Critical appraisal:Lecuona A, Heyns CF 2011

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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
How was the allocation schedule generated?
Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)
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

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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
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Topic area
Guidelines:PSA Testing
Clinical question
Form:Quality appraisal rct

Section below only relevant for Cancer Council Project Officer

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