Kim 2017.

Study characteristics
Patient sampling	Aim of the study: to determine the added value of prostate MRI to the Prostate Cancer Prevention Trial risk calculator Type of study: retrospective study of prospective database Selection: consecutive patients who received prostate MRI prior to Bx Enrolled/eligible: 421/unclear (185 Bx‐naïve‐, 154 prior‐negative Bx and 82 active surveillance participants). Inclusion period: January 2012‐December 2015
Patient characteristics and setting	Inclusion criteria: indication for MRI and Bx, no details reported Exclusion criteria not reported Setting: St. Louis, MO, USA. University hospital Age*: mean 63.9 years (SD 7.6) PSA*: mean 10.2 ng/mL (SD 15.1) Prostate volume: not reported Positive DRE*: 48 participants *only reported for the whole group (Bx‐naïve and prior‐negative Bx participants combined)
Index tests	Index test 1: MRI‐pathway: a 3 Tesla machine (Siemens) was used with T2, DWI and DCE sequences. 2 MRI‐scoring systems were used: in the first 205 participants a binary in‐house score, in the last 194 participants a PI‐RADS version 1 and version 2 Likert 1‐5 score. The MRI‐TBx thresholds for positivity and MRI‐TBx were a comparable triple suspicious (on T2, DWI, DCE) or a PIRADS version 2 4/5 lesion. MRI‐TBx was performed prior to SBx: 70 participants received cognitive MRI‐TBx using the TargetScan system (Best Nomos); 129 with software fusion MRI‐TBx (UroNav system, Invivo). Index test 2: 12‐core transrectal SBx, without blinding for MRI results
Target condition and reference standard(s)	No reference standard is used in this agreement analyses study (MRI‐pathway vs SBx), therefore the reference standard domain is not applicable and disregarded.
Flow and timing	All participants underwent the same type of tests and were included in the analysis.
Comparative
Notes	Study authors provided additional data. We excluded from our analysis the 82 active surveillance participants. Furthermore we excluded 2 Bx‐naïve participants because only the highest GS was recorded (not differentiating between Bx methods). The remaining 337 (183 Bx‐naïve‐ and 154 prior‐negative Bx‐) participants were included.
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	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 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?	Yes
Was the reference standard performed independent from the index test?	Yes
		Low	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