Cancer Economics
Clinical Practice Guidelines: Tools for Raising Quality of Care and
Reducing Costs
Albert B. Einstein, Jr, MD, and Jan Marshburn, MPH
H. Lee Moffitt Cancer Center & Research Institute
Background
As health care markets move rapidly toward managed care, the cost of care in the
practice of medicine has become an overriding consideration, with quality of care
receiving little attention. Managed care firms that are bottom-line-oriented scrutinize
and often ignore academic institutions as providers. These academic institutions, while
bearing the costs of education and research, are often perceived by managed care firms as
inefficient, unwilling to be economically responsible, and expectant that insurance
companies should bear the costs of research and education. However, these same
institutions are charged with training future health care providers who will be required
to function in the managed care environment.
In response to the threat of losing patient access, many academic institutions have
initiated the development of practice guidelines not only to become more cost competitive,
but also - and more importantly - to establish criteria for quality of patient care as
defined by the experts. Clinical practice guidelines have been touted as tools for
standardizing physician practice patterns and thus reducing costs and increasing
efficiency.
The Institute of Medicine defines practice guidelines as systematically developed
statements to assist practitioner and patient decisions regarding appropriate health care
for specific clinical circumstances.[1] The Agency for Health Care Policy and Research
(AHCPR), the American Medical Association (AMA), and other organizations have defined
criteria for effective practice guidelines. Organizations must have both the clinical and
the scientific expertise in the content of the guidelines, and physicians who will
implement those guidelines must be involved in their development. A guideline must be
linked to the scientific evidence on which it is based, as well as to the outcomes it is
expected to produce. According to theories of quality improvement, patient outcomes cannot
be improved without first understanding and standardizing the process of care.
Developing Clinical Practice Guidelines
Our institution is a freestanding, 163-bed cancer hospital and research center
affiliated with the University of South Florida (USF) in Tampa, Florida. The medical staff
is comprised of full-time faculty of the USF College of Medicine. Oncology services are
coordinated and provided through multidisciplinary teams that function within disease-site
programs. This structure provides patients with access to the full range of oncology
expertise and services throughout the disease process. Issues impacting clinical care are
discussed routinely in program meetings and in bimonthly meetings of our Clinical Affairs
Council.
Recognition of the rapidly increasing trend toward managed care in our geographic area
led to an increased awareness by clinical staff of the need to reduce clinical costs by
reducing variability in practice. As an academic institution, we have the clinical,
research, and administrative expertise to support practice guideline development. A
community oncology network spanning the surrounding five-county area provides a means for
external validation and local dissemination of guidelines. The paucity of available
guidelines for oncology diagnosis and care provided the opportunity to demonstrate
leadership within the cancer community.
In July 1995, our Clinical Affairs Council considered a proposal for the development of
clinical practice guidelines. We anticipated that the process would promote changes in
clinical practice to further enhance the quality and value of services and to position our
center competitively as managed care evolved in our local area. The specific purposes of
the guideline development process were:
- to describe the optimal treatment plan for cancer patients based on cancer site, disease
stage, and treatment complications;
- to ensure that clinical practice is consistent with state-of-art scientific knowledge;
- to identify areas in which variability in treatment regimens is high;
- to achieve consensus regarding treatment options;
- to improve cost efficiency in clinical practice;
- to promote continual learning through application of evidence-based medicine;
- to enhance communication among physicians, health care professionals, and patients
regarding treatment options;
- to identify opportunities for future clinical research;
- to identify patient clinical and economic outcomes associated with practice guidelines;
and
- to provide educational tools for resident physicians, fellows, nurses, and other health
care professionals.
Establishing Clinical Practice Guidelines
Anticipating the rigor and time constraints involved in guideline development, we
established priorities for cancer sites that represent high volume, high cost, or
exceptional variability within the institution. To facilitate progress, an agenda was
developed to establish goals, to define the methodology, to assign responsibilities, and
to designate a time frame for completion. A specialist in developing clinical practice
guidelines was assigned to provide methodologic support to the overall effort. Other
support staff from information systems, library resources, finance, quality assurance, and
administration were recruited.
Multidisciplinary groups were formed within each disease-site program including
representatives from surgery, medical oncology, radiation oncology, pathology, nursing,
and pharmacy. These groups addressed cancer treatment from the point of diagnosis through
staging, treatment, and follow-up, thereby providing a plan for disease management
throughout the continuum of care.
A review of existing oncology guidelines was conducted by each disease-site program. At
the onset of activity in the fall of 1995, few organizations had published cancer
site-specific guidelines. Cancer guidelines developed through AHCPR and AMA were limited
to screening and early detection. However, guidelines by the Society of Surgical Oncology
published in November 1995 were useful sources of information.
Guidelines were based on an annotated algorithm approach. The flowchart format was
consistent with that described by AHCPR.[2] These broad-based algorithms were used to
identify the major decision factors that assign patients to different treatment paths.
They also were used to establish current practice and to identify areas needing further
research or consensus. Procedural detail and citations to the scientific literature were
provided in the annotations.
Our methodology included an evidence-based review of the scientific literature. A
formal literature search was conducted with assistance from medical librarians who
accessed MEDLINE, CANCERLIT, HSTAT, and other medical databases. Review of the current
literature was assigned to individual team members who were responsible for leading
discussions in his or her area of expertise. When evidence from published clinical trials
was lacking, institutional studies and expert consensus were considered and analyzed.
Thus, our guidelines were developed by a combination of evidence-based and consensus-based
methodologies.
As guidelines were completed, they were disseminated internally and to community
oncologists for review. Selected guidelines have been presented to regional and national
professional organizations.
As part of the guideline development process, patient outcomes were identified for
monitoring, including survival, financial consequences, patient satisfaction, service use,
complications, and quality of life. A performance report is being developed to disseminate
data on outcomes across categories to physicians and managers. This information will be
used to identify interventions for improving quality and initiating benchmarking
activities.
Implementing Clinical Practice Guidelines
Clinical guidelines are intended to be descriptions of the optimal manner in which
patients with cancer are managed. Guidelines are based on disease site and stage as
determined by the multidisciplinary teams at our center. They are not applicable to all
patients with a particular disease site and stage, since individual characteristics may
dictate other approaches be used for their management. Deviations from these guidelines
can be justified by the comorbid characteristics of the patient, the unique
characteristics of the cancer, and preferences of the patient. The treating physician will
need to use his or her own judgment regarding the application of scientific knowledge,
these guidelines, or other guidelines in the management of individual patients.
Our guidelines were designed to establish optimal management approaches for cancer
patients with similar conditions and risk factors. Clinical pathways are now being
developed that define high-volume, high-cost procedures to achieve the highest quality of
care at the lowest cost. Our guidelines will be reviewed and revised regularly to
integrate new information on disease management. As it becomes available, appropriate
computer software will be used within the context of our guidelines to manage cancer care
in our institution and community network, to evaluate costs and clinical outcomes, and to
monitor use. We hope our guidelines will be critically reviewed and compared with other
guidelines or will serve as models for some providers.
This issue of Cancer Control features a summary of the first of a series of
site-specific clinical practice guidelines that we have developed. They cover the most
common gynecologic neoplasms. Subsequent issues will feature other disease site-oriented
guidelines.
References
- Institute of Medicine, Committee to Advise the Public Health Service on Clinical
Practice Guidelines. In: Field MJ, Lohr KN, eds. Clinical Practice Guidelines:
Directions for a New Program. Washington, DC: National Academy Press;1990.
- Using Clinical Practice Guidelines to Evaluate Quality of Care. AHCPR, Public
Health Service, US Department of Health and Human Services. AHCPR Publication No 95-0046,
Vol 2, March 1995.
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