Disease Activity Indices for Pouchitis: A Systematic Review.
index development
operating properties
pouchitis disease
systematic review
Journal
Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162
Informations de publication
Date de publication:
30 03 2022
30 03 2022
Historique:
received:
22
01
2021
pubmed:
29
6
2021
medline:
5
4
2022
entrez:
28
6
2021
Statut:
ppublish
Résumé
Several indices exist to measure pouchitis disease activity; however, none are fully validated. As an initial step toward creating a validated instrument, we identified pouchitis disease activity indices, examined their operating properties, and assessed their value as outcome measures in clinical trials. Electronic databases were searched to identify randomized controlled trials including indices that evaluated clinical, endoscopic, or histologic pouchitis disease activity. A second search identified studies that assessed the operating properties of pouchitis indices. Eighteen randomized controlled trials utilizing 4 composite pouchitis disease activity indices were identified. The Pouchitis Disease Activity Index (PDAI) was most commonly used (12 of 18; 66.7%) to define both trial eligibility (8 of 12; 66.7%), and outcome measures (12 of 12; 100%). In a separate search, 21 studies evaluated the operating properties of 3 pouchitis indices; 90.5% (19 of 21) evaluated validity, of which 42.1% (8 of 19) evaluated the construct validity of the PDAI. Criterion validity (73.7%; 14 of 19) was evaluated through correlation of the PDAI with fecal calprotectin (FCP; r = 0.188 to 0.71), fecal lactoferrin (r = 0.570 to 0.582), and C-reactive protein (CRP; r = 0.584). Two studies assessed correlation of the modified PDAI (mPDAI) with FCP (r = 0.476 and r = 0.565, respectively). Fair to moderate inter-rater reliability of the PDAI (k = 0.440) and mPDAI (k = 0.389) was reported in a single study. Responsiveness of the PDAI pre-antibiotic and postantibiotic treatment was partially evaluated in a single study of 12 patients. Development and validation of a specific pouchitis disease activity index is needed given that existing instruments are not valid, reliable, or responsive.
Sections du résumé
BACKGROUND
Several indices exist to measure pouchitis disease activity; however, none are fully validated. As an initial step toward creating a validated instrument, we identified pouchitis disease activity indices, examined their operating properties, and assessed their value as outcome measures in clinical trials.
METHODS
Electronic databases were searched to identify randomized controlled trials including indices that evaluated clinical, endoscopic, or histologic pouchitis disease activity. A second search identified studies that assessed the operating properties of pouchitis indices.
RESULTS
Eighteen randomized controlled trials utilizing 4 composite pouchitis disease activity indices were identified. The Pouchitis Disease Activity Index (PDAI) was most commonly used (12 of 18; 66.7%) to define both trial eligibility (8 of 12; 66.7%), and outcome measures (12 of 12; 100%). In a separate search, 21 studies evaluated the operating properties of 3 pouchitis indices; 90.5% (19 of 21) evaluated validity, of which 42.1% (8 of 19) evaluated the construct validity of the PDAI. Criterion validity (73.7%; 14 of 19) was evaluated through correlation of the PDAI with fecal calprotectin (FCP; r = 0.188 to 0.71), fecal lactoferrin (r = 0.570 to 0.582), and C-reactive protein (CRP; r = 0.584). Two studies assessed correlation of the modified PDAI (mPDAI) with FCP (r = 0.476 and r = 0.565, respectively). Fair to moderate inter-rater reliability of the PDAI (k = 0.440) and mPDAI (k = 0.389) was reported in a single study. Responsiveness of the PDAI pre-antibiotic and postantibiotic treatment was partially evaluated in a single study of 12 patients.
CONCLUSIONS
Development and validation of a specific pouchitis disease activity index is needed given that existing instruments are not valid, reliable, or responsive.
Identifiants
pubmed: 34180986
pii: 6310706
doi: 10.1093/ibd/izab124
pmc: PMC8972820
doi:
Substances chimiques
Leukocyte L1 Antigen Complex
0
C-Reactive Protein
9007-41-4
Types de publication
Journal Article
Systematic Review
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
622-638Subventions
Organisme : NIDDK NIH HHS
ID : P30 DK120515
Pays : United States
Organisme : NIDDK NIH HHS
ID : K08 DK110415
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK123233
Pays : United States
Informations de copyright
© 2021 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Références
Aliment Pharmacol Ther. 1997 Dec;11(6):1041-6
pubmed: 9663827
Am J Gastroenterol. 2012 Aug;107(8):1228-35
pubmed: 22613902
Aliment Pharmacol Ther. 2003 Feb 15;17(4):509-15
pubmed: 12622759
Ann Intern Med. 2011 Oct 18;155(8):529-36
pubmed: 22007046
Inflamm Bowel Dis. 1997 Fall;3(3):239-40
pubmed: 23282811
J Crohns Colitis. 2015 Mar;9(3):231-7
pubmed: 25585596
Dis Colon Rectum. 2002 May;45(5):621-7
pubmed: 12004211
Gut. 2000 Sep;47(3):404-9
pubmed: 10940279
Dis Colon Rectum. 2002 Jun;45(6):776-86; discussion 786-8
pubmed: 12072630
Gut. 2017 Jan;66(1):50-58
pubmed: 26475633
Inflamm Intest Dis. 2019 May;4(1):1-6
pubmed: 31172007
BMJ. 2009 Jul 21;339:b2700
pubmed: 19622552
Inflamm Bowel Dis. 2007 Oct;13(10):1250-5
pubmed: 17567869
Scand J Gastroenterol. 2016 Sep;51(9):1087-92
pubmed: 27150635
Gut. 2017 Jan;66(1):43-49
pubmed: 26464414
Int J Colorectal Dis. 2020 Sep;35(9):1619-1628
pubmed: 32617664
J Crohns Colitis. 2013 May;7(4):e133-42
pubmed: 22922006
Gastrointest Endosc. 2018 Aug;88(2):360-369.e2
pubmed: 29660321
J Crohns Colitis. 2018 Jun 28;12(7):811-818
pubmed: 29617750
Scand J Gastroenterol. 2001 Nov;36(11):1179-84
pubmed: 11686218
Dis Colon Rectum. 2013 Jun;56(6):733-7
pubmed: 23652747
Scand J Gastroenterol. 2019 Feb;54(2):188-193
pubmed: 30739519
Ann Surg. 2013 Apr;257(4):679-85
pubmed: 23299522
Surg Today. 2016 Aug;46(8):939-49
pubmed: 26510664
Colorectal Dis. 2012 Apr;14(4):e181-6
pubmed: 21951549
Aliment Pharmacol Ther. 2002 Jan;16(1):27-34
pubmed: 11856075
Dig Dis Sci. 1994 Jun;39(6):1193-6
pubmed: 8200250
J Chronic Dis. 1985;38(1):27-36
pubmed: 3972947
Inflamm Bowel Dis. 2015 Mar;21(3):589-95
pubmed: 25659085
Inflamm Bowel Dis. 2001 Nov;7(4):301-5
pubmed: 11720319
Gastroenterology. 2001 Aug;121(2):261-7
pubmed: 11487535
Dis Colon Rectum. 2002 Oct;45(10):1289-94
pubmed: 12394424
Scand J Gastroenterol. 2009;44(4):431-40
pubmed: 19101844
Br J Surg. 2000 Jun;87(6):808-13
pubmed: 10848863
Scand J Gastroenterol. 2016;51(2):211-7
pubmed: 26359672
Am J Gastroenterol. 2015 Jun;110(6):881-7
pubmed: 25916224
BMJ. 2009 Jul 21;339:b2535
pubmed: 19622551
Dis Colon Rectum. 2003 Jun;46(6):748-53
pubmed: 12794576
Eur J Gastroenterol Hepatol. 2008 Mar;20(3):174-9
pubmed: 18301296
Gastroenterology. 2003 May;124(5):1202-9
pubmed: 12730861
Inflamm Bowel Dis. 2010 Oct;16(10):1678-84
pubmed: 20186934
Br J Surg. 1998 Jun;85(6):800-3
pubmed: 9667712
Surg Today. 2009;39(11):962-8
pubmed: 19882318
Gastroenterology. 1994 Jul;107(1):3-11
pubmed: 8020674
Rev Esp Enferm Dig. 2016 Apr;108(4):190-5
pubmed: 26901424
Aliment Pharmacol Ther. 2017 Oct;46(8):748-757
pubmed: 28833287
Mayo Clin Proc. 1994 May;69(5):409-15
pubmed: 8170189
N Engl J Med. 1987 Dec 24;317(26):1625-9
pubmed: 3317057
Gastroenterology. 2000 Aug;119(2):305-9
pubmed: 10930365
Gut. 2004 Jan;53(1):108-14
pubmed: 14684584
Cochrane Database Syst Rev. 2019 Nov 30;11:CD001176
pubmed: 31785173
Inflamm Bowel Dis. 1998 Nov;4(4):280-4
pubmed: 9836080
Clin Gastroenterol Hepatol. 2014 May;12(5):831-837.e2
pubmed: 24075890