|Domain||Patient selection||Index test*||Reference standard||Flow and timing|
|Description||Describe methods of patient 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 patients who did not receive the index test(s) and/or reference standard or who were excluded from the 2x2 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?||Were index test acquisition and analysis parameters determined a priori and consistent for all study participants?||Were the reference standard results interpreted without knowledge of the results of the index test?||Did all patients receive a reference standard?|
Did the study avoid inappropriate exclusions?|
i.e. Participants may be excluded if justified in terms of interference with index test measurement (corneal opacities preventing visualisation of anterior structures).
Did all patients receive the same reference standard?|
i.e. Was the reference test conducted in the same way for each patient?
For slit lamp examination: observer, slit lamp settings
For laboratory protein measurements: method of aqueous extraction, sample storage and analysis.
|Were all patients included in the analysis?|
|Risk of bias: High/low/unclear||Could the selection of patients 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 patient flow have introduced bias?|
|Concerns regarding applicability: High/low/unclear||Are there concerns that the included patients 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?|