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Browsing by Author "Miehlke, Stephan"
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Item Monitoring patients with eosinophilic esophagitis in routine clinical practice - International Expert Recommendations(Elsevier, 2023) von Arnim, Ulrike; Biedermann, Luc; Aceves, Seema S.; Bonis, Peter A.; Collins, Margaret H.; Dellon, Evan S.; Furuta, Glenn T.; Gonsalves, Nirmala; Gupta, Sandeep; Hirano, Ikuo; Lucendo, Alfredo J.; Miehlke, Stephan; Oliva, Salvatore; Schlag, Christoph; Schoepfer, Alain; Straumann, Alex; Vieth, Michael; Bredenoord, Albert J.; Pediatrics, School of MedicineBackground & Aims There are no studies or recommendations on optimal monitoring strategies for patients with eosinophilic esophagitis (EoE). Our objective was to develop guidance on how to monitor EoE patients in routine clinical practice, on the basis of available clinical evidence and expert opinion. Methods A multidisciplinary, international group of EoE experts identified the following important three questions during several consensus meetings: why, by what means and when to monitor EoE patients. A steering committee was named and three teams were formed to review literature and to formulate statements for each topic. In a Delphi survey a level of agreement of ≥75% was defined as threshold value for acceptance. In a final conference, results were presented, critical points and comments on the statements were discussed and statements were rephrased/rewritten if necessary. Results 18 EoE experts (14 adult and pediatric gastroenterologists, 2 pathologists and 2 allergists) with a median of 21.7 years in clinical practice, mostly academic or university- based, completed the Delphi survey, which included 11 statements and a proposed algorithm for monitoring EoE patients. Each statement attained ≥75% agreement. Participants discussed and debated mostly about the statement concerning surveillance intervals for EoE patients with stable disease. Conclusions It was concluded that effective maintenance treatment probably reduces the development of EoE complications, and regular, structured and under certain conditions individualized clinical follow-up is recommended to assess disease activity while opening a window to monitoring side-effects, adjusting therapy and encouraging adherence to treatment. Follow-up should comprise symptom assessment and periodic or repeated endoscopy with histological assessment in specific EoE settings.Item Reliability and Responsiveness of Endoscopic Disease Activity Assessment in Eosinophilic Esophagitis(Elsevier, 2022) Ma, Christopher; Bredenoord, Albert J.; Dellon, Evan S.; Alexander, Jeffrey A.; Biedermann, Luc; Hogan, Malcolm; Guizzetti, Leonardo; Zou, Guangyong; Katzka, David A.; Chehade, Mirna; Falk, Gary W.; Furuta, Glenn T.; Gupta, Sandeep K.; Kagalwalla, Amir F.; Schoepfer, Alain M.; Miehlke, Stephan; Moawad, Fouad J.; Peterson, Kathryn; Gonsalves, Nirmala P.; Straumann, Alex; Wechsler, Joshua B.; Rémillard, Julie; Shackelton, Lisa M.; Almonte, Hector S.; Feagan, Brian G.; Jairath, Vipul; Hirano, Ikuo; Pediatrics, School of MedicineBackground and Aims Endoscopic outcomes have become important measures of eosinophilic esophagitis (EoE) disease activity, including as an endpoint in randomized controlled trials (RCTs). We evaluated the operating properties of endoscopic measures for use in EoE RCTs. Methods Modified Research and Development/University of California Los Angeles (RAND/UCLA) appropriateness methods and a panel of 15 international EoE experts identified endoscopic items/definitions with face validity, which were used in a 2-round voting process to define simplified (all items graded absent/present) and expanded versions (additional grades for edema, furrows, and/or exudates) of the EoE Endoscopic Reference Score (EREFS). Inter- and intra-rater reliability of these instruments (expressed as intraclass correlation coefficients [ICC]), were evaluated using paired endoscopy video assessments of two blinded central readers before and after 8 weeks of proton pump inhibitors, swallowed topical corticosteroids, or dietary elimination. Responsiveness was measured using the standardized effect size (SES). Results The appropriateness of 41 statements relevant to EoE endoscopic activity (endoscopic items, item definitions/grading, and other considerations relevant for endoscopy) was considered. The original and expanded EREFS demonstrated moderate-to-substantial inter-rater reliability (ICCs 0.472-0.736, and 0.469-0.763, respectively) and moderate-to-almost perfect intra-rater reliability (ICCs 0.580-0.828, and 0.581-0.828, respectively). Strictures were least reliably assessed (ICCs 0.072-0.385). The original EREFS was highly responsive (SES 1.126 [95% CI 0.757, 1.534]), although both expanded versions of EREFS, scored based on worst affected area, were numerically most responsive to treatment (expanded furrows, SES 1.229 [95% CI: 0.858, 1.643]; all items expanded, SES 1.252 [95% CI: 0.880, 1.667]). The EREFS and its modifications were not more reliably scored by segment, and also not more responsive when proximal and distal EREFS scores were summed. Conclusions EREFS and its modifications were reliable and responsive, and the original or expanded versions of the EREFS may be preferred in RCTs. Disease activity scored based on the worst affected area optimizes reliability and responsiveness.