Browsing by Author "von Arnim, Ulrike"

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    Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS)
    (Elsevier, 2021) Ma, Christopher; Schoepfer, Alain M.; Dellon, Evan S.; Bredenoord, Albert J.; Chehade, Mirna; Collins, Margaret H.; Feagan, Brian G.; Furuta, Glenn T.; Gupta, Sandeep K.; Hirano, Ikuo; Jairath, Vipul; Katzka, David A.; Pai, Rish K.; Rothenberg, Marc E.; Straumann, Alex; Aceves, Seema S.; Alexander, Jeffrey A.; Arva, Nicoleta C.; Atkins, Dan; Biedermann, Luc; Blanchard, Carine; Cianferoni, Antonella; Ciriza de los Rios, Constanza; Clayton, Frederic; Davis, Carla M.; de Bortoli, Nicola; Dias, Jorge A.; Falk, Gary W.; Genta, Robert M.; Ghaffari, Gisoo; Gonsalves, Nirmala; Greuter, Thomas; Hopp, Russell; Hsu Blatman, Karen S.; Jensen, Elizabeth T.; Johnston, Doug; Kagalwalla, Amir F.; Larsson, Helen M.; Leung, John; Louis, Hubert; Masterson, Joanne C.; Menard-Katcher, Calies; Menard-Katcher, Paul A.; Moawad, Fouad J.; Muir, Amanda B.; Mukkada, Vincent A.; Penagini, Roberto; Pesek, Robert D.; Peterson, Kathryn; Putnam, Philip E.; Ravelli, Alberto; Savarino, Edoardo V.; Schlag, Christoph; Schreiner, Philipp; Simon, Dagmar; Smyrk, Thomas C.; Spergel, Jonathan M.; Taft, Tiffany H.; Terreehorst, Ingrid; Vanuytsel, Tim; Venter, Carina; Vieira, Mario C.; Vieth, Michael; Vlieg-Boerstra, Berber; von Arnim, Ulrike; Walker, Marjorie M.; Wechsler, Joshua B.; Woodland, Philip; Woosley, John T.; Yang, Guang-Yu; Zevit, Noam; Safroneeva, Ekaterina; Medicine, School of Medicine
    Background End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. Objective We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. Methods Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists. Results The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life. Conclusions This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.
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    International consensus recommendations for eosinophilic gastrointestinal disease nomenclature
    (Elsevier, 2022-02-16) Dellon, Evan S.; Gonsalves, Nirmala; Abonia, J. Pablo; Alexander, Jeffrey A.; Arva, Nicoleta C.; Atkins, Dan; Attwood, Stephen E.; Auth, Marcus K.H.; Bailey, Dominique D.; Biederman, Luc; Blanchard, Carine; Bonis, Peter A.; Bose, Paroma; Bredenoord, Albert J.; Chang, Joy W.; Chehade, Mirna; Collins, Margaret H.; Di Lorenzo, Carlo; Dias, Jorge Amil; Dohil, Ranjan; Dupont, Christophe; Falk, Gary W.; Ferreira, Cristina T.; Fox, Adam T.; Genta, Robert M.; Greuter, Thomas; Gupta, Sandeep K.; Hirano, Ikuo; Hiremath, Girish S.; Horsley-Silva, Jennifer L.; Ishihara, Shunji; Ishimura, Norihisa; Jensen, Elizabeth T.; Gutiérrez-Junquera, Carolina; Katzka, David A.; Khoury, Paneez; Kinoshita, Yoshikazu; Kliewer, Kara L.; Koletzko, Sibylle; Leung, John; Liacouras, Chris A.; Lucendo, Alfredo J.; Martin, Lisa J.; McGowan, Emily C.; Menard-Katcher, Calies; Metz, David C.; Miller, Talya L.; Moawad, Fouad J.; Muir, Amanda B.; Mukkada, Vincent A.; Murch, Simon; Nhu, Quan M.; Nomura, Ichiro; Nurko, Samuel; Ohtsuka, Yoshikazu; Oliva, Salvatore; Orel, Rok; Papadopoulou, Alexandra; Patel, Dhyanesh A.; Pesek, Robert D.; Peterson, Kathryn A.; Philpott, Hamish; Putnam, Philip E.; Richter, Joel E.; Rosen, Rachel; Ruffner, Melanie A.; Safroneeva, Ekaterina; Schreiner, Philipp; Schoepfer, Alain; Schroeder, Shauna R.; Shah, Neil; Souza, Rhonda F.; Spechler, Stuart J.; Spergel, Jonathan M.; Straumann, Alex; Talley, Nicholas J.; Thapar, Nikhil; Vandenplas, Yvan; Venkatesh, Rajitha D.; Vieira, Mario C.; von Arnim, Ulrike; Walker, Marjorie M.; Wechsler, Joshua B.; Wershil, Barry K.; Wright, Benjamin L.; Yamada, Yoshiyuki; Yang, Guang-Yu; Zevit, Noam; Rothenberg, Marc E.; Furuta, Glenn T.; Aceves, Seema S.; Pediatrics, School of Medicine
    Background & Aims Substantial heterogeneity in terminology used for eosinophilic gastrointestinal diseases (EGID), particularly the catchall term “eosinophilic gastroenteritis”, limits clinical and research advances. We aimed to achieve an international consensus for standardized EGID nomenclature. Methods This consensus process utilized Delphi methodology. An initial naming framework was proposed and refined in iterative fashion, then assessed in a first round of Delphi voting. Results were discussed in two consensus meetings, the framework was updated, and re-assessed in a second Delphi vote, with a 70% threshold set for agreement. Results Of 91 experts participating, 85 (93%) completed the first and 82 (90%) completed the second Delphi surveys. Consensus was reached on all but two statements. “EGID” was the preferred umbrella term for disorders of GI tract eosinophilic inflammation in the absence of secondary causes (100% agreement). Involved GI tract segments will be named specifically and use an “Eo” abbreviation convention: eosinophilic gastritis (now abbreviated EoG), eosinophilic enteritis (EoN), and eosinophilic colitis (EoC). The term “eosinophilic gastroenteritis” is no longer preferred as the overall name (96% agreement). When >2 GI tract areas are involved, the name should reflect all of the involved areas. Conclusions This international process resulted in consensus for updated EGID nomenclature for both clinical and research use. EGID will be the umbrella term rather than “eosinophilic gastroenteritis”, and specific naming conventions by location of GI tract involvement are recommended. As more data are developed, this framework can be updated to reflect best practices and the underlying science.
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    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 Medicine
    Background & 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.