283 results on '"Bozzette, Samuel A."'
Search Results
252. Routine Screening for HIV Infection — Timely and Cost-Effective.
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Bozzette, Samuel A.
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DIAGNOSIS of HIV infections , *MEDICAL screening , *MEDICAL care costs , *COST effectiveness , *MEDICAL care , *PUBLICATIONS - Abstract
The article introduces a series of articles published in the February 2005 issue of the "New England Journal of Medicine" that elaborate on the significance of routine screening for HIV infection in the U.S. In their article, A.D. Paltiel, M.C. Weinstein, A.D. Kimmel and others explain the cost effectiveness of HIV screening in the U.S. G.D. Sanders, A.M. Bayoumi, V. Sundaram and other explain the cost effectiveness of screening for HIV in the era of highly active antiretroviral therapy.
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- 2005
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253. Cardiovascular and Cerebrovascular Events in Patients Treated for Human Immunodeficiency Virus Infection.
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Bozzette, Samuel A., Ake, Christopher F., Tam, Henry K., Chang, Sophia W., and Louis, Thomas A.
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THERAPEUTICS , *HIV infections , *METABOLIC disorders , *HYPERLIPIDEMIA , *LIPID metabolism disorders , *CEREBROVASCULAR disease , *CARDIOVASCULAR diseases - Abstract
Background: Metabolic abnormalities associated with human immunodeficiency virus (HIV) infection, including dysglycemia and hyperlipidemia, are increasingly prevalent, and there is concern about the possibility of an association with accelerated cardiovascular and cerebrovascular disease. Methods: We conducted a retrospective study of the risk of cardiovascular and cerebrovascular disease among the 36,766 patients who received care for HIV infection at Veterans Affairs facilities between January 1993 and June 2001. Results: For antiretroviral therapy, 70.2 percent of the patients received nucleoside analogues, 41.6 percent received protease inhibitors, and 25.6 percent received nonnucleoside reverse-transcriptase inhibitors for a median of 17 months, 16 months, and 9 months, respectively. Approximately 1000 patients received combination therapy with a protease inhibitor for at least 48 months, and approximately 1000 patients received combination therapy with a nonnucleoside reverse-transcriptase inhibitor for at least 24 months. Between 1995 and 2001, the rate of admissions for cardiovascular or cerebrovascular disease decreased from 1.7 to 0.9 per 100 patient-years, and the rate of death from any cause decreased from 21.3 to 5.0 deaths per 100 patient-years. Patient-level regression analyses indicated that there was no relation between the use of nucleoside analogues, protease inhibitors, or nonnucleoside reverse-transcriptase inhibitors and the hazard of cardiovascular or cerebrovascular events, but the use of antiretroviral drugs was associated with a decreased hazard of death from any cause. Conclusions: Use of newer therapies for HIV was associated with a large benefit in terms of mortality that was not diminished by any increase in the rate of cardiovascular or cerebrovascular events or related mortality. Fear of accelerated vascular disease need not compromise antiretroviral therapy over the short term. However, prolonged survival among HIVinfected patients means that longer-term observation and analysis are required. N Engl J Med 2003;348:702-10. [ABSTRACT FROM AUTHOR]
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- 2003
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254. A Model for a Smallpox-Vaccination Policy.
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Bozzette, Samuel A., Boer, Rob, Bhatnagar, Vibha, Brower, Jennifer L., Keeler, Emmett B., Morton, Sally C., and Stoto, Michael A.
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BIOTERRORISM , *PREVENTIVE medicine , *SMALLPOX , *TERRORISM , *IMMUNIZATION , *VACCINATION , *SMALLPOX vaccines - Abstract
Background: The new reality of biologic terrorism and warfare has ignited a debate about whether to reintroduce smallpox vaccination. Methods: We developed scenarios of smallpox attacks and built a stochastic model of outcomes under various control policies. We conducted a systematic literature review and estimated model parameters on the basis of European and North American outbreaks since World War II. We assessed the trade-offs between vaccine-related harms and benefits. Results: Nations or terrorists possessing a smallpox weapon could feasibly mount attacks that vary with respect to tactical complexity and target size, and patterns of spread can be expected to vary according to whether index patients are hospitalized early. For acceptable results, vaccination of contacts must be accompanied by effective isolation. Vaccination of contacts plus isolation is expected to result in 7 deaths (from vaccine or smallpox) in a scenario involving the release of variola virus from a laboratory, 19 deaths in a human-vector scenario, 300 deaths in a building-attack scenario, 2735 deaths in a scenario involving a low-impact airport attack, and 54,729 deaths in a scenario involving a high-impact airport attack. Immediate vaccination of the public in an attacked region would provide little additional benefit. Prior vaccination of health care workers, who would be disproportionately affected, would save lives in large local or national attacks but would cause 25 deaths nationally. Prior vaccination of health care workers and the public would save lives in a national attack but would cause 482 deaths nationally. The expected net benefits of vaccination depend on the assessed probability of an attack. Prior vaccination of health care workers would be expected to save lives if the probability of a building attack exceeded 0.22 or if the probability of a high-impact airport attack exceeded 0.002. The probability would have to be much higher to make vaccination of the public life-saving. Conclusions: The analysis favors prior vaccination of health care workers unless the likelihood of any attack is very low, but it favors vaccination of the public only if the likelihood of a national attack or of multiple attacks is high. N Engl J Med 2003;348:416-25. [ABSTRACT FROM AUTHOR]
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- 2003
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255. Expenditures for the Care of HIV-Infected Patients in the Era of Highly Active Antiretroviral Therapy.
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Bozzette, Samuel A., Joyce, Geoffrey, McCaffrey, Daniel F., Leibowitz, Arleen A., Morton, Sally C., Berry, Sandra H., Rastegar, Afshin, Timberlake, David, Shapiro, Martin F., and Goldman, Dana P.
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THERAPEUTICS , *HIV infections , *MEDICAL care costs , *ANTIRETROVIRAL agents , *MEDICAL care of HIV-positive persons , *MEDICAL economics , *COST - Abstract
Background: The introduction of expensive but very effective antiviral medications has led to questions about the effects on the total use of resources for the care of patients with human immunodeficiency virus (HIV) infection. We examined expenditures for the care of HIV-infected patients since the introduction of highly active antiretroviral therapy. Methods: We interviewed a random sample of 2864 patients who were representative of all American adults receiving care for HIV infection in early 1996, and followed them for up to 36 months. We estimated the average expenditure per patient per month on the basis of self-reported information about care received. Results: The mean expenditure was $1,792 per patient per month at base line, but it declined to $1,359 for survivors in 1997, since the increases in pharmaceutical expenditures were smaller than the reductions in hospital costs. Use of highly active antiretroviral therapy was independently associated with a reduction in expenditures. After adjustments for the interview date, clinical status, and deaths, the estimated annual expenditure declined from $20,300 per patient in 1996 to $18,300 in 1998. Expenditures among subgroups of patients varied by a factor of as much as three. Pharmaceutical costs were lowest and hospital costs highest among underserved groups, including blacks, women, and patients without private insurance. Conclusions: The total cost of care for adults with HIV infection has declined since the introduction of highly active antiretroviral therapy. Expenditures have increased for medications but have declined for other services. However, there are large variations in expenditures across subgroups of patients. (N Engl J Med 2001;344:817-23.) [ABSTRACT FROM AUTHOR]
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- 2001
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256. Efficacy of infliximab, abatacept, and cenicriviroc for the treatment of adults hospitalized with COVID-19 pneumonia.
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Lin, Dan-Yu, Wang, Jianqiao, Anstrom, Kevin J., LaVange, Lisa M., Wen, Jun, Bozzette, Samuel A., and Powderly, William G.
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COVID-19 , *CLINICAL trials , *CLINICAL deterioration , *INFLIXIMAB , *ABATACEPT - Abstract
• A randomized clinical trial was conducted on patients hospitalized with COVID-19. • The patient's clinical status was assessed daily on an 8-point ordinal scale. • Infliximab accelerated improvement and reduced deterioration of clinical status. • Abatacept was also beneficial. • Cenicriviroc was not beneficial. A randomized, double-blind, placebo-controlled clinical trial was conducted to investigate the efficacy of infliximab, abatacept, and cenicriviroc in treating patients hospitalized with COVID-19. The patient's clinical status was assessed daily on an 8-point ordinal scale. We evaluated the totality of evidence on the efficacy of the 3 immunomodulators by considering all possible changes in the clinical status of each patient over time. We demonstrated that infliximab accelerated improvement and reduced deterioration of clinical status when added to standard of care. There was also evidence for the benefit of abatacept. There was no evidence for the benefit of cenicriviroc. [ABSTRACT FROM AUTHOR]
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- 2024
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257. The Care of HIV-Infected Adults in the United States.
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Bozzette, Samuel A., Berry, Sandra H., Duan, Naihua, Frankel, Martin R., Leibowitz, Arleen A., Lefkowitz, Doris, Emmons, Carol-Ann, Senterfitt, J. Walton, Berk, Marc L., Morton, Sally C., Shapiro, Martin F., Andersen, Ronald M., Cunningham, William E., Marcus, Marvin, Wenger, Neil S., Athey, Leslie A., Smith, Stephen M., Bing, Eric G., Brown, Julie A., and Burnham, M. Audrey
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THERAPEUTICS , *HIV infections , *MEDICAL care , *MEDICAL care costs , *DISEASES - Abstract
Background: and Methods In order to elucidate the medical care of patients with human immunodeficiency virus (HIV) infection in the United States, we randomly sampled HIV-infected adults receiving medical care in the contiguous United States at a facility other than a military, prison, or emergency department facility during the first two months of 1996. We interviewed 76 percent of 4042 patients selected from among the patients receiving care from 145 providers in 28 metropolitan areas and 51 providers in 25 rural areas. Results: During the first two months of 1996, an estimated 231,400 HIV-infected adults (95 percent confidence interval, 162,800 to 300,000) received care. Fifty-nine percent had the acquired immunodeficiency syndrome according to the case definition of the Centers for Disease Control and Prevention, and 91 percent had CD4+ cell counts of less than 500 per cubic millimeter. Eleven percent were 50 years of age or older, 23 percent were women, 33 percent were black, and 49 percent were men who had had sex with men. Forty-six percent had incomes of less than $10,000 per year, 68 percent had public health insurance or no insurance, and 30 percent received care at teaching institutions. The estimated annual direct expenditures for the care of the patients seen during the first two months of 1996 were $5.1 billion; the expenditures for the estimated 335,000 HIV-infected adults seen at least as often as every six months were $6.7 billion, which is about $20,000 per patient per year. Conclusions: In this national survey we found that most HIV-infected adults who were receiving medical care had advanced disease. The patient population was disproportionately male, black, and poor. Many Americans with diagnosed or undiagnosed HIV infection are not receiving medical care at least as often as every six months. The total cost of medical care for HIV-infected Americans accounts for less than 1 percent of all direct personal health expenditures in the United States. (N Engl J Med 1998;339:1897-904.) [ABSTRACT FROM AUTHOR]
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- 1998
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258. Reply.
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Bozzette, Samuel A., Allen McCutchan, J., Spector, Stephen A., and Richman, Douglas D.
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- 1994
259. Clinical perspectives of emerging pathogens in bleeding disorders.
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Ludlam, Christopher A., Powderly, William G., Bozzette, Samuel, Diamond, Michael, Koerper, Marion A., Kulkarni, Roshni, Ritchie, Bruce, Siegel, Jamie, Simmonds, Peter, Stanley, Samuel, Tapper, Michael L., and von Depka, Mario
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BLOOD coagulation factors , *PLASMA products , *PREVENTION of communicable diseases , *PATHOGENIC microorganisms , *RECOMBINANT blood proteins , *PLASMA exchange (Therapeutics) , *THERAPEUTIC complications , *MEDICAL quality control , *BLOOD transfusion reaction , *BLOOD coagulation disorders , *ZOONOSES , *PREVENTION , *SAFETY , *BLOOD disease treatment , *THERAPEUTICS - Abstract
Summary As a result of immunological and nucleic-acid screening of plasma donations for transfusion-transmissible viruses, and the incorporation of viral reduction processes during plasma fractionation, coagulation-factor concentrates (CFC) are now judged safe in terms of many known infectious agents, including hepatitis B and C viruses, HIV, and human T-cell lymphotropic virus. However, emerging pathogens could pose future threats, particularly those with blood-borne stages that are resistant to viral-inactivation steps in the manufacturing process, such as non-lipid-coated viruses. As outlined in this Review, better understanding of infectious diseases allows challenges from newly described agents of potential concern in the future to be anticipated, but the processes of zoonotic transmission and genetic selection or modification ensure that plasma-derived products will continue to be subject to infectious concerns. Manufacturers of plasma-derived CFC have addressed the issue of emerging infectious agents by developing recombinant products that limit the need for human plasma during production. Such recombinant products have extended the safety profile of their predecessors by ensuring that all reagents used for cell culture, purification steps, and stabilisation and storage buffers are completely independent of human plasma. [ABSTRACT FROM AUTHOR]
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- 2006
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260. Cost of managing meningitis and encephalitis among infants and children in the United States.
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Balada-Llasat, Joan M, Rosenthal, Ning, Hasbun, Rodrigo, Zimmer, Louise, Bozzette, Samuel, Duff, Steven, Chung, Jessica, and Ginocchio, Christine C.
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ARBOVIRUS diseases , *INFANTS , *CHILDREN , *MENINGITIS - Abstract
Abstract A retrospective cohort study design was used to assess the use and costs of diagnostic tests, medication, and total hospitalization costs for pediatric patients with suspected meningitis/encephalitis who received a lumbar puncture (LP) procedure. Related costs were calculated by timing of LP performed and infectious etiology for infants (<1 year) and children (1–17 years). A total of 3030 infants and 3635 children with suspected ME diagnosed between 2011 and 2014 were included in the study. The mean hospitalization cost for infants and children was $12,759 and $11,119, respectively, with medication and laboratory test costs of $834 and $1771 for infants and $825 and $855 for children, respectively. Total visit cost increased with delayed LP procedure, ICU stay, and if the etiology was viral (other than enterovirus or arbovirus) or bacterial. Higher diagnostic and treatment costs were associated with delayed LP procedure, etiologic agent, and ICU stay. [ABSTRACT FROM AUTHOR]
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- 2019
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261. Cost of managing meningitis and encephalitis among adult patients in the United States of America.
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Balada-Llasat, J.M., Rosenthal, Ning, Hasbun, Rodrigo, Zimmer, Louise, Ginocchio, Christine C., Duff, Steven, Allison, Jessica, and Bozzette, Samuel
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TREATMENT of encephalitis , *MENINGITIS , *PUBLIC health , *MEDICAL care costs , *HOSPITALIZATION insurance , *PATIENTS - Abstract
Objective To determine the associated costs related to the diagnosis and treatment of meningitis and encephalitis (ME) in adult patients in the USA. Methods A retrospective observational study design was used to assess the use and costs of diagnostic tests and antimicrobial treatment and the total hospitalization costs for adult patients with suspected ME, who received a lumbar puncture procedure during an emergency department visit or during the first two service days of an inpatient stay. Related costs were calculated by timing of lumbar puncture performed and infectious etiology. Results A total 26 429 adult patients with suspected ME diagnosed between 2011 and 2014 were included in the study. The mean hospitalization cost was $15 572 ± 27 168, with antimicrobial medication cost of $1144 ± 4052 and laboratory test cost of $210 ± 244. The total visit cost increased with delayed lumbar puncture procedure, intensive care unit stay, and if the etiology was fungi, arbovirus, or bacteria. Conclusions Higher diagnostic and treatment costs are associated with a delayed lumbar puncture procedure, the etiological agent, and the requirement for an intensive care unit stay. [ABSTRACT FROM AUTHOR]
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- 2018
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262. Epidemiology of Meningitis and Encephalitis in the United States, 2011–2014.
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Hasbun, Rodrigo, Rosenthal, Ning, Balada-Llasat, J. M., Chung, Jessica, Duff, Steve, Bozzette, Samuel, Zimmer, Louise, and Ginocchio, Christine C.
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MENINGITIS treatment , *TREATMENT of encephalitis , *EPIDEMIOLOGY , *MORTALITY , *ANTIBIOTICS - Abstract
Background. Large epidemiological studies evaluating the etiologies, management decisions, and outcomes of adults with meningitis or encephalitis in the United States (US) are lacking. Methods. Adult patients (≥18 years) with meningitis or encephalitis by International Classification of Diseases, Ninth Revision codes available in the Premier Healthcare Database during 2011–2014 were analyzed. Results. A total of 26 429 patients with meningitis or encephalitis were identified. The median age was 43 years; 53% were female. The most common etiology was enterovirus (13 463 [51.6%]), followed by unknown (4944 [21.4%]), bacterial meningitis (3692 [14.1%]), herpes simplex virus (2184 [8.3%]), noninfectious (921 [3.5%]), fungal (720 [2.7%]), arboviruses (291 [1.1%]), and other viruses (214 [0.8%]). Empiric antibiotics, antivirals, and antifungals were administered in 85.8%, 53.4%, and 7.8%, respectively, and varied by etiologies. Adjunctive steroids were utilized in 15.9% of all patients and in 39.3% of patients with pneumococcal meningitis, with an associated decrease in mortality (6.67% vs 12.5%, P = .0245). The median length of stay was 4 days, with the longest duration in those with fungal (13), arboviral (10), and bacterial meningitis (7). Overall inpatient mortality was 2.9% and was higher in those with bacterial (8.2%), fungal (8.2%), or arboviral (8.9%) disease. Overall readmission rate at 30 days was 3.2%; patients with arboviral (12.7%), bacterial (6.7%), and fungal (5.4%) etiologies had higher rates. Conclusions. Viruses are the most common cause of meningitis and encephalitis in the United States and are treated with antibiotic therapy in the majority of cases. Adjunctive steroid treatment is underutilized in pneumococcal meningitis, where it has shown to decrease mortality. [ABSTRACT FROM AUTHOR]
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- 2017
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263. Effect of Procalcitonin Testing on Health-care Utilization and Costs in Critically Ill Patients in the United States.
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Balk, Robert A., Kadri, Sameer S., Cao, Zhun, Robinson, Scott B., Lipkin, Craig, and Bozzette, Samuel A.
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CRITICALLY ill patient care , *CALCITONIN , *MULTIVARIATE analysis , *DIAGNOSIS , *ANTIBIOTICS , *SEPSIS , *CATASTROPHIC illness , *COST effectiveness , *DEMOGRAPHY , *CLINICAL pathology , *DIPHOSPHONATES , *LENGTH of stay in hospitals , *INTENSIVE care units , *PROBABILITY theory , *SOCIOECONOMIC factors , *RETROSPECTIVE studies , *PHARMACODYNAMICS , *THERAPEUTICS - Abstract
Background: There is a growing use of procalcitonin (PCT) to facilitate the diagnosis and management of severe sepsis. We investigated the impact of one to two PCT determinations on ICU day 1 on health-care utilization and cost in a large research database.Methods: A retrospective, propensity score-matched multivariable analysis was performed on the Premier Healthcare Database for patients admitted to the ICU with one to two PCT evaluations on day 1 of ICU admission vs patients who did not have PCT testing.Results: A total of 33,569 PCT-managed patients were compared with 98,543 propensity score-matched non-PCT patients. In multivariable regression analysis, PCT utilization was associated with significantly decreased total length of stay (11.6 days [95% CI, 11.4 to 11.7] vs 12.7 days [95% CI, 12.6 to 12.8]; 95% CI for difference, 1 to 1.3; P < .001) and ICU length of stay (5.1 days [95% CI, 5.1 to 5.2] vs 5.3 days [95% CI, 5.3 to 5.4]; 95% CI for difference, 0.1 to 0.3; P < .03), and lower hospital costs ($30,454 [95% CI, 29,968 to 31,033] vs $33,213 [95% CI, 32,964 to 33,556); 95% CI for difference, 2,159 to 3,321; P < .001). There was significantly less total antibiotic exposure (16.2 days [95% CI, 16.1 to 16.5] vs 16.9 days [95% CI, 16.8 to 17.1]; 95% CI for difference, -0.9 to 0.4; P = .006) in PCT-managed patients. Patients in the PCT group were more likely to be discharged to home (44.1% [95% CI, 43.7 to 44.6] vs 41.3% [95% CI, 41 to 41.6]; 95% CI for difference, 2.3 to 3.3; P = .006). Mortality was not different in an analysis including the 96% of patients who had an independent measure of mortality risk available (19.1% [95% CI, 18.7 to 19.4] vs 19.1% [95% CI, 18.9 to 19.3]; 95% CI for difference, -0.5 to 0.4; P = .93).Conclusions: Use of PCT testing on the first day of ICU admission was associated with significantly lower hospital and ICU lengths of stay, as well as decreased total, ICU, and pharmacy cost of care. Further elucidation of clinical outcomes requires additional data. [ABSTRACT FROM AUTHOR]- Published
- 2017
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264. Participation in Research and Access to Experimental Treatments by HIV-Infected Patients.
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Gifford, Allen L., Cunningham, William E., Heslin, Kevin C., Andersen, Ron M., Nakazono, Terry, Lieu, Dale K., Shapiro, Martin F., and Bozzette, Samuel A.
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HIV-positive persons , *CLINICAL trials , *HIV infections , *MEDICAL care of minorities - Abstract
Background: Although there is concern that minority groups and women are underrepresented in research involving patients with human immunodeficiency virus (HIV) infection, the available data are inconclusive. Methods: We used nationally representative data from the HIV Cost and Services Utilization Study to determine the characteristics of the participants and nonparticipants in trials of medications for HIV infection and whether or not patients had access to experimental treatments. A probability sample of 2864 persons, representing all 231,400 adults with known HIV infection who are cared for in the contiguous United States, were interviewed on three occasions between 1996 and 1998. They were asked about participation in clinical research studies of medications and past receipt of experimental medications for HIV. Results: We estimate that 14 percent of adults receiving care for HIV infection participated in a medication trial or study; 24 percent had received experimental medications; and 8 percent had tried and failed to obtain experimental treatments. According to multivariate models, non-Hispanic blacks and Hispanics were less likely to be participating in trials than non-Hispanic whites (odds ratio for participation among non-Hispanic blacks, 0.50 [95 percent confidence interval, 0.28 to 0.91]; odds ratio among Hispanics, 0.58 [95 percent confidence interval, 0.37 to 0.93]) and to have received experimental medications (odds ratios, 0.41 [95 percent confidence interval, 0.32 to 0.54] and 0.56 [95 percent confidence interval, 0.41 to 0.78], respectively). Patients who were cared for in private health maintenance organizations were less likely to participate in trials than those with fee-for-service insurance (odds ratio, 0.43 [95 percent confidence interval, 0.21 to 0.88]). Women were not underrepresented in research trials and had a similar likelihood of receiving experimental treatments. Conclusions: Among patients with HIV infection, participation in research trials and access to experimental treatment is influenced by race or ethnic group and type of health insurance. (N Engl J Med 2002;346:1373-82.) [ABSTRACT FROM AUTHOR]
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- 2002
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265. Prophylaxis against Disseminated Mycobacterium avium Complex with Weekly Azithromycin, Daily Rifabutin, or Both.
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Havlir, Diane V., Dubé, Michael P., Sattler, Fred R., Forthal, Donald N., Kemper, Carol A., Dunne, Michael W., Parenti, David M., Lavelle, James P., White, A. Clinton, Witt, Mallory D., Bozzette, Samuel A., and McCutchan, J. Allen
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MYCOBACTERIUM avium , *AZITHROMYCIN , *MACROLIDE antibiotics , *RANDOMIZED controlled trials , *DRUG side effects , *INFECTION prevention , *COMPARATIVE studies , *HIV-positive persons , *PREVENTION - Abstract
Background: Azithromycin is active in treating Mycobacterium avium complex disease, but it has not been evaluated as primary prophylaxis in patients with human immunodeficiency virus (HIV) infection. Because the drug is concentrated in macrophages and has a long half-life in tissue, there is a rationale for once-weekly dosing. Methods: We compared three prophylactic regimens in a multicenter, double-blind, randomized trial involving 693 HIV-infected patients with fewer than 100 CD4 cells per cubic millimeter. The patients were assigned to receive rifabutin (300 mg daily), azithromycin (1200 mg weekly), or both drugs. They were monitored monthly with blood cultures for M. avium complex. Results: In an intention-to-treat analysis, the incidence of disseminated M. avium complex infection at one year was 15.3 percent with rifabutin, 7.6 percent with azithromycin, and 2.8 percent with both drugs. The risk of the infection in the azithromycin group was half that in the rifabutin group (hazard ratio, 0.53; P = 0.008). The risk was even lower when two-drug prophylaxis was compared with rifabutin alone (hazard ratio, 0.28; P<0.001) or azithromycin alone (hazard ratio, 0.53; P = 0.03). Among the patients in whom azithromycin prophylaxis was not successful, 11 percent of M. avium complex isolates were resistant to azithromycin. Dose-limiting toxic effects were more common with the two-drug combination than with azithromycin alone (hazard ratio, 1.67; P = 0.03). Survival was similar in all three groups. Conclusions: For protection against disseminated M. avium complex infection, once-weekly azithromycin is more effective than daily rifabutin and infrequently selects for resistant isolates. Rifabutin plus azithromycin is even more effective but is not as well tolerated. (N Engl J Med 1996;335:392-8.) [ABSTRACT FROM AUTHOR]
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- 1996
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266. Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.
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O'Halloran JA, Ko ER, Anstrom KJ, Kedar E, McCarthy MW, Panettieri RA Jr, Maillo M, Nunez PS, Lachiewicz AM, Gonzalez C, Smith PB, de Tai SM, Khan A, Lora AJM, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Wen J, Silverstein A, O'Brien SM, Al-Khalidi HR, Maldonado MA, Melsheimer R, Ferguson WG, McNulty SE, Zakroysky P, Halabi S, Benjamin DK Jr, Butler S, Atkinson JC, Adam SJ, Chang S, LaVange L, Proschan M, Bozzette SA, and Powderly WG
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- Male, Humans, Adult, Middle Aged, Female, Abatacept, Infliximab, SARS-CoV-2, Pandemics, COVID-19
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Importance: Immune dysregulation contributes to poorer outcomes in COVID-19., Objective: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia., Design, Setting, and Participants: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and December 2021., Interventions: Single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day)., Main Outcomes and Measures: The primary outcome was time to recovery by day 28 evaluated using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined as the first day the participant scored at least 6 on the ordinal scale., Results: Of the 1971 participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and 1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, 0.98-1.28]; P = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; P = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; P = .08) compared with placebo. All-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]). Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies., Conclusions and Relevance: Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo., Trial Registration: ClinicalTrials.gov Identifier: NCT04593940.
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- 2023
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267. Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.
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O'Halloran JA, Kedar E, Anstrom KJ, McCarthy MW, Ko ER, Nunez PS, Boucher C, Smith PB, Panettieri RA, de Tai SMT, Maillo M, Khan A, Mena Lora AJ, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Lachiewicz AM, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Benjamin DK, McNulty SE, Zakroysky P, Halabi S, Butler S, Atkinson J, Adam SJ, Melsheimer R, Chang S, LaVange L, Proschan M, Bozzette SA, and Powderly WG
- Abstract
Background: Immune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care., Methods: We conducted a master protocol investigating immunomodulators for potential benefit in treatment of participants hospitalized with Covid-19 pneumonia. We report results for infliximab (single dose infusion) versus shared placebo both with standard of care. Primary outcome was time to recovery by day 29 (28 days after randomization). Key secondary endpoints included 14-day clinical status and 28-day mortality., Results: A total of 1033 participants received study drug (517 infliximab, 516 placebo). Mean age was 54.8 years, 60.3% were male, 48.6% Hispanic or Latino, and 14% Black. No statistically significant difference in the primary endpoint was seen with infliximab compared with placebo (recovery rate ratio 1.13, 95% CI 0.99-1.29; p=0.063). Median (IQR) time to recovery was 8 days (7, 9) for infliximab and 9 days (8, 10) for placebo. Participants assigned to infliximab were more likely to have an improved clinical status at day 14 (OR 1.32, 95% CI 1.05-1.66). Twenty-eight-day mortality was 10.1% with infliximab versus 14.5% with placebo, with 41% lower odds of dying in those receiving infliximab (OR 0.59, 95% CI 0.39-0.90). No differences in risk of serious adverse events including secondary infections., Conclusions: Infliximab did not demonstrate statistically significant improvement in time to recovery. It was associated with improved 14-day clinical status and substantial reduction in 28- day mortality compared with standard of care., Trial Registration: ClinicalTrials.gov ( NCT04593940 ).
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- 2022
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268. Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.
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Ko ER, Anstrom KJ, Panettieri RA, Lachiewicz AM, Maillo M, O'Halloran JA, Boucher C, Smith PB, McCarthy MW, Segura Nunez P, Mendivil Tuchia de Tai S, Khan A, Mena Lora AJ, Salathe M, Kedar E, Capo G, Rodríguez Gonzalez D, Patterson TF, Palma C, Ariza H, Patelli Lima M, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Benjamin DK, Wen J, Zakroysky P, Halabi S, Silverstein A, McNulty SE, O'Brien SM, Al-Khalidi HR, Butler S, Atkinson J, Adam SJ, Chang S, Maldonado MA, Proscham M, LaVange L, Bozzette SA, and Powderly WG
- Abstract
Background: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19., Methods: We conducted a master protocol to investigate immunomodulators for potential benefit treating patients hospitalized with Covid-19 and report results for abatacept. Intravenous abatacept (one-time dose 10 mg/kg, maximum dose 1000 mg) plus standard of care (SOC) was compared with shared placebo plus SOC. Primary outcome was time-to-recovery by day 28. Key secondary endpoints included 28-day mortality., Results: Between October 16, 2020 and December 31, 2021, a total of 1019 participants received study treatment (509 abatacept; 510 shared placebo), constituting the modified intention-to-treat cohort. Participants had a mean age 54.8 (SD 14.6) years, 60.5% were male, 44.2% Hispanic/Latino and 13.7% Black. No statistically significant difference for the primary endpoint of time-to-recovery was found with a recovery-rate-ratio of 1.14 (95% CI 1.00-1.29; p=0.057) compared with placebo. We observed a substantial improvement in 28-day all-cause mortality with abatacept versus placebo (11.0% vs. 15.1%; odds ratio [OR] 0.62 [95% CI 0.41- 0.94]), leading to 38% lower odds of dying. Improvement in mortality occurred for participants requiring oxygen/noninvasive ventilation at randomization. Subgroup analysis identified the strongest effect in those with baseline C-reactive protein >75mg/L. We found no statistically significant differences in adverse events, with safety composite index slightly favoring abatacept. Rates of secondary infections were similar (16.1% for abatacept; 14.3% for placebo)., Conclusions: Addition of single-dose intravenous abatacept to standard-of-care demonstrated no statistically significant change in time-to-recovery, but improved 28-day mortality., Trial Registration: ClinicalTrials.gov ( NCT04593940 ).
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- 2022
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269. Economic analysis of rapid multiplex polymerase chain reaction testing for meningitis/encephalitis in adult patients.
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Duff S, Hasbun R, Balada-Llasat JM, Zimmer L, Bozzette SA, and Ginocchio CC
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- Adult, Aged, Aged, 80 and over, Humans, Middle Aged, Young Adult, Encephalitis diagnosis, Meningitis diagnosis, Multiplex Polymerase Chain Reaction economics
- Abstract
Purpose: Many patients with suspected meningitis do not require hospitalization yet are admitted, often resulting in unnecessary care and additional cost. We assessed the possible economic impact of a rapid multiplex test for suspected adult community-acquired meningitis/encephalitis., Methods: A model simulated diagnosis, clinical decisions, resource use/costs of standard of care (SOC) and two cerebrospinal fluid (CSF) testing strategies using the FDA-cleared BioFire® FilmArray® System (FA) which provides results in approximately one hour., Results: Pathogens detected by FA caused approximately 74% of cases, 97% of which would be accurately diagnosed with FA. False positives and false negatives more often led to extended/unnecessary admission than inappropriate discharge/missed admission. Mean cost per case ranged from 16829 to 20791. A strategy of testing all suspected cases yielded greater savings (2213/case) than testing only those with abnormal CSF (812/case) and both were less expensive than SOC., Conclusion: This economic analysis demonstrates that FA can inform more appropriate clinician decisions resulting in cost savings with greater economic benefits achievable with syndromic testing of all cases, rather than SOC or targeted syndromic testing.
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- 2019
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270. Outcomes associated with conventional versus lipid-based formulations of amphotericin B in propensity-matched groups.
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Campbell RS, Chaudhari P, Hays HD, Taylor RJ, Nathanson BH, Bozzette SA, and Horn DL
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Background: Lipid-based formulations of amphotericin B (LF-AMB) are indicated for treatment of invasive fungal infections in patients intolerant to conventional amphotericin B (CAB) or with refractory infections. Physicians still may choose to administer CAB to such patients. We described the use of CAB and LF-AMB in this population and quantified differences in post-amphotericin B length of stay (LOS) among survivors and hospital mortality in matched patients., Methods: Data were extracted from Health Facts (Cerner Corporation, Kansas City, MO, USA) for a retrospective cohort analysis. Inpatients aged ≥18 years with evidence of fungal infection and with orders for LF-AMB or CAB on ≥2 days from January 2001 to June 2010 were identified. Patients were required to have renal insufficiency or other relative contraindications to use of CAB, exposure to nephrotoxic agents, or evidence of a CAB-refractory infection. Multilevel (hierarchical) mixed-effects logistic regression was used to determine factors associated with initial exposure to LF-AMB versus CAB. Multivariate adjustment of outcomes was done using propensity score matching., Results: 655 patients were identified: 322 patients initiated therapy with CAB and 333 initiated treatment with LF-AMB. Compared to those initiating CAB, patients initiating LF-AMB had greater acuity and underlying disease severity. In unadjusted analyses, hospital mortality was significantly higher in the LF-AMB group (32.2% versus 23.7%; P = 0.02). After propensity score matching and covariate adjustment, mortality equalized and observed differences in LOS after amphotericin B initiation decreased., Conclusion: Among patients at risk for amphotericin B toxicity, differences between CAB and LF-AMB seen in crude outcomes analyses relate to channeling of sicker patients to initiate treatment with LF-AMB. Failing to account for differences among patients that drive clinical decision-making will result in inaccurate conclusions about the real-world effectiveness of different amphotericin B formulations.
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- 2013
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271. HIV testing of at risk patients in a large integrated health care system.
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Owens DK, Sundaram V, Lazzeroni LC, Douglass LR, Tempio P, Holodniy M, Sanders GD, Shadle VM, McWhorter VC, Agoncillo T, Haren N, Chavis D, Borowsky LH, Yano EM, Jensen P, Simberkoff MS, and Bozzette SA
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- Adult, Aged, Aged, 80 and over, Cohort Studies, Female, HIV Infections blood, HIV Infections diagnosis, HIV Seropositivity blood, Humans, Male, Middle Aged, Retrospective Studies, Risk Factors, United States, United States Department of Veterans Affairs, Delivery of Health Care, Integrated methods, HIV Infections epidemiology, Mass Screening methods
- Abstract
Objective: Early identification of HIV infection is critical for patients to receive life-prolonging treatment and risk-reduction counseling. Understanding HIV screening practices and barriers to HIV testing is an important prelude to designing successful HIV screening programs. Our objective was to evaluate current practice patterns for identification of HIV., Methods: We used a retrospective cohort analysis of 13,991 at-risk patients seen at 4 large Department of Veterans Affairs (VA) health-care systems. We also reviewed 1,100 medical records of tested patients. We assessed HIV testing rates among at-risk patients, the rationale for HIV testing, and predictors of HIV testing and of HIV infection., Results: Of the 13,991 patients at risk for HIV, only 36% had been HIV-tested. The prevalence of HIV ranged from 1% to 20% among tested patients at the 4 sites. Approximately 90% of patients who were tested had a documented reason for testing., Conclusion: One-half to two-thirds of patients at risk for HIV had not been tested within our selected VA sites. Among tested patients, the rationale for HIV testing was well documented. Further testing of at-risk patients could clearly benefit patients who have unidentified HIV infection by providing earlier access to life-prolonging therapy.
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- 2007
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272. An HIV collaborative in the VHA: do advanced HIT and one-day sessions change the collaborative experience?
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Fremont AM, Joyce G, Anaya HD, Bowman CC, Halloran JP, Chang SW, Bozzette SA, and Asch SM
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- HIV Infections economics, Humans, Information Systems economics, Patient Education as Topic, Quality Assurance, Health Care economics, Reminder Systems, United States, United States Department of Veterans Affairs economics, Cooperative Behavior, HIV Infections therapy, Information Systems statistics & numerical data, Quality Assurance, Health Care organization & administration, United States Department of Veterans Affairs organization & administration
- Abstract
Background: Many organizations participate in quality collaboratives, yet the return on investment of the associated time and costs is unclear., Method: Semistructured interviews, surveys, and direct observation were used to assess experiences, improvement activities, and costs associated with participation in a year-long modified Institute for Healthcare Improvement-style collaborative designed to improve HIV care within the Veterans Health Administration. All nine sites had access to automated patient registries and semi-automated clinical measure reports; five sites also received computerized clinical reminders. Three one-day learning sessions were conducted., Results: Participants reported that burden was small and value high, although many suggested that more time for peer-to peer learning would have been helpful. Teams averaged five quality improvement activities per site and most reported improvements in HIV care processes. The average annual cost per site was dollars 28,000 but costs varied considerably by site., Discussion: Shortened learning sessions and the incorporation of health information technology can reduce some of the costs and burdens associated with collaboratives, yet peer-to-peer interaction and local organizational factors remain important to ensuring perceived effectiveness of collaboratives.
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- 2006
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273. Creating a crosswalk to estimate AIDS Clinical Trials Group quality of life scores in a nationally representative sample of persons in care for HIV in the United States.
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Wu AW, Huang IC, Gifford AL, Spritzer KL, Bozzette SA, and Hays RD
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- Adolescent, Adult, Aged, Clinical Trials as Topic methods, Cohort Studies, Female, HIV Infections drug therapy, Humans, Male, Middle Aged, Regression Analysis, Surveys and Questionnaires, United States, HIV, HIV Infections psychology, Quality of Life
- Abstract
Background: Optimizing health-related quality of life (HRQOL) is an increasingly important goal in the treatment of HIV/AIDS. Interpretation of HRQOL scores in clinical trials is enhanced by comparative data., Purpose: To estimate AIDS Clinical Trials Group (ACTG) QOL 601-602 questionnaire scale scores for a nationally representative sample of persons in care for HIV., Method: The study cohort was from the HIV Cost and Services Utilization Study (HCSUS), a multistage national probability sample. We derived HCSUS HRQOL scale scores from the items shared between the ACTG QOL 601-602 and HCSUS HRQOL questionnaires using regression equations. Cronbach's alpha coefficient was used to estimate the reliability of the multi-item scales in the ACTG QOL 601-602 and HCSUS HRQOL instruments. Correlation Coefficients and R2s of regression models were calculated to determine the concordance of the models. Multiple regression was used to determine if patient characteristics accounted for differences (residuals) between scores observed from the full HCSUS HRQOL instruments and scores predicted using the subset of shared items in ACTG QOL 601-2., Results: Internal consistency reliability estimates were acceptable (>0.70) for all scales in the ACTG QOL 601-602 and HCSUS HRQOL instruments. Correlations between corresponding ACTG QOL 601-602 and HCSUS HRQOL scale scores were high (>0.9). The R2s for predicting HCSUS HRQOL scores from the ACTG QOL 601-602 scales were also high (>0.8). For physical functioning, emotional well-being, and general health perceptions, the predictors of differences (residuals) in observed and predicted HCSUS HRQOL scores were gender and CDC stage of HIV infection (P < .05)., Conclusion: This study provides normative data from the US HIV/AIDS population for comparison to the ACTG QOL 601-602 questionnaire. Accuracy of estimation is enhanced if done separately by gender and HIV disease stage.
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- 2005
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274. The prevalence of antiretroviral drug resistance in the United States.
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Richman DD, Morton SC, Wrin T, Hellmann N, Berry S, Shapiro MF, and Bozzette SA
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- Adolescent, Adult, Aged, Female, HIV Infections epidemiology, Humans, Male, Middle Aged, Prevalence, United States epidemiology, Antiretroviral Therapy, Highly Active, Drug Resistance, Viral, HIV Infections drug therapy
- Abstract
Background: Antiretroviral therapy has dramatically reduced the morbidity and mortality of infection due to HIV. The emergence of drug-resistant virus has limited the usefulness of many drugs., Objective: To determine the prevalence of HIV drug resistance in the population of adults receiving care in the United States., Design and Methods: HIV drug susceptibility assays were performed on plasma virus from a random sample representative of the 132500 HIV-infected American adults who had received medical care in early 1996 yet were viremic with > 500 copies/ml of HIV RNA in late 1998. A blood sample was obtained from 1797 patients who comprised a representative sample of the 208900 adults receiving urban care for HIV infection in early 1996 who survived to late 1998. The sampling procedure permitted weighting each evaluated patient to reflect demographic and other characteristics of the target population., Results: We estimated that 132500 (63%) of the target population had HIV viremia of > 500 copies/ml. Among viremic patients, an estimated 76% had resistance to one or more antiretroviral drugs. The odds of resistance were significantly higher in patients with a history of antiretroviral drug use, advanced HIV disease, higher plasma HIV viral load and lowest CD4 cell count by self-report., Conclusions: The frequent selection for drug-resistant virus among viremic patients during the first 3 years of widespread use of potent antiretroviral combination therapy has significant implications for HIV treatment and transmission.
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- 2004
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275. Lipid screening in HIV-infected veterans.
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Korthuis PT, Asch SM, Anaya HD, Morgenstern H, Goetz MB, Yano EM, Rubenstein LV, Lee ML, and Bozzette SA
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- Adolescent, Adult, Databases, Factual, Female, HIV Infections drug therapy, HIV Infections transmission, Humans, Hyperlipidemias epidemiology, Male, Mass Screening, Middle Aged, Racial Groups, Registries, Regression Analysis, Smoking, United States, Veterans, HIV Infections blood, Lipids blood
- Abstract
Background: Lipid screening is recommended for patients taking protease inhibitors (PIs)., Methods: We examined data from the Veterans Administration Immunology Case Registry to assess lipid screening among HIV-infected veterans who received PIs for at least 6 consecutive months during 1999 and 2001. We estimated crude and adjusted associations between lipid screening and patient characteristics (age, gender, HIV exposure, and race/ethnicity), comorbidities (AIDS, cardiovascular disease, diabetes, hypertension, smoking, and hyperlipidemia), and facility characteristics (urban location, case management, guidelines, and quality improvement programs)., Results: Among 4065 patients on PIs, clinicians screened 2395 (59%) for lipids within 6 months of initiating treatment. Adjusting for patient characteristics, comorbidities, facility traits, and clustering, lipid screening was more common among patients who were cared for in urban areas (relative risk [RR] = 1.3, confidence limits: 1.0-1.5), diabetic (RR = 1.2, confidence limits: 1.1-1.3), or previously hyperlipidemic (RR = 1.4, confidence limits: 1.3-1.5) and less common among patients with a history of intravenous drug use (IVDU) (RR = 0.90, confidence limits: 0.79-1.0) or unknown HIV risk (RR = 0.85, confidence limits: 0.75-0.95)., Conclusions: Six in 10 patients taking PIs receive lipid screening within 6 months of PI use. Systemic interventions to improve overall HIV quality of care should also address lipid screening, particularly among patients with unknown or IVDU HIV risk and those cared for in nonurban areas.
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- 2004
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276. Differences in symptom expression in older HIV-positive patients: The Veterans Aging Cohort 3 Site Study and HIV Cost and Service Utilization Study experience.
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Zingmond DS, Kilbourne AM, Justice AC, Wenger NS, Rodriguez-Barradas M, Rabeneck L, Taub D, Weissman S, Briggs J, Wagner J, Smola S, and Bozzette SA
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- Adult, Age Factors, Aged, Cohort Studies, Demography, Female, HIV Seropositivity classification, HIV Seropositivity complications, HIV Seropositivity psychology, Humans, Income, Insurance, Health, Interviews as Topic, Male, Middle Aged, Risk-Taking, United States, HIV Seropositivity physiopathology, Veterans statistics & numerical data
- Abstract
Symptom recognition is critical for patient care but has been little studied in older HIV-infected individuals. The authors examined differences in symptom expression between younger (younger than age 50 years) and older (older than age 50 years) HIV-infected individuals. The authors analyzed data from two cross-sectional studies of HIV-infected individuals: 2864 individuals from the HIV Cost and Service Utilization Study (HCSUS) and 881 individuals from the Veterans Aging Cohort 3 Site Study (VACS 3). The authors compared the prevalence of eight symptoms common to both studies and 10 symptoms examined only in the VACS 3 population, stratified by age and race. Disease severity was assessed by CD4 count and 18 HIV-related diseases reported. Multivariate logistic regression models were used to account for demographics and severity differences. VACS 3 versus HCSUS participants were more likely nonwhite and older. In unadjusted comparisons, older nonwhites were less likely to report experiencing symptoms than younger whites. They reported the fewest total number of symptoms and the fewest individual symptoms common to both studies (headache, fever, nausea/vomiting, and diarrhea) or in the VACS 3 only (dizziness, sleeping difficulty, fatigue, rashes, bloating, and myalgias/arthalgias). Multivariate regression estimates suggest older age predicts a greater likelihood of reporting peripheral neuropathy, weight loss, or hair loss, but a lower likelihood of reporting headaches, depressed mood, white oral patches, or diarrhea. Nonwhites appeared less likely to report symptoms. Age is a determinant of reporting certain symptoms in HIV disease but may be masked or accentuated by other factors such as race.
- Published
- 2003
277. Underdiagnosis of depression in HIV: who are we missing?
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Asch SM, Kilbourne AM, Gifford AL, Burnam MA, Turner B, Shapiro MF, and Bozzette SA
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- Adolescent, Adult, Aged, Cross-Sectional Studies, Delivery of Health Care, Depression economics, Depression epidemiology, Female, HIV Infections economics, Health Care Costs, Humans, Logistic Models, Male, Middle Aged, Depression diagnosis, Depression etiology, HIV Infections complications
- Abstract
Objective: To determine the sociodemographic and service delivery correlates of depression underdiagnosis in HIV., Design: Cross-sectional survey., Patients/participants: National probability sample of HIV-infected persons in care in the contiguous United States who have available medical record data., Measurements and Main Results: We interviewed patients using the Composite International Diagnostic Interview (CIDI) survey from the Mental Health Supplement. Patients also provided information regarding demographics, socioeconomic status, and HIV disease severity. We extracted patient medical record data between July 1995 and December 1997, and we defined depression underdiagnosis as a diagnosis of major depressive disorder based on the CIDI and no recorded depression diagnosis by their principal health care provider in their medical records between July 1995 and December 1997. Of the 1140 HIV Cost and Services Utilization Study patients with medical record data who completed the CIDI, 448 (37%) had CIDI-defined major depression, and of these, 203 (45%) did not have a diagnosis of depression documented in their medical record. Multiple logistic regression analysis revealed that patients who had less than a high school education (P <.05) were less likely to have their depression documented in the medical record compared to those with at least a college education. Patients with Medicare insurance coverage compared to those with private health insurance (P <.01) and those with >or=3 outpatient visits (P <.05) compared to <3 visits were less likely to have their depression diagnosis missed by providers., Conclusions: Our results suggest that providers should be more attentive to diagnosing comorbid depression in HIV-infected patients.
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- 2003
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278. Complementary and alternative medicine use and substitution for conventional therapy by HIV-infected patients.
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Hsiao AF, Wong MD, Kanouse DE, Collins RL, Liu H, Andersen RM, Gifford AL, McCutchan A, Bozzette SA, Shapiro MF, and Wenger NS
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- Adolescent, Adult, Attitude to Health, Confidence Intervals, Cross-Sectional Studies, Decision Making, Female, HIV Infections epidemiology, Humans, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Prevalence, United States epidemiology, Complementary Therapies statistics & numerical data, HIV Infections therapy
- Abstract
Background: HIV-infected patients commonly use complementary and alternative medicine (CAM), but it is not known how often CAM is used as a complement or as a substitute for conventional HIV therapy., Objectives: To evaluate the prevalence and factors associated with CAM use with potential for adverse effects and CAM substitution for conventional HIV medication., Design and Participants: Cross-sectional survey of U.S. national probability sample of HIV-infected patients (2,466 adults) in care from December 1996 to July 1997., Main Outcome Variables: Any CAM use, CAM use with potential for adverse effects, and use of CAM as a substitute for conventional HIV therapy. Substitution was defined as replacement of some or all conventional HIV medications with CAM., Results: Fifty-three percent of patients had recently used at least one type of CAM. One quarter of patients used CAM with the potential for adverse effects, and one-third had not discussed such use with their health care provider. Patients with a greater desire for medical information and involvement in medical decision making and with a negative attitude toward antiretrovirals were more likely to use CAM. Three percent of patients substituted CAM for conventional HIV therapy. They were more likely to desire involvement in medical decision-making (odds ratio, 1.8; 95% confidence interval, 1.0-3.2) and to have a negative attitude toward antiretrovirals (odds ratio, 7.8; 95% confidence interval, 3.0-19.0)., Conclusions: Physicians should openly ask HIV-infected patients about CAM use to prevent adverse effects and to identify CAM substitution for conventional HIV therapy.
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- 2003
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279. The diverse older HIV-positive population: a national profile of economic circumstances, social support, and quality of life.
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Crystal S, Akincigil A, Sambamoorthi U, Wenger N, Fleishman JA, Zingmond DS, Hays RD, Bozzette SA, and Shapiro MF
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- Acquired Immunodeficiency Syndrome economics, Acquired Immunodeficiency Syndrome physiopathology, Acquired Immunodeficiency Syndrome psychology, Aged, Cohort Studies, Educational Status, Employment, Female, HIV Seropositivity economics, Humans, Income, Insurance, Health, Male, Middle Aged, Patient Selection, Socioeconomic Factors, HIV Seropositivity physiopathology, HIV Seropositivity psychology, Quality of Life, Social Support
- Abstract
The objectives of this study were to provide a national profile of socioeconomic circumstances of the middle-aged and older population living with HIV and to evaluate variations in social support and quality of life (QOL) across age and socioeconomic subgroups, controlling for indicators of disease progression. The design used was a cross-sectional analysis of nationally representative interview data on HIV-infected individuals collected in the HIV Cost and Services Utilization Study. Multiple measures of social support and QOL were used. Bivariate comparisons of outcomes across categories of age and exposure category were performed; multivariate analyses to isolate the effect of older age on outcomes within exposure categories were performed, controlling for socioeconomic and clinical co-variates. Study results indicate that older gay men with HIV/AIDS are a predominantly white population and more likely to have health insurance than their younger counterparts; 38% were employed and 48% reported incomes of more than $25,000. Older injection drug users (IDUs) with HIV/AIDS are a predominantly black population with a particularly high concentration of disadvantages; only 11% were employed and 74% reported incomes of less than $10,000. Older IDUs reported especially low levels of physical functioning and emotional support in comparison with their younger counterparts, whereas older gay men did not significantly differ from younger gay men in these respects. The authors conclude that characteristics and care needs of the older HIV-positive population are very diverse and vary sharply by exposure route. Interventions need to be tailored to the needs of these distinct subpopulations, with an emphasis on development of supportive care interventions for older IDUs.
- Published
- 2003
280. Physician specialization and antiretroviral therapy for HIV.
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Landon BE, Wilson IB, Cohn SE, Fichtenbaum CJ, Wong MD, Wenger NS, Bozzette SA, Shapiro MF, and Cleary PD
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- Adult, Clinical Competence, Cohort Studies, Female, Humans, Male, Medicine standards, Medicine statistics & numerical data, Middle Aged, Multivariate Analysis, Practice Patterns, Physicians' standards, Primary Health Care standards, Quality Assurance, Health Care, Referral and Consultation, Surveys and Questionnaires, Time Factors, United States, Antiretroviral Therapy, Highly Active, Education, Medical, HIV Infections drug therapy, Practice Patterns, Physicians' statistics & numerical data, Specialization
- Abstract
Background: Since the introduction of the first protease inhibitor in January 1996, there has been a dramatic change in the treatment of persons infected with HIV. The changing nature of HIV care has important implications for the types of physicians that can best care for patients with HIV infection., Objective: To assess the association of specialty training and experience in the care of HIV disease with the adoption and use of highly active antiretroviral (ARV) therapy (HAART)., Design: Observational cohort study of patients under care for HIV infection and their physicians., Patients and Setting: This analysis used data collected from a national probability sample of noninstitutionalized persons with HIV infection participating in the HIV Costs and Service Utilization Study and their primary physicians. We analyzed 1,820 patients being cared for by 374 physicians., Measurements: Rates of HAART use at 12 months and 18 months after the approval of the first protease inhibitor., Results: Forty percent of the physicians were formally trained in infectious diseases (ID), 38% were general medicine physicians with self-reported expertise in the care of HIV, and 22% were general medicine physicians without self-reported expertise in the care of HIV. The majority of physicians (69%) reported a current HIV caseload of 50 patients or more. In multivariable models controlling for patient characteristics, there were no differences between generalist experts and ID physicians in rates of HAART use in December 1996. When compared to ID physicians, however, patients being treated by non-expert general medicine physicians were less likely to be on HAART (odds ratio [OR], 0.32; 95% confidence interval [95% CI], 0.17 to 0.61). Patients being treated by low-volume physicians were also much less likely to be on HAART therapy than those treated by high-volume physicians (OR, 0.26; 95% CI, 0.14 to 0.48). These findings were attenuated by June 1997, suggesting that over time, the broader physician community successfully adopted HAART therapy. This finding is consistent with prior research on the diffusion of innovations., Conclusions: Similar proportions of patients treated by expert generalists and ID specialists were on appropriate HAART therapy by December 1996 and July 1997. Patients treated by non-expert generalists, most of whom were the lowest-volume physicians, were much less likely to be on appropriate ARV therapy in the earlier time period. Our findings demonstrate that expert generalists who develop specialized expertise are able to provide care of quality comparable to that of specialists.
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- 2003
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281. Insurance status of HIV-infected adults in the post-HAART era: evidence from the United States.
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Goldman DP, Leibowitz AA, Joyce GF, Fleishman JA, Bozzette SA, Duan N, and Shapiro MF
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- Adult, Antiretroviral Therapy, Highly Active, Disease Progression, Employment, Female, HIV Infections drug therapy, HIV Infections pathology, Humans, Insurance Coverage classification, Insurance, Health classification, Male, Medicaid statistics & numerical data, Medicare statistics & numerical data, United States, HIV Infections economics, Insurance Coverage statistics & numerical data, Insurance, Health statistics & numerical data
- Abstract
In the United States, universal public insurance is only available for the elderly. But unlike most other major diseases, HIV/AIDS predominantly affects the nonelderly. The result is that insurance availability and public programme participation are linked to disease progression in a complicated way. This paper uses data from a unique, nationally representative sample of HIV-infected adults receiving medical care, to describe the relationship between disease progression and insurance coverage in the United States. We find that public insurance is the predominant source of coverage for those in care for HIV, and that coverage increases as disease progresses. Those with public coverage have substantial work experience and earnings capacity, but do not work. This suggests that reforms allowing HIV positive (+) patients to maintain public coverage while returning to work could increase employment and earnings significantly. More speculatively, it suggests that the United States system for financing health care is not well-equipped to deal with epidemics that afflict a population in its prime work years.
- Published
- 2003
282. Measuring medication: do interviews agree with medical record and pharmacy data?
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Korthuis PT, Asch S, Mancewicz M, Shapiro MF, Mathews WC, Cunningham WE, McCutchan JA, Gifford A, Lee ML, and Bozzette SA
- Subjects
- Humans, Interviews as Topic, Medical Records, Prospective Studies, United States, Antiretroviral Therapy, Highly Active, Drug Utilization statistics & numerical data, HIV Infections drug therapy
- Abstract
Background: Medication measurement is crucial in assessing quality for chronic conditions yet agreement of alternate data sources remains uncertain., Objectives: To evaluate medication agreement between interviews, medical records, and pharmacy data; to assess data source contribution to attributing medication exposure; and to describe the impact of combining data sources on models that predict medication use., Research Design: Prospective cohort study., Subjects: Probability sample of HIV-infected participants in the HIV Cost and Services Utilization Study., Measures: Medications reported in 2267 interviews, 1936 medical records, and 457 pharmacy records were compared using crude agreement, kappa, and the proportion of average positive and negative agreement. The percent of medications reported in each source alone was used to assess their relative contribution to attributing exposure status. We performed weighted logistic regression in alternate data sources., Results: Kappa varied from 0.38 for nucleoside reverse transcriptase inhibitors to 0.70 for protease inhibitors, when comparing drug classes in interview versus medical record, interview versus pharmacy data, and medical record versus pharmacy data. The percentage of medications reported in medical records was greater than that reported in interviews or pharmacy data. Pharmacy data contributed little to the attribution of medication exposure. Adding medication data to interview data did not appreciably change analytic models predicting medication use., Conclusions: For specific medications, agreement between alternative data sources is fair to substantial, but is lower for key drug classes. Relying on one data source may lead to misclassification of drug exposure status, but combining data sources does not change the results of analytic models predicting appropriate medication use.
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- 2002
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283. Specialty training and specialization among physicians who treat HIV/AIDS in the United States.
- Author
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Landon BE, Wilson IB, Wenger NS, Cohn SE, Fichtenbaum CJ, Bozzette SA, Shapiro MF, and Cleary PD
- Subjects
- Acquired Immunodeficiency Syndrome therapy, Adult, Cross-Sectional Studies, Female, Humans, Logistic Models, Male, Middle Aged, Multivariate Analysis, Referral and Consultation, Surveys and Questionnaires, United States, Clinical Competence, Education, Medical, Continuing, HIV Infections therapy, Health Knowledge, Attitudes, Practice, Practice Patterns, Physicians' standards, Quality Assurance, Health Care standards
- Abstract
Objective: To assess the association of specialty training and experience in the care of HIV disease with HIV-specific knowledge, referral patterns, and HIV-related education activities., Design: Cross-sectional survey., Setting: The United States., Participants: Physicians caring for patients in the HIV Costs and Service Utilization Study, a study of a probability sample of HIV-infected individuals in the United States., Measurements and Main Results: Measures included physicians' reports of specialty training and HIV caseload, scores on an HIV-specific knowledge test, referral patterns, and attendance rates at HIV-related educational activities. Approximately 72% (379) of the eligible physicians completed a survey. Of these, 152 (40%) had infectious disease (ID) training, and 213 (56%) were generalists; 4% of ID-trained physicians and 37% of generalist physicians did not consider themselves HIV experts. The median current caseloads were 150 and 200 patients for ID experts and generalist experts, respectively. In contrast, the median caseload for non-expert generalists was 5. Mean scores on the knowledge scale were similar for ID and generalist experts (9.0 items correct out of 11 vs 8.5; P=not significant), but lower for generalist non-experts (6.5 items correct; P <.01). Experts had attended more local and national HIV meetings than non-experts (9.3 vs 2.7; P <.01, and 2.3 vs.40; P <.01, respectively) in the past year. Fewer ID experts ever referred than generalist experts (13.0% vs 27.3%; P=.01). In multivariable models that included specialty training and caseload, physicians with caseloads of 20 to 49 and >50 were more likely to have a high knowledge score (defined as 80% or more correct, odds ratio [OR], 2.8; P=.04 and OR, 5.7; P <.001, respectively), and the effect of specialty was attenuated (OR, 2.7; P=.02 decreased from OR, 7.8; P <.001 in a model without caseload). In the models predicting referral practices, both experience (OR,.25; P <.01 and OR,.17; P <.01 for caseloads of 20 to 49 and >50, respectively) and specialty (OR,.19; P <.01 and OR,.09; P <.01 for generalist and ID experts, respectively) were significant., Conclusions: In a national sample of physicians, HIV-specific knowledge was more strongly associated with HIV caseload than with specialty training. In addition, although referral practices were related to both experience and specialty, generalist experts and ID physicians reported similar behaviors. This suggests that generalist physicians, through clinical experience and self-education, can develop specialized knowledge in HIV care.
- Published
- 2002
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