Critical appraisal:Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, et al 2012

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Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012 Jul 19;367(3):203-13 Abstract available at
Assigned to
Topic area
Guidelines:PSA Testing
Clinical question
Form:Quality appraisal rct
Prostate cancer-specific mortality

Section below only relevant for Cancer Council Project Officer

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Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?
Trial was double-blinded but may have limitations (eg method of blinding inappropriate, tablet vs injection with no double-dummy, different treatment schedules, side-effects may unblind)

single-blinded (eg outcomes assessed blind, objective outcomes, no revealing side-effects).

Was the treatment allocation schedule concealed?
Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).
Were all randomised participants included in the analysis?
No exclusions or survival analysis used with all subjects included (>95% follow-up for all groups).
The field below is not considered when calculating the risk of bias rating
How was the allocation schedule generated?
Inadequate or not reported
Overall risk of bias
Moderate risk of bias Additional comments: Scores were based on the primary outcome of overall mortality and PCa mortality. QoL and adverse event outcomes were self-assessed thus no blinding occurred (score =0). A central interactive phone system was used for concealment of treatment allocation schedule. ITT analysis was used for mortality outcomes, thus all patients randomized were included in analysis. <80% of patients in comparison groups were included in assessment of QoL and adverse event outcomes (score =0)