Living by the Rules

As guidelines become an increasing part of medical practice, controversy remains regarding their usefulness.

In an era of managed care, guidelines and care pathways are becoming an increasing part of medical practice.^1-4 Should we, as clinicians, accept this trend, or should we resist the use of these new approaches?

In my opinion, a properly crafted guideline can be extremely useful for the care of patients with complicated respiratory diseases, but only if developed with a proper understanding of what constitutes a good guideline. As clinicians, we must understand the guideline-development process and participate in writing guidelines that will be used in our specific patient populations. After all, a guideline is only as useful as the data used in its development. If we, as involved clinicians, participate in the process, then the guidelines that emerge should help us better manage our patients. Guideline development is an active process, and it is important for us to collect data that validate the utility of any given guideline. Developing guidelines should be viewed as a continually evolving process that reflects our patient care needs. If we do not become actively involved in such a process, then we run the risk of being given guidelines and care plans developed by others, which is not likely to be satisfying to either us or our patients.

THE GROWTH OF GUIDELINES

Guidelines certainly are not a new concept, and have been applied to the field of medicine with growing frequency since the 1980s. Guidelines have been developed by a number of organizations including the federal government, specialty societies, hospitals, academic centers, insurance carriers, managed care organizations, and other commercial enterprises. In the late 1980s, the Health Care Financing Administration (HCFA) became interested in patient outcomes research and, through the development of the Agency for Health Care Policy and Research, developed a mandate to foster the growth of guidelines. The usefulness of the guideline concept, however, will depend on how success is defined, and different sponsoring groups have different goals. Is success defined by quality of care, cost reduction, reduced litigation risk, protection of professional autonomy, or minimization of practice variation?

In my opinion, guidelines are successful only to the extent to which they improve patient outcomes, particularly if they can achieve this in a cost-effective and efficient fashion. I have been involved in the development of guidelines for the treatment of respiratory infections for the past 5 years. This process has been an interesting one, and ultimately, through the development of guidelines and the collection of validation data, I believe we have been able to improve the care of patients with a variety of respiratory infections, particularly community-acquired pneumonia.

Guidelines differ from care pathways in that they are a general view of how to manage a disease while care pathways are a step-by-step approach to patient care. Guidelines present a broader view of a subject than a care pathway, which may be very much institution-specific.

There are reasons guidelines have become so popular. A well-written guideline can synthesize vast amounts of information and, in doing so, serve as a state-of-the-art review to update individuals not familiar with the complex details of a particular disease process. In the case of pneumonia and other illnesses, initial therapy can be directed by guideline recommendations and such therapy, if accurate, may lead to improved patient outcomes. For example, recent studies of community-acquired pneumonia have shown that the sooner antibiotic therapy is administered, the better the outcome for hospitalized patients.⁵ If a guideline allows for accurate and timely empiric therapy, a number of benefits may accrue, including a reduced mortality rate.

From a managed care perspective, guidelines have been particularly popular because they assure a uniform approach to patient care. For some, however, they present a double-edged sword. On the one hand, a uniform approach to care assures patients will receive a basic minimum of treatment. On the other hand, it may present a threat to physician autonomy. A guideline that advocates a specific approach to patient care may concern some practitioners that if they deviate from such a guideline, they will be disciplined or possibly subjected to litigation. It is my belief, however, that guidelines are simply a starting point and that deviations are okay provided there is a good reason. It is certainly not the intent of the individuals who develop guidelines to see them applied in every patient care circumstance. It is important to recognize that physician judgment should always supercede guideline recommendations provided there is appropriate and well-documented justification.

On the other hand, there are reasons to believe guidelines can lead to improved outcomes.4 Ultimately, this will depend on to what extent guidelines reflect local concerns and are locally validated. A guideline should not be viewed as a proscription from on high, but simply as a starting point from which to develop local care plans based on data collection. If guidelines are individualized to specific circumstances and modified based on local data collection, it is likely they will improve outcomes.

In the case of community-acquired pneumonia, for example, the use of recommended antibiotic therapy regimens has been shown to lead to reduced mortality for hospitalized patients.⁵ In addition, the emphasis on timely empiric therapy, as opposed to extensive diagnostic testing, may minimize the time between admission and administration of antibiotics, an endpoint that also seems to lead to a reduced mortality rate in patients with community-acquired pneumonia.⁵

There are reasons to believe that guidelines can lead to improved outcomes. In the case of hospitalized patients who receive antibiotic therapy, the use of a computerized guideline at the LDS Hospital in Salt Lake City has also been associated with improved antibiotic utilization and reduced costs.⁷ It is exactly this type of outcome that should be evaluated and encouraged with the introduction of any guideline.

GUIDELINE DEVELOPMENT

Controversy remains, however, regarding the best way to develop guidelines.3 A number of processes currently exist, including an informal consensus conference in which expert recommendations are made without a systematic review of the literature. Although this method is fast and easy, it is probably not ideal. A more formal consensus process, in which selected articles are reviewed and supplemented with expert opinion, can be followed. An even more formal process is to use an evidence-based approach, in which all of the available data are graded and then weighted for the purpose of making recommendations.⁸ The problem with this approach is that it is limited to providing recommendations only in areas where evidence is available. In addition, the evidence-based approach places heavy emphasis on published, randomized controlled trials and, to some extent, negates local experience and local data collection.^9,10 When published data show a benefit for a new therapy, will you be able to apply it to your patients? In some instances, you may not be able to because the types of patients you see may differ from those included in trials, or your area of expertise may be different from that of the publishing investigators. For this reason, new therapies, such as noninvasive positive-pressure ventilation, can have a range of reported success.

Although an evidence-based approach is intellectually appealing, I believe in certain instances it is not an ideal process-for example, in the development of respiratory infection guidelines. Such an approach may not be dynamic enough to include new information such as local antibiotic-resistance patterns. In addition, the population you treat may be very different from the population included in a prospective, randomized control trial.9 The ideal approach, in my mind, is to start with a combination of data and experience and use this to develop an initial guideline. The guideline should then be viewed as a hypothesis, which can be validated or proven incorrect on the basis of data collection that follows the implementation of the guideline. In this way, all of the available data, including the efficacy of the guideline in a specific practice situation, can be applied. The net result will be an evolutionary set of recommendations that reflect the best available literature, experience of experts, and the local efficacy of the guideline.

CONCLUSION

In the future, we are likely to see a proliferation of a large number of guidelines for the treatment of respiratory disease patients. There is reason to believe this process is a helpful one and will lead to improved patient care. I believe our role as practitioners is not to resist the process, but rather to understand it and participate in adapting national guidelines to a local level. By collecting local data and validating the utility of a guideline on a local level, we will be reassured of the value of guidelines for our patients and our local circumstances. We should feel encouraged to become active participants and not feel threatened by this growing and important movement to improve patient outcomes.

Michael S. Niederman, MD, FACP, FCCP, FCCM, is Chief, Division of Pulmonary and Critical Care Medicine, Winthrop University Hospital, Mineola, NY, and Professor of Medicine, Health Science Center, the State University of New York at Stony Brook.

REFERENCES

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4. Woolf SH. Practice guidelines: a new reality in medicine. III. Impact on patient care. Arch Intern Med. 1993;153:2646-2655.

5. Meehan P, Fine MJ, Krumholz HM, et al. Quality of care, process, and outcomes in elderly patients with pneumonia. JAMA. 1997;278:2080-2084.

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8. Guyatt GH, Sackett DL, Sinclair JC, et al. Users’ guides to the medical literature: IX. A method for grading health care recommendations. JAMA. 1995;274:1800-1804.

9. Niederman MS. Evidenced-based medicine in critical care: will it take us over the cutting edge? Crit Care Med. 1997; 25:1448-1449.

10. Grahame-Smith D. Evidence-based medicine: Socratic dissent. BMJ. 1995; 310:1126-1127.