Editorials

Creating Practice Guidelines for Chronic Kidney Disease: An Insider's View

CYNDA ANN JOHNSON, M.D., M.B.A.

Brody School of Medicine at East Carolina University
Greenville, North Carolina

See article on page 869.

Evidenced-based guidelines are still subjective. That statement summarizes the rather frightening conclusion I made after my first involvement in a large-scale effort to engage in literature review, synthesis, and preparation of evidenced-based guidelines as part of the Kidney Disease Outcome Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF).

I expect that my conclusion about the subjectivity of evidence-based guidelines seems heretical, but I was not altogether surprised. In the 30 years since I began my medical education, I have observed that medical opinions "based on the literature" change. I will never forget my third year of medical school at the University of California, Los Angeles, when a young (now older and famous) infectious disease specialist, talking to our small group of on-service students, avowed, "You can't say anything without an article, but the evidence keeps changing!" That was a conversation stopper-for me, anyway.

I know that quoting an article is not the same as referring to a conclusion that comes from a rigorous evidence-based review, and that the strength of evidence from a single article is weak, but I was struck by how, even when an initial literature search yields thousands of articles, there will be few articles that can be compared easily. It is even difficult to narrow down a topic in a manner that allows reasonable comparisons.

Do not think that I am being negative-I actually was fascinated. I was surrounded by experts in the field of chronic kidney disease. These professionals were friendly, inclusive, and hardworking, but the evidence-extraction process was painful for all of us. At all steps along the way, subjective decisions had to be made. For example, the data summary form that a member of the team prepared for our use dictated what data would be extracted for later use and, to some extent, how it would be interpreted. From this beginning, we sorted and combined information, and then began debating what the evidence really was saying to us. Throughout the process, more subjective interpretation was required than I would have expected. Individual biases could not be removed totally from the equation-nor, in my opinion, should they have been.

Finally, we began to write the guidelines. I could feel the near desperation of some Work Group members who believed deeply that certain guidelines were crucial to the appropriate management of the patient with chronic kidney disease, although the evidence in favor of these guidelines did not seem to be compelling. For my part, I was keenly aware of my role of representing practicing family physicians who would be responsible for carrying out the guidelines within the largest segment of the population. Were the guidelines practical? Were they affordable? Would the care of our patients be improved by adherence to these guidelines? Would funding or oversight agencies use nonadherence to the guidelines against us? How could we become attuned to a set of guidelines on a topic that is much less familiar to us than hypertension or high cholesterol levels?

Eventual consensus resulted in the NKF K/DOQI guidelines that were published in 20021,2 and now are being summarized in a two-part article in American Family Physician.3,4 I am pleased with the guidelines. I supported their use by family physicians and immediately began incorporating them into my practice.

During the process of developing the clinical practice guidelines, I greatly increased my understanding of chronic kidney disease. For me, the most important lessons were as follows:

In summary, the K/DOQI guidelines recommend testing for proteinuria and estimating the GFR in patients who are at risk for chronic kidney disease.

The process of applying clinical evidence to practical recommendations is evolving. It already had evolved by the time that I participated in an NKF Work Group on hypertension in chronic kidney disease. As this process continues to improve, I am reassured that the principles involved in evidence-based medicine remain sound. I urge family physicians to participate in the formulation of clinical practice guidelines if they are given the opportunity to do so.

REFERENCES

The Author

Cynda Ann Johnson, M.D., M.B.A., is dean of the Brody School of Medicine at East Carolina University, Greenville, N.C.

Address correspondence to Cynda Ann Johnson, M.D., M.B.A., Dean, Brody School of Medicine at East Carolina University, 600 Moye Blvd., Suite AD-52, Greenville, NC 27834 (e-mail: johnsoncyn@mail.ecu.edu). Reprints are not available from the author.

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Management of Patients with Newly Diagnosed Epilepsy: A Systematic Literature Review

SUSAN ROSS, M.D., and
RHONDA P. ESTOK, R.N., B.S.N.

MetaWorks, Inc.
Medford, Massachusetts

SAMEER S. CHOPRA, M.A.

Vanderbilt University School of Medicine
Nashville, Tennessee

JACQUELINE FRENCH, M.D.

University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania

See page 886 for definitions of evidence labels.

As part of a multiphase project under contract with the Agency for Healthcare Research and Quality (AHRQ) and a topic nomination by the Centers for Disease Control and Prevention, we conducted a systematic review of the literature on interventions in patients with newly diagnosed epilepsy. Of the 120 studies identified as eligible for inclusion, most qualified as evidence level B with only 25 percent qualifying as Level A evidence. Thirty-eight of the studies involved children, 38 involved adults, and the remainder included both children and adults. Key project questions and literature findings are presented in this editorial and are reported in full, along with methods, in an AHRQ publication.1

What expertise, services, and tests are required to make the diagnosis of epilepsy and to initiate and monitor optimal treatment?

The literature suggests that diagnostic interventions should be tailored to the specific patient population. Different diagnostic approaches may be required in elderly patients, young children, and patients with suspected juvenile myoclonic epilepsy, absence seizures, or temporal lobe epilepsy.

The literature supports the value of a careful history, especially in diagnosing juvenile myoclonic epilepsy but also in obtaining a description (e.g., focal onset) that is sufficient to determine seizure type. The evidence indirectly supports the contribution of a careful neurologic examination (i.e., abnormal neurologic findings after a first seizure predict recurrence). The literature does not provide enough evidence to determine whether blood tests performed at the time of a first seizure are useful in diagnosing epilepsy and predicting seizure recurrence, although such testing may be useful in ruling out secondary causes of seizures.

Nearly all of the studies we reviewed mentioned the standard electroencephalogram (EEG) as an absolute requirement for the diagnosis of epilepsy. The literature suggests that antiepileptic drugs can confound EEG diagnosis of juvenile myoclonic epilepsy. In elderly patients with new-onset epilepsy, magnetic resonance imaging appears to be useful. Ambulatory EEG and video EEG may have a role in the initial diagnosis of epilepsy in very young children, patients with poorly characterized seizure types, and patients with suspected psychogenic seizures.

The literature provides insufficient evidence to determine the cumulative contribution of each test to an accurate diagnosis. There also is not enough evidence to determine the sensitivity and specificity of individual diagnostic tests.

What criteria should be used to guide decisions about the timing and selection of treatments for patients with newly diagnosed epilepsy?

Antiepileptic drugs used in the reviewed studies were (in order of decreasing frequency) carbamazepine, valproate, vigabatrin, phenobarbital, oxcarbazepine, phenytoin, gabapentin, lamotrigine, ethosuximide, clonazepam, and primidone. The type of seizure appeared to be the main determinant of the choice of agent. Studies of comparable patient populations typically showed no differences in the efficacy of antiepileptic drugs, although we performed no formal statistical comparisons.

What interventions are necessary to monitor the first epileptic drug regimen adequately or to ensure that the diagnosis of epilepsy was correct?

None of the reviewed studies had, as a primary objective, an assessment of monitoring interventions that are necessary for optimal patient care. Thus, necessary and appropriate monitoring remains to be determined by the treating physician without support from the literature.

What aspects of clinical and pharmacologic expertise have been demonstrated to result in optimal outcomes in patients with epilepsy?

Although evidence is sparse, the literature suggests that access to clinical expertise could minimize misdiagnosis and delay in diagnosis. Access to clinical expertise also could improve the choice and timing of initial antiepileptic drug monotherapy. Although remission rates ranging from 35 to 60 percent were reported in most of the antiepileptic drug studies, the highest remission rates (79 to 84 percent) were reported in the studies that employed clinical or pharmacologic expertise for treatment decisions.1

What social services, counseling, and information are necessary for patients at the time of first diagnosis of epilepsy?

No published evidence addressed the social services, counseling, and information that are necessary for patients with newly diagnosed epilepsy.

In the care of patients with epilepsy, "no seizures and no side effects equals control."2 There are three steps to achieving this goal: prompt and accurate diagnosis of epilepsy in patients presenting with epileptic seizures; administration of an appropriate first treatment intervention; and adequate monitoring to ensure not only the efficacy and safety of the treatment intervention but also the accuracy of the initial epilepsy diagnosis. Although evidence supporting the best approach to these steps is limited, physicians should strive to control epilepsy by using sound clinical judgment and applying the best available evidence.

This study was conducted by the MetaWorks Evidence-based Practice Center under contract with the AHRQ (contract no. 290-97-0016).

The authors are responsible for the content of this editorial, including any clinical or treatment recommendations. No statement in this article should be construed as representing an official position of the AHRQ or the U.S. Department of Health and Human Services.

REFERENCES

The Authors

Susan Ross, M.D., is chief scientific advisor at MetaWorks, Inc., Medford, Mass.

Rhonda P. Estok, R.N., B.S.N., is clinical information specialist at MetaWorks, Inc.

Sameer S. Chopra, M.A., is a doctoral candidate at Vanderbilt University School of Medicine, Nashville.

Jacqueline French, M.D., is professor in the Department of Neurology and director of the epilepsy center at the University of Pennsylvania School of Medicine, Philadelphia.

Address correspondence to Susan Ross, M.D., MetaWorks, Inc., 10 President's Landing, Medford MA 02155. Reprints are not available from the authors.

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