Grey 2015.

Study characteristics
Patient sampling	Aim of the study: to determine the sensitivity and specificity of mpMRI for significant PCa with transperineal sector Bx as the reference standard Type of study: prospective cohort Selection: consecutive patients Enrolled/eligible: 201/205 (83 Bx‐naïve‐, 103 prior‐negative Bx‐, 15 active surveillance participants; 4 participants were excluded due to contraindications to MRI) Inclusion period: July 2012‐November 2013
Patient characteristics and setting	Inclusion criteria: a prior‐negative PBx with ongoing suspicion of PCa because of rising PSA levels (n = 103); those undergoing a primary PBx because of raised PSA level or abnormal DRE (n = 83) Exclusion criteria: previous history of PBx, prostate surgery or radiotherapy or medical treatment for benign prostate hyperplasia Setting: London, UK. University hospital Age*: mean (SD) 65 years (7.6); 64.1 (6.8). PSA*: mean (SD) 12.6 ng/mL (13.7); 13.3 (12.1) Prostate volume*: mean (SD) 54 mL (31); 68 (35) *Although test results are reported only for the mix of the 2 participant groups, these basic characteristics are reported for the 2 groups separately (103 prior‐negative Bx‐; Bx‐naïve patients, respectively)
Index tests	Index test: MRI only. A 1.5 Tesla MRI machine (Signa Excite, GE Healthcare) with T2 and DWI sequences was used. The PI‐RADS version 1 Likert 1‐5 score was used, with threshold ≥ 3 for positivity
Target condition and reference standard(s)	Target condition: GS ≥ 3+3, GS ≥ 3+4 and GS ≥ 4+3 Reference standard: transperineal sector Bx, with 24‐40 cores (depending on prostate size) with a brachytherapy grid. MRI‐positive lesions were targeted by cognitive registrated MRI‐TBx, but results were not reported separately
Flow and timing	All participants underwent the same reference test and were included in the analysis.
Comparative
Notes	All active surveillance participants (n = 15) were excluded from our analysis after additional information was received from study authors
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 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	Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
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