Table A1

ADA evidence grading system for clinical practice recommendations*

Level of evidenceDescription
*Diabetes Care 2003;26(suppl 1):S1.
†Either all patients died before 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 diabetes ketoacidosis.
A Clear evidence from well conducted, generalisable, randomised controlled trials that are adequately powered, including:
• Multicentre trial
• Meta-analysis incorporating quality ratings
• Compelling non-experimental evidence (i.e. “all or none” rule) developed by the Centre for Evidence Based Medicine at Oxford†
Supportive evidence from well conducted randomised controlled trials that are adequately powered, including:
• Well conducted trials at one or more institutions
B Supportive evidence from well conducted cohort studies, including:
• Prospective cohort studies or registry
• Meta-analysis of cohort studies
Supportive evidence from a well conducted case-control study
C Supportive evidence from poorly controlled or uncontrolled studies including:
• Randomised clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
• Observational studies with high potential for bias
• Case series or case reports
Conflicting evidence with the weight of evidence supporting the recommendation
E Expert consensus or clinical experience