Section
II: Tools
and Methods for Creating Guidelines
- Step
One: Determine the Guideline Scope and Clinical
Objectives
Topic
Selection
ACC/AHA clinical practice guidelines are written
on three general categories: health conditions,
procedures, and diagnostics. The Task Force determines
the topics for guidelines and selects the writing
committee members, while the writing committee
is responsible for developing the guideline's
content.
Determining
the Guideline's Scope
Before and during the first meeting, the writing
committee primarily focuses on coming to consensus
about the guideline's scope (see Checklist
1). Literature searching is conducted
to determine the scope of the guideline, as appropriate
(see Step Two).
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Ideally,
a set of guidelines should give practitioners,
patients, and policymakers an explicit description
of the projected health benefits and the
projected harms or risks. In addition, projected
outcomes should be compared with those for
alternative courses of care for the clinical
condition in question.
-Institute
of Medicine, 1990
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ACC/AHA
guidelines are usually intended to provide recommendations
applicable in the United States; however some
guidelines written in collaboration with the European
Society of Cardiology or other partners have a
broader target audience. The methodology for international
guidelines is the same as national guidelines,
with conclusions and recommendations based on
expert judgement applied to clinical evidence.
International differences in disease management
and health care resource availability may be noted
when such differences might have significant impact
on the implementation of recommendations.
Although
some guidelines also address issues of cost-effectiveness
and related economic analyses, ACC/AHA guidelines
are generally meant to provide clinically relevant
information outside of the context of costs and
reimbursement. If cost issues must be included,
guideline writers should limit the scope to previously
published analyses and not attempt to create any
new economic analysis within the document.
Guideline
Updates and Revisions
Maintaining guideline content that is up-to-date
with the clinical evidence and best practices
in the field of cardiology is an ongoing challenge.
The Task Force is exploring new systems to update
guideline content more regularly. In the meantime,
all guidelines are reviewed for possible update
within one year after publication. The research
analyst and the chair monitor literature on the
topic, and compare the current guideline recommendations
against the latest data. The entire writing committee
is periodically surveyed to determine if the guideline
(or sections within the guideline) needs updating.
Guideline updates should focus on substantive
changes to recommendations rather than editorial
changes to the document. Otherwise, all methodology
in this manual applies to updates and revisions.
Guideline
Structure
Guideline writers are encouraged to define as
precisely as possible the overall guideline structure
at the early stages of guideline creation. The
Task Force has provided standard guideline outlines
for each guideline type (see Table
2). These outlines improve consistency
across guidelines and facilitate the effectiveness
of on-line searching of our guidelines. They provide
a common structure while allowing for flexibility
as the topic demands. Guideline writers should
determine at the outsets which "standard concepts"
apply to their guideline, then proceed with creating
detailed clinical objectives under each concept.
The standard outlines are not prescriptive, nor
are they meant to encourage the creation of textbook-style
guidelines.
Identifying
the Clinical Objectives
The main goal of guideline creation is to develop
recommendations that allow providers to understand
the evidence on the topic and apply it to clinical
practice. As such, guideline writers should progress
with specific clinical objectives in mind. It
may be very helpful at the outset to consider
what kind of guidance the readers will expect
in the completed document, such as:
- The
role of exercise testing in asymptomatic patients
- The
use of inotropic agents in patients with end-stage
heart failure
-
Managing mitral regurgitation medically versus
surgically
A
comprehensive collection of clinical objectives
should be created within each main concept addressed
by the guideline outline. These clinical objectives
serve as the basis for literature searching and
sorting, and later for the compilation of guideline
recommendations.
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Checklist
1. Determining the Guideline Scope and Clinical
Objectives
Questions
related to the guideline overall
- What
is the guideline's targeted health condition,
procedure, or diagnostic?
- What
is the purpose of the guideline?
- What
is within the scope of the guideline?
- What
is outside the scope of the guideline?
- What
is the epidemiology of the topic?
- Who
are the guideline's intended users?
- What
is the target patient population to be
addressed in the guideline?
- How
does the guideline relate to other existing
ACC/AHA guidelines?
-
Can a few flow diagrams summarize the
guideline, or at least key sub-sections?
Questions
related to the guideline's clinical objectives
- What
are the important clinical objectives
related to the guideline topic?
- What
sub-topics and related topics must be
included in the guideline?
- Are
flow diagrams appropriate to these sub-topics
and related topics?
- What
are the potential benefits and risks for
individual patients associated with an
intervention or procedure?
- What
amount of clinical flexibility is appropriate
for the topic area?
- What
clinical options are available?
- What
topics have already been covered in existing
ACC/AHA guidelines?
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