|Domain||Patient selection||Index test||Reference standard||Flow and timing|
Describe methods of patient selection|
Describe included patients (previous 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 standard or who were excluded from the 2 × 2 table (refer to flow diagram)|
Describe the interval and any interventions between index tests and the reference standard
|Signalling questions (yes, no, or unclear)||
Was a consecutive or random sample of patients enrolled?|
Was a case–control design avoided?
Did the study avoid inappropriate exclusions?
Were the index test results interpreted without knowledge of the results of the reference standard?|
If a threshold was used, was it prespecified?
Is the reference standard likely to correctly classify the target condition?|
Were the reference standard results interpreted without knowledge of the results of the index test?
Was there an appropriate interval between index tests and reference standard?|
Did all patients receive a reference standard?
Did all patients receive the same reference standard?
Were all patients included in the analysis?
|Risk of bias (high, low, or unclear)||Could the selection of patients have introduced bias?||Could the conduct or interpretation of the index test have introduced bias?||Could reference standard, its conduct, or its interpretation have introduced bias?||Could the patient flow have introduced bias?|
|Concerns about applicability (high, low, or unclear)||Are there concerns that included patients do not match the review question?||Are there concerns that the index test, its conduct, or its interpretation differ from the review question?||Are there concerns that the target condition as defined by the reference standard does not matched the review question?|