Transcript Slide - Iowa Cancer Consortium

80% by 2018:
Getting FIT to Reach Our Goal
Richard C. Wender, MD
Chief Cancer Control Officer
American Cancer Society, Inc.
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10 Steps to Achieving 80% by 18
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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.
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 socioeconomic populations.
10. Believe we will achieve this goal!
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.
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.
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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 averagerisk 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
Types of Stool Occult Blood Tests
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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!
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!
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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)
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.
FITs With Published Data* - Available in the US
Name
Manufacturer
InSure
Enterix, Quest Company
Hemoccult-ICT
Beckman-Coulter
OC Fit-Chek
Polymedco
OC Auto Micro
Polymedco
Hemosure One Step WHPM, Inc.
Magstream Hem Sp Fujirebio, Inc.
*This list may not be comprehensive
FOBT/FIT: Efficacy (USPSTF 2015)
Meta-analysis of FIT and Hemoccult Sensa
Conclusion: Both have high sensitivity for cancer detection.
FIT
Hemoccult Sensa
Sensitivity:
73-89%
64-80%
Specificity:
92-95%
87-90%
Lee, JK et. al. Ann Intern Med. 2014 160 (3): 171
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.
Making the Best Use of Scarce Resources:
Screening colonoscopy vs. FIT
• Represents 20 patients
Screening colonoscopy
(refer 1,000 patients)
Eligible
population,
referred
Patient
refusal, no
shows
FIT testing (2,000 patients)
Eligible
population
Patients with
a positive FIT
1 cancer in 4001000 colonoscopies
1 cancer in 20
colonoscopies
Slide courtesy of Dr. G.Coronado
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.
Patient Preferences
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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.
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.
Colonoscopy recommended:
38% completed colonoscopy
FOBT recommended:
67% completed FOBT
Colonoscopy or FOBT:
69% completed a test
Adherence to Colorectal Cancer Screening: A Randomized Clinical Trial of Competing Strategies
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
FIT
6157 (60%)
5.5%
FOBT
4836 (47%)
2.4%
Polyps
679
220
Adv. Adenoma
Cancer
145
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57
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Participation
Pos. rate
Van Rossun et al. Gastro. 2008 ; 135: 82-90 .
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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.”
Quality
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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.
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….”
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!
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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
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-thescience information about
guaiac and
immunochemical FOBT, test
performance and
characteristics of high
quality screening programs.
Evidence-Based Interventions
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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
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!
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
Mailed Outreach
Gupta et al, JAMA IM 2013
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).
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)
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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
FIT
336 (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
438 (15.2%)
996 (29.7%)
Any Test
(Am J Pub Health, 2012)
<0.001
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Getting to 80%
• 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
@RichWender
This and the next few
slides weren’t included
in the deck
Mary sent. I
2014 CRC Screening Performance
Measure
wasn’t sure if you’d
• “…Stool specimens for FOBT,
wantincluding
to integrateFIT,
them
into theat
presentation
should be collected by patients
home, asor
discard them.
recommended by the manufacturer. An inoffice obtained stool specimen does not meet
the measurement standard, nor does it comply
with manufacturers’ recommendations or
national screening guidelines….”
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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.
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
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