- QUADAS-2 Scoring System
- Domain 1: patient selection
- Risk of bias: could the selection of patients have introduced bias? Signalling question 1: was a consecutive or random sample of patients enrolled? Signalling question 2: was a case–control design avoided? Signalling question 3: did the study avoid inappropriate exclusions?
- Applicability: are there concerns that the included patients and setting do not match the review question?
- Domain 2: index test risk of bias: could the conduct or interpretation of the index test have introduced bias? Signalling question 1: Were the index test results interpreted without knowledge of the results of the reference standard? Signalling question 2: If a threshold was used, was it pre-specified?
- Applicability: are there concerns that the index test, its conduct, or interpretation differ from the review question?
- Domain 3: reference standard risk of bias: could the reference standard, its conduct, or its interpretation have introduced bias? Signalling question 1: is the reference standard likely to correctly classify the target condition? Signalling question 2: were the reference standard results interpreted without knowledge of the results of the index test?
- Applicability: are there concerns that the target condition as defined by the reference standard does not match the question?
- Domain 4: flow and timing risk of bias: could the patient flow have introduced bias? Signalling question 1: was there an appropriate interval between index test and reference standard?
- Signalling question 2: did all patients receive the same reference standard?
- Signalling question 3: were all patients included in the analysis?
