Pieter Hindryckx1, Vipul Jairath2, Guangyong Zou3, Brian G Feagan4, William J Sandborn5, Jaap Stoker6, Reena Khanna7, Larry Stitt3, Tanja van Viegen8, Lisa M Shackelton8, Stuart A Taylor9, Cynthia Santillan10, Banafsche Mearadji6, Geert D'Haens11, Marie-Paule Richard12, Julian Panes13, Jordi Rimola14. 1. Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Gastroenterology, University of Ghent, Ghent, Belgium. 2. Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, University of Western Ontario, London, Ontario, Canada; Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. Electronic address: vjairath@uwo.ca. 3. Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. 4. Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, University of Western Ontario, London, Ontario, Canada; Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. 5. Robarts Clinical Trials, Inc, London, Ontario, Canada; Division of Gastroenterology, University of California San Diego, La Jolla, California. 6. Department of Radiology and Nuclear Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. 7. Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, University of Western Ontario, London, Ontario, Canada. 8. Robarts Clinical Trials, Inc, London, Ontario, Canada. 9. Centre for Medical Imaging, University College London, London, UK. 10. Department of Radiology, University of California San Diego, La Jolla, California. 11. Robarts Clinical Trials, Inc, London, Ontario, Canada; Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, The Netherlands. 12. Tigenix, SAU, Madrid, Spain. 13. Department of Gastroenterology, Hospital Clínic de Barcelona, The August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Barcelona, Spain. 14. Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain.
Abstract
BACKGROUND & AIMS: There is no validated magnetic resonance imaging (MRI) index for assessment of perianal fistulas in patients with Crohn's disease (CD). We developed and internally validated a new instrument. METHODS: We used paired baseline and week-24 MRI scans from 160 participants in a randomized placebo-controlled trial of stem cell therapy for patients with perianal fistulizing CD. Four radiologists scored disease activity using index items identified during previous studies and exploratory items. Reliability was assessed using intraclass correlation coefficients. We developed an index using backward elimination linear regression analysis, in which potential independent variables were items having intraclass correlation coefficients of at least 0.4 and the dependent variable was perianal fistulizing disease activity, measured on a 100-mm visual analogue scale. The final model was internally validated using the .632 bootstrap method to correct model optimism and quantify calibration accuracy. We evaluated responsiveness of the index by assessing longitudinal validity and estimating standardized effect sizes. RESULTS: We developed the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD) using 6 items. The optimism-corrected R2 of the model was 0.71, which was comparable to R2 for the original sample (0.74). The calibration slope for the model was 0.98. Compared with the original and modified versions of the Van Assche Index, the MAGNIFI-CD had improved operating characteristics. Estimates of intraclass correlation coefficients for MAGNIFI-CD, the modified Van Assche Index, and Van Assche Index were 0.85 (95% confidence interval [CI], 0.77-0.90), 0.81 (95% CI, 0.74-0.86), and 0.81 (95% CI, 0.71-0.86) for intra-rater reliability, and 0.74 (95% CI, 0.63-0.80), 0.67 (95% CI, 0.55-0.75) and 0.68 (95% CI, 0.56-0.77) for inter-rater reliability. Corresponding standardized effect size estimates were 1.02 (95% CI, 0.65-1.39), 0.84 (95% CI, 0.48-1.21), and 0.68 (95% CI, 0.33-1.03). CONCLUSIONS: We developed an index called the MAGNIFI-CD, which is based on 6 items. It assesses MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to previous indices. This index may be used as an outcome measure in clinical trials comparing treatment effects in patients with perianal fistulizing CD. Although the performance of the MAGNIFI-CD indicates its stability and reasonable external validity, external validation is needed.
BACKGROUND & AIMS: There is no validated magnetic resonance imaging (MRI) index for assessment of perianal fistulas in patients with Crohn's disease (CD). We developed and internally validated a new instrument. METHODS: We used paired baseline and week-24 MRI scans from 160 participants in a randomized placebo-controlled trial of stem cell therapy for patients with perianal fistulizing CD. Four radiologists scored disease activity using index items identified during previous studies and exploratory items. Reliability was assessed using intraclass correlation coefficients. We developed an index using backward elimination linear regression analysis, in which potential independent variables were items having intraclass correlation coefficients of at least 0.4 and the dependent variable was perianal fistulizing disease activity, measured on a 100-mm visual analogue scale. The final model was internally validated using the .632 bootstrap method to correct model optimism and quantify calibration accuracy. We evaluated responsiveness of the index by assessing longitudinal validity and estimating standardized effect sizes. RESULTS: We developed the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD) using 6 items. The optimism-corrected R2 of the model was 0.71, which was comparable to R2 for the original sample (0.74). The calibration slope for the model was 0.98. Compared with the original and modified versions of the Van Assche Index, the MAGNIFI-CD had improved operating characteristics. Estimates of intraclass correlation coefficients for MAGNIFI-CD, the modified Van Assche Index, and Van Assche Index were 0.85 (95% confidence interval [CI], 0.77-0.90), 0.81 (95% CI, 0.74-0.86), and 0.81 (95% CI, 0.71-0.86) for intra-rater reliability, and 0.74 (95% CI, 0.63-0.80), 0.67 (95% CI, 0.55-0.75) and 0.68 (95% CI, 0.56-0.77) for inter-rater reliability. Corresponding standardized effect size estimates were 1.02 (95% CI, 0.65-1.39), 0.84 (95% CI, 0.48-1.21), and 0.68 (95% CI, 0.33-1.03). CONCLUSIONS: We developed an index called the MAGNIFI-CD, which is based on 6 items. It assesses MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to previous indices. This index may be used as an outcome measure in clinical trials comparing treatment effects in patients with perianal fistulizing CD. Although the performance of the MAGNIFI-CD indicates its stability and reasonable external validity, external validation is needed.
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