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...
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