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Development of a coordinated registry network for pelvic organ prolapse technologies

OBJECTIVES: The 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...

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Autores principales: Baird, Courtney E, Chughtai, Bilal, Bradley, Catherine S, Kobashi, Kathleen, Jung, Mary, Sedrakyan, Art, Andrews, Sharon, Ferriter, Ann, Cornelison, Terri, Marinac-Dabic, Danica
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9660621/
https://www.ncbi.nlm.nih.gov/pubmed/36393893
http://dx.doi.org/10.1136/bmjsit-2020-000076
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author Baird, Courtney E
Chughtai, Bilal
Bradley, Catherine S
Kobashi, Kathleen
Jung, Mary
Sedrakyan, Art
Andrews, Sharon
Ferriter, Ann
Cornelison, Terri
Marinac-Dabic, Danica
author_facet Baird, Courtney E
Chughtai, Bilal
Bradley, Catherine S
Kobashi, Kathleen
Jung, Mary
Sedrakyan, Art
Andrews, Sharon
Ferriter, Ann
Cornelison, Terri
Marinac-Dabic, Danica
author_sort Baird, Courtney E
collection PubMed
description OBJECTIVES: The 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. DESIGN: A 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. RESULTS: Twenty-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. CONCLUSIONS: The 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.
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spelling pubmed-96606212022-11-15 Development of a coordinated registry network for pelvic organ prolapse technologies Baird, Courtney E Chughtai, Bilal Bradley, Catherine S Kobashi, Kathleen Jung, Mary Sedrakyan, Art Andrews, Sharon Ferriter, Ann Cornelison, Terri Marinac-Dabic, Danica BMJ Surg Interv Health Technol Original Research OBJECTIVES: The 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. DESIGN: A 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. RESULTS: Twenty-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. CONCLUSIONS: The 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. BMJ Publishing Group 2022-11-11 /pmc/articles/PMC9660621/ /pubmed/36393893 http://dx.doi.org/10.1136/bmjsit-2020-000076 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Baird, Courtney E
Chughtai, Bilal
Bradley, Catherine S
Kobashi, Kathleen
Jung, Mary
Sedrakyan, Art
Andrews, Sharon
Ferriter, Ann
Cornelison, Terri
Marinac-Dabic, Danica
Development of a coordinated registry network for pelvic organ prolapse technologies
title Development of a coordinated registry network for pelvic organ prolapse technologies
title_full Development of a coordinated registry network for pelvic organ prolapse technologies
title_fullStr Development of a coordinated registry network for pelvic organ prolapse technologies
title_full_unstemmed Development of a coordinated registry network for pelvic organ prolapse technologies
title_short Development of a coordinated registry network for pelvic organ prolapse technologies
title_sort development of a coordinated registry network for pelvic organ prolapse technologies
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9660621/
https://www.ncbi.nlm.nih.gov/pubmed/36393893
http://dx.doi.org/10.1136/bmjsit-2020-000076
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