Critical appraisal:Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, et al 2013

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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: 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;


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Article
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
User:Dana.stefanovic
Topic area
Guidelines:PSA Testing
Clinical question
Form
Form:Quality appraisal rct


Section below only relevant for Cancer Council Project Officer

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