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Clinical Studies

AIDS/HIV

Outcomes of Pharmaceutical Therapy of HIV Disease
Grant/Contract Number: HS07809
Project Period: 02/93-01/98
Principal Investigator: Richard D. Moore, M.D.
Institution: Johns Hopkins University
Baltimore, MD 21205
Purpose: To (1) develop a comprehensive longitudinal database of human immunodeficiency virus (HIV) infected individuals cared for in an urban setting, (2) examine the effectiveness of antiretroviral and antimicrobial therapies in preventing progression of HIV disease and its complications, (3) determine the association of surrogate laboratory markers with clinical outcomes, (4) delineate the frequency and consistency of prescription drug use, and (5) identify the sociodemographic and clinical patient characteristics associated with consistent use of and response to drug therapy.

Cost Effective Management of HIV Related Illness
Grant/Contract Number: HS06694
Project Period: 07/90-06/93
Principal Investigator: Anna N.A. Tosteson, Sc.D.
Institution: Dartmouth Medical School
Lebanon, NH 03756
Purpose: To (1) develop a model for HIV infected patients presenting with central nervous system disorders (CNS model), (2) integrate the CNS model with previously developed models for respiratory disorders, and (3) explore the feasibility of developing a natural clinical history model of HIV infection. The CNS model assessed the life expectancy, quality adjusted life expectancy, short term morbidity, cost, and cost effectiveness of all clinically reasonable management strategies.

A Health Status Measure to Evaluate Drug Therapy for PCP
Grant/Contract Number: HS07824
Project Period: 09/93-08/95
Principal Investigator: Albert W. Wu, M.D., M.P.H.
Institution: Johns Hopkins University
Baltimore, MD 21205
Purpose: To examine the reliability and validity of a brief health status measure for acquired immunodeficiency syndrome (AIDS) patients infected with Pneumocystis carinii pneumonia (PCP). The study analyzed data collected in a randomized AIDS clinical trial comparing three treatment regimens for acute PCP. The results help in planning future AIDS trials incorporating health status measures.

Cancer

Prostate Cancer: A Retrospective Survival Analysis
Grant/Contract Number: HS06770
Project Period: 04/91-07/94
Principal Investigator: Peter C. Albertsen, M.D., M.S.
Institution:University of Connecticut
Farmington, CT 06032-9984
Purpose: To calculate the disease-specific mortality rate for conservatively treated localized prostate cancer. Using a detailed retrospective analysis, the study compared this rate with the general population of men alive during the same time period. The implications of the findings for clinical practice and health policy and future research are important. The study led to a better understanding of the natural progression of prostate cancer and provided the necessary statistical and ethical foundation for constructing case-control studies and treatment algorithms.

Breast and Colon Screening Evaluated by Cancer Mortality
Grant/Contract Number: HS07038
Project Period: 12/91-02/97
Principal Investigator: Graham A. Colditz, M.D., Dr.P.H.
Institution: Channing Laboratory
Boston, MA 02115
Purpose: To evaluate the effectiveness of screening for breast and colon cancers. Breast screening behaviors are being evaluated in relation to age-specific breast cancer mortality during 5 years of followup. Using data from the Health Professionals Follow-up Study and Nurses' Health Study, a model of colon cancer incidence and mortality will be developed to estimate the number of colon cancers prevented through screening.

Care, Costs, and Outcomes of Local Breast Cancer (PORT II)
Grant/Contract Number: HS08395
Project Period: 09/94-09/99
Principal Investigator: Jack Hadley, Ph.D.
Institution: Georgetown University Medical Center
Washington, DC 20007
Purpose: To identify the determinants of and calculate cost-effectiveness ratios for three alternative treatments for local breast cancer in the elderly: modified radical mastectomy (MRM), breast-conserving surgery (BCS) with radiotherapy (RT), and BCS without RT. A prospective convenience cohort of newly diagnosed elderly (65+) breast cancer patients are being interviewed post treatment and followed for up to 2 years; their surgeons are being surveyed; and surveys of nationally representative, retrospective, random samples of breast cancer surgeons and their patients are being conducted. The project will develop clear recommendations regarding the appropriateness of observed patterns of treating local breast cancer in the elderly, taking account of circumstances that may differ with age, initial health, and access to different types of providers.

Cancer Prevention for Minority Women in a Medicaid HMO
Grant/Contract Number: HS07720
Project Period: 09/93-09/96
Principal Investigator: Alan L. Hillman, M.D., M.B.A.
Institution: University of Pennsylvania
Philadelphia, PA 19104-6218
Purpose: To investigate the impact of feedback and financial incentives on compliance with cancer screening guidelines in a mandatory Medicaid health maintenance organization. With a focus on improving the quality of care delivered to a traditionally underserved minority population, the study investigated whether the provision of feedback to primary care sites every 6 months, when linked to a financial bonus program specifically based on the extent of cancer prevention provided, improves on primary care provider attention to prevention for women aged 50 years and older. Approximately 100 primary care sites participated in the prospective, randomized controlled study. Computerized scoring algorithms were used to determine compliance.

Enhanced Accuracy of MRI for Staging Prostate Cancer
Grant/Contract Number: HS07027
Project Period: 12/91-12/95
Principal Investigator: Barbara J. McNeil, M.D., Ph.D.
Institution: Harvard Medical School
Boston, MA 02115
Purpose: To identify the perceptual features of magnetic resonance imaging (MRI) that are diagnostically relevant and to aid the image reader in numerically scaling those features and combining them into an estimate of the probability of the disease stage in question. An evaluation involving five MRI readers was conducted to compare their average accuracy in reading the cases in the standard manner with their average accuracy in reading as enhanced by perceptual and decision techniques. Steps in this project included interviews and consensus meetings with experts, perceptual studies, and psychometric analyses.

Evaluation of Practice Variations and Costs for Cancer
Grant/Contract Number: HS06589
Project Period: 08/91-07/94
Principal Investigator: Sheldon M. Retchin, M.D., M.S.P.H.
Institution: Medical College of Virginia
Richmond, VA 23298-0270
Purpose: To (1) evaluate the choice of initial treatment for cancer; (2) assess the influence of initial choice of therapy, patient characteristics, tumor characteristics, comorbidity, and geographic location on outcomes; and (3) estimate the costs of cancer care according to patient characteristics, tumor stage, type of cancer, as well as comorbid illnesses. The study used tumor registry, Medicare claims, and state personal income tax data. The results help policymakers in their efforts to reduce practice variations and therefore improve the effectiveness of care for cancer patients.

Regional Variation in Cancer Treatment and Mortality
Grant/Contract Number: HS06879
Project Period: 04/91-07/93
Principal Investigator: Jonathan M. Samet, M.D., M.S.
Institution: The Johns Hopkins University
Baltimore, MD 21205-2179
Purpose: To develop a comprehensive multivariate model of the risk of death and other adverse health outcomes as functions of a common set of important risk factors, using data from the 1987 National Health and Nutrition Examination Survey Epidemiological Follow-up Study. The model provided a picture of the impact of different risk factors on health. It permitted the effects of a wide variety of interventions against those risk factors to be estimated in a common framework so that valid comparisons could be made across interventions.

Treatment Choices and Outcomes in Prostate Cancer (II)
Grant/Contract Number: HS08208
Project Period: 04/94-03/99
Principal Investigator: James A. Talcott, M.D., S.M.
Institution: Dana Farber Cancer Institute
Boston, MA 02115
Purpose: To enhance the understanding of treatment for early prostate cancer by extending the project's multidisciplinary, multi-institutional pilot study to an additional 600 patients. The purpose of the pilot study is to develop the most effective approach to creating a large scale database to assess global and disease specific health and symptom status before treatment, and 3 and 12 months later. The project assesses issues of generalizability by comparing the results of the study with a population-based cohort of early prostate cancer patients in Hartford, Conn., and a cross sectional survey of patients in a California health maintenance organization. It also evaluates the economic costs of alternative treatments, including indirect costs.

Treatment Choices and Outcomes in Prostate Cancer (I)
Grant/Contract Number: HS06824
Project Period: 01/92-12/93
Principal Investigator: James A. Talcott, M.D., S.M.
Institution: Dana Farber Cancer Institute
Boston, MA 02115
Purpose: To characterize (1) the appropriateness of staging studies preceding therapy for newly diagnosed early prostate cancer patients; (2) the variability in treatment choices; and (3) patient functional, psychosocial, and psychosexual outcomes 6 months after treatment, and the factors influencing each of these outcomes. This multidisciplinary, multi institutional pilot study tested the feasibility of collecting highly detailed information from newly diagnosed cancer patients, and provided descriptive, hypothesis generating data necessary to design definitive studies of treatment variability, patient decision making, and functional outcomes of treated patients with early prostate cancer.

Breast Cancer Screening Policy and Practice
Grant/Contract Number: HS06545
Project Period: 09/91-09/94
Principal Investigator: Thomas R. Taylor, M.D., Ph.D.
Institution: University of Washington
Seattle, WA 98195
Purpose: To (1) describe primary care physician performance related to screening mammography in a randomly selected group of family medicine practices, (2) identify factors associated with differences in primary care physician decision policies and practice, and (3) test the efficacy of an educational intervention based on physician decision policies in improving physician breast cancer screening practice. Reviews of medical records were conducted to examine the characteristics of 60 randomly selected practices, and 236 practices were randomly assigned to one of two interventions or a control group.

Cardiovascular Disease

Right Heart Catheterization: Appropriate/Effective Use
Grant/Contract Number: HS08354
Project Period: 07/96-06/98
Principal Investigator: Alfred F. Connors, Jr., M.D.
University of Virginia
Charlottesville, VA 22908
Purpose: To determine the (1) the effectiveness of right heart catheterization (RHC) in terms of survival, functional status, quality of life, and satisfaction with care; (2) variation in use of RHC in seriously ill patients; and (3) association of RHC and utilization of resources in the critically ill. The study will use the Cleveland Health Quality Choice Project, the APACHE III, and the SUPPORT datasets. These datasets are designed to allow adjustment for severity of illness, diagnosis, acute physiology, and other important patient characteristics; demonstrate large interhospital differences in use of RHC; and are representative of both critically ill patients in general and of the current use of RHC. The results of this study will be of direct relevance to health policy makers, to purchasers of medical care, to physicians and their patients who seek guidance in the effective use of RHC, and to investigators who wish to refine the indications for use of this common and expensive technology.

Outcome Assessment Program in Ischemic Heart Disease (PORT)
Grant/Contract Number: HS06503
Project Period: 07/90-12/95
Principal Investigator: Elizabeth R. DeLong, Ph.D.
Institution: Clinical Research Institute
Durham, NC 27705
Purpose: To identify sources of variation in the medical care of patients with chronic ischemic heart disease. The study aimed to (1) develop strategies for the appropriate referral of patients for cardiac catheterization and for the revascularization with either coronary angioplasty or bypass surgery; and (2) examine the variations in the use of cardiac catheterization, angioplasty, and bypass surgery that result in adverse outcomes or inappropriate use of resources.

CORSAGE: A Hybrid Expert System for Myocardial Infarction
Grant/Contract Number: HS06065
Project Period: 07/88-06/93
Principal Investigator: George A. Diamond, M.D.
Institution: Cedars Sinai Medical Center
Los Angeles, CA 90048
Purpose: To develop and evaluate an expert system called CORSAGE, which serves as an interface between a relevant clinical database and the practicing physician. It also aids the management of patients admitted to the coronary care unit with a suspected myocardial infarction. By implementing CORSAGE, the monetary cost of care, length of hospital stay, subsequent coronary event rate, and quality of life will be measured. The study quantified physician acceptance and used epidemiologic followup and psychosocial assessment to determine the impact on patient management.

Outcomes Following Community Interventions for Acute MI
Grant/Contract Number: HS06473
Project Period: 04/91-03/95
Principal Investigator: Mickey S. Eisenberg, M.D., Ph.D.
Institution: Kings County Emergency Medical Services
Seattle, WA 98164
Purpose: To measure the effectiveness of interventions encouraging people with symptoms of an acute myocardial infarction (AMI) to seek medical care early and to call 911 for paramedic evaluation to reduce AMI mortality. Two types of interventions were tested: (1) personalized mailings and (2) mailings and a phone call from a public health nurse. Each intervention had a control group to be compared with, and each was preceded by an awareness campaign via television and radio. Outcomes of this prospective, randomized trial were determined by a community wide hospital surveillance system.

Cost/Utility of Stroke Prevention
Grant/Contract Number: HS06098
Project Period: 12/88-12/93
Principal Investigator: Theodore G. Ganiats, M.D.
Institution: University of California
La Jolla, CA 92093-0807
Purpose: To evaluate the relative benefit cost/utility of various practice styles across the United States, using the General Health Policy Model and Quality of Well Being questionnaire. The project worked in conjunction with medical schools involved in two National Institutes of Health (NIH) studies of two significant risk factors of stroke: asymptomatic carotid atherosclerosis and nonvalvular atrial fibrillation. Telephone interviews focusing on quality of life issues were conducted with all consenting participants of both NIH studies. The results of the study helped to inform physicians in making treatment decisions by adding quality of life information to the NIH studies.

Effectiveness/Outcomes Linkages in CHF by Neurocomputing
Grant/Contract Number: HS06830
Project Period: 09/93-08/97
Principal Investigator: Philip H. Goodman, M.D., M.S.
Institution: University of Nevada
Reno, NV 89520
Purpose: To (1) evaluate the usefulness of neurocomputational techniques for extracting clinically meaningful information from massive health care databases; (2) exploit the ability of neural networks to discern multivariate patterns (i.e., cluster meaningful local interactions among predictor variables) in order to select important predictors and detect heretofore unanticipated patterns of comorbidity, service utilization, and practice style; and (3) obtain practical health services results useful for concurrently evaluating and improving the practice of coronary artery bypass surgery. The study is using case and administrative records.

Diagnostic Uncertainty and Variation in Use of Services
Grant/Contract Number: HS06409
Project Period: 09/90-12/92
Principal Investigator: Lee A. Green, M.D., M.P.H.
Institution: University of Michigan
Ann Arbor, MI 48109-0708
Purpose: To demonstrate that differences in hospital admission rates for acute ischemic heart disease result directly from different physician decision making patterns, and to show that the differences are concentrated among those patients presenting the greatest uncertainty in diagnosis. This study was accomplished by comparing doctors' hospital admission decisions under conditions of uncertainty in two demographically similar communities with differing rates of hospital use. A retrospective examination of decisions to admit or release approximately 1,000 patients was conducted.

Assessing Risk Factors and Hospital Quality for CABG
Grant/Contract Number: HS07086
Project Period: 09/91-09/94
Principal Investigator: Edward L. Hannan, Ph.D., M.S.
Institution: State University of New York
Rensselaer, NY 12144-3456
Purpose: To (1) determine which preoperative risk factors are significantly related to the probability of a coronary artery bypass graft (CABG) patient experiencing an in-hospital mortality or perioperative complicatio; and (2) use this information to assess the relative quality of care provided by hospitals and surgeons performing CABG. This project, an extension of a previous study conducted by the investigators, used a new and substantially expanded database to identify preoperative risk factors and to relate them to perioperative complications.

Cardiac Arrhythmia Management: Patient and Economic Outcomes (PORT II)
Grant/Contract Number: HS08362
Project Period: 08/94-07/99
Principal Investigator: Mark A. Hlatky, M.D.
Institution: Stanford University
Stanford, CA 94305-5092
Purpose: To develop a comprehensive decision model to screen and treat patients at risk for sudden cardiac death due to ventricular arrhythmias. Information regarding mortality, morbidity, functional status, quality of life, cost, and patient preferences are being incorporated in the model. Six interrelated projects are being performed to accomplish this goal. The study involves use of administrative data and a nested case control study to determine risk factors.

CNNC and Outcomes in Cardiovascular Surgical Population
Grant/Contract Number: HS06611
Project Period: 08/90-08/91
Principal Investigator: Mary E. Kerr, Ph.D., R.N.
Institution: University of Pittsburgh
Pittsburgh, PA 15261
Purpose: To examine the effectiveness of a taxonomy of nursing diagnoses—Conditions that Necessitate Nursing Care (CNNC)—in predicting selected patient outcomes following cardiovascular surgery. The nursing care needs were measured at four time points: (1) at hospital admission, (2) 24 hours after surgery, (3) when transferred from the intensive care unit, and (4) on the day of discharge. Functional health status and quality of life factors were also measured in 100 patients undergoing coronary artery bypass graft surgery. This study provided health care institutions with a method to assess the effect of nursing care on patient outcomes.

Cardiac Procedure Use: A Prospective Cohort Study
Grant/Contract Number: HS08302
Project Period: 09/96-08/00
Principal Investigator: Thomas H. Lee, M.D., M.Sc.
Partners Community Healthcare, Inc.
Boston, MA 02199-8001
Purpose: To evaluate the reasons for the racial and gender differences in the use of cardiac tests and procedures. This prospective cohort study will examine the use of exercise tolerance tests, coronary angiography, coronary artery bypass surgery, and percutaneous transluminal coronary angioplasty over a 1-year period for approximately 3,400 patients with acute chest pain, of whom approximately 2 percent will be African American and 50 percent will be women. The study will test the following hypotheses: (1) African Americans and women are as likely as whites and males to undergo procedures if they meet criteria for appropriateness, but are less likely to undergo procedures if the appropriateness of a procedure is uncertain; (2) the probability that a patient will undergo an invasive cardiac procedure is influenced by attitudes toward the risk of procedures; and (3) the outcomes of patients with chest pain are not influenced by race and gender and use of procedures if adjustments are made for their clinical and nonclinical data.

Secondary and Tertiary Prevention of Stroke (PORT)
Grant/Contract Number: 290-91-0028
Project Period: 09/91-03/00
Principal Investigator: David Matchar, M.D.
Institution: Duke University
Durham, NC 27705
Purpose: To investigate clinical strategies for preventing stroke in people who are at high risk for such events. This investigation identifies and explains variations in clinical strategies for stroke prevention, including medical interventions such as aspirin and anticoagulants, and surgical interventions such as carotid endarterectomy. These clinical strategies are analyzed in terms of relative patient outcomes, resource use, and scientific uncertainties. Specific groups targeted in this effort include patients who have had either minor strokes or transient ischemic attacks (TIAs), as well as individuals who have never had strokes or TIAs but who do have either medically defined markers of cerebrovascular disease or conditions associated with embolism.

Prospective Outcome Study of Intermittent Claudication
Grant/Contract Number: HS07184
Project Period: 08/93-07/97
Principal Investigator: Walter J. McCarthy, M.D.
Institution: Northwestern University Medical School
Chicago, IL 60611
Purpose: To analyze treatment selection and outcomes for approximately 600 consecutive patients who make an initial visit to 20 Chicago-area vascular surgeons and are diagnosed with intermittent claudication. The objectives are to (1) model selection for treatmen; (2) evaluate the effects of smoking and exercise habits on outcomes for treated and untreated patients; and (3) describe and evaluate the clinical and functional outcomes within and between treatment groups. Patients are surveyed at baseline and during home visits; clinical data are abstracted from office, laboratory, and hospital records; and surgeons are surveyed.

Health Related Quality of Life in Intermittent Claudication
Grant/Contract Number: HS06675
Project Period: 09/90-06/92
Principal Investigator: Martha D. McDaniel, M.D.
Institution: Veterans Administration Medical Center
White River Junction, VT 05009
Purpose: To develop an accurate instrument for the evaluation of health related quality of life in a broad range of patients with intermittent claudication (deficient arterial blood supply in an exercising muscle). The pilot study used this instrument to study the relative effects on functional health of a range of therapies for intermittent claudication. A questionnaire was administered and tests on resting flow, pressure measurements, and treadmill were conducted.

The Consequences of Variation in Treatment for Acute Myocardial Infarction (PORT)
Grant/Contract Number: HS06341
Project Period: 09/89-02/95
Principal Investigator: Barbara J. McNeil, M.D., Ph.D.
Institution: Harvard Medical School
Boston, MA 02115
Purpose: To study the treatment of acute myocardial infarction (AMI), specifically, the use of diagnostic and therapeutic interventions during and shortly after hospitalization for AMI, and their value in improving patient survival, health status, functional capacity, and quality of life in the chronic post AMI period. The results of these analyses were used to develop and disseminate recommendations that will help physicians effectively treat AMI patients.

Quality of Care Measures for Cardiovascular Patients
Grant/Contract Number: HS09487
Project Period: 09/96-09/01
Principal Investigator: Barbara J. McNeil, M.D., Ph.D.
Institution: Harvard Medical School
Boston, MA 02115
Purpose: To address the care of individuals with chronic diseases of the cardiovascular system, particularly those affecting vulnerable populations such as the elderly, the poor, or minority groups, with the development of a set of quality measures. The clinical performance measures will link all sites of care for patients from the inpatient setting to the rehabilitation setting. The study will involve work with four health plans Allina, Pacificare, United HealthCare, and Prudential at four delivery sites, and through them will be able to evaluate patients in a variety of financing systems. These performance measures will range from components of care (e.g., treatment approaches) to individual processes within components (e.g., a particular drug type).

Angina in Primary Care
Grant/Contract Number: HS06901
Project Period: 02/92-01/97
Principal Investigator: Alvin Ira Mushlin, M.D., Sc.M.
Institution: University of Rochester
Rochester, NY 14642
Purpose: To improve the diagnosis and outcome of patients in the primary care system with suspected angina. The accuracy of diagnostic tests is being calculated with reference to followup information about patients' clinical course and functional status outcomes. Information from this project will be linked to the stable angina PORT to develop guidelines for more informed diagnostic decision making in primary care settings.

Primary Care Lipid Practice and Policy
Grant/Contract Number: HS06574
Project Period: 09/90-02/94
Principal Investigator: William E. Neighbor, M.D.
Institution: University of Washington
Seattle, WA 98195
Purpose: To validate Case Policy Analysis as a measure of lipid screening and management practices in hypertensive patients, and to develop and pilot an intervention based on case policy feedback as a means of modifying physician practice. The study determined the degree to which primary care physician clinical decision policies accurately reflect practice in screening and management of hypercholesterolemia in hypertensive patients. It also identified factors associated with differences in primary care physician decision policies and practice.

Home-Based Exercise in Patients with Heart Failure
Grant/Contract Number: HS08772
Project Period: 07/95-06/97
Principal Investigator: Roberta K. Oka, D.N.Sc., R.N.
Institution: University of California
San Francisco, CA 94143-0610
Purpose: To evaluate the efficacy of a physical activity program versus usual care in improving physical performance and quality of life/well-being in eligible patients with New York Heart Association class II to IV heart failure, stable for at least 3 months. The study tests the hypothesis that individuals who receive the physical activity regimen will demonstrate significant improvements in physical fitness, functional status, and quality of life/well-being compared with subjects in the usual care group.

Predictions and Outcomes in Congestive Heart Failure
Grant/Contract Number: HS06274
Project Period: 04/90-03/95
Principal Investigator: Roy M. Poses, M.D.
Institution: Memorial Hospital of Rhode Island
Pawtucket, RI 02860
Purpose: To develop predictive models of important outcomes (short and medium term complications, mortality, and functional limitations) for patients with congestive heart failure, and to compare these models' performance with that of physicians' unaided predictions to distinguish between patients with congestive heart failure who do need intensive care and those who do not. The study also examined whether the quality of physicians' predictions were influenced unfavorably by cognitive biases or inappropriate use of heuristics, and whether the variability in physicians' decisions resulted from variability in how they weight patient variables and institutional factors.

Race and Gender Differences in Clinical Decision Making
Grant/Contract Number: HS07315
Project Period: 12/94-11/97
Principal Investigator: Kevin A. Schulman, M.D., M.B.A.
Institution: Georgetown University Medical Center
Washington, DC 20007
Purpose: To examine whether physician decision making contributes to race and gender differences in patterns of medical care for coronary artery disease (CAD). The study hypothesizes that physicians underestimate the risks of CAD in blacks compared with whites and in women compared with men and that physicians have higher thresholds for recommending diagnostic procedures in blacks compared with whites and in women compared with men. Case descriptions and a survey are being developed using interactive video disc technology. The project should provide insight into the role of physician decision making in limiting access to cardiac procedures among blacks and women.

Thrombolytic Predictive Instrument (TPI) Clinical Trial
Grant/Contract Number: HS08212
Project Period: 06/94-06/97
Principal Investigator: Harry P. Selker, M.D., M.S.P.H.
Institution: New England Medical Center
Boston, MA 02111
Purpose: To demonstrate the clinical impact of the use of the thrombolytic predictive instrument (TPI) and to test the accuracy of the TPI's predictions. Based on multivariate regression models derived from the study's large database including major thrombolytic therapy (TT), the TPI will predict acute (30-day) mortality; 1-year mortality; and complications of TT, including hemorrhagic stroke, major bleeding, and cardiac arrest. Completion of this clinical trial should show the potential impact of the use of multiple clinical data sources for effectiveness research and of a new type of predictive instrument to promote effectiveness of an important therapy in the actual clinical setting.

Assessment of Coronary Care Unit Use in Different Hospitals
Grant/Contract Number: HS05549
Project Period: 05/87-04/92
Principal Investigator: Harry P. Selker, M.D., M.S.P.H.
Institution: New England Medical Center
Boston, MA 02111
Purpose: To examine variations in the decision to admit patients to coronary care units in different hospitals, including both clinical factors and demographic characteristics such as patient age, sex, race, and insurance status. The study further developed the methodology of assessing the performance of logistic regression models. The results are useful to those who use logistic regression in health services, epidemiologic, and other research.

An MI Thrombolytic Therapy Outcome Predictive Instrument
Grant/Contract Number: HS06208
Project Period: 09/89-09/92
Principal Investigator: Harry P. Selker, M.D., M.S.P.H.
Institution: New England Medical Center
Boston, MA 02111
Purpose: To develop a real time thrombolysis predictive instrument for emergency room and emergency medical service use. This instrument optimized outcomes of thrombolytic therapy by specifically identifying those patients likely to benefit from thrombolytic therapy and facilitating the earliest possible thrombolytic therapy administration.

Thrombolytic Predictive Instrument (TPI) Clinical Trial
Grant/Contract Number: HS08212
Project Period: 06/94-06/97
Principal Investigator: Harry P. Selker, M.D., M.S.P.H.
Institution: New England Medical Center
Boston, MA 02111
Purpose: To demonstrate the clinical impact of the use of the thrombolytic predictive instrument (TPI) and to test the accuracy of the TPI's predictions. Based on multivariate regression models derived from the study's large database including major thrombolytic therapy (TT), the TPI will predict acute (30 day) mortality; 1 year mortality; and complications of TT, including hemorrhagic stroke, major bleeding, and cardiac arrest. Completion of this clinical trial should show the potential impact of the use of multiple clinical data sources for effectiveness research and of a new type of predictive instrument to promote effectiveness of an important therapy in the actual clinical setting.

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