PragmaticTrial Design to Compare Real-world Effectiveness of DifferentTreatments for Inflammatory Bowel Diseases:The PRACTICE-IBD European Consensus

Fantini MC, Fiorino G, Colli A, Laharie D, Armuzzi A, Caprioli FA, Gisbert JP, Kirchgesner J, Macaluso FS, Magro F, Ghosh S, Allez M, Amiot A, Atreya R, Barreiro-De Acosta M, Biancone L, Castiglione F, Chaparro M, Dignass A, Doherty G, Domènech E, Fries W, Halfvarson J, Kopylov U, Onali S, Pugliese D, Ribaldone DG, Saibeni S, Savarino EV (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 18

Pages Range: 1222-1231

Journal Issue: 8

DOI: 10.1093/ecco-jcc/jjae026

Abstract

Background and Aims: Pragmatic studies designed to test interventions in everyday clinical settings can successfully complement the evidence from registration and explanatory clinical trials. The European consensus project PRACTICE-IBD was developed to identify essential criteria and address key methodological issues needed to design valid, comparative, pragmatic studies in inflammatory bowel diseases [BDs]. Methods:Statements were issued by a panel of 11 European experts in IBD management and trial methodology, on four main topics: [I] study design; [II] eligibility, recruitment and organisation, flexibility; [III] outcomes; [IV] analysis. The consensus process followed a modified Delphi approach, involving two rounds of assessment and rating of the level of agreement [1 to 9; cut-off ≥7 for approval] with the statements by 18 additional European experts in IBD. Results: At the first voting round, 25 out of the 26 statements reached a mean score ≥7. Following the discussion that preceded the second round of voting, it was decided to eliminate two statements and to split one into two. At the second voting round, 25 final statements were approved: seven for study design; six for eligibility, recruitment and organisation, flexibility; eight for outcomes; and four for analysis. Conclusions: Pragmatic, randomised, clinical trials can address important questions in IBD clinical practice, and may provide complementary, high-level evidence, as long as they follow a methodologically rigorous approach. These 25 statements intend to offer practical guidance in the design of high-quality, pragmatic, clinical trials that can aid decision making in choosing a management strategy for IBDs.

Authors with CRIS profile

Involved external institutions

Università degli Studi di Cagliari Italy (IT) Azienda ospedaliera San Camillo-Forlanini Italy (IT) Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Italy (IT) Université de Bordeaux France (FR) Humanitas University Italy (IT) Université Sorbonne Paris Cité France (FR) Complejo Hospitalario Universitario de Santiago de Compostela Spain (ES) Università degli Studi di Roma 'Tor Vergata' Italy (IT) Università degli Studi di Napoli Federico II Italy (IT) Università degli studi di Milano Italy (IT) Instituto de Investigación Sanitaria Princesa Spain (ES) National Institute for Health and Medical Research / Institut national de la santé et de la recherche médicale (INSERM) France (FR) Ospedali Riuniti Villa Sofia-Cervello Italy (IT) Universidade do Porto Portugal (PT) Bicêtre Hospital France (FR) University of Turin / Università degli Studi di Torino (UNITO) Italy (IT) ASST Rhodense Italy (IT) University of Padua / Universita degli Studi di Padova Italy (IT) Fondazione Policlinico Universitario Agostino Gemelli IRCCS Italy (IT) Goethe-Universität Frankfurt am Main Germany (DE) St Vincent's University Hospital Ireland (IE) Health Sciences Research Institute of the “Germans Trias i Pujol” Foundation (IGTP) Spain (ES) University of Messina / Università degli Studi di Messina Italy (IT) Chaim Sheba Medical Center at Tel HaShomer / המרכז הרפואי עש חיים שיבא – תל השומר‎‎ Israel (IL)

How to cite

APA:

Fantini, M.C., Fiorino, G., Colli, A., Laharie, D., Armuzzi, A., Caprioli, F.A.,... Savarino, E.V. (2024). PragmaticTrial Design to Compare Real-world Effectiveness of DifferentTreatments for Inflammatory Bowel Diseases:The PRACTICE-IBD European Consensus. Journal of Crohns & Colitis, 18(8), 1222-1231. https://doi.org/10.1093/ecco-jcc/jjae026

MLA:

Fantini, Massimo Claudio, et al. "PragmaticTrial Design to Compare Real-world Effectiveness of DifferentTreatments for Inflammatory Bowel Diseases:The PRACTICE-IBD European Consensus." Journal of Crohns & Colitis 18.8 (2024): 1222-1231.

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