Abigail B. Shoben

Seasonal Variation in 25-Hydroxyvitamin D Concentrations in the Cardiovascular Health Study

Low circulating concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with adverse health outcomes in diverse populations. However, 25(OH)D concentrations vary seasonally with varying exposure to sunlight, so single measurements may poorly reflect long-term 25(OH)D exposure. The authors investigated cyclical trends in average serum 25(OH)D concentrations among 2,298 individuals enrolled in the Cardiovascular Health Study of community-based older adults (1992-1993). A sinusoidal model closely approximated observed 25(OH)D concentrations and fit the data significantly better than did a mean model (P < 0.0001). The mean annual 25(OH)D concentration was 25.1 ng/mL (95% confidence interval: 24.7, 25.5), and the mean peak-trough difference was 9.6 ng/mL (95% confidence interval: 8.5, 10.7). Male sex, higher latitude of study site, and greater physical activity levels were associated with larger peak-trough difference in 25(OH)D concentration (each P < 0.05). Serum concentrations of intact parathyroid hormone and bone-specific alkaline phosphatase also varied in a sinusoidal fashion (P < 0.0001), inversely to 25(OH)D. In conclusion, serum 25(OH)D varies in a sinusoidal manner, with large seasonal differences relative to mean concentration and laboratory evidence of biologic sequelae. Single 25(OH)D measurements might not capture overall vitamin D status, and the extent of misclassification could vary by demographic and behavioral factors. Accounting for collection time may reduce bias in research studies and improve decision-making in clinical care.

Estimating mean annual 25-hydroxyvitamin D concentrations from single measurements: the Multi-Ethnic Study of Atherosclerosis

BACKGROUND The seasonal variation in circulating 25-hydroxyvitamin D [25(OH)D] concentrations is large relative to mean values. Single measurements may misclassify annual exposure, which may lead to bias in research and complicate clinical decision making. OBJECTIVE We aimed to develop and validate a model for adjusting a single measurement of a serum 25(OH)D concentration to the time of year it was measured. DESIGN We measured serum 25(OH)D concentrations by using mass spectrometry in 6476 participants from the Multi-Ethnic Study of Atherosclerosis at baseline and again in a subset of 368 participants at a median of 17 mo later. We estimated a cosinor model to describe the seasonal variability in 25(OH)D concentrations and evaluated this model by using follow-up 25(OH)D measurements. RESULTS The mean age of subjects was 62.1 y, 61.2% of participants were nonwhite, and 53.3% of participants were women. The cosinor model predicted follow-up 25(OH)D concentrations better than a single measurement [difference in root mean squared error (RMSE): 1.3 ng/mL; P< 0.001]. The cosinor model also better predicted the measured annual mean 25(OH)D concentration (difference in RMSE: 1.0 ng/mL; P< 0.001). Annual mean 25(OH)D concentrations estimated from the cosinor model reclassified 7.1% of participants with regard to 25(OH)D deficiency, which was defined as <20 ng/mL. An estimated annual mean 25(OH)D concentration <20 ng/mL was significantly associated with lower bone mineral density, whereas an untransformed 25(OH)D concentration <20 ng/mL was not. CONCLUSIONS Cross-sectional data can be used to estimate subject-specific mean annual 25(OH)D concentrations from single values by using a cosinor model. The tool we developed by using this approach may assist research and clinical care of adults in North America by reducing the misclassification of 25(OH)D deficiency.

Does Consent Bias Research

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in “consent bias.” As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research.

Serum Parathyroid Hormone and 25‐Hydroxyvitamin D Concentrations and Risk of Incident Heart Failure: The Multi‐Ethnic Study of Atherosclerosis

Background Heart failure (HF) is common and is associated with high mortality. We aimed to determine associations of serum parathyroid hormone (PTH) and 25‐hydroxyvitamin D (25[OH]D) with incident HF and left ventricular mass. Methods and Results Among 6459 participants in the community‐based Multi‐Ethnic Study of Atherosclerosis, all of whom were free of prevalent clinical cardiovascular disease, we measured serum concentrations of PTH and 25(OH)D at the baseline examination. In longitudinal analyses, we tested associations of PTH and 25(OH)D with incident HF events, adjudicated by a panel of physicians. In cross‐sectional analyses of a subset of 4763 participants, we tested associations of PTH and 25(OH)D with left ventricular mass, measured by cardiac magnetic resonance imaging at baseline. Multivariable Cox proportional hazard and linear regression models were adjusted for demographics, physical examination measures, comorbidity, kidney function, and other mineral metabolism markers. Mean age was 62 years and 53% of participants were female. There were 180 incident HF events over a median (interquartile range) follow‐up time of 8.46 (7.67 to 8.63) years. Compared with participants with PTH <65 pg/mL, PTH ≥65 pg/mL was associated with a 50% greater risk of incident HF (95% CI: 3% to 210%) and a 5.3 g higher left ventricular mass (95% CI: 2.6, 7.9 g). In contrast, there was no association of 25(OH)D with risk of incident HF or elevated left ventricular mass. Conclusions In a racially/ethnically diverse population without prevalent cardiovascular disease, higher serum PTH concentration was associated with increased left ventricular mass and increased risk of incident HF. Further studies should be pursued to determine whether PTH excess may be a modifiable risk factor for HF.

Assessment of Life's Simple 7 in the primary care setting: the Stroke Prevention in Healthcare Delivery EnviRonmEnts (SPHERE) study.

BACKGROUND Adverse health behaviors and factors predict increased coronary heart disease and stroke risk, and effective use of health information technology (HIT) to automate assessment of and intervention on these factors is needed. A comprehensive, automated cardiovascular health (CVH) assessment deployed in the primary care setting offers the potential to enhance prevention, facilitate patient-provider communication, and ultimately reduce cardiovascular (CV) disease risk. We describe the methods for a study to develop and test an automated CVH application for stroke prevention in older women. METHODS AND RESULTS The eligible study population for the Stroke Prevention in Healthcare Delivery EnviRonmEnts (SPHERE) study is approximately 1600 female patients aged 65 years and older and their primary care providers at The Ohio State University Wexner Medical Center. We will use an intervention design that will allow for a run-in period, comparison group data collection, a provider education period, and implementation of a best practice alert to prompt provider-patient interactions regarding CVH. Our primary outcome is a CVH score, comprising Lifes Simple 7: smoking status, body mass index, blood pressure, cholesterol, fasting glucose, physical activity, and diet. The SPHERE application will generate visualizations of the CVH score within the electronic health record (EHR) during the patient-provider encounter. A key outcome of the study will be change in mean CVH score pre- and post-intervention. CONCLUSIONS The SPHERE application leverages the EHR and may improve health outcomes through HIT designed to empower clinicians to discuss CVH with their patients and enhance primary prevention efforts.

Using O*NET to estimate the association between work exposures and chronic diseases

BACKGROUND A standardized process using data from the Occupational Information Network (O*NET) is applied to estimate the association between long-term aggregated occupational exposure and the risk of contracting chronic diseases later in life. We demonstrate this process by analyzing relationships between O*NET physical work demand ratings and arthritis onset over a 32-year period. METHODS The National Longitudinal Survey of Youth provided job histories and chronic disease data. Five O*NET job descriptors were used as surrogate measures of physical work demands. Logistic regression measured the association between those demands and arthritis occurrence. RESULTS The risk of arthritis was significantly associated with handling and moving objects, kneeling, crouching, and crawling, bending and twisting, working in a cramped or awkward posture, and performing general physical activities. CONCLUSION This study demonstrates the utility of using O*NET job descriptors to estimate the aggregated long-term risks for osteoarthritis and other chronic diseases when no actual exposure data is available.

Effectiveness of Two Community Health Worker Models of Tobacco Dependence Treatment Among Community Residents of Ohio Appalachia.

Introduction Community health workers (CHW) may be effective in the delivery of tobacco dependence treatment with underserved groups. This study evaluated two evidence-based CHW models of treatment. It was hypothesized that smokers assigned to a CHW face-to-face condition would have higher abstinence at 12-month posttreatment than smokers enrolled in CHW referral to a state-sponsored quitline condition. Intrapersonal and treatment-related factors associated with abstinence at 12 months were determined. Methods A group-randomized trial was conducted with residents of 12 Ohio Appalachian counties with counties (n = 6) randomized to either a CHW face-to-face (F2F) or CHW quitline (QL) condition. Both conditions included behavioral counseling and free nicotine replacement therapy for 8 weeks. Follow-up data were collected at 3-, 6-, and 12-month posttreatment. Biochemically validated abstinence at 12 months served as the primary outcome. Results Seven hundred and seven participants were enrolled (n = 353 CHWF2F; n = 354 CHWQL). Baseline sample characteristics did not differ by condition. Using an intent-to-treat analysis (85.4% retention at 12 months), 13.3% of CHWF2F participants were abstinent at 12 months, compared to 10.7% of CHWQL members (OR = 1.28; 95% confidence interval [CI] = 0.810, 2.014; p = .292). No differences in abstinence were noted at 3 or 6 months by condition. Age, marital status, and baseline levels of cigarette consumption, depressive symptoms, and self-efficacy for quitting in positive settings were associated with abstinence, as was counseling dose during treatment. Conclusions This research adds to the body of science evaluating the effectiveness of CHW models of tobacco dependence treatment. Both approaches may offer promise in low-resource settings and underserved regions. Implications This 12-county community-based group-randomized trial in Ohio Appalachia adds to the body of science evaluating the effectiveness of CHW models of tobacco dependence treatment. Both CHW approaches may offer promise in low-resource settings and underserved regions. These findings are useful to national, state, and local tobacco control agencies, as they expand delivery of preventive health care services postadoption of the Affordable Care Act in the United States.

EHR-based Visualization Tool: Adoption Rates, Satisfaction, and Patient Outcomes

Background: Electronic health records (EHRs) have the potential to enhance patient-provider communication and improve patient outcomes. However, in order to impact patient care, clinical decision support (CDS) and communication tools targeting such needs must be integrated into clinical workflow and be flexible with regard to the changing health care landscape. Design: The Stroke Prevention in Healthcare Delivery Environments (SPHERE) team developed and implemented the SPHERE tool, an EHR-based CDS visualization, to enhance patient-provider communication around cardiovascular health (CVH) within an outpatient primary care setting of a large academic medical center. Implementation: We describe our successful CDS alert implementation strategy and report adoption rates. We also present results of a provider satisfaction survey showing that the SPHERE tool delivers appropriate content in a timely manner. Patient outcomes following implementation of the tool indicate one-year improvements in some CVH metrics, such as body mass index and diabetes. Discussion: Clinical decision-making and practices change rapidly and in parallel to simultaneous changes in the health care landscape and EHR usage. Based on these observations and our preliminary results, we have found that an integrated, extensible, and workflow-aware CDS tool is critical to enhancing patient-provider communications and influencing patient outcomes.

Recruiting Young Gay and Bisexual Men for a Human Papillomavirus Vaccination Intervention Through Social Media: The Effects of Advertisement Content

Background Web-based approaches, specifically social media sites, represent a promising approach for recruiting young gay and bisexual men for research studies. Little is known, however, about how the performance of social media advertisements (ads) used to recruit this population is affected by ad content (ie, image and text). Objective The aim of this study was to evaluate the effects of different images and text included in social media ads used to recruit young gay and bisexual men for the pilot test of a Web-based human papillomavirus (HPV) vaccination intervention. Methods In July and September 2016, we used paid Facebook advertisements to recruit men who were aged 18-25 years, self-identified as gay or bisexual, US resident, and had not received HPV vaccine. A 4x2x2 factorial experiment varied ad image (a single young adult male, a young adult male couple, a group of young adult men, or a young adult male talking to a doctor), content focus (text mentioning HPV or HPV vaccine), and disease framing (text mentioning cancer or a sexually transmitted disease [STD]). Poisson regression determined whether these experimental factors affected ad performance. Results The recruitment campaign reached a total of 35,646 users who viewed ads for 36,395 times. This resulted in an overall unique click-through rate of 2.01% (717/35,646) and an overall conversion rate of 0.66% (241/36,395). Reach was higher for ads that included an image of a couple (incidence rate ratio, IRR=4.91, 95% CI 2.68-8.97, P<.001) or a group (IRR=2.65, 95% CI 1.08-6.50, P=.03) compared with those that included an image of a single person. Ads that included an image of a couple also had a higher conversion rate (IRR=2.56, 95% CI 1.13-5.77, P=.02) than ads that included an image of a single person. Ads with text mentioning an STD had a higher unique click-through rate compared with ads with text mentioning cancer (IRR=1.34, 95% CI 1.06-1.69, P=.01). The campaign cost a total of US

Does Size Impact Attention and Recall of Graphic Health Warnings

413.72 and resulted in 150 eligible and enrolled individuals (US