Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network

• Published in: BMJ surgery, interventions, & health technologies interventions, & health technologies, 2022-11, Vol.4 (Suppl 1), p.e000075
• Main Authors: Baird, Courtney E, Guiahi, Maryam, Chudnoff, Scott, Loyo-Berrios, Nilsa, Garcia, Stephanie, Jung, Mary, Gressler, Laura Elisabeth, Mao, Jialin, Hodshon, Beth, Sedrakyan, Art, Andrews, Sharon, Colden, Kelly, Roberts, Jason, Anderson, Abby, Sewell, Catherine, Marinac-Dabic, Danica
• Format: Article
• Language: English
• Subjects: Birth control; contraceptive devices; Datasets; Decision making; delphi; Electronic health records; Information systems; Medical equipment; Medical technology; obstetrics and gynecology devices; Original Research; Product life cycle; real world evidence; Stakeholders; Surveillance; Task forces; women's health; Working groups
• ISSN: 2631-4940; 2631-4940
• DOI: 10.1136/bmjsit-2020-000075

ObjectivesA multistakeholder expert group under the Women’s Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies.DesignWe applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved.ResultsTwenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes.ConclusionsThe WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women’s health stakeholders.