|
Items in cart [4] |
Questions? Call 888-624-8373 |
PAPERBACK PDF BOOK Free Resources |
||||||||||||||||
|
||||||||||||||||
|
|
|||||||||||||||
| ||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Copyright © 2009. National Academy of Sciences. All rights reserved. Terms of Use and Privacy Statement |
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 19
1
Introduction and Background
. . .with Humility comes not only a reverence for truth, but also a
proper estimation of the difficulties encountered in our search for it.
William Osler, Aequanimitas
In November 1989, Congress amended the Public Health Service Act to
create the Agency for Health Care Polic y and Research (AHCPR). Under
the terms of Public Law 101-239 (Appendix A), this agency has been given
broad responsibilities for supporting research, data development, and other
activities that will "enhance the quality, appropriateness, and effectiveness
of health care services...." The needs and priorities of the Medicare
program are an important but not exclusive focus of the agency.
Many of AHCPR's responsibilities formerly belonged to the National
Center for Health Services Research, which AHCPR has now replaced,
but the emphasis on outcomes and effectiveness research is considerably
stronger. Other functions of the agency are new, in particular, those involv-
ing a joint public-private enterprise to develop, disseminate, and evaluate
guidelines for clinical practice under the sponsorship of the agency's Forum
for Quality and Effectiveness in Health Care. (Appendix B provides some
examples of guidelines already developed by public and private organiza-
tions.)
This report was prompted by AHCPR's request to the Institute of
Medicine (IOM) for advice about how the agency and the Forum might
approach their new and challenging responsibilities for practice guidelines.
19
OCR for page 20
20
CLINICAL PRACT CE GUIDELINES
The IOM agreed tO appoint a study committee that would work quickly tO
provide technical assistance and advice on definition of terms, specification
of key attributes of good guidelines, and certain aspects of planning for
Implementation and evaluation. This report largely confines itself to these
specific and limited tasks.: It is not a how-to-do-it manual, a methodology
text, a priori~-setting exercise, or a primer on guidelines for those seek-
ing an introduction to the subject. The report does, however, also aim
to encourage more standardization and consistency in guidelines develop-
ment, whether such development is supported directly by the Forum or is
undertaken independently by medical societies and other organizations.
The committee believes that the AHCPR initiative, taken as a whole,
has real potential to advance the state of the art for practice guidelines,
strengthen the knowledge base for health care practice, and, hence, improve
the appropriateness and effectiveness of health care. One objective of this
report is lo encourage realistic expectations about this potential by building
a broader understanding of the difficult but important steps needed to
move toward the goals for guidelines stated in P.L. 101-239 or, as it is
often called, the Omnibus Budget Reconciliation Act of 1989 (OBESE 89~.
CONTEXT
The legislation establishing AHCPR is one consequence of accumu-
lated public and private frustration about the perceived health and economic
consequences of inappropriate medical care. This frustration and the per-
ceptions that give rise to it stem from many sources including ceaselessly
escalating health care costs, wide variations in medical practice patterns,
evidence that some health care services delivered in this country are of
little or no value, and claims that various kinds of financial, educational,
and organizational incentives can reduce inappropriate utilization (IOM,
1989~.
The combination of high levels of expenditure and doubts about the
value of that spending explains policy makers' interest in improving the scope
and application of knowledge about what works and what does not work in
medical care- and at what price. AHCPR is supporting an extensive agenda
of outcomes and effectiveness research to add to the knowledge developed
through other sources such as the randomized clinical teals funded by
the National Institutes of Health. In fact, the major part of the agencies
1 In addition, in May 1990, the IOM embarked on a new 18-month project funded by the John
A. Hartford Foundation, Inc., and the Public Health Service to study both public and private
activities to develop, use, and evaluate guidelines and to recommend a framework for better
structuring of these activities where that is desirable and feasible (see Appendix C3. The report
of this study is planned for release in the fall of 1991.
OCR for page 21
INTRODUCTION AND BACKGROUND
21
work involves expanding the scope of knowledge rather than applying it.
Of AHCPR's appropriation of nearly 5100 million for fiscal year 1990, it
planned to obligate around $2 million for the Forum's work on practice
guidelines. (Some projects funded as research on outcomes will also involve
the development of guidelines.) In any case, the agency's responsibilities
for such guidelines reflect congressional recognition of the practical need
for ways to translate knowledge into patient and practitioner decisions that
improve the value received for the nation's health care spending.
More generally, the creation of a practice guidelines function within
AHCPR can be seen as part of a significant cultural shift, a move away
from unexamined reliance on professional judgment toward more structured
support and accountability for such judgment (Physician Payment Review
Commission, 1989, Roper et al., 1988~. Reflecting one element of this
shift, guidelines are intended to assist practitioners and patients in making
health care decisions; reflecting the second aspect, they are to serve as a
foundation for instruments to evaluate practitioner and health care system
performance.
As the interest in practice guidelines has grown, so has scrutiny of
existing guidelines and of processes for developing and using them (Brook,
1989; Eddy, 1987, 1988, 1990a-e, forthcoming (a,b); IOM, 1989, 1990;
Leape, 1989, 1990; Physician Payment Review Commission, 1988a,b, 1989~.
This scrutiny leads to one clear conclusion: the systematic development,
implementation, and evaluation of practice guidelines, based on rigorous
clinical research and soundly generated professional consensus, have been
progressing but also have serious limitations in method, scope, and sub-
stance. Concerns about these and other problems with practice guidelines
contributed to the legislation creating AHCPR and the Forum.
OVERVIEW OF PRACTICE GUIDELINES INITIATIVES
Ken together, the public and private activities related to practice
guidelines can be conceptualized, ideally, as having three basic stages:
development, intervention, and evaluation. The second and third stages
should again, ideally involve feedback loops to the first stage to prompt
the revision of guidelines when omissions, technical obsolescence, or other
problems are identified. Guidelines are thus dynamic, not static. They
reflect the interplay of scientific and technological progress, real-world
organizational pressures, and changes in social values.
~ date, most government and other initiatives emphasize the first of
the three stages, the development of practice guidelines. The intervention
stage involves much more diffuse and less studied efforts to disseminate
guidelines to target users and to encourage these users to actually apply
the guidelines in making health care decisions. Only recently has much
OCR for page 22
22
CLINICAL PRACTICE GUIDELINES
attention been paid to evaluating whether and why guidelines have any
impact.
PUBLIC INITL\TIVES
Under OBRA 89, AHCPR has responsibilities in several areas: (1)
health services research including research on effectiveness, efficiency, and
quality of health care with a particular emphasis on outcomes research;
(2) development, collection, and dissemination of data; (3) health care
technology assessment; and (4) practice guidelines. 1b promote activities
in the area of practice guidelines, Congress created a unit within AHCPR,
the Office of the Forum for Quality and Effectiveness in Health Care. As
described in more detail later in this chapter, the Forum must "arrange
for" the development and periodic review and updating of
(1) clinically relevant guidelines that may be used by physicians, educators, and
health care practitioners to assist in determining how diseases, disorders, and
other health conditions can most effectively and appropriately be prevented,
diagnosed, treated, and managed clinicalb; and
(23 standards of quality, performance measures, and medical review criteria
through which health care providers and other appropriate entities may assess
or review the provision of health care and assure the quality of such care.
As explained by one individual intimately involved in the develop-
ment of this legislation, the phrase arrange for is one key indicator of the
"extent to which the legislation was structured to create a public-private
enterprise with respect to guideline development. The Forum develops
no guidelines; guidelines are not to be federal creations" (Peter Budetti,
George Washington University, personal communication, July 13, 1989~.
The committee suspects, nonetheless, that most people will continue to use
the term develop to descn~e what the Forum does in this area
Other agencies of the federal government have or have recently had
responsibilities related to practice guidelines. These agencies include the
National Institutes of Health, the U.S. Preventive Services Ask Force,2
and the Health Care Financing Administration (HCFA) and its contracting
carriers, fiscal intermediaries, and peer review organizations. HCFA and its
contractors have developed criteria for reviewing services provided to Medi-
care beneficiaries. These criteria and their application, neither of which
are examined here, have been criticized for lack of rigor and accountabil-
ity (Institute of Medicine, 1990; Physician Payment Review Commission,
1988a, 1989).
. .
21he G~de to Clinical Preventive Services prepared by the U.S. Preventive Senaces Task Force
(1989) is a useful tart to read in conjunction with this report, although this report is not specifi-
cally cross-referenced to the guide.
OCR for page 23
INTRODUCTION AND BACKGROUND
PRIVATE INITIATIVES
23
Guidelines for clinical practice, broadly defined, are not new. The
processes of organized clinical education require various sorts of guidelines
as do the processes of professional licensure, board certification, quality
assurance, utilization review, and other aspects of health services adminis-
tration. However, in recent years, the interest in practice guidelines of the
medical community and others has grown exponentially.
The level of interest in guidelines is not all that has changed. Ibday,
there is a much greater emphasis on formal procedures and methods for
arriving at a more widely scrutinized and endorsed consensus about what
is appropriate clinical practice.
Among the medical groups involved for some years with the develop-
ment of guidelines are the American Academy of Family Physicians, the
American College of Cardiology, the American College of Physicians, and
the American Society of Anesthesiologists. In the research community,
the RAND Corporation has pioneered the development of important tools
and strategies. Newer initiatives are being undertaken or planned by the
American Board of Medical Specialties, the American Medical Association,
the Council of Medical Specialty Societies, and the academic medical and
health services research community.
Insurers, health maintenance organizations (HMOs), utilization man-
agement firms, and similar organizations have not ignored the potential of
practice guidelines as a basis for refusing payment for inappropriate care.
For example, several years ago the Blue Cross and Blue Shield Associa-
tion began its Medical Necessity Project, which supported and cooperated
with researchers and some medical organizations in their efforts to identify
obsolete procedures and set guidelines for the appropriate use of many
diagnostic and treatment services. The Health Insurance Association of
America recently established a similar function, and the Group Health
Association of America has been sponsoring programs on guidelines de-
velopment. Furthermore, individual members of each of these associations
are involved in additional efforts to develop or adapt practice guidelines lo
meet the needs of their different health plans. In addition, the activities of
dozens of firms supplying utilization management services to health plan
sponsors have focused attention on the quality, scope, and accessibility of
the criteria they use to review care on a prospective or concurrent basis.
The guidelines development efforts of private organizations are thus
proceeding on many fronts. Some coordinating strategies are emerging,
but important problems remain unexplained conflicts among guidelines,
neglected topics, lack of follow-up, and incomplete public disclosure of
the evidence, participants, and methods used to develop sets of guidelines.
There is no independent entity to certify that guidelines are sound in
OCR for page 24
24
CLINICAL PRACTICE GUIDEQNES
.
OFFI( ,E OF OFFIC1 . OF OFFICE OF THE OFFICE OF
PIANNING & SCIENCE & FORUM FOR HEALTH
RESOURCE DATA QUALITY & TECHNOLOGY
MANAGEMENT DEVELOPMENT EFFECTIVENES S AS S ES SMENT
IN HEAl,TH
CARE
OFFICE OF THE ADMINISTRATOR
r ~I
CENTER FOR CENTER FOR CENTER FOR
MED I CAL G ENERAL G EN ERAL
EFFECTIVENESS HEALTH SERVICES HEALTH SERVICES
RES EARCH INTRAMURAL EXTRAMURAL
RES EARCH RESEARCH
CENTER FOR
RESEARCH
DI S. SEMINATION
& LIAI SON
FIGURE 1-1 Organization chart for the Agency for Health Care Policy and Research.
SOURCE: Office of the Forum for Quality and Effectiveness in Health Care.
method and content and no "national bureau of standards" to set standards
for methods of guidelines development or their content. The legislation
creating AHCPR is one response to some of these problems.
SPECIFIC RESPONSIBILITIES OF AUCPR
The legislative mandate for AHCPR and its Forum sets forth several
specific responsibilities; it also identifies priorities and establishes certain
procedural requirements. In planning to implement this mandate, the
Forum has consulted with a broad allay of interested individuals and
organizations. The IOM committee is itself part of this consultation process.
Other efforts include presentations, meetings, and mailings to medical
societies, health care organizations, and other individuals and groups.
The following discussion notes the main elements of the legislative
mandate and describes the agency's initial steps to fulfill its responsibilities.
Figure 1-1 is an organization chart for the agency.
OCR for page 25
INDUCTION AND BACKGROUND
DEADLINES AND PRIORITIES
25
By January 1, 1991, AHCPR acting through the Forum must ar-
range for the development of an initial set of guidelines, standards, perfor-
mance measures, and rewew criteria for at least three clinical treatments
or conditions. AHCPR is also responsible for seeing that the guidelines
developed under its auspices are updated.
OBRA 89 created the Advisory Council for Health Care Policy, Re-
search, and Evaluation to advise the Secretary of the Department of Health
and Human Services (DHHS) and the administrator of AHCPR on pri-
orities and strategy. It also established the Subcouncil on Outcomes and
Guidelines (of the Advisory Council) to provide advice on priorities and
strategy for guidelines development and outcomes research.
A key explicit objective of the guidelines legislation is to help im-
prove the quality, appropriateness, and effectiveness of health care. More
implicit yet widely recognized-is the hope that guidelines will help con-
trol health care costs. In selecting conditions for guidelines development,
the agency is to consider the extent to which guidelines for the condition
can be expected to reduce variations in health care services and outcomes
and to improve care for significant numbers of people.
Priorities for the initial sets of guidelines to be developed by Jan-
ua~y 1, 1991, are more specific and stipulate that the clinical conditions
involved (1) account for significant expenditures in Medicare, (2) show
significant variation in the frequency or type of treatment provided, or
(3) otherwise meet the needs and priorities of the Medicare program.
Target users for the guidelines, standards, review critena, and performance
measures are "physicians, health care practitioners, medical educators,
medical review organizations, and consumers."
At this writing, the Forum is considering initial guidelines development
activities in the following areas:
Cataract surgery
Be nign pros tatic hype rpla s ia
Clinical depression
Sickle-cell disease
Management of incontinence
Management of chronic pain
Management of skin integrity and decubitus ulcers
Ambulatory care for human immunodeficiency virus infection
All of these areas except ambulatory care for patients with human immu-
nodeficiency virus had panel chairs appointed as of July 1, 1990. These
areas cover a wide varied of patients (not exclusively the elderly) and are
OCR for page 26
26
Cl [NICAL PRACTICE GUIDELINES
relevant for a variety of practitioners including physicians, nurses, nurse
practitioners, and social workers. According to Forum Director Stephen
King, these conditions and treatments are being considered because they
are important health problems characterized by a state of clinical knowl-
edge and professional judgment that warrants a guidelines development
effort and for which guidelines can be expected to reduce inappropriate
variation in services, improve the quality of care, and produce better health
outcomes. Additional clinical conditions or treatments will be identified
on an ongoing basis. The Forum expects to have several sets of guidelines
under development or assessment at any given time.
DEVELOPMENT PROCEDURES AND REQUIREMENTS
lathe director of the Forum may contract with public and nonprofit
private organizations to develop and update guidelines. The director may
also convene expert panels that can either develop guidelines or review
guidelines developed by contractors. (There is some disagreement about
whether the legislation requires the director to use both the contracting
and the panel mechanisms.) The process must include appropriate con-
sultations with interested individuals and organizations, including general
and specialty medical organizations and physicians in a variety of practice
settings. In addition, the director of the Forum must establish the standards
for methods and procedures to be followed by the contractors and expert
panels. The legislation permits pilot-testing of the guidelines.
One difficult task for the Forum has been deciding whether to convene
expert panels to develop guidelines or to contract with outside entities.
Initially, the Forum has adopted the first approach, namely, the convening
of its own expert panels. As the guidelines program expands, the Forum
may- some say, must use the contracting mechanism. Forum staff are
discussing such arrangements with a number of organizations.
In addition to arranging for the development of guidelines by expert
panels or contractors, the agency may adopt guidelines developed inde-
pendently of the Forum if they meet the requirements established by the
legislation. As described by one person involved in the drafting of OBRA
89, "This is a critical addition to the current ad hoc system. For the first
time, interested parties could turn over their products to a publicly con-
stituted, disinterested body for scrutiny. After appropriate modification,
the original guidelines would achieve an imprimatur of sorts from the dis-
interested body" (Peter Budetti, George Washington University, personal
communication, July 13, 1990~.
OCR for page 27
INTRODUCTION AND BACKGROUND
DISSEMINATION
27
The responsibilities of the Forum extend beyond the development of
guidelines to their dissemination. The legislation specifies that the director
of the Forum shall promote the dissemination of guidelines through organi-
zations representing health care providers and health care consumers, peer
review organizations, accrediting bodies, and other appropriate entities. In
addition, the guidelines must be presented in formats appropriate for use
by practitioners, medical educators, and medical care reviewers. Among
the first steps the agency is taking to promote the dissemination of guide-
lines is lo work with the National Library of Medicine for inclusion of the
guidelines in the library's various information systems.
USE OF GUIDELINES
The legislation establishing AHCPR and the Forum states that the
Secretary of Health and Human Services "shall provide for the use of
the [initial sets oil guidelines. . .to improve the quality, effectiveness, and
appropriateness of care" provided under the Medicare program. No further
details are offered. Presumably, providing for the use of the guidelines
will require that HCFA and its contracting fiscal intermediaries, carriers,
and peer review organizations take steps to incorporate medical review
criteria and other evaluation instruments into their programs to review
care provided to Medicare beneficiaries. Discussion of these matters is at
the most preliminary stages within DHHS.
EVALUATION AND lIJRTHER RESEARCH
The Secretary of Health and Human Services must determine the
impact of the initial set of guidelines on the cost, quality, appropriateness,
and effectiveness of health care and report these findings to Congress by
January 1, 1993. Because an adequate evaluation within this time period is
virtually impossible (see Chapter 4), the agency expects to provide Congress
with a status report at the start of 1993 rather than a complete evalua-
tion. More generally, the director of the Forum is to conduct and support
evaluations of the impact of guidelines on clinical practice. In addition,
the director is to recommend research projects to the AHCPR adminis-
trator that are related to (1) evaluating outcomes of health care services
and procedures, (2) developing standards and criteria for the guidelines
development process (what are called "attributes" in this report), and (3)
promoting the use of the guidelines, standards, performance measures, and
rewew criteria developed under the Forum's auspices.
OCR for page 28
28
CLINICAL PRACTICE GUIDEl rNES
THE INSTITUTE OF MEDICINE COMMITTEE AND PROJECT
~ conduct the study requested by AHCPR, the IOM appointed a
committee of experts in January 1990 (Appendix D). Members were se-
lected on the basis of their expertise and familiarity with characteristics
and uses of medical practice guidelines, desirable properties or attributes
of guidelines, and technical methods for preparing them. The committee
included practicing physicians, individuals experienced in the development
of guidelines, current and potential users of guidelines, and representatives
of relevant other disciplines such as nursing, law, and economics.
The IOM organized and conducted two meetings of the committee,
one in February and the other in April 1990. A major immediate goal of the
group was to help the Forum prepare to award and administer contracts for
the development of guidelines for three clinical treatments or conditions.
IOM staff provided background materials for the study committee that
included a survey of guidelines activity (Audet and Greenfield, 1989), a
case study of the mammography screening guideline for women aged 40 to
49 (Field, 1989), a chapter on attributes of quality of care indicators from
an earlier IOM report (IOM, 1990), selected journal articles, reports from
the American Medical Association and other medical organizations, and
two volumes of examples of guidelines and formats from various sources.
The committee also received status reports from the Forum director at
each meeting. The April meeting included presentations by Mark Chassin
and Sheldon Greenfield on practical implementation and evaluation issues.
Chapters 2, 3, and 4 describe sources of information in more detail. In
addition, IOM staff prepared papers for review by the committee as a basis
for recommendations and the final report
Staff from the Forum attended both meetings and received copies
of all draft and background materials prepared for the committee. Af-
ter each meeting, IOM staff prepared meeting summaries and circulated
them to committee members for their review and comment. Based on
committee discussion of Stan papers and the meeting summaries, this re-
port was drafted, circulated to the committee for comment, revised, and
then submitted for review in accordance with IOM and National Research
Council report review policies. After revisions were made based on the
latter review, this document was produced, constituting the committee's
final report.
OVERVIEW OF THE REPORT
The next chapter discusses definitions of key terms why the defi-
nitions are needed, how the committee approached this task, and what
the literature says about terminology. It sets forth specific definitions for
OCR for page 29
INTRODUCTION AND BACKGROUND
29
practice guidelines, medical review criteria, and standards of quality, and a
provisional definition for performance measures.
Chapter 3 takes up the attributes of good guidelines. It again de-
scribes how the committee approached the topic and what the literature
says about desirable properties of guidelines. The themes that underlie this
discussion are the importance of credibility and full disclosure of the pro-
cesses, sources, methods, and participants in guidelines development. The
committee has identified eight attributes of guidelines: validity, reliability/
reproducibility, clinical applicability, clinical flexibility, clanty, multidisci-
plinaIy process, scheduled review, and documentation. The stringency of
these attributes, especially taken together, is well recognized, and the com-
mittee realizes that a balance needs to be maintained between an ideal
process and a feasible one. In a second IOM project on practice guidelines
(Appendix C), one task will be to take the conceptual attributes described
in Chapter 3 and develop an operationally useful instrument for assessing
how specific sets of guidelines conform to these attributes.
In Chapter 4, the committee concentrates on implementation and
evaluation. This chapter differentiates between the Implementation of a
government program for guidelines (which includes hiring staff and conven-
ing expert panels) and the implementation or application of guidelines after
they are developed. It also differentiates between evaluating the impact of
clinical practices and evaluating the impact of practice guidelines.
Chapter 5 summarizes the committee's recommendations and conclu-
sions. The recommendations, although sensitive to broader congressional
expectations for the new agency, reflect the committee's relatively limited
charge tO advise the Public Health Service on definitions and attributes of
guidelines.
CONCLUSIONS AND CAUTIONARY NOTES
ldday, the field of guidelines development is a confusing mix of high
expectations, competing organizations, conflicting philosophies, and ill-
defined or incompatible objectives. It supers from imperfect and incomplete
scientific knowledge as well as imperfect and uneven means of applying that
knowledge. Despite the good intentions of many of the parties involved, the
enterprise lacks coherent structures and credible mechanisms for evaluating,
improving, and coordinating guidelines development to meet society's needs
for good-quality, affordable health care.
This situation will not change overnight, even though many promising
acquires, including those sponsored by AHCPR, are under way. Con-
sequently, expectations for quick results should be somewhat restrained.
Otherwise, dashed hopes may lead tO calls for premature abandonment of
OCR for page 30
30
Cr rNICAL PRACTICE GUIDELINES
a useful strategy for improving the appropriate use of health care services
and to the adoption of more draconian measures to control costs.
The committee is also concerned about other unrealistic expectations
or assumptions for example, the assumption that guidelines development
is a relatively simple or straightforward undertaking. It is not. For many
clinical conditions and services, the scientific base is [united. (This is one
reason why it is important that the guidelines and knowledge development
functions of AHCPR be coordinated.) Methods for analyzing evidence
and developing expert opinion vary, but none of the rigorous methods
can be properly applied by novices. Where considerable research has
been done and good methods have been applied to analyze it, honest
clinicians and analysts may come to different conclusions using the same
evidence. Agreement on facts may not be accompanied by agreement
on what health benefits are desirable at which economic cost with what
tolerable accompanying health nsks.
Such conflicts about the interpretation of evidence and the application
of value judgments cannot be ignored. Indeed, the whole process of guide-
lines development must be undertaken with care at every stage: selecting
participants, clarifying biases, adopting procedures and methods, identifying
and analyzing evidence, considering alternatives, providing for independent
reviews, preparing clear recommendations, and disclosing all important in-
formation about the process. This report is intended to reinforce these
points.
A second assumption of concern to the committee is that there is
only one right way to develop guidelines. There is not. Variations in the
topics, the clinical disciplines involved, the purposes, and the audiences
for guidelines will justify some differences in specific development meth-
ods. However, to grant some methodological diversity is not to accept all
approaches as equally good. Chapter 3 pursues this point but notes that
much remains to be tried and learned about the strengths and weaknesses
of different guidelines development methods.
One further questionable expectation, which is sometimes explicit but
often unstated, is that practice guidelines will help control health care
costs.3 They may not. The reasons for caution on this point are several. For
instance, variation in practice does not, by itself, demonstrate that the high-
use patterns are the inappropriate orles. Moreover, even if high use can
be identified as inappropriate, such identification does not automatically
change behavior. An array of incentives for behavioral change may be
tried, but not all will succeed. Even if behavior changes, expenditures may
3See, for example, the discussions of expenditure targets, volume performance standards, and
guidelines in the Physician Payment Review Commission's 1989 (Chapters 11 and 1V and 1990
(Chapter 2) reports.
OCR for page 31
INTRODUCTION AND BACKGROUND
31
not. Some gu~delmes undoubtedly will save money by reducing the use
of inappropriate services; some will increase costs by encouraging more
use of underutilized services; and some will shift costs from one service,
place, or payer to another. The net impact on costs cannot be predicted
with confidence, even if the priorities for guidelines development focus on
clinical conditions for which overuse of expensive services is suspected.
One of the main areas of disagreement among committee members
involved precisely how costs should be considered in the development of
practice guidelines. Some committee members believed that all guidelines
should incorporate judgments about cost-effectiveness whereas the majority
called for the development process, at a minunum, to include projections
of cost effects. In any case, if guidelines do succeed in improving the value
of the nation's expenditures of medical care by allowing more informed
individual and social decisionmaldng that in turn shifts expenditures from
less to more appropriate forms of care, then the endeavor will be successful.
As stated at the outset of this chapter, the committee believes that
AHCPR has the potential tO strengthen the knowledge base for health care
decisionmaking and contribute tO the development of practice guidelines.
It can be an important element in the much broader array of public and
private actions to improve the quality and effectiveness of health care.
This report suggests some ways in which the agency-with the help of
many others and a stance of constructive realism can move to meet its
mandate.
REFERENCES
Audet, An, and Greenfield, S. A Survey of Current Activities in Practice Guideline
Development. Paper prepared for an IOM Meeting on Medical Practice Guidelines:
Looking Ahead, November 8, 1989, Washington, D.C.
Brook, R. Practice Guidelines and Practicing Medicine. Are They Compatible? Journal of
the American Medical Association 262:3027-~30, 1989.
Eddy, D. Clinical Policies. Pp. 47-54 in Proceedings. Standards of Malay in Patient Care:
The Importance and Risks of Standard Setting Invitational Conference, Council of
Medical Specialty Societies, Washington, D.C., September 1987.
Eddy, D. Methods for Designing Guidelines. Paper prepared for the Physician Payment
Review Commission. Duke University, Durham, N.C, 1988.
Eddy, D. Comparing Benefits and Harms: The Balance Sheet. fioumal of the American
Medical Association 263:249~2505, 1990a.
Eddy, D. Guidelines for Polipy Statements: The Explicit Approach. Journal of the Arnerzcan
Medical Assoc~anon 263:22302240, 1990b.
Eddy, D. Practice Policies Guidelines for Methods. Joumal of the American Medical
Association 263:1839-1841, 1990c.
Eddy, D. Practice Policies What are They? Joumal of the American Medical Association
263:877 880, 1990d.
Eddy, D. Practice Policies Where Do They Come From? Journal of the American Medical
Association 263:1265-1275, 1990e.
Eddy, D. Designing a Practice Polio. Standards, Guidelines, and Options. Journal of the
Arnencan Medical Association, forthcoming (a).
OCR for page 32
32
CLINICAL PRACTICE GUIDELINES
Eddy, D. A Manual for Assessing Health Practices and Des~gn~g Practice Policies (draft dated
May 31, 1989). American College of Physicians, forthcoming (b).
Field, M. Health Policy and Medical Practice Guidelines: The Case of Mammography
Screening for Women Under 50. Paper prepared for an IOM Meeting on Medical
Practice Guidelines: Looking A-head, November 8, 1989, Washington, D.C
Institute of Medicine. Controlling Costs and Changing Portent Care? The Role of Utili~uon
Alanaf~ment, B. Gray and M. Field, eds. Washington, D.C.: National Academy Press,
1989.
Institute of Medicine. Medicare: A Strategy for Quality Assurance, vols. 1 and 2, K Lohr,
ed. Washington, D.C.: National Academy Press, 1990.
Leape, L Unnecessary Surgery. Health Services Research 24:352A07, 1989.
Leape, L Practice Guidelines and Standards: An Overview. Malay Review Bulletzn
16:42~9, 1990.
Physician Payment Review Commission. Annual Report lo Congress. Washington, D.C.,
1988a.
Physician Payment Review Commission. Improving the Quality of Care: Clinical Research
and Practice Guidelines. Appendix I. Background Paper for the Conference on
Practice Guidelines, Washington, D.C., October 1988b.
Physician Payment Review Commission. Annual Report lo Congress. Washington, D.C,
1989.
Physician Payment Review Commission. Annual Report to Congress. Washington, D.C,
1990.
Roper, W., W~nkenwerder, W., Hackbarth, G., et al. Effectiveness in Health Care. An
Initiative to Evaluate and Improve Medical Practice. New England Journal of Medic~ne
319:1197-1202, 1988.
U.S. Preventive Services Ask Force. Guide lo Clinical Preventive Services: On Assessment of
He Effectiveness of 169 Interventions. Baltimore, Md.: Williams & Wilkins, 1989.
Representative terms from entire chapter:
guidelines development
