Jambor 2017.
Study characteristics | |||
Patient sampling | Aim of the study: to evaluate the role of a MRI combined with MRI‐TBx for improving risk stratification of men with elevated PSA Type of study: prospective cohort Selection: unclear selection Enrolled/eligible: 161/175 (134 Bx‐naïve, 27 prior‐negative Bx participants and 14 exclusions) Inclusion period: March 2013‐February 2015 |
||
Patient characteristics and setting | Inclusion criteria: 2 repeated measurements of PSA in the range 2.5–20.0 ng/mL and/or abnormal DRE Exclusion criteria: previous PCa diagnosis, previous Bx within 6 months, prostate surgery, clinical infection or MRI contraindication Setting: Turku, Finland. University hospital Age: mean 64.7 years (SD 6.4) PSA: median 7.5 (IQR 5.7‐9.6). Prostate volume: median 37 (IQR 27.5‐49) |
||
Index tests | Index tests 1: MRI‐pathway: a 3 Tesla machine (Magnetom Verio 3T, Siemens) was used with T2 and DWI sequences. An in‐house MRI Likert 1‐5 scale was used, with threshold ≥ 3 for positivity and MRI‐TBx. Cognitive transrectal MRI‐TBx were taken of all index lesions, prior to SBx. Index test 2: 12‐core transrectal SBx, without blinding for MRI results (although strictly following the SBx scheme). |
||
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. Not all participants were included in analysis. 4 withdrew consent before and 7 after MRI, 1 had a non‐diagnostic MRI, 2 had a PSA < 2.5 or > 20 | ||
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? | 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 | 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? | No | ||
High |