The choice of a balanced allocation method for a clinical trial in otitis media with effusion

Stat Med. 1990 Mar;9(3):237-46. doi: 10.1002/sim.4780090306.


We review the choice of treatment allocation procedures in a specific small clinical trial of the effect of tympanostomy tubes on language development in patients with otitis media with effusion. The options for balanced allocation available at the planning stage are discussed. A clearly favourable method could not be identified. A simulation study was performed, and its results demonstrated least imbalance with the variance method. In practice this method produced considerable imbalance on relevant prognostic factors.

MeSH terms

  • Child, Preschool
  • Computer Simulation
  • Female
  • Humans
  • Infant
  • Language Development*
  • Male
  • Middle Ear Ventilation*
  • Models, Statistical
  • Otitis Media with Effusion / therapy*
  • Pilot Projects
  • Randomized Controlled Trials as Topic / methods*
  • Research Design*