Q UALITY R EPORTING F OR C OLONOSCOPY I N IBD Gil Y. Melmed, MD, MS Cedars-Sinai Medical Center CCFA...
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Transcript of Q UALITY R EPORTING F OR C OLONOSCOPY I N IBD Gil Y. Melmed, MD, MS Cedars-Sinai Medical Center CCFA...
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QUALITY REPORTING FOR COLONOSCOPY IN IBD
Gil Y. Melmed, MD, MSCedars-Sinai Medical Center
CCFA Advances in IBDOrlando, FL December 2014
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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
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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?
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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
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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
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Quality Reporting for Colonoscopy(not just IBD)
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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
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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
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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
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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
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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.
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• 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
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You’ve just seen this patient for a second opinion…..
What does this tell us about the patients prognosis?
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Disease Extent Matters (right?)So what does this mean?
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SES-CD
Range: 0-56
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Mayo Endoscopic Subscore
NormalColon (0)
MildUlcerativeColitis (1)
ModerateUlcerativeColitis (2)
SevereUlcerativeColitis (3)
Endoscopic pictures courtesy of Gil Melmed, Cedars-Sinai Medical Center
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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
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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…
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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
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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
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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?
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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)
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One example from “the real world…”
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One example from “the real world…”
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One example from “the real world…”
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One example from “the real world…”
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What does this look like in real life?
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What does this look like in real life?
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What does this look like in real life?
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One example from “the real world…”
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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?
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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