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1.  Agreement Between Electronic Medical Record-based and Self-Administered Pain Numeric Rating Scale: Clinical and Research Implications 
Medical care  2013;51(3):245-250.
Background
Pain screening may improve the quality of care by identifying patients in need of further assessment and management. Many healthcare systems use the numeric rating scale (NRS) for pain screening, and record the score in the patients’ electronic medical record (EMR).
Objective
Determine level of agreement between EMR and patient survey NRS, and whether discrepancies vary by demographic and clinical characteristics.
Methods
We linked survey data from a sample of Veterans receiving care in eight Veterans Affairs (VA) medical facilities, to EMR data including an NRS collected on the day of the survey in order to compare responses to the NRS question from these two sources. We assessed correlation, agreement on clinical cut-points (e.g. severe), and, using the survey as the gold standard, whether patient characteristics were associated with a discrepancy on moderate-severe pain.
Results
A total of 1,643 participants had a survey and EMR NRS score on the same day. The correlation was 0.56 (95% CI 0.52/0.59), but the mean EMR score was significantly lower than the survey score (1.72 vs. 2.79; p<0.0001). Agreement was moderate (kappa=0.35). Characteristics associated with a increased odds of a discrepancy included: diabetes (adjusted odds ratio (AOR)=1.48), post traumatic stress disorder (AOR=1.59), major depressive disorder (AOR=1.81), other race vs. white (AOR=2.29), and facility in which care was received.
Conclusions
The underestimation of pain using EMR data, especially clinically actionable levels of pain, has important clinical and research implications. Improving the quality of pain care may require better screening.
doi:10.1097/MLR.0b013e318277f1ad
PMCID: PMC3572341  PMID: 23222528
Veterans; pain measurement; electronic medical records
2.  Receipt of Opioid Analgesics by HIV-Infected and Uninfected Patients 
ABSTRACT
BACKGROUND
Opioids are increasingly prescribed, but there are limited data on opioid receipt by HIV status.
OBJECTIVES
To describe patterns of opioid receipt by HIV status and the relationship between HIV status and receiving any, high-dose, and long-term opioids.
DESIGN
Cross-sectional analysis of the Veterans Aging Cohort Study.
PARTICIPANTS
HIV-infected (HIV+) patients receiving Veterans Health Administration care, and uninfected matched controls.
MAIN MEASURES
Pain-related diagnoses were determined using ICD-9 codes. Any opioid receipt was defined as at least one opioid prescription; high-dose was defined as an average daily dose ≥120 mg of morphine equivalents; long-term opioids was defined as ≥90 consecutive days, allowing a 30 day refill gap. Multivariable models were used to assess the relationship between HIV infection and the three outcomes.
KEY RESULTS
Among the HIV+ (n = 23,651) and uninfected (n = 55,097) patients, 31 % of HIV+ and 28 % of uninfected (p < 0.001) received opioids. Among patients receiving opioids, HIV+ patients were more likely to have an acute pain diagnosis (7 % vs. 4 %), but less likely to have a chronic pain diagnosis (53 % vs. 69 %). HIV+ patients received a higher mean daily morphine equivalent dose than uninfected patients (41 mg vs. 37 mg, p = 0.001) and were more likely to receive high-dose opioids (6 % vs. 5 %, p < 0.001). HIV+ patients received fewer days of opioids than uninfected patients (median 44 vs. 60, p < 0.001), and were less likely to receive long-term opioids (31 % vs. 34 %, p < 0.001). In multivariable analysis, HIV+ status was associated with receipt of any opioids (AOR 1.40, 95 % CI 1.35, 1.46) and high-dose opioids (AOR 1.22, 95 % CI 1.07, 1.39), but not long-term opioids (AOR 0.94, 95 % CI 0.88, 1.01).
CONCLUSIONS
Patients with HIV infection are more likely to be prescribed opioids than uninfected individuals, and there is a variable association with pain diagnoses. Efforts to standardize approaches to pain management may be warranted in this highly complex and vulnerable patient population.
doi:10.1007/s11606-012-2189-z
PMCID: PMC3539026  PMID: 22895747
opioid; pain; HIV; narcotics; veterans
3.  Heterogeneity in outcomes of treated HIV-positive patients in Europe and North America: relation with patient and cohort characteristics 
Background HIV cohort collaborations, which pool data from diverse patient cohorts, have provided key insights into outcomes of antiretroviral therapy (ART). However, the extent of, and reasons for, between-cohort heterogeneity in rates of AIDS and mortality are unclear.
Methods We obtained data on adult HIV-positive patients who started ART from 1998 without a previous AIDS diagnosis from 17 cohorts in North America and Europe. Patients were followed up from 1 month to 2 years after starting ART. We examined between-cohort heterogeneity in crude and adjusted (age, sex, HIV transmission risk, year, CD4 count and HIV-1 RNA at start of ART) rates of AIDS and mortality using random-effects meta-analysis and meta-regression.
Results During 61 520 person-years, 754/38 706 (1.9%) patients died and 1890 (4.9%) progressed to AIDS. Between-cohort variance in mortality rates was reduced from 0.84 to 0.24 (0.73 to 0.28 for AIDS rates) after adjustment for patient characteristics. Adjusted mortality rates were inversely associated with cohorts’ estimated completeness of death ascertainment [excellent: 96–100%, good: 90–95%, average: 75–89%; mortality rate ratio 0.66 (95% confidence interval 0.46–0.94) per category]. Mortality rate ratios comparing Europe with North America were 0.42 (0.31–0.57) before and 0.47 (0.30–0.73) after adjusting for completeness of ascertainment.
Conclusions Heterogeneity between settings in outcomes of HIV treatment has implications for collaborative analyses, policy and clinical care. Estimated mortality rates may require adjustment for completeness of ascertainment. Higher mortality rate in North American, compared with European, cohorts was not fully explained by completeness of ascertainment and may be because of the inclusion of more socially marginalized patients with higher mortality risk.
doi:10.1093/ije/dys164
PMCID: PMC3535877  PMID: 23148105
HIV; AIDS; antiretroviral therapy; mortality; cohort; heterogeneity; prognostic model; socio-economic status
4.  Unhealthy Alcohol and Illicit Drug Use are Associated with Decreased Quality of HIV Care 
Background
HIV-infected patients with substance use experience suboptimal health outcomes, possibly to due to variations in care.
Objectives
To assess the association between substance use and the quality of HIV care (QOC) received.
Research Design
Retrospective cohort study.
Subjects
HIV-infected patients enrolled in the Veterans Aging Cohort Study.
Measures
We collected self-report substance use data and abstracted 9 HIV quality indicators (QIs) from medical records. Independent variables were unhealthy alcohol use (AUDIT-C score ≥4) and illicit drug use (self-report of stimulants, opioids, or injection drug use in past year). Main outcome was the percentage of QIs received, if eligible. We estimated associations between substance use and QOC using multivariable linear regression.
Results
The majority of the 3,410 patients were male (97.4%) and Black (67.0%) with a mean age of 49.1 years (SD 8.8). Overall, 25.8% reported unhealthy alcohol use, 22% illicit drug use, and participants received 81.5% (SD=18.9) of QIs. The mean percentage of QIs received was lower for those with unhealthy alcohol use vs. not (59.3% vs. 70.0%, p<.001) and those using illicit drugs vs. not (57.8% vs. 70.7%, p<.001). In multivariable models, unhealthy alcohol use (adjusted β −2.74; 95% CI −4.23, −1.25) and illicit drug use (adjusted β −3.51 95% CI −4.99, −2.02) remained inversely associated with the percentage of QIs received.
Conclusions
Though the overall QOC for these HIV-infected Veteran patients was high, gaps persist for those with unhealthy alcohol and illicit drug use. Interventions that address substance use in HIV-infected patients may improve the QOC received.
doi:10.1097/QAI.0b013e31826741aa
PMCID: PMC3460799  PMID: 22820808
Alcohol; Quality of Health Care; HIV; Quality Indicators; Health Care; Opioid-Related Disorders
5.  HIV infection, aging, and immune function: implications for cancer risk and prevention 
Current opinion in oncology  2012;24(5):506-516.
Purpose of review
Combination antiretroviral therapy (ART) has turned HIV infection into a complex chronic disease. This article documents cancer risk among HIV-infected persons, reviews immune system effects of HIV infection in relation to cancer risk, discusses implications for cancer prevention, and suggests future research directions.
Recent findings
There has been a shift in the cancer spectrum from AIDS-defining cancers (ADC) to non-ADC, although the burden of ADC remains high. Although a high prevalence of non-HIV cancer risk factors among HIV-infected persons contributes to cancer risk, substantial evidence has accumulated in favor of an independent association between HIV-induced immunodeficiency and elevated risk of many specific cancer types, most of viral cause, although further work is needed to disentangle immunodeficiency and smoking effects for lung cancer, and immunodeficiency and hepatitis virus effects for liver cancer. Relationships between cancer risk and two other immune system hallmarks of HIV infection, chronic inflammation, and immune dysfunction/senescence, remain poorly understood.
Summary
Early, sustained ART is a crucial component of cancer prevention. Continued epidemiologic monitoring is needed to detect possible effects on cancer risk of specific ART classes or medications, long-term exposure to systemic inflammation or immune dysfunction, or earlier or more effective ART.
doi:10.1097/CCO.0b013e328355e131
PMCID: PMC3695478  PMID: 22759737
aging; cancer; HIV; immune system; inflammation
6.  IMPACT OF CIGARETTE SMOKING ON MORTALITY IN HIV-POSITIVE AND HIV-NEGATIVE VETERANS 
It is unknown whether smoking confers similar mortality risk in HIV-positive as in HIV-negative patients. We compared overall mortality stratified by HIV and smoking of 1,034 HIV-positive block-matched to 739 HIV-negative veterans, enrolled 2001–2002 in the Veterans Aging Cohort 5 Site Study. Adjusted incidence rate ratios (IRR) for mortality were calculated using Poisson regression. Mortality was significantly increased in HIV-positive veterans according to both smoking status and pack-years in unadjusted and adjusted analyses (adjusted IRR 2.31, 95% confidence interval [CI] 1.53–3.49 for HIV-positive current smokers and IRR 1.32, 95% CI 0.67–2.61 for HIV-negative current smokers). Comorbid diseases were also significantly increased according to smoking status and pack-years. Current smoking is associated with poor outcomes; even lower levels of exposure appear to be detrimental in HIV-infected veterans. These findings support the need for improvements in smoking cessation and for studies of mechanisms and diseases underlying increased mortality in smokers with HIV.
doi:10.1521/aeap.2009.21.3_supp.40
PMCID: PMC3118467  PMID: 19537953
7.  Comparison of Two VA Laboratory Data Repositories Indicates That Missing Data Vary Despite Originating From the Same Source 
Medical care  2009;47(1):121-124.
Background
Assessing accuracy and completeness of data is an important component of conducting research. VA Healthcare System benefits from a highly developed electronic medical information system. The Immunology Case Registry was designed to monitor costs and quality of HIV care. The Decision Support System was developed to monitor utilization and costs of veterans in care. Because these systems extract data from the same source using independent methods, they provide an opportunity to compare the accuracy and completeness of each.
Objective
To compare overlapping laboratory data from the Veterans Affairs Health Information System between 2 data repositories.
Research Design
For hemoglobin, CD4+ lymphocyte counts (CD4), HIV RNA viral load, aspartate aminotransferase, alanine aminotransferase, glycosylated hemoglobin, creatinine, and white blood count, we calculated the percent of individuals with a value from each source. For results in both repositories, we calculated Pearson’s correlation coefficients.
Subjects
A total of 22,647 HIV + veterans in the Virtual Cohort with a visit in fiscal year 2002.
Results
For 6 out of 9 tests, 68% to 72% of the observations overlapped. For CD4, viral load, and glycosylated hemoglobin less than 31% of observations overlapped. Overlapping results were nearly perfectly correlated except for CD4.
Conclusions
Six of the laboratory tests demonstrated remarkably similar amounts of overlap, though Immunology Case Registry and Decision Support System both have missing data. Findings indicate that validation of laboratory data should be conducted before its use in quality and efficiency projects. When 2 databases are not available for comparison, other methods of validation should be implemented.
doi:10.1097/MLR.0b013e31817d69c2
PMCID: PMC3032537  PMID: 19106740
laboratory; DSS; ICR; VA
8.  Do Patterns of Comorbidity Vary by HIV Status, Age, and HIV Severity? 
Patterns of comorbidity among persons with human immunodeficiency virus (HIV) are not well described. We compared comorbidity among veterans with and without HIV infection. The sample consisted of 33,420 HIV-infected veterans and 66,840 HIV-uninfected veterans. We identified and clustered 11 comorbid conditions using validated International Classification of Diseases, 9th Revision, Clinical Modification codes. We defined multimorbidity as the presence of conditions in all clusters. Models restricted to HIV-infected veterans were adjusted for CD4 cell count and viral load. Comorbidity was common (prevalence, 60%–63%), and prevalence varied by HIV status. Differences remained when the veterans were stratified by age. In multivariable analyses, older HIV-infected veterans were more likely to have substance use disorder and multimorbidity. Renal, vascular, and pulmonary diseases were associated with CD4 cell count <200 cells/mm3; hypertension was associated with CD4 cell count >200 cells/mm3. Comorbidity is the rule, and multimorbidity is common among veterans with HIV infection. Patterns of comorbidity differ substantially by HIV status, age, and HIV severity. Primary care guidelines require adaptation for persons with HIV infection.
doi:10.1086/523577
PMCID: PMC3687553  PMID: 18190322
9.  Management of Human Immunodeficiency Virus Infection in Advanced Age 
Importance
Human immunodeficiency virus (HIV)-positive patients treated with antiretroviral therapy now have increased life expectancy and develop chronic illnesses that are often seen in older HIV-negative patients.
Objective
To address emerging issues related to aging with HIV. Screening older adults for HIV, diagnosis of concomitant diseases, management of multiple comorbid medical illnesses, social isolation, polypharmacy, and factors associated with end-of-life care are reviewed.
Evidence Acquisition
Published guidelines and consensus statements were reviewed. PubMed and PsycINFO were searched between January 2000 and February 2013. Articles not appearing in the search that were referenced by reviewed articles were also evaluated.
Findings
The population of older HIV-positive patients is rapidly expanding. It is estimated that by 2015 one-half of the individuals in the United States with HIV will be older than age 50. Older HIV-infected patients are prone to having similar chronic diseases as their HIV-negative counterparts, as well as illnesses associated with co-infections. Medical treatments associated with these conditions, when added to an antiretroviral regimen, increase risk for polypharmacy. Care of aging HIV-infected patients involves a need to balance a number of concurrent comorbid medical conditions.
Conclusions and Relevance
HIV is no longer a fatal disease. Management of multiple comorbid diseases is a common feature associated with longer life expectancy in HIV-positive patients. There is a need to better understand how to optimize the care of these patients.
doi:10.1001/jama.2013.2963
PMCID: PMC3684249  PMID: 23549585
10.  The Next Therapeutic Challenge in HIV: Polypharmacy 
Drugs & Aging  2013;30(8):613-628.
With the adoption of combination antiretroviral therapy (ART), most HIV-infected individuals in care are on five or more medications and at risk of harm from polypharmacy, a risk that likely increases with number of medications, age, and physiologic frailty. Established harms of polypharmacy include decreased medication adherence and increased serious adverse drug events, including organ system injury, hospitalization, geriatric syndromes (falls, fractures, and cognitive decline) and mortality. The literature on polypharmacy among those with HIV infection is limited, and the literature on polypharmacy among non-HIV patients requires adaptation to the special issues facing those on chronic ART. First, those aging with HIV infection often initiate ART in their 3rd or 4th decade of life and are expected to remain on ART for the rest of their lives. Second, those with HIV may be at higher risk for age-associated comorbid disease, further increasing their risk of polypharmacy. Third, those with HIV may have an enhanced susceptibility to harm from polypharmacy due to decreased organ system reserve, chronic inflammation, and ongoing immune dysfunction. Finally, because ART is life-extending, nonadherence to ART is particularly concerning. After reviewing the relevant literature, we propose an adapted framework with which to address polypharmacy among those on lifelong ART and suggest areas for future work.
doi:10.1007/s40266-013-0093-9
PMCID: PMC3715685  PMID: 23740523
11.  Patient-Reported Symptoms on the Antiretroviral Regimen Efavirenz/Emtricitabine/Tenofovir 
AIDS Patient Care and STDs  2012;26(6):312-319.
Abstract
Most patients (80–90%) newly diagnosed with HIV are started on the antiretroviral regimen efavirenz, emtricitabine, and tenofovir (EFV/FTC/TDF). Existing studies of patient tolerability, however, are limited. We compared symptom experiences of patients on EFV/FTC/TDF, and the subsequent impact on health-related quality of life, with those of patients on other combination antiretroviral therapy (cART). We conducted a cross-sectional analysis of the Veterans Aging Cohort Study from February 2008 to August 2009 to compare the symptom experiences of patients on EFV/FTC/TDF vs. other cART, unadjusted and then adjusted for treatment characteristics, and comorbid disease severity. We then assessed the association between EFV/FTC/TDF use and health-related quality of life. Among the 1,759 patients in our analytic sample, EFV/FTC/TDF use was associated with fewer symptoms than was other cART. The use of EFV/FTC/TDF was independently associated with health-related quality of life, and this association was at least partially explained by symptom burden.
doi:10.1089/apc.2012.0044
PMCID: PMC3412583  PMID: 22612469
12.  Rate and predictors of treatment prescription for hepatitis C 
Gut  2006;56(3):385-389.
Background
The true treatment rate for hepatitis C virus (HCV) in veterans is unknown.
Aim
To determine the treatment prescription rates and predictors of treatment prescription for HCV in a large national population.
Methods
The Department of Veterans Affairs National Patient Care Database (NPCD) was used to identify all HCV‐infected people between the fiscal years 1999 and 2003 using the International classification of diseases, 9th revision codes. Demographic information, medical and psychiatric comorbidities, and drug and alcohol use diagnoses were retrieved. Pharmacy data were retrieved from the Department of Veterans Affairs Pharmacy Benefits Management (PBM) database. Logistic regression analysis was used to determine the predictors of treatment for HCV in HCV.
Results
113 927 veterans in the Department of Veterans Affairs care with a diagnosis of HCV were identified. The treatment prescription rate for HCV was 11.8%. Patients not prescribed treatment were older, more likely to be from minority races, have more alcohol and drug misuse, and have medical and psychiatric comorbid conditions. In a multivariate logistic regression model, the following factors were predictive of non‐treatment for HCV: increasing age (odds ratio (OR) 0.77 for each 5‐year increase in age; 95% confidence interval (CI) 0.76 to 0.78); black race (OR 0.64; 95% CI 0.6 to 0.68); Hispanic race (OR 0.88; 95% CI 0.8 to 0.96); alcohol abuse and dependence (OR 0.62; 95% CI 0.59 to 0.65); drug abuse and dependence (OR 0.78; 95% CI 0.74 to 0.82); anaemia (OR 0.18; 95% CI 0.16 to 0.21); hepatitis B infection (OR 0.72; 95% CI 0.62 to 0.83); coronary artery disease (OR 0.9; 95% CI 0.85 to 0.97); stroke (OR 0.75; 95% CI 0.67 to 0.85); bipolar disorder (OR 0.64; 95% CI 0.58 to 0.70); major depression (OR 0.72; 95% CI 0.67 to 0.77); mild depression (OR 0.56; 95% CI 0.53 to 0.59); and schizophrenia (OR 0.71; 95% CI 0.65 to 0.77). The following factors were associated with a higher likelihood of treatment prescription for HCV: liver cirrhosis (OR 1.6; 95% CI 1.5 to 1.7); and diabetes (OR 1.07; 95% CI 1.02 to 1.12).
Conclusions
A small number of HCV‐infected veterans were prescribed treatment for HCV. Non‐treatment is associated with increasing age, non‐white race, drug and alcohol abuse, and dependence and comorbid illnesses. Reasons for non‐treatment need further study.
doi:10.1136/gut.2006.099150
PMCID: PMC1856823  PMID: 17005764
13.  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.
doi:10.1093/cid/cir1012
PMCID: PMC3297645  PMID: 22291097
14.  Does an Index Composed of Clinical Data Reflect Effects of Inflammation, Coagulation, and Monocyte Activation on Mortality Among Those Aging With HIV? 
The Veterans Aging Cohort Study (VACS) Index, based on age and 8 routine clinical tests, is strongly correlated with 3 biomarkers of inflammation: interleukin 6 (IL-6), D-dimer, and soluble CD14 (sCD14). After adjustment for the VACS Index, D-dimer and sCD14, but not IL-6, remain independently associated with mortality.
Background. When added to age, CD4 count and human immunodeficiency virus type 1 (HIV-1) RNA alone (Restricted Index), hemoglobin, FIB-4 Index, hepatitis C virus (HCV), and estimated glomerular filtration rate improve prediction of mortality. Weighted and combined, these 7 routine clinical variables constitute the Veterans Aging Cohort Study (VACS) Index. Because nonroutine biomarkers of inflammation (interleukin 6 [IL-6]), coagulation (D-dimer), and monocyte activation (sCD14) also predict mortality, we test the association of these indices and biomarkers with each other and with mortality.
Methods. Samples from 1302 HIV-infected veterans on antiretroviral therapy were analyzed. Indices were calculated closest to date of collection. We calculated Spearman correlations stratified by HIV-1 RNA and HCV status and measured association with mortality using C statistics and net reclassification improvement (NRI).
Results. Of 1302 subjects, 915 had HIV-1 RNA <500 copies/mL and 154 died. The VACS Index was more correlated with IL-6, D-dimer, and sCD14 than the Restricted Index (P < .001). It was also more predictive of mortality (C statistic, 0.76; 95% confidence interval [CI], .72–.80) than any biomarker (C statistic, 0.66–0.70) or the Restricted Index (C statistic, 0.71; 95% CI, .67–.75). Compared to the Restricted Index alone, NRI resulted from incremental addition of VACS Index components (10%), D-dimer (7%), and sCD14 (4%), but not from IL-6 (0%).
Conclusions. Among HIV-infected individuals, independent of CD4, HIV-1 RNA, and age, hemoglobin and markers of liver and renal injury are associated with inflammation. Addition of D-dimer and sCD14, but not IL-6, improves the predictive accuracy of the VACS Index for mortality.
doi:10.1093/cid/cir989
PMCID: PMC3297653  PMID: 22337823
15.  A Study of Financial Incentives to Reduce Plasma HIV RNA Among Patients in Care 
AIDS and Behavior  2013;17:2293-2300.
The role of financial incentives in HIV care is not well studied. We conducted a single-site study of monetary incentives for viral load suppression, using each patient as his own control. The incentive size ($100/quarter) was designed to be cost-neutral, offsetting estimated downstream costs averted through reduced HIV transmission. Feasibility outcomes were clinic workflow, patient acceptability, and patient comprehension. Although the study was not powered for effectiveness, we also analyzed viral load suppression. Of 80 eligible patients, 77 consented, and 69 had 12 month follow-up. Feasibility outcomes showed minimal impact on patient workflow, near-unanimous patient acceptability, and satisfactory patient comprehension. Among individuals with detectable viral loads pre-intervention, the proportion of undetectable viral load tests increased from 57 to 69 % before versus after the intervention. It is feasible to use financial incentives to reward ART adherence, and to specify the incentive by requiring cost-neutrality and targeting biological outcomes.
doi:10.1007/s10461-013-0416-1
PMCID: PMC3742414  PMID: 23404097
Financial incentives; Adherence; Antiretroviral therapy; HIV/AIDS
16.  Hepatic safety and antiretroviral effectiveness in HIV-infected patients receiving naltrexone 
Background
We sought to determine the impact of naltrexone on hepatic enzymes and HIV biomarkers in HIV-infected patients.
Methods
We used data from the Veterans Aging Cohort Study-Virtual Cohort, an electronic database of administrative, pharmacy and laboratory data. We restricted our sample to HIV-infected patients who received an initial oral naltrexone prescription, of at least seven days duration. We examined aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and HIV biomarker (CD4 and HIV RNA) values for the 365 days prior to, during, and for the 365 days post-naltrexone prescription. We also examined cases of liver enzyme elevation (LEE; defined as greater than 5 times baseline ALT or AST or greater than 3.5 times baseline if baseline ALT or AST was greater than or equal to 40 IU/L).
Results
Of 114 HIV-infected individuals, 97% were male, 65% white, 57% Hepatitis C co-infected, median age was 49 years; 89% of the sample had a history of alcohol dependence and 32% had opioid dependence. Median duration of naltrexone prescription was 49 (interquartile range 30–83) days, representing 9,525 person-days of naltrexone use. Mean ALT and AST levels remained below the upper limit of normal. Two cases of LEE occurred. Mean CD4 count remained stable and mean HIV RNA decreased after naltrexone prescription.
Conclusions
In HIV-infected patients, oral naltrexone is rarely associated with clinically significant ALT or AST changes and does not have a negative impact on biologic parameters. Therefore, HIV-infected patients with alcohol or opioid dependence can be treated with naltrexone.
doi:10.1111/j.1530-0277.2011.01601.x
PMCID: PMC3221963  PMID: 21797892
17.  Validating Smoking Data From the Veteran’s Affairs Health Factors Dataset, an Electronic Data Source 
Nicotine & Tobacco Research  2011;13(12):1233-1239.
Introduction:
We assessed smoking data from the Veterans Health Administration (VHA) electronic medical record (EMR) Health Factors dataset.
Methods:
To assess the validity of the EMR Health Factors smoking data, we first created an algorithm to convert text entries into a 3-category smoking variable (never, former, and current). We compared this EMR smoking variable to 2 different sources of patient self-reported smoking survey data: (a) 6,816 HIV-infected and -uninfected participants in the 8-site Veterans Aging Cohort Study (VACS-8) and (b) a subset of 13,689 participants from the national VACS Virtual Cohort (VACS-VC), who also completed the 1999 Large Health Study (LHS) survey. Sensitivity, specificity, and kappa statistics were used to evaluate agreement of EMR Health Factors smoking data with self-report smoking data.
Results:
For the EMR Health Factors and VACS-8 comparison of current, former, and never smoking categories, the kappa statistic was .66. For EMR Health Factors and VACS-VC/LHS comparison of smoking, the kappa statistic was .61.
Conclusions:
Based on kappa statistics, agreement between the EMR Health Factors and survey sources is substantial. Identification of current smokers nationally within the VHA can be used in future studies to track smoking status over time, to evaluate smoking interventions, and to adjust for smoking status in research. Our methodology may provide insights for other organizations seeking to use EMR data for accurate determination of smoking status.
doi:10.1093/ntr/ntr206
PMCID: PMC3223583  PMID: 21911825
18.  FIB-4 index is associated with hepatocellular carcinoma risk in HIV-infected patients 
Background
Chronic inflammation caused by hepatitis B virus infection, hepatitis C virus infection, and/or heavy alcohol use can lead to fibrosis, cirrhosis, and eventually hepatocellular carcinoma (HCC). FIB-4 is an index score calculated from platelet count, alanine transaminase, aspartate transaminase, and age that predicts fibrosis and cirrhosis. We hypothesized that high FIB-4 would be associated with development of HCC in HIV-infected persons, who are at high risk due to high prevalence of viral hepatitis and alcohol consumption, and possibly due to HIV infection itself.
Methods
Using proportional hazards models, we tested this hypothesis among 22,980 HIV-infected men from the Veterans Aging Cohort Study. We identified incident HCC cases from the VA Central Cancer Registry.
Results
During follow-up, there were 112 incident HCC diagnoses. The age-and race/ethnic group-adjusted HR was 4.2 (95% CI: 2.4, 7.4)for intermediate FIB-4 and 13.0 (95% CI: 7.2, 23.4) for high FIB-4, compared to low FIB-4. After further adjustment for enrollment year, CD4 count, HIV-1 RNA level, antiretroviral therapy use, hepatitis B and C virus infection, alcohol abuse/dependency, and diabetes, FIB-4 remained a strong, significant, independent risk factor for HCC. The multivariate-adjusted HR was 3.6 (95% CI: 2.1, 6.4) for intermediate FIB-4 and 9.6 (95% CI: 5.2, 17.4) for high FIB-4.
Conclusions
Calculated from routine, non-invasive laboratory tests, FIB-4 is a strong, independent HCC risk factor in HIV-infected patients.
Impact
FIB-4 might prove valuable as an easily measured index to identify those at highest risk for HCC, even prior to development of clinical cirrhosis.
doi:10.1158/1055-9965.EPI-11-0582
PMCID: PMC3237927  PMID: 22028407
hepatocellular carcinoma; FIB-4; HIV; liver neoplasms; hepatic fibrosis
19.  Adherence, virological and immunological outcomes for HIV-infected veterans starting combination antiretroviral therapies 
AIDS (London, England)  2007;21(12):1579-1589.
Objectives
We aimed to determine adherence, virological, and immunological outcomes one year after starting a first combination antiretroviral therapy (ART) regimen.
Design
Observational; synthesis of administrative, laboratory, and pharmacy data. Antiretroviral regimens were divided into efavirenz, nevirapine, boosted protease inhibitor (PI), and single PI categories. Propensity scores were used to control for confounding by treatment assignment. Adherence was estimated from pharmacy refill records.
Setting
Veterans Affairs Healthcare System, all sites.
Participants
HIV-infected individuals starting combination ART with a low likelihood of previous antiretroviral exposure.
Interventions
None.
Outcomes
The proportion of antiretroviral prescriptions filled as prescribed, a change in log HIV-RNA, the proportion with log HIV-RNA viral suppression, a change in CD4 cell count.
Results
A total of 6394 individuals unlikely to have previous antiretroviral exposure started combination ART between 1996 and 2004, and were eligible for analysis. Adherence overall was low (63% of prescriptions filled as prescribed), and adherence with efavirenz (67%) and nevirapine (65%) regimens was significantly greater than adherence with boosted PI (59%) or single PI (61%) regimens (P < 0.001). Efavirenz regimens were more likely to suppress HIV-RNA at one year (74%) compared with nevirapine (62%), boosted PI (63%), or single PI (53%) regimens (all P < 0.001), and this superiority was maintained when analyses were adjusted for baseline clinical characteristics and propensity for treatment assignment. Efavirenz also yielded more favorable immunological outcomes.
Conclusion
HIV-infected individuals initiating their first combination ART using an efavirenz-based regimen had improved virological and immunological outcomes and greater adherence levels.
doi:10.1097/QAD.0b013e3281532b31
PMCID: PMC3460378  PMID: 17630553
Adherence; resistance; ART; Veterans Affairs Healthcare System
20.  Measuring Performance Directly Using the Veterans Health Administration Electronic Medical Record 
Medical care  2007;45(1):73-79.
Background
Electronic medical records systems (EMR) contain many directly analyzable data fields that may reduce the need for extensive chart review, thus allowing for performance measures to be assessed on a larger proportion of patients in care.
Objective
This study sought to determine the extent to which selected chart review-based clinical performance measures could be accurately replicated using readily available and directly analyzable EMR data.
Methods
A cross-sectional study using full chart review results from the Veterans Health Administration's External Peer Review Program (EPRP) was merged to EMR data.
Results
Over 80% of the data on these selected measures found in chart review was available in a directly analyzable form in the EMR. The extent of missing EMR data varied by site of care (P < 0.01). Among patients on whom both sources of data were available, we found a high degree of correlation between the 2 sources in the measures assessed (correlations of 0.89–0.98) and in the concordance between the measures using performance cut points (kappa: 0.86–0.99). Furthermore, there was little evidence of bias; the differences in values were not clinically meaningful (difference of 0.9 mg/dL for low-density lipoprotein cholesterol, 1.2 mm Hg for systolic blood pressure, 0.3 mm Hg for diastolic, and no difference for HgbA1c).
Conclusions
Directly analyzable data fields in the EMR can accurately reproduce selected EPRP measures on most patients. We found no evidence of systematic differences in performance values among these with and without directly analyzable data in the EMR.
doi:10.1097/01.mlr.0000244510.09001.e5
PMCID: PMC3460379  PMID: 17279023
veterans; quality of care; medical records systems; quality measurement
21.  Incorporating Quality of Evidence into Decision Analytic Modeling 
Annals of internal medicine  2007;146(2):133-141.
Our objective was to illustrate the effects of using stricter standards for the quality of evidence used in decision analytic modeling. We created a simple 10-parameter probabilistic Markov model to estimate the cost-effectiveness of directly observed therapy (DOT) for individuals with newly diagnosed HIV infection. We evaluated quality of evidence on the basis of U.S. Preventive Services Task Force methods, which specified 3 separate domains: study design, internal validity, and external validity. We varied the evidence criteria for each of these domains individually and collectively. We used published research as a source of data only if the quality of the research met specified criteria; otherwise, we specified the parameter by randomly choosing a number from a range within which every number has the same probability of being selected (a uniform distribution). When we did not eliminate poor-quality evidence, DOT improved health 99% of the time and cost less than $100 000 per additional quality-adjusted life-year (QALY) 85% of the time. The confidence ellipse was extremely narrow, suggesting high precision. When we used the most rigorous standards of evidence, we could use fewer than one fifth of the data sources, and DOT improved health only 49% of the time and cost less than $100 000 per additional QALY only 4% of the time. The confidence ellipse became much larger, showing that the results were less precise. We conclude that the results of decision modeling may vary dramatically depending on the stringency of the criteria for selecting evidence to use in the model.
PMCID: PMC3460380  PMID: 17227937
22.  Delayed Presentation for Human Immunodeficiency Virus (HIV) Care Among Veterans 
Medical care  2007;45(11):1105-1109.
Background
Despite the effectiveness of antiretroviral therapy, nearly half of patients entering human immunodeficiency virus (HIV) care have advanced disease. Many attribute this delay to poor access to healthcare. Others argue that delays will persist until routine screening is adopted. The Veterans Health Administration (VA) is a unique laboratory to examine whether access to comprehensive health benefits results in earlier entry into HIV care.
Methods
Retrospective observational study of 4368 HIV-positive patients entering HIV care during 1998–2002 at VA medical centers nationwide. Outcomes of interest: rates of acquired immune deficiency syndrome in year of presentation; duration of VA utilization before HIV presentation; presence of “clinical triggers,” signaling greater risk of HIV infection, before presentation.
Results
Fifty-one percent (n = 2211) of all patients presented with CD4 counts of <200 cells/mm3. Thirty-nine percent (n = 1697) of all patients used other VA services before presentation for HIV care, with median duration of 3.6 years (interquartile range 25–75: 2.2–5.1 year) and 6 physician visits [interquartile range (IQR), 25–75: 2–18 visits] between first utilization and HIV presentation. No difference existed in the percentage presenting with CD4 counts <200 cells/mm3 among those with and without prior VA healthcare (50% vs. 51%, P = 0.76). Only 13% of those with prior VA healthcare demonstrated a clinical trigger before HIV presentation.
Conclusions
More than half of veterans entered HIV care with an acquired immune deficiency syndrome diagnosis at presentation irrespective of whether they had previously established healthcare in the VA. Access to care does not seem to be the primary cause of delayed HIV presentation. Widespread HIV screening is needed to improve rates of early detection.
doi:10.1097/MLR.0b013e3181271476
PMCID: PMC3460382  PMID: 18049352
HIV; AIDS; diagnosis; screening; access to care
23.  A Framework for Tailoring Clinical Guidelines to Comorbidity at the Point of Care 
Archives of internal medicine  2007;167(21):2361-2365.
Background
Evidence is accumulating to suggest that clinical guidelines should be modified for patients with comorbidities, yet there is no quantitative and objective approach that considers benefits together with risks.
Methods
We outline a framework using a payoff time, which we define as the minimum elapsed time until the cumulative incremental benefits of a guideline exceed its cumulative incremental harms. If the payoff time of a guideline exceeds a patient’s comorbidity-adjusted life expectancy, then the guideline is unlikely to offer a benefit and should be modified. We illustrate the frame-work by applying this method to colorectal cancer screening guidelines for 50-year-old men with human immunodeficiency virus (HIV) and 60-year-old women with congestive heart failure (CHF).
Results
We estimated that colorectal cancer screening payoff times for 50-year-old men with HIV would range from 1.9 to 5.0 years and that colorectal cancer screening payoff times for 60-year-old women with CHF would range from 0.7 to 2.9 years. Because the payoff times for 50-year-oldmen with HIV were lower than their life expectancies (12.5–24.0 years), colorectal cancer screening may be beneficial for these patients. In contrast, because payoff times for 60-year-old women with CHF were sometimes greater than their life expectancies (0.6 to > 5 years), colorectal cancer screening is likely to be harmful for some of these patients.
Conclusion
Use of a payoff time calculation may be a feasible framework to tailor clinical guidelines to the comorbidity profiles of individual patients.
doi:10.1001/archinte.167.21.2361
PMCID: PMC3460384  PMID: 18039996
24.  Alcohol Consumption and Depressive Symptoms Over Time: A Longitudinal Study of Patients With and Without HIV Infection 
Drug and alcohol dependence  2011;117(2-3):158-163.
Background
The impact of alcohol consumption on depressive symptoms over time among patients who do not meet criteria for alcohol abuse or dependence is not known.
Objective
To evaluate the impact of varying levels of alcohol consumption on depressive symptoms over time in patients with and without HIV infection.
Design
We used data from the Veterans Aging Cohort Study (VACS). We used generalized estimating equations models to assess the association of alcohol-related categories, as a fixed effect, on the time-varying outcome of depressive symptoms.
Participants
VACS is a prospectively enrolled cohort study of HIV-infected patients and age-, race- and site-matched HIV uninfected patients.
Main Measures
Hazardous, binge drinking, alcohol abuse and alcohol dependence were defined using standard criteria. Depressive symptoms were measured by the Patient Health Questionnaire (PHQ-9).
Key Results
Among the 2446 patients, 19% reported past but not current alcohol use, 50% non-hazardous drinking, 8% hazardous drinking, 14% binge drinking, and 10% met criteria for alcohol or dependence. At baseline, depressive symptoms were higher in hazardous and binge drinkers than in past and non-hazardous drinkers (OR=2.65; CI=1.50/4.69; p<.001) and similar to those with abuse or dependence. There was no difference in the association between alcohol-related category and depressive symptoms by HIV status (OR=0.99; CI=.83/1.18; p=.88). Hazardous drinkers were 2.53 (95% CI = 1.34/4.81) times and binge drinkers were 2.14 (95% CI = 1.49/3.07) times more likely to meet criteria for depression when compared to non-hazardous drinkers. The associations between alcohol consumption and depressive symptoms persisted over three years and were responsive to changes in alcohol-related categories.
Conclusions
HIV-infected and HIV-uninfected hazardous and binge drinkers have depressive symptoms that are more severe than non-hazardous and non-drinkers and similar to those with alcohol abuse or dependence. Patients who switch to a higher or lower level of drinking experience a similar alteration in their depressive symptoms. Interventions to decrease unhealthy alcohol consumption may improve depressive symptoms.
doi:10.1016/j.drugalcdep.2011.01.014
PMCID: PMC3113463  PMID: 21345624
Alcohol drinking; Alcoholism; Depression; Depressive disorder; HIV; Acquired Immunodeficiency Syndrome
25.  A Comparison of Treatment Eligibility for Hepatitis C Virus in HCV-Monoinfected Versus HCV/HIV-Coinfected Persons in Electronically Retrieved Cohort of HCV-Infected Veterans 
Abstract
Treatment rates for hepatitis C virus (HCV) are low in actual clinical settings. However, the proportion of patients eligible for treatment, especially among those coinfected with HIV, is not well known. Our aim was to determine and compare the rates for HCV treatment eligibility among HCV and HCV-HIV-coinfected persons. We assembled a national cohort of HCV-infected veterans in care from 1998–2003, using the VA National Patient Care Database for demographic/clinical information, the Pharmacy Benefits Management database for pharmacy records, and the Decision Support Systems database for laboratory data. We compared the HCV-monoinfected and HCV-HIV-coinfected subjects for treatment indications and eligibility using current treatment guidelines. Of the 27,452 subjects with HCV and 1225 with HCV-HIV coinfection, 74.0% and 84.6% had indications for therapy and among these, 43.9% of HCV-monoinfected and 28.4% of HCV-HIV-coinfected subjects were eligible for treatment. Anemia, decompensated liver disease (DLD), chronic obstructive pulmonary disease (COPD), recent alcohol abuse, and coronary artery disease were the most common contraindications in the HCV, and anemia, DLD, renal failure, recent drug abuse, and COPD in the HCV-HIV-coinfected group. Among those eligible for treatment, only 23% of the HCV-monoinfected and 15% of the HCV-HIV-coinfected subjects received any treatment for HCV. Most veterans with HCV are not eligible for treatment according to the current guidelines. Even for those who are eligible for treatment, only a minority is prescribed treatment. Several contraindications are modifiable and aggressive management of those may improve treatment prescription rates.
doi:10.1089/aid.2011.0004
PMCID: PMC3719436  PMID: 21338329

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