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author:("hosler, Leon")
1.  Relationship between Time to Clinical Response and Outcomes among Pneumonia Outcomes Research Team (PORT) Risk Class III and IV Hospitalized Patients with Community-Acquired Pneumonia Who Received Ceftriaxone and Azithromycin 
Recent Food and Drug Administration (FDA) guidance endorses the use of an early clinical response endpoint as the primary outcome for community-acquired bacterial pneumonia (CABP) trials. While antibiotics will now be approved for CABP, in practice they will primarily be used to treat patients with community-acquired pneumonia (CAP). More importantly, it is unclear how achievement of the new FDA CABP early response endpoint translates into clinically applicable real-world outcomes for patients with CAP. To address this, a retrospective cohort study was conducted among adult patients who received ceftriaxone and azithromycin for CAP of Pneumonia Outcomes Research Team (PORT) risk class III and IV at an academic medical center. The clinical response was defined as clinical stability for 24 h with improvement in at least one pneumonia symptom and with no symptom worsening. A classification and regression tree (CART) was used to determine the delay in response time, measured in days, associated with the greatest risk of a prolonged hospital length of stay (LOS) and adverse outcomes (in-hospital mortality or 30-day CAP-related readmission). A total of 250 patients were included. On average, patients were discharged 2 days following the achievement of a clinical response. In the CART analysis, adverse clinical outcomes were higher among day 5 nonresponders than those who responded by day 5 (22.4% versus 6.9%, P = 0.001). The findings from this study indicate that time to clinical response, as defined by the recent FDA guidance, is a reasonable prognostic indictor of real-world effectiveness outcomes among hospitalized PORT risk class III and IV patients with CAP who received ceftriaxone and azithromycin.
PMCID: PMC4068528  PMID: 24752270
3.  Comparison of β-Lactam and Macrolide Combination Therapy versus Fluoroquinolone Monotherapy in Hospitalized Veterans Affairs Patients with Community-Acquired Pneumonia▿  
Antimicrobial Agents and Chemotherapy  2007;51(11):3977-3982.
Data comparing the treatment outcomes of the two most frequently recommended empirical antibiotic regimens for community-acquired pneumonia (CAP)—combination therapy with an extended-spectrum β-lactam and a macrolide (BL+M) or fluoroquinolone (F) monotherapy—for patients with severe CAP are sparse. The purpose of this study was to compare empirical BL+M combination therapy with F monotherapy for Veterans Affairs (VA) patients with severe CAP. This retrospective study included patients with CAP who received empirical therapy with BL+M or F between October 1999 and May 2003 in the Upstate New York VA Network. Outcome measures were 14-day mortality, 30-day mortality, and length of hospital stay (LOS). Severe CAP was defined as a class V pneumonia severity index (PSI). During the study period, 261 patients received BL+M and 254 received F. Disease severity was similar for the two treatment groups at admission, and the presence of tachycardia was the only difference noted. For PSI class V patients, there were lower 14-day and 30-day mortality rates with BL+M than with F (14-day rates, 8.2% versus 26.8% [P = 0.02]; 30-day rates, 18.4% versus 36.6% [P = 0.05]). No differences in mortality between treatment groups were noted for the lower PSI classes. The overall median LOS was significantly longer for the BL+M combination group than for the F monotherapy group (6.0 days versus 5.0 days, respectively [P = 0.01]), but no difference in LOS was noted among PSI class V patients. Our study showed that improved outcomes may be realized with BL+M in cases of severe CAP. A randomized clinical study is warranted based on these results.
PMCID: PMC2151470  PMID: 17709460
5.  Relationship of Gender, Depression, and Health Care Delivery With Antiretroviral Adherence in HIV-infected Drug Users 
Antiretroviral adherence is worse in women than in men, and depression can influence medication adherence.
To evaluate the relationship of gender, depression, medical care, and mental health care to adherence in HIV-infected drug users.
Retrospective cohort study.
New York State Medicaid program.
One thousand eight hundred twenty-seven female and 3,246 male drug users on combination antiretroviral therapy for more than 2 months in 1997.
A pharmacy-based measure of adherence was defined as ≥95% days covered by at least 2 prescribed antiretroviral drugs. Independent variables were: depression, regular drug treatment (≥6 months), regular medical care (2+ and >35% of visits), HIV-focused care (2+ visits), psychiatric care (2+ visits), and antidepressant therapy.
Women were less adherent than men (18% vs 25%, respectively, P < .001) and more likely to be diagnosed with depression (34% vs 29%). In persons with depression, the adjusted odds ratio (AOR) for adherence was greater for those with psychiatric care alone (AOR 1.52; 95% confidence interval [95% CI], 1.03 to 2.26) or combined with antidepressants (AOR 1.49; 95% CI, 1.04 to 2.15). In separate models by gender in persons with depression, psychiatric care plus antidepressants had a slightly stronger association with adherence in women (AOR 1.92; 95% CI, 1.00 to 3.68) than men (AOR, 1.26; 95% CI, 0.81 to 1.98). In drug users without depression, antidepressants alone were associated with greater adherence (AOR, 1.23; 95% CI, 1.02 to 1.49) with no difference by gender. Regular drug treatment was positively associated with adherence only in men.
In this drug-using cohort, women had worse pharmacy-measured antiretroviral adherence than men. Mental health care was significantly associated with adherence in women, while regular drug treatment was positively associated with adherence in men.
PMCID: PMC1494846  PMID: 12709091
HIV infection; antiretroviral therapy; adherence; compliance; mental health services
6.  The effect of ethnicity and maternal birthplace on small-for-gestational-age deliveries to HIV-infected women 
To examine the relative role of ethnicity and maternal birthplace on small-for-gestational-age (SGA) deliveries of a cohort of mothers in New York who were infected with human immunodeficiency virus.
Medicaid claims and linked vital statistics records were examined for 2,525 singleton deliveries to HIV-infected women from 1993 through 1996. We estimated adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of SGA delivery associated with ethnicity (i.e., white, white-Latina, black, and black-Latina) and maternal birthplace (i.e., native US/Puerto Rican vs. foreign born) in a series of multivariate regression models to which we sequentially added demographic, health services, and lifestyle factors (i.e., alcohol, tobacco, and illicit drug use).
Of the deliveries, 10% were SGA. The odds of SGA infants for black and white women did not differ by maternal birthplace. Foreign-born white-Latinas and black-Latinas had lower unadjusted odds of a SGA delivery than their US-born counterparts (OR 0.29, CI 0.14, 0.61 and OR 0.22, CI 0.07, 0.71, respectively). After adjustment for maternal lifestyle characteristics, the odds of SGA delivery were 0.50 (CI 0.23, 1.09) for white-Latina mothers and 0.60 (CI 0.17, 2.08) for black-Latina mothers.
SGA outcomes did not differ by maternal birthplace for black and white women. Differences in lifestyle factors appear to contribute to lower odds of SGA delivery for foreign-born versus US-born white- and black-Latina HIV-infected women.
PMCID: PMC3456377  PMID: 11937623
African American; Hispanic American; HIV Infection; Medicaid; Small for Gestational Age; Substance Abuse-Related Disorders
7.  Clinic HIV-Focused Features and Prevention of Pneumocystis Carinii Pneumonia 
To examine the association of clinic HIV-focused features and advanced HIV care experience with Pneumocystis carinii pneumonia (PCP) prophylaxis and development of PCP as the initial AIDS diagnosis.
Nonconcurrent prospective study.
New York State Medicaid Program.
Medicaid enrollees diagnosed with AIDS in 1990–1992.
We collected patient clinical and health care data from Medicaid files, conducted telephone interviews of directors of 125 clinics serving as the usual source of care for study patients, and measured AIDS experience as the cumulative number of AIDS patients treated by the study clinics since 1986. Pneumocystis carinii pneumonia prophylaxis in the 6 months before AIDS diagnosis and PCP at AIDS diagnosis were the main outcome measures. Bivariate and multivariate analyses adjusted for clustering of patients within clinics. Of 1,876 HIV-infected persons, 44% had PCP prophylaxis and 38% had primary PCP. Persons on prophylaxis had 20% lower adjusted odds of developing PCP (95% confidence interval [CI] 0.64, 0.99). The adjusted odds of receiving prophylaxis rose monotonically with the number of HIV-focused features offered by the clinic, with threefold higher odds (95% CI 1.6, 5.7) for six versus two or fewer such features. Patients in clinics with three HIV-focused features had 36% lower adjusted odds of PCP than those in clinics with one or none. Neither clinic experience nor specialty had a significant association with prophylaxis or PCP.
PCP prevention in our study cohort appears to be more successful in clinics offering an array of HIV-focused features.
PMCID: PMC1496898  PMID: 9462490
Pneumocystis carinii pneumonia (PCP); AIDS; clinical competence; ambulatory care; case management

Results 1-7 (7)