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The Evolution and Future of ACC/AHA Clinical Practice Guidelines: A 30-Year Journey

2014; Lippincott Williams & Wilkins; Volume: 130; Issue: 14 Linguagem: Inglês

10.1161/cir.0000000000000090

1524-4539

Alice K. Jacobs, Jeffrey L. Anderson, Jonathan L. Halperin,

Health Systems, Economic Evaluations, Quality of Life

HomeCirculationVol. 130, No. 14The Evolution and Future of ACC/AHA Clinical Practice Guidelines: A 30-Year Journey Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBThe Evolution and Future of ACC/AHA Clinical Practice Guidelines: A 30-Year JourneyA Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Alice K. Jacobs, MD, FACC, FAHA, Jeffrey L. Anderson, MD, FACC, FAHA and Jonathan L. Halperin, MD, FACC, FAHA Alice K. JacobsAlice K. Jacobs , Jeffrey L. AndersonJeffrey L. Anderson and Jonathan L. HalperinJonathan L. Halperin Originally published4 Aug 2014https://doi.org/10.1161/CIR.0000000000000090Circulation. 2014;130:1208–1217Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2014: Previous Version 1 IntroductionIn 2014, we mark the 30th anniversary of the first publication of an American College of Cardiology (ACC) and American Heart Association (AHA) clinical practice guideline (CPG). This joint effort was undertaken in response to the US government's request to review the evidence concerning cardiac pacemakers and develop CPGs to mitigate potential overuse. Since then, fueled by a shared sense of responsibility to translate available evidence into clinical practice to guide cardiovascular clinicians, the ACC and AHA have developed 23 CPGs across the spectrum of cardiovascular diseases and procedures.The "why" and "how" of CPGs continue to evolve. Although the "why" is based on the directive to develop evidence-based recommendations for selection of diagnostic tests, procedures, and treatments to improve quality of care and outcomes for patients with cardiovascular disease, it is precisely where evidence is lacking or is controversial that clinicians need the most guidance. A 2012 survey of ACC and AHA members provides important insight into the way clinicians and other healthcare professionals apply CPGs; further details are provided below. The results highlight a natural tension between the needs of clinicians for comprehensive clinical advice from seasoned experts and for a clear delineation of diagnostic and therapeutic measures for which strong scientific evidence exists.Notably, there has been an increased focus on the "how" of CPGs and changes in the methodology used to collect and evaluate the evidence. In 2011, the Institute of Medicine (IOM) published 2 reports, Clinical Practice Guidelines We Can Trust1 and Finding What Works in Health Care: Standards for Systematic Reviews.2 In response to these reports and our own mandate to continually improve processes and methods while evaluating the continuous stream of new knowledge and maintaining relevance at the point of care, the ACC/AHA Task Force on Practice Guidelines (Task Force) held a Methodology Summit in December 2011. The Methodology Summit focused on the standards for systematic reviews and process improvements. The response to the 21 standards and 82 supporting elements proposed by the IOM was published in the "ACCF/AHA Clinical Practice Guideline Methodology Summit Report."3 However, many of the IOM recommendations and standards are themselves based more on consensus than data, and there is little evidence on the extent to which their implementation may have a favorable impact on clinical outcomes. Hence, the effectiveness of the IOM report recommendations must be assessed over time as organizations similar to the ACC and AHA begin the complex process of applying the proposed standards in CPG development.During the past few years, several process improvement initiatives have been implemented to limit the narrative text in CPGs by substituting increased use of summary and evidence tables (with references linked to abstracts in PubMed). Consensus conferences at which members of guideline writing committees (GWCs) reach agreement and concordance on overlapping recommendations are now held routinely. Methodological enhancements include development and future validation of a scoring tool to consistently assess the quality of randomized trials that inform recommendations in the domains of bias, relevance, and fidelity. In addition, an analysis of Bayesian approaches to evidence synthesis was undertaken.4 Other enhancements include separation of the Class III recommendations to delineate whether the recommendation is determined to be of "no benefit" or associated with "harm" to the patient, as well as inclusion of comparative-effectiveness recommendations based on comparative-effectiveness studies to indicate when one treatment/strategy is preferred to another. Lastly, to harmonize with other CPG classification schema, we now more precisely indicate the strength of the recommendation associated with the Class of Recommendation (COR).Rationale for CPGsIn the IOM report,1 CPGs were redefined as follows:Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative care options.CPGs that are rigorously developed have the potential to improve the quality of cardiovascular care, lead to better patient outcomes, improve cost-effectiveness by targeting resources to the most effective therapies, enhance the appropriateness of clinical practice, and identify critical gaps in evidence and areas needing additional research. In fact, when patients are treated according to ACC/AHA Class I recommendations, outcomes are improved. Specifically, data from the quality of care CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) Registry demonstrate that in patients with acute coronary syndromes, there is a 10% reduction in in-hospital mortality for every 10% increase in adherence to ACC/AHA Class I guideline-directed medical therapies.5 Similarly, data from ADHERE (Acute Decompensated Heart Failure National Registry) demonstrate that patients treated according to heart failure performance indicators have a significant reduction in in-hospital mortality and length of stay.6Development ProcessThe Task Force, which is composed of a broad constituency with varying content expertise, oversees and directs the CPG development process and methodology that are the foundation of the documents and the underpinning of their broad recognition. The process begins with selection of a topic for a new, revised, or updated CPG by the Task Force with the input of GWCs and ACC and AHA council and committee members. In view of the overarching goal of inclusivity and collaboration, selected organizations and professional societies with similar interests and expertise are invited to participate as partners or collaborators. Next, a GWC chair is selected by the Task Force, and, with input from the leadership of participating organizations, potential members of the GWC are identified, based on a detailed and specific policy on relationships with industry and other entities (RWI) and a desire to balance intellectual and practice perspectives in addition to sex, race, geographic location, and ethnicity. In view of the AHA's focus on the patient and the public it serves and its lay membership, the ACC's initiative on patient-centered care, and the recommendations of the Methodology Summit, the Task Force now invites lay representatives (ie, patients, patient advocates, or consumer organization representatives) to participate as members of GWCs and may include them on the Task Force. Methods to identify, select, train, and manage RWI and the intellectual perspectives of lay representatives are in development. Lay representatives may participate in topic selection; delineation of diagnostic and therapeutic options, values, preferences, and patient-oriented outcomes; and shared decision making.The GWC outlines the document content, performs a detailed and specific evidence acquisition and review, and drafts recommendations based on the strength and quality of evidence with limited preliminary text. On the basis of the Methodology Summit recommendations, the process has started to involve an Evidence Review Committee (ERC) that is separate from the GWC. The ERC includes methodologists, epidemiologists, clinicians, and biostatisticians tasked with formal systematic review of available evidence and responsibility for identification, abstraction, and quality assessment of the evidence. Given practical considerations, including limited resources and time constraints, the role of ERCs will be limited to addressing critical questions where the evidence lends itself to a systematic review and that are most clinically relevant to the CPG topic. The role of the ERC in selected CPGs may be fulfilled by a partnership with other highly regarded organizations that perform systematic reviews, such as the National Institutes of Health, the Cochrane Collaborative, and Kaiser Permanente. When appropriate, other stakeholders may be invited. In 2013, the Task Force successfully piloted a focused ERC approach to a confined topic using a PICOTS (Population, Intervention, Comparator, Outcomes, Timing, and Setting) format to develop critical questions for the systematic review. The PICOTS format specifically identifies the target population (P) for whom the intervention is intended; defines the intervention (I) and whether the comparator (C) is placebo, no intervention, or some alternative strategy; designates the outcome (O) as a clinical event (eg, mortality, nonfatal myocardial infarction) or a patient-oriented endpoint (eg, symptoms, functional capacity, quality of life, diagnosis, or prognosis); and specifies the timing (T) of measurement for the intended outcome and the setting (S) in which the outcome is measured. Developing appropriate questions is a collaborative process, with input from the GWC chair and members, the Task Force, partner organizations involved with the CPG, and the ERC. The questions may also be reviewed more broadly by organizational leadership and the public. It is then the responsibility of the GWC to develop recommendations using the evidence reviewed by the ERC.Once recommendations and limited text are drafted, the vetting process begins. In the absence of new evidence, prior recommendations in ACC/AHA CPGs do not change. Because recommendations often overlap across multiple documents (Figure 1), reconciliation can be complex and time consuming. The first consensus conference was held in 2009 and attended by members of the GWCs of the percutaneous coronary intervention, coronary artery bypass surgery, and ST-elevation myocardial infarction CPGs all of which were under revision. With input from the stable ischemic heart disease GWC, the attendees crafted a combined section on coronary revascularization for inclusion in all 3 CPGs. The consensus conference approach broadens input on related recommendations, facilitates consensus, enhances implementation at the point of care, expedites the CPG development process, and promises to be useful in similar future applications.Download figureDownload PowerPointFigure 1. Concordance among existing guideline recom mendations 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 intervention; 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.Although usually approved by consensus, every recommendation is ratified by a majority of votes by the members of the GWC; those members with relevant RWI are required to recuse themselves from voting on sections to which their specific RWI applies. The finished document then undergoes peer review by ACC and AHA official reviewers, content experts (many of whom serve on ACC and AHA councils and committees), participating organizations, and the Task Force (Figure 2). The peer review process has been expanded to encompass a broad spectrum of relevant stakeholders, including lay representatives and constituencies and governmental agencies when appropriate (eg, the Agency for Healthcare Research and Quality and the US Food and Drug Administration).Download figureDownload PowerPointFigure 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.Each peer reviewer's comment is reviewed by the chair and members of the GWC, and a response is generated; it is not unusual to receive >1000 comments from peer reviewers. A lead reviewer from the Task Force ensures appropriate reconciliation of all peer reviewer comments. Changes in recommendations require approval by a formal vote of the members of the GWC according to the voting policy. The document then requires ratification by the ACC Board of Trustees, the AHA Science Advisory and Coordinating Committee, and partnering or collaborating organizations. After thorough vetting within the academic and clinical communities and the leadership of the ACC and AHA, the CPG is jointly published in the Journal of the American College of Cardiology, Circulation, and the flagship journals of partnering and collaborating organizations as appropriate. Once published, CPG recommendations become the official policy of both the ACC and AHA, informing strategic initiatives, advocacy, education programs, and services. To accelerate access to CPGs that have received final approval, the ACC and AHA release the manuscripts before typesetting, allowing the documents to be available nearly 2 months ahead of formal publication in the journals.Relationships With Industry and Other EntitiesThe validity and reliability of CPGs have been questioned, based on concerns that the CPGs are composed by individuals with perceived conflicts of interest (COI), primarily due to RWI engaged in the development or marketing of medical technology or pharmaceutical agents. The perception that all RWI imply COI is not inherently accurate.7,8 There is no evidence to confirm or deny that RWI lead to a bias in writing recommendations, and the quantitative impact of RWI is unknown. Bias may also exist without RWI, and individuals with RWI often have the greatest expertise in the subject.Even so, strict policies are in place to prevent undue influence of commercial or other special interests on the CPG development process.9 In late 2009, well in advance of the IOM report, policies were updated to require more rigorous management of RWI. The ACC and AHA believe that, when transparent and properly managed, including experts with RWI on GWCs strengthens the writing effort and results in improved documents by ensuring the availability of necessary expertise. The 2011 Methodology Summit participants supported this view, noting that the "absence of experts (perhaps with relevant RWI) on the GWC would undermine the credibility of the review and CPG as much or more than the presence of committee members with RWI."3 Moreover, the term "RWI" is preferred over "COI" because the former does not imply ethically conflicting interests or objectives.In addition to managing RWI, the ACC and AHA monitor and manage other potential biases that may be relevant to the writing effort, including academic settings, race, sex, geography, intellectual stance, or scope of clinical practice. On the basis of the Methodology Summit recommendations, the intellectual (referring to prior published opinion or research) and practice (applying when an individual's income is enhanced by or derived from reimbursement for performing specific tests or procedures) perspectives relevant to the guideline topic are recognized, defined, disclosed, and managed. As with the choice of the term "RWI" rather than "COI," the ACC and AHA have chosen the terms "intellectual perspective" and "clinical practice perspective" (rather than bias) to denote intellectual and practice-related opinions and expertise based on knowledge or experience.To address these issues, the ACC and AHA rely on the principles of define, disclose, and manage. The relevance, scope, and level of RWI are clearly defined. For the purpose of identifying a chair and/or member of a GWC, the following criteria are used to determine if a relevant relationship with a company or other entity exists: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; orThe person or a member of the person's family or 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.In terms of scope, the ACC and AHA require disclosure of all RWI (comprehensive for the previous 12 months) involved in the production, marketing, distribution, or reselling of healthcare goods, services, advice, or information consumed by patients, investors, or physicians. This may include relationships with government entities as well as not-for-profit institutions and organizations, which differs from and is more comprehensive than the IOM standards. In addition, authors are strongly discouraged from engaging in new RWI until the document has been approved by the organizations and published.The amount or level of RWI is defined as:None—If the individual has no conflicts or relationships to disclose, he or she must indicate none.Modest (<$10 000)—A relationship is considered modest if it is less than significant. (In the fall of 2014, this will change to <$5000 to align with US Public Health Service regulations.)Significant (≥$10 000)—A person is deemed to have a significant interest in a business if it represents ownership of ≥5% of the voting stock or share of the entity, ownership of ≥$10 000 of the fair market value of the entity, or if funds received from the entity exceeded 5% of the individual's gross income during the prior year. (In the fall of 2014, this will change to ≥$5000 to align with US Public Health Service regulations.)Disclosure of relationships of members of the GWC is performed as follows:In advance—RWI are reviewed and vetted during initiation of the GWC to ensure fair balance on the GWC.On an ongoing basis—verbally and in writing at the start of every meeting and conference call.Published—in print and online using a tabular format to highlight type and level of relationship; publication of all relevant relationships for authors and peer reviewers with each guideline, including documentation of sections from which authors recused themselves from writing or voting; and online posting of comprehensive RWI for each author and oversight Task Force member.Reporting categories include consultancies, speakers bureaus, ownership, partnerships, principal roles, research support, salary, institutional and organizational relationships, and expert witness activities.Management of RWI involves selection of a balanced GWC and requires that both the chair and a majority of members have no relevant RWI. Authors are restricted with respect to writing or voting on sections to which RWI apply. Although they are permitted to participate in discussion and comment on the draft, the chair is responsible for ensuring that this does not result in undue or unfair influence. All CPG recommendations require approval by a majority of the members of the GWC without relevant RWI through confidential balloting. Members recused from voting are listed in the RWI table. Members of the final approving bodies of the ACC Board of Trustees and AHA Science Advisory and Coordinating Committee also recuse themselves from voting if they have relevant RWI. The RWI of GWC members and peer reviewers pertinent to the CPG are located in the Appendix. In addition, to ensure complete transparency, comprehensive disclosure information—including RWI not pertinent to the document—is available online for all members of the GWC, as is disclosure information for the entire Task Force. The creation of CPGs and the work of the GWC are supported exclusively by the ACC, AHA, and partnering organizations without commercial support. Members of the GWC and Task Force volunteer for this activity without compensation. The ACC and AHA are fully committed to transparency in the development of CPGs, have aligned RWI policies with respect to CPG documents, and continuously evaluate these policies.Recommendation Classification SystemIn analyzing evidence and developing recommendations, GWCs use benchmarks developed by the Task Force.9 The COR is a statement of the strength of the recommendation and continues to serve as the primary guide for clinicians. The choice of the COR may involve consideration of an estimate of the size and strength of the effect of the intervention (diagnostic test or therapeutic strategy, medication, device, procedure, or other intervention) and the magnitude of benefit in relation to risk. The Level of Evidence (LOE) describes the certainty or precision of the information supporting the recommendation based on the type and quality of the evidence. Class I and III recommendations are considered strong recommendations and are based on size, strength, and positive or negative benefit–risk estimate of the effect and generalizability of benefit over risk. Class IIa recommendations carry intermediate strength and correspond to less benefit in proportion to risk. Class IIb recommendations, the weakest, address measures associated with marginal benefit–risk ratios or uncertain outcome advantages and suggest that additional evidence is needed to clarify the relative benefit–risk of the intervention.Class III recommendations are unique in that they have 2 qualifiers. Class III: Harm is a strong recommendation usually derived from 1 or more trials in which outcomes were worse with the intervention than with the control. Class III: No Benefit is a moderate recommendation that is applied infrequently when evidence suggests that a strategy is no better than the control. Class III: No Benefit recommendations should not be associated with weak evidence or expert opinion—LOE C or E—because it is virtually impossible to ascertain lack of benefit without randomized trials or carefully conducted observational studies when safety is not the primary concern. Class III: No Benefit recommendations should be supported by moderate or high-quality evidence. The adequacy of the supporting data, including sample size and event rates, needs careful consideration based upon objective criteria (ie, validated grading tools).The LOE rates the precision and quality of the scientific evidence supporting the effect of an intervention based on the type, quantity, consistency, and quality of clinical trials and other relevant evidence. The ERC or GWC grades the evidence supporting each recommendation, depending on whether this includes randomized, observational, prospective, or retrospective studies, and their quality, including objectively defined criteria for assessment of potential bias in addition to their relevance and fidelity. When published scientific evidence is lacking, a consensus of expert opinion is sought to gauge standards of care based on clinical experience and ranked as Level E.To accommodate the more quantitative, graded approach to evidence assessment, the Task Force has cautiously modified the COR/LOE schema (Table 1) to provide additional categories that offer greater granularity with separate categories for randomized and nonrandomized/observational evidence to define the level and quality of evidence. The COR/LOE schema continues to evolve as we refine tools to assess the quality of evidence and collaborate with other organizations such as the European Society of Cardiology to enhance the clarity, accuracy and utility of guideline recommendations. Suggested phrases for writing recommendations are provided in the interest of consistency. The revised grading schema consists of the following categories, with studies assessed by the GWC or (selectively) the ERC, increasingly using standardized evidence grading tools where useful to facilitate consistent evaluation of the quality of evidence:Table 1. Applying Class of Recommendations and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care*Table 1. Applying Class of Recommendations and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care*Level AHigh-quality evidence* from more than 1 randomized controlled trial (RCT)Meta-analyses of high-quality RCTsOne or more RCTs corroborated by high-quality registry studiesLevel B-R (Randomized)Moderate-quality evidence* from 1 or more RCTsMeta-analyses of moderate-quality RCTsLevel B-NR (Nonrandomized)Moderate-quality evidence* from 1 or more well-designed, well-executed nonrandomized studies, observational studies, or registry studiesMeta-analyses of such studiesLevel CRandomized or nonrandomized observational or registry studies with limitations of design or executionMeta-analyses of such studiesPhysiological or mechanistic studies in human subjectsLevel EConsensus of expert opinion based on clinical experience when evidence is insufficient, vague, or conflictingIn view of the increasing number of studies involving active controls rather than placebos, recommendations addressing the relative effectiveness of one clinical strategy compared with another continue to be included with specific phraseology. These apply to COR I and IIa recommendations only and to LOE A or B-R/B-NR.To address the concern about coupling the strong COR categories I and III with lower LOEs or expert opinion, specific new guidance from the Task Force is being given to GWCs as follows: Class I recommendations based only on LOE C/E should be minimized, and Class III: No Benefit recommendations should be avoided whenever possible if supported only by LOE C/E.An analysis of the 3271 recommendations across 19 CPGs published by 2013 showed that nearly 50% were Class I recommendations. In addition, 50% of recommendations were informed by LOE C and 80% of cardiologists apply CPGs in managing patients in most circumstances. The CPG features found most useful are clinical applicability and authority, brevity and clarity, comprehensiveness, ease of access and use, and currency.For cardiovascular or multispecialty practice clinicians, the most frequent use of CPGs is to address a sp