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

Okcelik 2016.

Study characteristics
Patient sampling Aim of the study: to analyse the contribution of MRI and PCA3 in detecting PCa
Type of study: prospective cohort
Selection: unclear
Enrolled/eligible: 53/unclear
Inclusion period: February 2013‐March 2014
Patient characteristics and setting Inclusion criteria: serum PSA level 3‐10 ng/mL participants with normal DRE scheduled for initial PBx
Exclusion criteria: none reported
Setting: Ankara, Turkey. Single‐centre, university hospital
Age: median 62 years (IQR 43‐79)
PSA: 5 ng/mL (range 3‐8.9)
Prostate volume: median 45 mL (range 17‐93)
Index tests Index tests 1: MRI‐pathway: a 1.5 Tesla MRI (Avanto, Siemens) was used, with T2, DWI, DCE and spectroscopy sequencing. A binary MRI score was reported, with additional cognitive transrectal MRI‐TBx taken from all positive lesions.
Index test 2: transrectal extended sextant SBx with a mean number of 12.7 cores (including the additional MRI‐TBx only in MRI‐positive men), no further details reported
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. 1 participant did not undergo MRI for unclear reasons and was not included in 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? 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? Unclear    
    Unclear 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? Unclear    
    Unclear