Screening intervention

Diagnostic accuracy

Level of evidence

A systematic or integrative literature review of level II studies

A systematic or integrative literature review of level II studies

I

A randomised controlled trial

Valid reference standard, among consecutive persons with a defined clinical presentation

II

A pseudo-randomised controlled trial (i.e., alternate allocation or some other method)

A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive persons with a defined clinical presentation

III-1

A comparative study with concurrent controls:

▪ Non-randomised, experimental trial

▪ Cohort study

▪ Case-control study

A comparison with reference standard that does not meet the criteria required for Level II and III-1 evidence

III-2

A comparative study without concurrent controls:

▪ Historical control study

▪ Two or more single-arm study

Diagnostic case-control study

III-3

Case series

Study of diagnostic yield (no reference standard)

IV