Table 2.
Therapeutic Study | Prognostic Study | Diagnostic Study | |
---|---|---|---|
Level I | • High-quality RCT with statistically significant difference or no statistically significant difference but narrow confidence intervals • Systematic review of Level I RCT (and study results were homogeneous) |
• High-quality prospective trial (all patients were enrolled at the same point in their disease with > 80% follow-up of enrolled patients) • Systematic review of Level I studies |
• Testing of previously developed diagnostic criteria in series of consecutive patients (with universally applied reference “gold” standard) • Systematic review of Level I studies |
Level II | • Lesser quality RCT (<80% follow-up, no blinding, or improper randomization) • Prospective comparative study • Systematic review of Level II studies or Level I studies with inconsistent results |
• Retrospective study • Untreated controls from an RCT • Lesser quality prospective study (patients enrolled at different points in their disease or <80% follow-up) • Systematic review of Level II studies |
• Development of diagnostic criteria on basis of consecutive patients (with universally applied reference “gold” standard) • Systematic review of Level II studies |
Level III | • Case-control study • Retrospective comparative study • Systematic review of Level III studies |
• Case-control study | • Study of nonconsecutive patients (without consistently applied reference “gold” standard) • Systematic review of Level III studies |
Level IV | • Case series | • Case series | • Case-control study • Poor reference standard |
Level V | • Expert opinion | • Expert opinion | • Expert opinion |
RCT = Randomized Controlled Trial.