A cross-sectional examination of the early-onset hypertensive disorders of pregnancy and industrial emissions of toxic metals using Kentucky birth records, 2008-2017.

This cross-sectional study assessed geospatial patterns of early-onset hypertensive disorders of pregnancy (eHDP) in primiparous mothers and exposure to industrial emissions using geocoded residential information from Kentucky live (N = 210,804) and still (N = 1,247) birth records (2008-2017) and census block group estimates of aerosol concentrations of arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), mercury (Hg), selenium (Se), and zinc (Zi) from the Risk Screening Environmental Indicators (RSEI) model. A latent class analysis allowed for the identification of four district exposure classes-As, Cd, and Pb (12.6%); Se and Zi (21.4%); Pb and Cr (8%); and low or no exposures (57.9%). Women classified as having a high probability of exposure to both Pb and Cr had a statistically significantly greater prevalence of eHDP after adjusting for demographic factors (aPR = 1.22, 95% CI: 1.04, 1.44) relative to those with low or no exposure. Our findings contribute to the emerging literature on the association of metal exposures with pregnancy outcomes.

The Association of Dietary Choline and Betaine With the Risk of Type 2 Diabetes: The Atherosclerosis Risk in Communities (ARIC) Study.

OBJECTIVE: To examine the association between dietary intake of choline and betaine and the risk of type 2 diabetes. RESEARCH DESIGN AND METHODS: Among 13,440 Atherosclerosis Risk in Communities (ARIC) study participants, the prospective longitudinal association between dietary choline and betaine intake and the risk of type 2 diabetes was assessed using interval-censored Cox proportional hazards and logistic regression models adjusted for baseline potential confounding variables. RESULTS: Among 13,440 participants (55% women, mean age 54 [SD 7.4] years), 1,396 developed incident type 2 diabetes during median follow-up of 9 years from 1987 to 1998. There was no statistically significant association between every 1-SD increase in dietary choline and risk of type 2 diabetes (hazard ratio [HR] 1.01 [95% CI 0.87, 1.16]) nor between dietary betaine intake and the risk of type 2 diabetes (HR 1.01 [0.94, 1.10]). Those in the highest quartile of dietary choline intake did not have a statistically significant higher risk of type 2 diabetes than those in the lowest choline quartile (HR 1.09 [0.84, 1.42]); similarly, dietary betaine intake was not associated with the risk of type 2 diabetes comparing the highest quartile to the lowest (HR 1.06 [0.87, 1.29]). Among women, there was a higher risk of type 2 diabetes, comparing the highest to lowest dietary choline quartile (HR 1.54 [1.06, 2.25]), while in men, the association was null (HR 0.82 [0.57, 1.17]). Nevertheless, there was a nonsignificant interaction between high choline intake and sex on the risk of type 2 diabetes (P = 0.07). The results from logistic regression were similar. CONCLUSIONS: Overall and among male participants, dietary choline or betaine intakes were not associated with the risk of type 2 diabetes. Among female participants, there was a trend for a modestly higher risk of type 2 diabetes among those with the highest as compared with the lowest quartile of dietary choline intake. Our study should inform clinical trials on dietary choline and betaine supplementation in relationship with the risk of type 2 diabetes.

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

BACKGROUND: Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. METHODS: The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. RESULTS: We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators. CONCLUSIONS: Although we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.