Table 4.1

Example of GRADE Depiction of Evidence Profile Across Studies

GRADE Evidence Profile: Antibiotics for Children With Acute Otitis Media
Quality AssessmentSummary of Findings
Number of PatientsAbsolute Risk
No. of studies (Design)LimitationsInconsistencyIndirectnessImprecisionPublication BiasPlaceboAntibioticsRelative Risk (95% CI)Control RiskaRisk Difference (95% CI)Quality
Pain at 24h
5 (RCT)No serious limitationsNo serious inconsistencyNo serious indirectnessNo serious imprecisionUndetected241/605223/624RR 0.9 (0.78–1.04)367/1,000Not SignificantHigh
Pain at 2–7 d
10 (RCT)No serious limitationsNo serious inconsistencyNo serious indirectnessNo serious imprecisionUndetected303/1,366228/1,425RR 0.72 (0.62–0.83)257/1,00072 fewer per 1,000 (44–98)High
Hearing, inferred from the surrogate outcome abnormal tympanometry—1 mo
4 (RCT)No serious limitationsNo serious inconsistencySerious indirectness (because of indirectness of outcome)No serious imprecisionUndetected168/460153/467RR 0.89 (0.75–1.07)350/1,000Not SignificantModerate
Hearing, inferred from the surrogate outcome abnormal tympanometry—3 mo
3 (RCT)No serious limitationsNo serious inconsistencySerious indirectness (because of indirectness of outcome)No serious imprecisionUndetected96/39896/410RR 0.97 (0.76–1.24)234/1,000Not SignificantModerate
Vomiting, diarrhea, or rash
5 (RCT)No serious limitationsSerious inconsistency (because of inconsistency in absolute effects)No serious indirectnessNo serious imprecisionUndetected83/711110/690RR 1.38 (1.09–1.76)113/1,00043 more per 1,000 (10–86)Moderate

Reproduced from Guyatt et al. (16).

CI indicates confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; RCT, randomized controlled trial; and RR, risk ratio.