Methodology Manual and Policies
From the ACCF/AHA Task Force on
Practice Guidelines

June 2010
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are notpermitted without the express permission of the American College of Cardiology Foundation. Please direct requests
to copyright_permissions@acc.org.

© 2010 American College of Cardiology Foundation and American Heart Association, Inc.
1

Table of Contents
1. Overview of Methodology .......................................................................................................... 4
1.1. Importance of ACCF/AHA Guidelines ............................................................................... 4
1.2. Purpose and Scope of the Manual ........................................................................................ 5
1.3. Staff Support ........................................................................................................................ 8
2. Tools and Methods for Developing Guidelines .......................................................................... 92.1. Selecting Topic and Chair/Writing Committee ................................................................... 92.2. Determining the Guideline Scope and Clinical Objectives ............................................... 15
2.2.1. Determining the Guideline’s Scope ............................................................................ 15
2.2.2. Identifying the Clinical Objectives ............................................................................. 18
2.2.3. Development of the Guideline Outline ....................................................................... 18
2.2.4. Determining Writing Assignments ............................................................................. 20
3. Defining and Conducting Appropriate and Comprehensive Literature Searches ..................... 22
3.1. Finding the Evidence ......................................................................................................... 22
3.1.1. Literature Search Methodology .................................................................................. 22
3.1.2. Documentation of Literature Search ........................................................................... 23
3.1.3. Balancing Scientific Rigor With Feasibility ............................................................... 24
3.2. Sorting the Evidence .......................................................................................................... 32
3.2.1. Reviewing the Evidence ............................................................................................. 32
3.3. Synthesizing and Interpreting the Evidence ...................................................................... 33
3.3.1. Synthesizing the Evidence .......................................................................................... 33
3.4. Expert Interpretation of the Evidence ................................................................................ 35
4. Writing Recommendations ....................................................................................................... 36
4.1. Overview of Recommendations ......................................................................................... 36
4.1.1. Patient-Centered Care ................................................................................................. 39
4.2. Assigning Classification of Recommendations and Level of Evidence ............................ 39
4.2.1. Classification of Recommendations and Level of Evidence ...................................... 41
4.2.2. Applying the Classifications and Levels..................................................................... 42
4.2.3. Performance Measures ................................................................................................ 43
4.3. Creating Visual Descriptions of Recommendations and Evidence ................................... 44
4.3.1. Communicating the Key Points .................................................................................. 44
4.3.2. Creating Tables ........................................................................................................... 45
4.3.3. Creating Figures .......................................................................................................... 48
4.3.4. Additional Important Points on Tables and Figures ................................................... 50
5. Writing Committee Discussions and Consensus Development ................................................ 51
5.1. Group Decision-Making .................................................................................................... 51
5.2. Maintaining Consistency with Other Documents on the Same or Related Topics ............ 53
5.3. Writing Committee Sign-off .............................................................................................. 56
5.4. Peer Review ....................................................................................................................... 57
5.4.1. Selection of Peer Reviewers ....................................................................................... 57
5.4.2. Writing Committee Response to Peer Review and Final Sign-Off ............................ 57
5.4.3. Document Sent to Governing Bodies of ACCF, AHA, and Partner Organizations ... 58
6. Web Posting and Publication .................................................................................................... 59
6.1. Preparing the Pocket Guide ............................................................................................... 59
7. Maintaining Guideline Relevance and Updating Evidence ...................................................... 592

7.1. Evidence Review ............................................................................................................... 60
7.1.1. Currency Review ........................................................................................................ 60
7.1.2. Late-Breaking Clinical Trials ..................................................................................... 60
7.2. Development Process ......................................................................................................... 61
7.2.1. Focused Updates ......................................................................................................... 62
8. General Operating Procedures .................................................................................................. 64
8.1. Disclosure of Relationships with Industry and Other Entities Policy................................ 64
8.2. Confidentiality/Nondisclosure Agreement ........................................................................ 65
8.3. Copyright Assignment and License Agreement ................................................................ 66
8.4. Editorial Response Policy .................................................................................................. 66
Appendix A. Suggested Readings................................................................................................. 68
Appendix B. RWI: Policies and Procedures for the Development of Guidelines ........................ 73
Appendix C. Types of Organizational Relationships and Nature of Relationship ....................... 80
Appendix D. Literature Search Request Form .............................................................................. 85
Appendix E. Checklists for Ensuring Guidelines Incorporate Desired Criteria ........................... 86

3

1. Overview of Methodology
1.1. Importance of ACCF/AHA Guidelines
The Institute of Medicine defines clinical practice guidelines as “systematically developed
statements to assist practitioner and patient decisions about appropriate healthcare for specificclinical circumstances.” (1990) Evidence-based medicine is a coherent approach to clinicaldecision making. The Institute of Medicine defines evidence-based medicine as the “integrationof best researched evidence and clinical expertise with patient values.” (Institute of Medicine(2001). Crossing the quality chasm: A new health system for the 21st century. Washington, DC:
National Academies Press).Well-developed guidelines have the potential to enhance theappropriateness of clinical practice, improve the quality of cardiovascular care, lead to better
patient outcomes, improve cost effectiveness, and identify areas of further research needs.

The creation of clinical practice guidelines has been a joint activity between the American
College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) since the1980s. Practice guidelines are clinical documents of high methodological rigor, which facilitate
evidence-based decision making and incorporate group values and patient preferences. The
development of these guidelines is intended to be evidence-based, transparent, and systematic.
Guidelines advance the missions of both organizations by providing clinical recommendations tohealthcare providers for the purpose of improving cardiovascular health.

ACCF/AHA Guidelines are intended to assist healthcare providers in clinical decision making bydescribing a range of generally acceptable approaches for the diagnosis, management, or
prevention of specific diseases or conditions. These guidelines attempt to define practices thatmeet the needs of most patients in most circumstances. They reflect a consensus of expert
opinion after a thorough review of the available, current scientific evidence and are intended to
improve patient care. These guidelines may be used as the basis for regulatory/payer decision
making; however, the ultimate goal is quality of care and serving the patient’s best interests. The

4

final judgment regarding the care of a particular patient must be made by the healthcare provider
and patient in light of circumstances specific to that patient.

Appropriately constructed practice guidelines intend to minimize harm, reduce inappropriate
practice variations, and assist in producing optimal health outcomes for patients. Patient centric
guidelines will be a keystone of patient-centered care.

The following nonexhaustive list includes important common uses of ACCF/AHA Practice
Guidelines:•

Improve patient outcomes•

Synthesis of latest clinical research•

Determine whether practice follows the current evidence-based recommendations•

Reduce practice variation•

Influence policy•

Promote efficient resource usage•

Identify gaps in the evidence base•Serve as a basis for development of Performance Measures and Appropriate Use Criteria

1.2. Purpose and Scope of the Manual
To continue as a leader in the field of clinical practice guidelines, the ACCF/AHA Task Force on
Practice Guidelines (Task Force) has overseen the creation of this manual to assist guideline
writing committees in navigating guideline development. This manual is intended to assist
guideline authors with crafting recommendations that will influence care or assess performance
and/or quality. The recommendations can then be translated into action or activity that can be
implemented and measured.

The bulk of this manual consists of tools to assist guideline writers in interpreting and applying
the methodology. A flowchart highlighting the key steps in the development of evidence-based
guidelines (Figure 1) serves as the basis for organizing the manual. Section 8 describes general5operating procedures that are integral to the guideline development process. These include
relationships with industry and other entities (RWI), confidentiality agreement, copyrightassignment and license agreement and the ACCF/AHA editorial response policy.

The Task Force understands the challenges in applying a uniform methodology to guidelines that
represent diverse diseases, conditions, diagnostics, and interventions. In all cases, writing
committee members should familiarize themselves thoroughly with the manual, as these policies
and standards provide the framework for guideline development. However, if warranted, theTask Force may allow exceptions to the written policies.

6Figure 1. Process of Document Development

7

1.3. Staff Support
The ACCF and AHA provide scientific and project management staff to support thedevelopment of evidence-based guidelines. A Research Analyst/Evidence-Based Medicine
Specialist and Document Manager are assigned to each guideline to assist writers with themethodology and process of guideline development. Table 1 describes the roles andcontributions of the Research Analyst/Evidence-Based Medicine Specialist and the Document
Manager.
Table 1. Staff Support for ACCF/AHA Guidelines
Document Manager
•

•
•

•
•

•
•
•
•
•
•
•
•
•
•

Track potential writing committee nominees,collect RWI and assist vetting of relevant
companies for Task Force and Chair review
Coordinate the invitation process for committees
Create and maintain document timeline, outline andwriting assignments, rosters, disclosures of RWI,
and copyright assignment and license agreement
Monitor status of guideline process with frequent
updates to chair and/or writing committee
Draft communication from the chair to committee
members (e.g., agendas, meeting minutes, monthly
updates)
Distribute materials to committee members
Maintain copy of citations relevant to the guideline
content
Coordinate conference calls and writing committee
meetings
Track committee member adherence to deadlines
Brief chair regarding important matters
Compile, enter, and edit text, references,recommendations, and tables/figures
Manage peer review process, including invitations
and comment spreadsheet
Manage preparation of executive summary andpocket guide
Facilitate Board approval and endorsement byoutside organizations
Assist chair with galley review/publication

8

•
•
•

•
•

•
•
•

Research Analyst/Evidence-Based Medicine
Specialist
Assist chair(s) with outline development
Conduct, review, and maintain records ofliterature searches
Assist writing committee members with thecreation of evidence tables, graphs, charts, metaanalysis, the creation of algorithms and othervisual summaries of recommendations
Assist the chair in writing the methodology
section of the guideline
Assist the chair and Task Force Liaison inensuring that the recommendations are consistent
with other ACCF/AHA Guidelines and otherdocuments on the same or related topics
Assist the chair in responding to peer review and
Board comments
Assist chair with executive summary and pocket
guide development
Provide other scientific, technical, and writing
support as requested

2. Tools and Methods for Developing Guidelines
2.1. Selecting Topic and Chair/Writing Committee
The Task Force on Practice Guidelines establishes overall policy, chooses the individual topics
for guidelines, and monitors existing guidelines to determine when revisions and focused updates
are required. The members of the Task Force are senior, very well-respected individuals with avariety of expertise who generally have previously served on a guideline writing committee.

ACCF/AHA clinical practice guidelines are written on 3 general categories: health conditions,procedures, and diagnostics. Generally high-volume, high-cost, major treatment-impact andhigh-practice variation procedures and treatments are given highest priority. Once a topic is
identified, a writing committee is organized to develop the guideline (Table 2).

The Task Force identifies nominees, who are cardiologists or other experts in the field ofcardiology or cardiovascular research, for consideration for chair, individual writing committee
members and organizations that will be invited to participate in the development effort. The
chair (and co-chair and/or vice chair if necessary or desired) should be a known leader in theclinical community who is committed to building consensus. At meetings, the chair must be able
to facilitate equitable discussion and to negotiate among differing opinions. Beyond attending
official all-committee meetings and participating in conference calls, s/he must also be willing tocommit time and make him/herself available to staff and committee members, especially whileworking independently reviewing and editing sections authored by members of the writing
committee, and while resolving peer review comments towards the end of the process.

Chair and/or Vice Chair Responsibilities:
 Assist the Task Force and staff in determining writing committee membership, e.g., expertiseneeded, organizational involvement
 Refine scope of document, determine outline, and make writing assignments


Review studies and data
9



Review areas of expertise of writing committee members to determine appropriate
writing assignments.
♦ Assign writing committee members with RWI to write and participate on
sections not relevant to their RWI

 Manage RWIWork with oversight Task Force and staff to identify companies (and competingcompanies) that produce products and services relevant to the document

Enforce disclosure policy during meetings and/or conference calls. Options fordisclosing:♦ Disclosure table distributed to each member for call or meeting♦ Each member states RWI♦ Slides/tent cards for each member showing disclosures during discussion

Require experts with RWI to recuse themselves from writing and/or voting per
current policy

Determine if policy exemptions may be required due to necessary expertiseWork with staff to track RWI for each vote

 Manage the document


Maintain timeline and encourage writing committee to meet deadlines

Write or facilitate writing of sections if writing committee members fail to submit
sections

Edit full document for consistency of style and voiceFacilitate consensus throughout development

 Manage the meetings
Enforce adherence to document outline and scopeEnsure discussion is balanced

Facilitate consensus development



Maintain RWI policy compliance Respond to peer review and BOT/SACC review
Work with staff and the writing committee to determine list of peer reviewers

Work with staff to review and respond to all peer review comments

10

Assign peer review comments to writing committee members, based on areas ofexpertise, when appropriateConsider RWI of reviewers who seem particularly invested in one topic when
responding to their specific comments



Respond to Advance BOT, BOT, and SACC review comments as necessary

 Develop executive summary, pocket guide and participate in development of derivative
products as requested

 Assist throughout publication and promotion phases of document, e.g., page proof review,press release, interviews

Writing committee members must also be committed to building consensus and comfortable witha collaborative writing process. Attendance at scheduled face-to-face meetings and on allcommittee conference calls is essential, as is the ability to work independently on assigned
sections of the guideline and to review and comment on the draft as needed via e-mail. Ideally,
committee members will be easily available to staff and fellow committee members as theywork.
Writing Committee Member Responsibilities:
 Review and reach consensus on the scope of the document
 Participate in outline discussions and volunteer/agree to writing assignments
Distill studies and data pertinent to assigned sections

 Adhere to RWI policyDisclose all RWI related to healthcare goods and services during the invitation
process

Report new RWI that arise during the writing effort immediately to staff and writing
committee chairAvoid initiation of new relevant RWI during the writing effort to ensure writing
committee balance

Agree to publish disclosure information relevant to the document and webpost
comprehensive disclosure informationComply with disclosure policy during writing effort
11 Create the document
Work with other writing committee members to draft recommendations



Edit sections written by other authors as requested by the chairs

Write and edit assigned sections by the agreed upon deadlinesWork with staff to incorporate and process data and evidenceProvide appropriate references to support section

 Review and approvalSubmit ballot during pre-peer review sign-off and final sign-off as needed

Submit names of possible content reviewers



Review section carefully and check references, tables/figures and cover pageFor each guideline, the Task Force also nominates a member to serve as the Task Force Liaison.
The Liaison is a full voting member of the writing committee and must therefore abide by all
current RWI policies and attend the meetings and conference calls. The Liaison monitors the
progress of the effort, may be a section author, and provides feedback to the parent task force
concerning any problems or issues that need to be addressed. This member has the
responsibility of ensuring that the document under development is consistent withpreviously published ACCF/AHA documents. This member also maintains close contact withother writing committees in progress pertinent to the topic and facilitates (with staff) the sharingof drafts. If there are significant differences among ongoing writing committees, these should bemade known to the parent Task Force Chair and every attempt should be made to reach acompromise. We have recently expanded this role to include participation in the RWI
adjudication process which initially occurs during writing committee formulation; however, theliaison may be asked to also review companies periodically throughout the process. The newrequirement for all writing committees to have 51% of its members (including the chair) with norelevant RWI requires intense discussions about company relevance. The adjudication process
will now include the Task Force Liaison in addition to the Writing Committee Chair/Vice Chair
and Task Force Chair.

12

Table 2. ACCF/AHA Selection of Writing Committee Members
Writing Committee Role

Responsible for Selection

Writing Committee Chairperson(s)Task Force

Writing Committee Members (including
Liaison and Lead Reviewer)

Task Force
Writing Committee Chair(s)Collaborating Organizations
Performance Measurement Task Force
Chair

Performance Measurement Representative

In addition to the varied scientific and clinical expertise that is germane to the guideline
development, a broad spectrum of healthcare practitioners are identified to diversify
representation from different geographical regions, genders, ethnicities, and experts from bothacademic and nonacademic settings. The Task Force also attempts to balance the number ofcontent experts (potentially including a pharmacologist, QI representative, statistician and a
representative from the Performance Measures Task Force) and senior practicing clinicians.

Finally, every writing committee has an official Task Force Lead Reviewer. The Lead Reviewer
assumes the responsibility to conduct a thorough review of the document on behalf of the
Task Force, including consideration of concordance with other ACCF/AHA documents. All
Task Force members have the opportunity to review the document, but the Lead Reviewer
reviews the document as an “official” peer reviewer on behalf of the Task Force. The Lead
Reviewer also ensures that the guideline is consistent with other associated documents, that all
peer review comments are responded to and that all controversial issues are resolved. S/He thenmakes a recommendation in writing to the Task Force Chair that the document is ready forformal approval.

Part- or full-time employees of industry (PhARMA) are prohibited from serving as members of aguideline writing committee. The chair/co-chair(s) and all prospective members of writing
committees are required to disclose RWI during the past 12 months with 1) the manufacturer(s)of any commercial product(s) and/or provider(s) of commercial services related to the content of
the document and 2) any commercial supporters of the activity and 3) any relationships with13

other entities (i.e., academic institution, government, not-for-profit corp., or foundations).
Participation on the writing committee is dependent upon a review of all relevant RWI by the
Task Force. A majority of writing committee members must be free of relevant RWI.* At least
50% of writing committee members, plus the Chair, may have no relevant RWI. The Task Forcemonitors writing committee composition for RWI, as well as other potential areas of bias, suchas intellectual bias/perspectives or organizational relationships potentially competitive with theCollege, and must approve each writing committee before work begins. Once chosen, authors
are requested to withhold from forming any new relevant RWI during the writing effort in orderto maintain the RWI balance of the writing committee.

Of note, the Task Force also reviews writing committee balance for other issues such as adiversity of geographic location, private practice versus academic physicians, gender, race, andappropriate organizational/content expertise.

At the discretion of the TFOG/TFPG, certain disclosed relationships of the chair, co-chair, vicechair, or writing committee member such as participation in government-sponsored oruniversity-managed Data Safety Monitoring Boards or research, as well as certain
institutional/organizational and government/nonprofit relationships may be considered as NOT
relevant to the writing of the document.

All recommendations will be balloted during the approval process. Writing committee memberswith a relevant RWI may participate in the discussion but must recuse themselves from voting on
the recommendations where their RWI applies. Recusal information is published on theguideline title page and with the RWI table as an appendix to the document. The detailed andcomplete RWI policies and form are included in Appendix B. See Section 5.4.2. for more details
about the consensus building process and balloting process.

Writing committee representation is increasingly diversified, which gives the guidelines greater
impact on clinical practice and acceptance by more stakeholders. Healthcare providers with astake in caring for patients during the course of treatment should be represented on the writing
committee as appropriate to ensure that physician guidance is unified from all specialty areas.
14

Other medical associations or societies may be asked to join the effort at varying levels ofparticipation (see Appendix C for elaboration on the specific levels of organizational
participation). The decision regarding the level of participation is determined by the Task Forcewith input from the writing committee chair/co-chair.

The above policy will vary slightly with the implementation of the new Guideline Focused
Update process (see Section 8).

2.2. Determining the Guideline Scope and Clinical Objectives
2.2.1. Determining the Guideline’s Scope
Before and during the first meeting, the writing committee primarily focuses on coming toconsensus on the guideline’s scope and determining writing assignments (see Checklist 1). A
literature search is conducted to define the scope of the guideline (see Section 3.1., Finding the
Evidence). The draft scope is shared with invited organizations to ensure all parties are confident
with the guideline direction and inclusion topics.

Once the date range for literature inclusion is determined, it is added to the Introduction of the
document so that we are able to track which studies are included and which are not. It is also
important for the reader to know this information.

ACCF/AHA Guidelines are usually intended to provide recommendations applicable in the
United States; however, some guidelines written in collaboration with the European Society ofCardiology or other partners have a broader target audience. The methodology for internationalguidelines is the same as national guidelines, with conclusions and recommendations based on
expert judgment applied to clinical evidence. International differences in disease management
and healthcare resource availability may be noted when such differences might have significant
impact on the implementation of recommendations.

15

ACCF/AHA Guidelines are generally meant to provide clinically relevant information based onclinical effectiveness 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. Cost effectiveness is notfactored into recommendations, which are strictly based on the scientific evidence. However, ona case-by-case basis, if cost effectiveness information is available, the writing committee may
choose to mention it in the supporting text for a given recommendation.

16

Checklist 1. Determining the Guideline Scope and Clinical Objectives
Questions related to the guideline overallWhat is the guideline’s targeted health condition(s), diagnostic test(s), or interventional
procedure(s)?

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 literature inclusion date range?

What is the epidemiology of the topic?



Who are the guideline’s intended users?



What is the public health impact?

What is the target patient population to be addressed in the guideline?

How does the guideline relate to other existing ACCF/AHA documents (e.g., expert consensus,
scientific statements, performance measures, data standards, appropriate use criteria, quality
improvement)?

Can flow diagrams and evidence tables help summarize the guideline, or at least key subsections?



How does the guideline impact and improve broad health system based public health improvement
goals such as the Healthy People 2010 Initiative?

Questions related to the guideline’s clinical objectives
What are the important clinical objectives related to the guideline topic?

What subtopics and related topics must be included in the guideline? Are the subtopics and related
topics already covered by another organization? What comorbidities are being covered or should
be covered by the topic area/guideline?

Are flow diagrams appropriate to these subtopics and related topics?

What are the potential benefits and risks for individual patients associated with an intervention orprocedure?

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?

17

2.2.2. Identifying the Clinical Objectives
The main goal of guideline creation is to develop recommendations that allow users tounderstand the evidence on the topic and apply it to clinical practice (see articles by Shaneyfelt
and Grilli in the Suggested Readings). As such, guideline writers should progress with specificclinical objectives in mind. It may be helpful at the outset to consider what kind of guidance thereaders 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, and•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 literaturesearching and sorting, and later for the compilation of guideline recommendations.

2.2.3. Development of the Guideline Outline
Guideline writers are encouraged to define as precisely as possible the overall guideline outline
during the early stages of development. The Task Force has provided standard guideline outlines
for each guideline type (see Table 3). These outlines improve consistency across guidelines andfacilitate the effectiveness of online searching of our guidelines. They provide a common
structure while allowing for flexibility as the topic demands. Guideline writers should determine
at the outset 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.
Table 3. Standard Outlines by Guideline Concept from the ACCF/AHA Task Force
Disease or Condition Guidelines
Standard Concepts
Possible Content
Introduction
Purpose of the guidelines
Scope
Definition of the disease/condition
Overview
Epidemiology
18Classifications
Characterization
Recognition
Methods for risk stratification
Other issues related to clinical assessment
Clinical comparative effectivenessNoninvasive testingInvasive testing
Laboratory testing
Risk assessment
Principles of management
Therapy
Medication
ProceduresInterventions
Alternative/complementary medicine
Monitoring
Concomitant disorders
Patient groups (e.g., elderly, women, pediatric)
Discharge
Long-term management
Patient education
Address areas lacking evidence or that haveconflicting evidence
Address newer and/or better designed studies
Head-to-head comparisons of pharmacologicaltreatments, new clinically applicable tests, and/or
instruments

Clinical Evaluation

Diagnosis and Testing

Treatment

Special populations
Follow-up

Future directions

Interventional ProceduresStandard Concepts
Introduction
Definition of intervention/procedureSpecific conditions
Management strategies

Outcomes

Institutional/operator issues

Related Content
Purpose of the guideline
Scope
General considerations
Background
Clinical uses
Procedure-specific considerations
Associated medical therapies
Procedural complications
Reducing risk
Definitions of success
Short-term and long-term outcomes
Comparisons with other interventions/ Clinicalcomparative effectivenessQuality assurance/improvement
Volume considerations
19

Special populations

Patient groups (e.g., elderly, women, pediatric)
Diagnostic ProceduresStandard Concept
Introduction
Description of the diagnostic toolSpecific conditions

Special populations

Related Content
PurposeScopeSpecific procedures
Equipment
Sensitivity/specificity
General considerations
Comparison with other diagnostic tools/ Clinicalcomparative effectiveness
Clinical uses (Note: Diagnostic guidelines are usuallysubdivided by the diseases/conditions that they candiagnose. These discussions include diagnosis,
assessment, prognosis, risk stratification, screening,
etc.)
Patient groups (e.g., elderly, women, pediatric)

Prior to the first writing committee meeting of new or revised guidelines, staff works with thechair to begin development of a comprehensive outline. The Research Analyst may conduct a
preliminary search from terms provided by the chair and forward the abstracts to the chair to help
frame the backbone of the outline. For guideline focused updates, staff works with the chair to
identify specific areas in the outline for which there is sufficient clinical evidence to justify
updating. The scope, outline, and writing assignments are preferably determined prior to the firstwriting committee meeting.
2.2.4. Determining Writing Assignments
Writing assignments are determined by the guideline chair/co-chairs in concert with writing
committee members. Each section (or subsection) of the guideline is assigned both a primaryauthor and secondary author/reviewer(s). The primary author is responsible for drafting theoriginal content of the section(s) to which he/she is assigned. The secondary author/reviewer(s)edits and provides additional content as requested to the primary author or chair. The primarysection author MAY NOT have any relevant RWI specific to the document section; thesecondary author/reviewer MAY have relevant RWI. RWI writing and voting procedures requirethat relevant relationships be managed according to the following policy:

20

•

If a member of a writing committee has a relevant RWI regarding a product or competingproduct, and the section of the document relates to the specific or competing product,
then the member is permitted to participate in the discussions but is not permitted todraft or vote on a recommendation or corresponding text.

•

If a member of a writing committee has a relevant RWI regarding a product or competingproduct, and the section of the document is not related to the specific or competingproduct, and the company does not manufacture or sponsor any relevant product/service
or competing product/service, then the member is permitted to participate in thediscussions and is permitted to draft and vote on the recommendation and/or
corresponding text.

•

If a member of a writing committee has a relevant RWI regarding a product or competingproduct, and the section of the document relates to the company that manufactures orsponsors the product/service or competing product/service but not the specific product orclass of products involved in their relationship, then the member is permitted toparticipate in the discussions but is not permitted to draft or vote on the recommendation
and/or corresponding text.

For determining eligibility to serve on a writing committee, aperson has a relevant relationship IF:–

The relationship or interest relates to the same or similar
subject matter, intellectual property or asset, topic, orissue addressed in the document; or–The company/entity (with whom the relationshipexists) makes a drug, drug class, or device addressed in
the document, or makes a competing drug or device
addressed in the document; or–

The person or a member of the person’s household, has

21

Because a guideline basedon an incomplete or biased
evaluation of the literature
can lead to inappropriate
recommendations, thesearch for relevant researchshould be comprehensive,
research should be selectedusing explicit criteria, andthe validity of the results
should be judged in arigorous and reproducible
fashion.
-Cook, 1997

a reasonable potential for financial, professional or other personal gain or loss as a resultof the issues/content addressed in the document.

3. Defining and Conducting Appropriate and Comprehensive
Literature Searches
3.1. Finding the Evidence
Once the outline, scope, and writing assignments of the guideline have been determined,
comprehensive searching of the published literature occurs. A key component of the
ACCF/AHA Guidelines methodology is the development of recommendations based on theentirety of the evidence currently available. The Institute of Medicine describes literaturesearching as the key step in developing valid guidelines.

It has been estimated that over 2 million articles and more than 17,000 biomedical books are
published annually. The challenge of finding relevant articles among the millions iscompounded by the availability of multiple electronic databases, all of which offer different but
partially overlapping pools of information.

The current resources for guidelines development allow for searching in MEDLINE (via
PubMed), the Cochrane Library, and a clinical trials database. The Research Analyst assigned to
the guideline will compile requested searches and citations relevant to the guideline topic fromthe above mentioned databases and forward them to the writers.
3.1.1. Literature Search Methodology
The ACCF/AHA process for conducting comprehensive guideline literature search is briefly
described in the following text. Initial literature searches requested by guideline writing
committee authors focus on published articles (i.e., RCTs followed by observational studies,
meta-analyses and systematic reviews). If high quality, relevant, and up-to-date meta-analyses
or systematic reviews are found, these articles allow writers to focus on critiquing and updating
an existing review as opposed to creating one (see articles by Pogue and Lau in Suggested
Readings). For the majority of topics, literature searches focus mostly on randomized clinical22

trials, and is expanded to nonrandomized studies, case studies, and opinion documents until theevidence base is sufficient for each clinical question identified in Section 2.2.2. Each article isevaluated as to quality and clinical limitations, as discussed in Section 3.1.3. At the beginning ofa guideline development process, the section authors will be provided with a summary table
template and requested to populate the table with relevant article/study summaries. Whenappropriate/feasible and at the request of the writing committee, the Research Analyst will help
the writing committee member compile/complete the summary table for easy review andinclusion in the guideline. The Research Analyst will also help to compile a list of key literaturesearch terms, for the searches conducted by staff, to be included in the final published document.
Guideline authors who conduct their own searches will be asked to provide their list of key
search terms which will then be added to the list created by the research staff.
3.1.2. Documentation of Literature Search
All literature searches for guideline development must be documented by the Researcher andstored as an electronic file. This enables the chair and Research Analyst to construct the text ofthe guideline describing the literature search criteria, thereby allowing guideline users to assess
the comprehensiveness of the search.

In addition to searches conducted by staff, writing committee members are welcome to conduct
their own literature searches, including search criteria beyond what the ACCF/AHA resources
are able to provide (see Section 3.1.2.1., Standard Search Criteria for ACCF/AHA Guidelines).
The documentation for all literature searches should be forwarded to the Research Analyst using
the literature search request form, included in Appendix E.
3.1.2.1. Standard Search Criteria for ACCF/AHA Guidelines•

Literature searching includes the following online databases:•

MEDLINE/PubMed;•

Cardiosource Clinical Trials Database; and•Cochrane Library .

23

•Searches are limited to English language. (Searches will be expanded to languages otherthan English as requested.)•

Searches are limited to human subjects.

•

In the case of a guideline update, searches are limited to the time period following the
publication of the last version of the guideline.

•

In the case of a new guideline or full revision, no time limits on searches are imposed, unlessthe writing committee determines that a different time frame is appropriate (e.g., a guideline
on a diagnostic that did not exist before a certain date).

•

Gender and age are not limited, except when a specific clinical objective applies only to aparticular sex or age group.

•

Publication type is initially limited to meta-analyses and systematic reviews. Publication
type is expanded on an as-needed basis to include randomized controlled trials,
nonrandomized studies, case studies, and opinion documents.

•

If an acceptable systematic review or meta-analysis is identified, searches to update it are
typically limited to the time period following the search cut-off date reported in the review.

3.1.3. Balancing Scientific Rigor With Feasibility
The Cochrane Collaboration publishes perhaps the most rigorous and comprehensive guide to
conducting systematic reviews of evidence, and their methodology has provided the basis formuch of this manual. However, due to time and economic constraints, some components of their
methodology (such as creating and validating criteria for which articles to include and removing
the journal and author names from articles being reviewed) are beyond the scope of ACCF/AHA
Guidelines development. A less resource-intensive, more feasible approach is to establish a few
basic criteria (such as randomized controlled trials only or studies with at least six-month followup) and to be as inclusive and unbiased as possible. See Figure 3 to compare the interplay
between bias and evidence.

Figure 3. Systematic Evidence Reviews

24Systematic Reviews

•
•
•
•
•
•
•

Bias
Case report
Case series
Case-control
Cohort studies
Clinical Trial
Randomized clinical trial
Blinded randomized
clinical trial

The Task Force recommends rigorous review of the articles used in evidence tables and metaanalyses—those articles that are most fundamental to the guideline recommendations. Scientificrigor and transparency is also provided through the inclusion/citation of relevant statisticalfindings in an effort to provide clinicians with a comprehensive set of data, whenever possible.
The exact event rates in various treatment arms of clinical trials are presented, when available, topermit calculation of the absolute risk difference (ARD) and number needed to treat (NNT) or
harm (NNH); the relative treatment effects are described either as odds ratio (OR), relative risk
(RR), or hazard ratio (HR), or incidence rate ration (IRR), depending on the format in theoriginal publication. Along with other point statistics, confidence intervals (CI) for thosestatistics are added when available.

3.1.3.1. Unpublished Data

25

Guideline writers are frequently familiar with data from review articles, abstracts, and latebreaking trials that may impact the guideline’s content. The results from unpublished data
should not be considered except in a few instances: First, only unpublished data in trials
presented at a major national or international scientific meeting are allowed; and second, suchdata should be no older than two years old. Unpublished data may not be used to support a
recommendation. Additionally, unpublished data should not be used in guideline figures andtables. The rare exception for including unpublished data in the guideline text, figures, or tables
is when the data have important public health implications. The Task Force will review suchcases on an ad-hoc basis. When trial data are discussed, the text should clearly state that the data
are preliminary. Additionally, guideline writers should obtain slides from the trial presentation,
perform a detailed review, and ask the presenter of the trial for guidance, keeping in mind thatthe trial group has the prerogative to request that the information not be published in a guideline.

Publication bias, which is defined as the tendency to publish articles containing positive findings,
especially new results, in contrast to reports that do not yield significant results, or results that do
not accord with previously published findings (A Dictionary of Epidemiology, 3 ed. New York:
Oxford University Press, 1995), must be considered by the writing committee.

Searching clinical trial registries (e.g., Current Controlled Trials [CCT] www.controlledtrials.com and NIH’s Clinical Trials registry www.clinicaltrials.gov) provides additional
unpublished information pertaining to specific trials and assists with eliminating publication bias.

Guideline staff shares guideline topics with the National Cardiovascular Data Registry (NCDR)
staff and with AHA’s Get With the Guidelines (GWTG) staff to facilitate early coordination
among topics, obtain data pertinent to the guideline topic, or request specific analysis of data.
However, this data may not be used to support a recommendation unless published in a peer
reviewed journal.

3.1.3.2. Discussing Pharmacotherapy in Guidelines

26

The Task Force has provided a detailed list of policies on discussing pharmacotherapy in
guidelines (see Checklist 2 and Table 4). In addition, when necessary, a pharmacologist is
assigned to a guideline or is used in a consulting role to review the guideline’s pharmacotherapy
discussions before publication.

Investigational treatments or drugs that are not available for general use may be mentioned but
should be clearly described as such and not given Class I, IIa, or IIb recommendations. The
writing committee should decide whether to list them as Class III or to not list them at all. The
presence or absence of FDA approval of a drug or device for a specific purpose should generally
not be mentioned. When addressing recently published/approved drugs, recommendations will
be based on the available strength of evidence instead of waiting for FDA post-marketingsurveillance data. The criteria used by regulatory authorities to approve and to follow approved
drugs and issue recommendations/alerts when necessary are frequently different, and the
ACCF/AHA process should be independent of these regulatory issues.

27Checklist 2. Discussing Pharmacotherapy in GuidelinesUse generic or chemical name not trade name
• e.g., simvastatin, not Zocor



Use broadest and most generic name of class appropriate• e.g., sirolimus-eluting stent, not Cypher stentList classes of drugs or drugs within classes according to evidence-based rationale, andstate rationale• e.g., first-line, second-line or side effects or cost effectiveness• If no evidence-based rationale for listed order, list alphabetically

List all drugs (or none) within class• Indicate whether each is approved for the indication(s) under discussion• e.g., statins for primary prevention• Indicate whether each has evidence for the indication(s) under discussion• e.g., GP IIb/IIIa inhibitors

Discuss evidence for or against “class effect”• e.g., issue raised by ramipril in HOPE studyWhen so-called “alternative medicines” are known to be widely used, discuss the evidence
about them and the issues raised by their use• e.g., possible interactions



Avoid the use of symbols and abbreviations when discussing drug dosing and timing• e.g., use “micrograms” or “mcg” instead of “µg”
• The Institute for Safe Medication Practices has issued a drug error alert regardingsome commonly used abbreviations (included in this section)

Whenever a guideline includes specific drug information, such sections of the guideline
should be reviewed by a pharmacologist during peer review

28

In the case of international guidelines cosponsored by the ACCF/AHA/ESC, it is understandable
that rare occasions may require a discussion of international availability of certain medications.
However, such content should be addressed from the perspective of the patient or clinical use,and not from a policy (i.e., drug-approval) perspective.
3.1.3.3. Therapeutic Substitution
The Task Force recommends that in developing recommendations for drugs, the writing
committee should consider the following major criteria that must be present for a therapeuticclass effect:•a clearly defined biological target or pathway•

comparable efficacy demonstrated for multiple agents within the class (with multiple
randomized trials for each agent)•absence of convincing evidence that there is a member of the class that does not havecomparable benefit to that of other agents within the class•no demonstrated ineffectiveness for any of the class members for the recommended
indications.

In practical terms it is unusual for all these criteria to be met, making it difficult to determine if aclass effect is truly present.

Additional considerations that should be reviewed when evaluating the interchangeability ofdrugs:•

side-effect profile

•

cost

•

inclusion and exclusion criteria in supporting clinical trials•

absolute and relative degree of benefit•

the particular subgroups in which benefit (or lack of benefit) was demonstrated.

Where appropriate, drugs in a therapeutic class are listed in tables in alphabetical order unlessthere is a preference, along with indications for their use and recommendations as to which
agents (if any) can be substituted within the class.
29

Table 4. The Institute for Safe Medication Practices List of Error-Prone Abbreviations
Abbreviations
µg
BT
cc
D/C

Intended Meaning
Microgram
BedtimeCubic centimeters
Discharge or discontinue

IJ

Injection

IU

International unit

o.d. or OD

Per osq.d. or QD

qhs
qn
q.o.d. or QOD

q1d
q6pm, etc.

Once daily

By mouth, orally
Every dayAt bedtime
Nightly
Every other day

Daily
Every evening at 6 PM

SC, SQ, sub q

Subcutaneoust/d
TIW or tiw

One daily
3 times a week

U or uUnit

Misinterpretation
Correction
Mistaken as “mg”
Use “mcg”
Mistaken as “BID” (twice daily) Use “bedtime”
Mistaken as “u” (units)
Use mL
Premature discontinuation of
medications if D/C (intended tomean “discharge”) has been
misinterpreted as “discontinued”
when followed by a list ofdischarge medications
Mistaken as “IV” or
Use “injection”“intrajugular”
Mistaken as IV (intravenous) or Use “units”
10 (ten)Mistaken as “right eye” (ODUse “daily”
oculus dexter), leading to an oral
liquid medications administered
to the eye
The “os” can be mistaken as “lefteye” (OS-oculus sinister)
Mistaken as q.i.d., especially if Use “daily”
the period after the “q” or the tailof the “q” is misunderstood as an“i”
Mistaken as “qhr” or every hour Use “at bedtime”
Mistaken as “qh” (every hour)
Use “nightly”
Mistaken as “q.d.” (daily) or“q.i.d. (four times daily) if the“o” is poorly written
Mistaken as q.i.d. (four times
Use “daily”
daily)
Mistaken as every 6 hours
Use “6 PM nightly” or “6PM daily”
SC mistaken as SL (sublingual); Use “subcut” or
SQ mistaken as “5 every”; the“subcutaneously”“q” in “sub q” has been mistaken
as “every” (e.g., a heparin doseordered “sub q 2 hours before
surgery” misunderstood as every
2 hours before surgery)
Mistaken as “tid”
Use “1 daily”
Mistaken as “3 times a day” or Use “3 times weekly”“twice a week”
Mistaken as the number 0 or 4, Use “unit”
causing a 10-fold overdose or
greater (e.g., 4U seen as “40” or

30

Dose
Intended meaning
Designations and
Other
Information
Trailing zero after 1 mg
decimal point(e.g., 1.0 mg)
No leading zero 0.5 mg
before a decimaldose (e.g., .5 mg)
Numerical dose 10 mg
and unit ofmeasure run
100 mL
together (e.g.,
10mg, 100mL)
Large doses
100,000 units
without properly
placed commas(e.g. 100000 units)
Symbolsx3d> and </ (slash mark)

@
&
+
°

4u seen as “44”); mistaken as“cc” so dose given in volume
instead of units (e.g., 4u seen as
4cc)
Misinterpretation

Correction

Mistaken as 10 mg if the decimal Do not use trailing zeros forpoint is not seen
doses expressed in whole
numbers
Mistaken as 5 mg if the decimal Use zero before a decimal
point is not seen
point when the dose is lessthan a whole unit
The “m” is sometimes mistaken Place adequate spaceas the number 1 if written poorly between the dose and unitof measure

100000 has been mistaken as
10,000 or 1,000,000

Use commas for dosing
units at or above 1,000 or
use words such as 100“thousand” to improvereadability
Intended meaning
Misinterpretation
Correction
For three days
Mistaken as “3 doses”
Use for three days
Greater than and less than
Mistaken as opposite of
Use “greater than” or “lessintended; mistakenly use correct than”
symbol; “< 10” mistaken as “40”Separates two doses or indicates Mistaken as the number 1 (e.g. Use “per” rather than a“per”“25 units/10 units” misread asslash mark to separate doses“25 units and 110 units” units)At
Mistaken as “2”Use “at”
And
Mistaken as “2”Use “and”
Plus or andMistaken as “4”Use “and”
Hour
Mistaken as a zero (e.g., 2° seen Use “hr”, “h” or “hour”
as q 20)

Adapted from ISMP list of error-prone abbreviations, symbols, and dose designations. Institute for Safe Medication Practices
Medication Safety Alert 2003 (Nov 27);8(24):3-4. Available at http://www.ismp.org/Tools/abbreviationslist.pdf. Accessed
April 6, 2006. See ISMP Web site for updates at www.ismp.org.

31

3.1.3.4. Use of Other Guidelines/Authorities
Guideline text, recommendations, and evidence tables may be replicatedfrom previous ACCF/AHA Guidelines and statements endorsed by bothorganizations (e.g., National Cholesterol Education Program). Without
the support of published new evidence, such existent recommendations
and tables cannot be changed. Instances allowing such changes will haveto be approved by the Task Force and allowable where an unique patient
population is addressed or patient characteristics differ significantly fromwhat exits. Consensus statements or guidelines developed by others andnot endorsed by the AHA and ACCF should not be cited or referenced
unless absolutely necessary, as this implies endorsement on the part of

It is important to err on
the side of overinclusion because oncea trial has been
excluded from theselection process it isunlikely to bereconsidered.
Questionable articles
which are included at
one stage can be
excluded at a latterstage when more
information on the study
is available.
-Mulrow, 1996

the organizations.

3.2. Sorting the Evidence
3.2.1. Reviewing the Evidence
Literature search results are maintained by the Research Analyst who reviews the abstracts andremoves nonrelevant citations. At this step, only the article’s title and abstract are assessed, so
any article likely to be relevant to the guideline is maintained. Additionally, the Research
Analyst sorts the abstracts to correspond with the specific clinical objectives identified in Section
2.2.2. This initial sort creates a comprehensive set of potentially relevant studies.

Although the Research Analyst does a preliminary level of sorting, the clinical expertise ofwriting committee members is necessary to make the final decision as to whether the article is arelevant piece of evidence that should be included in the development of a recommendation.
This often requires review of the article’s full text and critique of the research methodology
employed. As necessary, the Research Analyst will provide the full text of all peer-reviewed,
published randomized controlled trials, meta-analyses, systematic reviews of evidence, anddiagnostic studies using comparison with a gold standard.

32

3.3. Synthesizing and Interpreting the Evidence
3.3.1. Synthesizing the Evidence
Evidence based
practice is theintegration of best
research evidencewith clinicalexpertise and patient
values.
-IOM, 2001

Guidelines rest on a foundation of peer-reviewed clinical research.
Once the evidence has been gathered, the writer is challenged withsynthesizing the evidence in a systematic way that lends itself todecision making. After choosing the studies to include, the research
results must be assessed so conclusions can be made on the basis of the
body of evidence as a whole. As a guide to interpreting evidence, aseries of articles on basic statistics for healthcare providers is includedin Appendix A: Suggested Readings.
For each clinical objective within the guideline, the writer should attempt to include thefollowing components:(1) Statement of the clinical objective/question. This statement is defined in Section
2.2.2. and serves as the “heading.”(2) Recommendation. One or more clinical recommendations that answer the clinicalquestion/objective and is written in full sentences. Each recommendation is assigned
a classification and level of evidence along with the supporting reference(s). All
levels of evidence A and B must have references. Level of evidence C does not
require a reference since it corresponds to expert opinion. (see Section 4.2. Assigning
Classification of Recommendation and Level of Evidence).
(3) Explanatory text. See 3.3.1.1. Narrative Synthesis of Evidence.
(4) References. The references include both citations in the text (including all
publications reviewed in writing the text and recommendations) and the tabularsummary of relevant trials.
(5) Evidence table. See 3.3.1.2. Visual Synthesis of Evidence and 3.3.1.3. Analytic
Synthesis of Evidence.
(6) Diagram, table, or graphic summary. The clinical objective should be linked back toalgorithms, diagrams, or tables that summarize the key points (see Section 4.3.
Creating Visual Descriptions of Recommendations and Evidence).

3.3.1.1. Narrative Synthesis of Evidence
33Summaries of evidence should generally be in tabular form and not in the text of the guideline.
Text should be reserved for qualifying or clarifying the recommendations. The Task Forceprefers that clinical trial data and other evidence be displayed in an evidence table or included inmeta-analysis. When multiple trials have yielded similar, noncontroversial results (e.g., the useof aspirin postmyocardial infarction) a single sentence with appropriate references may suffice.
Long, descriptive paragraphs of the methodology and findings of individual trials are
discouraged.
3.3.1.2. Visual Synthesis of Evidence
Preparing an evidence table involves identifying and extracting the key data from the relevant
studies. The Cochrane Collaboration recommends beginning by deciding what comparisonsneed to be made, then identifying the data elements necessary to make those comparisons.
Salient data elements may include, but are not limited to, number of patients, morbidity,
mortality, dose–response, sensitivity, specificity, p values, confidence intervals, positive
predictive value, negative predictive value, and absolute and relative risk.

The next step is to prepare visual summaries of the results of the studies included in eachcomparison. The data are usually displayed in a table that allows the studies’ designs and results
to be easily compared. However, sometimes the data are better summarized in a bar chart orother graphic summary. Information presented graphically can replace the need for “text-heavy”
sections of the guideline (see Section 4.3. Creating Visual Descriptions of Recommendations andEvidence).
3.3.1.3. Analytical Synthesis of Evidence
Sometimes recommendations can confidently and succinctly be written based on theorganization of evidence in tables or graphs. Other times, an additional step is necessary;
analyzing the data statistically to get an estimate of the heterogeneity of the individual effectsizes, an estimate of the summary effect size, and a measure of its variance. Guideline writers
generally rely upon meta-analytic methods and Cochrane meta-analytic studies are frequently

34

used for evidence review/analysis. A detailed guide to the methods of meta-analysis is beyond
the scope of this manual.

3.4. Expert Interpretation of the Evidence
Despite all the evidence that may be available for writing the guideline, expert interpretation isalways necessary. Expert interpretation serves as a funnel through which evidence on multiple
questions and clinical situations is combined, condensed, and formulated into recommendations(see Figure 4).

Unfortunately, much of the evidence falls into the “gray zone” of uncertainty. The evidence
from different trials may come to divergent conclusions, the evidence may only apply to specificsubpopulations, the evidence may be from methodologically weak studies, or the evidence may
simply be insufficient to make a decision. Less often is there an abundance of evidence available
that leads directly to an indisputable recommendation.

However, the final interpretation of evidence and the recommendation based on the evidence
synthesis needs to be concordant with other recommendations in other ACCF/AHA guidelines
along with nationally recognized standard setting guidelines such as Seventh Report of the Joint
National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure (JNC 7) when there is an exact overlap of patient populations, treatment therapies anddisease states between different guidelines. A lack of concordance among new and existing
recommendations is allowable based on new published evidence only.
Figure 4. Turning Evidence Into a Recommendation
EVIDENCE

EXPERT
INTERPRETATIONRECOMMENDATION

35

Writing guidelines and formulating recommendations can be less than straightforward, and very
time-consuming. The guideline writer is frequently in a dilemma as to whether to delay making
a decision or come to a conclusion despite lacking complete evidence (see Checklist 3). Section
4.1., Overview of Recommendations, provides a list of qualities of guideline recommendations to
consider when writing the document. Also, an article on the development of recommendationsin clinical practice guidelines is included in Appendix A: Suggested Readings for further
guidance.

4. Writing Recommendations
4.1. Overview of Recommendations
Previous sections of this document describe the methodology
of guideline development as well as meta-analysis andsystematic review. Guideline development, unlike the othermethodologies, goes beyond the compilation and analysis ofPatients should receive carebased on the best available
scientific knowledge. Careshould not vary illogicallyfrom clinician to clinician orfrom place to place.
-IOM, 2001

data to include recommendations. Guideline writers are challenged with considering a vast arrayof evidence and creating clinically applicable and clear recommendations. While explanatory
text covering topic areas is an important element of the guideline, the concisely-stated full
sentence recommendations are more likely to be read and guide practice.

As the evidence is considered, conclusions and recommendations naturally evolve. Wheneverthis occurs, the recommendation should be condensed into a sentence or two and separated fromthe text. The recommendations are the core guideline content, while the text enhances therecommendations by providing further descriptive information, such as exceptions to therecommendations and clinical options. The recommendations are assigned strengths ofrecommendation based upon evidence, benefit vs. harm, and patient preference.

Given the current guideline methodology environment and the increased use of clinicalcomparative effectiveness, Class I and IIa - Level of Evidence A and B recommendations, only,
can make statements regarding the comparative effectiveness of one treatment with respect toanother, these words or phrases may be accompanied by the additional terms “in preference to”
or “to choose” to indicate the favored intervention. For example, "Treatment A is recommended36

in preference to treatment B for..." or "It is reasonable to choose Treatment A over Treatment B
for..." Studies that support the use of comparator verbs should involve direct comparisons of thetreatment or strategy being evaluated.

Furthermore, recommendations are solely based on the merit of available clinical evidence;
therefore, even though a new-just approved-drug may not have postmarketing surveillance dataon population based effects, the drug may be mentioned in guidelines and recommended as an
option for treatment. There may be instances where there is a lack of evidence and/or treatment
options available, at such times off-label drugs, i.e. pharmacotherapies already approved andavailable in the United States, can be used to craft recommendations. For further information
please refer to Section 3.1.3.1. Unpublished Data.

Furthermore, newly crafted recommendations that overlap with and are directly related toexistent recommendations and address the exact same disease states, patient populations ortreatments should be concordant with the “older” recommendations unless there is a compelling
reason not to do so. The only instances where two recommendations are allowed to be discordant
is when there is a special consideration such as new evidence, an orphan drug/population or avery specific sub-set of the general patient population. For further discussion of concordanceplease refer to Section 5.2. Maintaining Concordance with Other Documents on the Same or
Related Topics.

If Checklist One determined that flow diagrams were appropriate, recommendations should beincorporated into the flow diagrams where appropriate.

Because guidelines often serve as the basis for other ACCF and AHA activities (such as pocket
guides, performance measures, data standards, appropriate use criteria and Guidelines Applied inPractice [GAP] projects), recommendations should be stand-alone text that are written incomplete sentences with as much detail as possible. The Task Force suggests specific language
for full sentence recommendations that reflect the definitions of the classification ofrecommendations (see Checklist 3). Guidelines are intended to be applied by healthcare37

providers in real-world settings, so the recommendations should be practical, feasible, andclinically flexible, thus facilitating the translation and implementation of recommendations.
Checklist 3. How to Write a Recommendation

Write all recommendations in complete sentences, using the correct verb for the COR, as follows:

•
•
•
•

shouldis recommended
is indicatedis useful/effective/beneficial•••

may/might be considered
may/might be reasonable
usefulness/effectiveness is
unknown/unclear/uncertain/not wellestablishedClass IClass IIa••••Class IIb

is reasonable
can be useful/effective/beneficial
is probably recommended
is probably indicatedClass III-No Benefit
Procedure/Test-Not helpful
Treatment-No proven benefit

•
•
•
•
•

is not recommended
is not indicatedshould not be done
is not useful/effective/beneficial
may be harmful
Class III-Harm
Procedure/Test-Excess cost w/o benefit
or Harmful
Treatment-Harmful

•
•
•
•

potentially harmful
causes harm
associated with excess morbidity/mortality
should not be doneAssign each recommendation a reference (LOE:C does not require a reference).



Write separate recommendations that apply to specific clinical objectives.



Write recommendations that are practical in the real world setting.

Describe the patients to whom the recommendation applies. Specify subpopulation variability andexceptions in the recommendations. List the exceptions whenever possible.



Use unambiguous language and clearly defined terms when writing recommendations.



Write recommendations in terms of active/positive actions rather than passive/negative actions (e.g.,
Class I recommendation to perform a test/give a treatment that is useful/effective rather than a Class III
recommendation not to perform/give it).

The following examples were Class IIa recommendations published in the 2006 ACC/AHA/ESC
Guidelines for the Management of Patients with Atrial Fibrillation (emphasis added);38

1. For primary prevention of thromboembolism in patients with nonvalvular AF who havejust 1 of the following validated risk factors, antithrombotic therapy with either aspirin ora vitamin K antagonist is reasonable, based upon an assessment of the risk of bleeding
complications, ability to safely sustain adjusted chronic anticoagulation, and patient
preferences: age greater than or equal to 75 y (especially in female patients),
hypertension, HF, impaired LV function, or diabetes mellitus. (Level of Evidence: A)
2. For patients with nonvalvular AF who have 1 or more of the following less well-validated
risk factors, antithrombotic therapy with either aspirin or a vitamin K antagonist isreasonable for prevention of thromboembolism: age 65 to 74 y, female gender, or CAD.
The choice of agent should be based upon the risk of bleeding complications, ability tosafely sustain adjusted chronic anticoagulation, and patient preferences. (Level of
Evidence: B)
3. Patient preference is a reasonable consideration in the selection of infrequently repeatedcardioversions for the management of symptomatic or recurrent AF. (Level of Evidence:C)

4.1.1. Patient-Centered Care
To assist with shared decision-making between clinicians and patients, writing committees
should consider the role of patient preferences in decisions with substantial personal choice orvalues. Patient-specific modifiers, comorbidities, and issues of patient preference that may
influence the choice of particular tests or therapies are considered as well as frequency of followup. This should especially be considered when two or more treatment therapies arerecommended at the same class of recommendation.

4.2. Assigning Classification of Recommendations and Level of Evidence
The Task Force developed a color grid to adjudicate the evidence including consideration ofvalidity and clinical relevance, which provides a transparent, explicit mechanism forclassifying recommendations.
Once recommendations are written, a classification of recommendation (e.g., anticipated benefit,
harm, risk are considered) and level of evidence (e.g., quality of individual studies, including
design and execution) grade must be assigned to each recommendation. Every recommendation
requires at least one reference as support if assigned a Level of Evidence of A or B; Level of39

Evidence C does not require a reference unless one exists as this refers to expert opinion,case studies or standards of care. Also note that recommendations are crafted based on thetreatment effect, i.e., risk versus benefit continuum, and now allow for Class III
recommendations to be separated into ‘no benefit’ or ‘harm’ categories. Classification ofrecommendations (COR) and levels of evidence (LOE) are expressed in the ACCF/AHA
COR/LOE Table referenced in every guideline (see Table 5).
Table 5. COR/LOE Table (always Table 1 in an ACCF/AHA guideline)40

4.2.1. Classification of Recommendations and Level of Evidence
Classification Types
Class I:

Conditions for which there is evidence and/or general agreement that a given
procedure or treatment is useful and effective.

Class II:

Conditions for which there is conflicting evidence and/or a divergence of opinion
about the usefulness/efficacy of a procedure or treatment.
• IIa: Weight of evidence/opinion is in favor of usefulness/efficacy• IIb: Usefulness/efficacy is less well established by evidence/opinion.

Class III:

Conditions for which there is evidence and/or general agreement that theprocedure/treatment is not useful/effective and in some cases may be harmful.
 No Benefit- Procedure/Test not helpful or Treatment w/o established provenbenefit Harm- Procedure/Test leads to excess cost w/o benefit or is harmful, and or
Treatment is harmful

Level of Evidence

Like the collection andquality analysis ofscientific data from anexperimental study,
collection and grading of
the evidence for guideline
development allow
conclusions (i.e., guideline
recommendations) to be
developed in a mannerthat is supportable by thedata (i.e., scientificevidence in the literature).
-Heffner, 1998

Level of Evidence A:

Data derived from multiple
randomized clinical trials or metaanalyses. References used todetermine level of evidence must be
provided and cited with therecommendation.

Level of Evidence B:

Data derived from a single
randomized trial, or nonrandomized
studies. References used to determine
level of evidence must be provided and cited with therecommendation.

Level of Evidence C:

Consensus opinion of experts, case studies, or standard of care

41

Comparator Verbs:
Class I:
Treatment/strategy A is recommended/indicated in preference to treatment B
Treatment A should be chosen over treatment B
Class IIa: Treatment/strategy A is probably recommended/indicated in preference totreatment B
It is reasonable to choose treatment A over treatment B
Given the current interest in and research opportunities for comparative effectiveness, along with
the new health reform initiatives, the ACCF/AHA Guideline Task Force members have added tothe current COR/LOE and introduced specifications for crafting comparative effectiveness
related recommendations. The current COR/LOE allows for the use of comparative
effectiveness phrases/verbiage for Class I and Class IIa recommendations with LOE A or B
only. Studies supporting the use of comparator verbs are required to have been directcomparisons of treatments or strategies being evaluated and addressed. These direct comparison
studies can be RCTs, longitudinal registries and or observational studies; furthermore, due to thestrength of evidence requirements, the recommendations are restricted to LOE A and B.

4.2.2. Applying the Classifications and Levels
Some writers prefer to assign the classification of recommendation and level of evidence whenwriting the recommendations, whereas others prefer to state the recommendation and assign theclassification later after re-examining the data. Writers preferring the first method sort, review,
synthesize, and interpret the evidence concurrently.

The classification of recommendations and level of evidence are considered by many to be thecore of the guidelines. As such, they are among the most debated aspects of the guideline within
the writing group. Any combination of classification of recommendation and level of evidence
is possible. For example, a recommendation can be a Class I, even if it is based entirely on
expert opinion and no research studies have ever been conducted on the recommendation (Level
C). Similarly, a Class IIa or IIb can be assigned a Level A if there are multiple randomized
controlled trials coming to divergent conclusions. Mega-trials should not be consideredsufficient sole justification for assigning a recommendation to Level of Evidence A.
42Assigning a Level of Evidence B or C should not be construed as implying that therecommendation is weak. Many important clinical questions addressed in the guidelines either
do not lend themselves to experimentation or have not yet been addressed by high quality
investigations. Even though randomized controlled trials may not be available, the clinicalquestion may be so relevant that it would be delinquent to not include it in the guideline.

Comparative effectiveness statements in recommendations are based solely on clinicalcomparative effectiveness and can be made for Class I and IIa - Level of Evidence A and B
recommendations, only. Studies that support the use of comparator verbs should involve directcomparisons of the treatment or strategy being evaluated. For example, "Treatment A is
recommended/indicated in preference to treatment B for..." or "It is reasonable to choose
Treatment A over Treatment B for..."4.2.3. Performance Measures
Performance measures must be quantifiable (i.e., precisely defined numerator and denominatorwith valid reasons to exclude patients from the measure identified) so that data for the measurecan be collected in a reliable way. Ideally, guideline recommendations should be written withminimal ambiguity and with adequate specificity to support translation into performancemeasures and facilitate the rapid incorporation of the best evidence into practice. Guideline
recommendations that clearly specify, for example, the characteristics of the patient population
appropriate for a given treatment or the optimal timing for initiation of a therapy (e.g., within 30
minutes of arrival to the hospital, prior to hospital discharge, early outpatient period) lendthemselves best to translation into performance measures.

Selecting performance measures involves:
1) Evaluating the strength of evidence supporting the potential performance measure (class ofrecommendation and LOE);
2) Defining the clinical significance of the outcome most likely to be achieved by adherence withthe performance measure (e.g., decreased mortality, improved functional status); and433) Assessing the magnitude of the association between adherence to the potential performancemeasure and a clinically important outcome.

In addition, performance measure writing committees must also weigh the feasibility of any
potential performance measure and the costs associated with implementing it, which may include
the relative cost of the therapy/intervention addressed by the performance measure, theavailability of reimbursement for the therapy/intervention, as well as the cost of collecting thedata required for the measure

In general, ACCF/AHA Class I and III guideline recommendations identify potential dimensionsof care and processes that are considered for performance measurement, although not all such
recommendations are translated into performance measures. The goal is to identify a set ofmeasures that address areas where there are gaps in care; that are likely to improve quality; that
address, to the degree possible, the full spectrum of care; and that conform to the ACCF/AHA
Attributes of Performance Measures.

4.3. Creating Visual Descriptions of Recommendations
and Evidence
4.3.1. Communicating the Key Points
Once the evidence tables and recommendations have beencreated, guideline writers should look for ways to visuallysummarize the key points in tables, diagrams, and mnemonics.
The flow diagrams identified in Section 2.2.1., Checklist 1,
should be considered again in light of the evidence collected
and recommendations written. Frequently, the text and/or
recommendations can be condensed into a clinical pathway,

The broad mandate of
most guidelines
ensures that guideline
documents tend to belonger and lessformulaic than otherarticles . . . [but]surveys reveal thatclinicians preferpocket cards, concise
pamphlets, andjournal article
summaries.
-Cook, 1999

algorithm, or decision-tool. These visual summaries assist
physicians in understanding and applying the best care for individual patients. Visualpresentations should be:44•

written in clear and unambiguous language;•

logically organized;•

easy to follow;•

specific about relevant populations and clinical circumstances; and•specific about which elements of care are appropriate, inappropriate, and equivocal.

The guideline users expect the evidence to be presented as proof of the recommendations’quality. However, in clinical circumstances, the key points of how the evidence applies topatients are the take-home messages that must be clearly presented and easily accessible in theguideline. Examples of good summaries of recommendations are included in this section.
4.3.2. Creating Tables
The purpose of a table is to augment the text, display data, or organize information visually. A
well-organized, legible table helps the reader comprehend content. In general, tables fall into 2
categories: text tables and data tables.
4.3.2.1. Characteristics of a Good Table
The following criteria define a good table and are shown in examples in this document.
•

Includes supplemental content original to the table—not merely a repetition of
information already presented in text;•

Brief but explanatory title—titles and headings should indicate units of measurement if
applicable;•

Each column and each row has its own descriptive heading—again, data should be easily
identifiable;•

Each cell of a data table makes sense across the matrix—the x and y axes shouldintersect logically;•

Can be taken out of context—readers should be able to understand the table without
having read the text;•

Abbreviations are spelled out—do not assume the reader knows all terms (exceptions
include common units of measurement and abbreviations accepted in the dictionary aswords, such as HIV/AIDS);•

All data sources cited; reprint/modification information indicated;
45

•Concise but clear;•

Entries in alphabetical order.

4.3.2.2. Text Tables
Text tables are used for description and/or explication. The text in word tables is not meant toreplace scientific text in article, but is meant to provide clarification by simplifying burdensome
language. Text tables should be used sparingly to provide explanations when needed, list signs
and/or symptoms when necessary and unnecessary repetition of information already included in
the text should be avoided.

If highlighting bullet points is the aim, a bulleted or numbered (or lettered) list is the proper
format if a sentence containing an itemized list simply will not do.
Example A. Text table.
Table X. Selection of Initial Treatment Strategy: Invasive Versus Conservative Strategy
Strategy
StatusPatient Characteristic
Invasive
Preferred
Recurrent angina or ischemia at rest or with low level
activities despite intensive medical therapy
Elevated cardiac biomarkers (TnT or TnI)
New or presumably new ST-segment depression
Signs or symptoms of HF or new or worsening mitral
regurgitation
High-risk findings from noninvasive testing
Hemodynamic instability
Sustained ventricular tachycardia
PCI within 6 months
Prior CABGHigh risk TIMI or GRACE score
Patient prefers invasive evaluation
Reduced left ventricular function (LVEF less than 40%)
Invasive
Considered Diabetes
Chronic renal insufficiency
Conservative Preferred
Low risk TIMI or GRACE score
Patient or physician preference in the absence of high risk
featuresCABG indicates coronary artery bypass graft surgery; GRACE, Global Registry of Acute Coronary
Events; HF, heart failure; LVEF, left ventricular ejection fraction; PCI, percutaneous coronary
intervention; TIMI, thrombolysis in myocardial infarction; TnI, troponin I; and TnT, troponin T (Ref).

46

4.3.2.3. Statistical Analysis
Often the best way to determine what type of format to use is to go by type of statistical analysis.
A useful reference guide to structures of tables organized by type of statistical analysis is
Presenting Your Findings: A Practical Guide for Creating Tables (Nicol & Pexman, 1999).

Relative Risk
In clinical documents, relative risk (RRs) and odds ratios (ORs) are used to compare risk
between 2 different groups. An absolute risk reduction (ARR) should be listed for tables that
contain values such as hazard ratio (HR), OR, or RR along with the 95% Confidence Intervals(95% CI) for the statistical point estimates when available.

The ARR is the difference in event rates (i.e., rate of harmful outcome in the control group − rateof harmful outcome in the experimental group). No content is associated with it, that is, nocomparison with any other risk, but a probability of something occurring. ARR is known as thearithmetic difference (or risk difference) in rates of harmful outcomes between experimental andcontrol groups. ARR and RR can be combined and balanced with many factors that are notlimited to seriousness of disease, commonness or rarity of the condition, absolute risk reducedwith treatment, side effects, costs, and so forth.

Relative risk is the difference between risk levels in relative terms (control group harmful
outcome − rate of harmful outcome in the experimental group/rate of harmful outcome in thecontrol group); however, it is not the same as an increase in risk. When the study involves an OR
or RR, the ARR is simply a subtraction between the events rates. However, if an HR is given, a 2
× 2 table is needed to calculate the ARR.

Multiple references are provided below to help assist you create the ARR, including calculatorsthat will calculate the 95% confidence interval. A recommended calculator can be found at
http://ebem.org/nntcalculator.html. Many studies do not include the 95% CI in the study abstract;
however, we prefer to list this value in tables. If an OR, HR, RR, or a 95% CI is not reported in47

the study, the table should simply reflect “not reported.” (see Section on Web Resources at endof Appendix A.)
Example C. Descriptive Statistics.
Table X. Outcome of Death or Myocardial Infarction in Clinical Trials of GP IIb-IIIa Antagonists
Involving More Than 1000 Patients
Trial

Study
Population

Drugs
Placebon

Results
IIb-IIIa
%
n

%

ARR

RR

95%
CI

p

0.63
to
1.06
0.46
to
0.84
0.68
to
1.55

0.134

PCI
IMPACTII (1)All PTCA

eptifibatide

112/1328

8.4

93/1349

6.9*

0.015

0.83

ESPRIT(2)

Electivestenting

eptifibatide

104/1024

10.2

66/1040

6.4

0.038

0.62

ISARREACT (3)Elective
abciximab
stenting withclopidogrel
pretreatment

42/1080

3.9

43/1079

4.0

0.00096

1.02

UA/NQWMI eptifibatide

744/4739

15.7

67/47221.42*

0.014280.09

0.00160.91

ACS
0.07 Less
PURSUITtothan(4)0.12 0.0001
GUSTO
UA/NQWMI abciximab
209/2598 8.0
450/5202† 8.7-0.0060 1.08 0.92 0.36
to
IV ACS (5)1.26
UA/NQWMI lamifiban296/2597 11.4 278/2628
10.6
0.00810.94 0.77 0.32
PARAGON
to
B (6)
1.09
ACS indicates acute coronary syndrome; ARR, absolute relative risk; CI, confidence interval; NQWMI, non-Q wave
myocardial infarction; PCI, percutaneous coronary intervention; PTCA, percutaneous transluminal coronary
angioplasty; RR, risk ratio; and UA, unstable angina. * Best treatment group selected for analysis. † Pooled resultsfor 24 and 48 hr infusion arms.

4.3.3. Creating Figures
4.3.3.1. Characteristics of a Good Figure
Like tables, figures should be self-explanatory. It should not be assumed that the reader ascribes
the same meaning to all abbreviations, so all abbreviations should be explained in the figure
caption (in alphabetical order).
48Camera-ready figures should be submitted with crisp, clear lines, along with the author’s nameand figure reference. The preferred file format is .TIF; however, if staff needs to edit a figure, it
should be submitted in Microsoft PowerPoint (.PPT). JACC’s Instructions to authors is a solidreference for how to submit figures.
4.3.3.2. Color Figures
Example D. Color line graph using shapes for data points.
Figure X. Mitral regurgitation grade by echocardiogram according to location and time
periodFigures submitted in four color format will be printed as such; figures submitted in black andwhite (B/W) will be submitted as such. It is suggested that simple line graphs and charts be
submitted in B/W. ACCF/AHA Guidelines, in addition to being published in JACC, are printed
in the AHA journal Circulation, which is not in color. When using color for charts and graphs, it
should be remembered that not all colors translate well to B/W. If a figure is to be published in
Circulation as well, techniques such as shapes and line patterns work well to differentiate data,
as in the following example.

49

4.3.4. Additional Important Points on Tables and Figures
If a cell in a table does not contain data for some reason, use an ellipsis (…) and explain its
significance in the footnote (e.g., “Ellipses indicate that data could not be computed because thesample was too small for analysis”).

Because of the error-prone abbreviation alert released by the Institute for Safe Medication
Practices, the ACCF does not use symbols in its documents for dosages. For example, to show
range in dosing, ACCF uses the word “to” instead of a dash (0.5 to 0.1 mg versus 0.5–0.1).
Follow this practice for CIs as well, to avoid a dash being misread as a minus sign.
The order of appearance for footnote symbols is as follows: (top to bottom, left to right; forfigures, use this order for the caption)*, †, ‡, §,║,¶, #, **, ††, ‡‡, §§, ║║, ¶¶, ##, etc.
Table notes and figure captions may contain the following material (in order): general note,
explanation of symbols, copyright note (see Section 4.3.4.1. Permissions) and finally references.
4.3.4.1. Permissions
Sources are cited by including a reference in the table note or figure caption. Tables and figuresthat are to become intellectual property of the American College of Cardiology Foundation thatare copyrighted by another source will require the College to obtain permission for their use. For
this reason, the entire reference should be written out and should include an indication about
whether the table or figure is reprinted or modified.

If an original table or figure is created with data from multiple sources or by reconfiguring datafrom one source, it is not necessary to obtain copyright permission from those sources. The
source of the data should be noted, however. For the sake of uniformity, the entire reference
from which the data are obtained should again be written out.

50

Items in the public domain are those for which the copyright is not privately held. Thesematerials are usually produced by government agencies or government employees and are clearlymarked “In the public domain” and do not require permission.

5. Writing Committee Discussions and Consensus Development
5.1. Group Decision-Making
Writing committee discussions and consensus development are ongoing at all stages of guideline
development. Since ACCF/AHA Guidelines are team-written documents, coming to consensus
on the scope, clinical objectives, evidence tables, text, recommendations, and visual summaries
occurs throughout document development. Subsection writers often come to consensus throughconference calls or email exchanges of information, while the entire writing committee comes toconsensus during the 2 to 4 meetings, whole committee conference calls, and mail ballots.

In evidence-based documents such as clinical practice guidelines, consensus development isoften most important around topics that have no literature base. Writing groups are faced withthe challenge of addressing an important clinical question despite a lack of data. If consensus
can not be reached due to lack of supporting data, the ACCF/AHA Guidelines development
process allows for the incorporation of controversial discussions in the text since minority
opinions are not permitted. For certain
ACCF/AHA Guidelines consensus development ischallenging due to a lack of supporting data.

Consensus Development
The process for tracking a vote must be flexible
enough to address the specific area(s) of concern

The safeguards of a groupprocess should be initiated so
as to ensure that theconsensus achieved by theguideline development experts
would reflect the consensus of
the larger group of experts on
the topic around the world.
-Heffner, 1998

and therefore may vary by writing committee. Because the decision to call for a vote is at thediscretion of the chair (or designee), so too is the administration of some aspects of the voting
process. In all cases, the name and vote of each writing committee member must be maintained51

for the record. Circumstances for which an informal vote may be necessary include (but are notlimited to) the following:•

When consensus is not obvious•

When there are numerous or significant RWI such that there may be a real or perceived
conflict of interest•

When one or more individuals appear to be unduly influencing the outcome of the
discussion on the recommendation (Note: this individual may be asked to leave the room
during a portion or all of the discussion at the discretion of the Chair)•

When trying to reconcile a new guideline recommendation with one being developed byanother guideline writing committee or one that exists in a published guideline

Formal Balloting
All guideline recommendations are formally voted on during pre-peer review writing committee
sign-off, and then again on recommendations that changed as a result of peer review following
the finalization of the draft but prior to the ACCF Board of Trustees (BOT) and AHA Science
Advisory Coordinating Committee (SACC) reviews. Writing committee members are required torecuse themselves from voting on any recommendations to which they have a relevant RWI.
Recusal information is published on the cover of the document. A tracking cover sheet isdeveloped and the ballots maintained as part of the permanent files. Confidential balloting isrequired for ALL guidelines and all voting is based on the context of quorum as defined inRobert's Rules of Order - 10th Edition*.

In all cases the name and vote of each writing committee member must be maintained for therecord indefinitely.
•

Voting MUST be by confidential written ballot•

Chair must review all votes to ensure accurate recusal by all writing committee members•

Individuals who have identified relevant RWI may participate in the discussion but MUST
recuse themselves when the vote is taken•

A recommendation is considered approved if it receives a majority vote of those present tovote52

* Definition of quorum and the number needed to approve:

1. "A quorum in an assembly is the number of voting members (see definition below) who must
be present in order that business can be legally transacted. A quorum refers to the numberof such members present, not those actually voting on a particular question. The number ofmembers constituting a quorum is a majority of those present and may vary (depending on how
many members are present)." (unless organizational bylaws indicate otherwise)“In all other committees and in boards, the quorum is a majority of the members of the board orcommittee unless a different quorum is fixed… by the bylaws… or some other rule of parent
organization.”

2. The number of members needed to carry a vote is a majority (more than half) of the votes castby persons legally entitled to vote, excluding blanks, abstentions, & recusals, at any meeting or
conference call where a quorum is present.

In the case of a guideline: 1) at least 51% of the members must be present (at the meeting or on
the call) in order to have a quorum; 2) it does not matter how many members do NOT vote(recuse/abstain from voting) as long as there is a quorum and the number of voting
members does not go below 3 (which is the minimum number you can have and still have a"majority"). If the number of members is uneven, the number needed to pass must be rounded“up” (e.g., if 19 votes are cast, a majority [more than 9 1/2] is 10).

Specific quotes from Robert's Rules of Order - 10th Edition.

5.2. Maintaining Consistency with Other Documents on the Same or Related
TopicsGuidelines in development often cover the same or related material as other documents, such asother ACCF/AHA Guidelines, NHLBI guidelines, expert consensus documents, performance53

measures, data standards and scientific statements. An example of this interconnectedness forrevascularization is shown in Figure 5. The policy for addressing instances ofnonconcordance is that all ACCF/AHA Guidelines must be consistent unless there is new
evidence or a change in patient practice patterns. If there is a change, it must be vetted andreconciled with the respective writing committee and the Task Force.

Whenever possible, guidelines should refer to each other, rather than repeat already-publishedinformation. The chair, along with staff and the Task Force Liaison, will help the writing
committee to identify related material in other guidelines. The Task Force Liaison to the writing
committee and research staff should monitor consistency across guidelines (and other documents
as appropriate) to identify potential areas of disagreement. When adjudicating recommendations
among multiple writing committees that may overlap, disease-based guidelines will takeprecedence over procedure-based guidelines (assuming there is no new evidence and theguidelines in question address the same patient populations).

Further information on concordance is provided in Section 4.

Additionally, the Task Force Lead Reviewer is charged to look for consistency issues with otherguidelines at the time of peer review. If the issues are substantial, the writing committee chair
may agree to have a member from another guideline committee participate in a conference callor face-to-face meeting for a specific time period in order to hear the views of the othercommittee without spending too much time on one particular issue (e.g., primary PCI in the
STEMI guidelines, in the UA/NSTEMI guideline, and in the PCI guideline focused update,shown in Figure 6). If consensus cannot be reached within the writing committees of therespective guidelines, the chairs of the pertinent guidelines will confer and make the final
decision about the Class of Recommendation or exact wording.

54

Figure 5. Associated Guidelines
Revascularization

PCI

STEMI

UA/NSTEMI

Figure 6. Overlapping Guidelines

55

CABG

SIHD

5.3. Writing Committee Sign-off
At the final stages of guideline development, writers should re-examine the original goals
regarding the scope of the guideline, as identified in Section 2.2.2. Any identified gaps should
be filled or explained before the document is sent for peer review. The writing committee will
be asked to give formal approval of the document both before peer review and after peer review
edits have been incorporated.

Approval is obtained from all writing committee members through a formal ballot of every
recommendation PRIOR to peer review and then again PRIOR to leadership review onrecommendations that may have changed. Recommendation ballots received from writing
committee members, a cover tally sheet, and recusal information are printed and maintained in
the permanent paper files.

Writing committee members with relevant RWI specific to a recommendation must recuse
themselves from voting. Recusal information and RWI information is reviewed by the writing
committee Chair and Task Force Chair to ensure that all members have appropriately interpreted
and implemented the RWI/recusal procedures. The ballot recusal information is included on the
cover page of the document and on the RWI table.

Checklist 3 in section 4.1 is provided as a tool to conduct an internal review of the guideline
recommendations at both of these junctions. Additionally, the Conference on GuidelineStandardization (COGS) has developed a framework, listed in Checklist A in Appendix F,with 18 characteristics for standard guideline reporting that is designed to promote quality andfacilitate implementation. Checklists B and C (also in Appendix F) list 2 other systems ofreporting criteria: The National Guideline Clearinghouse (NGC) database, which is an initiativeof the Agency for Healthcare Research and Quality (www.Guideline.gov) posts guidelines thatmeet quality standards; and the Appraisal of Guidelines Research & Evaluation (AGREE)
instrument is a widely used generic measure of guideline quality and provides its attributes forevaluation as well.

56

5.4. Peer Review
A critical stage in the development process of practice guidelines is peer review. Peer reviewers
are relied on for expert, critical, and unbiased scientific and literary appraisals of the document.

5.4.1. Selection of Peer Reviewers
The Task Force has adopted a policy to collect relevant information regarding reviewers' RWI
pertaining to the topics covered in the reviewed guideline. Reviewers are required to provide
this information and sign a confidentiality agreement in order to participate in the review
process. As with guideline writing committee members, RWI information for reviewers is
included in an appendix of the published document.

Practice guideline peer review should seek to include diverse, competing viewpoints, withinvitations sent to organizational representatives and other stakeholders (based on the topic of theguideline) who will use and implement the guideline. Collaborating and endorsing organization
also participate by peer reviewing the document. Peer reviewers are classified as “official,”“content” and “organizational” reviewers. Official reviewers are nominated by the partneringorganizations with an effort to maintain an equal number of reviewers from each organization.
The Task Force Lead Reviewer is also considered an official reviewer. All other reviewers are
considered content or organizational (from endorsing organizations) reviewers. The types oforganizational relationships and the nature of these relationships are listed in Appendix D.

5.4.2. Writing Committee Response to Peer Review and Final Sign-Off
The final stages of document development involve review and approval from the guideline
writing committee, the Task Force Lead Reviewer, the Task Force, the ACCF BOT and the AHA
SACC.

The chairs (or their designees) should consider, and respond to, each comment received.
Detailed responses must be provided for official peer reviewer comments since they are
officially representing their organizations. Staff will construct a peer review spreadsheet to track57

comments and responses. While content reviewers do not receive formal responses back to theircomments they should be equally considered and responses to their comments included in the
spreadsheet. The chairs should revise the document, as appropriate, based on the responses. In
addition, the responses are sent to the ACC BOT and AHA SACC, and shared with partneringorganization staff.

All responses to peer review comments and the revised document are sent back to the writing
committee for final sign-off prior to leadership review. Any recommendations that changed as aresult of peer review will be balloted a second time.

5.4.3. Document Sent to Governing Bodies of ACCF, AHA, and Partner Organizations
5.4.3.1. Partner Organization Approval
The ACC Board and AHA SACC receive the document for review and approval. Once any/allchanges are incorporated (if substantive, these must be approved by the writing committee), therevised guideline is then sent to all partnering organizations, and then lastly the guideline is sent
to the organizations that have requested endorsement consideration.

5.4.3.2. Collaborator/Endorsement Approval
Collaborating/endorsing organizations that have been invited to participate in the development of
the guideline get a final chance to review and approve the final document.

If an organization decides to endorse the guideline, it is given the opportunity to publish theguideline and provide its Web posting information. The Publication Manager and/or Document
Manager coordinates with the endorsing organizations to determine file transfer requests and toschedule copublication.

If an organization decides not to endorse the document, the introduction will note that theorganization provided a representative to serve on the writing committee but their name will be
removed from the cover page.
58

6. Web Posting and Publication
The document is not final until approved and posted on ACCF and AHA Web sites. Guideline
focused updates are a summary article that accompanies the full-text guidelines and contains a tablehighlighting changes in recommendations. The full-text guideline is updated to incorporate links tosections where the focused update information would be most current. For new guidelines or
guideline revisions, an executive summary provides an abridged version of the full-text guidelines,
including all recommendations. Publication of the summary article or executive summary and epublication of the full-text guidelines appear in the Journal of the American College of Cardiology andCirculation.

6.1. Preparing the Pocket Guide
The information in the pocket guide should flow directly from the full guideline; thus, guideline
writers are responsible for ensuring that the guideline lends itself to the pocket guide format.
The Task Force recommends that each writing committee designate one writer who will be
responsible for the pocket guide. The Document Manager and Research Analyst coordinate
production and help ensure consistency among the full-text guidelines, executive
summary/summary article, and the pocket guide content. Material that does not appear in the
full-text guidelines should not appear in the pocket guide. An online version of the pocket guideis produced for all guidelines. When industry funding is obtained for a particular pocket guide, acolor laminated pocket guide is produced for distribution to ACCF members and others tofacilitate implementation of the guideline, specifically at the point of care.

However, ACCF and AHA prepare other supplemental materials independently of each other.

7. Maintaining Guideline Relevance and Updating Evidence
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 continuously explores newprocesses to update guideline content more regularly.
597.1. Evidence Review
7.1.1. Currency Review
All guidelines are reviewed by the Task Force for possible update one year after publication andyearly thereafter. The Research Analyst and the chair monitor significant new clinical trials andpeer reviewed literature on the topic, and they compare the current guideline recommendations
against the latest data. After the new data is compiled, the entire writing committee is surveyed
to determine whether the guideline (or sections within the guideline) needs updating. Other thanpeer reviewed documents and clinical trials, the research analyst also monitors key federal
regulatory bodies for changes/announcements/policies on both existing and emerging areas ofcardiovascular disease assessment and treatment. The information gathered from these agencies
is then shared with the chair and a determination is made regarding the necessity of a guideline
review.

The following Federal Agencies and specific agency programs will be followed /monitored:
US Food and Drug Administration (FDA)-Center for Devices and Radiological Health; FDACenter for Drug Evaluation and Research; FDA-Drug and Device Safety Alerts such as BlackBox Warnings; Centers for Medicare and Medicaid Services (CMS)-National Coverage
Analyses, Medicare Payment Advisory Commission (Med PAC) Reports/findings/
recommendations; FDA-Circulatory Systems Devices Advisory Committee
Decisions/Outcomes; FDA-Cardiovascular and Renal Drugs Advisory Committee
Decisions/Outcomes.
7.1.2. Late-Breaking Clinical Trials
Late-breaking clinical trials (LBCTs) are reviewed from all major medical meetings and the list
is compiled twice yearly (first for the period from January through June and second for theperiod from July through December). The Research Analyst compiles the reference articles anddata from the LBCTs, and then the respective writing committees are balloted, in addition to the
Task Force, to determine which guidelines will require an update or revision.

60

7.2. Development Process
A full revision of a guideline occurs when there have been at least two previous focused updates
and/or there is enough new evidence that a significant number of the recommendations need tobe revised or when there is a compelling reason to change the scope or focus of an existing
guideline. Revisions are managed the same as a new guideline, except for writing committee
selection. One half of the previous writing committee is rotated off to allow for the inclusion of
new members; however, new RWI rules must be followed so additional member changes may berequired to in order to maintain the 50% free of RWI plus the chair.

Unless otherwise stated, the methodology and general operating procedures described in thismanual applies to focused updates and revisions, as well as new guidelines. See Table 6.

Table 6. Standard Formats/Definition for ACCF/AHA Guideline Focused Updates, Revisions,and New Guidelines
Focused Update

Revision/New Guideline

Scope

Focused update based on new evidence
from LBCTs during a specified time
periodSubstantial rewrite of entire documentwith comprehensive literature review

Number of meetings

Two 4-hour meetings held in conjunction
with ACCF/AHA sessions and multiple
conference calls

Up to 2-3 full-day meetings

Target time frame to 6-9 months
peer review

12-18 months

Publication

Executive summary (includes allrecommendations and substantive
comments regarding document)
No track changes shown in full-text Web
publication

Summary article (table format tohighlight recommendation changes)
Updated and new sections arehighlighted in the Table of Contents ofthe full-text guideline with links to thefocused update where necessary617.2.1. Focused Updates
7.2.1.1. Topic Selection
As noted above in 7.1.2, research staff compile LBCT summary sheets by guideline topic twice
yearly noting which guidelines are potentially impacted. These are then forwarded to theappropriate writing committees for review and balloting. Criteria considered by writing
committees include:
•
•
•
•
•
•
•
•
•

Publication in a peer reviewed journal (this element assures time for the evidence to “simmer” inthe clinical community, which helps protect against being too reactionary)
Large, randomized, placebo-controlled trial(s)Nonrandomized data deemed important on the basis of results impacting current safety andefficacy assumptions
Strengths/weakness of research methodology and findings
Likelihood of additional studies influencing current findings
Impact on current and/or likelihood of need to develop new performance measure(s)Requests and requirements for review and update from the practice community, key stakeholders,and other sources free of relationships with industry or other potential bias
Number of previous trials showing consistent results
Need for consistency with a new guideline or guideline revision

If a majority of the writing committee agrees via ballot that a potential change torecommendations may be required, their comments are shared with the Task Force OversightGroup (TFOG) and a decision is made about whether to convene a teleconference. A fullcommittee conference call is held to further discuss the evidence and make a recommendation to
the Task Force on whether a focused update writing group should be convened.
Recommendations that impact multiple guidelines will be updated in all relevant guidelines
simultaneously so that concordance can be maintained.

Once all decisions are finalized, the researcher develops a list containing all guideline
recommendations that potentially may be impacted by the new evidence. This becomes the basisof the focused update. In addition, research staff will maintain a master list to track all LBCT
decisions over time.
7.2.1.2. Chair and Committee Selection
The writing committee for a focused update consists of previous members of the original
guideline writing committee, while taking into consideration the RWI relevant to the new trials.
62

The Document Manager sends an invitation letter, confidentiality agreement, and RWI form to
the potential chair/s and all writing committee members. Writing committee members are given
the option to participate or not. Those who accept are listed as the Focused Update Writing
Group (“writing on behalf of … [full writing committee]”).

If the chair has a relationship relevant to the LBCTs that have prompted the update, a new chairis selected. Focused updates also must abide by the writing committee chair rotation process,which states that a chair may only remain as chair for 2 focused update rotations. If the chairmust rotate off, then the Task Force will select another member of the current writing committee
to serve as chair.

Previous organizational representatives are invited to continue to represent their respective
organizations upon approval by organization staff.
7.2.1.3. Development Format
A new ‘Consensus Conference-Style’ approach to facilitating guideline development will bepiloted for focused updates. This includes a mandatory one- to two-day face-to-face meeting toreview, edit and finalize the draft guideline. When appropriate, it is recommended that evidence
tables or hyper-linking to studies be utilized instead of lengthy text to support recommendations.
The focused update is a summary article which contains ONLY the changes made to the fullguideline(s). A table of recommendations is developed that identifies all recommendations thathave been deleted and/or modified as well as all new recommendations. Every attempt is madeto “match by row” each deleted, changed and new recommendations. This can be difficult when
one recommendation is replaced with two or more recommendations and vice versa.

The full-text guidelines should remain the “go-to” material that a user would consult for all
relevant information to date regarding the subject. Sections that require update to be consistent
with the focused update will contain links back to the focused update. New text will not be added
to the full-text guidelines. Updated sections will be prominently called out in the table ofcontents.
63

7.2.1.3.1. Incorporation into Full Text Guideline

The full-text guideline will again be e-published to incorporate links to the focused update as a‘living’ guideline, and the title changed to reflect the incorporation of the focused update.

The table of contents will show which sections have been updated. Next to the specific updated
section the word Updated will be included in bold, red font and a hyperlink will be added to thesection. Unless specifically noted as being updated in the focused update, all material from thefull-text guidelines remains current.

The Focused Update writing group will be included on the cover page of the e-published versionof the full-text guideline. The full guideline writing committee (last full revision) is also listed on
the cover since the entire original writing committee is asked to peer review the focused update.

8. General Operating Procedures
8.1. Disclosure of Relationships with Industry and Other Entities Policy (seeAppendix B for formal ACCF/AHA Guideline Policy and Procedures; see Appendix D for typesof organizational relationships)
Because ACCF and AHA produce critical, truthful, independent practice guidelines, muchrecognition is given to the importance of maintaining high ethical standards and avoiding
conflicts of interests. ACCF and AHA recognize that it is difficult to form an expert panel
devoid of industry relationships. Therefore, all prospective writing committee member’s
participation is dependent on a review of all RWI by the Task Force, which makes every possible
effort to formulate a writing committee with a reasonable balance of RWI. All guidelines must
maintain 50% of the writing committee without relevant RWI plus a chair free of relevant RWI
for a total of 51%. The purpose of this review is to ensure that an adequate number of writing
committee members are available at all times to reach consensus should recusal from a vote on
any given recommendation be required due to relevant RWI. (See details in Section 2.1.
64Selecting Topic and Chair/Writing Committee and Section 2.2.4. Determining Writing
Assignments)

8.2. Confidentiality/Nondisclosure Agreement
All Writing Committee members must sign a Confidentiality/Nondisclosure Agreement
attestation as part of the completion of the ACC online disclosure system. Members of aguideline in progress have been or may be exposed to certain confidential and/or proprietary
information, materials, or data related to the writing committee’s work and final document(s). It
is important to the integrity of the writing process and final document that this information is
kept strictly confidential and not disclosed at any time. All writing committee members, Task
Force members, outside reviewers, and staff are required to maintain confidentiality for any
guideline in progress.

All guideline content is confidential and embargoed until approved by the governing bodies ofboth ACCF and AHA and posted on ACCF and AHA Web sites. Guideline content(recommendations, algorithms, figures, tables, text) cannot be disclosed under any
circumstances. During the course of guideline development, writing committee members may beapproached (e.g., by colleagues, industry, or media) to provide their expert opinion on an issue
relevant to the guideline content. Additionally, staff members may be contacted within the
ACCF and AHA and by outside organizations to provide information relevant to the Guidelines.
It is allowable to discuss the science and the issues under consideration based on any new
evidence. However, disclosure of any guideline content or indication of areas of writing
committee agreement or disagreement on any topic is prohibited. Writing committee members
may share content from any previously published guideline, but they may not indicate/imply thatthe content will or will not change. All guideline materials are the property of the ACCF and
AHA. Reproduction of guideline material (recommendations, algorithms, figures, tables, text) inany form whatsoever prior to the guideline publication is strictly prohibited. Breach ofconfidentiality may result in removal from the guideline writing committee and possibly otherconsequences.

65

8.3. Copyright Assignment and License Agreement (see Appendix B)
All writing committee members must sign a Copyright Assignment and License agreement. Thisagreement assigns, conveys, and otherwise transfers all rights, title, interest, and copyrightownership of the Work to the ACCF and AHA. The writing committee member retains the rightto subsequently include the published guidelines in articles, books, or derivative works that he or
she authors or edits provided said use does not imply the endorsement of the ACCF or AHA.
Multiple copies, modification, alteration, enhancement, and/or distribution of this document are
not permitted without the express permission of the ACCF and the AHA. It is important to go
through the proper channels to obtain permission to reprint/modify guideline content. A fee isassociated with obtaining permission to use guideline content in for-profit publications.
Permission requests are directed to healthpermissions@elsevier.com.

8.4. Editorial Response Policy
Due to the rigorous process for document development, the ACCF/AHA Task Force on Practice
Guidelines does not formally respond to specific comments about published guidelines. Rather,
the Task Force sends a form letter to acknowledge receipt of the letter that summarizes theprocess for handling letters to the editor (as indicated below).

“Letters to the Editor” will be sent to the appropriate writing committee for consideration todetermine whether they address a patient safety issue.

•

If yes, and the letter is correct, an erratum will be drafted and published as early as
feasibly possible but at least within 30 days to address the issue.

•

If not, the information will be taken into consideration by the writing committee during
the next update or revision of the guideline unless an earlier response is considerednecessary by the Task Force or Writing Group Chair.

Of note, JACC and CIRC policy, established by the journal editors independently from ACCF
and AHA, prohibits printing of letters to the editor regarding ACCF/AHA guidelines.

66

Other journals may allow publication of letters to the editor about ACCF/AHA Guidelines.
When this occurs, if the chair and/or writing committee believe that a response is necessary tocorrect the inaccuracies of the letter to the editor, they may request permission from the Task
Force to publish a letter of response.

67Appendix A. Suggested Readings
Copies of these articles are available from Guidelines staff.

The AGREE Collaboration. Appraisal of Guidelines for Research & Evaluation (AGREE) Instrument.
www.agreecollaboration.org
Ackman ML, Druteika D, Tsuyuki RT. Levels of evidence in cardiovascular clinical practice guidelines.
Can.J.Cardiol. 2000;16(10):1249-54.
Barratt A, Irwig L, Glasziou P, Cumming RG, Raffle A, Hicks N et al. Users' guides to the medical
literature: XVII. How to use guidelines and recommendations about screening. Evidence-Based Medicine
Working Group. JAMA 1999;281(21):2029-34.
Bucher HC, Guyatt GH, Cook DJ, Holbrook A, McAlister FA. Users' guides to the medical literature:
XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on
surrogate end points. Evidence-Based Medicine Working Group. JAMA 1999;282(8):771-8.
Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA et al. Why don't physicians follow
clinical practice guidelines? A framework for improvement. JAMA 1999;282(15):1458-65.
Callaham ML, Wears RL, Weber EJ, et al. Positive-outcome bias and other limitations in the outcome ofresearch abstracts submitted to a scientific meeting. JAMA 1998;280(3):254-7.
Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines andthe pharmaceutical industry. JAMA 2002; 287:612-7.
Cook D, Giacomini M. The trials and tribulations of clinical practice guidelines [editorial; comment].
JAMA 1999;281(20):1950-1.
Cook DJ, Greengold NL, Ellrodt AG, Weingarten SR. The relation between systematic reviews andpractice guidelines. Ann.Intern.Med. 1997;127(3):210-6.
Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991;
337(8746):867-72.
Field MJ and Lohr KN, eds. Clinical Practice Guidelines: Directions for a New Program. Institute ofMedicine, Washington, DC: National Academy Press; 1990:38..
Field MJ and Lohr KN, eds. Guidelines for Clinical Practice: From Development to Use. Washington,
DC: National Academy Press; 1992.

68

Friedland DJ, Go AS, Davoren JB, Shlipak MG, Bent SW, Subak LL, Mendelson T. Evidence-Based
Medicine: A Framework for Clinical Practice. Stamford: Appleton & Lange; 1998.
Gibbons RJ, Smith S, Antman EM. American College of Cardiology/American Heart Association
Clinical Practice Guidelines: Part I: Where do they come from? Circulation 2003;107:2979-2986.
Gibbons RJ, Smith S, Antman EM. American College of Cardiology/American Heart Association
Clinical Practice Guidelines: Part II: Evolutionary changes in a continuous quality improvement project.
Circulation 2003;107:3101-3107.
Greenhalgh T. How to read a paper. Getting your bearings (deciding what the paper is about). BMJ
1997;315(7102):243-6.
Greenhalgh T. Assessing the methodological quality of published papers. BMJ 1997;315(7103):305-8.
Greenhalgh T. Papers that summarise other papers (systematic reviews and meta-analyses). BMJ
1997;315(7109):672-5.
Grilli R, Magrini N, Penna A, Mura G, Liberati A. Practice guidelines developed by specialty societies:
the need for a critical appraisal. Lancet 2000;355(9198):103-6.
Grimshaw J, Eccles M, Russell I. Developing clinically valid practice guidelines. J.Eval.Clin.Pract.
1995;1(1):37-48.
Grimshaw J, Freemantle N, Wallace S, Russell I, Hurwitz B, Watt I et al. Developing and implementing
clinical practice guidelines. Qual.Health Care 1995;4(1):55-64.
Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review ofrigorous evaluations [see comments]. Lancet 1993;342(8883):1317-22.
Guyatt G, Jaeschke R, Heddle N, Cook D, Shannon H, Walter S. Basic statistics for clinicians: 1.
Hypothesis testing. CMAJ. 1995;152(1):27-32.
Guyatt G, Jaeschke R, Heddle N, Cook D, Shannon H, Walter S. Basic statistics for clinicians: 2.
Interpreting study results: confidence intervals. CMAJ. 1995;152(2):169-73.
Guyatt G, Walter S, Shannon H, Cook D, Jaeschke R, Heddle N. Basic statistics for clinicians: 4.
Correlation and regression. CMAJ. 1995;152(4):497-504.
Guyatt GH, Sinclair J, Cook DJ, Glasziou P. Users' guides to the medical literature: XVI. How to use atreatment recommendation. Evidence-Based Medicine Working Group and the Cochrane Applicability
Methods Working Group. JAMA 1999;281(19):1836-43.
Haycox A, Bagust A, Walley T. Clinical guidelines-the hidden costs. BMJ 1999;318(7180):391-3.

69

Hayward RS, Wilson MC, Tunis SR, Bass EB, Guyatt G. Users' guides to the medical literature. VIII.
How to use clinical practice guidelines. A. Are the recommendations valid? The Evidence- Based
Medicine Working Group. JAMA 1995;274(7):570-4.
Heffner JE. Does evidence-based medicine help the development of clinical practice guidelines? Chest
1998;113(3 Suppl):172S-8S.
Ioannidis JP, Cappelleri JC, Sacks HS, Lau J. The relationship between study design, results, andreporting of randomized clinical trials of HIV infection. Control Clin Trials 1997 Oct;18(5):431-44.
Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. 2001
National Academy of Science, US. (6th Printing May 2005)
Jadad A. Randomized Controlled Trials. London: BMJ Books; 1998.
Jaeschke R, Guyatt G, Shannon H, Walter S, Cook D, Heddle N. Basic statistics for clinicians: 3.
Assessing the effects of treatment: measures of association [published erratum appears in Can Med Assoc
J 1995 Mar 15;152(6):813]. CMAJ. 1995;152(3):351-7.
Jones RH, Ritchie JL, Fleming BB, Hammermeister KE, Leape LL. 28th Bethesda Conference. Task
Force 1: Clinical practice guideline development, dissemination and computerization. J Am Coll Cardiol
1997 May;29(6):1133-41.
Juni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for metaanalysis [see comments]. JAMA 1999;282(11):1054-60.
Kennedy HL. The importance of randomized clinical trials and evidence-based medicine: a clinician's
perspective. Clin.Cardiol. 1999;22(1):6-12.
Krahn, M., Naglie, G. The next step in guideline development: incorporating patient preferences. JAMA
2008:300:436-8.
Kuntz KM, Tsevat J, Weinstein MC, Goldman L. Expert panel vs decision-analysis recommendations for
postdischarge coronary angiography after myocardial infarction. JAMA 1999;282(23):2246-51.
Landrum MB, Normand SL. Applying Bayesian ideas to the development of medical guidelines.
Stat.Med. 1999;18(2):117-37.
Lau J, Ioannidis JP, Schmid CH. Summing up evidence: one answer is not always enough. Lancet
1998;351(9096):123-7.

70

Mulrow DC, Oxman AD, eds. Cochrane Collaboration Handbook [updated 1 March 1997]. In: The
Cochrane Library [database on disk and CD-ROM]. The Cochrane Collaboration. Oxford: Update
Software; 1996-. Updated quarterly.
Nicol AAM, Pexman PM. Presenting Your Findings: A Practical Guide for Creating Tables. Washington:
American Psychological Association, 1999.
Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials ofinterventions to improve professional practice. CMAJ. 1995;153(10):1423-31.
Parmley WW. Practice guidelines and cookbook medicine--who are the cooks? [editorial].
J.Am.Coll.Cardiol. 1994;24(2):567-8.
Petitti DB. Meta-Analysis, Decision-Analysis, and Cost-Effectiveness Analysis: Methods for
Quantitative Synthesis in Medicine. New York: Oxford University Press; 1994.
Pogue J, Yusuf S. Overcoming the limitations of current meta-analysis of randomised controlled trials.
Lancet 1998;351(9095):47-52.
Sackett DL, Richardson WS, Rosenberg W, and Haynes BR. Evidence-based Medicine: How to Practiceand Teach EBM. Edinburgh: Churchill Livingston; 1998.
Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodologicalquality of clinical practice guidelines in the peer-reviewed medical literature. JAMA 1999;281(20):19005.
Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ
1999;318(7183):593-6.
Shekelle PG, Kravitz RL, Beart J, Marger M, Wang M, Lee M. Are nonspecific practice guidelines
potentially harmful? A randomized comparison of the effect of nonspecific versus specific guidelines on
physician decision making. Health Serv.Res. 2000;34(7):1429-48.
Schiffman RN, Shekelle P, Overhage M, et al. Standardized reporting of clinical practice guidelines: A
proposal from the conference on guideline standardization. Ann Intern Med 2003; 139:493-8.
Ullyot DJ. President's page: practice guidelines [news]. J.Am.Coll.Cardiol. 1994;24(2):569-70.
Woolf SH. Practice guidelines, a new reality in medicine. II. Methods of developing guidelines.
Arch.Intern.Med. 1992;152(5):946-52.
Woolf SH. Do clinical practice guidelines define good medical care? The need for good science and thedisclosure of uncertainty when defining 'best practices'. Chest 1998;113(3 Suppl):166S-71S.

71

Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits,
limitations, and harms of clinical guidelines. BMJ 1999;318(7182):527-30.

Web Resources
The following Web sites may be useful (type Ctrl and click mouse to follow the link):
The Centre for Evidence-Based Medicine, University Health Network(http://www.cebm.utoronto.ca/) has an online stats calculator available at
http://www.cebm.utoronto.ca/practise/ca/statscal/, and an online resource center available at
http://www.cebm.utoronto.ca/resources/websites.htm.
The Evidence-Based Resource Center (http://www.ebmny.org/thecentr2.html) also has an evidencebased medicine calculator (http://www.cebm.utoronto.ca/palm/ebmcalc/), stats calculator(http://www.cebm.utoronto.ca/practise/ca/statscal/) and software for critically appraised topics(http://www.cebmh.com/).
References
Antman EM, Califf RM, Kupersmith J. Tools for assessment of cardiovascular tests and therapies. In
Antman EM, editor. Cardiovascular Therapeutics: A Companion to Braunwald’s Heart Disease .Third
edition. Philadelphia: Elsevier Saunders, 2007.
Nicol AAM, Pexman PM. Presenting your findings: a practical guide for creating tables. Washington,
DC: American Psychological Association, 1999.

72

Appendix B.
ACCF/AHA Relationship With Industry (RWI) and Other Entities:
Policies and Procedures for the Development of Guidelines
1.0. Introduction
The American College of Cardiology Foundation (ACCF) and American Heart Association(AHA) are committed to the very highest ethical standards in all its activities, including
development of clinical policy. Guideline development is core to our missions so no industry
funding is accepted for development. The ACCF/AHA have always taken a stringent approachto ensuring responsible, transparent relationships in which industry support and other relevant
entities have no influence on scientific content. The ACCF/AHA believes that including experts
who have relationships with industry and other relevant entities on writing committees, whentransparent and properly managed, strengthens the writing effort and final published document.
However, part- or full-time employees of industry are prohibited from serving as members ofguideline writing committees. The following policy outlines the ACCF/AHA methodology forensuring a document development process without improper bias or influence.
1.1. Scope
For those involved in the writing effort (i.e., authors, external peer reviewers, and Task Force on
Practice Guidelines), the ACCF and AHA require the disclosure of all relationships with industry
and other entities (as defined in Section 2.1.2.) involved in the production, marketing,
distribution or reselling of healthcare goods, services, advice or information consumed bypatients, investors and/or physicians. This may include relationships with government entities aswell as not-for-profit institutions and organizations (see category definitions for detail).
1.2. Terminology
1.2.1. Relationships with Industry (RWI) Versus Conflict of Interest (COI)The ACCF and AHA prefer the term Relationships with Industry (RWI) and Other Entities as
opposed to the term Conflict of Interest (COI). RWI, by definition, does NOT necessarily imply
a conflict. When all relationships are disclosed with the appropriate detail regarding category
and amount, and managed appropriately for building consensus and voting, the ACCF/AHA
believes that potential bias can be avoided and the final published document is strengthened
since the necessary expertise is accessible.
In addition to managing RWI, the ACCF/AHA monitors and manages other potential biases that
may be relevant to the writing effort including the views of academic versus nonacademic
physicians, as well as other potential biases that may stem from race, gender, geographic
location, or intellectual position on a particular issue.
1.2.2. The Task Force on Practice Guidelines
The ACCF/AHA Task Force on Practice Guidelines (TFPG) directs and oversees thedevelopment of guidelines in addition to the policies and procedures utilized for development.
73

The TFPG coordinates: topic selection and prioritization, writing committee formation,
document development methodology and procedures, external peer review, document approval,
and publication.
1.2.3. Writing Committees
Writing Committees are commissioned by the TFPG and charged with developing a guideline on
an assigned topic to be published in the respective journals. ACCF/AHA policy is based on the
ACC/AHA guidelines.
1.2.4. Chair, Co-Chairs, Vice Chairs
The term Co-Chair refers to two or more chairs who share equal responsibility. Co-Chairs (asfor Chairs) may have no relevant RWI. The term Vice Chair refers to an individual who serves in
conjunction with a Chair but is subordinate to that Chair. Unlike Chairs and Co-Chairs, Vice
Chairs may have relevant RWI.
2.0. General Principles for Managing RWI
2.1. Collecting RWI
Listed below is the information the ACCF/AHA collects for the purposes of managing
relationships with industry and other entities for guideline development.
2.1.1. Reporting Timeframe
The ACCF/AHA requires the disclosure of all relationships with industry and other entities forthe past 12 months, consistent with the reporting timeframe for the National Institutes of Healthand the Food and Drug Administration. In addition, authors are discouraged from adding new
RWI during the writing effort and prior to publication; however, if relevant relationships areadded, this information must be verbally disclosed during any conference calls or meetings, aswell as added to the author disclosure table.
2.1.2. Relationship TypeThe following definitions are used to define categories for reporting relationships with industry
and other entities.
REPORTING
CATEGORY
Consultant*

Speaker’s Bureau*
Ownership/Partnership/
Principal (excluding
mutual diversified funds)
Personal Research

DEFINITION
Includes relationships resulting in honoraria from a third party, gifts or otherconsideration, or "in kind" compensation, including directing such honoraria be donatedto a nonprofit 501 C3 organization, whether for consulting, lecturing, travel, service onan advisory board, or for any other similar purpose in the prior calendar year. (Thisincludes private sector payers as well as pharmaceutical, device or other mission-relatedcompanies as well as consulting or advisory board membership on any federal orstate government agency such as CMS and FDA).
Includes compensation from speaker’s bureaus.
Includes status as any stock‡, stock option‡, ownership, partnership, membership orother equity position in an entity regardless of the form of the entity, or any option orright to acquire such position, and any rights and/or royalties in any patent or otherintellectual property.
Includes principal investigator (PI) or co-PI (if so, please specify), investigator, steeringcommittee member, collaborator or consultant for pending grants as well as grants

74

Salary
Institutional or
Organizational(including but not limited
to research)already awarded or received (including commercially-funded, NIH, and universitymanaged grants and DSMBs). Also includes receipt of drugs, supplies, equipment orother in-kind support over which you have direct decision making responsibility.
Funding of a salary or position (partial or full) or “in-kind” support of program.
Institutional: Includes any institutional relationship between your employer or academic
institution and a business or other entity (including NIH grants or other government
agencies). Examples: If your institution is recruiting patients for a trial and you are a
sub-investigator† or co-investigator† (as defined below) and/or if you are a Chief ofCardiology and therefore have fiscal authority and/or direct decision-making
responsibility (such as support for research grants, fellowships, grand rounds, andinstitutional supplies). These relationships should be reported here.
Organizational: Organizational competing relationships include any leadership orgovernance responsibilities or roles in another professional or other nonprofit
organization, whether or not remuneration is received (e.g., Officer, Director, Trustee orother Fiduciary Role, Editor) that may have interests potentially competitive with the
ACC or AHA.

Expert Witness

Disclose all court cases or other legal proceedings for which you served as a consultant,expert witness, or gave deposition at any time during the past year –compensated or
uncompensated. Disclose the year the involvement occurred, plaintiff or defendantside, and the topic of the case/testimony, even if the case did not go to trial. Also
disclose if you are working on a document or engaged in an activity that specificallyreferences or relates to a court case for which you gave testimony. In this regard, casesthat occurred more than 12 months ago must be noted. In all cases, disclosure of expert
witness testimony should be consistent with applicable requirements and restrictions,such as HIPAA, court rules, and confidentiality agreements.

*ACCME-accredited programs do NOT have to be disclosed due to firewall restrictions between industry andprogram content.
†Sub-investigator or co-investigator in this instance are defined as an individual who has signed a Form 1572 and is
NOT a primary or co-author of data analyses including abstracts and manuscripts; does NOT have oversight of theresearch, report data, or receive money from the trial sponsor (including direct salary support and/or staff salary
support [including staff that you share], overhead charges); and does NOT receive travel funds to attend investigatormeetings hosted by the sponsor. If the answer to any of these modifiers is ‘YES’, then the relationship should be
disclosed under the personal research category and if all answers are ‘NO’, the relationship should be disclosed
under the institutional category.
‡The divesting of stock or stock options will immediately nullify the specific relationship; therefore, the 12 month
rule does not apply.

2.1.3. Financial Value/Level of Relationship
Financial disclosures should be classified as significant, modest, or no financial relationship. A
person is deemed to have a significant interest in a business if the interest represents ownershipof 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or
more of the fair market value of the business entity, or if funds received by the person from thebusiness entity exceed 5% of the person’s gross income for the previous year. A relationship isconsidered to be modest if it is less than significant under the preceding definition. No financial
relationship pertains to relationships for which you receive no monetary reimbursement.
2.1.4. Relevance to Document /Topic
Authors must report ALL relationships with industry and other entities.

75

For determining eligibility to serve on a writing committee, all relationships are evaluated by therespective oversight committee for relevancy. A person has a relevant relationship IF:–––

The relationship or interest relates to the same or similar subject matter, intellectual
property or asset, topic, or issue addressed in the document; orThe company/entity (with whom the relationship exists) makes a drug, drug class, or
device addressed in the document, or makes a competing drug or device addressed in the
document; or
The person or a member of the person’s household, has a reasonable potential for
financial, professional or other personal gain or loss as a result of the issues/content
addressed in the document.

For determining eligibility to vote on and draft recommendations and text, a person has a
relevant relationship:

If a member of a writing committee has a relevant RWI regarding a product or competingproduct, and the section of the document relates to the specific or competing product,
then the member is permitted to participate in the discussions but is not permitted todraft or vote on a recommendation or corresponding text.



If a member of a writing committee has a relevant RWI regarding a product or competingproduct, and the section of the document is not related to the specific or competingproduct, and the company does not manufacture or sponsor any relevant product/service
or competing product/service, then the member is permitted to participate in thediscussions and is permitted to draft and vote on a recommendation and/or
corresponding text.



If a member of a writing committee has a relevant RWI regarding a product or competingproduct, and the section of the document relates to the company that manufactures orsponsors the product/service or competing product/service but not the specific product orclass of products involved in their relationship, then the member is permitted toparticipate in the discussions but is not permitted to draft or vote on a recommendation
and/or corresponding text.

2.1.5. Disclosure Timing
Relationships are disclosed 1) in writing or online in advance of the writing effort to determine
eligibility of members to serve on a writing committee and 2) during the document development
process to ensure complete transparency throughout the writing and sign-off processes.
Relationships that develop during the writing process must be reported to the writing group chair
immediately.
2.2. RWI Management
2.2.1. Writing Committee Balance (bias)
Chair/Co-Chairs: The Chair or Co-Chairs may have no relevant RWI.* The writing groupchair is selected primarily for the competency of effectively managing the writing group. A
76

general working knowledge and competency in the writing topic is also necessary, but thechairperson does not have to be a leading expert in that topic. The chairperson must be selected
to avoid relationships that could undermine the credibility of the writing group or its work
product.
Vice Chair: A vice chair may be added to the writing effort if needed for content expertise. Vice
chairs may have relevant RWI but may not have a significant relationship in the ownershipcategory as defined above.
Committee: A majority of writing committee members must be free of relevant RWI.* At least
50% of writing committee members, plus the Chair, may have no relevant RWI. The TFPG
monitors writing committee composition for RWI, as well as other potential areas of bias, suchas intellectual bias/perspectives or organizational relationships potentially competitive with theCollege, and must approve each writing committee before work begins. Once chosen, authors
are requested to avoid forming any new relevant RWI during the writing effort and prior to
publication in order to maintain the RWI balance of the writing committee.
Of note, the TFPG also reviews writing committee balance for other issues such as specialty,
geographic location, private practice (versus academic setting/practice), gender, race, andappropriate organizational/content expertise.
*At the discretion of the TFOG/TFPG, certain disclosed relationships of the chair, co-chair, vicechair, or writing committee member such as participation in government-sponsored oruniversity-managed Data Safety Monitoring Boards or research, as well as certain
institutional/organizational and government/nonprofit relationships may be considered as NOT
relevant to the writing of the document.
2.2.2. Consensus Development
All writing committee members are invited to discuss all aspects of the document, including
those for which they have relevant relationships with industry or other entities. The ACCF/AHA
values the expertise of all writing committee members and allows open discussion to inform thewriting committee’s final deliberation on document content. However, if one or moreindividuals appear to be unduly influencing the outcome of the discussion, whether they have a
relevant relationship with industry related to the topic under discussion, a relevant relationshipwith another (non-industry) entity related to the topic (see above definition), or other bias related
to the discussion, the individual may be asked to leave the room or conference call during a
portion or all of the discussion at the discretion of the chair.
2.2.3. Voting on Recommendations
In general, all committee members, even those with relevant RWI, may participate in all
discussions. However, writing committee members may not draft or vote on recommendations
and/or text if they have a relevant relationship as defined in Section 2.1.4 above. For the purposeof tracking adherence to this policy, a confidential written vote is taken for every document
recommendation prior to external peer review and then again on recommendations that change asa result of peer review following the finalization of the draft prior to the ACC Board and SACC
review/approval process. The writing committee chair must review all votes to ensure accurate
77

recusal by all writing committee members. Recusals from voting are published in the document
by author and section for the purpose of transparency.
2.2.4. External Peer Review
There are no RWI restrictions for participation in the external peer review process of adocument; however, all reviewers must disclose all relevant relationships with industry and otherentities related to the topic for publication in an appendix of the document. This promotes theopportunity for comment on the document from a variety of constituencies/viewpoints to inform
final document content.
2.2.5. ACCF Board of Trustees and AHA Science Advisory and Coordinating Committee
Review and Approval
BOT and SACC members may not comment or vote on clinical documents at the time of board
review and approval if they have relevant RWI related to the document topic. Documents areapproved as ACCF and AHA policy by a majority vote of BOT and SACC members who haveno relevant RWI related to the document under consideration.
2.2.6. Public Disclosure of RWI
The ACCF/AHA disclosure policy is cited in the published document and relevant relationships
with industry and other entities of authors and peer reviewers are published in a document
appendix. In addition, to ensure complete transparency, a hyperlink to the comprehensive RWIof each author (in effect at the time of the writing effort) and TFPG member (updated in realtime) is included in the document. This information resides on www.acc.org and on
www.americanheart.org.

78II. Copyright Assignment and License Agreement ACCF/AHA
In consideration of the American College of
Cardiology Foundation (ACCF) and the American Heart
Association (AHA) reviewing and editing the following
described work for first publication on an exclusive
basis,
Journal: Journal of the American College of
Cardiology; Circulation
Anticipated Date of Publication:
First author:
Title of Work:the undersigned author(s) hereby assigns, conveys, andotherwise transfers all rights, title, interest, and copyrightownership in the Work to the ACCF and AHA effective
upon acceptance of said work for publication. "Work"
includes the material submitted for publication and any
derivatives thereof, and any other related material
submitted to the ACCF and AHA.
The assignment of rights to the ACCF and AHA
includes but is not expressly limited to rights to edit,
publish, reproduce, distribute copies, prepare derivative
works, include in indexes or search databases in print,
electronic, or other media, whether or not in use at thetime of execution of this agreement, and claim copyrightin said work throughout the world for the full duration of
the copyright and any renewals or extensions thereof.
All accepted works become the property of the ACCF
and AHA and may not be published elsewhere without
prior written permission from the ACCF and AHA.
ACCF and AHA hereby license to author the right tosubsequently include the Work in articles, books, orderivative works that he/she authors or edits provided
said use does not imply the endorsement of ACCF and
AHA.

Other uses of reproduction require the express
permission from the ACCF and AHA which shall not be
unreasonably withheld.
Author represents and warrants to AHA and ACCF
that the Work shall be Author's original and unpublishedwork, or, if applicable, that Author owns all right, title
and interest in the Work; and that it has the sole andexclusive right to dispose of the Work and grant therights granted under this Agreement, and that the Workwill contain no defamatory or unlawful matter and will in
no way infringe on the copyright or violate the
proprietary rights of any person. Author agrees toindemnify and hold the AHA and ACCF, harmless fromany suit, demand, or claim made against the AHA and
ACCF, by reason of any breach of this warranty, andAuthor further agrees to pay any judgment or reasonable
settlement offer resulting from any such suit, demand, or
claim, and to pay any reasonable attorneys' fees incurred
by AHA or ACCF in defending against such suit,demand, or claim. For purposes of this Paragraph, theparties indemnified and insured shall include the AHA,
the ACCF, their officers, directors, members, agents,
volunteers, and employees.
In the event that the ACCF and AHA does not publish
the Work, author(s) will be so notified and all rights
assigned hereunder will revert to author.
If a joint work, all co-authors must transfer rights insaid work to the ACCF and AHA by executing thisAgreement.
This Agreement is governed by the laws of the UnitedStates.
This Agreement must be executed as is without revisionor substitution of terms. An original signature of theauthor is required; imprints, facsimiles, or photocopies
are not acceptable. The original will be housed with
ACCF and copies will be held at AHA.

Author(s) Name

Signature ..............................................

Date_______________________________________________________________________________For U.S. Government Employee Author (s):The undersigned author (s) hereby warrants that the above described Work was authored by employees of theUnited States Government as part of their official duties and therefore may be published and reproduced
without restriction. (All non-government employee authors or co-authors must sign the prior portion ofthis agreement transferring copyright.)
Name
Signature
Date______________________________________________________________________________

79

Appendix C. Types of Organizational Relationships and Nature of Relationship*

General Principle

Funding

Joint Partnership(e.g., ACC/AHA/SCAI GLs on PCI)Collaboration w/Endorsement

Collaboration w/out Endorsement OR
Endorsement w/out Collaboration (veryrare)

Welcome unlimited number of partner organizations
whose constituencies have vested interest in treating
patients specific to disease/procedure under development.
To maintain rigor and credibility, organizations should be
ACGME accredited. Number of members and/or size oforganization should be a criterion for partnership howeverorganization should be considered a “mainstream”
organization representing a major and legitimate area ofinterest (not a “fringe” group or narrowly focusedorganization). In general, organizations will be given theoption of participating at partner level or collaborationlevel but this is at the discretion of the Task Force on
Practice Guidelines and the Writing Committee Chair(s).
Partnering organizations pay for the travel expenses
associated with their representative(s) – All other direct
costs and overhead are supported by ACC and AHA.

Welcome unlimited number of collaboratingorganizations whose constituencies have vested
interest in treating patients specific todisease/procedure under development. To maintainrigor and credibility organizations should be
ACGME accredited. In general, organizations will
be given the option of participating at partner levelor collaboration level but this is at the discretion of
the Task Force on Practice Guidelines and the
Writing Committee Chair(s).

Endorsement w/out Collaboration: In
situations where an organization was NOT
invited to collaborate in the beginning (wewere unaware of interest/existence) but
requests to endorse the final document.

Collaborating organization(s) does not pay for
travel costs for their rep(s) – ALL direct andindirect guideline expenses are supported by ACC
and AHA – including staff & overhead.

Formal Policy

Recommendations are formal policy of all partneringorganizations.

Generally recommendations are NOT formal
policy of the collaborating organizations. (WhenACC endorses a document developed by anotherorganization, the document does NOT become
official ACC policy).

Staff

ACC (funded by ACC/AHA); Staff from cosponsoringorganizations are welcome to attend the meetings at theirown expense.

ACC (funded by ACC/AHA)

80

Collaboration w/out Endorsement: An
organization signs on as a collaborator andappoints a representative. They do NOT
endorse the final document because ofunresolved differences. In this case they
may or may not request that theirrepresentative be removed from the WC.
Collaborating organization(s) does not pay
for travel costs for their rep(s) – ALL
direct and indirect guideline expenses aresupported by ACC and AHA – including
staff & overhead.
N/A

ACC (funded by ACC/AHA)Shared Marquee

Writing Committee
Chair

Yes – names of all partnering orgs are included in the titleof the document with ACC/AHA listed first and all others
following in alpha order.
Title: ACC/AHA/SCAI GLs on PCIName of collaborating orgs not listed in title.
2nd line billing ONLY.
Title: ACC/AHA GLs on Device Based Therapy
2nd line: Developed in Collaboration with HRS,etc.

Name not listed in title or in 2nd line.
Organizational rep may have asterisk
indicating organization; name oforganization may be listed in Intro if they
endorse the document but did not have a
representative.

Task Force on Practice Guidelines recommends
individuals for the ACC/AHA chair position with thefinal decision made by the Task Force Oversight Group.
Chair may have no relevant RWI.

ACC/AHA appoint the chair

ACC/AHA appoint the chair

Official but NOT Equal, usually one representative

Official but NOT equal, usually one
representative. If document is NOT
endorsed the participating organization
MAY request representatives name beremoved from the W.C. (but this action is
discourage)

Decision to invite additional co-chair(s) and/or vice chairrepresenting a 2nd/3rd specialty area (i.e., radiology &surgery, or when vice chair has RWI, is at the discretionof the Task Force on Practice Guidelines and may occur
one of several ways:
1) Potential co-chairs may be nominated by the Task
Force on Practice Guidelines for consideration OR; 2) the
2nd/3rd organization(s) may appoint its co-chair position
through its own process; or 3) Partnering organizations
are polled for suggestions for chair of a writing
committee that are discussed by the Task Force on
Practice Guidelines.
If any organization voices concern about a proposed
chair, another person is chosen for the position. (Thisprocess may vary for Guideline Updates/Revisions due tocommittee rotation policy.)
Committee
Representation

Official & equal (2 to 4 members per organization,
depending on participation by other organizations withsingle representatives; pharmacologist and Task Forceliaison members are also in addition to officialorganizational representatives.) Equal refers to the same
number by both ACC and AHA in addition to any otherpartners.
Once all organizational members have been appointed, the81writing committee roster is reviewed by the Task Force on
Practice Guidelines one final time to ensure appropriatebalance among specialty areas and RWI.
Relationships with
Industry and Other
Entities (RWI)The RWI for writing committee members must be
thoroughly reviewed and vetted for relevancy in order tomaintain the required 51% without relevant RWI (which
includes a chair with no relevant RWI). Every effort will
be made to implement the 51% rule equally across allorganizational reps in order to maintain equality within theselection process. This may require the partner submitting
multiple names during the RWI vetting process.

A balance of RWI must be maintained including
the 51% requirement which includes thecollaborating organizations. This may mean thatmultiple reps need to be recommended, some withno relevant RWI before a final member is selected.

Partnering organizations must also abide by this policy(except in rare instances where an exception would be
negotiated in advance) if a joint partner had different RWI
policies.

Content Control/
Approval

ACC/AHA

ACC/AHA

ACC/AHA methods and policies are mandated.

ACC/AHA

ACC/AHA

Two official reviewers from each organization; official
reviewers receive a detailed response from the chair

Invited to provide organizational review andindicate desire to review final document for

Invited to provide organizational review
and indicate desire to review final

ACC and AHA are required to negotiate areas ofdisagreement among BOT and SACC. If a 3rd partner isadded, the Task Force will work to negotiate finalizing the
document with their respective Board.
If multiple partnering organizations are involved, they
conduct their own process within a time frame of three to
six weeks. They have an “up/down” vote toapprove/disapprove document.
It should be noted that at the Board approval phase in
document development, we are seeking formal approval
only and trying to avoid major document revision. Majorchanges are best made earlier during the peer review
stage, however every effort is made to facilitate approval
if/when there are areas of controversy.

Policy Decisions/
Methodology
Peer Review

82regarding the disposition of their comments. In addition,
content reviewers are invited and the names/number are at
the discretion of the WC. Additional content reviewers arewelcomed from the partnering organizations with arequest that they be combined into 1 or 2 reviews
representing the views of the organization.

endorsement consideration (thank you letter only;
no detailed response).

document for endorsement consideration(thank you letter only; no detailed
response)

ACC coordinates the peer review process.
A lead reviewer from the ACC/AHA Task Force on
Practice Guidelines provides oversight of the process toensure that all appropriate revisions are made.
Copyright
Ownership

ACC/AHA holds the copyright; however, unrestrictedlicense is granted to all partner orgs. This is done only tofacilitate the administration and management of theintellectual property.

ACC/AHA

ACC/AHA

Publication

Joint publication. A partnering organization press release
will be jointly developed and approved which will include
the writing committee chair(s) as the guideline
spokesperson.

Joint encouraged but not mandated

ACC/AHA

Endorsement

ImpliedImpliedAll organizations have endorsement
option; if endorsed, organization can opt tobe listed as “collaborating” (2nd line
billing) or may be listed as “endorser” (3rdline billing). For organizations that do notendorse a guideline, the guideline
Introduction mentions participation on thewriting committee and in the peer review
process.

Derivative
Products

ACC and AHA share costs and revenues for pocket
guidelines, slides sets, and PDAs which fall under thejoint ACC/AHA Guideline Task Force budget andunderwrite continuing guideline development. Other
derivative products fall under the purview of the ACC or
AHA and do not have to be done, but may be done,
jointly.

83

Partnering organizations are free to develop derivate
products based on the guideline. They assume
responsibility for costs associated with the use of the
Guideline or any derivative works and retain any revenue
associated with sale or distribution of the derivative work.
Partner organizations may not license the guideline toother entities without written permission from the ACC or
AHA.
Concordance

New documents developed subsequently by the partnering
and/or collaborating organization, based on the sameevidence, must maintain concordance with the guideline
recommendations. This does not apply if/when newevidence is published which would render the guideline
recommendations out of date.

Guideline recommendations are endorsed bycollaborating organizations but are not consideredorganizational policy. Therefore, collaboratingorganizations are not obligated to maintainconcordance.

Updating a
Guideline

ACC/AHA will notify all partnering organizations when
an update is initiated to ascertain interest in continued
participation.

Notify collaborating organization when time to
update to inquire if they would like to continue
participation.

Notify participating organization whentime to update to inquire if they would liketo continue participation.

EXAMPLES

ACC/AHA/HRS DBT GL;; ACC/AHA/SCAI PCI GL;
ASA/ACC/AHA/SCAI/SIR/ SVMB/SVS Guideline on
ECVD

HF GL with ISHLTAF GL with HRS

HF GL with HFSA (3rd line billing forendorsement; did not desire collaboration
billing)
HF GL with ACP and AAFP (no billing on
cover preferred; just indicated participationin GL Intro)

Note: This table reflects current policy as of 10/09/09; however, the ACC/AHA Task Force on Practice Guidelines revisits these policies periodically and revises them as needed.

84

Appendix D. Literature Search Request Form
The ACCF/AHA methodology for guideline development requires the documentation of all literaturesearches performed for the creation of guidelines. Please complete this form for each literature searchrequested or conducted and return it to your ACCF/AHA Guidelines committee Research Analyst.

TO BE COMPLETED BY THE REQUESTOR
Name of Guideline: _________________________________________________Name of Requestor: _____________________________ DATE: ________________
Years requested: __________ – __________
Publication types:❏ Meta-analyses & systematic reviews❏ Nonrandomized studies❏ Opinion documents/letters❏ Randomized controlled trials❏ Case studies

Describe clinical question or keywords:

TO BE COMPLETED BY THE SEARCHER

Template: Stored literature search summary
Guideline Name:
Requestor:
Daterequested

SearchrequestedYearsrequested

Publication
types
requested

Database(s)searched85

Yearsrequested

LimitsNo.
searchresultsNo.
references
selected

Notes

Initials

Appendix E. Checklists for Ensuring Guidelines Incorporate
Desired Criteria
Checklist A. Conference on Guideline Standardization (COGS) Checklist for Reporting
Clinical Practice Guidelines
1. Overview Material
2. Focus

3. Goal
4. Users/setting

5. Target Population
6. Developer

7. Funding source/sponsor

8. Evidence collection

9. Recommendation grading
criteria

10. Method for synthesizing
evidence
11. Prerelease review
12. Update plan
13. Definitions
14. Recommendations andrationale

15. Potential benefits andProvide a structured abstract that includes the guideline’s releasedate, status (original, updated), and print and electronic sources.
Describe the primary disease/condition andintervention/service/technology that the guideline addresses.
Indicate any alternative preventive, diagnostic, or therapeuticinterventions that were considered during development.
Describe the goal that following the guideline is expected to achieve,
including the rationale for development of a guideline on this topic.
Describe the intended users of the guideline (e.g., provider types,
patients) and the settings in which the guideline is intended to be
used.
Describe the patient population eligible for guideline
recommendations and list any exclusion criteria.
Identify the organization(s) responsible for guideline development
and the names/credentials/potential conflicts of interest of
individuals involved in the guideline’s development.
Identify the funding source/sponsor and describe its role indeveloping and/or reporting the guideline. Disclose potential
conflict of interest.
Describe the methods used to search the scientific literature,including the range of dates and databases searched, and criteria
applied to filter the retrieved evidence.
Describe the criteria used to rate the quality of evidence that
supports the recommendations and the system for describing thestrength of recommendations. Recommendation strengthcommunicates the importance of adherence to a recommendationand is based on both the quality of the evidence and the magnitudeof anticipated benefits or harms.
Describe how evidence was used to create recommendations (e.g.,through evidence tables, meta-analysis, decision analysis).
Describe how the guideline developer reviewed and/or tested theguidelines prior to release.
State whether or not there is a plan to update the guideline and, if
applicable, an expiration date for this version of the guideline.
Define unfamiliar terms and those critical to correct application of
the guideline that might be subject to misinterpretation.
State the recommended action precisely and the specificcircumstances under which to perform it. Justify each
recommendation by describing the linkage between therecommendation and its supporting evidence. Indicate the qualityof evidence and the recommendation strength, based on the criteria
described in 9.
Describe anticipated benefits and potential risks associated with86

harms
16. Patient preferences
17. Algorithm
18. Implementationconsiderations

implementation of guideline recommendations.
Describe the role of patient preferences when a recommendation
involves a substantial element of personal choice or values.
Provide (when appropriate) a graphical description of the stages
and decisions in clinical care described by the guideline.
Describe anticipated barriers to application of therecommendations. Provide reference to any auxiliary documentsfor providers or patients that are intended to facilitate
implementation. Suggest review criteria for measuring changes incare when the guideline is implemented.

Checklist B. National Guideline Clearinghouse (NGC) Database inclusion criteria
1. Content

The guideline contains systemically developed statements that include
recommendations, strategies, or information that assist physicians and/or
other healthcare practitioners and patients make decisions about
appropriate healthcare for specific clinical circumstances.

2. Production

The guideline was produced under the auspices of medical specialty
associations; relevant professional societies, public or privateorganizations; government agencies at the federal, state, or local level;or healthcare organizations or plans.

3. Corroboration

Corroborating documentation can be produced and verified that asystematic literature search and review of existing scientific evidence
published in peer-reviewed journals was performed during the guideline
development.

4. Language and Date of Creation

The full text guideline is available in English language. The guideline iscurrent and the most recent version produced. Documented evidence
can be produced or verified that the guideline was developed, reviewed,
or revised within the last 5 years.

Checklist C. Appraisal of Guidelines Research & Evaluation (AGREE) Attributes
1. Explicit scope and purpose

Specific descriptions are given of the overall guideline objective(s), theclinical questions(s) covered, and the patients to whom the guideline ismeant to apply.

2. Stakeholder involvement

The development group includes individuals from all relevant
professional groups; patients’ views and preferences are sought; target
users are clearly defined; and the guideline has been piloted amongtarget users.
Systematic methods are used to search for and select evidence; methods
for formulating recommendations are clearly described;
recommendations take into account health benefits; side effects; andrisks; recommendations are linked explicitly to supporting evidence; theguideline is externally reviewed by experts prior to publication; and aprocedure for updating the guideline is provided.

3. Rigor of development

874. Clarity of presentation

Recommendations are specific and unambiguous; different options for
management are clearly presented; key recommendations are easily
identifiable; and the guideline is supported with tools for applications.

5. Applicability

Potential organizational barriers in applying the recommendations are
discussed; potential cost implications are considered; and the guideline
presents key review criteria for monitoring and/or audit purposes.

6. Editorial independence

Externally funded guidelines should state explicitly that views andinterests of the funding body have not influenced final
recommendations; all group members should explicitly state potential
conflicts of interest, which are recorded in the guideline.

88