Symptoms or Symptom-Based Scores Cannot Predict

Acute Otitis Media at Otitis-Prone Age

WHATS KNOWN ON THIS SUBJECT: Acute symptoms and scores
are used as tools in the diagnosis and management of AOM.
However, their predictive value for AOM is not known for young
children whose parents suspect AOM.
WHAT THIS STUDY ADDS: The occurrence, duration, and severity
of symptoms are not predictive for AOM at otitis-prone age.
Symptom-based scores cannot differentiate AOM from
respiratory tract infection. Tympanic-membrane examination is
crucial for the diagnosis and scoring of AOM.

abstract
OBJECTIVE: Acute symptoms are used to diagnose and manage acute
otitis media (AOM). We studied whether AOM could be predicted by the
reason for parental suspicion of AOM or by the occurrence, duration,
and/or severity of symptoms. We also compared scores including or excluding tympanic-membrane examination of children with and without AOM.
PATIENTS AND METHODS: Children aged 6 to 35 months with parental
suspicion of AOM were eligible. Before tympanic-membrane examination, we registered on a structured questionnaire the reason for parental suspicion of AOM, symptoms, and score components.
RESULTS: Of 469 children studied, 237 had AOM and 232 had respiratory tract infection without AOM. The most common reason for parental
suspicion of AOM, restless sleep, was not predictive for AOM (RR: 1.0
[95% CI: 0.8 1.2]), nor was ear-rubbing (relative risk [RR]: 0.7 [95%
condence interval (CI): 0.51.0]). Neither the occurrence of fever (RR:
1.2 [95% CI: 1.0 1.4]) nor the highest mean temperature within 24
hours predicted AOM, nor did the occurrences of ear-related, nonspecic, respiratory, or gastrointestinal symptoms. The duration and severity of symptoms were not predictive for AOM, although rhinitis
lasted longer and conjunctivitis was more severe in children with AOM.
The clinical/otologic score (median: 4.0 vs 2.0; P .000) and the AOM
total-severity index (11.0 vs 6.0; P .000), both including symptoms
and tympanic-membrane examination, were higher in those with AOM.
The AOM severity-of-symptom scale, based solely on symptoms, was
equal in children with and without AOM (6.0 vs 6.0; P .917).

AUTHORS: Miia K. Laine, MD,a Paula A. Tahtinen, MD,a

Olli Ruuskanen, MD, PhD,a Pentti Huovinen, MD, PhD,b and
Aino Ruohola, MD, PhDa
aDepartment of Pediatrics, Turku University Hospital, Turku,
Finland; and bDivision of Health Protection, National Institute for
Health and Welfare, Turku, Finland

KEY WORDS
acute disease, diagnosis, otitis media, respiratory tract
infections, signs and symptoms
ABBREVIATIONS
AOMacute otitis media
OS-8 otoscopy score, 8 grades
AOM-SiAOM total-severity index
AOM-SOSAOM severity-of-symptom scale
AAPAmerican Academy of Pediatrics
RRrelative risk
CI condence interval
RTIrespiratory tract infection
This trial has been registered at www.clinicaltrials.gov
(identier NCT00299455).
www.pediatrics.org/cgi/doi/10.1542/peds.2009-2689
doi:10.1542/peds.2009-2689
Accepted for publication Dec 4, 2009
Address correspondence to Aino Ruohola, MD, PhD, Department
of Pediatrics, Turku University Hospital, PL 52, 20521 Turku,
Finland. E-mail: aino.ruohola@utu.
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright 2010 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have
no nancial relationships relevant to this article to disclose.

CONCLUSIONS: AOM cannot be predicted by the occurrence, duration,

or severity of symptoms at otitis-prone age. Likewise, solely symptombased scores do not differentiate between respiratory tract infections
with or without AOM. Thus, tympanic-membrane examination is crucial
in the diagnosis and severity classication of AOM in clinical practice
and research settings. Pediatrics 2010;125:e1154e1161

e1154

LAINE et al

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Acute symptoms play a crucial role in

the diagnosis of acute otitis media
(AOM). These symptoms, such as ear
pain and fever, are included in the diagnostic criteria of AOM.1 Parents base
their suspicion of AOM on the symptoms of their child. The guidelines advise physicians to use the severity of
symptoms to choose the most appropriate treatment (antimicrobial therapy versus observation option) of AOM
and to follow-up the episode of AOM.2 In
clinical trials of AOM, symptoms have
been used for severity scoring to assign children to different treatment
groups,3 to study only 1 severity grade
of AOM,4 and as the primary outcome in
randomized trials that assess the effect of antimicrobial treatment.3,58
Clinical experience gives the impression that symptoms occurring at the
time of AOM are variable. Only a few
studies have focused on symptoms of
AOM in the outpatient setting.911 All of
the studies have included children
with verbal skills, and none have examined the severity of symptoms. Thus,
there is a lack of data on the predictive
value of the occurrence, duration, and
severity of symptoms in children aged
6 to 35 months, which is the age group
with the highest incidence of AOM.
We studied the symptoms of children
in this otitis-prone age group when
their parents sought medical attention
because AOM was suspected. The aim
of this study was to nd out if AOM
could be predicted by the occurrence,
duration, and/or severity of symptoms.
We also compared scores from recent
literature that included or excluded
tympanic-membrane examination of
children with and without AOM.

PATIENTS AND METHODS

Study Population
This study was conducted between November 2006 and December 2008 and
was part of a project examining the diagnosis, microbiology, and treatment
PEDIATRICS Volume 125, Number 5, May 2010

of AOM at the primary care level. After

telephone contact by parents, children
aged 6 to 35 months were brought for
an outpatient visit because of parental
suspicion of AOM based on suggestive
symptoms.
Written informed consent was obtained from a parent of each child before any study procedure was performed. All visits were free of charge,
and no compensation for participation
was given. The study protocol was approved by the ethical committee of the
Hospital District of Southwest Finland.
Symptom Questionnaire
Before tympanic-membrane examination, the study physician asked the reason for parental suspicion of AOM and
the occurrence, duration, and severity
of 17 symptoms by using a standardized, structured questionnaire. The highest measured temperature (38C)
within 24 hours was recorded. For the
occurrence and duration of fever, we
also accepted the parents assessment of fever with no temperature
measurement. Severity was classied
as mild, moderate, or severe for the
following symptoms: ear pain reported
by parents and the childs verbal expression of ear pain; ear-rubbing; and
irritability. In the following symptoms,
the severity was classied as mild
or severe: excessive crying; restless
sleep; less playful or active; poor appetite; rhinitis; nasal congestion; cough;
hoarse voice; conjunctivitis; mucus
vomiting (retching and throwing up
swallowed mucus); vomiting (throwing up partially digested foods and
drinks); and diarrhea. The duration of
symptoms was measured in days (with
an accuracy of 0.5 days). Parents evaluated their childs overall condition
with the AOM-faces scale,12 scoring 1 to
7, at worst within 24 hours and at the
time of the visit (used with the kind
permission of David P. McCormick,
MD).

Tympanic-Membrane Examination
The study physicians rst performed
tympanometry (MicroTymp2 [Welch Allyn, Skaneateles Falls, NY]). After careful cerumen removal, we systematically assessed the middle-ear status
(position, translucency, color, hyperemia, light reex, mobility of the tympanic membrane, and possible airuid interfaces) by using pneumatic
otoscopy (Macroview otoscope model
23810 [Welch Allyn]); the otoscopy
score (8 grades) (OS-8)13; and which
ear had the worse status. Digital pneumatic video otoscopy (Jedmed, St
Louis, MO) was used to document the
ndings.
The diagnosis of AOM required 3 criteria: (1) middle-ear uid detected by
pneumatic otoscopy (at least 2 of the
following signs on the tympanic membrane: bulging position; decreased or
absent mobility; abnormal color or
opacity not caused by scarring; or airuid interfaces); (2) at least 1 acute
inammatory sign of the tympanic
membrane (distinct erythematous
patches/streaks or increased vascularity over full/bulging/yellow convexity); and (3) symptoms and signs of
acute infection.
Before examining the study population, all study physicians were
validated to assess the tympanicmembrane ndings and the OS-8. Of
the 5 study physicians, 3 of us (Drs
Laine, Tahtinen, and Ruohola) made
more than 90% of the diagnoses and
had an excellent agreement ( values from 0.80 to 0.92). An ear-nosethroat specialist assessed the images and videos of 150 children
without knowing their symptoms
and/or our diagnosis. He agreed with
95% of our AOM diagnoses.
Scores
On the basis of our detailed symptom questionnaire and tympanicmembrane examination, we calculated

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e1155

3 scores used in previous literature.

First, we used the clinical/otologic
score14 primarily developed by Dagan
et al15 to determine the severity of AOM
and to measure the treatment outcome of AOM (temperature, irritability,
redness of tympanic membrane, and
bulging position were scored from 0 to
3, for a total range of 0 12). Second,
we used the modied AOM totalseverity index (AOM-Si) as suggested by
McCormick et al4 who used this score to
determine the severity of AOM for studying the treatment of nonsevere AOM only.
The AOM-Si score (range: 114) was calculated by including the highest OS-8 in
pneumatic otoscopy (measuring the
severity of tympanic-membrane inammation [range: 0 7]) and the
highest AOM-faces scale (measuring
parental perception of their childs
worst overall condition within 24
hours [range: 17]). Third, we used the
AOM severity-of-symptom scale (AOMSOS) (version 3.0) created by Shaikh et
al16 to measure the outcome in clinical
studies of AOM. The AOM-SOS score
consisted of ear-rubbing, excessive
crying, irritability, restless sleep, less
playful or active, poor appetite, and fever, scored as 0 (none), 1 (a little, including our categories mild and moderate),
or 2 (a lot, including our category severe). We classied temperature of
38C as 0 (none), 38.0C to 38.9C as 1
(a little), and 39C as 2 (a lot). A score
range of 0 to 14 was the result.
In addition, we assessed illness severity according to the American Academy
of Pediatrics (AAP) 2004 guidelines for
the diagnosis and management of
AOM.2 The child had severe illness if
ear pain (parentally reported and/or
reported by the child verbally) was
moderate or severe and/or the highest
temperature within 24 hours was
39C. Otherwise, the child had nonsevere illness.
We did not analyze these 3 scores or
the AAPs denition for illness severity
e1156

LAINE et al

if 1 or more components of a score

(except measured temperature) were
missing. If the child had had fever and
the temperature had not been measured within 24 hours, we used the
highest measured mean temperature
of his or her study group.
Statistical Analysis
The proportions were compared with
2 test or Fishers test as applicable.
The means were compared with the t
test and the medians with the MannWhitney U test. The likelihoods were estimated by calculating the relative risk
(RR) with respective 95% condence
intervals (CIs). The relationships between the scores were assessed by
Spearman correlation coefcients.
The statistical analyses were performed by using the SPSS 16.0 statistical package (SPSS Inc, Chicago, IL).

RESULTS
The study population comprised 469
children: 237 had AOM (AOM group)
and 232 had respiratory tract infection
(RTI) without AOM (non-AOM group).
Accordingly, parental suspicion of AOM
proved to be correct for 51% of all children, for 48% (68 of 141) of children
with no previous AOM, and for 52%
(169 of 325) of children with previous
AOM. Characteristics of children in
the AOM and non-AOM groups are
shown in Table 1. In the non-AOM
group, 61 children (26%) had unilateral or bilateral middle-ear uid. The
symptoms of these 61 children did
not differ from those with completely
healthy ears; rather, the latter
tended to have more severe symptoms (data not shown).
Reasons for Parental Suspicion of
AOM
The most common reason for parental
suspicion of AOM was restless sleep,
listed for 134 of 468 (29%) children (data
missing for 1 child in the AOM group).
However, restless sleep could not pre-

dict AOM (RR: 1.0 [95% CI: 0.8 1.2]) (Fig

1), nor could irritability that had evoked
parents suspicion of AOM in 84 children
(18%). Parents suspected AOM because
of ear-rubbing in 64 children (14%), but
when ear-rubbing was a reason for suspicion, AOM was improbable (RR: 0.7
[95% CI: 0.51.0]). Ear pain (parentally
reported or reported by the child verbally), fever, and severe or prolonged
rhinitis/cough were rare reasons
for parental suspicion and could not
predict AOM.
Occurrence, Duration, and
Severity of Symptoms
The occurrence of ear-related symptoms could not predict which children
had AOM (Table 2). Almost all parents
reported that their child had ear
pain, although children themselves
had rarely expressed it verbally. Earrubbing tended to be more common in
children who did not have AOM (70%
[AOM group] vs 78% [non-AOM group];
P .050). Occurrence of fever could
not predict AOM (RR: 1.2 [95% CI: 1.0
1.4]). Furthermore, the highest mean
temperature within 24 hours (38.7C
[AOM group] vs 38.6C [non-AOM
group]; P .508) (Fig 2) and the duration of fever (2.1 days [AOM group] vs
1.8 days [non-AOM group]; P .234)
did not differ between the groups. The
occurrences of nonspecic symptoms
(irritability, excessive crying, restless
sleep, less playful or active, and poor
appetite) were not predictive for AOM.
In fact, irritability suggested that the
child did not have AOM (RR: 0.7 [95% CI:
0.6 0.9]). Respiratory symptoms, conjunctivitis, mucus vomiting, vomiting,
and diarrhea could not predict which
children had AOM.
The duration of symptoms had no predictive value for AOM in children having RTI with and without AOM except
for rhinitis that had lasted 1 day
longer in those with AOM compared
with children with no AOM (Table 2).

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TABLE 1 Characteristics of 469 Children With Parental Suspicion of AOM

Age, mean (range), mo

Age, n (%)
611 mo
1223 mo
2435 mo
Male gender, n (%)
Race, n (%)
White
Caucasian-African
Age at rst AOM episode, mean (range), moa
No. of previous AOM episodes, n/N (%)
0
13
46
6
Sibling(s) in the household, n/N (%)
Daycare attendance, n/N (%)
Tobacco-smoke exposure, n/N (%)
Current use of pacier, n/N (%)
Duration of breastfeeding, mean (range), mob
OS-8 score at the visit, n (%)
0 (normal or effusion, no erythema)
1 (erythema only, no effusion)
2 (erythema, air-uid level, clear uid)
3 (erythema, complete effusion, no
opacication)
4 (erythema, opacication with air-uid level,
no bulging)
5 (erythema, complete effusion, opacication,
no bulging)
6 (erythema, bulging)
7 (erythema, bulging, complete effusion,
opacication, bulla formation)
Position of tympanic membrane, n (%)
Normal
Retracted
Full or bulging
Quality of middle-ear uid, n (%)
No visible uid
Clear or serous
Cloudy
Purulent
Tympanogram (peak pressure), n/N (%)
A (more than 100 dPa)
C (less than 100 dPa)
B (no peak)

AOM Group
(N 237)

Non-AOM Group
(N 232)

16 (635)

16 (635)

87 (37)
103 (43)
47 (20)
130 (55)

93 (40)
98 (42)
41 (18)
122 (53)

237 (100)
0 (0)
10 (027)

230 (99)
2 (1)
10 (029)

68/237 (29)
130/237 (55)
31/237 (13)
8/237 (3)
129/237 (54)
129/236 (55)
68/236 (29)
126/237 (53)
8 (030)

73/229 (32)
107/229 (47)
37/229 (16)
12/229 (5)
131/229 (57)
89/229 (39)
60/228 (26)
134/229 (59)
8 (024)

0 (0)
0 (0)
0 (0)
0 (0)

206 (89)c
23 (10)
3 (1)
0 (0)

49 (21)d

0 (0)

81 (34)e

0 (0)

84 (35)
23 (10)

0 (0)
0 (0)

16 (7)
0 (0)
221 (93)

159 (69)
42 (18)
31 (13)

0 (0)
5 (2)
40 (17)
192 (81)

171 (74)
32 (14)
28 (12)
1 (0.4)

P
.327
.712

.623
.244

.457
.308

.547
.001
.547
.245
.956
.001

.001

.001

.001
26/172 (15)
22/172 (13)
124/172 (72)

96/188 (51)
78/188 (41)
14/188 (7)

Data were missing for 77 children in the AOM group and 94 children in the non-AOM group.
Data were missing for 4 children in the non-AOM group.
c No effusion in 72% (148 of 206) of the children.
d Tympanic membrane had full or bulging position in 90% (44 of 49) of the children.
e All tympanic membranes had full position.
b

The severity of parentally reported ear

pain, childs verbal expression of ear
pain, ear-rubbing, and irritability did not
differ between children with and without
AOM (Fig 3). Furthermore, nonspecic,
respiratory, and gastrointestinal symptoms were equally severe in both groups
(Table 3). Only conjunctivitis was more
PEDIATRICS Volume 125, Number 5, May 2010

severe in those children who had AOM

compared with those with only RTI.
Scores
The clinical/otologic score was signicantly higher in children who had AOM
than in children who had only RTI (median: 4.0 vs 2.0; P .000) (Fig 4). The

AOM-Si score was likewise higher in

the AOM group than in the non-AOM
group (11.0 vs 6.0; P .000). However,
the AOM-SOS score based solely on
symptoms was equal between the AOM
and non-AOM groups (6.0 vs 6.0; P
.917). The same applied to the scoring
of the overall condition of the child by
the AOM-faces scale. According to the
AAPs denition for illness severity,
68% of children with AOM and 60% of
children without AOM would have been
categorized as having severe illness
(P .087).

DISCUSSION
Our main nding was that the occurrence, duration, and severity of symptoms did not predict AOM in children at
otitis-prone age when their parents
suspected AOM. Furthermore, solely
symptom-based scores could not differentiate children with AOM from
those without AOM. These results are
important, because symptoms are
used in the diagnosis and management of AOM.
For a new perspective, we analyzed the
reasons parents had when they suspected AOM in their child. The most
common reason given was restless
sleep, the symptom that most disturbs
the parents own life, although it
should be noted that it was not predictive for AOM. Parents of almost half of
the children suspected AOM on the
basis of a nonspecic symptom, and
none of the reasons for suspicion
could predict AOM.
Ear pain has been the symptom commonly associated with AOM.911 In our
study, the occurrence of parentally reported or the childs verbal expression
of ear pain could not predict AOM. Similarly, the severity of ear pain did not
differentiate children with and without
AOM. Our study design requiring AOM
suspicion might explain why almost all
parents reported ear pain in their
child. In contrast, fewer than one-fth

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e1157

FIGURE 1
RR for AOM according to the reasons for parental suspicion of AOM and the occurrence of each symptom in children diagnosed as having AOM (AOM group)
and in children with RTI without AOM (non-AOM group). a Parents of 62 children (32 in AOM group, 30 in non-AOM group) suspected AOM for a miscellaneous
reason or for several reasons.

TABLE 2 Occurrence and Mean Duration of Symptoms in 469 Children With Parental Suspicion of
AOM
Symptom

Parentally reported ear

pain
Childs verbal expression
of ear pain
Ear-rubbing
Fever
Irritability
Excessive crying
Restless sleep
Less playful or active
Poor appetite
Rhinitis
Nasal congestion
Cough
Hoarse voice
Conjunctivitis
Mucus vomiting
Vomiting
Diarrhea
a

Occurrences, n (%)
AOM Group
(N 237)

Non-AOM Group
(N 232)

219 (92)

213 (92)

.811

44 (19)

31 (13)

165 (70)
102 (43)
206 (87)
206 (87)
205 (87)
112 (47)
150 (63)
222 (94)
177 (75)
187 (79)
81 (34)
44 (19)
25 (11)
3 (1)
31 (13)

180 (78)
81 (35)
216 (93)
204 (88)
199 (86)
104 (45)
148 (64)
220 (95)
171 (74)
172 (74)
82 (35)
33 (14)
24 (10)
5 (2)
22 (10)

RR (95% CI)
for AOM

Mean Duration, da
AOM
Group

Non-AOM
Group

1.0 (0.71.5)

1.7

1.6

.661

.124

1.2 (1.01.5)

1.1

1.3

.427

.050
.071
.026
.741
.821
.598
.910
.591
.809
.223
.791
.204
.943
.500
.219

0.8 (0.71.0)
1.2 (1.01.4)
0.7 (0.60.9)
1.0 (0.71.2)
1.0 (0.81.3)
1.0 (0.91.3)
1.0 (0.81.2)
0.9 (0.61.3)
1.0 (0.81.3)
1.1 (0.91.4)
1.0 (0.81.2)
1.2 (0.91.4)
1.0 (0.81.4)
0.7 (0.31.8)
1.2 (0.91.5)

2.4
2.1
3.5
3.4
3.4
2.5
3.9
7.8
6.9
6.2
4.4
3.5
2.7
0.5
2.6

2.6
1.8
3.1
3.0
3.5
2.6
3.9
6.2
5.6
5.5
3.8
2.6
2.7
2.3
2.8

.318
.234
.134
.204
.800
.712
.945
.025
.076
.377
.260
.193
.946
.304
.861

Duration of each symptom among those children who had the symptom.

of these young children verbally expressed ear pain, a nding that agrees
with previous study results.9,11,17,18
Shaikh et al16 excluded ear pain from
the AOM-SOS score, which, as in our
results, points to parental difculties
with assessing ear pain in children at
this preverbal and otitis-prone age.
We found it surprising that earrubbing tended to be more common in
children without AOM than in children with AOM. This nding disagrees with the results of Niemela et
al,9 who included children with any
e1158

LAINE et al

kind of acute illness. Ear-rubbing has

been used almost as a synonym for
ear pain.24,9 However, infants may
rub their ear because of a blocked
ear or merely when becoming acquainted with their body. Furthermore, Baker19 reported that if earrubbing was a childs only complaint,
then no child had AOM. On the basis
of these results, we recommend
against using ear-rubbing as evidence of ear pain or as a sign of AOM.
Consistent with the results of previous
studies,911 the occurrence of fever did

not predict AOM in young children, although pediatric textbooks describe

fever as indicative of AOM.1,20,21 As in
our study, fever usually has occurred
in less than half of the AOM population.4,5,9,11,2224 The distribution of the
highest mean temperature in children
with and without AOM was surprisingly
similar. For this reason, fever might be
associated with the viruses causing RTI
rather than specically with AOM.17,25
The occurrence, duration, and severity
of nonspecic symptoms were equal in
children with and without AOM. Nonspecic symptoms occur during viral
infections, and frequently with no infection, in young children. As others
have shown, nonspecic symptoms
are not predictive for AOM at otitisprone age.9,11
Respiratory symptoms could not predict AOM, with the exception of
conjunctivitis, which was more severe in children with AOM than in
children with only RTI. The so-called
conjunctivitis-otitis syndrome is well
known26,27 but has a limited role in
predicting AOM because of its rare
occurrence.9,11
Gastrointestinal symptoms were not
predictive for AOM. In previous studies,
the occurrence of vomiting was more
than 10 times higher than in our
study.9,28,29 However, we asked separately about actual vomiting and mucus

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FIGURE 2
The highest measured temperature within 24 hours in children diagnosed to have acute otitis media (AOM
group) and in children with RTI without AOM (non-AOM group). The horizontal lines show the highest
measured mean temperature of each group (38.7C [AOM group], 38.6C [non-AOM group]; P .508).

vomiting and found that mucus vomiting

was reported 10 times more frequently
than actual vomiting. On the basis of this
new nding, it would be important to report these 2 symptoms separately, because mucus vomiting is a respiratory
symptom rather than a gastrointestinal
symptom, and antimicrobial agents may
cause mainly actual vomiting.
Applying the scores from recent literature to our data raised interesting and
new considerations. The clinical/otologic score and the AOM-Si score, both
based on symptoms and ear-related
signs, were signicantly higher in children with AOM than in children with
only RTI. It is important to note that this
was because of the ear-related signs
of the scores; the symptom-based
components did not differ. Similar to
the AOM-faces scale, the AOM-SOS
score based solely on symptoms gave
equal scores to children having RTI
with and without AOM. It should be
noted that Shaikh et al16,30 developed
the AOM-SOS score not to determine
the severity of AOM but, rather, specifically to measure outcome in clinical
studies of AOM. The AAPs criteria for
PEDIATRICS Volume 125, Number 5, May 2010

severe illness is designed to determine the optimal treatment for AOM.2

In our study population, illness severity could not predict the probability of
AOM. Because solely symptom-based
scores and the AAPs denition of illness severity lead to similar results in
young symptomatic children with and
without AOM, we recommend validating scoring systems that would include
tympanic-membrane examination.
This study has several strengths. We
used a standardized, structured questionnaire for the symptom survey.
Data were collected before tympanicmembrane examination. Although our
AOM diagnosis was based on pneumatic
otoscopy, which is somewhat subjective,
our physicians also used tympanometry
and had excellent interobserver agreement. We had a prespecied denition
for AOM, even stricter than that of the
AAP.2 Our AOM group had typical ndings
of positive bacterial culture: full/bulging
position of tympanic membrane; purulent middle-ear uid; and tympanometric B curve.24,31,32 In contrast, our nonAOM group had typical ndings of
negative bacterial culture or nonexist-

FIGURE 3
Severity (none, mild, moderate, or severe) of
parentally reported ear pain (A), childs verbal
expression of ear pain (B), ear-rubbing (C), and
irritability in the AOM and non-AOM groups (D).

ence of middle-ear uid: retracted position of tympanic membrane and tympanometric C curve.24,33 Our approach was
based on what is daily encountered in
an outpatient setting: an acutely ill,

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e1159

TABLE 3 Severity of Symptoms in Children in the AOM and Non-AOM Groups

Symptom

Excessive crying
Restless sleep
Less playful or active
Poor appetite
Rhinitis
Nasal congestion
Cougha
Hoarse voice
Conjunctivitis
Mucus vomiting
Vomiting
Diarrhea

AOM Group (N 237), n (%)

Non-AOM Group (N 232), n (%)

None

Mild

Severe

None

Mild

Severe

31 (13)
32 (14)
125 (53)
86 (36)
15 (6)
60 (25)
48 (20)
156 (66)
193 (81)
212 (89)
234 (99)
206 (87)

128 (54)
73 (31)
93 (39)
100 (42)
101 (43)
103 (43)
121 (51)
67 (28)
30 (13)
23 (10)
3 (1)
27 (11)

78 (33)
132 (56)
19 (8)
51 (22)
121 (51)
74 (31)
67 (28)
14 (6)
14 (6)
2 (1)
0 (0)
4 (2)

28 (12)
33 (14)
128 (55)
84 (36)
12 (5)
61 (26)
60 (26)
149 (64)
199 (86)
208 (90)
227 (98)
210 (91)

124 (53)
64 (28)
88 (38)
99 (43)
121 (52)
88 (38)
120 (52)
68 (29)
31 (13)
22 (9)
4 (2)
20 (9)

80 (34)
135 (58)
16 (7)
49 (21)
99 (43)
83 (36)
52 (22)
15 (6)
2 (1)
2 (1)
1 (0)
2 (1)

.910
.746
.828
.992
.118
.438
.202
.928
.011
.996
.550
.429

Percentages may not total 100% because of rounding.

a Data were missing for 1 child in the AOM group.

young child with anxious parents who

suspect AOM.
The limitations also must be elucidated. Our results cannot be generalized to older children with verbal skills.
Because we focused on children with
parental suspicion of AOM, our results
are not applicable to the entire age
group. Children without AOM in our
study may have had more severe
symptoms than did children with RTI in
general. In addition, children with AOM
in our study may have had a different
prole of symptoms than did children
with accidentally diagnosed AOM. Fi-

nally, the methodology could have

been improved by asking the parents
to complete the questionnaire.
The message of our study for clinicians
and parents is that symptoms cannot
predict AOM at otitis-prone age. Therefore, the diagnosis and management
of AOM cannot be made by telephone
contact. All children with symptoms
that cause parental anxiety deserve
careful clinical examination, including
cerumen removal followed by pneumatic otoscopy.
The signicance of this study for the
otitis media authorities, guideline-

makers, and researchers is that the

symptom-based scores can poorly differentiate young children with AOM
from those with only RTI. Even if children have the same diagnosis, each
one has an individual spectrum of
symptoms. Furthermore, each child
has a different spectrum of symptoms
in different episodes of infections
caused by different microbes. Accordingly, if the severity scores are based
solely on symptoms, the scoring actually depends more on the occurrence
of the symptoms than on the severity
of the symptoms. We propose that the
scores also include evaluation of the
tympanic membrane.

CONCLUSIONS
AOM cannot be predicted by the occurrence, duration, or severity of
symptoms at otitis-prone age. Likewise, solely symptom-based scores
do not differentiate RTI with and
without AOM. Therefore, treatment
recommendations should not be entirely based on symptom severity,
and the role of tympanic-membrane examination should be emphasized in the

FIGURE 4
Distributions of the score values in the AOM and non-AOM groups. The boxplots show the 25th, 50th (median), and 75th quartiles together with the minimum
and maximum values of each score. The Spearman correlation coefcient between the clinical/otologic and AOM-Si scores was positive within the AOM
group (r 0.462; P .001) and within the non-AOM group (r 0.344; P .001), and also positive between AOM-SOS and AOM-faces scale within the AOM
group (r 0.258; P .001) and within the non-AOM group (r 0.386; P .001).

e1160

LAINE et al

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ARTICLES

diagnosis and scoring of AOM in clinical practice and research settings.

ACKNOWLEDGMENTS
This work was supported by grants
from the Foundation for Paediatric
Research; the Research Funds from
Specied Government Transfers; the
Finnish Cultural Foundation, Varsinais-

Suomi Regional Fund; Turku University Hospital Research Foundation;

the Maud Kuistila Memorial Foundation; the Jenny and Antti Wihuri Foundation; and the Paulo Foundation. We
acknowledge the European Society
for Paediatric Infectious Diseases
for the fellowship to Dr Ruohola
(2006 2007).

We thank Raakel Luoto, MD, and Elina

Lahti, MD (residents of pediatrics at
Turku University Hospital) for their
contribution to data collection, and
Tuomo Puhakka, MD (ear-nose-throat
specialist at Turku University Hospital)
for assessing digital images and videos of tympanic-membrane ndings of
the study patients.

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PEDIATRICS Volume 125, Number 5, May 2010

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e1161

Symptoms or Symptom-Based Scores Cannot Predict Acute Otitis Media at

Otitis-Prone Age
Miia K. Laine, Paula A. Thtinen, Olli Ruuskanen, Pentti Huovinen and Aino Ruohola
Pediatrics 2010;125;e1154; originally published online April 5, 2010;
DOI: 10.1542/peds.2009-2689
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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
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Symptoms or Symptom-Based Scores Cannot Predict Acute Otitis Media at

Otitis-Prone Age
Miia K. Laine, Paula A. Thtinen, Olli Ruuskanen, Pentti Huovinen and Aino Ruohola
Pediatrics 2010;125;e1154; originally published online April 5, 2010;
DOI: 10.1542/peds.2009-2689

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/125/5/e1154.full.html

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

publication, it has been published continuously since 1948. PEDIATRICS is owned,
published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
Boulevard, Elk Grove Village, Illinois, 60007. Copyright 2010 by the American Academy
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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