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. 2016 Oct 10;2016(10):CD012388. doi: 10.1002/14651858.CD012388
DOMAIN PATIENT SELECTION   INDEX TEST  REFERENCE STANDARD FLOW AND TIMING 
Description Describe methods of patient selection: Describe included participants (prior testing, presentation, intended use of index test and setting):  Describe the index test and how it was conducted and interpreted:  Describe the reference standard and how it was conducted and interpreted:  Describe any participants who did not receive the index test(s) and/or reference standard or who were excluded from the 2x2 table (refer to flow diagram): Describe the time interval and any interventions between index test(s) and reference standard:
Signalling questions(yes/no/unclear) Was a consecutive or random sample of participants enrolled?
Yes: a consecutive or random sample of participants with newly diagnosed colorectal cancer were enrolled in the study.
No: selection of participants was reported.
Unclear: insufficient data were reported to permit a judgment.
Were the index test results interpreted without knowledge of the results of the reference standard?
Yes: the index tests results were interpreted blinded to the results of the reference standard.
No: the index tests results were not interpreted blinded to the results of the reference standard.
Unclear: insufficient data were reported to permit a judgment.
Is the reference standard likely to correctly classify the target condition?
Yes: If all patients have undergone the reference standard as described.
No: If not all participants have undergone the reference standard as described.
Unclear: insufficient data were reported to permit a judgment.
Was there an appropriate interval between index test(s) and reference standard?
Yes: the period of time for the index tests and the reference standard to be executed was shorter than or equal to three months.
No: the period of time for the index tests and the reference standard to be executed was longer than three months.
Unclear: insufficient data were reported to permit a judgment.
Was a case‐control design avoided?
Yes: case‐control design was avoided.
No: case‐control design was not avoided.
Unclear: insufficient information was reported to permit a judgment.
If a threshold was used, was it pre‐specified?
Yes: a threshold was used, and the threshold was pre‐specified.
Or:
A threshold was not used.
No: a threshold was used, and the threshold was not pre‐specified.
Unclear: insufficient data were reported to permit a judgment.
Were the reference standard results interpreted without knowledge of the results of the index test?
Yes: the reference standard results were interpreted blinded to the results of the index tests.
No: the reference standard results were not interpreted blinded to the results of the index tests.
Unclear: insufficient data were reported to permit a judgment.
Did all participantsreceive the reference standard?
Yes: all participants received the reference standard (see description under the headline "Reference standards".)
No: not all participants received the reference standard (see description under the headline "Reference standards".)
Unclear: insufficient data were reported to permit a judgment.
Did the study avoid inappropriate exclusions?
Yes: the study avoided exclusions of participants who were difficult to diagnose, e.g. not clearly positive or negative test results due to sub optimal examinations.
No: the study excluded participants who were difficult to diagnose.
Unclear: insufficient data were reported to permit a judgment.
Did all participants receive the same reference standard?
Yes: all participants received the same reference standard (see description under the headline "Reference standards".)
No: not all participants received the same reference standard (see description under the headline "Reference standards".)
Unclear: insufficient data were reported to permit a judgment.
Were all participants included in the analysis?
Yes: all participants meeting the selection criteria (selected participants) were included in the analysis, or data on all the selected participants were available so that a 2 x 2 table including all selected participants could be constructed.
No: not all participants meeting the selection criteria (selected participants) were included in the analysis, and data on all the selected participants were not available so that a 2 x 2 table could be constructed using data on all selected participants.
Unclear: insufficient data were reported to permit a judgment.
Risk of bias: High/low/unclear Could the selection of participants have introduced bias?
High risk of bias: if at least one of the answers to the signalling questions on the selection of participants are "no".
Low risk of bias: if all the answers to the signalling questions on the selection of participants are "yes".
Unclear risk of bias: if the answers to the signalling questions on the selection of participants are either "unclear" or any combination of "unclear" with "yes" and/or "no".
Could the conduct or interpretation of the index test have introduced bias?  
High risk of bias: if at least one of the answers to the signalling questions on the conduct or interpretation of the index tests are "no".
Low risk of bias: if all the answers to the signalling questions on the conduct or interpretation of the index tests are "yes".
Unclear risk of bias: if the answers to the signalling questions on the conduct or interpretation of the index tests are either "unclear" or any combination of "unclear" with "yes" and/or "no".
Could the reference standard, its conduct, or its interpretation have introduced bias?
High risk of bias: if at least one of the answers to the signalling questions on the conduct or interpretation of the reference standard are "no".
Low risk of bias: if all the answers to the signalling questions on the conduct or interpretation of the reference standard are "yes".
Unclear risk of bias: if the answers to the signalling questions on the conduct or interpretation of the reference standard are either "unclear" or any combination of "unclear" with "yes" and/or "no".
Could the patient flow have introduced bias?
High risk of bias: if at least one of the answers to the signalling questions on flow and timing are "no".
Low risk of bias: if all the answers to the signalling questions on flow and timing are "yes".
Unclear risk of bias: if the answers to the signalling questions on flow and timing are either "unclear" or any combination of "unclear" with "yes" and/or "no".
Concerns regarding applicability: High/low/unclear Are there concerns that the included participants do not match the review question?
High concern: if the included participants do not match the description under the headline "Participants".
Low concern: if the included participants match the description under the headline "Participants".
Unclear: If it is unclear whether the included participants match the description under the headline "Participants" or not.
Are there concerns that the index test, its conduct, or interpretation differ from the review question?
High concern: if the conduct or interpretation of the index tests do not match the description under the headline "Index test(s)".
Low concern: if the conduct and interpretation of the index tests match the description under the headline "Index test(s)".
Unclear: If it is unclear whether the conduct and/or interpretation of the index tests match the description under the headline "Index test(s)" or not.
Are there concerns that the target condition as defined by the reference standard does not match the review question?
High concern: if the participant are diagnosed with any other cancer disease than colorectal cancer.
Low concern: if the participant are diagnosed with colorectal cancer.
Unclear: If it is unclear wether the participant are diagnosed with colorectal cancer or not.