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SIZE OF TREATMENT EFFECT
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CLASS I
- Benefit >>> Risk
- Procedure/Treatment SHOULD be performed/administered
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CLASS IIa
- Benefit >> Risk
Additional studies with focused objectives needed
- IT IS REASONABLE to perform procedure/administer treatment
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CLASS IIb
-
Benefit ≥ Risk
Additional studies with broad objectives needed; additional registry data would be helpful
- Procedure/Treatment
MAY BE CONSIDERED
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CLASS III
- Risk ≥ Benefit
- Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL
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ESTIMATE OF CERTAINTY (PRECISION) OF TREATMENT EFFECT
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LEVEL A
- Multiple populations evaluated*
- Data derived from multiple randomized clinical trials or meta-analyses
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- Recommendation that procedure or treatment is useful/effective
- Sufficient evidence from multiple randomized trials or meta-analyses
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- Recommendation in favor of treatment or procedure being useful/effective
- Some conflicting evidence from multiple randomized trials or meta-analyses
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- Recommendation’s usefulness/efficacy less well established
- Greater conflicting evidence from multiple randomized trials or meta-analyses
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- Recommendation that procedure or treatment is not useful/effective and may be harmful
- Sufficient evidence from multiple randomized trials or meta-analyses
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LEVEL B
- Limited populations evaluated*
- Data derived from a single randomized trial or nonrandomized studies
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- Recommendation that procedure or treatment is useful/effective
- Evidence from single randomized trial or nonrandomized studies
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- Recommendation in favor of treatment or procedure being useful/effective
- Some conflicting evidence from single randomized trial or nonrandomized studies
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- Recommendation’s usefulness/efficacy less well established
- Greater conflicting evidence from single randomized trial or nonrandomized studies
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- Recommendation that procedure or treatment is not useful/effective and may be harmful
- Evidence from single randomized trial or nonrandomized studies
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LEVEL C
- Very limited populations evaluated*
- Only consensus opinion of experts, case studies, or standard of care
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- Recommendation that procedure or treatment is useful/effective
- Only expert opinion, case studies, or standard of care
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- Recommendation in favor of treatment or procedure being useful/effective
- Only diverging expert opinion, case studies, or standard of care
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- Recommendation’s usefulness/efficacy less well established
- Only diverging expert opinion, case studies, or standard of care
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- Recommendation that procedure or treatment is not useful/effective and may be harmful
- Only expert opinion, case studies, or standard of care
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