Jambor 2017.

Study characteristics
Patient sampling	Aim of the study: to evaluate the role of a MRI combined with MRI‐TBx for improving risk stratification of men with elevated PSA Type of study: prospective cohort Selection: unclear selection Enrolled/eligible: 161/175 (134 Bx‐naïve, 27 prior‐negative Bx participants and 14 exclusions) Inclusion period: March 2013‐February 2015
Patient characteristics and setting	Inclusion criteria: 2 repeated measurements of PSA in the range 2.5–20.0 ng/mL and/or abnormal DRE Exclusion criteria: previous PCa diagnosis, previous Bx within 6 months, prostate surgery, clinical infection or MRI contraindication Setting: Turku, Finland. University hospital Age: mean 64.7 years (SD 6.4) PSA: median 7.5 (IQR 5.7‐9.6). Prostate volume: median 37 (IQR 27.5‐49)
Index tests	Index tests 1: MRI‐pathway: a 3 Tesla machine (Magnetom Verio 3T, Siemens) was used with T2 and DWI sequences. An in‐house MRI Likert 1‐5 scale was used, with threshold ≥ 3 for positivity and MRI‐TBx. Cognitive transrectal MRI‐TBx were taken of all index lesions, prior to SBx. Index test 2: 12‐core transrectal SBx, without blinding for MRI results (although strictly following the SBx scheme).
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 tests. Not all participants were included in analysis. 4 withdrew consent before and 7 after MRI, 1 had a non‐diagnostic MRI, 2 had a PSA < 2.5 or > 20
Comparative
Notes
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?	Yes
		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	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