STATUS: Completed Project
Clinical registries collect and maintain detailed clinical data on millions of patients receiving treatment involving medical devices. Registries also provide critical infrastructure that can be used for future analyses related to patient care and outcomes. There are clinical conditions that uniquely affect women (e.g., pelvic floor disorders, uterine fibroids, and elective female sterilization). A consortium of registries focused on women’s health using data elements and measures expressed in standard structured definitions with the capability to capture and exchange data via software apps and application programming interfaces (APIs) is valuable to researchers beyond what can be accomplished in a single registry.
A number of federal partners worked on registries to establish data collection and analysis infrastructure that provides a basis for postmarked surveillance of medical devices and for development of evidence to support medical device innovation. The data sets, methods, and tools developed are used for quality benchmarking, coverage decisions, and comparative effectiveness research. These three registries were the focus of the Coordinated Registry Network (CRN) for Women’s Health Technology. These registries include the National Pelvic Floor Disorder (NPFD) registry, the COMPARE UF registry for fibroid treatments, and the Collaborative Registry of Sterilization Therapies.
PROJECT PURPOSE & GOALS
This collaborative project with FDA, ONC, and NLM aligned existing registries of women’s health technologies through a CRN. The registry network included two existing nationwide registries, COMPARE UF registry for fibroid treatments; and the National Pelvic Floor Disorder (NPFD) registry, and the new Collaborative Registry of Sterilization Therapies. These registries were linked to other major data networks including partners in the FDA’s Sentinel system, Medicare, and Medicaid data, PCORnet clinical data networks, and available state data. The CRN incorporated data from patient reported outcomes (PROs) and employed Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) standards for Structured Data Capture (SDC) from EHRs, to both enhance these registries and enrich PCOR data infrastructure used to treat or manage women’s health conditions. This resource served as infrastructure for evaluation of medical devices in clinical areas unique to women. The project was expected to reduce the complexity and certain costs of conducting comparative effectiveness research, and to inform the evaluation of therapy combinations within defined cohorts of women.
Establish a CRN for research on women’s health technologies by developing a community of stakeholders interested in working together to make system changes in an area of women’s health device safety and effectiveness.
Develop tools to facilitate collection of data within registries, improve the value and sustainability of registries through leveraging electronic data, and demonstrate that the data in the registries can be reused to answer additional questions through the addition of new data elements and patient cohorts.
PROJECT ACHIEVEMENTS & HIGHLIGHTS
- The project team established four clinical working groups: sterilization/long-acting reversible contraceptives, pelvic organ prolapse, stress urinary incontinence, and uterine fibroids. The team also formed a working group of informatics leaders to translate clinical data sets, definitions, and value sets into standard vocabularies. Each clinical working group arrived at a consensus on a core minimum data set for each of the four conditions, and successfully identified a set of common data elements (CDEs).
- The project created a repository to coordinate data element standardization and harmonization. The repository included a landscape analysis that examined the state of women’s health CRNs and how the registries capture, utilize, and share data.
- The team submitted HL7 FHIR Implementation Guide (IG): Women’s Health Technology Coordinated Registry Network (CRN), Release 1 to HL7. Enhancements were made to the NIH CDE Repository in support of the IG. The team completed the identification of comparable concepts across the different clinical working groups for the purpose of creating a harmonized set of CRN data elements.
- The project team conducted several pilots and demonstration projects. One used existing registries to improve WHT-CRN FHIR IG recommendations for use in a test or production environment. Another integrated the uterine fibroids core minimum data set into the Uterine Leiomyoma Treatment with Radiofrequency Ablation (ULTRA) registry (UCSF), to be used for research, education, and quality purposes.
- As part of an effort to ensure sustainability of the project work, the team pilot-tested of two modules. The first was the Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse module, which is included in the American Urogynecologic Society AQUIRE registry. The second module tested the core minimum data elements for Pelvic Organ Prolapse and supported the implementation and refinement of specifications in the WHT-CRN IG in a test environment.
PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES
- The FDA published a final report, “The Women’s Health Technologies Coordinated Registry Network (WHT CRN).” The report is available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/wht-crn-final-reoprt-to-aspe.pdf
- ONC published a final report, “Developing a Strategically Coordinated Registry Network (CRN) for Women’s Health Technologies,” in June 2020. The report is available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/Strategically-CRN-for-Womens-Health-Technologies-Final-Report.pdf
- ONC published a blog post titled, “PCOR Coordinated Registry Network for Women’s Health Technologies.” The post is available here: https://www.healthit.gov/buzz-blog/interoperability/pcor-coordinated-registry-network-for-womens-health-technologies
- ONC conducted an environmental scan of women’s health registries and CRNs and their use of health standardsand other relevant tools. The report descries key findings and emerging themes, challenges, and areas for future consideration. The report is available here: https://confluence.hl7.org/display/BRR/CRN+-+FHIR+Investigation+and+Implementation+Guide?preview=/19136854/31687480/ONC%20CRN%20Enviromental%20Assesment%206-11-2018.pdf
- In collaboration with the Medical Device Epidemiology Network (MDEpiNet), the WHT-CRN project team developed a project website. The website is accessible at https://www.mdepinet.net/womenshealth and links to relevant working group activities.
- The project team established a CRN project page under the HL7 Biomedical Research and Regulation Confluence site to track all ballot artifacts: http://confluence.hl7.org/display/BRR/Biomedical+Research+and+Regulation
- The team submitted a CRN Implementation Guide FHIR proposal: http://wiki.hl7.org/index.php?title=CRN_FHIR_IG_Proposal
- The HL7 FHIR CRN Implementation Guide is available here: http://hl7.org/fhir/us/womens-health-registries/2019May/
- The WHT-CRN common core data set, inclusive of the four core clinical data sets, can be found at the NIH CDE Repository. The form containing the initial core minimum set of harmonized data elements in the NIH CDE Repository is available here: https://cde.nlm.nih.gov/formView?tinyId=XJwYSNJ4I
- The initial set of minimum core harmonized data elements is available in an Excel tool for collecting and developing data elements for patient registries, here: https://drive.google.com/file/d/1GGRZOJcLBAW_p_czcfaSe7xAirs8KPw6/view?usp=sharing
- The SUI Surgery Module, in conjunction with the American Urogynecologic Society AQUIRE registry, can be found here: https://www.augs.org/clinical-practice/aquire-sui-surgery-module/
- A webinar on the WHT-CRN featuring speakers from the FDA, ONC, American Urogynecologic Society, and Weil Cornell Medicine is available here: https://ospcortfreporting.norc.org/content/file?id=113
Below is a list of ASPE-funded PCORTF projects that are related to this project
Bridging the PCOR Infrastructure and Technology Innovation through Coordinated Registry Networks (CRN) Community of Practice – This FDA project’s purpose is to strengthen the CRNs as a real-world data source for high quality, relevant, reliable, timely, and actionable evidence to improve patient outcomes of medical devices, specifically for technologies affecting women’s health. The CRN COP will promote registries’ maturity through harmonization of their minimum core data sets, commitment to incorporation of device identification, and patient engagement throughout and by facilitating the linking of registries to other data sources.
Development of Data Infrastructure for Use of EHRs in Comparative Effectiveness Research (ONC/NLM CDEs) - The ONC and NLM common data elements (CDE) project was developed to standardize the collection and exchange of data, i.e., CDEs. For the electronic Case Report Forms (eCRFS), the project developed the standards for the eCRF structure/template as well as the CDEs that were used with them. These forms were ‘extensible forms’ which means that they were developed in a high-level computer language. This computer language facilitates defining the form as a single, stand-alone object. Taken together, these two ONC/NLM CDE products make evident that the project fits the functionality of Standardized Collection of Standardized Data.