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Original article
Development and validation of a histological index for UC
  1. Mahmoud H Mosli1,2,3,
  2. Brian G Feagan1,2,4,
  3. Guangyong Zou1,4,
  4. William J Sandborn1,5,
  5. Geert D'Haens1,6,
  6. Reena Khanna1,2,
  7. Lisa M Shackelton1,
  8. Christopher W Walker1,
  9. Sigrid Nelson1,
  10. Margaret K Vandervoort1,
  11. Valerie Frisbie1,
  12. Mark A Samaan1,
  13. Vipul Jairath1,7,8,
  14. David K Driman9,
  15. Karel Geboes10,
  16. Mark A Valasek11,
  17. Rish K Pai12,
  18. Gregory Y Lauwers13,14,
  19. Robert Riddell15,
  20. Larry W Stitt1,4,
  21. Barrett G Levesque1,5
  1. 1Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
  2. 2Department of Medicine, University of Western Ontario, London, Ontario, Canada
  3. 3Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
  4. 4Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada
  5. 5Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA
  6. 6Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands
  7. 7Nuffield Department of Medicine, University of Oxford, Oxford, UK
  8. 8Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK
  9. 9Department of Pathology, University of Western Ontario, London, Ontario, Canada
  10. 10Department of Pathology, University Hospital of KU Leuven and UZ Gent, Leuven, Belgium
  11. 11Department of Pathology, University of California, San Diego, USA
  12. 12Department of Laboratory Medicine and Pathology, Mayo Clinic Arizona, Scottsdale, USA
  13. 13Massachusetss General Hospital, Boston, USA
  14. 14Department of Pathology, Harvard Medical School, Boston, USA
  15. 15Department of Pathology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Barrett G Levesque, Division of Gastroenterology, University of California, San Diego, 9500 Gilman Dr., La Jolla, CA 92093, USA; bglevesque{at}ucsd.edu

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.

  • ULCERATIVE COLITIS
  • HISTOPATHOLOGY

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