Timing matters: recommendations for outcome assessment in real-world evidence studies of Crohn’s disease

We provide the first expert-endorsed temporal framework for outcome assessment in RWE studies of CD. Standardized measurement timing can enhance study comparability and methodological rigor, supporting more consistent interpretation of real-world data. Claims are limited to framework development and do not extend to direct clinical or regulatory impact.

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Publication Details

Journal
Journal of Crohn s and Colitis
Published
2026-03-01
DOI
https://doi.org/10.1093/ecco-jcc/jjag030
Primary Topic
Inflammatory Bowel Disease
Type
article
Field-Weighted Citation Impact
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article

Timing matters: recommendations for outcome assessment in real-world evidence studies of Crohn’s disease

Gerassimos J. Mantzaris, Vipul Jairath, M Santiago, Bruce E Sands et al.
Journal of Crohn s and Colitis
Inflammatory Bowel Disease
article

Timing matters: recommendations for outcome assessment in real-world evidence studies of Crohn’s disease

Gerassimos J. Mantzaris, Vipul Jairath, M Santiago, Bruce E Sands, Maria Manuela Estevinho, Silvio Danese, Paula Leão Moreira, Walter Reinisch, Laurent Peyrin-Biroulet, Iris Dotan, Fernando Magro, Geert D’Haens, Axel Dignass
article en

Abstract

We provide the first expert-endorsed temporal framework for outcome assessment in RWE studies of CD. Standardized measurement timing can enhance study comparability and methodological rigor, supporting more consistent interpretation of real-world data. Claims are limited to framework development and do not extend to direct clinical or regulatory impact.

Journal of Crohn s and ColitisVol. 20(3)
Goethe University Frankfurt (DE), Vita-Salute San Raffaele University (IT), Tel Aviv University (IL), Universidade do Porto (PT), Rabin Medical Center (IL), McGill University Health Centre (CA), Hospital de São João (PT), Instituto Português de Oncologia Francisco Gentil (PT), Administração Regional de Saúde de Lisboa e Vale do Tejo (PT), Hygeia Hospital (GR), IRCCS Ospedale San Raffaele (IT), Centre for Health Technology and Services Research (PT), Centro Hospitalar de Vila Nova de Gaia (PT), Agaplesion Markus Hospital (DE), Amsterdam University Medical Centers (NL), Nutrition-Génétique et Exposition aux Risques Environnementaux (FR), Medical University of Vienna (AT), Université de Lorraine (FR), McMaster University (CA), Icahn School of Medicine at Mount Sinai (US)
Partnerships for the goals
Openalex Percentile: Top 5%
Inflammatory Bowel Disease
DOISourceOpenAlex
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