Pepe 2013.
Study characteristics | |||
Patient sampling | Aim of the study: to evaluate MRI accuracy in PCa diagnosis in men submitted to saturation PBx Type of study: prospective, single‐centre, multi‐departmental study Selection: unclear. Men were selected from a PCa case‐finding protocol (including 14,453 patients) if meeting the inclusion criteria and when having an indication for saturation Bx Enrolled/eligible: 78/unclear Inclusion period: June 2011‐December 2012 |
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Patient characteristics and setting | Inclusion criteria: 1 single prior‐negative Bx > 6 months before. Indications for saturation Bx: a persistently high or increasing PSA value, abnormal DRE and PSA > 10 ng/mL or PSA values 4.1‐10 or 2.6‐4 ng/mL with free/total PSA ≤ 25% and ≤ 20%, respectively Setting: Catania, Italy. University Hospital Age: median 63 years (range 49‐72) PSA: median 11 ng/mL (range 3.7‐45) Prostate volume: not reported |
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Index tests | Index test: MRI only, MRI‐TBx and MRI‐pathway. A 3 Tesla MRI (Achieva, Philips) was used, with T2, DWI, DCE and spectroscopy sequences. An in‐house binary MRI score was used, with positive lesions cognitively targeted by MRI‐TBx, after the performance of saturation Bx. | ||
Target condition and reference standard(s) | Target condition: GS ≥ 3+3, GS ≥ 3+4 Reference standard: transperineal TSB with a median of 28 cores (range 26‐32) including 4‐6 cores in the transition and anterior zone. MRI results were not blinded during Bx procedure. |
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Flow and timing | All participants underwent same reference standard and were included in the analysis. | ||
Comparative | |||
Notes | |||
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? | Unclear | ||
Unclear | High | ||
DOMAIN 2: Index Test MRI‐TBx | |||
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? | Yes | ||
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies? | |||
Low | High | ||
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 | High | ||
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? | Unclear | ||
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 |