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Clinical Studies

Gastrointestinal Diseases

Health Care Utilization and Recurrence of Abdominal Pain
Grant/Contract Number: HS05705
Project Period: 05/90-04/94
Principal Investigator: Alan M. Adelman, M.D.
Institution: Hershey Medical Center
Hershey, PA 17033-0850
Purpose: To provide information on the natural history of abdominal pain; assess the risk factors associated with its recurrence and resolution, as well as factors associated with seeking medical attention for this problem; and describe the health utilization patterns of individuals with abdominal pain. The study led to more efficient and cost effective ways of dealing with this common problem.

Evaluation of Clinical Outcomes in Small Areas of Michigan
Grant/Contract Number: HS06486
Project Period: 08/90-07/93
Principal Investigator: Laurence F. McMahon, Jr., M.D., M.P.H.
Institution: University of Michigan
Ann Arbor, MI 48109-0376
Purpose: To examine small area variations in Michigan communities for cholecystectomies and procedures used in the diagnosis, treatment, and screening of colon cancer. The study involved a disease specific meta analysis and, with the help of a clinician panel, derived a set of accepted approaches to the patient. The appropriateness of technology usage was assessed, and patient outcomes were conducted. A community based educational intervention was designed, conducted, and assessed to improve care and patient outcomes.

Pediatric Gastroenteritis Patient Outcomes Research
Grant/Contract Number: 290-90-0043
Project Period: 09/90-12/96
Principal Investigator: Nancy Merrick, M.D.
Institution: MEDSTAT Group
Santa Barbara, CA 93111-2348
Purpose: To (1) evaluate alternative therapies for pediatric gastroenteritis and describe which are most effective within different clinical populations; (2) identify the factors that inhibit use of the most effective and appropriate therapies, including physician practice patterns and patient access problems; (3) investigate physician-patient interaction and measure the effect and extent of patient compliance; and (4) recommend improvements in interventions for pediatric gastroenteritis. The study will evaluate findings in the literature and analyze primary and secondary data sources.

Outcome Assessment of Patients with Biliary Tract Disease (PORT)
Grant/Contract Number: HS06481
Project Period: 08/90-09/95
Principal Investigator: J. Sanford Schwartz, M.D.
Institution: University of Pennsylvania
Philadelphia, PA 19104-6218
Purpose: To improve the evaluation, management, and health outcomes of patients with biliary tract disease. The study (1) determined the rates of use, variation in rates of use, and health outcomes associated with alternative diagnostic tests and therapeutic modalities; (2) identified appropriate indications for alternative tests and treatments and optimal management strategies; (3) used this information to help physicians improve their practice and the health outcomes of their patients; (4) assessed the impact of the interventions on physician practice and health outcomes; and (5) demonstrated the feasibility of strategies involving physicians in developing and implementing effective intervention programs. Researchers analyzed claims data and primary data on patient outcomes and patient and physician preferences.

Minority Health

Urban Health Institute at Harlem Hospital Center
Grant/Contract Number: HS07399
Project Period: 09/92-09/97
Principal Investigator: Charles K. Francis, M.D.
Institution: Harlem Hospital Center
New York, NY 10037
Purpose: To establish the Harlem Hospital Center Urban Health Institute to help optimize the effectiveness of medical resources and services in urban African American populations by examining variability in current medical practice and the relation between clinical outcomes and practice variation. Areas of research include HIV, hypertension and heart disease, and prevention of violence and injury to children and adolescents.

Midwest Latino MEDTEP Research Center
Grant/Contract Number: HS07376
Project Period: 04/93-05/96
Principal Investigator: Aida L. Giachello, Ph.D.
Institution: University of Illinois
Chicago, IL 60608-6906
Purpose: At the University of Illinois, a Midwest Latino MEDTEP Research Center was funded to assess the effectiveness and appropriateness of health and medical services at the primary care level to the Puerto Rican communities in Illinois and other midwestern states. Areas of research included type 2 diabetes, asthma, prenatal care, and hypertension.

UCLA/MEDTEP Center for Asians and Pacific Islanders
Grant/Contract Number: HS07370
Project Period: 09/92-08/97
Principal Investigator: Takashi Makinodan, Ph.D.
Los Angeles, CA 90073
Purpose: To coordinate the research, training and education, information dissemination, and technical assistance activities related to the Asian- and Pacific Islander-American population. Areas of research include (1) cultural adaptation of self-report instruments; (2) comparison of these self-report activity measures; (3) end-of-life decision making; (4) birth outcomes; and (5) tuberculosis.

Morehouse Medical Treatment Effectiveness Center (MMEDTEC)
Grant/Contract Number: HS07400
Project Period: 09/92-08/97
Principal Investigator: Robert M. Mayberry, Ph.D., M.P.H.
Institution: Multidisciplinary Research Center
Atlanta, GA 30310-1495
Purpose: To develop the Morehouse School of Medicine's Medical Treatment Effectiveness Center (MMEDTEC), which will conduct research on the effectiveness and appropriateness of medical care services and procedures related to health outcomes of African Americans, particularly in the South. The support hospitals and other provider affiliates of MMEDTEC will provide a coordinated program of research, technical assistance, dissemination, and training of minority researchers. Staff and researchers will address problem areas such as hypertension and selected sequelae, women and infant health, and cancer. Each study conducted will address the effectiveness of interventions on the well-being of African Americans. Staff training and curriculum development for training researchers will also be developed.

Meharry Minority MEDTEP Research Center
Grant/Contract Number: HS07387
Project Period: 03/93-08/96
Principal Investigator: Bettie Nelson Knuckles, Dr.P.H.
Institution: Meharry Medical College
Nashville, TN 37208
Purpose: To establish a developmental minority MEDTEP health services research center at Meharry Medical College in order to search for more effective ways of providing quality medical care for the growing number of poor and medically underserved African Americans. Areas of research include hypertension and sickle cell disease.

AAMC HSR Institute for Minority Faculty
Grant/Contract Number: HS09262
Project Period: 09/96-09/00
Principal Investigator: Herbert W. Nickens, M.D.
Institution: Association of American Medical Colleges
Washington, DC 20037-1127
Purpose: To develop the health services research skills of 50 junior underrepresented faculty (Black, American Indian/Alaska Native, Mexican-American, and mainland Puerto Ricans) through a series of seminars and workshops as well as independent study. The principal component of this program is the development of a concept paper into a full-fledged proposal suitable for submission for funding to the Agency for Health Care Policy and Research. The program will be evaluated using both process and outcome measures.

Mexican American Effectiveness Research Center
Grant/Contract Number: HS07397
Project Period: 09/92-08/97
Principal Investigator: Jacqueline A. Pugh, M.D.
Institution: University of Texas
San Antonio, TX 78284
Purpose: To establish a Mexican American Effectiveness Research Center (MERECE) to study treatment effectiveness for chronic disabling conditions in Mexican Americans. Areas of research include type 2 diabetes, mental health issues, and functional status measures. The center also provides training to investigators for outcomes research within the Mexican American population, provides technical assistance to MERECE related projects, and disseminates research information.

Ethnic/Racial Minority Health Policy Research Institute
Grant/Contract Number: HS08671
Project Period: 10/94-03/97
Principal Investigator: Carla J. Serlin, Ph.D., M.S.N., B.S.N.
Institution: American Nurses Association
Washington, DC 20024-2571
Purpose: To develop an Ethnic/Racial Minority Health Policy Institute that will support 10 Fellows who are early in their research careers. Institute goals are to increase the health policy-relevant research skills and generation of research grant applications of doctorally prepared minority nurses. Institute Fellows' research applications focus on the delivery of health care services to vulnerable, disadvantaged, or racial/ethnic minority populations in order to reduce the health disparities among Americans.

University of Maryland Center for Minority Health Research
Grant/Contract Number: HS07392
Project Period: 01/93-01/98
Principal Investigator: Bonita Stanton, M.D.
Institution: University of Maryland
Baltimore, MD 21201
Purpose: To establish a Center for Minority Health Care Research at the University of Maryland, Baltimore Campus. The primary goals of this Center are to identify interventions that improve the health outcomes of inner city African Americans and conduct research on areas such as reproductive health, adolescent health, violence, effective health communications, and asthma.

MEDTEP Research Center on Minority Populations
Grant/Contract Number: HS07386
Project Period: 02/93-01/98
Principal Investigator: Barbara Tilley, Ph.D.
Institution: Henry Ford Health System
Detroit, MI 48202-3450
Purpose: To focus and improve the health status and clinical outcomes of African Americans served in a large HMO health care setting. The center will focus its research efforts on clinical outcomes in the areas of child and adult asthma and type 2 diabetes.

New Mexico MEDTEP Research Center for Ethnic Populations
Grant/Contract Number: HS07389
Project Period: 09/92-11/95
Principal Investigator: Christopher E. Urbina, M.D., M.P.H.
Institution: University of New Mexico
Albuquerque, NM 87131-5141
Purpose: To develop and manage a Medical Treatment Effectiveness Program Research Center on Minority Populations in order to prioritize health research issues pertinent to American Indians and Hispanics in New Mexico. Research areas included cervical and breast cancer, childhood asthma, and alcoholism.

Medical Effectiveness Research Center for Diverse Populations
Grant/Contract Number: HS07373
Project Period: 01/93-01/98
Principal Investigator: A. Eugene Washington, M.D.
Institution: San Francisco General Hospital
San Francisco, CA 94110
Purpose: To establish a MEDTEP Research Center on Minority Populations at the San Francisco branch of the University of California, targeting African Americans and Hispanics/Latinos. Areas of research include cancer, cardiovascular disease, type 2 diabetes, reproductive health, glaucoma, prenatal care, and depression.

Hawaii Asian Pacific Island MEDTEP Research Center
Grant/Contract Number: HS07381
Project Period: 09/92-08/95
Principal Investigator: Robert M. Worth, M.D., Ph.D.
Institution: Pacific Health Research Institute
Honolulu, HI 96813
Purpose: To develop an Asian and Pacific Islander MEDTEP Research Center in Hawaii in order to improve the practice of medicine and patient care through outcomes research for Asians and Pacific Islanders. Areas of research included primary care, maternal and child health, medical decision making, functional status measures, thyroid disease, cancer, and type 2 diabetes.

Musculoskeletal Conditions

Manual Therapy in Primary Care of Acute Low Back Pain
Grant/Contract Number: HS08293
Project Period: 02/95-07/98
Principal Investigator: Timothy S. Carey, M.D., M.P.H.
Institution: University of North Carolina
Chapel Hill, NC 27599-7590
Purpose: To determine (1) whether allopathic physicians can effectively integrate manual therapy, including simple spinal manipulation, into primary care practice; and (2) whether the use of simple spinal manipulation therapy (SMT) can improve the clinical outcomes of patients with acute back pain. The study is training physicians in SMT and conducting a randomized trial. Outcome measures include patient function as measured by the Roland Morris functional status scale for low back pain, patient satisfaction, and the time it takes the patient to improve and return to work.

Low Back Pain: Outcomes and Efficiency of Care
Grant/Contract Number: HS06664
Project Period: 08/91-07/95
Principal Investigator: Timothy S. Carey, M.D., M.P.H.
Institution: University of North Carolina
Chapel Hill, NC 27599-7590
Purpose: To track low back pain problems from the onset of symptoms and patient's decision to seek care, through clinical decisions about diagnosis and treatment of patients in office practices. The research program focused on the outcomes of care and costs. It involved two studies: (1) a telephone survey of North Carolina households that described the incidence of low back pain, the rate at which individuals sought care from practitioners, and the type of practitioner they sought care from; and (2) a cohort study of patients presenting to practitioners' office. The results determined which factors contribute most to recovery from acute back pain.

Chiropractic Versus Physical Therapy: A Randomized Trial
Grant/Contract Number: HS07915
Project Period: 08/93-01/97
Principal Investigator: Daniel C. Cherkin, Ph.D.
Institution: Group Health Cooperative of Puget Sound
Seattle, WA 98101-1448
Purpose: To compare the effectiveness of three types of nonsurgical treatments for low back pain: spinal manipulation as performed by chiropractors, the McKenzie method of physical therapy, and standard medical care supplemented by an inexpensive educational booklet. The study will recruit subjects from two primary care clinics in a large health maintenance organization and randomize them to receive one of the three treatments. Outcomes, utilization, and costs will be estimated to provide information on the relative benefits and costs of these treatments for low back pain.

Effectiveness of Treatment Strategies for Low Back Pain
Grant/Contract Number: HS08194
Project Period: 08/94-07/98
Principal Investigator: Richard A. Deyo, M.D., M.P.H.
Institution: University of Washington
Seattle, WA 98195
Purpose: To build on and extend the work of the low back pain PORT (HS06344, see below) by providing more definitive information for refining and implementing clinical guidelines about lumbar spine surgery and its alternatives, and to evaluate a novel program for enhancing the effectiveness for primary care guidelines. Specific aims are (1) to compare long term functional and work related outcomes of alternative surgical and nonsurgical treatments for patients with sciatica or spinal stenosis; and (2) to assess the impact of back pain guidelines and health care reform efforts on regional and national trends in back surgery rates, reoperation rates, fusion rates, and nonsurgical hospitalization rates.

Videodisc for Back Surgery Decisions: A Randomized Trial
Grant/Contract Number: HS08079
Project Period: 09/94-08/97
Principal Investigator: Richard A. Deyo, M.D., M.P.H.
Institution: University of Washington
Seattle, WA 98195
Purpose: To conduct a randomized trial to evaluate the impact of an already developed interactive media educational program on patient functional status, satisfaction with medical care, knowledge of low back problems relevant to making informed choices, likelihood of selecting surgical therapy, and health care utilization. This trial compares the low back interactive videodisc program with written educational materials as adjuncts to usual care for low back pain in a closed panel health maintenance organization and a fee for service academic surgical practice.

Back Pain Outcome Assessment Team (PORT)
Grant/Contract Number: HS06344
Project Period: 09/89-02/95
Principal Investigator: Richard A. Deyo, M.D., M.P.H.
Institution: University of Washington
Seattle, WA 98195
Purpose: To assess alternative types of lumbar spine surgery, a variety of nonsurgical interventions, and diagnostic tests commonly used for patients with back pain. Findings were disseminated via targeted feedback to physicians and hospitals in areas with high surgical rates and by means of special materials for educating patients whose decision making role is especially important in these usually elective procedures.

Assessing and Improving Outcomes: Total Knee Replacement (PORT)
Grant/Contract Number: HS06432
Project Period: 04/90-09/95
Principal Investigator: Deborah A. Freund, Ph.D., M.P.H.
Institution: Indiana University
Indianapolis, IN 46202-5102
Purpose: To advance the state of knowledge about total knee replacement (TKR) by (1) determining and explaining variation in TKR rates and outcomes in the United States (Indiana and Western Pennsylvania) and the province of Ontario; and (2) constructing and analyzing a comprehensive decision model to aid physicians and patients in deciding whether to undertake TKR. These results were then disseminated to physicians and patients in order to improve patient care.

Analysis of Practices: Hip Fracture Repair and Osteoarthritis (PORT)
Grant/Contract Number: HS06658
Project Period: 09/90-03/96
Principal Investigator: James I. Hudson, M.D.
Institution: University of Maryland
Baltimore, MD 21201
Purpose: To assess the effectiveness of alternative management pathways for hip fracture and total hip replacement for osteoarthritis. This project will help optimize utilization of health care resources for patients undergoing these procedures. A retrospective analysis of Medicare billing data and a prospective analysis of two patient cohorts, process of care, and physician questionnaires are being conducted.

Chiropractic Versus Medical Care for Low Back Pain
Grant/Contract Number: HS07755
Project Period: 04/95-03/00
Principal Investigator: Hal Morgenstern, Ph.D.
Institution: UCLA School of Public Health
Los Angeles, CA 90095-1772
Purpose: To assess the effectiveness and cost effectiveness of four popular management strategies used in the treatment of low back pain. The randomized study is being conducted in a multispecialty group practice over a 5 year period. The results of this project will have important implications to national health care policy and clarify the roles of medical doctors, chiropractors, and physical therapists in the treatment of low back pain.

Selective Cervical Spine Radiography in Blunt Trauma
Grant/Contract Number: HS08239
Project Period: 08/96-07/98
Principal Investigator: William R. Mower, M.D., M.E.
UCLA Emergency Medicine Center
Los Angeles, CA 90024
Purpose: To reduce radiographic cervical spine imaging by demonstrating that clinical criteria can reliably exclude cervical spine injury in "no risk" blunt trauma victims without misidentifying any injured patient. This multicenter prospective study will test two hypotheses: (1) Blunt trauma victims have no risk of cervical spine fracture or dislocation if they are awake and alert, are not intoxicated, have no tenderness on palpation of the bony cervical spine, and have no other painful distracting injuries; and (2) Implementation of these criteria will reduce the number of radiographic spine evaluations without missing any significant cervical spine injuries. Reductions in the number of radiographic evaluations will be determined by counting the number of radiographic evaluations performed on "no risk" patients. Charge reductions will be estimated by summing radiographic charges for all "no risk" patients. Reductions in radiation exposure will be determined by summing the life-time decrease in radiation morbidity and mortality for all "no risk" individuals.

Functional Outcomes in Patients With Hip Fractures
Grant/Contract Number: HS09459
Project Period: 09/96-09/01
Principal Investigator: Albert L. Siu, M.D.
Institution: Mount Sinai Medical Center
New York, NY 10029-6574
Purpose: To determine the feasibility and validity of functional status as a measure of quality for patients with hip fracture by following a network of 26 hospitals and 12 nursing homes in the New York metropolitan area. Analyses will (1) describe the functional outcomes; (2) adjust the functional outcomes for baseline function, other health, and sociodemographic variables; (3) evaluate the reliability and validity of different approaches by which functional outcomes could have been obtained; (4) evaluate the extent to which the process of care influenced the risk-adjusted functional outcomes; and (5) evaluate the extent to which an intervention to improve medical care resulted in improved function.

Pediatric Conditions

Outcomes Associated with Therapy for Otitis Media
Grant/Contract Number: HS07816
Project Period: 07/93-06/97
Principal Investigator: Stephen Berman, M.D.
Institution: University of Colorado
Denver, CO 80262
Purpose: To describe current practice patterns and expenditures for the management of otitis media in pediatric Medicaid recipients using the Colorado Medicaid Medical Events Database (M-Med) as a source of data. Dependent variables in the M-Med analysis include visits for otitis media and surgical procedures; independent variables include age, sex, pharmacological therapies, other interventions, source of care, and location of care.

Natural History of Blood Lead and Effect of Intervention
Grant/Contract Number: HS08764
Project Period: 05/95-04/96
Principal Investigator: Helen J. Binns, M.D.
Institution: Children's Memorial Hospital
Chicago, IL 60614
Purpose: To determine the natural history of blood lead (BPb) levels over 1 year among inner city children, focusing on children receiving testing before the 1991 Centers for Disease Control (CDC) statement lowered the BPb level of concern. Data are being collected via a retrospective medical record review of children having blood drawn for Bpb level determination at three Chicago inner city pediatric offices during defined enrollment periods before and after the CDC lowered the BPb level of concern. The study also evaluates the efficacy of intervention programs in place at these practices in 1992 to determine if lead intervention programs alter the natural history of BPb levels over 1 year.

Physician Opinions on the Diagnosis and Referral of Children with Cerebral Palsy to Physical Therapy
Grant/Contract Number: HS06429
Project Period: 04/90- 06/91
Principal Investigator: Suzanne K. Campbell, Ph.D., P.T.
Institution: University of Illinois
Chicago, IL 60612
Purpose: To explore the nature of physicians' beliefs in the efficacy of physical therapy in the management of children with cerebral palsy and to identify differences in referral decisions based on physician and child characteristics. By using a questionnaire with case descriptions and videotapes of children with motor dysfunction, the study asked physicians whether they would refer each child to physical therapy and what outcomes they expected. This study sought to (1) compare decisions across medical specialties; (2) compare decisions with previously reported training in developmental disabilities, beliefs in the efficacy of physical therapy, and propensities to refer; and (3) capture decisions in a period of increased uncertainty regarding both cerebral palsy diagnosis and physical therapy efficacy.

Poor Outcome Following Acute Otitis Medi
Grant/Contract Number: HS07035
Project Period: 09/93-08/97
Principal Investigator: Jack Froom, M.D.
Institution: State University of New York
Stony Brook, NY 11794-8461
Purpose: To examine the separate and combined effects of antibiotic therapy, patient variables, day care, and signs and symptoms present at the initial physician visit for acute otitis media (AOM) on either the resolution of an attack or evidence of poor outcome at a followup examination in three primary care populations in the United States, the United Kingdom, and the Netherlands. A decision tree is being developed to identify the relative benefits in terms of health care utilization and costs, days of illness, and parental time lost from work associated with the three treatment strategies for patients with different risk characteristics

Pediatric Preventive Care Incentives in a Medicaid HMO
Grant/Contract Number: HS07634
Project Period: 04/93-09/96
Principal Investigator: Alan L. Hillman, M.D., M.B.A.
Institution: University of Pennsylvania
Philadelphia, PA 19104-6218
Purpose: To assess the impact of a system of periodic feedback and financial incentives on compliance with pediatric preventive care clinical guidelines in a mandatory Medicaid health maintenance organization (HMO) and to investigate whether the provision of detailed feedback reports to sites every 6 months, linked with a financial bonus program specifically tied to preventive care, improves on the HMO's currently observed pediatrics standards compliance rate of 60 percent. Approximately 51 pediatric primary care sites are participating in the prospective, randomized controlled trial. Computerized scoring algorithms will be used to determine compliance.

Improving Children's Health Outcomes: Negotiated Care
Grant/Contract Number: HS06897
Project Period: 09/91-12/95
Principal Investigator: Sherrie H. Kaplan, Ph.D., M.P.H.
Institution: New England Medical Center Hospitals
Boston, MA 02111
Purpose: To establish whether an intervention program that involves children, parents, and physicians in treatment decisions for children with chronic disease improves the active involvement of children and leads to more accurate assessments of their health status, both clinically and through self reports. Inflammatory bowel disease and juvenile diabetes were used as models for the development of this program. This program included the use of tools that piqued the interest of children, including video games, board games, and a videotape.

Office Systems To Improve Preventive Care for Children
Grant/Contract Number: HS08509
Project Period: 09/96-09/00
Principal Investigator: Peter A. Margolis, M.D., Ph.D.
Institution: University of North Carolina
Chapel Hill, NC 27599-7225
Purpose: To implement and evaluate an intervention to increase rates of preventive services in private pediatric practices in North Carolina. In this randomized clinical trial, physicians will be encouraged to develop practice-specific "office systems" that involve members of office staff as a team to provide preventive care and patient education. The impact of the intervention will be measured on rates of preventive services, changes in physicians' and staff knowledge and attitudes about organizing the practice to provide preventive care, and changes in patients' knowledge about preventive care and attitudes toward its importance.

Homemade Cereal Based Oral Rehydration Therapy (PORT II)
Grant/Contract Number: HS08335
Project Period: 08/94-09/96
Principal Investigator: Alan Meyers, M.D., M.P.H.
Institution: Boston City Hospital
Boston, MA 02118
Purpose: To evaluate the safety and effectiveness of homemade cereal based oral rehydration solutions (CORS) in a controlled experimental fashion. If the experimental C ORS is found to be safe and effective, child health providers may choose it as a low cost alternative to commercial ORS. With proper supervision, it may then be recommended to families who may otherwise find the cost of oral rehydration therapy to be prohibitive.

Nursing Effectiveness in Preventive Child Health Program
Grant/Contract Number: HS06510
Project Period: 02/91-01/94
Principal Investigator: Dorothy S. Oda, D.N.Sc., R.N.
Institution: University of California
San Francisco, CA 94143-0608
Purpose: To test the effectiveness of two public health nursing interventions on the rate of health assessments received by low income children eligible for the Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program. Thisstudy evaluated the impact of services such as telephone contacts and home visits on the rate of health assessments. The results provided information regarding the effect of interventions on efforts to increase EPSDT program participation.

Strategies for Care of the Very Low Birthweight Infant
Grant/Contract Number: HS08385
Project Period: 08/96-07/99
Principal Investigator: Nigel S. Paneth, M.D., M.P.H.
Michigan State University
East Lansing, MI 48824-1316
Purpose: To develop ethical, cost-effective, and appropriate strategies for the clinical management of the very low birthweight (VLBW) infants as well as for resource allocation. The study will assess school-age outcomes in VLBW survivors in three population-based data sets from the Netherlands, Canada, and the United States. It will also estimate costs of care used in the three cohorts at current U.S. prices. A randomized trial will be undertaken, involving infants for whom administration of intensive care is uncertain, to determine whether exposure of parents to a multimedia interactive video educational intervention will improve decision making in the nursery. The study will develop recommendations to guide both clinical care and public policy.

Assessment of Febrile Infants Less Than 2 Months of Age
Grant/Contract Number: HS06485
Project Period: 05/93 04/97
Principal Investigator: Robert H. Pantell, M.D.
Institution: University of California
San Francisco, CA 94143
Purpose: To assess which factors in the management of febrile infants are associated with variations in clinical outcomes. The questions being addressed include the following: (1) What is the nature of diagnostic and treatment variability of febrile (>38 C) infants (<2 months) by office based pediatricians? (2) How effective are current clinical strategies in predicting which febrile infants have serious illness? (3) What are the benefits, harms, and costs in febrile infants associated with these varying diagnostic and treatment strategies? (4) Can physicians identify febrile infants for whom the risk of disease is sufficiently low that a "treat all" policy is unwarranted because the harms (morbidity) and costs of this policy exceed the benefits and costs of a more selective strategy? Participating physicians will gather clinical, laboratory, diagnostic, and management information during the 2-year study period. Followup diagnostic assessments also will be made.

Child Development in Relation to Early Otitis Media
Grant/Contract Number: 92-112 F
Project Period: 06/91-05/96
Principal Investigator: Jack L. Paradise, M.D.
Institution: Children's Hospital of Pittsburgh
Pittsburgh, PA 15213-3417
Purpose: To determine whether persistent otitis media with effusion during the first 3 years of life results in lasting impairments of speech, language, cognitive, or psychosocial development, and if so, whether prompt tympanotomy tube placement (TTP) is efficacious in preventing or lessening the impairments. The study will also determine whether and to what extent the number of TTP operations can be reduced by increasing the duration of otitis media with effusion required before TTP is undertaken. It will delineate the occurrence and natural history of otitis media and associated hearing loss in infants and young children. Middle ear status will be monitored frequently, hearing levels will be monitored monthly, standardized questionnaires will be used to assess developmental functioning in a random sample, and otological and audiological status will be monitored systematically.

Regional Variation in Pediatric Hospitalization
Grant/Contract Number: HS06060
Project Period: 09/90-08/94
Principal Investigator: James M. Perrin, M.D.
Institution: Massachusetts General Hospital
Boston, MA 02114
Purpose: To identify and explain documented variations in rates of pediatric hospitalization for five common childhood illnesses in three Northeast cities. The study used Poisson regression models, contingency tables, and linear and logistic regression models to analyze hospitalization rates. The results provided insight into pediatric admission decisions and helped to determine appropriate criteria for childhood hospital utilization.

Illness Severity and Practice Variation Among Newborn ICUs
Grant/Contract Number: HS07015
Project Period: 04/94-03/97
Principal Investigator: Douglas K. Richardson, M.D., M.B.A.
Institution: Beth Israel Deaconess Medical Center
Boston, MA 02215
Purpose: To (1) measure the degree of variability in outcomes of neonatal intensive care unit (NICU) patients, holding constant severity of illness, gestational age, weight, and other variables; and (2) measure the degree of variability in resource use at the study sites, including length of stay and a proxy for costs. The purpose is to ascertain variability in outcome (mortality, complications, resource use) from the NICU not attributable to patient severity, and identify variations in practice that may increase cost without improving outcome.

Pharmaceutical Care and Pediatric Asthma Outcomes
Grant/Contract Number: HS07834
Project Period: 03/93-02/97
Principal Investigator: Andreas S. Stergachis, Ph.D.
Institution: University of Washington
Seattle, WA 98195
Purpose: To conduct a study that will analyze the results of pharmacists' services on health outcomes and costs for young asthma patients, who often represent the most chronic asthma cases. This includes the recruitment of 400 chronic asthma patients from youth to late teens who receive baseline medical tests. They will be serviced by selected and randomized pharmacies that will deliver usual care or pharmacy based intervention and will be tracked by the pharmacists up to 1 year after their program entry. The study will ultimately measure the patient's pulmonary function, functional status, school attendance, and asthma related health care costs to determine the cost effectiveness of pharmaceutical care for pediatric asthma patients.

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