Pepe 2013.

Study characteristics
Patient sampling	Aim of the study: to evaluate MRI accuracy in PCa diagnosis in men submitted to saturation PBx Type of study: prospective, single‐centre, multi‐departmental study Selection: unclear. Men were selected from a PCa case‐finding protocol (including 14,453 patients) if meeting the inclusion criteria and when having an indication for saturation Bx Enrolled/eligible: 78/unclear Inclusion period: June 2011‐December 2012
Patient characteristics and setting	Inclusion criteria: 1 single prior‐negative Bx > 6 months before. Indications for saturation Bx: a persistently high or increasing PSA value, abnormal DRE and PSA > 10 ng/mL or PSA values 4.1‐10 or 2.6‐4 ng/mL with free/total PSA ≤ 25% and ≤ 20%, respectively Setting: Catania, Italy. University Hospital Age: median 63 years (range 49‐72) PSA: median 11 ng/mL (range 3.7‐45) Prostate volume: not reported
Index tests	Index test: MRI only, MRI‐TBx and MRI‐pathway. A 3 Tesla MRI (Achieva, Philips) was used, with T2, DWI, DCE and spectroscopy sequences. An in‐house binary MRI score was used, with positive lesions cognitively targeted by MRI‐TBx, after the performance of saturation Bx.
Target condition and reference standard(s)	Target condition: GS ≥ 3+3, GS ≥ 3+4 Reference standard: transperineal TSB with a median of 28 cores (range 26‐32) including 4‐6 cores in the transition and anterior zone. MRI results were not blinded during Bx procedure.
Flow and timing	All participants underwent same reference standard and were included in the analysis.
Comparative
Notes
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Unclear
Did the study avoid inappropriate exclusions?	Unclear
		Unclear	High
DOMAIN 2: Index Test MRI‐TBx
Was the MRI assessed without knowledge of the results of the (reference or other index) biopsies?
Were the MRI‐TBx performed independent of the (reference or other index) biopsies?	Yes
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies?
		Low	High
DOMAIN 2: Index Test MRI
Was the MRI assessed without knowledge of the results of the (reference or other index) biopsies?	Yes
Were the MRI‐TBx performed independent of the (reference or other index) biopsies?
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies?
		Low	High
DOMAIN 2: Index Test MRI‐pathway
Was the MRI assessed without knowledge of the results of the (reference or other index) biopsies?	Yes
Were the MRI‐TBx performed independent of the (reference or other index) biopsies?	Yes
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies?
		Low	High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Unclear
Was the reference standard performed independent from the index test?	No
		High	Low
DOMAIN 4: Flow and Timing
Did all patients receive the same reference standard?	Yes
Were all enrolled patients included in the analysis, or were exclusions explained and not leading to a relevant bias?	Yes
		Low