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Family Practice 2012; 29:6368
doi:10.1093/fampra/cmr042
Advance Access published on 4 August 2011
Treatment of acute otitis media in general practice:
quality variations across countries
Malene Plejdrup Hansen
a,
*, Dorte Ejg Jarbol
a
,
Bente Gahrn-Hansen
b
, Rene dePont Christensen
a
, Anders Munck
c
,
Christina Ellegaard Trankjr Ryborg
a
and Lars Bjerrum
d
a
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winslws Vej 9A, 5000
Odense C,
b
Department of Clinical Microbiology, Odense University Hospital, J.B. Winslws Vej 21, 5000 Odense C,
c
Audit Pro-
ject Odense, Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winslws Vej
9A, 5000 Odense Cand
d
Section of General Practice, Department of Public Health, University of Copenhagen, ster Farimagsgade 5,
1014 Copenhagen K, Denmark.
*Correspondence to Malene Plejdrup Hansen, Research Unit of General Practice, Institute of Public Health, University of Southern
Denmark, J.B. Winslws Vej 9A, 5000 Odense C, Denmark; E-mail: mplejdrup@health.sdu.dk
Received 24 January 2011; Revised 1 June 2011; Accepted 28 June 2011.
Background. Recommendations for antibiotic treatment of acute otitis media (AOM) have
changed over the years, and today many experts recommend initial observation. However, an-
tibiotic prescribing should be considered in children aged <2 years or if AOM is accompanied by
discharging ear.
Objectives. To investigate the quality of treatment of AOM in general practice and to explore the
inuence of selected GP and patient characteristics on antibiotic prescribing.
Methods. During the winter 2008, a prospective registration of patients diagnosed with AOM
was conducted in general practice in Lithuania, Kaliningrad, Spain, Argentina, Sweden and Den-
mark. Some 1175 patients diagnosed with AOM were registered. Information about age and sex
of the patient, duration of symptoms (days), temperature >38.5C, ear discharge and the antibi-
otic treatment given was recorded.
Results. Danish GPs had the lowest antibiotic prescription rate for AOM [72.7% (95% condence
interval (CI) = 67.077.8)] and GPs in Kaliningrad had the highest [97.1% (95% CI = 89.899.6)].
Narrow-spectrumpenicillin was almost exclusively prescribed in the two Nordic countries, while
broad-spectrum penicillins, often in combination with clavulanic acid, were prescribed in the
other four countries. Macrolides comprised 510% of prescriptions. Antibiotic prescribing was
associated with the following characteristics of the patients: symptoms for >3 days, ear dis-
charge and fever.
Conclusion. The majority of patients with AOM were treated with antibiotics in all six countries,
but considerable variations in both prescribing rate and choice of antibiotics were identied.
Keywords. Antibiotics, family practice, otitis media, purulent otitis media, quality indicators.
Introduction
Acute otitis media (AOM) is a common community-
acquired infection and up to 80% of children aged
3 years have had at least one episode of AOM.
1
The
diagnostic criteria for AOM include rapid onset of
symptoms, middle ear inammation and effusion.
2
Fe-
ver, ear pain, ear rubbing, irritability and restless sleep
are common but non-specic symptoms.
3
Historically, the majority of patients with AOM
have been treated with antibiotics, making it one of
the most common conditions for which antibiotics are
prescribed.
4
High antibiotic use is correlated with
increased antibiotic resistance and in many countries
resistance is increasing among bacterial pathogens
causing AOMsuch as Streptococcus pneumoniae.
5
In some European countries, the rate of penicillin
non-susceptible strains of S. pneumoniae has increased
to >50%, while in the Nordic countries, it is still rela-
tively low, e.g. 2.4% in Denmark.
6,7
Recommendations for antibiotic treatment of AOM
have changed over the years, and today most experts
recommend initial observation.
8
Most children with
AOM recover spontaneously within a few days, and
on average, 16 children have to be treated to prevent
one child suffering from ear pain after 27 days
63

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[number-needed-to-treat (NNT) = 16].
9
However, anti-
biotic prescribing should be considered in children aged
<2 years or if AOM is accompanied by discharging ear.
8
A meta-analysis has found that three children have to
be treated to prevent an extended course of the disease
in one child with discharging ear (NNT = 3).
10
Serious
complications like mastoiditis are rare and it has been
shown that >4000 patients have to be treated with
antibiotics to prevent one case of mastoiditis.
11
Based on a prospective registration of patients diag-
nosed with AOM in six countries, we aimed to investi-
gate the quality of treatment of AOM in general
practice by use of a set of newly developed quality in-
dicators.
12
Moreover, we wanted to explore the inu-
ence of selected GP and patient characteristics on
antibiotic prescribing.
Methods
Setting
This study is part of a European Union (EU)-funded
project with the overall focus of lowering bacterial re-
sistance by reducing prescribing of unnecessary antibi-
otics for respiratory tract infections and by improving
the use of appropriate antibiotics in suspected bacte-
rial infections.
13
The EU-funded project was designed
to evaluate the impact of a multifaceted intervention
targeting GPs and patients in six countries with differ-
ent prevalence of after antibiotic resistance.
14
This
study shows baseline results before the intervention.
During a 3-week period in the winter 2008, 618
GPs from six countries participated in a prospective
registration of patients diagnosed with a respiratory
tract infection. The GPs originated from Lithuania (n =
31), Kaliningrad (n = 39), Spain (n = 309), Argentina
(n = 60), Sweden (n = 77) and Denmark (n = 102).
There was a 6-month gap between the registrations in
Argentina (July/August 2008) and in the other ve
countries (January/February 2008) because of its loca-
tion in the southern hemisphere. Argentina has a very
different culture and traditions compared to the Euro-
pean countries and represented a non-European coun-
try with excessive problems of antibiotic resistance.
The other ve countries were selected for this project
because they represented the well-known difference
in antibiotic consumption in Northern, Southern and
Central Europe.
15
The registration was performed ac-
cording to the Audit Project Odense method de-
scribed by Munck et al.
16,17
The GPs were invited by
email, mail or personal contact and they all partici-
pated on a voluntary basis. Registration material was
prepared in English and translated into Lithuanian,
Russian, Spanish, Swedish and Danish by means of
a standardized forwardbackward translation.
18
De-
tails dealing with the entire EU project are described
in the study protocol.
13
Subjects and analyses
A total of 33 273 patients with a respiratory tract in-
fection were registered, of which 1255 had AOM, cor-
responding to 3.8% of all patients with a respiratory
tract infection. Some 80 patients were excluded due to
insufcient registration, resulting in the inclusion of
1175 patients with complete registrations of AOM.
During the 3-week registration period, a total of 409
GPs registered one or more patients with AOM. Only
patients who consulted the GP for the rst time for
the current disease were included. The diagnosis of
AOM was based on the assessment and diagnostics of
the GP. For each contact, the GP registered age and
sex of the patient, the duration of symptoms (days),
occurrence of temperature >38.5C, occurrence of ear
discharge and antibiotic treatment given. Antibiotics
were classied according to the Anatomical Therapeu-
tic Chemical classication dened by the World
Health Organisation.
19
National guidelines for treatment of AOM were not
implemented in Argentina, Kaliningrad and Lithuania,
and furthermore, standards for optimal prescribing for
AOM are not universally accepted. In this study, the
GPs antibiotic prescribing patterns for treatment of
AOM were compared between countries and the in-
ternational National Institute for Health and Clinical
Excellence (NICE) guidelines were used as a standard
for good quality.
8
In 2008, a set of 41 disease-specic
quality indicators for diagnosis and treatment of respi-
ratory tract infections in general practice was devel-
oped by means of a Delphi study.
12
Eight of these
quality indicators were related to AOM (Box 1) and
applicable in evaluating the quality of antibiotic treat-
ment of AOM as dened by the NICE guidelines.
8
The GPs were asked to complete a questionnaire fo-
cussing on personal information and practice charac-
teristics. The association between selected GP (gender,
age, and minutes per consultation) and patient charac-
teristics (age, days with symptoms, ear discharge, and
fever) and antibiotic prescribing was investigated us-
ing logistic regression analysis. Odds ratios (ORs) with
95% condence intervals (CIs) were reported. The
analysis was adjusted for confounding by country. All
BOX 1 Quality indicators for antibiotic treatment of AOM
1. Proportion of patients treated with antibiotics
Proportion of patients treated with:
2. Narrow-spectrum penicillin (phenoxymethylpenicillin)
3. Broad-spectrum penicillin (ampicillin, pivampicillin, amoxicillin
+/ clavulanic acid)
4. Macrolides
5. Cephalosporins
6. Quinolones
7. Proportion of patients with discharging ear treated with antibiotics
8. Proportion of patients >2 years with <3 days of symptoms of AOM
treated with antibiotics
Family PracticeThe International Journal for Research in Primary Care 64

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statistical analyses were conducted using Stata version
10.0.
20
Results
Table 1 shows the characteristics of the GPs and the pa-
tients included in the study. In all countries, except
Denmark, the majority of GPs were female, and the
average age was between 43 years (Argentina) and
54 years (Denmark). There was a 3-fold variation in
the duration of the consultation ranging from 7 minutes
in Spain to 20 minutes in Sweden. The median age of
patients varied from 3 years in Denmark to 33 years in
Spain. No notable difference in the duration of symp-
toms (23 days) before the rst consultation was found.
The majority of diagnosed patients were treated
with antibiotics (Table 2). Overall, 84.1% (95%
CI = 81.986.1) were prescribed antibiotics at rst con-
sultation (data not shown). Danish and Lithuanian
GPs had the lowest prescribing rate, 72.7% (95%
CI = 67.077.8) and 77.2% (95% CI = 66.485.9)
respectively, while almost all patients in Kaliningrad
were treated with antibiotics (97.1%, 95% CI = 89.8
99.6). A considerable variation in the type of antibiotic
used was demonstrated (Table 2). Narrow-spectrum
penicillin was almost exclusively prescribed in the two
Nordic countries, while GPs in the other four coun-
tries often prescribed broad-spectrum penicillins, fre-
quently in combination with clavulanic acid. Macrolides
were prescribed for 510% of patients in all countries,
except Argentina where it was prescribed for <1% of
patients.
The antibiotic prescribing rate in patients with ear
discharge is shown in Figure 1. More than 90% of pa-
tients with ear discharge were prescribed antibiotics in
Kaliningrad, Lithuania, Spain, Argentina and Sweden,
while only 76.1% (95% CI = 64.185.7) were treated
with antibiotics in Denmark.
Figure 2 illustrates that the majority of patients >2
years with <3 days of symptoms of AOM were treated
with antibiotics at rst consultation in all six countries.
Generally, AOM is considered to be a childhood
infection. A subgroup analysis was, therefore, per-
formed, including only children aged 010 years. The
subgroup analysis showed the same distribution of pa-
tient characteristics (duration of symptoms and pro-
portion of patients with ear discharge) and of the
antibiotic prescription pattern (data not shown). How-
ever, the proportion of patients with temperature
>38.5C was higher in the subgroup analysis (children)
compared to the analysis of the total study population
(data not shown).
Table 3 shows crude and adjusted OR for GP and
patient characteristics associated with antibiotic pre-
scribing for AOM. The crude analysis of the GP char-
acteristics showed a signicant association between
antibiotic prescribing and both female gender and
young GP. However, after adjustment, these associa-
tions were no longer signicant. The characteristics of
the patients associated with antibiotic prescribing were
age <2 years, 3+ days with symptoms, ear discharge
and fever. In the crude as well as in the adjusted anal-
ysis, these characteristics, except for age <2 years, had
a signicant inuence on antibiotic prescribing.
Discussion
Main ndings
We found that the majority of patients with AOM
were treated with antibiotics, but the study showed
considerable variations in both prescribing rate and
choice of antibiotics between countries. Danish GPs
demonstrated the lowest antibiotic prescription rate
and GPs in Kaliningrad the highest. Narrow-spectrum
penicillin was almost exclusively prescribed in the two
Nordic countries in accordance with national guide-
lines, while broad-spectrum penicillins, often in combi-
nation with clavulanic acid, were the preferred
antibiotics in the other four countries. Macrolides
were prescribed in 510% of patients in all countries,
except Argentina, even though macrolides are only
recommended for patients allergic to penicillins.
2,21
TABLE 1 Characteristics of GPs and patients
Denmark Sweden Lithuania Kaliningrad Spain Argentina
GP characteristics n = 83 n = 59 n = 23 n = 20 n = 178 n = 46
Females
a
40 (48) 31 (53) 18 (78) 17 (85) 113 (63) 32 (70)
Age in years
b
54 (4758) 52 (4059) 47 (4250) 47 (4252) 46 (4149) 43 (3445)
Minutes per consultation
b
12 (1015) 20 (2023) 15 (1015) 15 (1218) 7 (58) 15 (1015)
Patient characteristics n = 278 n = 196 n = 79 n = 68 n = 392 n = 162
Females
a
144 (52) 95 (48) 44 (56) 36 (53) 228 (58) 76 (47)
Age in years
b
3 (16) 4 (27) 10 (417) 11 (530) 33 (1749) 10 (420)
Days with symptoms
b
3 (25) 3 (27) 3 (24) 2 (24) 3 (25) 2 (23)
Patients with temperature > 38.5
a
148 (53) 113 (58) 45 (57) 36 (53) 124 (32) 111 (69)
Patients with ear discharge
a
67 (24) 47 (24) 39 (49) 60 (88) 214 (55) 129 (80)
a
Data presented as n (%).
b
Data presented as median (25 and 75 percentile).
65 AOM and quality variations in antibiotic treatment

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In accordance with international guidelines, the ma-
jority of patients with AOM accompanied with ear
discharge were treated with antibiotics. However,
a more restrictive attitude was found in Denmark,
where only 76.1% of patients with ear discharge were
treated. In all six countries, the majority of patients
>2 years with <3 days of symptoms of AOM were
treated with antibiotics, even though experts recom-
mend initial observation for this group of patients.
8,9
We found no signicant inuence on antibiotic pre-
scribing associated with any characteristics of the
GPs, but a number of characteristics of the patients
were associated with an increased prescribing rate,
e.g. long symptom duration, ear discharge and fever.
Strengths and limitations
The strength of this study is the inclusion of a large
group of GPs and patients from six very different
countries. Our results are based on a pragmatic study
design that reects the presentation and daily manage-
ment of patients with AOM in general practice.
16
Some limitations have to be kept in mind when inter-
preting the study results. Firstly, the GPs participated
on a voluntary basis and their prescribing habits may
not necessarily represent the average prescribing of
antibiotics in their country.
13,22
Secondly, as all data
were self-reported by the GPs, we are not able to ex-
plore the accuracy of the diagnosis of AOM or the
symptoms reported. A major limitation is the lack of
a gold standard regarding the diagnosis of AOM, and
there may have been a certain degree of diagnostic mis-
classication.
3
In Kaliningrad, the overwhelming ma-
jority of patients appear to have had ear discharge,
whereas only 24% of patients in the Nordic countries
demonstrated this symptom. This variation can explain
some, though not all, of the differences in antibiotic
prescribing. Thirdly, in Spain, many children are exam-
ined by a paediatrician and not by a GP. In this study,
only 60% of the Spanish GPs attended to children
<16 years, while almost all GPs in the other countries
attended to this group of patients (data not shown).
Finally, relative few patients were included in each
of the six countries resulting in a low statistical power,
thus only fairly strong associations are detectable. Fur-
thermore, there can be several other explanations for
the demonstrated differences since the study design
did not allow for e.g. inuence of the pharmaceutical
industry or differences in case-mix.
Comparison with existing literature
This study demonstrated a variation in antibiotic pre-
scription rates for AOM from 72.7% (95% CI = 67.0
77.8) in Denmark to 97.1% (95% CI = 89.899.6) in
Kaliningrad. These ndings are in accordance with
a newly published international study which found that
>80% of physicians (pediatricians and family practi-
tioners) from France, Spain, Argentina, Mexico, Saudi
Arabia, South Korea and Thailand used antibiotic as
their rst-line treatment for AOM.
23
A Swedish study
showed that patients with AOM were prescribed an an-
tibiotic at 76% of visits, and a UK cohort study over
a 10-year period (19912001) demonstrated a constant
antibiotic rate of 8084% for treatment of AOM.
24,25
The present study showed a large variation in the
proportion of patients presenting with ear discharge.
In all six countries, it was higher than in a newly pub-
lished UK study, where 15% of patients presented
with ear discharge at rst visit.
26
In accordance with
the UK study, we also found that ear discharge was
a strong predictor of antibiotic prescription.
In most countries, beta-lactam antibiotics are rec-
ommended as rst-line antibiotics for treatment of
AOM; nevertheless, macrolides are increasingly pre-
scribed worldwide. A Dutch study showed that 8.8%
of prescriptions for AOM comprised macrolides, and
an American study demonstrated that the prescribing
of macrolides for AOM increased from 9% to 15% in
the period from 1998 to 2004.
27,28
We showed that
macrolides comprised 510% of the prescriptions in
Spain, Kaliningrad, Lithuania, Sweden and Denmark.
These ndings are critical, not only because of in-
creasing problems with antibiotic resistance but also
because it is documented that patients receiving mac-
rolides for the treatment of AOM are more likely to
experience clinical failure than those receiving rst-
line antibiotics.
29
TABLE 2 Antibiotics used for treatment of AOM
a
Denmark Sweden Lithuania Kaliningrad Spain Argentina
Patients treated with antibiotics 72.7 (67.077.8) 86.7 (81.291.1) 77.2 (66.485.9) 97.1 (89.899.6) 86.5 (82.789.7) 92.6 (87.496.1)
Narrow-spectrum penicillin 58.4 (51.365.3) 81.2 (74.586.8) 6.6 (1.815.9) 3.0 (0.410.5) 0.3 (0.01.6) 0.0 (0.02.4
b
)
Broad-spectrum penicillin 31.2 (24.938.1) 10.0 (5.915.5) 39.3 (27.152.7) 45.5 (33.158.2) 20.4 (16.225.0) 51.3 (43.059.6)
Broad-spectrum penicillin with clavulanic acid 0.5 (0.02.7) 0.6 (0.03.2) 44.3 (31.557.6) 33.3 (22.246.0) 50.7 (45.356.2) 40.0 (32.148.3)
Macrolides 6.4 (3.510.8) 5.9 (2.910.6) 6.6 (1.815.9) 10.6 (4.420.6) 5.9 (3.69.0) 0.7 (0.03.7)
Cephalosporins 0.0 (0.01.8
b
) 1.2 (0.14.2) 3.3 (0.411.3) 0.0 (0.05.4
b
) 12.7 (9.316.7) 6.0 (2.811.1)
Quinolones 0.5 (0.02.7) 0.0 (0.02.1
b
) 0.0 (0.05.9
b
) 7.6 (2.516.8) 7.4 (4.810.7) 0.7 (0.03.7)
Others 3.0 (1.16.4) 1.2 (0.14.2) 0.0 (0.05.9
b
) 0.0 (0.05.4
b
) 2.7 (1.25.0) 1.3 (0.24.7)
a
Data presented in percentages (95% CI).
b
One-sided, 97.5% CI.
Family PracticeThe International Journal for Research in Primary Care 66

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Implications for future research and clinical practice
This study demonstrated that the majority of patients
with AOM were treated with antibiotics, although
guidelines recommend initial observation for most pa-
tients with AOM. Antibiotics can cause adverse ef-
fects like diarrhoea, stomach pain and rash and may
also select for antibiotic resistance. Moreover, children
who receive antibiotics are at greater risk of recur-
rence than children not treated with antibiotics.
30
Con-
sequently, it is of great importance to identify the
patients, who will benet from antibiotic treatment.
Several studies have identied the subgroups of pa-
tients with AOM who will benet the most from anti-
biotic treatment, but nevertheless, there is still an
ongoing discussion about the antibiotic treatment of
this group of patients. Further studies dealing with the
antibiotic treatment of patients with AOM are neces-
sary to clarify this very essential issue.
This study also demonstrated that patient character-
istics like long symptom duration, fever and ear dis-
charge were associated with an increased prescribing
rate, which is in accordance with guideline recommen-
dations.
A considerable variation in both prescribing rate and
choice of antibiotics was identied. It is possible that
a systematic use of quality indicators focussing on the
diagnostic process and choice of antibiotics will im-
prove the quality of treatment in patients with AOM.
This initiative should be explored in further studies.
Acknowledgement
We would like to thank the GPs who participated in
this study and all our colleagues in the European pro-
ject, Health Alliance for Prudent Prescribing, Yield
And Use of Anti-microbial Drugs In the Treatment of
Respiratory Tract Infections.
Declarations
Funding: The European Commission: DG SANCO
under the Frame Program 6 (SP5A-CT-2007_044154);
The Danish Research Foundation for General Prac-
tice and the Institute of Public Health, University of
Southern Denmark.
FIGURE 1 Percentage of patients with AOM and ear
discharge treated with antibiotics
FIGURE 2 Percentage of patients >2 years with <3 days of
symptoms of AOM treated with antibiotics
TABLE 3 GP and patient characteristics associated with antibiotic
prescribing in patients with AOM
Crude OR (95%
CI)
Adjusted OR (95%
CI)
GP characteristics
Gender
Male 1.00 1.00
Female 1.61 (1.182.21) 1.42 (0.992.03)
Age (years)
<39 1.00 1.00
4059 0.49 (0.310.79) 0.60 (0.361.01)
60+ 0.41 (0.210.81) 0.78 (0.361.69)
Minutes per consultation
010 1.00 1.00
11+ 1.04 (0.761.42) 0.93 (0.571.51)
Patient characteristics
Age (years)
01 1.00 1.00
2+ 1.03 (0.681.59) 0.90 (0.551.47)
Days with symptoms
02 1.00 1.00
3+ 1.68 (1.232.31) 2.09 (1.482.95)
Ear discharge
No 1.00 1.00
Yes 4.49 (3.076.57) 4.29 (2.816.56)
Fever
No 1.00 1.00
Yes 2.94 (2.094.15) 3.22 (2.204.70)
Country
Denmark 1.00 1.00
Sweden 2.46 (1.514.01) 2.41 (1.374.25)
Lithuania 1.28 (0.712.30) 0.80 (0.411.56)
Kaliningrad 12.42 (2.9751.95) 5.27 (1.1923.31)
Spain 2.41 (1.633.56) 2.21 (1.273.85)
Argentina 4.70 (2.478.96) 2.13 (1.034.39)
67 AOM and quality variations in antibiotic treatment

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Ethical approval: The Scientic Ethical Committee for
Vejle and Funen Counties, Denmark, approved the
HAPPY AUDIT project.
Conict of interests: none.
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