Collaborative inference for treatment effect with distributed data-sharing management in multicenter studies.

Data sharing barriers present paramount challenges arising from multicenter clinical studies where multiple data sources are stored and managed in a distributed fashion at different local study sites. Merging such data sources into a common data storage for a centralized statistical analysis requires a data use agreement, which is often time-consuming. Data merging may become more burdensome when propensity score modeling is involved in the analysis because combining many confounding variables, and systematic incorporation of this additional modeling in a meta-analysis has not been thoroughly investigated in the literature. Motivated from a multicenter clinical trial of basal insulin treatment for reducing the risk of post-transplantation diabetes mellitus, we propose a new inference framework that avoids the merging of subject-level raw data from multiple sites at a centralized facility but needs only the sharing of summary statistics. Unlike the architecture of federated learning, the proposed collaborative inference does not need a center site to combine local results and thus enjoys maximal protection of data privacy and minimal sensitivity to unbalanced data distributions across data sources. We show theoretically and numerically that the new distributed inference approach has little loss of statistical power compared to the centralized method that requires merging the entire data. We present large-sample properties and algorithms for the proposed method. We illustrate its performance by simulation experiments and the motivating example on the differential average treatment effect of basal insulin to lower risk of diabetes among kidney-transplant patients compared to the standard-of-care.

Fathers Matter: Black Fathers' Relationships with their Partners during Pregnancy and Postpartum.

PURPOSE: To describe the characteristics of participants in the Fathers Matter study for a better understanding of fathers of the baby who engage in pregnancy research involving primarily Black couples and their relationships with their partners. STUDY DESIGN AND METHODS: The Fathers Matter Study uses a prospective design, identifying father-mother dyads during pregnancy and following them until birth as part of the Biosocial Impacts on Black Births Study. Participants completed prenatal and postpartum questionnaires. RESULTS: Our analyses are based on 111 fathers. Nearly all ( n = 101, 91.1%) of fathers identified as Black and 51.4% ( n = 57) had a high school diploma, graduate equivalency diploma, or higher. About half ( n = 57, 51.4%) reported annual incomes of $10,000 or less. Most reported that relationships with the mother were very close both before ( n = 100, 89.9%) and during ( n = 85, 76.6%) pregnancy. However, substantial variability was found in relationship satisfaction, involvement in the pregnancy, financial support provided, and scales of conflict and support. CLINICAL IMPLICATIONS: We found homogeneity in sociodemographic and basic relationship measures. Complex measures of the father-mother relationships demonstrated considerable variability. Data from fathers may identify their contributions to successful birth outcomes. Understanding relationships between fathers and mothers could identify risk or protective characteristics to be addressed at the family or community levels.

Relationship with the Father of the Baby and Pregnancy-Related Anxiety among Pregnant Black Women.

PURPOSE: Pregnancy-related anxiety may increase the risk of preterm birth. Effective coping strategies and social support may help minimize pregnancy-related anxiety. STUDY DESIGN: Secondary analysis of cross-sectional data. METHODS: A sample of 408 pregnant non-Hispanic Black women completed questionnaires between 19 and 31 weeks gestation. Mediation analysis with structural equation modeling was used to explore effects of the relationship with the father of the baby on pregnancy-related anxiety. RESULTS: Support from the father of the baby was negatively associated with avoidance coping ( r = -.22, p < .001) and pregnancy-related anxiety ( r = - .17, p < .001), whereas conflict with the father of the baby was positively associated with avoidance coping ( r = .37, p < .001) and pregnancy-related anxiety ( r = .29, p < .001). Avoidance coping was positively associated with pregnancy-related anxiety ( r = .34, p < .001). After adjustment, avoidance coping partially mediated the effect of conflict with the father of the baby on pregnancy-related anxiety. CLINICAL IMPLICATIONS: Discussions with women about management of pregnancy-related anxiety should consider her current social support and coping mechanisms. Providers should offer support and resources on adaptive coping strategies.