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. 2019 Apr 25;2019(4):CD012663. doi: 10.1002/14651858.CD012663.pub2

Chen 2015.

Study characteristics
Patient sampling Aim of the study: to determine the detection rate of 3‐Tesla MRI and MRI‐TBx compared to SBx
Type of study: prospective cohort
Selection: consecutive selection of participants who presented with a suspicion of PCa
Enrolled/eligible: 420/429
Inclusion period: June 2008‐December 2013
Patient characteristics and setting Inclusion criteria: abnormal DRE findings and/or persistently elevated PSA levels
Exclusion criteria: not reported
Setting: Shanghai, China. University hospital
Age: median 67 years (range 45‐91)
PSA: median 9.7 ng/mL (range 2.4‐35.7)
Prostate volume: median 44.8 mL (range 21.2‐83.2)
DRE positive: 52 participants
Index tests Index test 1: MRI‐pathway: a 3 Tesla MRI machine (Philips Achieva) was used, with T1, T2, T2 spectral presaturation attenuated inversion recovery (SPAIR) and DWI sequences. An in‐house MRI score 1‐5 with threshold ≥ 3 for positivity were used. Cognitive transperineal MRI‐TBx were performed from all MRI‐positive lesions.
Index test 2: a 10‐core fan‐shaped transperineal SBx from the peripheral zone with 2‐cores from transition zone was performed, blinded for MRI results, before taking 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 the same reference test
Except for the 9 excluded participants (DWI artifacts due to movement of the participant) 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? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Low Low
DOMAIN 2: Index Test SBx
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?      
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies?      
    Low 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? 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