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

Area of Science:

• Reproductive Health
• Medical Device Technology
• Health Informatics

Background:

• A multistakeholder expert group was convened under the Women's Health Technology Coordinated Registry Network (WHT-CRN).
• The group aimed to establish a national infrastructure for capturing the performance of long-acting and permanent contraceptives.
• Key objectives included defining the role and feasibility of the CRN and identifying essential data elements for assessing contraceptive technologies.

Purpose of the Study:

• To achieve consensus on a core minimum data set for the Women's Health Technology Coordinated Registry Network (WHT-CRN).
• To identify critical data elements for evaluating the safety and effectiveness of contraceptive medical products.
• To lay the foundation for a national infrastructure to capture contraceptive performance data.

Main Methods:

• A Delphi survey method was employed with a multistakeholder expert panel.
• Anonymously administered surveys were conducted over a 6-month period, with iterative analysis and discussion.
• Consensus was achieved through multiple rounds of surveys and conference calls.

Main Results:

• Twenty-three experts participated in the Delphi process, with high participation rates (83% and 100% in rounds 1 and 2).
• Consensus was reached on 121 core data elements.
• These elements encompass a comprehensive range of information, including patient history, procedure details, product specifics, complications, and outcomes related to safety and effectiveness.

Conclusions:

• A consensus-based core data set was successfully established by the WHT-CRN expert group.
• This data set will facilitate the study of current and future contraceptives.
• The identified data elements are crucial for informing patient and provider decisions and improving the understanding of contraceptive safety and effectiveness.