Publications

Tobacco and alcohol use are strongly associated. This cross-sectional study examined the relationship of smoke-free law coverage and smoke-free bar law coverage with hazardous drinking behaviors among a representative sample of U.S. adult drinkers ( = 17,057). We merged 2009 National Health Interview Survey data, American Nonsmokers' Rights Foundation U.S. Tobacco Control Laws Database, and Census Population Estimates. Hazardous drinking outcomes included heavy drinking (>14 drinks/week for men; >7 drinks/week for women) and binge drinking (≥5 drinks on one or more days during past year). Chi-square tests compared hazardous drinking by sociodemographic factors. Multivariable logistic regression models were used to examine if smoke-free law and bar law coverages were associated with hazardous drinking, controlling for sociodemographics and smoking status. Subset analyses were conducted among drinkers who also smoked ( = 4074) to assess the association between law coverages and hazardous drinking. Among all drinkers, smoke-free law coverage was not associated with heavy drinking (adjusted odds ratio (AOR) = 1.22, 95% confidence interval (CI) = 0.99-1.50) or binge drinking (AOR = 1.09, 95% CI = 0.93-1.26). Smoke-free bar law coverage was also found to be unrelated to hazardous drinking. Similar results were found among those drinkers who smoked. Findings suggest that smoke-free laws and bar laws are not associated with elevated risk for alcohol-related health issues.

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

BACKGROUND

Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES).

OBJECTIVES

This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up.

METHODS

The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively.

RESULTS

Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (p = 0.49).

CONCLUSIONS

Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993).

We sought to develop a multiple biomarker approach for prediction of incident major adverse cardiac events (MACE; composite of cardiovascular death, myocardial infarction, and stroke) in patients referred for coronary angiography. In a 649-participant training cohort, predictors of MACE within 1 year were identified using least-angle regression; over 50 clinical variables and 109 biomarkers were analyzed. Predictive models were generated using least absolute shrinkage and selection operator with logistic regression. A score derived from the final model was developed and evaluated with a 278-patient validation set during a median of 3.6 years follow-up. The scoring system consisted of N-terminal pro B-type natriuretic peptide (NT-proBNP), kidney injury molecule-1, osteopontin, and tissue inhibitor of metalloproteinase-1; no clinical variables were retained in the predictive model. In the validation cohort, each biomarker improved model discrimination or calibration for MACE; the final model had an area under the curve (AUC) of 0.79 (p <0.001), higher than AUC for clinical variables alone (0.75). In net reclassification improvement analyses, addition of other markers to NT-proBNP resulted in significant improvement (net reclassification improvement 0.45; p = 0.008). At the optimal score cutoff, we found 64% sensitivity, 76% specificity, 28% positive predictive value, and 93% negative predictive value for 1-year MACE. Time-to-first MACE was shorter in those with an elevated score (p <0.001); such risk extended to at least to 4 years. In conclusion, in a cohort of patients who underwent coronary angiography, we describe a novel multiple biomarker score for incident MACE within 1 year (NCT00842868).

Individuals experiencing homelessness in the United States are aging; little is known about chronic pain in this population. In a cross-sectional, population-based study, we interviewed 350 homeless individuals aged 50 years and older to describe pain experienced by older persons experiencing homelessness and to assess factors associated with chronic moderate to severe pain, defined as pain lasting ≥3 months, with a past week average severity score of 5 to 10 (scale 0-10). The median age of participants was 58 years. Participants were predominantly African American (79.6%) and male (77.3%). Overall, 46.8% reported chronic moderate to severe pain. Almost half of participants reported a diagnosis of arthritis (44.3%) and one-third reported symptoms consistent with post-traumatic stress disorder (PTSD; 32.8%). Three-quarters (75.3%) endorsed a personal history of abuse. In multivariate analyses, PTSD (adjusted odds ratio [AOR]: 2.2, 95% confidence interval [CI], 1.4-3.7), arthritis (AOR: 4.8, 95% CI, 3.0-7.8), and history of experiencing abuse (AOR: 2.4, 95% CI, 1.3-4.3) were associated with chronic moderate to severe pain. HIV status, diabetes, depressive symptoms, and substance use were not associated with pain. Clinicians should consider the management of associated mental health conditions and the sequelae of experiencing abuse in the treatment of chronic pain in older adults experiencing homelessness.

PERSPECTIVE

This article describes the prevalence and factors associated with chronic pain in older homeless adults. Almost half report chronic pain, which was associated with PTSD, arthritis, and personal history of abuse. Clinicians should address chronic pain, trauma, and the associated mental health conditions in this high-risk population.

BACKGROUND

Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a "triple marker" CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital.

METHODS/DESIGN

Non-diabetic hypertensive veterans age 18-80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months.

RESULTS

A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61-72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%.

CONCLUSION

We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD.

TRIAL REGISTRATION

NCT01978951 ; Date or Registration: 1/17/2014.