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 |