Original Article
Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD

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Background

Healing of mucosal lesions appears to offer significant benefit and is an important end point in clinical trials of treatment for Crohn's disease. The only validated endoscopic activity score at present is the Crohn's Disease Endoscopic Index of Severity, which is complicated and time consuming and, hence, is unsuitable for routine use. The aim of this study was to develop and to prospectively validate a simpler endoscopic score of disease activity, the Simple Endoscopic Score for Crohn's Disease.

Methods

Selected endoscopic parameters (ulcer size, ulcerated and affected surfaces, stenosis) were scored from 0 to 3. Reproducibility for scoring of these parameters was evaluated through 71 examinations in which the endoscopist was paired with an observer. The simplest score (Simple Endoscopic Score for Crohn's Disease) that was highly correlated with both the Crohn's Disease Endoscopic Index of Severity and Crohn's Disease Activity Index was derived for 70 patients and then was prospectively validated in 121 different patients with Crohn's disease.

Results

The interobserver agreement for all selected endoscopic variables was excellent (kappa coefficient 0.791-1.000). Based on multiple linear regression, the Simple Endoscopic Score for Crohn's Disease resulted in the sum of the scores for ulcer size, ulcerated surface, affected surface, and luminal narrowing. In the validation phase of the study, a strong correlation was demonstrated for the Simple Endoscopic Score for Crohn's Disease with Crohn's Disease Endoscopic Index of Severity (r = 0.920). In addition, the Simple Endoscopic Score for Crohn's Disease was correlated to clinical parameters and serum C-reactive protein level.

Conclusions

Simple Endoscopic Score for Crohn's Disease is a simple, reproducible, and easy-to-use endoscopic scoring system for Crohn's disease.

Section snippets

Patients and methods

The study was divided into 4 parts. In the first part, the most relevant endoscopic variables were selected and their reproducibility level was evaluated in an interobserver variation study. For the second part, the development phase, an endoscopic score was derived from the selected endoscopic variables and further simplified (the SES-CD) to obtain a score that was still highly correlated to the CDEIS but was simpler and easier to calculate. In the third part, the validation phase, a set of

Patient characteristics

The clinical characteristics of the patients are described in Table 2 for patients included in the development phase, those of the validation set, and for the entire sample. There was no significant difference in clinical characteristics among the patients by center or between patients in both phases of the study.

Selection of parameters and reproducibility levels

The items included in the SES-CD were the result of a careful review of the GETAID studies with regard to the importance and the reproducibility of the most relevant endoscopic

Discussion

The assessment of mucosal involvement in patients with Crohn's disease in an objective and a reliable way is an important issue for clinicians who care for patients with this disease. Endoscopy is by far the best and the most widely used modality for assessment of the extent and the severity of Crohn's disease in the terminal ileum and the colon; it is markedly superiority to barium contrast radiography.13 Although earlier studies have clearly demonstrated that mucosal healing is not predictive

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Preliminary data of this study were presented as posters at Digestive Diseases Week, May 19-23, 2002, San Francisco, California (Gastroenterology 2002;122:S1376), and Digestive Diseases Week, May 18-21, 2003, Orlando, Florida, and as an oral presentation at United European Gastroenterology Week 2002, October, 2002, Geneva, Switzerland (Gut 2002;51(Suppl III):A56).

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