Acute otitis media (AOM) is the most common diagnosis for which antibiotics are prescribed for children.1 Different sets of criteria have been used for the diagnosis of AOM. In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians devised an evidence-based guideline2 for diagnosing and managing AOM. For the diagnosis of AOM, the guideline specifies a recent onset of ear symptoms, a middle ear effusion (MEE), and signs or symptoms of middle ear inflammation.
The purpose of this study was to determine whether and how frequently AOM occurs during colds in young children. Ordinarily, diagnosis requires a patient (parent) initiated visit to a physician; whether AOM occurs in the absence of an office visit has not been studied. The following accommodations were made in the study design: (1) prospectively enrolled children had a baseline examination of the tympanic membrane (TM) prior to the onset of the cold; (2) the study pediatrician who examined and photographed the TMs during the cold had no role in diagnosis or management of AOM; (3) after each child had completed the study, AOM was diagnosed based on reported symptoms and objective findings during the cold.
Between 2004 and 2008, 39 healthy children between 6 months and 3 years of age were enrolled from a private pediatric practice in Charlottesville and followed up during September to May. In order for a child to participate, the family had to willingly return for a study visit every 2 to 3 weeks while healthy and 6 to 10 times during the cold. Exclusion criteria were tympanostomy tubes or chronic conditions; the study pediatrician could not be the child's primary physician. Informed consent was obtained from each parent; the study was approved by the Human Investigation Committee of the University of Virginia Health System.
After enrollment, 5 children were excluded because they could not tolerate the introduction of the video otoscope into the external auditory canal. Four additional children had not developed a cold by the end of surveillance period. The children who completed the study had 31 evaluable colds (1 child had 2).
It was expressly stated that the study pediatrician (C.E.A.) would have no role in the care of the child during the study; parents understood that the child should be seen by a primary (nonstudy) physician for any illness, at the parents' discretion. Each family received a daily symptom diary; study visits occurred at 2 to 3 week intervals until the onset of a cold. The visit immediately preceding the cold was designated the “baseline” visit.
At each visit, the nurse reviewed the symptom diary and performed tympanometry (GSI Auto Tymp, Grason-Stadler, Milford, NH); the study pediatrician performed pneumatic otoscopy and obtained a digital photograph of each TM (Ultra-View Portable Video Otoscope, MedRx Inc., Seminole, FL). Parents did not tell the study pediatrician about the child's symptoms; the nurse did not tell the pediatrician or the family about the tympanometry; the study pediatrician did not tell the family about the appearance of the TM. When a cold occurred, children came for the study visit up to 10 times during the 2 weeks following the onset of a cold. The schedule of the visits was dictated by the availability of the parents, study pediatrician, and nurse.
The onset of a cold was evidenced by 2 consecutive days of upper respiratory infection (URI) symptoms (rhinorrhea, nasal congestion, cough, hoarseness, and sneezing). A sign of middle ear inflammation was distinct erythema of the TM (Figure 1). Symptoms indicative of middle ear inflammation were otalgia or, in these children, the “otalgia equivalents” of irritability, poor sleeping, or ear pulling. Pneumatic otoscopy was done, but we chose to define MEE as present in an ear with a tympanometric recording of a B curve (no measureable peak pressure or compliance < 0.2cm3).
After completing the study, the diagnosis of AOM was established by the study pediatrician who compiled the symptom data with the tympanometry and the appearance of the TM. The criteria used for AOM were same as those published in 2004,2 which are as follows: (1) recent, abrupt onset of ear symptoms; (2) the presence of an MEE; and (3) signs or symptoms of middle ear inflammation. Diagnoses of AOM by nonstudy pediatricians were not considered in the analysis.
Nasal secretions were obtained by the study nurse at the first 2 visits during the cold using a technique described previously.3 Secretions were kept at 4°C before being combined into 1 sample and stored at −70°C for later testing using reverse transcription-polymerase chain reaction for respiratory viruses as described in a previous study.4
Each study visit during the cold was analyzed to ascertain whether AOM criteria were met on that day of the cold. Distinct erythema of the TM on the day of the visit and symptoms recorded for the day of and 2 days prior to the visit were used in the assessment of inflammation of the middle ear. The effect of MEE at baseline (before the onset of the cold) on the occurrence of AOM during the cold was assessed using Fisher exact test, 2-tailed.
The age distribution of the 30 children (15 female) studied at the time of the 31 colds was: 7 to 11 months, 5 children; 12 to 23 months, 9 children; 24 months to 35 months, 9 children; and 36 to 47 months, 8 children. In addition to the baseline visit for each cold, there were 200 study visits over the 2 weeks after onset of the 31 colds, with a mean of 6.45 visits per cold (median 7). Of 31 colds, 20 were seen within the first 3 days after onset, 10 were first seen on day 4 or 5 of illness, and 1 was first seen on day 6.
AOM During Colds.
AOM occurred in 17 (55%) of the 31 colds (Table 1 and Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690). In 5 colds (children numbers 28, 31, 35, 36, and 39, Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690), AOM was present at a single visit; in the remaining 12, AOM was present at multiple visits. There was temporal clustering of the onsets of AOM; 15 of 17 episodes began by day 5 (Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690). The appearance of the TM corresponding to “f” (middle ear fluid), “e” (distinct erythema), and “b” (bulging TM) in the Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690, are presented in Fig. 1.
Criteria for Middle Ear Inflammation and Effect of MEE at Baseline.
The influence of the criteria used for determining inflammation of the middle ear (symptoms and/or erythema of the TM) and of MEE at baseline on frequency of AOM detection during the 31 colds was examined (Table 1). AOM was detected in 11 colds (35%) if both symptoms and erythema of the TM were required for diagnosis. Three additional colds had erythema without symptoms; 3 other colds had symptoms without erythema. If either erythema of the TM or symptoms was accepted as evidence of middle ear inflammation, 17 (55%) colds demonstrated AOM. Using either erythema or symptoms as a determinant of the middle ear inflammation, AOM was diagnosed in all 12 (100%) colds with MEE at baseline (Table 1) and in only 5 (26%) of 19 colds with no MEE at baseline (P < 0.0001). Bulging TMs occurred in 6 colds (5 with pre-existing MEE). Of the 6 with bulging TMs, 3 sought medical attention and received antibiotics from a nonstudy pediatrician (Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690). The other 3 (children numbers 7, 33, 37, in Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690) were not treated with antibiotics, and bulging resolved spontaneously in 2 (bulging remained at the last visit in the third). Serial photographs of TMs at study visits during 4 representative colds illustrate the diagnoses of AOM (Fig., Supplemental Digital Content 2, http://links.lww.com/INF/A691).
Five children visited their primary (nonstudy) pediatrician 6 times during the colds. An antibiotic for AOM was prescribed by the nonstudy physician during 4 (13%) of the colds (children numbers 17, 2, 23, and 10, Table, Supplemental Digital Content 1, http://links.lww.com/INF/A690), starting on days of illness 2, 6, 14, and 8, respectively. The remainder of nonstudy physician visits did not result in an antibiotic prescription.
A respiratory virus was detected by polymerase chain reaction in nasal secretions from 24 of the 31 colds: rhinovirus (18), coronavirus (4), adenovirus (1), and parainfluenza (1).
This unique study provides insight into the frequency with which AOM could be diagnosed in children during colds. AOM by the American Academy of Pediatrics (AAP) criteria developed in more than half and commonly persisted throughout the cold. The presence of residual MEE from a previous cold virtually guaranteed that AOM would develop.
MEE, a requisite for diagnosing AOM, was often brief or intermittent and shifted from side to side during the course of illness. This variability in pressure and fluid in the middle ear, previously reported during colds in school children,5 is consistent with Eustachian tube dysfunction from inflammation of the nasopharynx at the terminus of the tubes.5
As evident in our study and others,6,7 the onset of AOM occurs early in the course of the colds. A recent report8 states that occurrence, duration, and severity of symptoms did not differentiate colds with AOM from colds without AOM. Our findings are troublesome, because a diagnosis of AOM usually results in a prescription for antibiotic, either as immediate or delayed treatment (wait-and-see9 or safety net10 prescription), in spite of the fact that placebo-controlled trials of treatment for AOM have shown that only 7% to 20% of patients benefit from an antibiotic.1,11,12
Limitations of this study include that only 31 colds were studied, and that there was an unavoidable selection bias because only patients who could tolerate the introduction of the video otoscope were included.
In light of our findings, what should we do about AOM in young children? It seems reasonable to refine the diagnostic requirements for the diagnosis of AOM. Some authors have suggested that bulging of the TM should be required for the diagnosis of AOM.13–16 Managing AOM as currently defined with an antibiotic prescription, even with a wait-and-see approach, presupposes that AOM is a bacterial process. Perhaps, a more prudent option for managing AOM would be emphasizing systemic and topical analgesia along with follow-up when the child does not improve quickly.
The authors thank Kirsten Hanley, Claudia Wisman, and Hilary Paschall for their assistance with this study. The authors thank Keith R. Powell, MD and Leigh Grossman, MD for their review of the manuscript.
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