In the 1990s, the focus of health care research began to shift toward outcomes, effectiveness, and efficiencies. The Agency for Health Care Policy and Research (AHCPR) was legislatively charged with initiating programs and research to provide a more rational basis for decisions about which treatments to offer and which technologies to purchase. Dr. Clifton Gaus, the agency administrator, represents the mission of AHCPR in terms of a quality-accountability continuum (Figure 1) . Basic science and biomedical research precede this continuum or provide a basis for the type of health services research that AHCPR sponsors. Outcomes and effectiveness research, clinical practice guidelines, technology assessments, and the science of quality measurement are the necessary ingredients to yield outcomes management (the assessment of clinical practice) and institutional or individual accountability.
The computer-based patient record is the most useful tool to manage the data from outcomes, effectiveness, and efficiencies research. In the outcomes initiative, we define "effectiveness" as outcomes experienced by, or observed in, patients in routine clinical practice. This is distinct from "efficacy," which refers to the potential benefit of clinical interventions provided under ideal circumstances to patients who meet specific criteria. "Cost effectiveness" summarizes the cost and effect of treatment in terms of specified outcomes measured in nonmonetary units; it indicates value obtained for resources expended. In the past, the concept that "knowledge is power" held sway, but this has shifted in a market-driven system to the concept that "knowledge is money" .
Outcomes data are an integration of administration and patient care data for determining outcomes and resource management. Outcomes are only one part of the assessment of a health system's performance. Other components include access, utilization, cost, resources, and patient satisfaction.
The focus of outcomes is also moving toward transaction-information-based patterns of care and quality of care measurement. This type of focus emphasizes the use of clinical practice guidelines. Recently, attention has centered on the possibility of using clinical practice guidelines developed by AHCPR as content driving the computerized patient record . Others have described the placement of clinical practice guidelines on the physician workstation to provide access to up-to-date information .
Guidelines can be useful in managing care, since they define the appropriate diagnostic and treatment interventions/procedures to achieve outcomes while reducing variability in practice. The computer programmed with clinical practice guideline content can lead to improved collection of data and act as a decision platform upon which to guide practice . Practice guidelines include recommendations for diagnostic and treatment procedures that might be overlooked in the routine delivery of care, but they still require clinician decision making, since many options are provided.
This manuscript describes the need for integration of the concepts of outcomes data management, clinical practice guidelines, and the development of review criteria to provide feedback systems to monitor critical paths (clinical pathways) and performance measures (benchmarks of care), and ultimately cost out care through the computer-based patient record. The examples given in this manuscript relate to oncology care, but other conditions could be substituted.
One definition of outcomes is the end result of a treatment or intervention. While this definition looks and sounds simple, in actual practice establishing realistic and measurable outcomes is more difficult. Many types of outcomes are being used in a variety of types of health services research. Outcomes management examines the treatment of clinical conditions rather than individual procedures or treatments. It is the systematic assessment of clinical practice, encompassing outcomes that are relevant to patients--mortality, morbidity, complications, symptom reduction, functional improvement--as well as physiologic and biologic indicators. It involves all reasonably held theories and alternative clinical practice interventions .
Many of the concepts of outcome management are wrapped up in the terms health status and health-related quality of life (HRQOL). Health status measures a patient's clinical, biological, and physiological status such as morbidity, mortality, blood pressure, hemoglobin, and temperature. Health-related quality of life measures physical function such as activities of daily living (ADLs), instrumental ADLs (eg, medication administration), emotional and psychological functioning and well-being, social functioning and support, role functioning, general health perceptions, pain, vitality (energy/fatigue), and cognitive functioning.
One method of monitoring outcomes in the computerized patient record is the use of disease-specific health status and health-related quality of life measurements. The tools to measure health status and quality of life, however, have been described for only a few diseases and conditions.
Once the health status or health-related quality of life indicators are chosen for specific diseases or conditions, patient trends for groups of patients with the same condition can be monitored. These types of systems help to define episodes of care, ie, when a patient's problem began and when it "ended," and also which procedures were attached to which episode or patient condition.
The socioeconomic and sociodemographic characteristics of patients are often forgotten in defining content in databases to monitor outcomes. Unless the computer database is built interrelating patient outcomes with patient demographics, it is difficult to determine if the outcomes of the condition are a result of practitioner interventions or the patient's environmental, demographic, social, or economic conditions. For example, it is difficult to determine patients' responses to chemotherapy when they are also taking megadoses of vitamins, changing diet, and consuming enormous volumes of shark cartilage. Similarly, it is more challenging to manage patients who are homeless than those who have a residence.
Demographic data are also needed to relate the role and influence of comorbidities, eg, history of substance abuse, age of patient, obesity, or failure of previous treatment interventions. Different outcomes can be expected after breast cancer surgery for a 65-year-old patient with no comorbidities and a 65-year-old patient who also has insulin-dependent diabetes, a history of congestive heart failure, and hypertension.
Two other forgotten areas to monitor for outcomes are safety and claims databases. The safety database includes error reports, falls, and other patient liabilities. The claims database includes not only patient liabilities but also personnel or employee claims for back injuries, falls, and workmen's compensation claims.
Table 1 is a composite list of data requirements in the patient record for better integration of outcomes with patient care [6-8].
The activities of the AHCPR include research efforts, the development of clinical guidelines, and technology assessments. The Medical Treatment Effectiveness Program (MEDTEP) research portfolio includes studies designed to describe breast cancer screening policies and practice; evaluate practice variations and costs of cancer; study hysterectomy outcomes (a community-based study); identify treatment choices and outcomes in prostate cancer, ie, TURP versus open prostatectomy or nonoperative treatments; examine regional variations in cancer treatment and mortality; study the impact of a physician's insurer on early cancer detection; evaluate breast and colon screening by cancer mortality; study cancer prevention for minority women in a Medicaid HMO; and perform a retrospective survival analysis for prostate cancer.
Large PORT (patient outcomes research team) studies in oncology include the assessment of therapies for benign prostatic hypertrophy and localized prostate cancer (Dr. Wennberg, Dartmouth) and a new PORT II project concerning the care, costs, and outcomes of localized breast cancer (Dr. Hadley, Georgetown University) and prostatic disease (Dr. Barry, Boston).
The AHCPR also funds a number of Research Centers on Minority Populations. Those that focus on cancer include the University of California-San Francisco, Henry Ford Hospital in Detroit, Pacific Health Research Institute in Honolulu, and the University of New Mexico, Albuquerque.
Clinical practice guidelines developed by the AHCPR that are useful to the oncologist include those on acute pain management; depression detection, diagnosis, and treatment; benign prostatic hyperplasia; quality determinants of mammography; and the management of cancer pain.
The AHCPR technology assessment program has conducted assessments of the selection criteria for hyperthermia in conjunction with cancer chemotherapy and the use of autologous peripheral stem cell transplantation. In addition, health technology reviews have been published on lymphedema pumps, pneumatic compression devices, external and implantable infusion pumps, and hematopoietic stem cell transplantation for multiple myeloma.