Ploussard 2014.

Study characteristics
Patient sampling	Aim of the study: comparison of the PCa detection rate between SBx versus template Bx Type of study: prospective cohort Selection: consecutive Enrolled/eligible: 2753/2753 Inclusion period: December 2001‐December 2011
Patient characteristics and setting	Inclusion criteria: suspicious for PCa, by abnormal DRE, regardless of PSA level a PSA level > 4 ng/mL (or 3 ng/mL in men < 60 years) a free:total PSA ratio (%fPSA) < 10% Exclusion criteria: none Setting: Créteil, France. Tertiary care hospital Age: mean 64.2 years (SD 7.8) PSA: mean 12.5 ng/mL (SD 7.2) Prostate volume: mean 46.4 mL (SD 25.3) Positive DRE: 318 participants
Index tests	Index test: transrectal extended sextant 12‐cores SBx, as part of a 21‐core transrectal Bx protocol
Target condition and reference standard(s)	Target condition: GS ≥ 3+3, GS ≥ 3+4 Reference standard: 21‐core transrectal Bx protocol: first 6 sextant biopsies (standard 45° angle), then 3 Bx in each peripheral zone (80° angle), then 3 Bx in each transition zone, and finally 3 Bx in the midline peripheral zone. The SBx were part of the 21‐core saturation Bx protocol, and therefore the reference standard is not independent of the index test.
Flow and timing	All participants underwent the same 21‐core Bx protocol. No participants were excluded for 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?	Yes
Did the study avoid inappropriate exclusions?	Yes
		Low	Low
DOMAIN 2: Index Test SBx
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?
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies?	No
		High	Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	No
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