What determines “quality” for endoscopy reporting in IBD patients?

Report
QUALITY REPORTING FOR
COLONOSCOPY IN IBD
Gil Y. Melmed, MD, MS
Cedars-Sinai Medical Center
CCFA Advances in IBD
Orlando, FL December 2014
Disclosure
Gil Y. Melmed, MD, MS
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
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 2006
2Armstrong 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
438 000 reports
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: 645-53
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
Crohn’s Disease Activity Index (CDAI)
Clinical Symptoms vs Mucosal Appearance
NO CORRELATION!
Correlation of CDAI vs CDEIS (N=142)
600
500
400
300
200
100
R=0.13; P=NS
0
0
5
10
15
20
25
30
Crohn’s Disease Endoscopic Index of Severity (CDEIS)
Modigliani R et al. Gastroenterology. 1990;98:811-817.
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)
de Chambrun GP, et al. Nat Rev Gastroenterol Hepatol. 2010;7:15-29. 11
• 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
% Colectomy
Prognosis of Crohn’s Disease Patients with
Severe Ulcerations
62%
42%
31%
18%
8%
6%
1
3
5
Years
Allez M, et al. Am J Gastroenterol. 2002;97(4):947-53.
What does this tell us
about the patients prognosis?
You’ve just seen this patient for a second opinion…..
Disease Extent Matters (right?)
So what does this mean?
SES-CD
Range: 0-56
Mayo Endoscopic Subscore
Normal
Colon (0)
Moderate
Ulcerative
Colitis (2)
Mild
Ulcerative
Colitis (1)
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
I0
No lesions
I1
< 5 aphthous
ulcerations
I2
> 5 aphthous
ulcerations
Diffuse
Aphthous ulcerations
Large ulcerations,
nodules, narrowing
I3
I4
Rutgeerts P, et al. Gastro 1990;99:956-963
Reporting Software
Love…
• 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
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
Topics:
1. Disease background
2. Findings
3. Dysplasia surveillance
4. Crohn’s disease with anastomosis
5. Pouchoscopy
Literature review – 120
proposed elements
1st Round of online voting of
90 proposed elements
51 elements were included in the final content set
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

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