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Endoscopy in Gastrointestinal Oncology - Slide 15 - D. Fisher - Colorectal cancer screening
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Endoscopy in Gastrointestinal Oncology - Slide 15 - D. Fisher - Colorectal cancer screening

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  • And they live happily forever after
  • The patient comes in complaining of Index and you offer screening because they are over 50
  • Our discussions of prevention and screening will be for AVERAGE risk patients. There are additional guidelines and considerations for patients with symptoms or individuals at increased risk for colorectal cancer Not all polyps carry a risk of future cancer. Adenomatous polyps are pre-cancer lesion – not all will become cancers, but they have the potential Hyperplastic polyps are not pre-cancer lesions and do not place an individual at higher future risk of cancer
  • These (EU) aims fit into the model of quality for cancer care as a continuum, a process, and not a single event
  • GI and VA faculty Most available screening option
  • The shift from cancer death to cancer prevention is a fundamental redefining of what a screening test is meant to do. A set up for failure and liability VA is an example of population screening
  • The shift from cancer death to cancer prevention is a fundamental redefining of what a screening test is meant to do. A set up for failure and liability VA is an example of population screening
  • NEED to update with new data Add country Not all polyps carry a risk of future cancer. Adenomatous polyps are pre-cancer lesion – not all will become cancers, but they have the potential 1 in 20 will Could the lack of effectiveness (remember vs efficacy) in the right colon be overcome with optimal quality?? Are all observational studies and not necessarily of SCREENING colonoscopy
  • The shift from cancer death to cancer prevention is a fundamental redefining of what a screening test is meant to do. A set up for failure and liability VA is an example of population screening
  • More definitions
  • Along the same lines of all the services that are recommended to be performed - many quality indicators are ratios of individuals receiving a recommended service - such as a screening test – to all the eligible individuals being measured. This is usually cross sectional with a different denominator at each measurement. Also a bench mark is chosen – what proportion is acceptable These are usually designed to address underuse of a service. There is not a consideration of duplicate testing among individuals or assessment of testing in individuals who are eligible. There is also concern that to meet the targets overuse or misuse may occur
  • Along the same lines of all the services that are recommended to be performed - many quality indicators are ratios of individuals receiving a recommended service - such as a screening test – to all the eligible individuals being measured. This is usually cross sectional with a different denominator at each measurement. Also a bench mark is chosen – what proportion is acceptable These are usually designed to address underuse of a service. There is not a consideration of duplicate testing among individuals or assessment of testing in individuals who are eligible. There is also concern that to meet the targets overuse or misuse may occur
  • 1171 had neoplasia in phase I 501 without neoplasia assigned to return at 5 years Total numbers (1193 at 5 years) – 93 advanced neoplasia, 485 adenomas In no polyps group, 41 adenomas, 7 advanced adenomas and 1 invasive cancer
  • And even reminders
  • And even reminders
  • Maui, Hawaii

Endoscopy in Gastrointestinal Oncology - Slide 15 - D. Fisher - Colorectal cancer screening Presentation Transcript

  • 1. Colorectal Cancer Screening - Update Deborah A. Fisher, MD, MHS Associate Professor of Medicine Duke University Medical Center Durham, North Carolina, USA March 12, 2011
  • 2. Duke, Durham, North Carolina, USA
  • 3. News and current controversies
    • New guidelines from European Union (EU) Council
    • Increasing uptake of organized and opportunistic colorectal cancer (CRC) screening
    • Randomized controlled trial (RCT) data available for endoscopic screening (flexible sigmoidoscopy)
    • Expanded role of colonoscopy and recent questioning of role
    • Greater emphasis on quality of screening
  • 4. Outline
    • Definitions
    • CRC statistics
    • EU CRC guidelines
    • Quality issues
    • Closing remarks
    http://bookshop.europa.eu Search “colorectal cancer” Free pdf download
  • 5. Screening vs Surveillance
    • Screening : employed in average risk populations to stratify into higher and lower risk of disease
    • Surveillance : the ongoing follow-up of patients at increased risk of disease
  • 6. Efficacy verses effectiveness
    • Efficacy:
    • Can the intervention (screening) be successful when properly implemented under controlled conditions
    • Effectiveness:
    • Is the intervention (screening) typically successful in actual clinical practice
  • 7. Efficacy – Ideal conditions
  • 8. Effectiveness –Real world Dina Goldstein www.dinagoldstein.com
  • 9. Opportunistic screening / case finding
    • A test is offered to an individual without symptoms of the disease
    • When they present for reasons unrelated to the disease
  • 10. Population or organized screening
    • Test is offered systematically to all individuals in the defined target group
    • Established policies, protocols, quality monitoring
    • Resources used to maximize benefits and minimize risk at the
    population level
  • 11. Average risk screening
      • Asymptomatic
      • No personal history of colon or rectal neoplasia neoplasia =cancer or adenomatous polyps
      • No personal history of inflammatory bowel disease
      • No first degree relatives with colorectal cancer
  • 12. Burden of CRC & screening uptake
    • Second leading cause of cancer in EU
    • Second leading cause of cancer death among men and women in EU
    • By 2008 10 countries (including Italy) with population-based screening, 7 with opportunistic screening
    • By 2010 10 newly established or upgraded programs, 2 more in the decision process
    EU guideline 2011
  • 13. General aims of EU guideline
    • Principles from invitation to management of screen-detected lesions
    • Training, multidisciplinary teamwork, monitoring & evaluation, cost effectiveness, minimizing adverse events, timeliness of further investigation
    • Optimize screening for modalities in current use: Fecal occult blood test (FOBT), fecal immunochemical test (FIT), sigmoidoscopy, colonoscopy
    • EU currently only recommends FOBT (guaiac) at ages 50-74 years
  • 14. Model of quality: cancer care continuum adapted from Zapka Cancer Epidemiol Biomarkers Prev 2003 Types of Care Outcomes Potential Failures during Processes of Care Risk Assessment Primary Prevention Detection -screening -diagnostic testing Diagnosis Treatment Surveillance Clinical status Functional status Quality of life Survival Failure to identify need for screen /counsel Failure in access to care Failure in primary prevention Failure to screen Failure to detect Failure during follow-up of abnormal result Failure during diagnostic evaluation Failure of treatment Failure to follow surveillance plan Failure of surveillance Failure in access to care
  • 15. EU guiding principles of screening
    • To discover cancer in an earlier and more treatable state to improve outcomes (not necessarily to prevent cancer)
    • Target population is predominantly healthy therefore must consider harms and benefits
    • Good evidence for FOBT every 1-2 years
    • Reasonable evidence for FIT every 1-3 years
    • Reasonable evidence for sigmoidoscopy every 10 years
    • Limited evidence for colonoscopy every 10 years
    • No evidence for other modalities
  • 16. Evidence for colorectal cancer screening
    • Controlled trials and case-control studies support screening reduces cancer death
    • National Polyp Study and polyp prevention trials data suggest that removing adenomatous polyps reduces cancer incidence
    • Cost-effectiveness ratios comparable to other generally accepted screening programs
    • Strength of evidence for each screening strategy varies considerably
  • 17. Screening hubris Horner http://seer.cancer.gov/
  • 18. Presentation focus on colonoscopy
      • Endoscopy conference
      • Colonoscopy is the final common pathway for screening
      • Colonoscopy in the recent press for an apparent lack of effectiveness in the right colon
      • Ongoing and upcoming RCT for colonoscopy
  • 19. Evidence for the colonoscopy strategy
    • No mortality data from randomized controlled trials
    • Extrapolation of sigmoidoscopy data
    • Extrapolation of FOBT randomized controlled trials
    • Comparisons of cancer incidence in populations undergoing colonoscopy to “expected” cancer incidence
    • Some show a reduction of cancer 1,2
    • Some do not 3
    1 Winawer NEJM 1993 3 Robertson Gastroenterol 2005 2 Kahi Clin Gastroenterol Hep 2009
  • 20. Problems with estimating “expected” cancer rate
    • The comparison population will have both screen-detected and symptom-detected cancers
    • If condition has a long latency then:
      • Clinically silent cases are underestimated (prevalence)
      • The rate of new cases is overestimated (incidence)
      • Impact of screening on cancer incidence is overestimated
  • 21. Cancer detection
    • Colonoscopy population
    • Background population
    • Prevalence Incidence
    x x x x x x x x x x x x
  • 22. If sigmoidoscopy is good colonoscopy must be better
    • An assumption of colonoscopy for primary screening
    • What is the evidence?
  • 23.  
  • 24. Right vs Left colon controversy Mandel 2000 1993 Atkin 2010 Brenner 2011 Singh 2010 Brenner 2010 Baxter 2009 Source M:0.88 NS W:0.99 NS M:0.44 W:0.44 M:0.59 W:0.71 Incidence 45985 Cohort Canada County Design N Outcome Overall Distal Proximal Canada Case-control 61752 Death 0.63 0.33 0.99 NS Germany Case-control 3287 Incidence (adv neoplasia) 0.52 0.33 1.05 NS Germany Case-control 3620 Incidence 0.23 0.16 0.44 UK RCT Flex Sig 170432 Incidence Death 0.77 0.69 0.64 0.98 NS US RCT FOBT 46,551 Incidence Death 0.80 0.67
  • 25. Is this a Quality issue?
    • Is this biology of right sided colon cancers (e.g. microsatellite instability) OR…
    • Poor bowel preparation, particularly in right colon
    • Missed lesions, especially flat lesions
    • Quality of endoscopist
  • 26. Types of quality measures (indicators)
    • Structural measures : Characteristics of providers and hospitals, e.g. case volume
    • Process measures: What is done in giving and receiving care, e.g. CRC screening / testing
    • Outcome measures The net effect of healthcare delivery e.g. 5-year survival rates
  • 27. New direction of quality indicators
      • Previously: “Was it done?”
      • Now: “Was it done well?”
      • Quality of screening program
      • Quality of the colonoscopy itself
  • 28. EU guideline performance standards >300 300 Annual volume of colonoscopies per endoscopist >95% >90% Rate of cecal intubation >90% 85% Compliance with follow-up colonoscopy after + sigmoidoscopy >95% >90% ≤ 31 days from + test until referral for colonoscopy >95% 90% Referral for colonoscopy after + test >65% >45% Uptake rate >95% 95% Invitation coverage Desirable level Acceptable level Quality Indicator
  • 29. Potential markers of good colonoscopy technique
      • Withdrawal time: time from cecum to removal of colonoscope minus time for interventions
      • Adenoma detection rate (ADR): the proportion of patients with at least 1 adenoma detected. Usually stratified by gender, occasionally by age
      • Cecal intubation: proportion of colonoscopy in which the cecum is reached and documented *
      • Missed lesions
      • Endoscopist training (specialty), volume *
    * EU guideline
  • 30. Withdrawal time and future neoplasia
    • US prospective cohort study
    • Asymptomatic subjects age 50-75 years, at 13 centers
    • If adenomas at baseline then surveillance colonoscopy within 5.5 years
    • If no polyps at baseline then age-matched controls for subjects with large adenomas
    Gellad Am J Gastroenterol 2010
  • 31. Sample Selection Screening Colonoscopy N=3121 Polyps N=1680 No Polyps N=1441 Interval Colonoscopy N=302 Interval Neoplasia N=49 Interval Colonoscopy N=891 No Neoplasia N=362 No Neoplasia N=253 Interval Neoplasia N=529
  • 32. Patient-level results
    • No significant difference in baseline withdrawal time in patients with interval neoplasia as compared to those without
    • Withdrawal time was not independently associated with detection of interval neoplasia
  • 33. Withdrawal Time Results
    • Withdrawal time was associated with adenoma detection rate
    • Withdrawal time was not a predictor of interval neoplasia
  • 34. ADR and future cancer
    • Study in Poland as part of colonoscopy-based CRC screening
    • 186 endoscopists 45026 individuals
    • Interval cancer defined as diagnosed before scheduled surveillance (based on guideline)
    • Adenoma detection rate >20% was associated with lower risk of interval cancer
    • Unclear if rates higher than 20% would be better
    • Cecal intubation NOT associated with interval cancer
    Kaminski N Eng J Med 2010
  • 35. ADR and interval cancer Cumulative hazard rates for interval CRC by endoscopist’s ADR
  • 36. Endoscopist specialty and volume
    • New CRC <36 months after colonoscopy 1
      • Endoscopist specialty (non GI, non surgeon)
      • Endoscopist colonoscopy completion rate
      • NOT endoscopist volume
    • New CRC up to 15 years after a “negative” colonoscopy 2
      • Endoscopist specialty (non GI)
      • NOT endoscopist volume
    • Perforation or GI bleed after colonoscopy 3
      • Low volume endoscopist (<284/year on average)
      • NOT endoscopist specialty
    • All studies using Canadian administrative claims data (procedure codes)
    1 Baxter Gastroenterol 2011 2 Rabeneck Clin Gastro Hep 2010 3 Rabeneck Gastroenterol 2008
  • 37. Summary Colonoscopy Quality Indicators
    • ADR may be useful within a certain range
    • Withdrawal time not predictive of future neoplasia-time alone may not be a good marker of technique
    • Cecal intubation rate – mixed results
      • Not predictive of future cancer - likely because it only affects missed lesions is a limited area
      • May be a marker for a better endoscopist
    • Training (specialty) and volume mixed data
    • Missed lesions - impractical to determine at the time of colonoscopy
    • Better markers of careful technique are needed
  • 38. Closing remarks
    • Screening is a process that begins with invitation and ends with management of screen detected lesions
    • There is a tension between individual risk / benefit and population risk / benefit
    • Quality monitoring is an essential component of successful screening
    • Current quality indicators have limitations and some are not strongly linked to outcomes of interest
  • 39. sunset