Observational Study

. 2022 Feb;149(2):659-670.

doi: 10.1016/j.jaci.2021.07.001. Epub 2021 Jul 6.

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

COREOS Collaborators:; Christopher Ma¹, Alain M Schoepfer², Evan S Dellon³, Albert J Bredenoord⁴, Mirna Chehade⁵, Margaret H Collins⁶, Brian G Feagan⁷, Glenn T Furuta⁸, Sandeep K Gupta⁹, Ikuo Hirano¹⁰, Vipul Jairath⁷, David A Katzka¹¹, Rish K Pai¹², Marc E Rothenberg¹³, Alex Straumann¹⁴, Seema S Aceves¹⁵, Jeffrey A Alexander¹¹, Nicoleta C Arva¹⁶, Dan Atkins¹⁷, Luc Biedermann¹⁴, Carine Blanchard¹⁸, Antonella Cianferoni¹⁹, Constanza Ciriza de Los Rios²⁰, Frederic Clayton²¹, Carla M Davis²², Nicola de Bortoli²³, Jorge A Dias²⁴, Gary W Falk²⁵, Robert M Genta²⁶, Gisoo Ghaffari²⁷, Nirmala Gonsalves¹⁰, Thomas Greuter²⁸, Russell Hopp²⁹, Karen S Hsu Blatman³⁰, Elizabeth T Jensen³¹, Doug Johnston³², Amir F Kagalwalla³³, Helen M Larsson³⁴, John Leung³⁵, Hubert Louis³⁶, Joanne C Masterson³⁷, Calies Menard-Katcher⁸, Paul A Menard-Katcher³⁸, Fouad J Moawad³⁹, Amanda B Muir⁴⁰, Vincent A Mukkada⁴¹, Roberto Penagini⁴², Robert D Pesek⁴³, Kathryn Peterson⁴⁴, Philip E Putnam⁴¹, Alberto Ravelli⁴⁵, Edoardo V Savarino⁴⁶, Christoph Schlag⁴⁷, Philipp Schreiner¹⁴, Dagmar Simon⁴⁸, Thomas C Smyrk⁴⁹, Jonathan M Spergel¹⁹, Tiffany H Taft¹⁰, Ingrid Terreehorst⁵⁰, Tim Vanuytsel⁵¹, Carina Venter¹⁷, Mario C Vieira⁵², Michael Vieth⁵³, Berber Vlieg-Boerstra⁵⁴, Ulrike von Arnim⁵⁵, Marjorie M Walker⁵⁶, Joshua B Wechsler⁵⁷, Philip Woodland⁵⁸, John T Woosley⁵⁹, Guang-Yu Yang⁶⁰, Noam Zevit⁶¹, Ekaterina Safroneeva⁶²

Affiliations

¹ Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Alimentiv Inc, London, Ontario, Canada.
² Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland.
³ Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
⁴ Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
⁵ Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY.
⁶ Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
⁷ Alimentiv Inc, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁸ Digestive Health Institute, Children's Hospital Colorado, Gastrointestinal Eosinophilic Diseases Program, Section of Pediatric Gastroenterology, Hepatology, and Nutrition, University of Colorado School of Medicine, Aurora, Colo.
⁹ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Riley Hospital for Children/Indiana University School of Medicine, Indianapolis, Ind.
¹⁰ Division of Gastroenterology & Hepatology, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
¹¹ Division of Gastroenterology, Mayo Clinic, Rochester, Minn.
¹² Department of Pathology and Laboratory Medicine, Mayo Clinic Arizona, Scottsdale, Ariz.
¹³ Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.
¹⁴ Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
¹⁵ Division of Allergy Immunology, University of California, San Diego, Rady Children's Hospital, San Diego, Calif.
¹⁶ Department of Pathology and Laboratory Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
¹⁷ Gastrointestinal Eosinophilic Diseases Program, Children's Hospital of Colorado, Section of Allergy and Immunology, University of Colorado School of Medicine, Aurora, Colo.
¹⁸ Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé, Vevey, Switzerland.
¹⁹ Division of Allergy and Immunology, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa.
²⁰ Department of Gastroenterology, Hospital Clínico San Carlos, Universidad Complutense, Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain.
²¹ Department of Pathology, The University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah.
²² Immunology, Allergy, and Retrovirology Section of the Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, Tex.
²³ Department of Translational Research and New Technology in Medicine and Surgery, Division of Gastroenterology, University of Pisa, Cisanello Hospital, Pisa, Italy.
²⁴ Pediatric Gastroenterology, Centro Hospitalar S. João, Porto, Portugal.
²⁵ Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pa.
²⁶ Inform Diagnostics, Irving, Tex; Department of Pathology, Baylor College of Medicine, Houston, Tex.
²⁷ Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Pennsylvania State College of Medicine, Hershey, Pa.
²⁸ Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
²⁹ University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha, Neb.
³⁰ Section of Allergy and Clinical Immunology, Dartmouth-Hitchcock Medical Center, Dartmouth Geisel School of Medicine, Hanover, NH.
³¹ Wake Forest University School of Medicine, Department of Epidemiology and Prevention, Winston-Salem, NC.
³² Asthma and Allergy Specialists, Charlotte, NC.
³³ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill; Division of Gastroenterology, Department of Pediatrics, John H. Stroger Jr Hospital of Cook County, Chicago, Ill.
³⁴ Department of ENT, Head, and Neck Surgery, NÄL Medical Centre, Trollhättan, Sweden.
³⁵ Division of Gastroenterology, Tufts Medical Center, Boston, Mass.
³⁶ Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
³⁷ Department of Biology, Maynooth University, Kildare, Ireland.
³⁸ Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colo.
³⁹ Division of Gastroenterology & Hepatology, Scripps Clinic, La Jolla, Calif.
⁴⁰ Center for Pediatric Eosinophilic Diseases, Division of Gastroenterology and Hepatology & Nutrition, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pa.
⁴¹ Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
⁴² Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
⁴³ Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
⁴⁴ Division of Gastroenterology, The University of Utah, Salt Lake City, Utah.
⁴⁵ University Department of Pediatrics, Children's Hospital-Spedali Civili, Brescia, Italy.
⁴⁶ Department of Surgery, Oncology, and Gastroenterology, DiSCOG, University of Padua, Padua, Italy.
⁴⁷ II. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.
⁴⁸ Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
⁴⁹ Department of Pathology, Mayo Clinic, Rochester, Minn.
⁵⁰ Department of ENT, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
⁵¹ Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium; Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
⁵² Department of Pediatrics, Pontifical Catholic University of Paraná and Center for Pediatric Gastroenterology, Hospital Pequeno Príncipe, Curitiba, Brazil.
⁵³ Institute for Pathology, Klinikum Bayreuth, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
⁵⁴ OLVG Hospital, Department of Pediatrics, Amsterdam, The Netherlands.
⁵⁵ Department of Gastroenterology, Hepatology, and Infectious Diseases, University Hospital, Magdeburg, Germany.
⁵⁶ Centre of Research Excellence in Digestive Health, University of Newcastle, Newcastle, Australia.
⁵⁷ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
⁵⁸ Wingate Institute of Neurogastroenterology, Barts, and the London School of Medicine and Dentistry, Queen Mary University of London, London, England, United Kingdom.
⁵⁹ Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
⁶⁰ Division of Pathology, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
⁶¹ Institute of Gastroenterology, Nutrition, and Liver Diseases, Schneider Children's Medical Center of Israel, Petach Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
⁶² Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. Electronic address: ekaterina.safroneeva@ispm.unibe.ch.

PMID: 34242635
PMCID: PMC8733049
DOI: 10.1016/j.jaci.2021.07.001

Observational Study

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

COREOS Collaborators: et al. J Allergy Clin Immunol. 2022 Feb.

. 2022 Feb;149(2):659-670.

doi: 10.1016/j.jaci.2021.07.001. Epub 2021 Jul 6.

Authors

Affiliations

¹ Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Alimentiv Inc, London, Ontario, Canada.
² Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland.
³ Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
⁴ Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
⁵ Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY.
⁶ Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
⁷ Alimentiv Inc, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁸ Digestive Health Institute, Children's Hospital Colorado, Gastrointestinal Eosinophilic Diseases Program, Section of Pediatric Gastroenterology, Hepatology, and Nutrition, University of Colorado School of Medicine, Aurora, Colo.
⁹ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Riley Hospital for Children/Indiana University School of Medicine, Indianapolis, Ind.
¹⁰ Division of Gastroenterology & Hepatology, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
¹¹ Division of Gastroenterology, Mayo Clinic, Rochester, Minn.
¹² Department of Pathology and Laboratory Medicine, Mayo Clinic Arizona, Scottsdale, Ariz.
¹³ Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.
¹⁴ Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
¹⁵ Division of Allergy Immunology, University of California, San Diego, Rady Children's Hospital, San Diego, Calif.
¹⁶ Department of Pathology and Laboratory Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
¹⁷ Gastrointestinal Eosinophilic Diseases Program, Children's Hospital of Colorado, Section of Allergy and Immunology, University of Colorado School of Medicine, Aurora, Colo.
¹⁸ Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé, Vevey, Switzerland.
¹⁹ Division of Allergy and Immunology, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa.
²⁰ Department of Gastroenterology, Hospital Clínico San Carlos, Universidad Complutense, Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain.
²¹ Department of Pathology, The University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah.
²² Immunology, Allergy, and Retrovirology Section of the Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, Tex.
²³ Department of Translational Research and New Technology in Medicine and Surgery, Division of Gastroenterology, University of Pisa, Cisanello Hospital, Pisa, Italy.
²⁴ Pediatric Gastroenterology, Centro Hospitalar S. João, Porto, Portugal.
²⁵ Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pa.
²⁶ Inform Diagnostics, Irving, Tex; Department of Pathology, Baylor College of Medicine, Houston, Tex.
²⁷ Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Pennsylvania State College of Medicine, Hershey, Pa.
²⁸ Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
²⁹ University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha, Neb.
³⁰ Section of Allergy and Clinical Immunology, Dartmouth-Hitchcock Medical Center, Dartmouth Geisel School of Medicine, Hanover, NH.
³¹ Wake Forest University School of Medicine, Department of Epidemiology and Prevention, Winston-Salem, NC.
³² Asthma and Allergy Specialists, Charlotte, NC.
³³ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill; Division of Gastroenterology, Department of Pediatrics, John H. Stroger Jr Hospital of Cook County, Chicago, Ill.
³⁴ Department of ENT, Head, and Neck Surgery, NÄL Medical Centre, Trollhättan, Sweden.
³⁵ Division of Gastroenterology, Tufts Medical Center, Boston, Mass.
³⁶ Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
³⁷ Department of Biology, Maynooth University, Kildare, Ireland.
³⁸ Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colo.
³⁹ Division of Gastroenterology & Hepatology, Scripps Clinic, La Jolla, Calif.
⁴⁰ Center for Pediatric Eosinophilic Diseases, Division of Gastroenterology and Hepatology & Nutrition, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pa.
⁴¹ Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
⁴² Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
⁴³ Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
⁴⁴ Division of Gastroenterology, The University of Utah, Salt Lake City, Utah.
⁴⁵ University Department of Pediatrics, Children's Hospital-Spedali Civili, Brescia, Italy.
⁴⁶ Department of Surgery, Oncology, and Gastroenterology, DiSCOG, University of Padua, Padua, Italy.
⁴⁷ II. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.
⁴⁸ Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
⁴⁹ Department of Pathology, Mayo Clinic, Rochester, Minn.
⁵⁰ Department of ENT, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
⁵¹ Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium; Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
⁵² Department of Pediatrics, Pontifical Catholic University of Paraná and Center for Pediatric Gastroenterology, Hospital Pequeno Príncipe, Curitiba, Brazil.
⁵³ Institute for Pathology, Klinikum Bayreuth, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
⁵⁴ OLVG Hospital, Department of Pediatrics, Amsterdam, The Netherlands.
⁵⁵ Department of Gastroenterology, Hepatology, and Infectious Diseases, University Hospital, Magdeburg, Germany.
⁵⁶ Centre of Research Excellence in Digestive Health, University of Newcastle, Newcastle, Australia.
⁵⁷ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
⁵⁸ Wingate Institute of Neurogastroenterology, Barts, and the London School of Medicine and Dentistry, Queen Mary University of London, London, England, United Kingdom.
⁵⁹ Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
⁶⁰ Division of Pathology, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
⁶¹ Institute of Gastroenterology, Nutrition, and Liver Diseases, Schneider Children's Medical Center of Israel, Petach Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
⁶² Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. Electronic address: ekaterina.safroneeva@ispm.unibe.ch.

PMID: 34242635
PMCID: PMC8733049
DOI: 10.1016/j.jaci.2021.07.001

Abstract

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.

Keywords: Eosinophilic esophagitis; clinical trials; end points; endoscopy; histology; histopathology; outcomes; patient-reported outcomes; quality of life; symptoms.

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Figures

**FIG 1.**
Core outcome set development process.

**FIG 2.**
Outcome domains for inclusion in the eosinophilic esophagitis core outcome set.

See this image and copyright information in PMC

Comment in

The importance of using core outcome measures during therapeutic studies of eosinophilic esophagitis.
Hill DA. Hill DA. J Allergy Clin Immunol. 2022 Feb;149(2):541-542. doi: 10.1016/j.jaci.2021.09.025. Epub 2021 Sep 29. J Allergy Clin Immunol. 2022. PMID: 34599977 No abstract available.

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

Comment in

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical