Risk of bias assessment: randomised controlled trial
Was the trial double-blinded?
- Outcomes not blinded, substantial side-effects, or not reported.
Was the treatment allocation schedule concealed?
- No concealment or unclear (e.g. no approach described, open randomisation lists, person doing recruitment tossing a coin).
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
|High risk of bias||Additional comments: patients informed of assigned arm prior to biopsy, no mention of any blinding (examiners/pathologists); random sequence generation with random number table "prepared by a nurse with no involvement in the trial" - unclear if allocation was concealed; follow-up >98% for cancer detection, >80% for adverse events, but >5% difference between groups;|
This appraisal has been completed.
- Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, et al. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol 2013 Jul;190(1):77-83 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23313205.
- Assigned to
- Topic area
- Guidelines:PSA Testing
- Clinical question
Section below only relevant for Cancer Council Project Officer