Domain | 1. Participant selection | 2. Index test | 3. Reference standard | 4. Flow and timing |
Signalling questions and criteria | Q.1: "Was a consecutive or random sample of participants enrolled?" Yes ‐ If the study reports on a consecutive or a random selection of participants. No ‐ if the study reports on another form of selection of participants. Unclear ‐ if the study does not report on how the participants were enrolled. Q.2: "Was a case‐control design avoided?" Yes ‐ if the case‐control design was avoided. No ‐ if the study was a case‐control. Unclear ‐ if the study design was not clear. Q.3: "Did the study avoid inappropriate exclusions?" Yes ‐ if the study definitions of exclusion criteria are appropriate (i.e. previous bleeding or treatment for oesophageal varices) and all exclusions are reported. No ‐ if exclusion criteria are inappropriate and exclusions are not reported. Unclear ‐ if the study does not report causes of exclusions. |
Q.1: "Were the index test results interpreted without knowledge of the results of the reference standard?" Yes ‐ if the study reports that results of the index test were interpreted without the knowledge of results of the reference standard. No ‐ if the study reports that results of the index test were interpreted with results of the reference standard. Unclear ‐ if the study does not report information about blinding of results of the index test and reference standard. Q.2: "If a threshold was used, was it prespecified?" Yes ‐ if the threshold used was reported in the methods section. No ‐ if the study reports that the threshold was chosen during the data analysis stage (e.g. maximum of Youden index). Unclear ‐ if the study does not report information about threshold selection. |
Q.1: "Is the reference standard likely to correctly classify the target condition?" Yes ‐ if the reference standard correctly classifies oesophageal varices (according to common grading scores or systems detailed in "Reference Standard" section). No ‐ if there is some doubt whether the reference standard classifies oesophageal varices. Unclear ‐ if the study does not report on the reference standard used. Q.2: "Were the reference standard results interpreted without knowledge of results of the index test?" Yes ‐ if the study reports that results of the reference standard were interpreted without knowledge of results of the index test. No ‐ if the study reports that results of the reference standard were interpreted with results of the test index. Unclear ‐ if the study does not report information about blinding of results of the reference standard and the index test. |
Q.1: "Was there an appropriate interval between the index test and the reference standard?" Yes ‐ if the interval between the index test and the reference standard was less than 3 months. No ‐ if the interval was longer than 3 months. Unclear ‐ if the study does not report the interval between the index test and the reference standard. Q.2: "Did all participants receive the same reference standard?" Yes ‐ if the study has only one reference standard for all participants (OGD with appropriate classification of oesophageal varices). No ‐ if the study has more than one reference standard. Unclear‐ if the study is not clear about the reference standard used. Q.3 "Were all participants included in the analysis?" Answer: Yes ‐ if all enrolled participants were included in the analysis (even in the case of uninterpretable index test result). No ‐ if any participant was excluded from the analysis for any reason. Unclear ‐ if it is not clear about exclusions of participants from the analysis. |
Risk of bias |
Could the selection of participants have introduced bias? Low risk: "Yes" for all signalling questions. High risk: "No" or "Unclear" for at least one signalling question. |
Could the conduct or interpretation of the index test have introduced bias? Low risk: "Yes" for the signalling question. High risk: "No" or "Unclear" for the signalling question. |
Could the reference standard, its conduct, or its interpretation have introduced bias? Low risk: "Yes" for all signalling questions. High risk: "No" or "Unclear" for at least one signalling question. |
Could the participant flow have introduced bias? Low risk: "Yes" for all signalling questions. High risk: "No" or "Unclear" for at least one signalling question. |
Concerns about applicability |
Are there concerns that the included participants and setting do not match the review question? Low concern: Participants included in the review represent participants for whom the test is used in clinical practice. High concern: Participants included in the review differ from participants for whom the test is used in clinical practice. |
Are there concerns that the index test, its conduct, or interpretation differ from the review question? High concern: The index test, its conduct, or interpretation of the index test differs from the way it is used in clinical practice. Low concern: The index test, its conduct, or interpretation of the index test does not differ from the way it is used in clinical practice. |
Are there concerns that the target condition as defined by the reference standard does not match the question? | ‐ |