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Table 3 The adherence to the study

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

Adherence to the study

Prednisolone (n = 31)

Control (n = 31)

Not compliant to the completion of symptom diary

No data after baseline for primary outcome analysis

2

0

Data collected retrospectively by interview

4

13

Unclear responses clarified by interview

5

3

Not compliant to study medicationa

  

Missed one dose, but taken on the next day

1

–

Vomited constantly and stopped the study medication

1

–

Took half of dose, vomited < 30 min and took another half of dose

1

–

Took medicine in the afternoon (not in the morning)

2

–

Not compliant to the follow-up visits

  

Delayed timing of follow-up visit

3

3

Left study

2

2

Additional interventions

  

Received additional oral corticosteroids

3b

1c

Received intervention of co-medication from study investigator

2

5

  1. aNine patients did not complete diary, but the adherence confirmed by interview
  2. bAt day 10, 12 and 60
  3. cAt day 7