comprise only 9% of NCDB but 33% of PIVOT. Lastly, PIVOT
enrolled men with cancer characteristics that greatly
differed from the typical Americanman considering surgery:
clinical stage T2 (45% vs 27%), prostate specific antigen
>
10 ng/ml (34% vs 11%), and Gleason 6 (71% vs 47%),
although Gleason differences are likely impacted by era-
specific evolution of pathologic definitions
[10] .Even if a discussion of generalizability leads to somno-
lence, you should be jolted awake to learn when a landmark
trial may not be as germane to your patients as previously
thought. Finally, and perhaps most importantly, guideline
statements from
[1_TD$DIFF]
US Preventive Services Task Force matter.
But so do the methodology, internal validity, and generaliz-
ability of the studies used to inform them.
Conflicts of interest:
The author has nothing to disclose.
References
[1]
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Andriole GL, Crawford ED, G rubb 3rd RL, et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009;360:1310.[3]
Moyer VA, U.S. Preventive Services Task Force. Screening for pros- tate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2012;157:120–34.[4]
Hayes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491–9.[5]
Urbach DR, Govindarajan A, Saskin R, et al. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med 2014;370: 1029–38.[6]
Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012;367: 203–13.[7]
Moyer VA, US Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation state- ment. Ann Intern Med 2012;157:120–34.
[8]
Walsh PC. Re: Radical prostatectomy versus observation for local- ized prostate cancer. J Urol 2012;188:2225–32.[9]
Dalela D, Karabon D, Sammon J. Generalizability of the Prostate Cancer Intervention versus Observation Trial (PIVOT) results to contemporary North American men with prostate cancer. Eur Urol 2017;71:511–4.[10]
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