Grey 2015.
Study characteristics | |||
Patient sampling | Aim of the study: to determine the sensitivity and specificity of mpMRI for significant PCa with transperineal sector Bx as the reference standard Type of study: prospective cohort Selection: consecutive patients Enrolled/eligible: 201/205 (83 Bx‐naïve‐, 103 prior‐negative Bx‐, 15 active surveillance participants; 4 participants were excluded due to contraindications to MRI) Inclusion period: July 2012‐November 2013 |
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Patient characteristics and setting | Inclusion criteria: a prior‐negative PBx with ongoing suspicion of PCa because of rising PSA levels (n = 103); those undergoing a primary PBx because of raised PSA level or abnormal DRE (n = 83) Exclusion criteria: previous history of PBx, prostate surgery or radiotherapy or medical treatment for benign prostate hyperplasia Setting: London, UK. University hospital Age*: mean (SD) 65 years (7.6); 64.1 (6.8). PSA*: mean (SD) 12.6 ng/mL (13.7); 13.3 (12.1) Prostate volume*: mean (SD) 54 mL (31); 68 (35) *Although test results are reported only for the mix of the 2 participant groups, these basic characteristics are reported for the 2 groups separately (103 prior‐negative Bx‐; Bx‐naïve patients, respectively) |
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Index tests | Index test: MRI only. A 1.5 Tesla MRI machine (Signa Excite, GE Healthcare) with T2 and DWI sequences was used. The PI‐RADS version 1 Likert 1‐5 score was used, with threshold ≥ 3 for positivity | ||
Target condition and reference standard(s) | Target condition: GS ≥ 3+3, GS ≥ 3+4 and GS ≥ 4+3 Reference standard: transperineal sector Bx, with 24‐40 cores (depending on prostate size) with a brachytherapy grid. MRI‐positive lesions were targeted by cognitive registrated MRI‐TBx, but results were not reported separately |
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Flow and timing | All participants underwent the same reference test and were included in the analysis. | ||
Comparative | |||
Notes | All active surveillance participants (n = 15) were excluded from our analysis after additional information was received from study authors | ||
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? | Yes | ||
Low |