Rocio Sedano1,2, Tran M Nguyen2, Ahmed Almradi1,2, Florian Rieder3,4, Claire E Parker2, Lisa M Shackelton2, Geert D'Haens2,5, William J Sandborn2,6, Brian G Feagan1,2,7, Christopher Ma2,8, Vipul Jairath1,2,7. 1. Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada. 2. Alimentiv Inc., London, Ontario, Canada. 3. Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA. 4. Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA. 5. Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, the Netherlands. 6. Division of Gastroenterology, University of California, San Diego, La Jolla, California, USA. 7. Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada. 8. Division of Gastroenterology and Hepatology, Cumming School of Medicine, Departments of Medicine & Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
Abstract
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.
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.
Authors: Carlo F M Welters; Erik Heineman; Frederik B J M Thunnissen; Anthony E J M van den Bogaard; Peter B Soeters; Cor G M I Baeten Journal: Dis Colon Rectum Date: 2002-05 Impact factor: 4.585
Authors: Mahmoud H Mosli; Brian G Feagan; Guangyong Zou; William J Sandborn; Geert D'Haens; Reena Khanna; Lisa M Shackelton; Christopher W Walker; Sigrid Nelson; Margaret K Vandervoort; Valerie Frisbie; Mark A Samaan; Vipul Jairath; David K Driman; Karel Geboes; Mark A Valasek; Rish K Pai; Gregory Y Lauwers; Robert Riddell; Larry W Stitt; Barrett G Levesque Journal: Gut Date: 2015-10-16 Impact factor: 23.059
Authors: Klaudia Farkas; Zoltán Saródi; Anita Bálint; Imre Földesi; László Tiszlavicz; Mónika Szűcs; Tibor Nyári; János Tajti; Ferenc Nagy; Zoltán Szepes; Renáta Bor; Anita Annaházi; Richárd Róka; Tamás Molnár Journal: J Crohns Colitis Date: 2015-01-12 Impact factor: 9.071
Authors: W J Tremaine; W J Sandborn; B G Wolff; H A Carpenter; A R Zinsmeister; P P Metzger Journal: Aliment Pharmacol Ther Date: 1997-12 Impact factor: 8.171
Authors: Penny F Whiting; Anne W S Rutjes; Marie E Westwood; Susan Mallett; Jonathan J Deeks; Johannes B Reitsma; Mariska M G Leeflang; Jonathan A C Sterne; Patrick M M Bossuyt Journal: Ann Intern Med Date: 2011-10-18 Impact factor: 25.391