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Clinical Studies

Pharmaceutical Outcomes

Impact of Prospective Drug Use Review on Health Outcomes
Grant/Contract Number: HS09075
Project Period: 08/96-07/98
Principal Investigator: Frank M. Ahern, Ph.D.
Pennsylvania State University
University Park, PA 16802
Purpose: To compare two different models of outpatient prospective drug utilization review (ProDUR) programs in the state of Pennsylvania, one of which allows active participation by a pharmacist in the process while the other does not. The study aims to (1) conduct a descriptive epidemiological analysis of psychotropic drug use, prescribing patterns, and yield of ProDUR interventions, and compute estimates of drug-related outcome measures; and (2) evaluate the independent effects of two different ProDUR procedures on health outcomes. The investigators will use data from PACE and Medicaid. Outcomes to be studied include hospitalization and utilization of other health-related resources.

Pharmaceutical Care Outcomes: The Patient Role
Grant/Contract Number: HS07773
Projct Period: 03/93-02/98
Principal Investigator: Betty A. Chewning, Ph.D., M.S.
Institution: University of Wisconsin
Madison, WI 53706
Purpose: To examine from a patient's perspective the process and outcomes of arthritis patients' drug regimen decisions by examining (1) how patients' perceptions about quality of life, symptoms, and medication benefits affect adherence and over-the-counter self care use; (2) the effects of patient medication taking behaviors on arthritis outcomes, including quality of life, clinical symptoms, and health care utilization; and (3) how patients' perceptions of quality of life vary with their clinical symptoms. Individuals will be interviewed (over the phone and in the clinic), client diaries reviewed, pharmacy patient profiles collected, and laboratory and physical measurements taken. In addition, the investigators will examine whether the AIMS 2 and SF-36 differ in their sensitivity to changes in clinical symptoms.

Preference Assessment for Pharmaceutical Evaluation
Grant/Contract Number: HS07818
Project Period: 03/93-08/96
Principal Investigator: Alan Garber, M.D.
Institution: Stanford University
Stanford, CA 94305-8715
Purpose: To develop multimedia instruments to assess preferences toward alternative states of health. These instruments will be used to analyze the cost effectiveness of pharmaceutical therapies that may have substantial effects on quality of life, with a specific application to alglucerase, a new treatment for Gaucher's disease. The results of the analysis will help to quantify inter-individual variation and inter temporal consistency in preferences.

Pharmaceutical Cost, Use, and Outcome among Insured Elderly
Grant/Contract Number: HS08217
Project Period: 09/93-09/96
Principal Investigator: Laura B. Gardner, M.D., Ph.D., M.P.H.
Institution: Axiomedics Research, Inc.
Los Altos, CA 94022-3611
Purpose: To describe and analyze pharmaceutical consumption patterns, health care utilization, and costs of care for older Americans. The specific aim was to analyze the impact of changes in pharmaceutical benefit structure on (1) utilization and expenditures for drugs overall and selected therapeutic categories; (2) use of brand-name compared with generic drug;, and (3) medical care costs and utilization rates overall and for selected conditions. Data were obtained from the Oregon Public Employees Retirement System and Medicare.

Cognitive Impairment and Medication Appropriateness
Grant/Contract Number: HS07819
Project Period: 03/93-05/95
Principal Investigator: Joseph T. Hanlon, Pharm.D.
Institution: Duke University Medical Center
Durham, NC 27710
Purpose: To describe drug use patterns in cognitively impaired and cognitively intact subjects and to assess the associations between the use of specific therapeutic drug classes and cognitive impairment. The Duke Established Population for Epidemiological Studies of the Elderly (EPESE) database was used. The study helped enhance the health of the cognitively impaired elderly by improving medication appropriateness.

Comparative Outcomes of Ambulatory Pharmaceutical Agents
Grant/Contract Number: HS07782
Project Period: 03/93-02/97
Principal Investigator: Joseph Lau, M.D.
Institution: New England Medical Center
Boston, MA 02111
Purpose: To improve the outcomes of pharmaceutical therapies in ambulatory settings by providing physicians, researchers, and opinion leaders with up-to-date pooled results from meta-analyses of randomized controlled trials. By using recently developed methods and cumulative meta-analysis (CMA), and by creating a Real-Time Meta-Analysis System to facilitate experts' knowledge base and the prompt recognition of effective and appropriate use of ambulatory pharmaceutical therapies, this project is tracking these outcomes and reporting findings to journals and opinion leaders.

Geriatric Drug Related Hospitalization
Grant/Contract Number: HS06443
Project Period: 04/90-01/92
Principal Investigator: Helene L. Lipton, Ph.D.
Institution: University of California
San Francisco, CA 94109
Purpose: To examine whether inappropriate physician prescribing practices and poor patient compliance with drug regimen are associated with drug related problems leading to hospital admission. The protocol listed the clinical manifestations produced by the drug related problem, assessed the severity of the problem, determined its specific nature, rated its preventability, determined the degree to which the problem contributed to patient hospitalization, and established a level of certainty of a causal relationship between the identified drug related problem and the hospital admission. This study helped to identify the critical first steps for developing effective interventions designed to reduce drug related problems leading to hospitalizations among geriatric populations.

Use of Record Linkage to Study Outcomes of Drug Therapy
Grant/Contract Number: HS07821
Project Period: 08/93-07/97
Principal Investigator: Richard Platt, M.D., M.S.
Institution: Brigham and Women's Hospital
Boston, MA 02115
Purpose: To assess the usefulness of an automated record linkage system that contains pharmacy dispensing data as well as both ambulatory and inpatient clinical data for studying the indications for, outcomes of, and resource utilization associated with prescribed drug therapy for hypertension. The study will determine whether either prescribing or dispensing data is a sufficiently accurate measure of drug exposure. The degree of compliance will be determined from use of an automated medication monitor, dispensing records, and the patient's blood pressure. The results will be used to determine the outcomes of therapy and total resource utilization associated with specific treatment regimens.

Improving Outcomes in Elderly NSAID Users
Grant/Contract Number: HS07768
Project Period: 07/93-06/98
Principal Investigator: Wayne A. Ray, Ph.D., M.S.
Institution: Vanderbilt University
Nashville, TN 37232-2637
Purpose: To develop and test an educational program that will allow selected physicians to reassess elderly users of nonsteroidal anti inflammatory drugs (NSAIDs). When appropriate, trial tests of acetaminophen are also being conducted. Three hypotheses are being tested: NSAID use will decrease by one third and consequently reduce the price of analgesics; there will be a corresponding reduced rate in the cost of treating peptic ulcers; and there will be no detectable increase in undesirable results. The randomized controlled trial is occurring within the Tennessee Medicaid program, with a 2 year followup to evaluate the results.

Patient Outcomes with Antibiotic Therapy of Lyme Disease
Grant/Contract Number: HS07813
Project Period: 03/93-02/98
Principal Investigator: G. Thomas Strickland, M.D., Ph.D.
Institution: University of Maryland
Baltimore, MD 21201
Purpose: To improve the quality of care in patients suspected of having Lyme disease by (1) investigating differences in patient outcomes resulting from variations in antibiotic therapy and (2) performing a cost effective analysis of the management of Lyme disease. The project administers and utilizes the Maryland Department of Health and Mental Hygiene's Lyme disease registry. Using telephone interviews, the project is obtaining information on the antibiotics prescribed, patient compliance and adverse reaction to the drugs, and clinical responses to different regimens for treating Lyme disease.

Computer-Based Prospective Drug Utilization Review
Grant/Contract Number: HS07763
Project Period: 07/93-01/97
Principal Investigator: William M. Tierney, M.D.
Institution: Regenstrief Institute
Indianapolis, IN 46202-2859
Purpose: To examine, in a randomized trial, the effect of drug utilization review reminders generated by a rule-based, expert system that are fed to physicians at the time of prescribing or to pharmacists at the time of dispensing. The expert system combines condition- and patient-specific treatment recommendations for heart disease (ischemic heart disease and heart failure), reactive airways disease, and uncomplicated hypertension. Study outcomes will include satisfaction with care, general and condition-specific functional/health status, measures of disease activity/severity, and condition-specific hospitalizations.

Prostate Diseases

PORT II for Prostatic Diseases (PORT II)
Grant/Contract Number: HS08397
Project Period: 09/94 08/99
Principal Investigator: Michael J. Barry, M.D.
Institution: Massachusetts General Hospital
Boston, MA 02114
Purpose: To continue the work of the Prostate PORT (HS06336, see next page) for 5 more years. The goals of the project are (1) to define the current pattern of screening, diagnosis, and treatment of prostate disease among primary care physicians and urologists; (2) to better define the effectiveness and cost of screening for carcinoma of the prostate with the tumor marker prostate specific antigen (PSA); (3) to better define the effectiveness of aggressive treatment of clinically localized prostate cancer with radical prostatectomy or radiation therapy; and (4) to define and optimize outcomes for men with prostatic diseases seen in primary care settings. The study includes a physician survey, a multiinstitutional retrospective cohort study, a comparison of population-based rates of metastatic disease and death in two states, and a randomized trial of an educational program for patients and physicians.

Randomized Trial of the SDP for Patients with BPH
Grant/Contract Number: HS06540
Project Period: 08/91-07/95
Principal Investigator: Michael J. Barry, M.D.
Institution: Massachusetts General Hospital
Boston, MA 02114
Purpose: To evaluate the efficacy of Shared Decision Making Procedure (SDP), an interactive educational program to educate men about benign prostatic hyperplasia (BPH) and the available treatment alternatives. More specifically, the study determined whether SDP use led to improved health and well being, greater patient willingness to participate in treatment decisions, a change in treatment decisions, greater patient satisfaction with both the decisions made and the process of decision making, and more weight in decision making placed on patient preferences.

TURP Versus Open Prostatectomy or Nonoperative Treatments
Grant/Contract Number: HS06689
Project Period: 01/92-04/93
Principal Investigator: Abraham T.K. Cockett, M.D.
Institution: American Urological Association
Baltimore, MD 21201
Purpose: To compare treatment strategies for benign prostatic hyperplasia (BPH). More specifically, the study aimed to (1) "rule out" a higher mortality among men treated with transurethral prostatectomy (TURP) compared with open prostatectomy or a strategy of nonoperative treatment; (2) establish the relative effectiveness of a drug treatment (alpha blockade), balloon dilation, and expectant management compared with TURP; (3) compare the relative effectiveness of TURP versus open prostatectomy; and (4) determine whether delayed intervention or other clinically useful predictors are associated with unsatisfactory outcomes. This project provided critical information for the development of guidelines for BPH treatment.

Assessing Therapies for Benign Prostatic Hypertrophy and Localized Prostate Cancer (PORT)
Grant/Contract Number: HS06336
Project Period: 09/89-02/95
Principal Investigator: John E. Wennberg, M.D., M.P.H.
Institution: Dartmouth Medical School
Hanove, NH 03755-3863
Purpose: To assess diagnostic and therapeutic interventions for benign prostatic hyperplasia (BPH) and localized adenocarcinoma of the prostate. The study aimed to (1) identify and describe the use of existing and emerging technologies, (2) identify the full spectrum of relevant patient outcomes, (3) build decision models that provide a framework for evaluating alternative treatment theories and practice, (4) establish probabilities of the various outcomes associated with alternative treatments, and (5) develop models predicting patient satisfaction or dissatisfaction with their ultimate outcome state. The findings were published to aid patients and their physicians in making better clinical decisions.

Psychiatric Conditions

Patient Outcomes Associated with Antidepressant Drugs
Grant/Contract Number: HS07772
Project Period: 03/93-02/98
Principal Investigator: Judith M. Garrard, Ph.D.
Institution: University of Minnesota
Minneapolis, MN 55455-0381
Purpose: To examine the association between patient outcomes and antidepressant treatment of community dwelling elderly with depressive symptoms, concentrating on (1) treatment versus nontreatment of symptomatic elderly, (2) symptomatic treated versus healthy elderly, (3) group comparisons of patient characteristics (improved/not improved), and (4) outcomes as a function of physician diagnosis and treatment. A stratified, random sample will be followed longitudinally.

Schizophrenia Patient Outcomes Research Team (PORT)
Grant/Contract Number: 282 92 0054
Project Period: 09/92-09/97
Principal Investigator: Anthony F. Lehman, M.D.
Institution: University of Maryland
Baltimore, MD 21201
Purpose: To assess practice variations in the treatment and management of schizophrenia and analyze them for relative patient outcomes, resource use, and remaining scientific uncertainties. Recommendations for treatment and management will be developed and disseminated to practitioners and the public. This project also will evaluate the effectiveness of this dissemination effort in terms of measurable patient outcomes, practice patterns, public awareness and attitudes, and resource use.

Improving Cost Effectiveness of Prepaid Depression Care (PORT II)
Grant/Contract Number: HS08349
Project Period: 07/94-06/99
Principal Investigator: Kenneth B. Wells, M.D., Ph.D.
Institution: RAND
Santa Monica, CA 90407-02138
Purpose: To (1) evaluate the cost effectiveness of alternative approaches to improving care for depression in prepaid group practices, and (2) obtain information on the linkages between processes of care and mental health specialty settings. The study hypothesizes that each intervention will be cost effective compared with the usual care. It also includes bivariate analyses, multiple regression analyses, and decision analysis to identify effects of the interventions and linkages between treatments and outcomes.

Variations in the Process and Outcomes of Care for Depression
Grant/Contract Number: HS06802
Project Period: 04/91-03/94
Principal Investigator: Kenneth B. Wells, M.D., M.P.H.
Institution: RAND Corporation
Santa Monica, CA 90407-2138
Purpose: To (1) examine variations in quality and outcomes of care for depression for different groups of depressed patients (age groups, men versus women, poor and nonpoor, ethnic minority versus white) and for different types of treatment locations (rural versus urban, for-profit versus nonprofit organizations, public versus private); and (2) determine how variations in outcomes correspond with variations in process of care for depressed patients. This study used data from two large quasi-experimental studies, the Medical Outcomes Study and the Prospective Payment Quality of Care Study.

Women's Health

Surgical Treatments Outcomes Project for DUB (STOP-DUB)
Grant/Contract Number: HS09506
Project Period: 09/96-09/01
Principal Investigator: Kay Dickersin, Ph.D.
Institution: University of Maryland
Baltimore, MD 21201
Purpose: To assess the effectiveness of hysterectomy compared to endometrial ablation (EA) for women with dysfunctional uterine bleeding (DUB) who have failed medical management. The 5-year study will (1) assess the effectiveness of hysterectomy and EA using a set of related outcomes by conducting a large, simple randomized clinical trial; (2) follow the natural history of DUB in women not yet eligible for the trial or preferring a non-surgical approach, including age at presentation, progression of symptoms, bleeding experience, medical interventions used and the associated outcomes, rates of surgical treatment, quality-of-life outcomes, and cost of care; (3) describe the demographic and baseline characteristics of patients with DUB; and (4) perform cost analyses comparing hysterectomy and EA using data collected in the trial. The study team will follow randomized clinical trial and medical patients for 2 years.

Hysterectomy and Dysfunctional Uterine Bleeding
Grant/Contract Number: HS09502
Project Period: 09/96-09/01
Principal Investigator: Sarah E. Fowler, Ph.D.
Institution: Case Western Reserve University
Detroit, MI 48202
Purpose: To compare patient outcomes and relative costs of hysterectomy versus endometrial ablation versus gonadotropin release hormone (GnRH) against therapy for women presenting with refractory dysfunctional uterine bleeding. This multicenter, randomized clinical trial will test the relative effects of hysterectomy versus endometrial ablation versus medical management with GnRH and oral contraceptives on patient outcomes and on costs.

Community Physician's Diagnostic Accuracy in Colposcopy
Grant/Contract Number: HS07162
Project Period: 07/93-06/96
Principal Investigator: Paul R. Gordon, M.D.
Institution: Family Practice Office
Tucson, AZ 85716
Purpose: To develop normative statements about the diagnostic accuracy of community-based physicians (CBPs) performing colposcopies in order to identify physicians at risk for substandard diagnostic accuracy, and to assess the ability of the four-quadrant biopsy technique alone to define diagnostic accuracy. This objective will be achieved by collecting demographic and practice profiles of CBPs performing colposcopies.

Medicine or Surgery? (MS?)
Grant/Contract Number: HS09478
Project Period: 09/96-09/01
Principal Investigator: Stephen B. Hulley, M.D.
Institution: University of California
San Francisco, CA 94105
Purpose: To evaluate medical and surgical treatments for abnormal uterine bleeding in premenopausal women with or without co-existing uterine myomata. The study will plan and implement randomized clinical trials that efficiently and definitively compare the outcomes of medicine and surgery for abnormal uterine bleeding to help women make more informed decisions about treatment choices. The study team will conduct a 2-year followup to examine differences in function and well-being, and in other quality-of-life, clinical, and economic outcomes.

Effectiveness and Outcomes of Hysterectomy
Grant/Contract Number: HS06865
Project Period: 09/91-02/96
Principal Investigator: Kristen H. Kjerulff, Ph.D.
Institution: University of Maryland
Baltimore, MD 21201
Purpose: To (1) examine the decision making process and outcomes of hysterectomy by focusing on mortality, morbidity, health status, functional capacity, and quality of life; (2) examine the extent to which surgical procedures (vaginal versus abdominal) and ovary removal affect outcomes; and (3) examine the extent to which patient race and other socioeconomic factors affect the decision making process and outcomes of hysterectomy. The 2 year study included patient interviews before and five times after the surgery, chart reviews, and physician interviews.

Community-Based Study of Hysterectomy Outcomes
Grant/Contract Number: HS06726
Project Period: 04/92-03/95
Principal Investigator: Donna C. Kritz Silverstein, Ph.D.
Institution: University of California
La Jolla, CA 92093-0631
Purpose: To evaluate the effect of hysterectomy on long term physical and psychosocial outcomes in upper middle class women ages 50-89. This study tested the hypotheses that women who have had a hysterectomy and were not using exogenous estrogen had a higher prevalence of menopausal symptoms and urinary incontinence; higher scores of depressed mood; and lower ratings of life satisfaction, physical and emotional functioning, and health than naturally postmenopausal women. The study included analysis of existing data, collection and analysis of new data, and a survey.

The Hysterectomy Decision: Assessment of Outcomes
Grant/Contract Number: HS06121
Project Period: 04/89-09/92
Principal Investigator: Buell A. Miller, M.D.
Institution: Maine Medical Assessment Foundation
South Portland, ME 04106
Purpose: To examine the effectiveness and appropriateness of hysterectomies with the overall goal of improving decision making regarding hysterectomy versus alternative treatment for individual patients. The project developed decision analytic models to define key probabilities and patient utilities driving the hysterectomy decision. It then conducted a prospective observational followup study of women ages 25 to 50 presenting to gynecologists throughout Maine. The results of the study were disseminated to Maine gynecologists and facilitated optimal decisions regarding hysterectomy.

Effectiveness of Outpatient Treatment for PID (PORT II)
Grant/Contract Number: HS08358
Project Period: 09/95-09/00
Principal Investigator: Roberta B. Ness, M.D.
Institution: University of Pittsburgh
Pittsburgh, PA 15261
Purpose: To conduct a randomized controlled trial to directly compare the effectiveness and cost effectiveness of outpatient and inpatient antimicrobial regimens recommended for treatment of pelvic inflammatory disease (PID). Baseline data will be collected from all subjects by interview, physical examination, serum testing, cervical culture, and endometrial biopsy. The results of this trial will contribute to efforts to prevent the prevalent and morbid reproductive consequences of PID.

A Clinical Decision Aid for Genital Chlamydia in Women
Grant/Contract Number: HS06396
Project Period: 05/91-12/94
Principal Investigator: Frank A. Sonnenberg, M.D.
Institution: UMDNJ Robert Wood Johnson Medical School
New Brunswick, NJ 08903
Purpose: To develop and independently validate an aid for deciding whether to test for chlamydia by classifying women with respect to their risk for chlamydia infection, and to develop a policy model to study the marginal costs and effectiveness of clinical decision aid assisted strategies versus other strategies. The results of the study enhanced the knowledge of risk factors for chlamydia and the prevalence of chlamydia in a primary care population. They also helped reduce unnecessary treatment and lower overall costs of testing.

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