TY - JOUR
T1 - Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)
AU - The COREOS Collaborators:
AU - Ma, Christopher
AU - Schoepfer, Alain M.
AU - Dellon, Evan S.
AU - Bredenoord, Albert J.
AU - Chehade, Mirna
AU - Collins, Margaret H.
AU - Feagan, Brian G.
AU - Furuta, Glenn T.
AU - Gupta, Sandeep K.
AU - Hirano, Ikuo
AU - Jairath, Vipul
AU - Katzka, David A.
AU - Pai, Rish K.
AU - Rothenberg, Marc E.
AU - Straumann, Alex
AU - Aceves, Seema S.
AU - Alexander, Jeffrey A.
AU - Arva, Nicoleta C.
AU - Atkins, Dan
AU - Biedermann, Luc
AU - Blanchard, Carine
AU - Cianferoni, Antonella
AU - Ciriza de los Rios, Constanza
AU - Clayton, Frederic
AU - Davis, Carla M.
AU - de Bortoli, Nicola
AU - Dias, Jorge A.
AU - Falk, Gary W.
AU - Genta, Robert M.
AU - Ghaffari, Gisoo
AU - Gonsalves, Nirmala
AU - Greuter, Thomas
AU - Hopp, Russell
AU - Hsu Blatman, Karen S.
AU - Jensen, Elizabeth T.
AU - Johnston, Doug
AU - Kagalwalla, Amir F.
AU - Larsson, Helen M.
AU - Leung, John
AU - Louis, Hubert
AU - Masterson, Joanne C.
AU - Menard-Katcher, Calies
AU - Menard-Katcher, Paul A.
AU - Moawad, Fouad J.
AU - Muir, Amanda B.
AU - Mukkada, Vincent A.
AU - Penagini, Roberto
AU - Pesek, Robert D.
AU - Peterson, Kathryn
AU - Putnam, Philip E.
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2022/2
Y1 - 2022/2
N2 - 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.
AB - 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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U2 - 10.1016/j.jaci.2021.07.001
DO - 10.1016/j.jaci.2021.07.001
M3 - Article
C2 - 34242635
AN - SCOPUS:85111964162
SN - 0091-6749
VL - 149
SP - 659
EP - 670
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 2
ER -