Release: (Embargoed until April 28, 1999)
Contact: Kenneth Satterfield (Until 4/22/99 703-519-1563;
4/23 - 4/29 760-776-8503) [email protected]

TYMPANOSTOMY TUBES IMPROVE QUALITY-OF-LIFE OF CHILDREN SUFFERING FROM ACUTE OTITIS MEDIA

Some parents are reluctant to have tubes inserted into their child's ears to relieve the pain caused by chronic middle ear infection. A cohort study carried out at 14 pediatric otolaryngology centers reveals that both patient and parents benefit from this surgical procedure.

For many parents, the decision to have tympanostomy tubes inserted in their child's ears is the first major decision they must make regarding their son or daughter's health. Many hesitate, not knowing whether the surgical procedure is safe and effective. Now, a major study carried out by ear, nose, and throat specialists at 14 medical facilities has measured patient quality of life and parental satisfaction regarding this treatment option. Their findings should satisfy the concerns of thousands of parents of young children anxious about the pain and suffering brought on by chronic otitis media with effusion.

Participating in the study, "Impact on Tympanostomy Tubes on Child Quality of Life," were Richard M. Rosenfeld MD and Mahesh H. Bhaya MD (SUNY Health Science Center, Brooklyn, NY); Charles M. Bower MD (University of Arkansas, Little Rock); Patrick E. Brookhouser MD (Boys Town National Research Hospital, Omaha, NE); Margaretha L. Casselbrant MD (Children's Hospital of Pittsburgh), Kenneth H. Chan MD (Children's Hospital, Denver, CO), Michael J. Cunningham MD (Massachusetts Eye & Ear Infirmary, Boston, MA); Craig S. Derkay, MD (Eastern Virginia Medical School, Norfolk, VA); Steven D. Gray MD (University of Utah, Salt Lake City); Scott C. Manning MD Children's Hospital and Medical Center, Seattle, WA); Anna H. Messner MD (Stanford University Medical Center, Stanford, CA); and Richard J.H. Smith MD (University of Iowa Hospital and Clinics, Iowa City, IA). The study findings were presented April 28 at the annual meeting of the American Society of Pediatric Otolaryngology, being held Apri

Methodology: The study was conducted at 14 pediatric otolaryngology centers between September, 1997 and June, 1998. Inclusion criteria were: (1) aged six months to 12 years (2) scheduled for bilateral tympanostomy tube placement as an isolated surgical procedure and (3) child accompanied by parent or primary care giver. Data was collected three consecutive times during routine child care: (visit 1) when the decision was made to schedule the child for tube placement, (visit 2) the day of surgery, and the first post-operative visit. The data collection process took an average of four months..

Changes in disease-specific quality of life were assessed using an OM-6 survey, a valid and reliable measure of clinical change in six domains: physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and care giver concerns.

Results: The initial study sample consisted of 248 children from 14 pediatric otolaryngology centers. One hundred and eleven children (45 percent) were from the central United States, 36 percent from the eastern U.S. and 48 (19 percent), resided in the western states. The median age of entry was 1.4 years with upper and lower qualities of 1.0 and 2.3 years. Most of the children (60 percent) were boys.

The primary reason for tube insertion was acute otitis media (56 percent), followed by OME (otitis media with effusion) (42 percent) and retraction type ear disease (2 percent). At their first visit, most children had bilateral OME (68 percent), with the remainder having either unilateral OME (16 percent) or no OME (16 percent). Thirteen percent of the children had previously had tubes, and 83 percent were otitis prone. Audiometry results were available for 183 children.

Eighty-eight percent of care givers were worried or concerned about their child's ear infections or fluid at least some of the time, with 42 percent spending most or all of their time preoccupied about the condition.

At the first visit, prior to tube insertion, physical suffering and emotional stress were the conditions most reported by care givers.

Half the study participants noted a large change in the quality of life following the tube insertion. Physical symptoms, care giver concerns, emotional distress, and hearing loss were most improved, but significant changes were also noted in activity limitations and speech impairment. The typical patient hearing loss was bilateral. However, four of the 12 experienced unilateral hearing loss as a symptom onset.

The researchers noted that quality of life declined with the presence of otorrhea (ear discharge) for three or more days.

The researchers' findings should reassure parents considering whether to have their child undergo this surgical procedure.

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Contact Ken Satterfield at 703-519-1563 (until 4/22) or 760-776-8503 (4/22-4/29) for an interview with Dr. Rosenfeld or additional information.

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