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2014 ; 18
(5
): 1-118
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Adenoidectomy with or without grommets for children with otitis media: an
individual patient data meta-analysis
#MMPMID24438691
Boonacker CW
; Rovers MM
; Browning GG
; Hoes AW
; Schilder AG
; Burton MJ
Health Technol Assess
2014[Jan]; 18
(5
): 1-118
PMID24438691
show ga
BACKGROUND: Otitis media (OM) is a leading cause of medical consultations,
antibiotic prescription and surgery in children. The surgical procedures offered
to children with recurrent or persistent OM are insertion of grommets,
adenoidectomy or a combination of the two. There is clear National Institute for
Health and Care Excellence guidance for the use of grommets in subgroups of
children with persistent OM with effusion (OME), but similar guidance is not
available for adenoidectomy, either in persistent OME or in recurrent acute OM
(AOM). OBJECTIVES: (1) To develop a model to predict the risk of children
referred for adenoidectomy having a prolonged duration of their OM. Then, (2a) to
evaluate the overall effect of adenoidectomy, with or without grommets, on OM
using individual patient data (IPD) and (2b) to identify those subgroups of
children who are most likely to benefit from adenoidectomy with or without
grommets. DATA SOURCES: A number of electronic databases were searched from their
inception including the Cochrane Ear, Nose and Throat Disorders Group Trials
Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed,
EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL),
metaRegister of Current Controlled Trials (mRCT), ClinicalTrials.gov,
International Clinical Trials Registry Platform (ICTRP), ClinicalStudyResults.org
and Google. REVIEW METHODS: Studies eligible for inclusion in this IPD
meta-analysis were randomised controlled trials (RCTs) in children up to 12 years
of age diagnosed with recurrent AOM and/or persistent OME in which adenoidectomy
(with or without grommets) was compared with non-surgical treatment or grommets
alone. The final selection of eligible studies and the quality assessment were
carried out according to standard methods and disagreement was resolved by
discussion. RESULTS: A total of 503 articles were identified of which 10 trials
were included in the meta-analysis; eight of these were at a low risk of bias and
two were at moderate risk. The primary outcome was failure at 12 months, defined
by a set of persisting symptoms and signs. In the prognostic analysis 56% of
those children referred for adenoidectomy (but randomised to the non-surgical
group) failed to improve (38% of the children with recurrent AOM and 89% of the
children with persistent OME). Children who had adenoidectomy had a greater
chance of clinical improvement. The size of that effect is, in general, small but
persists for at least 2 years. Two subgroups of children are most likely to
benefit from adenoidectomy: first, children aged < 2 years with recurrent AOM -
16% of those who had adenoidectomy failed at 12 months whereas 27% of those who
did not have adenoidectomy failed [rate difference (RD) 12%, 95% confidence
interval (Cl) 6% to 18%; number needed to treat (NNT)?= 9]; second, children aged
? 4 years with persistent OME - 51% of those who had adenoidectomy failed at 12
months whereas 70% of those who did not have adenoidectomy failed (RD 19%, 95% Cl
12% to 26%; NNT?= 6). No significant benefit of adenoidectomy was found in
children aged ? 2 years with recurrent AOM and children aged < 4 years with
persistent OME. LIMITATIONS: The need to use a composite end point and the
limited number of subgroup variables that could be studied are factors that
reduce the robustness of these results; however, we do not believe that this
reduces the validity of the conclusions. CONCLUSIONS: Adenoidectomy is most
beneficial in children with persistent OME aged ? 4 years. A smaller beneficial
effect was found in children with recurrent AOM aged < 2 years. Consideration
must be given to the balance between benefits and harms. Future research is
required in a number of key areas, including defining the best methods of
selecting, developing and administering patient-reported outcome measures to
assess the value of treatments for children with persistent OME and recurrent AOM
and upper respiratory infections; investigating the clinical effectiveness and
cost-effectiveness of hearing aids (air or bone conduction) and the use of
interventions to improve classroom acoustics for children with different degrees
of persistence and severity of hearing loss associated with OME; and
investigating why professionals' and parents'/carers' treatment preferences vary
so much both nationally and internationally. We do not understand why
adenoidectomy works in different subgroups at different ages, nor its effects in
special populations, such as children with Down syndrome. We also need further
research on the impact and optimal management of otitis media in these special
situations and others, such as in children with a cleft palate or developmental
problems. STUDY REGISTRATION: The study is registered as PROSPERO CRD42011001549.
FUNDING: The National Institute for Health Research Health Technology Assessment
programme.