TY - JOUR
T1 - Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies
AU - Golan, Ron
AU - Bernstein, Adrien
AU - Sedrakyan, Art
AU - Daskivich, Timothy J.
AU - Du, Dongyi T.
AU - Ehdaie, Behfar
AU - Fisher, Benjamin
AU - Gorin, Michael A.
AU - Grunberger, Ivan
AU - Hunt, Bradley
AU - Jiang, Hongying H.
AU - Kim, Hyung L.
AU - Marinac-Dabic, Danica
AU - Marks, Leonard S.
AU - McClure, Timothy D.
AU - Montgomery, Jeffrey S.
AU - Parekh, Dipen J.
AU - Punnen, Sanoj
AU - Scionti, Stephen
AU - Viviano, Charles J.
AU - Wei, John T.
AU - Wenske, Sven
AU - Wysock, James S.
AU - Rewcastle, John
AU - Carol, Mark
AU - Oczachowski, Marc
AU - Hu, Jim C.
N1 - Funding Information:
Supported by United States Food and Drug Administration Grant U01FD005478 (Principal Investigator: Sedrakyan) and The Frederick J. and Theresa Dow Wallace Fund of the New York Community Trust (JCH).
Publisher Copyright:
© 2018 American Urological Association Education and Research, Inc.
PY - 2018/6
Y1 - 2018/6
N2 - 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. 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. 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. 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.
AB - 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. 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. 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. 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.
KW - biomedical technology
KW - high-intensity focused ultrasound ablation
KW - patient outcome assessment
KW - prostatic neoplasms
KW - registries
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U2 - 10.1016/j.juro.2017.12.058
DO - 10.1016/j.juro.2017.12.058
M3 - Article
AN - SCOPUS:85046031856
VL - 199
SP - 1488
EP - 1493
JO - Investigative Urology
JF - Investigative Urology
SN - 0022-5347
IS - 6
ER -