| 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. |
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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. |
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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. |
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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. |