514 692
who underwent definitive treatment (surgery, radiation, or
any other local treatment) after 12 mo of observation (NCDB
records only the primary course of treatment). Regardless,
our results are not meant to compare the outcomes of RP
with observation; rather, we posit that the PIVOT sample
may not have been truly random and that its baseline
characteristics and treatment selection differed significantly
from the intended source population (ie, US men undergoing
RP or observation for clinically localized PCa) in a manner
that could influence the reported outcomes. This indicates
that the PIVOT results are not generalizable to contemporary
(2004–2012) clinical practice in the United States.
Author contributions:
Firas Abdollah had full access to all the data in the
study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design:
Abdollah, Trinh, Dalela.
Acquisition of data:
Dalela, Abdollah, Karabon.
Analysis and interpretation of data:
Karabon, Dalela, Abdollah.
Drafting of the manuscript:
Dalela, Abdollah.
Critical revision of the manuscript for important intellectual content:
Dalela,
Karabon, Sammon, Sood, Lo¨ppenberg, Trinh, Menon, Abdollah.
Statistical analysis:
Karabon.
Obtaining funding:
Menon, Trinh.
Administrative, technical, or material support:
Menon, Trinh.
Supervision:
Menon, Trinh.
Other (specify):
None.
Financial disclosures:
Firas Abdollah certifies that all conflicts of interest,
including specific financial interests and relationships and affiliations
relevant to the subject matter or materials discussed in the manuscript
(eg, employment/ affiliation, grants or funding, consultancies, honoraria,
stock ownership or options, expert testimony, royalties, or patents filed,
received, or pending), are the following: Firas Abdollah is a consultant for
GenomeDx Biosciences. Quoc-Dien Trinh is supported by the Professor
Walter Morris-Hale Distinguished Chair in Urologic Oncology at Brigham
and Women’s Hospital, an unrestricted educational grant from Vattikuti
Urology Institute.
Funding/Support and role of the sponsor:
None.
Acknowledgments:
The National Cancer Data Base (NCDB) is a joint project
of the Commission on Cancer (CoC) of the American College of Surgeons
and the American Cancer Society. The CoC’s NCDB and the hospitals
participating in the CoC NCDB are the source of de-identified data used
herein; they have not verified and are not responsible for the statistical
validity of the data analysis or the conclusions derived by the authors.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at
http://dx.doi.org/10.1016/j. eururo.2016.08.048 .References
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