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Outcomes of Pharmaceutical Therapy Program (OPT) Update: RFA HS-92-03

RFA HS-92-03 Projects: Study of Patient Outcomes Associated with Pharmaceutical Therapy

Comparative Outcomes of Ambulatory Pharmaceutical Agents

Principal Investigator: Joseph Lau, M.D., New England Medical Center
Grant Number: HS07782
Project Period: 03/93-02/97
NTIS Number: PB98-115405

Summary: The project developed a computer-based automatic process called Real-Time Meta-Analysis System (RTMAS). This process organizes, routinely updates, and displays randomized controlled trials (RCT) and meta-analyses of pharmaceuticals in a simple and easy to understand matrix format. This significantly reduces the time required to conduct a systematic review and/or meta-analysis of the effectiveness or comparative effectiveness of one or more therapeutic agents. A major contribution of the project is in the methodological improvement of meta-analysis with the development of control rate meta-regression. This latter methodological innovation was supported in a well-recognized study on the discrepancies between meta-analysis and a large RCT.

Publications to Date

The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature (1996). Checklist of information for inclusion in reports of clinical trials. Annals of Internal Medicine 124(8):741-3.

Barza, M., Ioannidis, J.P., Cappelleri, J.C., & Lau, J. (1996). Single or multiple daily doses of aminoglycosides: a meta-analysis. British Medical Journal 312(7027):338-45.

Berkey, C.S., Mosteller, F., Lau, J., & Antman, E.M. (1996). Uncertainty of the time of first significance in random effects cumulative meta-analysis. Controlled Clinical Trials 17(5):357-71.

Bonis, P.A., Ioannidis, J.P., Cappelleri, J.C., Kaplan, M.M., & Lau, J. (1997). Correlation of biochemical response to interferon alfa with histological improvement in hepatitis C: a meta-analysis of diagnostic test characteristics. Hepatology 26(4):1035-44.

Cappelleri, J.C., & Trochim, W.M. (1994). An illustrative statistical analysis of cutoff-based randomized clinical trials. Journal of Clinical Epidemiology 47(3):261-70.

Cappelleri, J.C., & Trochim, W.M. (1995). Ethical and scientific features of cutoff-based designs of clinical trials: a simulation study. Medical Decision Making 15(4):387-94.

Cappelleri, J.C., Darlington, R.B., & Trochim, W.M. (1994). Power analysis of cutoff-based randomized clinical trials. Evaluation Review 18(2):141-52.

Cappelleri, J.C., Fiore, L., Brophy, M., & Lau, J. (1994). Efficacy and safety of anticoagulant and antiplatelet therapy versus anticoagulant therapy after heart-valve replacement: A meta-analysis [abstract]. Controlled Clinical Trials: Design, Methods, and Analysis 15(3, suppl.):47S-48S.

Cappelleri, J.C., Fiore, L.D., Brophy, M.T., Deykin, D., & Lau, J. (1995). Efficacy and safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy after mechanical heart-valve replacement: A meta-analysis. American Heart Journal 130(3, pt. 1):547-52.

Cappelleri, J.C., Ioannidis, J.P., Schmid, C.H., de Ferranti, S.D., Aubert, M., Chalmers, T.C., & Lau, J. (1996). Large trials vs. meta-analysis of smaller trials: how do their results compare? Journal of the American Medical Association 276(16):1332-8.

Cappelleri, J.C., Lau, J., Kupelnick, B., & Chalmers, T.C. (1994). Efficacy and safety of different aspirin dosages on vascular diseases: A meta-analysis [abstract]. Clinical Research 42(2):289A.

Cappelleri, J.C., Lau, J., Kupelnick, B., & Chalmers, T.C. (1995). Efficacy and safety of different aspirin dosages on vascular diseases in high-risk patients. A metaregression analysis. Online Journal of Current Clinical Trials Doc No. 174: Mar 14.

Chalmers, T.C., & Lau, J. (1993). Meta-analytic stimulus for changes in clinical trials. Statistical Methods in Medical Research 2(2):161-72.

Chalmers, T.C., & Lau, J. (1993). Randomized control trials and meta-analyses in gastroenterology: Major achievements and future potential. Annals of the New York Academy of Sciences 703: 96-105; discussion 105-6.

Chalmers, T.C., & Lau, J. (1996). Changes in clinical trials mandated by the advent of meta-analysis. Statistics in Medicine 15(12):1263-8; discussion 1269-72.

de Ferranti, S.D., Ioannidis, J.P., Lau, J., Anninger, W.V., & Barza, M. (1998). Are amoxycillin and folate inhibitors as effective as other antibiotics for acute sinusitis? A meta-analysis. British Medical Journal 317(7159):632-7.

Engels, E.A., Lau, J., & Barza, M. (1998). Efficacy of quinolone prophylaxis in neutropenic cancer patients: a meta-analysis. Journal of Clinical Oncology 16(3):1179-87.

Freedberg, K.A. Hardy, W.D. Holzman, R.S. Tosteson, A.N. and Craven, D.E. (1996). Validating literature-based models with direct clinical trial results: The cost-effectiveness of secondary prophylaxis for PCP in AIDS patients. Medical Decision Making 16(1):29-35.

Giatras, I., Lau, J., & Levey, A.S. (1997). Effect of angiotensin-converting enzyme inhibitors on the progression of nondiabetic renal disease: a meta-analysis of randomized trials. Angiotensin-Converting-Enzyme Inhibition and Progressive Renal Disease Study Group. Annals of Internal Medicine 127(5):337-45.

Insua, J.T., Sacks, H.S., Lau, T.S., Lau, J., Reitman, D., Pagano, D., & Chalmers, T.C. (1994). Drug treatment of hypertension in the elderly: a meta-analysis. Annals of Internal Medicine 121(5):355-62.

Ioannidis, J.P.A., & Lau, J. (1996). The impact of high-risk patients on the population risk and on the population treatment effect. Journal of Clinical Epidemiology 46(1):48-56.

Ioannidis, J.P.A., & Lau, J. (1997). The impact of high-risk patients on the results of clinical trials. Journal of Clinical Epidemiology 50(10):1089-98.

Ioannidis, J.P.A., Cappelleri, J.C., Lau, J., Sacks, H.S., & Skolnik, P.R. (1996). Predictive value of viral load measurements in asymptomatic untreated HIV-1 infection: a mathematical model. AIDS 10(3):255-62.

Ioannidis, J.P.A., Cappelleri, J.C., Lau, J., Skolnik, P.R., Melville, B., Chalmers, T.C., & Sacks, H.S. (1995). Early or deferred zidovudine therapy in HIV-infected patients without an AIDS-defining illness. Annals of Internal Medicine 122(11):856-66.

Ioannidis, J.P.A., Cappelleri, J.C., Sacks, H.S., & Lau, J. (1997). The relationship between study design, results, and reporting of randomized clinical trials of HIV infection. Controlled Clinical Trials 18(5):431-44.

Ioannidis, J.P.A., Cappelleri, J.C., Skolnik, P.R., Lau, J., & Sacks, H.S. (1996). A meta-analysis of the relative efficacy and toxicity of Pneumocystis carinii prophylactic regimens. Archives of Internal Medicine 156(2):177-88.

Ioannidis, J.P.A., Sacks, H.S., Cappelleri, J.C., & Lau, J. (1997) Clinical efficacy of antiretroviral changes in treatment-experienced HIV-infected patients: A meta-analysis. Online Journal of Current Clinical Trials Doc No. 204; May 15.

Lau, J. (1997). Comparative outcomes of ambulatory pharmaceutical agents: Abstract, executive summary, and final report. Report for March 1993-February 1997. Boston, MA: New England Medical Center.

Lau, J., & Chalmers, T.C. (1994). Should intravenous magnesium be given to patients with acute myocardial infarction? [abstract]. Clinical Research 42(2):290A.

Lau, J., & Chalmers, T.C. (1995). The rational use of therapeutic drugs in the 21st century: important lessons from cumulative meta-analyses of randomized control trials. International Journal of Technology Assessment in Health Care 11(3):509-22.

Lau, J., Schmid, C.H., & Chalmers, T.C. (1995). Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. Journal of Clinical Epidemiology 48(1):45-57; discussion 59-60.

Levey, A.S., Schmid, C.H., & Lau, J. (1998). Antilymphocyte antibodies, renal transplantation, and meta-analysis [editorial; comment]. Annals of Internal Medicine 128(10):863-5.

Pedrini, M.T., Levey, A.S., Lau, J., Chalmers, T.C., & Wang, P.H. (1996). The effect of dietary protein restriction on the progression of diabetic and nondiabetic renal diseases: a meta-analysis. Annals of Internal Medicine 124(7):627-32.

Reichardt, C.S., Trochim, W.M.K., & Cappelleri, J.C. (1995). Reports of the death of regression-discontinuity analysis are greatly exaggerated. Evaluation Review 19(1):39-63.

Schmid, C.H., Cappelleri, J.C., & Lau, J. (1994). Applying Bayesian meta-regression to the study of thrombolytic therapy [abstract]. Clinical Research 42(2):290A.

Wang, P.H., Lau, J., & Chalmers, T.C. (1994). Meta-analysis of the effect of intensive therapy on nephropathy in type I diabetes mellitus. In C.E. Mogensen (Ed.) The Kidney and Hypertension in Diabetes Mellitus, 2nd ed. Norwell, MA: Kluwer Academic Publishers. pp. 361-8.

Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. (1994). Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Annals of Internal Medicine 121(11):894-5.

Zucker, D.R., Schmid, C.H., McIntosh, M.W., D'Agostino, R.B., Selker, H.P., & Lau, J. (1997). Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. Journal of Clinical Epidemiology 50(4):401-10.

Computer-Based Prospective Drug Utilization Review

Principal Investigator:William M. Tierney, M.D., Regenstrief Institute, Indianapolis, IN 46202-2859
Grant Number: HS07763
Project Period: 07/93-01/97
NTIS Number: PB2002-102310

Summary: The investigators developed an automated medical system that incorporated existing treatment guidelines. A randomized controlled clinical trial was conducted to demonstrate the impact of this computer-based system on patient-centered outcomes. The trial concluded without a positive result, which demonstrates the difficulties in implementing a computer-based treatment guideline system and the need for further research in the field.

Publications to Date

Bates, A.S., Harris, L.E., Tierney, W.M., & Wolinsky, F.D. (1998). Dimensions and correlates of physician work satisfaction in a midwestern city. Medical Care 36(4):610-7.

Berg, A.O., Atkins, D., & Tierney, W. (1997). Clinical practice guidelines in practice and education. Journal of General Internal Medicine 12(2, suppl.):S25-33.

Callahan, C.M., & Tierney, W.M. (1995). Health services use and mortality among older primary care patients with alcoholism. Journal of the American Geriatrics Society 43(12):1378-83.

Callahan, C.M., Dittus, R.S., & Tierney, W.M. (1996). Primary care physicians' medical decision making for late-life depression. Journal of General Internal Medicine 11(4):218-25.

Callahan, C.M., Hendrie, H.C., & Tierney, W.M. (1996). The recognition and treatment of late-life depression: a view from primary care. Internal Journal of Psychiatry in Medicine 26(2):155-71; discussion 173-5.

Callahan, C.M., Hendrie, H.C., Nienaber, N.A., & Tierney, W.M. (1996). Suicidal ideation among older primary care patients. Journal of the American Geriatrics Society 44(10):1205-9.

Callahan, C.M., Kesterson, J.G., & Tierney, W.M. (1997). Association of symptoms of depression with diagnostic test charges among older adults. Annals of Internal Medicine 126(6):426-32.

Callahan, C.M., Wolinsky, F.D., Stump, T.E., Nienaber, N.A., Hui, S.L., & Tierney, W.M. (1998). Mortality, symptoms, and functional impairment in late-life depression. Journal of General Internal Medicine 13(11):746-52.

Harris, L.E., Luft, F.C., Rudy, D.W., & Tierney, W.M. (1995). Correlates of health care satisfaction in inner-city patients with hypertension and chronic renal insufficiency. Social Sciences and Medicine 41(12):1639-45.

Harris, L.E., Luft, F.C., Rudy, D.W., Kesterson, J.G., & Tierney, W.M. (1998). Effects of multidisciplinary case management in patients with chronic renal insufficiency. American Journal of Medicine 105(6):464-71.

Harris, L.E., Weinberger, M., & Tierney, W.M. (1997). Assessing inner-city patients' hospital experiences. A controlled trial of telephone interviews versus mailed surveys. Medical Care 35(1):70-6.

Litzelman, D.K., & Tierney, W.M. (1996). Physicians' reasons for failing to comply with computerized preventive care guidelines. Journal of General Internal Medicine 11(8):497-9.

McDonald, C.J., Tierney, W.M., Overhage, J.M., Martin, D.K., Smith, B., Wodniak, C., Blevins, L., Warvel, J., Warvel, J., Meeks-Johnson, J., et al. (1994). The Regenstrief Medical Record System—experience with MD order entry and community-wide extensions. Proceedings of the Annual Symposium on Computer Applications in Medical Care 1059.

McDonald, C.J., & Overhage, J.M. (1994). Guidelines you can follow and can trust. An ideal and an example [editorial; comment]. Journal of the American Medical Association 271(11):872-3.

Melfi, C.A., Drake, B.G., & Tierney, W.M. (1996). The role of public opinion in drug resource allocation decisions. PharmacoEconomics 9(2):106-12.

Murray, M.D., & Tierney, W.M. (1996). Predicting exacerbations of reactive airways disease using electronic medical records [abstract]. Journal of General Internal Medicine 11(suppl.):52.

Murray, M.D., & Tierney, W.M. (1996). Using computer-based records to predict mortality risk for inner-city patients with reactive airways disease [abstract]. Journal of General Internal Medicine 11(suppl.):53.

Murray, M.D., Harris, L.E., Overhage, J.M., Zhou, X.H., Smith, F., & Tierney, W.M. (1997). Association between medication possession ratio and reported compliance [abstract]. Journal of General Internal Medicine 12(suppl.):77.

Murray, M.D., Loos, B., Tu, W., Eckert, G.J., Zhou, X.H., & Tierney, W.M. (1998). Effects of computer-based prescribing on pharmacist work patterns. Journal of the American Medical Informatics Association 5(6):546-53.

Murray, M.D., Loos, B., Tu, W., Eckert, G.J., Zhou, X.H., & Tierney, W.M. (1999). Work patterns of ambulatory care pharmacists with access to electronic guideline-based treatment suggestions. American Journal of Health System Pharmacy 56(3):225-32.

Murray, M.D., Rupp, M.T., Overhage, J.M., Ebbeler, D.E., Main, J.W., & Tierney, W.M. (1995). Multidimensional work sampling in an outpatient pharmacy. Pharmacy Practice Management Quarterly 15(3):44-56.

Murray, M.D., Stang, P., & Tierney, W.M. (1997). Health care use by inner-city patients with asthma. Journal of Clinical Epidemiology 50(2):167-74.

Overhage, J.M., Hayward, R.S.A., Wolinsky, F.D., & Tierney, W.M. (1995). Effect of individual internist's characteristics on attitudes toward guidelines [abstract]. Journal of General Internal Medicine 10(4):76.

Overhage, J.M., Mamlin, B., Warvel, J., Warvel, J., Tierney, W., & McDonald, C.J. (1995). A tool for provider interaction during patient care: G-CARE. Proceedings of the Annual Symposium on Computer Applications in Medical Care 178-82.

Overhage, J.M., Tierney, W.M., & McDonald, C.J. (1993). Computer-assisted order-writing improves compliance with ordering guidelines [abstract]. Clinical Research 41(3):716A.

Overhage, J.M., Tierney, W.M., & McDonald, C.J. (1993). Intelligent orders enhance inpatient care process [abstract]. Medical Decision Making 13(4):395.

Overhage, J.M., Tierney, W.M., & McDonald, C.J. (1995). Design and implementation of the Indianapolis Network for Patient Care and Research. Bulletin of the Medical Library Association 83(1):48-56.

Redelmeier, D.A., & Tierney, W.M. (1994). On the distinction between probability and trickiness when diagnosing patients with chest pain [abstract]. Journal of General Internal Medicine 9(2, suppl.):40.

Tierney, R.M. (1998). Computer-based prospective drug therapy: Abstract, executive summary, and final report. Report for July 1993-December 1997. Indianapolis, IN: Indiana University.

Tierney, R.M., Horton, S.M., Hannan, T.J., & Tierney, W.M. (1998). Relationships between symptom relief, quality of life, and satisfaction with hospice care. Palliative Medicine 12(5):333-344.

Tierney, W.M., & Harris, L.E. (1996). Using electronic medical records to predict all-cause among inner-city patients with uncomplicated hypertension [abstract]. Journal of General Internal Medicine 11(suppl.):55.

Tierney, W.M., Murray, M.D., Gaskins, D.L., & Zhou, X.H. (1997). Using computer-based medical records to predict mortality risk for inner-city patients with reactive airways disease. Journal of the American Medical Informatics Association 4(4):313-21.

Tierney, W.M., Overhage, J.M., & McDonald, C.J. (1994). A plea for controlled trials in medical informatics [editorial]. Journal of the American Medical Informatics Association 1(4):353-5.

Tierney, W.M., Overhage, J.M., & McDonald, C.J. (1995). Toward electronic medical records that improve care [editorial; comment]. Annals of Internal Medicine 122(9):725-6.

Tierney, W.M., Overhage, J.M., & McDonald, C.J. (1996). Computerizing guidelines: factors for success. Proceedings of the American Medical Informatics Association Annual Fall Symposium 459-62.

Tierney, W.M., Overhage, J.M., & McDonald, C.J. (1997). Demonstrating the effects of an IAIMS on health care quality and cost. Journal of the American Medical Informatics Association 4(2, suppl.):S41-46.

Tierney, W.M., Overhage, J.M., McDonald, C.J., & Wolinsky, F.D. (1994). Medical students' and housestaff's opinions of computerized order-writing. Academic Medicine 69(5):386-9.

Tierney, W.M., Overhage, J.M., Takesue, B.Y., Harris, L.E., Murray, M.D., Vargo, D.L., & McDonald, C.J. (1995). Computerizing guidelines to improve care and patient outcomes: the example of heart failure. Journal of the American Medical Informatics Association 2(5):316-22.

Tierney, W.M., Takesue, B.Y., Vargo, D.L., & Zhou, X.H. (1996). Using electronic medical records to predict mortality in primary care patients with heart disease: prognostic power and pathophysiologic implications. Journal of General Internal Medicine 11(2):83-91.

Tierney, W.M., Zhou, X.H., Takesue, B.Y., & Vargo, D.L. (1994). Changing clinical data and unstable predictions of mortality in congestive heart failure [abstract]. Journal of General Internal Medicine 9(2, suppl.):37.

Wolinsky, F.D., Wyrwich, K.W., Nienaber, N.A., & Tierney, W.M. (1998). Generic versus disease-specific health status measures. An example using coronary artery disease and congestive heart failure patients. Evaluation of the Health Professions 21(2):216-43.

Wyrwich, K.W., Nienaber, N.A., Tierney, W.M., & Wolinsky, F.D. (1999). Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Medical Care 37(5):469-78.

Wyrwich, K.W., Tierney, W.M., & Wolinsky, F.D. (1998). Does the standard error of measurement identify clinically relevant individual change in health related quality of life measures? Quality of Life Research 7(7):676-7.

Wyrwich, K.W., Tierney, W.M., & Wolinsky, F.D. (1999). Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. Journal of Clinical Epidemiology 52(9):861-73.

Zhou, X.H. (1995). Testing an underlying assumption on a ROC curve based on rating data. Medical Decision Making 15(3):276-82.

Zhou, X.H. (1996). Empirical Bayes combination of estimated areas under ROC curves using estimating equations. Medical Decision Making 16(1):24-8.

Zhou, X.H., Melfi, C.A., & Hui, S.L. (1997). Methods for comparison of cost data. Annals of Internal Medicine 127(8, pt. 2):752-6.

Improving Outcomes in Elderly NSAID Users

Principal Investigator:Wayne A. Ray, Ph.D., M.S., Vanderbilt University
Grant Number: HS07768
Project Period: 07/93-06/98
NTIS Number: PB2002-102310

Summary: The investigators designed an intervention to reduce the use of non-steroidal anti-inflammatories (NSAIDs) for osteoarthritis in an elderly population. Two randomized controlled trials (RCTs) were designed to test the effectiveness of a physician education program in reducing use of NSAIDs. The first RCT, among community dwelling elderly NSAID users, showed that a completed educational visit could produce a 10 percent (6 to 14 percent) reduction in NSAID use. The second, a RCT for nursing home patients, demonstrated an even greater reduction where the mean number of days of NSAID use (7 day periods prior to and after the intervention) decreased from 7.0 to 1.9 days in intervention home subjects compared to a decrease from 7.0 to 6.2 days in control homes (P=0.0001).

Publications to Date

Burnett, C.B., Steakley, C.S., & Tefft, M.C. (1995). Low-income, minority women: Barriers to cancer screening. Annals of the New York Academy of Sciences 768:277-80.

Griffin, M.R. (1993). NSAID Use in the Elderly: Prevalence and Problems. New Jersey: Scientific Therapeutics Information, Inc.

Griffin, M.R. (1998) Nonsteroidal anti-inflammatory drugs. In K.D. Brandt, S. Lohmander, & M. Doherty (Eds.). Osteoarthritis. Oxford; New York: Oxford University Press. p. 261-71.

Griffin, M.R., Brandt, K.D., Liang, M.H., Pincus, T., & Ray, W.A. (1995). Practical management of osteoarthritis. Integration of pharmacologic and nonpharmacologic measures. Archives of Family Medicine 4(12):1049-55.

Griffin, M.R., Smalley, W.E. (1995). Drugs and ulcers: clues about mucosal protection from epidemiologic studies. Journal of Clinical Gastroenterology 21(Suppl 1):S113-119.

Griffin, M.R., Yared, A., Ray, W.A. (2000). Nonsteroidal anti-inflammatory drugs and acute renal failure in elderly persons. American Journal of Epidemiology 151(5):488-96.

Hochberg, M.C., Altman, R.D., Brandt, K.D., Clark, B.M., Dieppe, P.A., Griffin, M.R., Moskowitz, R.W., & Schnitzer, T.J. (1995). Guidelines for the medical management of osteoarthritis—Part I: Osteoarthritis of the hip. Arthritis and Rheumatism 38(11):1535-40.

Hochberg, M.C., Altman, R.D., Brandt, K.D., Clark, B.M., Dieppe, P.A., Griffin, M.R., Moskowitz, R.W., & Schnitzer, T.J. (1995). Guidelines for the medical management of osteoarthritis—Part II: Osteoarthritis of the knee. Arthritis and Rheumatism 38(11):1541-6.

Puett, D.W., & Griffin, M.R. (1994). Published trials of nonmedicinal and noninvasive therapies for hip and knee osteoarthritis. Annals of Internal Medicine 121(2):133-40.

Ray, W.A. (1997). Policy and program analysis using administrative databases. Annals of Internal Medicine 127(8, pt. 2):712-8.

Ray, W.A. (1998) Economic considerations in the use of nonsteroidal anti-inflammatory drugs. In K. Brandt, M. Doherty, L.S. Lohmander (Eds.) Osteoarthritis. New York: Oxford University Press.

Ray, W.A., & Murray, K.T. (2002). Aspirin: redundant in users of nonaspirin, nonsteroidal antiinflammatory agents? American Heart Journal 143(3):381-2.

Ray, W.A., Stein, C.M., Byrd, V., Shorr, R., Pichert, J.W., Brandt, K.D., Pincus, T., & Griffin, M.R. (2001). Educational program for physicians to reduce use of non-steroidal anti-inflammatory drugs among community-dwelling elderly persons: a randomized controlled trial. Medical Care 39(5):425-35.

Ray, W.A., Stein, C.M., Daugherty, J.R., Hall, K., Arbogast, P.G., & Griffin, M.R. (2002). COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 360(9339):1071-3.

Ray, W.A., Stein, C.M., Hall, K., Daugherty, J.R., & Griffin MR. (2002). Non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease: an observational cohort study. Lancet 359(9301):118-23.

Smalley, W.E., & Griffin, M.R. (1996). The risks and costs of upper gastrointestinal disease attributable to NSAIDS [review]. Gastroenterology Clinics of North America 25(20):373-96.

Smalley, W.E., Griffin, M.R., Fought, R.L., & Ray, W.A. (1996). Excess costs from gastrointestinal disease associated with nonsteroidal anti-inflammatory drugs. Journal of General Internal Medicine 11(8):461-9.

Smalley, W.E., Griffin, M.R., Fought, R.L., Sullivan, L., & Ray, W.A. (1995). Effect of a prior-authorization requirement on the use of nonsteroidal antiinflammatory drugs by Medicaid patients. New England Journal of Medicine 332(24):1612-7.

Smalley, W.E., Ray, W.A., Daugherty, J.R., & Griffin, M.R. (1995). Nonsteroidal anti-inflammatory drugs and the incidence of hospitalizations for peptic ulcer disease in elderly persons. American Journal of Epidemiology 141(6):539-45.

Smalley, W., Stein, C.M., Arbogast, P.G., Eisen, G., Ray, W.A., & Griffin, M. (2002). Underutilization of gastroprotective measures in patients receiving nonsteroidal antiinflammatory drugs. Arthritis and Rheumatism 46(8):2195-200.

Stein, C.M., Griffin, M.R., Taylor, J.A., Pichert, J.W., Brandt, K.D., & Ray, W.A. (2001). Educational program for nursing home physicians and staff to reduce use of non-steroidal anti-inflammatory drugs among nursing home residents: a randomized controlled trial. Medical Care 39(5):436-45.

Outcomes Associated with Therapy for Otitis Media

Principal Investigator:Stephen Berman, M.D., University of Colorado, Denver, CO, 80262
Grant Number: HS07816
Project Period:07/93-06/97
NTIS Number: PB98-1194980

Summary: This study focused on the comparative cost-effectiveness of various antibiotic treatments of otitis media. The investigators used the Colorado State Medicaid database to identify exposure and outcomes. The findings of this project suggest that physicians often prescribed the more expensive antibiotics. However, these products were not associated with better outcomes.

Publications to Date

Berman, S. (1995). Otitis media in children. New England Journal of Medicine 332(23):1560-5.

Berman, S. (1997). Utilization of services for otitis media by children enrolled in Medicaid. Archives of Pediatrics and Adolescent Medicine 151:407-13.

Berman, S. (1998). Outcomes associated with therapy for otitis media: abstract, executive summary, and final report. Report for July 1993-June 1997. Denver, CO: Children's Hospital.

Berman, S. (1999). A three step approach to treating otitis media [letter; comment]. Pediatric Infectious Diseases Journal 18(6):571-2.

Berman, S., Bondy, J., Lezotte, D., Stone, B., & Byrns, P.J. (1999). The influence of having an assigned Medicaid primary care physician on utilization of otitis media-related services. Pediatrics 104(5, pt. 2):1192-7.

Berman, S., Byrns, P., Roark, R., & Bondy, J. (1995). The effect of having a Medicaid primary care provider on the utilization of otitis related services [abstract]. Pediatric Research 37(4, pt. 2):103A.

Berman, S., Byrns, P., Roark, R., & Bondy, J. (1995). The effect of having a Medicaid primary care provider on the utilization of otitis related services [abstract]. Archives of Pediatrics and Adolescent Medicine 149(suppl.).

Berman, S., Byrns, P.J., Bondy, J., Smith, P.J., & Lezotte, D. (1997). Otitis media-related antibiotic prescribing patterns, outcomes, and expenditures in a pediatric Medicaid population. Pediatrics 100(4):585-92.

Berman, S., Wu, K., & Roark, R. (1999). Management of otitis media with effusion with prednisone in combination with an antibiotic. International Pediatrics 14(4):30-3.

Byrns, P.J., Bondy, J., Glazner, J.E., & Berman, S. (1997). Utilization of services for otitis media by children enrolled in Medicaid. Archives of Pediatrics and Adolescent Medicine 151(4):407-13.

Roark, R., Petrofski, J., Berson, E., & Berman, S. (1995). Practice variations among pediatricians and family physicians in the management of otitis media. Archives of Pediatrics and Adolescent Medicine 149:839-44.

Outcomes of Compliance with an AMI Practice Guideline

Principal Investigator:Stephen B. Soumerai, M.D.,Harvard Medical School, Boston, MA 02215
Grant Number: HS07631
Project Period:12/93-11/96
NTIS Number: PB2000-107000

Summary: This study used Medicaid data to confirm that beta-blocker therapy reduces mortality and cardiac hospitalizations of myocardial infarction (MI) in elderly patients. The study was the first of several peer-reviewed articles that provided real-world confirmation of clinical trial evidence for the benefit of these agents.

Publications to Date

Gillman, M.W., Ross-Degnan, D., McLaughlin, T.J., Gao, X., Spiegelman, D., Hertzmark, E., Goldman, L., & Soumerai, S.B. (1999). Effects of long-acting versus short-acting calcium channel blockers among older survivors of acute myocardial infarction. Journal of the American Geriatric Society 47(5):512-7.

Soumerai, S.B. (1998). Outcomes of compliance with an AMI practice guideline: Abstract, executive summary, and final report. Report for December 1993-November 1997. Boston, MA: Harvard Medical School.

Soumerai, S.B., McLaughlin, T.J., Ross-Degnan, D., Casteris, C.S., & Bollini, P. (1994). Effects of a limit on Medicaid drug-reimbursement benefits on the use of psychotropic agents and acute mental health services by patients with schizophrenia. New England Journal of Medicine 331(10):650-5.

Soumerai, S.B., McLaughlin, T.J., Spiegelman, D., Hertzmark, E., Thibault, G., & Goldman, L. (1997). Adverse outcomes of underuse of beta-blockers in elderly survivors of acute myocardial infarction. Journal of the American Medical Association 277(2):115-21.

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Current as of June 2004
Internet Citation: Outcomes of Pharmaceutical Therapy Program (OPT) Update: RFA HS-92-03 . June 2004. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/final-reports/pharmaceutical-outcomes-research/update/hs9203a.html