Development of a coordinated registry network for pelvic organ prolapse technologies

Courtney E Baird; Bilal Chughtai; Catherine S Bradley; Kathleen Kobashi; Mary Jung; Art Sedrakyan; Sharon Andrews; Ann Ferriter; Terri Cornelison; Danica Marinac-Dabic

doi:10.1136/bmjsit-2020-000076

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Development of a coordinated registry network for pelvic organ prolapse technologies

Journal article

Open access

Peer reviewed

Development of a coordinated registry network for pelvic organ prolapse technologies

Courtney E Baird, Bilal Chughtai, Catherine S Bradley, Kathleen Kobashi, Mary Jung, Art Sedrakyan, Sharon Andrews, Ann Ferriter, Terri Cornelison and Danica Marinac-Dabic

BMJ surgery, interventions, & health technologies, Vol.4(Suppl 1), p.e000076

11/14/2022

DOI: 10.1136/bmjsit-2020-000076

PMCID: PMC9660621

PMID: 36393893

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Abstract

ObjectivesThe accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the 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 important to assess POP technologies.DesignA Delphi method approach was employed to achieve consensus on a core minimum dataset 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 the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved.ResultsTwenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors.ConclusionsThe CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety.

Delphi

device evaluation

Original research

real world evidence

urology devices

women's health

Details

Title: Subtitle: Development of a coordinated registry network for pelvic organ prolapse technologies
Creators: Courtney E Baird - Brown University
Bilal Chughtai - Department of Urology, Weill Cornell Medicine, New York, New York, USA
Catherine S Bradley - University of Iowa
Kathleen Kobashi - Department of Urology, Houston Methodist Hospital, Houston, Texas, USA
Mary Jung - Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
Art Sedrakyan - Population Health Sciences, Weill Cornell Medicine, New York, New York, USA
Sharon Andrews - Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
Ann Ferriter - Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
Terri Cornelison - Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
Danica Marinac-Dabic - Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
Resource Type: Journal article
Publication Details: BMJ surgery, interventions, & health technologies, Vol.4(Suppl 1), p.e000076
DOI: 10.1136/bmjsit-2020-000076
PMID: 36393893
PMCID: PMC9660621
NLM abbreviation: BMJ Surg Interv Health Technol
eISSN: 2631-4940
Publisher: BMJ Publishing Group Ltd
Grant note: Interagency Agreement #750119PE060048 / Patient-Centered Outcomes Research Trust Fund (PCORTF)
Language: English
Date published: 11/14/2022
Academic Unit: Epidemiology; Obstetrics and Gynecology; Urology
Record Identifier: 9984317109402771

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