PROBLEMS IN RECRUITING PATIENTS TO CONTROLLED TRIALS ON CHILDREN WITHSECRETORY OTITIS-MEDIA - A DEMOGRAPHIC COMPARISON OF EXCLUDED VERSUS INCLUDED PATIENTS

One thousand one hundred and sixty-four patients formed the pool of pa tients from which we intended to recruit children to a controlled tria l evaluating the efficacy of amoxicillin-clavulanate and penicillin-V in the treatment of secretory otitis media (SOM). Only 360 patients en ded up to be evaluated, consisting only 30% of the primarily involved patients. The spontaneous improvement of the tympanometric condition w as the major course of pre-trial dropouts. The demographic composition of included and excluded patients did not differ, as one might have e xpected. Very little has previously been published about this great nu mber of excluded patients even though other authors must have had the same experience. It is concluded that a 3-month duration of SOM, evalu ated by tympanometry by the investigators, is required as a minimum to qualify for entering a trial evaluating SOM. (C) 1998 Elsevier Scienc e Ireland Ltd. All rights reserved.