Evidence map›Paper›PMID 38367197›Full record

ArticleJournal of Crohn's & colitis2024

Pragmatic Trial Design to Compare Real-world Effectiveness of Different Treatments for Inflammatory Bowel Diseases: The PRACTICE-IBD European Consensus.

Massimo Claudio Fantini, Gionata Fiorino, Agostino Colli, David Laharie, Alessandro Armuzzi, Flavio Andrea Caprioli, Javier P Gisbert, Julien Kirchgesner, Fabio Salvatore Macaluso, Fernando Magro and 2 more

Open access · hybridAbstract readConsensus Statement
In one paragraph

Article in Journal of Crohn's & colitis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
5.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Incorporating Real-World Variability in Clinical IBD Research.Journal of evaluation in clinical practice · 2025
    Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 20 institutions in 8 countries.

Massimo Claudio FantiniDepartment of Medical Science and Public Health, University of Cagliari, Cagliari, Italy; Gastroenterology Unit, Azienda Ospedaliero-Universitaria di Cagliari,Italy.
Gionata FiorinoIBD Unit, Department of Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini, Rome, Italy; Department of Gastroenterology and Digestive Endoscopy, San Raffaele Hospital and Vita-Salute San Raffaele Hospital, Milan, Italy.ORCID 0000-0001-5623-2968
Agostino ColliDepartment of Transfusion Medicine and Haematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.
David LaharieCHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et Oncologie Digestive, Université de Bordeaux, Bordeaux, France.
Alessandro ArmuzziDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Flavio Andrea CaprioliDepartment of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.ORCID 0000-0002-8077-8175
Javier P GisbertGastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-Princesa], Universidad Autónoma de Madrid [UAM], Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBEREHD], Madrid, Spain.ORCID 0000-0003-2090-3445
Julien KirchgesnerINSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Department of Gastroenterology, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France.ORCID 0000-0002-2314-9284
Fabio Salvatore MacalusoIBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.ORCID 0000-0001-5128-3846
Fernando MagroCINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Clinical Pharmacology, São João University Hospital Center [CHUSJ], Porto, Portugal; Center for Health Technology and Services Research [CINTESIS], Porto, Portugal.
Subrata GhoshCollege of Medicine and Health, University College Cork, Cork, Ireland.ORCID 0000-0002-1713-7797
PRACTICE-IBD study group
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEHospital Universitario de La Princesa · ESTel Aviv University · ILUniversità Cattolica del Sacro Cuore · ITUniversité Paris Cité · FRUniversity College Dublin · IEUniversity of Messina · ITUniversity of Padua · ITUniversity of Rome Tor Vergata · ITAziende Socio Sanitaria Territoriale RhodenseFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITGoethe University Frankfurt · DEHumanitas University · ITInserm · FROspedale Vincenzo Cervello · ITUniversidade do Porto · PTUniversité de Bordeaux · FRUniversity College Cork · IEUniversity of Cagliari · ITUniversity of Milan · IT

Funding

Havas Life Italy S.r.l.
6 · The paper itself

Abstract

BACKGROUND AND

aimsPragmatic 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].

methodsStatements 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.

resultsAt 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.

conclusionsPragmatic, 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.

Indexed as

ConsensusDelphi TechniqueInflammatory Bowel DiseasesPragmatic Clinical Trials as TopicResearch DesignEuropeHumansPatient Selectionconsensus procedureinflammatory bowel diseasesPragmatic clinical trials

Identifiers

PMID38367197
PMCPMC11324339
OpenAlexW4391919085

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.