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. 2023 Sep 26;2023(9):CD015253. doi: 10.1002/14651858.CD015253.pub2

Brooker 1992.

Study characteristics
Methods Two‐arm, parallel‐group, randomised controlled trial of 3 weeks treatment and follow‐up
Participants Setting:
Single‐centre, conducted in a hospital audiology clinic in the UK. Study dates were not reported.
Sample size:

  • Number randomised: 40 participants (78 ears)

  • Number completed: 40 participants (78 ears)


Participant (baseline) characteristics:

  • Age:

    • 3 to 10 years

    • Average age 5.7 years

  • Gender:

    • Not reported


Inclusion criteria:
Children aged less than 10 years referred to audiology clinic with unilateral or bilateral glue ears diagnosed by otoscopy, audiogram and tympanogram. The children had to be able to inflate a carnival blower nasally.
Exclusion criteria:
Not reported
Interventions Autoinflation group (n = 21 (41 ears) randomised)
Three times daily for 3 weeks. Device comprised of a toy balloon attached to a carnival blower mouthpiece. Pressure required to inflate was in the range 35 to 40 mmHg then settled to 20 to 23 mmHg once the balloon had started to inflate. Children were taught how to do it initially.
Control group (n = 19 (37 ears) randomised)
No treatment
Outcomes Primary outcomes relevant to this review:

  • Hearing

    • Not reported

  • Disease‐specific quality of life

    • Not reported

  • Adverse events

    • Not reported


Secondary outcomes relevant to this review:

  • Presence/persistence of OME: proportion of ears with persistence of OME

    • Number of ears with persistent flat tympanogram at 3 weeks
Funding sources Not reported
Declarations of interest None reported
Notes Research integrity checklist

  • No retraction notices or expressions of concern were identified

  • The trial was published prior to 2010, therefore prospective registration is not applicable

  • Very few baseline characteristics were reported, therefore we cannot assess whether the groups were excessively similar

  • No loss to follow‐up was reported, but the groups were extremely small, therefore this may be plausible

  • No implausible results were reported

  • Different numbers of participants were allocated to each group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The children so selected were, with the informed consent of their parents, allocated at random into two groups.”
Comment: insufficient information to judge random sequence generation.
Allocation concealment (selection bias) Unclear risk No description of allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk It is not possible to blind participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes High risk There is no statement to indicate that outcome assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing outcome data.
Selective reporting (reporting bias) Unclear risk No protocol was identified.
Other bias High risk Follow‐up was for 3 weeks ‐ this is insufficient time for as assessment of the 'no treatment' group, as they would not be expected to have improved during this time frame.