Development and Testing of a New Simplified Endoscopic Mucosal Assessment for Crohn’s Disease: The SEMA-CD

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.

The Pediatric Crohn Disease Morbidity Index (PCD-MI): Development of a Tool to Assess Long-Term Disease Burden Using a Data-Driven Approach

“…We have also focused on pediatric-onset patients; however, with minor adjustments this score could be utilized as an adult CD morbidity index. The future inclusion of standardized measures of disease extent through endoscopic, histological, and radiological tools would also be desirable ( 29 , 30 ). To date, the retrospective scoring of these tools and the lack of standardization of repeating radiological or endoscopic investigations was too limited to include in this iteration; however, as electronic data capture improves then we would envisage these tools being incorporated into PCD-MI.…”

Precise infliximab exposure and pharmacodynamic control to achieve deep remission in paediatric Crohn’s disease (REMODEL-CD): study protocol for a multicentre, open-label, pragmatic clinical trial in the USA

“…As noted, EH is assessed by the SES-CD, while the Simplified Endoscopic Mucosal Assessment for CD (SEMA-CD) will be scored as an exploratory measure. 16 17 Deep remission has been chosen as the primary endpoint as it was identified as a major long-term therapeutic goal by the STRIDE-II consortium. 18 Key secondary endpoints ( table 2 ) will also include assessments of immunogenicity (ATI), patient-reported outcomes (PRO), quality of life assessments 19–21 and growth restoration in Tanner I–III children consistent with other key STRIDE-II outcome measures.…”

Machine and deep learning in inflammatory bowel disease

“…As target treatment outcomes have evolved over time for IBD, several indices for scoring the severity of inflammation on endoscopy have been developed [16][17][18][19][20]; however, these metrics have not been widely adopted and require clinicians to manually calculate the scores [21]. Several studies have investigated the use of machine learning models to score bowel inflammation severity -particularly in ulcerative colitis -using traditional endoscopy images and video as well as capsule endoscopy footage [22,23,24 & ,25].…”