DISEASE MANAGEMENT

Volume 9, Number 2, 2006

© Mary Ann Liebert, Inc.

The Impact of the Laboratory on Disease Management

MARYBETH REGAN, Ph.D.1 and RODNEY FORSMAN, B.S.2

ABSTRACT

The laboratory has been an integral part of the continuum of care for centuries. It has been
said that 60%–70% of critical decisions in diagnosis and treatment involve quantifiable lab-
oratory data. Disease management (DM) outcomes can be influenced through effective use
of this information. Today’s laboratory supports DM in the following ways: disease screen-
ing for early identification of disease; predictive measures to identify those at risk for a dis-
ease; disease identification to diagnose and confirm a disease; treatment which can be ini-
tially identified or changed based upon the results of a lab test; and compliance/surveillance
to identify whether a treatment is working or if the appropriate level of medication has been
prescribed for a patient. This paper discusses the importance of laboratory testing in all phases
of DM. (Disease Management 2006;9:122–130)

INTRODUCTION 95% of costs.1 It can be shown that the labora-

tory contributes as much as 94% of the objec-

T HE LABORATORY has been an integral part of

the continuum of care for centuries. It has
been said that 60%–70% of all critical, patient
care decisions are impacted by laboratory re-
sults.1 The laboratory provides benefits by of-
fering diagnostic testing services to patients. A
serious medical condition such as heart disease,
prostate cancer, or diabetes can exist without
noticeable symptoms for up to two years.2 A
simple blood test can assist in the identification
process, the treatment and monitoring of prob-
lem areas, and the establishment of a baseline
of normal laboratory ranges against which fu-
ture tests can be compared.
The cost of the laboratory for most health
systems is less than 5% of the total budget.
Physicians regularly use laboratory informa-
tion to make critical decisions regarding diag-
nosis and treatment, affecting the remaining
tive data in a clinical record and that this in-
formation is accessed as often as 200,000 times
per day as evidenced by retrievals from elec-
tronic medical records within the Mayo Health
System.1
The laboratory plays an essential role in the
continuum of care and can affect hospital ad-
missions, discharges, treatment, and other test-
ing. In fact, according to an article titled,
“Methodology and rationale for the measure-
ment of harm with trigger tools,” 22 of the 24
triggers mentioned are lab tests for identifying
adverse drug reactions. This supports not only
a retrospective view of laboratory results but,
in the electronic age, a potential real-time iden-
tification of patients at risk.3
Disease management (DM) is a system of co-
ordinated healthcare interventions and strate-
gies for patient care across the healthcare de-

1Accenture, Libertyville, Illinois.

2Mayo Collaborative Services, Inc., and Mayo Clinic College of Medicine, Rochester, Minnesota.

122
IMPACT OF THE LABORATORY ON DISEASE MANAGEMENT 123

livery system throughout the life cycle of the
disease. The laboratory supports DM in the fol-
lowing different ways:
• Disease screening
• Disease prediction
• Disease identification
• Treatment
• Monitoring/compliance
Disease screening is a major force in the early
detection of disease. For example, women of a
certain age in many parts of the world are en-
couraged to have regular cervical smears to
permit earlier detection of cervical cancer. Sim-
ilarly, prostate-specific antigen (PSA) tests are
effective as the first identification of prostate
cancer, one of the most common cancers in
American men.
Disease prediction is the identification of
persons at risk for being affected by a disease.
An example of this is the determination of
those at risk for a genetic disorder, heart dis-
ease, and individualized treatment based upon
genetic testing for altered rates of drug metab-
olism.
Disease identification positively diagnoses
and confirms a disease, usually without other
treatments. For example, a laboratory test can
positively identify patients with myocardial in-
farction, often the first sign of heart disease, as
they present to the operating room.
Treatment can be initially identified or
changed based upon the results of a lab test.
An example of this application is the identifi-
cation of the optimal immunosuppressant ther-
apy to monitor serum levels for effectiveness
and safety for transplant patients.
Monitoring/compliance monitors a disease
to ensure that the treatment regimen produces
the expected outcomes. For example, hemo-
globin A1c (HbA1c) tests traditionally are used
for diabetic patients to evaluate and modify
their treatment regimen and to monitor com-
pliance with pharmacology regimen. Table 1
identifies specific lab tests and how they sup-
port DM.
WHY DISEASE MANAGEMENT?
DM is a strategy for patient care that coor-
dinates resources across the entire healthcare
delivery system throughout the life cycle of a
disease. DM’s focus differs from the traditional
managed care approach, which targets primar-
ily individual cost components such as hospi-
talization and physician services.
The growth, acceptance and proliferation of
DM in the United States has been significant.
This trend also has expanded internationally.
Early experience has shown that DM can lead
to demonstrably better clinical outcomes, cost
control, and patient satisfaction.4 There are var-
ious components of DM, including screening,
identification, treatment, and monitoring of
disease and the treatments. Laboratory results
assist in all of these areas.

TABLE 1. EXAMPLES OF LABORATORY TESTS BY DISEASE STATE

Disease state Laboratory tests

Screening Pap smear

Prostate-specific antigen (PSA)

Prediction Newborn screening

Screening for altered drug metabolism
Breast cancer genes BRCA1 and BRCA2

Identification Test for identification of multiple sclerosis

Treatment Test for identification of appropriate level of immunosuppressant

Monitoring surveillance Hemoglobin A1c (HbA1c)

124
DISEASE SCREENING
Various laboratory tests, such as a Papani-
colaou (Pap) smear, can save patients’ lives.
Pap smears are used primarily to detect cancer
of the uterine cervix or precancerous conditions
(ie, abnormalities of the cervix that may lead to
cancer). In the United States, the death rate
from cervical cancer has declined dramatically
during the last 40 years. This can be attributed
in large part to earlier diagnosis of precancer-
ous lesions by the Pap smear.5 The Pap smear
has been largely responsible for the 70% decline
in death due to cervical cancer over the past
decade. The costs of cervical cancer were ap-
proximately $737 million in the United States
in 1994.6
Cervical cancer is the fifth leading cause of
cancer death in women. Most of these deaths
occur in women who have never had a Pap
smear. While the disease process is fatal if left
untreated, early detection increases the chances
of survival. There is a direct relationship be-
tween the use of the Pap smear as a routine
screening tool and the reduction of the inci-
dence of cervical cancer.
Early treatment of cancer has been shown to
result in improved outcomes.6 Early identifica-
tion of cervical cancer provides patients with
the greatest potential for a normal healthy life.
Prostate cancer
Another common lab test, the PSA, is a blood
test used to detect a substance made by the
prostate called the prostate-specific antigen.
This test can detect many “silent” prostate can-
cers (ie, those that have not caused symptoms).
While one in six men will be diagnosed with
prostate cancer during his lifetime, only one
man in 33 will die of the disease. It is the sec-
ond leading cause of cancer death in men. More
than 30,000 men died of this disease in 2002,
generally some years after diagnosis.
Except for skin cancer, cancer of the prostate
is the most common malignancy in American
men. This year in the United States, 232,090
men will be diagnosed with prostate cancer.7
The disease grows very slowly in most men.
The majority of men with low-grade, early
prostate cancer (ie, confined to the gland) live
REGAN AND FORSMAN
a long time after their diagnosis. Even without
treatment, many of these men will not die of
the prostate cancer, but from some other unre-
lated cause.
The PSA test first became available in the late
1980s and its use led to an increase in the de-
tection of prostate cancer between 1986 and
1991. In the mid-1990s, deaths from prostate
cancer began to decrease, and some observers
credit PSA testing for the trend. Early detection
not only identifies prostate cancer, but also
provides for early treatment which increases
survival. A normal test result also can reassure
the patient.
Figure 1 identifies the clinical pathway for
prostate cancer. Relevant laboratory tests are
noted in several of the top boxes.
DISEASE PREDICTION
Each year, thousands of people seek genetic
testing to determine if they are at risk for cer-
tain diseases. Almost half come away with no
clear answer. The reason is that current tests
may not be sensitive or accurate enough to de-
tect all gene mutations.
For patients, this category of testing can pro-
vide many benefits. Within a given family,
relatives can be identified who carry these spe-
cific genes. A screening regimen can be estab-
lished for early detection and potential pre-
vention of disease. This can decrease patient
uncertainty. For example, in the case of heart
disease, major risk factors for coronary heart
disease are identified through cholesterol
screening, lipid profiles, and C-reactive pro-
tein.
Some of the benefits of disease prediction in-
clude the following:
• Prevent disease progression
• Decrease patient uncertainty
• Offer greater choice of surgical and other in-
tervention options
• Elimination unnecessary screening
• Provide information to target patient types
There are several examples of these predic-
tive measures. We will focus on testing for
breast cancer.
IMPACT OF THE LABORATORY ON DISEASE MANAGEMENT 125

PATIENT
SYMPTOMS

PCP
SCREENING

PSA TESTS

DRE TESTS

ADDITIONAL
TESTS

DIAGNOSIS OF
CANCER

TREATMENT
OPTIONS

WATCHFUL RADIATION METASTATIC HOSPICE

WAITING THERAPY DISEASE

SURGERY BRACHY
THERAPY

FIG. 1. The care continuum for prostate patients. The third, fourth, and fifth treatments are lab tests.

Breast cancer obesity, and lifestyle factors such as heavy alco-

Every three minutes a woman in the United
States is diagnosed with breast cancer. Approx-
imately 12% of American women will develop
breast cancer during their lifetime. About 211,240
women in the United States will be found to have
invasive breast cancer in 2005. About 40,410
women will die from the disease this year. Right
now, there are about 2 million women living in
the United States who have been treated for
breast cancer.8 Of those, 5%–10% have inherited
the BRCA1 and BRCA2 gene, which identifies
those predisposed for breast cancer.9
The exact cause of breast cancer is not known.
Factors that can increase a woman’s risk include
heredity, early puberty, late or no childbearing,
hol consumption and smoking. The biggest risk
factor for breast cancer is age. Most breast can-
cers occur in women over the age of 50, and
women over 60 are at the highest risk.10
A woman’s risk for developing breast cancer
increases if her mother, sister, daughter, or two
or more other close relatives (such as cousins)
have a history of breast cancer, especially at a
young age. However, 85% of women who de-
velop breast cancer have no known family his-
tory of the disease.9
Changes in certain genes (eg, BRCA1,
BRCA2) make women more susceptible to
breast cancer. Predictive measures such as ge-
netic testing can determine whether a woman
has these abnormal genes.10
126
Women affected with a BRCA1 or BRCA2
mutation are at high risk of experiencing breast
cancer, ovarian cancer or both, often at a young
age.9 Approximately one in 800 persons in the
general population carry a BRCA1 mutation.
For people who have a BRCA mutation, clini-
cal management choices may include increased
or more intensive monitoring, chemopreven-
tion, or prophylactic surgery to remove at-risk
organs. Although some of these options may
reduce the risk for developing breast and/or
ovarian cancer, no option totally eliminates this
risk.9
DISEASE IDENTIFICATION
Disease identification can positively diag-
nose and confirm a disease, usually without
other treatments. Newborn screening and the
HbA1c test for diabetes are both examples of
early identification.
Newborn screening
Supplemental newborn screening has had
major implications for newborns. Currently,
there are over 30 biochemical genetic disorders
that can be identified in the first days of life
which can be minimized through proper treat-
ment and medical attention. The goal of a new-
born screening program is to identify those
conditions for which early intervention can
prevent mortality, morbidity, and lifelong dis-
ability. Often, simple changes in diet and nu-
trition can permit the child to lead a functional
life.
Over 4 million screens are performed annu-
ally in the United States. Screening is per-
formed by analysis of diagnostic markers in
blood spots collected on filter paper on the sec-
ond day of life.
Growing public awareness of these new di-
agnostic capabilities among parent support
groups and healthcare providers can foster the
creation of alternative testing to supplement
state screening programs.11
The major benefit of newborn screening is
the potential for the child to lead a healthy, nor-
mal life. Presymptomatic detection of disorders
can reduce morbidity and mortality. Early di-
REGAN AND FORSMAN
agnosis allows for genetic counseling for fam-
ilies and the discussion of options for future
pregnancies.12
The economic impact of such screening is a
projected savings of $36.4 million annually in
the United States.13 As an example, Ohio saved
$4 billion in treatment and institutional costs
associated with mental retardation since im-
plementing newborn screening in 1965.12 Esti-
mated cost per quality-adjusted life year by
screening is $5,827 (range, $736–$11,419—data
presented in 2001).14
Multiple sclerosis
The process of disease identification can be
frustrating for both patients and providers.
There are lab tests that can positively identify
a disease, as in the case of myocardial infarc-
tion, newborn screening for errors of metabo-
lism, and testing for multiple sclerosis (MS).
MS is a chronic immune-mediated neuro-
logical disease that affects 400,000 people in the
United States. It is a major debilitating disease
in young adults, with 10,000 new cases occur-
ring each year. Early treatment may slow dis-
ease progression.15
The diagnosis of MS depends on clinical, ra-
diological, and laboratory findings. Symptoms
vary, and many disorders resemble MS, espe-
cially in the early stages of disease.15 MS is dif-
ficult to diagnose, and often requires repeated
tests and physician visits to determine the di-
agnosis.
Early treatment may delay disease progres-
sion, which optimizes the patient’s quality of
life. Additionally, there is far greater accuracy
in the test which increases the predictive value
of the results and decreases the need for repeat
testing and unnecessary follow-up procedures.
The method also requires fewer spinal taps due
to smaller specimen volumes.15
Immunotherapy is believed to be most ben-
eficial early in the disease process, when the di-
agnosis is most difficult and before irreversible
neurological injury occurs. In patients with ac-
tive disease, immunotherapy is recommended
at a very early point after diagnosis. Addition-
ally, treatment during the first attack may be
indicated in those individuals who have not
been diagnosed with MS, but who are deemed
IMPACT OF THE LABORATORY ON DISEASE MANAGEMENT
to be at high risk for MS. However, therapy is
expensive. A negative result may help identify
low-risk individuals and avoid the expense of
unnecessary treatment.
There has been a
30% improvement in de-
tection rate resulting in cost savings from
avoiding missed diagnoses and from avoiding
unnecessary therapy.15 There are potential
long-term with prompt initiation of correct
therapy as a result of minimized or delayed
symptom onset and related expenses. Disease
identification can result in fewer follow-up
physician visits, diagnostic test, and referrals
for diagnosis.
TREATMENT AND
THERAPEUTIC MONITORING
There are a variety of treatment options for
many diseases. The treatment progression can
impact the patient’s results, but identifying the
appropriate treatment is often very difficult.
With over 24,000 transplant patients each
year and over 80,000 candidates16 waiting for
organs, there is an ever-growing need for safe,
effective, rejection-suppressing drugs.17 The
current drugs of choice (eg, cyclosporine) are
effective at low therapeutic levels that cannot
be reliably quantified at low concentrations by
immunoassay.
Due to the growing demand, there is an in-
creasing need for immunosuppressant drugs.
The inability to accurately quantify these low
(but therapeutic) levels can create a perceived
need to increase the dosage of these costly
drugs. A 0.05 mg/kg/day change in the dos-
age administered to patients represents in-
creased prescription costs of $5,500 per patient
per year. Based on observations at the Mayo
Clinic, 20% of patient results that are actually
within the therapeutic range fall below the re-
liable quantization limit for immunoassay (re-
sults 5 ng/mL), suggesting that up to 2400
patients/year could have their dosages inap-
propriately increased. Unnecessary dose in-
creases result in extra drug costs of $13 million
nationally each year for new transplant recipi-
ents. Additional office visits and laboratory
testing further increase the cost of care,
127
whereas a higher dose increases the patient’s
risk of toxicity, side effects, and infection.18
DISEASE MONITORING/COMPLIANCE
Monitoring/compliance is undertaken to
monitor events in a disease and identify con-
trol measures. An effective monitoring/com-
pliance process includes the following:
• Detection and notification of health events
• Collection and consolidation of pertinent
data
• Investigation and confirmation (ie, epidemi-
ological, clinical, laboratory) of cases or out-
breaks
• Routine analysis and creation of reports
Accurate and timely
Disease monitoring of patients takes place at
each step of patient management, from disease
detection to diagnosis and through various
procedures—depending on the disease. Every
disease requires continual monitoring to en-
sure that the patient experiences the expected
outcomes. For example, in diabetes mellitus the
HbA1c test is often utilized to assess glycemic
control in order to reduce the risks of compli-
cations and manage the disease.
Approximately 18.2 million people in the
United States, or 6.3% of the population, have
diabetes. While an estimated 13 million have
been diagnosed with diabetes, 5.2 million peo-
ple (or nearly one third) are unaware that they
have the disease.19 Diabetes mellitus affects
about 7% of adults aged 45–64 years and 12%
of those over 65 years, contributing signifi-
cantly to morbidity and mortality related to
cardiovascular disease.20
There is ample evidence that careful man-
agement can significantly reduce complications
that contribute to morbidity, major disability
and early mortality among patients. In addition
to achieving better long-term health outcomes
for patients, both long-term and short-term
health benefits and cost savings can be realized
through well-coordinated care in ambulatory
settings, reduction of hospital readmissions,
and reduction of many complications requiring
128
costly interventions.21 A key to diabetes man-
agement is the HbA1c test as indicated in the
national guidelines.
Diabetes is a disease in which the body does
not produce or properly use insulin, a hormone
that is needed to convert sugar, starches and
other food into the energy needed for daily life.
The cause of diabetes is unknown, although
both genetics and environmental factors such
as obesity and lack of exercise appear to play
roles.
People with diabetes are more susceptible to
many other illnesses and, once they acquire
these illnesses, often have worse prognoses
than people without diabetes. For example,
they are more likely to die of pneumonia or in-
fluenza than people who do not have dia-
betes.22
In general, for every one point reduction in
HbA1c, the risk of developing microvascular
diabetic complications (eg, eye disease, kidney
disease, nerve disease) is reduced by up to
40%.22
Economic impact
Direct and indirect medical expenditures at-
tributable to diabetes in 2002 were estimated at
TABLE 2. IMPACT OF THE
Tenets of DM
Communications for populations with
conditions in which patient self-care efforts are
significant
Supports the physician or practitioner/patient
relationship and plan of care,
Emphasizes prevention of exacerbations and
complications utilizing evidence-based practice
guidelines and patient empowerment strategies,
and
Evaluates clinical, humanistic, and economic
outcomes on a going basis with the goal of
improving overall health.
DM, disease management.
REGAN AND FORSMAN
$132 billion.22 Direct medical expenditures
alone totaled $91.8 billion and comprised $23.2
billion for diabetes care, $24.6 billion for
chronic complications attributable to diabetes,
and $44.1 billion for excess prevalence of gen-
eral medical conditions.22 Inpatient days
(43.9%), nursing home care (15.1%), and office
visits (10.9%) constituted the major expendi-
ture groups by service settings. In addition,
51.8% of direct medical expenditures were in-
curred by people
65 years old.22 Attributable
indirect expenditures resulting from lost work-
days, restricted activity days, mortality, and
permanent disability due to diabetes totaled
$39.8 billion.22 Per capita medical expenditures
totaled $865 billion, of which $160 billion was
incurred by people with diabetes22; per capita
medical expenditures were $13,243 for people
with diabetes versus $2,560 for people without
diabetes.22
DISEASE MANAGEMENT AND
THE LABORATORY
DM supports the physician or practi-
tioner/patient relationship and plan of care,
LABORATORY ON DM TENETS
Laboratory impact
The results of laboratory tests can result in
various levels of treatment, one of which
is self-care.
The basis for DM is the exchange of
information between practitioner and patients.
Through the exchange of information gathered
from laboratory tests, this communication is
enhanced.
Laboratory results, whether used for
identification, treatment, or monitoring, help
identify and prevent exacerbations and
complications.
The collection of data, including laboratory
data, is important to evaluate all aspects of
DM. This data can be used on a patient-
specific basis and also can be accumulated
and applied in the aggregate.
IMPACT OF THE LABORATORY ON DISEASE MANAGEMENT
emphasizes prevention of exacerbations and
complications utilizing evidence-based prac-
tice guidelines and patient empowerment
strategies, and evaluates clinical, humanistic,
and economic outcomes on an ongoing basis
with the goal of improving overall health.23 The
impact of the laboratory on DM tenets is noted
in Table 2.22
DM components include (1) population iden-
tification processes, (2) evidence-based practice
guidelines, (3) collaborative practice models to in-
clude physician and support-service providers,
(4) patient self-management education (may in-
clude primary prevention, behavior modification
programs, and compliance/surveillance), (5)
process and outcome measurement, evaluation,
and management, and (6) routine reporting/
feedback loop (may include communication with
patient, physician, health plan and ancillary
TABLE 3. IMPACT OF THE
Components of DM
Population identification processes
Evidence-based practice guidelines
Collaborative practice models to include
physician and support-service providers
Patient self-management education (may
include primary prevention, behavior
modification programs, and
compliance/surveillance)
Process and outcomes measurement,
evaluation, and management
Routine reporting/feedback loop (may include
communication with patient, physician, health
plan and ancillary providers, and practice
profiling)
DM, disease management.
129
providers, and practice profiling).21 Full-service
DM programs must include all six components.
Programs consisting of fewer components are
DM support services. The impact of the labora-
tory on DM components is noted in Table 3.24
CONCLUSION
The healthcare industry is challenged to op-
timize care of patients while containing costs.
With consolidation of healthcare services, an
increased focus on DM, care management, and
the need for measurement of clinical and fi-
nancial performance, there are obvious and im-
mediate benefits in using innovative laboratory
data and reporting technologies. These tech-
nologies drive DM for both patients and the
healthcare system.
LABORATORY ON DM COMPONENTS
Laboratory impact
Laboratory tests can identify diseases and
confirm the diagnosis of diseases throughout
the population.
Laboratory results are included in the use and
application of guidelines.
Collaborative practice models should include
all providers and all available data, which
includes laboratory results.
Patient self-management education is
important for all phases in the continuum of
care, especially the ordering and results of
lab tests and the application of these results to
the disease continuum.
Laboratory tests are utilized for all phases of
DM, including both process and outcomes
management.
Evaluation standards must include laboratory
results as well as all other data. Lab tests are
sophisticated to the extent that they monitor the
actual disease process rather than just
observation. With the growing understanding
of genetics and new analytical tools, we have
the ability to zero in on the substance of
greatest interest whether it be a protein, drug,
toxin, etc.
130
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Address reprint requests to:
Marybeth Regan, Ph.D.
Accenture
880 Guérin Rd.
Libertyville, IL 60048
E-mail: Drmarybethregan@aol.com.