Critical appraisal:Annaházi A, Ábrahám S, Farkas K, Rosztóczy A, Inczefi O, Földesi I, et al 2016 2

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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
Overall, 109 patients (male/female: 58/51, age: 29–91 years, mean: 66.0 years) referred to our specialist colorectal unit in the First Department of Medicine, Szeged, Hungary were enrolled in the study, who all underwent colonoscopy.
Was a diagnostic case-control design avoided?
Yes
Consecutive or random sample?
Unclear
Did the study avoid inappropriate exclusions?
Unclear
Reasons
No patients had a history of UC or a history of other cancers.

This is the only exclusion criteria described.

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?
Unclear
Comments
Index test 1
Describe index test and how it was conducted and interpreted
Measurement of faecal MMP-9.

Samples were stored on �201C for a maximum of 3 months and then thawed at 41C for 1 day. In all, 1.0g of each faecal sample was diluted, mixed and homogenised in 4ml of ice-cold Tris-buffer (0.15 M NaCl þ20mM Tris-HCl, pH:8.3). After centrifugation (10min, 4500r.p.m., 41C), pellets were discarded and supernatants were recentrifuged (10min, 10000g; 41C). The final supernatants were filtered by 0.8-mm pore-sized syringe filters, and the aliquots were stored at �201C until analysed. MMP-9 was measured by the quantitative enzymelinked immunosorbent assay described above.

Were the index test results interpreted without knowledge of the results of the reference standard?
Unclear
If a threshold was used, was it pre-specified?
Unclear
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?
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
Colonoscopies were completed until reaching the terminal ileum. During colonoscopy, biopsies were taken from all suspect lesions, and histology was performed.
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
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
Faecal samples were collected from all patients 2–4 days before the colonoscopy and were frozen to �201C within 1h after defaecation.
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
Annaházi A, Ábrahám S, Farkas K, Rosztóczy A, Inczefi O, Földesi I, et al. A pilot study on faecal MMP-9: a new noninvasive diagnostic marker of colorectal cancer. Br J Cancer 2016 Mar 29;114(7):787-92 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26908323.
Assigned to
User:Ben.lee-bates
Topic area
Guidelines:Colorectal cancer
Clinical question
Form
Form:Quality appraisal quadas


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