Ma, Christopher and Schoepfer, Alain M. and Dellon, Evan S. and Bredenoord, Albert J. and Chehade, Mirna and Collins, Margaret H. and Feagan, Brian G. and Furuta, Glenn T. and Gupta, Sandeep K. and Hirano, Ikuo and Jairath, Vipul and Katzka, David A. and Pai, Rish K. and Rothenberg, Marc E. and Straumann, Alex and Aceves, Seema S. and Alexander, Jeffrey A. and Arva, Nicoleta C. and Atkins, Dan and Biedermann, Luc and Blanchard, Carine and Cianferoni, Antonella and Ciriza de los Rios, Constanza and Clayton, Frederic and Davis, Carla M. and de Bortoli, Nicola and Dias, Jorge A. and Falk, Gary W. and Genta, Robert M. and Ghaffari, Gisoo and Gonsalves, Nirmala and Greuter, Thomas and Hopp, Russell and Hsu Blatman, Karen S. and Jensen, Elizabeth T. and Johnston, Doug and Kagalwalla, Amir F. and Larsson, Helen M. and Leung, John and Louis, Hubert and Masterson, Joanne C. and Menard-Katcher, Calies and Menard-Katcher, Paul A. and Moawad, Fouad J. and Muir, Amanda B. and Mukkada, Vincent A. and Penagini, Roberto and Pesek, Robert D. and Peterson, Kathryn and Putnam, Philip E. and Ravelli, Alberto and Savarino, Edoardo V. and Schlag, Christoph and Schreiner, Philipp and Simon, Dagmar and Smyrk, Thomas C. and Spergel, Jonathan M. and Taft, Tiffany H. and Terreehorst, Ingrid and Vanuytsel, Tim and Venter, Carina and Vieira, Mario C. and Vieth, Michael and Vlieg-Boerstra, Berber and von Arnim, Ulrike and Walker, Marjorie M. and Wechsler, Joshua B. and Woodland, Philip and Woosley, John T. and Yang, Guang-Yu and Zevit, Noam and Safroneeva, Ekaterina (2022) Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS). Journal of Allergy and Clinical Immunology, 149 (2). pp. 659-670. ISSN 0091-6749

Preview

Download (534kB) | Preview

Abstract

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.

Item Type:	Article
Additional Information:	Cite as: Christopher Ma, Alain M. Schoepfer, Evan S. Dellon, Albert J. Bredenoord, Mirna Chehade, Margaret H. Collins, Brian G. Feagan, Glenn T. Furuta, Sandeep K. Gupta, Ikuo Hirano, Vipul Jairath, David A. Katzka, Rish K. Pai, Marc E. Rothenberg, Alex Straumann, Seema S. Aceves, Jeffrey A. Alexander, Nicoleta C. Arva, Dan Atkins, Luc Biedermann, Carine Blanchard, Antonella Cianferoni, Constanza Ciriza de los Rios, Frederic Clayton, Carla M. Davis, Nicola de Bortoli, Jorge A. Dias, Gary W. Falk, Robert M. Genta, Gisoo Ghaffari, Nirmala Gonsalves, Thomas Greuter, Russell Hopp, Karen S. Hsu Blatman, Elizabeth T. Jensen, Doug Johnston, Amir F. Kagalwalla, Helen M. Larsson, John Leung, Hubert Louis, Joanne C. Masterson, Calies Menard-Katcher, Paul A. Menard-Katcher, Fouad J. Moawad, Amanda B. Muir, Vincent A. Mukkada, Roberto Penagini, Robert D. Pesek, Kathryn Peterson, Philip E. Putnam, Alberto Ravelli, Edoardo V. Savarino, Christoph Schlag, Philipp Schreiner, Dagmar Simon, Thomas C. Smyrk, Jonathan M. Spergel, Tiffany H. Taft, Ingrid Terreehorst, Tim Vanuytsel, Carina Venter, Mario C. Vieira, Michael Vieth, Berber Vlieg-Boerstra, Ulrike von Arnim, Marjorie M. Walker, Joshua B. Wechsler, Philip Woodland, John T. Woosley, Guang-Yu Yang, Noam Zevit, Ekaterina Safroneeva, Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS), Journal of Allergy and Clinical Immunology, Volume 149, Issue 2, 2022, Pages 659-670, ISSN 0091-6749, https://doi.org/10.1016/j.jaci.2021.07.001.
Keywords:	Eosinophilic esophagitis;outcomes;clinical trials;end points;histology;histopathology;endoscopy;symptomspatient-reported; outcomes;quality of life
Academic Unit:	Faculty of Science and Engineering > Biology Faculty of Science and Engineering > Research Institutes > Human Health Institute
Item ID:	17337
Identification Number:	https://doi.org/10.1016/j.jaci.2021.07.001
Depositing User:	Joanne Masterson
Date Deposited:	22 Jun 2023 07:49
Journal or Publication Title:	Journal of Allergy and Clinical Immunology
Publisher:	Elsevier
Refereed:	Yes
URI:	Publisher
Use Licence:	This item is available under a Creative Commons Attribution Non Commercial Share Alike Licence (CC BY-NC-SA). Details of this licence are available here

Repository Staff Only(login required)

Item control page

Downloads

Origin of downloads