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

Humans Colon Colonoscopy Consensus Constriction, Pathologic Crohn Disease / diagnosis
Bowel preparation Crohn disease Inflammatory bowel diseases Trial recommendations

Journal

Digestive diseases and sciences
ISSN: 1573-2568
Titre abrégé: Dig Dis Sci
Pays: United States
ID NLM: 7902782

Informations de publication

Date de publication:
05 2023
Historique:
received: 15 07 2022
accepted: 14 11 2022
medline: 28 4 2023
pubmed: 28 11 2022
entrez: 27 11 2022
Statut: ppublish

Résumé

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. 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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1007/s10620-022-07775-3 PMID: 36436154
pubmed: 36436154
doi: 10.1007/s10620-022-07775-3
pii: 10.1007/s10620-022-07775-3
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1718-1727

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Références

Nishihara R, Wu K, Lochhead P et al. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013;369:1095–1105.
doi: 10.1056/NEJMoa1301969 pubmed: 24047059
Anderson JC, Butterly LF, Robinson CM, Goodrich M, Weiss JE. Impact of fair bowel preparation quality on adenoma and serrated polyp detection: data from the New Hampshire colonoscopy registry by using a standardized preparation-quality rating. Gastrointest Endosc. 2014;80:463–470.
doi: 10.1016/j.gie.2014.03.021 pubmed: 24818550 pmcid: 4134990
Clark BT, Protiva P, Nagar A et al. Quantification of adequate bowel preparation for screening or surveillance colonoscopy in men. Gastroenterology. 2016;150:396–405.
doi: 10.1053/j.gastro.2015.09.041 pubmed: 26439436
Hassan C, Manning J, Alvarez Gonzalez MA, Sharma P, Epstein M, Bisschops R. Improved detection of colorectal adenomas by high-quality colon cleansing. Endosc Int Open. 2020;8:E928–E937.
doi: 10.1055/a-1167-1359 pubmed: 32676536 pmcid: 7359847
Halphen M, Heresbach D, Gruss HJ, Belsey J. Validation of the Harefield cleansing scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013;78:121–131.
doi: 10.1016/j.gie.2013.02.009 pubmed: 23531426
Spadaccini M, Frazzoni L, Vanella G et al. Efficacy and tolerability of high- vs low-volume split-dose bowel cleansing regimens for colonoscopy: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2020;18:e1414.
Yuan X, Zhang Z, Xie J et al. Comparison of 1L adjuvant auxiliary preparations with 2L solely polyethylene glycol plus ascorbic acid regime for bowel cleaning: a meta-analysis of randomized, controlled trials. Biomed Res Int. 2021;2021:6638858.
doi: 10.1155/2021/6638858 pubmed: 33681359 pmcid: 7910058
van Riswijk MLM, van Keulen KE, Siersema PD. Efficacy of ultra-low volume (≤ 1 L) bowel preparation fluids: systematic review and meta-analysis. Dig Endosc. 2021;34:13–32.
doi: 10.1111/den.14015 pubmed: 33991373 pmcid: 9290948
Bjoersum-Meyer T, Skonieczna-Zydecka K, Cortegoso Valdivia P et al. Efficacy of bowel preparation regimens for colon capsule endoscopy: a systematic review and meta-analysis. Endosc Int Open. 2021;9:E1658–E1673.
doi: 10.1055/a-1529-5814 pubmed: 34790528 pmcid: 8589531
Mamula P, Adler DG, ASGE Technology Committee et al. Colonoscopy preparation. Gastrointest Endosc. 2009;69:1201–1209.
doi: 10.1016/j.gie.2009.01.035 pubmed: 19481646
Parmar R, Martel M, Rostom A, Barkun AN. Validated scales for colon cleansing: a systematic review. Am J Gastroenterol. 2016;111:197–204.
doi: 10.1038/ajg.2015.417 pubmed: 26782820
Denters MJ, Schreuder M, Depla AC et al. Patients’ perception of colonoscopy: patients with inflammatory bowel disease and irritable bowel syndrome experience the largest burden. Eur J Gastroenterol Hepatol. 2013;25:964–972.
doi: 10.1097/MEG.0b013e328361dcd3 pubmed: 23660935
Mohsen W, Williams AJ, Wark G et al. Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: does underlying inflammatory bowel disease impact tolerability and efficacy? World J Gastroenterol. 2021;27:1090–1100.
doi: 10.3748/wjg.v27.i11.1090 pubmed: 33776375 pmcid: 7985733
Neri B, Scarozza P, Giannarelli D et al. Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2021;33:977–982.
doi: 10.1097/MEG.0000000000002167 pubmed: 34034275
Maida M, Morreale GC, Sferrazza S et al. Effectiveness and safety of 1L PEG-ASC preparation for colonoscopy in patients with inflammatory bowel diseases. Dig Liver Dis. 2021;53:1171–1177.
doi: 10.1016/j.dld.2021.04.006 pubmed: 33994129
Briot C, Faure P, Parmentier AL et al. Efficacy, tolerability, and safety of low-volume bowel preparations for patients with inflammatory bowel diseases: the French multicentre CLEAN study. J Crohns Colitis. 2019;13:1121–1130.
doi: 10.1093/ecco-jcc/jjz040 pubmed: 30785181
Lazzaroni M, Petrillo M, Desideri S, Bianchi Porro G. Efficacy and tolerability of polyethylene glycol-electrolyte lavage solution with and without simethicone in the preparation of patients with inflammatory bowel disease for colonoscopy. Aliment Pharmacol Ther. 1993;7:655–659.
doi: 10.1111/j.1365-2036.1993.tb00148.x pubmed: 8161673
Manes G, Fontana P, de Nucci G, Radaelli F, Hassan C, Ardizzone S. Colon cleansing for colonoscopy in patients with ulcerative colitis: efficacy and acceptability of a 2-L PEG plus bisacodyl versus 4-L PEG. Inflamm Bowel Dis. 2015;21:2137–2144.
doi: 10.1097/MIB.0000000000000463 pubmed: 26164666
Gould SR, Williams CB. Castor oil or senna preparation before colonoscopy for inactive chronic ulcerative colitis. Gastrointest Endosc. 1982;28:6–8.
doi: 10.1016/S0016-5107(82)72955-4 pubmed: 7056466
Kim ES, Kim KO, Jang BI et al. Comparison of 4-L polyethylene glycol and 2-L polyethylene glycol plus ascorbic acid in patients with inactive ulcerative colitis. Dig Dis Sci. 2017;62:2489–2497.
doi: 10.1007/s10620-017-4634-7 pubmed: 28639128
Heron V, Parmar R, Menard C, Martel M, Barkun AN. Validating bowel preparation scales. Endosc Int Open. 2017;5:E1179–E1188.
doi: 10.1055/s-0043-119749 pubmed: 29202001 pmcid: 5698009
Restellini S, Kherad O, Bessissow T et al. Systematic review and meta-analysis of colon cleansing preparations in patients with inflammatory bowel disease. World J Gastroenterol. 2017;23:5994–6002.
doi: 10.3748/wjg.v23.i32.5994 pubmed: 28932092 pmcid: 5583585
Brook RH. The RAND/UCLA appropriateness method. In: McCormick KA, Moore SR, Siegel RA, eds. Clinical practice guideline development: Methodology practices, Rockville, MD; Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services;1994.
The RAND/UCLA Appropriateness Method User’s Manual, 2001. Available at: https://www.rand.org/pubs/monograph_reports/MR1269.html Accessed January 02, 2022.
DeMicco MP, Clayton LB, Pilot J, Epstein MS, NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018;87:e673.
Bisschops R, Manning J, Clayton LB, Ng Kwet Shing R, Alvarez-Gonzalez M, MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019;51:60–72.
doi: 10.1055/a-0638-8125 pubmed: 30025414
Schreiber S, Baumgart DC, Drenth JPH et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy. 2019;51:73–84.
doi: 10.1055/a-0639-5070 pubmed: 30025415
US Food and Drug Administration. Bowel cleansing for colonoscopy: efficacy and safety considerations for developing new products. Guidance for industry (draft guidance). 2021.
Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69:620–625.
doi: 10.1016/j.gie.2008.05.057 pubmed: 19136102 pmcid: 2763922
Calderwood AH, Jacobson BC. Comprehensive validation of the Boston bowel preparation scale. Gastrointest Endosc. 2010;72:686–692.
doi: 10.1016/j.gie.2010.06.068 pubmed: 20883845 pmcid: 2951305
Gao Y, Lin JS, Zhang HD, Lin MX, Cheng CS, Wu SZ. Pilot validation of the Boston bowel preparation scale in China. Dig Endosc. 2013;25:167–173.
doi: 10.1111/j.1443-1661.2012.01356.x pubmed: 23368700

Auteurs

Jennifer K 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.

Corey A Siegel (CA)

Department of Medicine, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH, 03766, USA.

Alan N Barkun (AN)

Division of Gastroenterology, McGill University and McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada.

Yoram Bouhnik (Y)

Gastroenterology and Nutrition Support Department, Department of Gastroenterology, Beaujon Hospital, 100 Bd du Général Leclerc, 92110, Clichy, France.

Brian Bressler (B)

Division of Gastroenterology, Department of Medicine, St Paul's Hospital, University of British Columbia, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.

Audrey H 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.

James E 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.

Monika Fischer (M)

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 340 W 10Th St, Indianapolis, IN, 46202, USA.

Johannes Grossmann (J)

Department of Internal Medicine I, Bethesda Hospital, Glindersweg 80, 21029, Hamburg, Germany.
Johanniter GmbH, Ludwig-Weber-Straße 15, 41061, Mönchengladbach, Germany.

Joshua R 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.

Stacy B 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.

Julian 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.

Douglas K Rex (DK)

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 340 W 10Th St, Indianapolis, IN, 46202, USA.

Michael S L Sey (MSL)

Division of Gastroenterology, Department of Medicine, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.

Michael K Allio (MK)

ColonaryConcepts LLC, 103 San Marco Dr, Palm Beach Gardens, FL, 33418, USA.

K Adam Baker (KA)

Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada.

Leonardo Guizzetti (L)

Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada.

Julie Remillard (J)

Alimentiv Inc, 100 Dundas St Suite 200, London, ON, N6A 5B6, Canada.

Rocio 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.

Brian G 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.

Christopher 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.

Vipul 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.
ORCID: 0000-0001-8603-898X

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