Format

Send to

Choose Destination
J Crohns Colitis. 2014 Apr;8(4):318-25. doi: 10.1016/j.crohns.2013.09.010. Epub 2013 Oct 10.

Comparing disease activity indices in ulcerative colitis.

Author information

1
Currently at Department of Gastroenterology, St Vincent's Hospital, Sydney, Australia.
2
Medical Sciences Division, University of Oxford, Oxford, UK.
3
Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK.
4
Currently at Department of Surgery, Universitas Hospital, University of the Free State, Bloemfontein, South Africa.
5
Currently at Department of Gastroenterology, Princess Alexandra Hospital, Brisbane, Australia.
6
Currently at Department of Biomedical Sciences, University of Sheffield, Sheffield, UK.
7
Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
8
Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK. Electronic address: simon.travis@ndm.ox.ac.uk.

Abstract

BACKGROUND:

Comparisons between disease activity indices for ulcerative colitis (UC) are few. This study evaluates three indices, to determine the potential impact of inter-observer variation on clinical trial recruitment or outcome as well as their clinical relevance.

METHODS:

One hundred patients with UC were prospectively evaluated, each by four specialists, followed by videosigmoidoscopy, which was later scored by each specialist. The Simple Clinical Colitis Activity (SCCAI), Mayo Clinic and Seo indices were compared by assigning a disease activity category from published thresholds for remission, mild, moderate and severe activity. Inter-observer variation was evaluated using Kappa statistics and its effect for each patient on recruitment and outcome measures for representative clinical trials calculated. Clinical relevance was assessed by comparing an independently assigned clinical category, taking all information into account as if in clinic, with the disease activity assigned by the indices.

RESULTS:

Inter-observer agreement for SCCAI (κ=0.75, 95% CI 0.70-0.81), Mayo Clinic (κ=0.72, 95% CI 0.67-0.78) and Seo (κ=0.89, 95% CI 0.83-0.95) indices was good or very good as was the agreement for rectal bleeding (κ=0.77) and stool frequency (κ=0.90). Endoscopy in the Mayo Clinic index had the greatest variation (κ=0.38). Inter-observer variation alone would have excluded up to 1 in 5 patients from recruitment or remission criteria in representative trials. Categorisation by the SCCAI, Mayo Clinic and Seo indices agreed with the independently assigned clinical category in 61%, 67% and 47% of cases respectively.

CONCLUSIONS:

Trial recruitment and outcome measures are affected by inter-observer variation in UC activity indices, and endoscopic scoring was the component most susceptible to variation.

KEYWORDS:

Activity index; Clinical trial design; Endoscopy; Mayo Clinic index; Ulcerative colitis

PMID:
24120021
DOI:
10.1016/j.crohns.2013.09.010
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center