Published online December 31, 2007
PEDIATRICS Vol. 121 No. 1 January 2008, pp. e24-e33 (doi:10.1542/peds.2007-0623)
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ARTICLE

Clinical Characteristics of New York City Children Who Received Tympanostomy Tubes in 2002

Salomeh Keyhani, MD, MPHa,b, Lawrence C. Kleinman, MD, MPHa, Michael Rothschild, MDc, Joseph M. Bernstein, MDd, Rebecca Anderson, MPHa, Melissa Simon, BSe and Mark Chassin, MD, MPP, MPHa

a Departments of Health Policy
c Otolaryngology and Pediatrics, Mount Sinai School of Medicine, New York, New York
b James J. Peters VA Medical Center, Bronx, New York
d Departments of Otolaryngology and Pediatrics, New York University School of Medicine, New York, New York
e University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
OBJECTIVE. Tympanostomy tube insertion is the most common procedure that requires general anesthesia for children in the United States. We report on the clinical characteristics of a cohort of New York City children who received tympanostomy tubes in 2002.

METHODS. This retrospective cohort study included all 1046 children who received tubes in 2002 in any of 5 New York City area hospitals. We analyzed clinical data for all 682 (65%) children for whom we were able to abstract data for the preceding year from all of 3 sources: hospital, pediatrician, and otolaryngologist medical charts.

RESULTS. Mean age was 3.8 years, 57% were male, and 74% had private insurance. More than 25% of children had received tubes previously. The stated reason for surgery was otitis media with effusion for 60.4% of children, recurrent acute otitis media for 20.7%, and eustachian tube dysfunction for 10.6%. Children with recurrent acute otitis media averaged 3.1 ± 0.2 episodes (median: 3.0) in the previous year; those with otitis media with effusion averaged effusions that were 29 ± 1.7 days long (median: 16 days) at surgery. Twenty-five percent of children had bilateral effusions of >42 days’ duration at surgery. Despite a clinical practice guideline for otitis media with effusion that recommends withholding tympanostomy tubes for otherwise healthy children until a bilateral effusion is at least 3 to 4 months old, 50% of children had surgery without having had 3 months of effusion cumulatively during the year before surgery.

CONCLUSIONS. The clinical characteristics of children who received tympanostomy tubes varied widely. Many children with otitis media with effusion had shorter durations of effusions than are generally recommended before surgery. The extent of variation in treating this familiar condition with limited treatment options suggests both the importance and the difficulty of managing common practice in accordance with clinical practice guidelines.

Key Words: tympanostomy tubes • epidemiology • physician's practice pattern • use

Abbreviations: RAOM—recurrent acute otitis media • OME—otitis media with effusion • AOM—acute otitis media • PCP—primary care provider • ETD—eustachian tube dysfunction • IQR—interquartile range • CV—coefficient of variation

Otitis media is the most common disease of childhood. The insertion of tympanostomy tubes for otitis media is the surgical procedure performed most frequently in children. Tympanostomy tubes may be inserted to treat recurrent episodes of acute otitis media (RAOM) or the persistence of otitis media with effusion (OME).1 Both RAOM and OME may be associated with hearing loss and may risk long-term damage to the ear structures.

Tympanostomy tubes are small implants that ventilate the middle ear space to the ear canal through the tympanic membrane, potentially improving the course of RAOM and OME. A critical justification in the literature for a timely surgical approach to managing OME is the belief that the associated conductive hearing loss has adverse long-term consequences on the cognitive, linguistic, and psychosocial development of children.2 The actual risk for poor developmental outcomes in patients who do not receive the surgery has recently come under question. A randomized, controlled trial found that prompt tube insertion in otherwise healthy children does not alter developmental outcomes at age 9.3–5 These data challenge the conventional wisdom regarding the use of tympanostomy tubes to promote improved speech and learning outcomes.

Short-term benefits of tympanostomy tube insertion include decreased frequency of AOM, shortened time with effusion, and improved hearing.6–8 The degree to which tube insertion affects the health-related quality of life of children remains largely unexplored. The risks of tube insertion include tympanic membrane scarring, chronic low-grade hearing loss, otorrhea, cholesteatoma, persistent perforation, and the risks of general anesthesia.9–17

The clinical practice guideline concerning tympanostomy tube insertion that would pertain to practice in 2002 (the year when data were collected) was published by the Agency for Healthcare Policy and Research (now known as Agency for Healthcare Research and Quality) in 1994.18 The 1994 guideline calls for (1) antibiotic therapy or bilateral myringotomy with insertion of tympanostomy tubes to manage bilateral OME that has lasted a total of 3 months in an otherwise healthy child who is aged 1 through 3 years and has a bilateral hearing deficit (defined as 20 dB hearing threshold level or worse in the better-hearing ear) or (2) insertion of tympanostomy tubes to manage bilateral OME that has lasted a total of 4 to 6 months in an otherwise healthy child who is aged 1 through 3 years and has bilateral hearing deficit. The most recent (2004) guideline for practice extends to children between the ages of 2 months and 12 years. The 2004 guideline, similar to the 1994 guidelines, calls for the insertion of tympanostomy tubes when OME lasts ≥4 months with persistent hearing loss or other signs and symptoms; however, the 200419 guideline also calls for insertion of tympanostomy tubes for recurrent OME in children who are "at risk" regardless of hearing status or duration. The 2004 guideline also calls for the insertion of tympanostomy tubes when there is structural damage to the tympanic membrane or middle ear. "At risk" children are defined to include those with hearing loss independent of OME; language or speech disorder; autism and other developmental symptoms; and Down syndrome or other craniofacial syndromes that include cognitive, speech, or language delay, visual impairment, cleft palate, and developmental delay.19 Both guidelines were developed jointly by the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics. We describe the clinical characteristics of a cohort of racially and ethnically diverse children who underwent tympanostomy tube insertion in 2002 in the New York City area.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Study Population
We conducted a retrospective study of all tympanostomy tubes that were placed in 2002 in 5 New York City metropolitan area hospitals. We used hospital administrative databases to identify all children who were younger than 18 years and underwent insertion of tympanostomy tubes between January 1, 2002, and December 31, 2002. All patients with the International Classification of Diseases, Ninth Revision code 20.01 as either the primary or the secondary procedure were included in the cohort. The 5 hospitals included 2 academic medical centers; 1 tertiary care teaching hospital; 1 private, not-for-profit community hospital; and 1 teaching public hospital. This study was approved by the institutional review boards of all 5 hospitals.

Data Collection and Measurement
We trained abstractors to use computerized data collection tools (developed for this study) to abstract the relevant data from the various medical charts. For promotion of validity and reliability, abstractors were trained until their findings were comparable to those of a study physician's independent abstraction. Data were downloaded and examined by the investigators and the project manager. Data included demographic and clinical information from each visit for every child in the study from hospital, primary care, and otolaryngologist charts for all 12 months before surgery.

Because the clinical experience of patients is continuous and clinical assessments are periodic, we needed to define a consistent approach for translating categorical data that are abstracted from medical charts into our understanding of these continuous clinical phenomena. To ensure consistency in our assessments, we made 2 key assumptions. When OME was last documented in an ear, we assumed it to be present for 60 more days unless the chart documented that it had cleared in a subsequent visit.20,21 When AOM was last noted on examination, we assumed that the child did not have a normal otoscopic examination for 28 days unless a subsequent examination documented otherwise. An AOM diagnosis interspersed with OME would also trigger another 60 days of effusion in addition to an AOM diagnosis. For example, a child who had OME documented on day 1 and AOM on day 50 was considered to have had an effusion for 110 days (50 plus 60) if no other examinations were documented.

The charts did not contain data that would permit us to assess with any consistency the thoroughness of examinations or the methods used. For example, frequently, the examination only noted right-sided OME or AOM without any description of the tympanic membrane. We noted the presence of any severe tympanic membrane retraction, atelectasis, or myringostapediopexy as the presence of marked otoscopic findings.

In addition to basic clinical information such as otoscopic findings, relevant historical data, treatment with antibiotics, and the clinicians’ assessments of the presence of AOM and/or OME, we abstracted data on the degree of documented hearing loss, the impact of otitis media on family life, and the presence of conditions that can be considered to put the child at risk for worse outcomes. We categorized hearing loss as mild (20–35 dB of loss in the best ear) and moderate to severe (>35 dB of loss in the better ear). For the 1% of cases when a physician documented hearing loss without an audiogram present in the medical chart, we considered hearing loss to be present. Similarly, we considered speech delay to be present on the basis of parent or physician report unless a subsequent assessment documented normal speech before surgery. We did not rely on evidence of formal language screening in the medical chart because parent or physician assessment of language may be all that is used in the decision-making process to insert a tympanostomy tube. We defined severe disruptions to family life to be present on the basis of documented comments by parents regarding missed school or work, an excessive number of appointments, serious disturbances in the family's usual affairs, or considerable anxiety about the impact of ear disease any time in the 3 months leading up to surgery. We considered children to have an at-risk condition when they had any of the following: genetic disease, congenital malformation, developmental delay, autism, hearing loss unrelated to otitis media, or a psychiatric condition. Surgeries or procedures that were performed concurrently with tympanostomy tube insertion were identified from hospital administrative data rather than from chart abstraction.

Statistical Analysis
Differences in patient characteristics between cases with complete and missing data were examined using {chi}2 tests or nonparametric tests when appropriate. We used Stata Statistical Software 8.2 (Stat Corp, College Station, TX) for statistical analyses.


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 CONCLUSIONS
 REFERENCES
 
We identified from the hospital administrative data 1087 children who received tympanostomy tubes (Fig 1). We excluded 41 cases: 6 patients were older than 18 years, 18 did not have tubes inserted, 16 had concurrent major craniofacial procedures, and 1 hospital chart could not be found, leaving 1046 in the cohort. We were able to obtain hospital, primary care provider (PCP), and otolaryngologist charts for 682 (65%) cases. Despite institutional review board authorization, physician office misunderstandings regarding the obligations of the Health Insurance Portability and Accountability Act limited our ability to obtain charts from some community physicians. As described next, we did not include in our clinical analyses the patients with incomplete data.


Figure 1
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  		FIGURE 1 Construction of the sample of childhood tympanostomies in 5 New York City hospitals from January 1, 2002, to December 31, 2002. The cases were identified by using hospital administrative data.

 
Patient Characteristics
All children had a PCP, 99% of whom were pediatricians. Mean age was 3.8 years (median: 3.3), 65% were between 1 and 5 years, and 28.4% were older than 5 years (Table 1). A total of 74% had private insurance. More than 25% of children had had a previous tympanostomy tube insertion. Among those, 73% had had 1, 20% had had 2, and 6% had had ≥3 . More than 20% of the children underwent another surgery at the time of tube insertion; adenotonsillectomy was the most common surgery at the time of tube insertion (15.9%). A total of 17% of children had conditions that we considered to put them at risk: genetic conditions (eg, Down syndrome), congenital malformations (eg, sacral agenesis), and conditions that were acquired at birth or in infancy (eg, cerebral palsy). Characteristics of patients with and without any missing data are shown in Table 1. The age, gender, and insurance status of patients with missing data were similar to those of patients with complete data, suggesting that the populations were similar; however, Table 1 summarizes the duration of effusion and episodes of AOM among children with missing and complete data and demonstrates the importance of abstracting clinical data from all 3 sources when measuring the clinical characteristics of otitis media. The following analysis includes only the 682 children for whom we collected data from all 3 medical charts.


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  		TABLE 1 Characteristics of Patients With Complete Compared With Those With Incomplete Data

 
Clinical Characteristics
As specified by the otolaryngologists, common indications for surgery included OME (60.4%), RAOM (20.7%), and eustachian tube dysfunction (ETD; 10.6%; Table 2). Tables 3 and 4 show the key clinical findings as well as the extent of variation from child to child. Of note, 21% of children had an ear examination documented at every visit in the year before surgery. On average, 18% of all visits in the year before surgery lacked a documented ear examination (median: 14%; interquartile range [IQR]: 4%–28%). At the time of surgery, half of all children had bilateral effusions of ≤2 weeks’ duration, one quarter had durations of ≥6 weeks, and 1 in 20 had a bilateral effusions for ≥4 months (120 days). The degree of variation is evident by comparing the SD (35.2 days) with the median (14 days) or by observing the coefficient of variation (CV) of 129%. The median cumulative (nonconsecutive) number of time for which a child had had an effusion in either ear during the 12 months before surgery was <3 months.


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  		TABLE 2 Otolaryngologist-Reported Indication for Surgery

 

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  		TABLE 3 Summary Data (Cases With Complete Data)

 

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  		TABLE 4 Summary Data: Clinical and Treatment Characteristics

 
Among the 412 children who were receiving tubes because of OME, 77.9% had at least 1 abnormal audiogram documented in the year before surgery (Tables 3 and 4). Among all 682 patients, fewer than 4% had marked otoscopic findings and 28.5% had speech delay, as defined previously. The median number of all visits in the year before surgery was 14 (2 otolaryngologist and 11 PCP visits).22

Table 5 demonstrates the clinical characteristics by the otolaryngologist's stated reason for surgery and other aspects of the child's medical history (concurrent surgery, previous tubes and/or at-risk conditions). Large variations persist within these groups. For example, the IQR for the number of infections in children whose reason for surgery included recurrent AOM was 1 to 5 infections in the previous year (mean: 3.1 ± 0.2; median: 3; range: 0–11; CV: 80%). Children whose reasons included OME had an IQR of 0 to 45 consecutive days of bilateral effusion at the time of surgery (mean: 29 ± 1.7; median: 16; range: 0–183; CV: 120%). Children whose primary reason for receiving tympanostomy tubes was ETD had a similar duration of effusion to children whose primary reason for surgery was OME. As expected, children who had had a previous tube insertion had on average less current disease than children who were receiving their first set of tubes. Also, children who had potentially extenuating circumstances, such as a concomitant procedure with their tube insertion, or who had at-risk conditions had shorter duration of effusions and fewer infections on average than children without any of these characteristics (Table 5, Figs 2 and 3).


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  		TABLE 5 Clinical Characteristics by Otolaryngologist's Reported Indication for Surgery

 

Figure 2
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  		FIGURE 2 Duration of effusion (months) according to presence of potential extenuating circumstances in children whose primary reason for surgery was OME. "Cumulative months" refers to the mean number of nonconsecutive months that an effusion was present during the entire year before surgery. "Consecutive months" refers to the mean duration of the effusion immediately before surgery. "Unilateral" represents the mean duration of effusion in the ear with the longer duration of a unilateral effusion. "Concurrent surgery" refers to children who had another procedure/surgery at the time of tube placement. "History of previous tubes" refers to children who had had a previous tube placement. "At-risk condition" refers to children with hearing loss independent of OME; language or speech disorder; autism and other developmental symptoms; Down syndrome; or other craniofacial syndromes that include cognitive, speech, or language delay, visual impairment, cleft palate, and developmental delay. "None" refers to children who have none of the previous characteristics (fresh cases).

 

Figure 3
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  		FIGURE 3 Mean number of episodes of AOM in the year before surgery according to presence of potential extenuating circumstances in children whose primary reason for surgery was RAOM. See the Fig 2 legend for an explanation of the conditions.

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
CONCLUSIONS
 REFERENCES
 
We examined the clinical characteristics of children who were younger than 18 years and received tympanostomy tubes in 5 New York metropolitan area hospitals in 2002. The cohort is urban, ethnically diverse, and mostly insured; virtually all of the PCPs are pediatricians. Although not representative of national practice, this study should offer insight into a substantial proportion of practice for children in the United States.

The data for this study describe practice in the eighth year after release of the first national guideline regarding the treatment of OME and 2 years before its update was to be released.18,19 We found that the clinical characteristics of children who received tympanostomy tubes in this cohort varied widely. All of the children had a history of otitis media. The histories of present illness included RAOM, persistent OME, problems with hearing and speech, and/or disruption of family life. Many had current clinical findings as well. The specifics of the current findings ranged from minor (eg, a resolved effusion without hearing loss) to more significant, such as ≥6 months of a current bilateral effusion with hearing loss. Children who previously had tympanostomy tubes tended to be older and to have less current disease than those who were receiving their first set of tubes. Both children with at-risk conditions and those who were scheduled to undergo another surgery or procedure at the time of tympanostomy tended to have disease of shorter duration.

This study has certain strengths and limitations. Although we did not have complete data on 35% of the cases, we restricted our clinical analyses to those for whom we had complete data. The children with missing data seem not to differ from those with complete data on key sociodemographic variables. This study confirms the importance of reviewing the PCP's chart when studying otitis media in children. Indeed, both clinical care and good research require satisfactory transfer of information contained in both the PCP's and the otolaryngologist's chart; the 2004 Academies’ Guideline even notes its importance for clinical decision-making.19 Also, the data collection in this study relied on information that was available in the medical chart with all of the limitations therein. We may have underestimated the extent of variables such as "severe disruption of family life," which clinicians may not routinely document.

We recognize the limitations that are inherent in relying on the otoscopic skills of a group of community practicing clinicians for diagnosis23–25; however, the decision to insert tubes is made on the basis of the collective information provided by PCPs and parents as well as the otolaryngologist's own clinical observations. Although more accurate clinical information could be collected in a prospective study, the data collected represent the clinical information used in actual practice when making decisions regarding surgical intervention, a significant strength of the study.

To make quantitative assessments about the course of otitis media, we needed to translate the intermittent assessments from the charts into the continuous variables that we used in our analysis. The explicit nature of how we imputed duration of illness is a strength of this study, but the need to do so is an unavoidable limitation.

The wide variations in the placement of tympanostomy tubes documented in this study suggest that a substantial amount of practice departs from expert recommendations, whether as codified in 1994 or 2004.18,19 These guidelines both generally hold that children who are not at risk and who have ETD or OME should not have tubes until at least 90 days of consecutive bilateral effusion (120 days in the 2004 version). In this study, 75% of children had <42 consecutive days of effusion. More than 50% had fewer than 77 cumulative days of bilateral effusion in the entire year before surgery and on average <2 episodes of AOM in the 6 months before surgery.

Despite a substantial clinical literature on otitis media, the reasons for such variations are unclear. Otitis media is a common disease, the presentation of which has historically been described using a limited number of clinical characteristics. These characteristics can be quantified (eg, number of acute infections, days of effusion, severity of hearing loss) or categorized (eg, marked otoscopic findings present) readily. It occurs in a population for which serious comorbidities are unusual and truly extenuating circumstances are rare. The treatment choices can be divided into 3 broad categories: medication (generally antibiotics), surgery, and watchful waiting. This condition, therefore, would seem an ideal candidate for which to develop and to implement an evidence-based clinical practice guideline.

PCPs, otolaryngologists, researchers, parents, and advocates all may want to consider our findings. If the guideline for OME that was developed in 1994 or the guideline developed in 2004 by the 3 clinical professional societies is credible, then the large number of children who receive tubes for OME of <90 days of bilateral effusion is concerning and may represent overuse of tympanostomy tubes in a substantial proportion of children. In this case, the costs of these procedures may well be better spent on other ways of enhancing children's well-being. If the 2 guidelines, which were developed by an interdisciplinary panel of experts using a formal process a decade apart, do not describe desirable practice adequately, then we should question whether the problem lies with the manner of the guideline development or, alternatively, the state of our understanding of otitis media in the community (or both). Historically, studies have looked at measures such as language development or long-term hearing loss to assess the outcomes for children with otitis media. Current thought is fueled by outcomes research that does not emphasize the comfort of the child, the impact of hearing loss on the family unit, or the contribution of communication difficulties to more global behavioral and socialization processes; therefore, outcomes research and evidence-based guidelines may fail to capture the effect of tympanostomy tubes on the overall well-being of children. Outcomes research in adults has evolved to incorporate and to measure the health-related quality of life. Assessing the well-being of children with otitis media and their families may require formally integrating health-related quality of life both into outcomes studies and into clinical decision-making by those who care for children. The systematic integration of expert observation into measures that assess the health of children has been used successfully in the past and may have a role in developing more meaningful outcome measures for otitis media.26–28 Well-designed measures might enhance both research and practice.

Guidelines may also not take into account the challenges of community practice. There may not be adequate communication between PCPs and otolaryngologists on the extent of ear disease before tube insertion. For some patients, the otolaryngologist would have had ready access to the PCP's medical chart. In most cases, the physicians were in completely unrelated practice settings. It was an extremely rare situation in which we identified a letter from a pediatrician in the otolaryngologist's chart. We also have no way of knowing whether telephone or e-mail contacts occurred, and we did not set out to measure formally the adequacy of communication between providers. Poor care coordination and communication may be factors that lead to overuse of tympanostomy tubes. In addition, the duration of effusion plays a key role in assessing the suitability of tympanostomy tubes for a given child. Pediatric and otolaryngology practices do not have ready tools available to track duration of effusion accurately or with which to share such information. This may represent a barrier in estimating the duration of effusion using all available information in real-world practice. Better office practice tools designed to measure duration of effusion and better care coordination could help to prevent overuse of tympanostomy tubes.

Another explanation for the variations observed may be the impact of otitis media on family life22,29 As described in other contexts, social stressors or anxiety regarding otitis media might lead parents to make erroneous judgments about how threatening the condition is to the health of their child.30–32 If this is the case, then pediatricians can serve their patients by taking a leadership role that includes comforting these families regarding the generally benign nature of their patients’ otitis media. By helping to alleviate these anxieties, pediatricians may promote a more balanced discussion of optimal clinical management. On those occasions when anxiety causes parents to encourage tympanostomy tube insertion for clinical circumstances that do not warrant the surgery, pediatricians and otolaryngologists alike must maintain their responsibility to match clinical interventions to patient needs and to discourage surgery. In such cases, good practice calls for the physicians to listen and to provide support, even as they educate parents about the natural history of otitis media and direct them toward appropriate treatment options.


   CONCLUSIONS
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
REFERENCES
 
The real-world use of tympanostomy tubes to treat children with otitis media varies widely and deviates from guidelines. Many children received tympanostomy tubes after brief episodes of OME and with few episodes of RAOM. This study of practice in the metropolitan New York area suggests that clinicians use variables other than those generally studied—duration of effusion, number of recurrent infections, hearing loss, speech delay, otoscopic findings, disruptions of family life, and presence of congenital or genetic defects—when deciding whether to insert tubes in children. The extent of variation in treating this familiar condition with limited treatment options suggests both the importance and the difficulty of managing common clinical practice to comport with guidelines. If our findings are generalizable, then they would be particularly troubling because otitis media is the most common illness with which children present to the doctor. Future research needs to explore both the optimal course of treatment and why clinical practice so frequently deviates from accepted guidelines.


   ACKNOWLEDGMENTS
 
This study was funded by the Agency for Healthcare Research and Quality (R01 HS 10302). The views expressed therein are solely those of the authors.

This work was presented in part in poster form at the annual meeting of Academy Health; June 26, 2006; Seattle, WA; and as an oral presentation at the annual meeting of Academy Health; June 3, 2007; Orlando, FL.


   FOOTNOTES
 
Accepted May 24, 2007.

Address correspondence to Salomeh Keyhani, MD, MPH, Department of Health Policy, Mount Sinai School of Medicine, One Gustave L. Levy Pl, Box 1077, New York, NY 10029. E-mail: salomeh.keyhani{at}mountsinai.org

The authors have indicated they have no financial relationships relevant to this article to disclose.


   REFERENCES
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 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 

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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics




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