Boesen 2018.

Study characteristics
Patient sampling	Aim of the study: to assess the diagnostic accuracy and negative predictive value of a novel bpMRI method in Bx‐naïve men in detecting and ruling out significant PCa. Type of study: prospective, single‐institutional, paired diagnostic study Selection: consecutive selection Enrolled/eligible: 1020/1063 (43 participants were excluded for various reasons) Inclusion period: November 2015–June 2017
Patient characteristics and setting	Inclusion criteria: Bx‐naïve men with a clinical suspicion of PCa (PSA ≥ 4 ng/mL and/or abnormal DRE results) Exclusion criteria: prior PBx, evidence of acute urinary tract infections, acute prostatitis, general contraindications for MRI, and prior hip replacement surgery or other metallic implants in the pelvic area Setting: Herlev, Denmark, University Hospital Age: median 67 years (IQR 61‐71) PSA: median 8 ng/mL (IQR 5.7‐13) Prostate volume: median 53 mL (IQR 40‐72) DRE positive: 377/1020 (37%) participants
Index tests	Index test 1: MRI‐pathway: a 3 Tesla MRI machine (Philips) with a pelvic‐phased‐array coil was used with T2, DWI sequences, without DCE (bpMRI). An in‐house modified PI‐RADS version 2 was used with score 1‐5 and score ≥ 3 for positivity. Transrectal software fused MRI‐TBx were performed from all MRI‐positive lesions, using Hitachi (n = 877) and Invivo (n = 143) systems. Index test 2: transrectal 10‐core SBx were taken before the MRI‐TBx, the performers were blinded for the 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. The minimal exclusions were sufficiently explained not leading to relevant bias.
Comparative
Notes	Study authors provided additional data.
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?	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 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