A systematic review of the measurement of endoscopic healing in ulcerative colitis clinical trials: recommendations and implications for future research
- Samaan, M. A., Mosli, M. H., Sandborn, W. J., Feagan, B. G., D'Haens, G. R., Dubcenco, E., Baker, K. A., and Levesque, B. G.
- BACKGROUND: Assessment of endoscopic disease activity, as measured by various endoscopic evaluative instruments, is an essential part of quantifying disease activity in clinical trials in patients with ulcerative colitis (UC). Evaluative instruments have specific definitions and operating properties that influence the interpretation of clinical trial results. Our objective was to systematically review all endoscopic evaluative instruments that measure endoscopic disease activity in UC and to describe their definitions and operating characteristics (reliability, responsiveness, and predictive validity).
METHODS: We performed a systematic review of evaluative instruments assessing endoscopic disease activity in UC. MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and Digestive Disease Week abstracts of clinical trials were searched from inception to January 2013.
RESULTS: In total, 5885 studies were identified and screened for inclusion criteria. Four hundred twenty-two studies involving 31 evaluative instruments were identified. Two types of indices were found, numerical scoring systems and stepwise grading scales.
CONCLUSIONS: Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for UC. Currently, the sigmoidoscopic component of the Mayo Score and the ulcerative colitis endoscopic index of severity show the most promise as reliable evaluative instruments of endoscopic disease activity. However, further validation is required.
- Inflamm Bowel Dis
- 1536-4844 (Electronic)
- Publication year:
- Biological and physiological variables:
- Biological and physiological variables
- Adults (18-65)
- Diseases of and symptoms related to the digestive system
- PRO / non-PRO:
- Non-patient Reported Outcome
- Type of measurement instrument:
- 6 - Clinical rating scales
7 - Observations
9 - Laboratory tests
- Baron Score
Blackstone endoscopic grading activity
EAI - Endoscopic Activity Index
ECCI - Endoscopic Clinical Correlation Index
Froslie endoscopic score
Mayo score (6 points)
McPhee proctoscopic grading scale
Modified Baron score
Osada Modified 6-point Activity Index
Sigmoidoscopic Inflammation Grade Score
Simple 5-point score
Sutherland index [alias DAI or UCDAI]
Truelove and Richards sigmoidoscopic appearance
Truelove and Witts sigmoidoscopic assessment
UCCIS - Ulcerative Colitis Colonoscopic Index of Severity