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. 2017 Nov 22;2017(11):CD012216. doi: 10.1002/14651858.CD012216.pub2
Domain Patient selection Index test Reference standard Flow and timing
Description Describe methods of patient selection: describe included participants (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 patient who did not receive the index test(s) or reference standard, or both, or who were excluded from
the 2 × 2 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? If a threshold was used, was it prespecified? 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? Did all patients receive the same reference standard?
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 participants did 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?