TY - JOUR
T1 - Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn's Disease Activity
AU - Solitano, Virginia
AU - Schaeffer, David F.
AU - Hogan, Malcolm
AU - Vande Casteele, Niels
AU - Pai, Rish K.
AU - Zou, Guangyong
AU - Pai, Reetesh K.
AU - Parker, Claire E.
AU - Rémillard, Julie
AU - Christensen, Britt
AU - Danese, Silvio
AU - Peyrin-Biroulet, Laurent
AU - Panaccione, Remo
AU - Sands, Bruce E.
AU - D'Haens, Geert
AU - Feagan, Brian G.
AU - Ma, Christopher
AU - Jairath, Vipul
N1 - Publisher Copyright:
© 2023 AGA Institute
PY - 2024
Y1 - 2024
N2 - Background & Aims: The operating properties of histologic indices for evaluating Crohn's disease (CD) activity are poorly characterized. We assessed the reliability and responsiveness of existing histologic indices/items used in CD and ulcerative colitis (UC), in addition to 3 novel items, and developed exploratory ileal, colonic, and colonic-ileal CD instruments. Methods: Blinded central readers independently reviewed paired baseline and week 12 image sets from the EXTEND trial. Disease activity was scored using 4 indices (the Global Histologic Activity Score, Geboes Score, Nancy Histological Index, and Robarts Histopathology Index) and 3 items identified by an expert panel (mucin depletion, basal plasmacytosis, and ileal pyloric gland metaplasia). Reliability and responsiveness were quantified using the intraclass correlation coefficient (ICC) and area under the receiver operating curve (AUC), respectively. Exploratory indices were developed using backward stepwise linear regression analysis. Candidate independent variables were items with an inter-rater ICC ≥0.40 and AUC ≥0.56. The dependent variable was histologic disease activity measured by a 100-mm visual analogue scale. Results: Paired image sets were available from 55 patients. Substantial to almost perfect inter-rater reliability (ICC, 0.63–0.87) and some responsiveness (AUC, 0.57–0.94) were observed for all existing indices regardless of whether individual colonic and ileal segments, combined colonic segments, or combined colonic and ileal segments were assessed and the calculation method used. Five items were tested as candidate items, and exploratory colonic, ileal, and colonic-ileal indices were developed. Conclusions: CD and UC indices were similarly reliable and responsive in measuring histologic CD activity. Exploratory index development did not offer benefit over current histologic instruments.
AB - Background & Aims: The operating properties of histologic indices for evaluating Crohn's disease (CD) activity are poorly characterized. We assessed the reliability and responsiveness of existing histologic indices/items used in CD and ulcerative colitis (UC), in addition to 3 novel items, and developed exploratory ileal, colonic, and colonic-ileal CD instruments. Methods: Blinded central readers independently reviewed paired baseline and week 12 image sets from the EXTEND trial. Disease activity was scored using 4 indices (the Global Histologic Activity Score, Geboes Score, Nancy Histological Index, and Robarts Histopathology Index) and 3 items identified by an expert panel (mucin depletion, basal plasmacytosis, and ileal pyloric gland metaplasia). Reliability and responsiveness were quantified using the intraclass correlation coefficient (ICC) and area under the receiver operating curve (AUC), respectively. Exploratory indices were developed using backward stepwise linear regression analysis. Candidate independent variables were items with an inter-rater ICC ≥0.40 and AUC ≥0.56. The dependent variable was histologic disease activity measured by a 100-mm visual analogue scale. Results: Paired image sets were available from 55 patients. Substantial to almost perfect inter-rater reliability (ICC, 0.63–0.87) and some responsiveness (AUC, 0.57–0.94) were observed for all existing indices regardless of whether individual colonic and ileal segments, combined colonic segments, or combined colonic and ileal segments were assessed and the calculation method used. Five items were tested as candidate items, and exploratory colonic, ileal, and colonic-ileal indices were developed. Conclusions: CD and UC indices were similarly reliable and responsive in measuring histologic CD activity. Exploratory index development did not offer benefit over current histologic instruments.
KW - Clinical Trials
KW - Inflammatory Bowel Diseases
KW - Pathology
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U2 - 10.1016/j.cgh.2023.11.032
DO - 10.1016/j.cgh.2023.11.032
M3 - Article
C2 - 38056798
AN - SCOPUS:85184046824
SN - 1542-3565
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
ER -