June 2012 - American Association for Clinical Chemistry

Screening Tests Spark Controversy
Screening Tests, continued from page 1 The Choosing Wisely Campaign
dilemma we face,” he said. “But I think
people trained in clinical lab science have
a lot to offer here, and I hope they can help
us educate clinicians.” Harris was a member
of the United States Preventive Services
Task Force (USPSTF) from 2003–2008.
Overuse Looms, But Evades
Easy Measurement
Whether they be regulators, lawmakers, or
pundits on the evening news, all seem to
agree that the cost of healthcare is becoming
unsustainable. Most recently, Medicare
has projected that by 2020, national health
spending could reach $4.6 trillion and
comprise nearly 20% of gross domestic
product. Making matters worse, it appears
that the nation is addicted to profligate
testing and treatments that by some estimates
consume up to 30% of healthcare
spending.
Despite this highly charged atmosphere,
professional and consumer groups have
chosen to team up and weigh in on how
the nation should grapple with its healthcare
spending problem. In a first-of-itskind
response to overuse, a new campaign
called Choosing Wisely from the American
Board of Internal Medicine Foundation
has brought together nine top medical
societies as well as Consumer Reports to
educate both physicians and patients about
common unnecessary tests and treatments.
Each physician specialty society published
a list of “Five Things Physicians and Patients
Should Question.” Many of the 45
items implicate unnecessary imaging or
laboratory screening tests (See Box, right).
Two separate but related initiatives from
the American College of Physicians (ACP)
parallel Choosing Wisely. ACP, a Choosing
Wisely participant, has announced its own
partnership with Consumer Reports. The
two organizations are developing patientoriented
brochures and other resources
to help patients understand the benefits,
harms, and costs of tests and treatments
for common clinical issues. The resources
will be derived from ACP’s evidence-based
clinical practice recommendations published
in Annals of Internal Medicine and
on the Consumer Reports website. This
patient-centered initiative comes 2 years
after ACP’s other project, the High Value,
Cost-Conscious Care Initiative, which was
aimed at physicians.
The most recent product from the
High Value, Cost-Conscious care series,
published in January 2012, focused on
screening and diagnostic tests. ACP convened
a workgroup of physicians under a
consensus-based process to identify tests
that did not reflect high-value care (Ann
Intern Med 2012;156:147–149). Similar to
Choosing Wisely, ACP’s list of 37 clinical
scenarios includes many imaging tests, but
about half encompass clinical lab tests (See
Online Extra).
Despite testing being a target, many
of the group’s recommendations may
not provoke much controversy in the lab
community. But if laboratorians do disagree
with such recommendations, new
research reveals that the medical literature
on overuse of lab tests is extremely limited.
A study published as part of the Archives of
Internal Medicine’s Less Is More series re-
viewed 114,831 publications over 21 years
and found only 172 articles that addressed
overuse of healthcare (Arch Intern Med
2012;172:171–178). The majority of the
studies focused on four interventions: antibiotics
for upper respiratory tract infections,
and three cardiovascular procedures.
Just a handful addressed lab tests, notably
PSA and fecal occult blood testing (FOBT).
According to study coauthor Salomeh
Keyhani, MD, MPH, the reason for the
paucity of studies on overuse of lab tests is
clear: too few definitive guidelines. “If you
want to eliminate inappropriate care, you
have to designate what exactly is inappropriate,
which is not an easy thing,” she said.
“Diagnostic tests are a particular challenge
in terms of establishing when it’s appropriate
to order them. The indications for diagnostic
testing are not routinely evaluated in
the same way as indications for therapeutic
procedures.” Keyhani is an assistant professor
of medicine and of health evidence and
policy at the Mount Sinai School of Medicine
in New York.
Moreover, where guidelines do exist,
whether for tests or treatments, they often
conflict, Keyhani noted. “In the U.S., we
have a free market for guidance,” she said.
“We have every single medical specialty society
with its own emphasis and own focus
putting out guidelines, and to some extent,
they disagree.”
Data and Decision-Making
With screening tests showing up on lists
of questionable practices and under the
spotlight for research on overuse, there
should be no surprise that screening tests
also stimulate the most public controversy.
To be sure, the public has strong opinions.
A seminal study in 2004 found that
74% of American adults believed that
finding cancer early via screening saved
lives most or all of the time, and many
said that an 80-year-old who chose not
to be screened was irresponsible (JAMA
2004;291:71–78). In addition, two-thirds
of respondents indicated they would
want to be screened for a cancer even if
no treatment was available.
More recently, in 2011 a draft “D” recommendation—the
strongest negative
statement—from USPSTF against PSA
screening at any age led to public outcry
and widespread media coverage (CLN
2011;37:11). USPSTF also took a more
cautious view of Pap testing in March of
this year, recommending women ages 21
to 65 be screened only every 3 years. Then
in April, USPSTF published draft recommendations
on screening for chronic kidney
disease that contains an “I” statement
for insufficient evidence. In recent years,
USPSTF advisories have taken on more
weight as most payers, including Medicare,
rely heavily on their recommendations to
make decisions about coverage and reimbursement.
Evidence suggests that cancer screening
tests in particular have unusual patterns of
utilization: potentially significant overuse
in some cases, and underuse in others. A
Government Accountability Office (GAO)
report released in January found that use
of some screenings—for cardiovascular
disease and cervical cancer—by Medicare
beneficiaries generally aligned with clini-
Group Urges Patients, Physicians to Question Tests
Nine leading physician specialty societies have identified specific
tests or procedures that they say are commonly used but not always
necessary in their respective fields and put forward “Five Things
Physicians and Patients Should Question.” Created by the American
Board of Internal Medicine (ABIM), the ABIM Foundation spearheaded
the campaign.
Consumer Reports—the world’s largest independent product
testing organization—is working with the ABIM Foundation and
the specialty societies to lead the effort. Consumer Reports will also
work with other consumer-oriented organizations such as AARP.
The nine participating specialty societies include the American
Academy of Allergy, Asthma and Immunology, American Academy of
Family Physicians, American College of Cardiology, American College
of Physicians, American College of Radiology, American Gastroenterological
Association, American Society of Clinical Oncology,
American Society of Nephrology, and American Society of Nuclear
Cardiology.
“By identifying tests and procedures that might warrant additional
conversations between doctors and patients, we are able to
help patients receive better care through easy-to-use and accessible
information,” said James A. Guest, JD, president and CEO of Consumer
Reports. “We’re looking forward to being a part of this innovative
effort working with the ABIM Foundation, the specialty societies,
and our eleven consumer communications collaborators to get this
important message out to diverse populations of patients.”
In addition, the campaign announced eight new participating
specialty societies that will release lists in fall 2012: American
Academy of Hospice and Palliative Medicine, American Academy of
Otolaryngology–Head and Neck Surgery, American College of Rheumatology,
American Geriatrics Society, American Society for Clinical
Pathology, American Society of Echocardiography, Society of Hospital
Medicine, and Society of Nuclear Medicine.
Examples from “Things Physicians and Patients Should
Question”:
® Don’t perform unproven diagnostic tests, such as immunoglobulin
G (IgG) testing or an indiscriminate battery of immunoglobulin
E (IgE) tests, in the evaluation of allergy.
® Don’t routinely do diagnostic testing in patients with chronic
urticaria.
® Don’t perform Pap smears on women younger than age 21 or
who have had a hysterectomy for non-cancer disease.
® In patients with low pretest probability of venous thromboembolism
(VTE), obtain a high-sensitivity D-dimer measurement as the
initial diagnostic test; don’t obtain imaging studies as the initial
diagnostic test.
® Do not repeat colorectal cancer screening by any method for 10
years after a high-quality colonoscopy is negative in average-risk
individuals.
® Don’t perform surveillance testing (biomarkers) or imaging (PET,
CT, and radionuclide bone scans) for asymptomatic individuals
who have been treated for breast cancer with curative intent.
® Don’t perform routine cancer screening (mammography, colonoscopy,
PSA, Pap smears) for dialysis patients with limited life expectancies
and without signs or symptoms of conditions detected by
these tests.
cal recommendations, but other cancer
screening tests did not. For example, even
though USPSTF recommends biannual
breast cancer screening in women ages 65
to 74, only two out of three beneficiaries
in this age group received a mammogram
in 2008 or 2009. In the case of colorectal
cancer screening, only one in four beneficiaries
ages 65 to 75 received any of the
recommended regimens. With PSA testing
for prostate cancer, overuse was the
problem: almost half of men age 75 or
older were tested, contrary to USPSTF
recommendations.
In a more striking example, researchers
at the University of Chicago Medical Center
evaluated changes in national screening
rates before and after the USPSTF 2008
recommendation against PSA screening in
men older than 75. They found that PSA
screening rates were unchanged from 2005
to 2010 in all age groups (JAMA 2012;
307:1692–1694). Apparently, physicians
See Screening Tests, continued on page 4
CliniCal laboratory news June 2012 3