Critical appraisal:Lee YC, Chiu HM, Chiang TH, Yen AM, Chiu SY, Chen SL, et al 2013

From Cancer Guidelines Wiki

Risk of bias assessment: diagnostic accuracy study

Patient Selection
Prior tests and any referral filters
Condition that defined entry into study
Setting
We recruited consecutive participants from hospital-based

and community-based screening sources; the former
(deviation cohort) was used to evaluate the test performance
and the latter (validation cohort) was to confirm the
reproducibility and applicability of the screening strategy
in the community.

Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Yes
Did the study avoid inappropriate exclusions?
Yes
Reasons
To enrich the deviation cohort with the

sample of gastrointestinal tract cancers, we also recruited
participants in whom gastrointestinal tract cancers were
suspected by the non-invasive screening test, such as radiology
and oral inspection, at the Gastroenterologic or
Otolaryngologic Clinics at National Taiwan University
Hospital.

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
only looking at FIT, but other (gFOBT and HPSA) tests also performed.
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?
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
only looking at FIT, but other (gFOBT and HPSA) tests also performed.
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
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
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?
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?
Unclear
Comments
unclear about blinding
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
Overall risk of bias
At 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
Lee YC, Chiu HM, Chiang TH, Yen AM, Chiu SY, Chen SL, et al. Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions. BMJ Open 2013 Oct 30;3(10):e003989 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24176798.
Assigned to
User:Albert.chetcuti
Topic area
Guidelines:Colorectal cancer
Clinical question
Form
Form:Quality appraisal quadas


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