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Slide1

80% by 2018: Getting FIT to Reach Our GoalRichard C. Wender, MDChief Cancer Control Officer American Cancer Society, Inc.

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Slide2

10 Steps to Achieving 80% by 18

2

Slide3

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

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!

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

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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.

Slide7

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

Slide8

Types of Stool Occult Blood Tests

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Slide9

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)

Slide10

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!

Slide11

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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

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.

Slide14

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 comprehensive

Slide15

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): 171

Slide17

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

.

Slide18

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

Slide19

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.

Slide20

Patient Preferences

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Slide21

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

Colonoscopy recommended:

38% completed colonoscopy

FOBT recommended:

67% completed FOBT

Colonoscopy or FOBT:

69% completed a test

Slide23

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 patients

Slide24

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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

Quality

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Slide27

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.

Slide28

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….”

Slide29

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!

Slide30

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

Slide31

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.

Slide32

Evidence-Based Interventions

32

Slide33

Standing Orders

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 2009

Slide34

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!

Slide35

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

Slide36

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 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 2013

Slide37

Mailed Outreach

Gupta et al, JAMA IM 2013

Slide38

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

Slide39

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

).

Slide40

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.

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)

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

)

Slide42

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

the

FLU-FOBT RCT

Number of Flu Shot Recipients

N

CRCS

Up-To-Date Among Flu Shot Recipients

N (%)

March 2008 (before)

3260

1385 (42.5%)

March 2009 (after)

3634

1982 (54.5%)

March 2010 (1 yr later)

4333

2440 (55.8%)

Slide43

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)

Slide44

44

Results

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

45

FluFIT Project: Walgreens Pharmacy Pilot Study

Slide46

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 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

Assoc

2010;50:181-7)

Slide47

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.

Slide48

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

Slide49

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%

Slide50

Slide51

Slide52

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.

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; 10:117-122

Slide55

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


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