1. September 7, 2018 Scott Chudnoff
Permanent contraception (sterilization) and Long-acting, reversible contraception Working Group
September 7, 2018
Scott Chudnoff

2. Working Group Members
Clinical Chairs: Maryam Guiahi (Society of Family Planning), Scott Chudnoff (ACOG)
FDA Chairs (CDRH): Nilsa Loyo-Berrios , Alex Koustenis, Douglas Dumont
Working Group Members
Rebecca Allen (Women & Infants Hospital in Rhode Island, ACOG)
Alex Asiimwe, Patricia Carney (Bayer HC)
Courtney Baird (Weill-Cornell Medical College)
Patricia Carney (Bayer HC)
Sean Currigan (ACOG)
Beth Hodshon (Patient Partner)
Rebecca Jamshidi (George Washington University, ACOG)
Melissa Kottke (Emory, Society of Family Planning, ACOG)
Mark Levie (Montefiore, ACOG)
Jialian Mao (Weill-Cornell Medical College)
Titilope Oduyebo (CDC)
Katina Robison (Women & Infants Hospital in Rhode Island, ACOG)
Katrina Serrano (NIH/ORWH)
Maura Whiteman (CDC)
FDA
CDRH - Ilynn Bulatao, Kelly Colden , Onyeka Illoh , Allison O’Neill , Jason Roberts
CDER - Abby Anderson , Michelle Carey, Catherine Sewell,

3. 1 2 3 4 5 Overview Goals of the working group
What has been accomplished thus far
REDCap demonstration of core minimum dataset
Next steps for the working group 1 2 3 4 5

4. Goals of the Working Group
Our goal:
Identify a core set of minimal data elements to support surveillance and quality improvement for permanent and long-acting contraceptive therapies and procedures.
Clinical Areas:
Permanent contraception (sterilization) procedures and therapies.
Long-acting reversible contraception – IUDs and contraceptive implants.
Group considerations:
Data to help patients identify treatment options, especially those with comorbidities.
Data on pregnancy outcomes and complications, and effectiveness (e.g. pregnancy rates).
Data on concomitant procedures and therapies.
Data on device and procedure complications, adverse events for safety surveillance.
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.

5. What has been Accomplished Thus Far
Date
Activity
August 2017
FDA team compiled an initial list of potential data elements based on prior clinical studies.
November 2017
Kick-off call and review of working group goals.
December 2017
Overview of DELPHI Process.
February 2018
Round 1 DELPHI Process and Patient Partner recruitment.
March 2018
Patient Partner Selection.
May 2018
Review of Round 1 DELPHI Results and Overview for Round 2.
June 2018
Round 2 DELPHI Process.
July 2018
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.

6. Overview of the DELPHI method
The Delphi Method seeks to achieve a consensus among group members through a series of questionnaires.
Working group members asked through the DELPHI survey to select data elements (or add additional data elements) that should be included in the data.
The answers are then summarized and sent back to the group members along with the next questionnaire.
Working group used two DELPHI rounds to determine the proposed dataset.

7. DELPHI - Survey Monkey Sample

8. General Overview of Dataset
Patient Demographics
Medical History
Reproductive/Gynecological History
Surgical History
General Medical History
Procedure Data – Index Procedure, Post-procedure Follow-up
General Encounter Information
Other Procedures Performed in Conjunction with Sterilization or LARC Procedure
Procedure Elements (Index Procedure or Follow-up)
Medications
Endpoints During and After Treatment
Events or Complications
Pregnancy
Methods for Evaluations of Endpoints

9. REDCap Demonstration of Dataset

10. REDCap 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 –we are just using REDCap to help organize and visualize the data elements specifically for this workshop.
REDCap Survey Link

11. Next Steps for the Working Group
Identify priority questions from stakeholders
Informed by patient partner work on patient perspectives and interest (presented by Beth Hodshon this afternoon).
Work iteratively with informatics team to harmonize and standardize the identified core dataset.
3. Discuss a potential pilot.

12. Thank you.