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Grommets in otitis media with effusion: an individual patient data meta-analysis
M M Rovers1, N Black, G G Browning
1Julius Center for Health Sciences and Primary Care and Department of Pediatrics, University Medical Center Utrecht, Netherlands. mrovers@umcutrecht.nl
Insights
Ventilation tubes offer limited benefits for most children with otitis media with effusion (OME). Watchful waiting is often adequate, but tubes may help children in day-care or those with significant hearing loss.
Area of Science:
- Pediatric Otolaryngology
- Evidence-Based Medicine
Background:
- Otitis media with effusion (OME) is common in children.
- Treatment decisions for OME, particularly the use of ventilation tubes, require careful consideration of potential benefits and patient-specific factors.
Purpose of the Study:
- To identify specific subgroups of children with OME who may experience greater benefits from ventilation tube treatment.
- To analyze interactions between treatment and various baseline characteristics in children with OME.
Main Methods:
- An individual patient data (IPD) meta-analysis was conducted on seven randomized controlled trials involving 1234 children.
- Key baseline characteristics analyzed included hearing level (HL), day-care attendance, and age.
- Outcome measures included time with effusion, hearing levels, and language development.
Main Results:
- No significant interactions were found between most baseline variables and ventilation tube treatment when both ears were treated.
- A significant interaction was observed between day-care attendance and surgery when hearing level was the outcome.
- In unilateral treatments, baseline hearing level showed a significant interaction with treatment at a 25 dB HL cutoff.
Conclusions:
- The overall effects of ventilation tubes for OME are small and temporary, supporting watchful waiting as a primary strategy.
- Ventilation tubes may be considered for children attending day-care due to high infection exposure or for older children with persistent hearing levels of 25 dB HL or greater.
Aims:
To identify subgroups of children with otitis media with effusion (OME) that might benefit more than others from treatment with ventilation tubes.
Methods:
An individual patient data (IPD) meta-analysis on seven randomised controlled trials (n = 1234 children in all), focusing on interactions between treatment and baseline characteristics--hearing level (HL), history of acute otitis media, common colds, attending day-care, gender, age, socioeconomic status, siblings, season, passive smoking, and history of breast feeding. Outcome measures that could be studied were mean time spent with effusion (n = 557), mean hearing levels (n = 557 in studies that randomised children, and n = 180 in studies that randomised ears), and language development (n = 381).
Results:
In the trials that treated both ears the only significant interaction was between day-care and surgery, occurring where mean hearing level was the outcome measure. None of the other baseline variables showed an interaction effect with treatment that would justify subgrouping. In the trials that treated only one ear, the baseline hearing level showed a significant but not pervasive interaction with treatment-that is, only with a cut-off of 25 dB HL.
Conclusions:
The effects of conventional ventilation tubes in children studied so far are small and limited in duration. Observation (watchful waiting) therefore seems to be an adequate management strategy for most children with OME. Ventilation tubes might be used in young children that grow up in an environment with a high infection load (for example, children attending day-care), or in older children with a hearing level of 25 dB HL or greater in both ears persisting for at least 12 weeks.
