Critical appraisal:Sonn GA, Chang E, Natarajan S, Margolis DJ, Macairan M, Lieu P, et al 2014

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Risk of bias assessment: diagnostic accuracy study

Patient Selection
Prior tests and any referral filters
Condition that defined entry into study
Subjects were culled from a prospective trial of magnetic resonance–ultrasound (MR–US) fusion biopsy at the University of California, Los Angeles (UCLA), which was approved in advance by the UCLA Institutional ReviewBoard. Those included in the present study were all 105men with one prior negative prostate biopsy or more and persistently elevated serum PSA levels who underwent multiparametric MRI (mpMRI) and MR–US fusion biopsy between March 2010 and August 2012.
Setting
Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Yes
Did the study avoid inappropriate exclusions?
No
Reasons
No MRI –ve patients in the study. Must include men who haven’t had MRI.
If comparing more than one index test was the design fully paired or paired randomly?
Yes
If a paired randomised design was used, was allocation to groups concealed and was the generation of allocation sequence adequate?
Not applicable
What is the risk that the selection of participants introduced bias?
High
Comments
Index test 1
Describe index test and how it was conducted and interpreted
In brief, subjects underwent mpMRI on a Siemens TrioTim Somatom 3-Tesla (Siemens Medical Solutions, Malvern, PA, USA) magnet using a multichannel external phased-array coil. The MRI protocol was recently published [19,21]; delineation of lesions and assignment of image grade (1–5) was by a uroradiologist with 10 yr of experience reading prostate MRI (DM). The MRI image grading system is detailed in Table 1 [21]. MRI was performed 1 to 3 wk before biopsy.
Were the index test results interpreted without knowledge of the results of the reference standard?
Not applicable
If a threshold was used, was it pre-specified?
Yes
If two tests are being compared, have they been assessed independently / blind to each other?
Unclear
What is the risk that the conduct or interpretation of the index test introduced bias?
Unclear
Comments
Not reported in the study about blinding of cores.
Index test 2
Describe index test and how it was conducted and interpreted, if applicable
Were the index test results interpreted without knowledge of the results of the reference standard?
Not applicable
If a threshold was used, was it pre-specified?
Not applicable
What is the risk that the conduct or interpretation of the index test introduced bias?
Not applicable
Comments
Reference Standard
Describe the reference standard and how it was conducted and interpreted
None to report.
Is the reference standard likely to correctly classify the target condition?
Not applicable
Were the reference standard results interpreted without knowedge of the results of the index test/s?
Not applicable
Was the reference test standard independent of the index test?
(i.e. the index test did not form part of the reference standard)
Not applicable
What is the risk that the reference standard, its conduct or interpretation introduced bias?
Not applicable
Comments
Flow and timing
Describe any patients who did not receive the index test(s) and/or reference standard or who were excluded from the 2x2 table
Describe the time interval and any interventions between index test(s) and reference standard
If a predictive test (the reference standard is a later event that the test aims to predict) were any subsequent interventions between test and later event blind to test result?
Not applicable
Was there an appropriate interval between index test(s) and reference standard?
Not applicable
Did either all participants or a random sample of participants receive a reference standard test?
Not applicable
Did all patients receive the same reference standard irrespective of index test result?
Not applicable
Were all test results including unclear results reported?
Yes
Were all patients included in the analysis?
Yes
What is the risk that the patient flow introduced bias?
Low
Comments
(>95% = YES, less than 5% diff) Targeted = 97/105, systematic = 102/105.
Overall risk of bias
At risk of bias Additional comments: Please replace this text and include any additional comments in regards to your quality rating


Jutta's tick icon.png This appraisal has been completed.


Article
Sonn GA, Chang E, Natarajan S, Margolis DJ, Macairan M, Lieu P, et al. Value of targeted prostate biopsy using magnetic resonance-ultrasound fusion in men with prior negative biopsy and elevated prostate-specific antigen. Eur Urol 2014 Apr;65(4):809-15. Epub 2013 Mar 17. Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23523537.
Assigned to
User:Albert.chetcuti
Topic area
Guidelines:PSA Testing
Clinical question
Form
Form:Quality appraisal quadas


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