Pelvic Organ Prolapse Working Group September 7, 2018 Cate Bradley and Kathleen Kobashi

1 2 3 4 5 Overview Year 1 goals of the working group What has been accomplished thus far Short-term and long-term goals for the core minimum dataset REDCap demonstration of core minimum dataset Next steps for the working group 1 2 3 4 5

Year 1 Goals of the Working Group Create core minimum dataset to evaluate performance of current and future devices and technologies used for Pelvic Organ Prolapse. Multi-round Delphi process to achieve consensus on data elements 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. Present dataset and discuss plans to pilot dataset at 2018 WHT CRN Annual Meeting.

What has been Accomplished Thus Far July-September 2018 ● Round 2 of the Delphi process initiated ● Selection committee reviewed applications and selected a patient partner ● Round 2 Delphi Survey completed, results analyzed by Cornell team and discussed with co-chairs ● Round 2 Delphi Survey Results presented and discussed with the WG on August 22, 2018. Core minimum dataset finalized. April-June 2018 ● Round 1 Delphi Survey completed ● Results analyzed by Cornell team and discussed in conference calls with co-chairs ● Working group solicited applications for patient partners January-March 2018 ● POP working group members selected and convened ● Conference call to kick-start the POP working group, review the Delphi process ● Round 1 of the Delphi process initiated October-December 2017 Data elements were compiled by FDA using (1) PFDR, (2) existing literature and (3) WHT-CRN elements suggested at September 2017 kick-off meeting 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 2017. 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, 2018. The core minimum dataset was finalized during this call.

Working Group Members Clinical Chairs: Catherine Bradley – American Urogynecologic Society (AUGS) Kathleen Kobashi – Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) FDA Chair: Tony Du – Center for Devices and Radiological Health (CDRH) Working Group Members: Other Members: FDA CDRH – Danica Marinac-Dabic, Nilsa Loyo-Berrios, Mary Jung Office of Device Evaluation (ODE) – Sharon Andrews, Jacqueline Cunkelman Cornell Art Sedrakyan, Courtney Baird, Molly Nowels, Nadia Kim Working Group Members Lenore Ackerman (SUFU) Matt Barber (AUGS) Diane Brinza (Coloplast) Maude Carmel (SUFU) Bilal Chughtai (Weill Cornell Medicine) Elisabeth Erekson (Dartmouth-Hitchcock) Michael Flynn (UMass Memorial) Donna Gardner (Boston Scientific) Alex Gomelsky (SUFU) Douglass Hale (IU Health) Gary Lemack (SUFU) Pamela Moali (AUGS) Victor Nitti (SUFU) Amy O'Boyle (AUGS) Priya Padmanabhan (SUFU) Samantha Pulliam (UNC) Charles Rardin (AUGS) Stuart Reynolds (AUGS) Holly Richter (AUGS) Eric Rovner (SUFU) Yahir Santiago-Lastra (SUFU) Colleen Skau (AUGS) Sherry Xiao (Patients Like Me)

Patient Partner’s Role Working group meets monthly via teleconference. Role of the patient partner is to: Serve for one-year in a volunteer capacity Provide input to working group on data elements Help identify priority questions for CRN of interest to patients making decisions on various treatment options for pelvic organ prolapse Participate in monthly meetings/calls (one hour each)

POP Patient Partner: Sherrie Palm Sherrie Palm is: Founder/CEO of the Association for Pelvic Organ Prolapse Support (APOPS) POP Key Opinion Leader Global women's pelvic health advocate Multi-published author of award-winning book Pelvic Organ Prolapse: The Silent Epidemic National and international speaker on POP QOL Sherrie’s points of focus are: Generating global POP awareness Developing guidance and support structures for women navigating POP Bridge-building within POP healthcare, research, academic, industry, and policy sectors toward evolution of POP directives Sherrie Palm is the Founder/CEO of Association for Pelvic Organ Prolapse Support (APOPS), a pelvic organ prolapse (POP) Key Opinion Leader, a global women's pelvic health advocate, multi-published author of the award-winning book Pelvic Organ Prolapse: The Silent Epidemic and has been a national and international speaker on multiple aspects of pelvic organ prolapse quality of life impact since 2011. Sherrie’s points of focus are generating global POP awareness, developing guidance and support structures for women navigating POP, and bridge building within POP healthcare, research, academic, industry, and policy sectors toward the evolution of POP directives. Sherrie’s engagement in POP projects and protocol enables patient voice to be an integral part of women’s healthcare and wellness evolution. Sherrie presented at the FDA Obstetrics and Gynecology Advisory Committee Panel meeting in 2011, related to transvaginal mesh surgical complications. Since that meeting, Sherrie has continued to share patient voice, networking with all engaged in the POP arena. Additional information about APOPS, pelvic organ prolapse, or Ms. Palm’s book or speaking presentations is available on the APOPS website

Survey Monkey Sample

Delphi Survey Results Round 1 to 2 Start to End of Round 2 Response rate: 20/21 working group members Results: 99 (88%) data elements had ≥50% consensus Start to End of Round 2 Response rate: 15/21 working group members Results: 153 (94%) data elements had ≥50% consensus Below are the number of data elements by round of the Delphi process. Start of Round 1: Patient factors pre-operative (10) medical history (11) surgical history (14) peri-operative (29) post-operative (25) Device factors (9) Surgeon factors (14) TOTAL: 112 data elements Start of Round 2: pre-operative medical history (17) surgical history (12) examination (5) peri-operative procedure (38) discharge (3) post-operative 0-30 days of follow-up (26) 31-90 days of follow-up (23) >90 days of follow-up (23) Device factors (4) Surgeon factors (12) TOTAL: 163 data elements End of Round 2: medical history (15) examination (3) procedure (33) 0-30 days of follow-up (25) 31-90 days of follow-up (22) Surgeon factors (11) TOTAL: 151 data elements

ST and LT Goals for the Core Minimum Dataset Short Term Goals Establish core minimum dataset to assess procedure quality and performance of POP devices through a Delphi Method Incorporate POP core minimum dataset as a new module into AQUIRE (AUGS Urogynecology Quality Registry). AQUIRE at present includes a module on SUI but is capable of including other modules for different urogynecological procedures, such as POP. AQUIRE is the AUGS Urogynecology Quality Registry, a national urogynecology-focused registry open to all physicians that is designed to measure and report healthcare quality and patient outcomes. AQUIRE has been approved by CMS as a Qualified Clinical Data Registry (QCDR) to report data through the Merit-Based Incentive Payment System (MIPS) for providers to potentially increase physician reimbursement. The registry has the capability to encompass multiple modules for different urogynecological procedures. AUGS is currently launching a module within ACQUIRE for Stress Urinary Incontinence (SUI). To build upon the success of this existing work, in a similar fashion, we envision the POP core minimum dataset to be launched as a new module within ACQUIRE. It is critical that AUGS and SUFU work jointly to ensure that urogynecologists and urologists from both societies participate in the ACQUIRE-POP registry. Long Term Goal Support establishment of a coordinated network that links existing registries and data networks to address clinical questions related to devices and technologies for the treatment of pelvic organ prolapse. Provide platform for potential future modular expansion: premarket investigation of POP devices, POP quality measure testing, additional research questions

REDCap Demonstration of Dataset

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 – 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

Next Steps for the Working Group Short-Term Next Step: Coordination between Clinical Working Groups (CWG) and the Informatics Working Group (IWG) on harmonizing and standardizing the CDEs identified by CWG Identification of Core Data Elements for each WHT-CRN clinical area Harmonize and Standardize CDEs for WHT-CRN Standards Development Develop data standards exchange specifications Tool Development and Implementation Long-Term Next Step: Pilot the CDEs identified by CWG through a POP module built within the AUGS AQUIRE registry Pilot: Evaluate WHT-CRN’s ability to address priority questions from stakeholders

Thank you.