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Size of Treatment Effect CLASS IIb CLASS III No Benefit or Benefit ≥ Risk CLASS III Harm Additional studies with broad Procedure/ objectives needed; additional registry Test data would be helpful Not Helpful COR III: Procedure/Treatment No benefit MAY BE CONSIDERED Excess Cost COR III: w/o Benefit Harm or Harmful ▪Recommendation's usefulness/ efficacy less well established ▪Greater conflicting evidence from multiple randomized trails or metaanalyses ▪Recommendation's usefulness/ efficacy less well established ▪Greater conflicting evidence from single randomized trial or nonrandomized studies Treatment No Proven Benefit Harmful to Patients ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Sufficient evidence from multiple randomized trials of meta-analyses ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Evidence from single randomized trial or nonrandomized studies ▪Recommendation's usefulness/ efficacy less well established ▪Recommendation that procedure or treatment is not useful/effective and may be ▪Only diverging expert opinion, case harmful studies, or standard of care ▪Only expert opinion, case studies, or standard of care may/might be considered may/might be reasonable usefulness/effectiveness is unknown/ unclear/uncertain or not well established COR III: No Benefit is not recommended is not indicated should not be performed/ administered/other is not useful/ beneficial/effective COR III: Harm potentially harmful causes harm associated with excess morbidity/mortality should not be performed/ administered/other Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior MI, history of HF, and prior ASA use. c For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. b 47

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