Racial and Economic Segregation Over the Life Course and Incident Hypertensive Disorders of Pregnancy Among Black Women in California.

Black women in the United States have the highest incidence of hypertensive disorders of pregnancy (HDP) and are disproportionately burdened by its adverse sequalae, compared with women of all racial and ethnic groups. Segregation, a key driver of structural racism for Black families, can provide information critical to understanding these disparities. We examined the association between racial and economic segregation at 2 points and incident HDP using intergenerationally linked birth records of 45,204 Black California-born primiparous mothers (born 1982-1997) and their infants (born 1997-2011), with HDP ascertained from hospital discharge records. Women's early childhood and adulthood neighborhoods were categorized as deprived, mixed, or privileged based on the Index of Concentration at the Extremes (a measure of concentrated racial and economic segregation), yielding 9 life-course trajectories. Women living in deprived neighborhoods at both time points experienced the highest odds of HDP (from mixed effect logistic regression, unadjusted odds ratio = 1.26, 95% confidence interval: 1.13, 1.40) compared with women living in privileged neighborhoods at both time points. All trajectories involving residence in a deprived neighborhood in early childhood or adulthood were associated with increased odds of HDP, whereas mixed-privileged and privileged-mixed trajectories were not. Future studies should assess the causal nature of these associations.

Effect of a Telephone-Based Lifestyle Intervention on Weight, Body Composition, and Metabolic Biomarkers in Rural Ohio: Results from a Randomized Pilot Study.

Rural residents experience higher rates of obesity, obesity-related chronic diseases, and poorer lifestyle. Promoting physical activity and healthy eating are critical for rural residents; however, lack of resources and access barriers limit the feasibility of in-person lifestyle interventions. There is a need to design and deliver remotely accessible lifestyle interventions in this population. This pilot study examined the effect of a telephone-based lifestyle intervention on weight, body composition, lipids, and inflammatory biomarkers among rural Ohio residents. Rural Ohio adults with overweight/obesity (n = 40) were 2:1 randomized to a 15-week telephone-based lifestyle intervention (n = 27) or control group (n = 13). The lifestyle intervention group received weekly telephone counseling sessions emphasizing healthy eating and increasing physical activity. The control group received educational brochures describing physical activity and dietary recommendations. Weight, body composition, fasting blood lipids, and inflammatory biomarkers were objectively measured at baseline and 15 weeks at local community centers (trial registration#: NCT05040152 at ClinicalTrial.gov). Linear mixed models were used to examine change over time by group. Participants were mostly female, with an average age of 49 years. Over the 15-week trial, the lifestyle intervention showed superior improvements in total cholesterol (∆ = -18.7 ± 7.8 mg/dL, p = 0.02) and LDL (∆ = -17.1 ± 8.1 mg/dL, p = 0.04) vs. control, whereas no significant between-group differences in weight, body composition, or inflammation were observed. Our findings suggest that a 15-week telephone-based lifestyle intervention may offer metabolic benefits that reduce disease risk in rural adults with obesity. Future large-scale studies are needed to determine the efficacy of remotely accessible lifestyle interventions in rural populations, with the goal of reducing obesity-related disparities.

BRCAShare-Assessment of an animated digital message for intrafamilial communication of pathogenic variant positive test results: A feasibility study.

While genetic testing for hereditary breast and ovarian cancer syndrome (HBOC) is well-established in the field of medicine, family members' uptake of cascade genetic testing for known familial pathogenic variants remains low. Probands often become responsible for initiating familial communication about their testing results, and barriers to communication may include difficulty in conveying information to relatives and a lack of communication resources for probands' use. In this study, we tested a two-minute animated digital message (ADM) intervention guided by the Health Belief Model (HBM) in an unselected sample to determine hypothetical individual perceptions of susceptibility and severity and behavioral intention to act on the information provided in the ADM. We recruited genetic testing naïve adults from the United States with no personal history of cancer through Amazon Mechanical Turk to participate in this study. Participants were presented a hypothetical scenario describing a relative's recent HBOC diagnosis, viewed the ADM, and answered a questionnaire assessing participants' perception of the HBM constructs in relation to the hypothetical scenario and participants' intentions to pursue cascade genetic testing, talk to a healthcare professional, or talk to family members after ADM viewing. Participants (n = 373) largely perceived HBOC as serious and believed that they could benefit from the information provided by genetic testing; 76% hypothetically intended to pursue genetic testing at a cost of $100 or less, and 90% intended to either pursue testing or talk to a healthcare provider or family members. This feasibility study in an unaffected population could mimic the experience of distant/less-engaged relatives in HBOC families after receiving unexpected information about cascade genetic testing. Most participants demonstrated behavioral intention toward cascade testing, at a rate higher than literature would suggest is typical in high-risk families, indicating that a theory-supported, simple to use intervention may be useful in clinical practice.

Multiple imputation by predictive mean matching in cluster-randomized trials.

BACKGROUND: Random effects regression imputation has been recommended for multiple imputation (MI) in cluster randomized trials (CRTs) because it is congenial to analyses that use random effects regression. This method relies heavily on model assumptions and may not be robust to misspecification of the imputation model. MI by predictive mean matching (PMM) is a semiparametric alternative, but current software for multilevel data relies on imputation models that ignore clustering or use fixed effects for clusters. When used directly for imputation, these two models result in underestimation (ignoring clustering) or overestimation (fixed effects for clusters) of variance estimates. METHODS: We develop MI procedures based on PMM that leverage these opposing estimated biases in the variance estimates in one of three ways: weighting the distance metric (PMM-dist), weighting the average of the final imputed values from two PMM procedures (PMM-avg), or performing a weighted draw from the final imputed values from the two PMM procedures (PMM-draw). We use Monte-Carlo simulations to evaluate our newly proposed methods relative to established MI procedures, focusing on estimation of treatment group means and their variances after MI. RESULTS: The proposed PMM procedures reduce the bias in the MI variance estimator relative to established methods when the imputation model is correctly specified, and are generally more robust to model misspecification than even the random effects imputation methods. CONCLUSIONS: The PMM-draw procedure in particular is a promising method for multiply imputing missing data from CRTs that can be readily implemented in existing statistical software.

Distribution of Cardiovascular Health by Individual- and Neighborhood-Level Socioeconomic Status: Findings From the Jackson Heart Study.

BACKGROUND: Data demonstrate a positive relationship between socioeconomic status (SES) and cardiovascular health (CVH). OBJECTIVE: To assess the association between individual- and neighborhood-level SES and CVH among participants of the JHS (Jackson Heart Study), a community-based cohort of African Americans in Jackson, Mississippi. METHODS: We included all JHS participants with complete SES and CVH information at the baseline study visit (n = 3,667). We characterized individual- and neighborhood-level SES according to income (primary analysis) and education (secondary analysis), respectively. The outcome of interest for these analyses was a CVH score, based on 7 modifiable behaviors and factors, summed to a total of 0 (worst) to 14 (best) points. We utilized generalized estimating equations to account for the clustering of participants within the same residential areas to estimate the linear association between SES and CVH. RESULTS: The median age of the participants was 55 years, and 64% were women. Nearly one-third of eligible participants had individual incomes <$20,000 and close to 40% lived in the lowest neighborhood income category (<$25,480). Adjusted for age, sex, and neighborhood SES, there was an average increase in CVH score of 0.31 points associated with each 1-category increase in individual income. Similarly, each 1-category increase in neighborhood SES was associated with a 0.19-point increase in CVH score. These patterns held for our secondary analyses, which used educational attainment in place of income. These data did not suggest a synergistic effect of individual- and neighborhood-level SES on CVH. CONCLUSIONS: Our findings suggest a potential causal pathway for disparities in CVH among vulnerable populations. These data can be useful to the JHS community to empower public health and clinical interventions and policies for the improvement of CVH.

Outsmart HPV: Acceptability and short-term effects of a web-based HPV vaccination intervention for young adult gay and bisexual men.

BACKGROUND: Effective interventions to promote human papillomavirus (HPV) vaccination are needed, particularly among populations at increased risk of HPV-related disease. We developed and pilot tested a web-based intervention, Outsmart HPV, to promote HPV vaccination among young gay and bisexual men (YGBM). METHODS: In 2016, we recruited a national sample (n = 150) of YGBM ages 18-25 in the United States who had not received any doses of HPV vaccine. Participants were randomized to receive either standard HPV vaccination information (control) or population-targeted, individually-tailored content (Outsmart HPV intervention). We assessed between group differences in HPV vaccination attitudes and beliefs immediately following the intervention using multiple linear regression. RESULTS: There were no differences in HPV vaccination attitudes, beliefs and intentions between groups at baseline. Compared to participants in the control group, intervention participants reported: greater perception that men who have sex with men are at higher risk for anal cancer relative to other men (b = 0.34); greater HPV vaccination self-efficacy (b = 0.15); and fewer perceived harms of HPV vaccine (b = -0.34) on posttest surveys (all p < .05). Overall, intervention participants reported high levels of acceptability and satisfaction with the Outsmart HPV intervention (all > 4.4 on a 5-point scale). CONCLUSIONS: Findings from this study provide preliminary support for a brief, tailored web-based intervention in improving HPV vaccination attitudes and beliefs among YGBM. An important next step is to determine the effects of Outsmart HPV on HPV vaccine uptake. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT02835755.

Who Uses a Midwife for Prenatal Care and for Birth in the United States? A Secondary Analysis of Listening to Mothers III.

BACKGROUND: Although midwife care is slowly but consistently increasing in the United States, not much is known regarding women who use a midwife. Our objectives were to compare the sociodemographic and health history characteristics, and the quality of patient-provider communication, between women who used a midwife and those who used a physician for prenatal care and/or birth. METHODS: We performed a cross-sectional analysis of the nationally representative Listening to Mothers III survey. We report descriptive findings using weighted proportions and means with standard deviations. We used the two one-sided tests procedure to assess the equivalence of women who used midwives and those who used physicians. RESULTS: Nearly 13% of women used a midwife for prenatal care or as a birth attendant. Women who used a midwife for prenatal care were similar to women who used a physician in most sociodemographic and health history characteristics, as well as their patient-provider communication scores, with the exception of the percentage of White (61.7 ± 5.0 [midwives], 54.3 ± 1.5 [physicians]) and married women (68.7 ± 4.9 [midwives], 60.6 ± 1.5 [physicians]). Women who used a midwife as a birth attendant were similar to women who used a physician as a birth attendant in most characteristics, with the exception of age over 35 years (7.5 ± 1.6 [midwives], 15.7 ± 1.1 [physicians]) and Special Supplemental Nutrition Program for Women, Infants, and Children support (56.8 ± 4.9 [midwives], 50.0 ± 1.6 [physicians]). CONCLUSIONS: Women who use midwives are similar to those who use physicians and our findings do not confirm the common perception that midwife patients are a self-selected group of wealthier, more educated women.

Progression of care among women who use a midwife for prenatal care: Who remains in midwife care?

BACKGROUND: Prenatal care provided by midwives provides a safe and cost-effective alternative to care provided by physicians. However, no studies have evaluated the frequency of women who leave midwifery care, in a hospital setting. Our study objectives were to measure the frequency of transfers of care to physicians, to describe the sociodemographic and pregnancy-related characteristics of women who transferred to the care of a physician during prenatal care and at delivery, and to assess correlates of these transfers. METHODS: We used electronic medical records to perform a retrospective cohort study of women who delivered at The Ohio State University Wexner Medical Center (OSUWMC) and had at least one prenatal care visit within OSUWMC's network. We report descriptive findings, using proportions and means with standard deviations. We used logistic regression, with Firth's bias correction as necessary, to assess correlates of transferring to a physician during prenatal care and at delivery. RESULTS: Most women who initiated prenatal care with a midwife remained in midwifery care throughout delivery, with 4.7% transferring to a physician during prenatal care, and an additional 21.4% transferring to a physician during delivery. After adjusting for pregnancy-related factors, the black race was statistically significantly associated with leaving midwifery care during prenatal care (adjusted odds ratio AOR 3.0 [95% CI 1.4-6.6]) and delivery (AOR 2.5 [95% CI 1.5-4.3]). CONCLUSION: Findings indicate that most women remain in midwifery care throughout pregnancy, but raise important questions with respect to the possible role that race has in pregnancy care.

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.

Electronic health record-based assessment of cardiovascular health: The stroke prevention in healthcare delivery environments (SPHERE) study.

< 3% of Americans have ideal cardiovascular health (CVH). The primary care encounter provides a setting in which to conduct patient-provider discussions of CVH. We implemented a CVH risk assessment, visualization, and decision-making tool that automatically populates with electronic health record (EHR) data during the encounter in order to encourage patient-centered CVH discussions among at-risk, yet under-treated, populations. We quantified five of the seven CVH behaviors and factors that were available in The Ohio State University Wexner Medical Center's EHR at baseline (May-July 2013) and compared values to those ascertained at one-year (May-July 2014) among intervention (n = 109) and control (n = 42) patients. The CVH of women in the intervention clinic improved relative to the metrics of body mass index (16% to 21% ideal) and diabetes (62% to 68% ideal), but not for smoking, total cholesterol, or blood pressure. Meanwhile, the CVH of women in the control clinic either held constant or worsened slightly as measured using those same metrics. Providers need easy-to-use tools at the point-of-care to help patients improve CVH. We demonstrated that the EHR could deliver such a tool using an existing American Heart Association framework, and we noted small improvements in CVH in our patient population. Future work is needed to assess how to best harness the potential of such tools in order to have the greatest impact on the CVH of a larger patient population.

A Comparison of Benefit Limits in Mental Health.

This study provides insight to policy makers and stakeholders on how three types of benefits limits on Medicaid-covered mental health services might affect access for consumers diagnosed with severe mental illness. The study used a retrospective cohort design with data for Medicaid-covered, community-based mental health services provided in Ohio during fiscal year 2010. Log-binomial regression was used for the analysis. Results indicate that limits compared have significant, varying consequences based on Medicaid coverage and diagnoses. When constraining Medicaid costs, policy makers should consider how limits will disrupt care and include clinicians in discussions prior to implementation.

How Long Do Adolescents Wait for Psychiatry Appointments?

Appointment wait times are a neglected dimension of children's access to psychiatry. We systematically examined how long an adolescent waits for a new patient appointment with a psychiatrist for routine medication management. From state directories, we identified 578 providers of adolescent psychiatric care in Ohio. Researchers posing as parents telephoned randomly selected offices, seeking care for a hypothetical 14-year-old patient under different scenarios. Overall, we measured 498 wait times at 140 unique offices. The median wait time was 50 days (interquartile range = 29-81 days). In adjusted models, adolescents with Medicaid waited longer than those with private insurance, especially during the spring (geometric mean = 50.9 vs. 41.9 days; p = 0.02). Wait times also varied markedly by region, with geometric means ranging from 22.4 to 75.1 days (p < 0.01). This study demonstrates that adolescents often experience lengthy wait times for routine care. This methodology represents a useful approach to real-time monitoring of psychiatric services.

Violations of the independent increment assumption when using generalized estimating equation in longitudinal group sequential trials.

In phase 3 clinical trials, ethical and financial concerns motivate sequential analyses in which the data are analyzed prior to completion of the entire planned study. Existing group sequential software accounts for the effects of these interim analyses on the sampling density by assuming that the contribution of subsequent increments is independent of the contribution from previous data. This independent increment assumption is satisfied in many common circumstances, including when using the efficient estimator. However, certain circumstances may dictate using an inefficient estimator, and the independent increment assumption may then be violated. Consequences of assuming independent increments in a setting where the assumption does not hold have not been previously explored. One important setting in which independent increments may not hold is the setting of longitudinal clinical trials. This paper considers dependent increments that arise because of heteroscedastic and correlated data in the context of longitudinal clinical trials that use a generalized estimating equation (GEE) approach. Both heteroscedasticity over time and correlation of observations within subjects may lead to departures from the independent increment assumption when using GEE. We characterize situations leading to greater departures in this paper. Despite violations of the independent increment assumption, simulation results suggest that operating characteristics of sequential designs are largely maintained for typically observed patterns of accrual, correlation, and heteroscedasticity even when using analyses that use standard software that depends on an independent increment structure. More extreme scenarios may require greater care to avoid departures from the nominal type I error rate and power.

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 Life's 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.

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.