QUALITY REPORTING FOR COLONOSCOPY IN IBD

Gil Y. Melmed, MD, MSCedars-Sinai Medical Center

CCFA Advances in IBDOrlando, 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

1Rex et al Gastroint Endos 20062Armstrong 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 consentRex AJG 2006Vader GIE 2000

Variation in Colonoscopy Reporting

Percentage of reports, with information on a prior colon examinationfor patients who received polyp surveillance, for each practice site.

Lieberman et al Gastro Intest Endos 2009; 69: 645-53438 000 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 AppearanceNO CORRELATION!

Modigliani R et al. Gastroenterology. 1990;98:811-817.

Correlation of CDAI vs CDEIS (N=142)

R=0.13; P=NS

Cro

hn

’s D

isea

se A

ctiv

ity

Ind

ex (

CD

AI)

Crohn’s Disease Endoscopic Index of Severity (CDEIS)

00

100

200

300

400

500

600

5 10 15 20 25 30 35

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)

11de 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

% C

olec

tom

y

Years

6%

62%

18%

42%

8%

31%

Allez M, et al. Am J Gastroenterol. 2002;97(4):947-53.

1 3 5

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

NormalColon (0)

MildUlcerativeColitis (1)

ModerateUlcerativeColitis (2)

SevereUlcerativeColitis (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

I0 No lesions

I1 < 5 aphthous ulcerations

I2 > 5 aphthous ulcerations

I3 DiffuseAphthous ulcerations

I4 Large ulcerations, nodules, narrowing

Rutgeerts P, et al. Gastro 1990;99:956-963

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

1st Round of online voting of 90 proposed elements

51 elements were included in the final content set

Topics: 1. Disease background2. Findings3. Dysplasia surveillance4. Crohn’s disease with anastomosis5. 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…”

One example from “the real world…”

One example from “the real world…”

One example from “the real world…”

What does this look like in real life?

What does this look like in real life?

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