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7–1: Appendix 7–1 Grade Evidence Profile: Antibiotics for Children with Acute Otitis Media

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Quality Assessment Summary of Findings
Number of patients Absolute risk
Number of studies (Design) Limitations Inconsistency Indirectness Imprecision Publication bias Placebo Antibiotics Relative risk (95% Cl) Control riska Risk difference (95% Cl) Quality
Pain at 24h
5 (RCT) No serious limitations No serious inconsistency No serious indirectness No serious imprecision Undetected 241/605 223/624 RR 0.9 (0.78-1.04) 367/1000 Not significant ⊕⊕⊕⊕ High
Pain at 2-7 d
10 (RCT) No serious limitations No serious inconsistency No serious indirectness No serious imprecision Undetected 303/1366 228/1425 RR 0.72 (0.62-0.83) 257/1000 72 fewer per 1000 (44-98) ⊕⊕⊕⊕ High
Hearing, inferred from the surrogate outcome abnormal tympanometry—1 mo
4 (RCT) No serious limitations No serious inconsistency Serious indirectness (because of indirectness of outcome) No serious imprecision Undetected 168/460 153/467 RR 0.89 (0.75-1.07) 350/1000 Not significant ⊕⊕⊕o Moderate
Hearing, inferred from the surrogate outcome abnormaltympamometry—3 mo
3 (RCT) No serious limitations No serious inconsistency (because of indirectness of outcome) Serious indirectness No serious imprecision Undetected 96/398 96/410 RR 0.97 (0.76-1.24) 234/1000 Not significant ⊕⊕⊕o Moderate
Vomiting, diarrhea, or rash
5 (RCT) No serious limitations Serious inconsistency (because of inconsistency in absolute effects) No serious indirectness No serious imprecision Undetected 83/711 110/690 RR 1.38 (1.09-1.76) 113/1000 43 more per 1000 (10-86) ⊕⊕⊕o Moderate

aThe control rate is based on the median control group risk across studies.

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

Reproduced from Journal of Clinical Epidemiology, Vol 64, Gordon Guyatt, Andrew D. Oxman, Elie A. Akl, Regina Kunz, Gunn Vist, et al. GRADE guidelines: 1. Introduction GRADE evidence profiles and summary of findings tables. Pp. 383-394, Copyright 2011, with permission from Elsevier.

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