Okcelik 2016.
Study characteristics | |||
Patient sampling | Aim of the study: to analyse the contribution of MRI and PCA3 in detecting PCa Type of study: prospective cohort Selection: unclear Enrolled/eligible: 53/unclear Inclusion period: February 2013‐March 2014 |
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Patient characteristics and setting | Inclusion criteria: serum PSA level 3‐10 ng/mL participants with normal DRE scheduled for initial PBx Exclusion criteria: none reported Setting: Ankara, Turkey. Single‐centre, university hospital Age: median 62 years (IQR 43‐79) PSA: 5 ng/mL (range 3‐8.9) Prostate volume: median 45 mL (range 17‐93) |
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Index tests | Index tests 1: MRI‐pathway: a 1.5 Tesla MRI (Avanto, Siemens) was used, with T2, DWI, DCE and spectroscopy sequencing. A binary MRI score was reported, with additional cognitive transrectal MRI‐TBx taken from all positive lesions. Index test 2: transrectal extended sextant SBx with a mean number of 12.7 cores (including the additional MRI‐TBx only in MRI‐positive men), no further details reported |
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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. 1 participant did not undergo MRI for unclear reasons and was not included in 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? | No | ||
High | 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? | Unclear | ||
Unclear | 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? | Unclear | ||
Unclear |