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Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.
- Source :
-
The Journal of urology [J Urol] 2018 Jun; Vol. 199 (6), pp. 1488-1493. Date of Electronic Publication: 2018 Jan 04. - Publication Year :
- 2018
-
Abstract
- Purpose: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies.<br />Materials and Methods: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics.<br />Results: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated.<br />Conclusions: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.<br /> (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Biopsy standards
Consensus
Delphi Technique
Feasibility Studies
Humans
Magnetic Resonance Imaging methods
Magnetic Resonance Imaging standards
Magnetic Resonance Imaging, Interventional methods
Magnetic Resonance Imaging, Interventional standards
Male
Patient Reported Outcome Measures
Postoperative Care methods
Postoperative Care standards
Prospective Studies
Prostate diagnostic imaging
Prostate pathology
Prostatic Neoplasms pathology
Quality of Life
Transurethral Resection of Prostate methods
Transurethral Resection of Prostate standards
United States
Prostate surgery
Prostatic Neoplasms surgery
Registries
Transurethral Resection of Prostate statistics & numerical data
Subjects
Details
- Language :
- English
- ISSN :
- 1527-3792
- Volume :
- 199
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- The Journal of urology
- Publication Type :
- Academic Journal
- Accession number :
- 29307684
- Full Text :
- https://doi.org/10.1016/j.juro.2017.12.058