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Colonoscopy Quality Metrics Glenn Eisen, MD, MPH, FASGE The Oregon Clinic- West Hills GI. Aren’t All Colonoscopies the Same?. How Good Is Your Colonoscopy?. New York Times December 16, 2008 “Colonoscopies Miss Many Cancers, Study Finds”
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Colonoscopy Quality MetricsGlenn Eisen, MD, MPH, FASGEThe Oregon Clinic- West Hills GI
How Good Is Your Colonoscopy? New York Times December 16, 2008 “Colonoscopies Miss Many Cancers, Study Finds” For many years doctors and patients thought colonoscopies, the popular screening test for colorectal cancer, were all but infallible. Have a colonoscopy, get any precancerous polyps removed , and you should almost never get colon cancer……..And now a Canadian study, published Tuesday in journal Annals………found the test much less accurate than anyone expected.
Colonoscopy as primary screening tool ? • 1990 “Lunatic fringe” • 1996 USPSTF : “No evidence for or against” • 1997 AGA/ACHPR: option • 2000 HCFA pays for it – its “policy” • 2001 ACS option • 2001 ACG “preferred strategy” • 2002 USPSTF – One of several options
Definition of Quality Institute of Medicine “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”
Elements of Quality Care 1. Recognize patients at risk for diseases2. Do appropriate evaluation3. Make the appropriate diagnosis4. Start the appropriate treatment5. Schedule the appropriate follow-up6. Stimulate the appropriate compliance/adherence to treatment
Why should we do this? • Improve patient outcomes • Differentiate high quality providers from poorly trained endoscopists • Outside interests (payors) will make us do this-Pay for performance (P4P) • It’s the right thing to do for our patients
Most Gastroenterologists Believe Quality Measurement is Important Survey of 182 Gastroenterologists (margin of error +/-7%) Survey sponsored by Provation and Caris Diagnostics
Quantity vs. Quality Production Pressure in Endoscopy: Balancing Quantity and Quality Lawrence B. Cohen, MD • Increase volume in response to decreased reimbursement • Production pressure can adversely impact outcomes • Be flexible in scheduling • Document quality and benchmark Gastroenterology 2008;135:1842-1844
Elements of Quality Care 1. Recognize patients at risk for diseases2.Do appropriate evaluation3. Make the appropriate diagnosis4. Start the appropriate treatment5. Schedule the appropriate follow-up6. Stimulate the appropriate compliance/adherence to treatment
Appropriate Indications • Studies suggest 21-39% of procedures inappropriate indications • When done for appropriate indications, more clinically relevant diagnoses • Difficult/Complex to implement
Elements of Quality Care 1. Recognize patients at risk for diseases2. Do appropriate evaluation3. Make the appropriate diagnosis4. Start the appropriate treatment5. Schedule the appropriate follow-up6. Stimulate the appropriate compliance/adherence to treatment
New or Missed Colon Cancers by Specialty P<0.001 *cancer within 3yrs of colonoscopy Bressler et al Gastro 2007 Data from Ontario Cancer Registry
New or Missed Colon Cancers by Colonoscopy Setting P<0.001 *cancer within 3yrs of colonoscopy Bressler et al Gastro 2007 Data from Ontario Cancer Registry
Even the Best of Us Miss Polyps • Back-to-back colonoscopy • Systematic review1: 6 studies • Pooled miss rate: 22% (CI, 19-26) • > 1cm: 2.1% (CI, 0.3-7.3) • CT colonography2,3: • > 1 cm polyps: 12-17% missed by colonoscopy • Van Rijn J, Am J Gastroenterol 2006; 101:343. • Van Gelder RE, Gastroenterology 2004; 127:41. • Pickhardt P, Ann Intern Med 2004; 141:352.
Achieving Competency Through Training • Competency: the minimal level of skill, knowledge, and/or expertisederived through training and experience that is required to safely and proficiently perform a task or procedure. • Applied to endoscopy: the endoscopist has gone through training to develop requisite skills and acquire the knowledge-base required to safely perform, interpret, and correctly manage findings of endoscopic procedures.
Training • 2-year GI fellowship, surgical residency or equivalent • Technical skills • Safe and technically successful procedures • Cognitive skills • Interpretation of findings, diagnoses and clinical management • Adequate case volume and mix • Threshold numbers do not ensure competence! • Many (most) trainees need to do more than the minimum See: ASGE Principles of Training in Gastrointestinal Endoscopy
Training: Competency Assessment • Once training is completed, competency is assessed • Questions: • Who does this? • Training director? Proctor? Both? • Criteria • Subjective? • Objective • Threshold numbers • Cecal Intubation, Adenoma Detection • Selective duct cannulation
Thresholds: Number needed to be completed BEFORE competency can be assessed See ASGE Methods for Granting Hospital Privileges to Perform Gastrointestinal Endoscopy
DDW 2007: Adequate Level of Training for Technical Competence in ColonoscopyLee S et al. South Korea Success rate in colonoscopy Level of experience (no. of colonoscopies) At least 150 procedures are needed
Ongoing Experience Important 45 Endoscopists at Mayo Rochester Harewood Dig Dis Sci 2005
Measuring Quality inGastrointestinal Endoscopy Advancing Gastroenterology Practice Through Endoscopic Excellence
Methods • Comprehensive list, measurable endpoints • Endoscopy report/EMR • Validation • Compliance rates • Not all would be ultimately adopted • Medline searches • Expert consensus • 3 time periods • Pre-procedure: all contacts until sedation/scope • Intra-procedure: until scope removal • Post-procedure: after scope removal through follow-up • Evidence level graded
Quality Indicators for Colonoscopy • Appropriate indication • Informed consent obtained including risks • Use of recommended polypectomy and post cancer resection surveillance intervals • Use of recommended IBD surveillance intervals • Documentation of prep quality Advancing
Quality Indicators for Colonoscopy 6. Cecalintubation rate with photo documentation • Rate of detection of adenomas in screening • Withdrawal time documentation • Biopsy obtained in patients with diarrhea • Number and distribution of biopsy samples in IBD surveillance (32) • Polyps < 2 cm resected or documented unresectability Advancing
Quality Indicators for Colonoscopy 12. Cancers found within 3 years of endo 13. Anticoagulation management 14. Complication rates Advancing
Elements of Quality Care 1. Recognize patients at risk for diseases2. Do appropriate evaluation3. Make the appropriate diagnosis4. Start the appropriate treatment5. Schedule the appropriate follow-up6. Stimulate the appropriate compliance/adherence to treatment
Improving compliance with postpolypectomy surveillance guidelines: an interventional study using a continuous quality improvement initiative.Sanaka et al GIE 2006 • Intervention: surveillance intervals on wallet cards, posters, monthly meeting • Compliance 57% to 81% (p<0.001) • Time to repeat colonoscopy: 4.5 to 5.2yrs (p=0.003) • 14% reduction in yearly surveillance colons
Adenoma Detection Rate • Best single indicator…but still • Average-risk screening colonoscopy • Patients >50 yrs • Men: >25% • Women: >15% • Complexities in measurement
ADR Based on Age and Gender-CORI GIE 2011 ADR: Adenoma detection rate; CI: 95% confidence interval
Variation in Practice: Withdrawal Time and Polyp Detection • Pvt practice in IL • 12 GI’s • Withdrawal time > 6 minutes: • Adenomas: 28% vs 12% (p<0.0001) • Advanced lesions: 6.4% vs. 2.6% (p=0.005) Barclay NEJM 2006
Impact of endoscopist withdrawal speed on polyp yield: implications for optimal colonoscopy withdrawal time. Median 6.7 mins, associated With higher PDR: OR 11.8, CI: 2.3-78.4 Simmons DT et al (Mayo) APT 2006
Adenoma Detection: Variations Rex AJG 2008 Millan DCR 2008
Effect of a time-dependent colonoscopic withdrawal protocol on adenoma detection during screening colonoscopy Used a timer to “enforce” slower withdrawal, goal at least 8 mins Compared results to the previous no-timer data (NEJM publication) Withdrawal time: 12.5 vs. 9.3 mins (p<0.0001) Adenoma detection rate: 35% vs. 24% (p<0.001) 8 minute mean withdrawal, more: Adenomas (38% vs 23%, p<0.0001) Advanced adenomas (6.6% vs. 4.5%, p=0.13) Barclay et al CGH 2008
Effect of institution-wide policy of colonoscopy withdrawal time > or = 7 minutes on polyp detection. • Compared PDR before and after instituting a mandatory 7 min withdrawal time • >7 min withdrawal: 65% to 100% • PDR: no change (p=0.45) • Conclusion: no effect on PDR Sahwney et al (BI Boston) Gastro 2008
Increasing ADR- ‘the Holy Grail” • Being watched- videotaping • Others watching with you- fellows, nurses • Rotate pt • Improve optics • Retro on the right • Hawthorne effect
Interval Cancer:What is the risk? 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 Cooper et al; Gastroenterol 2010: 138: S24 Singh, Am J Gastroenterol 28 Sept 2010 on line Baxter et al; Gastroenterol 2011; 140: 65-72
Kaminski; NEJM 2010: 362: 1795-803 Risk of Interval Cancer Relationship between quality indicator (ADR) and key outcome (interval cancer)
Why colonoscopy might not be………“Twice as good as flexible sigmoidoscopy” • The hypothetical gain of colonoscopy is in detecting right-sided lesions • The only gains in screening occur by detecting lesions at an earlier stage • Right sided cancers are different • More likely to have a genetic basis • Possibly (probably) more likely to arise from flat mucosa (harder to detect pre cancerous lesions) • Possibly (probably) have shorter latency
Quality makes a difference Ontario 2000-2005 All Cancers: n = 14,064 Interval cancers: n = 1260 (9%) Baxter et al; Gastroenterology 2011: 140:65-72
Quality makes a difference Ontario 2000-2005 All Cancers: n = 14,064 Interval cancers: n = 1260 (9%) Baxter et al; Gastroenterology 2011: 140:65-72
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
Improving Colonoscopy • Focus on techniques which improve detection of significantneoplasia • Prep • Meticulous withdrawal technique • Chromo-endoscopy for flat lesions
Quality Measurement Hurdles • Measurable endpoints • “Indicators” • Clinically relevant • Representative of high quality care • Correlate with better outcomes
Quality Improvement Hurdles • Internal to the institution • Variability across institutions • Which indicators to measure? • Avoiding unintended consequences • Reversal agents (Narcan, Romazicon) • Providing incentives • Carrot ($$) • Stick (penalties, loss of privileges)
Benchmarking- To measure a rival's product according to specified standards in order to compare it with and improve one's own product
Benchmarking • Measure quality indicators • Large group of patients • Large group physicians • Diverse practice settings • Look at mean compliance and spread of data to determine acceptable compliance rates • Corrected for practice setting and patient demographics
Pilot Study 2008-2010 • Real-time clinical data collected • Direct endoscopy report writer to database upload • Manual data entry • Data collected on 25,000 colonoscopies