DOMAIN |
PATIENT SELECTION |
INDEX TEST |
REFERENCE STANDARD |
FLOW AND TIMING |
Description |
Describe methods of patient selection: Describe included patients (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 patients who did not receive the index test(s) and/or reference standard or who were excluded from the 2 x 2 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 patients enrolled? |
Were the index test results interpreted without knowledge of the results of the reference standard? |
Is the reference standard likely to correctly classify the target condition? |
Was there an appropriate interval between index test(s) and reference standard? |
Was a case‐control design avoided? |
If a threshold was used, was it pre‐specified? |
Were the reference standard results interpreted without knowledge of the results of the index test? |
Did all patients receive a reference standard? |
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Did the study avoid inappropriate exclusions? |
Did all patients receive the same reference standard? |
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Were all patients included in the analysis? |
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Risk of bias: high/low/unclear |
Could the selection of patients have introduced bias? |
Could the conduct or interpretation of the index test have introduced bias? |
Could the reference standard, its conduct, or its interpretation have introduced bias? |
Could the patient flow have introduced bias? |
Concerns regarding applicability: high/low/unclear |
Are there concerns that the included patients do not match the review question? |
Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
Are there concerns that the target condition as defined by the reference standard does not match the review question? |
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