Alberts 2017.

Study characteristics
Patient sampling	Aim of the study: to assess the potential of a risk‐based strategy including MRI to selectively identify men aged ≥ 70 years with high‐grade PCa Type of study: prospective, 2‐arm, PSA‐screening study: 179 men received 6 core SBx only; 158 received MRI+/‐MRI‐TBx and SBx Selection: consecutive selection based on invitation to participate in a population‐based PSA screening trial Enrolled/eligible: 337/406 (69 participants refused Bx) In the current analysis, only the 158 men in the group receiving MRI and MRI‐TBx are included, of which 85 had a prior‐negative Bx and 74 were Bx‐naïve Inclusion period: Octobr 2013‐April 2016
Patient characteristics and setting	Inclusion criteria: PSA ≥ 3.0 ng/mL Exclusion criteria: none Setting: PSA‐screening study. Rotterdam, the Netherlands. University hospital Age: median 73.1 years (IQR 72.4‐73.8)* PSA: median 4.2 ng/mL (IQR 3.4–5.8)* Prostate volume: median 52.9 (IQR 36.8‐70.9)* DRE positive: 14 participants* *of the 158 prior‐negative‐ and Bx‐naïve participants taken together
Index tests	Index test 1: MRI‐pathway: a 3 Tesla MRI machine (Discovery MR750, General Electric Healthcare) was used, with T2, DWI, and DCE sequences. PI‐RADS version 2 was used, with score 1‐5 and score ≥ 3 for positivity. The Koelis Urostation was used for software fused transrectal MRI‐TBx from all MRI‐positive lesions Index test 2: transrectal extended sextant SBx were taken, blinded for MRI results, before taking the MRI‐TBx
Target condition and reference standard(s)	No reference standard is used in this agreement analyses (MRI‐pathway vs SBx) study, therefore the reference standard domain is not applicable and disregarded
Flow and timing	All participants underwent the same reference test. During the study, 69 participants refused Bx.
Comparative
Notes	Only the 158 participants in the group receiving MRI and MRI‐TBx are included in the current analysis; the 179 participants with sextant Bx only are excluded from our analysis.
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	High
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?	Yes
		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?	No
		High