The environment for medical practice is changing very rapidly.
Much greater accountability is being demanded of all health-care
providers, including oncologists. Issues related to the philosophy
of care, financial management, and ethics are all being scrutinized
much more carefully than in the past.
The management of cancer patients constitutes a progressively
larger portion of the health-care industry budget. Thus, with
almost any of the possible new reform models for health care,
oncologists are going to be challenged much more than in the past
to provide information on the value of cancer care, asserted Dr.
Paul N. Anderson at an ASCO Health Services Research Committee
program, "Principles of Practice Guidelines," held last
year. "We need then, as cancer care providers, to become
very visibly and dependably accountable for outcomes, appropriateness,
necessity, effectiveness, and the cost of cancer management,"
said Dr. Anderson of the Cancer Center of Colorado Springs.
One definition of value is benefits minus harms over cost. Although
oncologists already have some good information regarding the benefits
of cancer treatment and are amassing more data related to harms
and toxicities, they are just beginning to get involved in the
area of cost-benefit and cost-effective analysis, Dr. Anderson
noted. He contends that each of these components in the value
equation will become progressively more important to clinicians'
ability to take care of cancer patients.
Dr. Anderson described several expected changes in health care
he believes will have a significant impact on oncology practice.
First, it is anticipated that budget restriction, particularly
capitation, will be a major mode of payment. Under capitation
plans, cancer subspecialists, such as radiation therapists, medical
oncologists, and surgeons, will compete with one another for each
dollar allotted to cancer treatment. In addition, the various
scans, follow-up examinations, and laboratory procedures will
all vie for those same limited dollars.
Second, in all of the reform plans, there is a movement toward
having primary-care doctors provide more cancer care than before.
The third major change will involve switching from a mode of cancer
care delivered with more and more services to achieve what is
felt to be a higher level of quality. Rather, clinicians will
have to provide data on outcomes, benefits, and costs to their
capitated revenue program in order to justify their diagnostic
and treatment approaches.
A Fourth Major Change
The fourth major change, according to Dr. Anderson, is that oncologists
will increasingly become integrated into multispecialty hospital
physicians' organizations, vertically integrated organiza- tions,
HMOs, or other types of managed care networks. Moreover, cancer
care will be delivered as part of a benefits package rather than
as unlimited individual patient selection of treatment.
As one key response to all of these changes in health care, Dr.
Anderson advised oncologists to become experts in the technologies
of health services management. In particular, he said, practitioners
ought to become well versed in four technologies that currently
are very much in vogue:
1) Outcomes definition, management, and evaluation;
2) Technology assessment;
3) Guidelines development; and
4) Oncology-defined cost-benefit and cost-effectiveness analysis.
"For our patients and for the perpetuation of excellence
in cancer care, we need to become skilled in these methodologies,"
Dr. Anderson asserted.
There are many reasons why oncologists should become involved
in these areas, Dr. Anderson stated, most of which are self-evident.
"We need to be able to organize evidence and outcomes better
than we have before. We need to be able to deal with insurance
companies and HMOs that are developing guidelines across this
country and in a relatively inconsistent manner. We need to be
able to develop guidelines that guarantee access of cancer patients
to cancer specialists, to clinical trials, and to off-label drugs,
amongst other issues. We need to be able to provide our own health-care
entities with information for marketing, patient satisfaction,
and these days, 'report cards' for the outcomes of cancer care.
We would like to be able to avoid the proprietary guidelines which
are not really clearly related to cancer data and outcomes."
In addition to involvement in guideline development on the national
level, Dr. Anderson urged oncologists to get involved in regional
and, especially, local efforts so that they can affect the systems
in which they work.
The purposes of clinical practice guidelines are sometimes confusing
and overlapping, said Dr. Anderson. "The overall purpose
of clinical practice guidelines and outcome-related activities
is to provide physicians and their patients with recommendations
for medical management in order to improve medical care. A second
benefit is to reduce inappropriate care."
While the goal of improving care is fairly straightforward, in
oncology the goal of reducing inappropriate care is much more
difficult, Dr. Anderson conceded. Many cancer treatments are being
challenged; the value of using second-, third-, or fourth-line
therapies is under particular scrutiny. Questions also are being
raised over whether patients with far-advanced, metastatic, or
refractory disease or those with a poor prognosis should be treated
at all, particularly when good outcome data are not available.
Consequently, oncologists need to become more involved in deciding
when, for whom, and how resources can be expended most helpfully.
Attributes of Good Guidelines
The Institute of Medicine has defined practice guidelines as systematically
developed strategies to assist practitioners make decisions about
appropriate patient care for specific clinical circumstances.
Attributes related to the development of good guidelines have
been worked out extensively by the American Medical Association,
the Agency for Health Care Policy and Research, and several other
organizations. Currently, at least 200 medical organizations have
created approximately 2,000 to 3,000 guidelines of varying degrees
of quality, Dr. Anderson noted. This number does not include the
various proprietary guidelines.
Dr. Anderson enumerated a long list of criteria for good practice
guidelines. First, he said, the practice parameters should be
developed by or in conjunction with physician organizations, not
just insurance companies or government agencies. The sponsoring
organization must have clinical and scientific expertise in the
content of the guideline, which is not always the case with proprietary
guidelines. Broad-based involvement of the physicians who will
use the parameters is very important as well.
"A guideline needs to be linked first, to evidence upon which
the guideline is based and second, to the outcomes which it is
hoped the guideline will produce. This requires very careful attention
to the methodology required to produce the guideline, but it is
very obvious in many situations that evidence-based methodology
is not used as widely as it should be."
Thus, asserted Dr. Anderson, the parameters must not only be comprehensive
and specific but also should be based not just on opinions, but
rather on reliable methodology that integrates research findings,
including evidence from the scientific literature, results of
clinical trials, large databases, and clinical expertise. The
evidence on which the parameters are based should be described
in the document, and the review and scoring process for evidence
should be spelled out. The credentials and affiliations of the
experts should be noted. The parameters need to be peer reviewed
and endorsed by relevant organizations.
Another important element that should be included is a discussion
of specific clinical management strategies, said Dr. Anderson.
"Appropriateness should be defined: whether the procedure
is appropriate, equivocal, or inappropriate with varying categories
of patients. Risks and benefits should be discussed, and expected
outcomes or desired outcomes noted. Economic outcomes also should
be estimated. This is not always happening in the guidelines that
you and I are being exposed to around the country."
The parameters should be based on current information. They should
be revised, updated, or, if necessary, rewritten at least every
3 years. They should include criteria for outcome and utilization
evaluation. In addition to the guideline itself, there needs to
be a plan for disseminating the information contained therein,
and for educating clinicians about and implementing the guideline's
Finally, patients' rights and preferences need to be considered
when guidelines are developed, Dr. Anderson stressed. As the Agency
for Health Care Policy and Research has stated very clearly, guidelines
should be very sensitive to patients' rights to make decisions
based on their preferences.
When developing guidelines, clinicians must be aware of the purposes
for which the guidelines will be used, Dr. Anderson warned, as
they are very often used for other purposes besides helping patients.
"Guidelines in the health care industry are being used as
decision support for practitioners, for medical education and
orientation, as criteria for self-evaluation, and as indicators
for quality review. They are used to minimize inappropriate variation,
hopefully to improve outcomes and improve medical practice. Frequently,
guidelines are being used for reimbursement decisions and choices
related to resource utilization. We hope they are used to improve
patients' quality of life and to evaluate new technology. Guidelines
are also obviously being used to credential physicians and in
cost-benefit analyses related to resource utilization."
ASCO Guideline Activity
Dr. Anderson concluded by summarizing the current status of ASCO's
practice guideline activity. Before the formulation of ASCO's
most recent strategic plan, a survey of ASCO membership indicated
a very high interest in the development of clinical practice guidelines.
As a result, the Health Services Research Committee was formed
by the Board of Trustees, with a subcommittee focused on guidelines
development, technology assessment, and outcomes research. The
first set of guidelines developed by the ASCO committee, related
to growth factors, has already been published [J Clin Oncol
12(11):2471, 1994]. Other topics under evaluation or in the early
stages of development include stem-cell support for high-dose
chemotherapy and the use of tumor biomarkers.
"It is very important too keep in mind that despite the involvement
of our national organization, guideline development is a slow
and cumbersome process nationally. We feel it is important that
individual oncologists, local hospitals and programs, and state
and regional organizations become experts in dealing with these
types of methodology," Dr. Anderson concluded.