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Three Part Question

In [preschool children with otitis media with effusion (Glue Ear)] does the [insertion of ventilation tubes (grommets) as opposed to watchful waiting] have an effect on [language development]

Clinical Scenario

A mother brings her 2 year old daughter to your clinic. She is concerned about her speech which she feels is poor for her age. Her daughter has failed two consecutive audiograms. On otoscopy she has signs of bilateral otitis media with effusion (OME) which you have confirmed on a previous occasion two months ago. Should you refer for insertion of grommets?

Search Strategy

MEDLINE 1966 to 11/2001, using OVID
"otitis media with effusion", "glue ear" , "otitis media" AND "Middle ear ventilation" , "grommets" AND filter "clinical trial" , "controlled clinical trial" , "metanalysis" , "randomized clinical trial " LIMIT to "English Language"

Search Outcome

Secondary Searches – Cochrane- 1 relevant protocol (planned systematic review). See references. Search results 127 articles - 3 relevant

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Rach et al Holland 1991	n=52 Age -2 year olds. Children from a larger cohort were screened for OME with tympanograms.Randomized to treatment	RCT (level 2b)	Recovery time (hrs) when hydration, weight and nature of stools were normal	formula 70.5 (60.3); breast 60.9(44.8); breast plus supplement 64.8(43.3); soya 61.4(43.5) P>0.05 NS	Follow up 100%. Small numbers in trial and follow up time not sufficient. Balanced randomization. Testers not blinded.
			Improvement in language scores at 6 months	Improvement in scores in the treatment group, but large overlapping CI
Maw et al UK 1999	n=182 Age 2-3 year olds. Confirmed to have OME and hearing loss with tympanograms Only those with problems in speech, learning, or behaviour were included Randomized to treatment.	RCT (level 2b)	Improvement in language scores at 9 and 18 months	Improvement in treated group at 9 months. Mean difference between groups was not significant 0.31 (-0.03 to 0.66) 95%CI. At 18 months smaller differences which were not significant.	Follow-up –83%.Large drop-out in trial makes results difficult to interpret- by 18 months 85% of watchful waiting group had grommets inserted. Data was analysed by intention to treat.
			13C in breath when ill and after recovery	Apparent absorption not different, 13 C diarrhoea 86.6%- recovery 94%. NS
Rovers et al 2000 Holland	n= 187 Age =16-24 months. From a larger cohort that were screened for hearing loss and OME. Randomized to treatment.	RCT (level 2b)	Median % weight change	Grp 1 0.005- grp 2 0.96 p=0.24 NS	Follow up – 79%. Balanced Allocation for groups but groups were different for confounding factors. Not clear if testers were blinded
			Median duration of diarrhoea	Grp1 66.5 h- grp2 56h p=0.4 not significant
			Complication rate	Similar- NS
			Improvement of language scores at 6 and 12 months	No difference between treatment and watchful waiting
			Complications	No significant diffences re complications
			Weight gain	After rehydration weight gain grA 95g, grB 2g p=0.01; during hospitalisation grA> 200g, grB < 100g p=0.001; weight gain similar by day 5 and 14.

Comment(s)

The use of language development as an outcome measure is problematic due to confounding factors, such as age, maternal education and comorbid conditions. These studies have attempted to overcome this by randomization but still have problems with small study populations leaving the possibility of uneven allocation. The large numbers of the watchful waiting group being treated despite the study protocol may bias the results, reducing the apparent effect of ventilation tubes. These problems need to be taken into consideration when interpreting the studies. In the UK, screening is not routinely carried out for OME, so the patient population in two of the studies is not similar to the UK population. The inclusion of 'asymptomatic' children is likely to reduce the effectiveness of ventilation tubes, should any truly exist. The large unintentional crossover in some studies highlights the major problem in that there are no clear indications for the insertion of grommets. Taken as a whole, there does seem to be some improvement in language skills a few months after the treatment. It is not evident that these effects persist long term and the differences seem to diminish with time, as one would expect with the natural history of the condition. As grommet insertion is the most common elective operation in preschool children, concerns both about risks of the anaesthesia and cost-benefit analysis of the procedure need to be addressed. The results of a further randomized controlled trial are awaiting publication.3

Clinical Bottom Line

In children with OME and language delay, there is no good evidence to suggest that insertion of ventilation tubes will improve language development. More important factors are mother's level of education, which have been shown to have a greater effect on language acquisition in young children.

References

1. Rach GH, Zielhuis GA, Van Baarle PW, van Den Broek P. The effect of treatment with ventilating tubes on language development in preschool children with otitis media with effusion. Clinical Otolaryngology & Allied Sciences 16(2):128-32,1991 Apr.
2. Maw R, Wilks J, Harvey I. Peters TJ, Golding J. Early surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomized controlled trial. Lancet 353(9157):960-3,1999 Mar 20.
3. Paradise JL. Dollaghan CA. Campbell TF. Feldman HM, Bernard BS, Colborn DK. Rockette HE, Janosky JE, Pitcairn DL, Sabo DL, Kurs-Larsky M, Smith CG. Language, Speech Sound Production, and cognition in three –year –old Children in relation to otitis media in their first three years of life. Pediatrics 105(5):1119-1130,May 2000.
4. Rovers MM, Straatman H, Ingels K, van der Wilt GJ, Van de Broek P. Zielhuis GA. The effect of ventilation tubes on language devlopment in infants with otitis media with effusion. A randomized contolled trial. Pediatrics 106(3):E42,2000 Sep.
5. Lous J, Burton MJ, Felding JU, Ovesen T, Wake M, Williamson IG. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children(Protocol for a Cochrane Review). In : The Cochrane Library, Issue 4,2001. Oxford Update. Software