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    Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)


    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 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

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    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: 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
    Related URLs:
    URI: https://mural.maynoothuniversity.ie/id/eprint/17337
    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

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