2
The practical implications of TARGET for adenoidectomy in children with otitis media with effusion James, A.L. Department of Otolaryngology – Head and Neck Surgery, Hospital for Sick Children, Toronto, Canada Accepted for publication 1 April 2012 Clin. Otolaryngol. 2012, 37, 174–175 The TARGET study 1 was a rigorously conducted RCT, which complies with CONSORT standards and provides data of the highest quality to help us better understand and manage middle ear effusions in young children. Although some TARGET data on tympanostomy tube, or grommets, effectiveness are already available, 2 this manu- script provides new information on the effectiveness of adenoidectomy. The conclusion that adenoidectomy leads to longer-term hearing benefit than grommets alone will certainly influence the care of children with middle ear effusions. The no-treatment arm of this study clearly reveals the natural tendency towards resolution of otitis media with effusion (OME) and the importance of a period of obser- vation to avoid unnecessary intervention. Some children still do improve spontaneously after this period of persis- tent OME, but only one in five experienced complete remission of OME without surgery during the 2-year study period. The tympanostomy tube alone group shows us the seemingly modest and short-term change in hear- ing threshold (average of 9 dB HL for <12 months) that grommets provide. However, it is important to consider this benefit in context as it was sufficient to take almost all children with this cause of hearing impairment into the range of normal hearing during an important period of their auditory, social and educational development. In this study, the term binaural hearing is used to describe the average hearing threshold in both ears. More commonly, binaural hearing refers to additional benefits of hearing with two ears that involve central processing such as sound localisation, avoidance of head shadow and detection of signals in noise that are not assessed here. The main message of this publication is that adjuvant adenoidectomy can provide a prolonged advantage by preventing recurrence of OME after grommet extrusion. We can calculate that if four children with OME had ade- noidectomy at the time of grommet insertion, one less child might become eligible for a second set of grommets (from table 3, number needed to treat = 4, based on hearing loss >25 dB HL at any time in the second year after surgery). This strengthens previous evidence show- ing benefit for adenoidectomy on hearing. 3 As is so often the case, this high-quality research pro- vides more questions than answers. How are we to apply these findings to our practice? Would all children who have OME benefit from adenoidectomy? Would more widespread adenoidectomy be cost-effective? What is the mechanism of benefit? Further understanding of how adenoidectomy prevents recurrent OME would help us identify children who might benefit the most. In this study, allocation to adenoidectomy was randomised and based purely on the presence of per- sistent OME: no attempt was made to identify factors, such as adenoid size, nasal symptoms or age, which might pre- dispose to a higher chance of benefit from adenoidectomy. So the findings do not exclude the possibility, for example, that adenoidectomy only benefits children with extensive adenoid hypertrophy or nasal symptoms. It is by no means certain that simply reducing adenoid size is the cause of this benefit. We know, for example, that nasal corticoster- oids are effective in reducing symptoms of adenoid hyper- trophy, 4 and yet, they have no apparent effect on OME. 5 The size of the adenoid pad is often said not to have any bearing on the likelihood of benefit from adenoidectomy, 6 although such claims are impaired by the difficulty of vali- dating methods for assessing adenoid size. 7 Perhaps chil- dren with persistent OME should be selected for adenoidectomy when laterally placed adenoid tissue is seen to impinge on to the Eustachian tube 8 rather than offering it to all of those with persistent OME as in this study, or those with recurrent upper respiratory tract infections as recommended by NICE. 9 Answering these more detailed questions will be difficult. Some of the challenges of deliv- ering high-quality evidence are illustrated by this study: the large number of contributors, the relatively small number of study participants (10% of nearly 4000 children who were referred) and the long gestation of the manuscript are some examples. The clinical implications of the study findings are care- fully discussed in the manuscript. It is pointed out that EDITORIAL 174 Ó 2012 Blackwell Publishing Ltd Clinical Otolaryngology 37, 174–175

The practical implications of TARGET for adenoidectomy in children with otitis media with effusion

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The practical implications of TARGET for adenoidectomy inchildren with otitis media with effusion

James, A.L.

Department of Otolaryngology – Head and Neck Surgery, Hospital for Sick Children, Toronto, Canada

Accepted for publication 1 April 2012

Clin. Otolaryngol. 2012, 37, 174–175

The TARGET study1 was a rigorously conducted RCT,

which complies with CONSORT standards and provides

data of the highest quality to help us better understand

and manage middle ear effusions in young children.

Although some TARGET data on tympanostomy tube, or

grommets, effectiveness are already available,2 this manu-

script provides new information on the effectiveness of

adenoidectomy. The conclusion that adenoidectomy leads

to longer-term hearing benefit than grommets alone will

certainly influence the care of children with middle ear

effusions.

The no-treatment arm of this study clearly reveals the

natural tendency towards resolution of otitis media with

effusion (OME) and the importance of a period of obser-

vation to avoid unnecessary intervention. Some children

still do improve spontaneously after this period of persis-

tent OME, but only one in five experienced complete

remission of OME without surgery during the 2-year

study period. The tympanostomy tube alone group shows

us the seemingly modest and short-term change in hear-

ing threshold (average of 9 dB HL for <12 months) that

grommets provide. However, it is important to consider

this benefit in context as it was sufficient to take almost

all children with this cause of hearing impairment into

the range of normal hearing during an important period

of their auditory, social and educational development. In

this study, the term binaural hearing is used to describe

the average hearing threshold in both ears. More

commonly, binaural hearing refers to additional benefits

of hearing with two ears that involve central processing

such as sound localisation, avoidance of head shadow and

detection of signals in noise that are not assessed here.

The main message of this publication is that adjuvant

adenoidectomy can provide a prolonged advantage by

preventing recurrence of OME after grommet extrusion.

We can calculate that if four children with OME had ade-

noidectomy at the time of grommet insertion, one less

child might become eligible for a second set of grommets

(from table 3, number needed to treat = 4, based on

hearing loss >25 dB HL at any time in the second year

after surgery). This strengthens previous evidence show-

ing benefit for adenoidectomy on hearing.3

As is so often the case, this high-quality research pro-

vides more questions than answers. How are we to apply

these findings to our practice? Would all children who

have OME benefit from adenoidectomy? Would more

widespread adenoidectomy be cost-effective? What is the

mechanism of benefit?

Further understanding of how adenoidectomy prevents

recurrent OME would help us identify children who might

benefit the most. In this study, allocation to adenoidectomy

was randomised and based purely on the presence of per-

sistent OME: no attempt was made to identify factors, such

as adenoid size, nasal symptoms or age, which might pre-

dispose to a higher chance of benefit from adenoidectomy.

So the findings do not exclude the possibility, for example,

that adenoidectomy only benefits children with extensive

adenoid hypertrophy or nasal symptoms. It is by no means

certain that simply reducing adenoid size is the cause of

this benefit. We know, for example, that nasal corticoster-

oids are effective in reducing symptoms of adenoid hyper-

trophy,4 and yet, they have no apparent effect on OME.5

The size of the adenoid pad is often said not to have any

bearing on the likelihood of benefit from adenoidectomy,6

although such claims are impaired by the difficulty of vali-

dating methods for assessing adenoid size.7 Perhaps chil-

dren with persistent OME should be selected for

adenoidectomy when laterally placed adenoid tissue is seen

to impinge on to the Eustachian tube8 rather than offering

it to all of those with persistent OME as in this study, or

those with recurrent upper respiratory tract infections as

recommended by NICE.9 Answering these more detailed

questions will be difficult. Some of the challenges of deliv-

ering high-quality evidence are illustrated by this study: the

large number of contributors, the relatively small number

of study participants (10% of nearly 4000 children who

were referred) and the long gestation of the manuscript are

some examples.

The clinical implications of the study findings are care-

fully discussed in the manuscript. It is pointed out that

ED

IT

OR

IA

L

174 � 2012 Blackwell Publishing Ltd • Clinical Otolaryngology 37, 174–175

the advantage of adjuvant adenoidectomy would be smal-

ler if grommets with longer duration were used. The dis-

advantages of adenoidectomy are also considered.

Complications such as haemorrhage and velopharyngeal

incompetence are very, and arguably acceptably, rare.

However, the additional surgery consumes significantly

more resource in operative time and postoperative care.

The availability of resources may be the principle obstacle

to adjuvant adenoidectomy as a first-line intervention.

NICE guidelines are not due to be updated until 2014,

so we will have to wait to see whether this study alters

the current recommendations beyond ‘adjuvant adenoid-

ectomy is not recommended in the absence of persistent

and ⁄ or frequent upper respiratory tract symptoms’.9 Until

now, adenoidectomy has often been considered for chil-

dren with otitis media and a history of recurrent acute

otitis media, nasal symptoms or recurrence of OME after

previous grommets, although supporting evidence is lim-

ited. We can still only speculate whether children with

clinical evidence of adenoid hypertrophy may have a

greater chance of benefit than those without, but at least

we now know with certainty that overall, adjuvant ade-

noidectomy provides long-term benefit in persistent

OME.

Conflict of interest

None to declare.

References

1 MRC Multicentre Otitis Media Study Group. (2012) Adjuvant

adenoidectomy in persistent otitis media with effusion (1): hear-

ing outcomes through 2 years in the TARGET randomised trial.

Clinical Otolaryngology 37, 107–116

2 Browning G.G., Rovers M.M., Williamson I. et al. (2010) Grommets

(ventilation tubes) for hearing loss associated with otitis media with

effusion in children. Cochrane Database Syst. Rev. CD001801

3 van den Aardweg M.T., Schilder A.G., Herkert E. et al. (2010)

Adenoidectomy for otitis media in children. Cochrane Database

Syst. Rev. CD007810

4 Zhang L., Mendoza-Sassi R.A., Cesar J.A. et al. (2008) Intranasal

corticosteroids for nasal airway obstruction in children with mod-

erate to severe adenoidal hypertrophy. Cochrane Database Syst.

Rev. CD006286

5 Simpson S.A., Lewis R., van der Voort J. et al. (2011) Oral or

topical nasal steroids for hearing loss associated with otitis media

with effusion in children. Cochrane Database Syst. Rev. CD001935

6 Gates G.A., Avery C.A. & Prihoda T.J. (1988) Effect of adenoidec-

tomy upon children with chronic otitis media with effusion.

Laryngoscope 98, 58–63

7 Feres M.F., Hermann J.S., Cappellette M. Jr et al. (2011) Lateral

X-ray view of the skull for the diagnosis of adenoid hypertrophy:

a systematic review. Int. J. Pediatr. Otorhinolaryngol. 75, 1–11

8 Nguyen L.H., Manoukian J.J., Yoskovitch A. et al. (2004) Ade-

noidectomy: selection criteria for surgical cases of otitis media.

Laryngoscope 114, 863–866

9 National Institute for Clinical Excellence (2008) Surgical manage-

ment of otitis media with effusion in children, http://guid-

ance.nice.org.uk/CG60

Editorial 175

� 2012 Blackwell Publishing Ltd • Clinical Otolaryngology 37, 174–175