Defining Comprehensive Disease Control for Use as a Treatment Target for Ulcerative Colitis in Clinical Practice : International Delphi Consensus Recommendations
Schreiber, Stefan (University Hospital Schleswig-Holstein (Kiel, Alemanya))
Danese, Silvio (IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University (Milan, Itàlia))
Dignass, Axel (Goethe University (Frankfurt, Alemanya))
Domènech, Eugeni (Universitat Autònoma de Barcelona. Departament de Medicina)
Fantini, Massimo C. (University of Cagliari)
Ferrante, Marc (University Hospitals Leuven (Bèlgica))
Halfvarson, Jonas (Örebro University)
Hart, Ailsa (St. Mark's Hospital (Londres, Regne Unit))
Magro, Fernando (University of Porto)
Lees, Charlie W. (Western General Hospital (Edinburgh, Regne Unit))
Leone, Salvo (European Federation of Crohn's & Ulcerative Colitis Associations (Brusel·les, Bèlgica))
Pierik, Marieke J. (Maastricht University Medical Centre (Maastricht, Països Baixos))
Peters, Michele (University of Oxford (Regne Unit))
Field, Polly (Oxford PharmaGenesis (Oxford, Regne Unit))
Fishpool, Helen (Oxford PharmaGenesis (Oxford, Regne Unit))
Peyrin-Biroulet, Laurent (Oxford PharmaGenesis (Oxford, Regne Unit))

Data:	2023
Resum:	Treatment of ulcerative colitis [UC] requires a patient-centric definition of comprehensive disease control that considers improvements in aspects not typically captured by classical landmark trial endpoints. In an international initiative, we reviewed aspects of UC that affect patients and/or indicate mucosal inflammation, to achieve consensus on which aspects to combine in a definition of comprehensive disease control, using a modified Delphi process. The Delphi panel comprised 12 gastroenterologists and one patient advocate. Two gastroenterologists were elected as chairs and did not vote. To inform statements, we asked 18 patients and the panel members about their experiences of remission and reviewed published literature. Panel members voted on statements anonymously in three rounds, with a live discussion before Round 3. Consensus was met if ≥67% of the panel agreed. Statements without consensus in Rounds 1 and 2 were revised or discarded after Round 3. The panel agreed to measure individual patient benefit using a definition of comprehensive disease control that combines aspects currently measured in trials [rectal bleeding, stool frequency, disease-related quality of life, endoscopy, histological inflammatory activity, inflammatory biomarkers, and corticosteroid use] with additional patient-reported symptoms [bowel urgency, abdominal pain, extraintestinal manifestations, fatigue, and sleep disturbance]. The panel agreed on scoring systems and thresholds for many aspects. Using a robust methodology, we defined comprehensive disease control in UC. Next, we will combine the measurement and scoring of these aspects into a multicomponent tool and will adopt comprehensive disease control as a treatment target in clinical practice and trials.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Ulcerative colitis ; Remission ; Delphi consensus ; Patient-reported symptoms
Publicat a:	Journal of Crohn's and colitis, Vol. 18 (august 2023) , p. 91-105, ISSN 1876-4479

DOI: 10.1093/ecco-jcc/jjad130
PMID: 37586038

15 p, 718.8 KB

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