TY - JOUR
T1 - Development and External Validation of an Endoscopic and Histologic Pouchitis Assessment Tool
T2 - The Atlantic Pouchitis Index
AU - Sedano, Rocio
AU - Ma, Christopher
AU - Hogan, Malcolm
AU - Silverberg, Mark S.
AU - Zou, Guangyong
AU - D'Haens, Geert R.
AU - Rémillard, Julie
AU - Shackelton, Lisa M.
AU - McFarlane, Stefanie C.
AU - Bojic, Bozidar
AU - Bressler, Brian
AU - Rosenfeld, Gregory
AU - Feakins, Roger M.
AU - Kirsch, Richard
AU - Marchal, Aude
AU - Samaan, Mark A.
AU - Panaccione, Remo
AU - Hart, Ailsa
AU - Sands, Bruce E.
AU - Dotan, Iris
AU - Travis, Simon
AU - Feagan, Brian G.
AU - Jairath, Vipul
N1 - Publisher Copyright:
© 2025 The Author(s)
PY - 2025
Y1 - 2025
N2 - Background & Aims: No fully validated indices to measure pouchitis activity exist. We aimed to develop and externally validate a novel endoscopic and histologic index. Methods: Endoscopists and pathologists used 11 (4 endoscopic, 4 histologic, 3 composite) existing indices and items from a prior Research and Development/University of California Los Angeles appropriateness exercise to assess pouchitis disease activity in videos and images from 98 patients with chronic antibiotic-refractory pouchitis who participated in a randomized placebo-controlled alicaforsen trial. Reliability was assessed with the intraclass correlation coefficient (ICC). Responsiveness was quantified by the area under the receiver operating characteristic curve (AUROC). A novel index was developed using linear regression with a visual analog scale (VAS) of pouchitis endoscopic and histologic disease activity as the dependent variable and was externally validated with the EARNEST vedolizumab trial data. Results: The Atlantic Pouchitis Index (API) (range, 0–69) comprises the Simple Endoscopic Score for Crohn's Disease and Robarts Histopathology Index. The API exhibited almost perfect intra-rater (ICC, 0.88; 95% confidence interval [CI], 0.81–0.92) and substantial inter-rater reliability (ICC, 0.72; 95% CI, 0.60–0.79). A high degree of responsiveness (AUROC, 0.95; 95% CI, 0.89–0.98), greater than existing endoscopic indices (ΔAUROC, 0.09–0.24; P ≤ .005), was observed when the change criterion was a decrease in the VAS of one-half of the standard deviation. Good responsiveness was observed in external validation when vedolizumab was the change criterion (AUROC, 0.63; 95% CI, 0.51–0.73). Conclusion: Development and validation of the API advances pouchitis disease assessment. Integration of endoscopy and histopathology results in an objective, reliable, and responsive instrument to evaluate therapy effectiveness in research and clinical settings.
AB - Background & Aims: No fully validated indices to measure pouchitis activity exist. We aimed to develop and externally validate a novel endoscopic and histologic index. Methods: Endoscopists and pathologists used 11 (4 endoscopic, 4 histologic, 3 composite) existing indices and items from a prior Research and Development/University of California Los Angeles appropriateness exercise to assess pouchitis disease activity in videos and images from 98 patients with chronic antibiotic-refractory pouchitis who participated in a randomized placebo-controlled alicaforsen trial. Reliability was assessed with the intraclass correlation coefficient (ICC). Responsiveness was quantified by the area under the receiver operating characteristic curve (AUROC). A novel index was developed using linear regression with a visual analog scale (VAS) of pouchitis endoscopic and histologic disease activity as the dependent variable and was externally validated with the EARNEST vedolizumab trial data. Results: The Atlantic Pouchitis Index (API) (range, 0–69) comprises the Simple Endoscopic Score for Crohn's Disease and Robarts Histopathology Index. The API exhibited almost perfect intra-rater (ICC, 0.88; 95% confidence interval [CI], 0.81–0.92) and substantial inter-rater reliability (ICC, 0.72; 95% CI, 0.60–0.79). A high degree of responsiveness (AUROC, 0.95; 95% CI, 0.89–0.98), greater than existing endoscopic indices (ΔAUROC, 0.09–0.24; P ≤ .005), was observed when the change criterion was a decrease in the VAS of one-half of the standard deviation. Good responsiveness was observed in external validation when vedolizumab was the change criterion (AUROC, 0.63; 95% CI, 0.51–0.73). Conclusion: Development and validation of the API advances pouchitis disease assessment. Integration of endoscopy and histopathology results in an objective, reliable, and responsive instrument to evaluate therapy effectiveness in research and clinical settings.
KW - Endoscopy
KW - Histopathology
KW - Inflammatory Bowel Disease
KW - Pouchitis
UR - https://www.scopus.com/pages/publications/105013666414
U2 - 10.1016/j.cgh.2025.06.030
DO - 10.1016/j.cgh.2025.06.030
M3 - Article
C2 - 40675404
SN - 1542-3565
JO - Clinical gastroenterology and hepatology
JF - Clinical gastroenterology and hepatology
ER -