Critical appraisal:Thompson IM, Ankerst DP, Chi C, Lucia MS, Goodman PJ, Crowley JJ, et al 2005 3
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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
- 55+ years old, normal DRE, PSA≤3.0ng/mL
Setting
- Multi-centre RCT
Was a diagnostic case-control design avoided?
- Yes
Consecutive or random sample?
- Yes
Did the study avoid inappropriate exclusions?
- Yes
Reasons
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
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?
- Yes
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?
- Yes
What is the risk that the conduct or interpretation of the index test introduced bias?
- Low
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?
- Yes
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?
- Low
Comments
Reference Standard
Describe the reference standard and how it was conducted and interpreted
- At least 6 cores
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)
(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
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
- End of study prostate biopsy within 90 days of the randomisation anniversary date or within 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?
- No
Were all test results including unclear results reported?
- Unclear
Were all patients included in the analysis?
- Unclear
What is the risk that the patient flow introduced bias?
- Low
Comments
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 |
This appraisal has been completed.
- Article
- Thompson IM, Ankerst DP, Chi C, Lucia MS, Goodman PJ, Crowley JJ, et al. Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower. JAMA 2005 Jul 6;294(1):66-70 Available from: http://www.ncbi.nlm.nih.gov/pubmed/15998892.
- Assigned to
- User:Tracy.tsang
- Topic area
- Guidelines:PSA Testing/PSA Protocols
- Clinical question
Section below only relevant for Cancer Council Project Officer