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

Lee 2017.

Study characteristics
Patient sampling Aim of the study: to determine the efficacy of cognitive MRI‐TBx using biparametric MRI for men with PSA levels < 10 ng/mL
Type of study: retrospective analysis
Selection: before PBx, each urologist explained the MRI‐TBx technique to the participants; the final choice regarding the use of the technique (MRI‐TBx or standard SBx) was left to each participant. Hence, all consecutive participants who chose MRI‐TBx were selected.
Enrolled/eligible: 123/464 (464 participants underwent PBx. Excluded were: 126 participants with a PSA > 10 ng/mL, 207 participants who chose SBx only, and 8 participants who had a prior‐negative Bx)
Inclusion period: 2016
Patient characteristics and setting Inclusion criteria: Bx indication by elevated PSA and choice for MRI‐pathway
Exclusion criteria: PSA > 10 ng/mL, previous PBx
Setting: Yangsan, Korea. University hospital
Age*: mean (SD) 61.8 years (11.7); 62 (7.8)
PSA*: mean (SD) 6.7 ng/mL (1.67); 6.19 (1.82)
Prostate volume* (SD): 38.6 mL (18.6); 40.2 (18.1)
*reported for the mpMRI participants (n = 55) and bpMRI‐participants (n = 68), respectively
Index tests Index test 1: MRI‐pathway: a 3 Tesla MRI (Intera Achieva, Phillips) was used. In 68 participants only T2 and DWI sequences were used, in 55 DCE was also used. A modified 1‐4‐point MRI score was used, based on PI‐RADS version 2:
  1. no suspicious findings

  2. weakly suspicious lesion

  3. moderately suspicious lesion

  4. highly suspicious lesion


Threshold for positive MRI and MRI‐TBx was score ≥ 2. Cognitive transrectal MRI‐TBx was performed of all positive lesions, prior to SBx.
Index test 2: transrectal extended sextant SBx, without blinding for MRI results
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 and were included in the analysis.
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? 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 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