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Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease.

Author information

Affiliations

  • 1. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Medicine, University of Western Ontario, London, Ontario, Canada.
      Authors
    • Khanna R 1
    (1 author)
  • 2. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada.
      Authors
    • Zou G 2
    (1 author)
  • 3. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, The Netherlands.
      Authors
    • D'Haens G 3
    (1 author)
  • 4. Department of Gastroenterology, University Hospital, Gasthuisberg, Leuven, Belgium.
      Authors
    • Rutgeerts P 4
    (1 author)
  • 5. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
      Authors
    • McDonald JW 5
    • Dubcenco E 5
    • Stitt L 5
    • Vandervoort MK 5
    • Donner A 5
    (5 authors)
    • Show all (9)

ORCIDs linked to this article

Gut, 02 May 2015, 65(7):1119-1125
https://doi.org/10.1136/gutjnl-2014-308973 PMID: 25935574 

Abstract 

Objective

The Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn's Disease (SES-CD) are commonly used to assess Crohn's disease (CD) activity; however, neither instrument has been fully validated. We assessed intra-rater and inter-rater reliability of these indices.

Design

Video recordings of colonoscopies obtained from 50 patients with CD who participated in an induction trial of a biological therapy were triplicated and reviewed in random order by four central readers. Data were used to assess intra-rater and inter-rater reliability for CDEIS, SES-CD and a global evaluation of lesion severity (GELS). Subsequently, readers participated in a consensus process that identified common sources of disagreement.

Results

Intraclass correlation coefficients (ICCs) for intra-rater reliability for CDEIS, SES-CD and GELS (95% CIs) were 0.89 (0.86 to 0.93), 0.91 (0.89 to 0.95) and 0.81 (0.77 to 0.89), respectively, with standard error of measurement (SEM) of 2.10, 2.42 and 1.15. The corresponding ICCs for inter-rater reliability were 0.71 (0.63 to 0.76), 0.83 (0.75 to 0.88) and 0.62 (0.52 to 0.70), with SEM of 3.42, 3.07 and 1.63, respectively. Correlation between CDEIS and GELS was 0.75, between SES-CD and GELS was 0.74 and between CDEIS and SES-CD was 0.92. The most common sources of disagreement were interpretation of superficial ulceration, definition of disease site at the ileocolonic anastomosis, assessment of anorectal lesions and grading severity of stenosis.

Conclusions

Central reading of CDEIS and SES-CD had 'substantial' to 'almost perfect' intra-rater and inter-rater reliability; however, the responsiveness of these instruments is yet to be determined.

Trial registration number

Clinicaltrials.gov NCT01466374.

Full text links 

Read article at publisher's site: https://doi.org/10.1136/gutjnl-2014-308973

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