Tonttilla 2016.

Study characteristics
Patient sampling	Aim of the study: to compare (TRUS)‐fusion mpMRI‐TBx with routine SBx for overall and clinically significant PCa detection among men with suspected PCa based on PSA values Type of study: prospective RCT, with randomisation 1:1 to the mpMRI or control group. Participants in the mpMRI group underwent pre‐Bx mpMRI followed by SBx and MRI‐TBx; the control group underwent SBx alone. For our current analysis only the mpMRI group is used. Selection: consecutive Enrolled/eligible: 53/65 (of the mpMRI group; 12 participants were excluded because of PSA normalisation, Bx protocol violation or MRI could not be performed) Inclusion period: April 2011‐December 2014
Patient characteristics and setting	Inclusion criteria: aged 40‐72 years PSA < 20 ng/mL or free‐to‐total PSA ratio 0.15 and PSA < 10 ng/mL in repeated measurements no evidence of PSA increase by noncancerous factors, such as catheterisation, bladder stones, or urinary tract infection including bacterial prostatitis signed informed consent Exclusion criteria: known contraindication for MRI examination previous PBx or prostate surgery abnormal DRE by referring doctors Setting: Oulu, Finland, University hospital Age: median 63 years (IQR 60‐66) PSA: median 6.1 ng/mL (IQR 4.2‐9.9) Prostate volume: median 27.8 mL (IQR 23.5‐36.6)
Index tests	Index test 1: MRI‐pathway: a 3 Tesla MRI (Skyra, Siemens) was used. An in‐house MRI score on a 1‐4‐point scale was used: no suspicious findings probably no cancer probably cancer highly suspicious of cancer. With score ≥ 3 considered a positive MRI and threshold for MRI‐TBx. MRI was reported before the Bx procedure. Cognitive‐fusion transrectal MRI‐TBx were performed independent from the SBx. Index test 2: standard transrectal 12‐core SBx were performed with blinding for the MRI results and before the performance of the MRI‐TBx
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 same tests. Participants with normalised PSA, Bx protocol violation or in which MRI could not be performed were excluded from analysis (n = 12).
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?	No
		High	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?	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	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?	No
		High