The accumulation of data through a prospective, multi-center coordinated registry network (CRN) is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urologic oncologists, targeted biopsy experts, industry representatives, and the Food and Drug Administration (FDA) convened to discuss the role, feasibility, and important data elements of a CRN to assess new and existing prostate ablation technologies.
A multi-round Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from HIFU device manufacturers. Stakeholders provided input in three consecutive rounds, with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for HIFU are compatible with other prostate ablation technologies. CRN elements were reviewed and supplemented with data elements from FDA's common study metrics.
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, which include IIEF-5, IPSS, EPIC-26, and MSHQ-EjD. Group consensus was to obtain a follow up multi-parametric MRI and prostate biopsy at approximately 12 months after ablation, with additional imaging or biopsy performed as clinically indicated.
A national prostate ablation CRN brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multi-stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.
This research output has an Altmetric Attention Score of 5. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 13 June 2018.
All research outputs
#10,409,163
of 34,600,706 outputs
Outputs from The Journal of Urology
#7,606
of 21,370 outputs
Outputs of similar age
#148,800
of 498,289 outputs
Outputs of similar age from The Journal of Urology
#62
of 165 outputs
Altmetric has tracked 34,600,706 research outputs across all sources so far. This one has received more attention than most of these and is in the 69th percentile.
So far Altmetric has tracked 21,370 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 10.1. This one has gotten more attention than average, scoring higher than 64% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 498,289 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 69% of its contemporaries.
We're also able to compare this research output to 165 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 62% of its contemporaries.
