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. 2023 Apr 21;14(3):292–304. doi: 10.1177/19476035231161806

Table 2.

Grades of Evidence.

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.