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1.  Hepatitis C Viremia and the Risk of Chronic Kidney Disease in HIV-Infected Individuals 
Lucas, Gregory M. | Jing, Yuezhou | Sulkowski, Mark | Abraham, Alison G. | Estrella, Michelle M. | Atta, Mohamed G. | Fine, Derek M. | Klein, Marina B. | Silverberg, Michael J. | Gill, M. John | Moore, Richard D. | Gebo, Kelly A. | Sterling, Timothy R. | Butt, Adeel A. | Kirk, Gregory D. | Benson, Constance A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Ken | Hogg, Robert S. | Harrigan, Richard | Montaner, Julio | Cescon, Angela | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Carey, John T. | Rodriguez, Benigno | Horberg, Michael A. | Silverberg, Michael J. | Horberg, Michael A. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann | Rachlis, Anita R. | Rico, Puerto | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M. John | Deeks, Steven G. | Martin, Jeffrey N. | Patel, Pragna | Brooks, John T. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Webster, Eric | Morton, Liz | Simon, Brenda | Gange, Stephen J. | Althoff, Keri N. | Abraham, Alison G. | Lau, Bryan | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
The Journal of Infectious Diseases  2013;208(8):1240-1249.
Background. The role of active hepatitis C virus (HCV) replication in chronic kidney disease (CKD) risk has not been clarified.
Methods. We compared CKD incidence in a large cohort of HIV-infected subjects who were HCV seronegative, HCV viremic (detectable HCV RNA), or HCV aviremic (HCV seropositive, undetectable HCV RNA). Stages 3 and 5 CKD were defined according to standard criteria. Progressive CKD was defined as a sustained 25% glomerular filtration rate (GFR) decrease from baseline to a GFR < 60 mL/min/1.73 m2. We used Cox models to calculate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs).
Results. A total of 52 602 HCV seronegative, 9508 HCV viremic, and 913 HCV aviremic subjects were included. Compared with HCV seronegative subjects, HCV viremic subjects were at increased risk for stage 3 CKD (adjusted HR 1.36 [95% CI, 1.26, 1.46]), stage 5 CKD (1.95 [1.64, 2.31]), and progressive CKD (1.31 [1.19, 1.44]), while HCV aviremic subjects were also at increased risk for stage 3 CKD (1.19 [0.98, 1.45]), stage 5 CKD (1.69 [1.07, 2.65]), and progressive CKD (1.31 [1.02, 1.68]).
Conclusions. Compared with HIV-infected subjects who were HCV seronegative, both HCV viremic and HCV aviremic individuals were at increased risk for moderate and advanced CKD.
PMCID: PMC3778973  PMID: 23904290
HIV; hepatitis C virus; chronic kidney disease; hepatitis C RNA; cohort study; glomerular filtration rate; injection drug use
2.  Strong Agreement of Nationally Recommended Retention Measures from the Institute of Medicine and Department of Health and Human Services 
PLoS ONE  2014;9(11):e111772.
We sought to quantify agreement between Institute of Medicine (IOM) and Department of Health and Human Services (DHHS) retention indicators, which have not been compared in the same population, and assess clinical retention within the largest HIV cohort collaboration in the U.S.
Observational study from 2008–2010, using clinical cohort data in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).
Retention definitions used HIV primary care visits. The IOM retention indicator was: ≥2 visits, ≥90 days apart, each calendar year. This was extended to a 2-year period; retention required meeting the definition in both years. The DHHS retention indicator was: ≥1 visit each semester over 2 years, each ≥60 days apart. Kappa statistics detected agreement between indicators and C statistics (areas under Receiver-Operating Characteristic curves) from logistic regression analyses summarized discrimination of the IOM indicator by the DHHS indicator.
Among 36,769 patients in 2008–2009 and 34,017 in 2009–2010, there were higher percentages of participants retained in care under the IOM indicator than the DHHS indicator (80% vs. 75% in 2008–2009; 78% vs. 72% in 2009–2010, respectively) (p<0.01), persisting across all demographic and clinical characteristics (p<0.01). There was high agreement between indicators overall (κ = 0.83 in 2008–2009; κ = 0.79 in 2009–2010, p<0.001), and C statistics revealed a very strong ability to predict retention according to the IOM indicator based on DHHS indicator status, even within characteristic strata.
Although the IOM indicator consistently reported higher retention in care compared with the DHHS indicator, there was strong agreement between IOM and DHHS retention indicators in a cohort demographically similar to persons living with HIV/AIDS in the U.S. Persons with poorer retention represent subgroups of interest for retention improvement programs nationally, particularly in light of the White House Executive Order on the HIV Care Continuum.
PMCID: PMC4222946  PMID: 25375099
3.  Physicochemical and sensory characteristics of fermented sheepmeat sausage 
Food Science & Nutrition  2014;2(6):669-675.
The aim of the study was to compare the physicochemical and sensory characteristics of fermented, cured sausages made from equivalent muscle groups of beef, pork, and sheepmeat. The last has no commercial examples and represents an unexploited opportunity. Using seven replicates of shoulder meat and subcutaneous fat, sausages were made with 64%, 29%, 4%, 2%, 0.2%, and 0.01% of lean meat, fat, NaCl, glucose, sodium pyrophosphate, and lactic culture, respectively. Following anaerobic fermentation (96 h, 30°C), there were no significant differences between the species in mean texture (hardness, springiness, adhesiveness, cohesiveness) and pH, and only minor differences were seen in color. However, although not consumer tested, it is argued that consumers would be able to pick a texture difference due to different fat melting point ranges, highest for sheepmeat. This work was followed by a sensory experiment to find out if characteristic sheepmeat flavors could be suppressed to appeal to unhabituated consumers. To simulate a very strongly characteristic sheepmeat, beef sausage mixtures (above) were spiked, or not, with 4-methyloctanoic, 4-methylnonanoic acid, and skatole (5.0, 0.35, and 0.08 mg kg−1, respectively). Sodium nitrite (at 0.1 g kg−1) and a garlic/rosemary flavor were variably added to create a 23 factorial design. In a randomized design, 60 consumers found that spiked sheepmeat flavors caused an overall significant decrease in mean liking on a 1–9 scale (5.83 vs. 5.35,P = 0.003), but this was completely negated by the garlic/rosemary addition (5.18 vs. 6.00,P < 0.001). Nitrite had no effect on liking (5.61 vs. 5.58,P = 0.82), although nitrite might be included in commercial examples to minimize fat oxidation and suppress growth of clostridia. Thus, sheepmeat flavors could be suppressed to appeal to unhabituated consumers. Commercial examples could thus be made for these consumers, but the mandatory use of the name “mutton” in some markets would adversely affect prospects.
PMCID: PMC4256571  PMID: 25493184
4-methyloctanoic acid; fermentation; sheepmeat; skatole; spicing
4.  Polypharmacy and Risk of Antiretroviral Drug Interactions Among the Aging HIV-Infected Population 
Journal of General Internal Medicine  2013;28(10):1302-1310.
Among aging HIV-infected adults, polypharmacy and its consequences have not been well-described.
To characterize the extent of polypharmacy and the risk of antiretroviral (ARV) drug interactions among persons of different ages.
Cross-sectional analysis among patients within the HIV Outpatient Study (HOPS) cohort who were prescribed ARVs during 2006–2010.
We used the University of Liverpool HIV drug interactions database to identify ARV/non-ARV interactions with potential for clinical significance.
Of 3,810 patients analyzed (median age 46 years, 34 % ≥ 50 years old) at midpoint of observation, 1,494 (39 %) patients were prescribed ≥ 5 non-ARV medications: 706 (54 %) of 1,312 patients ≥ 50 years old compared with 788 (32 %) of 2,498 patients < 50 years. During the five-year period, the number of patients who were prescribed at least one ARV/non-ARV combination that was contraindicated or had moderate or high evidence of interaction was 267 (7 %) and 1,267 (33 %), respectively. Variables independently associated with having been prescribed a contraindicated ARV/non-ARV combination included older age (adjusted odds ratio [aOR] per 10 years of age 1.17, 95 % CI 1.01–1.35), anxiety (aOR 1.78, 95 % CI 1.32–2.40), dyslipidemia (aOR 1.96, 95 % CI 1.28–2.99), higher daily non-ARV medication burden (aOR 1.13, 95 % CI 1.10–1.17), and having been prescribed a protease inhibitor (aOR 2.10, 95 % CI 1.59–2.76). Compared with patients < 50 years, older patients were more likely to have been prescribed an ARV/non-ARV combination that was contraindicated (unadjusted OR 1.44, 95 % CI 1.14–1.82), or had moderate or high evidence of interaction (unadjusted OR 1.29, 95 % CI 1.15–1.44).
A substantial percentage of patients were prescribed at least one ARV/non-ARV combination that was contraindicated or had potential for a clinically significant interaction. As HIV-infected patients age and experience multiple comorbidities, systematic reviews of current medications by providers may reduce risk of such exposures.
PMCID: PMC3785656  PMID: 23605401
polypharmacy; drug interactions; HIV; aging
5.  Effect of a care transition intervention by pharmacists: an RCT 
Pharmacists may improve medication-related outcomes during transitions of care. The aim of the Iowa Continuity of Care Study was to determine if a pharmacist case manager (PCM) providing a faxed discharge medication care plan from a tertiary care institution to primary care could improve medication appropriateness and reduce adverse events, rehospitalization and emergency department visits.
Design. Randomized, controlled trial of 945 participants assigned to enhanced, minimal and usual care groups conducted 2007 to 2012. Subjects. Participants with cardiovascular-related conditions and/or asthma or chronic obstructive pulmonary disease were recruited from the University of Iowa Hospital and Clinics following admission to general medicine, family medicine, cardiology or orthopedics. Intervention. The minimal group received admission history, medication reconciliation, patient education, discharge medication list and medication recommendations to inpatient team. The enhanced group also received a faxed medication care plan to their community physician and pharmacy and telephone call 3–5 days post-discharge. Participants were followed for 90 days post-discharge. Main Outcomes and Measures. Medication appropriateness index (MAI), adverse events, adverse drug events and post-discharge healthcare utilization were compared by study group using linear and logistic regression, as models accommodating random effects due to pharmacists indicated little clustering.
Study groups were similar at baseline and the intervention fidelity was high. There were no statistically significant differences by study group in medication appropriateness, adverse events or adverse drug events at discharge, 30-day and 90-day post-discharge. The average MAI per medication as 0.53 at discharge and increased to 0.75 at 90 days, and this was true across all study groups. Post-discharge, about 16% of all participants experienced an adverse event, and this did not differ by study group (p > 0.05). Almost one-third of all participants had any type of healthcare utilization within 30 days post-discharge, where 15% of all participants had a 30-day readmission. Healthcare utilization post-discharge was not statistically significant different at 30 or 90 days by study group.
The pharmacist case manager did not affect medication use outcomes post-discharge perhaps because quality of care measures were high in all study groups.
Trial registration registration: NCT00513903, August 7, 2007.
PMCID: PMC4262237  PMID: 25234932
Clinical pharmacist; Care transitions; Continuity of care; Medication reconciliation; Medication care plan
6.  Field methods in medical record abstraction: assessing the properties of comparative effectiveness estimates 
Comparative effectiveness studies using Medicare claims data are vulnerable to treatment selection biases and supplemental data from a sample of patients has been recommended for examining the magnitude of this bias. Previous research using nationwide Medicare claims data has typically relied on the Medicare Current Beneficiary Survey (MCBS) for supplemental data. Because many important clinical variables for our specific research question are not available in the MCBS, we collected medical record data from a subsample of patients to assess the validity of assumptions and to aid in the interpretation of our estimates. This paper seeks to describe and document the process used to collect and validate this supplemental information.
Medicare claims data files for all patients with fee-for-service Medicare benefits who had an acute myocardial infarction (AMI) in 2007 or 2008 were obtained. Medical records were obtained and abstracted for a stratified subsample of 1,601 of these patients, using strata defined by claims-based measures of physician prescribing practices and drug treatment combinations. The abstraction tool was developed collaboratively by study clinicians and researchers, leveraging important elements from previously validated tools.
Records for 2,707 AMI patients were requested from the admitting hospitals and 1,751 were received for an overall response rate of 65%; 1,601 cases were abstracted by trained personnel at a contracted firm. Data were collected with overall 96% inter-abstractor agreement across all variables. Some non-response bias was detected at the patient and facility level.
Although Medicare claims data are a potentially powerful resource for conducting comparative effectiveness analyses, observational databases are vulnerable to treatment selection biases. This study demonstrates that it is feasible to abstract medical records for Medicare patients nationwide and collect high quality data, to design the sampling purposively to address specific research questions, and to more thoroughly evaluate the appropriateness of care delivered to AMI patients.
PMCID: PMC4169833  PMID: 25223597
Acute myocardial infarction; Medical record abstraction; Medicare; Cardiovascular medications
7.  What is the Effect of Area Size When Using Local Area Practice Style as an Instrument? 
Journal of clinical epidemiology  2013;66(8 0):S69-S83.
Many researchers have used local area practice style measures as instruments in instrumental variable analysis. What constitutes the size of a “local area” for measuring practice styles may affect the strength of the relationship between the instrument and treatment choice, and whether the instrument is related to unmeasured confounding factors. Among previous studies using local area practice style measures as instruments, only two reported whether their estimates were robust to changes in the local area size. There has been no discussion on how area size may affect IV estimates when local area practice style measures are used as instruments. The objective of this study is to discuss the tradeoffs inherent in choosing a local area size when using a measure of local area practice style as an instrument. We used the effectiveness of angiotensin converting-enzyme inhibitors and angiotensin receptor blockers on survival post acute myocardial infarction as an example. Across local area size definitions we contrasted treatment effect estimates in terms of (1) the strength of the relationship between local area practice styles and individual patient treatment choices; and (2) indirect assessments of the assumption of no correlation between local area practice style and unmeasured confounders.
PMCID: PMC3718893  PMID: 23849157
8.  Primary cardiac sarcomas: a clinicopathologic analysis of a series with follow-up information in 17 patients and emphasis on long-term survival 
Human pathology  2008;39(9):1385-1395.
Although cardiac sarcomas are rare in comparison to their soft tissue counterparts, they are the second most common type of primary cardiac neoplasm. Of the few hundred cases reported, most has been based on autopsy series. A series of 27 cardiac sarcomas removed at surgery for curative and diagnostic intent were reviewed for clinicopathologic features with correlation to available postoperative follow-up data in 17 patients. There were 6 angiosarcomas, 6 myxofibrosarcomas, 3 malignant peripheral nerve sheath tumors, 3 leiomyosarcomas, 2 synovial sarcomas, 1 epithelioid hemangioendothelioma, 1 chondrosarcoma, 1 osteosarcoma, and 4 poorly differentiated sarcomas. There was a wide age and size range with slight female predilection. There were 20 cases that arose in the atria/pulmonary vessels, 4 in the ventricles, 1 in mitral valve, and 2 in epi/pericardium. There was a slight left predilection. The histologic grade was low in 4, moderate in 3, and high in 20 cases. Six high-grade and 1 low-grade tumors were also treated with adjuvant chemotherapy and/or radiation. In 17 patients with follow-up data, 6 of 12 patients with high-grade tumor died (4 within 5 days of the initial surgery, 1 in 21 months, and 1 in 131 months), and 1 patient with moderate-grade tumor and all 4 patients with low-grade tumor were alive without evidence of disease at the end of follow-up. Tumor grade appeared to be prognostically important in cardiac sarcoma. Long survival was achieved in patients who survived the initial surgery well.
PMCID: PMC4081532  PMID: 18602663
Cardiac; Pathology; Surgery; Sarcoma; Long survival
9.  Trends and Disparities in Antiretroviral Therapy Initiation and Virologic Suppression Among Newly Treatment-Eligible HIV-Infected Individuals in North America, 2001–2009 
Hanna, David B. | Buchacz, Kate | Gebo, Kelly A. | Hessol, Nancy A. | Horberg, Michael A. | Jacobson, Lisa P. | Kirk, Gregory D. | Kitahata, Mari M. | Korthuis, P. Todd | Moore, Richard D. | Napravnik, Sonia | Patel, Pragna | Silverberg, Michael J. | Sterling, Timothy R. | Willig, James H. | Lau, Bryan | Althoff, Keri N. | Crane, Heidi M. | Collier, Ann C. | Samji, Hasina | Thorne, Jennifer E. | Gill, M. John | Klein, Marina B. | Martin, Jeffrey N. | Rodriguez, Benigno | Rourke, Sean B. | Gange, Stephen J. | Benson, A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Ken | Hogg, Robert S. | Harrigan, Richard | Montaner, Julio | Cescon, Angela | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Rodriguez, Benigno | Horberg, Michael A. | Silverberg, Michael J. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann | Rachlis, Anita R. | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M. John | Deeks, Steven G. | Martin, Jeffrey N. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Platt, Aaron | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Webster, Eric | Morton, Liz | Simon, Brenda | Gange, Stephen J. | Abraham, Alison G. | Lau, Bryan | Althoff, Keri N. | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
In the last decade, timely initiation of antiretroviral therapy and resulting virologic suppression have greatly improved in North America concurrent with the development of better tolerated and more potent regimens, but significant barriers to treatment uptake remain.
Background. Since the mid-1990s, effective antiretroviral therapy (ART) regimens have improved in potency, tolerability, ease of use, and class diversity. We sought to examine trends in treatment initiation and resulting human immunodeficiency virus (HIV) virologic suppression in North America between 2001 and 2009, and demographic and geographic disparities in these outcomes.
Methods. We analyzed data on HIV-infected individuals newly clinically eligible for ART (ie, first reported CD4+ count <350 cells/µL or AIDS-defining illness, based on treatment guidelines during the study period) from 17 North American AIDS Cohort Collaboration on Research and Design cohorts. Outcomes included timely ART initiation (within 6 months of eligibility) and virologic suppression (≤500 copies/mL, within 1 year). We examined time trends and considered differences by geographic location, age, sex, transmission risk, race/ethnicity, CD4+ count, and viral load, and documented psychosocial barriers to ART initiation, including non–injection drug abuse, alcohol abuse, and mental illness.
Results. Among 10 692 HIV-infected individuals, the cumulative incidence of 6-month ART initiation increased from 51% in 2001 to 72% in 2009 (Ptrend < .001). The cumulative incidence of 1-year virologic suppression increased from 55% to 81%, and among ART initiators, from 84% to 93% (both Ptrend < .001). A greater number of psychosocial barriers were associated with decreased ART initiation, but not virologic suppression once ART was initiated. We found significant heterogeneity by state or province of residence (P < .001).
Conclusions. In the last decade, timely ART initiation and virologic suppression have greatly improved in North America concurrent with the development of better-tolerated and more potent regimens, but significant barriers to treatment uptake remain, both at the individual level and systemwide.
PMCID: PMC3657490  PMID: 23315317
antiretroviral therapy; healthcare disparities; HIV; time factors; viral load
10.  Preliminary evidence of within-subject changes in gray matter density associated with remission of bipolar depression 
Psychiatry research  2011;193(1):53-55.
A preliminary within-subjects MRI study of seven patients with a diagnosis of bipolar I disorder revealed that after remission from depression, gray matter density increases were observed in subgenual prefrontal cortex, parahippocampal gyrus, and inferior temporal gyri. Decreases were observed in superior and inferior frontal gyri and anterior cingulate.
PMCID: PMC3986411  PMID: 21561743
Bipolar Disorder; Depression; Magnetic resonance imaging; MRI; Prefrontal
11.  Invasive cervical cancer risk among HIV-infected women: A North American multi-cohort collaboration prospective study 
HIV infection and low CD4+ T-cell count are associated with an increased risk of persistent oncogenic HPV infection – the major risk factor for cervical cancer. Few reported prospective cohort studies have characterized the incidence of invasive cervical cancer (ICC) in HIV-infected women.
Data were obtained from HIV-infected and -uninfected female participants in the NA-ACCORD with no history of ICC at enrollment. Participants were followed from study entry or January, 1996 through ICC, loss-to follow-up or December, 2010. The relationship of HIV infection and CD4+ T-cell count with risk of ICC was assessed using age-adjusted Poisson regression models and standardized incidence ratios (SIR). All cases were confirmed by cancer registry records and/or pathology reports. Cervical cytology screening history was assessed through medical record abstraction.
A total of 13,690 HIV-infected and 12,021 HIV-uninfected women contributed 66,249 and 70,815 person-years (pys) of observation, respectively. Incident ICC was diagnosed in 17 HIV-infected and 4 HIV-uninfected women (incidence rate of 26 and 6 per 100,000 pys, respectively). HIV-infected women with baseline CD4+ T-cells of ≥ 350, 200–349 and <200 cells/uL had a 2.3-times, 3.0-times and 7.7-times increase in ICC incidence, respectively, compared with HIV-uninfected women (Ptrend =0.001). Of the 17 HIV-infected cases, medical records for the 5 years prior to diagnosis showed that 6 had no documented screening, 5 had screening with low grade or normal results, and 6 had high-grade results.
This study found elevated incidence of ICC in HIV-infected compared to -uninfected women, and these rates increased with immunosuppression.
PMCID: PMC3633634  PMID: 23254153
Human papilloma virus; HIV-infection; Invasive Cervical Cancer; Immunosuppression
12.  Retention Among North American HIV–infected Persons in Clinical Care, 2000–2008 
Retention in care is key to improving HIV outcomes. Our goal was to describe “churn” in patterns of entry, exit, and retention in HIV care in the US and Canada.
Adults contributing ≥1 CD4 count or HIV-1 RNA (HIV-lab) from 2000–2008 in North American Cohort Collaboration on Research and Design (NA-ACCORD) clinical cohorts were included. Incomplete retention was defined as lack of 2 HIV-labs (≥90 days apart) within 12 months, summarized by calendar year. We used beta-binomial regression models to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) of factors associated with incomplete retention.
Among 61,438 participants, 15,360 (25%) with incomplete retention significantly differed in univariate analyses (p<0.001) from 46,078 (75%) consistently retained by age, race/ethnicity, HIV risk, CD4, ART use, and country of care (US vs. Canada). From 2000–2004, females (OR=0.82, CI:0.70–0.95), older individuals (OR=0.78, CI:0.74–0.83 per 10 years), and ART users (OR= 0.61, CI:0.54–0.68 vs all others) were less likely to have incomplete retention, while black individuals (OR=1.31, CI:1.16–1.49, vs. white), those with injection drug use (IDU) HIV risk (OR=1.68, CI:1.49–1.89, vs. non-IDU) and those in care longer (OR=1.09, CI:1.07–1.11 per year) were more likely to have incomplete retention. Results from 2005–2008 were similar.
From 2000 to 2008, 75% of the NA-ACCORD population was consistently retained in care with 25% experiencing some change in status, or churn. In addition to the programmatic and policy implications, our findings identify patient groups who may benefit from focused retention efforts.
PMCID: PMC3661708  PMID: 23242158
retention; churn; HIV clinical care; North America; HRSA HAB; National HIV/AIDS Strategy
13.  Exercise and the Olympic bounce 
PMCID: PMC3553630  PMID: 23561677
14.  Preconditioning with Cations Increases the Attachment of Anoxybacillus flavithermus and Geobacillus Species to Stainless Steel 
Applied and Environmental Microbiology  2013;79(13):4186-4190.
Preconditioning of Anoxybacillus flavithermus E16 and Geobacillus sp. strain F75 with cations prior to attachment often significantly increased (P ≤ 0.05) the number of viable cells that attached to stainless steel (by up to 1.5 log CFU/cm2) compared with unconditioned bacteria. It is proposed that the transition of A. flavithermus and Geobacillus spp. from milk formulations to stainless steel product contact surfaces in milk powder manufacturing plants is mediated predominantly by bacterial physiological factors (e.g., surface-exposed adhesins) rather than the concentrations of cations in milk formulations surrounding bacteria.
PMCID: PMC3697576  PMID: 23645192
15.  Accounting for Unobservable Exposure Time Bias When Using Medicare Prescription Drug Data 
Medicare & Medicaid Research Review  2013;3(4):mmrr.003.04.a01.
To describe the prevalence and correlates of unobservable medication exposure time, and to recommend approaches for minimizing bias, in studies using Medicare Part D data..
179,065 Medicare patients hospitalized for an AMI in 2007 or 2008.
We compared two methods for creating medication exposure observation periods using acute care discharge vs. post-acute care discharge dates. We examined options for increasing cohort sizes by requiring different thresholds for observable days, or by using as a covariate, in the observation period. We calculated the extent and health status correlates of unobserved Medicare Part D exposure time and examined its association with receipt of beta-blockers.
39% of patients had unobservable time during the 30 day exposure assessment period following acute care; they were significantly older, had more comorbidity and longer acute care stays, had worse 1-year survival, and were significantly less likely to be classified as beta-blocker users. Using the alternative exposure assessment window, only 29% of the sample had unobservable time, and differences between groups were less pronounced. Significant gains in sample size can be obtained by restricting or controlling for the number of observable days required in the exposure assessment period.
Unobservable exposure time is common among Medicare Part D beneficiaries, and they are often in worse health. To retain patients with unobservable exposure time, we recommend stratifying patients on receipt of post-acute facility-based care, calculating and using observable days as a covariate and, when appropriate, using the discharge date from contiguous post-acute facility care for beginning the exposure assessment period.
PMCID: PMC4011646  PMID: 24834364
Administrative Data Uses; Epidemiology; Medicare; Pharmacy
16.  Standardizing Medicare Payment Information to Support Examining Geographic Variation in Costs 
Medicare & Medicaid Research Review  2013;3(3):mmrr.003.03.a06.
Examination of efficiency in health care requires that cost information be normalized. Medicare payments include both geographic and policy-based facility type differentials (e.g., wage index and disproportionate share hospital), which can bias cost comparisons of hospitals and averages across geographic areas. Standardizing payment information to remove the area- and policy-based payment differentials should normalize much of the observed geographic variability in payments, allowing for a more accurate comparison of resource use between providers and across geographic regions. Use of standardized payments will ensure that observed payment variation is due to differences in practice patterns and service use, rather than Medicare payment differences over which the providers have no control. This paper describes a method for standardizing claim payments, and demonstrates the difference in actual versus standardized payments by geographic region.
Study Design and Methods
We used a nationwide cohort of Medicare patients hospitalized with an acute myocardial infarction (AMI) in 2007, then limited our study to those with Medicare Part A and Part B fee-for-service (FFS), and Part D coverage (n = 143,123). Standardized payment amounts were calculated for each Part A and Part B claim; standardized and actual payments were summed for all services for each patient beginning with the index hospitalization through 12 months post discharge.
Principal Findings
Without standardization of payments, certain areas of the country are mischaracterized as either high or low healthcare resource-consuming areas. The difference between actual and standardized payments varies by care setting.
Standardized payment amounts should be calculated when comparing Medicare resource use across geographic areas.
PMCID: PMC3983731  PMID: 24753972
Medicare; Administrative Data Uses; Health Care Costs; Medical Geography
A study of HIV-infected persons in primary care in four U.S. found that 13% had a prevalent STD at enrollment and 7% an incident STD six months later.
To better understand the factors associated with HIV and STD transmitting behavior among HIV-infected persons, we estimated STD prevalence and incidence and associated risk factors among a diverse sample of HIV-infected patients in primary care.
We analyzed data from 557 participants in the SUN study, a prospective observational cohort of HIV-infected persons in primary care in four U.S. cities. At enrollment and six months thereafter, participants completed an audio computer-assisted self interview about their sexual behavior, and were screened for genitourinary, rectal and pharyngeal N. gonorrhoeae and C. trachomatis infections by nucleic acid amplification testing, and for serologic evidence of syphilis. Women provided cervicovaginal samples and men provided urine to screen for T. vaginalis by polymerase chain reaction.
Thirteen percent of participants had a prevalent STD at enrollment and 7% an incident STD six months later. The most commonly diagnosed infections were rectal chlamydia, oropharyngeal gonorrhea, and chlamydial urethritis among the men, and trichomoniasis among the women. Other than trichomoniasis, 94% of incident STDs were identified in MSM. Polysubstance abuse other than marijuana, and having ≥ 4 sex partners in the six months prior to testing were associated with diagnosis of an incident STD.
STDs were commonly diagnosed among contemporary HIV-infected patients receiving routine outpatient care, particularly among sexually active MSM who used recreational drugs. These findings underscore the need for frequent STD screening, prevention counseling, and substance abuse treatment for HIV-infected persons in care.
PMCID: PMC3740591  PMID: 22183836
HIV infection; sexual risk; sexually transmitted infections
18.  Mood-state effects on amygdala volume in bipolar disorder 
Journal of Affective Disorders  2012;139(3):298-301.
Prior structural neuroimaging studies of the amygdala in patients with bipolar disorder have reported higher or lower volumes, or no difference relative to healthy controls. These inconsistent findings may have resulted from combining subjects in different mood states. The prefrontal cortex has recently been reported to have a lower volume in depressed versus euthymic bipolar patients. Here we examined whether similar mood state-dependent volumetric differences are detectable in the amygdala.
Forty subjects, including 28 with bipolar disorder type I (12 depressed and 16 euthymic), and 12 healthy comparison subjects were scanned on a 3T magnetic resonance image (MRI) scanner. Amygdala volumes were manually traced and compared across subject groups, adjusting for sex and total brain volume.
Statistical analyses found a significant effect of mood state and hemisphere on amygdala volume. Subsequent comparisons revealed that amygdala volumes were significantly lower in the depressed bipolar group compared to both the euthymic bipolar (p=0.005) and healthy control (p=0.043) groups.
Our study was cross-sectional and some patients were medicated.
Our results suggest that mood state influences amygdala volume in subjects with bipolar disorder. Future studies that replicate these findings in unmedicated patient samples scanned longitudinally are needed.
PMCID: PMC3372678  PMID: 22521854
Bipolar Disorder; Depression; Magnetic resonance imaging; MRI; Amygdala
19.  Incremental Costs associated with Physician and Pharmacist Collaboration to Improve Blood Pressure Control 
Pharmacotherapy  2012;32(8):772-780.
Study Objective
To compare costs associated with a physician-pharmacist collaborative intervention with costs for usual care.
Cost calculation using healthcare utilization and outcomes from prospective, cluster randomized controlled clinical trials.
Eleven community-based medical offices in the Midwest.
496 patients with high blood pressure.
A physician-pharmacist collaborative care program to manage hypertension.
Measurements and Main Results
Total costs included provider time, laboratory tests, and antihypertensive medications. Provider time was calculated based on 1) an online survey of intervention pharmacists and 2) National Ambulatory Medical Care Survey. Cost parameters were taken from the Bureau of Labor Statistics, the Medicare laboratory fee schedule, and a publicly available drug price website. The total costs were adjusted for patient characteristics. Adjusted total costs were $774.90 in the intervention group and $445.75 in the control group (difference = $329.16; p< 0.001). In a sensitivity analysis, the difference in adjusted total costs between the two groups ranged from $224.27 to $515.56. The intervention cost was $1,338.05 ($329.16/24.6% blood pressure control rate) for each additional patient who attained blood pressure control within six months. The cost over 6 months to lower systolic and diastolic blood pressure 1 mm Hg was $36.25 and $94.32, respectively.
The physician-pharmacist collaborative intervention increased blood pressure control but also increased the cost of care. Additional research, such as a cost-benefit or a cost-minimization analysis, is needed to assess if financial savings related to reduced morbidity and mortality achieved from better blood pressure control outweighs the cost.
PMCID: PMC3545410  PMID: 23307525
Hypertension; physician-pharmacist collaboration; costs
20.  Risk of Anal Cancer in HIV-Infected and HIV-Uninfected Individuals in North America 
In a large North American cohort study, anal cancer incidence rates were substantially higher for HIV-infected men who have sex with men, other men, and women compared with HIV-uninfected individuals. Rates increased from 1996–1999 to 2000–2003 but plateaued by 2004–2007.
Background. Anal cancer is one of the most common cancers affecting individuals infected with human immunodeficiency virus (HIV), although few have evaluated rates separately for men who have sex with men (MSM), other men, and women. There are also conflicting data regarding calendar trends.
Methods. In a study involving 13 cohorts from North America with follow-up between 1996 and 2007, we compared anal cancer incidence rates among 34 189 HIV-infected (55% MSM, 19% other men, 26% women) and 114 260 HIV-uninfected individuals (90% men).
Results. Among men, the unadjusted anal cancer incidence rates per 100 000 person-years were 131 for HIV-infected MSM, 46 for other HIV-infected men, and 2 for HIV-uninfected men, corresponding to demographically adjusted rate ratios (RRs) of 80.3 (95% confidence interval [CI], 42.7–151.1) for HIV-infected MSM and 26.7 (95% CI, 11.5–61.7) for other HIV-infected men compared with HIV-uninfected men. HIV-infected women had an anal cancer rate of 30/100 000 person-years, and no cases were observed for HIV-uninfected women. In a multivariable Poisson regression model, among HIV-infected individuals, the risk was higher for MSM compared with other men (RR, 3.3; 95% CI, 1.8–6.0), but no difference was observed comparing women with other men (RR, 1.0; 95% CI, 0.5–2.2). In comparison with the period 2000–2003, HIV-infected individuals had an adjusted RR of 0.5 (95% CI, .3–.9) in 1996–1999 and 0.9 (95% CI, .6–1.2) in 2004–2007.
Conclusions. Anal cancer rates were substantially higher for HIV-infected MSM, other men, and women compared with HIV-uninfected individuals, suggesting a need for universal prevention efforts. Rates increased after the early antiretroviral therapy era and then plateaued.
PMCID: PMC3297645  PMID: 22291097
21.  Methicillin-Resistant Staphylococcus aureus Colonization of the Groin and Risk for Clinical Infection among HIV-infected Adults 
Emerging Infectious Diseases  2013;19(4):623-629.
Data on the interaction between methicillin-resistant Staphylococcus aureus (MRSA) colonization and clinical infection are limited. During 2007–2008, we enrolled HIV-infected adults in Atlanta, Georgia, USA, in a prospective cohort study. Nares and groin swab specimens were cultured for S. aureus at enrollment and after 6 and 12 months. MRSA colonization was detected in 13%–15% of HIV-infected participants (n = 600, 98% male) at baseline, 6 months, and 12 months. MRSA colonization was detected in the nares only (41%), groin only (21%), and at both sites (38%). Over a median of 2.1 years of follow-up, 29 MRSA clinical infections occurred in 25 participants. In multivariate analysis, MRSA clinical infection was significantly associated with MRSA colonization of the groin (adjusted risk ratio 4.8) and a history of MRSA infection (adjusted risk ratio 3.1). MRSA prevention strategies that can effectively prevent or eliminate groin colonization are likely necessary to reduce clinical infections in this population.
PMCID: PMC3647417  PMID: 23631854
HIV; methicillin-resistant Staphylococcus aureus; colonization; viruses; bacteria; Georgia; MRSA; staphylococci
22.  Diffuse large B-cell lymphoma in the elderly: diffusion of treatment with rituximab and survival advances with and without anthracyclines 
Leukemia & lymphoma  2011;52(6):994-1002.
Anthracycline-based chemotherapy (ABC) is the most effective therapy for diffuse large B-cell lymphoma (DLBCL). The addition of rituximab to ABC in controlled trials has demonstrated superior survival, yet ABC is inconsistently utilized in elderly patients, and little is known about the penetrance or impact of rituximab with other treatments. We analyzed the treatment and survival patterns of 7559 patients with DLBCL over age 66 diagnosed from 1992 to 2002 using a linked Surveillance, Epidemiology and End Results (SEER)–Medicare database. Rituximab use was first detected in 1999 and by 2002 was incorporated in 79% of ABC-treated patients and 71% of patients treated with non-anthracycline chemotherapy, but only 12% of patients not receiving cytotoxic chemotherapy. ABC rates remained constant across time as did rates of no therapy, which were highest among the very old. Rituximab-associated survival improvements were seen among elderly treated with or without anthracyclines. Patients treated with rituximab but not anthracyclines had comparable survival to those treated with anthracycline but not rituximab.
PMCID: PMC3601377  PMID: 21338277
Non-Hodgkin lymphoma; immunotherapy; survival; elderly
23.  Performances on the CogState and Standard Neuropsychological Batteries Among HIV Patients Without Dementia 
AIDS and behavior  2011;15(8):1902-1909.
HIV-associated neurocognitive disorders (HAND) remain prevalent but challenging to diagnose particularly among non-demented individuals. To determine whether a brief computerized battery correlates with formal neurocognitive testing, we identified 46 HIV-infected persons who had undergone both formal neurocognitive testing and a brief computerized battery. Simple detection tests correlated best with formal neuropsychological testing. By multivariable regression model, 53% of the variance in the composite Global Deficit Score was accounted for by elements from the brief computerized tool (p<0.01). These data confirm previous correlation data with the computerized battery, yet illustrate remaining challenges for neurocognitive screening.
PMCID: PMC3594991  PMID: 21877204
24.  U.S. Trends in Antiretroviral Therapy Use, HIV RNA Plasma Viral Loads, and CD4 T-Lymphocyte Cell Counts Among HIV-Infected Persons, 2000 to 2008 
Annals of internal medicine  2012;157(5):325-335.
The U.S. National HIV/AIDS Strategy targets for 2015 include increasing access to care and improving health outcomes for persons living with HIV in the United States (PLWH-US).
To demonstrate the utility of the NA-ACCORD (North American AIDS Cohort Collaboration on Research and Design) for monitoring trends in the HIV epidemic in the United States and to present trends in HIV treatment and related health outcomes.
Trends from annual cross-sectional analyses comparing patients from pooled, multicenter, prospective, clinical HIV cohort studies with PLWH-US, as reported to national surveillance systems in 40 states.
U.S. HIV outpatient clinics.
HIV-infected adults with 1 or more HIV RNA plasma viral load (HIV VL) or CD4 T-lymphocyte (CD4) cell count measured in any calendar year from 1 January 2000 to 31 December 2008.
Annual rates of antiretroviral therapy use, HIV VL, and CD4 cell count at death.
45 529 HIV-infected persons received care in an NA-ACCORD–participating U.S. clinical cohort from 2000 to 2008. In 2008, the 26 030 NA-ACCORD participants in care and the 655 966 PLWH-US had qualitatively similar demographic characteristics. From 2000 to 2008, the proportion of participants prescribed highly active antiretroviral therapy increased by 9 percentage points to 83% (P < 0.001), whereas the proportion with suppressed HIV VL (≤2.7 log10 copies/mL) increased by 26 percentage points to 72% (P < 0.001). Median CD4 cell count at death more than tripled to 0.209 × 109 cells/L (P < 0.001).
The usual limitations of observational data apply.
The NA-ACCORD is the largest cohort of HIV-infected adults in clinical care in the United States that is demographically similar to PLWH-US in 2008. From 2000 to 2008, increases were observed in the percentage of prescribed HAART, the percentage who achieved a suppressed HIV VL, and the median CD4 cell count at death.
Primary Funding Source
National Institutes of Health, Centers for Disease Control and Prevention, Canadian Institutes of Health Research, Canadian HIV Trials Network, and the government of British Columbia, Canada.
PMCID: PMC3534765  PMID: 22944874
25.  Provider Compliance With Guidelines for Management of Cardiovascular Risk in HIV-Infected Patients 
Compliance with National Cholesterol Education Program Adult Treatment Panel III (NCEP) guidelines has been shown to significantly reduce incident cardiovascular events. We investigated physicians’ compliance with NCEP guidelines to reduce cardiovascular disease (CVD) risk in a population infected with HIV.
We analyzed HIV Outpatient Study (HOPS) data, following eligible patients from January 1, 2002, or first HOPS visit thereafter to calculate 10-year cardiovascular risk (10yCVR), until September 30, 2009, death, or last office visit. We categorized participants into four 10yCVR strata, according to guidelines determined by NCEP, the Infectious Disease Society of America, and the Adult AIDS Clinical Trials Group. We calculated percentages of patients treated for dyslipidemia and hypertension, calculated percentages of patients who achieved recommended goals, and categorized them by 10yCVR stratum.
Of 2,005 patients analyzed, 33.7% had fewer than 2 CVD risk factors. For patients who had 2 or more risk factors, 10yCVR was less than 10% for 28.2%, 10% to 20% for 18.2%, and higher than 20% for 20.0% of patients. Of patients eligible for treatment, 81% to 87% were treated for elevated low-density lipoprotein cholesterol/non–high-density lipoprotein cholesterol (LDL-C/non–HDL-C), 2% to 11% were treated for low HDL-C, 56% to 91% were treated for high triglycerides, and 46% to 69% were treated for hypertension. Patients in higher 10yCVR categories were less likely to meet treatment goals than patients in lower 10yCVR categories.
At least one-fifth of contemporary HOPS patients have a 10yCVR higher than 20%, yet a large percentage of at-risk patients who were eligible for pharmacologic treatment did not receive recommended interventions and did not reach recommended treatment goals. Opportunities exist for CVD prevention in the HIV-infected population.
PMCID: PMC3557014  PMID: 23347705

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