A Comparison of Recruitment Strategies for a Long-Term Study at Two Maternal Stages: Effectiveness of Recruitment During Pregnancy vs. After Childbirth

Introduction. National Children’s Study (NCS) Provider Based Sampling (PBS) aims to conduct a pilot study to test cost, acceptability and feasibility of recruiting a representative sample of women/children using two recruitment strategies: through prenatal providers and hospitals. Methods. A sampling frame consisting of all providers of prenatal and delivery care within and 10-miles outside Worcester County, 16 provider and 3 hospital locations were selected as point of entry for study recruitment. During 1st prenatal care visits or post-delivery at these locations, face-to-face contact was utilized to: a) identify study eligibility and b) assess study recruitment. Preliminary Results. Certified Data Collectors made contact with prescreened women. Consent rates of women at prenatal provider locations were lower than the consent rates in hospital locations. On average, results have shown twice as many consents could be obtained per day at hospital locations than at provider locations. Preliminary Conclusions. Although both strategies utilized direct rapport, the two recruitment methods were associated with different consent rates. Consideration of preliminary results may lead one to consider recruitment after childbirth for several reasons: 1) greater likelihood of having opportunity to discuss study with the woman and partner from outset; 2) opportunity to check back with undecided women easily 3) longer periods to answer questions and conduct screening and consent; 4) support of nursing staff to foster participation; 5) daily presence of NCS staff; and 6) reality of infant’s birth to spur mother to consent. Recruitment during pregnancy visits may yield lower rates; further examination may be necessary to overcome challenges such as: 1) burden of adding recruitment session to often long and anxiety-laden1st prenatal visit; 2) need to develop rapport quickly during brief time periods; 3) making contact with potential participants outside of provider office when recruitment is not completed

Marginal structural models for the estimation of the risk of Diabetes Mellitus in the presence of elevated depressive symptoms and antidepressant medication use in the Women\u27s Health Initiative observational and clinical trial cohorts

BACKGROUND: We evaluate the combined effect of the presence of elevated depressive symptoms and antidepressant medication use with respect to risk of type 2 diabetes among approximately 120,000 women enrolled in the Women\u27s Health Initiative (WHI), and compare several different statistical models appropriate for causal inference in non-randomized settings. METHODS: Data were analyzed for 52,326 women in the Women\u27s Health Initiative Clinical Trials (CT) Cohort and 68,169 women in the Observational Study (OS) Cohort after exclusions. We included follow-up to 2005, resulting in a median duration of 7.6 years of follow up after enrollment. Results from three multivariable Cox models were compared to those from marginal structural models that included time varying measures of antidepressant medication use, presence of elevated depressive symptoms and BMI, while adjusting for potential confounders including age, ethnicity, education, minutes of recreational physical activity per week, total energy intake, hormone therapy use, family history of diabetes and smoking status. RESULTS: Our results are consistent with previous studies examining the relationship of antidepressant medication use and risk of type 2 diabetes. All models showed a significant increase in diabetes risk for those taking antidepressants. The Cox Proportional Hazards models using baseline covariates showed the lowest increase in risk , with hazard ratios of 1.19 (95 % CI 1.06 - 1.35) and 1.14 (95 % CI 1.01 - 1.30) in the OS and CT, respectively. Hazard ratios from marginal structural models comparing antidepressant users to non-users were 1.35 (95 % CI 1.21 - 1.51) and 1.27 (95 % CI 1.13 - 1.43) in the WHI OS and CT, respectively - however, differences among estimates from traditional Cox models and marginal structural models were not statistically significant in both cohorts. One explanation suggests that time-dependent confounding was not a substantial factor in these data, however other explanations exist. Unadjusted Cox Proportional Hazards models showed that women with elevated depressive symptoms had a significant increase in diabetes risk that remained after adjustment for confounders. However, this association missed the threshold for statistical significance in propensity score adjusted and marginal structural models. CONCLUSIONS: Results from the multiple approaches provide further evidence of an increase in risk of type 2 diabetes for those on antidepressants

Framing Hospital Engagement for the Recruitment of a Birth Cohort for the NCS: Lessons Learned for Ensuring Collaboration in Worcester County

In 2011, three designated NCS Study Centers began preparatory work for field implementation of a planned recruitment strategy called Provider Based Sampling (PBS). In each PBS primary sampling unit, three hospitals were selected to test the feasibility of recruiting a cohort of 125 women and their babies around delivery time. The selected hospitals for Worcester account for nearly 80% of County births and can be categorized into three distinct facility types and patient catchment areas: an academic medical center; a university-affiliated but independent community hospital; and a private for-profit community hospital with market share competitor of the academic medical center. Methods: We used tailored negotiations and engagement strategies to gain the cooperation and engagement of targeted hospitals/birthing centers. Preliminary Conclusions: The lessons learned from this exercise are:• Time to gain hospital engagement and clearance to initiate study activities ranges anywhere from 2 weeks to 2 months and depends largely upon the type of the institution, the profile of the Negotiator, and the nature of the scope of work.• A greater likelihood of hospital engagement in the NCS seems to be associated with the depth of existing relationships between the Study Center and targeted hospitals.• Thoughtful interactions and timely discussions with the key institutional stakeholders (either individually or in groups) are important to achieve collaboration and engagement.• Balancing sensitivity to clinical cultures and settings while preserving research integrity is essential for study implementation in busy hospital/clinical environments.• Planning for site compensation and/or the ability to support local clerical staff to help with study activities must be considered as a means to facilitate negotiations and site engagement.• Adequate resources must be planned for successful implementation and execution of research activities in settings (e.g community hospitals) unfamiliar with research activities.• Involvement of nursing personnel is crucial for successful implementation of any protocol

Assessment of Parental Mental Disorders in the National Children’s Study (NCS)

Introduction: Parental mental disorders are powerful risk factors for children’s behavioral and mental disorders, making it critical to obtain estimates of parental mental disorders in NCS baseline assessments. These disorders are usually clinically assessed and diagnosed using lengthy interview instruments. This study will validate a brief set of mental health screens against the gold-standard Composite International Diagnostic Interview (CIDI). Methods: Sample: Up to 1200 English-speaking pregnant women and their male partners, aged \u3e17 with over-sampling of racial and ethnic minorities. Instruments: A brief 25-minute set of REDCap based screening scales will be administered. Probability sub-samples of 450-600 respondents with or without DSM-IV diagnoses will be selected for clinical reappraisal using the CIDI. Patients without DSM-IV diagnoses but with subsyndromal disorders will be used to optimize the sensitivity and specificity of screening scales. Diagnostic Assessment: Major depression, bipolar spectrum disorders, generalized anxiety, panic, post-traumatic stress, and substance abuse will be assessed. Analytic Methods: Kappa statistics, Receiver Operating Curve and regression methods will be used to evaluate concordance between diagnoses from screening scales and the CIDI at the aggregate and individual levels. Sensitivity and specificity will be reported for the cohort and separately for mothers and fathers as well as racial and ethnic minorities. Significance: This is the largest investigation of the epidemiology of mental disorders in a representative sample of community based pregnant mothers and their male partners. Information will be used to study the importance of parental psychopathology in the emergence of mental disorders in children over 21 years of follow-up of the parents and their children

Determinants of Racial/Ethnic Disparities in Incidence of Diabetes in Postmenopausal Women in the U.S.: The Women’s Health Initiative 1993–2009

OBJECTIVE To examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women’s Health Initiative. RESEARCH DESIGN AND METHODS Data on race/ethnicity, baseline diabetes prevalence, and incident diabetes were obtained from 158,833 women recruited from 1993–1998 and followed through August 2009. The relationship between race/ethnicity, other potential risk factors, and the risk of incident diabetes was estimated using Cox proportional hazards models from which hazard ratios (HRs) and 95% CIs were computed. RESULTS Participants were aged 63 years on average at baseline. The racial/ethnic distribution was 84.1% non-Hispanic white, 9.2% non-Hispanic black, 4.1% Hispanic, and 2.6% Asian. After an average of 10.4 years of follow-up, compared with whites and adjusting for potential confounders, the HRs for incident diabetes were 1.55 for blacks (95% CI 1.47–1.63), 1.67 for Hispanics (1.54–1.81), and 1.86 for Asians (1.68–2.06). Whites, blacks, and Hispanics with all factors (i.e., weight, physical activity, dietary quality, and smoking) in the low-risk category had 60, 69, and 63% lower risk for incident diabetes. Although contributions of different risk factors varied slightly by race/ethnicity, most findings were similar across groups, and women who had both a healthy weight and were in the highest tertile of physical activity had less than one-third the risk of diabetes compared with obese and inactive women. CONCLUSIONS Despite large racial/ethnic differences in diabetes incidence, most variability could be attributed to lifestyle factors. Our findings show that the majority of diabetes cases are preventable, and risk reduction strategies can be effectively applied to all racial/ethnic groups

Determinants of Racial/Ethnic Disparities in Incidence of Diabetes in Postmenopausal Women in the U.S.: The Women\u27s Health Initiative 1993-2009

OBJECTIVE: To examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women\u27s Health Initiative. RESEARCH DESIGN AND METHODS: Data on race/ethnicity, baseline diabetes prevalence, and incident diabetes were obtained from 158,833 women recruited from 1993-1998 and followed through August 2009. The relationship between race/ethnicity, other potential risk factors, and the risk of incident diabetes was estimated using Cox proportional hazards models from which hazard ratios (HRs) and 95% CIs were computed. RESULTS: Participants were aged 63 years on average at baseline. The racial/ethnic distribution was 84.1% non-Hispanic white, 9.2% non-Hispanic black, 4.1% Hispanic, and 2.6% Asian. After an average of 10.4 years of follow-up, compared with whites and adjusting for potential confounders, the HRs for incident diabetes were 1.55 for blacks (95% CI 1.47-1.63), 1.67 for Hispanics (1.54-1.81), and 1.86 for Asians (1.68-2.06). Whites, blacks, and Hispanics with all factors (i.e., weight, physical activity, dietary quality, and smoking) in the low-risk category had 60, 69, and 63% lower risk for incident diabetes. Although contributions of different risk factors varied slightly by race/ethnicity, most findings were similar across groups, and women who had both a healthy weight and were in the highest tertile of physical activity had less than one-third the risk of diabetes compared with obese and inactive women. CONCLUSIONS: Despite large racial/ethnic differences in diabetes incidence, most variability could be attributed to lifestyle factors. Our findings show that the majority of diabetes cases are preventable, and risk reduction strategies can be effectively applied to all racial/ethnic groups

Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads

OBJECTIVE: In 2010, the National Children\u27s Study launched 3 alternative recruitment methods to test possible improvements in efficiency compared with traditional household-based recruitment and participant enrollment. In 2012, a fourth method, provider-based sampling (PBS), tested a probability-based sampling of prenatal provider locations supplemented by a second cohort of neonates born at a convenience sample of maternity hospitals. METHODS: From a sampling frame of 472 prenatal care provider locations and 59 maternity hospitals, 49 provider and 7 hospital locations within or just outside 3 counties participated in study recruitment. During first prenatal care visits or immediately postdelivery at these locations, face-to-face contact was used to screen and recruit eligible women. RESULTS: Of 1450 screened women, 1270 were eligible. Consent rates at prenatal provider locations (62%-74% by county) were similar to those at birth locations (64%-77% by county). During 6 field months, 3 study centers enrolled a total prenatal cohort of 530 women (the majority in the first trimester) and during 2 months enrolled a birth cohort of an additional 320 mother-newborn dyads. As personnel became experienced in the field, the time required to enroll a woman in the prenatal cohort declined from up to 200 hours to 50 to 100 hours per woman recruited. CONCLUSIONS: We demonstrated that PBS was feasible and operationally efficient in recruiting a representative cohort of newborns from 3 diverse US counties. Our findings suggest that PBS is a practical approach to recruit large pregnancy and birth cohorts across the United States

Depressive symptoms, Antidepressant Use and Diabetes in a Large Multiethnic National Sample of Postmenopausal Women

OBJECTIVE:To examine elevated depressive symptoms and antidepressant use in relation to diabetes incidence in the Women\u27s Health Initiative. RESEARCH DESIGN AND METHODS: A total of 161,808 postmenopausal women were followed for over an average of 7.6 years. Hazard ratios (HRs) estimating the effects of elevated depressive symptoms and antidepressant use on newly diagnosed incident diabetes were obtained using Cox proportional hazards models adjusted for known diabetes risk factors. RESULTS: Multivariable-adjusted HRs indicated an increased risk of incident diabetes with elevated baseline depressive symptoms (HR 1.13 [95% CI 1.07-1.20]) and antidepressant use (1.18 [1.10-1.28]). These associations persisted through year 3 data, in which respective adjusted HRs were 1.23 (1.09-1.39) and 1.31 (1.14-1.50). CONCLUSIONS: Postmenopausal women with elevated depressive symptoms who also use antidepressants have a greater risk of developing incident diabetes. In addition, longstanding elevated depressive symptoms and recent antidepressant medication use increase the risk of incident diabetes

Relations of Depressive Symptoms and Antidepressant Use to Body Mass Index and Selected Biomarkers for Diabetes and Cardiovascular Disease

Objectives. We investigated whether depressive symptoms and antidepressant use are associated with biomarkers for glucose dysregulation and inflammation, body mass index (BMI), and waist circumference. Methods. Postmenopausal women were recruited into the Women\u27s Health Initiative from 1993 to 1998, and data were collected at regular intervals through 2005. We used multiple linear regression models to examine whether depressive symptoms and antidepressant use are associated with BMI, waist circumference, and biomarkers. Results. Analysis of data from 71 809 women who completed all relevant baseline and year 3 assessments showed that both elevated depressive symptoms and antidepressant use were significantly associated with higher BMI and waist circumference. Among 1950 women, elevated depressive symptoms were significantly associated with increased insulin levels and measures of insulin resistance. Analyses of baseline data from 2242 women showed that both elevated depressive symptoms and antidepressant use were associated with higher C-reactive protein levels. Conclusions. Monitoring body habitus and other biomarkers among women with elevated depression symptoms or taking antidepressant medication may be prudent to prevent diabetes and cardiovascular disease. (Am J Public Health. Published online ahead of print June 13, 2013: e1-e10. doi:10.2105/AJPH.2013.301394)

Statin Use and Risk of Diabetes in Postmenopausal Women in the Women’s Health Initiative

BACKGROUND: This study investigates whether the incidence of new-onset diabetes mellitus (DM) is associated with statin use among postmenopausal women participating in the Women\u27s Health Initiative (WHI). METHODS: The WHI recruited 161,808 postmenopausal women aged 50 to 79 years at 40 clinical centers across the United States from 1993 to 1998 with ongoing follow-up. The current analysis includes data through 2005. Statin use was captured at enrollment and year 3. Incident DM status was determined annually from enrollment. Cox proportional hazards models were used to estimate the risk of DM by statin use, with adjustments for propensity score and other potential confounding factors. Subgroup analyses by race/ethnicity, obesity status, and age group were conducted to uncover effect modification. RESULTS: This investigation included 153,840 women without DM and no missing data at baseline. At baseline, 7.04% reported taking statin medication. There were 10,242 incident cases of self-reported DM over 1,004,466 person-years of follow-up. Statin use at baseline was associated with an increased risk of DM (hazard ratio [HR], 1.71; 95% CI, 1.61-1.83). This association remained after adjusting for other potential confounders (multivariate-adjusted HR, 1.48; 95% CI, 1.38-1.59) and was observed for all types of statin medications. Subset analyses evaluating the association of self-reported DM with longitudinal measures of statin use in 125,575 women confirmed these findings. CONCLUSIONS: Statin medication use in postmenopausal women is associated with an increased risk for DM. This may be a medication class effect. Further study by statin type and dose may reveal varying risk levels for new-onset DM in this population