Table 1—

ADA evidence grading system for clinical practice recommendations

Level of evidenceDescription
Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered including: 
 • Evidence from a well-conducted multicenter trial 
 • Evidence from a meta-analysis that incorporated quality ratings in the analysis. 
 • Compelling nonexperimental evidence, i.e., “all or none” rule developed by Center for Evidence Based Medicine at Oxford* 
 Supportive evidence from well-conducted randomized controlled trials that are adequately powered including: 
 • Evidence from a well-conducted trial at one or more institutions 
 • Evidence from a meta-analysis that incorporated quality ratings in the analysis 
Supportive evidence from well-conducted cohort studies 
 • Evidence from a well-conducted prospective cohort study or registry 
 • Evidence from a well-conducted prospective cohort study 
 • Evidence from a well-conducted meta-analysis of cohort studies 
 Supportive evidence from well-conducted case-control study 
Supportive evidence from poorly controlled or uncontrolled studies 
 • Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results 
 • Evidence from observational studies with high potential for bias (such as case series with comparison to historical controls) 
 • Evidence from case series or case reports 
 Conflicting evidence with the weight of evidence supporting the recommendation 
Expert consensus or clinical experience 
Level of evidenceDescription
Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered including: 
 • Evidence from a well-conducted multicenter trial 
 • Evidence from a meta-analysis that incorporated quality ratings in the analysis. 
 • Compelling nonexperimental evidence, i.e., “all or none” rule developed by Center for Evidence Based Medicine at Oxford* 
 Supportive evidence from well-conducted randomized controlled trials that are adequately powered including: 
 • Evidence from a well-conducted trial at one or more institutions 
 • Evidence from a meta-analysis that incorporated quality ratings in the analysis 
Supportive evidence from well-conducted cohort studies 
 • Evidence from a well-conducted prospective cohort study or registry 
 • Evidence from a well-conducted prospective cohort study 
 • Evidence from a well-conducted meta-analysis of cohort studies 
 Supportive evidence from well-conducted case-control study 
Supportive evidence from poorly controlled or uncontrolled studies 
 • Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results 
 • Evidence from observational studies with high potential for bias (such as case series with comparison to historical controls) 
 • Evidence from case series or case reports 
 Conflicting evidence with the weight of evidence supporting the recommendation 
Expert consensus or clinical experience 
*

Either all patients died prior to therapy and at least some survived with therapy, or some patients died without therapy and none died with therapy. Example: use of insulin in the treatment of DKA.

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