Muthuveloe 2016.
Study characteristics | |||
Patient sampling | Aim of the study: to assess the detection rate of significant PCa by transperineal template‐guided Bx Type of study: partial prospective and retrospective analysis Selection: all men who received MRI prior to template Bx were selected, no criteria reported for performing MRI or template Bx Enrolled/eligible: 200/unclear (9 Bx‐naïve‐, 162 prior‐negative Bx and 29 active surveillance participants). Inclusion period: March 2013‐December 2014 |
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Patient characteristics and setting | Inclusion criteria: transperineal template‐guided PBx and MRI prior to Bx Exclusion criteria: previous brachytherapy, previous template biopsies for anorectal abnormalities Setting: Birmingham, UK. Tertiary referral centre Age*: median (range) 68 years (46‐81); 65 (47‐78) PSA*: median (range) 11.5 ng/mL (1.2‐92.5); 10 (2.7‐61). Prostate volume: not reported *reported for template Bx positive (n = 71) and template Bx negative (n = 103) participants, respectively |
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Index tests | Index test: MRI only, assessed prior to template Bx. No details for MRI‐acquisition are reported. The PI‐RADS version 1 was used with a 1‐5 score and threshold ≥ 3 for positivity. | ||
Target condition and reference standard(s) | Target condition: GS ≥ 3+3, GS ≥ 3+4 and GS ≥ 4+3 Reference standard: a minimum of 24 sector transperineal prostatic Bx cores were taken in a systematic fashion using a 5 mm brachytherapy template grid, prostate volume depended. Blinding for MRI results was not reported. |
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Flow and timing | All participants underwent the same reference test and were included in the analysis. | ||
Comparative | |||
Notes | Study authors provided additional data. We excluded the 29 active surveillance or other indication participants from this current analysis. The remaining 9 Bx‐naïve‐ and 162 prior‐negative participants were included. | ||
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? | Yes | ||
Unclear | 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 | Unclear | ||
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? | Unclear | ||
Unclear | 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 |