There is a growing demand for evidence to evaluate the performance of women’s health devices related to sterilization, uterine fibroids (UF), pelvic organ prolapse (POP), and stress urinary incontinence (SUI), and to produce evidence that better reflects the patient experience during routine care. Registries can help meet this demand by collecting data on real-world patient care and the specific devices used for that care. However, registries can be expensive to maintain if they are not efficiently designed. Collecting long-term outcome data is also challenging and requires major investments. While each medical condition and relevant registry is unique, in most instances, these multiple registries collect the same demographic and comorbidity information but are not working together to gain efficiencies.
With this initiative to invest in infrastructure development to address the challenges in women’s health, MDEpiNet has created a WHT-CRN. This CRN illustrates the strength of big data to address specific questions and advances the registry model to use tools such as structured data capture and HL7 FHIR to efficiently extract, standardize and exchange data across multiple real-world data sources. The CRN concept was originally developed by the National Medical Device Registry Task Force and defined as “strategically partnered electronic health information systems that support 1) the implementation of structured device identifiers, core minimum data elements and definitions and 2) the ability to share complementary data across information systems.” The WHT-CRN aims to demonstrate the application of this vision in the clinical context of specific devices used in clinical areas unique to women.
The primary objective of the WHT-CRN is to develop tools to facilitate data collection within the existing and new registries by leveraging efficient clinical data capture mechanisms, taking advantage of relevant claims and EHRs data sources and creating patient-facing applications for capturing patient-reported outcomes. The secondary objective is to demonstrate that data in the CRN can be used to evaluate the effectiveness and safety of various device and non-device treatment options; provide a framework for the conducting of clinical studies within CRN, including industry-sponsored studies required to fulfill the FDA’s request for pre-market and post-market regulatory activities; enable more effective assessment of surgeon and patient outcomes related to device technology use as part of quality improvement activities (including for CMS purposes); and create collaborative opportunities for new and existing registries related to women’s health technologies to work with each other and link to other major data sources and networks.
WHT-CRN is a major MDEpiNet collaborative effort with a major grant to MDEpiNet Coordinating Center at Weill Cornel Medicine. It is governed by FDA and partners such as ONC, NLM, The Assistant Secretary for Planning and Evaluation (ASPE), ACOG, American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, AHRQ, and Patient Community (e.g., Fibroids Foundation, APOPS, Voices for PFD, etc.). The governing bodies responsible for advancing the WHT-CRN effort include: WHT-CRN leadership committee; WHT-CRN coordinating center; WHT-CRN clinical working groups; patient partners; informatics working group; funding partners (non-FDA); industry; payers; and professional societies.
All WHT-CRN co-chairs have established an MOU with the MDEpiNet Coordinating Center to join the CRN COP and are members of the EOC. Use of WHT-CRN data will be governed by specific DUAs between Weill Cornell Medicine, participating registries, and participating medical device companies.
The patient population in WHT-CRN includes patients in four major clinical areas of women’s health – POP, SUI, UF and Sterilization/LARC. Aside from growing registries, there were approximately 560,000 elderly women who underwent POP and SUI sling procedures between 2008 and 2016, in Medicare claims data. These data are comprised of both facility and physician billings. NY State discharge database research shows that approximately 50,000 women underwent sterilization between 2005 and 2016, approximately 85,000 women underwent POP and SUI sling procedures between 2008 and 2016, and approximately 220,000 women underwent UF treatment between 2007 and 2016.
UF – Registry, claims and patient generated data: For registry data, the WHT-CRN is collaborating with COMPARE-UF, a nationwide registry of women with uterine fibroids that hopes to answer questions about the outcomes of different treatment options. For claims data, members of the WHT-CRN Uterine Fibroids working group have performed several claims-based research studies to evaluate devices used for uterine fibroids. The primary procedures evaluated among women with uterine fibroids within claims thus far are endometrial ablation, myomectomy, hysterectomy, and uterine artery embolization. For patient-generated data, recommendations from Patient Reported Outcome Measures (PROMs) have been evaluated for patients with uterine fibroids. These include the UFS-QOL (UF Symptom and Quality of Life Questionnaire), the SF-36 (MOS 36-item Short Form Health Survey), and the EQ-5D (European Quality of Life Instrument).
SUI – Registry, claims and patient generated data
For registry data, the WHT-CRN is funding the AUGS Urogynecology Quality Registry (AQUIRE), which is a national urogynecology-focused registry open to all physicians and designed to measure and report healthcare quality and patient outcomes. The WHT-CRN activities have worked to establish two new modules within AQUIRE: one for SUI and one for POP. The SUI surgery module is currently enrolling patients and is planning to recruit 2000 patients. For claims data, New York State data have been the primary claims data source utilized to evaluate a number of effectiveness and safety concerns associated with medical devices indicated for the treatment of SUI. For patient-generated data, there are several SUI instruments/questionnaires, including a 6-week follow-up and a 1-year follow-up, that are included in the SUI module. ICIQ is a validated questionnaire that is used as a part of the 1-year follow-up. These questionnaires have two versions, one for mesh patients and the other for non-mesh patients. Additionally, the WHT-CRN is working on the development of a patient-facing mobile app to assist patients in submitting PROs.
POP – Delphi method
The POP working group used the Delphi method to create a core minimum dataset to evaluate the safety and efficacy of devices used for POP procedures. Current work focuses on identifying PROs of POP surgery, which were not included in the original set of data elements from the Delphi process. With WCM coordinating center facilitation, AUGS is collaborating with ONC as a pilot of the IG for the WHT-CRN, using the POP data elements as test CRN instruments to be published on the FHIR server and FHIR app. After the pilot, the planned version 2 of the POP registry will include PROs as identified by our patient group as well as collecting unique device identifiers and validating that data against the AccessGUDID database. In terms of patient-generated data, the current instruments/ questionnaires used to evaluate POP include: PFDI-20, Patient Global Impression of Improvement (PGI-I), Pelvic Floor Impact Questionnaire (PFIQ-7), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF), and PROMIS Global Health Questionnaire.
Sterilization/LARC – Delphi method
The Sterilization/LARC working group used the Delphi method to create a core minimum dataset to collect data to evaluate the safety and efficacy of devices used for sterilization and LARC procedures. The process of creating a registry for this condition is under discussion with relevant stakeholders. Members of the WHT-CRN Sterilization/LARC working group have performed extensive claims-based research studies to evaluate devices used for sterilization procedures. After successful claims data analyses conducted by our team the Essure device was taken out of the market and the current focus for this working group is on LARC. The group plans to use MDEpiNet HIVE for data implementation and pilot testing.
The WHT-CRN is conducting pilots to test the WHT-CRN infrastructure for the following clinical areas: UF, SUI, and POP.
The Uterine Fibroids pilot is being conducted by the UCSF, led by Dr. Vanessa Jacoby, who is collaborating with other appropriate UF stakeholders. UCSF is currently conducting a nationwide study for women who would like to share their experience with radiofrequency ablation (AcessaTM) to treat uterine fibroids (the ULTRA study). The study team will pilot the UF core minimum dataset within the ULTRA study. The data points will be structured to serve as a template for a case report form in the research environment (e.g. post-market surveillance) and/or to embed within the electronic health record for use in a general clinical care workflow. The study sponsor, Acessa Health, has agreed to collaborate with this project to allow the new data elements to be piloted in the ULTRA study.
The SUI pilot will support the implementation and refinement of specifications in the WHT-CRN Implementation Guide (IG) in a test environment, production environment (e.g. clinical or provider setting) and/or manufacturing setting. The purpose of the pilot is to test the CRN capabilities mapped to specific actors and interactions of the technical specifications of the CRN IG, including the underlying standards and common clinical data sets that are being developed as part of this project for collecting and sharing women’s health data. Currently, AUGS is working with ONC to stand up a FHIR server and FHIR app. The AUGS-SUI clinical team is finalizing the data elements for terminology in preparation for storing in the instrument repository. AQUIRE gets information from AccessGUDID based on UDI. The new module will continue this functionality.
The POP pilot will support the implementation and refinement of specifications in the WHT-CRN Implementation Guide (IG) in a test environment, production environment (e.g. clinical or provider setting) and/or manufacturing setting. The purpose of the pilot is to test the CRN capabilities mapped to specific actors and interactions of the technical specifications of the CRN IG, including the underlying standards and common clinical data sets that are being developed as part of this project for collecting and sharing women’s health data. The POP pilot is working to stand up a FHIR server on MDEpiNet HIVE platform, replicate/customize the FHIR app for POP, test/make available on mobile and connected devices, work with clinical team to determine/refine/finalize the data elements for terminology in preparation for storing in the instrument repository (for other conditions), gather clinician feedback on app design and usability, and update and refine app based on feedback.
There are also ongoing projects using claims database. We have recently examined the long-term reoperation after sterilization procedures using New York State data. A similar project to examine long-term outcomes following POP procedures is being carried out. For SUI sling, a project is being conducted to identify predictors of long-term reoperations and erosion diagnosis after initial sling procedures. The predictor analysis is utilizing both traditional predictive modeling and machine learning techniques to identify predictors of long-term outcomes.
For more information, please contact the FDA Project Director, Dr. Danica Marinac-Dabic (Danica.Marinac-Dabic@fda.hhs.gov), or Cornell University PI, Dr. Art Sedrakyan (email@example.com).
Lead Agencies Supporting the Women's Health CRN
CRN Data Partners
CRN Data Partners: link to other major data networks for longitudinal assessment. Use structured data capture and FHIR standards for efficient data ex-traction.
- Pelvic Floor Disorders Registry (PFDR)
- COMPARE-UF (Uterine Fibroids)
- Sterilization and Long-Acting Reversible Contraception Technologies (in development)
Link to other major data networks for longitudinal assessment. Use structured data capture and FHIR standards for efficient data extraction.