Critical appraisal:Thompson IM, Tangen CM, Goodman PJ, Lucia MS, Parnes HL, Lippman SM, et al 2007

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Risk of bias assessment: diagnostic accuracy study

Patient Selection
Prior tests and any referral filters
men with negative PSA and DRE (pre-screened);
Condition that defined entry into study
no significant comorbidities
Setting
No response
Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Yes
Did the study avoid inappropriate exclusions?
Yes
Reasons
No response
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?
Low
Comments
No response
Index test 1
Describe index test and how it was conducted and interpreted
annual PSA, DRE
Were the index test results interpreted without knowledge of the results of the reference standard?
Yes
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
No response
Index test 2
Describe index test and how it was conducted and interpreted, if applicable
unclear what was considered an abnormal DRE
Were the index test results interpreted without knowledge of the results of the reference standard?
Yes
If a threshold was used, was it pre-specified?
Unclear
What is the risk that the conduct or interpretation of the index test introduced bias?
Unclear
Comments
No response
Reference Standard
Describe the reference standard and how it was conducted and interpreted
inadequate biopsy scheme
Is the reference standard likely to correctly classify the target condition?
No
Were the reference standard results interpreted without knowedge of the results of the index test/s?
Unclear
Was the reference test standard independent of the index test?
(i.e. the index test did not form part of the reference standard)
Yes
What is the risk that the reference standard, its conduct or interpretation introduced bias?
High
Comments
No response
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
all screen-positives; and all negatives biopsied after 7 years
Describe the time interval and any interventions between index test(s) and reference standard
<1 year
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?
Yes
Did either all participants or a random sample of participants receive a reference standard test?
No
Did all patients receive the same reference standard irrespective of index test result?
Unclear
Were all test results including unclear results reported?
Unclear
Were all patients included in the analysis?
Yes
What is the risk that the patient flow introduced bias?
High
Comments
compliance with biopsy recommendation ~60%
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


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Article
Thompson IM, Tangen CM, Goodman PJ, Lucia MS, Parnes HL, Lippman SM, et al. Finasteride improves the sensitivity of digital rectal examination for prostate cancer detection. J Urol 2007 May;177(5):1749-52 Available from: http://www.ncbi.nlm.nih.gov/pubmed/17437804.
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Clinical question
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Form:Quality appraisal quadas


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