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Abstract
Objectives
Endoscopic mucosal improvement is the gold standard for assessing treatment efficacy in clinical trials of Crohn’s disease. Current endoscopic indices are not routinely used in clinical practice. The lack of endoscopic information in large clinical registries limits their use for research. A quick, easy, and accurate method is needed for assessing mucosal improvement for clinicians in real-world practice. We developed and tested a novel simplified endoscopic mucosal assessment for Crohn’s disease (SEMA-CD).
Methods
We developed a 5-point scale for ranking endoscopic severity of ileum and colon based on Simple Endoscopic Score for Crohn’s disease (SES-CD). Central readers were trained to perform SES-CD and SEMA-CD. Pediatric patients with Crohn’s disease undergoing colonoscopy were enrolled. Video recordings of colonoscopies were de-identified and randomly assigned to blinded central readers. The SES-CD and SEMA-CD were scored for each video. The SES-CD was considered the validated standard for comparison. Correlation was assessed with Spearman rho, inter- and intrarater reliability with kappa statistics.
Results
Fifty-seven colonoscopies were read a total of 212 times. Correlation between SEMA-CD and SES-CD was strong (rho = 0.98, P < 0.0001). Inter-rater reliability for SEMA-CD was 0.80, and intrarater reliability was 0.83. Central readers rated SEMA-CD as easier than SES-CD.
Conclusion
The SEMA-CD accurately and reproducibly correlates with the standard SES-CD. Central readers viewed SEMA-CD as easier than SES-CD. Use of SEMA-CD in practice should enable collecting mucosal improvement information in large populations of patients. This will improve the quality of research that can be conducted in clinical registries. External validation is needed.
Details
; Eder, Sally J 2 ; Acham Gebremariam 2 ; Kelley Rose French 3 ; Moncion, Ila 3 ; Singer, Andrew A M 3 ; Bass, Lee M 4 ; Moran, Christopher J 5 ; Picoraro, Joseph A 6 ; Moses, Jonathan 7 ; Lewis, Jeffery D 8 ; Sandberg, Kelly C 9 ; Mar, Shuemein J 3 ; Ebach, Dawn R 10 ; Saeed, Shehzad A 9 ; Rosh, Joel R 11 ; Neef, Haley C 3 ; Kaplan, Jess L 5 ; Goyal, Alka 12 ; del Rosario, J Fernando 13 ; Zacur, George M 3 1 Division of Pediatric Gastroenterology, C.S. Mott Children’s Hospital, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA; Susan B. Meister Child Health Evaluation and Research Center, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA
2 Susan B. Meister Child Health Evaluation and Research Center, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA
3 Division of Pediatric Gastroenterology, C.S. Mott Children’s Hospital, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA
4 Ann & Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
5 MassGeneral Hospital for Children, Harvard Medical School, Boston, MA, USA
6 Columbia University Irving Medical Center, New York, NY, USA
7 Rainbow Babies & Children’s Hospital, Cleveland, OH, USA
8 GI Care for Kids, Atlanta, GA, USA
9 Dayton Children’s Hospital, Wright State University, Dayton, OH, USA
10 University of Iowa Stead Family Children’s Hospital, Iowa City, IA, USA
11 Goryeb Children’s Hospital/Atlantic Health, Morristown, NJ, USA
12 Children’s Mercy Kansas City, University of Missouri, Kansas City, MO, USA
13 Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE, USA