Indications for Myringotomy and Tympanostomy Tube Placement: A Shared
Decision-Making Approach
Charles D. Bluestone, MD, FACS, FAAP
Distinguished Professor Emeritus of Otolaryngology
University of Pittsburgh School of Medicine
Department of Otolaryngology
Children’s Hospital of Pittsburgh of UPMC
INTRODUCTION
Ever since beveled grommet tympanostomy tubes were re-introduced in the 1950’s
by Beverly Armstrong, 1 they have become extremely popular for treating and
preventing middle-ear disease in children and adults and widely embraced very
early by otolaryngologists.2 They had been recommended by several authors in
the 19th century but really didn’t become popular until the invention of the
operating microscope in the mid- 20th century. 3 Since bacterial otorrhea is a
common complication following tube placement and antibiotic ototopical drops
didn’t become available until the mid- 20th century, post-tube otorrhea probably
impeded acceptance when first recommended over a hundred years ago. But, there
remains wide ranging controversy even today over many aspects of
tymananostomy tubes, including, but not limited to, indications for placement, type
of tube used, length of placement, follow-up care and management of
complications.
SHARED DECISION MAKING (SDM) FOR OTITIS MEDIA AND
SOCIETY FOR MIDDLE-EAR DISEASE (SMED)
Shared decision making (SDM) is a process in which the patient and clinician
faced with more than one acceptable treatment option jointly decide which option
is best based on current evidence and patient needs, preferences and values. 4
SDM is advocated in the Accountable Care Act (ACA) by federal law in the U.S.
in 2010. Patient-Decision Aids (PDA) are also recommended, e.g. computer-based,
print, audiovisual, and published guidelines on diagnosis and management. One
such very accessible PDA is the Society for Middle-Ear Disease (SMED) which is
a non-profit, community (lay) based advocacy society which has 8Advocates, and
42 professional Advisors from 25 countries. Similar guidelines have been
published in at least other 13 countries around the world and are available on the
SMED website (www.societyformiddleeardisease.org). Guidelines have most
recently been published in 2013 by the American Academy of Pediatrics 5 and the
American Academy of Otolaryngology-Head Neck Surgery. 6 The latter is
summarized in the Table and discussed in detail below. Clinical practice guideline
on otitis media with effusion was published in 2004 by a subcommittee composed
of members of the American Academy Family Practice, American Academy of
Otolaryngology-Head Neck Surgery, and the American Academy of Pediatrics.7
AMERICAN ACADEMY OF OTOLARYNGOLOGY-HEAD NECK
CLINICAL PRACTICE GUIDELINES: TYMPANOSTOMY TUBES IN
CHILDREN: 2013
As shown in the recently published guideline, 6 there are 17 authors listed in the
article, all of whom made up the multi-disciplinary committee that deliberated on
the contents. It is my opinion the committee has done a brilliant job in setting the
standards for current indications for placement of tympanostomy tubes in children
and I applaud the Committee’s recommendations about whether or not a Statement
should be “Recommended” for or “Against” and “Strongly” Recommended (i.e.,
Statement 11). Also, related to the discussion above about shared decision-making
(SDM) involving patients, families and clinicians, Statements 4 and 9 conclude
that there are “Options” available, which makes it important for all parties to be
knowledgeable of the risks and benefits of each option. But, I have concerns and
disagree with Statements 6 and 12.
Statement 6 states that “Clinicians should not perform tympanostomy tube
insertion in children with recurrent acute otitis media who do not have MEE
(middle-ear effusion) in either ear at the time of assessment for tube candidacy.”
My colleagues and I strongly disagree with this Statement. We conducted a
randomized clinical trial (RCT) in the 1990’s that specifically addressed this
question. 8 To my knowledge, our RCT has been the only one published that asked
this clinical question. We purposely entered infants and young children who had
had recurrent acute otitis media with no MEE for entry into our RCT for
tympanostomy tube placement, amoxicillin prophylaxis, or placebo. The criteria
for entry was 3 or more attacks in 6 months, or 4 or more in the prior year, with at
least 1 being in the previous 6 months; most of the subjects entered had more
episodes than the minimum number called for in the protocol. We concluded that
tympanostomy tubes and antibiotic prophylaxis were significantly superior to
placebo and recommended chemoprophylaxis for the initial prevention of recurrent
attacks and for those who failed on prophylaxis, tympanostomy tube insertion.
However, our trial was designed and conducted in the late 1980’s and early 1990’s
which was prior to the knowledge that antibiotic prophylaxis, and specifically
lowdose, long-term amoxicillin prophylaxis, was associated with the emergence of
resistant strains of pneumococci. Thus, if our RCT would have been conducted
more recently we would not have included an amoxicillin randomized arm. Our
decision to consciously exclude patients with MEE at entry was based on our
concern that the two previously published RCT’s included subjects with MEE and
concluded tympanostomy tubes were effective which we thought failed to answer
the question, since subjects with MEE effusion in the chemoprophylaxis arm could
fail due to the effusion being present at entry. 9, 10
Our recommendation today is that parents of children who have had recurrent
episodes should be fully informed that if they have had the number of attacks over
the duration we elected the parents should been given the option between watchful
waiting and tube placement, i.e., SDM. If the number of episodes were a great deal
more than the minimum number we had in our RCT, then the election of surgery is
more compelling. 11 The criteria for surgery versus watchful waiting should be
based on the number, severity and duration and if excessive, then surgery should
be considered, even in the absence of MEE when initially seen.
Statement 12 states “Clinicians should not encourage routine, prophylactic water
precautions (use of ear plugs or headbands: avoidance of swimming or water
sports) for children with tympanostomy tubes.” The Committee recommended
against water precautions. This conclusion was based primarily on the RCT
conducted at our Children’s Hospital of Pittsburgh of UPMC in which the
Principal Investigator and first author of the report, Nira Goldstein, MD, found that
subjects who used water protection versus those who did not had a slight advantage
with fewer episodes of otorrhea but concluded they were really not required. 12 My
own recommendation is that water precautions following tube placement should be
an option to use or not use, based SDM, i.e., following a discussion between the
parents and their child’s doctor. If the child is using protection during bathing
showering or washing his or her hair, then I concur that precautions are not
necessary, nor should protection of the ears be encouraged if swimming is not an
everyday activity. But, if the child is a frequent swimmer in which the head is
under water, then I recommend ear plugs and/or headbands. The issue is cost
versus benefit and since the cost for the protection is minimal and an episode of
otorrhea can be relatively expensive, given the visit(s) to the doctor and the cost of
antibiotic eardrops; Statement 11 recommends topical ear drops without systemic
antibiotics, and I concur.
TABLE:
PEDIATRIC TYMPANOSTOMY TUBES: KEY ACTION STATEMENTS*
RECOMMENDATIONS:
1. Recommended (Against)
Tympanostomy tube insertion should NOT be performed in children with a single episode of
OME of less than three months duration.
2. Recommend
An age-appropriate hearing test should be obtained if OME persists for three
months or longer OR prior to surgery in a child who is a candidate for
tympanostomy tube insertion.
3. Recommend
Bilateral tympanostomy tube insertion should be offered to children who
have bilateral OME for three months or longer AND documented hearing
difficulties.
4. Option
Tympanostomy tube insertion may be performed in children with unilateral
or bilateral OME for three months or longer AND symptoms likely attributable to
OME (e.g., vestibular problems, poor school performance, behavioral problems,
ear discomfort, reduced quality of life).
5. Recommend
Children with chronic OME who do not receive tympanostomy tubes should
be reevaluated at three- to six month intervals until the effusion is no longer
present, significant hearing loss is detected or structural abnormalities of the
tympanic membrane or middle ear are suspected.
6. Recommend (Against)
Tympanostomy tube insertion should NOT be performed in children with
recurrent AOM who do not have MEE in either ear at the time of assessment for
tube candidacy.
7. Recommend
Bilateral tympanostomy tube insertion should be offered to children with
recurrent AOM who have unilateral or bilateral MEE at the time of assessment for
tube candidacy.
8. Recommend
Children with recurrent AOM or with OME| of any duration should be
assessed to see if they are at increased risk for speech, language or learning
problems from OM because of baseline sensory, physical, cognitive or behavioral
factors.
9. Option
Tympanostomy tube insertion may be performed in at-risk children with
unilateral or bilateral OME that is unlikely to resolve quickly (i.e., as indicated by
a type B (flat) tympanogram or persistence of effusion for three months or longer).
10. Recommend
Caregivers of children with tympanostomy tubes should be educated before
surgery as to the expected duration of tube function, recommended follow-up
schedule and detection of complications.
11. Strongly Recommended
Topical antibiotic eardrops only, without oral antibiotics, should be
prescribed for children with uncomplicated acute tympanostomy tube otorrhea.
12. Recommend (Against)
Routine prophylactic water precaution (i.e., use of earplugs, headbands,
avoidance of swimming or water sports) should NOT be encouraged for children
with tympanostomy tubes.
*Adapted from: Rosenfeld RM, Schwartz SR, Pynnonen MA, Tunkel DE,
Hussey HM, Fichera JS, Grimes AM, Hackell JM, Harrison MF, Haskell H,
Haynes DS, Kim TW, Lafreniere DC, LeBlanc K, Mackey WL, Netterville
JL, Pipan ME, Raol NP, Schellhase KG. Clinical practice guideline:
Tympanostomy tubes in children. Otolaryngol Head Neck Surg. 2013.
149:S1-S35.
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September 4, 2015