Lee 2017.
Study characteristics | |||
Patient sampling | Aim of the study: to determine the efficacy of cognitive MRI‐TBx using biparametric MRI for men with PSA levels < 10 ng/mL Type of study: retrospective analysis Selection: before PBx, each urologist explained the MRI‐TBx technique to the participants; the final choice regarding the use of the technique (MRI‐TBx or standard SBx) was left to each participant. Hence, all consecutive participants who chose MRI‐TBx were selected. Enrolled/eligible: 123/464 (464 participants underwent PBx. Excluded were: 126 participants with a PSA > 10 ng/mL, 207 participants who chose SBx only, and 8 participants who had a prior‐negative Bx) Inclusion period: 2016 |
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Patient characteristics and setting | Inclusion criteria: Bx indication by elevated PSA and choice for MRI‐pathway Exclusion criteria: PSA > 10 ng/mL, previous PBx Setting: Yangsan, Korea. University hospital Age*: mean (SD) 61.8 years (11.7); 62 (7.8) PSA*: mean (SD) 6.7 ng/mL (1.67); 6.19 (1.82) Prostate volume* (SD): 38.6 mL (18.6); 40.2 (18.1) *reported for the mpMRI participants (n = 55) and bpMRI‐participants (n = 68), respectively |
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Index tests | Index test 1: MRI‐pathway: a 3 Tesla MRI (Intera Achieva, Phillips) was used. In 68 participants only T2 and DWI sequences were used, in 55 DCE was also used. A modified 1‐4‐point MRI score was used, based on PI‐RADS version 2:
Threshold for positive MRI and MRI‐TBx was score ≥ 2. Cognitive transrectal MRI‐TBx was performed of all positive lesions, prior to SBx. Index test 2: transrectal extended sextant SBx, without blinding for MRI results |
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Target condition and reference standard(s) | No reference standard is used in this agreement analyses study (MRI‐pathway vs SBx), therefore the reference standard domain is not applicable and disregarded. | ||
Flow and timing | All participants underwent the same tests and were included in the analysis. | ||
Comparative | |||
Notes | Study authors provided additional data. | ||
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 SBx | |||
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? | |||
Was the performance of the SBx not influenced by the performance of the (reference or other index) biopsies? | No | ||
High | Low | ||
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? | Yes | ||
Was the reference standard performed independent from the index test? | Yes | ||
Low | 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 |