PEDIATRICS Vol. 107 No. 6 June 2001, pp. 1251-1258

Otorrhea in Young Children After Tympanostomy-Tube Placement for Persistent Middle-Ear Effusion: Prevalence, Incidence, and Duration

Collette Ah-Tye, MD^*, , Jack L. Paradise, MD^*, , and D. Kathleen Colborn, BS

From the Department of Pediatrics, ^* University of Pittsburgh School of Medicine and  Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.

	ABSTRACT

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Objective.  To characterize the occurrence of tube otorrhea after tympanostomy-tube placement (TTP) for persistent middle-ear effusion (MEE) in a group of otherwise healthy infants and young children.

Methods.  In a long-term, prospective study of child development in relation to early-life otitis media, we enrolled by 2 months of age healthy infants who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric group practices. We monitored their middle-ear status closely. Children who developed persistent MEE of specified durations within the first 3 years of life became eligible for random assignment to undergo TTP either promptly or after an extended period if MEE persisted. The present report concerns 173 randomly assigned children who underwent bilateral TTP between ages 6 and 36 months and were followed for at least 6 months thereafter. Episodes of tube otorrhea were treated with oral antimicrobial drugs and, if persistent, with ototopical medication.

Results.  Socioeconomic status, as estimated from maternal education and type of health insurance, was lowest at the urban sites and highest at the suburban sites. The tenure of the 230 tubes that were extruded during the observation period ranged from 19 days to 38.5 months (mean = 13.8 months; median = 13.5 months). During the first 18 months after TTP, the proportion of children who had tubes in place and who developed 1 or more episodes of otorrhea increased progressively, reaching 74.8% after 12 months and 83.0% after 18 months. The mean number of episodes per child was 0.79 in the first 6 months, 1.50 in the first 12 months, 2.17 in the first 18 months, and 2.82 in the first 24 months. Overall, otorrhea occurred earliest and was most prevalent among urban children and occurred latest and was least prevalent among suburban children. The mean estimated duration of episodes of tube otorrhea was 16.0 days (standard deviation = 16.9 days), the median was 10 days, and the range was 3 to 131 days. The duration was >30 days in 13.2% of the episodes. Six of the 173 children (3.5%) developed on 1 or more occasions tube otorrhea that failed to improve satisfactorily with conventional outpatient management. Five of these children were hospitalized to receive parenteral antibiotic treatment, 1 child twice and 1 three times, and 1 also underwent tube removal. The sixth child underwent tube removal as an outpatient.

Conclusions.  Tube otorrhea is a common and often recurrent and/or stubborn problem in young children who have undergone tube placement for persistent MEE. The extent of the problem seems to be related inversely to socioeconomic status. Tube otorrhea does not always respond satisfactorily to outpatient management and for resolution may require parenteral antimicrobial treatment and/or tube removal.  Key words:  otitis media with effusion, middle-ear effusion, tympanostomy-tube placement, otorrhea, tube otorrhea, socioeconomic status.

Tympanostomy-tube placement (TTP) is the most commonly performed surgical operation among United States children beyond the newborn period; in 1996, an estimated 512 000 US children who were younger than 15 years underwent the operation,¹ of whom 280 000 were younger than 3 years (L.J. Kozak, National Center for Health Statistics, personal communication, September 1999). A common complication of TTP is otorrhea.² Consideration of tube otorrhea has taken place in various contexts, and virtually all of the published reports that referred in any way to tube otorrhea have appeared in otolaryngologic journals. The various studies have included comparisons of the efficacy of TTP with other modes of treatment for chronic or recurrent otitis media^3-7; determinations of whether otorrhea occurs at all as a complication of TTP^28-18; comparisons of tube placement techniques and/or tube types^19-28; consideration of demographic and/or clinical variables associated with the occurrence of tube otorrhea^1529-35; studies of whether swimming results in tube otorrhea^36-44; studies of the efficacy of ototopical antibiotic and/or steroid use prophylactically^3545-56; studies of the microbiology of tube otorrhea^57-60; and studies of ototopical treatment of tube otorrhea.^61-68 Investigators have measured the occurrence of tube otorrhea in various ways: prevalence (ie, the proportion of children who develop tube otorrhea at any time within an observation period^{18,19,22,25,26,29,30,34,37,39,40,42,43,46,48,52,53,57,69,70} or the proportion of ears that do so2,8,11-14,16,20,21,23-^{26,30,31,47,48,50,51,54,55,6971-75}); the proportion of patients who develop no episodes, 1 episode, 1 episode, or 2 episodes within an observation period^{3,5,7,28,32,36,44,52}; incidence (ie, the number of discrete episodes of tube otorrhea in a population within a specified time period, eg, 1 month or 1 year)^{5-7,22,43,49,76}; the proportion of follow-up visits at which otorrhea was found^15,28,44; and the character of the discharge.^26,28 Some studies have focused solely on tube otorrhea that occurred within a specific time period relatively soon after TTP: within 1 week,^24,28,45,46 2 weeks,^{26,47,48,51,55} 3 weeks,⁵⁰ or 7 weeks.³⁰ Investigators also have used other outcome measures in characterizing episodes of tube otorrhea: response or lack of response to treatment, duration of >1 week, rate of recurrence, or combinations of these measures.^{2,811-14,20,21,31,32,50,57} Published data on the duration, in particular, of individual episodes of tube otorrhea have been few and limited in scope.

We report here findings on the prevalence, incidence, and duration of tube otorrhea after TTP in a sample of otherwise healthy children who were followed prospectively both before and after the procedure. We reported previously that in these children the most important sociodemographic risk factors for the occurrence of otitis media generally (as distinct from tube otorrhea specifically) were low socioeconomic status (SES) and repeated exposure to large numbers of other children.⁷⁷

	METHODS

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Enrollment and Eligibility

The subjects were participants in an ongoing, long-term, prospective study of child development in relation to early-life otitis media.^77,78 They had been enrolled as normal infants by 2 months of age for continuing care at 1 of 2 urban hospital outpatient departments or 1 of 2 small-town/rural and 4 suburban private pediatric group practices. Enrollment of urban children was undertaken earliest, and enrollment of suburban children was undertaken latest. At the urban sites, most infants were black and a large majority were Medicaid beneficiaries; at the small-town/rural sites, a large majority were white and approximately two thirds were covered by private health insurance and one third by Medicaid; at the suburban sites, virtually all infants were white and a large majority were covered by private health insurance. According to the study protocol, children who developed middle-ear effusion (MEE) for protracted periods of specified duration became eligible for random assignment to undergo TTP either as soon as practicable or after an extended period if MEE persisted (6 months if MEE was bilateral; 9 months if MEE was unilateral).⁷⁸

Between January 24, 1992, and November 25, 1996, 184 children, having been assigned randomly to a treatment group, sooner or later underwent bilateral tube placement by 36 months of age and thereafter were followed for at least 6 months. A total of 173 of the children (94.0%) had no intervals longer than 90 days between follow-up visits, and these 173 constitute the subjects of the present article. For children who underwent tube placement on >1 occasion, only the first procedure is considered in the present analysis.

Tube Placement, Patient Follow-Up, and Medical Treatment of Otorrhea

For TTP, radial myringotomy and aspiration of MEE were performed, and a Teflon, Armstrong-type tube was placed anterosuperiorly or anteroinferiorly in the tympanic membrane. Parents were directed to instill polymixin B-neomycin-hydrocortisone ototopical suspension 3 times daily for 3 days. All subjects were scheduled for follow-up evaluation at least monthly; details of follow-up procedures have been described previously.⁷⁷ Protection of ears from water was advised routinely for children with tubes in place. The diagnosis of tube otorrhea was based on otoscopic visualization of discharge exuding through the tympanostomy tube lumen, after (when necessary) gently cleansing the external auditory canal. Medical management of tube otorrhea (and of otitis media generally) followed specified guidelines agreed to by all collaborating pediatricians. Aural toilet was undertaken to the extent practicable but usually was not feasible. Episodes of tube otorrhea were treated with an oral antimicrobial drug or drugs (amoxicillin usually; alternatively, mainly amoxicillin-clavulanate or azithromycin) for up to 2 weeks and, if persistent thereafter, with polymixin B-neomycin-hydrocortisone ototopical suspension. Cultures of aural discharge were performed only in cases that failed to respond to this regimen. Children with otorrhea that persisted despite treatment were referred to the Department of Otolaryngology; those judged not to eventually respond satisfactorily to outpatient management were, in most cases, hospitalized for parenteral antibiotic treatment.

Estimating Tube Tenure and Duration of Episodes of Tube Otorrhea

For estimations of tube tenure, children whose tubes were still in place at the end of the observation period were excluded from analysis. Similarly, for estimations of the durations of episodes of tube otorrhea, children who had otorrhea at the end of the observation period were excluded. We estimated the tenure of each tympanostomy tube as beginning on the date of tube placement and ending at the midpoint between the last visit at which the tube was observed to be in place and the succeeding visit at which the tube was observed to be extruded or missing. For each tube in place, we estimated the durations of episodes of tube otorrhea, on the basis of diagnoses at individual visits and interpolations for intervals between visits. Interpolation rules were as follows: if on 2 successive visits an ear was otorrhea-free, then the ear was assumed to have been otorrhea-free throughout the interval between the visits. Similarly, if on 2 successive visits otorrhea through a tube was observed, otorrhea was assumed to have persisted throughout the interval. The starting date for an episode of tube otorrhea was the date of the first visit at which the episode was observed. The ending date was considered to be the midpoint of the interval between the last visit at which otorrhea was observed and an immediately succeeding visit at which otorrhea was not present. In estimating the duration of an episode, both the starting date and the ending date of the episode were included.

Statistical Analysis

We categorized children with the use of methods detailed previously.⁷⁷ The variables of interest in the present analysis were study-site grouping, maternal education, health insurance status, and the extent of exposure to other children. To categorize children's SES, we constructed an index that consisted of health insurance status (Medicaid vs private) as the primary element and maternal education (less than high school, high school, and college graduate or higher) as the secondary element. To categorize overall exposure to other children, we constructed a child-exposure index that took into account the number of other children in the household and, for those in day care, also the modal value for the number of children in that setting. For the index, we classified children into 1 of 3 groups, without regard to weekly time in day care: 1) at home with no other children or in day care with no other children; 2) at home with 1 other child or in day care with <5 other children; and 3) in day care with 5 other children, irrespective of the number of other children at home. All statistical tests were 2-tailed. Statistical significance was set at P  .05. Times to occurrence of first, second, and third episodes of tube otorrhea were summarized with the use of life-table analyses and compared with the use of the log rank test.^{79,80 2} tests were used to test for differences between proportions; tests involving fourfold tables incorporated the Yates correction. The Extended Mantel-Haenszel ² test was used to analyze data for trends.⁸¹

	RESULTS

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Subjects' Characteristics, Duration of Follow-Up, Tympanostomy-Tube Tenure, and Level of Surveillance

Table 1 shows selected characteristics of study subjects. As in the larger study population, SES, as estimated from maternal education and type of health insurance, differed markedly between the 3 study site groupings. At the urban sites, a large majority of children were enrolled in Medicaid; at the small-town/rural sites, approximately half were covered by private health insurance and half were covered by Medicaid; and at the suburban sites, virtually all infants were covered by private health insurance. Correspondingly, levels of maternal education were lowest at the urban sites and highest at the suburban sites. The degree of exposure to other children differed little across study site groupings. Ages at the time of tube placement ranged from 6 to 36 months (mean = 16.4 months). Follow-up periods from the time of tube placement ranged from 6 to 57 months. Calculation of the tenure of individual tympanostomy tubes was based on experience with the 228 tubes that were extruded during the observation period (at children's last visit before the end of this study's follow-up period, 118 tubes remained in place). For these 228 tubes, tenure ranged from 19 days to 38.5 months; the mean tenure was 13.8 months (standard deviation [SD] = 16.4 months), and the median was 13.5 months. Of the 173 children, 161 (93.1%) were examined at least once in each month for 70% of the months during which tubes remained in place.

Prevalence, Time to First Occurrence, and Incidence of Tube Otorrhea

A total of 278 episodes of tube otorrhea were documented during the study period. During 274 (98.6%) of these episodes, intervals between examinations were consistently 30 days or less. Figure 1A shows the proportions of children who developed 1 or more episodes of otorrhea during time periods of increasing length after initial tube placement. During the first 18 months, the proportion of children who had tubes in place and who developed 1 or more episodes of otorrhea increased progressively, reaching 74.8% (86 of 115) after 12 months and 83.0% (44 of 53) after 18 months. Consistently, otorrhea was most prevalent among urban children and least prevalent among suburban children, with this trend being statistically significant during the first 3-month, 6-month, and 12-month time periods. Figure 1B shows a similar pattern regarding the proportions of children who developed 2 or more episodes of tube otorrhea. Prevalence was not significantly related to age at the time of tube placement; for example, among children who underwent tube placement at ages 12, 13-18, and 19-24 months, respectively, with tubes in place 6 months later, the proportions who developed 1 or more episodes of otorrhea within that period were 61% (34 of 56), 56% (33 of 59), and 50% (25 of 50), respectively (P = .54). Life-table analysis regarding times to occurrence of the first, second, and third episodes of otorrhea indicated that episodes tended to occur earliest among children from urban sites and latest among children from suburban sites, with all between-site differences being statistically significant (P < .02).

View larger version (45K): [in this window] [in a new window]   Fig. 1.   A, Proportions of children who had tympanostomy tubes in place and who developed 1 or more episodes of otorrhea. B, Proportions of children who had tympanostomy tubes in place and who developed 2 or more episodes of otorrhea.

The mean number of episodes per child was 0.79 in the first 6 months, 1.50 in the first 12 months, 2.17 in the first 18 months, and 2.82 in the first 24 months. The maximum numbers of episodes of tube otorrhea in any child were 4 episodes in the first 6 months, 6 in the first 12 months, 6 in the first 18 months, and 7 in the first 24 months. In general, episodes occurred most often among urban children and least often among suburban children. Episodes were distributed approximately evenly throughout the calendar year in children from each site category (urban, small-town/rural, suburban); of the total of 278 episodes, 72 (25.9%) had their onset during winter, 69 (24.8%) during spring, 67 (24.1%) during summer, and 70 (25.2%) during fall.

Duration of Episodes of Tube Otorrhea

The mean estimated duration of episodes of tube otorrhea was 16.0 days (SD = 16.9 days), the median was 10 days, and the range was 3 to 131 days. Figure 2 shows the distribution of the 278 episodes according to their duration in days. The duration was >30 days in 13.2% of the episodes. Mean (SD) durations were 17.0 (18.8) days, 14.5 (12.9) days, and 24.2 (32.3) days among urban, small-town/rural, and suburban children, respectively (P = .14).

View larger version (13K): [in this window] [in a new window]   Fig. 2.   Distribution of episodes of tube otorrhea by estimated duration in days.

Treatment Failure and Additional Treatment Measures

Of the 173 children who were followed for periods of 6 to 57 months, 6 (3.5%) developed on 1 or more occasions tube otorrhea that failed to improve satisfactorily with conventional outpatient management. Five of these children were hospitalized to receive parenteral antibiotic treatment, 1 child twice and 1 child three times, and 1 also underwent tube removal. The sixth child underwent tube removal as an outpatient. Cultures of aural discharge from these children variously showed, singly or in combination, Staphylococcus aureus; Streptococcus pneumoniae, both penicillin-sensitive and penicillin-nonsensitive; nontypable Haemophilus influenzae, both -lactamase negative and -lactamase positive; and Pseudomonas aeruginosa. No single organism predominated.

	DISCUSSION

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Measures of Otorrhea

Many reports have drawn attention to the occurrence of persistent or recurrent postoperative tube otorrhea as a complication of TTP. The reports have concerned subjects of varying age whose indications for surgery varied or were unspecified. Investigators also have used varying criteria in defining tube otorrhea as problematic. Among these have been an episode that required multiple courses of antibiotic treatment,⁵⁷ failure of an episode to respond to topical and/or systemic antibiotic treatment,^{2,12,16,20,50} abundance of discharge,³¹ excessive frequency^31,32 or duration of episodes,^{11,13,16,20,31,32} and otorrhea that required the surgical removal of a tube.^{811-14,20,21,50,57} A more quantitative appreciation of the scope and magnitude of the problem might be gained from studies that describe the prevalence, incidence, and duration of tube otorrhea in defined samples of children who underwent tube placement. The present study describes these parameters in a group of children whose primary indication for tube placement was persistent MEE and who ranged in age from 6 to 36 months at the time of tube placement.

A large number of studies have reported on the prevalence of tube otorrheaie, the proportion of children who (or ears that) develop otorrhea within a specified (or sometimes unspecified) time periodbut relatively few studies have reported on the incidence of otorrheaie, the number of discrete episodes per child within a specified time period. Even fewer studies have reported on the measure that is the principal focus of the present study, namely the duration of individual episodes.

Prevalence Reports of the prevalence of tube otorrhea in children who received varying postoperative regimens and during observation periods of varying length have ranged from 0%⁴⁶ to 75%³² (children) and from 1.7%²⁷ to 54.9%¹⁷ (ears). In the children in the present study, tube otorrhea became increasingly prevalent as the duration of tube tenure increased; 83.0% of the children overall whose tubes remained in place for 18 months or longer developed at least 1 episode. No previous study, to our knowledge, has reported prevalence comparably high.

Incidence Reported data on the incidence of tube otorrhea are limited. In 6 studies that involved children who ranged in age from 3 months to 12 years and who were followed-up for periods that ranged from 1 to 3 years, incidence ranged from 0.36 to 3.57 episodes per child-year.^5-7,22,32,43 In some of those studies, however, reported rates encompassed periods that followed tubal extrusion and thus probably were lower than would have been the case had consideration been limited to periods during which tubes remained in place. Notably, in the study that reported the highest incidence, the children had had at least 3 episodes of acute otitis media before 1 year of age or at least 6 episodes before 18 months of age, and the follow-up period excluded the summer season.³² For the children in the present study, calculation of the incidence of tube otorrhea was limited to periods during which tubes remained in place. The incidence remained relatively constant irrespective of the length of the period under consideration: 1.58 episodes per child-year in the first 6 months, 1.50 episodes per child-year in the first 12 months, 1.45 episodes per child-year in the first 18 months, and 1.41 episodes per child-year in the first 24 months.

Duration The few reports that described the duration of tube otorrhea in children who underwent tube placement differed considerably regarding the information reported.^{13,16,20,31,32,57,74} The age range of subjects, the frequency and duration of follow-up, and the range of durations of individual episodes have varied among studies or have not been reported. Maximum durations of individual episodes reported by various authors in differing patient groups have included >2 weeks (and refractory to ototopical antibiotic treatment),²⁰ 20 days,³² 1 month,¹³ 4 months,¹⁶ and 8 months.⁵⁷ No study to our knowledge has reported the distribution of individual episodes by duration, and only 1 study has reported mean duration (in that study, 13 days).⁷⁴ In the present study, the maximum duration was 131 days, and the mean duration was 16.2 days; the duration exceeded 30 days in 13.2% of the episodes.

Study Features and Clinical Relevance

We believe the present study to be unique in providing data on the prevalence, incidence, and duration of episodes of tube otorrhea in a defined population of young children. We believe it to be unique also in its comparison of the occurrence of tube otorrhea between groups of differing SES. Unlike most previous studies, the present study took into account only those periods during which tubes remained in place and children were at risk of developing otorrhea related specifically to tubal presence. We found in our study that tube otorrhea was a common and often recurrent and/or stubborn problem in the young children who had undergone tube placement because of persistent MEE. The extent of the problem was greatestin terms of prevalence, time to first occurrence, and number of episodesin the urban children, whose SES was lowest, and least in the suburban children, whose SES was highest, paralleling the situation regarding otitis media in general that we had found in the larger study population and that others had found in other populations.⁷⁷ The difference in the present study could not be attributed to differences in the degree of exposure to other childrenthe other factor that we had found most important in our larger study population⁷⁷because the degree of exposure in the present study sample tended to be greatest in the suburban children. Conceivably, SES-related differences in the degree to which water protection was exercised during bathing might have played a role.

An explanation for the relatively high values found in the present study sample as a whole may reside to some extent in the facts that 1) most of the children were from families of relatively low SES and 2) most were 18 months old and all were 36 months old at the time of TTP, whereas most other studies involved older children as well or exclusively. Relatedly, in the study reported by Debruyne and colleagues,³¹ tube otorrhea occurred more often in children who were younger than 2 years than in children who were older than 6 years.

A limitation of the present studyshared in common with all previous studies that addressed the same issuesstems from the fact that our estimates of tube tenure and of the duration of otorrhea were derived in part from interpolations concerning children's middle-ear status during the intervals between clinical examinations. However, intervals in the present study generally were short, allowing for reasonably precise estimates of the duration of individual episodes. Another limitation of the study relates to its generalizability. Particularly in view of the differences in outcome that we found in relation to SES, the results in our study sample as a whole would not properly be generalizable to groups of children whose SES is either more or less favorable. Also, because all of the children underwent tube placement primarily for persistent MEE, the findings may not be generalizable to children whose principal indication for surgery is recurrent acute otitis media. Finally, the recently available ototopical fluoroquinolone preparations seem to have offered more favorable treatment outcomes than those realized with previously available treatments.⁶⁸

Study limitations notwithstanding, our results illustrate the importance of otorrhea as a complication of TTP in young children, and they underscore the need to inform parents of children who are being considered for TTP that, in addition to other potential complications and sequelae of the proceduresuch as tympanic membrane perforation, atrophy, and tympanosclerosis^82-84tube otorrhea is a frequent consequence.

	ACKNOWLEDGMENTS

This work was supported by Grant HD26026 from the National Institute for Child Health and Human Development and the Agency for Health Care Policy and Research and by gifts from SmithKline Beecham Laboratories and Pfizer Inc.

We thank Howard E. Rockette, PhD; Janine E. Janosky, PhD; Charles D. Bluestone, MD; Beverly S. Bernard, CRNP; and Clyde G. Smith, MS. Each participated integrally in the planning and assisted in the implementation of the larger study from which data in the present report were derived.

We are indebted to the following pediatricians, who made the decisions, participated in the planning, and assisted in the efforts to incorporate the study into their practices and who, at no small inconvenience and cost, have provided unflagging support for study activities. At Beaver: David J. Cahill, MD; James Scibilia, MD; and Julius A. Vogel Jr., MD; at Brentwood: Mark Diamond, MD; and Thomas D. Skelly, MD; at Gibsonia: Amelia V. Agustin, MD; and Eva A. Vogeley, MD; at Kittanning: Harold A. Altman, MD; James K. Greenbaum, MD; Kenneth R. Keppel, MD; and Donald J. Vigliotti, MD; at Mt. Lebanon: Scott L. Tyson, MD; and Celeste J. Welkon, MD; at Pleasant Hills: K. Gopalkrishna Pai, MD; and Harvey M. Rubin, MD; and at Mercy Hospital of Pittsburgh: Bradley J. Bradford, MD.

In addition to J.L.P. and the clinicians named above, the following people served as study-team clinicians. At Children's Hospital of Pittsburgh: Irene Fabian, CRNP; Nancy J. Guerra, CRNP; Lisa M. Hakos-Zoffel, CRNP; Alejandro Hoberman, MD; and Phillip H. Kaleida, MD; at Beaver: Allen H. Chamovitz, MD; Sharon N. Cowden, MD; Valentina E. DiCenzo, MD; Verda S. Graf, BS, PA; S. Nasrin Ghorbanian, MD; George R. Haddad, MD; Janet D. Liljestrand, MD; and Jennifer J. Momen, MD; at Brentwood: Norman L. Cohen, MD; Kristin L. Frederick, MD; Joan Schiebel, RN; and Brenda E. Watkins, MD; at Kittanning: Tracy Balentine, RN; Shirley Baum, CRNP; Lawrence J. Butler, MD; Thomas G. Lynch, MD; and JoAnn Nickleach, MD; at Mt. Lebanon: Barbara J. Bahl, CRNP; Barbara Braman, CRNP; M. Bridgetta Devlin, CRNP; Holly A. Frost, MD; Thelma L. Herlich, MD; and Elizabeth H. Michael, CRNP; at Pleasant Hills: Todd H. Wolynn, MD; and at Mercy Hospital of Pittsburgh: Barbara L. Ayars, MD; Kimberly Brown, MD; Michael J. Daly, MD; Karla Falcon, MD; Pamela Heald, CRNP; Cynthia M. Hoess, MD; Barbara L. McNulty, CRNP; Yolanda Moore-Forbes, MD; Charles A. Pohl, MD; Sharon M. Roncevich, MD; Sherrill J. Rudy, CRNP; Evelyn J. Schmidt, RN; Sarah H. Springer, MD; and Karen S. Vargo, MD. We also are grateful to the many Children's Hospital of Pittsburgh and Mercy Hospital of Pittsburgh pediatric house officers who served as primary care clinicians for study subjects and whose collaboration was essential for the successful conduct of the study.

The following people also assisted in the study: Ida Smith (clinic support coordinator); Miki Rakay (volunteer patient liaison specialist); Robin L. Lavelle and Valerie S. Quickley (schedulers); Jennifer A. Aliberti, Sandra Barnett, Nanci Barrett, Susan Braden, Cindy Brown, Nancy Ciaburri, Christin E. Costella, Cyndi Getty, Sue Ellen Hall, Jerome Hill, Anthony Heard, Karen Horox, Isabel Hunter, Beverly Joyce, Andrew R. Kaleida, Deborah Klemm, Judy Lazzeri, Janet R. Marshall, Jean Martin, Sue Musser, Karen M. Noto, Shirley Petrie, Deborah M. Pettibon, Kathleen A. Rafferty, Dawn M. Rone, Leslie A. Schropp, Brenda Shaffer, Sunitha Somanath, Dana Wingard, and Sheila Vasbinder (study technicians); Kathleen A. Cecotti, BA; Sharon A. DiBridge, BS; Charlotte Heller; Toni L. McKeever; Karen S. Pourboghrat, BA; and Jennifer L. Schiebel (research/data assistants); Sharon M. Caputo, BS; Ron F. Hollis, BS; Sekip Firinciogullari, BS; Robert J. Molnar; Stephen Sefcik, BS; and Lingshi Tan, PhD (programmers); Marcia Kurs-Lasky, MS (statistician); Jennifer S. Dietrich, L. Annabelle Kyle, and Robin E. Rice, BS (administration); and Margaretha L. Casselbrant, MD, PhD; Kenny H. Chan, MD; Joseph E. Dohar, MD; Margaret A. Kenna, MD; J. Christopher Post, MD; Sylvan E. Stool, MD; and Robert F. Yellon, MD (otolaryngologist consultants).

	FOOTNOTES

Received for publication Jun 19, 2000; accepted Oct 2, 2000.

Presented in part at the combined annual meetings of the American Pediatric Society and the Society for Pediatric Research; May 2-6, 1997; Washington, DC.

Reprint requests to (J.L.P.) Children's Hospital of Pittsburgh, 3705 Fifth Ave, Pittsburgh, PA 15213-2583.

	ABBREVIATIONS

TTP, tympanostomy-tube placement; SES, socioeconomic status; MEE, middle-ear effusion; SD, standard deviation.

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