Cardiac-related clinical practice guidelines have become an integral part of the practice of cardiology. Unfortunately, these guidelines are often long, complex, and difficult for practicing cardiologists to use. Guidelines should be condensed and their format upgraded, so that the key messages are easier to comprehend and can be applied more readily by those involved in patient care. After presenting the historical background and describing the guideline structure, we make several recommendations to make clinical practice guidelines more user-friendly for clinical cardiologists. Our most important recommendations are that the clinical cardiology guidelines should focus exclusively on (1) class I recommendations with established benefits that are supported by randomized clinical trials and (2) class III recommendations for diagnostic or therapeutic approaches in which quality studies show no benefit or possible harm. Class II recommendations are not evidence based but reflect expert opinions related to published clinical studies, with potential for personal bias by members of the guideline committee. Class II recommendations should be published separately as “Expert Consensus Statements” or “Task Force Committee Opinions,” so that both majority and minority expert opinions can be presented in a less dogmatic form than the way these recommendations currently appear in clinical practice guidelines.
The initiation of clinical guidelines can be traced to the fourth century BC when Plato conceptualized panels made up of doctors and nondoctors to favorably influence “the way in which the treatment of the sick is practiced.” Plato observed that however effective practice by guidelines proved to be, it remained an inferior form of practice because guidelines presuppose care of an average patient rather than the individual patient the doctor is endeavoring to treat. Before the appearance of clinical guidelines as we know them today, physician’s scientific support for their clinical practice was based on strong grounding of the latest physiologic, anatomic, and pharmacologic studies and clinical research reports. This was supplemented by a robust number of review articles and textbooks by experts in the field. After the conclusion of World War II in 1945 and the full activation of the National Institutes of Health in 1951, biomedical research flourished in the United States, and there developed a broad array of new diagnostic tools, therapeutic techniques, and invasive procedures. The development and publication of clinical practice guidelines began in the early 1980s as an outgrowth of this new scientific advancement. As guidelines proliferated, limitations surfaced. These included the discrepancy between recommendations based on average patients and the requirements of individual patient care, difficulties in user access, and problems with conflict of interest among expert members responsible for the guidelines. These problems constrained the ability of guidelines to realize their full potential of informing and enhancing patient care.
Guideline Structure
Our current guidelines can be defined as systematically developed statements derived from research evidence and expert opinion that are used to provide clinical recommendations. The primary purpose of clinical practice guidelines is to provide recommendations to practitioners that optimize the diagnosis, management, and outcomes. It was anticipated that these recommendations would decrease the variability and cost of medical care by focusing resources on the most effective strategies. Ideally, the rationale of the guideline is to transfer more effectively evidence from scientific research into clinical practice.
In the past, medical research was carried out on a relatively small number of well-defined subjects. However, the results were difficult to apply to a broader population. This resulted in confusion and controversy in adapting the findings into clinical practice. What has changed is our current ability to study large randomized populations with statistical power that enhances the reliability of study conclusions. The limitation of these large clinical trials is that results and associated recommendations apply with greater certainty to a given population but not necessarily to an individual patient.
Guideline panels combine and analyze evidence usually gathered from research and clinical publications. Expert opinions from the chosen panel members have also been used as a source of evidence and have been incorporated into the guideline recommendations. Unlike reviews or textbooks, guidelines provide statements that address issues and values relevant to a clinical decision and prescribe a recommendation to the practitioner.
Cardiac guideline committees are mostly created by the established American College of Cardiology/American Heart Association (ACC/AHA) medical societies. They often include some members with potential for financial and personal bias. The primary reason for initiating the development of a specific cardiac guideline is to optimize patient care by practicing clinical cardiologists. However, societal, financial, insurance, corporate, journal, academic, and other forces are often operative. The panel of experts frequently contains several prominent academic leaders and members who are active consultants or have been consultants in the past to relevant medical corporations.
In 2008, the Institute of Medicine of the National Academy of Sciences was asked by the US Congress to undertake a study of the best methods to develop clinical practice guidelines. The rationale for this request was to ensure objective, scientifically valid, and consistent approaches to guideline recommendations in view of the plethora of clinical practice guidelines that were being published. Practitioners and other guideline users found it difficult to determine which guidelines were of high quality. In 2011, the Institute of Medicine published “Clinical Practice Guidelines We Can Trust” that included 8 standards for developing trustworthy guidelines. These standards hold the promise of improving health care quality and outcome, yet the recommendations of the Institute of Medicine standards have yet to be validated.
World Health Organization Reads the Current Clinical Guidelines?
Although an extensive amount of work goes into the creation of each clinical practice guideline, it is unclear how well they are read and digested by practicing clinical cardiologists. Eight ACC/AHA clinical practice guidelines have been published (also available on the World Wide Web) in 2014 ( Table 1 ), with the number of pages and the number of references detailed in the table. In addition, the ACC/AHA Task Force on Clinical Practice Guidelines published in 2014 an article entitled “The Evolution and Future of ACC/AHA Clinical Practice Guidelines: A 30-Year Journey.” This article included a 1-month on-line survey conducted in 2012 among US cardiologists including representative board members from a number of cardiac societies. It resulted in 206 responses (27% response rate). In brief, the responders reported that the clinical practice guidelines were relevant and useful in clinical practice. In contrast to that survey, the experience of one of the authors of this article (AJM) while serving as a course director of the ACC program entitled “Arrhythmias in the Real World” that was held at the Heart House of the ACC in September 2014 with 75 practicing clinical cardiologists in attendance was most interesting. The cardiologists were asked for a show of hands on how many had read at least 1 clinical practice guideline in the past year? Only 1 cardiologist raised his/her hand! When asked why they do not read the guidelines, the clinicians said they simply do not have time—the guidelines are too long, too detailed, and too absolute to be able to use them. Clinicians frequently learn about the guideline recommendations in summary formats from published editorials and reviews, newspaper commentary, Internet Web sites, and controversies that surface when experts disagree following guideline publications.
| First Author ref | Topic | Number of Text Pages | Number of References |
|---|---|---|---|
| Stone, NJ | Blood Cholesterol | 106 | 144 |
| Jensen, MD | Overweight and Obesity | 29 | 173 |
| Eckel, RH | Lifestyle Management | 17 | 132 |
| Goff, DC | Assessment of Cardiovascular Risk | 13 | 66 |
| Amsterdam, E | Non-ST Elevation Acute Coronary Syndromes | 114 | 827 |
| January, CT | Atrial Fibrillation | 47 | 201 |
| Fihn, SD | Stable Ischemic Heart Disease | 27 | 94 |
| Fleisher, LA | Non-cardiac Surgery | 86 | 490 |
Subjects and groups involved in payment/reimbursement issues often rely on the published guidelines and read them carefully. For example, the Centers for Medicare and Medicaid Services have developed a series of National Coverage Determinations for reimbursement, with many specific patient-care decisions based on published guidelines. Third-party private insurance companies frequently follow the guideline-based National Coverage Determinations. So, the use of clinical guidelines to establish physician reimbursement, for services rendered, is quite extensive.
World Health Organization Reads the Current Clinical Guidelines?
Although an extensive amount of work goes into the creation of each clinical practice guideline, it is unclear how well they are read and digested by practicing clinical cardiologists. Eight ACC/AHA clinical practice guidelines have been published (also available on the World Wide Web) in 2014 ( Table 1 ), with the number of pages and the number of references detailed in the table. In addition, the ACC/AHA Task Force on Clinical Practice Guidelines published in 2014 an article entitled “The Evolution and Future of ACC/AHA Clinical Practice Guidelines: A 30-Year Journey.” This article included a 1-month on-line survey conducted in 2012 among US cardiologists including representative board members from a number of cardiac societies. It resulted in 206 responses (27% response rate). In brief, the responders reported that the clinical practice guidelines were relevant and useful in clinical practice. In contrast to that survey, the experience of one of the authors of this article (AJM) while serving as a course director of the ACC program entitled “Arrhythmias in the Real World” that was held at the Heart House of the ACC in September 2014 with 75 practicing clinical cardiologists in attendance was most interesting. The cardiologists were asked for a show of hands on how many had read at least 1 clinical practice guideline in the past year? Only 1 cardiologist raised his/her hand! When asked why they do not read the guidelines, the clinicians said they simply do not have time—the guidelines are too long, too detailed, and too absolute to be able to use them. Clinicians frequently learn about the guideline recommendations in summary formats from published editorials and reviews, newspaper commentary, Internet Web sites, and controversies that surface when experts disagree following guideline publications.
