The Importance of Stool Occult Blood Tests in Getting to 80%

Durado Brooks, MD, MPHDirector, 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 TestsA) 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 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) 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• 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 SensaConclusion: 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

– 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.

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

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 TestingClinicians 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 kito Group 2 – mailed invitation to no-cost colonoscopyo 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 OutreachStrategies 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 kitso 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