Critical appraisal:Lecuona A, Heyns CF 2011 3

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Risk of bias assessment: diagnostic accuracy study

Patient Selection
Prior tests and any referral filters
PSA
Condition that defined entry into study
PSA>2.5ng/mL
Setting
University hospital
Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Yes
Did the study avoid inappropriate exclusions?
Yes
Reasons
Initial biopsy, Exclusion criteria described and PSA information
If comparing more than one index test was the design fully paired or paired randomly?
Not applicable
If a paired randomised design was used, was allocation to groups concealed and was the generation of allocation sequence adequate?
No
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
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
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
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
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
Overall risk of bias
At risk of bias Additional comments:


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Article
Lecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int 2011 Jul;108(2):204-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21087452.
Assigned to
User:Katherine.sheridan
Topic area
Guidelines:PSA Testing
Clinical question
Form
Form:Quality appraisal quadas


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