Quantification of Mucosal Activity from Colonoscopy Reports via the Simplified Endoscopic Mucosal Assessment for Crohn’s Disease (SEMA-CD)

Project start and end dates: 10/1/2020 to 4/30/2022

Background:
Mucosal healing is increasingly recognized as the gold standard for assessing treatment efficacy in Crohn’s disease (CD). We have recently developed a novel simplified endoscopic mucosal assessment for Crohn’s disease (SEMA-CD), the first endoscopic score developed for pediatric CD and the first designed to be used by clinicians (see recent publication). This score uses a simple Likert-like scale to rate the severity of mucosal involvement in the ileum and colon.  We propose to assess the accuracy of the SEMA-CD for scoring colonoscopy reports by evaluating SEMA-CD applied to the colonoscopy report in comparison to SEMA-CD and the simplified endoscopic score for Crohn’s disease (SES-CD) scoring of video recorded colonoscopy among pediatric patients with CD. The SEMA-CD applied to endoscopy reports will enable recording of colonoscopic assessment of mucosal disease activity in large clinical IBD registries.

Objectives:

• Aim 1. To determine the association between SEMA-CD applied to endoscopy report and both SEMA-CD and SES-CD scores applied to colonoscopy videos.
• Aim 2. To determine the inter- and intra-rater reliability of the SEMA-CD applied to endoscopy report.

Research Topics & Methods:
The study proposes to build on our previous SEMA-CD study to use the video recordings of colonoscopies from pediatric patients with CD who underwent colonoscopy for clinical indications. In the previous study, video recordings of colonoscopies were de-identified and evaluated by central readers who scored each video for SES-CD and PGA-CS. For the current study, colonoscopy reports from the same patients will be redacted. Central readers, blinded to the video scores and clinical information, will be randomly assigned colonoscopy reports for scoring. Correlation between SEMA-CD score of colonoscopy reports and both SEMA-CD and SES-CD scores of colonoscopy videos will be compared, and inter-rater reliability will be assessed.

Implications:
This study is important and innovative because, once validated, the SEMA-CD will provide a reliable measure of mucosal improvement that can be determined from colonoscopy reports routinely documented in practice. If successful, we expect the SEMA-CD to have a positive impact by facilitating the inclusion of routine colonoscopic evaluations into prospectively maintained clinical registries, and by providing an easy method for assessing mucosal improvement as an outcome measure in pragmatic trials, both of which will improve the quality of data for informing the clinical care of pediatric patients with Crohn’s disease.

Funders:

• Janssen Research & Development, LLC. through an agreement with the ImproveCareNow Network
• Pediatric Resource Organization for Kids with Inflammatory Intestinal Diseases (PRO-KIIDS)

Collaborators:
Acham Gebremariam; Sally J. Eder;Chrostopher J. Moran; Lee M. Bass; Jonathan Moses; Jeffery D. Lewis; Andrew A. M. Singer; Tina L. Morhardt; Joseph A. Picoraro; Vanessa Cardenas; George Zacur; Richard Colletti

Related Publications:

Adler J, Colletti RB, Noonan L, Berzin TM, Cheifetz AS, Conklin LS, Hoops TC, Huang CS, Lewis B, Mishkin DS, Hung Lo K, Xiao Y, Volger S.
Validating the Simplified Endoscopic Mucosal Assessment for Crohn's Disease: A Novel Method for Assessing Disease Activity.
Inflamm Bowel Dis. 2022 Sep 1:izac183. doi: 10.1093/ibd/izac183. Epub ahead of print. PMID: 36049024.

Adler J, Eder SJ, Gebremariam A, Moran CJ, Bass LM, Moses J, Lewis JD, Singer AAM, Morhardt TL, Picoraro JA, Cardenas V, Zacur GM, Colletti RB.
Quantification of Mucosal Activity from Colonoscopy Reports via the Simplified Endoscopic Mucosal Assessment for Crohn's Disease.
Inflamm Bowel Dis. 2022 Oct 3;28(10):1537-1542. doi: 10.1093/ibd/izab315. PMID: 34964861.

Adler J, Eder SJ, Gebremariam A, French KR, Moncion I, Singer AAM, Bass LM, Moran CJ, Picoraro JA, Moses J, Lewis JD, Sandberg KC, Mar SJ, Ebach DR, Saeed SA, Rosh JR, Neef HC, Kaplan JL, Goyal A, Del Rosario JF, Zacur GM.
Development and Testing of a New Simplified Endoscopic Mucosal Assessment for Crohn's Disease: The SEMA-CD.
Inflamm Bowel Dis. 2021 Oct 18;27(10):1585-1592. doi: 10.1093/ibd/izaa307. PMID: 33382069.