Colonoscopy: Quality Issuess3.gi.org/wp-content/uploads/2013/08/13ACG_Midwest_Regional_0015… ·...

David A. Lieberman, MD, FACG

Colonoscopy: Quality Issues

ACG Midwest Regional Postgraduate CourseSt Louis

August 25, 2013

David Lieberman MDChief, Division of Gastroenterology and Hepatology

Oregon Health and Science University

ACG Regional Postgraduate Course - St. Louis, MO Copyright 2013 American College of Gastroenterology

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Why are we worried about colonoscopy quality?

• Interval Cancer• Payers are asking• Patients are asking

GI endoscopist

How How can we improve colonoscopycan we improve colonoscopy? ?


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Colonoscopy Quality

•• Patient elementsPatient elements– Appropriateness of procedure– Bowel Prep

•• Technical elementsTechnical elements•• PostPost--procedure elementsprocedure elements

Colonoscopy Appropriateness

• Screening– Age to stop screening– 10 year interval after negative exams

• Surveillance intervals


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Colorectal Cancer (CRC) Screening:USPSTF Guidelines 2008

•• AgeAge– Age: 50 to 75 years – (A recommendation)– Age 76-85 years: No routine screening

(C recommendation). Individual considerations– Age 85 years and older: No screening

(D recommendation – i.e. no benefit)

USPSTF; Ann Intern Med 2008; 149: 627-37

Average-Risk Screening:Prevalence of Polyp/tumor >9mm

10

12N = 327,785

2

4

6

8

WomenMen

%

040-49 50-54 55-59 60-64 65-69 70-74 75-79 >79

5.0% 2.1%


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No Polyp at Baseline CSP:10 year interval• Evidence for 10 year interval

D t d t ti 10+ i d– Data demonstrating 10+ year gap in adenoma development and cancer

– RCT of sigmoidoscopy in UK, Italy, USA– Case-control/cohort studies of colonoscopy

• Evidence we would like: 10 year follow-upd h• Evidence we have:

– 5 year follow-up after negative exam – 10 year follow-up – indirect

No polyp at baseline:Risk of Interval Advanced Neoplasia @ 5 yrs

Study n Age (yrs) AdvancedNeoplasia@5 yrs

Lieberman, 2007 291 (USA men) 62 2.4%Imperiale, 2008 1256 (USA) 56.6 1.3%Leung, 2009 370 (Chinese) 60.6 1.4%Chung, 2011 1242 (Korean) 56.7 2.0%

Risk is lowRisk is low

Lieberman et al; Gastroenterology 2012; 143: 844-857


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Risk of CRC within 10 yrs after Colonoscopy

Study Country (n) Cancer risk over 10yrs

SinghJAMA 2006

Manitoba36,000 with CSP c/w expected rates

SIR1 yr 0.662 yr 0.595 yr 0.5510 yr 0.28

BrennerJ Clin Onc 2011

Germany1945 CRC cases2399 controls

OR1-2 yr 0.143-4 yr 0.125-9 yr 0.2610-19 yr 0.28


Durable Reduction in risk forat least 10 years

No Polyp at Baseline CSP:10-year interval

• Concern: Maybe the baseline prep was not pristine• Concern: Maybe the baseline prep was not pristine• Concern: Interval cancer after negative exam

– 2-9% of CRC patients in registries had prior colonoscopy within 3 yrs

• Recommended Interval: 10 years 10 years R l lif i t l ft l th 10ft l th 10• Real life interval: often less than 10 yearsoften less than 10 years



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Overuse of Screening After a Negative Colonoscopy in the Elderly (Medicare)

Goodwin JS et al. Arch Intern Med 2011;171:1335-43

% repeat

(-)Colonoscopy for screening indication(-) colonoscopy

(all indications)

% repeatCSP50%

30%

4yr 5yr 6

Utilization of Colonoscopy after Screening

Schoen et al; Gastroenterol 2010; 138: 73-81

Surveillance in 5 yrs >2 Surveillance in 7 yrs

Advanced Adenoma (n = 1342)

58.4% 33.2%

> 3 non-advanced adenomas (n = 177)

57.5% 26.9%

1-2 non-advancedadenomas (n = 905)

46.7% 18.2%( )

No adenomas 26.5% 10.4%


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Colonoscopy after negative baseline screening exam 2000-2006

(n = 17,525)80

74%

30

40

50

60

70Interval% inadequate baseline exam

10%

0

10

20

< 1 1-2 years 2-5 years 5-7 years 7-10 years

Lesion > 9mm 6.5% 3.1% 3.1% 3.4% 4.6%

Prep makes a difference


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Better prep, better detection

Harewood et al. GIE 2003;58:76-9

Colonoscopy Quality

• Poor prep at baseline– Lebwohl (Gastrointest Endosc 2011;73: 1207-14)

• 24% with suboptimal bowel prep• Repeat exams:

– Any adenoma 42%– Advance adenoma 27%

– Recommendations:– Recommendations: • If prep is poor, repeat exam• Try to make a fair prep a good prep


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Bowel Prep

• Split-dose better

Kilgore; GIE 2011; 73: 1240-5

– Meta-analysis – 5 trials

Criteria OR (95% CI) split-dose vs full-dose

Satisfactory prep 3.70 (2.79-4.91)Willing to repeat 1.76 (1.09-2.91)Likelihood of stopping prep 0.53 (0.28-0.98)Nausea 0.55 (0.38-0.79)

Quality Reporting: By provider

Prep Result Recorded

Procedure Volume


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Colonoscopy:Bowel Prep• Bowel prep

D t ti– Documentation– Was final prep good-excellent for each segment of

colon?– Every effort should be made to convert a “fair”

prep into good prep with cleaning during procedurep

– Goal: 95% “good-excellent” preps– High-quality practice should monitor prep quality

as a quality indicator

What about Surveillance?

•• EvidenceEvidence– Patients with neoplasia “have what it takes” to do

it again– Some low-risk, some high-risk


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Why Surveillance?

•• FearFear– Missed Lesions– Interval cancer after

complete colonoscopy

•• Cancer registry dataCancer registry data2 9% had prior colonoscopy– 2-9% had prior colonoscopywithin 36 months.

GI endoscopist

Interval Cancer: WHY?

• New, fast growing lesions

l l• Incomplete removal (19-27%)

• Missed lesions– Up to 17% of polyps > 1cm are missed !!– Less protection in proximal colon

Pohl; Gastroenterology 2013; 144: 74-80

Quality


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Surveillance after polypectomy:High-risk

*Assumes complete exam with adequate prep

Baseline: Most advanced finding* Recommended Interval

No polyp 10 yrs

Hyperplastic, left-sided 10 yrs

1-2 Tubular Adenomas <10mm 5-10 yrs

3 or more tubular adenomas 3 yrs

Tubular adenoma >10mm 3 yrs

Villous adenoma (>25% villous) 3 yrs

Low Risk

Adenoma with HGD 3 yrs

>10 adenomas <3 yrs

Piecemeal resection 2-6 months

Cancer 1 year


Higher Risk

Utilization of Colon SurveillanceSchoen et al; Gastroenterol 2010; 138: 73-81

Surveillance in 5 yrs >2 Surveillance in 7 yrs

Advanced Adenoma (n = 1342)

58.4% 33.2%

> 3 non-advanced adenomas (n = 177)

57.5% 26.9%

1-2 non-advancedadenomas (n = 905)

46.7% 18.2%( )

No adenomas 26.5% 10.4%

Evidence for both over-utilization and under-utilization


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Why Surveillance?

•• EvidenceEvidence•• FearFear•• PaymentPayment

GI endoscopist

PolypSurveillance

• Payers will expect – High-quality exams– Intervals consistent with evidence-based

guidelinesguidelines

• Poor quality: No Payment


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Pre-procedure Elements• Procedure appropriate: ?80%• Bowel prep adequate: goal >95%• Bowel prep adequate: goal >95%• Rate of repeat exams in less than 1 year for

poor preps

GIGIGI

GIPayersPayers

Colonoscopy Quality• Patient elements

– Appropriateness of procedure– Bowel Prepp

• Technical elements– Exam complete to cecum, with landmark

documentation– Adenoma detection– Serrated polyp detection– Management of large polyps 1-2cm

Surrogate for Interval Cancer

• Post-procedure elements– Reporting– Communication– Follow-up recommendations

• Surveillance• Repeat procedures


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Colonoscopy:Intra-procedure elements• Extent of exam

– Photo-documentation of cecum, preferably with appendiceal orifice.

18%47%

1%17%

Clinical Gastroenterology and Hepatology 2011;9:42-46

1%17%


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Risk of Interval CancerKaminski; NEJM 2010: 362: 1795-803

If Adenoma detection rate >20%,Lower rate of interval cancer

Physician ADR variability and subsequent CRC risk after a negative colonoscopy

• New Kaiser Study (DDW, 2013)– 316,334 colon exams; – 716 post-colon CRC cases

• Linear relationship between ADR and subsequent CRC after negative colonoscopy

Corley et al


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ADR Quartiles Hazard Ratio (95% CI)

<20.3% 1.74 (1.36-2.24)

20.3-25.2% 1.52 (1.14-2.04)

25.3-32.0% 1.31 (1.00-1.73)

>32.0% 1.00 ref

Adjusted for exam indication, sex, age, race, FHX and co-morbidity score

Corley et al

co morbidity score

Same result for Proximal and Distal CRCResults did not vary by sex


• Conclusions– ADR an independent predictor of subsequent CRC

risk– Supports use of ADR as quality indicator– Threshold may need to change with modern

colonoscopy

Corley et al


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Colonoscopy:Intra-procedure elements• Withdrawal time

– Probably important to document for medico-legal reasons

• Retroflexion in rectum – most experts recommend

Colonoscopy:Intra-procedure elements• Polyp descriptors

– Morphology • Pedunculated• Sessile• Flat


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Colonoscopy:Intra-procedure elements• Polyp descriptors

– Morphology – Size

• Ideal method is to compare with open biopsy forceps of known diameter – not practical

• Size estimates have been studied – there is variability

– Location – segment of colon

Colonoscopy:Intra-procedure elements• Polyp resection/retrieval

– Resection method– Completeness of resection– Suspicious lesion, large (?>2cm), piecemeal

resection: place tatoo• Exceptions: cecum, rectum

– Was polyp retrieved for pathology?


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Colonoscopy:Intra-procedure

• What should be monitored in high-quality practice?– Cecal intubation rate – goal >95% for screening

exams– Adenoma detection rate (ADR) in screening exams– Polyp descriptors: goal 100%Polyp descriptors: goal 100%– Polyp retrieval rate: 100% >10mm– Tatoo placement – all polyps >2cm or suspicious

for malignancy except in cecum or rectum.


– Appropriateness of procedure– Bowel Prepp

• Technical elements– Exam complete to cecum, with landmark documentation– Adenoma detection– Serrated polyp detection– Management of large polyps 1-2cm

• Post-procedure elements– Reporting

Communication– Communication– Follow-up recommendations



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Colonoscopy:Post-procedure elements• Documentation/Communication

– Appropriate post-procedure monitoring– Copy of report to patient– Copy of report sent to referring provider

Colonoscopy:Post-procedure elements• Post-pathology recommendations

f f llfor follow-up– Consistent with evidence-based guidelines– Communicated to both patient and referring

provider


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Colonoscopy:Post-procedure elements• Follow-up for adverse events

– Ideal world: 30 day f/u for any adverse events– Less than ideal world: contact with patient in 24-

48 hours to ascertain any adverse events.

The dark side


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Colonoscopy Adverse Events

Setting n Bleed Perforation Other*

Serious events/1000 procedures with 30d follow-up

Community; ProspectiveScreening/Surv; 30d f/u

21,375(40-85 yrs)

1.59 0.19 1.31

Group HealthRetrospectiveScreening/Surv;30d f/u

43,456(40-85 yrs)

2.8 0.5 Hosp: 10.23.34/1000

4.9/1000

Warren et al; Ann Intern Med 2009; 150: 849-57Ko, Lieberman; Clin Gastro Hep; 2010; 8: 166-73Day et al; Gastrointest Endosc 2011; 74: 885-96Rutter et al; Cancer Causes Control 2012; 23: 289-96

Colonoscopy Adverse Events

Setting n Bleed Perforation Other*

Serious events/1000 procedures with 30d follow-up

Community; ProspectiveScreening/Surv; 30d f/u

21,375(40-85 yrs)

1.59 0.19 1.31

Group HealthRetrospectiveScreening/Surv;30d f/u

43,456(40-85 yrs)

2.8 0.5 Hosp: 10.2

> 65 years

Medicare 53,220 6.4 0.6 CV events with

3.34/1000

4.9/1000

Claims data30d f/u

polypectomy

Meta-analysis:Perforation risk

248,732 1.0

7.0/1000

Warren et al; Ann Intern Med 2009; 150: 849-57Ko, Lieberman; Clin Gastro Hep; 2010; 8: 166-73Day et al; Gastrointest Endosc 2011; 74: 885-96Rutter et al; Cancer Causes Control 2012; 23: 289-96


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My Ideal World

Rates of earlyInterval

Colonoscopies2013

@30 days:Adverse Events

5 years1 yr 2yr

colonoscopy

Interval Cancer

PCP Questions to determine if endoscopist has high quality• Is the report complete?

Prep quality extent of exam– Prep quality, extent of exam– Polyp descriptors

• Is the endoscopist measuring performance indicators?– Adenoma detection rate– Rate of repeat exams for inadequate prepRate of repeat exams for inadequate prep

• Communication to PCP and Patient– Recommendation for f/u consistent with evidence-

based guidelines


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Quality affects outcomes

Surveillance after polypectomy: Low-risk

Baseline: Most advanced finding* Recommended Interval

No polyp 10 yrs

Hyperplastic, left-sided 10 yrs

1-2 Tubular Adenomas <10mm 5-10 yrsLow Risk

*Assumes complete exam with adequate prep



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Surveillance after polypectomy:Serrated polyps/lesions

Baseline: Serrated Polyps Recommended Interval

Polyposis 1 yrWith dysplasia or >10mm 3 yrsWithout dysplasia, <10mm 5 yrs

Like high-risk adenomaLike low-risk adenoma

Assumes complete exam with adequate prep


Evidence: Weak


– Appropriateness of procedure– Bowel Prep

• Technical elements– Exam complete to cecum, with landmark documentation– Adenoma detection– Serrated polyp detection– Management of large polyps 1-2cm

• Post-procedure elementsReporting

Surrogate for Interval Cancer

– Reporting– Communication– Follow-up recommendations



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Interval Cancer:What is the risk?

After Polypectomy

Incidence: 0.3-0.9% in 3-5 yrs

1.7-2.8 cancers /1000 person yrs

After (-) Colonoscopy

2-9% of ALL cancers in cancer registry (6-36 months)

Cooper et al; Gastroenterol 2010: 138: S24Singh, Am J Gastroenterol 28 Sept 2010 on lineBaxter et al; Gastroenterol 2011; 140: 65-72

Pabby, GIE 2005; 61: 385-91Alberts; NEJM 2000 342: 1156-62Robertson; Gastroenterol 2005;129:34-41Bertagnolli; NEJM 2006;355:873-84Arber; NEJM 2006; 355:885-95Baron; Gastroenterol 2006; 131:1674-82Lieberman; Gastroenterol 2007; 133: 1077-85

Arain; Am J Gastroenterol 2010; 105: 1189-95


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