Costa 2013.

Study characteristics
Patient sampling	Aim of the study: to assess the value of MRI and MRI‐TBx added to standard SBx for detecting clinical relevant PCa Type of study: retrospective analysis Selection: retrospective selection of participants meeting inclusion criteria Enrolled/eligible: 38/1053 (of the 1053 participants who had had an MRI, 38 participants met the inclusion criteria) Inclusion period: August 2003‐August 2008
Patient characteristics and setting	Inclusion criteria: men with ≥ 2 prior‐negative biopsies who underwent MRI and subsequent SBx complemented with MRI‐TBx of MRI‐suspicious lesions. All men were referred for MRI because of PSA > 4 ng/mL, PSA velocity > 0.75 ng/mL/year or equivocal histopathology from previous Bx Setting: Boston, USA. University hospital Age: mean 64 (range 48‐77) PSA: mean 14.4 (range 1.8‐33.1) Prostate volume: not reported
Index tests	Index test 1 : MRI‐pathway: a 3 Tesla MRI machine (Genesis Signa LX Excite, GE Healthcare) was used, with T1, T2 and DCE sequences. An in‐house MRI Likert 1‐5 scale was used, grouping score 1‐3 negative and 4‐5 positive. Cognitive MRI‐TBx from MRI‐positive lesions were taken, depending on judgement of urologist Index test 2: transrectal SBx was performed. Sequence of tests and number of cores were dependent on judgement of urologist. A total median of 19 (range 8‐28) cores (MRI‐TBx + SBx) were taken. MRI results were known at time of SBx performance
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. All participants were included in the analysis
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?	No
Did the study avoid inappropriate exclusions?	Yes
		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	High
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?	Unclear
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies?
		Unclear	High
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