1. 80% by 2018: Getting FIT to Reach Our Goal Richard C. Wender, MD Chief Cancer Control Officer American Cancer Society, Inc. 1

2. 10 Steps to Achieving 80% by 18 2

3. 10 Steps to Achieving 80% by 2018 1. Convene and educate clinicians, insurers, employers, and the general public. 2. Find strategies to reach newly insured Americans. 3. More effectively engage employers and payers. 4. Find new ways to communicate with the insured, unworried well. 5. Make sure that colonoscopy is available to everyone.

4. 10 Steps to Achieving 80% by 2018 6. Ensure everyone can be offered a stool blood test option. 7. Create powerful, reliable, committed medical neighborhoods around Federally Qualified Health Centers. 8. Recruit as many partner organizations as possible. 9. Implement intensive efforts to reach low socio- economic populations. 10. Believe we will achieve this goal!

5. 6. Ensure Everyone Can be Offered a Stool Blood Test Option Some people will not or cannot have a colonoscopy. Anyone who hesitates should be offered a Fecal Immunochemical Test. In some settings, FIT needs to be offered as the primary screening strategy.

6. 6 Stool Blood Testing: A Critical Part of ANY CRC Screening Strategy Even if you recommend colonoscopy for all, some people won’t get one, can’t get one, or shouldn’t get one. Using colonoscopy exclusively will, inevitably, lead to a screening gap. Must use other evidence-based screening tests more effectively for average risk patients.

7. Stool Blood Testing Remains Important in the “Age of Colonoscopy” Colonoscopy is now the most frequently used screening test for CRC. However, when provided annually to average- risk patients with appropriate follow-up, stool occult blood testing with high-sensitivity tests can provide similar reductions in mortality compared to colonoscopy and some reduction in incidence. Evaluating Test Strategies for Colorectal Cancer Screening: A Decision Analysis for the U.S. Preventive Services Task Force

8. Types of Stool Occult Blood Tests 8

9. Types of Stool Tests Tests that detect aberrant DNA – One test (Cologuard) available in U.S. – Very limited use at present Tests that detect blood (Fecal Occult Blood Tests – “FOBT”) – Two types (but multiple brands and variable performance) – Guaiac-based FOBT – Immunochemical (FIT)

10. Guaiac Tests Most common type in U.S. Solid evidence (3 RCT’s) 30 year f/u (NEJM Oct 2013) Need specimens from 3 bowel movements Non-specific Results influenced by foods and medications Better sensitivity with newer versions (Hemoccult Sensa) Older forms (Hemoccult II) not recommended!

11. 11 Fecal Immunochemical Tests (FIT) FIT tests are based on the immunochemical detection of human hemoglobin (Hb) as an indicator of blood in the stool. Immunochemical tests use a monoclonal or polyclonal antibody that reacts with the intact globin protein portion of human hemoglobin. More user friendly!

12. Fecal Immunochemical Tests (FIT) Results not influenced by foods or medications Some types require only 1 or 2 stool specimens Higher sensitivity than older forms of guaiac-based FOBT Costs more than guaiac tests (but higher reimbursement)

13. FOBT: Variation Among Brands FDA currently clears guaiac FOBTs and FITs only for “detection of blood” – no assessment of cancer detection capability required. Approval is obtained through determination of “substantial equivalence” – and comparator for most new tests is old, low sensitivity guaiac FOBT. Most newer FITs have no published data regarding their performance for CRC or adenoma detection. Limited data on performance of single vs multiple sample analysis for some tests that are currently marketed as “single sample” tests. FDA is updating criteria.

14. FITs With Published Data* - Available in the US NameManufacturer InSureEnterix, Quest Company Hemoccult-ICTBeckman-Coulter OC Fit-ChekPolymedco OC Auto MicroPolymedco Hemosure One StepWHPM, Inc. Magstream Hem SpFujirebio, Inc. *This list may not be comprehensive

15. FOBT/FIT: Efficacy (USPSTF 2015)

16. Meta-analysis of FIT and Hemoccult Sensa Conclusion: Both have high sensitivity for cancer detection. FITHemoccult Sensa Sensitivity:73-89%64-80% Specificity:92-95%87-90% Lee, JK et. al. Ann Intern Med. 2014 160 (3): 171

17. Advantages of Stool Blood Testing Stool blood testing – Is less expensive. – Can be offered by any member of the health team. – Requires no bowel preparation. – Can be done in privacy at home. – Does not require time off work or assistance getting home after the procedure. – Is non-invasive and has no risk of causing pain, bleeding, bowel perforation, or other adverse outcomes. Colonoscopy is required only if stool blood testing is abnormal.

18. FIT testing (2,000 patients) Making the Best Use of Scarce Resources: Screening colonoscopy vs. FIT Eligible population Patients with a positive FIT Screening colonoscopy (refer 1,000 patients) Eligible population, referred Patient refusal, no shows 1 cancer in 400- 1000 colonoscopies Represents 20 patients 1 cancer in 20 colonoscopies Slide courtesy of Dr. G.Coronado

19. PCPs and FOBT/FIT FOBT/FIT widely used, but: – Effectiveness questioned by many clinicians – Advantageous features often not considered – Lack of knowledge re: performance of new vs. older forms of stool tests, other quality issues Colonoscopy viewed as the best screening test, but many patients face barriers or not willing. – Often recommended despite access or other challenges. – Focus on colonoscopy associated with low screening rates in a number of studies. – Patient preferences rarely solicited.

20. Patient Preferences 20

21. Market Research on Unscreened Activating Messages that Motivate Colon cancer is the second leading cause of cancer deaths in the U.S., when men and women are combined, yet it can be prevented or detected at an early stage. There are several screening options available, including simple take home options. Talk to your doctor about getting screened. Preventing colon cancer, or finding it early, doesn’t have to be expensive. There are simple, affordable tests available. Get screened! Call your doctor today.

22. Many Patients Prefer Home Stool Testing Randomized clinical trial in which 997 ethnically diverse patients in San Francisco community health centers received different recommendations for screening. Adherence to Colorectal Cancer Screening: A Randomized Clinical Trial of Competing Strategies Colonoscopy recommended:38% completed colonoscopy FOBT recommended:67% completed FOBT Colonoscopy or FOBT:69% completed a test

23. Many Patients Prefer Home Stool Testing Diverse sample of 323 adults given detailed side-by-side description of FOBT and colonoscopy* 53% preferred FOBT. Almost half felt very strongly about their preference. 212 patients at four health centers in Texas rated different screening options with different attributes** 37% preferred colonoscopy. 31% preferred FOBT. *Community-based Preferences for Stool Cards versus Colonoscopy in Colorectal Cancer ScreeningCommunity-based Preferences for Stool Cards versus Colonoscopy in Colorectal Cancer Screening **Preferences for colorectal cancer screening among racially/ethnically diverse primary care patientsPreferences for colorectal cancer screening among racially/ethnically diverse primary care patients

24. 24 FIT was More Effective for CRC Screening than FOBT Population based random sample of 20,623 individuals, 50-75 yrs (Netherlands) Tests and invitations were sent together 1 FIT (I-FOBT) vs. 3 G-FOBT samples FITFOBT Participation6157 (60%)4836 (47%) Pos. rate5.5%2.4% Polyps679220 Adv. Adenoma14557 Cancer2411 Van Rossun et al. Gastro. 2008 ; 135: 82-90.

25. ACS Guidelines Update The ACS Colorectal Cancer Advisory Groups concluded that the current evidence, “provide a persuasive argument that [immunochemical tests] offer enhanced specificity in colorectal cancer screening over guaiac-based testing.” “..in comparison with guaiac-based tests for the detection of occult blood, immunochemical tests are more patient friendly, and are likely to be equal or better in sensitivity and specificity.”

26. Quality 26

27. Remember: Stool Collection Should Be Done AT HOME! Stool collected on rectal exam may not be sufficient or sufficiently representative of stool collected from a complete bowel movement. There is no evidence that any type of stool blood testing is sufficiently sensitive when used on a stool sample collected during a rectal exam. Therefore, HS-gFOBT and FIT should be completed by the patient at home, and NOT as an in-office test.

28. UDS Measure 2014 CRC Screening Performance Measure “…Stool specimens for FOBT, including FIT, should be collected by patients at home, as recommended by the manufacturer. An in-office obtained stool specimen does not meet the measurement standard, nor does it comply with manufacturers’ recommendations or national screening guidelines….”

29. 29 Poop On Demand: The New Rectal Exam? Several FQHC’s in Florida have dedicated a bathroom to FIT sample collection. “Have a cup of coffee on the way here!” If the patient is able, they have a BM in the dedicated bathroom and collect the FIT right there An in office test that makes sense!

30. Must Increase Use of High Quality Stool Testing for Those at Average Risk But to be effective must have: – Screening with FIT or highly sensitive guaiac – High compliance – Annual testing – Colonoscopy follow up of every positive stool test

31. High Quality Stool Testing Clinicians Reference: FOBT One page document designed to educate clinicians about important elements of colorectal cancer screening using fecal occult blood tests (FOBT). Provides state-of-the- science information about guaiac and immunochemical FOBT, test performance and characteristics of high quality screening programs.

32. Evidence-Based Interventions 32

33. Standing Orders Promotes team engagement in CRC screening Empowering nursing staff or medical assistants to discuss screening options, provide FOBT/FIT kits and instructions, and submit referrals for screening colonoscopy has been demonstrated to increase CRC screening rates Staff training on risk assessment, components of the screening discussion, … is essential for a successful program. Rules vary – check your state medical practice regulations J Am Board Fam Med 2009

34. Reminders Patient and provider reminders help ensure screening is offered; Educating patients on importance and personal relevance of CRC screening increases return rates; Provide patients with clear instructions on how to complete and return the FIT/FOBT kit (verbal and written instructions); Reminders* (phone call/postcard/email/text) are imperative if kit not returned within 10-14 days; *Studies show that reminders can double return rates!

35. Reminders Develop systems to support follow up for all patients who received FIT/FOBT kits Defined path to needed follow up care (all patients with a positive stool test must have colonoscopy!) Track test completion, reports, appropriate follow up for positives using: EMR “Tickler” System Logs and Tracking Endoscopy reports and pathology reports are critical! Ideal role for navigators/community health workers

36. Mailed Outreach Mailed invitations to CRC screening to patients from safety net hospital clinic who were not up to date with screening: Group 1 – mailed no-cost FIT kit Group 2 – mailed invitation to no-cost colonoscopy Group 3 – usual care, opportunistic PCP visit–based screening FIT and colonoscopy outreach groups received telephone follow-up to promote test completion. Gupta et al, JAMA IM 2013

37. Mailed Outreach Gupta et al, JAMA IM 2013

38. Mailed Outreach Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) – Randomized controlled trial involving 26 FQHCs in Oregon and N. California. (PI – Dr. G. Coronado) Intervention arm – Automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening – Mailed FIT kits – Improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program Control arm – Opportunistic colorectal-cancer screening to patients at clinic visits

39. FluFIT Annual flu shot visits are an opportunity to reach many people who also need CRC screening. Health center staff recommend CRC screening and provide FOBT kits to eligible patients when they get their annual flu shot. FluFIT programs are well accepted by patients. Studies show FluFOBT leads to higher CRC screening rates (including studies in community health centers).

40. 40 FluFIT Project: San Francisco Department of Public Health RCT in 6 public clinics in ethnically diverse and medically underserved neighborhoods in San Francisco. The following slides are from Mike Potter’s deck.

41. Results: RCT in 6 Public Clinics – Real World Conditions Data for flu shot recipients in 6 clinicsFlu Only Arm N=677 Flu-FOBT Arm N=695 CRCS Up-to-Date before (Oct 2009)31.3%32.5% CRCS Up-to-Date After (Mar 2010)35.6%45.5% Change (p=0.02)+4.3 points+13.0 points (Am J Prev Med, 2011) Intent-to-treat analysis Training from research team Intervention run and supervised entirely by clinic staff No post-intervention phone calls Odds Ratio for going from unscreened to screened in Mulitivariate Analysis: 2.22 (1.24-3.95)

42. Evidence of Lasting Benefits Observational Data – Established patients aged 50-75 (Health Educ Research, 2012) More patients got flu shots and CRC screening over time More knowledgeable clinic teams Many adaptations (e.g. most sites switched from older less effective FOBT to FIT by 2011, adjusted workflows, and some initiated year-round standing orders for staff to offer screening with FIT) Population data for 6 clinics that participated in the FLU-FOBT RCT Number of Flu Shot Recipients N CRCS Up-To-Date Among Flu Shot Recipients N (%) March 2008 (before)32601385 (42.5%) March 2009 (after)36341982 (54.5%) March 2010 (1 yr later)43332440 (55.8%)

43. 43 FluFIT Project: Kaiser Permanente Northern California RCT at Kaiser Permanente facilities in 5 different California cities. The Flu-FIT Assembly Line – used electronic health records to assess FIT eligibility while patients waited for flu shots. (Am J Managed Care, 2011)

44. 44 Results Intent-to-treat analysis. Nurse-run, no post-visit reminders In the intervention arm: – 53% of those due for screening were given a FIT kit – 35% of those given a FIT kit completed it within 90 days. Test(s) completed within 90 days Flu Only Arm N= 2884 Due for screening Flu-FIT Arm N=3351 Due for screening P value FIT336 (11.7%)900 (26.9%)<0.001 Flex Sig 68 (2.4%) 62 (1.9%)0.16 Colonoscopy 61 (2.1%) 86 (2.6%)0.24 Any Test 438 (15.2%)996 (29.7%)<0.001 (Am J Pub Health, 2012)

45. 45 FluFIT Project: Walgreens Pharmacy Pilot Study

46. 46 Results Comparing Flu-FIT vs. Flu plus Education/Referral for Screening Pharmacists could play a positive role in colorectal cancer screening: – Educating, referring, and/or providing FIT to eligible patients Challenges to address: – Methods to assess eligibility, closing the loop with primary care, and providing incentives for pharmacies to offer these services. (J Am Pharm Assoc 2010;50:181-7)

47. 47 FluFIT Summary Annual influenza vaccination campaigns represent an underutilized opportunity to offer FIT. FluFIT Programs engage clinical teams in offering colorectal cancer screening during annual influenza vaccination campaigns, encouraging and supporting annual colorectal cancer screening of average risk patients not reached by other interventions.

48. 48 FluFIT Summary Keys to success: – Identify an important clinical need – Involve end-users in the early development of the intervention – Define core components that are easy to understand, adopt, implement, scale, and sustain – Develop training materials and tools to aid with adaptation and implementation in diverse clinical settings – Engage with the health community on multiple levels to get the word out

49. Achieving 80% screening rate will require appropriate use of colonoscopy alternatives To increase screening rates PCPs must be aware of and embrace: – Evidence of FOBT/FIT efficacy – Stool test program quality features – Value of exploring patient preferences and offering options – Innovative approaches Getting to 80%

51. @RichWender

52. 52 2014 CRC Screening Performance Measure “…Stool specimens for FOBT, including FIT, should be collected by patients at home, as recommended by the manufacturer. An in- office obtained stool specimen does not meet the measurement standard, nor does it comply with manufacturers’ recommendations or national screening guidelines….” This and the next few slides weren’t included in the deck Mary sent. I wasn’t sure if you’d want to integrate them into the presentation or discard them.

53. Many Patients Prefer Home Stool Testing Some patients may forgo ANY colorectal cancer screening if they are not offered a home stool blood testing alternative to colonoscopy. Clinical evidence indicates that selecting annual stool blood testing instead of colonoscopy is a reasonable choice for average-risk patients. However, patients who select stool blood testing must also be prepared to accept follow-up colonoscopy if the stool blood test is abnormal.

54. Fecal Immunochemical Tests (FITs) Should Replace Guaiac FOBT FITs – Demonstrate superior sensitivity and specificity – Are specific for colon blood and are unaffected by diet or medications – Some can be developed by automated readers – Some improve patient participation in screening Allison JE, et.al. J Natl Cancer Inst. 2007; 191:1-9 Cole SR, et.al. J Med Screen. 2003; 10:117-122

55. Hemoccult ICT, HemeSelect, InSure, Fit-Chek, and MagStream 1000/Hem SP have been evaluated in large numbers. Levi Z, Ann Intern Med. 2007; 146:244-55