Chen 2015.
Study characteristics | |||
Patient sampling | Aim of the study: to determine the detection rate of 3‐Tesla MRI and MRI‐TBx compared to SBx Type of study: prospective cohort Selection: consecutive selection of participants who presented with a suspicion of PCa Enrolled/eligible: 420/429 Inclusion period: June 2008‐December 2013 |
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Patient characteristics and setting | Inclusion criteria: abnormal DRE findings and/or persistently elevated PSA levels Exclusion criteria: not reported Setting: Shanghai, China. University hospital Age: median 67 years (range 45‐91) PSA: median 9.7 ng/mL (range 2.4‐35.7) Prostate volume: median 44.8 mL (range 21.2‐83.2) DRE positive: 52 participants |
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Index tests | Index test 1: MRI‐pathway: a 3 Tesla MRI machine (Philips Achieva) was used, with T1, T2, T2 spectral presaturation attenuated inversion recovery (SPAIR) and DWI sequences. An in‐house MRI score 1‐5 with threshold ≥ 3 for positivity were used. Cognitive transperineal MRI‐TBx were performed from all MRI‐positive lesions. Index test 2: a 10‐core fan‐shaped transperineal SBx from the peripheral zone with 2‐cores from transition zone was performed, blinded for MRI results, before taking the MRI‐TBx |
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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 reference test Except for the 9 excluded participants (DWI artifacts due to movement of the participant) all participants were included in the analysis. |
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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? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Low | Low | ||
DOMAIN 2: Index Test SBx | |||
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 | 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? | 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 |