1. Uterine Fibroid Working Group
September 7, 2018
Vanessa Jacoby (University of CA, San Francisco)
Evan Myers (Duke University)
Allison O’Neil (FDA)

2. Goals of the Working Group
Identify a core set of minimal data elements to support surveillance and quality improvement for surgical and therapeutic devices to treat women with uterine fibroids
Pilot test data elements by embedding into EHR using EPIC platform
The Year 1 goal of the POP working group was to create a core minimum dataset that could be used to evaluate the performance of current and future devices and technologies used for Pelvic Organ Prolapse.
We planned to use a multi-round Delphi process to achieve consensus on the data elements among the working group members.
The final goal was to present the core minimum dataset and discuss future plans to pilot the dataset at the 2018 WHT CRN Annual Meeting on September 7 at the FDA.

3. Working Group Members
Clinical Chairs: Evan Myers (Duke), Vanessa Jacoby (University of CA, San Francisco)
FDA Chairs (CDRH): Allison O’Neill
Working Group Members
FDA
Angie Lee, Veronica Price, Christina Chang, Nneka McNeal-Jackson
Jim Spies (Georgetown)
Howard Sharp (Utah)
Sateria Venable (Fibroid Foundation)
Laura Kemp (Acessa Health)
Keith Isaacson (Partners Healthcare)
Kim Rodriguez (Acessa Health)
Shannon Laughlin-Tommaso (Mayo)
Bowdoin Su (AbbVie)
Wanda Nicholson (UNC)
Jeffrey Goldstein (Bayer)
Marie Paraiso (CCF)
Lizette Warner (Philips)
Roopina Sangha (Henry Ford Health System)
Sylvia Hanna (Allergan)
Erica Marsh (Michigan)
James Keller (Cooper Surgical)
Sean Currigan (ACOG)
Jan McComb (Minerva Surgical)
James Segars (JHU)
Marcus Garcia (Hologic)
Elizabeth Stewart (Mayo)
Nadir Alikacem (Insightec)
Larry Maxwell (Inova Health)
Doris Schecter (Insightec)
Katina Robison (Women & Infants Hospital in Rhode Island)
Thomas Bryne (Boston Scientific)

4. What has been Accomplished Thus Far
Date
Activity
August 2017
FDA team compiled an initial list of potential data elements based on Case Report Forms from COMPARE-UF.
June 2018
Kick-off call and review of working group goals.
June 2-18
Overview of DELPHI Process.
July 2018
Round 1 DELPHI Process and Patient Partner recruitment.
Review of Round 1 DELPHI Results and Overview for Round 2.
August 2018
Round 2 DELPHI Process.
Review of Round 2 DELPHI Results.
September 2018
Presentation of Proposed dataset and update from Patient Partner on priority questions and areas of interest.
Fall 2017:
an initial list of 300+ data elements was compiled by the FDA based on PFDR, the existing literature and the WHT CRN kick-off meeting in September This list was streamlined to about 120 data elements that could be used to begin a multi-round Delphi process for the full working group.
Winter 2018:
On February 9, 2018, an initial conference call was held to kick-start the working group. The Cornell team introduced the co-chairs, gave an overview of the timeline and purpose of the working group, presented a summary of the Delphi process, and demonstrated the Round 1 Delphi Survey.
Round 1 of the Delphi process was initiated
Spring 2018:
In April-May 2018, the working group completed the Round 1 Delphi Survey and the results were collated and analyzed by the Cornell team. These results were then discussed in a series of conference calls with the working group co-chairs and leads.
At the same time, a call was posted to solicit applications for a patient partner to join the POP working group.
Summer 2018:
The call for applications for patient partners was closed on June 18th and the selection committee reviewed applicant materials and conducted interviews.
The patient partner was selected at the end of July.
On July 6, 2018, the Round 1 Delphi Survey Results were presented and discussed with the full working group.
Round 2 of the Delphi process was initiated in early July.
The Round 2 Delphi Survey Results were presented and discussed with the full working group on August 22, The core minimum dataset was finalized during this call.

5. Considerations for DELPHI
Core minimum data can be applied to variety of scenarios including preoperative, postoperative, and long-term follow-up:
Safety surveillance for complications/adverse events related to new or existing devices 
QI/QA for short-term peri-procedural outcomes (particularly complications/adverse events) at individual provider or health system level
QI/QA for documenting process of care--e.g., documentation that provider and patient had all relevant information to make informed choice about treatment (provider or health system level)
The extent to which selections also contribute to other potential uses of the registry (surveillance of non-procedural treatments, comparative effectiveness) should be considered, but only if they also contribute to one of the goals listed above.  
The Year 1 goal of the POP working group was to create a core minimum dataset that could be used to evaluate the performance of current and future devices and technologies used for Pelvic Organ Prolapse.
We planned to use a multi-round Delphi process to achieve consensus on the data elements among the working group members.
The final goal was to present the core minimum dataset and discuss future plans to pilot the dataset at the 2018 WHT CRN Annual Meeting on September 7 at the FDA.

6. Candidate Variables Derived from Case Report Forms from COMPARE-UF
Not formal Delphi process, but iterative input from investigators, patient stakeholders, FDA
Additional suggestions from Working Group members

7. General Overview of Dataset
Patient Demographics
Medical History
General Medical History
Menstrual Cycle/Flow
Pregnancy History
UF History
Prior UF Procedures
Current Symptoms and Feeling (PROs)
Current UF Therapies or Supplements
Imaging Data
Procedure Data
Planned Procedure
Procedure Performed
Intra-operative Adverse events
Post Procedure (both medium- [6-12 weeks] and long-term [6-12 months])
Treatment failure
Post-procedure adverse events
Cancer findings
PROs

8. REDCap Demo Disclaimer
REDCap is a HIPAA-compliant data collection platform that is used to collect data for single and multi-site research studies.
We may or may not use REDCap when we finally pilot the datasets in practice – right now, we are just using REDCap to demonstrate what it would look like to actually fill out a form to collect one registry’s data elements in practice.
As you know, we will be working with the NIH CDE Repository, which supports form building that can be used in REDCap and other settings.
One of the goals for a minimum dataset is that it be as easy as possible for the physician to complete. What you’ll find is that data collection tools, like REDCap, can lessen physician burden through tools like branching logic and automatic data capture.
This is not a final form by any means. For example, not all of the questions would need to be asked at every encounter, and we still need to work with YOU and the informatics team to finalize the data element definitions, harmonizable data elements, collection methodologies, etc.
REDCap Survey Link

9. REDCap Demonstration of Dataset

10. Plan for Piloting Data
Embed data elements into EHR surgical form at UCSF
EPIC system
Template operative forms

11. Thank you.