COSMIN database

A systematic review of the measurement of endoscopic healing in ulcerative colitis clinical trials: recommendations and implications for future research

Authors:
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.
Abstract:
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.
DOI:
10.1097/MIB.0000000000000046
URL:
https://www.ncbi.nlm.nih.gov/pubmed/24831558
Journal:
Inflamm Bowel Dis
issn:
1536-4844 (Electronic)
Publication year:
2014
pages:
1465-71
Biological and physiological variables:
Biological and physiological variables
Age:
Adults (18-65)
Children (0-18)
Seniors (65+)
Disease:
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
Instrument:
Baron Score
Beattie score
Binder Scale
Blackstone endoscopic grading activity
Carbonnel score
Danielsson-Löfberg score
Dick Score
EAI - Endoscopic Activity Index
ECCI - Endoscopic Clinical Correlation Index
Endoscopic Index
Friedmann Score
Froslie endoscopic score
Lindgren score
Maier Scale
Matts Score
Mayo score (6 points)
McPhee proctoscopic grading scale
Modified Baron score
Osada Modified 6-point Activity Index
Powell-Tuck Index
Saverymuttu Index
Sigmoidoscopic grade
Sigmoidoscopic 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