Practice Guidelines

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This is the seventh article in the Medical Management "Signature Series" by Managed Care Resources, Inc. -- articles on topics in managed care written by experts in the field. The author of this article is Roberta L. Carefoote.

In some circles, practice guidelines are wildly heralded; in others, they are deeply mistrusted. Despite reported benefits of cost reduction and healthier outcomes, some segments of the industry remain skeptical about their value. Some physicians view attempts to map out processes of care as a restriction on their professional judgement, often citing that these tools are nothing more than "cookbook medicine". Even in the face of such resistance, most managed care organizations are devoting resources to the development and introduction of practice guidelines for two reasons:¹ One, practice guidelines are conceptually sound and seemingly logical. Getting practitioners together to define the process of good care makes good sense. And two, practice guidelines dovetail neatly with the impetus from the National Committee for Quality Assurance (NCQA)^A to improve the health outcomes of the members served by managed care organizations. As a result, the issues today are not whether practice guidelines are inherently good or evil, or whether they should be implemented or not, but whether they are appropriately used to improve the health status of the patient population².

The objective of this article is to provide an overview of practice guidelines -- how they differ from other practice tools, their use in practice, legal implications, the development process, the importance of physician involvement, and existing resources. The reader is encouraged to use the article as a basis for an initial understanding of some of the complexities of practice guideline development, and as a resource for pursuing more information about these managed care tools.

How do practice guidelines differ from other forms of practice recommendations? At the Mayo Clinic^B, practice guidelines and other forms of standardizing care are differentiated in the following ways²:

• Practice Guidelines are primary care based, focusing on outpatient activity, and guide physician decision making over time. They cover health maintenance, prevention, diagnosis, treatment, patient education, and patient self-care.

• Clinical or Critical Pathways are procedure based, tend to be focus on inpatient care, and coordinate the activities of a multidisciplinary team. The only decision making is whether the patient should enter the pathway; all the subsequent steps are already established.

• Clinical Protocols are specialty oriented, and focus on outpatient care. They serve as a consensus guide to physicians and nurses in treating unusual disease problems that occur relatively often in specialty clinics.

Practice guidelines assist practitioners in making decisions about appropriate health care for specific clinical circumstances. They are not standards or rules. They can be as simple or as detailed as a managed care organization believes is necessary to provide good care to members and to consistently monitor how well care is provided.

Practice guidelines are particularly helpful in³ the following areas:

• Comparing different patterns and approaches, to reduce variability in care;
• Facilitating communication among physicians about clinical issues;
• Discovering the points where clinical and administrative procedures interface;
• Planning how to improve clinical processes, to increase the cost effectiveness and appropriateness of care; and,
• Educating or transmitting information about agreed-upon methods.

Practice guidelines are not helpful when they are applied in a piece-meal fashion, when they are not connected to quality improvement efforts, or when they are introduced without the active support of the clinicians. They are not intended to reduce medical science to simple, routine formulas. Rather, they are tools designed to facilitate clinical and utilization decision making. It is widely recognized that practice guidelines are not appropriate for all cases. It is the responsibility of the individual physician to know and understand a guideline, and then to determine if and when it is applicable to his/her specific clinical case.

Given that practice guidelines can be expensive and time consuming to develop, disseminate, and implement, it behooves the managed care organization to carefully select the areas where practice guidelines can be most useful. Practice guidelines have proven to be effective for several clinical situations³:

• Procedures that can result in significant harm to patients, or diagnoses that may involve such procedures (e.g. coronary artery disease)
• Services that are high risk, in the sense that if the member does not receive the service, he or she may be at high risk for contracting the disease (e.g. measles) or for not detecting the disease at an early stage (e.g. cancer screening)
• Expensive procedures, such as organ transplantation or complex diagnostic work-ups
• Procedures or diagnostic work-ups for which significant overuse has been documented (e.g. cesarean section)

Dr. Gordon Mosser, Executive Director of the Institute for Clinical Systems Integration^C in Minneapolis, Minnesota, goes one step further and suggests that a critical determinant in selecting a practice guideline is the extent to which change can be achieved. The probability of achieving change requires that not only can an organization get agreement on a guideline but that it implements it⁴.

Physicians fear that they will increase their risk of adverse malpractice judgements if they pursue a medical practice or conclusion contrary to one recommended by a national practice guideline. This is not true. The Physician Payment Review Commission^D recently reached four conclusions regarding the impact of practice guidelines on medical malpractice³ --

1. Development and use of sound practice guidelines will not increase physicians' exposure to malpractice liability. In fact, guidelines will probably allow physicians to reduce existing risks.

2. Medical Societies that develop guidelines may expose themselves to tort liability if poorly created guidelines lead to patient injury. However a study commissioned by the AMA^E concluded that this risk is small and can be further reduced by following currently accepted procedures for the development of guidelines.

3. Well-designed guidelines and review criteria will decrease the incidence of substandard care and will help courts more accurately judge whether a physician was negligent. They also help injured patients and their attorneys to determine whether they have grounds for a malpractice suit.

4. Although guidelines will improve the quality of medical care and the accuracy of court determinations of negligence, the medical tort liability system will continue to be expensive and will not fairly compensate and redress injury from medical negligence, or deter substandard practice.

The ultimate legal implications of the availability and use of practice guidelines are still undetermined, but it is clear that in the early stages the benefits of practice guidelines outweigh the legal risks cited by many physicians. Strategies for minimizing liability have been put forth by the Agency for Health Care Policy and Research^F, as well as by the Institute of Medicine^G. The reader is encouraged to contact these organizations for more information if they are concerned about the legalities of using practice guidelines.

The length of time required to complete the development process can range from two months to two years. It depends on a number of factors, including management style, interdepartmental cooperation and commitment to guideline development, as well as the complexity of the guideline. The complexity refers to the degree of certainty surrounding the area under consideration, the level of detail required, and the extent of change required to implement the guideline. More important than the time to produce the guideline is the time taken to achieve true consensus among the clinicians designing and using the guideline. Consensus does not necessarily mean that everyone is cheering about the guideline, only that they can live with it. The extent to which consensus can be achieved usually depends on the level of supporting information on a subject. If there is a high level of supporting information on a topic, the probability is high that a group will achieve agreement⁴.

A practice guideline is rarely developed from scratch. There are many good guidelines available today that serve to start the development process; for the most part the development process is really a checking and refinement procedure. Clinicians often find that national guidelines can be "tweaked" to make them adaptable to the local setting. The critical element in development is active and wide spread clinician involvement, especially by those who are ultimately expected to put the guideline into practice. It has been suggested that clinicians will look skeptically at practice guidelines developed by entities (e.g. managed care organizations) rather than by their peers.

The literature supports using several principles to guide the development of practice guidelines ², ⁴, ⁵:

• The guidelines should be scientifically, not intuitively based
• Empiric evidence from state and local health programs should be sought, evaluated, and incorporated into the guidelines.
• Decisions about the final product should be consensus-based
• The guidelines should be descriptive, not prescriptive
• The guidelines should be dynamic, not static - they should be pilot tested before dissemination and then continuously evaluated.
• The guidelines should be widely disseminated and accompanied by education
• The guidelines should be practical and easily implemented
• There should be multidisciplinary and wide-spread involvement in the development process - all major stakeholders should be involved as a guideline is developed
• A guideline should be adapted to suit the purpose or setting in which it will be used. It is important that any local adaptation does not alter the science-based findings, but rather increases its utility in the setting and for the purposes of the user⁶.

Critical to the success of practice guideline implementation is physician involvement and buy-in. This involvement starts right from day one when the topics for practice guidelines are selected. Dr. Mosser suggests that the selection process has to be perceived by everyone as legitimate, and then it must actually be legitimate⁴! It should not be a process that is easily influenced by special interests.

Findings from research show that although nearly two-thirds of practicing internists think that guidelines are "good educational tools" and "a convenient source of advice," more than two-thirds also believe that guidelines are biased in some way⁷. A key challenge to those involved in the development of practice guidelines is ensuring that the process selected is sound and objective, that it facilitates the development of guidelines based on scientific evidence, not personal views.

Aliberti and Holt, in conducting research about physician attitudes towards computerized practice guidelines, revealed that physicians are willing to use clinical guidelines under the following conditions⁸.

• The guidelines are not totally prescriptive, allowing for deviation when appropriate.
• The guidelines are easy to incorporate into their daily routine of administering patient care.
• The guidelines do not significantly increase the workload for themselves or their office staff
• The guidelines improve patient outcomes, including patient satisfaction
• The guidelines reduce overall cost of care
• The guidelines decrease the "bureaucracy" of working with managed care authorization and administrative processes.

These statements can serve as guiding principles for guideline development as well as ensuring that the ultimate product is one that will gain the support of practitioners.

One of the more significant challenges in practice guideline development is determining how to identify and interpret current literature on a specific subject. The vast number of practice guidelines available can be daunting even to the most seasoned researcher. Worthy of note is the fact that the Agency for Health Care Policy and Research (AHCPR)^F, the American Association of Health Plans (AAHP), and the American Medical Association (AMA)^E have joined forces to produce an Internet-based National Guideline Clearinghouse (NGC). The NGC will make the full range of current clinical practice guidelines available to anyone with a computer⁹. The target date for launching the independent interactive Web site is the fall of 1998, and it is designed to:

• Contain standardized information for thousands of guidelines,
• Provide guideline abstracts, and full text where possible,
• Compare and contrast recommendations on similar topics, and
• Provide topic-specific electronic mailing lists to enable registered users to communicate with each other on guideline development, dissemination, implementation, and use.

In the meantime, the reader may benefit from knowing about the following three resources²:

• American Medical Association, Department of Practice Parameters: Directory of Practice Parameters: Titles, Sources, and Updates. This directory identifies approximately 1800 current practice parameters and their sponsoring organizations. Call the AMA Ordering Department at (800) 621-8335

• ECRI: 1996 Healthcare Standards Directory, Plymouth Meeting, PA, 1995. This Directory lists more than 26,000 standards, laws, regulations, and guidelines from more than 620 issuing organizations and government agencies. Call ECRI's Circulation Department at (610) 825-6000, extension 888.

• Legamed Publishing, Inc. of Raleigh, North Carolina produces a monthly newsletter tracking practice guideline developments in the U.S. Congress, state legislatures, and the courts. Call Stephen J. Schanz, Editor of Parameters, Guidelines & Protocols, at (919) 676-1137.

Practice guidelines are now being woven into the very fabric of primary care. It is rare to find a primary care practitioner who is not working within the parameters of preventive guidelines that were produced and disseminated at the national level. To debate the appropriateness of practice guidelines in today's environment is to risk sounding medically illiterate. Energies would be better spent on ensuring that the development process is sound - one that actively involves those clinicians who will ultimately use the final product. This article defines practice guidelines and identifies several principles to guide the development process, as well as resources to find a "seed" guideline to start the process.

For more information on Managed Care and Quality Management please contact us at (630) 325-6543 or by email at info@mcres.com .

We hope that you will join us as we explore all of the elements of medical management in the coming months. In addition, we are offering a "Signature Series" on "Managed Care Contracting". We hope that the two series combined will lessen the mystery of managed care and help level the playing field between providers and payers.

Ira H. Rosenberg

President, Managed Care Resources, Inc.

References:

1. Paul E. Plsek, "From the Editor", Quality Management in Health Care, 3:2, pp. v-vi.

2. Louise Kaegi, "From Paper to Practice to Point of Care: Reports from a Zitter Group Conference on Implementing Practice Guidelines", Journal on Quality Improvement, August 1996, pp. 549-589.

3. Norbert Goldfield, Michael Pine, and Joan Pine, "Measuring and Managing Health Care Quality - Procedures Techniques, and Protocols. Aspen Publishers, Inc., Gaithersburg, Maryland, 1992, Chapter 6.

4. Stephen L. Davidow, "Developing and Implementing Health Care Guidelines for Group Medical Practices: An Interview with Gordon Mosser." Journal on Quality Improvement. April, 1996, pp. 293-301.

5. ______, "Forum - Guideline Development Project Reports Feasibility of Population-Based Initiatives", Abstracts of Clinical Care Guidelines, February, 1996, p. 22.

6. ______, "Forum - How are National Guidelines Faring in Local Settings - Guest Essay: A Federal Perspective (AHCPR)", Abstracts of Clinical Care Guidelines, March, 1996, pp. 20-21.

7. Francis J. Crosson, "Why Outcomes Measurement Must be the Basis for the Development of Clinical Guidelines", Managed Care Quarterly, Spring, 1995, pp.6-11.

8. Ellen Aliberti and Timothy J. Holt, "Physician Attitudes Toward Computerized Practice Guidelines", Managed Care Quarterly, Spring, 1996, pp.70-76.

9. ______, "Forum - AHCPR, AAHP and AMA to Develop a National Clinical Guideline Clearinghouse", Abstracts of Clinical Care Guidelines, June, 1997, p. 19.

Related World Wide Web Sites:

A. National Committee for Quality Assurance (NCQA)

B. The Mayo Clinic

C. The Institute for Clinical Systems Integration (ICSI)

D. The Physician Payment Review Committee

E. American Medical Association (AMA)

F. Agency for Health Care Policy and Research (AHCPR)

G. Institute of Medicine

The Managed Care Resources, Inc. team has over 150 years of combined experience in the development and implementation of managed care services. Please visit our home page to learn more about how we can assist you with your managed care needs. We also invite you to contact us with questions or comments.

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