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?
- Too many exclusions, differential loss in comparison groups, or not reported.
The field below is not considered when calculating the risk of bias rating
Overall risk of bias
|High risk of bias||Additional comments: CDR: No mention of blinding, AE: no blinding, complications assessed by questionnaire filled in by patients, patients verbally asked to rate pain 1d after biopsy; allocation concealment or random sequence generation ("prospectively randomized); Follow-up 92.4% for cancer detection, 83.2% for complications, not reported for pain, not able to determine if balanced between groups (only % reported, but no N)|
This appraisal has been completed.
- Sur RL, Borboroglu PG, Roberts JL, Amling CL. A prospective randomized comparison of extensive prostate biopsy to standard biopsy with assessment of diagnostic yield, biopsy pain and morbidity. Prostate Cancer Prostatic Dis 2004;7(2):126-31 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15111980.
- Assigned to
- Topic area
- Guidelines:PSA Testing
- Clinical question
Section below only relevant for Cancer Council Project Officer