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

Outcomes of Pharmaceutical Therapy for HIV Disease

Principal Investigator: Richard D. Moore, M.D., Johns Hopkins University Baltimore, MD 21205 Grant Number: HS07809 Project Period: 02/93-01/98 NTIS Number: PB2000-100684 Summary:  The project developed a comprehensive, longitudinal, epidemiological database of more than 4,000 HIV-infected individuals who were followed for a total of more than 12,000 person-years.  A study published in the New England Journal of Medicine in 1994 showed racial disparities in the receipt of antiretroviral drug therapy and prophylactic therapy against one of the HIV complications. The article had a major public health policy impact.  The validity of the study was further enhanced by a followup article in the same journal that demonstrated clinical outcomes of HIV individuals are independent of race, gender and drug use behavior.

Publications to Date

Bartlett, J.G. & Moore, R.D. (1998). Improving HIV therapy. Scientific American 279:84-93.

Celentano, D.D., Vlahor, D., Cohn, S., Shadle, V., Obasanjo, O., & Moore, R.D. (1998). Self-reported antiretroviral therapy for HIV infection among injection drug users. Journal of the American Medical Association 280:544-6.

Chaisson, R.E. & Moore, R.D. (1997). Prevention of opportunistic infections in the era of improved antiretroviral therapy. Journal of Acquired Immune Deficiency Syndromes 16:S14-S22.

Chaisson, R.E., Gallant, J.E., Keruly, J.C., & Moore, R.D. (1998). Impact of opportunistic disease on survival in patients with HIV infection. AIDS 12(1):29-33.

Chaisson, R.E., Keruly, J.C., & Moore, R.D. (1995). Race, sex, drug use, and progression of human immunodeficiency virus disease. New England Journal of Medicine 333(12):751-6.

Chaisson, R.E., Keruly, J.C., McAvinue, S., Gallant, J.E., & Moore, R.D. (1996). Effects of an incentive and education program on return rates for PPD test reading in patients with HIV infection. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 11(5):455-9.

Chaisson, R.E., Stanton, D.L., Gallant, J.E., Rucker, S., Bartlett, J.G., & Moore, R.D. (1993). Impact of the 1993 revision of the AIDS case definition on the prevalence of AIDS in a clinical setting. AIDS 7:857-62.

Dal Pan, G.J., Skolasky, R.L., & Moore, R.D. (1997). The impact of neurologic disease on hospitalizations related to human immunodeficiency virus infection in Maryland, 1991-1992. Archives of Neurology 54(7):846-52.

Eldred, L.J., Wu, A.W., Chaisson, R.E., & Moore, R.D. (1998). Adherence to antiretroviral and Pneumocystis prophylaxis in HIV disease. Journal of Acquired Immune Deficiency Syndromes 18:117-25.

Erbelding, E.J., Merz, W.G., Romagnoli, M.J., Keruly, J.C., Moore, R.D., & Gallant, J.E. (1997). Acyclovir in combination with zidovudine does not prolong survival in advanced HIV disease. Antiviral Therapy 2(2):71-7.

Fortgang, I.S., & Moore, R.D. (1995). Hospital admissions of HIV-infected patients from 1988 to 1992 in Maryland. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 8(4):365-72.

Fortgang, I.S., Belitsos, P.C., Chaisson, R.E., & Moore, R.D. (1995). Hepatomegaly and steatosis in HIV-infected patients receiving nucleoside analog antiretroviral therapy. American Journal of Gastroenterology 90(9):1433-6.

Gallant, J.E., Chaisson, R.E., & Moore, R.D. (1998). The effect of adjunctive corticosteroids for the treatment of Pneumocystis carinii pneumonia on mortality and subsequent complications. Chest 114:1236-58.

Gallant, J.E., Chaisson, R.E., Keruly, J.C., & Moore, R.D. (1999). Stavudine in zidovudine (ZDV)-experienced compared with ZDV-naive patients. AIDS 13(2):225-9.

Gallant, J.E., McAvinue, S.M., Moore, R.D., Bartlett, J.G., Stanton, D.L., & Chaisson, R.E. (1995). The impact of prophylaxis on outcome and resource utilization in Pneumocystis carinii pneumonia. Chest 107(4):1018-23.

Gallant, J.E., Moore, R.D., & Chaisson, R.E. (1994). Prophylaxis for opportunistic infections in patients with HIV infection. Annals of Internal Medicine 120:932-44.

Gallant, J.E., Moore, R.D., Keruly, J., Richman, D.D., Chaisson, R.E., and the ZDV Epidemiology Study Group. (1995). Lack of association between acyclovir use and survival in patients with advanced human immunodeficiency virus disease treated with zidovudine. Journal of Infectious Diseases 172:346-52.

Gebo, K.A., Chaisson, R.E., Folkemer, J.G., Bartlett, J.G., & Moore, R.D. (1999). Costs of HIV medical care in the era of highly active antiretroviral therapy. AIDS 13(8):963-9.

Gebo, K.A., Moore, R.D., Keruly, J.C., & Chaisson, R.E. (1996). Risk factors for pneumococcal disease in human immunodeficiency virus-infected patients. Journal of Infectious Diseases 173(4):857-62.

Glesby, M.J., Moore, R.D., & Chaisson, R.E. (1995). Clinical spectrum of herpes zoster in adults infected with human immunodeficiency virus. Clinical Infectious Diseases 21(2):370-5.

Hall, C.S., Raines, C.P., Barnett, S.H., Moore, R.D., & Gallant, J.E. (1999). Efficacy of salvage therapy containing ritonavir and saquinavir after failure of single protease inhibitor-containing regimens. AIDS 13:1207-12.

Lucas, G.M., Chaisson, R.E., & Moore, R.D. (1999). Highly active antiretroviral therapy in a large urban clinic: Risk factors for virological failure and adverse drug reactions. Annals of Internal Medicine 131:81-7.

Maenza, J.R., Keruly, J.C., Moore, R.D., Chaisson, R.E., Merz, W.G., & Gallant, J.E. (1996). Risk factors for fluconazole-resistant candidiasis in human immunodeficiency virus-infected patients. Journal of Infectious Diseases 173(1):219-25.

Maenza, J.R., Merz, W.G., Romagnoli, M.J., Keruly, J.C., Moore, R.D., & Gallant, J.E. (1997). Infection due to fluconazole-resistant Candida in patients with AIDS: prevalence and microbiology. Clinical Infectious Diseases 24:28-34.

Manabe, Y.C., Clark, D.P., Moore, R.D., Lamadue, J.A., Dahlman, H.R., Belitos, P.C., Chaisson, R.E., & Sears, C.L. (1998). Cryptosporidiosis in AIDS: correlates of disease and survival. Clinical Infectious Diseases 27:536-42.

Manabe, Y.C., Vinetz, J.M., Moore, R.D., Merz, C., Charache, P., & Bartlett, J.G. (1995). Clostridium difficile colitis: the prediction of disease at the bedside and efficient use of laboratory testing for diagnosis. Annals of Internal Medicine 123:835-40.

Mehta, S., Moore, R.D., & Graham, N.M.H. (1997). Potential factors affecting adherence with HIV therapy. AIDS 11:1665-70.

Moore, R.D. (1999). Outcomes of pharmaceutical therapy of HIV disease: abstract, executive summary, and final report. Report for February 1993-January 1999. Baltimore, MD: Johns Hopkins University.

Moore, R.D. (1998). Understanding the clinical and economic outcomes of HIV therapy: the Johns Hopkins HIV Clinical Practice Cohort. Journal of Acquired Immune Deficiency Syndromes 17(1, suppl.):S38-S41.

Moore, R.D. (1999). HIV infection, anemia, and survival. Clinical Infectious Diseases 29:44-9.

Moore, R.D. (1999). Schistocytosis and a thrombotic microangiopathy-like syndrome in hospitalized HIV-infected patients. American Journal of Hematology 60(2):116-20.

Moore, R.D. & Bartlett, J.G. (1996). Combination antiretroviral therapy in HIV infection: an economic perspective. PharmacoEconomics 10(2):109-13.

Moore, R.D. & Chaisson, R.E. (1995). Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS 9:1337-442.

Moore, R.D., & Chaisson, R.E. (1996). Natural history of opportunistic disease in an HIV-infected urban clinical cohort. Annals of Internal Medicine 124(7):633-42.

Moore, R.D., & Chaisson, R.E. (1997). Cost-effectiveness of prophylaxis for Mycobacterium avium complex disease. American Journal of Medicine 333(12):751-56.

Moore, R.D., & Chaisson, R.E. (1997). Cost-utility analysis of prophylactic treatment with oral ganciclovir for cytomegalovirus retinitis. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 16(1):15-21.

Moore, R.D., & Chaisson, R.E. (1997). Costs to Medicaid of advancing immunosuppression in an urban HIV-infected patient population in Maryland. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 14(3):223-31.

Moore, R.D., & Chaisson, R.E. (1999). Natural history of HIV infection in the era of combination antiretroviral therapy. AIDS 13(14):1933-42.

Moore, R.D., Cheever, L., Keruly, J.C., & Chaisson, R.E. (1999). Lack of sex difference in CD4 to HIV-1 RNA viral load ratio [letter]. Lancet 353(9151):463-4.

Moore, R.D., Fortgang, I., Keruly, J., & Chaisson, R.E. (1996). Adverse events from drug therapy for human immunodeficiency virus disease. American Journal of Medicine 101(1):34-40.

Moore, R.D., Keruly, J.C., & Chaisson, R.E. (1995). Neutropenia and bacterial infection in acquired immunodeficiency syndrome. Archives of Internal Medicine 155(18):1965-70.

Moore, R.D., Keruly, J.C., & Chaisson, R.E. (1996). Duration of the survival benefit of zidovudine therapy in HIV infection. Archives of Internal Medicine 156(10):1073-7.

Moore, R.D., Keruly, J.C., & Chaisson, R.E. (1998). Anemia and survival in HIV infection. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 19(1):29-33.

Moore, R.D., Stanton, D., Gopalan, R., & Chaisson, R.E. (1994). Racial differences in the use of drug therapy for HIV disease in an urban community. New England Journal of Medicine 330(11):763-8.

Oursler, K.K., Moore, R.D., & Chaisson, R.E. (1999). Risk factors for cryptococcal meningitis in HIV-infected patients. AIDS Research and Human Retroviruses 15:625-31.

Stanton, D.L., Wu, A.W., Moore, R.D., Rucker, S.C., Piazza, M.P., Abrams, J.E., & Chaisson, R.E. (1994). Functional status of persons with HIV infection in an ambulatory setting. Journal of Acquired Immune Deficiency Syndromes 7(10):1050-6.

Sterling, T., Chaisson, R.E., & Moore, R.D. (1998). The impact of M. tuberculosis on subsequent disseminated MAC disease in HIV-infected persons. AIDS 12:1451-7.

Styrt, B.A., Chaisson, R.E., & Moore, R.D. (1997). Prior antimicrobials and staphylococcal bacteremia in HIV-infected patients. AIDS 11(10):1243-8.

Su, L., Moore, R.D., Keruly, J.C., Kaplan, B.H., Treisman, G.J., Royce, R.A., & Koch, G.G. (1997). Impact of HIV disease status, symptoms, and CD4 count on MOS-HIV scores. Drug Information Journal 31:1432-3.

Sulkowski, M.S., Chaisson, R.E., Karp, C.L., Moore, R.D., Margolick, J.B., & Quinn, T.C. (1998). The effect of acute infectious illnesses on plasma HIV-1 viral load and the expression of serological markers of immune activation among HIV-infected individuals. Journal of Infectious Diseases 178:1642-8.

Patient Outcomes Associate with Antidepressant Drugs

Principal Investigator: Judith M. Garrard, Ph.D., University of Minnesota, Minneapolis, MN 55455-0381 Grant Number: HS07772 Project Period: 03/93-02/98 NTIS Number: PB2001-106533 Summary:  This prospective study examined the association between patient outcomes and antidepressant treatment of community-dwelling elderly with depressive symptoms.  The patient outcomes included health services utilization, and health and functional status, including mortality and quality of life.  Study results suggest under-detection of depression among the elderly.  Minor depression appeared associated with perception of a more negative health related quality of life compared to asymptomatic elderly.

Publications to Date

Fisher, C. (1996). Measuring quality in assisted living facilities. Provider 22:12.

Fischer, L.R., Rolnick, S.J., Garrard, J., Jackson, J., & Luepke, L. (1996). The geriatric scale: a content analysis of respondent comments. Journal of Mental Health and Aging 2(2):125-35.

Fischer, L.R., Wei, F., Rolnick, S.J., Jackson, J.M., Rush, W.A., Garrard, J.M., Nitz, N.M., & Luepke, L.J. (2002). Geriatric depression, antidepressant treatment, and healthcare utilization in a health maintenance organization. Journal of the American Geriatrics  Society 50(2):307-12.

Garrard, J., Rolnick, S.J., Nitz, N.M., Luepke, L., Jackson, J., Fischer, L.R., Leibson, C., Bland, P.C., Heinrich, R., & Waller, L.A. (1998). Clinical detection of depression among community-based elderly people with self-reported symptoms of depression. Journals of Gerontology: Series A, Biological Sciences and Medical Sciences 53(2):M92-101.

Leibson, C.L., Garrard, J., Nitz, N., Waller, L., Indritz, M., Jackson, J., Rolnick, S.J., & Luepke, L. (1999). The role of depression in the association between self-rated physical health and clinically defined illness. Gerontologist 39(3):291-8.

Zelterman, D., & Curtsinger, J.W. (1995). Survival curves subjected to occasional insults. Biometrics 51(3):1140-6.

Patient Outcomes with Antibiotic Therapy for Lyme Disease

Principal Investigator: G. Thomas Strickland, M.D., Ph.D., University of Maryland, Baltimore, MD 21201 Grant Number: HS07813 Project Period: 03/93-02/98 NTIS Number: PB2000-106707 Summary:  By prospectively following up with patients reported to the Maryland Lyme Disease Registry, the project was designed to address the comparative effectiveness of different antibiotic regimens in treating Lyme disease. Lyme disease was found to be under-reported, and often inappropriately treated in Maryland.

Publications to Date

Coyle, B.S., Strickland, G.T., Liang, Y.Y., Pena, C., McCarter, R., & Israel, E. (1996). The public health impact of Lyme disease in Maryland. Journal of Infectious Diseases 173(5):1260-2.

Fix, A.D., Strickland, T., Grant, J. (1998). Tick bites and Lyme disease in an endemic setting. Journal of the American Medical Association 279(3):206-10.

Jung, P.I., Nahas, J.N., Strickland, G.T., McCarter, R., & Israel, E. (1994). Maryland physicians' survey on Lyme disease. Maryland Medical Journal 43(5):447-50.

Pena, C.A., Mathews, A.A., Siddiqi, N.H., & Strickland, G.T. (1999). Antibiotic therapy for Lyme disease in a population-based cohort. Clinical Infectious Diseases 29(3):694-5.

Pena, C.A., & Strickland, G.T. (1999). Incidence rates of Lyme disease in Maryland: 1993 through 1996. Maryland Medical Journal 48(2):68-73.

Steinberg, S.H., Strickland, G.T., Pena, C., & Israel, E. (1996). Lyme disease surveillance in Maryland, 1992. Annals of Epidemiology 6(1):24-9.

Strickland, G.T. (2000). Patient outcomes with antibiotic therapy of Lyme disease: abstract, executive summary, and final report. Report for March 1993-February 1999. Baltimore, MD: University of Maryland at Baltimore.

Strickland, G.T., Caisley, I., Woubeshet, M., & Israel, E. (1994). Antibiotic therapy for Lyme disease in Maryland. Public Health Reports 109(6):745-9.

Strickland, G.T., Karp, A.C., Mathews, A., & Pena, C.A. (1997). Utilization and cost of serologic tests for Lyme disease in Maryland. Journal of Infectious Diseases 176(3):819-21.

Strickland, G.T., Trivedi, L., Watkins, S., Clothier, M., Grant, J., Morgan, J., Schmidtman, E., & Burkot, T. (1996). Cluster of Lyme disease cases at a summer camp in Kent County, Maryland. Emerging Infectious Diseases 2(1):44-6.

Pharmaceutical Care and Pediatric Asthma Outcomes

Principal Investigator: Andreas S. Stergachis, Ph.D., University of Washington, Seattle, WA 98195 Grant Number: HS07834 Project Period: 03/93-02/97 NTIS Number: PB2000-101828 Summary:  This was a community-based, randomized controlled trial to demonstrate the effectiveness and cost-effectiveness of a pharmacist intervention program to enhance the outcomes of asthma care in children.  However, the final result failed to support the program's effectiveness.  It also raised a question on the value of conducting a randomized controlled trial when the assurance on protocol compliance could not be obtained.

Publications to Date

McRorie, T., Gardner, J., Sullivan, S., Walker, M., Andrilla, H., & Stergachis, A. (1995). A structured pharmaceutical care intervention for ambulatory pediatric asthma patients [abstract]. Pharmacotherapy 15:400.

McRorie, T., Walker, M., Sullivan, S., Gardner, J., Andrilla, H., & Stergachis, A. (1995). An instrument for the evaluation of prescribed and actual medication use in pediatric asthma [abstract]. Pharmacotherapy 15:395.

Stergachis, A.S. (1999). Pharmaceutical care and pediatric asthma outcomes: abstract, executive summary, and final report. Report for March 1993-February 1998. Seattle, WA: University of Washington.

Stergachis, A., Gardner, J.S., Anderson, M.T., & Sullivan, S.D. (2002). Improving pediatric asthma outcomes in the community setting: does pharmaceutical care make a difference? Journal of the American Pharmaceutical Association Sep-Oct; 42(5):743-52

Pharmaceutical Care Outcomes: The Patient Role

Principal Investigator: Betty Chewning, Ph.D., M.S., University of Wisconsin, Madison, WI 53706 Grant Number: HS07773 Project Period: 03/93-02/98 NTIS Number: PB2001-107624 Summary: This project examined from a patient's perspective the process and outcomes of arthritis patients' drug regimen decisions by seeing (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 were 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 examined whether the AIMS2 and SF-36 differed in their sensitivity to changes in clinical symptoms.  Research found that while physicians ordered a medication change every 6 months for over 90 percent of the patients, many patients engaged in self-care without input from health care providers or at times intentionally deviated from prescribed regimens.  Overall, findings suggest that patients' pharmaceutical care behaviors appear relatively safe in terms of their clinical status indicators related to arthritis.

Publications to Date

Chewning, B. and PCOPR Investigative Research Team (2001). Does the concordance concept serve patient medication management? International Journal of Pharmacy Practice 9:71-9.

Chewning, B., Bell, C., Nowlin, N., Wilson, D., Chappel, R., Boh, L., & Boh, D. (1994). A comparison of AIMS2 and SF-36 health quality of life measures [abstract]. Arthritis and Rheumatism 37(9, suppl.):S225.

Chewning, B.A., Bell, C.L., Nowlin, N.S., Wilson, D.A., Chappell, R., Boh, L.E., & Boh, D.M. (1994). A comparison of AIMS2 and SF-26 for measuring arthritis patients' quality of life and functional health status [abstract]. Arthritis and Rheumatism 37(6, suppl.):R13.

Nowlin, N.S., Bell, C.L., Chewning, B.A., Wilson, D.A., Boh, D.M., Boh, L.E., & Chappell, R. (1994). Nondrug alternative therapy for arthritis [abstract]. Arthritis and Rheumatism 37(6, suppl.):R14.

Use of Record Linkage to Study Outcomes of Drug Therapy

Principal Investigator: Richard Platt, M.D., M.S., Brigham and Women's Hospital, Boston, MA 02115 Grant Number: HS07821 Project Period: 08/93-07/98 NTIS Number: PB99-124042 Summary: This project sought to evaluate patient adherence to antihypertensive therapy in a managed care setting using a variety of methodologies including patient self-report, microelectronic technology in the medication container, pharmacy dispensing records, and pill counts.  By using relatively new microelectronic technology, the project aimed at achieving four major objectives: developing a standard definition of adherence; validating other alternative methods of adherence assessment such as patient-reports, pharmacy dispensing records, or pill counts; evaluating the relationship between adherence and a target medical condition; and examining the predictors of adherence.  The target condition was hypertension. Research was conducted in a managed care setting.  Adherence levels determined from pill counts and pharmacy dispensing records correlated more closely with quantity than with dose timing; and patient-reported non-adherence was a valid predictor of reduced adherence.

Publications to Date

Choo, P.W., Rand, C.S., Inui, T.S., Lee, M.L., Cain E.M., Cordeiro, M.A., Canning, C.F., & Platt, R. (1998). Assessment of exposure to antihypertensive agents by pharmacy records, pill counts, patient reports, and electronic monitors. Pharmacoepidemiology and Drug Safety 7(Suppl. 2):S94.

Choo, P.W., Rand, C.S., Inui, T.S., Lee, M.L., Cain E.M., Cordeiro, M.A., Canning, C.F., & Platt, R. (1998). Dose frequency and timing in validation of studies of pill counts and pharmacy refill adherence. Pharmacoepidemiology and Drug Safety 7(Suppl. 2):S93.

Platt, R. (1998). Record linkage and outcomes of drug therapy: abstract, executive summary, and final report. Report for August 1993-July 1998. Boston, MA: Brigham and Women's Hospital.

A Health Status Measure to Evaluate Drug Therapy for PCP

Principal Investigator: Albert W. Wu, M.D., M.P.H., Johns Hopkins University, Baltimore, MD 21205 Grant Number: HS07824 Project Period: 09/93-08/95 NTIS Number: PB96-182555 Summary:  As the first study in developing and using a health status measure in a clinical trial of an AIDS-related complication, this project was designed to demonstrate the reliability, validity, and usefulness of such a brief health status measure for acute Pneumocystis carinii pneumonia.  Unlike traditional methodology studies in the field, this project added two new dimensions, namely, responsiveness and clinical utility, in the evaluation of a health status instrument.  By doing so, the project has enhanced the traditional validation approach that was based exclusively on reliability and validity of the instrument and set a new model for future studies in the field.

Publications to Date

Gray, S.M., & Brookmeyer, R. (1998). Estimating a treatment effect from multidimensional longitudinal data. Biometrics 54(3):976-88.

Safrin, S., Finkelstein, D.M., Feinberg, J., Frame, P., Simpson, G., Wu, A., Cheung, T., Soeiro, R., Hojczyk, P., & Black, J.R. (1996). Comparison of three regimens for treatment of mild to moderate Pneumocystis carinii pneumonia in patients with AIDS. A double-blind, randomized, trial of oral trimethoprim-sulfamethoxazole, dapsone-trimethoprim, and clindamycin-primaquine. ACTG 108 Study Group. Annals of Internal Medicine 124(9):792-802.

Wu, A.W., & Lamping, D.L. (1994). Assessment of quality of life in HIV disease. AIDS 8(1, suppl.):S349-S359.

Wu, A.W., Brookmeyer, R., Gray, S., Rubin, H.R., & Steinwachs, D.A. (1996). Health status measure to evaluate drug therapy for PCP: abstract, executive summary, final report, and appendices A, B, D. Report for September 1993-August 1995. Baltimore, MD: Johns Hopkins University.

Wu, A.W., Gray, S.M., & Brookmeyer, R. (1999). Application of random effects models and other methods to the analysis of multidimensional quality of life data in an AIDS clinical trial. Medical Care 37(3):249-58.

Wu, A.W., Hays, R.D., Kelly, S., Malitz, F., & Bozzette, S.A. (1997). Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Quality of Life Research 6(6):531-54.

Wu, A.W., Revicki, D.A., Jacobson, D., & Malitz, F.E. (1997). Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Quality of Life Research 6(6):481-93.

Cognitive Impairment and Medication Appropriateness

Principal Investigator: Joseph T. Hanlon, Pharm.D., Duke University Medical Center, Durham, NC 27710 Grant Number: HS07819 Project Period: 03/93-05/95 NTIS Number: PB96-116223 Summary: Built on a series of secondary data analyses using the longitudinal data from a representative sample of community-dwelling elderly, the project evaluated the relationship between cognitive status and medication use.  Focused on two classes of commonly used medications in the elderly, the study demonstrated, in a dose-response fashion, that current benzodiazepine use is associated with memory impairment while NSAID use is not.  The study also provided some clues to the pattern of medication use after the elderly develop cognitive impairment.  In general, those elderly were less likely to use over-the-counter medications and analgesics than cognitively intact community-dwelling elderly.

Publications to Date

Fillenbaum, G.G., Hanlon, J.T., Landerman, L.R., & Schmader, K. (1998). Estrogen use and future performance on a cognitive screen. Gerontologist 38(SII):259.

Fillenbaum, G.G., Horner, R.D., Hanlon, J.T, Landerman, L.R., Dwason, D.V., & Cohen, H.J. (1995). Change in use of prescription and non-prescription drugs by black and white elderly living at home [abstract]. Gerontologist 35:257.

Fillenbaum, G.G., Horner, R.D., Hanlon, J.T., Landerman, L.R., Dawson, D.V., & Cohen, H.J. (1996). Factors predicting change in prescription and nonprescription drug use in a community-residing black and white elderly population. Journal of Clinical Epidemiology 49(5):587-93.

Hanlon, J.T. (1995). Cognitive impairment and medication appropriateness: Abstract, executive summary, and final report. Report for March 1993-May 1995. Durham, NC: Duke University Medical Center.

Hanlon, J.T., Horner, R.D., Schmader, K.E., Fillenbaum, G.G., Lewis, I.K., Wall, W.E., Landerman, L.R., Pieper, C.F., Blazer D.G., & Cohen, H.J. (1995). Benzodiazepine use and cognitive function among community dwelling elderly [abstract]. Pharmacotherapy 15:56-7.

Hanlon, J.T., Horner, R.D., Schmader, K.E., Fillenbaum, G.G., Lewis, I.K., Wall, W.E., Jr., Landerman, L.R., Pieper, C.F., Blazer, D.G., & Cohen, H.J. (1998). Benzodiazepine use and cognitive function among community-dwelling elderly. Clinical Pharmacology and Therapeutics 64(6):684-92.

Hanlon, J.T, Landerman, L.R., Wall, W., Horner, R., Fillenbaum, G., Dawson, D.V., Schmader, K., Blazer, D., & Cohen, H.J. (1994). Drug use patterns among cognitively impaired and intact community dwelling elderly [abstract]. Journal of the American Geriatrics Society 42:SA44.

Hanlon, J.T., Landerman, L.R., Wall, W.E., Jr., Horner, R.D., Fillenbaum, G.G., Dawson, D.V., Schmader, K.E., Cohen, H.J., & Blazer, D.G. (1996). Is medication use by community-dwelling elderly people influenced by cognitive function? Age and Aging 25:190-6.

Hanlon, J.T., Schmader, K., Landerman, L.R., Horner, R., Fillenbaum, G.G., Pieper, C., Wall, W.E., Koronkowski, M., & Cohen, H.J. (1995). Nonsteroidal anti-inflammatory drug use and cognitive function among community dwelling elderly [abstract]. American Geriatrics Society Meeting. SA5.

Hanlon, J.T., Schmader, K.E., Landerman, L.R., Horner, R.D., Fillenbaum, G.C., Pieper, C.F., Wall, W.E., Koronkowski, M.J., & Cohen, H.J. (1997). Relation of prescription nonsteroidal antiinflammatory drug use and cognitive function among community dwelling elderly. Annals of Epidemiology 7:87-94.

Hickey, A., Hanlon, J.T., & Guess, H.A. (1997). Digoxin and cognitive impairment in the elderly. Pharmacoepidemiology and Drug Safety 6(2, suppl.):223.

Schmader, K.E., Hanlon, J.T., Fillenbaum, G.G., Huber, M., Pieper, C., & Horner, R. (1998). Medication use patterns among demented, cognitively impaired and cognitively intact community-dwelling elderly people. Age and Aging 27(4):493-501.

Schmader, K., Hanlon, J.T., Huber, M., Fillenbaum, G.G., Horner, R., & Pieper, C. (1996). Medication use patterns among demented, cognitively impaired and cognitively intact community-dwelling elderly [abstract]. Journal of the American Geriatrics Society 44:S22.

Preference Assessment for Pharmaceutical Evaluation

Principal Investigator: Alan Garber, M.D., Stanford University, Stanford, CA 94305-8715 Grant Number: HS07818 Project Period: 03/93-08/96 NTIS Number: PB97-134431 Summary: The underlying economic principles for the preference assessment, which serves as the foundation for quality of life (QOL) measurement, are somewhat complicated.  Aimed at increasing a subject's understanding of the preference assessment instrument and to detect inconsistencies in response, the project developed a computer-based multimedia presentation of health states and preference elicitation to provide support for the preference assessment process.  The project demonstrated the validity, reliability and usefulness of this multimedia presentation.  In addition, the project also found that when a subject assigns a preference to a health state, that preference appears to be affected by the subject's current health state.

Publications to Date

Beutler, E., & Garber, A.M. (1994). Alglucerase for Gaucher's disease: dose, costs and benefits [editorial]. PharmacoEconomics 5(6):453-9.

Garber, A.M. (1996). Preference assessment for pharmaceutical evaluation: abstract, executive summary, and final report. Report for March 1993-September 1996. Stanford, CA: Stanford University.

Goldstein, M.K., Clarke, A.E., Michelson, D., Bergen, M.R., Garber, A.M., & Lenert, L.A. (1993). The impact of multi-media presentation on subjects' understanding of health states for preference assessment [abstract]. Clinical Research 41:270A.

Goldstein, M.K., Clarke, A.E., Michelson, D., Garber, A.M., Bergen, M.R., & Lenert, L.A. (1994). Developing and testing a multimedia presentation of a health-state description. Medical Decision Making 14(4):336-44.

Goldstein, M.K., Lenert, L.A., Brown, B.W., & Clarke, A.E. (1993). Measuring uncertainty in ratings of quality of life [abstract]. Medical Decision Making 13(4):387.

Goldstein, M.K., Lenert, L.A., Clarke, A.E., Michelson, D.J., & Garber, A.M. (1993). Assessing preferences for multidimensional health states: utilities of activities of daily living (ADLs) [abstract]. Medical Decision Making 13(4):386.

Goldstein, M.K., Lenert, L.A., Michelson, D.J., Clarke, A.E., & Garber, A.M. (1994). Learning effects during elicitation of utilities from frail elders for activities of daily living [abstract]. Clinical Research 42(2):227A.

Lenert, L.A., Michelson, D., Flowers, C., & Bergen, M.R. (1995). IMPACT: an object-oriented graphical environment for construction of multimedia patient interviewing software. Proceeding of the Annual Symposium on Computer Applications in Medical Care 319-23.

Pharmaceutical Cost, Use, and Outcome among Insured Elderly

Principal Investigator: Laura B.Gardner, M.D., Ph.D., M.P.H., Axiomedics Research, Inc., Los Altos, CA 94022-3611 Grant Number: HS08217 Project Period: 09/93-08/96 NTIS Number: PB97-165856 Summary:  The study database was a group of 19,350 retirees of the Public Employees Retirement System (PERS) who were demographically representative of the general Medicare population.  The database maximized its epidemiological potential by linking with Medicare claim data of the PERS individuals. Based on this combined database, the study found that none of the prescription co-payment options, except 50 percent prescription co-payment, affected utilization of and expenditures for pharmaceuticals and their generic substitutions.  Furthermore, none of those co-payment options produced observable changes on subsequent use and expenditures of medical care services among the retirees.

Publications to Date

Gardner, L.B. (1996). Pharmaceutical use and cost among insured elderly: abstract, executive summary, and final report. Report for September 1993-September 1996. Berkeley: Western Consortium for Public Health.

Sullivan, S.D., Gardner, L.B., & Strandberg, L.R. (1994). The economics of outpatient prescription drug coverage for the elderly: Implications for healthcare reform. Generations (summer):55-60.

Statistical Methods for Quality-of-Life Outcomes Research

Principal Investigator: Marcia Anne Testa, Ph.D., Harvard School of Public Health, Boston, MA 02115 Grant Number: HS07767 Project Period: 03/93-02/97 NTIS Number: PB98-115421 Summary:  The investigators 1) evaluated and analyzed current and potential measurement and statistical techniques used in assessing quality-of-life-related patient outcomes through a review of the literature; 2) refined existing analytical and statistical methodology so that it was appropriate for evaluation of pharmacologic therapies; and 3) developed clinical trials databases of hypertension, diabetes, and human immunodeficiency virus.  Research results formed the basis for the National Committee for Quality Assurances' (NQCA) Quality Dividend Calculator (QDC), which helped to establish both clinical and fiscal benefits to improving diabetes.  Additionally, guidelines for design and analysis were published for quality of life consideration in AIDS clinical trials.

Publications to Date

Anderson, R.B., & Testa, M.A. (1994). Symptom distress checklists as a component of quality of life measurement: comparing prompted reports by patient and physician with concurrent adverse event reports via the physician. Drug Information Journal 28: 89-114.

Anderson R.B., & Testa M.A. (1995). Symptom distress checklists as a component of quality of life measurement: comparing symptom reports with responses to multiple choice questionnaires. Drug Information Journal 29:1689S-1707S.

Andrade, S.E., Walker, A.M., Gottlieb, L.K., Hollenberg, N.K., Testa, M.A., Saperia, G.M., & Platt, R. (1995). Discontinuation of antihyperlipidemic drugs—do rates reported in clinical trials reflect rates in primary care settings? New England Journal of Medicine 332(17):1125-31.

Fuleihan, G.E., Testa, M.A., Angell, J.E., Porrino, N., & Leboff, M.S. (1995). Reproducibility of DXA absorptiometry: a model for bone loss estimates. Journal of Bone and Mineral Research 10(7):1004-14.

Lenderking, W.R., Gelber, R.D., Cotton, D.J., Cole, B.F., Goldhirsch, A., Volberding, P.A., & Testa, M.A. (1994). Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. The AIDS Clinical Trials Group. New England Journal of Medicine 330(11):738-43.

Lenderking W.R., Testa M.A., Katzenstein D., & Hammer S. (1997). Measuring quality of life in early HIV disease: the modular approach. Quality of Life Research 6(6):515-30.

Nackley, J.F., & Testa, M.A. (1993). How it works in the field: quality of life assessments in the clinical trials setting [abstract]. Drug Information Journal 27:855.

Testa, M.A., & Lenderking, W.R. (1995). Quality-of-life Considerations in AIDS Clinical Trials. Wiley-Liss Inc.: New York.

Testa, M.A., & Lenderking, W.R. (1999). The impact of AIDS-associated wasting on quality of life: qualitative issues of measurement and evaluation. Journal of Nutrition 129(1S, suppl.):282S-289S.

Testa, M.A., & Nackley, J.F. (1994). Methods for quality-of-life studies. Annual Review of Public Health 15:535-59.

Testa, M.A., & Simonson, D.C. (1996). Assessment of quality-of-life outcomes. New England Journal of Medicine 334 (13):835-40.

Testa, M.A., & Simonson, D.C. (1998). Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: a randomized, controlled, double-blind trial. Journal of the American Medical Association 280(17):1490-6.

Testa, M.A., Simonson, D.C., & Turner, R.R., (1998). Valuing quality of life and improvements in glycemic control in people with type 2 diabetes. Diabetes Care 21 Suppl 3:C44-52.

Testa, M.A., Turner, R.R., Simonson, D.C., Krafcik, M.B., Calvo, C., & Luque-Otero, M. (1998). Quality of life and calcium channel blockade with nifedipine GITS versus amlodipine in hypertensive patients in Spain. Gastrointestinal Therapeutic System. Journal of Hypertension 16(12 Pt 1):1839-47.

Turner, R.R., & Testa, M.A. (2000). Measuring the impact of onychomycosis on patient quality of life. Quality of Life Research  9(1):39-53.

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