Hansen 2018.
Study characteristics | |||
Patient sampling | Aim of the study: to analyse the detection rates of primary MRI‐fusion transperineal PBx using combined targeted and systematic core distribution in 3 tertiary referral centres Type of study: prospective cohort Selection: consecutive patients Enrolled/eligible: 856/807 (163 participants from centre 1, 402 from centre 2* and 242 from centre 3; 49 participants did not comply with the inclusion criteria) Inclusion period: October 2012‐May 2016 |
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Patient characteristics and setting | Inclusion criteria: first suspicion of PCa, based on raised PSA levels above age‐related normal range, a suspicious DRE, or other including family history Exclusion criteria: age > 79 years, PSA level > 30 ng/mL, prior‐negative Bx or previous diagnosis or treatment of PCa Setting Centre 1: Cambridge UK, tertiary care hospital Age: median 64 years (IQR 57‐69) PSA: 6.6 ng/mL (IQR 4.6‐9.0) Prostate volume: 44 mL (IQR 33‐55) Positive DRE: 39 participants Setting Centre 2: Heidelberg, Germany, University Hospital (participants from centre 2 in this study were excluded from analyses in this review to prevent overlapping data with the included study Distler 2017*) Age: median 65 years (IQR 60‐70) PSA: 6.9 ng/mL (IQR 5.2‐9.1) Prosate volume: 47 mL (IQR 32‐62) Postive DRE: 94 participants Setting Centre 3: Melbourne, Australia, tertiary care hospital Age: median 65 years (IQR 60‐70) PSA: 5.9 ng/mL (IQR 4.6‐8,0) Prostate volume: 25 mL (IQR 24‐47) Positive DRE: 54 participants |
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Index tests | Centre 1: index test: MRI only, a 1.5 Tesla (MR450) or a 3 Tesla (Discovery MR750 HDx) machine of GE Healthcare was used with T2, DWI and DCE sequences. The PI‐RADS version 1 (until 2015) and version 2 (onwards) with a Likert 1‐5 score were used, with threshold ≥ 3 for positivity. Transperineal software fusion MRI‐TBx cores were taken (BiopSee system, Medcom) of every suspicious lesion, followed by template Bx. However, MRI‐TBx results were not reported separately. Centre 3: index test: MRI only, a 3 Tesla Magnetom (Siemens) was used with T2, DWI and DCE sequences. The PI‐RADS version 1 (until 2015) and version 2 (onwards) with a Likert 1‐5 score were used, with threshold ≥ 3 for positivity. Transperineal cognitive MRI‐TBx cores were taken of every suspicious lesion, followed by template Bx. However, MRI‐TBx results were not reported separately. |
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Target condition and reference standard(s) | Target condition in both centres: GS ≥ 3+3, GS ≥ 3+4 and GS ≥ 4+3 Reference standard in both centres: volume‐based transperineal template Bx with a median of 24 cores according to the Ginsburg protocol. Bx operators had access to MRI data during whole procedure. MRI‐TBx were taken in addition to the template Ginsburg biopsies and included in the reference standard results. Centre 1 used the Biopsee system (Medcom) with a 5‐mm spacing brachytherapy grid Centre 3 used a 5‐mm spacing brachytherapy grid (BK Ultrasound) and a transrectal probe mounted on a stepper |
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Flow and timing | All participants underwent same reference standard. No participants were excluded for analysis. | ||
Comparative | |||
Notes | *Only the 163 participants from centre 1 and the 242 patients from centre 3 are included in our analysis; we excluded the 402 patients from centre 2 because they are also reported in Distler 2017 | ||
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 |