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 recommendations.
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.