Problems in recruiting patients to controlled trials on children with secretory otitis media: a demographic comparison of excluded versus included patients.
One thousand one hundred and sixty-four patients formed the pool of patients from which we intended to recruit children to a controlled trial evaluating the efficacy of amoxicillin-clavulanate and penicillin-V in the treatment of secretory otitis media (SOM). Only 360 patients ended up to be evaluated, consisting only 30% of the primarily involved patients. The spontaneous improvement of the tympanometric condition was the major course of pre-trial dropouts. The demographic composition of included and excluded patients did not differ, as one might have expected. Very little has previously been published about this great number of excluded patients even though other authors must have had the same experience. It is concluded that a 3-month duration of SOM, evaluated by tympanometry by the investigators, is required as a minimum to qualify for entering a trial evaluating SOM.
Sederberg-Olsen
J
J
Ear-Nose-Throat-Clinic, Elsinore, Denmark.
Sederberg-Olsen
N
N
Thomsen
J
J
Balle
V
V
D000158:Acoustic Impedance Tests; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000188:drug therapy*; D010352:Patient Dropouts; D018579:Patient Selection; D010404:Penicillin V / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
D019980:Amoxicillin-Potassium Clavulanate Combination; D010404:Penicillin V