The current American Academy of Pediatrics (AAP) guideline on acute otitis media (AOM) recommends the following diagnostic criteria for AOM: (1) moderate to severe bulging of the tympanic membrane (TM), (2) acute otorrhea not due to acute otitis externa or (3) mild bulging of the TM with either recent ear pain or intense erythema of the TM.1 However, this guideline excludes infants <6 months of age. Direct extrapolation of the AAP diagnostic criteria to younger infants is problematic due to challenges assessing ear pain and visualizing the TM through smaller ear canals, which may result in difficulty assessing more subtle TM examination findings. There are no widely agreed-upon diagnostic criteria for the diagnosis of AOM in young infants. Prior studies of AOM in young infants have utilized tympanocentesis for diagnosis,2,3 but this is impractical in most clinical settings and does not represent the standard of care in the management of uncomplicated AOM.
Accurately diagnosing AOM in infants ≤90 days is essential, as clinicians are more concerned about concomitant serious bacterial infections in this age group.2,4,5 It is unclear what examination findings clinicians use to diagnose AOM in young infants, if they vary from criteria established for older infants and children, and how these differences may impact their care. In our previously published study of afebrile infants ≤90 days with clinically diagnosed AOM,6 we briefly summarized the documented ear examination findings without assessing combinations of findings or whether examination findings differed across age subgroups. The primary aim of this study was to describe in detail the otologic examination findings documented by pediatric emergency medicine clinicians to diagnose AOM in afebrile young infants. As the diagnosis of AOM may engender further evaluation for systemic infection in different age categories of young infants, our secondary aim was to compare whether examination findings differed across important age groups: 0–28 days, 29–56 days and 57–90 days of age.
We conducted a secondary analysis of a 33-site retrospective cross-sectional study completed through the Pediatric Emergency Medicine Collaborative Research Committee (PEM CRC) of the AAP. We studied afebrile infants ≤90 days of age presenting to a participating emergency department from 2007 to 2017 who were clinically diagnosed with AOM. Eligible infants were identified using International Classification of Diseases codes for AOM and database review of blood and cerebrospinal fluid cultures. Infants were included in the cohort only if manual chart review determined that the clinician’s assessment confirmed the diagnosis of AOM. Details of the study protocol have been described elsewhere.6 The study was approved by the ethics boards of all participating sites.
Trained site investigators and research coordinators abstracted the following otologic findings and coded them as present, absent or not documented: (1) TM opacity, (2) TM erythema, (3) bulging TM, (4) TM dullness, (5) visualization of perforated TM, (6) decreased TM mobility on insufflation, (7) otorrhea and (8) decreased visualization of middle ear structures. The findings of TM dullness, TM opacity and decreased visualization of middle ear structures were each considered evidence of a middle ear effusion. For analysis, otologic findings were categorized as either present or absent. Those findings that were not documented were considered absent. Since the presence of otorrhea limits TM visualization, and the practice of cleaning the ear canal varies among physicians, we reported all other otologic examination findings only among those infants without documented otorrhea.
Age was categorized a priori as 0–28, 29–56 and 57–90 days. We performed descriptive statistics to calculate proportions of individual and combinations of examination findings suggestive of AOM diagnosis based on the AAP guideline. To compare differences in examination findings across age groups while accounting for site variation, we utilized univariable generalized linear mixed modeling, reporting odds ratios (OR) with 95% confidence intervals (CI). Analyses were conducted using SPSS 26 (IBM Corporation, Armonk, NY) or R (version 4.0.5, 2021).
Of 5270 infants screened, 1637 (31.1%) met eligibility criteria. Median age was 68 days (interquartile range 49–80 days), and 957 (58.5%) were male. Table 1 details ear examination findings of the overall cohort and by age group.
TABLE 1. -
Otologic Findings of Infants ≤90 Days With Clinically Diagnosed Acute Otitis Media
||N = 1637
||N = 100
||N = 444
||N = 1093
Excluding infants with otorrhea
||N = 1160
||N = 68
||N = 252
||N = 840
| Bulging TM
| Erythematous TM
| With bulging TM
| With ≥1 other finding(s)
| Middle ear effusion
| With bulging TM
| With erythematous TM
| Perforated TM
| Decreased TM mobility
*Presence of any documented ear examination findings are noted. Combination of ear examination findings used for the diagnosis of AOM in older children according to the AAP are presented first.
†Other findings include evidence of middle ear effusion, bulging TM, and decreased TM mobility.
‡Findings suggestive of middle ear effusion include TM dullness, TM opacity, or decreased visualization of middle ear structures.
AAP indicates American Academy of Pediatrics; AOM, acute otitis media; TM, tympanic membrane.
Among infants who did not have otorrhea (1160/1637, 70.9%), evidence of middle ear effusion was documented in 846/1160 (72.9%) infants, as evidenced by either TM opacity (499/1160, 43.0%), TM dullness (397/1160, 34.2%) or decreased visualization of middle ear structures (166/1160, 14.3%). Otologic findings supporting the diagnosis of AOM included TM erythema and bulging TM in 867/1160 (74.7%) and 519/1160 (44.7%) infants, respectively. In 124/1160 (10.7%) infants, TM erythema was the only documented physical examination finding supportive of AOM. Few infants in any age group had decreased TM mobility documented. Of the 477/1637 (29.1%) infants with documented otorrhea, 56 (11.7%) were diagnosed with concurrent possible or definite acute otitis externa, confirmed in 2 infants by otolaryngologist evaluation.
Compared with infants 0–28 days old, infants 57–90 days old had higher odds of documented TM erythema (OR: 1.9; 95% CI: 1.08–3.25; P = 0.025) and were less likely to be diagnosed based on evidence of middle ear effusion alone (OR: 0.5; 95% CI: 0.25–0.99; P = 0.048). Perforated TM was infrequently documented in the overall cohort (12/1160, 1.0%), with lower prevalence noted in 29–60 day old (OR: 0.1; 95% CI: 0.02–0.69; P = 0.018) and 57–90 (OR: 0.1; 95% CI: 0.03–0.39; P = 0.001) day old infants compared with those 0–28 days of age. No other constellation of meaningful examination findings differed significantly among the age subgroups.
In this multicenter study of afebrile infants with clinically diagnosed AOM, we found that pediatric emergency medicine clinicians generally documented physical examination findings consistent with the AAP guideline for children ≥6 months of age. Middle ear effusion, an important criterion for diagnosing AOM, was documented for the majority of infants in our cohort. Additionally, nearly two-thirds of infants had either evidence of a bulging TM or otorrhea, each of which may be considered a stand-alone characteristic for AOM, according to the guideline. TM erythema, which alone may be less specific for AOM,7 was documented in combination with other otologic findings suggestive of AOM in over 60% of the infants.
The observed frequency of otorrhea in our study (approximately 30%) is similar to the prevalence reported in older infants and children with AOM (21%).8 Our result carries important treatment implications since antibiotics have been shown to be most effective in reducing pain and fever in older children with AOM accompanied by otorrhea.9
Multiple examination findings consistent with AOM were more frequently documented in older infants, suggesting that clinicians may be using fewer or less stringent examination criteria to diagnose AOM in the youngest infants, despite the impact this diagnosis may have on additional testing and treatment in this age group.2,4,5 This is likely related to challenges inherent in visualizing the TM through smaller ear canals. It is unclear why the youngest infants in the study had a higher prevalence of tympanic membrane perforation documented, although a small case series suggests that it may be related to differences in otopathogens causing AOM in neonates.10
Our study has several limitations, primarily related to its retrospective nature. In addition to the accuracy of clinician examination findings, we were unable to confirm whether undocumented otologic examination findings were truly absent. It is likely that the most salient examination findings supporting the diagnosis of AOM were documented. While utilization of diagnosis codes can be unreliable for research purposes, we confirmed the diagnosis of AOM through detailed chart review, and further sought any missed cases by review of culture data. We did not compare clinical examination findings to middle ear fluid culture-proven diagnosis, as our goal was to describe the current diagnostic practice in this young cohort of infants, and tympanocentesis is rarely performed in this setting. Inclusion of infants with dual diagnoses of AOM and acute otitis externa, though a small proportion of our overall cohort, raises questions about diagnostic certainty in these infants, further highlighting the difficulty of otologic examination when otorrhea is present. Finally, our findings may not be generalizable to febrile young infants or infants outside of the emergency department setting.
In this large cohort of young afebrile infants with clinically diagnosed AOM, documented otologic findings generally aligned with the AAP diagnostic criteria for children ≥6 months of age. As clinicians continue to extrapolate the existing AOM guideline to this younger cohort, our study highlights the importance of clarifying age-appropriate diagnostic criteria for AOM.
The authors thank the investigators and research coordinators who contributed data to the primary study, as well as the AAP PEM CRC Steering Committee for their support.
Pediatric Emergency Medicine Collaborative Research Committee: Son H. McLaren, MD, Andrea T. Cruz, MD, MPH, Kenneth Yen, MD, MS, Matthew J. Lipshaw, MD, Kelly R. Bergmann, DO, Rakesh D. Mistry, MD, MS, Colleen K. Gutman, MD, Fahd A. Ahmad, MD, MS, Christopher M. Pruitt, MD, Graham C. Thompson, MD, Matthew D. Steimle, DO, Xian Zhao, MD, Abigail M. Schuh, MD, MMHPE, Amy D. Thompson, MD, Holly R. Hanson, MD, MS, Stacey L. Ulrich, MD, James A. Meltzer, MD, MS, Jennifer Dunnick, MD, MPH, Suzanne M. Schmidt, MD, Lise E. Nigrovic, MD, MPH, Muhammad Waseem, MD, MS, Roberto Velasco, MD, PhD, Samina Ali, MD, Danielle L. Cullen, MD, MPH, MSHP, Borja Gomez, MD, PhD, Ron L. Kaplan, MD, Kajal Khanna, MD, JD, Jonathan Strutt, MD, Paul L. Aronson, MD, MHS, Ankita Taneja, MD, David C. Sheridan, MD, Carol C. Chen, MD, MPH, Amanda L. Bogie, MD, Aijin Wang, MS, and Peter S. Dayan, MD, MSc
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