Guidelines recently published by the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) on tympanostomy tubes in children provide the first step in establishing some needed direction for the use of the most common ambulatory surgery performed in children in the United States (Otolaryng Head Neck Surg. 2013:149:S).
“Tympanostomy is the most common surgery performed in children, with between 600,000 and 700,000 sets of tubes placed annually in children in the United States,” said David E. Tunkel, MD, division director of pediatric otolaryngology in the department of otolaryngology–head and neck surgery at Johns Hopkins Medical School in Baltimore and one of the guideline’s authors. “Surprisingly, there are no uniform guidelines for the indication to place tubes or the care of children after tubes, so developing the guidelines was an opportunity for quality improvement.”
To fill this gap, a panel of experts representing a number of specialties undertook the rigorous process of culling the literature for the best evidence on the use of tympanostomy tubes in children and developed key action statements (see “Pediatric Tympanostomy Tubes: Key Actions Statements” below).
Characteristic of these types of practice guidelines, the authors emphasize that the guidelines are meant to guide and not to direct or mandate clinical decision making. Part of the guidance provided is in the level of recommendation accompanying each action statement based on the strength of the evidence, ranging from a “strong recommendation” to “option.”
As stated in the guidelines, “less frequent variation in practice is expected for ‘strong recommendations’ than might be expected with a ‘recommendation.’ ‘Options’ offer the most opportunity for practice variability.”
Dr. Tunkel emphasized that the purpose of the guidelines is not to restrict the use of tubes but to better clarify their most optimal use. “There is always a concern that a guideline will restrict the use of what has been perceived to be an historically effective procedure,” said Dr. Tunkel. “But when you look at the guideline in total and look at all the action statements together, it offers an excellent guidance on who benefits from the tubes the most, how these children should be assessed prior to surgery and how to care for them after surgery. In total, it probably won’t change the number of tubes placed, but it will make sure that the tubes are being used in the children who will receive the most benefit.”
Among the 12 action statements in the guideline, one highlighted by a number of experts as particularly important is action statement 1, which recommends against inserting tympanostomy tubes in children with a single episode of otitis media with effusion (OME) that lasts fewer than three months.
“If the effusion hasn’t been present for three months and the child is otherwise healthy, tubes are probably not a good idea,” said Lawrence Kleinman, MD, MPH, associate professor of pediatrics and health evidence and policy at the Mount Sinai Medical Center, New York, N.Y. “I think this is a very important take home message for physicians and parents.”
Dr. Tunkel said that this action statement addresses what some have seen as the overuse of tympanostomy tubes, and provides better guidance on the use of tympanostomy tubes in children with OME of short duration.
For Craig Derkay, MD, FACS, FAAP, director of pediatric otolaryngology at Children’s Hospital of the King’s Daughters in Norfolk, Va., the recommendation illustrates a truism of guidelines: that they are helpful for making clinical decisions for the vast majority of children who present with these problems, but that clinical judgment is always necessary to take into account patient factors that may result in practicing outside the guidelines.
He cited the example of a child with persistent middle ear effusions (MEE) in both ears for nine weeks who is scheduled to undergo general anesthesia for a hernia repair operation. The child is in daycare and has a brother who has had ear tubes inserted twice. The family lives in the northeast, and it is December, with the bulk of the winter season still ahead. “Based on this child’s family history and risk factors, it is not likely that the fluid will go away in the next few weeks, and it raises the question about whether you want to have the child undergo two general anesthetics in one winter,” he said. “The guidelines suggest that we wait until the effusion lasts up to 12 weeks, but it seems that the best advice would be to place the tubes during the procedure for hernia repair.”
Action statements highlighted by the authors as likely to generate the most discussion are statements 6 and 7 on recurrent acute otitis media (AOM). “We have distinguished for the first time between recurrent AOM with and without persistent MEE, with tubes indicated only when the effusion persists,” said the authors, who went on to emphasize the importance of education to justify not recommending tubes in a child with recurrent AOM but with no MEE, who will not benefit from tubes according to the evidence.
A Move in the Right Direction, but More Research Needed
Saying that the guidelines move the field forward in extrapolating the current evidence on tympanostomy tubes into meaningful recommendations, Dr. Kleinman also emphasized the work that still needs to be done to clarify issues that remain ambiguous regarding optimal use of tubes.
“I think the guidelines present a nice, organized presentation of both certainty and uncertainty, but what often comes through in the guidelines is the illusion of certainty, and that would be a false precision to think that we know enough,” he said, adding that he thinks the guidelines are a bit more aggressive than if they had been developed by pediatricians, who tend to be more cautious in their treatment approach.
For example, he cited statement 7, which recommends that children with unilateral or bilateral AOM and MEE at the time of assessment be offered tubes, as providing a stronger recommendation than he feels is warranted by the evidence. “This is a recommendation in the face of weak evidence, particularly since it doesn’t require that middle ear effusions have been present for any length of time at the moment of assessment,” he said, “and we know that middle ear effusions come and go.”
Another action statement or recommendation that he thinks is more aggressive than many pediatricians would prefer is statement 3, which recommends that physicians offer bilateral tube insertion in children with bilateral OME for three months or longer who have documented hearing difficulties. Implicit in this statement, he said, is the assumption, acknowledged by the authors as a value judgment, that optimizing auditory access will improve speech and language outcomes despite inconclusive evidence on the impact of OME on speech and language development. “There is actually pretty good evidence that the use of tympanostomy tubes does not improve developmental outcomes, at least in healthy children,” he said.
Emphasizing that the guidelines are not meant to be comprehensive but offer a good start to providing a more systematic approach to the use of tubes in children, Dr. Derkay mentioned several issues not discussed in the guidelines that are important for the practicing clinician to consider. These include the questions of when to insert a second set of tubes in the many children (one out of five) who will need them, whether an adenoidectomy should be done on all children who need a second set of tubes and how to choose among the many types of tubes available.
“The guidelines are a reasonably good first effort to establish some guidance, but they shouldn’t be interpreted as being the final word on tympanostomy tubes,” he emphasized.