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
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
Approval of guidelines by the preeminent oncology society and publication
In addition to the ASCO effort, guidelines have been, or are being,
Oncologists who gripe about using guidelines should understand two points
Oncologists should begin to think about testing a pilot guideline now,
Second, the most common types of guidelines will be developed in an
For example, developing a guideline for adjuvant stage I and stage II
The pattern of practice for the last 3 to 6 months can be evaluated.
The more we begin to score our own patterns of care, the more we will
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
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
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.