Use of a mobile app to capture supplemental health information during pregnancy: Implications for clinical research.

Purpose: Mobile applications ("apps") may be efficient tools for improving the quality of clinical research among pregnant women, but evidence is sparse. We assess the feasibility and generalizability of a mobile app for capturing supplemental data during pregnancy.

Methods: In 2017, we conducted a pilot study of the FDA MyStudies mobile app within a pregnant population identified through Kaiser Permanente Washington (KPWA), an integrated healthcare delivery system.

The FDA MyStudies app: a reusable platform for distributed clinical trials and real-world evidence studies.

We developed a mobile application and secure patient data storage platform, FDA MyStudies, to address privacy, engagement, and extensibility challenges in mobile clinical research. The system extends the capabilities of the mobile frameworks Apple ResearchKit and ResearchStack through an intuitive front-end application and secure storage environment that can support health research studies. The platform supports single or multisite studies via role-based access and can be implemented within highly secure data environments.

Cross-Network Directory Service: Infrastructure to enable collaborations across distributed research networks.

Introduction: Existing large-scale distributed health data networks are disconnected even as they address related questions of healthcare research and public policy. This paper describes the design and implementation of a fully functional prototype open-source tool, the Cross-Network Directory Service (CNDS), which addresses much of what keeps distributed networks disconnected from each other.

Methods: The set of services needed to implement a Cross-Directory Service was identified through engagement with stakeholders and workgroup members.