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.
Clinical practice guidelines have been a subject of increasing interestfor the past several years, and, recently, they have been developed foroncology. In March, 1996, the National Comprehensive Cancer Network (NCCN),a coalition of 15 major US cancer centers, presented the firstversion of their practice guidelines in oncology. These guidelinescovered most of the major cancer sites.
The American Society of Clinical Oncology (ASCO) has presented guidelineson the use of colony-stimulating factors and tumor markers, and will soonpublish a guideline for unresectable lung cancer. Another series of guidelines,developed by the University of California Cancer Care Consortium, has beenpublished in the Cancer Journal.
The major reason for this sudden appearance of guidelines for oncologyis the advent of managed care.
Reducing Variation, Reducing Cost
Managed care implies that the care is directed in some fashion. Theneed to direct care is an outgrowth of the tremendous variations that occurin the practice of medicine, many of which have been detailed in lengthby Wennberg and his associates at Dartmouth.
Not only are these variations seen in procedures, such as angioplastyvs bypass, or breast-conserving surgery vs mastectomy, but also in moremundane 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 wayto do that is to reduce variation. Managed care organizations also abhorspending money. Their second goal, therefore, is to reduce the cost ofmedical care.
Although the explicit message of managed care is to reduce variation,the implicit one is to reduce cost. We as physicians should support thefirst 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 equationsare difficult to prove. Well-developed guidelines should become our bestprotection against the pressure of managed care because they can provideus with appropriate treatment options without sacrificing quality of care.
We must pay careful attention to how guidelines are developed. Managedcare organizations will want guidelines that promote less expensive care.They may be less concerned about treatment benefits, as measured by survivaland quality of life, than about the bottom line.
This means that we oncologists are responsible for protecting patientsfrom the pressures of managed care; this can be done by developing guidelinesthat reflect the best available practices.
By Cary Presant, MD
In oncology, clinical guideline use is here to stay. Despite years offoot dragging, ASCO is now developing guidelines, which are printed inthe Journal of Clinical Oncology.
Approval of guidelines by the preeminent oncology society and publicationin the most prestigious peer-reviewed oncology journal should convinceeven the most skeptical medical oncologists that their activities willbe 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 outby Dr. Kattlove, the nation's leading academic cancer centers. Which oneswill be "best"?
Oncologists who gripe about using guidelines should understand two pointsmade by Dr. Kattlove. First, almost no oncologists admit to using guidelinesnow. This is unfortunate, considering their probable universal use in thenear future.
Oncologists should begin to think about testing a pilot guideline now,informally in their own practice, to see how their practice pattern conformsto a clinical guideline. Variances should be explored to determine frequency,importance, and appropriateness.
Second, the most common types of guidelines will be developed in anindividual practice. Oncologists should begin to develop their own guidelinesfor their own practices now, to compare their own practice preferenceswith other published guidelines and to begin to test their own practicepatterns.
For example, developing a guideline for adjuvant stage I and stage IIbreast cancer therapy is a good exercise in evaluating the literature anddefining 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 officestaff can attach the guideline to the charts of new patient referrals witha diagnosis of breast cancer.
The more we begin to score our own patterns of care, the more we willbe prepared for managed care partners who will later be scoring us.
The most common types of guidelines are probably those developed byseveral practitioners brought together by the needs of their practice ortheir managed care organization. These guidelines generally incorporatethe standard practices of those physicians, along with their knowledgeof the literature. Usually, after some negotiation, the physicians cancome up with something they call guidelines. Unfortunately, these guidelinesmay be driven more by desire to reduce the cost of care in a capitatedenvironment than by desire to ensure that patients are appropriately treated.
The next step in the evolutionary tree of guideline development is theexpert consensus approach. These guidelines are created when experts inthe field are brought together by a large sponsoring organization suchas the National Cancer Institute. Although the experts theoretically knowthe literature on their subject, there is no formal attempt to survey theliterature. This methodology is also subject to bias, since there is nospecific 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 formalevaluation of the quality of the literature. For example, metaanalysesor randomized controlled trials are given much more weight than phase IIor retrospective studies. Unfortunately, treatments for many clinical situationsin oncology have not yet been tested by randomized controlled trials, letalone 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 questionsconcerning the treatment.
Usually, this panel represents a blend of both academic and practicingphysicians with broad geographic representation. These physicians ratetheir agreement or disagreement with statements based on the literatureon a scale of 1 to 9. The answers are collated in a computer program thatnot only produces a median score but also qualifies the answers accordingto whether there has been significant agreement or disagreement.
At Value Oncology Sciences, we have refined this method by combiningthe strength of the panel vote and that of the literature to classify treatmentsinto three categories. Treatments are rated as recommended or not recommendedif both the panel and the literature agree. They are called optional whenthere is a disagreement between panel and literature, or uncertainty.
With this approach, we can provide oncologists with the tools to recommendappropriate therapy to all of their patients and to help them resist pressuresfrom managed care to reduce cost so much that treatment becomes inappropriate.At Value Oncology Sciences, we do recognize the need to provide cost-effectivetreatment. Therefore, we also specify the cost of the treatments so theoncologist can make the most cost-effective choice.
Getting Guidelines to Oncologists
Once, at a managed care conference attended largely by physicians andmedical directors working in managed care, someone asked the audience howmany actually used guidelines in their practice. No hands were raised.This is the major problem with guidelines; many are available, but fewhave ended up in front of the physicians' eyes.
Getting guidelines to physicians is perhaps the greatest challenge ofall in guideline implementation. There must be some methodology by whicha guideline will automatically appear for the practicing physician whenneeded.
We feel that the best approach would be to have the guidelines on lineas part of a computerized medical record system. This system would containlogic that presents the appropriate guideline for each patient, once thediagnosis, stage of disease, patient demographics, and functional statusare entered. This, of course, is a goal that will only be reached as morephysicians 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 EnhancementSystem), analyzes physician practice patterns so that by matching treatmentand diagnosis, we can assess whether physicians use appropriate guidelines.For example, this method would tell us whether a physician was providingappropriate adjuvant therapy for patients with early- stage breast andcolorectal cancer. With this methodology, we can improve physicians' practicesnot only by giving them data that show they practice differently than theirpeers, but also by providing them with continuing education on the bestavailable practices contained in the guidelines.
It is becoming increasingly clear, as managed care increases the pressureto reduce cost, that physicians need better defenses. Guidelines can providethese defenses if they are coupled with the proper information systems.This is where the future of medicine lies, and it explains the increasingneed for physicians to ally themselves with larger organizations in orderto develop the tools needed to practice quality care.