Critical appraisal:Roobol MJ, Kranse R, Bangma CH, van Leenders AG, Blijenberg BG, van Schaik RH, et al 2013 5

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Risk of bias assessment: diagnostic accuracy study

Patient Selection
Prior tests and any referral filters
ERSPC Rotterdam centre screening population men aged 60-75 at intial screening
Condition that defined entry into study
PSA greater or equal to 3ng/mL undergoing biopsy - screen positives for screening rounds 2,3, and 4
Setting
primary - screening population
Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Yes
Did the study avoid inappropriate exclusions?
Yes
Reasons
population based screening trial - screen positives referred for biopsy

89.9% screen positives underwent biopsy (rounds 1-4)

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?
Not applicable
What is the risk that the selection of participants introduced bias?
Low
Comments
screening population
Index test 1
Describe index test and how it was conducted and interpreted
PSA greater or equal to 3ng/mL Tandem E assay - calibration not described
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?
Not applicable
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?
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
lateralised sextant biopsy
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
minimum of 10 cores for acceptable accuracy - unclear as to whether pathologist blinded to PSA level - not such an issue here as only men with elevated PSA undergoing biopsy
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
TP and FP only
Describe the time interval and any interventions between index test(s) and reference standard
Not described assume < 1 year as index test is indication for reference test in a screening trial
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?
Unclear
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?
No
What is the risk that the patient flow introduced bias?
Low
Comments
verification bias not as issue as analyses restricted to TPs and FPs and >80% screen positives (patients) biopsied (included in analyses)
Overall risk of bias
At risk of bias Additional comments:


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Article
Roobol MJ, Kranse R, Bangma CH, van Leenders AG, Blijenberg BG, van Schaik RH, et al. Screening for prostate cancer: results of the rotterdam section of the European randomized study of screening for prostate cancer. Eur Urol 2013 Oct;64(4):530-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23759326.
Assigned to
User:Suzanne.hughes
Topic area
Guidelines:PSA Testing/PSA protocol
Clinical question
Form
Form:Quality appraisal quadas


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