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Table 4 Sample size assumptions for a clinical trial of corticosteroids for AOM conducted in different settings

From: Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

Proportion of children

Original assumption [38]a

Middle scenario

Pilot observed resultb

With severe AOM

35%

56%

78%

 With severe AOM AND ongoing pain

57.5%

50%

42%

With mild AOM

65%

43%

22%

 With mild AOM AND ongoing pain

36%

46%

57%

With severe and mild AOM AND ongoing pain

31.6%

38.4%

45.2%

Sample size calculationc

760

570

444

  1. aFrom a meta-analysis of studies conducted in developed countries
  2. bOur pilot study was conducted in a developing country, urban setting
  3. cThe sample size includes a 10% allowance for dropouts