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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
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Pilot and Feasibility Studies

ISSN: 2055-5784