Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease

BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina. RESULTS: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91). CONCLUSIONS: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .)

Does anal sex stigma impede engagement of men who have sex with men in HIV services and sexual prevention strategies? A mixed-methods study with structural equation modeling

Thesis (Ph.D.)--University of Washington, 2017Background: Men who have sex with men (MSM) continue to have the highest rates of HIV infection in the United States. Combinations of biomedical and behavioral interventions could lower incidence, but engagement of MSM has not occurred at the pace necessary to curb the epidemic. HIV primarily infects MSM during anal sex and social factors like stigma toward sexual behavior are likely barriers to healthcare engagement and HIV prevention in general. Objectives: We examined men’s perspectives on stigma toward anal sexuality, and sought to quantify the effects of this devaluation on their sexual concerns and their engagement in HIV services and safer sex practices. We proposed a conceptual model based on theory and literature, and hypothesized that stigma impedes engagement, mediated through elevated concerns. Methods: We conducted online searches and qualitative interviews (N = 35) to develop two new quantitative measures, an Anal Sex Stigma Scale (ASS-S) and an Anal Sex Questions Index (ASQx); refined these in an online sample of MSM (N = 218); then tested our conceptual model of their effects on engagement in a new online sample (N = 1263). Results: The final model accounted for 75% of the variance in engagement, had good fit, and found evidence for the effects of all factors. We did not find evidence of mediation by ASQx, but did find evidence that ASS-S impedes engagement (β = -.28, p < .001), wholly mediated by men’s discomfort talking about sexual orientation and anal sex practices with health workers, after controlling for informational and emotional social support specific to anal sex and socioeconomic status. Conclusions: How MSM cope with stigma and concerns specific to anal sex may not be readily known or easy to disclose and address within healthcare settings, but may inform novel engagement strategies. While interest in specific questions about anal sex are not directly associated with poor engagement, responding to these questions may function as social support, and to some extent encourage greater engagement. Interventions that bolster men’s emotional and informational social support with regard to anal sex may inoculate some men against the concealment effects of anal sex stigma

Self-Report After Randomly Assigned Supervision Does Not Predict Ability to Practice Motivational Interviewing

The objective of this study was to investigate the relation between self-report and objective assessment of motivational interviewing (MI) skills following training and supervision. After an MI workshop, 96 clinicians from 26 community programs (age 21-68, 65% female, 40.8% Black, 29.6% Caucasian, 24.5% Hispanic, 2.0% Asian, 3.1% other) were randomized to supervision (tele-conferencing or tape-based), or workshop only. At four time points, trainees completed a self-report of MI skill, using items from the MI understanding questionnaire (MIU), and were objectively assessed by raters using the Motivational Interviewing Treatment Integrity (MITI) system. Correlations were calculated between MIU and MITI scores. A generalized linear mixed model was tested on MIU scores, with MITI scores, supervision condition and time as independent variables. MIU scores increased from pre-workshop (mean = 4.74, SD= 1.79) to post-workshop (mean = 6.31, SD= 1.03) (t= 8.69, p\u3c .0001). With supervision, scores continued to increase, from post-workshop to week 8 (mean = 7.07, SD= 0.91, t= 5.60, p\u3c .0001) and from week 8 to week 20 (mean = 7.28, SD= 0.94, t= 2.43, p= .02). However, MIU scores did not significantly correlate with MITI scores, with or without supervision. Self-reported ability increased with supervision, but self-report was not an indicator of objectively measured skill. This suggests that training does not increase correspondence between self-report and objective assessment, so community treatment programs should not rely on clinician self-report to assess the need for ongoing training and supervision and it may be necessary to train clinicians to accurately assess their own skill

Correlates of health and financial literacy in older adults without dementia

<p>Abstract</p> <p>Background</p> <p>Recent research has begun to recognize the important influence of literacy levels and how they affect health and wellbeing, especially in older adults. Our study focuses on health and financial literacy, two domains of literacy which previous research has suggested may be significantly related to health and wellbeing. Our study examines the relation of health and financial literacy with health promoting behaviors and health status among community-based older persons.</p> <p>Methods</p> <p>We conducted a cross-sectional study using data from the Rush Memory and Aging Project, a community-based cohort study of aging in northeastern Illinois. The study consisted of 556 older persons without dementia, each determined by a clinical evaluation. Health and financial literacy were measured using a series of questions designed to assess the ability to understand and process health and financial information, concepts, and numeracy; the two scores were averaged to yield a total literacy score. Health promoting behaviors, including engagement in cognitive, physical, and social activities, were assessed using self report measures. Indicators of heath status, including cognition (global cognition and five specific cognitive abilities), functional status (basic and instrumental activities of daily living, mobility disability), and mental health (depressive symptoms, loneliness) were assessed.</p> <p>Results</p> <p>In a series of regression models adjusted for age, sex, and education, higher total literacy scores were associated with more frequent participation in health promoting behaviors, including cognitive, physical and social activities (all p values <0.05). Higher total literacy scores were associated with higher cognitive function, less disability, and better mental health (all p values < 0.05). Literacy remained associated with health promoting behaviors and health status in fully adjusted models that also controlled for income and the number of chronic medical conditions. Most of the findings were similar for health and financial literacy except that health literacy was more strongly associated with health promoting behaviors whereas financial literacy was more strongly associated with mental health.</p> <p>Conclusions</p> <p>Health and financial literacy are associated with more frequent engagement in health promoting behaviors and better health status in older persons without dementia.</p