Critical appraisal:Terhaar sive Droste JS, Oort FA, van der Hulst RW, van Heukelem HA, Loffeld RJ, van Turenhout ST, et al 2011

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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
Setting
Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Yes
Did the study avoid inappropriate exclusions?
Yes
Reasons
Not many exclusions.
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
Index test 1
Describe index test and how it was conducted and interpreted
FIT
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
6 cut-offs analysed.
Index test 2
Describe index test and how it was conducted and interpreted, if applicable
g-fobt, but not part of this SR.
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
Colonoscopy.
Is the reference standard likely to correctly classify the target condition?
Yes
Were the reference standard results interpreted without knowedge of the results of the index test/s?
Yes
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?
Low
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?
Yes
Did either all participants or a random sample of participants receive a reference standard test?
Yes
Did all patients receive the same reference standard irrespective of index test result?
Yes
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
2 excluded due to no histopath.
Overall risk of bias
Low risk of bias Additional comments: Please replace this text and include any additional comments in regards to your risk of bias rating


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Article
Terhaar sive Droste JS, Oort FA, van der Hulst RW, van Heukelem HA, Loffeld RJ, van Turenhout ST, et al. Higher fecal immunochemical test cutoff levels: lower positivity rates but still acceptable detection rates for early-stage colorectal cancers. Cancer Epidemiol Biomarkers Prev 2011 Feb;20(2):272-80 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21135261.
Assigned to
User:Albert.chetcuti
Topic area
Guidelines:Colorectal cancer
Clinical question
Form
Form:Quality appraisal quadas


Section below only relevant for Cancer Council Project Officer

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