Critical appraisal:Mariappan P, Chong WL, Sundram M, Mohamed SR 2004 4
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Risk of bias assessment: diagnostic accuracy study
Patient Selection
Prior tests and any referral filters
- PSA, DRE
Condition that defined entry into study
- <80 yrs, PSA 4-20ng/mL, No malignant features on DRE
Setting
- Urology clinic, prostate-awareness campaign
Was a diagnostic case-control design avoided?
- Yes
Consecutive or random sample?
- Yes
Did the study avoid inappropriate exclusions?
- Yes
Reasons
- Inclusion/exclusion criteria outlined, PSA and DRE, 1st biopsy
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)
(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?
- Unclear
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: |
This appraisal has been completed.
- Article
- Mariappan P, Chong WL, Sundram M, Mohamed SR. Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity. BJU Int 2004 Aug;94(3):307-10 Available from: http://www.ncbi.nlm.nih.gov/pubmed/15291857.
- Assigned to
- User:Katherine.sheridan
- Topic area
- Guidelines:PSA Testing
- Clinical question
Section below only relevant for Cancer Council Project Officer