DEVELOPMENT OF A COORDINATED REGISTRY NETWORK FOR WOMEN'S HEALTH TECHNOLOGIES
Author(s)
Baird CE1, Marinac-Dabic D2, Darbouze F3, Lang L4, Dumont D5, Sedrakyan A1
1Weill Cornell Medicine, New York, NY, USA, 2U.S. Food and Drug Administration, Silver Spring, MD, USA, 3Office of the National Coordinator for Health Information Technology (ONC), Washington, DC, USA, 4National Library of Medicine (NLM), Bethesda, MD, USA, 5U.S. Food and Drug Administration, Division of Epidemiology, Office of Surveillance and Biometrics, Silver Spring, MD, USA
OBJECTIVES: To develop a core minimum dataset to be used for device- and intervention-based studies and registries for three clinical conditions uniquely affecting women: pelvic organ prolapse, uterine fibroids, and sterilization/long-acting reversible contraception. To address these challenges, we will create a Coordinated Registry Network (CRN) capable of addressing questions on devices and therapies in clinical areas unique to women. METHODS: To develop the CRN, a group of experts was convened for each clinical condition led by professional society leaders, the FDA, academia and industry. An initial set of data elements was created from a review of the literature, regulatory requirements, and existing research efforts. A formal 2-3 round Delphi Method was employed to achieve consensus on a core minimum dataset. A series of questionnaires were sent to the panel and were answered by each expert anonymously and individually. The answers from each questionnaire were collected, collated and analyzed by a study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process, and were discussed with group members via conference call. This process was repeated 2-3 times until a group consensus was reached. RESULTS: The working groups achieved consensus in identifying a core minimum dataset for each clinical condition. Each dataset captures patient demographics, medical history, procedure data, medications, and endpoints during/after treatment. Common data elements among the three clinical conditions were harmonized to ensure interoperability of datasets stemming from future registries. The data elements conform to standards for EHR-based extractions. CONCLUSIONS: There is a growing demand for evidence that better reflects the patient experience during routine care. Registries can help meet this demand by collecting standardized data on real-world patient care. The development of core minimum datasets for these clinical conditions was an important first step in enabling the creation of this CRN.
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PMD122
Topic
Study Approaches
Topic Subcategory
Registries
Disease
Reproductive and Sexual Health