PRACTITIONER UPDATE
Outcomes Management:
The Why, What, and How of Data Collection
Brenda Motheral
STUDY OBJECTIVE: To describe
process of outcomes management (OM)
and discuss barriers to its success.
DATA SOURCES: Revelant literature.
health care system. OM applies continuous quality improvement (CQI) techniques
to medical care, assessing both the effectiveness of products and services and the
quality with which they are provided.
SELECTION: Not applicable.
Linking the structure and process of care
to the the outcomes of care is critical to
DATA SYNTHESIS: Quality endeavors,
such as outcomes management. are
receiving increased attention in the U.S.
In a 1994 survey of 102 managed care organizations
(MCOs), 69% of respondents reported that price was the
first or second most important factor in marketplace suc-
At the same time, 50% of respondents indicated
patient satisfaction, and only 20% reported quality
1
improvement processes as most important factors. While
these findings are consistent with managed care's historical
cess.
a
growing emphasis is being placed
on the quality of care.
This new focus is not a sudden development but the
result of an evolutionary process. The U.S. health care system moved through eras of expansion (1940s-1960s) and
cost containment (1970s-1990s) before turning the
full
potential will be
CONCLUSION: Outcomes management
represents a simultaneous focus on costs,
quality, assessment, and accountability.
Sophistication of information systems,
OM's success. Sources of data for OM
include claims databases, medical
records, and patient surveys, each with
inherent advantages and disadvantages
that must be considered. A number of barriers to true outcomes management must
DATA EXTRACTION: Not applicable.
focus on cost control,
be overcome before its
realized.
providers, purchases, and patients are key
ingredients to its success.
KEY WORDS: Outcomes management,
Quality of care, Managed care
surgery is 2.4 times greater in Boulder, Colorado, than the
rest of the nation, while the likelihood of undergoing heart
.bypass surgery is 1.6 times greater in Joliet, Illinois.4 This
simultaneous consideration of both cost and quality
reflects a heightened interest in the value of medical care
(Figure 1). While value typically is considered in other
types of consumer purchases, this is the first time in history that the technology has been available to support the
assessment of medical services' values.
The dual emphasis on cost and quality is manifesting
variety of forms. Familiar terms include pharmacoeconomics, treatment protocols, clinical pathways, evidence-based medicine, and demand management. While
itself in
a
emphasis to outcomes, assessment, and accountability'
This evolving focus has resulted, in part, because of the
questionable quality of the U.S. health care system, as evidenced by wide practice vàriations and high levels of
there are important differences between many of these
activities, each is a tool in outcof!les management, defined
as "the analysis, evaluation, and dissemination of the
unnecessary care3 For example, the rate of radical prostate
improve health.'" Outcomes management attempts to
...
results of medical processes or procedures intended to
Author
BRENDA MOTHERAl, MBA, Ph.D., is Assistant Professor, St. louis College of Pharmacy and Outcomes Researcher, Express Scripts, Inc..
I~I
FE
@
CE CREDIT: This article is article number 233-000-97-005-H04 in AMCP's continuing education program. It affords 10 hour (0.1 CEU) of
credit. learning objectives and test questions follow on page 353.
.
CORRESPONDENCE: Brenda Motheral, MBA, Ph.D, St. louis College of Pharmacy, 4588 Parkview PI., Room 215, St. louis, MO 63110.
Copyright
lid
1997, Academy of Managed Care Pharmacy, Inc. All rights reserved
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PRACTITIONER UPDATE: The Why, What, and How of Data Collection
Table 1. Advantages and Disadvantages of Outcomes
Figure 1. Value in Health Care
Measurement
Quality
VARIABLE
Clinical
Economic
EXAMPLES
ADVANTAGES
DISADVANTAGES
death, stroke,
not intrusive,
rare
heart attack
meaningful
confounders
cost per case
accounts for costs
difficult to determine
all the relevant costs
screened, cost
per life-year saved
Access
Cost
Humanistic
systematically assess what works, what doesn't work, and why,
while considering the associated costs.
Outcomes management is different from previously popular health management tools in that it is customer focused,
population based, and outcomes centered. It applies continuous quality improvement (CQI) techniques to medical care.
The underlying philosophy of CQI is the use of data to manage processes. Rather than presume an error-free system, CQI
assumes that mistakes will happen and has a process in place
patient
patient -centered
patient burden
confounders
satisfaction,
quality of life,
daily functioning
Intermediary
cholesterol levels, can be meaningful,
peak expiratory easy to measure
link to outcome can
be questionable,
volume
intrusive
to
guish between outcomes and intermediaries, which are measures used to assess the degree of disease (see Table 1).
Examples of intermediaries include blood pressure measures,
medical utilization management techniques, which identified
mistakes but made adjustments in a vacuum without allowing
the majority to learn from mistakes and without exploring
cholesterol levels, and forced expiratory volume. These measurements have no inherently intrinsic value but are only
important based on the degree to which they relate to the outcomes of care. Accordingly, the stronger the relationship
learn from such mistakes, thereby continually improving
the system. This approach is in direct contrast with previous
possible underlying causes6
Outcomes management focuses on two different pieces of
the quality question: outcomes research and outcomes measurement.? Outcomes research assesses the effectiveness of
medical products and services,8 examining whether they work
in the routine clinical practice with typical patients, average
providers, and ordinary treatment settings9 Outcomes
research attempts to answer whether we are doing the right
thing.!O Outcomes measurement examines the quality of care
being given by
between the intermediary and some outcome of care, the
more relevant the intermediate becomes.
Outcomes can take three different forms: clinical, economic, and humanistic.!3 Clinical outcomes are medical events
such as strokes, heart attacks, or broken ankles. Although
mortality is perhaps the ultimate clinical outcome, it is not a
commonly used measure of quality of care, mainly because it
often is difficult to isolate the specific causes of mortality.
While health care providers traditionally have focused on
11
provider or group of providers. In other
words, are we doing things right? Are there deficiencies in
quality anywhere along the structure-process continuum that
clinical outcomes and intermediaries, there is an increasing
customer focus, which means a greater emphasis on economic
a
and humanistic outcomes. Economic outcomes are the comparison of all costs of treating the disease with the clinical
are limiting the treatment's effectiveness? Outcomes measurement is essential to the success of outcomes management
!4
because "".you literally cannot manage what you do not measure."!2
Successful outcomes management will make medical care
better value by reducing costs and/or improving quality.
More specifically, it will aid in the development of treatment
guidelines, allow for reimbursement to be tied to quality,
and/or humanistic outcomes.
The field of pharmacoeconomics is devoted to assessing
the economic outcomes of care. Familiar terms include cost
per life-year saved, cost per quality-adjusted life year, and cost
a
per case treated. Examples of humanistic outcomes include
quality of life, functional status, health risk, patient satisfaction, and productivity. Employer groups are becoming increas-
inform patients in plan and therapy selection, assist in benefit
plan design, be used for provider credentialing, and guide
patient and provider education programs.
ingly interested in issues of patient functional status and quality of life as they impact work productivity.
While all three types of outcomes ideally would be con-
WHAT.ARE OUTCOMES?
sidered in any resource allocation or clinical decision, this is
not always possible or practical. Different groups have varying
Outcomes are the end results of medical care; they represent what happened to the patient. It is important to distin-
interests in these outcomes, and which outcomes are used to
measure/manage clearly depends on the objective of the program. For example, providers may concentrate on a patient's
346
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PRACTITIONER UPDATE: The Why, What, and How of Data Collection
clinical intermediates and outcomes, while patients may be
more concerned with the humanistic aspects.
Certainly; because resources are scarce, the payor will
consider the economic outcomes. The outcomes emphasized
also may vary by disease state. For example, in the case of
pediatric asthma, the focus may be on minimizing acute exacerbations to prevent emergency and hospital visits, while qual-
Table 2. Examples of Measures of Quality in Health Care:
Structure and Process
SETTING
STRUCTURE
PROCESS
Community
number of pharmacists,
pharmacy location,
number of patients
DUR software availability
number of potential
Pharmacy
adverse drug reactions
ity of life and work productivity may be of greatest concern in
the treatment of migraines.
Other factors to consider when deciding which outcome(s) to measure include the ~efiniteness, timing, and
IS
directness of the outcome. Definiteness refers to the objectivity of measuring the event. Whereas death is definite and can
be objectively determined, quality of life or patient satisfaction
are subjective measures, making them more difficult to meaningfully measure and assess. Timing refers to the length of
time needed to observe the event; clearly, some outcomes
take longer to observe than others. Directness refers to the
relationship between the structure and process and outcomes
of care.
STRUCTURE, PROCESS, AND OUTCOME
Critical to the success of any outcomes management
endeavor is the measurement of the structures and processes
of care and the ability to link these factors to the outcomes of
care. Structure refers to the tangible and intangible systems
counseled,
detected
Pharmacy
Benefit
drug fomlUlary,
number of clinical
Manager
pharmacists
number and type of
on-line edits,
number of therapeutic
interchanges made
want standardized information that focuses on the outcomes
of care rather than the structure or processes of care. I'
The greater emphasis on outcomes does not lessen the
importance of measuring the structure and processes of care.
In fact, each has no meaning except in the context of the others.!S It is only important to evaluate the process of care
because it affects the outcome, and outcomes indicate quality
only if they can be linked to the process and structure of care
and do not result from some outside factor, such as an environmental contingency. As one provider stated, "the primary
goal of outcomes is quality improvement, not outcomes; outcomes are only
a
tool to achieve that goal."!9
used to provide care.!6 It includes the sources, personnel, and
policies and procedures (Table 2). In a pharmacy setting, measures of structure may include the number and qualifications
MEASURING OUTCOMES
of the pharmacists, the number and quality of the computer
system(s), and the procedures in place for completing the dispensing function. For a pharmacy benefit manager (PBM),
There are two key questions in the measurement of outcomes. First, what types of outcomes will be measured? And
second, what type(s) of data will be used? The three major
examples of structure measures include the number and qualifications of the clinical staff, the availability of on-line edits,
and whether a procedure is in place for receiving prior autho-
sources of outcomes
rization of
Claims databases
a
nonformulary medication.
Process refers to the interactions that occur between practitioners and patients or what was done to the patient-in
other words, how the structures are used in the provision of
care. Process measures can include both the technical and
humanistic dimensions of care. Examples in a community
pharmacy would include the percentage of patients counseled
per day and the number of dispensing errors as a percentage
of prescriptions dispensed. For a PBM, a process measure
may include the number of patients switched to
a
preferred
product.
While there has been much debate about which of these
measures should be used as indicators of the quality of care,
historical quality a,ssurance techniques have focused on measuring the structùre and processes of care, primarily because
they are much easier to measure than the outcomes of care.
However, a study released by the General Accounting Office
(GAOIHEHS-95-201) found that consumers and employers
data-claims databases, medical
records,
and patient surveys-are discussed here.
The desire to examine clinical, economic, and humanistic
outcomes usually is limited by practical considerations, such
as financial and time constraints, as well as concerns about
patient privacy. Given these realities, most outcomes manage-
ment activities ,viII utilize a claims database for some or all
data collection. Claims databases offer a number of important
advantages for conducting outcomes management. Most
important, unlike randomized controlled trials (RCTs), they
reflect routine clinical practice (Table 3). RCTs include carefully selected populations of particular ages and disease severity
with few or no comorbidities. In addition, the procedures and
protocols are not often representative of routine clinical care.'o
Patient compliance typically is greater in RCTs than in the
"real world" because of the support services availab1e to treat
adverse effects and the tendency of RCT participants to be
1argeZl
more compliant than the population at
These artificial circumstances have important implications
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PRACTITIONER UPDATE: The Why, What, and How of Data Collection
timely means of analyzing a problem27 Answers can be
found in days or weeks, rather than months or years. Finally,
databases offer a great deal of flexibility28 Rare diseases or specific subpopulations can be researched, or a problem can be
Table 3. Advantages and Disadvantages of Various
Data Sources
vide
SOURCE
ADVANTAGES
DISADVANTAGES
Claims
inexpensive,
diagnosis uncertainty,
timely,
uncontrolled confounders,
missing data
reflects routine clinical
approached in
number of different ways.
Claims databases allow for the measurement of clinical
and economic outcomes (e.g., hospital and emergency room
visits). Beyond such high-level outcome measures, the avail-
practice,
depth of clinical
information
expensive,
timely, time-consuming,
unknown quality of record
Patient Surveys
relevance
patients with a particular diagnosis or combination of diagnoses. CPT-4 codes (Physicians' Current Procedural
Terminology, 4th Edition) identify procedures that are used to
bill physician and other professional services. For example,
expensive,
timely, time-consuming,
methodologically difficult
for clinical care. For example, a recent meta-analysis of antidepressant pharmacotherapy concluded that there was no evidence that the selective serotonin reuptake inhibitors (SSRIs)
offered any advantage over the less expensive tricyclic antidepressants that justified the additional costs of the SSRIs22 This
conclusion is not particularly surprising given that this metaanalysi~ included only randomized controlled trials and overlooked other forms of research that reflected routine clinical
practice. Had the issues of frequency of dose titration, management of side effects,23 organizational structure, and physician specialty been taken into account,24 different conclusions
may have been reached.
A second advantage of claims databases is that they are
a
ability of the diagnosis, procedure, and revenue codes allow
for further specification of a patient's outcome. ICD-9-CM
(International Classification of Diseases, 9th Revision) codes
provide diagnostic information allowing for identification of
flexibility
Medical Records
a
.
CPT-4 codes could be used to determine whether a depressed
patient received hypnotherapy The Healtl1 Care Financing
Administration Common Procedural Coding System (HCPCS)
can be used to provide further information on physician and
nonphysician services that are not included in the CPT-4, such
as whether a patient obtaining care in a physician's office for
asthma received an injection of epinephrine.
The processes of care also can be assessed from a claims
database. For example, the number of physician visits might
be considered a good measure of the quality of care in
depressed patients, as could whether a patient received care
from a specialist. 'Procedure codes allow for the measurement
of additional processes of care such as whether or not asth-
not influenced by patient or provider biases.'5 In addition,
matic patients are receiving annual pulmonary function tests.
Whether or not an asthmatic is using an inhaled steroid is a
they are unobtrusive and relatively inexpensive to use once
the information system is in place.'6 Further, databases pro-
measure of the process of care, which is purported to affect
outcomes such as hospitalizations for asthma and quality of life.
Figure 2. Possible Relationships Between the Structures, Processes, and Outcomes of Care for Asthma
Structu re
~
I
Process
..
I
Outcomes
411Þ/
~~
~ þ"--
KEY
..
C)
348
In database
Not in database
Some information
in database
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PRACTITIONER UPDATE: The Why, What, and How of Data Collection
Most measures of the structure of care are not found in
the database itself but within the patient benefit manual or
other records held by the MCO. Important examples include
copay amount, formulary coverage of specific drugs, prescription quantity limits, and limits on mental health benefits.
While using a claims database to actually measure the
various processes and outcomes of care can be difficult, often
more challenging is linking the variations in outcomes to recognized variations in the processes and structures of care. As
shown in Figure 2, there are multiple processes of care in the
As for the types of data that can be collected, medical
records allow for the examination of clinical outcomes and
intermediaries as well as many of the processes of care, such
frequency with which certain diagnostic procedures are
being performed.
as the
Patient surveys
Patient surveys represent the absolute consumer focus,
they
can be expensive to conduct. Self-administered surbut
veys may cost as little as $5 per person, while face-to-face
treatment of asthma; these processes often influence each
other, making it even more difficult to isolate the relevant
component. Despite these inherent difficulties, isolating the
"cause" of suboptimal outcomes is essential to developing suc-
interviews can cost upwards of $50. These surveys put a burden on patients and the MCO risks offending them, regardless
of its good intentions. In addition, it sometimes is difficult to
cessful interventions to improve these outcomes.
Although databases offer a number of advantages for con-
is particularly true with Medicaid patients. Finally, there
ducting outcomes management, they are not without their
limitations. It is widely recognized that the diagnosis found in
databases is not always valid/and or reliable29 While some
overcoding does occur, in most cases undercoding of actual
diagnoses is more common. Undercoding is an even bigger
problem with chronic diseases, which are notoriously underreported. Given these limitations, it is helpful to know for
which disease states the coding is insufficient, calling for a
review of the medical record. Unfortunately, there is no published research to provide guidance on this issue.
Another important consideration is patients' severity-ofillness. The goal often is to compare the outcomes of care for
persons receiving different treatments or receiving care from
different types of providers. However, there may be important
differences in the patients being compared that cannot be
measured or controlled when using the information in the
reach
a
representative sample of the MCO's population32 This
always is the question of whether patients can provide relevant, reliable, and valid information about their medical care.
Nonetheless, research suggests that these surveys can be useful
if they are constructed carefully.
While surveys allow for measurement of clinical, economic, and humanistic, they probably are most useful for
measurement of humanistic outcomes. In fact, the only means
of gathering most humanistic outcomes (e.g., patient satisfaction, quality of life, etc.) is by surveying the patient. Used in
isolation, surveys do not easily allow for the linkage of outcomes to the structure and process of care in most cases.
Automated collection of patient information is the ulti-
mate goal and the ideal for MCOs. An institution that has
taken a major step in this direction is the University of Utah
Hospital and Clinics' sports medicine and physician therapy
center. The center asks that patients use a touch-screen computer to complete a health-assessment survey during their first
database. An example of the difficulty of interpreting outcomes analyses comes from the Health Care Financing
visit and after their last visit. Satisfaction with care is also surveyed at the final visit. Neither assessment takes more than 10
Administration (HCFA)'s efforts to compare the quality of care
provided by hospitals using hospital-specific, age-adjusted
mortality rates for selected conditions. HCFA found difficulty
to IS minutes to complete, and the survey results are used to
make treatment decisionsD
In summary, one should not view a single type of data
source as superior to the others. Rather, each has advantages
in isolating outcomes resulting from quality of care versus
those due to adverse patient selection. While a number of
organizations offer proprietary severity-adjustment software,
one researcher compared 10 of these programs and found that
comparisons of individual hospitals varied according to the
software program used.30
and disadvantages, and each can and should play an important role in managing patient outcomes. Understanding the
inherent limitations and benefits of each source so that the
potential of each alternative will be maximized is essential.
GETTING STARTED
Medical record
The medièal record provides
a
wealth of information on
clinical outcomes and intermediaries. However, while the
medical record sometimes is considered the "gold standard"
for patient medical information, this is not necessarily the
case. The primary concern with medical records is whether
one is measuring the quality of care or the quality with which
The first step in developing an outcomes management
program is defining the goal(s). While the general goal is
always to improve the value of medical care, more specific
goals should be developed. A good approach is to start simple.
Rather than attempting to identify specific links between the
processes and outcomes of care, an initial step would be to
the care was recorded. Additionally, gaining access to medical
records can be difficult, and it is expensive and time-consum-
simply describe variation. For a particular disease state, group
of patients, or providers the trends and patterns of outcomes
ing to collect data from them.3'
may be desired. Once variations have been established, epi-
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PRACTITIONER UPDATE: The Why, What, and How of Data Collection
and purchaser groups are becoming more sophisticated in
evaluating the quality of care, this limitation is rapidly
diminishing.
conduct the research and quality assurance activities needed to
CONCLUSION
on value, accountability, and systematic management of outcomes is here to stay. The interesting questions are how long
will it take to fully realize the potential and who (i.e., pro-
a sensitivity to costs will always exist in health
the
but
as
information systems advance MCOs will have
care,
the ability to manage the entire medical system rather than
Certainly,
controlling each component in isolation. Only then can MCOs
~
provide truly cost-effective care.
Some have asked whether outcomes management is a
passing fancy. Regardless of the label attached to it, the focus
viders, type of institutions, specific organizations) will be successful in the new environment.
.
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