Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies

Ron Golan; Adrien Bernstein; Art Sedrakyan; Timothy J. Daskivich; Dongyi T. Du; Behfar Ehdaie; Benjamin Fisher; Michael A. Gorin; Ivan Grunberger; Bradley Hunt; Hongying H. Jiang; Hyung L. Kim; Danica Marinac-Dabic; Leonard S. Marks; Timothy D. McClure; Jeffrey S. Montgomery; Dipen J. Parekh; Sanoj Punnen; Stephen Scionti; Charles J. Viviano; John T. Wei; Sven Wenske; James S. Wysock; John Rewcastle; Mark Carol; Marc Oczachowski; Jim C. Hu

doi:10.1016/j.juro.2017.12.058

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies

Ron Golan, Adrien Bernstein, Art Sedrakyan, Timothy J. Daskivich, Dongyi T. Du, Behfar Ehdaie, Benjamin Fisher, Michael A. Gorin, Ivan Grunberger, Bradley Hunt, Hongying H. Jiang, Hyung L. Kim, Danica Marinac-Dabic, Leonard S. Marks, Timothy D. McClure, Jeffrey S. Montgomery, Dipen J. Parekh, Sanoj Punnen, Stephen Scionti, Charles J. VivianoJohn T. Wei, Sven Wenske, James S. Wysock, John Rewcastle, Mark Carol, Marc Oczachowski, Jim C. Hu

Urology

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

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. 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.

Original language	English (US)
Pages (from-to)	1488-1493
Number of pages	6
Journal	Journal of Urology
Volume	199
Issue number	6
DOIs	https://doi.org/10.1016/j.juro.2017.12.058
State	Published - Jun 2018

Keywords

biomedical technology
high-intensity focused ultrasound ablation
patient outcome assessment
prostatic neoplasms
registries

ASJC Scopus subject areas

Urology

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Golan, R., Bernstein, A., Sedrakyan, A., Daskivich, T. J., Du, D. T., Ehdaie, B., Fisher, B., Gorin, M. A., Grunberger, I., Hunt, B., Jiang, H. H., Kim, H. L., Marinac-Dabic, D., Marks, L. S., McClure, T. D., Montgomery, J. S., Parekh, D. J., Punnen, S., Scionti, S., ... Hu, J. C. (2018). Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies. Journal of Urology, 199(6), 1488-1493. https://doi.org/10.1016/j.juro.2017.12.058

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies. / Golan, Ron; Bernstein, Adrien; Sedrakyan, Art; Daskivich, Timothy J.; Du, Dongyi T.; Ehdaie, Behfar; Fisher, Benjamin; Gorin, Michael A.; Grunberger, Ivan; Hunt, Bradley; Jiang, Hongying H.; Kim, Hyung L.; Marinac-Dabic, Danica; Marks, Leonard S.; McClure, Timothy D.; Montgomery, Jeffrey S.; Parekh, Dipen J.; Punnen, Sanoj; Scionti, Stephen; Viviano, Charles J.; Wei, John T.; Wenske, Sven; Wysock, James S.; Rewcastle, John; Carol, Mark; Oczachowski, Marc; Hu, Jim C.

In: Journal of Urology, Vol. 199, No. 6, 06.2018, p. 1488-1493.

Research output: Contribution to journal › Article › peer-review

Golan, R, Bernstein, A, Sedrakyan, A, Daskivich, TJ, Du, DT, Ehdaie, B, Fisher, B, Gorin, MA, Grunberger, I, Hunt, B, Jiang, HH, Kim, HL, Marinac-Dabic, D, Marks, LS, McClure, TD, Montgomery, JS, Parekh, DJ, Punnen, S, Scionti, S, Viviano, CJ, Wei, JT, Wenske, S, Wysock, JS, Rewcastle, J, Carol, M, Oczachowski, M & Hu, JC 2018, 'Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies', Journal of Urology, vol. 199, no. 6, pp. 1488-1493. https://doi.org/10.1016/j.juro.2017.12.058

Golan, Ron ; Bernstein, Adrien ; Sedrakyan, Art ; Daskivich, Timothy J. ; Du, Dongyi T. ; Ehdaie, Behfar ; Fisher, Benjamin ; Gorin, Michael A. ; Grunberger, Ivan ; Hunt, Bradley ; Jiang, Hongying H. ; Kim, Hyung L. ; Marinac-Dabic, Danica ; Marks, Leonard S. ; McClure, Timothy D. ; Montgomery, Jeffrey S. ; Parekh, Dipen J. ; Punnen, Sanoj ; Scionti, Stephen ; Viviano, Charles J. ; Wei, John T. ; Wenske, Sven ; Wysock, James S. ; Rewcastle, John ; Carol, Mark ; Oczachowski, Marc ; Hu, Jim C. / Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies. In: Journal of Urology. 2018 ; Vol. 199, No. 6. pp. 1488-1493.

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title = "Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies",

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. 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.",

keywords = "biomedical technology, high-intensity focused ultrasound ablation, patient outcome assessment, prostatic neoplasms, registries",

author = "Ron Golan and Adrien Bernstein and Art Sedrakyan and Daskivich, {Timothy J.} and Du, {Dongyi T.} and Behfar Ehdaie and Benjamin Fisher and Gorin, {Michael A.} and Ivan Grunberger and Bradley Hunt and Jiang, {Hongying H.} and Kim, {Hyung L.} and Danica Marinac-Dabic and Marks, {Leonard S.} and McClure, {Timothy D.} and Montgomery, {Jeffrey S.} and Parekh, {Dipen J.} and Sanoj Punnen and Stephen Scionti and Viviano, {Charles J.} and Wei, {John T.} and Sven Wenske and Wysock, {James S.} and John Rewcastle and Mark Carol and Marc Oczachowski and Hu, {Jim C.}",

year = "2018",

month = jun,

doi = "10.1016/j.juro.2017.12.058",

language = "English (US)",

volume = "199",

pages = "1488--1493",

journal = "Journal of Urology",

issn = "0022-5347",

publisher = "Elsevier Inc.",

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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.

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

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