Lead author of included studies | Kobayashi | Masci | Campbell | Yamane |
---|---|---|---|---|
Domain 1: patient selection | ||||
Was a consecutive or random sample of patients enrolled? | Yes | Unclear | Unclear | Unclear |
Was a case-control design avoided? | Yes | Yes | Yes | Yes |
Did the study avoid inappropriate exclusions? | Yes | Yes | Yes | Yes |
Could the selection of patients have introduced bias? | Low | Unclear | Unclear | Unclear |
Are there concerns that the included patients do not match the review question? | Low | Low | Unclear | Low |
Domain 2: index test | ||||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | Yes | Yes | Unclear |
Did the study provide a clear definition of what was considered to be a ‘positive’ result? | Yes | Unclear | Yes | Unclear |
Could the conduct or interpretation of the index test have introduced bias? | Low | Unclear | Low | Unclear |
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | High | Low | Low | Low |
Domain 3: reference standard | ||||
Is the reference standard likely to correctly classify the target condition? | No | Yes | Yes | No |
Were the reference standard results interpreted without knowledge of the results of the index tests? | No | Yes | Yes | Unclear |
Did the study provide a clear definition of what was considered to be a ‘positive’ result? | Yes | Unclear | Yes | Yes |
Could the reference standard, its conduct, or its interpretation have introduced bias? | High | Unclear | Low | High |
Are there concerns that the target condition as defined by the reference standard does not match the question? | High | Low | Low | High |
Domain 4: flow and timing | ||||
Was there an appropriate interval between index test and reference standard? | Unclear | Yes | Yes | Yes |
Did all patients receive a reference standard? | No | Yes | Yes | Yes |
Did patients receive the same reference standard (protocol)? | Yes | Yes | Yes | Yes |
Did patients receive the same index test (protocol)? | Yes | Yes | No | Yes |
Were all patients included in the analysis? | Yes | Yes | Yes | No |
Could the patient flow have introduced bias? | High | Low | High | High |
In each domain: signalling questions (white background) are followed by summarising questions of ROB and applicability concerns (light grey background).