Table 3 Risks of bias and Applicability Judgements in Quadas-2

Description

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?