Mahmoud H Mosli1,2,3, Brian G Feagan1,2,4, Guangyong Zou1,4, William J Sandborn1,5, Geert D'Haens1,6, Reena Khanna1,2, Lisa M Shackelton1, Christopher W Walker1, Sigrid Nelson1, Margaret K Vandervoort1, Valerie Frisbie1, Mark A Samaan1, Vipul Jairath1,7,8, David K Driman9, Karel Geboes10, Mark A Valasek11, Rish K Pai12, Gregory Y Lauwers13,14, Robert Riddell15, Larry W Stitt1,4, Barrett G Levesque1,5. 1. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada. 2. Department of Medicine, University of Western Ontario, London, Ontario, Canada. 3. Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia. 4. Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. 5. Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA. 6. Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands. 7. Nuffield Department of Medicine, University of Oxford, Oxford, UK. 8. Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK. 9. Department of Pathology, University of Western Ontario, London, Ontario, Canada. 10. Department of Pathology, University Hospital of KU Leuven and UZ Gent, Leuven, Belgium. 11. Department of Pathology, University of California, San Diego, USA. 12. Department of Laboratory Medicine and Pathology, Mayo Clinic Arizona, Scottsdale, USA. 13. Massachusetss General Hospital, Boston, USA. 14. Department of Pathology, Harvard Medical School, Boston, USA. 15. Department of Pathology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
Abstract
OBJECTIVE: Although the Geboes score (GS) and modified Riley score (MRS) are commonly used to evaluate histological disease activity in UC, their operating properties are unknown. Accordingly, we developed an alternative instrument. DESIGN: Four pathologists scored 48 UC colon biopsies using the GS, MRS and a visual analogue scale global rating. Intra-rater and inter-rater reliability for each index and individual index items were measured using intraclass correlation coefficients (ICCs). Items with high reliability were used to develop the Robarts histopathology index (RHI). The responsiveness/validity of the RHI and multiple histological, endoscopic and clinical outcome measures were evaluated by analyses of change scores, standardised effect size (SES) and Guyatt's responsiveness statistic (GRS) using data from a clinical trial of an effective therapy. RESULTS: Inter-rater ICCs (95% CIs) for the total GS and MRS scores were 0.79 (0.63 to 0.87) and 0.80 (0.69 to 0.87). The correlation estimates between change scores in RHI and change score in GS and MRS were 0.75 (0.67 to 0.82) and 0.84 (0.79 to 0.88), respectively. The SES and GRS estimates for GS, MRS and RHI were: 1.87 (1.54 to 2.20) and 1.23 (0.97 to 1.50), 1.29 (1.02 to 1.56) and 0.88 (0.65 to 1.12), and 1.05 (0.79 to 1.30) and 0.88 (0.64 to 1.12), respectively. CONCLUSIONS: The RHI is a new histopathological index with favourable operating properties. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
OBJECTIVE: Although the Geboes score (GS) and modified Riley score (MRS) are commonly used to evaluate histological disease activity in UC, their operating properties are unknown. Accordingly, we developed an alternative instrument. DESIGN: Four pathologists scored 48 UC colon biopsies using the GS, MRS and a visual analogue scale global rating. Intra-rater and inter-rater reliability for each index and individual index items were measured using intraclass correlation coefficients (ICCs). Items with high reliability were used to develop the Robarts histopathology index (RHI). The responsiveness/validity of the RHI and multiple histological, endoscopic and clinical outcome measures were evaluated by analyses of change scores, standardised effect size (SES) and Guyatt's responsiveness statistic (GRS) using data from a clinical trial of an effective therapy. RESULTS: Inter-rater ICCs (95% CIs) for the total GS and MRS scores were 0.79 (0.63 to 0.87) and 0.80 (0.69 to 0.87). The correlation estimates between change scores in RHI and change score in GS and MRS were 0.75 (0.67 to 0.82) and 0.84 (0.79 to 0.88), respectively. The SES and GRS estimates for GS, MRS and RHI were: 1.87 (1.54 to 2.20) and 1.23 (0.97 to 1.50), 1.29 (1.02 to 1.56) and 0.88 (0.65 to 1.12), and 1.05 (0.79 to 1.30) and 0.88 (0.64 to 1.12), respectively. CONCLUSIONS: The RHI is a new histopathological index with favourable operating properties. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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