Surgery for persistent otitis media with effusion: generalizability of results from the UK trial (TARGET)

Mp. Haggard et al., Surgery for persistent otitis media with effusion: generalizability of results from the UK trial (TARGET), CLIN OTOLAR, 26(5), 2001, pp. 417-424
Citations number
Categorie Soggetti
Journal title
ISSN journal
0307-7772 → ACNP
Year of publication
417 - 424
SICI code
TARGET (Trial of Alternative Regimens in Glue Ear Treatment) is a multicent re UK randomized controlled trial (RCT) comparing bilateral ventilation tub es with and without adjuvant adenoidectomy against non-surgical management in children with bilateral, persistent otitis media with effusion (OME). Th is paper compares the recruited and randomized children with those that, al though eligible, were not included in the RCT for various reasons. This is necessary to identify any potential bias in the overall estimate of treatme nt effectiveness. At the first visit, 1315 children with OME satisfied the criteria of age (3 years 3 months-6 years 9 months), no previous ear or ade noid surgery, tympanometric evidence of fluid (bilateral B or B + C-2) and a hearing loss (conductive loss in both cars of greater than or equal to 20 dBHL). Of these children, 151 (11%) were not followed up because of overri ding concern and 70 (5%) because of parental refusal. Of the 506 children e ligible for randomization, because of persistence over 12 weeks of watchful waiting of bilateral OME with the same criteria, 20 (4%) were not randomiz ed because of overriding concern and 75 (15%) because of parental refusal. The distribution of the potential effect modifiers was determined for each group. At the first visit, the only significant differences (P < 0.05), com paring those not recruited because of overriding concern with those recruit ed, were in respect of sex (61% girls compared with 52% boys) and hearing l evel (34.6 compared with 33.0dBHL). At the second visit, the only significa nt difference involved less frequent upper respiratory tract infections (UR TIs) in children whose parents refused to allow randomization (8% compared with 18% had had episodic URTI more often than once every 3 months). It is probable that the findings from the TARGET trial will translate to the enti re clinic population in this age group as long as they meet the same audiom etric and tympanometric criteria. The differences found can be handled by p resentation of disaggregated results.