187 results on '"Römkens, P"'
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2. Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study
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Lloyd Brandts, Zlatan Mujagic, M Pierik, Tessa EH Römkens, Laura Janssen, Mariëlle Romberg-Camps, Reinier Cornelis Anthonius van Linschoten, Rachel Louise West, and Lennard P L Gilissen
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Medicine - Abstract
Introduction Crohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard.Methods and analysis In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn’s disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test.Ethics and dissemination This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20–085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.Trial registration number NCT05886322
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- 2024
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3. Modeling cadmium in the feed chain and cattle organs
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van der Fels-Klerx, I., Römkens, P., Franz, E., and van Raamsdonk, L.
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Feed safety ,food safety ,supply chain ,feedstuffs ,chemical contaminant ,heavy metals ,cadmium ,modeling ,carry-over ,cattle organs ,Biotechnology ,TP248.13-248.65 ,Environmental sciences ,GE1-350 - Abstract
The objectives of this study were to estimate cadmium contamination levels in different scenarios related to soil characteristics and assumptions regarding cadmium accumulation in the animal tissues, using quantitative supply chain modeling. The model takes into account soil cadmium levels, soil pH, soil-to-plant transfer, animal consumption patterns, and transfer into animal organs (liver and kidneys). The model was applied to cattle up to the age of six years which were fed roughage (maize and grass) and compound feed. Cadmium content in roughage and cadmium intake by cattle were calculated for six different (soil) scenarios varying in soil cadmium levels and soil pH. For each of the six scenarios, the carry-over of cadmium from intake into the cattle organs was estimated applying two model assumptions, i.e., linear accumulation and a steady state situation. The results showed that only in the most extreme soil scenario (cadmium level 2.5 mg.kg-1, pH 4.5), cadmium exceeded the EC maximum tolerated level in roughage. Assuming linear accumulation, cadmium levels in organs of cattle up to six years of age, ranged from 0.37-4.03 mg.kg-1 of fresh weight for kidneys and from 0.07 to 0.77 mg.kg-1 of fresh weight for livers. The maximum tolerated levels in one or both organs were exceeded in several scenarios. When considering organ excretion of cadmium, internal cadmium levels in organs were approximately one order of magnitude lower as compared to the results of the linear accumulation model. In this case only in the most extreme soil scenario, the maximum tolerated level in the kidney was exceeded. It was concluded that the difference between the two assumptions (linear model versus a steady state situation to estimate cadmium carry-over in cattle) is negligible in the animal's first five years of life, but will become relevant at higher ages. For the current case, the linear approach is a good descriptor for worst case situations. Furthermore, this study showed that quantitative supply chain modeling is an effective tool in assessing whether or not a specific combination of soil properties would lead to unacceptable contaminant levels in feedstuffs and animal products in the view of animal and human health.
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- 2011
4. Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease: study protocol for a multicentre randomised controlled trial (MindIBD).
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ter Avest, Milou M, van Velthoven, Annelieke S M, Speckens, Anne E M, Dijkstra, Gerard, Dresler, Martin, Horjus, Carmen S, Römkens, Tessa E H, Witteman, Ellen M, van Dop, Willemijn A, Bredero, Quirine M, Nissen, Loes H C, and Huijbers, Marloes J
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- 2023
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5. Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease: study protocol for a multicentre randomised controlled trial (MindIBD).
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Milou M ter Avest, Annelieke S M van Velthoven, Anne E M Speckens, Gerard Dijkstra, Martin Dresler, Carmen S Horjus, Tessa E H Römkens, Ellen M Witteman, Willemijn A van Dop, Quirine M Bredero, Loes H C Nissen, and Marloes J Huijbers
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Mindfulness ,Mindfulness-Based Cognitive Therapy ,Inflammatory Bowel Disease ,Crohn’s disease ,Ulcerative colitis ,Randomised controlled trial ,Psychology ,BF1-990 - Abstract
Abstract Background Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress, fatigue and sleep disturbances, which are associated with reduced quality of life (QoL) and increased societal costs. Only limited psychosocial treatment options are available. As Mindfulness-Based Cognitive Therapy (MBCT) has demonstrated to improve psychological distress, QoL and sleep in other populations, MBCT might also be effective in patients with IBD. Methods The MindIBD study is a prospective, multicentre, randomised controlled trial comparing MBCT plus Treatment As Usual (TAU) versus TAU alone in a targeted number of 136 IBD patients in remission, aged 16 years and older with at least mild psychological distress (Hospital Anxiety and Depression Scale (HADS) total score ≥ 11). Primary outcome is reduction of psychological distress post-intervention, measured by the HADS. In addition, the effect of MBCT on sleep quality (including actigraphy and electroencephalography recordings), fatigue, disease activity, perceived disease control, QoL and positive mental health will be examined. Assessments will be conducted at baseline and at 3, 6, 9 and 12 months follow-up. Cost-effectiveness will be determined and a process evaluation will be conducted. Discussion This study will provide valuable insight into the clinical effect of MBCT on psychological distress, sleep quality, fatigue and QoL in IBD patients and into the cost-effectiveness. If effective, MBCT can be a valuable addition to the available psychosocial interventions for patients with IBD. Moreover, findings from this study may also be applicable in patients with other chronic conditions. Trial registration ClinicalTrials.gov: NCT04646785, registered on 30/11/2020.
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- 2023
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6. Prediction of the mobility and persistence of eight antibiotics based on soil characteristics
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R.P.J.J. Rietra, B.J.A. Berendsen, Y. Mi-Gegotek, P.F.A.M. Römkens, and A.M. Pustjens
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Antibiotics ,Manure ,Sorption ,Persistence ,Fate ,Degradation ,Science (General) ,Q1-390 ,Social sciences (General) ,H1-99 - Abstract
Antibiotics are widely used in intensive animal husbandry in the Netherlands and are subsequently emitted to soil via manure. To predict degradation and mobility in soil, generic sorption models have been derived. However, most of the coefficients used in generic models are based on a limited range of soils and have not been validated for agricultural soils in the Netherlands. To improve model predictions and assess to what extent differences among soils affect sorption and degradation, an experimental study has been performed. Using a recently developed experimental approach, both the degradation (DT50) and mobility (Kd) of eight selected commonly used antibiotics were determined in 29 typical Dutch agricultural soils. Median DT50 values range from 5.3 days for Sulfadiazine to 120 days for Trimethoprim but are affected by soil type. The ratio of the lowest and highest DT50 for a given antibiotic among soils can be as large as 151, for Tylosin. Measured values of the logKd also range from 0.19 for Sulfadiazine to more than 2 for Doxycycline, Flumequine, Trimethoprim, Tylosin and Enrofloxacine. The impact of soil on Kd is large, especially for more mobile antibiotics such as Sulfadoxine and Sulfadiazine. Both the range in DT50 and Kd can be predicted reasonably well using a Freundlich type regression model that accounts for the variation in soil type and sampling depth. Organic matter, iron oxides, pH and clay content appear to be the main constituents and explain between 29 % (Trimethoprim) and 77 % of the variation in DT50 and between 64 % (Lincomycin) and 87 % (Sulfadoxine and Sulfadiazine) of the variation of Kd. The effect of depth on DT50 and Kd is however limited. The information thus obtained in combination with local data on soil type can be used to more accurately predict the potential risk of relevant antibiotics in soil and transport to ground- and nearby surface waters.
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- 2024
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7. Health State Questionnaires Deployed in Ulcerative Colitis Patients: The Medical, Psychological, and Economic Perspective
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Damien S.E. Broekharst, Pepijn W.A. Thomas, Maurice G.V.M. Russel, Rachel L. West, Jeroen M. Jansen, Sjaak Bloem, and Tessa E.H. Römkens
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Health state ,Health state questionnaire ,Ulcerative colitis ,Disease severity ,Health experience ,Health utility ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and Aims: To determine how the health state of ulcerative colitis patients is impacted by their disease, different health state questionnaires are deployed. This study examines to what extent these health state questionnaires determine the same underlying health state concept and to what extent the complementary use of the health state questionnaires has added value for physicians. Methods: In total, 307 patients were enrolled in this cross-sectional multicenter cohort study. Medical, psychological, economic, and composite health state questionnaires were administered to determine reliability, convergent validity, and explained variance. Reliability was determined using Cronbach’s alpha. Convergent validity was measured using Spearman’s correlation coefficients. Explained variance was interpreted using R-squared coefficients. Results: All questionnaires can be considered reliable. The medical, psychological, and economic health state questionnaires show weak to moderate convergent validity with each other. The medical, psychological, and economic health state questionnaires also explain limited variance in each other’s outcomes. The composite health state questionnaire shows moderate to strong convergent validity with the other health state questionnaires. The composite health state questionnaire further explains considerable variance in the outcomes of the other health state questionnaires. Conclusion: Deploying divergent medical, psychological, and economic health state questionnaires may have added value as they provide a multiperspective holistic insight into patients’ health states. Deploying the composite health state questionnaire combined with other health state questionnaires may have added value as it provides additional understanding of their outcomes. Deploying an independent psychological health state questionnaire may have added value as it shows particularly limited convergent validity and explained variance regarding other health state questionnaires.
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- 2023
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8. Effect of combined water drinking test and dark room provocative testing in Caucasian eyes with narrow angles
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Römkens, Hellen C. S., Beckers, Henny J. M., Schouten, Jan S. A. G., Berendschot, Tos T. J. M., and Webers, Carroll A. B.
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- 2022
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9. Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study
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Merve Sivridaş, Rob H. Creemers, Dennis R. Wong, Paul J. Boekema, Tessa E. H. Römkens, Lennard P. L. Gilissen, Adriaan A. van Bodegraven, Floris C. Loeff, Theo Rispens, and Luc J. J. Derijks
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vedolizumab ,trough level ,therapeutic drug monitoring ,maintenance ,IBD ,ulcerative colitis ,Pharmacy and materia medica ,RS1-441 - Abstract
There are limited data on therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients treated with vedolizumab (VDZ). Although an exposure–response relation has been demonstrated in the post-induction phase, this relationship is more uncertain in the maintenance phase of treatment. The aim of our study was to determine whether there is an association between VDZ trough concentration and clinical and biochemical remission in the maintenance phase. A prospective, observational multicenter study has been performed on patients with IBD on VDZ in the maintenance treatment (≥14 weeks). Patient demographics, biomarkers, and VDZ serum trough concentrations were collected. Clinical disease activity was scored by the Harvey Bradshaw Index (HBI) for Crohn’s disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Clinical remission was determined as HBI < 5 and SCCAI < 3. Biochemical remission was defined as fecal calprotectin p = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission.
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- 2023
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10. Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial
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T. M. Mackay, F. J. Smits, A. E. J. Latenstein, A. Bogte, B. A. Bonsing, H. Bos, K. Bosscha, L. A. A. Brosens, L. Hol, O. R. C. Busch, G. J. Creemers, W. L. Curvers, M. den Dulk, S. van Dieren, L. M. J. W. van Driel, S. Festen, E. J. M. van Geenen, L. G. van der Geest, D. J. A. de Groot, J. W. B. de Groot, N. Haj Mohammad, B. C. M. Haberkorn, J. T. Haver, E. van der Harst, G. J. M. Hemmink, I. H. de Hingh, C. Hoge, M. Y. V. Homs, N. C. van Huijgevoort, M. A. J. M. Jacobs, E. D. Kerver, M. S. L. Liem, M. Los, H. Lubbinge, S. A. C. Luelmo, V. E. de Meijer, L. Mekenkamp, I. Q. Molenaar, M. G. H. van Oijen, G. A. Patijn, R. Quispel, L. B. van Rijssen, T. E. H. Römkens, H. C. van Santvoort, J. M. J. Schreinemakers, H. Schut, T. Seerden, M. W. J. Stommel, A. J. ten Tije, N. G. Venneman, R. C. Verdonk, J. Verheij, F. G. I. van Vilsteren, J. de Vos-Geelen, A. Vulink, C. Wientjes, F. Wit, F. J. Wessels, B. Zonderhuis, C. H. van Werkhoven, J. E. van Hooft, C. H. J. van Eijck, J. W. Wilmink, H. W. M. van Laarhoven, M. G. Besselink, and for the Dutch Pancreatic Cancer Group
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Pancreatic cancer ,Survival ,Quality of life ,Stepped-wedge cluster randomized controlled trial ,Implementation ,Best practices ,Medicine (General) ,R5-920 - Abstract
Abstract Background Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. Methods/design PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. Discussion The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. Trial registration ClinicalTrials.gov, NCT03513705 . Trial opened for accrual on 22th May 2018.
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- 2020
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11. Lower gastrointestinal bleeding in a patient receiving sevelamer: Case report
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Tessa S Schoot, Tessa EH Römkens, and Ellen K Hoogeveen
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Medicine (General) ,R5-920 - Abstract
Phosphate binders such as sevelamer are widely used in patients with chronic kidney disease to lower serum phosphate levels. We present a case of a 67-year-old woman with lower gastrointestinal bleeding after 9 days of using sevelamer carbonate (Renvela ® ). Sigmoidoscopy revealed multiple deep ulcers (diameter 10–15 mm) and mucosal oedema. Histologic examination showed deposition of sevelamer crystals in these rectal ulcers. We hypothesized that the lower gastrointestinal bleeding was caused by deposition of sevelamer crystals. After cessation of sevelamer, gastrointestinal bleeding stopped. Deposition of sevelamer crystals in the gastrointestinal tract is a rare complication of sevelamer therapy. There are only 17 other recorded cases of gastrointestinal deposition of sevelamer crystals. This adverse effect should be considered in all patients taking sevelamer who present with gastrointestinal symptoms, such as gastrointestinal bleeding and abdominal pain. When sevelamer is discontinued, symptoms and mucosal damage appear to revert.
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- 2021
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12. Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS): study protocol for a nationwide prospective cohort study
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Frank P Vleggaar, Paul Fockens, Hjalmar C van Santvoort, Jeanin E van Hooft, Menno A Brink, Jan-Werner Poley, Robert C Verdonk, Hendrik M van Dullemen, Liesbeth M Kager, Devica S Umans, Hester C Timmerhuis, Nora D Hallensleben, Stefan A Bouwense, Marie-Paule GF Anten, Abha Bhalla, Rina A Bijlsma, Lieke Hol, Wouter L Curvers, Brechje C van Eijck, G Willemien Erkelens, Erwin J M van Geenen, Wouter L Hazen, Chantal V Hoge, Akin Inderson, Sjoerd D Kuiken, Lars E Perk, Rutger Quispel, Tessa EH Römkens, Adriaan CITL Tan, Annemieke Y Thijssen, Niels G Venneman, Annet MCJ Voorburg, Roy LJ van Wanrooij, and Ben J Witteman
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Medicine - Published
- 2020
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13. Lengthening adalimumab dosing interval in quiescent Crohn’s disease patients: protocol for the pragmatic randomised non-inferiority LADI study
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J Jansen, L J T Smits, R W M Pauwels, W Kievit, D J de Jong, A C de Vries, F Hoentjen, C J van der Woude, A.A. van Bodegraven, A.G.L. Bodelier, P.J. Boekema, N. de Boer, P.C.J. ter Borg, A.A. den Broeder, I.A.M Gisbertz, F.M Jansen, S.V. Jansen, D.J. de Jong, W. Kievit, R.C.A. van Linschoten, M Löwenberg, M.W.M.D. Lutgens, R.C. Mallant-Hent, A.E. van der Meulen, B. Oldenburg, R.W.M. Pauwels, M Pierik, M.J.L. Romberg-Camps, T.E.H. Römkens, M.G.V.M. Russel, L.J.T. Smits, A.C.I.T.L. Tan, M.L. Verhulst, A.C. de Vries, R.L. West, F.H.J. Wolfhagen, and C.J. van der Woude
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Medicine - Abstract
Introduction Adalimumab is effective for maintenance of remission in patients with Crohn’s disease (CD) at a dose of 40 mg subcutaneously every 2 weeks. However, adalimumab is associated with (long-term) adverse events and is costly. The aim of this study is to demonstrate non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening compared to standard dosing of every other week (EOW).Methods and analysis The Lengthening Adalimumab Dosing Interval (LADI) study is a pragmatic, multicentre, open label, randomised controlled non-inferiority trial. Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%. 174 CD patients on adalimumab maintenance therapy in long-term (>9 months) clinical and biochemical remission will be included (C-reactive protein (CRP) 250 µg/g, CRP≥10 mg/l, HBI≥5. Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness.Ethics and dissemination The study is approved by the Medical Ethics Committee Arnhem-Nijmegen, the Netherlands (registration number NL58948.091.16). Results will be published in peer-reviewed journals and presented at international conferences.Trial registration numbers EudraCT registry (2016-003321-42); Clinicaltrials.gov registry (NCT03172377); Dutch trial registry (NTRID6417).
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- 2020
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14. Reference values for anterior chamber morphometrics with swept-source optical coherence tomography in a Caucasian population
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Römkens HC, Beckers HJ, Schouten JSAG, Berendschot TT, and Webers CA
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reference value ,anterior chamber ,optical coherence tomography ,Caucasian ,Ophthalmology ,RE1-994 - Abstract
Hellen CS Römkens, Henny JM Beckers, Jan SAG Schouten, Tos TJM Berendschot, Carroll AB Webers Department of Ophthalmology, Maastricht University Medical Center+, Maastricht, the Netherlands Purpose: The aim of this study is to generate reference values for anterior chamber morphometrics to facilitate the interpretation of anterior chamber images acquired with swept-source optical coherence tomography (SS-OCT) in a Caucasian population.Materials and methods: Non-glaucomatous Caucasian subjects, who were newly referred to the outpatient department of the University Eye Clinic Maastricht UMC+, were asked to undergo anterior segment assessment with SS-OCT imaging prior to routine eye examination (including visual acuity and refractive error measurements, Goldmann applanation tonometry, slit lamp examination and funduscopy).Results: A total of 647 Caucasian subjects, aged 40–80 years, were included. Mean age (± standard deviation) was 61.7±10.3 years, and 294 were male (45%). Mean refractive error was -0.63±3.17 D. OCT images and measurements were obtained in all cases. The mean temporal trabecular iris angle at 500 µm (TIA500) was 27.04°±12.04°, the mean nasal TIA500 was 27.43°±11.75°, the mean anterior chamber depth (ACD) was 2.75±0.39 mm and the mean lens vault (LV) was 0.44±0.30 mm. A smaller temporal TIA500, shallower ACD and higher LV were found in female and hyperopic subjects.Conclusion: Reference values for anterior chamber morphometrics in Caucasians were generated, quantified and presented. These values offer tools for the interpretation of anterior segment images of Caucasians and differentiation between presumed mechanisms of angle closure. Keywords: reference value, anterior chamber, optical coherence tomography, Caucasian
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- 2018
15. Long-Term Outcome of Immediate Versus Postponed Intervention in Patients With Infected Necrotizing Pancreatitis (POINTER)
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Van Veldhuisen, Charlotte L., Sissingh, Noor J., Boxhoorn, Lotte, van Dijk, Sven M., van Grinsven, Janneke, Verdonk, Robert C., Boermeester, Marja A., Bouwense, Stefan A.W., Bruno, Marco J., Cappendijk, Vincent C., van Duijvendijk, Peter, van Eijck, Casper H J., Fockens, Paul, van Goor, Harry, Hadithi, Muhammed, Haveman, Jan Willem, Jacobs, Maarten A.J.M., Jansen, Jeroen M., Kop, Marnix P.M., Manusama, Eric R., Mieog, J. Sven D., Molenaar, I. Quintus, Nieuwenhuijs, Vincent B., Poen, Alexander C., Poley, Jan-Werner, Quispel, Rutger, Römkens, Tessa E.H., Schwartz, Matthijs P., Seerden, Tom C., Dijkgraaf, Marcel G.W., Stommel, Martijn W.J., Straathof, Jan Willem A., Venneman, Niels G., Voermans, Rogier P., van Hooft, Jeanin E., van Santvoort, Hjalmar C., and Besselink, Marc G.
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- 2024
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16. Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial
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Mackay, Tara M., Latenstein, Anouk E. J., Augustinus, Simone, van der Geest, Lydia G., Bogte, Auke, Bonsing, Bert A., Cirkel, Geert A., Hol, Lieke, Busch, Olivier R., den Dulk, Marcel, van Driel, Lydi M. J.W., Festen, Sebastiaan, de Groot, Derk-Jan A., de Groot, Jan-Willem B., Groot Koerkamp, Bas, Haj Mohammad, Nadia, Haver, Joyce T., van der Harst, Erwin, de Hingh, Ignace H., Homs, Marjolein Y. V., Los, Maartje, Luelmo, Saskia A. C., de Meijer, Vincent E., Mekenkamp, Leonie, Molenaar, I. Quintus, Patijn, Gijs A., Quispel, Rutger, Römkens, Tessa E. H., van Santvoort, Hjalmar C., Stommel, Martijn W.J., Venneman, Niels G., Verdonk, Robert C., van Vilsteren, Frederike G. I., de Vos-Geelen, Judith, van Werkhoven, C. Henri, van Hooft, Jeanin E., van Eijck, Casper H. J., Wilmink, Johanna W., van Laarhoven, Hanneke W. M., and Besselink, Marc G.
- Abstract
IMPORTANCE: Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal. OBJECTIVE: To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients). INTERVENTION: The 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care. MAIN OUTCOMES AND MEASURES: The primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score). RESULTS: Overall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, −1.09, 95% CI, −3.05 to 0.94). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03513705
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- 2024
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17. Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn's Disease Patients in Stable Remission: The Randomized Controlled LADI Trial.
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Jansen, Fenna M, Linschoten, Reinier C A van, Kievit, Wietske, Smits, Lisa J T, Pauwels, Renske W M, Jong, Dirk J de, Vries, Annemarie C de, Boekema, Paul J, West, Rachel L, Bodelier, Alexander G L, Gisbertz, Ingrid A M, Wolfhagen, Frank H J, Römkens, Tessa E H, Lutgens, Maurice W M D, Bodegraven, Adriaan A van, Oldenburg, Bas, Pierik, Marieke J, Russel, Maurice G V M, Boer, Nanne K de, and Mallant-Hent, Rosalie C
- Abstract
Background and Aims We aimed to assess cost-effectiveness of increasing adalimumab dose intervals compared to the conventional dosing interval in patients with Crohn's disease [CD] in stable clinical and biochemical remission. Design We conducted a pragmatic, open-label, randomized controlled non-inferiority trial, comparing increased adalimumab intervals with the 2-weekly interval in adult CD patients in clinical remission. Quality of life was measured with the EQ-5D-5L. Costs were measured from a societal perspective. Results are shown as differences and incremental net monetary benefit [iNMB] at relevant willingness to accept [WTA] levels. Results We randomized 174 patients to the intervention [ n = 113] and control [ n = 61] groups. No difference was found in utility (difference: −0.017, 95% confidence interval [−0.044; 0.004]) and total costs (−€943, [−€2226; €1367]) over the 48-week study period between the two groups. Medication costs per patient were lower (−€2545, [−€2780; −€2192]) in the intervention group, but non-medication healthcare (+€474, [+€149; +€952]) and patient costs (+€365 [+€92; €1058]) were higher. Cost–utility analysis showed that the iNMB was €594 [−€2099; €2050], €69 [−€2908; €1965] and −€455 [−€4,096; €1984] at WTA levels of €20 000, €50 000 and €80 000, respectively. Increasing adalimumab dose intervals was more likely to be cost-effective at WTA levels below €53 960 per quality-adjusted life year. Above €53 960 continuing the conventional dose interval was more likely to be cost-effective. Conclusion When the loss of a quality-adjusted life year is valued at less than €53 960, increasing the adalimumab dose interval is a cost-effective strategy in CD patients in stable clinical and biochemical remission. Clinical Trial Registration Number ClinicalTrials.gov , number NCT03172377. [ABSTRACT FROM AUTHOR]
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- 2023
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18. Ashes from fluidized bed combustion of residual forest biomass: recycling to soil as a viable management option
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Cruz, Nuno C., Rodrigues, Sónia M., Carvalho, Lina, Duarte, Armando C., Pereira, Eduarda, Römkens, Paul F.A.M., and Tarelho, Luís A.C.
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- 2017
- Full Text
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19. Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial
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Smeets, Xavier J. N. M., da Costa, David W., Fockens, Paul, Mulder, Chris J. J., Timmer, Robin, Kievit, Wietske, Zegers, Marieke, Bruno, Marco J., Besselink, Marc G. H., Vleggaar, Frank P., van der Hulst, Rene W. M., Poen, Alexander C., Heine, Gerbrand D. N., Venneman, Niels G., Kolkman, Jeroen J., Baak, Lubbertus C., Römkens, Tessa E. H., van Dijk, Sven M., Hallensleben, Nora D. L., van de Vrie, Wim, Seerden, Tom C. J., Tan, Adriaan C. I. T. L., Voorburg, Annet M. C. J., Poley, Jan-Werner, Witteman, Ben J., Bhalla, Abha, Hadithi, Muhammed, Thijs, Willem J., Schwartz, Matthijs P., Vrolijk, Jan Maarten, Verdonk, Robert C., van Delft, Foke, Keulemans, Yolande, van Goor, Harry, Drenth, Joost P. H., van Geenen, Erwin J. M., and for the Dutch Pancreatitis Study Group
- Published
- 2018
- Full Text
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20. Risicoschatting TGG voor de omgeving van de zeedijk Perkpolder (Zeeland). Evaluatie 2021
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Brand, E, Negash, A, Schouten, T, Römkens, P, van Breemen, P, Brand, E, Negash, A, Schouten, T, Römkens, P, and van Breemen, P
- Abstract
RIVM rapport:Bij de aanleg van de zeedijk in Perkpolder is thermische gereinigde grond (TGG) gebruikt. TGG bevat stoffen, zoals metalen en zouten, die naar het grondwater en oppervlaktewater naast de dijk kunnen verspreiden. Het RIVM heeft voor de tweede keer onderzocht of deze stoffen voorkomen in de omgeving van de zeedijk en welke mogelijke effecten hierdoor op de gezondheid en het milieu kunnen ontstaan. De aanleiding is dat er meer meetgegevens beschikbaar zijn over de concentraties van de stoffen in de bodem, het grondwater en het oppervlaktewater. Ook hebben omwonenden vragen over de effecten op de gezondheid en de omgeving. Uit het onderzoek blijkt dat de verontreinigingen uit de TGG geen risico’s veroorzaken voor de gezondheid van omwonenden. De stoffen zijn soms van nature al aanwezig, of de aangetroffen concentraties zijn te laag om effecten te geven. De TGG heeft de bodemkwaliteit van de moestuinen niet beïnvloed. Verder is het veilig om op de dijk te wandelen en in het oppervlaktewater te zwemmen, ook al is dat niet als zwemwater bedoeld. Het onderzochte zoete grondwater is geschikt om gewassen mee water te geven en vee te laten drinken. De landbouwpercelen en de toplaag op de dijk zijn geschikt voor vee om te grazen en voor akkerbouw. Tijdens het onderzoek zijn in de omgeving van de dijk ook stoffen aangetroffen die zeer waarschijnlijk niet uit de TGG komen. Het gaat onder meer om PFAS, dioxines en arseen. De PFAS in het oppervlaktewater komen zeer waarschijnlijk uit de Westerschelde. Arseen kan misschien uit de TGG komen, maar komt in ieder geval van nature in hogere concentraties voor in Zeeland. Vanwege de PFAS, arseen en dioxines raadt het RIVM af om zelfgevangen vis uit dit gebied te eten. Ook raadt het RIVM aan om te onderzoeken of PFAS in zwemwateren in de omgeving voorkomen en zo ja, wat het effect daarvan is. Direct naast de dijk is het grond- en oppervlaktewater van nature zout. Daardoor raadt het RIVM af om dit water voor de landbouw te gebruiken. Om dez, Thermally cleaned soil (TCS) was used for the construction of Perkpolder’s dike. TCS contains substances such as metals and salts that could spread to the groundwater and surface water next to the dike. For the second time now the National Institute for Public Health and the Environment (RIVM) has carried out a study to ascertain whether these substances are present in the vicinity of the dike and what possible effects this could have on health and the environment. The study was prompted by the fact that more measurement data has become available on the concentrations of the substances in the soil, groundwater and surface water. In addition to this, local residents have asked questions on the effects on their health and the environment. The study reveals that contamination from the TCS does not pose any risks to local residents’ health. The substances are sometimes already naturally present or the concentrations found are too low to have any effects. The TCS has not influenced the soil quality of the vegetable gardens. Moreover, it is safe to walk on the embankment and swim in the surface water, even though it is not intended to be swimming water. The fresh groundwater examined, the strips of farmland and the topsoil on the dike are suitable for watering plants and for cows to drink and graze. They are also suitable for arable farming. During the study, other substances that are most likely not to have come from TCS were found as well. These include PFAS, dioxins and arsenic. The PFAS in the surface water are very likely to have come from the Western Scheldt. It is possible that arsenic could come from the TCS, but in any case it is naturally present in high concentrations in the province of Zeeland. Due to the presence of the PFAS, arsenic and dioxins, RIVM would advise not eating fish that you have caught yourself in this area. RIVM also recommends that a study be conducted to establish whether PFAS are present in swimming water in the area and if so, what the eff
- Published
- 2022
21. Groen voor bodem, de bodem voor groen : Betekenis van de bodem voor het stadsecosysteem : special bodem
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Spijker, J., Römkens, P., Spijker, J., and Römkens, P.
- Abstract
De stadsbodem is de standplaats voor stedelijk groen, het leefmilieu voor het bodemecosysteem en een belangrijke waterbuffer. Een optimaal functionerende bodem is daarom van levensbelang voor een goed functionerend stadsecosysteem. Helaas heeft de stadsbodem een gecompliceerd verleden en is het met de bodemgezondheid in veel gevallen matig gesteld. Met inzet van nieuwe kennis zijn stadsbodems en stadsecosystemen te versterken en optimaal in te zetten voor mens en dier.
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- 2022
22. Risicoschatting TGG voor de omgeving van de zeedijk Perkpolder (Zeeland): evaluatie 2021
- Author
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Brand, E., Negash, A., Schouten, T., Römkens, P., van Breemen, P., Brand, E., Negash, A., Schouten, T., Römkens, P., and van Breemen, P.
- Abstract
Bij de aanleg van de zeedijk in Perkpolder is thermische gereinigde grond (TGG) gebruikt. TGG bevat stoffen, zoals metalen en zouten, die naar het grondwater en oppervlaktewater naast de dijk kunnen verspreiden. Het RIVM heeft voor de tweede keer onderzocht of deze stoffen voorkomen in de omgeving van de zeedijk en welke mogelijke effecten hierdoor op de gezondheid en het milieu kunnen ontstaan. De aanleiding is dat er meer meetgegevens beschikbaar zijn over de concentraties van de stoffen in de bodem, het grondwater en het oppervlaktewater. Ook hebben omwonenden vragen over de effecten op de gezondheid en de omgeving. Uit het onderzoek blijkt dat de verontreinigingen uit de TGG geen risico’s veroorzaken voor de gezondheid van omwonenden. De stoffen zijn soms van nature al aanwezig, of de aangetroffen concentraties zijn te laag om effecten te geven. De TGG heeft de bodemkwaliteit van de moestuinen niet beïnvloed. Verder is het veilig om op de dijk te wandelen en in het oppervlaktewater te zwemmen, ook al is dat niet als zwemwater bedoeld. Het onderzochte zoete grondwater is geschikt om gewassen mee water te geven en vee te laten drinken. De landbouwpercelen en de toplaag op de dijk zijn geschikt voor vee om te grazen en voor akkerbouw. Tijdens het onderzoek zijn in de omgeving van de dijk ook stoffen aangetroffen die zeer waarschijnlijk niet uit de TGG komen. Het gaat onder meer om PFAS, dioxines en arseen. De PFAS in het oppervlaktewater komen zeer waarschijnlijk uit de Westerschelde. Arseen kan misschien uit de TGG komen, maar komt in ieder geval van nature in hogere concentraties voor in Zeeland. Vanwege de PFAS, arseen en dioxines raadt het RIVM af om zelfgevangen vis uit dit gebied te eten. Ook raadt het RIVM aan om te onderzoeken of PFAS in zwemwateren in de omgeving voorkomen en zo ja, wat het effect daarvan is. Direct naast de dijk is het grond- en oppervlaktewater van nature zout. Daardoor raadt het RIVM af om dit water voor de landbouw te gebruiken. Om de
- Published
- 2022
23. Risks associated with the transfer of toxic organo-metallic mercury from soils into the terrestrial feed chain
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Bruno Henriques, S.M. Rodrigues, C. Coelho, N. Cruz, A.C. Duarte, P.F.A.M. Römkens, and E. Pereira
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Environmental sciences ,GE1-350 - Abstract
Although the transfer of organo-metallic mercury (OrgHg) in aquatic food webs has long been studied, it has only been recently recognized that there is also accumulation in terrestrial systems. There is still however little information about the exposure of grazing animals to OrgHg from soils and feed as well as on risks of exposure to animal and humans.In this study we collected 78 soil samples and 40 plant samples (Lolium perenne and Brassica juncea) from agricultural fields near a contaminated industrial area and evaluated the soil-to-plant transfer of Hg as well as subsequent trophic transfer. Inorganic Hg (IHg) concentrations ranged from 0.080 to 210 mg kg−1 d.w. in soils, from 0.010 to 84 mg kg−1 d.w. in roots and from 0.020 to 6.9 mg kg−1 d.w. in shoots. OrgHg concentrations in soils varied between 0.20 and 130 μg kg−1 d.w. representing on average 0.13% of the total Hg (THg). In root and shoot samples OrgHg comprised on average 0.58% (roots) and 0.66% (shoots) of THg. Average bioaccumulation factors (BAFs) for OrgHg in relation to soil concentrations were 3.3 (for roots) and 1.5 (for shoots).The daily intake (DI) of THg in 33 sampling sites exceeded the acceptable daily intake (ADI) of THg of both cows (ADI = 1.4 mg d−1) and sheep (ADI = 0.28 mg d−1), in view of food safety associated with THg in animal kidneys. Estimated DI of OrgHg for grazing animals were up to 220 μg d−1 (for cows) and up to 33 μg d−1 (for sheep).This study suggested that solely monitoring the levels of THg in soils and feed may not allow to adequately taking into account accumulation of OrgHg in feed crops and properly address risks associated with OrgHg exposure for animals and humans. Hence, the inclusion of limits for OrgHg in feed quality and food safety legislation is advised. Keywords: Organo-metallic mercury, Soil, Lolium perenne, Brassica juncea, Uptake, Exposure
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- 2013
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24. Derivation of soil to plant transfer functions for metals and metalloids: impact of contaminant's availability
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Rodrigues, S. M., Pereira, E., Duarte, A. C., and Römkens, P. F. A. M.
- Published
- 2012
25. Set-aside
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Ansell, D. J., ter Meulen, G. R. B., Traas, Th., Römkens, P., de Vries, W., Magid, J., Skop, E., Christensen, N., Schoute, Job F. Th., editor, Finke, Peter A., editor, Veeneklaas, Frank R., editor, and Wolfert, Henk P., editor
- Published
- 1995
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26. Long-term effectiveness and safety of ustekinumab in Crohn’s disease: a prospective cohort study
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Thomas, Pepijn W.A., van Caem, Mark, West, Rachel L., Russel, Maurice G.V.M, Jansen, Jeroen M., Römkens, Tessa E.H., and Hoentjen, Frank
- Published
- 2023
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27. Oral medicines for children in the European paediatric investigation plans.
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Diana A van Riet-Nales, Erwin G A W Römkens, Agnes Saint-Raymond, Piotr Kozarewicz, Alfred F A M Schobben, Toine C G Egberts, and Carin M A Rademaker
- Subjects
Medicine ,Science - Abstract
INTRODUCTION: Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric Investigation Plans (PIPs) are subject to agreement by the European Medicines Agency (EMA) and its Paediatric Committee (PDCO). The aim of this study was to evaluate the key characteristics of oral paediatric medicines in the PIPs and the changes implemented as a result of the EMA/PDCO review. METHODS: All PIPs agreed by 31 December 2011 were identified through a proprietary EMA-database. PIPs were included if they contained an agreed proposal to develop an oral medicine for children 0 to 11 years. Information on the therapeutic area (EMA classification system); target age range (as defined by industry) and pharmaceutical characteristics (active substance, dosage form(s) as listed in the PIP, strength of each dosage form, excipients in each strength of each dosage form) was extracted from the EMA website or the EMA/PDCO assessment reports. RESULTS: A hundred and fifty PIPs were included corresponding to 16 therapeutic areas and 220 oral dosage forms in 431 strengths/compositions. Eighty-two PIPs (37%) included tablets, 44 (20%) liquids and 35 (16%) dosage forms with a specific composition/strength that were stored as a solid but swallowed as a liquid e.g. dispersible tablets. The EMA/PDCO review resulted in an increase of 13 (207 to 220) oral paediatric dosage forms and 44 (387 to 431) dosage forms with a specific composition/strength. For many PIPs, the target age range was widened and the excipient composition and usability aspects modified. CONCLUSION: The EMA/PDCO review realized an increase in the number of requirements for the development of oral dosage forms and a larger increase in the number of dosage forms with a specific composition/strength, both targeting younger children. Changes to their pharmaceutical design were less profound.
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- 2014
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28. Favourable Tolerability and Drug Survival of Tioguanine Versus Methotrexate After Failure of Conventional Thiopurines in Crohn's Disease.
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Savelkoul, E H J, Maas, M H J, Bourgonje, A R, Crouwel, F, Biemans, V B C, Broeder, N den, Russel, M G V M, Römkens, T E H, Boer, N K de, Dijkstra, G, and Hoentjen, F
- Abstract
Background and Aims Both methotrexate and tioguanine can be considered as treatment options in patients with Crohn's disease after failure of conventional thiopurines. This study aimed to compare tolerability and drug survival of methotrexate and tioguanine therapy after failure of conventional thiopurines in patients with Crohn's disease. Methods We conducted a retrospective, multicentre study, including patients with Crohn's disease initiating monotherapy methotrexate or tioguanine after failure [all causes] of conventional thiopurines. Follow-up duration was 104 weeks or until treatment discontinuation. The primary outcome was cumulative therapy discontinuation incidence due to adverse events. Secondary outcomes included total number of [serious] adverse events, and ongoing monotherapy. Results In total, 219 patients starting either methotrexate [ n = 105] or tioguanine [ n = 114] were included. In all 65 [29.7%] patients (methotrexate 43.8% [46/105 people], tioguanine 16.7% [19/114 people], p <0.001) discontinued their treatment due to adverse events during follow-up. Median time until discontinuation due to adverse events was 16 weeks (interquartile range [IQR] 7-38, p = 0.812). Serious adverse events were not significantly different. Patients treated with methotrexate experienced adverse events more often [methotrexate 83%, tioguanine 46%, p <0.001]. Total monotherapy drug survival after 104 weeks was 22% for methotrexate and 46% for tioguanine [ p <0.001]. Conclusions We observed a higher cumulative discontinuation incidence due to adverse events for methotrexate [44%] compared with tioguanine [17%] in Crohn's disease patients after failure of conventional thiopurines. The total adverse events incidence during methotrexate use was higher, whereas serious adverse events incidence was similar. These favourable results for tioguanine treatment may guide the selection of immunosuppressive therapy after failure of conventional thiopurines. [ABSTRACT FROM AUTHOR]
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- 2022
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29. The role of soil surface water regimes and raindrop impact on hillslope soil erosion and nutrient losses
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An, Juan, Zheng, Fenli, Römkens, Mathias J. M., Li, Guifang, Yang, Qingsen, Wen, Leilei, and Wang, Bin
- Published
- 2013
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30. Hg transfer from contaminated soils to plants and animals
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Rodrigues, S. M., Henriques, B., Reis, A. T., Duarte, A. C., Pereira, E., and Römkens, P. F. A. M.
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- 2012
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31. Effect of land use and land cover change on soil erosion and the spatio-temporal variation in Liupan Mountain Region, southern Ningxia, China
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Quan, Bin, Römkens, M. J. M., Li, Rui, Wang, Fang, and Chen, Jie
- Published
- 2011
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32. Characterization of soil heavy metal pools in paddy fields in Taiwan: chemical extraction and solid-solution partitioning
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Römkens, Paul F., Guo, Horng-Yuh, Chu, Chien-Liang, Liu, Tsang-Sen, Chiang, Chih-Feng, and Koopmans, Gerwin F.
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- 2009
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33. Mishandelde vrouwen over onthulling aan de huisarts: praten helpt echt
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Wong, Sylvie Lo Fo, Wester, Fred, Mol, Saskia, Römkens, Renée, Hezemans, Door, and Lagro–Janssen, Toine
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- 2009
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34. Spatial-temporal pattern and population driving force of land use change in Liupan Mountains region, southern Ningxia, China
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Quan, Bin, Römkens, M. J. M., Tao, Jianjun, Li, Bicheng, Li, Chaokui, Yu, Guanghui, and Chen, Qichun
- Published
- 2008
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35. Spatially Explicit Integrated Risk Assessment of Present Soil Concentrations of Cadmium, Lead, Copper and Zinc in The Netherlands
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de Vries, W., Römkens, P. F. A. M., and Bonten, L. T. C.
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- 2008
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36. Predicting the Phytoextraction Duration to Remediate Heavy Metal Contaminated Soils
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Koopmans, G. F., Römkens, P. F. A. M., Song, J., Temminghoff, E. J. M., and Japenga, J.
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- 2007
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37. Visiedocument gebruik van biobeschikbaarheid in bodembeoordeling : Mogelijkheden voor metalen in bodem en waterbodem
- Author
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Lijzen JPA, Verschoor AJ, Mesman M, de Boer PT, Osté L, Römkens P, DDB, and M&V
- Subjects
quality assessment ,Total content ,ecotoxicologische risico's ,totaalgehaalte ,effecten ,soil ,bodem ,potential available concentration ,potentieel beschikbare concentratie ,sediment ,beleid ,effects ,biobeschikbaarheid ,kwaliteitsbeoordeling ,bioavailability ,RIVM rapport 2015-0215 ,policy - Abstract
Om te bepalen of de kwaliteit van een bodem geschikt is voor (her)gebruik, wordt een risicobeoordeling uitgevoerd. Daarmee wordt onder meer beoordeeld of de aanwezige metalen een risico vormen voor mens, plant en dier. Momenteel wordt hiervoor de totale concentratie van de aanwezige metalen gemeten. Bekend is echter dat niet al het aanwezige metaal schadelijke effecten veroorzaakt. Door de hoeveelheid metalen te bepalen die effecten kan veroorzaken, wordt de risicobeoordeling van metalen in land- en waterbodem verbeterd. Aanbevolen wordt een meetmethode met verdund salpeterzuur toe te passen waarmee dit kan. Het RIVM heeft een visiedocument opgesteld, waarin staat waar, hoe en waarom dit in het bodem- en waterbodembeleid mogelijk is. Het heeft de voorkeur de nieuwe werkwijze in de eerste stap van de risicobeoordeling voor land- en waterbodem te gebruiken. Met de voorgestelde methode wordt nauwkeuriger het deel van de metalen bepaald dat verantwoordelijk is voor effecten op organismen. Voor kwik in beide bodemsoorten blijkt deze methode vooralsnog niet geschikt. Geadviseerd wordt om uit te werken welke concentraties voor land- en waterbodem toelaatbaar zijn. Ook wordt aangeraden de consequenties van de voorgestelde methode in de eerste stap van de risicobeoordeling voor de uitvoering van het bodembeleid in de praktijk in beeld te brengen. De nieuwe werkwijze kan wel direct worden gebruikt als aanvullende risicobeoordeling (tweede stap) van land- en waterbodem en binnen het beleid voor de diepe plassen van de aankomende Omgevingswet.
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- 2020
38. Functional Stability of Microbial Communities in Contaminated Soils Near a Zinc Smelter (Budel, The Netherlands)
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Tobor-Kapłon, Maria A., Bloem, J., Römkens, P.F.A.M., and de Ruiter, P.C.
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- 2006
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39. Su1842 LIFESTYLE AND PSYCHOSOCIAL FACTORS IN IBD; PREVALENCE AND PATIENTS' PERSPECTIVE.
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Demers, Karlijn, Hendrix, Evelien, Ardabili, Ashkan Rezazadeh, Bredero, Quirine M., Van Bodegraven, Adriaan A., van der Horst, Daniëlle, Jonkers, Daisy M., Kimman, Merel L., Mujagic, Z, Romberg-Camps, Mariëlle, Römkens, Tessa E., Scherpenzeel, Menne, Schroevers, Maya J., Stassen, Laurents P., West, Rachel, Dijkstra, Gerard, and Pierik, Marie J.
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- 2024
- Full Text
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40. Validation and update of a prediction model for risk of relapse after cessation of anti-TNF treatment in Crohn’s disease
- Author
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ten Bokkel Huinink, Sebastiaan, de Jong, Djuna C., Nieboer, Daan, Thomassen, Doranne, Steyerberg, Ewout W., Dijkgraaf, Marcel G.W., Bodelier, Alexander G.L., West, Rachel L., Römkens, Tessa E.H., Hoentjen, Frank, Mallant, Rosalie C., van Tuyl, Bas A.C., Mares, Wout G.N., Wolfhagen, Frank H.J., Dijkstra, Gerard, Reijnders, Jurriën G.P., de Boer, Nanne K., Tan, Adriaan C.I.T.L., van Boeckel, Petra G.A., Tack, Greetje J., van Asseldonk, Dirk P., D’Haens, Geert R.A.M., van der Woude, C Janneke, Duijvestein, Marjolijn, and de Vries, Annemarie C
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- 2022
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41. Soil organic matter dynamics after the conversion of arable land to pasture
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Römkens, P. F. A. M., van der Plicht, Johannes, and Hassink, Jan
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- 1999
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42. De-escalation of biological therapy in inflammatory bowel disease patients following prior dose escalation
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Thomas, Pepijn W. A., Smits, Lisa J. T., Te Groen, Maarten, West, Rachel L., Russel, Maurice G. V. M., Jansen, Jeroen M., Römkens, Tessa E. H., and Hoentjen, Frank
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- 2022
- Full Text
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43. Heavy metals.
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Vries, W. de, primary, Römkens, P. F. A. M., additional, Leeuwen, T. van, additional, and Bronswijk, J. J. B., additional
- Published
- 2002
- Full Text
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44. Functional stability of microbial communities in contaminated soils
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Tobor-Kapłon, M. A., Bloem, J., Römkens, P. F. A. M., and De Ruiter, P. C.
- Published
- 2005
45. Effects of Chemical Applications to Metal Polluted Soils on Cadmium Uptake by Rice Plant
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Yoo J. H., Kim W. I., Kim J. Y., Römkens P. F. A. M., Lee J. H., and Kim D. H.
- Subjects
Heavy metal ,soil ,sulfur ,iron ,cadmium ,rice ,Environmental sciences ,GE1-350 - Abstract
Pot experiment using metal polluted soils was conducted to investigate the effects of lime, iron and sulfur on changes in Cd availability and uptake by rice plant. Drainage and irrigation of water were performed to develop redox changes like field cultivation. Iron chloride and sodium sulfate solutions were applied to the pots in the middle of growth period of rice plant. Reactive metal pool in heavily polluted soils was slightly decreased after treatments with lime, iron chloride, sodium sulfate and combination of these chemicals. However, cadmium uptake by rice plant was significantly different across the treatments and the extent of Cd pollution. For highly polluted soils, more Cd reduction was observed in iron chloride treatments. Cd content in polished rice for iron chloride and (iron chloride+organic matter) treatments was only 16-23% and 25-37% compared to control and liming, respectively. Treatment of (iron chloride+sulfate) rather increased Cd content in rice. For moderately polluted soils, Cd reduction rate was the order of (OM+iron chloride) > iron chloride > lime. Other treatments including sulfate rather increased Cd content in rice maximum 3 times than control. It was proposed to determine the optimum application rate of iron for minimizing hazardous effect on rice plant.
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- 2013
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46. A Classification Algorithm for Types of Diabetes in Chronic Pancreatitis Using Epidemiological Characteristics
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Kempeneers, Marinus A., Issa, Yama, Ahmed Ali, Usama, Bruno, Marco J., van Geenen, Erwin J. M., van Hooft, Jeanin E., Römkens, Tessa E. H., Siersema, Peter D., Spanier, B. W. Marcel, Yahya, Ibtisam, DeVries, J. Hans, Besselink, Marc G., van Santvoort, Hjalmar C., and Boermeester, Marja A.
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Supplemental digital content is available in the text.
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- 2021
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47. Clinical Outcomes of Covid-19 in Patients With Inflammatory Bowel Disease: A Nationwide Cohort Study.
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Derikx, Lauranne A A P, Lantinga, Marten A, Jong, Dirk J de, Dop, Willemijn A van, Creemers, Rob H, Römkens, Tessa E H, Jansen, Jeroen M, Mahmmod, Nofel, West, Rachel L, Tan, Adriaan C I T L, Bodelier, Alexander G L, Gorter, Moniek H P, Boekema, Paul J, Halet, Eric R C, Horjus, Carmen S, Dijk, Maarten A van, Hirdes, Meike M C, Stippel, Ludger S M Epping, Jharap, Bindia, and Lutgens, Maurice W M D
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Background and Aims The COVID-19 risk and disease course in inflammatory bowel disease [IBD] patients remains uncertain. Therefore, we aimed to assess the clinical presentation, disease course, and outcomes of COVID-19 in IBD patients. Second, we determined COVID-19 incidences in IBD patients and compared this with the general population. Methods We conducted a multicentre, nationwide IBD cohort study in The Netherlands and identified patients with COVID-19. First, we assessed the COVID-19 disease course and outcomes. Second, we compared COVID-19 incidences between our IBD study cohort and the general Dutch population. Results We established an IBD cohort of 34 763 patients. COVID-19 was diagnosed in 100/34 763 patients [0.29%]; 20/100 of these patients [20%] had severe COVID-19 defined as admission to the intensive care unit, mechanical ventilation, and/or death. Hospitalisation occurred in 59/100 [59.0%] patients and 13/100 [13.0%] died. All patients who died had comorbidities and all but one were ≥65 years old. In line, we identified ≥1 comorbidity as an independent risk factor for hospitalisation (odds ratio [OR] 4.20, 95% confidence interval [CI] 1.58–11.17,; p = 0.004). Incidences of COVID-19 between the IBD study cohort and the general population were comparable (287.6 [95% CI 236.6–349.7] versus 333.0 [95% CI 329.3–336.7] per 100000 patients, respectively; p = 0.15). Conclusions Of 100 cases with IBD and COVID-19, 20% developed severe COVID-19, 59% were hospitalised and 13% died. A comparable COVID-19 risk was found between the IBD cohort [100/34 763 = 0.29%] and the general Dutch population. The presence of ≥1 comorbidities was an independent risk factor for hospitalisation due to COVID-19. [ABSTRACT FROM AUTHOR]
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- 2021
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48. Discrepancy between patient‐ and healthcare provider‐reported adverse drug reactions in inflammatory bowel disease patients on biological therapy
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Thomas, Pepijn W. A., Römkens, Tessa E. H., West, Rachel L., Russel, Maurice G. V. M., Jansen, Jeroen M., Lint, Jette A., Jessurun, Naomi T., and Hoentjen, Frank
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Only limited data is available on the extent and burden of adverse drug reactions (ADRs) to biological therapy in inflammatory bowel disease (IBD) patients in daily practice, especially from a patient's perspective. The aim of this study was to systematically assess patient‐reported ADRs during biological therapy in IBD patients and compare these with healthcare provider (HCP)‐reported ADRs. This multicentre, prospective, event monitoring study enrolled IBD patients on biological therapy. Patients completed bimonthly comprehensive web‐based questionnaires regarding description of biological induced ADRs, follow‐up of previous ADRs and experienced burden of the ADR using a five‐point Likert scale. The relationship between patient‐reported ADRs and biological therapy was assessed. HCP‐reported ADRs were extracted from the electronic healthcare records. In total, 182 patients (female 51%, mean age 42.2 [standard deviation 14.2] years, Crohn's disease 77%) were included and completed 728 questionnaires. At baseline, 60% of patients used infliximab, 30% adalimumab, 9% vedolizumab and 1% ustekinumab. Fifty percent of participants reported at least one ADR with a total of 239 unique ADRs. Fatigue (n= 26) and headache (n= 20) resulted in the highest burden and a correlation in time with the administration of the biological was described in 56% and 85% respectively. Out of 239 ADRs, 115 were considered biological‐related. HCPs reported 119 ADRs. Agreement between patient‐reported ADRs and HCP‐reported ADRs was only 13%. IBD patients often report ADRs during biological therapy. We observed an important significant difference between the type and frequency of patient‐reported ADRs versus HCP‐reported ADRs, leading to an underestimation of more subjective ADRs and patients' ADR‐related burden. Summarise the established knowledge on this subject Adverse drug reactions (ADRs) are severely underreported by healthcare providers (HCP) and do not capture the full spectrum of biological‐related ADRs.Patient self‐reporting may be used to detect ADRs and offers more insight in the patient's perception and experience of an ADR.Data on self‐reporting ADRs in inflammatory bowel disease (IBD) patients is limited. Adverse drug reactions (ADRs) are severely underreported by healthcare providers (HCP) and do not capture the full spectrum of biological‐related ADRs. Patient self‐reporting may be used to detect ADRs and offers more insight in the patient's perception and experience of an ADR. Data on self‐reporting ADRs in inflammatory bowel disease (IBD) patients is limited. What are the significant and/or new findings of this study? IBD patients frequently reported ADRs during biological use (50%) and 48% of these ADRs were considered biological‐related.Fatigue and headache resulted in the highest patient‐reported burden.Patients often reported a correlation in time (44%) for the top six patient‐reported ADRs.There was a significant difference between type and frequency of patient‐reported ADRs and HCP‐reported ADRs. IBD patients frequently reported ADRs during biological use (50%) and 48% of these ADRs were considered biological‐related. Fatigue and headache resulted in the highest patient‐reported burden. Patients often reported a correlation in time (44%) for the top six patient‐reported ADRs. There was a significant difference between type and frequency of patient‐reported ADRs and HCP‐reported ADRs.
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- 2021
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49. Publieke en private handhaving van het kartelverbod – een convergente toepassing van dezelfde norm?
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Römkens, Ellen, Prompers, Anke, Bouman, Aron, Kuijper, Marc, and Lamberti, Reinier
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- 2020
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50. Increased Discontinuation Rates of Anti-TNF Therapy in Elderly Inflammatory Bowel Disease Patients.
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Jong, M E de, Smits, L J T, Ruijven, B van, Broeder, N den, Russel, M G V M, Römkens, T E H, West, R L, Jansen, J M, and Hoentjen, F
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Background and Aims There is paucity of data on safety and efficacy of anti-tumour necrosis factor [TNF] in elderly inflammatory bowel disease [IBD] patients. We aimed to compare the long-term treatment failure rates and safety of a first anti-TNF agent in IBD patients between different age groups [<40 years/40–59 years/≥60 years]. Methods IBD patients who started a first anti-TNF agent were identified through IBDREAM, a multicentre prospective IBD registry. Competing risk regression was used to study treatment failure, defined as time to drug discontinuation due to adverse events [AEs] or lack of effectiveness, with discontinuation due to remission as a competing risk. Results A total of 895 IBD patients were included; 546 started anti-TNF at age <40 [61.0%], 268 at age 40–59 [29.9%], and 81 at age ≥60 [9.1%]. Treatment failure rate was higher in the two older groups (subhazard rate [SHR] age ≥60 1.46, SHR age 40–59 1.21; p = 0.03). The SHR in the elderly [>60] was 1.52 for discontinuation due to AEs and 1.11 for lack of effectiveness. Concomitant thiopurine use was associated with a lower treatment failure rate (SHR 0.78, 95% confidence interval [CI] 0.62–0.98, p = 0.031). Serious adverse event [SAE] rate, as well as serious infection rate, were significantly higher in elderly IBD patients [61.2 versus 16.0 and 12.4 per 1000 patient-years, respectively] whereas the malignancy rate was low in all age groups. Conclusions Elderly IBD patients starting a first anti-TNF agent showed higher treatment failure rates, but concomitant thiopurine use at baseline was associated with lower failure rates. Elderly IBD patients demonstrated higher rates of SAEs and serious infections. [ABSTRACT FROM AUTHOR]
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- 2020
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