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OCR for page 133
E
The Development of Clinical Guidelines for
Primary Care Practice: A Systems Approach
Steven A. Wartman, M.D., Ph.D.
ABSTRACT
The division of health care delivery into primary and specialty care is
somewhat artificial because the actual delivery of medical care is not so nicely
hierarchical and compartmentalized. In reality, primary care is part of a
continuum of care that ranges over a broad spectrum of health issues. The
diverse nature and content of primary care practice requires a unique perspective
for guidelines development, one that addresses the underlying complexities that
exist in actual health care delivery. A systems perspective is offered as a means
to approach the structure that underlies this complex situation.
Using this perspective, the proposed framework for primary care clinical
guidelines development is based on the principal characteristics of the type of
care delivered. The three essential descriptors of type of care for primary care
services are: (1) the unselected nature of the patients, (2) continuous and
longitudinal care over extended periods, and (3) integrative care that links other
health care services to the patient. Three key health system elements are defined
that, when combined with the descriptors of primary care, produce a model for
the generation of guideline topics. Built in to this proposed model of guidelines
Paper prepared by Steven A. Wartman, M.D., Ph.D., Chairman, Department of
Medicine and Director of Medical Services, Mount Sinai Medical Center of Greater
Miami, and Professor of Medicine, University of Miami.
133
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134
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
development is the direct incorporation of outcomes studies in a continuous
feedback loop so as to facilitate further guidelines improvement and refinement.
The advantages of this model for guideline development in primary care is
the linking of process and outcome in a systems approach to primary care. It is
suggested that specific funding be devoted in addition to enlarging our
understanding of medical practice so that attempts to influence this practice
through clinical guidelines will have a greater chance of success.
The development of clinical guidelines that address issues in primary care
poses both theoretical arid practical challenges since the scope and content of
primary care practice is neither easily defined nor well circumscribed. This
becomes evident if one attempts to adopt a disease-specific approach to
guidelines development for primary care. While clinical practice guidelines for
kidney disease, for example, would include such disorders as nephrolithiasis,
renal failure, and pyelonephritis, the diagnosis and management of kidney disease
in primary care medicine does not generally permit such neat patterns of
categorization. Patients often present to their primary care providers with vague
or ill-defined complaints such as fatigue or back pain. These complaints require
a diagnostic evaluation before disease-specific guidelines can be employed.
Further, patients' decisions to seek care are often highly individual and complex,
and include the full array of psychosocial factors that can interface with health
and disease. The characteristics of the health care delivery system to which the
patient belongs, including factors such as availability and accessibility, also can
play a pivotal role. These important factors lie outside the scope of clinical
practice guidelines based on disease entities. The nature and content of primary
care practice simply defies a traditional, biomedical-based approach to the
development of clinical practice guidelines. It is my intent to suggest an
alternate perspective be applied to guidelines development for primary care based
on the assumption that a conceptual paradigm different from that which is
generally applied to the analysis of most health care issues is needed.
BACKGROUND: FLAWS IN THE CURRENT
CONCEPTUALIZATION OF PRIMARY CARE
Primary care is usually defined as the continuous, comprehensive health care
of patients regardless of the presence or absence of disease and which integrates
other health resources when necessary (Alpert and Charney, 1973~. It stresses
accessibility as well as comprehensiveness, and is coordinated, continuous, and
accountable first-contact care (IOM, 1978~. Primary care is often viewed as a
parallel partner of specialist care. In this view, both "systems" of care operate
within well-defined boundaries, with patients shuffled back and forth as
necessary (Figure E.1~. In a sense, the age-old "breadth" versus "depth" debate
is reflected in the attempts to dichotomize care into the two realms of primary
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APPENDIX E
135
and specialty care. As depicted in Figure E.2, the practice patterns of generalists
and specialists diverge over time; the former are characterized by increasing
breadth at the expense of depth, the latter by increasing depth at the expense of
breadth. This fundamental divergence reflects not just practice patterns, but also
different intellectual paradigms. Specialty care lends itself more readily to a
reductionist approach while primary care favors a more integrative,
generalizeable approach. Over time, the primary care physician has greatly
extended his or her scope of practice to include a wide variety of clinical
entities; the specialist physician has narrowed his or her scope of practice to
include a great deal of information about fewer entities. But breadth and depth
are not mutually exclusive from the point of view of the patient. For example,
the primary care physician's scope of practice certainly includes some elements
of kidney disease such as pyelonephritis and early renal failure. The
nephrologist also treats these two entities. At what point does the patient
"belong" to one or both realms of care?
LL
cr
hi:
a:
cc
FIGURE E.1 Parallel systems of care.
1 ~
En
m
:>
m
This problem of categorization becomes clear in reviewing the proposed, in
progress, and completed lists of clinical practice guidelines funded by the Agency
for Health Care Policy and Research (AHCPR). If the following question were
posed, "Does this guideline fall within the purview of primary or specialty
care?", at least thirteen of the twenty-one guideline topics listed could be
considered as both within the purview of the primary care physician and the
specialist Table E.1~. For example, headache is an exceedingly common
problem in primary care practice; a guideline for the management of chronic
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136
SEfTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
._
o
ce
a,
/
/
/
/
G/
~/ G - Generalist
: ,
/
/
/
/
/
/
/
S
Depth over time
S = Specialist
FIGURE E.2 Practice patterns of generalists versus specialists over time.
headache would be helpful to both primary care providers and neurologists. The
same is true for many of the guideline topics listed in Table E.1.
Thus, primary care is not a parallel system of the specialty system of care.
The actual delivery of medical care is not often so hierarchical and
compartmentalized. Even in the managed care model of practice, patients and
their health concerns pass through both "systems" of care freely because the
boundaries of care for individual health problems are not well established.
Primary care is part of a continuum of care that ranges over a broad spectrum
of health issues. A systems model perhaps best illustrates this point (Figure E.3~.
This model reflects the considerable overlap that exists in most areas of medical
practice. The boundaries of care, between the specialties themselves and
between primary and specialty care, are not well defined. The systems model,
especially the "chaotic" center, is more reflective of the real-world practice of
medicine. The nephrologist, cardiologist, and general internist all have roles in
the treatment of congestive heart failure. The general surgeon, dermatologist,
and plastic surgeon overlap in the care of many skin lesions. The systems model
of care reflects this complexity and avoids the artificially tidy approach suggested
by the traditional compartmentalization of medical care into a series of specialty
domains. As will be elucidated farther in this paper, the systems approach offers
a new framework for the development of clinical guidelines for primary care.
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APPENDIX E
TABLE E.1 AHCPR's Clinical Practice Guidelines by Type of Care*
. . .
137
Type of Care
Guidelines
Specialist Primary Both
Acute pain management
Urinary incontinence in adults
Pressure Ulcers in Adults
Cataracts in adults .
Depression in primary care
Sickle cell disease
Early HIV infection
Benign pro static hyperplasia
Cancer pain
Unstable angina
Heart failure
Acute low back problems in adults
Otitis media with effusion in children
Mammography
Post stroke rehabilitation
Recognition and initial assessment of
Alzheimer's and related dementias
Cardiac rehabilitation i/
Smoking prevention and cessation
Anxiety and panic disorders
Screening for colorectal cancer
Headache pain ~
TOTAL 5 3 13
*As categorized by the author (SAW).
The point should be clear: primary care is not a discrete field confined to
the management of a particular set of health care issues. Applying the standard
view of primary care as a parallel system to the specialty system of care in the
development of primary care guidelines will not work. It will lead to a
confusing selection of topics that artificially separates what is, in reality, a
continuum of care from the patient's point of view. A different
conceptualization of primary health care is needed in order to properly address
the issue of clinical practice guidelines for primary care.
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138
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
PRIMARY CARES ~ j ~
DOMAIN \~ ~ \ ~ / SPECIALTY CARE
| ,~\~,-\~4~'< \ / DOMAINS
~ ~ ,' ~
Of - ~ \ /
/ an/ \ >a
SPECIALlY CARE / >a ~ \
DOMAINS / / ~\ \
FIGURE E3 Systems model of care.
PRIMARY CARE: A DIFFERENT VIEW
In approaching the development of clinical guidelines for primary care, it is
essential to define the perspective from which the guidelines are to be derived.
This perspective can be sought from a version of the "unit of analysis" question.
Is the unit of analysis the problem, the provider, the patient, or the type of care?
I have already suggested why analysis of the "problem" might not offer the
best approach. As pointed out previously, medical "problems" do not neatly fit
into primary or specialist care indeed it is impossible to confine many problems
to one sphere or the other. There is significant overlap and any approach to
guideline setting for primary care by "problem" is likely to fall prey to
conflicting constituencies and interpretations.
From the viewpoints of training, certification, and reimbursement, the world
of providers is certainly divided into primary care and speciality. Perhaps it
makes more sense to focus on the provider. While it is certainly possible to do
so, a closer view reveals the futility of this approach. First, there is considerable
variety in the kinds of primary care providers, including many physician
assistants, nurse practitioners, family physicians, osteopathic physicians, general
internists, and general pediatricians. Each has very different scopes of practice
OCR for page 139
APPENDIX E
139
based on education, training, patient population, type of health care environment,
and so forth. It is unclear that a single guideline for primary care practitioners
could effectively embrace this large and diverse constituency. Second, there are
many specialists who practice some amount of primary care; the exact numbers
are unknown but are felt to be substantial (Aiken, Lewis, Craig, et al., 19794.
Thus, an approach by type of provider in our current pluralistic system of health
care delivery is likely to be confusing if not misleading.
Could an approach be developed based on the patient? The idea initially
is attractive. After all, the patient should be the focus of the health care system.
The needs of patients, both individually and collectively, could be determined on
an epidemiologic basis. Guidelines could then be constructed for the most
pressing of these needs, based on the patient's social, environmental, economic,
and other circumstances. While initially challenging, such an approach would
simply be impractical because it would call for the manipulation of resources
well outside the domain of current health care practice, involving such areas as
housing, controls on violence, economic disenfranchisement, and the like.
Lastly, the perspective to be used could be based on type of care. This
approach focuses on the systems involved in health care delivery. It is
compatible with the model depicted in Figure E.3. It facilitates the use of
"systems thinking," which develops a framework for "seeing interrelationships
rather than linear cause-effect chains," and is useful in situations where "cause
and effect are subtle and where the effects over time are not obvious" (Serge,
1990~. Systems thinking is particularly applicable to health care because health
is affected by a myriad of forces, including individual values, beliefs,
expectations and genetic predispositions, all of which are immersed in a
particular environment, social milieu, and health care network. In such a
complex environment, it is not unusual for small events, such as a change in
medication or weather, to have large arid unpredictable effects on the patient
(Lipsitz and Goldberger, 1992~. Rather than be overwhelmed by all this
complexity, systems thinking helps see the structure underlying complex
situations (Serge, 1990~. Taking a systems perspective offers the opportunity
to discern those issues that can have a great impact on health.
PRIMARY CARE AS A SYSTEM OF CARE
Type of care analysis lends itself to a systems perspective. It offers an
approach that deals with the underlying complexities that exist in primary care
practice. Instead of pursuing simplistic cause-and-effect relationships (as when
using the "problem" as the basis of the analysis), type of care analysis
emphasizes the circumstances surrounding the occurrence of events (e.g.,
symptoms, decision to seek care, how complaints are expressed) and the
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140
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
interrelationships among such variables as the provider's work-up, role of stress,
and family traits. It reflects the observations that, in attempting to look at health
and well-being, (a) the whole is greater than the sum of its parts; (b) whatever
affects the system as a whole affects each part; and (c) any change in one part
affects other parts and the system as a whole (Glenn, 1984~.
Given the overlap between specialty care and primary care as depicted in
Figure E.3, it makes sense to distinguish primary care from other Morons of care
by the type of care provided. Primary care is a system of care that involves
three basic components: care of an unselected panel of patients, care that is
continuous and longitudinal over time, and care that is integrative in scope.
Patients are unselected in that those receiving primary care services have no
thematic set of reasons for doing so. Their reasons are theoretically unbounded
and range from periodic health maintenance exams, vague and ill-defined
complaints, to chronic and acute disease. The primary care system must be
prepared to deal with this wide variety of patients and health care issues.
Continuous and longitudinal care is received by patients in an accessible primary
care setting, is ongoing and comprehensive, and is provided by the same health
care professional over considerable periods of time in both illness and health.
Specialty care may or may not fulfill this criteria; primary care always must do
so. Integrative care includes other health-related services (e.g., specialist
consultations, rehabilitation, counseling) that are applied and coordinated to the
patient's overall care in a socially responsible (i.e., accountable) manner. These
three components compose the essential descriptors of the primary care system.
The descriptors of primary care operate, of course, within the complex
ecology ofthe patient and the larger hearth care system. The practice of primary
care involves the interactions of these descriptors with certain elements in the
patient's environment. These elements represent the key environmental dynamics
that influence primary care health care delivery. From a systems perspective,
these elements include: the context in which the care takes place; the interactions
that bring the various components of the health care system together in the
management ofthe patient; and the reaction ofthe health care system to changes
in the patient's health needs (Glenn, 1984~.
The context is the social, cultural, and medical milieu of the patient. It
largely determines the basis for the patient's decision to seek care. From the
point of view of the health care system, care seeking ignites the medical care
apparatus. From a policy and practical perspective, it is important to
understand end attempt toinfluence hearth seeking behavior. Theinteractions
are to the combination of factors that permit the health-care system to interact
with a given patient. These include the accessibility and availability of health
care services, financing of care, established practice patterns, and so forth. The
reaction of the health care system to changes in the patient's symptoms, needs,
and disease states is an important element of health care delivery because a
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APPENDLY E
141
patient's state of health is not constant, but constantly varying. Health needs
change frequently over time in both predictable and unpredictable ways. New
issues arise and change in their relevance and importance. Old issues wax and
wane in their severity. The manner in which the health system reacts to these
changes is the third key element in the ongoing primary care of the patient.
This conceptualization of primary care as a system of care consisting of a
set of descriptors and elements (l able E.2) facilitates a rational approach toward
the development of clinical practice guidelines that are uniquely suited for
primary care medical practice.
TABLE E.2 Descriptors and Elements of the Primary Care Health System
Descriptors
(basic features of the
delivery of primary care)
Elements
(key environmental dynamics that
influence the delivery of primary care)
Unselected Patients: Primary care Context: The social, cultural, and
patients who seek care for an unlimited medical milieu of the patient.
set of reasonse.
Continuous and Longitudinal: The Interactions: The combination of
ongoing, comprehensive care of a factors that permit the health system
patient over time by the same provider. to interact with a given patient.
Integrative: The coordination of all ~ The ~a ~r i
health system resources in the care of a which the health system reacts to
given patient. changes in the patient's symptoms,
needs, and disease states.
DEVELOPMENT OF GUIDELINES FOR PRIMARY CARE
In developing guidelines for primary care, the intersections of the
descriptors and elements of primary care practice suggest the type of strategic
issues that can serve as a foundation for specific guidelines. These issues tend
not to be disease specific, rather, they are "systems" oriented. They involve such
questions as: When should patients seek primary care services? Who practices
primary care, and if there is more than one type of practitioner, what are their
appropriate scopes of practice? Is all primary care the same? What are the key
differences between generalist and specialist care? What is the nature of the
interface between generalist and specialist care?
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SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
These kinds of questions lend themselves to an enlargement of the disease
orientation for guidelines development in primary care to include a systems
orientation. An example of the utility of this approach may be taken from
patients with chronic illnesses. In general, chronic illness cannot be cured; it
must be managed. The patient's biologic abnormality is but one of many
interacting components, including treatment effects, emotional state, ability to
perform work, healing capability, and so forth; further, the pattern of the
patient's illness changes over time as the interacting factors change (Holman,
1993~. The precise cause-and-effect relationships among these interacting factors
are often not apparent. It n~akes sense therefore to focus on the broader issues,
such as appropriate referrals, intervals between arid timing of follow-up visits,
and the impact of social support.
The kinds of issues for guidelines development appropriate to primary care
are outlined in Table E.3 . In this table, the essential descriptors of primary care
are cross-tabulated with the health system elements to produce nine cells that
outline suggested guideline topics.
Cell #1 (l~escr~tor: Unselected Patients; Element: Context of Care)
The context of health care when applied to the essential primary care
descriptor unselected suggests a number of issues related to the social, cultural,
and medical milieu of the patient. Because primary care patients have such a
wide variety of reasons for seeking or needing medical care, it is proposed that
guidelines development be explored for patients' decisions to seek health care.
Rather than viewing the patient as a passive "victim" or as a greedy "abuser,"
this approach places some of the responsibility on the patient, something which
makes sense in a constrained health care system. These guidelines could be
symptom oriented and health maintenance oriented. The former could address
such issues as the level, intensity, or tinning of specific symptoms. Specific
examples might include chronic fatigue or back or abdominal pain. From the
health maintenance point of view there exists already a loose amalgam of these
kinds of guidelines, including those from the American Cancer Society and the
U.S. Preventive Services Task Force. The challenge is to convert these into
meaningful, workable guidelines for patients. The development of patient
guidelines offers a particularly unique opportunity to bring the patient into the
primary care health system as a partner.
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APPENDIX E
143
TABLE E.3 Potential Issues for Clinical Guidelines Development In Pnmary
Care Using Me Systems Approach
Health Systems Elements
Primary Care Health System Reaction to
Descriptors Context of Cares Interactions Change
Unselected
Patients
Cell #1 Cell #4 Cell #7
When patients Scope of practice of When changes in
should seek care various types of pri- symptoms in pa
(e.g., chronic fa- mary care providers tients with diagno
tigue, abdominal sed illnesses
pain, back pain) warrant care (e.g.,
congestive heart
failure, chronic
obstructive pul
monary disease)
.
Cell #2 Cell #5 Cell #8
Behavioral and life Communications Intervals for
style modifications among providers appropriate follow
(e.g., stress reduc- (e.g., content, up and routine
lion, dietary modify- frequency, role of care (e.g., arthritis,
cations electronic peripheral vascular
communications disease
Cell #3 Cell #6 Cell #9
Role of other Boundaries of Health care
health-related generalist and decision making
services (e.g., specialist care (e.g., (e.g., provider
limited psycho- hypertension, patient communi
therapy, rehabilita- diabetes cation, patient
lion post CVA, role preferences,
of social support in medical-legal
chronic disease) ~issues
Continuous/
Longitudinal
Care
Integrative
Care
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SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Cell #2 (Descriptor: Continuous and
Longitudinal; Element: Context of Care)
The descriptor continuous and longitudinal, when applied to the context of
care, suggests the development of guidelines for specific behavioral and lifestyle
modifications. Such guidelines could pertain to both patients and providers.
Examples are: stress reduction and selected dietary modifications. Smoking
cessation, a guideline already under development, fits into this category.
Cell #3 (Descriptor: Integrative Care; Element: Context of Care)
This descriptor refers to other health-related services that are applied ~ the
care of the patient. Given the context of care, examples for guidelines
development include: beef, limited psychotherapy for reactive depression,
rehabilitation post cerebral vascular accident, and the role of social support in
patients with specific chronic illnesses.
Cell #4 (Descriptor: Unselected Patients;
Ele'``ent: Health System Interactions)
The second element involves the interactions of the various components of
the health system that impact on the patient, such as the availability and
accessibility of services and the financing of care. From the point of view of the
unselected patient, a major guideline topic involves the scopes of practice of the
various types of primary care providers. At least six kinds of such providers can
be identified and include: family physicians, general internists, general
pediatncians, nurse practitioners, physician assistants, and osteopathic physicians.
Can their individual roles and scopes of practice be defined? How can they best
be differentiated from each other? Can guidelines be developed to facilitate
these providers working together in a coherent system of primary care?
Cell #5 (Descriptor: Continuous and Longitudinal
Care; Element: Health System Interactions)
The descriptor continuous arid longitudinal suggests guidelines that address
health system interactions among multiple providers involved in the care of the
saline patient. What kinds of communication, in terns of content and frequency,
would maximize efficient and timely care of the patient? How should such
communication be unmanaged by the primary care provider? What is the role of
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APPENDIX E
145
communication be managed by the primary care provider? What is the role of
electronic information in this regard and should there be a standardized system
of such communication among providers?
Cell #6 (Descriptor: Integrative Care;
Element: Health System Interactions)
A central theme for the descriptor integrative care involves the interactions
of the various providers involved in the care of the patient. What should be the
boundaries of generalist and specialist care? Can guidelines be developed for
appropriate referral? For example, when should a patient with hypertension or
diabetes be referred from a primary care provider to a specialist?
Cell #7 (Descriptor: Unselected Patients; Element: Reaction to Change)
From the point of view of the unselected patient, guidelines could be
developed that address when patients with specific health problems should seek
medical attention because of a change in symptoms. This is somewhat similar
to the patients' decision to seek care guideline mentioned above, but differs in
that the patients are already diagnosed. Examples could include patients with
congestive heart failure and chronic obstructive pulmonary disease.
Cell #8 (Descriptor: Continuous and Longitudinal
Care; Elel1'ent: Reaction to Change)
The continuous and longitudinal descriptor together with the element
reaction to change suggests topics for guidelines development that include the
appropriate intervals for patients with particular problems to be seen in follow-up
by their providers. How does this vary for specific chronic or recurring medical
problems? Can realistic goals or standards be set for each visit? What are the
appropriate intervals for routine care and can guidelines for such care be
established?
Cell #9 (Descriptor: Integrative Care; Element: Reaction to Change)
The descriptor integrative care with this element raises issues concerning
health care decision making. Can guidelines be responsive to patient
preferences? Can they play a role in facilitating provider-patient communication,
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SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
particularly in explaining tile medical, epidemiologic, and prognostic information?
Can they help providers explain risks and benefits to patients? Can guidelines
serve a positive role in reducing medical-legal practices such as the perceived or
actual need for malpractice actions?
THE ROLE OF OUTCOMES IN GUIDELINE DEVELOPMENT
As noted above, the three health system elements~context, interactions, and
reaction to change) when combined with the principal descriptors of primary
care (unselected patients, continuous and longitudinal care, and integrative care)
form the basis for generating a series of generic topics for clinical guidelines
development in primary care. These generic topics may be applied to specific
health-related concerns as desired. For example, the treatment of hypertension
could be selected as a topic for guidelines for specialist referral. Abdominal pain
could be used as a symptom to define guidelines for when patients should seek
care. The specific entities chosen for further study may be selected on
epidemiologic, cost, academic, or theoretical bases.
The proposed model for primary care guidelines development is, as yet,
incomplete. The health care outcome resulting from the guideline must be
viewed as an intrinsic part of the guidelines development process. The
advantage gained is the linking of process and outcome in a systems approach
to primary care. The measured outcome should be fed back in a continuous loop
such that a modified guideline results. The general model suggested is depicted
in Figure E.4.
An example illustrates how the model in Figure E.4 works. When a
primary care provider feels that a patient needs more specialized care, a referral
is generally made. We know relatively little about the criteria for referral.
When is a referral usually necessary? What kinds of communication should take
place between the providers involved? How often should the patient to be seen
by the specialist? How best can multiple referrals be coordinated? The issue of
patient referral touches on the integration descriptor of primary care. From the
point of view of the health care system, to interaction of the various caregivers
form part of the health system framework. A topic for guidelines development
ill this framework could be, "When should primary care providers refer a patient
with hypertension to a specialist?"
Following the selection of a topic, the types of primary care providers and
specialists to be included in the guideline must be addressed. This is a
complicated systems issue since the United States is unique in having a
pluralistic system of primary care providers along with many specialist
physicians who also deliver primary care type services. Since it is obvious that
We competency, knowledge, patient base, arid legal basis for practice of all these
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Representative terms from entire chapter:
clinical practice
APPENDIX E
Topic
\
Primary
Care |
Descriptors ~
)
'1 ~
Health
System
Elements
.
<`
\
148
SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
The model suggested brings a dynamism into guidelines development by
linking outcomes with the systems issues involved in primary health care
delivery.
A SPECIAL CONCERN REGARDING GUIDELINE
DEVELOPMENT FOR CLINICAL PRACTICE
Guidelines, despite their recent proliferation, have been viewed as largely
voluntary and their use in clinical practice has not been well studied. What
evidence does exist suggests that they often do not impact on clinical practice
(Kosecoff, Kanouse, Rogers, et al., 1987; Lomas, Anderson, Domnick-Pierre, et
al., 19891. A recent national survey of a random sample of members of the
American College of Physicians is enlightening in this regard (Tunis, Hayward,
Wilson, et al., 1994~. Only 18 percent of respondents reported that a change had
occurred in their practice during the past year as a result of any guideline.
Physicians' confidence in guidelines appears to be related to their familiarity with
the organizations issuing the guideline, and physicians in fee-for-service
environments were less positive about guidelines in general. The authors note
that guidelines are perceived to have many different purposes and that "factors
other than validity may influence which guidelines are followed." Creating
guideline after guideline does not address their viability in clinical practice and
may be an exercise in futility. This is particularly apt for primary care practice,
given its diversity and broad scope.
Short of enforcing guidelines through some form of regulation, more work
is needed to develop strategies to enhance their implementation into clinical
practice. The challenge here clearly goes beyond one of dissemination; it gets
to the heart of why providers do what they do. The model presented in Figure
E.4 suggests one approach: linking guidelines to medical outcomes. If some
guidelines can be shown to lead to good (or better) outcomes, then the rationale
for their use becomes more compelling and more easily translated into "standards
of care." This further supports the recommendation that guidelines for primary
care (or other areas) be programmatically linked to outcomes studies. In
addition, specific research funds should be devoted to enlarging our
understanding of medical practice so that attempts to influence this practice will
have a greater chance of success. The funding for this research must be viewed
as a legitimate part of the process of guidelines development.
CONCLUSION
The development of clinical guidelines for primary care practice would
benefit from a systems approach. The key features that distinguish primary care
APPENDIX E
149
medical practice encompass a dynamic system that does not lend itself readily
to a static (e.g., single-focused) analysis. As pointed out in Table E. 1, many of
the guidelines that have been disseminated, or are currently under way or
planned, may legitimately be viewed as falling within the boundaries of the
primary care delivery system. A disease orientation for guidelines development
will not work well for primary care practice, where clinical guidelines must
reflect the deeper dynamics of health care delivery.
A theoretical model for guidelines development in primary care is presented
based on the interfacing of the essential descriptors of primary care practice with
the health system elements that result in health care delivery for the patient. A
series of generic topics can be derived from this model that may then be applied
to specific health care issues related to the practice of primary care. These
issues, which reflect the epidemiologic realities of primary care practice, may be
readily found in the literature ~J.S. Department of Health and Human Services,
1990; Schappert, 19921. They include the common reasons for office visits by
patients and the principal diagnoses given by primary care providers. A critical
feature of this model is the direct incorporation of outcomes studies in a
continuous feedback loop so as to facilitate further improvement and refinement
of each guideline.
This approach to primary care guidelines development reflects the "real
world" of primary care practice, in which an imposing array of forces and
contingencies ultimately result in a particular medical care outcome. In this
model, guidelines arise not just from specific illnesses but from the broader
characteristics that embrace the practice of primary care medicine.
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