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; ... (2021). Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS). (In Press). Journal of allergy and clinical immunology Mosby 10.1016/j.jaci.2021.07.001

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BACKGROUND

Endpoints 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

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 four outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life (QoL). A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a two-round Delphi process and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, EoE Histology Scoring System, EoE Endoscopic Reference Score, and patient-reported measures of dysphagia and QoL.

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, which will facilitate meaningful treatment comparisons and improve the quality of data synthesis.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Dermatology

UniBE Contributor:

Simon, Dagmar and Safroneeva, Ekaterina

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0091-6749

Publisher:

Mosby

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

27 Jul 2021 15:08

Last Modified:

29 Jul 2021 07:07

Publisher DOI:

10.1016/j.jaci.2021.07.001

PubMed ID:

34242635

Uncontrolled Keywords:

Eosinophilic esophagitis clinical trials endoscopy endpoints histology histopathology outcomes patient reported outcomes quality of life symptoms

BORIS DOI:

10.48350/157531

URI:

https://boris.unibe.ch/id/eprint/157531

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