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 patient who did not receive the index test(s) or reference standard, or both, or who were excluded from the 2 × 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 prespecified? | Were the reference standard results interpreted without knowledge of the results of the index test? | Did all patients receive a reference standard? | |
Did the study avoid inappropriate exclusions? | Did all patients receive the same reference standard? | |||
Were all patients included in the analysis? | ||||
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 participants did 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? |