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

Abd‐Alazeez 2014.

Study characteristics
Patient sampling Aim of the study: to assess the performance of mpMRI in men with prior‐negative SBx
Type of study: retrospective cohort
Selection: unclearly reported
Enrolled/eligible: 54/58
Inclusion period: not reported, but before April 2013
Patient characteristics and setting Inclusion criteria: men who had ≥ 1 negative SBx and underwent mpMRI (index test) followed by TTMB (reference standard). All men included in the study had either increasing or persistently high PSA level
Exclusion criteria: 4 men were excluded from the study as they received limited TTMB (< 20 cores were taken)
Setting: London, UK. University hospital
Age: median 64 years (range 39‐75)
PSA: 10 ng/mL (range 2‐23)
Prostate volume: 53 mL (range 19‐136)
Previous number of negative Bx: 33 men had 1, 16 had 2, 5 had 3
Index tests Index tests: MRI only, with an MRI‐score 1‐5 with threshold ≥ 3 for positivity. A 1.5 Tesla (Philips Achiva) and 3.0 Tesla (Siemens Avanto) MRI machine, with T2, DWI and DCE sequences were used. Index test performed first, then the reference test.
Target condition and reference standard(s) Target condition: GS ≥ 3+3, GS ≥ 3+4, GS ≥ 4+3 and others. Pathology grading before ISUP 2005: GS was based upon most frequent pattern instead of highest grade detected.
Reference standard: systematic TTMB with the use of a brachytherapy grid under general anaesthesia, as described by Barzell. Basal and apical cores were obtained routinely, and the minimum number of samples was 20. MRI results were available during TTMB.
Flow and timing All men underwent the same reference test. No men were excluded from analysis
Comparative  
Notes Study authors provided additional data
Although MRI‐TBx were taken in a subset of 15 men, their results are not reported nor are they taken into account in our analysis.
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? Unclear    
    High Low
DOMAIN 2: Index Test MRI
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 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? No    
    High 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