A (Strong Scientific Evidence) |
Statistically significant evidence of benefit from >2 properly randomized trials (RCTs), OR evidence from one properly conducted RCT AND one properly conducted meta-analysis, OR evidence from multiple RCTs with a clear majority of the properly conducted trials showing statistically significant evidence of benefit AND with supporting evidence in basic science, animal studies, or theory. |
B (Good Scientific Evidence) |
Statistically significant evidence of benefit from 1–2 properly randomized trials, OR evidence of benefit from ≥1 properly conducted meta-analysis OR evidence of benefit from >1 cohort/case-control/non-randomized trials AND with supporting evidence in basic science, animal studies, or theory. |
C (Unclear or conflicting scientific evidence) |
Evidence of benefit from ≥1 small RCT(s) without adequate size, power, statistical significance, or quality of design by objective criteria, OR conflicting evidence from multiple RCTs without a clear majority of the properly conducted trials showing evidence of benefit or ineffectiveness, OR evidence of benefit from ≥1 cohort/case-control/non-randomized trials AND without supporting evidence in basic science, animal studies, or theory, OR evidence of efficacy only from basic science, animal studies, or theory. |
D (Fair Negative Scientific Evidence) |
Statistically significant negative evidence (i.e., lack of evidence of benefit) from cohort/case-control/non-randomized trials, AND evidence in basic science, animal studies, or theory suggesting a lack of benefit. |
F (Strong Negative Scientific Evidence) |
Statistically significant negative evidence (i.e. lack of evidence of benefit) from ≥1 properly randomized adequately powered trial(s) of high-quality design by objective criteria. |
Lack of Evidence |
Unable to evaluate efficacy due to lack of adequate available human data. |