A Resource for Measuring and Improving Patient Outcomes
The Glioma Outcomes Project (GO Project) is designed to conduct outcomes research and develop educational materials that benefit patients with glioma. An advisory committee of neuro-radiologists, neuro-oncologists and neurosurgeons has established the policies governing this project and controls the dissemination of aggregate data on treatment practices and outcomes.
Key objectives of the GO Project are to:
- identify opportunities to improve the quality of care for patients with glioma,
- describe diagnostic and treatment strategies and patient outcomes,
- provide physicians with data to evaluate and improve their practices,
- publish objective data on temporal trends and regional differences in the care of patients with glioma, and
- develop hypotheses for future clinical trials.
As a first step toward improving the care of patients with glioma, a national cooperative database of glioma outcomes is being developed. This database is designed to:
1) guide the development of educational projects to improve the care of patients with glioma.
2) provide a mechanism for physicians to evaluate the impact of their diagnostic and therapeutic decisions in a manner that is timely, confidential and objective.
3) track patient-reported functional status and quality of life following glioma surgery.
The GO Project will promote the improvement of outcomes for patients with glioma by publishing key findings of the database and by developing and disseminating educational materials for both physicians and patients. This project has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Tumors. A pilot project will begin in Summer, 1997. The pilot will include between 20 to 40 centers from across the US that will each submit at least 20 cases to the study during a six-month enrollment period. Patients will be followed at three-month intervals for up to two years following surgery for glioma.
In the United States, the incidence of glioma has been estimated to be 20,000 cases per year. The prevalence of glioma is also estimated to be 20,000 cases per year, illustrating the limited prognosis for these patients. Existing databases are based on tumor registry data, which contain basic pathologic and clinical data, but which do not contain patient-reports of health status and quality of life, and do not provide data to follow changes in health status and quality of life over the course of treatment. Thus, the impact of glioma management on patients is difficult to ascertain from existing databases.
The time is right to start a cooperative glioma outcomes database. The pace of basic and clinical glioma research is increasing. The recently approved GLIADEL® WAFER (polifeprosan 20 with carmustine implant) is an example of a new therapy that appears likely to improve the outcomes of patients with glioma. A large, national database of glioma outcomes will provide valuable data for the evaluation and improvement of patient care. In addition, this database will provide an opportunity to track trends in glioma care, including natural history, risk factors, diagnostic approaches and treatment methods.
Background to Outcomes Assessment
Most physicians have little or no opportunity for ongoing, objective feedback about the relationship between their patterns of clinical practice and patient outcomes. Moreover, physicians may change practices in response to anecdotal information, such as a particularly good (or bad) outcome in an individual patient, which may not be representative of their overall clinical experience. Clearly, physicians need, but seldom have access to, benchmark data that allow comparison of individual practice patterns and outcomes with the experiences of their peers in caring for comparable patients.
The outcomes movement was founded on the principle that patient care will improve if physicians are provided with timely and credible information linking local clinical practices and patient outcomes. The outcomes movement combines features of clinical research, continuing medical education, and quality assurance. Patient outcomes can be characterized in terms of at least seven distinct dimensions, including clinical factors, death, disease, functional status, well-being, satisfaction and cost.
While the concept that improvement in standards of care must include continuous assessment of individual patient outcomes was proposed in 1914 by E.A. Codman, a Boston surgeon, the recent rebirth of the outcomes concept is widely attributed to Paul Ellwood's 1988 Shattuck Memorial Lecture "Outcomes Management: A Technology of Patient Experience." In less than ten years, the concept of health outcomes assessment has gone from the relatively obscure domain of health services research to one of the most widely discussed topics in health care, including strong interest by hospitals, insurers, employers, and professional medical societies.
Despite their common interest in health outcomes, it is apparent that these players do not have the same priorities. When they think of outcomes assessment, payers think primarily of the opportunity for cost savings (achieved by denying payment for interventions that do not produce measurable improvements in outcome). Providers think primarily of improving the quality of care (achieved by promoting practices that lead to improved outcomes). Outcomes assessment is also critical to the development and validation of clinical practice guidelines. Given the pressures of the new managed care environment, costly treatment practices may be rationed or eliminated unless their benefit can be documented. To ensure that fair and valid criteria are applied, it is essential that physicians become leaders in the design and evaluation of outcomes studies. It is increasingly important for neuro-oncologists and neurosurgeons to demonstrate that they provide care that leads to superior outcomes, particularly in comparison with care rendered by other practitioners. Payers are rapidly shifting the burden of health care costs to hospitals and providers. Hospital administrators are under intense pressure to reduce their costs of providing care. Increasingly, this is being accomplished by limiting access to specialists.
While the outcomes movement has received extensive attention and the concepts are both simple and appealing, putting these concepts into practice has proved more difficult than anticipated. The resources necessary to conduct outcomes research are significant and include:
- definition of data elements,
- design of data collection forms,
- data collection,
- creation of computer databases,
- data entry,
- data analysis, and
- distribution of individual and aggregate data to participating physicians.
Stumbling blocks include the decision of which outcomes to measure, limitations of hospital information systems as sources of outcomes data, lack of an adequate number of patients for meaningful analysis, and the challenge of obtaining comparable benchmarks. Also, with the possible exception of high-volume, high-cost conditions, such as total hip arthroplasty or cardiac surgery, hospitals have been unwilling to commit the resources required to adequately monitor clinical outcomes.
In rare diseases, adequate sample size can only be achieved by large, collaborative databases. Individual physicians and hospitals seldom see a volume of patients sufficient to develop a cohort of patients with glioma to adequately define the relationship between clinical practices and patient outcomes.
The GO Project will provide a unique opportunity to improve clinical outcomes in glioma through routine monitoring of outcomes data, combined with regular reports to participating physicians. The GO Project Advisory Committee will use this database to monitor practices in the care of patients with glioma. The Advisory Committee will continually compare current clinical practices with the latest findings from controlled clinical trials. Where clinical practices are found to be less than optimal, feedback will be provided to physicians through newsletters, journal articles and presentations at regional and national meetings. Where large variations in practices are observed, without a scientific basis to advise physicians concerning the optimal practice, the GO Project Advisory Committee will apprise the research community of the need for more controlled clinical trials in these areas.
Participating neurosurgeons will complete standard data forms for their patients who undergo surgery for glioma. It is intended that this will require no more than 10 to 15-minutes per visit. It will often be possible for a nurse or physician's assistant to collect these data. Additional self-reported outcomes data will be obtained using patient surveys. Data will be collected at predetermined intervals.
These data will allow assessment of important outcomes, including changes in functional capacity, general health status and rates of complications. Sociodemographic and clinical characteristics will be collected to allow stratification of cases into important subgroups, for example, site of onset, disease duration, and types of treatment.
A data coordinating center has been established in the Center for Outcomes Research at the University of Massachusetts Medical Center. The center will obtain IRB approval for this project, provide a model IRB application to participants, distribute data collection forms and instructions to participating sites, keep a log of enrolled patients and physicians, mail follow-up data forms to study patients at 3-month intervals, perform data analysis, and promote the publication of aggregate data.
The director of the Center for Outcomes Research at the University of Massachusetts Medical Center has been entrusted with the responsibility to protect the rights and confidentiality of patients, physicians and hospitals participating in the GO Project. Provisions for the protection of patients participating in this research project have been reviewed and approved by the Institutional Review Board (IRB) at the University of Massachusetts Medical Center. A model IRB application will be supplied to participating physicians.
Acting as trustee for participating physicians and patients, the GO Project Advisory Committee retains all authority for the rules governing the operation of this project, including the dissemination of aggregate findings and development of educational materials. The Advisory Committee is comprised of clinical scientists, neuro-oncologists and neurosurgeons with a special interest in glioma. The Committee is independent and will work cooperatively with all parties interested in advancing the care of glioma patients, including, but not limited to, patient advocacy groups and professional societies.
As a service to physicians and their patients, Rhône-Poulenc Rorer Pharmaceuticals (RPR) will provide financial support for this project through an unrestricted grant. This support has been guaranteed for a minimum of two years. RPR is not interested in influencing the variables collected or in gaining access to data concerning the outcomes of specific hospitals/physicians/patients. If RPR should decide to limit or discontinue its support of the GO Project, they will assist the Advisory Committee to identify an alternate source of financial support, for example, a commercial sponsor, patient advocacy group or a professional medical society.
The GO Project represents an exciting new initiative that will provide the opportunity to improve the care of patients. The long-term goal is to ensure a uniformly high standard of care for all patients. By obtaining data on practice patterns and patient outcomes, we hope to identify and advocate the best approach to caring for patients with glioma.