DOMAIN | PATIENT SELECTION | INDEX TEST | REFERENCE STANDARD | FLOW AND TIMING |
Description | Describe methods of participant 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 participants 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 prespecified? | Were the reference standard results interpreted without knowledge of the results of the index test? | Did all participants receive a reference standard? | |
Did the study avoid inappropriate exclusions? | Did all participants receive the same reference standard? | |||
Were all participants included in the analysis? | ||||
Risk of bias: High/low/ unclear | Could the selection of participants 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 participant flow have introduced bias? |
Concerns regarding applicability: High/low/ unclear | Are there concerns that the included participants 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? |