Coady Wing

Effects of Written Informed Consent Requirements on HIV Testing Rates: Evidence From a Natural Experiment

OBJECTIVES I evaluated the effects of written informed consent requirements on HIV testing rates in New York State to determine whether such consent creates barriers that discourage HIV testing. METHODS New York streamlined its HIV testing consent procedures on June 1, 2005. If written informed consent creates barriers to HIV testing, then New Yorks streamlining exercise should have reduced such barriers and increased HIV testing rates. I used logistic regression to estimate the effects of New Yorks policy change. RESULTS New Yorks streamlined consent procedures led to a 31.4% (95% confidence interval [CI] = 20.9%, 41.9%) increase in the states HIV testing rate. In absolute terms, 7% of the states population had been tested for HIV in the preceding 6 months under the streamlined procedures, whereas only 5.3% would have been tested under the original procedures. These estimates imply that the streamlined consent procedures accounted for approximately 328 000 additional HIV tests in the 6 months after the policy change. CONCLUSIONS Written informed consent requirements are a substantial barrier to HIV testing in the United States.There may be a trade-off between efforts to increase HIV testing rates and efforts to improve patient awareness.

Evaluation of Dabigatran Bleeding Adverse Reaction Reports in the FDA Adverse Event Reporting System during the First Year of Approval

Evaluate dabigatran adverse event reports with a reported bleeding event and/or reported fatal outcome compared with warfarin.

Effects of occupational regulations on the cost of dental services: Evidence from dental insurance claims

In the United States, occupational regulations influence the work tasks that may legally be performed by dentists and dental hygienists. Only a dentist may legally perform most dental procedures; however, a smaller list of basic procedures may be provided by either a dentist or a dental hygienist. Since dentists and hygienists possess different levels of training and skill and receive very different wages, it is plausible that these regulations could distort the optimal allocation of skills to work tasks. We present simple theoretical framework that shows different ways that such regulations might affect the way that dentists and dental hygienists are used in the production of dental services. We then use a large database of dental insurance claims to study the effects of the regulations on the prevailing prices of a set of basic dental services. Our empirical analysis exploits variation across states and over time in the list of services that may be provided by either type of worker. Our main results suggest that the task-specific occupational regulations increase prices by about 12%. We also examine the effects of related occupational regulations on the utilization of basic dental services. We find that allowing insurers to directly reimburse hygienists for their work increases one year utilization rates by 3-4 percentage points.

Workplace Compliance With the Law: The Case of the Family and Medical Leave Act

Using the 2008 National Study of Employers to analyze employers’ compliance with the Family and Medical Leave Act (FMLA), we show that prior studies have overestimated compliance due to the treatment of missing values and incomplete definitions of the FMLA. Using partial identification methods, we estimate that FMLA compliance among firms with 50 or more employees in the private sector is at least 54.3% and at most 76.8%. We also look at organizational characteristics that predict compliance, noncompliance, and nonresponse. This analysis suggests that firms with missing data are more similar to noncompliant than compliant firms and that nonresponse may indicate organizational defiance of policy.

A national examination of pharmacy-based immunization statutes and their association with influenza vaccinations and preventive health

BACKGROUND A series of state-level statute changes have allowed pharmacists to provide influenza vaccinations in community pharmacies. The study aim was to estimate the effects of pharmacy-based immunization statutes changes on per capita influenza vaccine prescriptions, adult vaccination rates, and the utilization of other preventive health services. METHODS A quasi-experimental study that compares vaccination outcomes over time before and after states allowed pharmacy-based immunization. Measures of per capita pharmacy prescriptions for influenza vaccines in each state came from a proprietary pharmacy prescription database. Data on adult vaccination rates and preventive health utilization were studied using multiple waves of the Behavioral Risk Factor Surveillance System (BRFSS). The primary outcomes were changes in per capita influenza vaccine pharmacy prescriptions, adult vaccination rates, and preventive health interventions following changes. RESULTS Between 2007 and 2013, the number of influenza vaccinations dispensed in community pharmacies increased from 3.2 to 20.9 million. After one year, adopting pharmacist immunization statutes increased per capita influenza vaccine prescriptions by an absolute difference (AD) of 2.6% (95% CI: 1.1-4.2). Adopting statutes did not lead to a significant absolute increase in adult vaccination rates (AD 0.9%, 95% CI: -0.3, 2.2). There also was no observed difference in adult vaccination rates among adults at high-risk of influenza complications (AD 0.8%, 95% CI: -0.2, 1.8) or among standard demographic subgroups. There also was no observed difference in the receipt of preventive health services, including routine physician office visits (AD -1.9%, 95% CI: -4.9, 1.1). CONCLUSIONS Pharmacists are providing millions of influenza vaccines as a consequence of immunization statutes, but we do not observe significant differences in adult influenza vaccination rates. The main gains from pharmacy-based immunization may be in providing a more convenient way to obtain an important health service.

Association of aldosterone synthase polymorphism (CYP11B2 -344T>C) and genetic ancestry with atrial fibrillation and serum aldosterone in African Americans with heart failure.

The objective of this study was to examine the extent to which aldosterone synthase genotype (CYP11B2) and genetic ancestry correlate with atrial fibrillation (AF) and serum aldosterone in African Americans with heart failure. Clinical data, echocardiographic measurements, and a genetic sample for determination of CYP11B2 -344T>C (rs1799998) genotype and genetic ancestry were collected from 194 self-reported African Americans with chronic, ambulatory heart failure. Genetic ancestry was determined using 105 autosomal ancestry informative markers. In a sub-set of patients (n = 126), serum was also collected for determination of circulating aldosterone. The CYP11B2 −344C allele frequency was 18% among the study population, and 19% of patients had AF. Multiple logistic regression revealed that the CYP11B2 −344CC genotype was a significant independent predictor of AF (OR 12.7, 95% CI 1.60–98.4, p = 0.0150, empirical p = 0.011) while holding multiple clinical factors, left atrial size, and percent European ancestry constant. Serum aldosterone was significantly higher among patients with AF (p = 0.036), whereas increased West African ancestry was inversely correlated with serum aldosterone (r = −0.19, p = 0.037). The CYP11B2 −344CC genotype was also overrepresented among patients with extreme aldosterone elevation (≥90th percentile, p = 0.0145). In this cohort of African Americans with chronic ambulatory heart failure, the CYP11B2 −344T>C genotype was a significant independent predictor of AF while holding clinical, echocardiographic predictors, and genetic ancestry constant. In addition, increased West African ancestry was associated with decreased serum aldosterone levels, potentially providing an explanation for the lower risk for AF observed among African Americans.

REPORTS OF BLEEDING-RELATED FATALITIES WITH DABIGATRAN AND WARFARIN: AN ANALYSIS USING THE FOOD AND DRUG ADMINISTRATION ADVERSE EVENTS REPORTING SYSTEM

results: Bleeding-related fatalities increased during the reported period for dabigatran compared to a stable number of reports with warfarin (Figure 1). Dabigatran was the primary or secondary agent in 4,270 bleeding events with 638 bleeding-related fatalities. In comparison, warfarin had 827 bleeding events with 44 bleeding-related fatalities. We estimated a lower bound of 88 bleeding-related fatalities per 100,000 dabigatran treated patients. Because of under-reporting bias these estimates represent a lower bound on the population bleeding mortality rates.

Weight and Veterans’ Environments Study (WAVES) I and II: Rationale, Methods, and Cohort Characteristics

Purpose: To present the rationale, methods, and cohort characteristics for 2 complementary “big data” studies of residential environment contributions to body weight, metabolic risk, and weight management program participation and effectiveness. Design: Retrospective cohort. Setting: Continental United States. Participants: A total of 3 261 115 veterans who received Department of Veterans Affairs (VA) health care in 2009 to 2014, including 169 910 weight management program participants and a propensity score–derived comparison group. Intervention: The VA MOVE! weight management program, an evidence-based lifestyle intervention. Measures: Body mass index, metabolic risk measures, and MOVE! participation; residential environmental attributes (eg, food outlet availability and walkability); and MOVE! program characteristics. Analysis: Descriptive statistics presented on cohort characteristics and environments where they live. Results: Forty-four percent of men and 42.8% of women were obese, whereas 4.9% of men and 9.9% of women engaged in MOVE!. About half of the cohort had at least 1 supermarket within 1 mile of their home, whereas they averaged close to 4 convenience stores (3.6 for men, 3.9 for women) and 8 fast-food restaurants (7.9 for men, 8.2 for women). Forty-one percent of men and 38.6% of women did not have a park, and 35.5% of men and 31.3% of women did not have a commercial fitness facility within 1 mile. Conclusion: Drawing on a large nationwide cohort residing in diverse environments, these studies are poised to significantly inform policy and weight management program design.

Genetic ancestry as an effect modifier of naltrexone in smoking cessation among African Americans: an analysis of a randomized controlled trial.

Objectives To determine whether there were differential quit rates between African Americans (AA) and European Americans with the experimental treatment naltrexone, and examine the role of genetic ancestry on these outcomes among AAs. Methods Data from a previous randomized trial of 315 smokers to naltrexone versus placebo were reanalyzed using West African (WA) genetic ancestry to define subpopulations. Logistic regression models were used to estimate treatment effects on early and end of treatment quit rates, by race and WA ancestry. Results Among European Americans (n=136), naltrexone significantly increased quit rates at 4 weeks (62 vs. 43%, P=0.03) with directional, but not statistically significant effects at 12 weeks (30 vs. 18%, P=0.12). In contrast, among the AAs (n=95), quit rates did not differ between naltrexone and placebo groups at either interval (4 weeks: 43 vs. 32%, P=0.27; 12 weeks: 22 vs. 18%, P=0.60). A median split was conducted in AAs for WA ancestry. Among AAs with low WA ancestry, quit rates were significantly higher with naltrexone compared with placebo (60 vs. 27%, P=0.03). There was no advantage in quit rates with naltrexone for the high WA ancestry group. Conclusion Naltrexone efficacy for smoking cessation varies across AA individuals with different levels of WA ancestry. These results suggest that genetic background may partially explain racial differences in drug response.

Long-Term Weight Loss Effects of a Behavioral Weight Management Program: Does the Community Food Environment Matter?

This study examined whether community food environments altered the longer-term effects of a nationwide behavioral weight management program on body mass index (BMI). The sample was comprised of 98,871 male weight management program participants and 15,385 female participants, as well as 461,302 and 37,192 inverse propensity-score weighted matched male and female controls. We measured the community food environment by counting the number of supermarkets, convenience stores, and fast food restaurants within a 1-mile radius around each person’s home address. We used difference-in-difference regression models with person and calendar time fixed effects to estimate MOVE! effects over time in sub-populations defined by community food environment attributes. Among men, after an initial decrease in BMI at 6 months, the effect of the program decreased over time, with BMI increasing incrementally at 12 months (0.098 kg/m2, p < 0.001), 18 months (0.069 kg/m2, p < 0.001), and 24 months (0.067 kg/m2, p < 0.001). Among women, the initial effects of the program decreased over time as well. Women had an incremental BMI change of 0.099 kg/m2 at 12 months (p < 0.05) with non-significant incremental changes at 18 months and 24 months. We found little evidence that these longer-term effects of the weight management program differed depending on the community food environment. Physiological adaptations may overwhelm environmental influences on adherence to behavioral regimens in affecting longer-term weight loss outcomes.