JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 64, NO.

13, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 0735-1097/$36.00
AND THE AMERICAN HEART ASSOCIATION, INC. http://dx.doi.org/10.1016/j.jacc.2014.06.001
PUBLISHED BY ELSEVIER INC.

TASK FORCE STATEMENT

The Evolution and Future of

ACC/AHA Clinical Practice Guidelines:
A 30-Year Journey
A Report of the American College of Cardiology/American Heart Association Task Force on
Practice Guidelines

Alice K. Jacobs, MD, FACC, FAHA, Immediate Past Chair Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect
Jeffrey L. Anderson, MD, FACC, FAHA, Chair

ACC/AHA Task Jeffrey L. Anderson, MD, FACC, FAHA, Chair Judith S. Hochman, MD, FACC, FAHA*
Force Members Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect Richard J. Kovacs, MD, FACC, FAHA
E. Magnus Ohman, MD, FACC
Nancy M. Albert, PhD, CCNS, CCRN, FAHA Susan J. Pressler, PhD, RN, FAHA
Biykem Bozkurt, MD, PhD, FACC, FAHA Frank W. Sellke, MD, FACC, FAHA
Ralph G. Brindis, MD, MPH, MACC Win-Kuang Shen, MD, FACC, FAHA
Lesley H. Curtis, PhD, FAHA Duminda N. Wijeysundera, MD, PhD
David DeMets, PhD*
Lee A. Fleisher, MD, FACC, FAHA
*Former Task Force member during the writing effort.
Samuel Gidding, MD, FAHA

In 2014, we mark the 30th anniversary of the first publication of The “why” and “how” of CPGs continue to evolve. Although
an American College of Cardiology (ACC) and American Heart the “why” is based on the directive to develop evidence-based
Association (AHA) clinical practice guideline (CPG). This joint recommendations for selection of diagnostic tests, proce-
effort was undertaken in response to the U.S. government’s dures, and treatments to improve quality of care and out-
request to review the evidence concerning cardiac pacemakers comes for patients with cardiovascular disease, it is precisely
and develop CPGs to mitigate potential overuse. Since then, where evidence is lacking or is controversial that clinicians
fueled by a shared sense of responsibility to translate available need the most guidance. A 2012 survey of ACC and AHA
evidence into clinical practice to guide cardiovascular clini- members provides important insight into the way clinicians
cians, the ACC and AHA have developed 23 CPGs across the and other healthcare professionals apply CPGs; further details
spectrum of cardiovascular diseases and procedures. are provided below. The results highlight a natural tension

This document was approved by the American College of Cardiology Board of Trustees and the American Heart Association Science Advisory and
Coordinating Committee in May 2014.
The American College of Cardiology requests that this document be cited as follows: Jacobs AK, Anderson JL, Halperin JL. The evolution and future of
ACC/AHA clinical practice guidelines: a 30-year journey: a report of the American College of Cardiology/American Heart Association Task Force on
Practice Guidelines. J Am Coll Cardiol 2014;64:1373–84.
This article is copublished in Circulation.
Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org) and the American
Heart Association (my.americanheart.org). For copies of this document, please contact the Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail
reprints@elsevier.com.
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express
permission of the American College of Cardiology. Requests may be completed online via the Elsevier site (http://www.elsevier.com/ authors/obtaining-
permission-to-re-use-elsevier-material).
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Evolution and Future of ACC/AHA CPGs SEPTEMBER 30, 2014:1373–84

between the needs of clinicians for comprehensive clin- RATIONALE FOR CPGS
ical advice from seasoned experts and for a clear delin-
eation of diagnostic and therapeutic measures for which In the IOM report (1), CPGs were redefined as follows:
strong scientific evidence exists.
Clinical practice guidelines are statements that
Notably, there has been an increased focus on the
include recommendations intended to optimize
“how” of CPGs and changes in the methodology used to
patient care that are informed by a systematic review
collect and evaluate the evidence. In 2011, the Institute
of the evidence and an assessment of the benefits and
of Medicine (IOM) published 2 reports, Clinical Practice
harms of alternative care options.
Guidelines We Can Trust (1) and Finding What Works in
Health Care: Standards for Systematic Reviews (2). In CPGs that are rigorously developed have the potential
response to these reports and our own mandate to con- to improve the quality of cardiovascular care, lead to
tinually improve processes and methods while evaluat- better patient outcomes, improve cost-effectiveness by
ing the continuous stream of new knowledge and targeting resources to the most effective therapies,
maintaining relevance at the point of care, the ACC/AHA enhance the appropriateness of clinical practice, and
Task Force on Practice Guidelines (Task Force) held a identify critical gaps in evidence and areas needing
Methodology Summit in December 2011. The Method- additional research. In fact, when patients are treated
ology Summit focused on the standards for systematic according to ACC/AHA Class I recommendations, outcomes
reviews and process improvements. The response to the are improved. Specifically, data from the quality of care
21 standards and 82 supporting elements proposed by the CRUSADE (Can Rapid Risk Stratification of Unstable Angina
IOM was published in the “ACCF/AHA Clinical Practice Patients Suppress Adverse Outcomes With Early Imple-
Guideline Methodology Summit Report” (3). However, mentation of the ACC/AHA Guidelines) Registry demon-
many of the IOM recommendations and standards are strate that in patients with acute coronary syndromes,
themselves based more on consensus than data, and there is a 10% reduction in in-hospital mortality for every
there is little evidence on the extent to which their 10% increase in adherence to ACC/AHA Class I guideline-
implementation may have a favorable impact on clinical directed medical therapies (5). Similarly, data from
outcomes. Hence, the effectiveness of the IOM report ADHERE (Acute Decompensated Heart Failure National
recommendations must be assessed over time as organ- Registry) demonstrate that patients treated according to
izations similar to the ACC and AHA begin the complex heart failure performance indicators have a significant
process of applying the proposed standards in CPG reduction in in-hospital mortality and length of stay (6).
development.
During the past few years, several process improve- DEVELOPMENT PROCESS
ment initiatives have been implemented to limit the
narrative text in CPGs by substituting increased use of The Task Force, which is composed of a broad con-
summary and evidence tables (with references linked to stituency with varying content expertise, oversees and
abstracts in PubMed). Consensus conferences at which directs the CPG development process and methodology
members of guideline writing committees (GWCs) reach that are the foundation of the documents and the
agreement and concordance on overlapping recom- underpinning of their broad recognition. The process
mendations are now held routinely. Methodological begins with selection of a topic for a new, revised, or
enhancements include development and future vali- updated CPG by the Task Force with the input of GWCs
dation of a scoring tool to consistently assess the quality and ACC and AHA council and committee members. In
of randomized trials that inform recommendations in the view of the overarching goal of inclusivity and collabo-
domains of bias, relevance, and fidelity. In addition, an ration, selected organizations and professional societies
analysis of Bayesian approaches to evidence synthesis with similar interests and expertise are invited to partic-
was undertaken (4). Other enhancements include sepa- ipate as partners or collaborators. Next, a GWC chair is
ration of the Class III recommendations to delineate selected by the Task Force, and, with input from the
whether the recommendation is determined to be of “no leadership of participating organizations, potential
benefit” or associated with “harm” to the patient, as members of the GWC are identified, based on a detailed
well as inclusion of comparative-effectiveness recom- and specific policy on relationships with industry and
mendations based on comparative-effectiveness studies other entities (RWI) and a desire to balance intellectual
to indicate when one treatment/strategy is preferred to and practice perspectives in addition to sex, race, geo-
another. Lastly, to harmonize with other CPG classi- graphic location, and ethnicity. In view of the AHA’s focus
fication schema, we now more precisely indicate the on the patient and the public it serves and its lay mem-
strength of the recommendation associated with the Class bership, the ACC’s initiative on patient-centered care, and
of Recommendation (COR). the recommendations of the Methodology Summit, the
JACC VOL. 64, NO. 13, 2014 Jacobs et al. 1375
SEPTEMBER 30, 2014:1373–84 Evolution and Future of ACC/AHA CPGs

Task Force now invites lay representatives (i.e., patients, successfully piloted a focused ERC approach to a confined
patient advocates, or consumer organization representa- topic using a PICOTS (Population, Intervention, Com-
tives) to participate as members of GWCs and may include parator, Outcomes, Timing, and Setting) format to
them on the Task Force. Methods to identify, select, train, develop critical questions for the systematic review. The
and manage RWI and the intellectual perspectives of lay PICOTS format specifically identifies the target pop-
representatives are in development. Lay representatives ulation (P) for whom the intervention is intended; defines
may participate in topic selection; delineation of diag- the intervention (I) and whether the comparator (C) is
nostic and therapeutic options, values, preferences, and placebo, no intervention, or some alternative strategy;
patient-oriented outcomes; and shared decision making. designates the outcome (O) as a clinical event (e.g.,
The GWC outlines the document content, performs mortality, nonfatal myocardial infarction) or a patient-
a detailed and specific evidence acquisition and review, oriented endpoint (e.g., symptoms, functional capacity,
and drafts recommendations based on the strength and quality of life, diagnosis, or prognosis); and specifies
quality of evidence with limited preliminary text. On the the timing (T) of measurement for the intended outcome
basis of the Methodology Summit recommendations, the and the setting (S) in which the outcome is measured.
process has started to involve an Evidence Review Com- Developing appropriate questions is a collaborative
mittee (ERC) that is separate from the GWC. The ERC process, with input from the GWC chair and members,
includes methodologists, epidemiologists, clinicians, and the Task Force, partner organizations involved with the
biostatisticians tasked with formal systematic review of CPG, and the ERC. The questions may also be reviewed
available evidence and responsibility for identification, more broadly by organizational leadership and the
abstraction, and quality assessment of the evidence. public. It is then the responsibility of the GWC to develop
Given practical considerations, including limited resour- recommendations using the evidence reviewed by the
ces and time constraints, the role of ERCs will be limited ERC.
to addressing critical questions where the evidence lends Once recommendations and limited text are drafted,
itself to a systematic review and that are most clinically the vetting process begins. In the absence of new evi-
relevant to the CPG topic. The role of the ERC in selected dence, prior recommendations in ACC/AHA CPGs do not
CPGs may be fulfilled by a partnership with other highly change. Because recommendations often overlap across
regarded organizations that perform systematic reviews, multiple documents (Figure 1), reconciliation can be
such as the National Institutes of Health, the Cochrane complex and time consuming. The first consensus con-
Collaborative, and Kaiser Permanente. When appropriate, ference was held in 2009 and attended by members of
other stakeholders may be invited. In 2013, the Task Force the GWCs of the percutaneous coronary intervention,

2012 2011
ACC/AHA ACC/AHA
UA/NSTEMI CABG
Guideline Guideline

2013 ACC/AHA
PCI 2012
ACC/AHA SIHD
STEMI Guideline
Guideline

2011
AHA/ACC Secondary
Prevention Guideline

F I G U R E 1 Concordance Among Existing Guideline Recommendations and Those From the 2011 ACC/AHA/SCAI PCI Guideline

ACC indicates American College of Cardiology; AHA, American Heart Association; CABG, coronary artery bypass graft; PCI, percutaneous coronary inter-
vention; SCAI, Society for Cardiovascular Angiography and Interventions; SIHD, stable ischemic heart disease; STEMI, ST-elevation myocardial infarction; and
UA/NSTEMI, unstable angina/non–ST-elevation myocardial infarction.
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Evolution and Future of ACC/AHA CPGs SEPTEMBER 30, 2014:1373–84

coronary artery bypass surgery, and ST-elevation myo- when appropriate (e.g., the Agency for Healthcare
cardial infarction CPGs all of which were under revision. Research and Quality and the U.S. Food and Drug
With input from the stable ischemic heart disease GWC, Administration).
the attendees crafted a combined section on coronary Each peer reviewer’s comment is reviewed by the chair
revascularization for inclusion in all 3 CPGs. The con- and members of the GWC, and a response is generated; it
sensus conference approach broadens input on related is not unusual to receive >1,000 comments from peer
recommendations, facilitates consensus, enhances reviewers. A lead reviewer from the Task Force ensures
implementation at the point of care, expedites the CPG appropriate reconciliation of all peer reviewer comments.
development process, and promises to be useful in similar Changes in recommendations require approval by a for-
future applications. mal vote of the members of the GWC according to the
Although usually approved by consensus, every rec- voting policy. The document then requires ratification by
ommendation is ratified by a majority of votes by the the ACC Board of Trustees, the AHA Science Advisory and
members of the GWC; those members with relevant RWI Coordinating Committee, and partnering or collaborating
are required to recuse themselves from voting on sections organizations. After thorough vetting within the aca-
to which their specific RWI applies. The finished docu- demic and clinical communities and the leadership of the
ment then undergoes peer review by ACC and AHA official ACC and AHA, the CPG is jointly published in the Journal
reviewers, content experts (many of whom serve on ACC of the American College of Cardiology, Circulation, and the
and AHA councils and committees), participating organ- flagship journals of partnering and collaborating organ-
izations, and the Task Force (Figure 2). The peer review izations as appropriate. Once published, CPG recom-
process has been expanded to encompass a broad spec- mendations become the official policy of both the ACC
trum of relevant stakeholders, including lay representa- and AHA, informing strategic initiatives, advocacy, edu-
tives and constituencies and governmental agencies cation programs, and services. To accelerate access to

GWC
Member Consensus

Partner/
Official ACC Official AHA Content ACC/AHA
Collaborator
Reviewers Reviewers Reviewers Task Force
Reviewers

GWC Revision/Response

Task Force Lead Reviewer

Additional Approval of
Reviewers Task Force Chair
Task Force

ACC Board of AHA Science Advisory and Other

Trustees Coordinating Committee Organizations

Webpost
“Accepted Manuscript”
Publication

Journal Publication

F I G U R E 2 ACC/AHA CPG Peer Review Process

ACC indicates American College of Cardiology; AHA, American Heart Association; CPG, clinical practice guideline; and GWC, guideline writing committee.
JACC VOL. 64, NO. 13, 2014 Jacobs et al. 1377
SEPTEMBER 30, 2014:1373–84 Evolution and Future of ACC/AHA CPGs

CPGs that have received final approval, the ACC and AHA purpose of identifying a chair and/or member of a GWC,
release the manuscripts before typesetting, allowing the the following criteria are used to determine if a relevant
documents to be available nearly 2 months ahead of for- relationship with a company or other entity exists:
mal publication in the journals.
 The relationship or interest relates to the same or sim-
ilar subject matter, intellectual property or asset, topic,
RELATIONSHIPS WITH INDUSTRY
or issue addressed in the document; or
AND OTHER ENTITIES
 The company/entity (with whom the relationship
exists) makes a drug, drug class, or device addressed in
The validity and reliability of CPGs have been questioned,
the document or makes a competing drug or device
based on concerns that the CPGs are composed by indi-
addressed in the document; or
viduals with perceived conflicts of interest (COI), primarily
 The person or a member of the person’s family or
due to RWI engaged in the development or marketing of
household has a reasonable potential for financial,
medical technology or pharmaceutical agents. The per-
professional, or other personal gain or loss as a result of
ception that all RWI imply COI is not inherently accurate
the issues/content addressed in the document.
(7,8). There is no evidence to confirm or deny that RWI
lead to a bias in writing recommendations, and the quan- In terms of scope, the ACC and AHA require disclosure
titative impact of RWI is unknown. Bias may also exist of all RWI (comprehensive for the previous 12 months)
without RWI, and individuals with RWI often have the involved in the production, marketing, distribution, or
greatest expertise in the subject. reselling of healthcare goods, services, advice, or infor-
Even so, strict policies are in place to prevent undue mation consumed by patients, investors, or physicians.
influence of commercial or other special interests on the This may include relationships with government entities
CPG development process (9). In late 2009, well in as well as not-for-profit institutions and organizations,
advance of the IOM report, policies were updated to which differs from and is more comprehensive than the
require more rigorous management of RWI. The ACC and IOM standards. In addition, authors are strongly dis-
AHA believe that, when transparent and properly man- couraged from engaging in new RWI until the document
aged, including experts with RWI on GWCs strengthens has been approved by the organizations and published.
the writing effort and results in improved documents by The amount or level of RWI is defined as:
ensuring the availability of necessary expertise. The 2011
Methodology Summit participants supported this view,  None—If the individual has no conflicts or relationships
noting that the “absence of experts (perhaps with rele- to disclose, he or she must indicate none.
vant RWI) on the GWC would undermine the credibility of  Modest (<$10,000)—A relationship is considered mod-
the review and CPG as much or more than the presence of est if it is less than significant. (In the fall of 2014, this
committee members with RWI” (3). Moreover, the term will change to <$5,000 to align with U.S. Public Health
“RWI” is preferred over “COI” because the former does Service regulations.)
not imply ethically conflicting interests or objectives.  Significant ($$10,000)—A person is deemed to have a
In addition to managing RWI, the ACC and AHA mon- significant interest in a business if it represents own-
itor and manage other potential biases that may be rele- ership of $5% of the voting stock or share of the
vant to the writing effort, including academic settings, entity, ownership of $$10,000 of the fair market value
race, sex, geography, intellectual stance, or scope of of the entity, or if funds received from the entity
clinical practice. On the basis of the Methodology Summit exceeded 5% of the individual’s gross income during
recommendations, the intellectual (referring to prior the prior year. (In the fall of 2014, this will change
published opinion or research) and practice (applying to $$5,000 to align with U.S. Public Health Service
when an individual’s income is enhanced by or derived regulations.)
from reimbursement for performing specific tests or pro-
Disclosure of relationships of members of the GWC is
cedures) perspectives relevant to the guideline topic are
performed as follows:
recognized, defined, disclosed, and managed. As with the
choice of the term “RWI” rather than “COI,” the ACC and  In advance—RWI are reviewed and vetted during ini-
AHA have chosen the terms “intellectual perspective” and tiation of the GWC to ensure fair balance on the GWC.
“clinical practice perspective” (rather than bias) to denote  On an ongoing basis—verbally and in writing at the start
intellectual and practice-related opinions and expertise of every meeting and conference call.
based on knowledge or experience.  Published—in print and online using a tabular format to
To address these issues, the ACC and AHA rely on the highlight type and level of relationship; publication
principles of define, disclose, and manage. The relevance, of all relevant relationships for authors and peer re-
scope, and level of RWI are clearly defined. For the viewers with each guideline, including documentation
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Evolution and Future of ACC/AHA CPGs SEPTEMBER 30, 2014:1373–84

of sections from which authors recused themselves positive or negative benefit–risk estimate of the effect and
from writing or voting; and online posting of compre- generalizability of benefit over risk. Class IIa recom-
hensive RWI for each author and oversight Task Force mendations carry intermediate strength and correspond
member. to less benefit in proportion to risk. Class IIb recom-
mendations, the weakest, address measures associated
Reporting categories include consultancies, speakers
with marginal benefit–risk ratios or uncertain outcome
bureaus, ownership, partnerships, principal roles, research
advantages and suggest that additional evidence is nee-
support, salary, institutional and organizational relation-
ded to clarify the relative benefit–risk of the intervention.
ships, and expert witness activities.
Class III recommendations are unique in that they have
Management of RWI involves selection of a balanced
2 qualifiers. Class III: Harm is a strong recommendation
GWC and requires that both the chair and a majority of
usually derived from 1 or more trials in which outcomes
members have no relevant RWI. Authors are restricted
were worse with the intervention than with the control.
with respect to writing or voting on sections to which
Class III: No Benefit is a moderate recommendation that is
RWI apply. Although they are permitted to participate in
applied infrequently when evidence suggests that a
discussion and comment on the draft, the chair is
strategy is no better than the control. Class III: No Benefit
responsible for ensuring that this does not result in
recommendations should not be associated with weak
undue or unfair influence. All CPG recommendations
evidence or expert opinion—LOE C or E—because it is
require approval by a majority of the members of the
virtually impossible to ascertain lack of benefit without
GWC without relevant RWI through confidential ballot-
randomized trials or carefully conducted observational
ing. Members recused from voting are listed in the RWI
studies when safety is not the primary concern. Class III:
table. Members of the final approving bodies of the
No Benefit recommendations should be supported by
ACC Board of Trustees and AHA Science Advisory and
moderate or high-quality evidence. The adequacy of the
Coordinating Committee also recuse themselves from
supporting data, including sample size and event rates,
voting if they have relevant RWI. The RWI of GWC
needs careful consideration based upon objective criteria
members and peer reviewers pertinent to the CPG are
(i.e., validated grading tools).
located in the Appendix. In addition, to ensure complete
The LOE rates the precision and quality of the scientific
transparency, comprehensive disclosure information—
evidence supporting the effect of an intervention based
including RWI not pertinent to the document—is avail-
on the type, quantity, consistency, and quality of clinical
able online for all members of the GWC, as is disclosure
trials and other relevant evidence. The ERC or GWC
information for the entire Task Force. The creation of
grades the evidence supporting each recommendation,
CPGs and the work of the GWC are supported exclusively
depending on whether this includes randomized, obser-
by the ACC, AHA, and partnering organizations without
vational, prospective, or retrospective studies, and their
commercial support. Members of the GWC and Task
quality, including objectively defined criteria for assess-
Force volunteer for this activity without compensation.
ment of potential bias in addition to their relevance
The ACC and AHA are fully committed to transparency in
and fidelity. When published scientific evidence is lack-
the development of CPGs, have aligned RWI policies
ing, a consensus of expert opinion is sought to gauge
with respect to CPG documents, and continuously eval-
standards of care based on clinical experience and ranked
uate these policies.
as Level E.
RECOMMENDATION CLASSIFICATION SYSTEM To accommodate the more quantitative, graded
approach to evidence assessment, the Task Force has
In analyzing evidence and developing recommendations, cautiously modified the COR/LOE schema (Table 1) to
GWCs use benchmarks developed by the Task Force (9). provide additional categories that offer greater gran-
The COR is a statement of the strength of the recom- ularity with separate categories for randomized and
mendation and continues to serve as the primary guide nonrandomized/observational evidence to define the
for clinicians. The choice of the COR may involve con- level and quality of evidence. The COR/LOE schema
sideration of an estimate of the size and strength of the continues to evolve as we refine tools to assess the quality
effect of the intervention (diagnostic test or therapeutic of evidence and collaborate with other organizations such
strategy, medication, device, procedure, or other inter- as the European Society of Cardiology to enhance the
vention) and the magnitude of benefit in relation to risk. clarity, accuracy and utility of guideline recom-
The Level of Evidence (LOE) describes the certainty or mendations. Suggested phrases for writing recom-
precision of the information supporting the recom- mendations are provided in the interest of consistency.
mendation based on the type and quality of the evidence. The revised grading schema consists of the following
Class I and III recommendations are considered strong categories, with studies assessed by the GWC or (selec-
recommendations and are based on size, strength, and tively) the ERC, increasingly using standardized evidence
JACC VOL. 64, NO. 13, 2014 Jacobs et al. 1379
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Applying Class of Recommendations and Level of Evidence to Clinical Strategies, Interventions, Treatments, or
TABLE 1
Diagnostic Testing in Patient Care*
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Evolution and Future of ACC/AHA CPGs SEPTEMBER 30, 2014:1373–84

grading tools where useful to facilitate consistent evalu- has prompted criticism and questions about whether CPGs
ation of the quality of evidence: should define the standard of care (8,10). Yet, when evi-
dence is weak, conflicting, or absent, clinicians seek and
 Level A
need the most guidance. Moreover, it is recognized that
B High-quality evidence* from more than 1 randomized
certain LOE C recommendations that represent common
controlled trial (RCT)
sense and conventional wisdom are unlikely to be studied.
B Meta-analyses of high-quality RCTs
However, a review of past LOE C recommendations sug-
B One or more RCTs corroborated by high-quality reg-
gested that many were, in fact, supported by lower levels
istry studies
of evidence as well as expert opinion. Overall, these
 Level B-R (Randomized)
observations and concerns highlight the need for evi-
B Moderate-quality evidence* from 1 or more RCTs
dence-based and practice-directed CPG recommendations
B Meta-analyses of moderate-quality RCTs
and have prompted the revisions in evidence analysis and
 Level B-NR (Nonrandomized)
COR/LOE grading schema shown in Table 1.
B Moderate-quality evidence* from 1 or more well-
designed, well-executed nonrandomized studies, 2012 GUIDELINE SURVEY:
observational studies, or registry studies SUMMARY OF RESULTS AND IMPLICATIONS
B Meta-analyses of such studies
 Level C To better understand the views and requirements of
B Randomized or nonrandomized observational or reg- the ACC/AHA CPG user, a survey was taken from Sep-
istry studies with limitations of design or execution tember to October 2012. The survey was conducted via 2
B Meta-analyses of such studies online sources: 1) the ACC CardioSurve Panel, which is
B Physiological or mechanistic studies in human subjects composed of U.S. cardiologists who are currently active
 Level E Fellows of the ACC, and 2) an open, online survey emailed
B Consensus of expert opinion based on clinical experi- to representative members of the ACC Board of Trustees,
ence when evidence is insufficient, vague, or AHA, Heart Rhythm Society, and Society for Car-
conflicting diovascular Angiography and Interventions. The Car-
dioSurve survey received a total of 166 responses from 450
In view of the increasing number of studies involving active
CardioSurve panelists for a response rate of 37%. A total of
controls rather than placebos, recommendations addressing
40 of 301 members of the organizations above completed
the relative effectiveness of one clinical strategy compared
the survey for an overall response rate of 13%. Thus, the
with another continue to be included with specific phrase-
final number of responses for this survey was 206.
ology. These apply to COR I and IIa recommendations only
The findings of the survey are summarized as follows:
and to LOE A or B-R/B-NR.
To address the concern about coupling the strong COR  When members were asked to rate the relevance of
categories I and III with lower LOEs or expert opinion, weaker COR and LOE (Class IIa and IIb and LOE C) to
specific new guidance from the Task Force is being given their practice, more than two thirds of cardiologists
to GWCs as follows: Class I recommendations based only indicated that the weaker class/levels were helpful or
on LOE C/E should be minimized, and Class III: No Benefit very helpful when making informed diagnostic and
recommendations should be avoided whenever possible if therapeutic decisions. This is an important observa-
supported only by LOE C/E. tion, because it indicates that clinicians seek guidance
An analysis of the 3,271 recommendations across 19 on important topics even in situations where the evi-
CPGs published by 2013 showed that nearly 50% were Class dence base is weak. It also suggests that focusing CPGs
I recommendations. In addition, 50% of recommendations only on strong evidence is not adequate for clinicians
were informed by LOE C and <10% were based on LOE A. to deliver comprehensive best practices. These obser-
Of the Class I recommendations, only 11% were based on vations highlight the natural tension between the value
LOE A, and 46% were informed by LOE C; even fewer were to clinicians of a comprehensive CPG and a more
assigned LOE A within COR IIa, IIb, and III. Taken together, restricted CPG limited to a few recommendations
these results indicate an important gap in evidence sug- informed by a strong scientific evidence base.
gesting a need for clinical trial evidence in the future.  More than 90% of cardiologists found the ACC/AHA
Across CPGs, the proportion of LOE C recommendations CPGs routinely useful in clinical practice. In fact, >80%
of cardiologists apply CPGs in managing patients in
most circumstances. The CPG features found most
useful are clinical applicability and authority, brevity
* The method of assessing quality is evolving, including the application of
standardized, widely used, and preferably validated evidence grading tools; and clarity, comprehensiveness, ease of access and use,
and for systematic reviews, the incorporation of an ERC. and currency.
JACC VOL. 64, NO. 13, 2014 Jacobs et al. 1381
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 For cardiovascular or multispecialty practice clinicians, the ERC. To ensure transparency and consistency, the
the most frequent use of CPGs is to address a specific ERC uses a standardized quantitative tool for assessing
clinical question at the point of care, such as in the RCT data and a separate standardized, quantitative tool
office, in the hospital, or on rounds. For cardiologists in for grading registry/observational data.
medical schools and universities, CPGs are most com-  The challenge to generate CPGs based on a more delib-
monly used as a teaching tool. erative, independent, and transparent approach to evi-
 Cardiologists are almost uniformly more interested in dence review while responding to the desire for more
an electronic means to access CPGs compared with timely, responsive, “living” guidelines will be addressed
print access alone. However, they do not have a single by compiling CPGs from individual recommendations,
preference for electronic means of accessing CPGs. each a concise knowledge “byte,” accompanied by con-
They are nearly evenly split between ACC/AHA web- cise supporting text and linked to supporting references
sites through topic listings, smartphone applications, and evidence tables (as piloted in the 2014 AHA/ACC
search engines, or electronic tablet applications. The valvular heart disease guideline [11]) and stored in an
majority of cardiologists prefer a comprehensive CPG electronic repository. The individual recommendations
separated into different sections or chapters, with all for each CPG will then be assembled together for the
sections published together as a single document. web-published and print versions. Not only will these
 More than two thirds of cardiologists prefer a be accessible through a variety of electronic search
“dynamic” update of CPGs, either continuously as a strategies, enabled by a standard taxonomy, but they
“living” electronic document or as an update that will be capable of being shared among overlapping
occurs whenever new information requires changes to documents and individually updated or expanded in a
the content/recommendations. “living” document fashion as new evidence becomes
 The majority of cardiologists are very or extremely available. Accessing and updating individual modules
satisfied with the current use of a color-coded recom- from the electronic guideline content management
mendation table format. In addition, more than two system will be much less onerous and more efficient
thirds of cardiologists prefer limited text informing the once the initial guideline has been developed. These
recommendations, with links to an evidence table that documents may include revision history and can be
provides pertinent details of each study that can be accessed from mobile devices at the point of care and
accessed as desired. can eventually be integrated into electronic medical
 Nearly three fourths of cardiologists believe that clini- record systems and other patient management tools.
cians have a responsibility to help society provide
optimal care for all patients and that CPGs should CPG UPDATES: CURRENT PROCESS
incorporate available information about cost/resource
utilization to educate providers, payers, and patients The process for initiating, revising, and updating CPGs
about the value of various strategies. continues to evolve under the direction of the Task Force.
Keeping pace with new data is an ongoing challenge in the
The IOM recommendation to have CPGs informed by the
development of CPGs. In the early 1980s, the Task Force
highest-quality (i.e., RCT) evidence and meta-analyses,
established policies and procedures for maintaining the
assessed by an independent ERC, may seem to be discordant
relevancy of published recommendations. The process
with the views and needs of these CPG users, that is, to
involved full revisions and shorter updates. Full revision
include not only strong evidence-based recommendations,
occurred after 2 updates or when new evidence required
but also those based on lesser evidence and expert opinion
revision of a significant portion of the recommendations.
and to do so in a timely, concise, and accessible way. This
Each topic was reviewed a year after publication of a CPG
dilemma presents an ongoing and major challenge to the
document and annually thereafter. There was on average
Task Force in charting the future course for CPGs.
a 4- to 5-year span between revisions of each topic.
Recognizing the necessity to review new and rapidly
EVOLUTION IN CPG METHODS AND PROCESSES
changing evidence in an ongoing fashion and the time
required to initiate, develop, review, and publish a CPG,
To provide a balanced response to the IOM, clinicians, and
the Task Force developed a new initiative in 2005 to
CPG users and the concern that recommendations are not
integrate an accelerated focused update process. The
based only on the highest LOE, the following initiatives
GWC (whose membership often spans >1 document) and
were undertaken in 2013 and 2014:
Task Force members review late-breaking clinical trials
 An ERC was established to provide an independent presented at major meetings and scan the literature
systematic review of evidence related to key PICOTS pertaining to each guideline topic twice annually.
questions generated by the GWC in collaboration with The decision to initiate a focused update of a CPG is based
1382 Jacobs et al. JACC VOL. 64, NO. 13, 2014

Evolution and Future of ACC/AHA CPGs SEPTEMBER 30, 2014:1373–84

on specific criteria, including the publication of ade- Task Force on Performance Measures. Performance
quately powered RCTs or nonrandomized studies with measures focus on critical recommendations carrying
safety or efficacy implications (see criteria below). They large benefit based on high-quality evidence to provide
do not require comprehensive accounting for all literature quantitative metrics for assessing the quality of patient
published since the date of the previous CPG evidence care for specific cardiovascular conditions. Failure to
review; the evidence review period is noted in the intro- deliver this care to an eligible patient suggests a quality
duction of each CPG. lapse. Increasingly, performance measures are used as the
The criteria and considerations for new data include basis for public reporting and pay-for-performance pro-
the following: grams. Recommendations selected for performance
measures must be measureable, valid, reliable, and
 Publication of the full report (rather than the abstract)
actionable; address demonstrable gaps in care; and lead to
in a peer-reviewed journal
improved patient outcomes (14,15). Currently, the num-
 Adequately powered RCT(s)
ber of measures, feasibility of data collection, exceptions,
 Important nonrandomized data that affect safety and
and correct attribution are under active consideration by
efficacy assumptions
the ACC/AHA Task Force on Performance Measures.
 Strengths/weaknesses of research methodology and
The ACC appropriate use criteria documents, another
findings
derivative of CPGs, supplement the recommendations by
 The likelihood that additional studies will influence the
providing representative clinical scenarios that allow
findings or conclusions
clinicians to document practice patterns for comparison
 The impact on current performance measure(s) or the
against established benchmarks. In addition, they address
need to develop new measures
scenarios for which evidence is lacking. The appropriate
 Requests for review and update from the practice
use criteria methodology is based on the RAND (Research
community, key stakeholders, and other sources free of
And Development) Delphi model, which provides con-
bias or commercial relationships
sensus judgments about the utility of interventions in
 The number of previous studies with consistent results
specific clinical situations. Clinical scenarios are con-
 Consistency with other CPGs or CPG revisions
structed by a committee using CPG recommendations and
 Approval of new drugs, devices, or applications by the
are then evaluated by a separate technical panel to trans-
U.S. Food and Drug Administration that have an impact
late and implement CPG recommendations in clinical
on cardiovascular care
practice. When CPGs and appropriate use criteria docu-
Initiation of a focused update does not imply that a ments were directly mapped against each other for coro-
recommendation must change but rather that new evi- nary revascularization indications in validation testing,
dence is critically reviewed by the GWC to reach a deci- all Class I recommendations were appropriate and all
sion. With the exception of the recommendations Class III recommendations mapped to inappropriate (16).
modified in focused updates, the full CPG remains current. Whereas CPG recommendations are “should” or
Recommendations in focused updates are current until “should not” directives, performance measures represent
superseded by another update or a full revision of the “must do” and appropriate use criteria “reasonable to do”
CPG. Since the publication of the first 2 focused updates in clinical steps. Taken together, these documents define
2007 (12,13), they have been created as stand-alone best practices based on evidence, measure how con-
documents with section numbers corresponding to the sistently these practices are implemented in patient care,
CPG and new and revised recommendations denoted in and facilitate benchmarking of practice patterns relative
adjacent tabular columns. The focused updates are also to peers to promote quality improvement in the interest
incorporated into the full CPG, which is republished online of safe and effective patient care.
in order to provide a complete, comprehensive CPG. The AHA scientific statements and the ACC clinical
expert consensus documents represent another important
CPG DERIVATIVES educational product ancillary to CPGs. These documents
provide expert opinion and evidence summaries on
The recommendations in CPGs remain the primary source important focused cardiovascular topics too narrow or
of guidance for clinicians. Access to CPGs will increasingly immature to warrant a full CPG but for which there is
be through sources other than the full, written versions of significant scientific and clinical interest.
the CPGs, including Web sites (such as those of the AHA
and ACC), pocket guides, and electronic access such as ONGOING CHALLENGES
smartphone applications. Performance measures oper-
ationalize CPG recommendations and are developed as Responding to the continually expanding evidence base
derivatives of CPGs by a separate task force, the ACC/AHA in a timely manner while maintaining rigorous processes
JACC VOL. 64, NO. 13, 2014 Jacobs et al. 1383
SEPTEMBER 30, 2014:1373–84 Evolution and Future of ACC/AHA CPGs

and methodology, that is, to lead rather than lag behind various digital platforms. Embedding CPG recom-
clinical practice, remains an ongoing challenge. The mendations and prompts within electronic medical record
addition of formal systematic reviews, expansion of the systems and mobile devices accessible at the point of care
peer review process to include patients and other stake- will require new ways of crafting and parsing information
holders, and selection of the GWC in accordance with a into “bytes” of data that support individual recom-
strict RWI policy are time-consuming endeavors. Future mendations and will require resource utilization efforts.
challenges in delineation of RWI policy include recog- Although past GWCs have excluded cost con-
nition that manufacturers of recently approved devices siderations from recommendations, it is clear that with
are typically required to provide operator training to limited healthcare resources and rising costs, it is impor-
promote safe deployment of new technology. The ACC tant and appropriate to consider cost, cost-effectiveness,
and AHA encourage training of clinicians to ensure suffi- and value. Going forward, it is recommended that the
cient expertise while requiring disclosure of industry- COR and LOE criteria summarizing the strength/level and
sponsored training by members of GWCs. Although the quality of evidence supporting clinical benefit, based on
delivery of timely CPGs is essential, it is also important to validated evidence assessment tools, be supplemented by
balance speed with deliberation and accuracy and to an assessment of value (17). Furthermore, although CPGs
allow new treatments to adequately dwell in the clinical are more broadly disease based (rather than procedure
arena to assess generalizability and long-term outcomes based), the documents are sometimes crafted in silos;
in clinical practice. recognition and incorporation of multiple comorbidities
Most apparent, particularly to members of the GWC, will become increasingly important as the patient pop-
are the gaps in evidence. A lack of quality studies in many ulation ages and people live longer with more advanced
areas contributes to the relatively high proportion of LOE cardiovascular disease. The future also may see innova-
C/E recommendations, particularly in the many specific tions in clinical trial designs and an important interaction
conditions and circumstances where clinicians need between CPGs and data registries, which may expand
guidance. Like the research on which most recom- patient/subject subgroups of interest poorly represented
mendations are based, clinical science is an iterative in clinical trials and create a “learning health system”
process in continual evolution. Initiatives such as the where a continuous cycle of evidence-based practice
AHA’s Get With the Guidelines and Mission: Lifeline and leads to feedback of practice-based evidence to validate
the ACC’s Door to Balloon Alliance and Hospital2Home and further refine clinical evidence (18).
have led to improvements in quality of care. However, the To maintain consistency and facilitate implementation
relative paucity of funding for implementation science of CPG recommendations, it is important to harmonize
and other barriers challenge the uptake of CPG recom- our CPGs with those issued by other organizations
mendations in the clinical community. within the United States and abroad. Notwithstanding
Furthermore, despite the privilege and reward of differences in resources, economy, RWI policies, and
serving on ERCs or GWCs, the requisite time commitment availability of guideline-directed medical therapies, har-
may preclude participation in future endeavors as the monization across CPGs has the potential to minimize
demands of clinical practice and academic responsibilities confusion in the caregiver community and enhance
continue to increase. adherence to recommendations.
Perhaps most important is to preserve the steadfast
FUTURE DIRECTIONS commitment to the development and dissemination of
CPGs based on a thorough, unbiased evaluation of avail-
Looking to the future, it is clear that the ACC/AHA able evidence combined with a focus on patient-centric
CPG methodology will evolve in response to a changing care and shared decision making. What will remain
healthcare environment and the availability of new unchanged is the overall goal of providing guidance to
formats with which to deliver recommendations. Creation clinicians to improve quality of care and outcomes for
of ongoing “living” documents is under development on patients with cardiovascular disease.

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11. Nishimura RA, Otto CM, Bonow RO, et al. 2014 14. Spertus JA, Eagle KA, Krumholz HM, et al. KEY WORDS ACC/AHA Clinical Practice
AHA/ACC guideline for the management of patients American College of Cardiology and American Heart Guidelines, evidence-based medicine, health
with valvular heart disease: a report of the American Association methodology for the selection and creation care, methodology

AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT)*—

THE EVOLUTION AND FUTURE OF ACC/AHA CLINICAL PRACTICE GUIDELINES: A 30-YEAR JOURNEY

Institutional,
Organizational,
Ownership/ or
Committee Speaker’s Partnership/ Personal Other Financial Expert
Member Employment Consultant Bureau Principal Research Benefit Witness

Jeffrey L. Anderson Intermountain Heart Institute, None None None None None None
Intermountain Healthcare—Associate
Chief of Cardiology

Jonathan L. Halperin The Cardiovascular Institute, Mount Sinai None None None None None None
Medical Center, Division of Cardiology—
Professor of Medicine

Alice K. Jacobs Boston University School of Medicine— None None None None None None
Professor of Medicine; Boston Medical
Center, Department of Medicine—Vice
Chair for Clinical Affairs

This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were
reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily
reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the voting
stock or share of the business entity, or ownership of $$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of
the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are
modest unless otherwise noted. Please refer to http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.
aspx for definitions of disclosure categories or additional information about the ACC Disclosure Policy for Writing Committees. According to the ACC/AHA, a person has a relevant
relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The 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 c) 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 transparency, the authors’ comprehensive disclosure information is available as an online supplement (http://jaccjacc.cardiosource.com/acc_documents/Guidelines_Perspective_
Article_Author_Comprehensive_RWI.pdf).
ACC indicates American College of Cardiology and AHA, American Heart Association.