Critical appraisal:Mariappan P, Chong WL, Sundram M, Mohamed SR 2004

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

How was the allocation schedule generated?

Inadequate or not reported

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 or random sequence generation; 100% follow-up for cancer detection, most complications, ~81.8% for pain (VAS score) with >5% difference between groups ("too many exclusions, differential loss in comparison groups"), N/A for fever

Comments

The quality was assessed for the outcome of adverse events.

This appraisal has been completed.

Article

Mariappan P, Chong WL, Sundram M, Mohamed SR. Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity. BJU Int 2004 Aug;94(3):307-10 Available from: http://www.ncbi.nlm.nih.gov/pubmed/15291857.

Assigned to

User:Dana.stefanovic

Topic area

Guidelines:PSA Testing

Clinical question

• For men undergoing an initial prostate biopsy how many biopsy cores, which pattern of biopsy sampling sites and which approach constitute an adequate prostate biopsy?

Form

Form:Quality appraisal rct

Section below only relevant for Cancer Council Project Officer

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