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: no mention of any blinding (impossible to blind patients; outcomes not objective); no mention of allocation schedule concealment; 100% follow-up for cancer detection, 59.7% for complications (2.9% difference between groups); computer-generated random numbers|
This appraisal has been completed.
- Lecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int 2011 Jul;108(2):204-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21087452.
- Assigned to
- Topic area
- Guidelines:PSA Testing
- Clinical question
Section below only relevant for Cancer Council Project Officer