Table 1Summary of the protocol (PICO table)

PopulationAll children under 12 years with confirmed otitis media with effusion (OME) who are undergoing ventilation tube (VT) surgery for OME-related hearing loss.
Intervention

Intraoperative interventions*:

  • Antiseptic and/or saline washouts
  • Antibiotic ear drops with or without corticosteroid
  • Systemic antibiotics
  • Systemic corticosteroids

Postoperative interventions*:

  • Antibiotic ear drops with or without corticosteroid
  • Oral antibiotics (either immediately after operation or within 6 months)
  • Water precautions (actions to ensure ears are kept dry, for example, wearing ear plugs, swimming cap and headband and avoidance of swimming)

*Interventions alone or in combination

Comparison
  • Head-to-head comparisons between the above intraoperative intervention categories** (alone or in combination)
  • Head-to-head comparisons between the above postoperative intervention categories** (alone or in combination)
  • The above intraoperative interventions (alone or in combination) versus placebo
  • The above postoperative interventions (alone or in combination) versus placebo
  • The above intraoperative interventions (alone or in combination) versus no intervention for preventing otorrhoea
  • The above postoperative interventions (alone or in combination) versus no intervention for preventing otorrhoea

**Please note, head-to-head comparisons between different interventions within each category (e.g., comparisons between different types of systemic antibiotics) were not included, only head-to-head comparisons of interventions from different categories (e.g., a systemic antibiotic versus a systemic corticosteroid)

Outcome
Critical
  • Otorrhoea (ear discharge) – frequency (either clinically confirmed or parent-reported)
  • Adverse effects of intervention (including antimicrobial resistance)
  • Acceptability
Important
  • Tube blockage
  • Tube extrusion
  • Surgical intervention to remove VTs
  • Quality of life (measured by OM8-30 questionnaire, Health Utilities Index Mark 3 (HUI3) questionnaire, Otitis Media-6 (OM-6) questionnaire, Quality of Life in Children’s Ear Problems (OMQ-14) questionnaire, Evaluation of Children’s Listening and Processing Skills (ECLiPS) questionnaire, Auditory Behaviour in Everyday Life (ABEL) questionnaire, Early Listening Function (ELF) questionnaire, Parents’ Evaluation of Aural/Oral Performance of Children (PEACH) questionnaire, EuroQol 5 Dimensions (EQ-5D) questionnaire, Infant Toddler Quality of Life Questionnaire, or Child Heath Questionnaire)

From: Evidence reviews for preventing otorrhoea after surgery for hearing loss associated with OME in children

Cover of Evidence reviews for preventing otorrhoea after surgery for hearing loss associated with OME in children
Evidence reviews for preventing otorrhoea after surgery for hearing loss associated with OME in children: Otitis media with effusion in under 12s: Evidence review K.
NICE Guideline, No. 233.
Copyright © NICE 2023.

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