Q UALITY R EPORTING F OR C OLONOSCOPY I N IBD Gil Y. Melmed, MD, MS Cedars-Sinai Medical Center CCFA Advances in IBD Orlando, FL December 2014

Disclosure I disclose the following financial relationships with commercial entities that produce health care–related products or services relevant to the content I am planning, developing, or presenting: Consultant: Amgen, AbbVie, Celgene, Given Imaging, Janssen, Luitpold, Takeda, UCB Research funding: Pfizer, Shire, Prometheus Clinical trial investigator: AbbVie, Amgen, Celgene, Given Imaging, Hutchison Pharma, Janssen, Pfizer, Takeda Gil Y. Melmed, MD, MS

Overview Why are we discussing this? – Variation – Mucosal healing What is a high quality endoscopy report? What can we start doing on Monday to improve the quality of endoscopy reporting?

What is the purpose of an endoscopy procedure report? What was done – Type of procedure, interventions, biopsies Why was it done – Indication for procedure How was it done – Scope, distance, biopsies – Standardized mucosal description – Perianal description IBD needs more! – Pre-procedure Disease phenotype Current medications Last procedure – Intraprocedure: Mucosal inflammation and healing Disease extent – Postprocedure Implications Next steps

Improving the Quality of Endoscopy Reporting in IBD Recommended elements to be included in colonoscopy reports have been proposed by societies, but primarily in the context of colon cancer screening. 1,2 There is little literature and no consensus on what elements constitute a high quality procedure report for patients with IBD 1 Rex et al Gastroint Endos Armstrong Can J Gastro 2012

Quality Reporting for Colonoscopy (not just IBD)

Generic Quality Indicators: Indication for Procedure Indication for Procedure – Is the procedure indication appropriate? Up to 40% of endoscopic procedures may be inappropriate – Justify! Disease monitoring Dysplasia surveillance Exclude infection Assess disease extent Informed consent Rex AJG 2006 Vader GIE 2000

Variation in Colonoscopy Reporting Percentage of reports, with information on a prior colon examination for patients who received polyp surveillance, for each practice site. Lieberman et al Gastro Intest Endos 2009; 69: reports

Endoscopy for IBD Critical for management/decision-making Increased focus on mucosal healing Dysplasia issues often come back to endoscopic appearance  documentation Despite this, the quality of endoscopic reporting for patients with inflammatory bowel disease is variable

Clinical Symptoms vs Mucosal Appearance NO CORRELATION! Modigliani R et al. Gastroenterology. 1990;98: Correlation of CDAI vs CDEIS (N=142) R=0.13; P=NS Crohn’s Disease Activity Index (CDAI) Crohn’s Disease Endoscopic Index of Severity (CDEIS)

Why is Mucosal Healing Important? In clinical trials, mucosal healing is an important treatment endpoint – Increasingly used in clinical trials – Mucosal healing is a more objective endpoint than clinical remission for evaluating inflammatory disease activity In clinical practice, mucosal healing can guide medical therapy – Assess disease activity – Growing evidence that mucosal healing is an important goal as it appears to be associated with improved long-term outcomes Decreased likelihood of a flare Decreased progression to disease complications Decreased need for surgery and hospitalization Decreased risk of dysplasia and colorectal cancer (CRC) 11 de Chambrun GP, et al. Nat Rev Gastroenterol Hepatol. 2010;7:15-29.

Retrospective cohort 102 patients with active CD Severe endoscopic lesions (SEL) defined as deep ulcerations >10% of mucosal area with at least one colonic segment Risk of colectomy associated with SELs, high CDAI, absence of immunosuppression Prognosis of Crohn’s Disease Patients with Severe Ulcerations % Colectomy Years 6% 62% 18% 42% 8% 31% Allez M, et al. Am J Gastroenterol. 2002;97(4):

You’ve just seen this patient for a second opinion….. What does this tell us about the patients prognosis?

Disease Extent Matters (right?) So what does this mean?

SES-CD Range: 0-56

Mayo Endoscopic Subscore Normal Colon (0) Mild Ulcerative Colitis (1) Moderate Ulcerative Colitis (2) Severe Ulcerative Colitis (3) Endoscopic pictures courtesy of Gil Melmed, Cedars-Sinai Medical Center

Rutgeert’s Score Predicts Post-operative Course Higher endoscopic evidence of inflammation (I3 or I4) indicates a higher risk of clinical symptoms and surgery I0I0 No lesions I1I1 < 5 aphthous ulcerations I2I2 > 5 aphthous ulcerations I3I3 Diffuse Aphthous ulcerations I4I4 Large ulcerations, nodules, narrowing Rutgeerts P, et al. Gastro 1990;99:

Reporting Software Defined fields Structured data entry Enhanced communication Safety reporting Quality measures Standardized Patient portals Transcription cost saving Hate… Cumbersome at times Language often incoherent Uses classifications systems with no embedded descriptors Reliance on existing descriptor fields leads to uninformative reports Use of free text (how fast can you type?) prohibits data searching function Time / Learning curve Love…

UMPIRe Project Aim: to utilize an evidence-based consensus approach to develop a QUality TeMPlate for IBD Endoscopy Reporting (UMPIRe) – To incorporate the results of UMPIRe into commercially available endoscopy reporting programs RAND/UCLA appropriateness methodology – A modified Delphi panel iterative approach

Methods RAND Methodology Literature review – 120 proposed elements 1 st Round of online voting of 90 proposed elements 51 elements were included in the final content set Topics: 1. Disease background 2. Findings 3. Dysplasia surveillance 4. Crohn’s disease with anastomosis 5. Pouchoscopy

High Level UMPIRe Results I “Quality Endoscopy Report” Background information – Disease phenotype – Disease duration (especially if surveillance) – Therapy at the time of exam Indication – Describe clinical sx’s (asymptomatic? Flare?) – Dysplasia surveillance? – Disease monitoring?

High Level UMPIRe Results II “Quality Endoscopy Report” Procedure details – Maximum extent of exam (TI intubation? A limb?) – If surveillance – technique used Findings – Descriptors of disease SES-CD Mayo (UC) Rutgeerts score (postop)

One example from “the real world…”

What does this look like in real life?

One example from “the real world…”

What can I do next week? Pick One! – When was surgery? – When last colonoscopy? – What drug(s) is patient on? – How far into ileum? – Rutgeerts score?

Summary Endoscopic appearance of the gut mucosa is one our most important endpoints Endoscopy reporting for IBD is probably highly variable Not all elements are required in every procedure Inclusion of these elements will hopefully improve the quality of reports and improve the quality of care UMPIRe content being added to commercial endoscopy reporting templates