In an effort to achieve cost-effective disease management, health care systems are developing standards of care and practice guidelines for oncologists. Although some physicians have begrudged the inescapable trend, speakers at this ASCO educational session explained how such guidelines, or care pathways, for common cancers are positively affecting the quality of cancer care.
NCCN Treatment Guidelines
The National Comprehensive Cancer Network (NCCN) has published practice guidelines for the treatment of most common cancers. These have been enthusiastically received. Patient versions of NCCN guidelines for breast, prostate, and colorectal cancers also have been published.
According to Jane Weeks, MD, who moderated the educational session, the NCCN has been remarkably successful in ensuring buy-in among both the clinical and research communities. A key factor in this success, she said, is that the content of the guidelines strikes the right balance between strict evidence-based medicine and a consensus-based clinical approach. Frequent updating and the inclusion of patient input have also contributed to acceptance of the guidelines.
Clearly, there is interest in this concept. The NCCN patient-oriented breast cancer guidelines, in fact, received 1 million hits the first day it was online, Dr. Weeks remarked.
NCCN Outcomes Databaes
In addition to developing guidelines, it is also critical for institutions to produce and utilize their own prospective database, evaluate adherence to the guidelines, and assess outcomes under the guidelines. The data from this exercise will help identify the most effectiveand especially the most cost-effectivestrategies for managing the common cancers. This is the NCCNs research mission, Dr. Weeks noted.
The same data, if it is of sufficient quality, can be used for two different purposes. The first is to evaluate providers, which addresses quality-of-care questions. The second is to evaluate treatments and interventions, which answers the research questions, Dr. Weeks pointed out.
A project was initiated to collect uniform sociodemographic, clinical, treatment, and outcomes data for women treated for breast cancer in the NCCN. Breast cancer was selected as the first disease for study because of its importance as a public health problem, and because it accounts for a large proportion of overall clinical activities in the NCCN. Initially, five institutions participated in this project. In the future, there are plans to include more NCCN institutions, and other disease sites. We also are very anxious to bring some community institutions into this project to begin getting a more heterogeneous data set for research purposes. We want to see whether these methods can be exported out of the large tertiary care centers into the real world, where most of oncology is practiced, Dr. Weeks told the audience.
In addition, the NCCN will seek partnerships with pharmaceutical and biotechnology industries for financial support. I think we need to start incorporating standards-of-care into the fabric of what we do, she suggested. And we cant expect the doctors or the hospitals to simply pick up the expenses for this out of good will.
M.D. Andersons Mitchell Morris, MD, commented on the value of the NCCN guidelines. They are good starting points for private oncologists or institutions that want to begin thinking systematically about how to treat the most common cancers. They set a foundation for acceptable practice but allow for variability and tailoring to individual needs, he said.
Assessing Quality of Care and Performance
Cancer care in the United States is good, but how can it become absolutely superb? asked Lee Newcomer, MD, of UnitedHealth Group. He suggested three main ways to improve quality: (1) measure physicians performance and correct deficiencies; (2) for rare cancers or complex disease states, use centers of excellence; and (3) when evidence-based data are lacking, enroll patients in clinical trials.
As we do these things, we will start improving cancer care, and it will be a lot more fun to practice medicine, he remarked.
Dr. Newcomer approached the topic of performance measurements by describing a personal experience. Three months after I went to work for the HMO, my boss called me in and said she would like to spend 30 minutes reviewing my performance. She went over a number of objective parameters pertaining to things Id done well, and things I could continue to improve on. What struck me was that I had practiced oncology for the past decade without a single performance review, without seeing any objective performance data, and for that matter, without even a subjective performance review. I used the standards that most clinicians in private practice usedwas my office full, did I have a new set of referrals each day, did I take care of physicians families?and since I answered yes to those questions, I assumed I was performing very well.
Dr. Newcomers experience was not unusual, but the assumption was wrong. According to the UnitedHealth Group database, physicians comply with published standards of care only about 50% of the time. Its not because they are particularly bad physicians. Rather, its because they have never measured their performance. They may not even realize they have a problem, so obviously they have not done anything to solve it, explained Dr. Newcomer.
One needs only to go to the medical literature to substantiate this lack of compliance with standards of care by oncologists. A study by Timothy Lash in the mid-1980s found that 16% of patients with breast cancer were not correctly staged, and another 18% did not receive definitive adjuvant therapy; not unexpectedly, mortality for inaccurately staged patients was 80% higher than mortality for correctly staged patients.
The Physicians Data Corporation, which extracts data from transcribed notes and creates practice profiles, painted a similar picture. However, taking the procedure out of the hands of the average physician is not easy, Dr. Newcomer conceded. Nevertheless, I think an honest discussion about this at your tumor board, medical staff meeting, or department meeting is called for. Start thinking about how to handle the unusual or rare cases, he advised the audience.
Participation in Clinical Trials
Finally, when the answer is not obvious or the condition is unusual, Dr. Newcomer believes that patients should be considered for participation in clinical trials. The National Randomized Trials for Breast Cancer announced at ASCO that 1,300 women participated in trialsbut this means an additional 12,000 women were treated off-trial, from whom we will never get scientific information, he noted.
It is not only the quantity of trials that should be encouraged but also the quality, Dr. Newcomer added, noting that small, nonrandomized trials and case series compete for the same patients as national trials and do not produce the caliber of results that can contribute to clinical decision-making. As a case in point, he said that the 1997 May/June issue of Cancer listed 29 inadequate clinical trials involving stages II, III, and IV breast cancer.
At present, the majority of cancer patients initiate enrollment in clinical trials themselves. Although oncologists agree in principle that they would like to put patients on trials, it doesnt happen, Dr. Newcomer observed. And it is not for lack of coverage. In June 1993, for example, UnitedHealth waived its exclusion for experimental trials and instituted coverage for any patient enrolling in a national breast cancer trial. We had 2 women take us up on that offer, while 600 women were treated off-trial with bone marrow transplants during that time, he said. In December 1998, UnitedHealth expanded coverage to include any cooperative cancer center trial, but only eight patients have enrolled in 6 months, six being self-referrals.
Their oncologists did not recommend trials at all. We need to get rid of the duplication, to prioritize good trials, and to make sure that the patients get on them, Dr. Newcomer stated.
The M. D. Anderson Experience
Patients at M. D. Anderson Cancer Center who are not included in clinical trials are treated under practice guidelines or care pathways derived from research-driven patient care, better known as evidence-based medicine. These programs encompass disease management guidelines and performance measurements, and yield outcome information that can give clini- cians feedback and provide data for further institutional efforts at improvement, according to Mitchell Morris, md, who described M. D. Andersons disease management system to the audience.
The process evolves as follows: a disease site core group reviews the medical literature pertaining to the condition, agrees on basic treatment parameters throughout the continuum of care, and writes guidelines for each subspecialty component of care. Every clinical oncologist at M. D. Anderson reviews the content, after which there is a final peer review process before the guidelines are put in place. These care paths not only guide the day-to-day disease management of patients but also allow for the assessment of overall survival, disease-free survival, toxicity, treatment cost, quality of life, and other functional assessmentsie, they provide the all-important outcome measurements.
According to Dr. Morris, the program is basically a means of formatting and using information that is already being gathered. There is not a single element in our database that we dont already collect when a patient comes in with a history and physical and treatment plan, he said. Its just that we normally collect this information in a format that is relatively useless for structured data.
The new system captures and makes more efficient use of structured data, ultimately eliminates waste (eg, by eliminating tests that do not contribute to outcome), and encourages adherence to the most rational treatment plan. This reduces treatment costs in the long run.
To ensure that the guidelines are readily available and useful, they are provided in an Internet-based system that allows for online viewing, patient enrollment, and disease management. Utilization is controlled through physician order sets (sets of physician orders that outline the tests and procedures [eg, chemotherapy, surgery] for a plan of care). Using order sets reduces variability in ordering patterns by eliminating unnecessary tests and treatments. This has been shown to both lower costs and increase quality of care.
Reductions in Length of Stay, Resource Utilization
Guidelines have been completed for most of the major cancer diagnoses, and almost 12,000 patients have been enrolled in 70 completed care paths to date. In most disease areas, the program has reduced length of hospital stay and resource utilization. Surrogate measures of quality have shown that, even with reductions in costs and earlier hospital discharges, the quality of care has actually been maintained or has even improved, Mr. Morris reported.
For example, in an evaluation of hysterectomies for uterine cancer during three time periods, analysts found that median hospital stay was shortened from 6 to 4 days after the care path was accepted (and is now at 3 days). Laboratory costs were reduced by 35%, and total hospital costs dropped by 20%. There were no readmissions for complications, and a survey indicated that patients were satisfied with length of hospital stay and with the medical personnel.
Similarly, an evaluation of colon resections found that average length of stay was 5.6 days for patients on the care path, compared to 8.7 days for patients treated otherwise; average total costs were $12,000 and $20,000, respectively. The program also streamlined care on the pulmonary service, eliminating 2,000 unnecessary chest x-rays annually without an increase in mortality.
Although the program was enthusiastically embraced by most administrators and some early adapter oncologists, not every physician was immediately sold on the concept, Dr. Morris admitted. As we started to roll out this program of practice guidelines and care paths, we ran into, as one might expect, significant resistance from the physician community. They claimed it was cookbook medicine, represented a loss of independence, and would not be applicable to their more complicated patients. We pointed out, This is not a rigid system but a framework or a guideline for care....We had to show the physicians some data to convince them of the benefits of this program.
Dr. Morris cited several key factors as critical to M. D. Andersons success in creating care pathways for common cancers: (1) establish a sense of urgency with physicians, explaining the need for change; (2) make this a physician-driven process, not a nursing exercise; (3) obtain adequate financial resources; (4) share a group vision and work in a multidisciplinary fashion; (5) keep quality of care, and not cost-savings, as the focus; (6) maintain evidence-based medicine as the programs core.
Future directions at M. D. Anderson may include the alignment of financial incentives with quality-of-care goals. We have to provide value for patients, for payors, and for doctors as well, and I think we are approaching that, he said.