As new and more complex medical interventions are developed and scientific knowledge about disease origins and progression continues to expand, the healthcare system will need to adopt approaches that ensure evidence generated is relevant to real-world patient populations and is incorporated effectively into clinical practice. Essential to these approaches will be new roles and responsibilities for the patients and providers at the front lines of care. Anticipated shifts in the behaviors, beliefs, and practices of these stakeholders are described in this chapter.
Because of the overwhelming amount of new evidence and information that healthcare providers must incorporate into their practices, William W. Stead suggests that the healthcare system will shift from expert-based practice, which is built around the extensive knowledge and experience of the physician, to a systems-supported practice centered on teams supported by well-defined processes and information technology (IT) tools. While both approaches rely on evidence for decision making, the difference is in how evidence is translated into action. Stead describes how this approach has been used at Vanderbilt University Medical Center (VUMC) to improve care of patients on ventilators and discusses the major barriers inherent to health care that might limit broader implementation of this approach, and possible solutions.
In his paper, Marc Boutin highlights the diversity of patients, each with differing life circumstances, cultural needs, preferences, and socioeconomic status. Broader acceptance of evidence-based medicine (EBM) will require
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Contending with the Changes
INTRODUCTION
As new and more complex medical interventions are developed and
scientific knowledge about disease origins and progression continues to
expand, the healthcare system will need to adopt approaches that ensure
evidence generated is relevant to real-world patient populations and is in-
corporated effectively into clinical practice. Essential to these approaches
will be new roles and responsibilities for the patients and providers at the
front lines of care. Anticipated shifts in the behaviors, beliefs, and practices
of these stakeholders are described in this chapter.
Because of the overwhelming amount of new evidence and information
that healthcare providers must incorporate into their practices, William W.
Stead suggests that the healthcare system will shift from expert-based prac-
tice, which is built around the extensive knowledge and experience of the
physician, to a systems-supported practice centered on teams supported by
well-defined processes and information technology (IT) tools. While both
approaches rely on evidence for decision making, the difference is in how
evidence is translated into action. Stead describes how this approach has
been used at Vanderbilt University Medical Center (VUMC) to improve
care of patients on ventilators and discusses the major barriers inherent to
health care that might limit broader implementation of this approach, and
possible solutions.
In his paper, Marc Boutin highlights the diversity of patients, each with
differing life circumstances, cultural needs, preferences, and socioeconomic
status. Broader acceptance of evidence-based medicine (EBM) will require
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an evidence base that appropriately accounts for these differences, and
better communication to patients on the importance of best evidence in
healthcare decision making. Strengthening the patient-provider relation-
ship is also essential to ensuring the use of EBM results in the best medical
outcomes and closes the quality chasm across geographic regions, treatment
settings, and patients’ socioeconomic levels.
BEYOND EXPERT-BASED PRACTICE
William W. Stead, M.D., and John M. Starmer, M.D.
Introduction
Most healthcare providers believe their practice is evidence-based.
Their education includes the scientific basis of health and disease. They
have been trained to use scientific literature to compare alternative ap-
proaches to diagnosis and treatment. They do their best to stay up-to-date
through reading and conferences. Yet despite their attention to evidence,
studies repeatedly show marked variability in what healthcare providers
actually do in a given situation. When challenged about why they do not
practice consistently, healthcare providers point out that health care is both
art and science. Explicit evidence is available for only a portion of what
they do.
Instead of focusing on the use or non-use of evidence, we contrast
expert-based practice to a systems approach to practice. Both approaches
use evidence. The difference between the approaches is the way in which
the evidence is translated into practice. We provide a framework of steps for
developing, using, and iteratively improving a systems approach to practice.
We provide examples using VUMC’s approach to ventilator management.
We conclude with implications of our experience with a systems approach
to practice for healthcare workforce and infrastructure policy.
1 This paper presents ideas developed through VUMC’s efforts at the intersection of qual-
ity improvement, evidence-based medicine, and informatics. C. Wright Pinson has provided
executive oversight for quality, and Nancy Lorenzi has facilitated the informatics components
of quality. Larry Goldberg and Marilyn Dubree provided executive leadership for the ventila-
tor management initiative. Lee Parmley and the Critical Care Committee provided medical
direction for ventilator management. Devin Carr prototyped change in nursing practice for
ventilator management. John Bingham and the Center for Clinical Improvement supported
process mapping and performance audits. John Doulis and the Informatics Center developed
information technology tools.
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Expert-Based Practice
In expert-based practice, the focus is on the individual’s performance.
The individual expert provides extensive knowledge and technical skill
based on education and experience. The individual expert is expected to
remember facts, assimilate data, recognize patterns, judge, and make deci-
sions wisely. The individual expert’s opinion is valued. Disagreement among
experts is expected. The result is no better than the performance of the
individual expert. The individual expert is responsible for recognizing and
learning from his or her mistakes.
System-Supported Practice
In system-supported practice, the focus is on the system’s performance.
Teams of people, well-defined processes, and information technology tools
work in concert to produce the desired result consistently. People provide
compassion, pattern recognition, and judgment. Well-defined processes
standardize and simplify work flow. IT tools decrease dependence on
memory and force action when needed. Agreement among individuals is
required. The desired result is expected every time. Each failure feeds back
to support just-in-time correction or iterative adaptive design. The system
of behaviors, processes, and tools makes it easy for the individual to do the
right thing every time.
Figure 4-1 depicts our systems approach to practice. The left-hand
circle represents cycles of iterative system development and refinement. We
focus our efforts by working on one population at a time. By population,
we mean every instance of the circumstance that we want to manage to a
consistent outcome, such as patients on a ventilator. A patient is likely in
multiple populations at once. The first system development step is selection
and definition of a high-priority population to target. A population might
be high priority because of risk for morbidity or mortality, such as patients
with central lines who have a high incidence of nosocomial bloodstream
infection. Another population might be a priority because of opportunity
to reduce cost by streamlining throughput, eliminating unnecessary proce-
dures, or using more cost-effective drugs. We try to make the definition of
the population explicit. This definition consists of the environmental, clini-
cal, or procedural characteristics that collectively frame the circumstance
we want to manage consistently. We restrict the definition to characteristics
that are present in our information systems or can reasonably be obtained
through supplemental manual audit. Once we agree on such a definition,
we can identify each member or instance of the population across our
enterprise.
The second system development step involves gathering the evidence
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Individualize & Act
• Assess
• Plan
• Order
Pick Population
• Risk
• Cost
• Variability
System-Supported
Practice
Evidence
System
• Research
Development
• Guidelines
• Practice database
Monitor & Correct
Process Patient
• Sentinel Events • Status
Work flow • Process Outcomes • Results
• Clinical Outcomes • Trends
• People’s roles
• Process
• Te chnology Tools
FIGURE 4-1 The systems approach to practice joins system development to
system-supported practice. The left-handw.eps
4-1 ne circle represents the four steps in each
iterative cycle of system development. The right-hand circle represents the two
steps in each cycle of system-supported practice.
related to that population into a common fact base. We look for three types
of evidence. We search the literature for clinical trials related to the target
population. We obtain consensus practice guidelines related to the popula-
tion from the literature and from sources such as the University Hospital
Consortium (UHC) and quality improvement organizations. We obtain the
pathways, protocols, and order sets from our practice groups that relate
to the target population. We reduce this information into a table with a
row for each explicit practice related to the target population and a col-
umn showing the recommendations for each practice for each of the above
sources. This table highlights variance in available evidence. We then charge
a core team of subject matter experts to develop a “straw person bundle”
for use across the enterprise. The bundle is a set of standardized practices
with specific process steps and measures of performance for each practice.
The core team also drafts one or more overarching idealized processes that
would result in consistent execution of the bundle. The core team is not
a representative consensus-forming body. Instead, it is as small as possible
while bringing critical information to the table across medicine, nursing,
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ancillaries, etc. These individuals work as a team, viewing each member as
a partner in the solution, rather than as representative of an area. We com-
plete the common fact base by documenting the performance of our units
or practice groups against the “straw person” set of standardized practices
through either electronic or manual spot audit.
The third system development step makes the jump from the shared
fact base to cross-enterprise agreement. This agreement includes a set of
standard practices; metrics to assess performance on each practice; explicit
definitions for both practices and metrics; simplified standard work flows to
implement the practices; IT tools; staffing and education; and implementa-
tion time line. When the needed agreement cuts across disciplines and care
settings, we take time out for a day of cross-enterprise design. We bring
together executives that will have to approve change in policy or resource
allocations, medical and nursing leadership of each affected practice group
or unit, representatives of affected ancillaries and subject matter experts
from clinical areas, quality improvement process, informatics, and finance.
After sharing the fact base, we identify points of disagreement and use
breakouts to work alternative solution designs. We constrain the design
by restricting suggestions to ideas that can be implemented across the
enterprise in 6 weeks to 3 months. Longer-term suggestions are noted and
parked for future consideration.
The fourth system development step involves monitoring performance
at the population level and iteratively refining the system of practice as
needed. Sentinel events are monitored as early indications of unexpected
problems during the rollout of changes. Metrics provide an early indica-
tor of where we are and are not achieving reproducible performance on
the set of standard practices, and we adapt education, tools, or process as
needed.
The rapid cycle iterative nature of the system development steps cannot
be overemphasized. For example, an initial population definition focuses
an initial search for evidence. Our review of the evidence may suggest
modification of the population definition followed by a revised search for
evidence. Similarly, the bundle of practices developed from the evidence
guides the initial audit of our performance. Our review of the audit may
feed back suggestions for refinement in the bundle.
The right-hand circle of Figure 4-1 depicts the related iterative cycles
of system-supported practice in the care of an individual patient. System-
supported practice is not cookbook medicine. At the start of each cycle, the
clinical team assesses the patient, develops or refines the plan of evaluation
and care, and orders the next actions. As a patient matches the definition
for one or more of the populations for which we have developed a systems
approach, the clinical team is alerted and prompted with orders appropriate
to implement the related standard practices. As they round, they are shown
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the status of each of their patients on each of the standard practices (Stead
et al., In press). As they start the next cycle of system-supported care, they
take corrective action as needed in addition to updating the plan and orders
to reflect new information and trends.
To this point, our system development steps yield reliable execution on
standard practices reflecting the literature and consensus. These practices
may or may not actually be the right thing to do. Even if they are, they
will get out of date as the biomedical knowledge base changes. In time,
we expect our systems approach to practice to become self-correcting as
we add indicators of good and bad clinical outcomes to the metrics of
performance on the standard practices for each patient. Whenever the
clinical team elects to vary from the standard practice, in effect it creates
an experimental group. If outcomes of that group appear better, or even
no worse, we will be able to do targeted clinical trials leading to change in
the set of standard practices if appropriate. In addition, whenever clinical
outcomes for a population deteriorate or diverge in the wrong direction
from external benchmarks, we will know to reassess the standard set of
practices for that population.
Example of Expert Management of System-Supported Practice
VUMC selected the ventilator management bundle as one of the test
cases for our systems approach to practice. The following examples from
that work are presented to highlight the gap between the available evidence
and the set of standard practices needed to consistently produce the desired
result. We also provide examples of decisions by the experts as they manage
the cycles of system development and apply judgment within the resulting
system-supported practice. We show how IT can decrease dependence on
memory and provide a forcing function to help close the gap between intent
and execution. Throughout the examples, we provide an indication of the
number of people involved and the elapsed time.
We selected the ventilator management bundle as a test case for our
systems approach to practice because of evidence of high morbidity and
mortality associated with ventilator-acquired pneumonia (Bueno-Cavanillas
et al., 1994; Girou et al., 1998); evidence linking specific practices to reduc-
tion in risk for (Ibrahim et al., 2001) or incidence of (Doebbeling et al.,
1992; Thompson, 1994) ventilator-acquired pneumonia; and use of ventila-
tors by several specialties in many units across our enterprise. Past VUMC
initiatives had focused on tracking ventilator-acquired pneumonia and
unit-specific practices to reduce the incidence. Our approach this time was
different in that we started with three executive-level agreements. We would
not focus on ventilator-acquired pneumonia. Instead, we would focus on
cross-enterprise agreement on a bundle of well-defined standard practices
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for ventilator management, on how we would measure performance, and
on the processes we would use to quickly achieve consistent performance
house-wide. These decisions sidestepped pitfalls such as clinical arguments
about what does or does not constitute ventilator-acquired pneumonia
and the tendency to say why a unit is unique instead of what units have in
common. The constrained time horizon forced people to think of simple
solutions instead of requesting complicated support systems to get better
results without having to change what people do.
In this test case, the definition of the population was straightforward,
a VUMC inpatient on a ventilator. Although aspects of ventilator manage-
ment involve multiple information systems, nurse charting provides a single
source for an up-to-date indicator that a patient is currently on a ventilator.
We made the executive decision that we were ready to launch the effort in
mid-December 2006 and assembled the core team just after the holidays.
Since this effort was a cross-enterprise test case, the initial core team in-
cluded the corporate strategy and nursing officers and the chief executive
officer of the adult hospital. The chair of the Critical Care Committee,
a physician, and the nurse director of the Surgical Intensive Care Unit,
together with leaders from Clinical Improvement and Informatics, com-
pleted the team. Over the course of January, that team oversaw the compi-
lation of the common fact base, obtained initial agreement of the medical
directors of the nine intensive care units on the set of practices to include
in the bundle, and identified the people to include in the cross-enterprise
design day. The key decisions during this phase of the system development
work included affirmation of the focus on the bundle of standard practices
instead of the incidence of ventilator-acquired pneumonia; selection of goal-
directed sedation monitored by the Richmond Agitation Sedation Score
(RASS) (Thompson, 1994) as an alternative to sedation interruption since
the latter is inappropriate for certain patients such as those with extreme
burns; and preference for house-wide implementation of the bundle instead
of unit by unit.
On the last Saturday in January 2007, 45 individuals from across
VUMC participated in the cross-enterprise ventilator bundle design day.
This group included medical and nursing leadership from each unit, post-
graduate fellows, front-line nurses, pharmacy, respiratory therapy, infection
control, nurse educators, informatics, evidence-based order set develop-
ment, decision support and order entry, clinical documentation, business
analytics, process reengineering, process audit, chief quality officer, and
executives from the core team. Their objectives included a common under-
standing of the fact base; refined agreement on the set of practices; specific
process steps and measures for each practice; and identification of the IT
tools, education, and staffing needed for consistent execution. This design
work was constrained to solutions that might be implemented house-wide
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by mid-March. We were able to agree on cross-enterprise practice standards
by decomposing high-level guidelines into components and agreeing on an
approach to each component that is both supported by evidence and practi-
cal in our environment. For example, we replaced the UHC-recommended
standard of oral care, defined to include everything from teeth brushing to
supra- and subglottic suctioning, with three VUMC standard practices (oral
swabs, teeth brushing, and hypopharyngeal suctioning). The more granular
approach permits more focused accountability, performance measurement,
and refinement over time. In addition, when the standard practice should
change with patient condition, we made the criteria for branch points ex-
plicit. Practices requiring patient-specific variation ranged from stress ulcer
prevention to goal-directed sedation. We agreed on which team role would
be responsible for specific actions. For example, the physician should or-
der and reassess the target RASS, and the nurse should assess the patient’s
condition against that target. We identified two ways our IT tools could
support the clinical teams.
We would use a modular order set (Figure 4-2) to present the bundle
of standard practices, together with definitions or patient-specific criteria
directly in clinical work flow, and use exit checks for reminders if something
was missed.
In addition, we would create a process control dashboard, as illustrated
in Figure 4-3, with a line for each ventilator patient on a unit and a column
for each element of the bundle, with a red, yellow, or green (gray scale in
figure) square to indicate the status of the patient for that element.
Finally, we identified the teaching materials needed to support the
change to the bundle of standard practices.
Over the course of February and March, work proceeded according
to the time line from the design day. Since the cross-enterprise agreements
were in place, the executives dropped off the core team to let the work
proceed close to the action. Order sets were revised and education materi-
als developed and distributed. However, we did not get traction until the
process control dashboard was available in mid-May. At that point, any
members of the team could see where action was needed as they walked
onto the unit. As people began to question the many red squares on their
unit, the core team was able to decide if the problem reflected a poorly
defined standard practice, education, the documentation used to derive the
status of a patient relative to a practice, or the algorithm used to calculate
whether the status was acceptable (green), trending out of control (yellow),
or unacceptable (red). By early September we felt we had reached a point
of face validity and decided to launch a targeted education effort to close
additional performance gaps.
All of our work to date has involved starting from the evidence base
and developing the agreements and infrastructure to achieve consistent per-
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FIGURE 4-2 (a) Ventilator management order set with a module for each element
of the VUMC bundle of standard practices. (b) Expansion on selection of stress
ulcer prophylaxis. (c) Expansion on selection of Target RASS.
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FIGURE 4-3 Process control dashboard.
4-3.eps
bitmap image
formance on standard practices. The next step will add outcomes such as
time on mechanical ventilation, unplanned extubations, failed extubations,
and complications (pneumonia, stress ulcer, and deep venous thrombosis)
to the measures of process performance. This outcome feedback will in
time provide the evidence to guide continued refinement of the standard
practices.
Implications for Healthcare Workforce and Infrastructure Policy
The demise of expert-based practice is inevitable. The complexity of
biomedical information and technology will increasingly overwhelm an
individual expert’s cognitive capacity. Specialization is not an answer be-
cause of the accompanying fragmentation. Fragmentation is incompatible
with the personalization of care that is becoming possible with progress
in genomics and systems biology. Even if its demise was not inevitable,
we would want to move beyond expert-based practice. Other industries
have shown that a standard process is the key to consistently producing
the desired result. There is no reason to believe that health care can be an
exception to this rule. A process that varies on a case-by-case basis accord-
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ing to the opinion of individual experts will not consistently produce the
desired outcome.
The move beyond expert-based practice is not straightforward. Health
care differs from other industries in three ways that make transfer of ap-
proaches to standardization difficult. First, the manufacturing plants or
services of other industries handle fewer inputs and outputs than their
counterparts in health care. For example, a microchip fabricating plant
has limited inputs that are translated into limited outputs through a limited
number of manufacturing processes. Most healthcare facilities and ser-
vices handle much greater variety. For example, an emergency department
handles all comers, even if only to stabilize and transfer patients beyond
their capability or to treat and return to primary care those patients whose
problems are non-emergent. Highly specialized healthcare facilities have
achieved consistent performance by limiting services to a few related clini-
cal conditions and mimicking manufacturing by standardizing the complete
process end-to-end. End-to-end standardization works when handling many
instances of the same clinical condition, one after another. It does not scale
up to handle a variety of clinical conditions at once. How might health care
consistently produce the desired result in the face of this clinical variety?
Second, most other industries deal with physical systems while most of
health care deals with biological systems. Each instance of a physical system
is identical, produced from the same blueprint and behaving consistently
according to the laws of physics. Variation is evidence of an error in the
manufacturing process. To continue the analogy of a microprocessor plant,
if a variation occurs, the error is identified, the process is corrected, and the
variants are discarded. In contrast, biological systems are inherently vari-
able. They evolve through random change in DNA sequence and survival
of the fittest. An individual’s environment and behavior affect his or her
characteristics. Because of this variability, two individuals might present
with the same condition, yet need different treatment. For example, the
most effective drug might be safe for many, but hurt a few. This risk may
or may not be known. Even if it is known, there may or may not be a way
of testing individuals to see which group they are in. In addition, individual
patients may place different values on the alternative outcomes. One might
value cure enough to accept a significant risk while another might prefer
to continue to cope with the illness rather than take the risk of treatment.
How might health care consistently produce the desired result while accom-
modating biological variation, uncertainty, and differing value systems?
Third, other industries are able to isolate change and stage its introduc-
tion into routine production more systematically than health care. Model
development and simulation minimize the need for production trial and
error. Change can be isolated in major steps. For example if a new genera-
tion of chip becomes possible, the microprocessor factory can shut down
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and completely retool to accommodate the changes. The rate of discovery
in the biological sciences and the rate of introduction of new healthcare
technology continue to increase. Yet new approaches are tested in produc-
tion healthcare settings. Many of the changes are incremental, changing
part of an approach to diagnosis or treatment. Many such changes occur
in parallel. How might health care consistently produce the desired result
while accommodating both experimentation and rapid change?
If health care did not differ from other industries, we could move
beyond expert-based practice by agreeing on a standard practice for each
condition and its use by all healthcare providers. Given the three major
differences outlined above, such a simplistic solution cannot be expected
to work. How then can health care achieve consistent performance, ac-
commodating variety in clinical problems handled, variability in biology
and values, and the rate of change in biomedical knowledge? We suggest
that the answer involves standardization around a systems approach to
practice, not around specific practices. Continuous system development
and refinement through iterative cycles of the system development steps
might yield local standard practices, consistent with global knowledge yet
adapted to local resources and capabilities, changing evidence, and system
performance. The linked cycles of system-supported practice permit flexing
of standard practice for individual patients based upon expert judgment,
but under the control of monitors that can warn of problematic trends in
real time. Data reflecting the improvement or deterioration resulting from
such flexing in turn provide evidence at the local level. Global correlation
of local lessons in turn might feed back into the collective evidence base.
Simply put, we still need the experts. Instead of spending the bulk of
their time managing each individual patient as experiments with an n of
one, they spend most of their time developing and iteratively refining the
system of practice for their organization and working within the resulting
system-supported practice. In both modes, whenever explicit evidence does
not provide the next step, they make an expert judgment. In contrast to
expert-based practice, this judgment takes place within a systems approach
that turns the decision and the resulting outcome into information to guide
the next iteration.
If correct, our suggestion to standardize around a systems approach to
practice instead of around specific practices for specific patient conditions
has three implications for healthcare workforce and infrastructure policy.
First, we need to communicate more clearly to policy makers and payers
the characteristics of health care that make moving beyond expert-based
practice challenging. Without this understanding they will continue to ask
for and pay for changes that are unlikely to produce the desired result.
Similarly we need to help healthcare providers appreciate the synergy of a
systems approach and the expert. The systems approach provides the con-
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text and feedback for the expert. The systems approach does not replace
or devalue the expert.
Second, we should call for health services and biomedical informatics
research into techniques and technologies to support local development
and iterative refinement of systems approaches to practice. For example,
we might test approaches permitting “mass customization” of standard
practices. If we try to define a guideline at such a high level that anyone
can use it, many details must be left to expert interpretation. Instead we
might define modules or components that are small and targeted enough to
gain agreement on one approach. Local flexibility might then be achieved
by mixing and matching components.
Third, we should call for direct payment to clinical and process experts
for their work in the four system development steps. Since this work im-
pacts all patients in their system, we can argue for payment at a multiple
of payment for work with individual patients. Similarly, we should work
to focus payment for work with individuals on the steps that require an
expert—applying judgment within the system-supported practice or exert-
ing technical skill. In parallel we could deemphasize payment for time spent
working around the non-system. Collectively these changes would create
strong economic incentives toward a systems approach to practice while
highlighting a role for the expert that will stand the test of time.
THE PARTNERSHIP IMPERATIVE IN AN
EVIDENCE-DRIVEN ENVIRONMENT
Marc Boutin, Executive Vice President, National Health Council
To begin, I’d like to give you a simple illustration of one of the chal-
lenges of looking at “the patient perspective.” Imagine that you have just
received a diagnosis of acute lymphocytic leukemia, a type of leukemia that
progresses very quickly. Treatment can range from chemotherapy to radia-
tion to a bone marrow transplant.
In one scenario, you are a 38-year-old parent who has three children
at home under the age of 12. In another scenario, you are a 65-year-old
individual who has recently retired from a career, with a husband or wife
of 40 years who has also recently retired, and the two of you are looking
forward to spending more time visiting your two grown children and three
grandchildren. In yet another scenario, you are an 86-year-old widower
with three children in their 60s and eight grandchildren.
Each of these patients has the exact same medical diagnosis on the
surface, yet every person’s circumstance is different, illustrating that a key
challenge is to develop the evidence base that acknowledges that, even with
identical diagnoses, a patient’s life stage, underlying health, social support,
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attitudes about health and illness, faith, culture, and other factors will
greatly influence what is for each individual “appropriate treatment.”
We’ve heard much about EBM from the point of view of many health-
care stakeholders, but what about the people the healthcare system is
supposed to serve? It seems that we have an underlying assumption that,
of course, all these parties exist to serve the patient and have the patients’
best interest at heart, but does it really work that way? Is it possible for us
to build an evidence base that takes into account the unique needs of each
patient, delivering and ensuring the “right” health care for each person?
We know that when well used, in a strong provider-patient relation-
ship, EBM can be a powerful tool to ensure the best possible medical
outcome. EBM can indeed help close the quality chasm across geographic
regions, treatment settings, and socioeconomic levels of patients. It can
help us use resources where they are most effective. The challenge, how-
ever, is to balance our nation’s urgent need to ensure quality care and
use resources wisely, with the understanding that different patients react
differently to different treatments and, just as importantly, have different
priorities and personal values.
At the National Health Council (NHC) we frequently hear from
patients whose chronic conditions require ongoing treatment to maintain
their quality of life and enable them to remain productive members of
society. The NHC has a broad and diverse membership, but representing
the needs of patients is our primary focus. We have heard from many of our
members that so-called EBM has been used to deny coverage to Medicaid
patients in several states for treatments including asthma, epilepsy, and
depression. This short-sighted view may save money for the payer in the
near future, but it often later results in costly emergency room visits and
hospitalizations, not to mention physical and/or emotional suffering for
the patient, often accompanied by financial loss, all of which might have
been prevented—or certainly lessened. We have all heard of similar cases in
which the precepts of EBM have been distorted to look at short-term cost
efficiency as the primary criterion.
If EBM is to be implemented systematically through a variety of
mechanisms, it must be structured with the realization that what works
for 80 percent of patients may actually cause harm to or be inappropriate
for the other 20 percent. In other words, as we embrace an epidemiologi-
cal view and use public health decision models, we should also remember
and embrace the promise of personalized medicine. In the patient-centered
world of personalized medicine, we allow individual patient data, in the
hands of an individual health professional, to be given equal standing
with aggregated public health data: as the IOM Roundtable has stated,
“to account appropriately for individual variation in patient needs.” That
is our ideal.
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We are encouraged and excited that many in the healthcare industry
are coming together to create a healthcare system that is more consistently
effective, safe, efficient, and affordable. Yet, as is often the case, many of
these efforts have not really focused on the needs of the patient, or even
on the simple concept that engaging patients more fully in their care can
directly improve medical outcomes.
There are additional factors we must keep in mind as we consider how
to go forward with EBM. One is that the quality of the evidence base is
often not consistent—that is, some evidence is based on large, double-blind
studies over long periods of time, while other research put forth as “evi-
dence” is based on very small groups of as few as 20 patients in very short
time frames. Also, of course we all can remember research results touted as
strong evidence that were later discredited when new, more robust research
was conducted. So we must remember that “all evidence is not equal.”
Another factor to consider, which may be harder to grasp, is that if
patients do not perceive a problem, they will not utilize the so-called solu-
tion to that problem. They may have many complaints about the way they
receive health care, and we have all heard many of them, but the NHC’s
research among patients repeatedly shows that they do not think qual-
ity—or more specifically, lack of adherence to evidence-based guidelines—is
the problem. So, if we want patients to be accepting of the concept of EBM,
we must be willing to explain it and convince them it is something they
need and something that will improve their health care and their health
and well-being.
Without true patient engagement and clear and honest communica-
tion about EBM, it is likely that many—maybe even most—patients will
perceive that “the system” is out to limit their access to the care they need.
And it is it likely to be much more complicated and expensive to imple-
ment than it needs to be. We believe the key is to protect and preserve the
patient-provider relationship, so that it is on equal footing with public
health and epidemiological evidence. The NHC wants to see us work
together to address the needs of payers, industry, providers, and patients
and their families alike.
REFERENCES
Bueno-Cavanillas, A., M. Delgado-Rodriguez, A. Lopez-Luque, S. Schaffino-Cano, and
R. Galvez-Vargas. 1994. Influence of nosocomial infection on mortality rate in an inten-
sive care unit. Critical Care Medicine 22(1):55-60.
Doebbeling, B. N., G. L. Stanley, C. T. Sheetz, M. A. Pfaller, A. K. Houston, L. Annis, N. Li,
and R. P. Wenzel. 1992. Comparative efficacy of alternative hand-washing agents in re-
ducing nosocomial infections in intensive care units. New England Journal of Medicine
327(2):88-93.
OCR for page 93
0 EVIDENCE-BASED MEDICINE
Girou, E., F. Stephan, A. Novara, M. Safar, and J. Y. Fagon. 1998. Risk factors and outcome of
nosocomial infections: Results of a matched case-control study of ICU patients. American
Journal of Respiratory and Critical Care Medicine 157(4 Pt 1):1151-1158.
Ibrahim, E. H., L. Tracy, C. Hill, V. J. Fraser, and M. H. Kollef. 2001. The occurrence of
ventilator-associated pneumonia in a community hospital: Risk factors and clinical out-
comes. Chest 120(2):555-561.
Stead, W. W., N. Patel, and J. M. Starmer. In press. Closing the loop in practice to ensure the
desired performance. 200 Transactions of the American Clinical and Climatological
Association.
Thompson, R. 1994. Prevention of nosocomial pneumonia. Medical Clinics of North America
78(5):1185-1198.