Presentations text content in 80 % by 2018:
80% by 2018: Getting FIT to Reach Our GoalRichard C. Wender, MDChief Cancer Control Officer American Cancer Society, Inc.
10 Steps to Achieving 80% by 18
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.Slide4
10 Steps to Achieving
80% by 2018
6. Ensure everyone can be offered a stool blood test option.
7. Create powerful, reliable, committed
around Federally Qualified Health Centers.
8. Recruit as many
9. Implement intensive efforts to reach
we will achieve this goal!Slide5
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.Slide6
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.
colonoscopy exclusively will, inevitably, lead to a screening
Must use other evidence-based screening tests more
for average risk
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 ForceSlide8
Types of Stool Occult Blood Tests
Types of Stool Tests
that detect aberrant
) available in U.S.
Very limited use at
blood (Fecal Occult Blood Tests – “FOBT”)
(but multiple brands and variable performance)
Most common type in U.S.
Solid evidence (3 RCT’s)
30 year f/u (NEJM Oct 2013)
Need specimens from 3 bowel movements
Results influenced by foods and
Better sensitivity with newer
versions (Hemoccult Sensa)
Older forms (Hemoccult II)
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!Slide12
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)Slide13
FOBT: Variation Among Brands
FDA currently clears guaiac FOBTs and FITs only for “detection of blood” – no assessment of cancer detection capability
Approval is obtained through determination of “substantial equivalence” – and comparator for most new tests is old, low sensitivity guaiac
Most newer FITs have no published data regarding their performance for CRC or adenoma
Limited data on performance of single vs multiple sample analysis for some tests that are currently marketed as “single sample”
FDA is updating
FITs With Published Data* - Available in the US
NameManufacturerInSureEnterix, Quest CompanyHemoccult-ICTBeckman-CoulterOC Fit-ChekPolymedcoOC Auto MicroPolymedcoHemosure One StepWHPM, Inc.Magstream Hem SpFujirebio, Inc.
*This list may not be comprehensiveSlide15
FOBT/FIT: Efficacy (USPSTF 2015)Slide16
Meta-analysis of FIT and Hemoccult Sensa
Conclusion: Both have high sensitivity for cancer detection.
FITHemoccult SensaSensitivity: 73-89% 64-80%Specificity: 92-95% 87-90%
Lee, JK et. al. Ann Intern Med. 2014 160 (3): 171Slide17
Advantages of Stool Blood Testing
Stool blood testingIs 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
FIT testing (2,000 patients)
Making the Best Use of Scarce Resources:Screening colonoscopy vs. FIT
Patients with a positive FIT
refer 1,000 patients)
Eligible population, referred
Patient refusal, no shows
1 cancer in 400-1000 colonoscopies
1 cancer in 20 colonoscopies
Slide courtesy of Dr. G.CoronadoSlide19
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
Often recommended despite access or other
Focus on colonoscopy associated with low screening rates in a number of
Patient preferences rarely
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.Slide22
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
38% completed colonoscopy
67% completed FOBT
Colonoscopy or FOBT:
69% completed a testSlide23
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 Screening
Preferences for colorectal cancer screening among racially/ethnically diverse primary care patientsSlide24
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 together1 FIT (I-FOBT) vs. 3 G-FOBT samples
FITFOBTParticipation 6157 (60%)4836 (47%)Pos. rate5.5%2.4%Polyps679220Adv. Adenoma14557Cancer2411
Van Rossun et al. Gastro. 2008 ; 135: 82-90 .Slide25
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.”Slide26
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.
that any type of stool blood testing is sufficiently sensitive when used on a stool sample collected during a rectal exam.
HS-gFOBT and FIT should be completed by the patient at home, and NOT as an in-office test.Slide28
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….”Slide29
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!
Must Increase Use of High Quality Stool Testing for Those at Average Risk
But to be effective must have:
with FIT or highly sensitive guaiac
Colonoscopy follow up of every positive stool testSlide31
High Quality Stool Testing
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.Slide32
Promotes team engagement in CRC screeningEmpowering 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 ratesStaff 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 2009Slide34
Patient and provider reminders help ensure screening is offered;
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);
* (phone call/postcard/email/text) are imperative if kit not returned within 10-14 days;
Studies show that reminders can double return rates!Slide35
Develop systems to support follow up for
patients who received FIT/FOBT kits
Defined path to needed follow
patients with a positive stool test must have
Track test completion, reports, appropriate follow up for
Logs and Tracking
reports and pathology reports are critical!
Ideal role for navigators/community health workersSlide36
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 kitGroup 2 – mailed invitation to no-cost colonoscopyGroup 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 2013Slide37
Gupta et al, JAMA IM 2013Slide38
Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC)
Randomized controlled trial involving 26 FQHCs in Oregon and N. California. (PI – Dr. G. Coronado)
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
Opportunistic colorectal-cancer screening to patients at clinic visitsSlide39
Annual flu shot visits are an opportunity to reach many people who also need CRC
Health center staff recommend CRC screening and provide FOBT kits to eligible patients when they get their annual flu
programs are well accepted by
leads to higher CRC screening rates (including studies in community health centers
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.Slide41
Results: RCT in 6 Public Clinics – Real World Conditions
Data for flu shot recipients in 6 clinicsFlu Only ArmN=677Flu-FOBT ArmN=695CRCS 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)
Training from research team
run and supervised entirely
Odds Ratio for going from unscreened to screened in
Analysis: 2.22 (1.24-3.95
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 teamsMany 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
Number of Flu Shot Recipients
Up-To-Date Among Flu Shot Recipients
March 2008 (before)
March 2009 (after)
March 2010 (1 yr later)
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)Slide44
Intent-to-treat analysis. Nurse-run, no post-visit remindersIn the intervention arm:53% of those due for screening were given a FIT kit35% of those given a FIT kit completed it within 90 days.
Test(s) completed within 90 daysFlu Only ArmN= 2884Due for screeningFlu-FIT ArmN=3351Due for screeningP valueFIT 336 (11.7%)900 (26.9%)<0.001Flex Sig 68 (2.4%) 62 (1.9%)0.16Colonoscopy 61 (2.1%) 86 (2.6%)0.24Any Test 438 (15.2%)996 (29.7%)<0.001
(Am J Pub Health, 2012)Slide45
FluFIT Project: Walgreens Pharmacy Pilot StudySlide46
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 patientsChallenges to address: Methods to assess eligibility, closing the loop with primary care, and providing incentives for pharmacies to offer these services.
J Am Pharm
Annual influenza vaccination campaigns represent an underutilized opportunity to offer FIT.
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.Slide48
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 outSlide49
Achieving 80% screening rate will require appropriate use of colonoscopy
alternativesTo increase screening rates PCPs must be aware of and embrace:Evidence of FOBT/FIT efficacyStool test program quality featuresValue of exploring patient preferences and offering optionsInnovative approaches
Getting to 80%Slide50Slide51Slide52
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.Slide53
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.Slide54
Fecal Immunochemical Tests (FITs) Should Replace Guaiac FOBT
FITsDemonstrate superior sensitivity and specificityAre specific for colon blood and are unaffected by diet or medicationsSome can be developed by automated readersSome 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; 10:117-122Slide55
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