas, Cees A. W., Vonkeman, Harald E., Taal, Erik, Krishnan, Eswar, Bernelot Moens, Hein J., Boers, Maarten, Terwee, Caroline B., van Riel, Piet L. C. M., and van de Laar, Mart A. F. J.
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RHEUMATOID arthritis ,ACADEMIC medical centers ,STATISTICAL correlation ,QUESTIONNAIRES ,RESEARCH funding ,SEVERITY of illness index ,RESEARCH methodology evaluation ,DESCRIPTIVE statistics ,PROGNOSIS - Abstract
Objective. To evaluate the content validity and measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) physical function item bank and a 20-item short form in patients with RA in comparison with the HAQ disability index (HAQ-DI) and 36-item Short Form Health Survey (SF-36) physical functioning scale (PF-10). Methods. The content validity of the instruments was evaluated by linking their items to the International Classification of Functioning, Disability and Health (ICF) core set for RA. The measures were administered to 690 RA patients enrolled in the Dutch Rheumatoid Arthritis Monitoring registry. Measurement precision was evaluated using item response theory methods and construct validity was evaluated by correlating physical function scores with other clinical and patient-reported outcome measures. Results. All 207 health concepts identified in the physical function measures referred to activities that are featured in the ICF. Twenty-three of 26 ICF RA core set domains are featured in the full PROMIS physical function item bank compared with 13 and 8 for the HAQ-DI and PF-10, respectively. As hypothesized, all three physical function instruments were highly intercorrelated (r 0.74-0.84), moderately correlated with disease activity measures (r 0.44-0.63) and weakly correlated with age (rs 0.07-0.14). Item response theory-based analysis revealed that a 20-item PROMIS physical function short form covered a wider range of physical function levels than the HAQ-DI or PF-10. Conclusion. The PROMIS physical function item bank demonstrated excellent measurement properties in RA. A content-driven 20-item short form may be a useful tool for assessing physical function in RA. [ABSTRACT FROM AUTHOR]
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- 2015
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21. Aggressive therapy in patients with early arthritis results in similar outcome compared with conventional care: the STREAM randomized trial.
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van Eijk, Izhar C., Nielen, Markus M. J., van der Horst-Bruinsma, Irene, Tijhuis, Gerard J., Boers, Maarten, Dijkmans, Ben A. C., and van Schaardenburg, Dirkjan
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- 2012
22. Updating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis.
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Smolen, Josef S., Boers, Maarten, Abadie, Eric C., Breedveld, Ferdinand C., Emery, Paul, Bardin, Thomas, Goel, Niti, Ethgen, Dominique J., Avouac, Bernard P., Durez, Patrick, Flamion, Bruno, Laslop, Andrea, Miossec, Pierre, Reiter, Susanne, and Reginster, Jean-Yves
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- 2011
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23. A simple model that suggests possible cost savings when modified-release prednisone 5 mg/day is added to current treatment in patients with active rheumatoid arthritis.
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Boers, Maarten and Buttgereit, Frank
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- 2013
24. 217 Results of a patient survey on feasibility and face validity of outcome measures for intended use in future studies enrolling participants with polymyalgia rheumatica.
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Yates, Max, Owen, Claire E, Muller, Sara, Graham, Karly, Neill, Lorna, Twohig, Helen, Boers, Maarten, Pujades-Rodriguez, Mar D M, Goodman, Susan, Cheah, Jonathan T L, Dejaco, Christian, Mukhtyar, Chetan, Nielsen, Berit Dalsgaard, Robson, Jo, Simon, Lee S, Shae, Bev, Mackie, Sarah L, and Hill, Catherine
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CONFERENCES & conventions ,TEST validity ,EXPERIENCE ,POLYMYALGIA rheumatica - Published
- 2019
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