1. Quality of Colonoscopy Using an endoscopic database to measure and improve quality AAPCE Memphis- November 5, 2011 David Lieberman MD Chief, Division of Gastroenterology and Hepatology Oregon Health Sciences University Portland VAMC

2. Colorectal Cancer Screening Normal Colon AdvancedAdenoma 10-20% Lifetime Risk Genetic Environmental Lifestyle 5-6% Lifetime Risk FIT gFOBT

3. Early Cancer Detection Tests Requires programmatic adherence with (+) and (-) tests Programmatic performance: Unlikely to result in much cancer prevention gFOBT FIT UNKNOWN

4. Colorectal Cancer Screening Normal Colon AdvancedAdenoma 10-20% Lifetime Risk Genetic Environmental Lifestyle 5-6% Lifetime Risk

5. gFOBT FIT Genetic/Proteomics Imaging All paths lead to colonoscopy Colonoscopy

6. CRC Screening in USA MMWR 2010; 59: 808-12

7. Goals of Colonoscopy How are we doing? GoalsEndpoints Early cancer detectionMortality reduction Detection/removal of cancer precursor lesions 1.Reduce CRC incidence 2.Absence of interval cancer within 3 years

8. Canada - Ontario Rabenek et al; Am J Gastroenterol advance online pub. 2 March 2010; doi 10.1038/ajg2010.83 Regional rates of complete colonoscopy in Ontario, per 1,000 population aged 50–90 years, by year 3% For every increase in colonoscopy rate of 1% (10/1000), there is a 3% decrease in hazard of death (HR 0.97; 95% CI 0.949-0.991) Colonoscopy per 1000 1%3%

9. CRC Death Rates in USA Better treatment? Early detection? Reduced Incidence? MalesFemales

10. CRC risk reduction with colonoscopy StudyIncidence reductionMortality Reduction COLONOSCOPY Singh, 2006 45% Lakoff, 2008 75% Baxter, 2009;Case-Control 31% Kahi, 2009 67%65% Brenner, 2011;Case-Control 77% Singh;JAMA 2006;295:2366-73 Bressler; Gastroenterol 2007; 132:96-102 Lakoff; ClinGastro Hep 2008;6:1117-21 Baxter;Ann Intern Med 2009; 150:1-8 Brenner Ann Intern Med 2011; 154:22-30 Atkin; The Lancet, early online publication, 28,April, 2010 Segnan; JNCI; Sept 7, 2011 Less protection or No protection in Proximal Colon

11. Interval Cancer: What is the risk? Cooper et al; Gastroenterol 2010: 138: S24 Singh, Am J Gastroenterol 28 Sept 2010 on line Baxter et al; Gastroenterol 2011; 140: 65-72 Pabby, GIE 2005; 61: 385-91 Alberts; NEJM 2000 342: 1156-62 Robertson; Gastroenterol 2005;129:34-41 Bertagnolli; NEJM 2006;355:873-84 Arber; NEJM 2006; 355:885-95 Baron; Gastroenterol 2006; 131:1674-82 Lieberman; Gastroenterol 2007; 133: 1077-85 After Polypectomy Incidence: 0.3-0.9% in 3-5 yrs 1.7-2.8 cancers /1000 person yrs After (-) Colonoscopy 2-9% of cancers in registry (within 6-36 months)

12. Interval Cancer: WHY? New, fast growing lesions –Sawhney et al; Gastroenterology 2006; 131: 1700-5 Incomplete removal (19-27%)Incomplete removal (19-27%) –Pabby et al; Gastrointest Endosc 2005; 61: 385-91 Soetikno;JAMA 2008; 299: 1027-35 Farrar; CGH 2006; 4: 1259-64

13. Interval Cancer: WHY? New, fast growing lesions Incomplete removal (19-27%) Missed lesionsMissed lesions –2-12% of polyps > 1cm are missed !! –Less protection in proximal colon

14. Interval Cancer NCI Pooling ProjectNCI Pooling Project Robertson, Lieberman, Winawer; DDW 2008 58 Interval Cancers

15. Colonoscopy: how do we assess quality?

16. Quality in Medicine How do we know high quality? How do we measure it? How do we monitor it? How do we improve it?

17. Quality makes a difference Interval Cancers (7-36 mos) Distal (n=584)Proximal (n=676) High completion rate (>95% vs < 80%) OR = 0.73OR = 0.72 Ontario 2000-2005 All Cancers: n = 14,064 Interval cancers: n = 1260 (9%) Baxter et al; Gastroenterology 2011: 140:65-72

18. Variation in Practice: Withdrawal Time and Polyp Detection Barclay R et al. NEJM 2006;355

19. Quality makes a difference Interval Cancers (7-36 mos) Distal (n=584)Proximal (n=676) High polypectomy rate (>25% vs <10%) (surrogate for adenoma detection rate) 0.79-0.87 (NS)0.52-0.61 (significant) Ontario 2000-2005 All Cancers: n = 14,064 Interval cancers: n = 1260 (9%) Baxter et al; Gastroenterology 2011: 140:65-72

20. Risk of Interval Cancer Kaminski; NEJM 2010: 362: 1795-803 Relationship between quality indicator (ADR) and key outcome (interval cancer)

21. Colonoscopy Quality: Impact on Cost Poor prep: repeat procedures Incomplete exams: repeat procedures Concern about interval cancers: Shortened intervals between exams Surveillance over-utilization Adverse events: cost of care $$$

22. Set Standard Evidence-based Collect Data Assess performance Improve/ refine Post-Modern Colonoscopy Quality Assessment 1.Demonstrate that indicator is linked to key outcome 2.Develop measuring tools

23. NationalEndoscopicDatabase www.cori.org

24. Data Collection/Transmission Central Databank Patient Privacy

25. Central Data Bank DATA ? ?

26. Levels of Quality Reporting IndicatorsReporting Indicators –Bowel Prep Quality Performance Indicators Key Outcomes

27. Levels of Quality Reporting Indicators:Reporting Indicators: Bowel Prep Quality Quality of Prep documented Non-rural CORIRural CORICROP- Oregon # with documented bowel prep 90,57521,3073230 % adequate95.5%96.6%94.1%

28. Levels of Quality Reporting Indicators Performance Indicators :Performance Indicators : Depth of insertion Cecum reachedNon-rural CORIRural CORICROP- Oregon # with documented insertion depth 90,57521,3073230 % cecal intubation90.3%91.0%87.0% photodocumentation8.5%16.8%7.8% Landmarks noted11.0%18.9%19.4%

29. Levels of Quality Reporting Indicators Performance Indicators :Performance Indicators : Withdrawal Time Cecum reachedNon-rural CORIRural CORICROP- Oregon # exams with no bx or polypectomy 33,9059,2541,453 % documented w/d time 54.1%53.3%55.1% Time <6min4.7%12.6%9.1%

30. Levels of Quality Reporting Indicators Performance Indicators PolypsNon-rural CORIRural CORICROP- Oregon #51,84112,4292,366 Polyps removed (%)83.778.988.0 % retrieved91.391.484.9

31. Polyp Detection Rate PolypsNon-rural CORIRural CORICROP- Oregon # screening CSP33,9059,2541,453 Polyps detected (%)41.342.738.7 Largest >9mm21.919.225.6 Future Indicator: Recommendation of appropriate surveillance interval after polyps detected and removed

32. Levels of Quality Reporting Indicators Performance Indicators Key OutcomesKey Outcomes –Disease-free survival – rates of interval cancer –Harms –Quality of life

33. Levels of Quality Reporting Indicators Performance Indicators Key OutcomesKey Outcomes –Disease-free survival – rates of interval cancer –Harms –Quality of life

34. Set Standard Evidence-based Collect Data Assess performance Improve/ refine Post-Modern Colonoscopy Quality Assessment Preliminary Data from Rural Oregon: Performance meeting benchmarks