Skip to main content
. 2023 Sep 26;2023(9):CD015253. doi: 10.1002/14651858.CD015253.pub2

Blanshard 1993.

Study characteristics
Methods Two‐arm, parallel‐group, randomised controlled trial, with 3 months of treatment and follow‐up
Participants Setting:
Single‐centre, conducted in an ENT clinic in the UK from July to December 1991
Sample size:

  • Number randomised: 85 participants

  • Number completed: 83 participants


Participant (baseline) characteristics:

  • Age:

    • Autoinflation group: mean 57.3 months (SD 14.2)

    • Control group: mean 59.9 months (SD 18.3)

  • Gender:

    • Autoinflation group:

      • 25 males

      • 17 females

    • Control group:

      • 27 males

      • 14 females

  • Duration of disease

    • Autoinflation group: mean 27.8 (SD 16.2)

    • Control group: mean 27.2 (SD 15.2)


Inclusion criteria:
Aged 3 to 10 years with confirmation of bilateral type B or C2 tympanograms on 2 occasions separated by at least 3 months and on the waiting list for grommets
Exclusion criteria:

  • Children treated previously by adenoidectomy or tonsillectomy

  • Chromosomal abnormalities

  • Cranio‐facial abnormalities
Interventions Autoinflation group (n = 42 completed)
The Otovent device is a rounded plastic nose piece with a balloon attached. Used once through each nostril 3 times a day. Balloon changed every 3 days.
Not to be used during the first few days of an URTI, or an episode of otalgia
Control group (n = 41 completed)
No intervention
Outcomes Primary outcomes relevant to this review:

  • Hearing

    • Mean (SD) change in hearing thresholds (dB) from baseline: pure tone audiometry

  • 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:

    • Type B or C2 tympanogram at 3 months

  • Episodes of acute otitis media: mean (SD) number of episodes

    • At least 1 episode of AOM at 3 months
Funding sources Not reported
Declarations of interest None reported
Notes Research integrity checklist

  • No retraction notices or expressions of concern were identified

  • Prospective trial registration was not applicable as this study was published before 2010

  • Baseline characteristics of the groups were not excessively similar, although limited information was provided

  • Some loss to follow‐up was reported

  • No implausible results were reported

  • The number randomised to each group is not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “They were allocated to either the treatment or to the control group by computer generated random numbers”.
Comment: computer‐generated method of randomisation.
Allocation concealment (selection bias) Unclear risk No information on 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 No information is provided regarding whether outcome assessors were blinded. It is likely they were unblinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk There was minimal dropout.
Selective reporting (reporting bias) Unclear risk No protocol available. Most analyses are conducted according to a per protocol analysis of those with high compliance versus control, rather than the entire treatment group.
Other bias Low risk No other concerns.