This appraisal has been completed.
- 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 http://www.ncbi.nlm.nih.gov/pubmed/22808955.
- 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
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
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)|