Filson 2016.

Study characteristics
Patient sampling	Aim of the study: to evaluate the performance of MRI‐TBx in diagnosing clinically significant PCa Type of study: prospective cohort Selection: consecutive selection Enrolled/eligible: 1042/1042 (328 Bx‐naïve‐, 324 prior‐negative Bx‐ and 390 active surveillance men) Inclusion period: September 2009‐February 2015
Patient characteristics and setting	Inclusion criteria: elevated PSA level or abnormal DRE or 2) confirmation of low‐risk PCa for men considering active surveillance Exclusion criteria: none reported Setting: Los Angeles, USA. University hospital Age*: median (IQR) 64.4 years (58.5‐69.4); 65.7 (59.3‐70.2) PSA*: median (IQR) 5.8 ng/mL (4.4‐8.1); 7,6 (5‐11.5) Prostate volume*: median (IQR) 45 mL (33‐61.5); 57.7 (39.8‐83.5) *respectively, for the Bx‐naïve‐ and prior‐negative Bx participant groups
Index tests	Index tests 1: MRI‐pathway: a 3 Tesla MRI machine (Trio Trim/Somatom, Philips) was used, with T2, DWI and DCE sequences. An in‐house Likert 1‐5 score was used, with threshold ≥ 3 for positivity. MRI‐TBx (Artemis fusion device (Eigen, Grass Valley, Calif) were taken first in case of a suspicious lesion, then SBx were taken Index test 2: transrectal 12‐core SBx were taken in all participants, after MRI‐TBx. No blinding for MRI is reported
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 reference test. All participants were included in the analysis.
Comparative
Notes	Participants on active surveillance (n = 390) were excluded from our analysis. Although in text 328 participants are reported in the biopsy‐naïve group, in the data tables 329 participants are reported
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?	Unclear
		Unclear	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	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?	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