UCLA
UCLA Previously Published Works
Title
Screening for Colorectal Cancer US Preventive Services Task Force Recommendation
Statement
Permalink
https://escholarship.org/uc/item/46f220f0
Journal
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 315(23)
ISSN
0098-7484
Authors
Bibbins-Domingo, Kirsten
Grossman, David C
Curry, Susan J
et al.
Publication Date
2016-06-21
DOI
10.1001/jama.2016.5989
Peer reviewed
eScholarship.org Powered by the California Digital Library
University of California
Screening for Colorectal Cancer
US Preventive Services Task Force
Recommendation Statement
US Preventive Services Task Force
T
he US Preventive Services Task Force (USPSTF) makes rec-
ommendations about the effectiveness of specific preven-
tive careservices for patients without obviousrelatedsigns
or symptoms.
It bases its recommendations on the evidence of both the
benefits and harms of the service and an assessment of the bal-
ance. The USPSTF does not consider the costs of providing a ser-
vice in this assessment.
TheUSPSTF recognizesthatclinical decisions involvemorecon-
siderations than evidence alone. Clinicians should understand the
evidence but individualize decision making to the specific patient
or situation. Similarly, the USPSTF notes that policy and coverage
decisions involve considerations in addition to the evidence of clini-
cal benefits and harms.
Summary of Recommendations and Evidence
The USPSTF recommends screening for colorectal cancer starting
at age 50 years and continuing until age 75 years (A recommenda-
tion) (Figure 1).
The risks and benefits of different screening methods vary. See
the Clinical Considerations section later in this article and the Table
for details about screening strategies.
The decision to screen for colorectal cancer in adults aged 76 to
85yearsshould beanindividual one, takinginto accountthe patient’s
overall healthand prior screening history(C recommendation).
• Adults in this age group who have never been screened for colo-
rectal cancer are more likely to benefit.
IMPORTANCE Colorectal cancer is the second leading cause of cancer death in the United
States. In 2016, an estimated 134 000 persons will be diagnosed with the disease, and about
49 000 will die from it. Colorectal cancer is most frequently diagnosed among adults aged 65
to 74 years; the median age at death from colorectal cancer is 73 years.
OBJECTIVE To update the 2008 US Preventive Services Task Force (USPSTF)
recommendation on screening for colorectal cancer.
EVIDENCE REVIEW The USPSTF reviewed the evidence on the effectiveness of screening with
colonoscopy, flexible sigmoidoscopy, computed tomography colonography, the guaiac-based
fecal occult blood test, the fecal immunochemical test, the multitargeted stool DNA test, and
the methylated SEPT9 DNA test in reducing the incidence of and mortality from colorectal
cancer or all-cause mortality; the harms of these screening tests; and the test performance
characteristics of these tests for detecting adenomatous polyps, advanced adenomas based
on size, or both, as well as colorectal cancer. The USPSTF also commissioned a comparative
modeling study to provide information on optimal starting and stopping ages and screening
intervals across the different available screening methods.
FINDINGS The USPSTF concludes with high certainty that screening for colorectal cancer in
average-risk, asymptomatic adults aged 50 to 75 years is of substantial net benefit. Multiple
screening strategies are available to choose from, with different levels of evidence to support
their effectiveness, as well as unique advantages and limitations, although there are no
empirical data to demonstrate that any of the reviewed strategies provide a greater net
benefit. Screening for colorectal cancer is a substantially underused preventive health
strategy in the United States.
CONCLUSIONS AND RECOMMENDATIONS The USPSTF recommends screening for colorectal
cancer starting at age 50 years and continuing until age 75 years (A recommendation). The
decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one,
taking into account the patient’s overall health and prior screening history (C recommendation).
JAMA. 2016;315(23):2564-2575. doi:10.1001/jama.2016.5989
Published online June 15, 2016. Last corrected on June 6, 2017.
Viewpoint page 2519 and
Editorial
page 2529
Author Audio Interview at
jama.com
Related articles pages 2576
and 2595 and JAMA Patient
Page pages 2635 and 2636
CME Quiz at
jamanetworkcme.com
Related articles at
jamaoncology.com
jamainternalmedicine.com
Author/Group Information: The
USPSTF members are listed at the
end of this article.
Corresponding Author: Kirsten
Bibbins-Domingo, PhD, MD, MAS
(
chair@uspstf.net)
Clinical Review & Education
US Preventive Services Task Force | RECOMMENDATION STATEMENT
2564 JAMA June 21, 2016 Volume 315, Number 23 (Reprinted) jama.com
Downloaded From: http://jamanetwork.com/ by a University of California - Los Angeles User on 09/06/2017
• Screening would be most appropriate among adults who (1) are
healthy enough to undergo treatment if colorectal cancer is de-
tected and (2) do not have comorbid conditions that would sig-
nificantly limit their life expectancy.
Rationale
Importance
Colorectal cancer is the second leading cause of cancer death in
the United States. In 2016, an estimated 134 000 persons will be
diagnosed with the disease, and about 49 000 will die from it.
Colorectal cancer is most frequently diagnosed among adults
aged 65 to 74 years; the median age at death from colorectal can-
cer is 73 years.
3
Detection
The USPSTF found convincing evidence that screening for colorec-
talcancerwithseveral different methodscanaccurately detectearly-
stage colorectal cancer and adenomatous polyps.
Although single test performance is an important issue in the
detection of colorectal cancer, the sensitivity of the test over time
is more important in an ongoing screening program. However, data
that permit assessment anddirect comparisonofscreening methods
Figure 1. US Preventive Services Task Force Grades and Levels of Certainty
What the USPSTF Grades Mean and Suggestions for Practice
Grade
Definition
A
The USPSTF recommends the service. There is high certainty that the net benefit is substantial. Offer or provide this service.
Suggestions for Practice
B
The USPSTF recommends the service. There is high certainty that the net benefit is moderate, or
there is moderate certainty that the net benefit is moderate to substantial.
Offer or provide this service.
C
The USPSTF recommends selectively offering or providing this service to individual patients
based on professional judgment and patient preferences. There is at least moderate certainty
that the net benefit is small.
Offer or provide this service for selected
patients depending on individual
circumstances.
D
The USPSTF recommends against the service. There is moderate or high certainty that the service
has no net benefit or that the harms outweigh the benefits.
Discourage the use of this service.
I statement
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits
and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of
benefits and harms cannot be determined.
Read the Clinical Considerations section
of the USPSTF Recommendation
Statement. If the service is offered,
patients should understand the
uncertainty about the balance of benefits
and harms.
USPSTF Levels of Certainty Regarding Net Benefit
Level of Certainty
Description
High
The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care
populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be
strongly affected by the results of future studies.
Moderate
The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate
is constrained by such factors as
the number, size, or quality of individual studies.
inconsistency of findings across individual studies.
limited generalizability of findings to routine primary care practice.
lack of coherence in the chain of evidence.
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large
enough to alter the conclusion.
The USPSTF defines certainty as “likelihood that the USPSTF assessment of the net benefit of a preventive service is correct.” The net benefit is defined as
benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature
of the overall evidence available to assess the net benefit of a preventive service.
Low
The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of
the limited number or size of studies.
important flaws in study design or methods.
inconsistency of findings across individual studies.
gaps in the chain of evidence.
findings not generalizable to routine primary care practice.
lack of information on important health outcomes.
More information may allow estimation of effects on health outcomes.
USPSTF Recommendation Statement: Screening for Colorectal Cancer US Preventive Services Task Force Clinical Review & Education
jama.com (Reprinted) JAMA June 21, 2016 Volume 315, Number 23 2565
Downloaded From: http://jamanetwork.com/ by a University of California - Los Angeles User on 09/06/2017
to detect colorectal neoplasia in screening programs over time are
limited to those from analytic modeling.
Benefits of Screening and Early Intervention
The USPSTF found convincing evidence that screening for colorec-
tal cancer in adults aged 50 to 75 years reduces colorectal cancer
mortality. The USPSTF found no head-to-head studies demonstrat-
ing that any of the screening strategies it considered are more ef-
fective than others, although the tests have varying levels of evi-
dence supporting their effectiveness, as well as different strengths
and limitations(Table).Aboutone-thirdofeligibleadultsintheUnited
States have never been screened for colorectal cancer,
4
and offer-
ing choice in colorectal cancer screening strategies may increase
screening uptake.
5
As such, the screening tests are not presented
in any preferred or ranked order; rather, the goal is to maximize the
total number of persons who are screened because that will have
the largest effect on reducing colorectal cancer deaths.
The benefit of early detection of and intervention for colorec-
tal cancer declines after age 75 years. Among older adults who have
beenpreviouslyscreened forcolorectalcancer, there isatbesta mod-
erate benefit to continuing screening during the ages of 76 to 85
years. However, adults in this age group who have never been
screened for colorectal cancer are more likely to benefit than those
who have been previously screened.
The time between detection and treatment of colorectal
cancer and realization of a subsequent mortality benefit can be
substantial. As such, the benefit of early detection of and inter-
vention for colorectal cancer in adults 86 years and older is at
most small.
To date, no method of screening for colorectal cancer has been
shown to reduce all-cause mortality in any age group.
1,6
Harms of Screening and Early Intervention
The harms of screening for colorectal cancer in adults aged 50 to 75
years are small. The majority of harms result from the use of colo-
noscopy, either as thescreeningtest oras follow-up for positive find-
ings detected by other screening tests. The rate of serious adverse
events from colorectal cancer screening increases with age.
1
Thus,
the harms of screening for colorectal cancer in adults 76 years and
older are small to moderate.
Table. Characteristics of Colorectal Cancer Screening Strategies
a
Screening Method Frequency
b
Evidence of Efficacy Other Considerations
Stool-Based Tests
gFOBT Every year RCTs with mortality end points:
High-sensitivity versions (eg, Hemoccult SENSA)
have superior test performance characteristics
than older tests (eg, Hemoccult II)
Does not require bowel preparation, anesthesia,
or transportation to and from the screening
examination (test is performed at home)
FIT
c
Every year Test characteristic studies:
Improved accuracy compared with gFOBT
Can be done with a single specimen
Does not require bowel preparation, anesthesia,
or transportation to and from the screening
examination (test is performed at home)
FIT-DNA Every 1 or 3 y
d
Test characteristic studies:
Specificity is lower than for FIT, resulting in more
false-positive results, more diagnostic
colonoscopies, and more associated adverse
events per screening test
Improved sensitivity compared with FIT
per single screening test
There is insufficient evidence about appropriate
longitudinal follow-up of abnormal findings after
a negative diagnostic colonoscopy; may
potentially lead to overly intensive surveillance
due to provider and patient concerns over the
genetic component of the test
Direct Visualization Tests
Colonoscopy
c
Every 10 y Prospective cohort study with mortality end point Requires less frequent screening
Screening and diagnostic follow-up of positive
findings can be performed during the same
examination
CT colonography
e
Every 5 y Test characteristic studies There is insufficient evidence about the potential
harms of associated extracolonic findings,
which are common
Flexible sigmoidoscopy Every 5 y RCTs with mortality end points:
Modeling suggests it provides less benefit
than when combined with FIT or compared
with other strategies
Test availability has declined in the United States
Flexible sigmoidoscopy
with FIT
c
Flexible sigmoidoscopy
every 10 y plus FIT
every year
RCT with mortality end point (subgroup analysis) Test availability has declined in the United States
Potentially attractive option for patients who
want endoscopic screening but want to limit
exposure to colonoscopy
Abbreviations: FIT, fecal immunochemical test; FIT-DNA, multitargeted stool
DNA test; gFOBT, guaiac-based fecal occult blood test; RCT, randomized
clinical trial.
a
Although a serology test to detect methylated SEPT9 DNA was included in the
systematic evidence review, this screening method currently has limited
evidence evaluating its use (a single published test characteristic study met
inclusion criteria, which found it had a sensitivity to detect colorectal cancer of
<50%).
1
It is therefore not included in this table.
b
Applies to persons with negative findings (including hyperplastic polyps) and
is not intended for persons in surveillance programs. Evidence of efficacy is
not informative of screening frequency, with the exception of gFOBT and
flexible sigmoidoscopy alone.
c
Strategy yields comparable life-years gained (ie, the life-years gained with the
noncolonoscopy strategies were within 90% of those gained with the
colonoscopy strategy) and an efficient balance of benefits and harms in
CISNET modeling.
2
d
Suggested by manufacturer.
e
Strategy yields comparable life-years gained (ie, the life-years gained with the
noncolonoscopy strategies were within 90% of those gained with the
colonoscopy strategy) and an efficient balance of benefits and harms in
CISNET modeling when lifetime number of colonoscopies is used as the proxy
measure for the burden of screening, but not if lifetime number of cathartic
bowel preparations is used as the proxy measure.
2
Clinical Review & Education US Preventive Services Task Force USPSTF Recommendation Statement: Screening for Colorectal Cancer
2566 JAMA June 21, 2016 Volume 315, Number 23
(Reprinted) jama.com
Downloaded From: http://jamanetwork.com/ by a University of California - Los Angeles User on 09/06/2017
USPSTF Assessment
The USPSTF concludes with high certainty that the net benefit
(ie, the benefit minus the harms) of screening for colorectal cancer
in adults aged 50 to 75 years is substantial.
The USPSTF concludes with moderate certainty that the net
benefit ofscreening forcolorectalcancer inadultsaged76to85years
who have been previously screened is small. Adults who have never
been screened for colorectal cancer are more likely to benefit.
Clinical Considerations
Patient Population Under Consideration
This recommendation applies to asymptomatic adults 50 years and
older who are at average risk of colorectal cancer and who do not
have a family history of known genetic disorders that predispose
them to a high lifetime risk of
colorectal cancer (suchas Lynch
syndrome or familial adenoma-
tous polyposis), a personal his-
tory of inflammatory bowel dis-
ease, a previous adenomatous
polyp, or previous colorectal
cancer (Figure 2).
When screening results in
the diagnosis of colorectal ad-
enomas or cancer, patients are
followed up with a surveillance
regimen, and recommenda-
tions for screening no longer
apply. The USPSTF did not re-
view or consider the evidence on the effectiveness of any particu-
lar surveillance regimen after diagnosis and removal of adenoma-
tous polyps or colorectal cancer.
Assessment of Risk
For the vast majority of adults, the most important risk factor for
colorectal cancer is older age. Most cases of colorectal cancer oc-
cur among adults older than 50 years; the median age at diagnosis
is 68 years.
3
A positivefamily history (excludingknown inherited familial syn-
dromes) is thought to be linked to about 20% of cases of colorectal
cancer.
1
About 3% to 10% of the population has a first-degree rela-
tive with colorectal cancer.
7
The USPSTF did not specifically review
the evidence on screening in populations at increased risk; how-
ever,otherprofessionalorganizationsrecommendthatpatients with
a familyhistoryofcolorectal cancer (a first-degreerelative withearly-
onset colorectalcanceror multiplefirst-degree relatives with the dis-
ease)bescreened morefrequently startingat a younger ageandwith
colonoscopy.
8
Male sex and black race are also associated with higher colo-
rectal cancer incidence and mortality. Black adults have the high-
est incidence and mortality rates compared with other racial/
ethnic subgroups.
3
The reasons for these disparities are not
entirely clear. Studies have documented inequalities in screening,
diagnostic follow-up, and treatment; they also suggest that equal
treatment generally seems to produce equal outcomes.
9-11
Accordingly, this recommendation applies to all racial/ethnic
groups, with the clear acknowledgment that efforts are needed to
ensure that at-risk populations receive recommended screening,
follow-up, and treatment.
Screening Tests
The Table lists the various screening tests for colorectal cancer and
notes potential frequency of use as well as additional consider-
ations for each method. Figure 3 presents the estimated number of
life-years gained, colorectal cancer deaths averted, lifetime colo-
noscopies required, and resultingcomplications per 1000 screened
adults aged50 to 75years for each of thescreening strategies. These
estimates are derived from modeling conducted by the Cancer In-
tervention and Surveillance Modeling Network (CISNET) to inform
this recommendation.
2,12
Stool-Based Tests
Multiple randomized clinical trials (RCTs) have shown that screen-
ing with the guaiac-based fecal occult blood test (gFOBT) reduces
colorectal cancer deaths.
1
Fecal immunochemical tests (FITs),
which identify intact human hemoglobin in stool, have improved
sensitivity compared with gFOBT for detecting colorectal cancer.
1
Among the FITs that are cleared by the US Food and Drug Adminis-
tration (FDA) and available for use in the United States, the OC
FIT-CHEK family of FITs (Polymedco)—which include the OC-Light
and the OC-Auto—have the best test performance characteristics
(ie, highest sensitivity and specificity).
1
Multitargeted stool DNA
testing (FIT-DNA) is an emerging screening strategy that combines
a FIT with testing for altered DNA biomarkers in cells shed into the
stool. Multitargeted stool DNA testing has increased single-test
sensitivity for detecting colorectal cancer compared with FIT
alone.
13
The harms of stool-based testing primarily result from
adverse events associated with follow-up colonoscopy of positive
findings.
1
The specificity of FIT-DNA is lower than that of FIT
alone,
13
which means it has a higher number of false-positive
results and higher likelihood of follow-up colonoscopy and experi-
encing an associated adverse event per screening test. There are
no empirical data on the appropriate longitudinal follow-up for an
abnormal FIT-DNA test result followed by a negative colonoscopy;
there is potential for overly intensive surveillance due to clinician
and patient concerns about the implications of the genetic compo-
nent of the test.
Direct Visualization Tests
Several RCTs have shown that flexible sigmoidoscopy alone
reduces deaths from colorectal cancer.
1
Flexible sigmoidoscopy
combined with FIT has been studied in a single trial and was found
to reduce the colorectal cancer–specific mortality rate more than
flexible sigmoidoscopy alone.
14
Modeling studies conducted by
CISNET also consistently estimate that combined testing yields
more life-years gained and colorectal cancer deaths averted com-
pared with flexible sigmoidoscopy alone.
2
Flexible sigmoidoscopy
can result in direct harms, such as colonic perforations and bleed-
ing, although the associated event rates are much lower than those
observed with colonoscopy.
1
Harms can also occur as a result of
follow-up colonoscopy.
Completed trialsof flexiblesigmoidoscopy provideindirect evi-
dence that colonoscopy—a similar endoscopic screening method—
reducescolorectal cancermortality. A prospective cohort study also
JAMA.COM +
Animated Summary Video
Screening for Colorectal
Cancer: US Preventive
Services Task Force
Recommendation Statement
USPSTF Recommendation Statement: Screening for Colorectal Cancer US Preventive Services Task Force Clinical Review & Education
jama.com (Reprinted) JAMA June 21, 2016 Volume 315, Number 23 2567
Downloaded From: http://jamanetwork.com/ by a University of California - Los Angeles User on 09/06/2017
