Transcript 19- Implementing Stool Based Testing and

The Importance of Stool Occult Blood
Tests in Getting to 80%
Durado Brooks, MD, MPH
Director, Cancer Control Interventions
American Cancer Society, Inc.
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Getting to 80%
• Colonoscopy is essential but not
sufficient to reach our goal.
•Access barriers for many
•Not all patients are willing
• Must use other evidence-based
screening tests more effectively
for average risk patients
Types of Stool Occult Blood Tests
Types of Stool Tests
A) Tests that detect aberrant DNA
– One test (Cologuard) available in U.S.
– Very limited use at present
B) Tests that detect blood (Fecal Occult Blood
Tests – “FOBT”)
– Two types (but multiple brands and variable
performance)
• Guaiac-based FOBT
• Immunochemical (FIT)
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
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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)
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Specific for human blood and for
lower GI bleeding
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
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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
Highly Sensitive Guaiac FOBTs With Published
Data - Available in the US
Name
Manufacturer
Hemoccult II Sensa
Beckman-Coulter
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
Fecal Occult Blood Testing Remains
Important in the “Age of Colonoscopy”
• Colonoscopy is the most frequently used
screening test for CRC (by a wide margin).
• However:
– FIT and high sensitivity guaiac tests perform well for
cancer detection.
– When provided annually to average-risk patients
with appropriate follow-up, stool occult blood
testing with high-sensitivity tests can provide similar
reductions in incidence and mortality compared to
colonoscopy.
Efficacy and Accuracy
Colorectal Diisease, 2012
NEJM 2014
Fecal Occult Blood Tests: Accuracy
Lee, JK et. al. Annals IM 2014
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
Colonoscopy every 10 years and FIT/FOBT
annually prevent the same number of colon
cancer deaths
Zauber et. al. Ann Intern Med. 2008
Advantages of Stool Blood Testing
• Stool blood testing
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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
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 Stool Testing
•
Randomized
clinical trial in
which 997
ethnically diverse
patients in San
Francisco
community health
centers received
different
recommendations
for screening.
Inadomi, Arch Intern Med 2012
Many Patients Home Stool Testing
• 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 patients
Quality
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.
• Largest study of samples from rectal exam
missed 19 of 21 cancers found at colonoscopy!
Remember: Stool Collection Should Be
Done AT HOME!
• Therefore, specimen collection for high
sensitivity guaiac FOBT 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….”
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-the-science
information about guaiac and
immunochemical FOBT, test
performance and
characteristics of high quality
screening programs.
Evidence Based Interventions
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
Standing Orders
San Francisco Health Plan
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!
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
Mailed Outreach
• Mailed invitations to CRC screening to patients from
safety net hospital clinic who were not up to date
with screening
o Group 1 – mailed no-cost FIT kit
o Group 2 – mailed invitation to no-cost colonoscopy
o 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
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
o Automated, data-driven, electronic health record-embedded
program to identify patients due for colorectal screening
o Mailed FIT kits
o Improvement process (e.g. Plan-Do-Study-Act) to enhance the
adoption, reach, and effectiveness of the program
• Control arm
o Opportunistic colorectal-cancer screening to patients at clinic
visits
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)
Stool DNA Test
 Polyps and cancer cells
contain abnormal DNA
 Stool DNA tests look for
abnormal DNA in colon
cells that are passed in
the stool
 Colon cells are shed
continuously (whereas
FOBT/FIT rely on bleeding,
which is often
intermittent)
NEJM 2014
NEJM 2014
Stool DNA Test
• One test (Cologuard) currently available
• Combines an FIT with tests for stool DNA markers
associated w/ cancers and adenomas
• Every 3 year testing interval recommended by
manufacturer
• FDA has cleared it for marketing as CRC screening test
• CMS has agreed to cover Cologuard for Medicare
beneficiaries age 50 – 85 yrs
– Medicare will reimburse $502 q 3 yrs for the test
– Private insurance coverage – tbd
• All positive tests must be evaluated by colonoscopy
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