An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease.

Autor: Maratt JK; Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 340 W 10Th St, Indianapolis, IN, 46202, USA.; Richard L. Roudebush Veterans Affairs Medical Center, 1481 W 10Th St, Indianapolis, IN, 46202, USA.; Regenstrief Institute, Inc, 1101 W 10Th St, Indianapolis, IN, 46202, USA., Siegel CA; Department of Medicine, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH, 03766, USA., Barkun AN; Division of Gastroenterology, McGill University and McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada., Bouhnik Y; Gastroenterology and Nutrition Support Department, Department of Gastroenterology, Beaujon Hospital, 100 Bd du Général Leclerc, 92110, Clichy, France., Bressler B; Division of Gastroenterology, Department of Medicine, St Paul's Hospital, University of British Columbia, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada., Calderwood AH; Department of Medicine, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH, 03766, USA.; The Geisel School of Medicine at Dartmouth, 1 Rope Ferry Rd, Hanover, NH, 03755, USA.; Dartmouth Institute of Health Policy and Clinical Practice, 1 Medical Center Dr, Lebanon, NH, 03766, USA., East JE; Translational Gastroenterology Unit, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.; Division of Gastroenterology and Hepatology, Mayo Clinic Healthcare London, 15 Portland Pl, London, W1B 1PT, UK., Fischer M; Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 340 W 10Th St, Indianapolis, IN, 46202, USA., Grossmann J; Department of Internal Medicine I, Bethesda Hospital, Glindersweg 80, 21029, Hamburg, Germany.; Johanniter GmbH, Ludwig-Weber-Straße 15, 41061, Mönchengladbach, Germany., Korzenik JR; Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, USA.; Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA., Menees SB; Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, 500 S State St, Ann Arbor, MI, 48109, USA.; Veterans Affairs Ann Arbor Healthcare System, 2215 Fuller Rd, Ann Arbor, MI, 48105, USA., Panes J; Inflammatory Bowel Disease Unit, Department of Gastroenterology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigaciones Biomédicas en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Hospital Clínic de Barcelona, C. de Villarroel, 170, 08036, Barcelona, Spain., Rex DK; Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 340 W 10Th St, Indianapolis, IN, 46202, USA., Sey MSL; Division of Gastroenterology, Department of Medicine, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada., Allio MK; ColonaryConcepts LLC, 103 San Marco Dr, Palm Beach Gardens, FL, 33418, USA., Baker KA; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada., Guizzetti L; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada., Remillard J; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada., Sedano R; Division of Gastroenterology, Department of Medicine, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada., Feagan BG; Division of Gastroenterology, Department of Medicine, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada.; Department of Epidemiology and Biostatistics, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada., Ma C; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada.; Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, 2500 University Dr NW, Calgary, AB, T2N 1N4, Canada., Jairath V; Division of Gastroenterology, Department of Medicine, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada. vjairath@uwo.ca.; Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada. vjairath@uwo.ca.; Department of Epidemiology and Biostatistics, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada. vjairath@uwo.ca.; Department of Medicine, Western University, 399 Windermere Road, London, ON, N6A 5A5, Canada. vjairath@uwo.ca.
Jazyk: angličtina
Zdroj: Digestive diseases and sciences [Dig Dis Sci] 2023 May; Vol. 68 (5), pp. 1718-1727. Date of Electronic Publication: 2022 Nov 27.
DOI: 10.1007/s10620-022-07775-3
Abstrakt: Background: Despite regular need for colonoscopy in patients with Crohn's disease (CD), the efficacy and tolerability of bowel preparation (BP) agents is rarely assessed in this population. Assessing BP quality with existing scales may be challenging in CD due to presence of inflammation, bowel resection, and strictures.
Aims: To provide recommendations for assessing BP quality in clinical trials for CD using a modified Research and Development/University of California, Los Angeles appropriateness process.
Methods: Based on systematic reviews and a literature search, 110 statements relating to BP quality assessment in CD were developed. A panel of 15 gastroenterologists rated the statements as appropriate, uncertain, or inappropriate using a 9-point Likert scale.
Results: Panelists considered it appropriate that central readers, either alone or with local assessment, score BP quality in clinical trials. Central readers should be trained on scoring BP quality and local endoscopists on performing high-quality video recording. Both endoscope insertion and withdrawal phases should be reviewed to score BP quality in each colonic segment and segments should align with endoscopic disease activity indices. The Harefield Cleansing Scale and the Boston Bowel Preparation Scale were considered appropriate. The final score should be calculated as the average of all visualized segments. Both total and worst segment scores should also be assessed.
Conclusions: We developed a framework for assessing BP quality in patients with CD based on expert feedback. This framework could support the development or refinement of BP quality scales and the integration of BP quality assessment in future CD studies.
(© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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