Colorectal a late stage when treatment is

Colorectal cancer (CRC) is the third most commonly diagnosed
cancer for men and women in the US. The American Cancer Society (ACS) estimates
135,430 new cases and 50,260 deaths from CRC in 2017 (Smith et al., 2017).
Fortunately, both the incidence and mortality rates have declined in recent
decades (Figure 1). A reduction of risk factors including decreased consumption
of red meat, reduced smoking rates, and the use of aspirin have helped reduce
the incidence rates. The introduction and uptake of screening tests have
promoted early detection and treatment as well as prevention by the removal of
polyps through colonoscopy before they can turn to cancer. Improved treatments
have also reduced the mortality (Siegel et al., 2017).

Figure 1 Trends in Colorectal Cancer Incidence and Mortality
(1975-2014) Rates by Age and Sex, US (Siegel, et al., 2017).

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Four of five North Dakotans are not up-to-date with the CRC
screening recommendations and 42% of CRC is diagnosed at a late stage when
treatment is more difficult (North Dakota Statewide Cancer Registry, 2004 –
2013). The North Dakota CRC Roundtable (NDCCRT) is promoting strategies to
increase CRC screening in clinics and healthcare systems across our state.  This effort is part of the National
Colorectal Cancer Roundtable’s goal to achieve an 80% CRC screening rate
nationwide by the year 2018.

 

Screening Recommendations for Individuals at Average Risk
for CRC

-All men and women aged 50 years and older should be
screened for CRC (Smith et al., 2017).

-Screening should continue until age 75 years.

-Adults ages 76 to 85 years should have individualized
screening based upon overall health and prior screening results.

-Adults ages 76 to 85 years who have never been screened are
more likely to benefit as are individuals who are healthy enough to endure CRC
treatment and do not have other life-limiting comorbid conditions
(Bibbins-Domingo et al., 2016).

 

Screening Recommendations for Individuals at Greater Risk
for CRC

Some individuals are at greater risk for CRC and should
therefore begin screening at an earlier age, be screened more frequently, and
with a specific recommendation for colonoscopy if available.

Individuals at greater risk for CRC include those:

1) with a history of adenomatous polyps;

2) with a personal history of curative-intent resection of
CRC;

3) with a family history of either CRC or colorectal
adenomas diagnosed in a first-degree relative (mother, father, sister, brother,
or children), with differing recommendations based on the relative’s age at
diagnosis;

4) individuals at significantly higher risk because of a
history of inflammatory bowel disease of significant duration; or

5) individuals at significantly higher risk because of a
known or suspected presence of 1 of 2 hereditary syndromes, specifically, Lynch
syndrome or familial adenomatous polyposis (Smith et al., 2017).

Screening Tests that Detect Adenomatous Polyps and Cancer
versus Tests that Primarily Detect Cancer

A joint guideline from the American Cancer Society, the US
Multi-Society Task Force on Colorectal Cancer, and the American College of
Radiology has divided the CRC screening tests into 2 groups: those that detect
adenomatous polyps and cancer versus tests that primarily detect cancer (Levin
et al., 2008).

 

spontaneously passed stools, and their instructions for each
of these tests state that the specimen for analysis should be collected by
“scraping the surface of the fecal sample with the sample probe” or using a
brush or other device, and the sample should be obtained “from the collection
paper or from a

specimen caught in a clean cup,” or from toilet bowl water
adjacent to the stool specimen.

Adapted from Smith et al., 2017

 

Screening Tests Versus Diagnostic Tests

The screening guidelines listed above are for asymptomatic,
average risk individuals (Smith et al., 2017). Early CRC has no symptoms but
later-stage CRC can have the following symptoms: blood in the stool; dark,
tarry stool; abdominal pain; or a change in bowel habits. Most people have no
symptoms early in the disease, so routine screening for colon cancer is
important (American Academy of Family Practice, 2015). Providers should be
aware that patients of any age presenting with CRC symptoms merit a referral
for a diagnostic colonoscopy to determine the cause of the symptoms. Figure 1
(above) demonstrates an increase in both the incidence and mortality from CRC
in individuals under age 50 years (Siegel, et al., 2017). Therefore, there are
discussions of lowering the screening age for CRC. The American College of
Gastroenterology does recognize that African-American men and women and
patients with an extreme smoking history or obesity are at higher risk and they
therefore recommend CRC screening start at age 45 years for these populations
(Rex, Johnson, Schoenfeld, Burke, & Inadomi, 2009).

 

The Best Screening Test is the Test the Patient Will
Complete

Some primary care providers consider the colonoscopy as the
“gold standard” yet experts agree that the best screening test is the one that
gets done (Safarty et al., 2013). No CRC screening test is perfect, either for
cancer detection or adenoma detection. Each test has unique advantages, each
has been shown to be cost-effective, and each has associated limitations and
risks. Patient preferences and availability of resources play an important role
in the selection of screening tests (Levin et al., 2008).

 

The Fecal Immunochemical Test (FIT): An Inexpensive, At-Home
Screening Option Well-Received by Patients

The use of the gFOBT for CRC screening is well supported by
randomized trials demonstrating effectiveness in short-term and long-term
reductions in CRC incidence and mortality. The FIT is a direct measure of human
hemoglobin in stool and has advantages over the gFOBT. Hemoglobin is

degraded as it moves through the gastrointestinal tract, so
FIT testing is viewed as specific for lower tract bleeding. With a 1-time
application, FIT tests are approximately 80% sensitive for cancer detection and
approximately 20%–30% sensitive for advanced neoplasia detection. Repeated
applications of FIT are required. Individuals choosing FIT should understand
the need for recurring testing and for colonoscopy to evaluate a positive FIT
result. Colonoscopy is recommended when the test is positive, not repeat FIT.
Patient participation is approximately 20% better greater for those offered FIT
compared with gFOBT due to a simpler sampling method (fewer samples needed for
FIT completion usually 1 or 2 tests compared with gFOBT 3 tests), and
removing the need for dietary and medication restriction. Adherence to FIT is
better than adherence to colonoscopy for CRC screening (Robertson et al.,
2017). One study showed that an annual FIT test yielded similar life-years
gained compared with colonoscopy performed every 10 years (Zauber, 2008).
Patients must comply with the annual FIT testing to gain these equivalent
benefits.

 

The Stool DNA Test

Stool DNA testing detects altered DNA markers from CRC cells
shed into the lumen of the bowel. The multitarget stool DNA test includes a FIT
test. With 1-time testing, sensitivity for CRC was better with the multitarget
stool DNA test (Robertson et al., 2017) and detects 92% of CRC and 69% of
high-risk pre-cancers. This is also a convenient, at-home test with no special
preparation, time off from work, or changes in diet or medication required.
Medicare covers this option with a $0 copay or deductible. Many insurance
companies cover this test but the out-of-pocket cost can be up to $649. This
product has a Patient Support Team to help patients and perform follow-up to
help make this an easy option for a provider to order (Cologuard, 2017).

 

Health Policy and CRC Screening

Insurance coverage policies may contribute to failed
follow-up after a positive initial screening test. The

Patient Protection and Affordable Care Act requires most
health plans (including Medicare) to cover CRC screening with no cost-sharing
by the patient, but this applies only to the first-line screening test. If a
patient chooses a stool test as their initial screen and that test is positive,
then the colonoscopy performed in follow-up to the positive stool test is often
coded as a diagnostic procedure, leading

 

some insured patients to become responsible for a portion of
the costs for the procedure. This policy varies from one insurer to the next.
Fortunately, some insurers have recognized the “Catch-22” nature of this
approach (ie, it encourages patients to choose the more expensive option of
colonoscopy as their first choice to avoid the possible out–of-pocket costs
that can be incurred as the result of a positive stool

test) and have opted to treat the colonoscopy after a
positive stool test as a continuation of the screening process. This is the
approach that ACS and other organizations advocate with insurers and a policy
issue that is being actively promoted at the state and federal levels. This
potential payment issue should not come as a surprise so it is important that
all patients who are offered stool testing (or other non-colonoscopy screening
tests) be informed that: 1) if the test is positive, they must be willing to
undergo colonoscopy; and 2) if they choose stool testing as their initial
screening test, they may become responsible for some of the costs of
colonoscopy (Smith et al., 2017).

 

Building a High-Quality Screening Program

Building a high-quality screening program requires an
investment in system change and the support of the leadership team. The
following are steps proven to standardize clinics and promote higher screening
rates.

Step 1: Develop a Screening Policy.

A policy should specify the screening program. If
colonoscopy capacity is inadequate, which is true in most locations, a FIT or a
guaiac-based stool test for age- and risk-appropriate patients is a practical

and evidence-based approach. Colonoscopies must also be
available for patients at higher risk or for

diagnostic purposes following positive stool screens.

Step 2: Use a Protocol

Use a protocol that includes delivering a recommendation for
CRC screening to every eligible patient. The provider’s recommendation for
screening is highly effective to promote adherence to CRC screening! A quality
improvement system should ensure that every patient gets a risk assessment,
that prior screening is updated regularly, and that every patient who is
eligible for screening gets an appropriate screening recommendation. A quality
protocol will clarify which team member(s) are responsible for these tasks.
Someone should provide the patient with instructions and make sure the patient
can “teach back,” explaining the steps to complete the testing process.
Cultural, linguistic, and literacy appropriateness must be considered. Patient
handouts may be found in the “How to Increase Colorectal Cancer Screening Rates
in Practice: A Primary Care Clinician’s Evidence-Based Toolbox and Guide”
(nccrt.org/about/provider-education/crc-clinician-guide/).

Step 3: Use Reminders.

Reminders are valuable to both patients and providers.
Patient reminders can be provided in several ways: in person, via telephone, or
through the mail. Reminders can let patients know they are due or over-due for
screening. A reminder sent before a clinic visit can save the provider the time
needed to make the recommendation; however, it takes only a few minutes to make
this recommendation. If a stool test is not returned within 1 month, the
patient should be reminded to return it, with a second reminder at 2 months if
needed.

Step 4: Track Test Results and Follow-up.

Staff should keep track of all referrals and all stool
tests. If a stool screen is positive, the patient must be contacted to arrange
for a diagnostic colonoscopy. If the patient is a no-show for colonoscopy and
needs rescheduling, making a personal contact with him or her will make a
difference. Responsibility for follow-up and rescheduling should be an explicit
understanding between the clinic and the GI specialist, and reflected in the
clinic screening protocol discussed above to ensure that the colonoscopy takes
place. All screening results should be recorded in the Electronic Health Record
in searchable fields that include:

-The test(s)

-The date the test was performed

-The results

-Follow-up recommendation(s)

-Dates on which follow-up was attempted and completed
(Safarty et al., 2013).

 

Quality Indicators of Colonoscopy Services

All adults undergoing colonoscopy should receive a
high-quality test. Factors that are accepted as indicators of the quality of
colonoscopy include adequacy of the bowel preparation to allow good
visualization of the colon lumen and wall, the cecal intubation rate (Smith et al.,
2017, the use of

recommended surveillance intervals (Robertson et al., 2017),
and perhaps most importantly, the adenoma detection rate (ADR). The ADR is
defined as the proportion of patients undergoing screening colonoscopy that had
one or more adenomas detected. The recommended target composite ADR is 25% (30%
for men and 20% for women). Most interval CRCs are believed to arise from
lesions missed at the time of the most recent colonoscopy. Several studies have
shown a correlation between the average ADR recorded for an endoscopist and the
likelihood of interval cancers among the patients s/he served. These variations
in colonoscopy performance on CRC detection and mortality reinforce the need
for colonoscopy quality-assurance programs. Primary care providers should ask
their consulting endoscopists to provide information on colonoscopy quality to
ensure that referrals are made to a service that is undertaking the delivery of
high-quality examinations (Smith et al., 2017).

 

Evidence-Based Tools and Resources Available

Information on the policy points (described above) is
available: “How to Increase Colorectal Cancer Screening Rates in Practice: A
Primary Care Clinician’s Evidence-Based Toolbox and Guide”
(nccrt.org/about/provider-education/crc-clinician-guide/).

 

The FOBT Clinician’s Reference Resource is designed to
improve screening rates using the gFOBT or FIT. A slide set addresses key
issues for implementing a quality testing program
(nccrt.org/about/provider-education).

 

The FLU-FIT Program: FIT kits are distributed during annual
influenza vaccination campaigns (FLUFIT.org).

 

The CDC’s Screen for Life: National Colorectal Cancer Action
Campaign provides educational materials

for patients. The Web site offers downloadable pamphlets,
usable educational text, and video recordings in English and Spanish that
feature celebrity testimonials and individual stories
(cdc.gov/cancer/colorectal/sfl).

 

The Prevent Cancer Foundation offers public education
materials
(preventcancer.org/prevention/preventable-cancers/colorectal-cancer/).

 

The ACS has CRC tools and resources for providers and
patients. Education and awareness tools including videos, PowerPoint
presentations, examination room posters, and brochures can be viewed,
downloaded, or ordered at no cost (cancer.org/colonmd).

 

An article commissioned by the Roundtable helps frame the
needs and opportunities with respect to integrating cancer screening into the
medical home (Sarfaty, Wender, & Smith, 2011).

 

Roundtable reports on colonoscopy quality and the
responsibilities of primary care providers in assuring high-quality colonoscopy
services for their patients are available (Safarty et al., 2013).

 

Summary

Colorectal cancer is the third most commonly diagnosed
cancer for men and women in the US but the incidence and mortality rates have
declined in recent decades. One reason for this improvement is increased
screening rates that allow for early detection and treatment.

 

All men and women aged 50 years and older should be screened
for CRC and screening should continue until age 75 years and then on a
case-by-case basis. The ACS recommends several types of screening tests, some
of which detect adenomatous polyps and cancers versus those that primarily
detect cancer. Most people have no symptoms early in the disease, so routine
screening for colon cancer is important. Providers should be aware that
patients of any age presenting with CRC symptoms merit a referral for a
diagnostic colonoscopy to determine the cause of the symptoms. There has been
an increase in both the incidence and mortality from CRC in individuals under
age 50 years so providers need to keep a high index of suspicion for these
patients.

 

The best screening test is the one that gets done. The FIT
is an inexpensive, at-home screening option that is well-received by patients.
The annual FIT test yielded similar life-years gained compared with colonoscopy
performed every 10 years.

 

Clinics need to develop a high-quality screening program
which requires 1) a policy that specifies the screening program, 2) a protocol
that includes delivering a recommendation for CRC screening to every eligible
patient, 3) reminders which are beneficial to both the patient and provider, 4)
staff who keeps track of all referrals and stool tests and results, and 5)
searchable records for test(s), dates, results, and follow-up
recommendation(s).

 

Various campaigns promote CRC screening. The FLU-FIT Program
distributes FIT tests during the annual influenza vaccinations. The ACS has
free CRC tools and resources for providers and patients including education and
awareness tools, videos, PowerPoint presentations, examination room posters,
and brochures. These resources will help clinics reach the NCRCRT’s goal of 80%
screened for CRC by 2018.