Please note: In 2003, the CTF updated its Grades of Recommendations to include an "I Recommendation" for situations where insufficient evidence exists to allow a recommendation to be made. (Formerly, these situations were captured under a "C Recommendation".) This change is not retroactive, and all "C Recommendations" made prior to 2003 have not been reevaluated in light of the new "I" recommendation grade. For a discussion of these recommendation grades, please link to the 2003 article in the Canadian Medical Association Journal here.
Preventive Health Care, 2000 Update: Screening for Otitis Media with Effusion
Prepared by Christopher C. Butler, BA, MBChB, DCH, MRCGP, CCH, MD, and Harriet MacMillan, MD, MSc, FRCP(C) with the Canadian Task Force on Preventive Health Care
These recommendations were finalized by the Task Force in September 2000.
Contents
ObjectiveTo consider the evidence for the early detection of otitis media with effusion (OME), defined as the accumulation of fluid the middle ear without signs and symptoms of ear infection, in the first four years of life in the asymptomatic child in a periodic health examination. However, evidence from other settings such as screening the general asymptomatic population and follow-up of children after acute otitis media was also considered if relevant to the periodic health examination setting.
Burden
of SufferingOME (with its potential
for hearing loss) is commonest during the most intensive period of language
acquisition. Hearing loss
fluctuates from a few decibels (DB) to as much as 50 DB, with a mean hearing
level loss of 20-30 DB
.
This hearing loss is often considered to be sufficiently serious to
warrant intervention. Some children
with OME do not have important hearing loss, particularly when OME is
unilateral. Documenting hearing
before intervention is important.
Different aspects of
language may be important in OME. Expressive
language (articulation) or receptive language (the ability to comprehend the
meaning of speech) may be impaired to different degrees.
Furthermore, behaviour rather than language may be more affected since
children with effusions may have to concentrate harder to hear.
Their capacity to attend to language could suffer, reducing sustained
attention to tasks.
Otitis media (including
acute otitis and OME) costs the Canadian health care system about $600 million
per year. The insertion of
ventilation tubes is the second commonest surgical procedure performed on
children. OME is a common reason
for prescribing antibiotics to children, a practice that contributes to the
growing problem of bacterial resistance.
OptionsThe following screening tools were considered: tympanometry, microtympanometry, acoustic reflectometry and pneumatic otoscopy. Manoeuvres that examine hearing deficits, such as audiograms or distraction tests, are not yet useful for early detection.
The following treatment interventions were considered: mucolytics, antibiotics, steroids and surgical insertion of ventilation tubes.
Other treatment interventions considered included: auto-inflation, non-steroidal anti-inflammatories, homeopathic treatment and antihistamines combined with decongestant therapy.
OutcomesPrevention of delay in language acquisition was considered the primary outcome.
EvidenceMEDLINE was searched for
articles published between January 1966 and August 1999 using the terms
“otitis media with effusion”, “middle ear effusion”, “developmental
disabilities”, “learning disorders”, “child development”, “language
development disorders”, “speech disorders”, “mass screening”,
“sensitivity”, and “specificity”. The
Cochrane Database Systematic Reviews and Controlled Trials Register, the
National Health Service Centre for Reviews and Dissemination Database, and the
New Zealand Health Technology Assessment Clearinghouse for Health Outcomes and
Health Technology Assessment were also searched for relevant studies and
meta-analyses. Relevant references
from articles were reviewed.
Studies were excluded if: 1) the assessment of exposure was retrospective, inadequate, or cross-sectional; 2) samples other than the general population were used; 3) OME was evaluated after the first four years of life; and 4) findings were published in abstract form or in conference proceedings only.
Recommendations were graded as:
| Good evidence to support the recommendation that the condition be specifically considered in a PHE. | |
| Fair evidence to support the recommendation that the condition be specifically considered in a PHE. | |
| Poor evidence regarding inclusion or exclusion of the condition in a PHE, but recommendations may be made on other grounds. | |
| Fair evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE. | |
| Good evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE. |
Quality of evidence was rated according to 5 levels:
| Evidence from at least 1 properly randomized controlled trial (RCT). | |
| Evidence from well-designed controlled trials without randomization. | |
| Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group. | |
| Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here. | |
| Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees. |
ValuesThe 9 member Task Force of experts in family medicine, geriatric medicine, paediatrics, psychiatry and epidemiology used an evidence-based method for evaluating the effectiveness of preventive health care interventions. Recommendations were not based on cost-effectiveness. Patient preferences were not discussed. The lead author prepared a manuscript providing critical appraisal of the evidence. This included identification and critical appraisal of key studies, and ratings of the quality of this evidence using the Task Force's established methodological hierarchy. The resulting summary of proposed conclusions and recommendations for consideration was presented and deliberated upon at 3 Task Force Meetings in June and November of 1999 and September and January of 2000.
Benefits,
Harms, and CostsThe potential benefit of screening for OME
depends on the proof that that early detection and treatment will prevent delay
in language acquisition. No randomised controlled trials assessing the overall process of earlier
detection of OME and early intervention to prevent delay in acquiring language
were identified, although one trial evaluated treatment in a screened population
and found no benefit. The evidence
regarding the use of screening tools such as tympanometry, microtympanometry,
acoustic reflectometry and pneumatic otoscopy in the general population of
children in the first four years of life is unclear.
Some treatments (mucolytics, antibiotics, and steroids) resulted in the
short-term resolution of effusions as measured by tympanometry.
Ventilation tubes resolved effusions and improved hearing.
Ventilation tubes in children with hearing loss associated with OME
benefited children in the short term, but after 18 months, assessment of
language did not differ from those children initially assigned to a period of
watchful waiting. Most prospective
cohort studies that evaluated the association between OME and language
development lacked adequate measurement of exposure and/or outcome, or suffered
from attrition bias. Findings with
regard to the association were inconsistent.
There is potential harm from the sequelae of false-positive or false-negative results from screening. A single screening measure of any type will fail to document clinically relevant chronicity. Not all children with OME experience important hearing loss especially if the OME is unilateral. Children with positive tests would need to begin a period of observation with repeated testing.
OME is a common reason for prescribing antibiotics to children and may contribute to the growing problem of bacterial resistance. The risks of surgery include exposure to anaesthetics, surgical complications, ear discharge, and psychological trauma.
RecommendationsRecommendation
grade [A, B, C, D, E] and level of evidence [I, II-1, II-2, II-3, III]
are indicated after each recommendation. Citations in support of individual
recommendations are identified in the guideline text.
There is insufficient evidence to recommend for or against the use of tympanometry, microtympanometry, acoustic reflectometry and pneumatic otoscopy for early detection of OME in the general population of children up to four years of age [C, II-2].
There
is insufficient evidence to recommend for or against the early detection of
OME in children in the first four years of life to prevent delayed language
development [C, I, II-2].
ValidationThe members of the Canadian Task Force on Preventive Health Care reviewed the findings of this analysis through an iterative process. The Task Force sent the final review and recommendations to selected external expert reviewers and their feedback was incorporated.
SponsorsThe Canadian Task Force on Preventive Health Care is
funded through a partnership between the Provincial and Territorial Ministries
of Health and Health Canada.
Selected
ReferencesButler, CC, MacMillan, HL. Early
detection of OME in the first four years of life to prevent delayed language
development: Systematic Review & Recommendations. CTFPHC Technical
Report #01-3. September, 2000. London, ON: Canadian Task Force.
Link to Recommendation Statement of this review
Link to Full Technical Report (in pdf)
Link to Summary Table of Recommendations of this review
Link to Selected References list of this review
Copyright © 2000 Canadian
Task Force on Preventive Health Care
For any technical issues please contact: webmaster@ctfphc.org
Last modified: August 05, 2003
