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PRISMA flow diagram of search history.
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Figure 1

PRISMA flow diagram of search history.

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'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Grommets versus active monitoring, outcome: 1.1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.
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Figure 4

Forest plot of comparison: 1 Grommets versus active monitoring, outcome: 1.1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.

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Forest plot of comparison: 2 Grommets versus antibiotic prophylaxis, outcome: 2.1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.
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Figure 5

Forest plot of comparison: 2 Grommets versus antibiotic prophylaxis, outcome: 2.1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.

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Forest plot of comparison: 3 Grommets versus placebo medication, outcome: 3.1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.
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Figure 6

Forest plot of comparison: 3 Grommets versus placebo medication, outcome: 3.1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.

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Comparison 1 Grommets versus active monitoring, Outcome 1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.
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Analysis 1.1

Comparison 1 Grommets versus active monitoring, Outcome 1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.

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Comparison 1 Grommets versus active monitoring, Outcome 2 Proportion of patients who have no AOM recurrences at 12 months post‐randomisation.
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Analysis 1.2

Comparison 1 Grommets versus active monitoring, Outcome 2 Proportion of patients who have no AOM recurrences at 12 months post‐randomisation.

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Comparison 1 Grommets versus active monitoring, Outcome 3 Total number of AOM recurrences at six months post‐randomisation.
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Analysis 1.3

Comparison 1 Grommets versus active monitoring, Outcome 3 Total number of AOM recurrences at six months post‐randomisation.

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Comparison 2 Grommets versus antibiotic prophylaxis, Outcome 1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.
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Analysis 2.1

Comparison 2 Grommets versus antibiotic prophylaxis, Outcome 1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.

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Comparison 2 Grommets versus antibiotic prophylaxis, Outcome 2 Total number of AOM recurrences at six months post‐randomisation.
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Analysis 2.2

Comparison 2 Grommets versus antibiotic prophylaxis, Outcome 2 Total number of AOM recurrences at six months post‐randomisation.

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Comparison 3 Grommets versus placebo medication, Outcome 1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.
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Analysis 3.1

Comparison 3 Grommets versus placebo medication, Outcome 1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation.

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Comparison 3 Grommets versus placebo medication, Outcome 2 Total number of AOM recurrences at six months post‐randomisation.
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Analysis 3.2

Comparison 3 Grommets versus placebo medication, Outcome 2 Total number of AOM recurrences at six months post‐randomisation.

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Summary of findings for the main comparison. Grommets versus active monitoring for recurrent acute otitis media in children

Grommets versus active monitoring for recurrent acute otitis media in children

Patients: children with recurrent acute otitis media
Setting: secondary and tertiary care
Intervention: grommets
Control: active monitoring

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with active monitoring

Risk with grommets

Proportion of patients who have no AOM recurrences at 6 months post‐randomisation

Study population

RR 9.49
(2.38 to 37.80)

95
(1 RCT)

⊕⊕⊝⊝
low1

The NNTB based on the study population risk was 1/ (463‐49)* 1000 = 2.41

49 per 1000

463 per 1000
(116 to 1000)

Significant adverse effect: a tympanic membrane perforation persisting for 3 months or longer

—

0 (0/54)

n/a

54 (1 RCT)

⊕⊕⊝⊝
low1

—

Proportion of patients who have no AOM recurrences at 12 months post‐randomisation

Study population

RR 1.41
(1.00 to 1.99)

200
(1 RCT)

⊕⊕⊝⊝
low1

The NNTB based on the study population risk was 1/ (479‐340)* 1000 = 7.19

340 per 1000

479 per 1000
(340 to 677)

Total number of AOM recurrences at 6 months post‐randomisation

89 AOM recurrences in 41 children; mean number of AOM recurrences per child: 2.17

36 AOM recurrences in 54 children; mean number of AOM recurrences per child: 0.67

MD ‐1.50, 95% CI ‐1.99 to ‐1.01

95 (1 RCT)

⊕⊕⊝⊝
low1

—

Total number of AOM recurrences at 12 months post‐randomisation

119 AOM recurrences in 100 children; incidence rate 1.70

92 AOM recurrences in 100 children; incidence rate 1.15

Incidence rate difference ‐0.55, 95% ‐0.17 to ‐0.93

200
(1 RCT)

⊕⊕⊝⊝
low1

—

Disease‐specific health‐related quality of life of the child at 4 and 12 months post‐randomisation using the OM‐6 questionnaire

"no statistically significant differences between treatment groups were reported at 4 and 12 months for any of the six subdomains of the OM‐6 questionnaire"

85 and 81, respectively (1 RCT)

⊕⊕⊝⊝
low1

—

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AOM: acute otitis media; CI: confidence interval;MD: mean difference; n/a: not applicable; NNTB: number needed to treat to benefit; OM‐6: Otitis Media‐6; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1We downgraded the evidence from high to low quality due to study limitations and imprecise effect estimates (only one study with a small sample size).

Figuras y tablas -
Summary of findings for the main comparison. Grommets versus active monitoring for recurrent acute otitis media in children
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Summary of findings 2. Grommets versus antibiotic prophylaxis for recurrent acute otitis media in children

Grommets versus antibiotic prophylaxis for recurrent acute otitis media in children

Patients: children with recurrent acute otitis media
Setting: secondary and tertiary care
Intervention: grommets
Control: antibiotic prophylaxis

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with antibiotic prophylaxis

Risk with grommets

Proportion of patients who have no AOM recurrences at 6 months post‐randomisation

Study population

RR 1.68
(1.07 to 2.65)

96
(2 RCTs)

⊕⊝⊝⊝
very low1

The NNTB based on the study population risk was 1/ (586‐349)* 1000 = 4.22

349 per 1000

586 per 1000
(373 to 924)

Total number of AOM recurrences at 6 months post‐randomisation

29 AOM recurrences in 21 children; mean number of AOM recurrences per child: 1.38

19 AOM recurrences in 22 children; mean number of AOM recurrences per child: 0.86

MD ‐0.52, 95% CI ‐1.37 to 0.33

43 (1 RCT)

⊕⊝⊝⊝
very low2

—

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AOM: acute otitis media; CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1We downgraded the evidence from high to very low quality due to study limitations (when we excluded the trial with high risk of bias from the analysis, no statistically significant difference was observed between groups) and imprecise effect estimates (only two studies with small sample sizes).

2We downgraded the evidence from high to very low quality due to study limitations and imprecise effect estimates (only one study with a very small sample size).

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Summary of findings 2. Grommets versus antibiotic prophylaxis for recurrent acute otitis media in children
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Summary of findings 3. Grommets versus placebo medication for recurrent acute otitis media in children

Grommets versus placebo medication for recurrent acute otitis media in children

Patients: children with recurrent acute otitis media
Setting: secondary and tertiary care
Intervention: grommets
Control: placebo medication

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo medication

Risk with grommets

Proportion of patients who have no AOM recurrences at 6 months post‐randomisation

Study population

RR 3.64
(1.20 to 11.04)

42
(1 RCT)

⊕⊝⊝⊝
very low1

The NNTB based on the study population risk was 1/ (546‐150)* 1000 = 2.53

150 per 1000

546 per 1000
(180 to 1000)

Significant adverse effect: a tympanic membrane perforation persisting for 3 months or longer

—

4% (3/76)

n/a

76 (1 RCT)

⊕⊕⊝⊝
low2

—

Total number of AOM recurrences at 6 months post‐randomisation

40 AOM recurrences in 20 children; mean number of AOM recurrences per child: 2.0

19 AOM recurrences in 22 children; mean number of AOM recurrences per child: 0.86

MD ‐1.14, 95% CI ‐2.06 to ‐0.22

42
(1 RCT)

⊕⊝⊝⊝
very low1

—

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AOM: acute otitis media; CI: confidence interval; MD: mean difference; n/a: not applicable; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1We downgraded the evidence from high to very low quality due to study limitations and imprecise effect estimates (only one study with a very small sample size).

2We downgraded the evidence from high to low quality due to study limitations and imprecise effect estimates (only one study with a small sample size).

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Summary of findings 3. Grommets versus placebo medication for recurrent acute otitis media in children
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Table 1. Interventions and comparison pairs included in this review

Study ID

Grommets

Grommets plus adenoidectomy

Active monitoring

Placebo medication

Antibiotic prophylaxis

Adenoidectomy

Casselbrant 1992

x

x

x

El‐Sayed 1996

x

x

Gebhart 1981

x

x

Gonzalez 1986

x

x

x

Kujala 2012

x

x

x

Comparison pairs for this review

#

Intervention

Comparator

Number of trials

Study ID

1

Grommets

Active monitoring

2

Gebhart 1981; Kujala 2012

2

Grommets

Antibiotic prophylaxis

3

Casselbrant 1992; El‐Sayed 1996; Gonzalez 1986

3

Grommets

Placebo medication

2

Casselbrant 1992; Gonzalez 1986

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Table 1. Interventions and comparison pairs included in this review
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Table 2. Overview of the outcomes reported in the included studies

Outcomes

Casselbrant 1992

El‐Sayed 1996

Gebhart 1981

Gonzalez 1986

Kujala 2012

Primary outcomes

Proportion of children who have no AOM recurrences at 3 to 6 months post‐randomisation

x

x

x

Significant adverse effect: tympanic membrane perforation persisting for 3 months or longer

x

x

Secondary outcomes

Proportion of children who have no AOM recurrences at 6 to 12 months post‐randomisation

x

Total number of AOM recurrences

< 3 months

3 to 6 months

x

x

6 to 12 months

x

Disease‐specific health‐related quality of life

< 3 months

3 to 6 months

x

6 to 12 months

x

Generic health‐related quality of life of the child and parent

< 3 months

3 to 6 months

6 to 12 months

Presence of middle ear effusion

< 3 months

3 to 6 months

6 to 12 months

Other adverse effects: ventilation tube misplaced in middle ear, otorrhoea within 1 week of ventilation tube placement, myringosclerosis

x
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Table 2. Overview of the outcomes reported in the included studies
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Comparison 1. Grommets versus active monitoring

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation Show forest plot

1

95

Risk Ratio (M‐H, Fixed, 95% CI)

9.49 [2.38, 37.80]

2 Proportion of patients who have no AOM recurrences at 12 months post‐randomisation Show forest plot

1

200

Risk Ratio (M‐H, Fixed, 95% CI)

1.41 [1.00, 1.99]

3 Total number of AOM recurrences at six months post‐randomisation Show forest plot

1

95

Mean Difference (IV, Fixed, 95% CI)

‐1.5 [‐1.99, ‐1.01]
Figuras y tablas -
Comparison 1. Grommets versus active monitoring
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Comparison 2. Grommets versus antibiotic prophylaxis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation Show forest plot

2

96

Risk Ratio (M‐H, Fixed, 95% CI)

1.68 [1.07, 2.65]

2 Total number of AOM recurrences at six months post‐randomisation Show forest plot

1

43

Mean Difference (IV, Fixed, 95% CI)

‐0.52 [‐1.37, 0.33]
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Comparison 2. Grommets versus antibiotic prophylaxis
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Comparison 3. Grommets versus placebo medication

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of patients who have no AOM recurrences at 6 months post‐randomisation Show forest plot

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

3.64 [1.20, 11.04]

2 Total number of AOM recurrences at six months post‐randomisation Show forest plot

1

42

Mean Difference (IV, Fixed, 95% CI)

‐1.14 [‐2.06, ‐0.22]
Figuras y tablas -
Comparison 3. Grommets versus placebo medication
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