A Questionnaire-Based Survey of Indian ENT Surgeons to Estimate Clinic Prevalence of Acute Otitis Media, Diagnostic Practices, and Management Strategies

Abstract

Acute otitis media (AOM) is common in Indian children, but there is limited published information on its clinic prevalence, clinicians’ diagnostic practices, and their management strategies. We approached 649 ear-nose-throat (ENT) surgeons to assess these aspects of AOM. We conducted the survey between May 2010 and February 2011 with the same set of ENT surgeons practising across India, once each during summer, monsoon and winter, using a validated 36-item questionnaire to record their reflective recall. 78 % (506/649) of approached ENT surgeons responded. The clinic prevalence of AOM was 43 % with peaks reported in July and December. 96 % (486/506) of the surgeons used otoscopy to diagnose AOM. 86 % (435/506) prescribed analgesics, and 89 % (449/506) prescribed decongestants. 98 % (495/506) treated AOM with an antibiotic at initial consultation: amoxicillin/clavulanic acid 78 % (395/506), amoxicillin 29 % (144/506), cefpodoxime 29 % (149/506), cefixime 28 % (141/506) and azithromycin 27 % (134/506). Amoxicillin/clavulanic acid 32 % (162/506) and cefpodoxime 27% (137/506) were mostly prescribed for relapse. The average reported duration of initial antibiotic therapy was 7 days and for relapse was 9 days. The reported clinic prevalence of AOM was higher (43 %) than anticipated (about 10 %) in ENT practice. Almost all the ENT surgeons used an otoscope to diagnose AOM. Amoxicillin/clavulanic acid was the preferred antibiotic for treating AOM either initially or for relapse. Most surgeons also used analgesics and decongestants for symptomatic relief.

Introduction

Acute otitis media (AOM) is an infectious disease typical of children. Such patients are most frequently seen by ear-nose-throat (ENT) surgeons and pediatricians. Epidemiology studies of otitis media in India have focused mainly on suppurative otitis media, its prevalence, risk factors and hearing impairment resulting from it [1–3]. However, information on the prevalence of AOM and the diagnostic and therapeutic strategies practiced by ENT surgeons is limited. The purpose of this survey was to collect such information based upon the memory recall of ENT surgeons so that it could help improve the current perception of AOM in children and perhaps suggest areas for improvement or change.

Methods

The survey was carried out between May 2010 and February 2011 using a 36-item questionnaire, which was validated for content by the Center for Otitis Media Research and Education (CORE) (Bangalore), a body comprised of ENT surgeons and pediatricians. The section pertaining to prevalence of AOM was printed in triplicate, one for each season, viz., summer, monsoon, and winter. The section pertaining to diagnostic and therapeutic practices had only one copy. The survey was done by field workers of a clinical research organisation (CRO) who visited the participating doctors and got the questionnaire filled by them: once in each season for the prevalence section, and once only for the diagnostic and therapeutic sections.

Exploratory discussion with ENT surgeons had suggested that the prevalence of AOM in their clinic patients would be approximately 10 %. We decided that the estimated prevalence should not differ from the real prevalence by more than 2 %, and we should have 95 % confidence in the accuracy of our estimate. With these inputs, Stata (version 8.2, Stata Corporation, College Station, Texas, USA) yielded a sample size of 30. Making allowance for possible attritions and to ensure a pan-India representation of ENT surgeons catering to patients belonging to different socioeconomic strata across different regions of the country, we decided to enrol 500 participants.

An independent ethics committee (Inter System Biomedica Ethics Committee, ISBEC) approved the survey. Using a national list of ENT surgeons, the field workers approached prospective, randomly selected respondents so as to enrol approximately 125 participants each from the east, west, south, and north regions of the country, thus representing all regions equally. All eligible participants had to hold a postgraduate diploma or degree in ENT surgery; be in active practice; agreeable to receive three visits from the field worker, one in each season; and willing to give written consent for participating in the survey. The sampling process was also designed to provide approximately equal representation of ENT surgeons catering to patients from the lower, middle, and higher socioeconomic strata.

The completed questionnaires were checked by the field workers and the CRO head office staff and sent to our office. Epi Info (version 3.5.1, Centers for Disease Control and Prevention, Atlanta, Georgia, USA) was used for entry, management, and analysis of data; other software used were True Epistat (version 5.3, Epistat Services, Richardson, Texas, USA) and Microsoft Excel. Proportions were expressed with their 95 % confidence intervals, and compared using Chi-square test with Yates’ correction. Interval data were compared using ANOVA, followed by Tukey’s multiple comparison test where appropriate.

Results

Profile of Respondents

Of the 649 respondents approached, 506 (78 %) participated. Among these, 440 (87 %) were males, and 66 (13 %) females. The average age of participants was 45 years (SD 10) and the average duration of practice was 16 years (SD 10). By qualification, 283 (56 %) held a postgraduate degree, 124 (25 %) a postgraduate diploma, and 99 (20 %) both. The proportion of respondents was very similar between regions (north = 125/506 or 25 %, south = 129/506 or 26 %, east = 125/506 or 25 %, west = 127/506 or 25 %), and the socioeconomic strata served by them (high = 166/506 or 33 %, middle = 180/506 or 36 %, low = 160/506 or 32 %). Their places of practice included government hospitals (51/506 or 10 %) as well as various private health care outlets (455/506 or 90 %).

Clinic Prevalence of AOM

The reported mean annual clinic prevalence of AOM was 43 % (95 % CI, 42–45). Amongst those diagnosed with AOM, the prevalence of concurrent upper respiratory tract infection was 54 % (95 % CI, 52–56). The prevalence of AOM was markedly different across regions (Fig. 1). Seasonal worsening of the disease was not evident, but December was reported as the month with the highest incidence of AOM followed by a second peak in July (Fig. 2). The reported prevalence of AOM was similar among respondents catering to different socioeconomic strata of patients. The use of otoscopy did not have an impact on the reported prevalence of AOM.

Fig. 1.

Regional prevalence of AOM (n = 506). The graph shows four bars. The top of each bar corresponds to the average clinic prevalence in the four regions and their 95 % confidence limits. ANOVA revealed that the difference among the regions was significant, and so Tukey’s multiple comparison test was done to determine which of the six possible differences were significant. This test showed that the prevalence in North was significantly lower than in South or in West (p = 0.0103), and no other differences were significant. Graphically this is revealed by the fact that the 95 % CI for North does not overlap the 95 % CI for either South or West

Fig. 2.

Incidence of AOM during the calendar year (n = 506). December was reported as the month with the highest incidence of AOM followed by a second peak in July

Risk Factors for AOM

According to the respondents, frequent upper respiratory tract infection (453/506 or 90 %), allergies (393/506 or 78 %), bottle feeding (278/506 or 55 %), exposure to recurrent ear infection in siblings (189/506 or 37 %), attending a crèche (89/506 or 18 %), exposure to tobacco smoke (84/506 or 17 %) and/or genetic predisposition (53/506 or 10 %) increased the risk of AOM.

Presenting Symptoms for AOM

Of the 506 respondents, 440 ranked otalgia as the most common (Rank 1) presenting symptom of AOM followed by irritability/excessive crying (Rank 2, n = 178), fever (Rank 3, n = 154), nasal discharge/nasal stuffiness (Rank 3, n = 108), cough (Rank 4, n = 112), vomiting (Rank 6, n = 43) and hearing loss (Rank 6, n = 55).

Diagnosis of AOM

Almost all (486/506 or 96 %) respondents used otoscopy to diagnose AOM. Majority (450/506 or 89 %) used it ‘always’ and the remaining (36/506 or 7 %) used the tool ‘sometimes’. The situations that prompted the use of otoscopy included an atypical presentation of AOM, a co-operative child, inability to visualize the tympanic membrane with usual instruments, a narrow, hairy external ear canal, presence of debris or foreign body in ear canal, affording patient or presence of complications of AOM.

Simple otoscopy was mostly used for diagnosing AOM (Table 1). Redness (460/506 or 91 %) and bulging of tympanic membrane (456/506 or 90 %) were the most commonly reported otoscopic features. Amongst those who used pneumatic otoscopy when examining a child’s ear, 72 % (43/60) reported reduced or absent mobility of the tympanic membrane. The use of otoscopy was lowest in the east as compared to other regions (Table 2). Socioeconomic status of patients and the type of practice (government or private setup) did not influence the respondent’s decision to use otoscopy.

Table 1.

Type of otoscopy (n = 482)

	Simple otoscopy	Pneumatic otoscopy	Simple + Pneumatic otoscopy
Respondents, n (%)	422 (88)	14 (3)	46 (9)

Most of the respondents used simple otoscopy to diagnose AOM

Table 2.

Use of otoscopy in different regions (n = 506)

Respondents, n (%)	East	North	South	West
Reported use of otoscopy	112 (90)	122 (98)	128 (99)	124 (98)
Never reported use of otoscopy	13 (10)	3 (2)	1 (1)	3 (2)

The use of otoscopy was lowest in the east as compared to the north (p = 0.0087), south (p = 0.0005) or west (p = 0.0079)

A few (20/506 or 4 %) respondents admitted to ‘never using’ otoscopy to diagnose AOM. The reasons cited for not using this tool were lack of cooperation from the patient (3 %), inadequate training (2 %), time consuming procedure (2 %), technically difficult procedure (1 %), and low yield of any additional information (0.2 %).

Management of AOM

Antibiotic Treatment for AOM

Antibiotics were consistently prescribed by 98 % (495/506) of the respondents at initial consultation in 90 % (95 % CI, 89–92) of their patients. When an antibiotic for initial treatment was necessary, about three fourths (395/506 or 78 %) prescribed amoxicillin/clavulanic acid (Fig. 3), nearly one third of whom (135/395 or 34 %) prescribed only amoxicillin/clavulanic acid, while the remaining may have used it with other antibiotics.

Fig. 3.

Initial oral antibiotic therapy (n = 506). Amoxicillin/clavulanic acid was the preferred initial oral antibiotic to treat AOM. The categories are not exclusive and therefore the % add to more than 100

The average reported duration of antibiotic therapy was 7 days (Median: 7 days; Range: 3–15 days). The respondents believed that after initiation of initial antibiotic, the average duration to achieve symptom relief was 4 days (Median: 3 days; Range: 1–15 days), and to achieve clinical resolution of signs of AOM was 7 days (Median: 7 days; Range: 1–49 days). According to the respondents, 15 % of children (95 % CI, 14–16) in their clinical practice needed a change of initial antibiotic mostly because of treatment failure (337/506 or 67 %) and/or intolerance to the antibiotic (257/506 or 51 %).

The respondents believed that 19 % of children (95 % CI, 18–21) in their practice reported with relapse of AOM despite being treated with an antibiotic at initial consultation. When asked to indicate their choice of antibiotic for relapse, 162 respondents used amoxicillin/clavulanic acid (Table 3), of whom 93 used only amoxicillin/clavulanic acid while the remaining may have used it with other antibiotics. The average reported duration of antibiotics for treatment of relapse was 9 days (Median: 10 days; Range: 3–45 days).

Table 3.

Antibiotics for relapse (n = 506)

Antibiotic	Respondents, n (%)
Amoxicillin/clavulanic acid	162 (32)
Cefpodoxime	137 (27)
Cefixime	84 (17)
Azithromycin	74 (15)
Cefuroxime	37 (7)
Amoxicillin	28 (6)
Cefprozil	24 (5)
Cefaclor	18 (4)
Quinolones	12 (2)
Cefdinir	12 (2)
Clarithromycin	11 (2)

Most of the respondents used amoxicillin/clavulanic acid to treat relapse of AOM. The categories are not exclusive and therefore the numbers add to more than 506

Overall the respondents were positive about adherence to antibiotic therapy. According to the respondents, 87 % of children (95 % CI, 85–88) took the antibiotic therapy as recommended. The commonest reasons for not taking antibiotics as recommended were intolerance to the antibiotic (172/506 or 34 %), symptom relief (87/506 or 17 %), distaste (75/506 or 15 %), high cost (61/506 or 12 %), negligence of patient (42/506 or 8 %), dosing issues (25/506 or 5 %), fear of antibiotic (18/506 or 4 %), forgetfulness (16/506 or 3 %), parental issues (13/506 or 3 %), and/or illiteracy (9/506 or 2 %).

Complementary Therapy for AOM

When asked about the use of complementary therapy for AOM, 99 % (502/506) of the respondents confirmed the use of decongestants (449/506 or 89 %), analgesics (435/506 or 86 %), non-steroidal anti-inflammatory drugs (89/506 or 18 %), and/or corticosteroids (61/506 or 12 %). Corticosteroids and non-steroidal anti-inflammatory drugs (NSAID) were mainly prescribed in the east and north regions respectively (Tables 4, 5) but there were no regional variations in prescription of decongestants and analgesics. The use of complementary medicines was similar among respondents catering to different socioeconomic strata of patients.

Table 4.

Use of corticosteroids across regions (n = 506)

Respondents, n (%)	East	North	South	West
Reported use of corticosteroids	27 (22)	13 (10)	1 (1)	21(17)
Never reported use of corticosteroids	98 (78)	112 (90)	128 (99)	106 (83)

Use of corticosteroids was significantly lower in the south as compared to east (p < 0.0001), north (p = 0.0005) or west (p < 0.0001) and significantly higher in the east as compared to north (p = 0.0120)

Table 5.

Use of NSAID across different regions (n = 506)

Respondents, n (%)	East	North	South	West
Reported use of NSAID	13 (10)	30 (24)	22 (17)	24 (19
Never reported use of NSAID	112 (90)	95 (76)	107 (83)	103 (81)

The use of NSAID was significantly lower in the east as compared to the north (p = 0.0034) or west (p = 0.0414)

Discussion

The reported clinic prevalence of AOM in an ENT surgeon’s practice was higher (43 %) than anticipated (about 10 %). Almost all respondents used otoscopy to diagnose AOM. Amoxicillin/clavulanic acid was the preferred antibiotic for treating AOM either initially or for relapse. Most respondents also used analgesics and decongestants for symptomatic relief.

A face-to-face conduct of this survey allowed field workers to explain the objective of the survey and clarify issues, which helped to achieve a better response rate (78 %) compared to postal surveys (51 %) [4]. We consider the sample to be more or less representative of the country and of different socioeconomic strata of patients.

The clinic prevalence of AOM (43 %) was considerably higher than generally anticipated (about 10 %) or than that reported in a study at an ENT center in Jaipur (3.9–4.8 %) [5]. This high figure probably reflects the prevalence of AOM in a select population of children with ear disease (either self referred or referred from another physician) that seeks medical treatment from an ENT surgeon, rather than prevalence of AOM in the entire population visiting the clinic of an ENT surgeon. This high figure could also be explained by the inclusion of both newly diagnosed and follow-up cases of AOM. The higher than expected prevalence even amongst those who did not use otoscopy could be based upon the clinical impression of the respondents rather than a confirmed diagnosis with otoscopy.

Although many studies have reported a lower prevalence of otitis media in children from lower socioeconomic status because of underreporting, there was no difference in the clinic prevalence of AOM among respondents catering to different socioeconomic strata of patients in this survey [6, 7]. This was similar to a study by Teele et al. [8] in which socioeconomic status did not significantly influence the risk of AOM.

Interestingly, December was reported as the month with the highest incidence of AOM followed by a second peak in July, but there was no seasonal variation in the clinic prevalence of AOM when the respondents were surveyed during the three seasons separately. Both peaks may be explained by an increase in upper respiratory infections [7, 9]. In addition, influenza may also be responsible for the July peak [7, 10]. The impression that the incidence of AOM was highest during winter may be supported by text book knowledge but was not corroborated in our survey.

29–50 % of upper respiratory infections get complicated by AOM [11]. According to the respondents, only around 50 % of children with AOM had concurrent upper respiratory infection. This indicates that a diagnosis of AOM should not be excluded if the patient does not present with clinical signs and symptoms of upper respiratory infection.

It is well known that symptoms are neither sensitive nor specific for the diagnosis of AOM. A study in 363 children with AOM reported that 94 % had cough or rhinitis, 90 % had rhinitis, 78 % had cough, 56 % were irritable, 55 % had fever and 47 % had earache [12]. In our survey, otalgia was reported as the most common presenting symptom of AOM (90 %). This was probably expected as ENT surgeons usually attend to children who are old enough (>2 years) to complain of pain in the ear.

While pneumatic otoscopy has higher sensitivity than simple otoscopy and is advocated by the American Academy of Pediatrics and American Academy of Family Physicians (AAP/AAFP) guidelines as an adjunct to assist in achieving diagnostic accuracy of AOM, most physicians find it inconvenient or remain unconvinced of its value[13–15]. In addition, pneumatic otoscopy may elicit severe pain. This perhaps explains why only 12 % of the respondents used pneumatic otoscopy.

The use of antibiotics in AOM has always been a controversial issue for several decades [16]. According to AAP/AAFP and Indian Academy of Pediatrics (IAP) treatment guidelines, the need and choice of antibiotics is based upon age, severity of disease and certainty of diagnosis [15, 17]. Immediate initiation of antibiotics is recommended in children <6 months of age irrespective of diagnostic certainty, in children 6 months to 2 years of age with a confirmed diagnosis or severe illness (moderate to severe otalgia or fever ≥39 °C) at presentation and an uncertain diagnosis and in children ≥2 years of age with severe illness and a certain diagnosis. In India, ENT surgeons often see children who come to their clinics for the first time with severe AOM or with complications of the disease. Therefore it is not surprising that almost all respondents in this survey preferred to prescribe an antibiotic at initial diagnosis of AOM in line with guideline recommendations. This practice is supported by the recent data that antibiotics reduce the duration of illness and the chances of treatment failure in children with a confirmed diagnosis of AOM [16]. Children with moderate to severe disease are most likely to benefit from antibiotic therapy. Since a physician cannot determine the clinical course at the onset of the illness and cannot identify children who are more likely to benefit from antimicrobial therapy, there is a school of thought that supports the prompt initiation of antibiotics rather than the ‘wait and watch or observation’ approach for 48 h.

Once a decision to treat with antibiotics is taken, the choice of antibiotic is important. Treatment guidelines recommend initial treatment with an amoxicillin based regimen (amoxicillin or amoxicillin/clavulanic acid) [15, 17]. The preference for amoxicillin or amoxicillin/clavulanic acid is based upon the age of the child, severity of AOM, and the requirement to cover beta-lactamase–positive pathogens. An amoxicillin based regimen was the preferred antibiotic policy in this survey, with more ENT surgeons preferring amoxicillin/clavulanic acid over amoxicillin. The use of amoxicillin/clavulanic acid as initial therapy is supported by guideline recommendations in patients less than 2 years of age or in those with severe illness or in those for whom additional coverage for beta-lactamase–positive Haemophilus influenzae and Moraxella catarrhalis is desired [15, 17].

Treatment with an oral regimen which does not include amoxicillin is recommended only in case of an allergic reaction to penicillin [15]. Use of cefdinir, cefpodoxime, or cefuroxime is recommended for non-type I allergic reaction to penicillin and azithromycin, clarithromycin, erythromycin-sulfisoxazole, sulfamethoxazole-trimethoprim or clindamycin for type I allergic reaction to penicillin. The use of cefpodoxime and azithromycin in this survey appears to be disproportionately higher compared to patients who could have had an allergic reaction to penicillin. Therefore usage of these antibiotics does not appear to be in line with treatment guidelines.

Although there are no guideline defined recommendations for clinical relapse, antibiotic selection is usually based on response to previous therapy. Most of the respondents prescribed amoxicillin/clavulanic acid for relapse of AOM.

The use of azithromycin as an initial antibiotic (27 %) and for relapse (15 %) of AOM is a matter of concern as macrolides in general, and particularly azithromycin, are associated with an increased risk of treatment failure (macrolides RR 1.31, p = 0.008; azithromycin RR 1.34, p = 0.02) compared to amoxicillin or amoxicillin/clavulanic acid treatment [18].

The respondents estimated that 18 % children relapsed after initial antibiotic therapy. This figure seems high and it is possible that they clubbed clinical relapse, bacteriological relapse, treatment failure, and recurrent AOM while responding to this question.

Guidelines recommend the use of effective analgesia for pain management in AOM and most of the respondents reported the use of analgesics and/or NSAID in our survey [15, 17]. Oral decongestants may be used to relieve nasal congestion but are not routinely recommended [17, 19]. Most of the respondents prescribed decongestants; however, we did not differentiate between oral and nasal decongestants. While animal studies have highlighted the possible role of corticosteroids in controlling inflammation in acute middle ear inflammation, there is limited clinical data available on the use of corticosteroids in AOM and they are not recommended by treatment guidelines [15, 20]. Some of the respondents reported the use of corticosteroids, particularly from North, East, and West regions of India.

Key Messages

The reported in-clinic prevalence of AOM among a population that seeks medical treatment from ENT specialists appears to be higher than anticipated. This will need to be examined in a well designed prospective study. It is a matter of concern if AOM is being diagnosed based on the clinical impression of the respondents rather than a confirmed diagnosis with otoscopy. It could lead to unnecessary use of antibiotics which in turn could increase the chances of antibiotic resistance. This survey provides useful information regarding current diagnostic and management practices for this disease.