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Summary
In the Omnibus Budget Reconciliation Act of 1989 (P.L. 101-239), Congress
created the Agency for Health Care Policy and Research (AHCPR). One mission
of the agency through its Forum for Quality and Effectiveness in Health
Care was to sponsor and encourage the development, dissemination, and
evaluation of clinical practice guidelines. Reflecting concerns about the Forum's
initial choice of guidelines topics, the 1992 legislation that reauthorized the
agency directed it to report to Congress in June 1995 on "optimal methods for
setting priorities for guidelines topics" (P.L. 102-410~. The AHCPR, in turn,
requested guidance from the Institute of Medicine (IOM). This report presents
the Institute's analyses and recommendations as developed by a formally
appointed study committee.
STUDY APPROACH
To undertake the study, the IOM appointed a 12-member committee with
ex pertise in Sidelines development and implementation, health services research,
health care delivery, and health policy. The committee met twice, once in
conjunction with an invitational workshop. It also commissioned three
background papers, reviewed relevant literature, and examined priority-setting
processes used by other public and private organizations.
In assessing processes for setting priorities for guidelines development, the
committee considered five principles. The first four were consistency of the
process with the organization's mission, implementation feasibility, efficiency,
and utility of results to the organization. The fifth principle, which is particularly
1
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2
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
important for a public agency, is essentially a corollary of the first: the priority-
setting process should be open and defensible.
For purposes of this report, clinical practice guidelines are "systematically
defined statements to assist practitioner and patient decisions about appropriate
health care for specific clinical circumstances." They provide clinical advice
(and sometimes ethical, organizational, and other advice), and they may take
many forms such as algorithms, computer-based protocols, and policy documents.
Technology assessments present information on patient care alternatives for
patients, clinicians, and others, or, more narrowly, they provide analyses of
individual technologies as "input to decisions" regarding insurance coverage,
reimbursement policies, or equipment purchases. Medical technologies include
"drugs, devices, medical and surgical procedures, and the organizational and
supportive systems" employed in patient care. Although the line between
technology assessments and practice guidelines is not sharp, the former are more
often focused on individual technologies, intended to support coverage or
purchase decisions rather than clinical decisionmal~ing, and prepared by staff
rather than expert panels.
One reference point for this study was the IOM's 1992 report Setting
Priorities for Hearth Technology Assessment: A Model Process. That study was
prepared for another unit of AHCPR, the Office of Health Technology
Assessment (OHTA), which was originally created to provide assessments that
would inform Medicare coverage decisions. Much of this report draws
comparisons and contrasts between the priority-setting processes used by the two
AHCPR units as a basis for considering future directions for the Forum.
FINDINGS AND RECOMMENDATIONS: PRIORITY SETTING
The procedures for the selection of AHCPR's first guidelines topics were
relatively informal and driven by a tight legislative timetable. The agency has
since developed a more formal process. The committee concluded that the
current priority-setting approach used by the Forum (Figure 1) is relatively open,
fairly explicit, and generally defensible.
The committee also concluded that the model process recommended in the
1992 IOM report on technology assessment provides a clear and reasonable
alternative framework for an organization willing and able to commit resources
for the required data collection and analytic steps. OHTA has provisionally
adopted the model process with some modifications. As AHCPR tracks and
evaluates the experience of OHTA, the agency will be able to assess the
process's strengths and limitations (e.g., in terms of efficiency and usable
results), identify ways to improve it, and decide whether and to what extent the
process should be adopted or modified by the Forum.
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SUMMARY
ACTIVITY
1. Select priority-setting criteria.
RESPONSIBLE
PARTY
Congress, AHCPR Forum
2. Solicit nominations of topics ~ AHCPR Forum
for guidelines development.
3. Use expert practitioner groups
to nominate and rank additional
topics in selected condition areas.
4. Screen nominations against
priority-setting criteria, taking
resources and existing guidelines
into account.
AHCPR Forum, private
sector
AHCPR Forum
5. Solicit comments on possible ~ AHCPR Forum
topics in the Federal Register.
1 1
6. Review comments and propose ~ AHCPR Forum
list of priority topics.
7. Designate final topics.
3
AHCPR Administrator
-'1
FIGURE 1 Process for setting priorities for guideline development, Office of the Forum
for Quality and Effectiveness in Health Care. SOURCE: Adapted from AHCPR, 1993.
Format adapted from TOM, 1 992b.
In the meantime, the committee agreed that the Forum should move forward
in systematizing and improving its current priority-setting process. OHTA
should also consider some similar steps.
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4
SEWING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Criteria and Their Application
Both the Forum and OHTA have made public the criteria they will apply in
selecting topics for guidelines development and technology assessment,
respectively. Although the criteria now used by the two organizations do not
differ radically, the committee believes that more commonality in criteria,
definitions, and measures is desirable. Where the Forum and OHTA differ, the
differences should be explained by differences in organizational responsibilities
or resources.
The committee recommended that six general criteria be applied in
considering topics for either guidelines development or technology assessment.
These criteria are prevalence of the clinical problem (number of affected persons
per 1,000 persons in the general U.S. population); burden of illness imposed by
the problem (individual mortality, morbidity, or functional impairment); cost
(cost per person of managing the problem); variability in practice (significant
differences in utilization rates for prevention, diagnosis, or treatment options);
potential of a guideline or assessment to improve health outcomes (expected
effect on health outcomes); and potential of a guideline or assessment to reduce
costs (expected effect on costs to sponsoring organization, other relevant
agencies, patients and families, and/or society generally).
Unfortunately, the data used to score particular topics on these six criteria
will often be incomplete, either because data are not available or because they
are too expensive to collect. To limit the distortions that may arise from reliance
on obviously incomplete data (e.g., using only mortality data to measure burden
of illness), the committee agreed that the agency's process for setting priorities
should provide an explicit opportunity for important unmeasured factors to be
considered, perhaps by using expert estimates in lieu of data.
The Forum now considers as a criterion for topic selection the potential for
a guideline to reduce significant clinical variation in the use of services. The
committee concluded that the emphasis should be on the potential for a set of
guidelines to influence behavior in ways that improve patient care outcomes or
increase efficiency without harming patients. On occasion, however, the Forum
may reasonably proceed with guidelines when the scientific evidence is clear that
an alternative to current practice is preferable-even if it appears that clinicians
or patients may resist such guidelines at first. Guidelines may, in such
circumstances, be viewed as an initial, educational phase of a long-term effort
to change behavior and improve outcomes.
The OH1 A has stated that the availability of scientific evidence on a topic
should not affect whether a topic is chosen for technology assessment but only
how it is assessed (for example, by relying entirely on expert opinion). Although
the committee understood the rationale for this position, it noted that one of the
comparative advantages of the AHCPR as a health services and outcomes
research entity is that it is better situated to mobilize expertise to analyze
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SUMMARY
5
scientific evidence than most health care delivery and professional organizations.
It makes sense for the Forum to capitalize on these strengths and, thus, to
consider the availability of evidence as one factor in topic selection. Some
consideration of whether an issue is controversial and whether the controversy
is amenable to technical clarification is also reasonable. Nonetheless, it may
sometimes be appropriate for the Forum to select a topic for which little evidence
is available if, for example, a strong case can be made that misleading claims of
effectiveness for an intervention need to be countered. In any case, available
scientific evidence almost always is insufficient to answer all important questions
about a clinical problem, and guidelines can make important contributions by
identifying major gaps in clinical knowledge.
One question that arose in the committee deliberations is whether the Forum
should apply additional criteria to ensure-or at least make it likely that the
topic list recommended to the administrator includes subjects related to specific
population subgroups (e.g., children), to certain broad clinical problems or
diseases (e.g., cardiovascular disease), or to particular legal, ethical, or social
concerns (e.g., malpractice). The committee concluded that it was acceptable for
the agency to establish separate "tracks" for considering such issues. The Forum
has essentially done this in the past when it singled out certain clinical areas such
as prenatal care and then convened special panels to nominate and rank topics
in these areas. In the future, the committee recommended that the Forum should
define more clearly its rationales for designating such special topic categories as
worthy of such special consideration. The rationales should reflect explicit
judgments about how important it is to have the special categories represented
in the topic list presented to the AHCPR administrator for final decisions. The
rationales can then be critiqued, which may, in turn, suggest alternative emphases
that would be more consistent with program and policy objectives.
In addition to giving special consideration to certain topic categories, the
Forum also should consider whether past guidelines need to be updated. Some
updates may involve the correction of errors, refinements in formatting, or other
revisions that can be handled primarily by staff without a large investment of
Forum resources. The availability of new evidence, however, raises the question
of substantive reassessments and their priority. For the foreseeable future, the
committee concluded it would be prudent for the Forum both to include existing
guideline topics routinely when it solicits comments on proposed topics for
guidelines development and to designate a separate "track" for considering
reassessment topics.
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6
SETTING PRIORITIES FOR CLINICALPR'4CTICE GUIDELINES
Procedure Modifications
The committee's recommendations for improving the Forum's current
procedures focused on (1) methods for obtaining expert judgment and developing
consensus positions and (2) the desirability of a basic procedure manual. With
respect to the first point, Forum staff should
· develop model Delphi or Delphi-like procedures for obtaining expert
judgments or topic rankings by mail, fax, or electronic mail;
· devise questions that are specific, explicit, and consistent with standard
methods for questionnaire construction and with program purposes; and
· experiment with more formal procedures to arrive at group judgments
during meetings convened as part of priority-setting activities.
The dual objectives of these recommendations are, first, to help participants
clarify their thinking and, second, to help AHCPR make more productive use of
expert judgment. This report includes questionnaires for the Forum to consider
when it next surveys practitioners or others for their views on guidelines
priorities (see Appendix F).
Another useful step the Forum could take is to develop a basic procedure
manual for priority setting activities. This manual, which could be developed
with assistance from elsewhere in AHCPR, should cover standard activities such
as questionnaire construction and analysis and consensus development methods.
The purposes would be to simplify and regularize the priority-setting process and
to allow continuing and new staff to work more efficiently. The committee
agreed that the Forum should also extend the basic procedure manual to cover
the guidelines development procedures and methods.
Topic Definition
During its work, the committee heard repeated concerns that the Forum's
priority-setting process needed to define more narrowly and precisely the topics
selected for guidelines development. The committee agreed. For example, if
the major quality, cost, and other concerns about lower back pain involve the
management of acute lower back pain and if it appears that reasonable scientific
evidence is available for evaluation, then the priority-setting process should
identify that target, not back pain generally.
The combination of earlier attention to topic definition and a focus on
narrower topics should have several positive effects: (1) the composition and
work of the development panel can be more efficiently organized from the
outset, permitting the panel to spend more time on content rather than topic
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SUMMARY
7
definition; (2) some apparent controversies may disappear when clinical issues
are more precisely defined; (3) the guidelines product will be more responsive
to the problems of most interest to clinicians, patients, and other users; and (4)
the implementation and evaluation ofthe guidelines will be easier. To the extent
that the focus turns to issues most amenable to clarification through authoritative
assessment of scientific evidence, the result should be clearer, more specific
guidelines. The committee recognized, however, that even if more attention is
paid to topic definition during the topic selection stage, the panels developing
guidelines will also need to consider topic boundaries and foci.
The committee also heard some suggestions that guidelines developers
should abandon the focus on clinical problems and concentrate on specific
technologies. The committee did not find the arguments for such a wholesale
shift persuasive. An initial focus on clinical conditions encourages a broad view
of patient care issues and alternatives (including preventive, diagnostic, and
treatment strategies) and an emphasis on health problems and outcomes of care
as they are experienced, managed, or evaluated by patients, clinicians, and health
care organizations. The committee concluded that the Forum should generally
continue to direct its attention toward clinical problems, although the priority-
setting process should not preclude the nomination or selection of technology-
based topics.
FUTURE ROLES FOR AHCPR
As this report was being drafted, the AHCPR was engaged in a broad
reassessment of its activities, including those of the Forum. One of its questions
was: should AHCPR cede the work of guidelines development to others? In
this committee's view, the answer at least for now is no. Although the
number of groups involved in guidelines development is larger than when
AHCPR was created, the Forum's work is more visible and inclusive than most,
making its activities more accessible as examples or prototypes from which
others can learn both positive and negative lessons. The value ofthis experience
may diminish as the methodological, procedural, and other challenges of
guidelines development are better resolved and as agreement on preferred
approaches grows. Thus, the continuing contribution of AHCPR involvement in
the function should be reevaluated periodically.
Another rationale for some continuing AHCPR involvement in guidelines
development is that as a public agency, AHCPR may consider topics relevant to
the problems of uninsured or otherwise disadvantaged populations that would be
low priorities for private groups that develop guidelines. In addition, the
pressures of health care restructuring may lead private groups to avoid guidelines
in areas in which financial incentives may encourage undertreatment or disregard
for patient preferences about treatment options.
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8
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
National and Local Guidelines
Increasing experience with clinical practice guidelines suggests that it is
unreasonable- indeed impossible-to expect nationally developed guidelines to
cover every operational issue for every kind of setting, practitioner, and patient
or to specify care processes in sufficient detail that the guidelines can be directly
integrated into local practice. Yet, guidelines that leave too much to be decided
at the local level or during implementation run the risk of being ignored,
misused, and modified in ways detrimental to patients. The restructuring of the
health care system now underway adds both urgency and complexity to the task
of defining roles for national and local organizations in guideline development
that draw on the strengths of each and minimize their limitations. (In this
context, the committee made an inexact but convenient distinction between
"national" organizations that develop guidelines for use by others and "local"
organizations that both develop and apply them in health care settings.)
The committee recommended that the Forum build on its current work in
both development and implementation to design and test alternative models of
guideline development that include both national and local components. As very
generally envisioned by this committee, such models would have two stages, one
"national," the other "local." The first stage would be similar to the current
guideline development process and would rely either on panels convened by the
Forum or on outside contractors. The second phase would shin activity from the
national to the local level. Work at the local level would involve a combination
of two steps: further "specification" of the guideline (e.g., process-of-care
protocols) and operational testing by organizations involved in health care
delivery products might still have to be modified to account for local operating
differences (e.g., differences in computer-based patient information systems), but
the model would challenge those who wish to modify the guidelines to develop
evidence that their modifications improved patient care or permitted equivalent
care at lower cost.
Clearinghouse, Assessment, and Other Activities
In addition to the Forum's continued involvement in guidelines development,
the committee concluded that the Forum could play a useful role as a guidelines
clearinghouse that collected and disseminated guidelines developed by other
private and public organizations. The committee also concluded that the Forum
needed an explicit, open, and defensible process for assessing the soundness of
guidelines developed by other organizations. Both the clearinghouse and
assessment Unctions were considered in the 1992 IOM report, Guidelines for
Clinical Practice: From Development to Use. The committee noted that a
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SUMMARY
9
provisional assessment instrument was included as an appendix to that report and
that efforts by various groups to apply the instrument warranted study. One
caution: it is possible that an assessment process would reveal significant
deficiencies in many of the guidelines assessed and that this prospect might
generate political opposition to an assessment process from organizations
responsible for such guidelines.
Another potential role for the Forum involves the encouragement of methods
and objectives for the formulation of procedure- or task-specific proficiency or
performance guidelines. Unlike practice guidelines that assist practitioners and
patients in deciding what course of care is appropriate (e.g., surgery or "watchful
waiting"), proficiency or performance guidelines would set forth methods and
measures for assessing an individual practitioner's competence in carrying out
a specific task (e.g., a surgical procedure). Conceptual and methodological
problems have historically troubled efforts by educators, hospital officials, state
licensing bodies, and others to assess and ensure professional competence in
general and with respect to specific skills or tasks. AHCPR might wish to
consider whether some part of the agency should pursue work in this area as an
extension of the organization's involvement in outcomes and effectiveness
research and guidelines development.
The committee was not asked to consider either the implementation of
guidelines or the evaluation of their impact. Earlier TOM committees have,
however, stressed that planning for successful implementation of guidelines must
begin at the development stage and that the effectiveness of guidelines should be
evaluated, not assumed. Topic selection and definition are critical first steps in
the process of looking ahead to the attitudes, needs, and circumstances of those
who must act if guidelines are to have the intended effects.
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Representative terms from entire chapter:
setting priorities
