American College of Cardiology/American Heart Association Clinical Practice Guidelines: Part II
Evolutionary Changes in a Continuous Quality Improvement Project
Case Presentation: A 50-year-old male presents to your office for evaluation of a recent episode of atrial fibrillation. The patient had no prior history of atrial fibrillation until 3 days ago. At that time, he was working in his home woodworking shop on a large cabinet. The cabinet slipped out of the clamps holding it and fell on his right great toe. The patient was having moderate to severe toe pain when he noticed that his heart was beating rapidly and irregularly. His palpitations were not associated with any chest pain, shortness of breath, or lightheadedness. He went to his local emergency room. His blood pressure was 135/80, and his pulse was rapid and irregularly irregular. An ECG showed that he was in atrial fibrillation with a ventricular response rate of 160. There were no ST segment changes. Before the patient received any therapy, he converted to normal sinus rhythm. The total duration of his episode of atrial fibrillation was ≈2 hours. A subsequent ECG was entirely normal. X-rays of his right foot did not show any fracture. He was discharged from the local emergency room and advised to see you.
The patient is physically active. He denies any history of chest pain or chest pressure. He has no history of hypertension, diabetes, or tobacco use. His only other medical problem is mild asthma, treated with occasional inhalers. Both his mother and father lived into their late 80s and died of cancer. His two siblings are both alive and well without any cardiovascular disease.
On physical examination, his blood pressure is 120/80 mm Hg. His heart rate is 70 bpm and regular. His cardiac examination is normal. On lung examination, there are rare wheezes over both lung fields. His right great toe is badly bruised. His ECG from the local emergency room is available and is normal.
What are the appropriate next steps in the evaluation of this patient, as outlined in the American College of Cardiology (ACC)/American Heart Association (AHA)/European Society of Cardiology (ESC) Guidelines for the Management of Patients With Atrial Fibrillation?1
Appropriate clinical evaluation is shown in Table 1. This patient merits a chest x-ray (to evaluate his rare wheezes), a transthoracic echocardiogram, and blood tests of thyroid function. None of the additional tests listed, ie, exercise testing, Holter monitoring, transesophageal echocardiography, or electrophysiological study, are appropriate at this time.
Evolution of the ACC/AHA Guidelines
This illustrative case example is intended to demonstrate the evolution of the ACC/AHA practice guidelines in recent years. Part I of this review2 provided an overview of the guidelines process and its fundamental principles. This review will describe the further evolution of the guidelines process, including the increasing focus on patient conditions rather than procedures, efforts to provide more rapid updates, its international extension, and its interface with efforts at implementation and overall quality improvement.
As outlined in Part I of this series,2 the ACC/AHA effort began with procedure-based guidelines, such as those regarding the implantation of permanent pacemakers. This led to a series of guidelines about procedures including radionuclide imaging, exercise testing, echocardiography, and coronary angiography. However, these procedure-based guidelines did not provide sufficient help to practicing clinicians, who more often confronted patients with clinical problems rather than questions about procedures. The publication of the ACC/AHA/ESC Guidelines on the Management of Patients with Atrial Fibrillation in 2001 was the first attempt to provide the practicing clinician with useful steps in the evaluation and management of such patients. It is an example of the shift in focus of the ACC/AHA Guidelines effort to patient conditions rather than procedures. These new disease-based guidelines have priority from the standpoint of resources; their recommendations take precedence over older or less comprehensive recommendations in the procedure-based guidelines. The procedure-based guidelines are still maintained and updated. They serve as a single repository of all the potential applications of procedures such as echocardiography, and they include both additional technical information and applications to less common patient conditions, eg, pericarditis, for which there are not any current disease-based guidelines. Inevitably, there is overlap between the recommendations that appear in disease-based guidelines such as those for atrial fibrillation and procedure-based guidelines such as those for echocardiography; the ACC/AHA Task Force on Practice Guidelines follows a series of steps in an attempt to make sure this overlapping information is consistent across guidelines to avoid confusion. As mentioned above, the recommendations of the writing committees for the disease-based guidelines have precedence unless the procedure-based guidelines are more recent and provide compelling new evidence for a given application of a procedure.
Acceleration of the Revision Process
Another important step in the evolution of the ACC/AHA Guidelines process has been to shorten the time required for updates and revisions. In the late 1980s and the early 1990s, revision of any practice guideline required the formation of a new writing committee and completion of the exhaustive process outlined in Part I of this series. This usually led to a considerable time interval between guidelines. The first 2 echocardiography guidelines were separated by 7 years. Successive guidelines for percutaneous transluminal coronary angiography (PTCA),3,4 radionuclide imaging,5,6 and exercise testing7,8 were separated by 8, 9, and 11 years, respectively.
The Task Force on Practice Guidelines recognized in the mid-1990s that this time lag was no longer acceptable; it initiated the concept of a “living committee” for each writing group. The writing committee was instructed that its work was not complete when a guideline was published. It was directed to monitor ongoing literature that was pertinent to the subject of the guideline with the assistance of the ACC scientific staff. When the writing committee felt that new evidence warranted a limited number of either revised or new recommendations, the Task Force would initiate a guideline “update.” At the start of this process, one third of the membership of the original writing committee is replaced to ensure new input. The principles outlined in Part I of this review2 for the election of the original writing committee members are again followed in the selection of the new members. The new committee then holds a series of meetings and conference calls to identify specific portions of the guideline that merit new or revised recommendations. Minor changes in text, tables, and references are discouraged. One of the first examples of such an update occurred in the myocardial infarction guidelines. In 1996, primary PTCA was in a Class IIa recommendation for the treatment of patients with cardiogenic shock. The 1999 update of this guideline altered this recommendation in response to the publication of the SHOCK Trial.9 Patients with cardiogenic shock, ST elevation, or left bundle branch block; age <75 years; and revascularization within 18 hours were now appropriately considered to have a Class I indication for primary PTCA on the basis of that trial (Figure 1). Guideline updates, along with their focus, are listed in Table 2. These updates should be distinguished from “revisions,” which are more extensive rewrites of the entire guideline when the magnitude of new evidence is greater. The process for a guideline revision includes formation of a new writing committee.
Guideline updates are subject to the same rigorous review process that was outlined in Part I of this series.2 The reviewers are asked to focus on the specific areas of change to shorten the timeline of the entire process.
Rapid publication of these updates poses a challenge. The full-length version of the guideline, which is published on both the ACC and the AHA web sites, provides the most rapid venue to publish these changes. Two different versions of the update appear on the web sites. The first version shows the update in “track-changes” mode. The second version is “clean,” with all the changes incorporated. A print article summarizing the most important changes appears subsequently in both Circulation and the Journal of the American College of Cardiology. This article is hopefully useful to the reader in a “stand-alone format” and also alerts the reader to the presence of the updated full-length versions of the guideline on the 2 web sites. The print summary articles for these updates have followed a wide variety of different formats. Efforts are currently under way to survey practicing physicians to determine which of these formats is most useful. As indicated in Part 1 of this review,2 pocket and PDA versions of the guidelines are critical to their bedside application. Whenever necessary, these are also updated as part of the process.
Involvement of Other Organizations
During the first decade of the ACC/AHA Guidelines effort, other organizations often played a collaborative role. This included providing representatives to the writing committee, designating reviewers from their organization, formally endorsing the guideline, and, occasionally publishing the guideline in their own journal. Although this was a useful model, the ACC/AHA Task Force on Practice Guidelines gradually recognized that it was an inadequate one. Patients with cardiovascular disease often receive care from general internists and family medicine physicians. Thus, it was imperative that those organizations be included to a greater degree. In addition, there was a clear need for medicine to speak with “one voice.” Other organizations, including the cardiovascular subspecialty organizations and the ESC, were publishing an increasing number of clinical practice guidelines that overlapped in content with the ACC/AHA Guidelines.
The initial effort to involve other organizations in a “full partnership” involved the American College of Physicians and the American Society of Internal Medicine in development of the Guidelines for the Management of Chronic Stable Angina. This full partnership reflected the reality that most patients with stable angina are under the care of general internists rather than cardiologists. The writing committee included 3 official representatives from the American College of Physicians and the American Society of Internal Medicine who contributed greatly to the work of the writing committee. These same individuals published 2 articles in the Annals of Internal Medicine10,11 that were based on the stable angina guidelines but focused on the needs of internists. One of these individuals has now been asked to serve as co-chair of the writing committee for the next update of the stable angina guidelines.
The Guidelines for the Management of Patients with Atrial Fibrillation represented a landmark effort to formally partner with the ESC. The ESC had its own long history of working groups and practice guidelines on a spectrum of topics. During the early 1990s, the ACC/AHA effort and the European effort often shared information regarding the topics that they were developing and drafts of documents that were under development. However, there was a concern that formal partnership would be difficult because of the wide variety of health care systems and resources available in Europe. Thanks to the initiative of Jean Pierre Bassand, who suggested that the topic of atrial fibrillation might be suitable for a formal partnership, this effort was undertaken and successfully completed. Similar joint efforts with the ESC are now near completion for the topic of supraventricular arrhythmias and have just begun on the topic of ventricular arrhythmias and sudden cardiac death. In each case, the writing committee is jointly chaired by an ACC/AHA representative and an ESC representative. There are 4 members of the committee from each of the 3 organizations.
The latest step in the evolution of the involvement of other organizations has featured the cardiovascular subspecialty societies. They have been asked to formally partner with the ACC/AHA on procedure-based guidelines that are of major interest to them. For example, the American Society of Echocardiography is now a formal partner on the echocardiography guidelines, the American Society for Nuclear Cardiology is now a formal partner on the radionuclide imaging guidelines, the North American Society of Pacing and Electrophysiology is now a formal partner on the pacemaker/implantable cardioverter-defibrillator guidelines, and the Society for Cardiac Angiography and Interventions is a formal partner on the percutaneous coronary intervention guideline update. These organizations continue to play a more limited collaborative role on the disease-based guidelines. For example, the guidelines on atrial fibrillation were developed in collaboration with the North American Society of Pacing and Electrophysiology.
Other organizations have had contact with the AHA and ACC about topics of joint interest. For example, the Canadian Cardiovascular Society is represented on the writing committee for the pending revision of the acute myocardial infarction guidelines. A variety of other domestic and international organizations interface in a number of different ways with the ACC/AHA practice guidelines effort.
Over the past decade, it has become clear that the quality of cardiovascular care is not always as uniformly high as we would wish. The therapies recommended in practice guidelines are not applied nearly as consistently as would be desirable. The ACC and AHA have separately developed efforts in an attempt to meet the challenge of implementing guidelines more uniformly throughout the country.
The ACC Guidelines Applied in Practice (GAP) project began in 2000 as a brainstorming session to consider what was known in this area and what might be done to initiate a rapid cycle of improvement. A request for proposals was put out to the ACC membership. The GAP Steering Committee selected a proposal from southeastern Michigan directed by Dr Kim Eagle from the University of Michigan in partnership with the Michigan Peer Review Organization and the Greater Detroit Area Health Council. This project sought to implement a 7-component tool kit (Table 3) in 18 hospitals in southeastern Michigan. The results of this effort were published in JAMA in early 2002.12 They demonstrated significant improvement in multiple indices of both acute and discharge care of patients with acute myocardial infarction (Figures 2 and 3⇓).
At the same time, the American Heart Association initiated its Get With the Guidelines (GWTG) project. This effort focused on the discharge planning of patients with acute myocardial infarction and included a data collection system for individual hospitals to monitor their progress. The pilot results in western Massachusetts were highly favorable, revealing significant improvement in the implementation of those secondary prevention therapies that were underutilized.13 This project is now active in >163 hospitals.
GAP and GWTG both provide information about adherence to guidelines and about problems with “real-world” applications that is fed back to the Task Force on Practice Guidelines and, when appropriate, to the writing committees.
The ACC and AHA are not the only organizations interested in improving the quality of care. Medicare has encouraged its state peer review organizations under the Health Care Financing Administration Healthcare Quality Improvement Program. Details of successful efforts for lipid evaluation in management of myocardial infarction patients and in coronary artery bypass surgery improvement have now been published.14,15 Data standards and performance measures are critical to these efforts. The ACC and AHA have separate joint task forces on performance measures, and on data standards, to help define the appropriate standards and measures for quality improvement efforts.
Future Challenges for the Guideline Effort
There is a growing recognition of the importance of evidence-based clinical practice guidelines in the delivery of cardiovascular care. The ACC/AHA Task Force receives numerous suggestions to develop clinical practice guidelines in a broad range of topics. The need for these guidelines must be balanced against the limited financial, staff, and volunteer resources that are available for this purpose. Both organizations have made strong commitments to this effort over the last 2 decades and attempt to accommodate the many requests within the confines of available resources.
The Task Force has undertaken an extensive evaluation of the entire guideline development process that was detailed in Part I of this series. This review has been a quality improvement process with a specific focus on literature review, authoring tools, and dissemination of the guidelines. It has led to the development and implementation of a writer’s manual, as mentioned in the first part of the series. This manual is available to the public online.16
The review has also led to the development of an electronic, Internet-based authoring tool that is currently being used as the foundation of 2 ongoing guideline-writing efforts. Early indications are that this will greatly streamline the process, shorten timelines, reduce travel costs, and improve communication between guideline writers, reviewers, and the leadership of both organizations.
There is a clear need to improve the speed of the process to reflect the latest published evidence in existing guidelines. However, this process should never become “instantaneous,” as it is on some commercial web sites. The Task Force has recognized that there is a need to balance speed with rigor and deliberation. The initial enthusiasm that accompanies the first presentation of data, as well as the “spin” that commercial interests and protagonists may put on their initial publication, must be balanced with more deliberate consideration by the broader scientific community. The scientific community may judge a trial differently 6 months after publication when perusal and discussion of the data have exposed important themes that were not recognized on the day of publication. The rigor of the review process that was outlined in Part I of this series2 requires several months. Any attempt to compress it further will sacrifice scientific rigor and reduce the quality of the ACC/AHA Guidelines.
Practice guidelines are only one part of the quality improvement effort, which some have described as a “great circle” (Figure 4). The guidelines should inspire quality improvement efforts, and those efforts should provide feedback to the guidelines development process.17 Ultimately, the goal is clear—improving cardiovascular care.
Guideline-Based Patient Management
To return now to our patient, he undergoes a chest x-ray and an echocardiogram, which are both entirely normal. Blood tests of thyroid function are also normal. His appropriate pharmacological management is found in Figure 5, which is taken from the ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation.1 Given his paroxysmal atrial fibrillation and the absence of severe symptoms, the only therapy to be considered is anticoagulation. Table 4 shows the recommendations for antithrombotic therapy in patients with atrial fibrillation. In this patient, who is <60 years of age and has no heart disease (this condition is sometimes called lone atrial fibrillation), either aspirin or no therapy is acceptable. The recommendation for no therapy is based on a population-based study referenced in the guidelines.18
In most other patients with atrial fibrillation, anticoagulation is indicated. Several available surveys have shown that the recommendations for antithrombotic therapy featured in Table 4 are practiced inconsistently. The care of the >2 million Americans with atrial fibrillation would clearly be enhanced, and multiple strokes would be avoided, if these recommendations were followed uniformly throughout the country.
This article is Part II of a 2-part article. Part I appeared in the June 17, 2003, issue of Circulation (Circulation. 2003;107:2979–2986).
Fuster V, Rydén LE, Asinger RW, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). Circulation. 2001; 104: 2118–2150.
Gibbons RJ, Smith S, Antman EM. The ACC/AHA clinical practice guidelines: part I: where do they come from? Circulation. 2003; 107: 2979–2986.
Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty: a report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988; 78: 486–502.
Ryan TJ, Bauman WB, Kennedy JW, et al. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol. 1993; 22: 2033–2054.
O’Rourke RA, Chatterjee K, Dodge HT, et al. Guidelines for clinical use of cardiac radionuclide imaging, December 1986: a report of the American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovascular Procedures (Subcommittee on Nuclear Imaging). J Am Coll Cardiol. 1986; 8: 1471–1483.
Ritchie JL, Bateman TM, Bonow RO, et al. ACC/AHA Task Force Report: guidelines for clinical use of cardiac radionuclide imaging. Report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Radionuclide Imaging), developed in collaboration with the American Society of Nuclear Cardiology. J Am Coll Cardiol. 1995; 25: 521–547.
LaBresh KA, Ellrodt AG, Giliklich RG, et al. Get with the guidelines for cardiovascular secondary prevention: pilot results. Arch Intern Med. In press.
Manual for ACC/AHA Guideline Writing Committees. Available at: http://www.acc.org/clinical/manual/manual_introltr.htm. and http://circ.ahajournals.org./ Accessed June 5, 2003.