Thompson 2016.
Study characteristics | |||
Patient sampling | Aim of the study: to assess the accuracy of mpMRI for significant PCa detection before diagnostic Bx in men with an abnormal PSA/DRE Type of study: prospective cohort Selection: consecutive Enrolled/eligible: 344/388 (44 participants were excluded due to refusing informed consent, MRI or Bx) Inclusion period: April 2012‐March 2014 |
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Patient characteristics and setting | Inclusion criteria: men > 40 years, scheduled to undergo Bx for abnormal PSA or DRE, with a life expectancy > 10 years and no previous prostate MRI or Bx Exclusion criteria: none Setting: Sydney, Australia, University hospital Age: median 62.9 years (IQR 55.9‐67.1) PSA: median 5.2 ng/mL (IQR 3.7‐7.1) Prostate volume: median 40 mL (IQR 30‐54) |
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Index tests | Index test: MRI only. A 1.5 and 3 Tesla MRI (vendor unknown) was used in 2 centres. PI‐RADS version 1 was used, with score ≥ 3 considered positive. MRI was reported before the Bx procedure. Cognitive‐fusion transperineal MRI‐TBx were performed, independent of the reference test. However, the MRI‐TBx results are not reported separately from template Bx results. Therefore the MRI‐TBx could not be assessed as an index test. | ||
Target condition and reference standard(s) | Target condition: GS ≥ 3+3, GS ≥ 3+4 and GS ≥ 4+3 Reference standard: transperineal mapping biopsies (median 30 cores, using a brachytherapy grid, with relative periurethral zone sparing) from 18 template locations. MRI outcomes were known at time of Bx. MRI‐TBx were taken in addition to the TTMB and could not be disaggregated from the TTMB results and were therefore included in the reference standard results. |
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Flow and timing | All participants underwent same TTMB technique. 44 participants were excluded: 16 refused consent, 8 refused MRI and 10 refused Bx |
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Comparative | |||
Notes | Study authors provided additional information | ||
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 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? | No | ||
High |