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 |
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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 |
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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. |
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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. |
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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 |