Clinical practice guidelines have been a subject of increasing interest for the past several years, and, recently, they have been developed for oncology. In March, 1996, the National Comprehensive Cancer Network (NCCN), a coalition of 15 major US cancer centers, presented the first version of their practice guidelines in oncology. These guidelines covered most of the major cancer sites.
The American Society of Clinical Oncology (ASCO) has presented guidelines on the use of colony-stimulating factors and tumor markers, and will soon publish a guideline for unresectable lung cancer. Another series of guidelines, developed by the University of California Cancer Care Consortium, has been published in the Cancer Journal.
The major reason for this sudden appearance of guidelines for oncology is the advent of managed care.
Reducing Variation, Reducing Cost
Managed care implies that the care is directed in some fashion. The need to direct care is an outgrowth of the tremendous variations that occur in the practice of medicine, many of which have been detailed in length by Wennberg and his associates at Dartmouth.
Not only are these variations seen in procedures, such as angioplasty vs bypass, or breast-conserving surgery vs mastectomy, but also in more mundane issues such as hospital utilization.
Managed care organizations, or any business venture for that matter, abhor uncertainties. They want to be able to predict costs, and one way to do that is to reduce variation. Managed care organizations also abhor spending money. Their second goal, therefore, is to reduce the cost of medical care.
Although the explicit message of managed care is to reduce variation, the implicit one is to reduce cost. We as physicians should support the first goal but be very circumspect about the second.
Certainly, if two treatments are of equal value and one costs less, we should use the less expensive option. Unfortunately, these equations are difficult to prove. Well-developed guidelines should become our best protection against the pressure of managed care because they can provide us with appropriate treatment options without sacrificing quality of care.
We must pay careful attention to how guidelines are developed. Managed care organizations will want guidelines that promote less expensive care. They may be less concerned about treatment benefits, as measured by survival and quality of life, than about the bottom line.
This means that we oncologists are responsible for protecting patients from the pressures of managed care; this can be done by developing guidelines that reflect the best available practices.
Guidelines Are Here to Stay
By Cary Presant, MD
In oncology, clinical guideline use is here to stay. Despite years of foot dragging, ASCO is now developing guidelines, which are printed in the Journal of Clinical Oncology.
Approval of guidelines by the preeminent oncology society and publication in the most prestigious peer-reviewed oncology journal should convince even the most skeptical medical oncologists that their activities will be guided by or measured against some guidelines. But whose?
In addition to the ASCO effort, guidelines have been, or are being, developed by the NCCN, ACCC, American Cancer Society, and, as pointed out by Dr. Kattlove, the nation's leading academic cancer centers. Which ones will be "best"?
Oncologists who gripe about using guidelines should understand two points made by Dr. Kattlove. First, almost no oncologists admit to using guidelines now. This is unfortunate, considering their probable universal use in the near future.
Oncologists should begin to think about testing a pilot guideline now, informally in their own practice, to see how their practice pattern conforms to a clinical guideline. Variances should be explored to determine frequency, importance, and appropriateness.
Second, the most common types of guidelines will be developed in an individual practice. Oncologists should begin to develop their own guidelines for their own practices now, to compare their own practice preferences with other published guidelines and to begin to test their own practice patterns.
For example, developing a guideline for adjuvant stage I and stage II breast cancer therapy is a good exercise in evaluating the literature and defining treatment options.
The pattern of practice for the last 3 to 6 months can be evaluated. The guideline can be compared with the NCCN and ACCC guidelines. The office staff can attach the guideline to the charts of new patient referrals with a diagnosis of breast cancer.
The more we begin to score our own patterns of care, the more we will be prepared for managed care partners who will later be scoring us.
The most common types of guidelines are probably those developed by several practitioners brought together by the needs of their practice or their managed care organization. These guidelines generally incorporate the standard practices of those physicians, along with their knowledge of the literature. Usually, after some negotiation, the physicians can come up with something they call guidelines. Unfortunately, these guidelines may be driven more by desire to reduce the cost of care in a capitated environment than by desire to ensure that patients are appropriately treated.
The next step in the evolutionary tree of guideline development is the expert consensus approach. These guidelines are created when experts in the field are brought together by a large sponsoring organization such as the National Cancer Institute. Although the experts theoretically know the literature on their subject, there is no formal attempt to survey the literature. This methodology is also subject to bias, since there is no specific methodology for arriving at consensus.
Finally, at the pinnacle of methodology, sits the evidence-based guideline. This approach relies primarily on a complete literature search with a formal evaluation of the quality of the literature. For example, metaanalyses or randomized controlled trials are given much more weight than phase II or retrospective studies. Unfortunately, treatments for many clinical situations in oncology have not yet been tested by randomized controlled trials, let alone metaanalyses.
This deficiency has led to the RAND methodology of guideline development. With this method, in addition to a literature search and evidence review, a panel of nine physicians is enlisted to comment on specific questions concerning the treatment.
Usually, this panel represents a blend of both academic and practicing physicians with broad geographic representation. These physicians rate their agreement or disagreement with statements based on the literature on a scale of 1 to 9. The answers are collated in a computer program that not only produces a median score but also qualifies the answers according to whether there has been significant agreement or disagreement.
At Value Oncology Sciences, we have refined this method by combining the strength of the panel vote and that of the literature to classify treatments into three categories. Treatments are rated as recommended or not recommended if both the panel and the literature agree. They are called optional when there is a disagreement between panel and literature, or uncertainty.
With this approach, we can provide oncologists with the tools to recommend appropriate therapy to all of their patients and to help them resist pressures from managed care to reduce cost so much that treatment becomes inappropriate. At Value Oncology Sciences, we do recognize the need to provide cost-effective treatment. Therefore, we also specify the cost of the treatments so the oncologist can make the most cost-effective choice.
Getting Guidelines to Oncologists
Once, at a managed care conference attended largely by physicians and medical directors working in managed care, someone asked the audience how many actually used guidelines in their practice. No hands were raised. This is the major problem with guidelines; many are available, but few have ended up in front of the physicians' eyes.
Getting guidelines to physicians is perhaps the greatest challenge of all in guideline implementation. There must be some methodology by which a guideline will automatically appear for the practicing physician when needed.
We feel that the best approach would be to have the guidelines on line as part of a computerized medical record system. This system would contain logic that presents the appropriate guideline for each patient, once the diagnosis, stage of disease, patient demographics, and functional status are entered. This, of course, is a goal that will only be reached as more physicians computerize their offices.
Practice Analysis Methodology
A second method would be to educate the physician by retrospective review. Our practice analysis methodology, called OPES (Oncology Practices Enhancement System), analyzes physician practice patterns so that by matching treatment and diagnosis, we can assess whether physicians use appropriate guidelines. For example, this method would tell us whether a physician was providing appropriate adjuvant therapy for patients with early- stage breast and colorectal cancer. With this methodology, we can improve physicians' practices not only by giving them data that show they practice differently than their peers, but also by providing them with continuing education on the best available practices contained in the guidelines.
It is becoming increasingly clear, as managed care increases the pressure to reduce cost, that physicians need better defenses. Guidelines can provide these defenses if they are coupled with the proper information systems. This is where the future of medicine lies, and it explains the increasing need for physicians to ally themselves with larger organizations in order to develop the tools needed to practice quality care.