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Otovent package.Otovent® package containing balloons with device and instructions.
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Figure 1

Otovent package.

Otovent® package containing balloons with device and instructions.

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Child using Otovent.Child demonstrating the use of Otovent® device
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Figure 2

Child using Otovent.

Child demonstrating the use of Otovent® device

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Politzer ‐ EarPopper.Young woman demonstrating use of modified Politzer device (EarPopper™)
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Figure 3

Politzer ‐ EarPopper.

Young woman demonstrating use of modified Politzer device (EarPopper™)

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Comparison 1 Tympanometry Improvement, Outcome 1 Tympanogram improvement: 1 month or less.
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Analysis 1.1

Comparison 1 Tympanometry Improvement, Outcome 1 Tympanogram improvement: 1 month or less.

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Comparison 1 Tympanometry Improvement, Outcome 2 Tympanogram improvement: > 1 month.
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Analysis 1.2

Comparison 1 Tympanometry Improvement, Outcome 2 Tympanogram improvement: > 1 month.

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Comparison 2 Improvement (tympanogram or composite), Outcome 1 Improvement composite: 1 month or less.
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Analysis 2.1

Comparison 2 Improvement (tympanogram or composite), Outcome 1 Improvement composite: 1 month or less.

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Comparison 2 Improvement (tympanogram or composite), Outcome 2 Improvement composite: > 1 month.
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Analysis 2.2

Comparison 2 Improvement (tympanogram or composite), Outcome 2 Improvement composite: > 1 month.

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Comparison 2 Improvement (tympanogram or composite), Outcome 3 Improvement composite by intervention: 1 month or less.
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Analysis 2.3

Comparison 2 Improvement (tympanogram or composite), Outcome 3 Improvement composite by intervention: 1 month or less.

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Comparison 2 Improvement (tympanogram or composite), Outcome 4 Improvement composite by intervention: > 1 month.
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Analysis 2.4

Comparison 2 Improvement (tympanogram or composite), Outcome 4 Improvement composite by intervention: > 1 month.

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Comparison 3 Audiometry Improvement, Outcome 1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz).
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Analysis 3.1

Comparison 3 Audiometry Improvement, Outcome 1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz).

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Comparison 3 Audiometry Improvement, Outcome 2 Pure tone threshold.
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Analysis 3.2

Comparison 3 Audiometry Improvement, Outcome 2 Pure tone threshold.

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Table 1. Methodology of included studies

Study

Randomisation method

Groups comparable

Allocation concealed

Ascertainment

Notes

Brooker 1992

Sealed envelope

Not stated

Not used

100%

Stangerup 1992

Consecutively randomised

Yes

Not used

87% at 30 days, 74% at 90 days

Blanshard 1993

Computer generated

Yes

Not used

Over 90% at all outcome points

Intervention group analysed as low and high compliance subgroups

Fraser 1977

Not stated. Three factorial study

Yes

Not used

97%

Lesinskas 2003

Independent person envelopes

Not stated

Not used

100%

Autoinflation performed by the physician

Arick 2005

4 pieces of paper (2 Exp, 2 Control) in a bag, one selected by parent

Yes

Not used

100%

Autoinflation in children performed by parent using modyfied Politzer
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Table 1. Methodology of included studies
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Table 2. Side effects and compliance

Trial

Side effects

Compliance

Brooker 1992

None reported

Parents reported good compliance

Stangerup 1992

"We have not observed an increase incidence in middle ear infection or eardrum perforation in connection with autoinflation."
No comment given on baseline incidence level.

Compliance at 2 weeks:
33/51 (65%) High compliance,
10/51 (20%) Low compliance,
3/51 ( 6%) No compliance
No data given on the other 5 children.

Blanshard 1993

Stratified by compliance level:
Attacks of OM
44% control, 36% HC, 30% LC.
URTI
61% LC, 32% HC, 23% control
Tonsillitis
22% LC, 5% HC, 13% Control
Antibiotics
43% LC, 21% HC, 33% control
"No complications arose from using the treatment."

45% High compliance(HC), 43% low compliance (LC), 12% unable to use device

Some children with OME find doing the Valsalva manoeuvre painful.

Fraser 1977

Some children developed further symptoms and abnormal signs while receiving treatments (do not mention which group)

Not reported

Lesinskas 2003

Treatment ME inflation stopped for 1 adult patient due to painfulness of procedure

100% follow up and compliance (done by physician)

Arick 2005

As part of 1 year follow up
2 children with MEE (hearing restored)
3 children had either grommets inserted and/or enlarged adenoid

Compliance of 97.9% (46/47)
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Table 2. Side effects and compliance
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Comparison 1. Tympanometry Improvement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tympanogram improvement: 1 month or less Show forest plot

3

Relative risk (Random, 95% CI)

Subtotals only

1.1 B or C2 to C1 or A

3

Relative risk (Random, 95% CI)

1.65 [0.49, 5.56]

1.2 B to C1 or A

2

Relative risk (Random, 95% CI)

2.71 [1.43, 5.12]

1.3 C2 to C1 or A

2

Relative risk (Random, 95% CI)

3.84 [1.94, 7.59]

2 Tympanogram improvement: > 1 month Show forest plot

2

Relative Risk (Random, 95% CI)

Subtotals only

2.1 B or C2 to C1 or A

2

Relative Risk (Random, 95% CI)

1.89 [0.77, 4.67]
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Comparison 1. Tympanometry Improvement
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Comparison 2. Improvement (tympanogram or composite)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Improvement composite: 1 month or less Show forest plot

4

Relative Risk (Random, 95% CI)

2.47 [0.93, 6.58]

2 Improvement composite: > 1 month Show forest plot

4

Relative Risk (Random, 95% CI)

2.20 [1.71, 2.82]

3 Improvement composite by intervention: 1 month or less Show forest plot

4

Risk Ratio (Random, 95% CI)

2.47 [0.93, 6.58]

3.1 Intervention A ‐Classic Otovent or Carnival blower+balloon

3

Risk Ratio (Random, 95% CI)

1.65 [0.49, 5.55]

3.2 Intervention C ‐ Politzer

1

Risk Ratio (Random, 95% CI)

7.07 [3.70, 13.51]

4 Improvement composite by intervention: > 1 month Show forest plot

4

Risk Ratio (Random, 95% CI)

2.20 [1.71, 2.82]

4.1 Intervention A ‐Classic Otovent or Carnival blower+balloon

2

Risk Ratio (Random, 95% CI)

1.89 [0.77, 4.67]

4.2 Intervention C ‐ Politzer

2

Risk Ratio (Random, 95% CI)

2.25 [1.67, 3.04]
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Comparison 2. Improvement (tympanogram or composite)
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Comparison 3. Audiometry Improvement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz) Show forest plot

2

Relative Risk (Random, 95% CI)

0.80 [0.22, 2.88]

2 Pure tone threshold Show forest plot

2

Mean difference (Random, 95% CI)

7.02 [‐6.92, 20.96]
Figuras y tablas -
Comparison 3. Audiometry Improvement
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