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Clinical Studies

Childbirth and Prenatal Care

Components of Prenatal Care and Low Birthweight
Grant/Contract Number: HS06785
Project Period: 08/91-04/93
Principal Investigator: Shirley A. Beresford, Ph.D.
Institution: University of Washington
Seattle, WA 98195
Purpose: To provide information on the relative effectiveness of different components of care in preventing poor pregnancy outcomes. The study verified or revised components of care by using a modified Delphi technique. A population based case control study was carried out to compare medical/obstetrical, behavioral, social, and nutritional components of prenatal care. The results led to a better understanding of the preventive role of prenatal care.

Measuring Outcomes and Costs in High Risk Obstetrics
Grant/Contract Number: HS08830
Project Period: 08/95-07/96
Principal Investigator: Susan Berman, M.D.
Institution: Brigham and Women's Hospital
Boston, MA 02115
Purpose: To develop tools to quantitate initial obstetric risk upon entry to a perinatal center. The study also examines the utility of an established newborn severity of illness score, the Score for Neonatal Acute Physiology (SNAP), as an obstetric outcome measure. By characterizing initial risk and validating an outcome measure that reflects the immediate condition of the newborn, this project will provide tools for comparison of high risk obstetric services, identification of effective practice styles, and evaluation of resource use.

Effectiveness of Prenatal Care: Two Approaches
Grant/Contract Number: HS06605
Project Period: 08/90-05/92
Principal Investigator: Betsy J. Brach, Ph.D., M.S.N., M.P.H.
Institution: Johns Hopkins University
Baltimore, MD 21205
Purpose: To determine the extent to which comprehensiveness, continuity, and coordination in the delivery of prenatal care affect maternal and infant morbidity. The study used a sample consisting of low income pregnant women who were given perinatal care according to two different approaches, namely, the traditional medical model of specialty care and the multidisciplinary team approach. By identifying effective approaches and remaining gaps in patient care delivery, the study provided information to policy makers and planners for continuing development of maternal and child health programs.

Hospital and Regional Factors in C-Section Rate Variations
Grant/Contract Number: HS06642
Project Period: 03/91-02/93
Principal Investigator: Laura B. Gardner, M.D., Ph.D., M.P.H.
Institution: Axiomedics Research, Inc.
Los Altos, CA 94022-3611
Purpose: To assess the relationship between hospital and regional characteristics and variations in Caesarean section rates in California. The study analyzed 5 years of California hospital discharge abstract data, hospital specific data, and regional data. It observed changes in regional, hospital, and patient related variables over time. Because it used pooled cross sectional and time series data, the study minimized the problem of multicollinearity among the independent variables.

Low Birthweight in Minority and High Risk Women (PORT)
Grant/Contract Number: 282-92-0055
Project Period: 09/92-09/97
Principal Investigator: Robert L. Goldenberg, M.D.
Institution: University of Alabama
Birmingham, AL 35233-7333
Purpose: To (1) identify and understand practice variations prior to and during pregnancy that aim to prevent low birthweight and related negative sequelae; (2) determine the overall effectiveness of different practices by examining their association with pregnancy outcomes; and (3) develop and disseminate clinical, client, and care system recommendations to maximize improvements in the use of effective practices for minority and high risk women.

Decision Making in Prenatal Genetic Testing
Grant/Contract Number: HS06945
Project Period: 09/93-08/96
Principal Investigator: Paul S. Heckerling, M.D.
Institution: University of Illinois
Chicago, IL 60680
Purpose: To determine the value perceived by patients and physicians for the outcomes that follow prenatal diagnostic testing (chorionic villus sampling and amniocentesis), and to understand how these values affect their decision making. Linear rating scales will be used to assess patients' and physicians' values. Sociodemographic, obstetric, and health care provider data will be analyzed in relationship to formal decision analytic models.

The Impact of Specialty on Caesarean Section Rates
Grant/Contract Number: HS07012
Project Period: 01/92-09/93
Principal Investigator: William J. Hueston, M.D.
Institution: Eau Claire Family Medicine Clinic
Eau Claire, WI 54701-3832
Purpose: To expand on the hypothesis that Caesarean section rates differ for family physicians and obstetricians by examining physician specialty along with other variables that are known to influence Caesarean section rates. Maternal and neonatal outcomes for patients of varying risk status were compared between the two specialties to determine if physician specialty influences the quality of obstetric care. Differences in Caesarean section rates between family physicians and obstetricians may suggest alterations in physician training, which may be useful in curtailing the rapid rise in Caesarean section rates.

Variations in Management of Childbirth and Patient Outcomes (PORT)
Grant/Contract Number: 282-90-0039
Project Period: 09/90-09/96
Principal Investigator: Emmett Keeler, Ph.D.
Institution: RAND
Santa Monica CA 90401-2138
Purpose: To (1) examine the use and outcomes of Caesarean section versus its alternatives (oxytocin, trial of labor, normal and assisted vaginal delivery); (2) analyze variations and correlates of specific diagnostic and treatment procedures utilized in the course of labor and delivery; and (3) develop clinical recommendations and a series of interventions for disseminating information to distinct audiences of patients and physicians. Final steps include evaluating the impact of these interventions on practice and preparing public use data files to support further research.

The Effects of Rural Obstetric Care Provider Shortages
Grant/Contract Number: HS07321
Project Period: 07/92-12/94
Principal Investigator: Wayne A. Ray, Ph.D., M.S.
Institution: Vanderbilt University
Nashville, TN 37232-2637
Purpose: To test the hypothesis that women residing in rural areas with obstetric care provider shortages receive less prenatal care and have more adverse pregnancy outcomes than other women. The study used data from a statewide review of primary health care services, a linked vital records maternal Medicaid enrollment database, and the Perinatal Risk Factor Surveillance Program database. It explored risk factors associated with adverse perinatal outcomes, such as maternal life style, maternal medical problems, complications of labor and delivery, transport of mother and infant, and newborn complications.

Practice Variations in Prenatal and Intrapartum Care
Grant/Contract Number: HS06166
Project Period: 07/89-06/93
Principal Investigator: Roger A. Rosenblatt, M.D., M.P.H.
Institution: University of Washington
Seattle, WA 98195
Purpose: To study the variations in obstetrical care for women with low risk pregnancies in Washington State. The dependent variables in this study were the charges (as a proxy for cost) associated with the prenatal and obstetric protocols; the independent variables included the training and experience of physician or midwife attending the birth, the characteristics of the birth setting, the malpractice experience of the provider, and the characteristics of the patient. This study contributed information to reduce the cost of routine obstetrical care for women with low risk pregnancies without impairing patient outcomes.

A Prospective Study of an Out-Of-Hospital Birth Center
Grant/Contract Number: HS07161
Project Period: 09/93-09/97
Principal Investigator: William H. Swartz, M.D.
Institution: Primary Care Perinatal Services, Incorporated
San Diego, CA 92103
Purpose: To evaluate whether the out of hospital birth center model is a safe and cost effective alternative for the delivery of prenatal and perinatal services for underserved, low income women. The study assesses the maternal and infant outcomes and costs of care at the out of hospital birth center and compares them with the traditional model using physician providers and hospital delivery. Data are being collected primarily through medical and financial record abstraction and questionnaires. The findings of this study could have significant implications for the delivery of perinatal services nationwide. Study subjects primarily are low risk, Medicaid-eligible, Hispanic women.

Dental Disease

Determinants of Oral Health in Older Persons
Grant/Contract Number: HS07084
Project Period: 07/91-06/96
Principal Investigator: Ronald M. Andersen, Ph.D.
Institution: University of California
Los Angeles, CA 90024-1772
Purpose: To provide a description and better understanding of the oral health status of older persons by employing a generic model of health service use and health status and by using findings from the gerontological and dental care literature. The results of this study will be used to suggest policies to improve the oral health status of older persons in general as well as specific groups of this population with special problems.

Evaluation of Guidelines for Prescribing Dental X-Rays
Grant/Contract Number: HS06670
Project Period: 08/90-07/94
Principal Investigator: Kathryn A. Atchison, D.D.S., M.P.H.
Institution: University of California
Los Angeles, CA 90095-1668
Purpose: To assess the effectiveness of clinical guidelines for ordering selected radiographs to detect dental disease. Using a blinded comparison group study design, the study evaluated whether clinical application of these guidelines reduced patient exposure and whether their use introduced unacceptable levels of undiagnosed disease. The results of this experiment enhanced the refinement of selection criteria for ordering dental radiographs and may thereby lead to a substantial savings in patient exposure.

Clinical Performance Measures for Dental Care Plans
Grant/Contract Number: HS09453
Project Period: 09/96-09/98
Principal Investigator: James D. Bader, D.D.S.
Institution: University of North Carolina
Chapel Hill, NC 27599-7450
Purpose: To describe the development and evaluation of clinical performance measures with which to assess the provision of dental care. The measures will assess outcomes of the prevention and treatment of the two major dental diseases, dental caries, and periodontal diseases. The development of a comprehensive set of standardized, tested measures will permit valid comparisons of managed care plan performance as well as to strengthen plans' internal quality improvement activities.

A New Multicarrier Database for Dental Care Evaluation
Grant/Contract Number: HS06786
Project Period: 07/91-06/95
Principal Investigator: William J. Hayden, Jr., D.D.S., M.P.H.
Institution: University of Missouri
Kansas City, MO 64108-2795
Purpose: To develop a multipayer database from dental claims data provided by an electronic claims service company and to investigate its usefulness for dental health services research. The purpose of the database was to examine provider and practice variation of charges and to explore provider treatment behaviors.

Developing a Dental Implant Patient Satisfaction Survey
Grant/Contract Number: HS06826
Project Period: 07/91-06/93
Principal Investigator: Mary A. Tavares, D.M.D., M.P.H.
Institution: Forsyth Dental Center
Boston, MA 02115
Purpose: To develop and validate a self-reporting instrument to assess patient satisfaction with dental implant procedures and outcomes. The validation consisted of (1) a review of the survey by clinical and measurement experts; (2) a prepilot study of a small group of implant patients; (3) a revised draft of the instrument that will be used in a large-scale pilot study; and (4) a factor analysis that will be used to determine which items are the strongest predictors.


Diabetic Retinopathy Education Study II
Grant/Contract Number: HS06798
Project Period: 04/91-09/93
Principal Investigator: Lawrence P. Chong, M.D.
Institution: Doheny Eye Institute
Los Angeles, CA 90033
Purpose: To evaluate the effectiveness of five different educational strategies in improving primary care physicians' ability to recognize vision threatening diabetic retinopathy. By increasing the physicians' awareness, it is believed that the number of new cases of legal blindness may be decreased through education and early detection. The educational process included one or more of the following: independent study materials, slide script program, and direct ophthalmoscopy on model eyes. A randomized multicentered evaluation was conducted.

Diabetic Retinopathy Education Study I
Grant/Contract Number: HS06799
Project Period: 04/91-09/93
Principal Investigator: Howard P. Cupples, M.D.
Institution: Georgetown University Medical Center
Washington, DC 20007
Purpose: To evaluate the effectiveness of educational strategies in improving primary care physicians' ability to recognize vision-threatening diabetic retinopathy and to develop a standardized educational program. The study tested the hypothesis that through the proposed education, more physicians will appropriately refer patients with diabetic retinopathy. A multicenter investigation compared the effect of five educational strategies on the diagnostic accuracy, clinical knowledge, and practice patterns of groups of physicians. The cost effectiveness of each strategy also was evaluated.

Variations in the Management and Outcomes of Diabetes (PORT)
Grant/Contract Number: HS06665
Project Period: 09/90-03/96
Principal Investigator: Sheldon M. Greenfield, M.D.
Institution: New England Medical Center
Boston, MA 02111
Purpose: To develop a comprehensive, prospective, longitudinal database that is tailored to the special requirements for addressing the medical effectiveness questions related to type 2 diabetes. The database will monitor the costs, quality, and outcomes of care for patients with type 2 diabetes in three large health care delivery organizations. The study utilizes a quality of life scale to measure the medical effectiveness, as well as study the financial costs to the health system and to the patient. The results will then be translated into intervention strategies that target change in physician behaviors with respect to utilization, expenditures, and ultimately, increased quality of care for the patient.

Emergency Medicine/Trauma

Research in Trauma Outcomes Using the MTOS Database
Grant/Contract Number: HS06721
Project Period: 07/91-01/94
Principal Investigator: Howard R. Champion, F.R.C.S., F.A.C.S.
Annapolis, MD 21403
Purpose: To use, for outcomes research, data collected at selected sites for the Major Trauma Outcome Study (MTOS). Controlled site data were used to (1) evaluate TRISS norms and compare TRISS and ASCOT outcome predictions; (2) determine the effect of preinjury illness on outcome; and (3) develop relationships for predicting the occurrence of serious complications, for patient disability at discharge from acute care, and for lengths of stay in hospitals and in the intensive care units. The MTOS database enabled outcomes-related research to extend and improve institutional care evaluations and quality assurance and to identify an improved basis for trauma care reimbursement.

Head Injury Outcome
Grant/Contract Number: HS06497
Project Period: 08/91-07/95
Principal Investigator: Sureyya S. Dikmen, Ph.D.
Institution: University of Washington
Seattle, WA 98195
Purpose: To study the determinants of head injury outcome and the factors that predict outcomes. Factors examined were severity of head and other system injuries, preexisting conditions, and basic demographics. The study examined the sensitivity of the Abbreviated Injury Scale and the Injury Severity Score—scales developed for major trauma—to central nervous system injury. Secondary analyses based on three longitudinal studies of head injury outcome were conducted. The study also examined the reliability of neuropsychological tests used to assess head injury outcomes.

Assessing the Technology of CPR Strategies: A Randomized Trial
Grant/Contract Number: HS08197
Project Period: 04/94-03/98
Principal Investigator: Alfred P. Hallstrom, Ph.D.
Institution: University of Washington
Seattle, WA 98105
Purpose: To determine whether a simplified form of cardiopulmonary resuscitation (CPR) instruction (involving the use of chest compressions only) provided by the dispatcher to the person calling to report a potential cardiac arrest provides greater survival rates than ABC instructions (involving airway, breathing, and chest compression). A positive answer (1) would prove that bystander CPR directly affects survival rates, (2) would reduce the burden on the dispatcher by simplifying and shortening the interaction with the caller while providing better outcome, and (3) could have public health implications vis a vis the concern about transmission of AIDS. Each episode is assigned randomly, and paramedic field reports are reviewed.

Prospective Study of Functional Limitation After Trauma
Grant/Contract Number: HS07611
Project Period: 08/93-07/98
Principal Investigator: Troy L. Holbrook, Ph.D.
Institution: University of California
San Diego, CA 92103-8213
Purpose: To determine the incidence and determinants of functional limitation after major trauma by using the computerized San Diego County Regional Trauma System Registry trauma patient database to identify patients for followup. A questionnaire will be administered at 3 month intervals following treatment at an emergency department. The study will also determine the strength and independence of individual predictors of functional limitation. This information will help facilitate appropriate interventions for trauma patients dependent on their predictors of functional limitation.

Outcomes Following Minor Head and Abdominal Trauma
Grant/Contract Number: HS07336
Project Period: 08/94-07/97
Principal Investigator: David H. Livingston, M.D.
Institution: University Hospital-New Jersey Trauma Center
Newark, NJ 07103-2406
Purpose: To evaluate the current practice of mandatory hospitalization for observation only, following two specific types of injury: minimal closed head injury and blunt abdominal trauma; and to develop practice guidelines that could reliably exclude significant injuries without hospitalization. Attainment of these objectives will allow patients to be safely discharged from the emergency department without hospital admission and result in a better utilization of health care resources for these types of injuries. Prospective evaluations of the standard diagnostic workup, construction of a diagnostic algorithm, and patient followup are being conducted.

Rural Emergency Medical Services and Trauma Outcomes
Grant/Contract Number: HS06814
Project Period: 01/93-09/94
Principal Investigator: Michael A. Morrisey, Ph.D.
Institution: University of Alabama
Birmingha, AL 35294-2010
Purpose: To study the effects of the rural hospital emergency department, the elements of the time to definitive treatment, and the relative use of advanced life support versus basic life support trained ambulance personnel on the outcomes of patients suffering traumatic injuries in rural areas. The project provided a multivariate statistical analysis of the likelihood of trauma survival. It also described the clinical and demographic characteristics of rural trauma patients, the types and frequency of prehospital services provided, and the types of hospitals used. The results provided insight on the advisability of programs to promote the use of advanced life support personnel on rural ambulances and transport protocols for rural trauma victims. Ambulance trip data from rural Georgia in 1991 were used.

Clinical Standards and Quality/Cost of Emergency Care
Grant/Contract Number: HS06284
Project Period: 02/91-01/94
Principal Investigator: David L. Schriger, M.D., M.P.H.
Institution: University of California
Los Angeles, CA 90024-2924
Purpose: To develop a computerized charting system containing clinical algorithms for five common problems (convulsions, lacerations, back pain, pediatric fever, and exposure of health care workers to body fluids) and to test for their effects on the process, outcomes, and cost of care. The study tested the hypothesis that the computerized charting system improves the quality of care, reduces the cost of emergency care, and provides education for physicians in training.

Sestamibi for ED Triage for Suspected Cardiac Ischemia
Grant/Contract Number: HS09110
Project Period: 08/96-07/99
Principal Investigator: Harry P. Selker, M.D., M.S.P.H.
New England Medical Center
Boston, MA 02111
Purpose: To assess the impact of Tc99m-sestamibi scanning on emergency department (ED) triage decisions, that is, the degree to which those ED patients with acute cardiac ischemia (ACI) are hospitalized and those without ACI are not hospitalized. This proposed multicenter prospective controlled clinical trial will evaluate the ED use of sestamibi scanning to aid ED triage of patients presenting with symptoms suggestive of ACI who have normal or nondiagnostic electrocardiograms. The study will also assess the impact of the use of sestamibi scanning on actual hospital costs.

Emergency Medicine Diagnostic and Treatment Units
Grant/Contract Number: HS07103
Project Period: 04/92-07/97
Principal Investigator: Robert J. Zalenski, M.D., M.A.
Institution: University of Illinois
Chicago, IL 60612
Purpose: To test whether an Emergency Diagnostic and Treatment Unit can provide equal or improved quality of care and is a cost-effective alternative to hospital admission for two major conditions: the diagnosis of low-risk cardiac chest pain and the treatment of acute asthma. This study also aims to enable the establishment and utilization of such units by disseminating the clinical, operational, and cost-effectiveness findings to physicians and reimbursement agencies.

Eye Diseases

Cataract Extraction: An International Comparison
Grant/Contract Number: HS07085
Project Period: 08/91-01/96
Principal Investigator: Gerard F. Anderson, Ph.D.
Institution: Johns Hopkins University
Baltimore, MD 21205
Purpose: To expand the U.S. PORT study of cataract management to Manitoba, Canada; Denmark; and Barcelona, Spain. Collection of parallel data will permit international comparisons of practice patterns, physician attitudes and beliefs, patient expectations, and outcomes.

Value of Medical Testing Prior to Cataract Surgery (PORT II)
Grant/Contract Number: HS08331
Project Period: 09/94-08/98
Principal Investigator: Oliver D. Schein, M.D., M.P.H.
Institution: Johns Hopkins Hospital
Baltimore, MD 21287 9019
Purpose: To test the hypothesis that routine preoperative medical laboratory testing for cataract surgery is not cost effective and may provide no health benefit. This study will randomize a large cohort of cataract surgical patients to receive or not receive a routine battery of preoperative laboratory tests. It is (1) comparing the rates of postoperative adverse events in two groups, (2) assessing the cost effectiveness of a routine battery of preoperative medical tests, and (3) developing a practice guideline on the appropriate use of medical tests before cataract surgery that is endorsed by the principal relevant medical societies.

Variations in Cataract Management: Patient and Economic Outcomes (PORT)
Grant/Contract Number: HS06280
Project Period: 09/89-02/95
Principal Investigator: Earl P. Steinberg, M.D., M.P.P.
Institution: Covance Health Economics and Outcomes Services, Inc.
Washington, DC 20005-3934
Purpose: To (1) document variation in clinical outcomes, patient functioning, patient satisfaction, and health care costs as a function of alternative strategies for cataract management; (2) define "appropriate" or "optimal" management strategies for different categories of cataract patients; and (3) develop a policy-relevant decision model and clinical recommendations. To achieve these aims, the project's multidisciplinary team used four major data sources, namely, the clinical literature, Medicare claims data, a national survey of ophthalmologists, and surveys of patients and ophthalmologists in four geographic areas.

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