TY - JOUR T1 - Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies JF - BMJ Surgery, Interventions, & Health Technologies DO - 10.1136/bmjsit-2021-000094 VL - 4 IS - Suppl 1 SP - e000094 AU - Courtney E Baird AU - Evan Myers AU - Vanessa Jacoby AU - Laura Elisabeth Gressler AU - Sateria Venable AU - Allison O'Neill AU - Veronica Price AU - Angie Lee AU - Jason Roberts AU - Sharon Andrews AU - Art Sedrakyan AU - Danica Marinac-Dabic Y1 - 2022/11/01 UR - http://sit.bmj.com/content/4/Suppl_1/e000094.abstract N2 - Objectives The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies.Design A Delphi method approach was employed to achieve consensus on a core minimum data set for the 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. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved.Results Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data.Conclusions The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author, CEB, upon reasonable request. ER -