Clinical data registries store patient health data that are often organized around a single disease, condition, or procedure. The data stored in these registries enable researchers and clinicians to help improve patient’s quality of care and outcomes. For example, registries can track the performance of medical devices over time, which can inform their use and national policies that regulate them. However, these registries can be time- and cost-intensive, and the process for populating and extracting patients’ data from these registries for patient-centered outcomes research (PCOR) can be complex. A coordinated registry network (CRN) could enable research across registries to study multiple interventions, better reflecting patients’ experiences in the real world.
To address these challenges and the need for a comprehensive approach to women’s health, this project was conducted in partnership with the Food and Drug Administration and the National Library of Medicine at the National Institutes of Health.
This project began in 2017 and ended in 2019.
The goals of this project were to develop and test a standards-based approach to establishing a new CRN for women’s health technologies (WHT) and to develop tools that facilitate data collection to populate registries.
The project utilized a phased approach that included the following:
- Conducting an environmental assessment;
- Defining the actors and capabilities required to implement the WHT CRN in the real world;
- Identifying and harmonizing the data elements across the women’s health registries;
- Leveraging existing interoperable health standards; and
- Creating and pilot testing interoperable technology with a registry.
This work led to the development of an implementation guide leveraging work from other PCOR project artifacts: Patient-Reported Outcomes through Health IT, which built upon Structured Data Capture, and Data Access Framework, which was renamed the U.S. Core Data Implementation Guide.
The CRN guide was piloted in partnership with two registries focused on women’s health.
For an abstract model of the CRN workflow from data collection to data access, review the Health Level Seven International® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) Implementation Guide.