| Benefit >>> Risk Procedure/Treatment SHOULD be performed/administered | Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment | Benefit ≥ Risk Additional studies with broad objectives needed; additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED | Risk ≥ Benefit No additional studies needed Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL |
Level A Multiple (3–5) population risk strata evaluated(fn1) General consistency of direction and magnitude of effect | •Recommendation that procedure or treatment is useful/effective•Sufficient evidence from multiple randomized trials or meta-analyses | •Recommendation in favor of treatment or procedure being useful/effective•Some conflicting evidence from multiple randomized trials or meta-analyses | •Recommendation’s usefulness/efficacy less well established•Greater conflicting evidence from multiple randomized trials or meta-analyses | •Recommendation that procedure or treatment is not useful/effective and may be harmful•Sufficient evidence from multiple randomized trials or meta-analyses |
Level B Limited (2–3) population risk strata evaluated(fn1) | •Recommendation that procedure or treatment is useful/effective•Limited evidence from single randomized trial or nonrandomized studies | •Recommendation in favor of treatment or procedure being useful/effective•Some conflicting evidence from single randomized trial or nonrandomized studies | •Recommendation’s usefulness/efficacy less well established•Greater conflicting evidence from single randomized trial or nonrandomized studies | •Recommendation that procedure or treatment is not useful/effective and may be harmful•Limited evidence from single randomized trial or nonrandomized studies |
Level C Very limited (1–2) population risk strata evaluated(fn1) | •Recommendation that procedure or treatment is useful/effective•Only expert opinion, case studies, or standard-of-care | •Recommendation in favor of treatment or procedure being useful/effective•Only diverging expert opinion, case studies, or standard-of-care | •Recommendation’s usefulness/efficacy less well established•Only diverging expert opinion, case studies, or standard-of-care | •Recommendation that procedure or treatment is not useful/effective and may be harmful•Only expert opinion, case studies, or standard-of-care |
| Suggested phrases for writing recommendations(fn2) | should is recommended is indicated is useful/effective/beneficial | is reasonable can be useful/effective/beneficial is probably recommended or indicated | may/might be considered may/might be reasonable usefulness/effectiveness is unknown/unclear/uncertain or not well established | is not recommended is not indicated should not is not useful/effective/beneficial may be harmful |