Emerging from the shadows: Trends in HIV ambulatory care, viral load testing, and viral suppression in a U.S. HIV cohort, 2019-2022: Impact of COVID-19 pandemic.

This article aimed at analyzing the acute impact and the longer-term recovery of COVID-19 pandemic effects on clinical encounter types, HIV viral load (VL) testing, and suppression (HIV VL < 200 copies/mL). This study was a longitudinal cohort study of participants seen during 2019-2022 at nine HIV Outpatient Study (HOPS) sites. Generalized linear mixed models (GLMMs) estimated monthly rates of all encounters, office and telemedicine visits, and HIV VL tests using 2010-2022 data. We examined factors associated with nonsuppressed VL (VL ≥ 200 copies/mL) and not having ambulatory care visits during the pandemic using GLMM for logistic regression with 2017-2022 and 2019-2022 data, respectively. Of 2351 active participants, 76.0% were male, 57.6% aged ≥ 50 years, 40.7% non-Hispanic White, 38.2% non-Hispanic Black, 17.3% Hispanic/Latino, and 51.0% publicly insured. The monthly rates of in-person and telemedicine visits varied during 2020 through mid-year 2022. Multivariable logistic regression showed that persons with no encounters were more likely to be male or have VL ≥ 200 copies/mL. For participants with ≥1 VL test, the prevalence rate of HIV VL ≥ 200 copies/mL during 2020 was close to the rates from 2014 to 2019. The change in probability of viral suppression was not associated with participant's age, sex, race/ethnicity, or insurance type. In the HOPS, overall patient encounters declined over 2 years during the pandemic with variations in telemedicine and in-person events, with relative maintenance of viral suppression. Ongoing recovery from the impact of COVID-19 on ambulatory care will require continued efforts to improve retention and patient access to medical services.

Incidence of Hyperlipidemia among Adults Initiating Antiretroviral Therapy in the HIV Outpatient Study (HOPS), USA, 2007-2021.

Current U.S. guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) as initial treatment for people with HIV (PWH). We assessed long-term effects of INSTI use on lipid profiles in routine HIV care. We analyzed medical record data from the HIV Outpatient Study's participants in care from 2007 to 2021. Hyperlipidemia was defined based on clinical diagnoses, treatments, and laboratory results. We calculated hyperlipidemia incidence rates and rate ratios (RRs) during initial ART and assessed predictors of incident hyperlipidemia by using Poisson regression. Among 349 eligible ART-naïve PWH, 168 were prescribed INSTI-based ART (36 raltegravir (RAL), 51 dolutegravir (DTG), and 81 INSTI-others (elvitegravir and bictegravir)) and 181 non-INSTI-based ART, including 68 protease inhibitor (PI)-based ART. During a median follow-up of 1.4 years, hyperlipidemia rates were 12.8, 22.3, 22.7, 17.4, and 12.6 per 100 person years for RAL-, DTG-, INSTI-others-, non-INSTI-PI-, and non-INSTI-non-PI-based ART, respectively. In multivariable analysis, compared with the RAL group, hyperlipidemia rates were higher in INSTI-others (RR = 2.25; 95% confidence interval (CI): 1.29-3.93) and non-INSTI-PI groups (RR = 1.89; CI: 1.12-3.19) but not statistically higher for the DTG (RR = 1.73; CI: 0.95-3.17) and non-INSTI-non-PI groups (RR = 1.55; CI: 0.92-2.62). Other factors independently associated with hyperlipidemia included older age, non-Hispanic White race/ethnicity, and ART without tenofovir disoproxil fumarate. PWH using RAL-based regimens had lower rates of incident hyperlipidemia than PWH receiving non-INSTI-PI-based ART but had similar rates as those receiving DTG-based ART, supporting federal recommendations for using DTG-based regimens as the initial therapy for ART-naïve PWH.

Weight Gain and Metabolic Effects in Persons With HIV Who Switch to ART Regimens Containing Integrase Inhibitors or Tenofovir Alafenamide.

BACKGROUND: The timing and magnitude of antiretroviral therapy-associated weight change attributions are unclear. SETTING: HIV Outpatient Study participants. METHODS: We analyzed 2007-2018 records of virally suppressed (VS) persons without integrase inhibitor (INSTI) experience who switched to either INSTI-based or another non-INSTI-based ART, and remained VS. We analyzed BMI changes using linear mixed models, INSTI- and tenofovir alafenamide (TAF) contributions to BMI change by linear mixed models-estimated slopes, and BMI inflection points. RESULTS: Among 736 participants (5316 person-years), 441 (60%) switched to INSTI-based ART; the remainder to non-INSTI-based ART. The mean follow-up was 7.15 years for INSTI recipients and 7.35 years for non-INSTI. Preswitch, INSTI and non-INSTI groups had similar median BMI (26.3 versus 25.9 kg/m 2 , P = 0.41). INSTI regimens included raltegravir (178), elvitegravir (112), and dolutegravir (143). Monthly BMI increases postswitch were greater with INSTI than non-INSTI (0.0525 versus 0.006, P < 0.001). A BMI inflection point occurred 8 months after switch among INSTI users; slopes were similar regardless of TAF use immediately postswitch. Among INSTI + TAF users, during 8 months postswitch, 87% of BMI slope change was associated with INSTI use, 13% with TAF use; after 8 months, estimated contributions were 27% and 73%, respectively. For non-INSTI+TAF, 84% of BMI gain was TAF-associated consistently postswitch. Persons switching from TDF to TAF had greater BMI increases than others ( P < 0.001). CONCLUSION: Among VS persons who switched ART, INSTI and TAF use were independently associated with BMI increases. During 8 months postswitch, BMI changes were greatest and most associated with INSTI use; afterward, gradual BMI gain was largely TAF-associated.

Disparities in Treatment with Direct-Acting Hepatitis C Virus Antivirals Persist Among Adults Coinfected with HIV and Hepatitis C Virus in US Clinics, 2010-2018.

Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection carries substantial risk for all-cause mortality and liver-related morbidity and mortality, yet many persons coinfected with HIV/HCV remain untreated for HCV. We explored demographic, clinical, and sociodemographic factors among participants in routine HIV care associated with prescription of direct-acting antivirals (DAAs). The HIV Outpatient Study (HOPS) is an ongoing longitudinal cohort study of persons with HIV in care at participating clinics since 1993. There are currently eight study sites in six US cities. We analyzed medical records data of HOPS participants diagnosed with HCV since June 2010. Sustained virological response (SVR) was documented with first undetectable HCV viral load (VL). We assessed factors associated with being prescribed DAAs by multi-variable logistic regression and described the cumulative rate of SVR. Among 306 eligible participants, 131 (43%) were prescribed DAA therapy. Factors associated with greater odds of being prescribed DAA were older age, private health insurance, higher CD4 cell count, being a person who injects drugs, and receiving care at publicly funded sites (p < 0.05). Of 127 (97%) participants with at least 1 follow-up HCV VL, 110 (87%) achieved SVR at 12 weeks. Of the total 131 participants, 123 (94%) eventually achieved SVR. Less than half of HIV/HCV coinfected patients in HOPS have been prescribed DAAs. Interventions are needed to address deficits in DAA prescription, including among patients with public or no health insurance, younger age, and lower CD4 cell count.

The impact of race and ethnicity on outcomes in 19,584 adults hospitalized with COVID-19.

INTRODUCTION: At the population level, Black and Hispanic adults in the United States have increased risk of dying from COVID-19, yet whether race and ethnicity impact on risk of mortality among those hospitalized for COVID-19 is unclear. METHODS: Retrospective cohort study using data on adults hospitalized with COVID-19 from the electronic health record from 52 health systems across the United States contributing data to Cerner Real World DataTM. In-hospital mortality was evaluated by race first in unadjusted analysis then sequentially adjusting for demographics and clinical characteristics using logistic regression. RESULTS: Through August 2020, 19,584 patients with median age 52 years were hospitalized with COVID-19, including n = 4,215 (21.5%) Black and n = 5,761 (29.4%) Hispanic patients. Relative to white patients, crude mortality was slightly higher in Black adults [22.7% vs 20.8%, unadjusted OR 1.12 (95% CI 1.02-1.22)]. Mortality remained higher among Black adults after adjusting for demographic factors including age, sex, date, region, and insurance status (OR 1.13, 95% CI 1.01-1.27), but not after including comorbidities and body mass index (OR 1.07, 95% CI 0.93-1.23). Compared with non-Hispanic patients, Hispanic patients had lower mortality both in unadjusted and adjusted models [mortality 12.7 vs 25.0%, unadjusted OR 0.44(95% CI 0.40-0.48), fully adjusted OR 0.71 (95% CI 0.59-0.86)]. DISCUSSION: In this large, multicenter, EHR-based analysis, Black adults hospitalized with COVID-19 had higher observed mortality than white patients due to a higher burden of comorbidities in Black adults. In contrast, Hispanic ethnicity was associated with lower mortality, even in fully adjusted models.

Despite early Medicaid expansion, decreased durable virologic suppression among publicly insured people with HIV in Washington, DC: a retrospective analysis.

BACKGROUND: Despite widely available access to HIV care in Washington, DC, inequities in HIV outcomes persist. We hypothesized that laboratory monitoring and virologic outcomes would not differ significantly based on insurance type. METHODS: We compared HIV monitoring with outcomes among people with HIV (PWH) with private (commercial payer) versus public (Medicare, Medicaid) insurance receiving care at community and hospital clinics. The DC Cohort follows over 8000 PWH from 14 clinics. We included those ≥18 years old enrolled between 2011 and 2015 with stable insurance. Outcomes included frequency of CD4 count and HIV RNA monitoring (> 2 lab measures/year, > 30 days apart) and durable viral suppression (VS; HIV RNA < 50 copies/mL at last visit and receiving antiretroviral therapy (ART) for ≥12 months). Multivariable logistic regression models examined impact of demographic and clinical factors. RESULTS: Among 3908 PWH, 67.9% were publicly-insured and 58.9% attended community clinics. Compared with privately insured participants, a higher proportion of publicly insured participants had the following characteristics: female sex, Black race, heterosexual, unemployed, and attending community clinics. Despite less lab monitoring, privately-insured PWH had greater durable VS than publicly-insured PWH (ART-naïve: private 70.0% vs public 53.1%, p = 0.03; ART-experienced: private 80.2% vs public 69.4%, p < 0.0001). Privately-insured PWH had greater durable VS than publicly-insured PWH at hospital clinics (AOR = 1.59, 95% CI: 1.20, 2.12; p = 0.001). CONCLUSIONS: Paradoxical differences between HIV monitoring and durable VS exist among publicly and privately-insured PWH in Washington, DC. Programs serving PWH must improve efforts to address barriers creating inequity in HIV outcomes.

Utilization of Direct Oral Anticoagulants in People Living with Human Immunodeficiency Virus: Observational Data from the District of Columbia Cohort.

BACKGROUND: Direct oral anticoagulants (DOACs) have become first-line treatment for venous thrombotic events. DOAC prescribing trends among people living with human immunodeficiency virus (PWH) are not well described. The coadministration of DOACs with the antiretroviral (ARV) pharmacokinetic boosters ritonavir (RTV) or cobicistat (COBI) may be complicated by pharmacokinetic interactions. METHODS: A longitudinal cohort study was conducted using the D.C. Cohort Database in Washington, D.C., from January 2011 to March 2017, to describe oral anticoagulant prescribing among PWH ≥ 18 years old and the prevalence of DOAC use with RTV or COBI. Data collection included demographic and clinical characteristics, ARV and anticoagulant prescriptions, and International Classification of Diseases Ninth and Tenth Edition diagnosis codes. RESULTS: Among 8315 PWH, there were 236 anticoagulant prescriptions (96 DOAC, 140 warfarin) for 206 persons. PWH prescribed anticoagulants were predominantly Black (82%) and male (82%), with a mean age at anticoagulant initiation of 56 years. DOAC use increased from 3% of total anticoagulant prescribing in 2011 to 43% in 2016, accounting for 64% of all newly recorded anticoagulant prescriptions by 2016. There were 19 bleeding events recorded among 16 individuals. Despite the Food and Drug Administration label recommendation to avoid rivaroxaban with boosted ARVs, 41% remained on boosted ARVs after rivaroxaban initiation. CONCLUSIONS: DOAC use increased substantially in PWH by 2016. Although rivaroxaban is not recommended with RTV or COBI, concomitant use was recorded in 41% of rivaroxaban recipients in this cohort. As DOAC usage increases, clinicians need to be aware of potential DOAC/ARV interactions in order to select the most appropriate oral anticoagulant and monitoring plan for PWH.

Incidence and Risk Factors for Renal Disease in an Outpatient Cohort of HIV-Infected Patients on Antiretroviral Therapy.

INTRODUCTION: Prior studies found renal disease was common among HIV-infected outpatients. We updated incident renal disease estimates in this population, comparing those with and without tenofovir exposure. METHODS: We conducted a retrospective analysis of the DC Cohort, a longitudinal study of HIV patients in Washington, DC, from 2011 to 2015. We included adults prescribed antiretroviral therapy (ART) with baseline glomerular filtration rate (GFR) ≥15 ml/min per 1.73 m2. We defined renal disease as 50% decrease in GFR or doubled serum creatinine (Cr) within 3 months. We defined cumulative viral load as area under the curve (AUC) of log10 transformed longitudinal HIV RNA viral load (VL). Correlates of time to incident renal disease were identified using Cox proportional hazard regression models, adjusted for demographics and known risk factors for kidney disease. RESULTS: Among 6068 adults, 77% were Black and median age was 48 years. Incident renal disease rate was 0.77 per 100 person-years (95% confidence interval [CI]: 0.65-0.9). Factors associated with renal disease were age (adjusted hazard ratio [aHR]: 1.4; CI 1.1-1.7 per 10 years), public non-Medicaid, non-Medicare insurance (aHR: 3.4; CI: 1.9-6.4), AUC VL (aHR: 1.1; CI: 1.1-1.2), diabetes mellitus (aHR: 1.6; CI: 1.0-2.4), and mildly reduced GFR (60-89 ml/min per 1.73 m2) (aHR: 1.5; CI: 1.0-2.3); recent tenofovir exposure was not associated with renal disease (aHR: 0.7; CI: 0.5-1.1). CONCLUSION: Our study revealed a substantial burden of renal disease among HIV patients. Cumulative VL was associated with renal disease, suggesting that early VL suppression may decrease its incidence.

Candidemia and invasive candidiasis among hospitalized neonates and pediatric patients.

OBJECTIVE: To investigate the epidemiology, treatment, length of stay (LOS) and costs for neonatal and pediatric inpatients with invasive candidiasis (IC). METHODS: The Cerner Health Facts Database was used to assess inpatients (2005-2014) identified by positive blood or cerebrospinal fluid (CSF) Candida cultures. Log-transformed LOS and cost were examined in candidemia-only patients (n = 191) using multivariable linear regression. RESULTS: A total of 202 patients had a positive culture (blood: n = 192; CSF: n = 10; both: n = 2). The most prevalent species were C. parapsilosis (n = 70, 34.7%), and C. albicans (n = 66, 32.7%). Mean (SD) age was 5 (5.5) years; 30 (14.9%) patients were <4 months. Comorbidities included sepsis (n = 85, 42.1%), coagulation disorders (n = 57, 28.2%), cancer (n = 64, 31.7%), and low birthweight (n = 26, 12.9%). Antifungals (AFs) included azoles (57.4%), polyenes (28.7%), and echinocandins (35.1%); 20.8% of patients received no AF during their encounter. The mean (SD) cost per encounter was $97,392 ($149,253), with a mean (SD) LOS of 45.6 (59.5) days and 9.9% mortality at discharge. Results were similar across Candida species. In regression analysis, intensive care unit (ICU) exposure, central catheter, sepsis, AF >48 hours prior to index culture, and age <4 months were associated with increased LOS; treatment at a non-teaching hospital was associated with reduced LOS (p < .05). AF use >48 hours before index, in-hospital mortality, Midwest region and ventricular shunt were associated with increased cost (p ≤ .05). CONCLUSIONS: This analysis confirms the association between pediatric candidemia and increased resource utilization and LOS. Given high observed rates of potential under-treatment, an opportunity may exist to improve AF therapy in this population.

Impact of Employer-Sponsored Onsite Pharmacy and Condition Management Programs on Medication Adherence.

BACKGROUND: Poor medication adherence is associated with worsened health outcomes and higher health care expenditures. An increasing number of employers are sponsoring wellness initiatives designed to support healthy lifestyles, improve productivity, and offer a return on investment. Onsite pharmacies may facilitate higher medication adherence rates by providing employees a convenient, low-cost option for filling prescriptions that is integrated with other onsite health services. OBJECTIVES: To (a) assess the impact of an employer's onsite pharmacy on health plan members' medication adherence using multiple measures of medication adherence and persistence, including medication possession ratio (MPR), average number of days until discontinuation (60-day gap in coverage), and percentage of members without a 30-day gap in coverage, and (b) evaluate these outcomes between those members who participated in condition management programs and those who did not. METHODS: A retrospective analysis of a self-insured employer's claims data was undertaken. Medication adherence was assessed among the self-insured employer's health plan members, which included subscribers and their dependents who filled an asthma, depression, diabetes, hypertension, or hyperlipidemia medication at an onsite pharmacy, compared with those who used a community pharmacy. Multiple standard measures of medication adherence were considered. These measures included MPR, which was assessed for 1- and 2-year time periods. MPR was chosen because it is one of the most commonly referenced formulas in the literature and represents adherence over a fixed period of time. In addition, medication persistence was estimated by 30-day gaps in coverage and discontinuation of treatment. To assess the impact of onsite pharmacy use and account for covariate effects, the linear mixed model approach was applied with the logit transformed MPR as the response variable. An analysis of MPR among condition management participants was also performed. RESULTS: In total, 2,498 subscribers and their dependents were included in the analysis. The average MPR at 365 days was significantly higher (P < 0.0001) among onsite pharmacy users for all medication types, ranging from 13% higher for depression medications to 20% higher for hypertension medications. This trend persisted at 730 days (P < 0.001), with average MPRs ranging from 6% higher for hyperlipidemia medications to 11% higher for hypertension medications. A mixed model analysis indicated that members who used the onsite pharmacy were 3.44 times more likely to demonstrate medication adherence (95% CI = 2.84-4.16; P < 0.0001) at 365 days. Likewise, at 180 and 365 days, onsite pharmacy users were less likely to have 30-day gaps in treatment. The average number of days until discontinuation (defined as a 60-day gap) was also significantly longer (P < 0.0001) among onsite pharmacy users, ranging from an average of 56 additional days for depression medications to 105 additional days for hypertension medications. While the average MPR tended to be higher among those subscribers and their dependents who participated in condition management programs, this trend was not statistically significant for all medication types. CONCLUSIONS: Based on multiple measures, onsite pharmacy use was associated with higher medication adherence, while the results were inconclusive for condition management participation.

Impact of chiropractic services at an on-site health center.

OBJECTIVE: To compare the influence of employer-sponsored, on-site chiropractic care against community-obtained care on health care utilization. METHODS: This was a retrospective claims analysis of members of a single employee health plan receiving chiropractic care on-site or off-site from 2010 to 2012. Utilization differences were evaluated by having 1 health care event or more, including radiology or clinical visits. RESULTS: There were 876 on-site and 759 off-site participants. The off-site group received more radiology services overall (55.5% vs 38.2%; P < 0.001) including magnetic resonance imaging, ultrasound, and radiograph (all P < 0.0001); had higher outpatient (P < 0.0001) and emergency department (P = 0.022) utilization; and demonstrated greater use of chiropractic care and physical therapy (both P < 0.0001). CONCLUSIONS: Compared with off-site care, on-site chiropractic services are associated with lower health care utilization. These results support the value of chiropractic services offered at on-site health centers.

Comparative assessment of adherence measures and resource use in SSRI/SNRI-treated patients with depression using second-generation antipsychotics or L-methylfolate as adjunctive therapy.

BACKGROUND: Antidepressant monotherapy is effective in achieving treatment remission in only approximately one third of patients with depression, and even switching to a second antidepressant brings the cumulative remission rate to only 50%-55%. This has led to an interest in augmentation therapy for the management of treatment-resistant depression. OBJECTIVES: To assess (a) selective serotonin reuptake inhibitor/selective norepinephrine reuptake inhibitor (SSRI/SNRI) adherence when augmented with second-generation atypical antipsychotics (SGAs) or L-methylfolate using a modified application of the Healthcare Effectiveness Data and Information Set (HEDIS) acute medication management (AMM) measures at the time of augmentation, and (b) the depression-specific and total health care cost, comparing the 2 forms of augmentation therapy in the treatment of depressive disorder. METHODS: Patients with a diagnosis of depression and a pharmacy claim for an SSRI/SNRI between January 1, 2006, and December 31, 2009 (index date), and receiving concomitant augmentation therapy with either an SGA or L-methylfolate (augmentation date), were identified in the MarketScan database and followed for 231 days (follow-up). Patients were excluded for having any pharmacy claim for an antidepressant or SGA 90 days pre-index; having an L-methylfolate claim 6 months pre-index; age < 18 years on the index date; or a diagnosis of pregnancy, dementia, psychotic-related mental disorders, Alzheimer's disease, or Parkinson's disease in the 12-month pre-index period. Propensity score matching (3:1 ratio, atypical antipsychotic to L-methylfolate) was used to select the final study cohorts, using covariates of age, gender, comorbidities, index SSRI/SNRI, and index SSRI/SNRI dose. Adherence to antidepressant therapy was measured from the augmentation date and included a modified application of the HEDIS (mHEDIS) AMM acute and chronic phase measures as well as the 6-month medication possession ratio. Health care utilization and cost were measured for the 6-month postaugmentation period and included both total as well as depression-related utilization/cost. Comparisons between the closely matched SGA and L-methylfolate-augmented cohorts were made using chi-square tests for binary measures and t-tests for continuous measures. RESULTS: Following propensity score matching, 4,053 SGA and 1,351 L-methylfolate patients were found to have augmentation of the index SSRI/SNRI within 12 months of the index date. The comparison groups were well matched on age, gender, comorbidities, and the type and dose of the SSRI/SNRI being augmented. The most common antidepressants augmented in both groups were escitalopram, duloxetine, and venlafaxine. Mean (standard deviation [SD]) time from index to augmentation was 73.5 [96.7] days for SGA and 105.9 [108.7] days for L-methylfolate (P < 0.001). The most common SGAs utilized for augmentation were quetiapine, aripiprazole, and risperidone. L-methylfolate was primarily dosed at 7.5 mg/day. The mHEDIS AMM acute phase measure was met by 68.7% of the SGA cohort and 78.7% of the L-methylfolate cohort (P < 0.001). The mHEDIS continuation phase measure was met by 50.3% of the SGA cohort and 62.1% of the L-methylfolate cohort (P < 0.001) following augmentation. Medical utilization (inpatient, emergency department, and outpatient) was significantly higher for the SGA group, while total prescription utilization was significantly higher in the L-methylfolate group. Mean [SD] total 6-month postaugmentation costs for the SGA group was $8,499 [$13,585] and $7,371 [$12,404] for the L-methylfolate group (P = 0.005), and 6-month depression-related costs were $2,688 [$4,201] for the SGA group and $1,613 [$2,315] for the L-methylfolate group (P < 0.001). CONCLUSIONS: Patients who augmented SSRI/SNRI therapy with SGA or L-methylfolate achieved mHEDIS AMM acute phase and continuation phase adherence scores of 69%-79% and 50%-62%, respectively. These modified scores exceeded the 2012 national median benchmarks for unmodified HEDIS AMM measures for commercial health plans. In this study, augmentation with L-methylfolate was associated with significantly higher adherence measures compared with augmentation with SGA. In addition, health care utilization and total health care costs, as well as depression-related costs, were significantly lower in the L-methylfolate augmentation group compared with augmentation with SGA.

Impact of race on cumulative exposure to antihypertensive medications in dialysis.

BACKGROUND: Racial minorities typically have less exposure than non-minorities to antihypertensive medications across an array of cardiovascular conditions in the general population. However, cumulative exposure has not been investigated in dialysis patients. METHODS: In a longitudinal analysis of 38,381 hypertensive dialysis patients, prescription drug data from Medicaid was linked to Medicare data contained in United States Renal Data System core data, creating a national cohort of dialysis patients dually eligible for Medicare and Medicaid services. The proportion of days covered (PDC) was calculated to determine cumulative exposure to angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), ß-blockers, and calcium-channel blockers (CCDs). The factors associated with use of these medications were modeled through weighted linear regression, with derivation of the adjusted odds ratios (AORs) for exposure. RESULTS: Relative to non-Hispanic Caucasians, African-American, Hispanic, or Other race/ethnicity were significantly associated with less exposure to ß-blockers (AOR 0.56-0.69, P < 0.001 in each case) and CCBs (AOR 0.84-0.85, P < 0.001 in each case); African-American race and Hispanic ethnicity had AORs of 0.78 and 0.73 for ACEIs and ARBs, respectively (P < 0.001 in both cases). Collectively, the odds of exposure to each class of medication for minorities was about three-quarters of that for Caucasians. CONCLUSIONS: Given that dually Medicare-and-Medicaid-eligible dialysis patients have insurance coverage for prescription medications as well as regular contact with health care providers, differences by race in exposure to antihypertensive medications should with time be minimal among patients who are candidates for these drugs. The causes of differences by race in exposure to antihypertensive medications over the course of time should be further examined.

Atrial fibrillation and risk of stroke in dialysis patients.

PURPOSE: Both stroke and chronic atrial fibrillation (AF) are common in dialysis patients, but uncertainty exists in the incidence of new strokes and the risk conferred by chronic AF. METHODS: A cohort of dually eligible (Medicare and Medicaid) incident dialysis patients was constructed. Medicare claims were used to determine the onset of chronic AF, which was specifically treated as a time-dependent covariate. Cox proportional hazards models were used to model time to stroke. RESULTS: Of 56,734 patients studied, 5629 (9.9%) developed chronic AF. There were 22.8 ischemic and 5.0 hemorrhagic strokes per 1000 patient-years, a ratio of approximately 4.5:1. Chronic AF was independently associated with time to ischemic (hazard ratio [HR], 1.26; 99% confidence interval [CI], 1.06-1.49; P = .0005), but not hemorrhagic, stroke. Race was strongly associated with hemorrhagic stroke: African Americans (HR, 1.46; 99% CI, 1.08-1.96), Hispanics (HR, 1.64; 99% CI, 1.16-2.31), and others (HR, 1.76; 99% CI, 1.16-2.78) had higher rates than did Caucasians (all P < .001). CONCLUSIONS: Chronic AF has a significant, but modest, association with ischemic stroke. Race/ethnicity is strongly associated with hemorrhagic strokes. The proportion of strokes owing to hemorrhage is much higher than in the general population.

Input data quality control for NDNQI national comparative statistics and quarterly reports: a contrast of three robust scale estimators for multiple outlier detection.

BACKGROUND: To evaluate institutional nursing care performance in the context of national comparative statistics (benchmarks), approximately one in every three major healthcare institutions (over 1,800 hospitals) across the United States, have joined the National Database for Nursing Quality Indicators (NDNQI). With over 18,000 hospital units contributing data for nearly 200 quantitative measures at present, a reliable and efficient input data screening for all quantitative measures for data quality control is critical to the integrity, validity, and on-time delivery of NDNQI reports. METHODS: With Monte Carlo simulation and quantitative NDNQI indicator examples, we compared two ad-hoc methods using robust scale estimators, Inter Quartile Range (IQR) and Median Absolute Deviation from the Median (MAD), to the classic, theoretically-based Minimum Covariance Determinant (FAST-MCD) approach, for initial univariate outlier detection. RESULTS: While the theoretically based FAST-MCD used in one dimension can be sensitive and is better suited for identifying groups of outliers because of its high breakdown point, the ad-hoc IQR and MAD approaches are fast, easy to implement, and could be more robust and efficient, depending on the distributional property of the underlying measure of interest. CONCLUSION: With highly skewed distributions for most NDNQI indicators within a short data screen window, the FAST-MCD approach, when used in one dimensional raw data setting, could overestimate the false alarm rates for potential outliers than the IQR and MAD with the same pre-set of critical value, thus, overburden data quality control at both the data entry and administrative ends in our setting.

Association of race with cumulative exposure to statins in dialysis.

BACKGROUND: Patients on dialysis have high rates of cardiovascular disease and are frequently treated with HMG-CoA reductase inhibitors. Given that these patients have insurance coverage for medications as well as regular contact with health care providers, differences by race in exposure to statins over time should be minimal among patients who are candidates for the drug. METHODS: We created a cohort of incident dialysis patients who were dually eligible for Medicare and Medicaid services. We determined the proportion of days covered (or PDC, a marker of cumulative medication exposure) by a statin prescription over a mean of 2.0 ± 1.4 years. Ordinary least squares regression was used to determine the factors associated with cumulative drug exposure. RESULTS: Of the 18,727 patients who filled at least one prescription for a statin, mean PDC was 0.57 ± 0.32. The unadjusted PDC was higher for Caucasians (0.63 ± 0.31) than for African-Americans (0.51 ± 0.32), Hispanics (0.54 ± 0.31), and individuals of other race/ethnicity (0.58 ± 0.32). In multivariable modeling, Caucasian race was independently associated with greater exposure to statins. Relative to Caucasians, the adjusted odds ratios for the PDC for African-Americans was 0.47 (95% confidence interval, CI, 0.43-0.50), for Hispanics 0.52 (0.48-0.56) and for others, 0.72 (0.64-0.81). CONCLUSIONS: Despite insurance coverage, regular contact with health care providers, and at least one prescription for a statin, there are large differences by race in statin exposure over time. The provider- and patient-associated factors related to this phenomenon should be further examined.

Geographic variation in HMG-CoA reductase inhibitor use in dialysis patients.

BACKGROUND: Despite uncertainty about their effectiveness in chronic dialysis patients, statin use has increased in recent years. Little is known about the demographic, clinical, and geographic factors associated with statin exposure in end-stage renal disease (ESRD) patients. OBJECTIVE: To analyze the demographic, clinical, and geographic factors associated with use of statins among chronic dialysis patients. DESIGN: Cross-sectional analysis. SETTING: Prevalent dialysis patients across the U.S. PARTICIPANTS: 55,573 chronic dialysis patients who were dually eligible for Medicaid and Medicare services during the last four months of 2005. METHODS: Using Medicaid prescription drug claims and United States Renal Data System core data, we examined demographics, comorbid conditions, and state of residence using hierarchical logistic regression models to determine their associations with statin use. INTERVENTION: Prescription for a statin. OUTCOME MEASURES: Factors associated with a prescription for a statin. RESULTS: Statin exposure was significantly associated with older age, female sex, Caucasian (versus African-American) race, body mass index, use of self-care dialysis, diabetes, and comorbidity burden. Moreover, there was substantial state-by-state variation in statin use, with a greater than 2.3-fold difference in adjusted odds ratios between the highest- and lowest-prescribing states. CONCLUSIONS: Among publicly insured chronic dialysis patients, there were marked differences between states in the use of HMG-CoA reductase inhibitors above and beyond patient characteristics. This suggests substantial clinical uncertainty about the utility of these medications. Understanding how such regional variations impact patient care in this high-risk population is an important focus for future work.

The prevalence of and factors associated with chronic atrial fibrillation in Medicare/Medicaid-eligible dialysis patients.

Atrial fibrillation is an important comorbidity with substantial therapeutic implications in dialysis patients but its prevalence varies in different studies. We used a database that includes patients in the United States on hemodialysis who were eligible for government assistance with prescription drugs. We then used ICD-9 codes from billing claims in this database to identify patients with chronic atrial fibrillation. Multivariable logistic regression was used to determine adjusted prevalence odds ratios for associated factors. Of 63,884 individuals, the prevalence of chronic atrial fibrillation was 7%. The factors of age over 60 years, male, Caucasian, body mass index over 25 kg/m(2), coronary artery disease, and heart failure were all significantly associated with chronic atrial fibrillation. Prevalence rates, particularly in younger patients, were far higher than those reported in an age group-matched nondialysis population. Thus, given its clinical impact, future efforts are needed to examine risk factors for adverse outcomes in chronic atrial fibrillation, and to identify appropriate management strategies for this disorder, as well as opportunities for quality improvement in this vulnerable population.

The Box-Cox power transformation on nursing sensitive indicators: does it matter if structural effects are omitted during the estimation of the transformation parameter?

BACKGROUND: Many nursing and health related research studies have continuous outcome measures that are inherently non-normal in distribution. The Box-Cox transformation provides a powerful tool for developing a parsimonious model for data representation and interpretation when the distribution of the dependent variable, or outcome measure, of interest deviates from the normal distribution. The objectives of this study was to contrast the effect of obtaining the Box-Cox power transformation parameter and subsequent analysis of variance with or without a priori knowledge of predictor variables under the classic linear or linear mixed model settings. METHODS: Simulation data from a 3 × 4 factorial treatments design, along with the Patient Falls and Patient Injury Falls from the National Database of Nursing Quality Indicators (NDNQI® for the 3rd quarter of 2007 from a convenience sample of over one thousand US hospitals were analyzed. The effect of the nonlinear monotonic transformation was contrasted in two ways: a) estimating the transformation parameter along with factors with potential structural effects, and b) estimating the transformation parameter first and then conducting analysis of variance for the structural effect. RESULTS: Linear model ANOVA with Monte Carlo simulation and mixed models with correlated error terms with NDNQI examples showed no substantial differences on statistical tests for structural effects if the factors with structural effects were omitted during the estimation of the transformation parameter. CONCLUSIONS: The Box-Cox power transformation can still be an effective tool for validating statistical inferences with large observational, cross-sectional, and hierarchical or repeated measure studies under the linear or the mixed model settings without prior knowledge of all the factors with potential structural effects.

The effect of simulation on clinical performance: a junior nursing student clinical comparison study.

INTRODUCTION: Patient simulation has been used to augment the traditional clinical model, but its value is unclear. The aim of this study was to evaluate the effects of a theory-driven pediatric simulation curriculum on nursing students' clinical performance. METHODS: The convenience sample included 116 junior nursing students enrolled in a pediatric course. Using a staggered timing model, students attended simulation instead of clinical for 2 weeks (25%) of an 8-week semester. The students spent the same amount of time in simulation as in clinical (12 hours per week). Student clinical performance was assessed using a Likert-style tool at 2-week intervals by the clinical faculty. Scores of students who attended simulation in the first 2 weeks were compared with students who had not yet attended simulation. Data were analyzed using repeated measure analysis with the mixed model, and covariate effects were considered. A Compound Symmetry covariance model was used to control the correlation between weeks within each subject. Statistical significance was determined at the 5% level. RESULTS: Faculty rated students with patient simulation experience higher than those who had not yet attended simulation (mean ± standard error: 1.74 ± 0.75, P = 0.02). On item-level analysis, therapeutic skills were positively impacted by simulation (P = 0.02). CONCLUSIONS: Time in simulation enhanced clinical performance, as simulation students achieved higher scores more quickly than those without simulation and maintained high performance levels. These findings suggest patient simulation is a valuable addition to augment the apprenticeship model.