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Press Release Date: April 18, 2001
A new study co-sponsored by the Agency for Healthcare Research and Quality (AHRQ) and the National Institute of Child Health and Human Development indicates that, in most cases, inserting tubes in the eardrums—a procedure called tympanostomy—of children under age three years who have fluid in the middle ear has no measurable effect on improving children's speech, language, cognitive, or psychosocial development at age three.
"While this study is limited to children age three and under, it clearly demonstrates the importance of making treatment decisions based on a broad range of outcomes and quality-of-life measures," said Lisa A. Simpson, M.B., B.Ch., M.P.H., AHRQ's deputy director.
Fluid in the middle ear—otitis media with effusion (OME)—is usually associated with a mild to moderate hearing loss which, although temporary, has been thought by some health professionals to result in long-term impairment of children's development. Approximately 280,000 children under the age of three undergo tympanostomy each year, according to 1996 estimates.
Jack L. Paradise, M.D., and his colleagues at the Children's Hospital of Pittsburgh and the University of Pittsburgh found that, in 402 of 588 children in the study who developed persistent OME within the first three years, there were no differences in the outcomes of speech, language, cognitive, and psychosocial assessments. This was true for the children who were randomly assigned to have tympanostomy surgery early as well as those who were assigned to have the surgery only after their effusion persisted. Most of the children in the early-surgery group received surgery within 60 days, whereas most in the late-surgery group either received surgery after more than six months or had not received surgery by age three. Infants up to two months of age were enrolled in the study, which was conducted between May 1991 and December 1995.
On the General Cognitive Index of the McCarthy Scales of Children's Abilities, the children in the early-surgery group tested at 99, and the children in the late-surgery group tested at 101; both scores are in the average range. On a test of the children's expressive language, the children in the early-surgery group scored 124 while the others scored 126, which are average scores. Other assessments used in the study are measures of receptive language, sentence length, grammatical complexity, speech-sound production (pronunciation), parent-child stress levels, and children's behavior. These measures showed no significant differences between the two groups.
According to the researchers, these findings should not be applied to children who have experienced OME for longer periods than those studied by the researchers or to children with more severe degrees of hearing loss. Also, they cautioned that the results of tests when the children reach ages four and six years may differ from those found at age three.
In an accompanying editorial, James M. Perrin, M.D., Director, Division of General Pediatrics and Center for Child and Adolescent Health Policy, Massachusetts General Hospital for Children, and a member of AHRQ's National Advisory Council, writes that "the study by Paradise, et. al., provides evidence to support the use of a cautious approach in referring young children with middle-ear effusion to receive tympanostomy tubes." He notes that "the study by Paradise, et. al., provides no evidence that the insertion of tubes improves developmental outcomes at the age of three years, although it does decrease the persistence of effusion and reduce short-term hearing loss."
Editor's Note: The study "Effect of Early or Delayed Insertion of Tympanostomy-Tubes for Persistent Otitis Media on Developmental Outcomes at the Age of Three Years," will be published in the April 19, 2001, issue of the New England Journal of Medicine. For interviews with the researchers, contact Mike Laffin, Department of Public and Government Affairs, Children's Hospital of Pittsburgh at (412) 692-7919.
For additional information, please contact AHRQ Public Affairs, (301) 427-1364.