Chang 2017.

Study characteristics
Patient sampling	Aim of the study: to investigate the overall and clinically significant PCa detection rates of MRI‐TBx and SBx in prior‐negative Bx men Type of study: retrospective study Selection: consecutive selection, but performance of MRI according to the physicians’ clinical considerations Enrolled/eligible: 185/185 (65 men underwent MRI and Bx, 120 men underwent only Bx without prior MRI) Inclusion period: March 2012–December 2014
Patient characteristics and setting	Inclusion criteria: men with prior‐negative Bx, persistently elevated serum PSA level and normal DRE Exclusion criteria: positive DRE Setting: Taichung, Taiwan. University hospital Age: median 64 years (IQR 60.3‐67.8) PSA: median 10.9 ng/mL (IQR 7.2‐14.7) Prostate volume: median 48 mL (IQR 33.5‐62.5) DRE positive: none
Index tests	Index test 1: MRI‐pathway: a 3 Tesla MRI machine (Signa HDx, General Electric Healthcare) was used with T2, DWI, and DCE sequences. PI‐RADS version 1 was converted to PI‐RADS version 2, with score 1‐5 and score ≥ 3 for positivity. Transrectal cognitive MRI‐TBx were performed from all MRI‐positive lesions with ≥ 2 cores Index test 2: transrectal SBx were taken with ≥ 16 cores from the peripheral zone and transitional zone, after the MRI‐TBx were taken by the same operator.
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. No participants were excluded.
Comparative
Notes	The 120 participants in the control group who underwent only SBx without prior MRI were excluded from our analysis. 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?	No
Did the study avoid inappropriate exclusions?	No
		High	Low
DOMAIN 2: Index Test SBx
Was the MRI assessed without knowledge of the results of the (reference or other index) biopsies?	No
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?
		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	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