Formal development of clinical practice guidelines has been part of the U.S. healthcare system in various forms and from various sources for more than three decades. Initially, such guidelines were condemned by organized medicine and physicians alike as intrusive into the physician-patient relationship and for promoting a “cookbook” approach to medical care that restricts individualized, innovative care and clinical practices. Fueling this debate were attempts by third-party payers to use proprietary guidelines to streamline healthcare management, reduce the cost of care and, some argue, improve the bottom line of those payers at the expense of patients.

Partially in response to these third-party payers and acknowledging the increasing burden on physicians to stay current with rapidly developing changes in clinical medicine, many medical specialty societies undertook meaningful clinical guideline development in the early-to-mid 1990s. The AAOS was a leader in these early efforts and has gained recognition and accolades for its work in this area.

What’s wrong with consensus?

As the demand for clinical practice guidelines grew, medical specialty societies rushed to develop their own guideline products, which often ended up “competing” with similar guidelines developed by private payers or government entities. With concurrent development of multiple clinical practice guidelines on the same topic from varying sources, it rapidly became clear to even the casual observer that practice guidelines on the same clinical topic often came to different conclusions regarding probable prognoses, diagnoses, and treatment of a clinical condition.

Well-developed clinical guidelines with rigorous literature searches can still present biased conclusions. These early guideline recommendations were often either intentionally or unintentionally consistent with the opinions and viewpoints of their development team. These guidelines also were frequently developed by a consensus-driven process, and while the validity of the conclusions of a “consensus” process can, to a degree, be systematically and rigorously improved, in most cases these early guidelines often reflected merely the uniform agreement among a panel of experts with uniform and often preconceived notions.

Thus, a panel of experts might develop guidelines, making recommendations about prognosis, diagnosis and treatment of a clinical problem based upon their own expert experience and then “cherry-pick” the literature that supported these opinions. This approach has been rightfully referred to as decision-based evidence making.

Although guideline development has always been a worthwhile effort, socioeconomic needs have recently driven it to the forefront. Clinical practice guidelines are now viewed as educational aids for over-burdened physicians, as a way of promoting better healthcare outcomes, and as a means of decreasing practice variations and identifying possibly inappropriate care.

Finally, with public and private payers developing pay-for-performance systems to improve quality of care and guide reimbursement, clinical practice guideline development will play a crucial role in selecting appropriate performance measures for these new physician payment systems.

Why evidence-based practice?

During the period of consensus-driven guideline development, the tenets of evidence-based practice (EBP) were independently developed and promulgated by groups of physicians in the United Kingdom, Canada and, later, in the United States. EBP purported to improve patient care by combining the learning and experiences of the practitioner; the values and needs of the patient; and the information available from the best clinical research evidence.

Implicit in this definition of EBP was that the practitioner had to be up-to-date on the best research information available for the patient’s clinical needs. In an ideal world, the practitioner would have access to large databases to search for the best information available to solve patient needs.

Systems for formal evidence evaluation, such as Levels of Evidence, were developed to rate individual clinical studies as to their validity based on the rigor with which these studies were designed and implemented. Additional systems, such as Grades of Recommendation, were developed to rate groups of studies and grade the conclusions of these multiple studies as to how confident the practitioner could be in using these conclusions in caring for patients.

Applying the principles of EBP to guideline development has formalized the guideline development process by objectively evaluating the clinical literature into Levels of Evidence and allowing guideline recommendations to be graded on the soundness and surety of the scientific evidence supporting those recommendations. This use of evidence that is objectively evaluated according to a specific set of rules minimizes the use of informal, opinion-based recommendations and adds great transparency to the guideline development process.

As J.E. Heffner, MD, a chest surgeon, has noted, “A formal method of guideline development creates an explicit linkage between the final recommendations and the evidence on which they are based.”2 Thus, the recommendations of evidence-based guidelines promote evidence-based decision making, not decision-based evidence making.

What’s in a guideline?

Systematically developed, evidence-based clinical guidelines must promote safe, effective care that can be adopted by practitioners. They must be valid and reliable—meaning they should be closely linked to the available evidence and their conclusions should be based on this evidence, and not vary according to the viewpoints of the parties involved in their creation. Furthermore, the clinical outcomes of evidence-based practice should be reproducible among different caregivers who interpret and apply the guidelines similarly in similar clinical contexts.

What’s the role of the expert?

Guidelines, however, must be flexible, accommodating to the use of the clinician’s experience, and should allow for tailoring to an individual patient’s needs and values. The guidelines should be clear, and their documentation should illustrate a transparency in the source of the guideline information and the manner in which the decisions were made in arriving at the conclusions and recommendations.

There simply is insufficient high-quality data available in the contemporary clinical literature to produce clinical guidelines with uniformly high grades of recommendation. Thus, there remains a role for expert opinion and consensus in guideline development.

The use of expert opinion as a form of “evidence” requires a formal consensus development process among the guideline creators with rigorous rules that will lead to the same attributes of validity, reliability and applicability demanded of more rigorous EBP methodology. Thus, prior to guideline development, how consensus is to be arrived at must be specified and used consistently among the guideline developers, and when consensus enters into a guideline recommendation, it must be clearly stated. Finally, evidence-based clinical practice guidelines should be created by a multidisciplinary team of developers.

The introduction of the principles of evidence-based practice into clinical guideline development means that these guidelines are no longer fully consensus-driven documents, reducing the potential for the bias of a particular group, regulatory body or payer. Evidence-based clinical practice guidelines will add to the improvement in quality, effectiveness and appropriateness of patient care.

Currently, the AAOS is actively involved in extensive clinical practice guideline development on a wide variety of topics and plans to collaborate with several other medical societies in developing multispecialty guideline products. Your Academy has committed to developing an effective and excellent process for and program of evidence-based clinical guideline development to benefit the membership by:

1. Providing practice guidelines for common clinical problems based on the best and most recent evidence available
2. Providing evidence-based alternatives to the proprietary guidelines being promoted by some third-party payers and workmen’s compensation systems
3. Developing performance measures to be provided to the Centers for Medicare and Medicaid Services (CMS) through the AMA’s Physician Consortium for Performance Improvement to influence CMS on the appropriate choice of such measures in a pay-for-performance reimbursement system.

Critical to this process is AAOS member awareness and support.

William C. Watters III, MD, is chairman of the AAOS Guidelines Oversight Committee. He can be reached at spinedoc@pdq.net

References

1. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: Institute of Medicine, 2001.
2. Heffner, JE. Does evidence-based medicine help the development of clinical practice guidelines? Chest. 1998, Mar; 113 (3 Suppl): 172S-178S.