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* Division of General Medical Sciences
Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Methods. Compliance with CDC’s recommended diagnostic criteria and antimicrobial treatments for management of AOM was assessed by chart review and self-report for 29 community pediatricians in St. Louis, Missouri. For each physician, a simple random sample of AOM visits was selected and reviewed by trained reviewers. In addition, each physician completed a questionnaire.
Results. Compliance with recommended diagnostic criteria was 38% (95% confidence interval: 34%–42%; n = 573) by chart audit and 41% (95% confidence interval: 24%–61%; n = 29) by self-report. Antimicrobial selection assessed by chart audit was consistent with CDC guidelines in 68% (95% confidence interval: 64%–72%) of visits for a new infection, 63% (95% confidence interval: 47%–78%) of visits for treatment failure, and 50% (95% confidence interval: 33%–67%) for recurrent disease. Self-reported compliance with treatment guidelines for new infection was 100% (95% confidence interval: 88%–100%) and 83% (95% confidence interval: 64%–94%) for treatment failure. Noncompliance was most frequently attributable to overuse of broad-spectrum antimicrobials. Most patients treated with amoxicillin received a 10-day course (98%). Subtherapeutic dosing occurred in 26% of patients treated with amoxicillin.
Conclusions. Overdiagnosis of AOM is common. Efforts to improve the judicious use of antimicrobials for AOM should focus on improving diagnostic accuracy, limiting the use of broad-spectrum antimicrobials to cases where they offer clinical benefit, and ensuring that amoxicillin dosing regimens are optimal.
Key Words: acute otitis media • guidelines • antimicrobial
Abbreviations: CDC, Centers for Disease Control and Prevention • AOM, acute otitis media • MEE, middle ear effusion • TM, tympanic membrane • MIC90, minimum inhibitory concentration
Overuse of antimicrobials is associated with the development and spread of bacteria with antimicrobial resistance.1,2 Widespread reduction in antimicrobial use can reduce the prevalence of bacteria with resistance to those drugs.3 Antimicrobials are frequently used in ambulatory pediatric practice to treat acute upper respiratory tract illnesses,4,5 and overuse is known to occur.1,6 Evidence-based guidelines to improve the judicious use of antimicrobial agents in children with 5 acute upper respiratory tract illnesses in the United States have been developed by the Centers for Disease Control and Prevention (CDC) in partnership with the American Academy of Pediatrics and others. The guidelines were published in Pediatrics in January 1998.7–11
Acute otitis media (AOM) accounts for 30% of all pediatric outpatient antimicrobial prescriptions.12 Although difficult to assess, overdiagnosis of AOM and overtreatment with broad-spectrum antimicrobials is thought to occur.1,6,11 The CDC guidelines for AOM recommend use of specific diagnostic criteria to identify patients with an increased probability of bacterial infection. These include the presence of otorrhea of middle-ear origin, or the presence of middle-ear fluid or effusion (MEE) and signs or symptoms of acute local or systemic illness. Pneumatic otoscopy is recommended to confirm the presence of MEE.11 The guidelines also recommend shortened duration of antimicrobial treatment for some children, depending on the child’s age and disease severity. A shorter course of antimicrobials is recommended for children older than 2 years of age with mild disease (5–7 days). A 10-day course is recommended for children under 2 years of age, and for those with a perforation of the tympanic membrane (TM), comorbidities, or recurrent AOM disease. Specific treatment recommendations are not included in the CDC guidelines. These have been addressed by a CDC-sponsored Working Group for treatment of Streptococcus pneumoniae,13 the bacterial pathogen most frequently associated with AOM.12,14 In January 1999, this group published specific AOM treatment recommendations to address the increasing prevalence of S pneumoniae resistant to penicillins.13 Amoxicillin, 40 to 45 mg/kg/d, is recommended for initial treatment of AOM patients at low risk for infection with penicillin-resistant S pneumoniae (usual dose). A higher dose (80–90 mg/kg/d) is recommended for those at high risk of penicillin-resistant S pneumoniae infection. These include children exposed to an antimicrobial in the prior 3 months, those younger than 2 years old, and those attending child care. If initial treatment fails, the guidelines recommend limiting the use of broad-spectrum antimicrobials to those that are most likely to be efficacious—amoxicillin-clavulanate, ceftriaxone, or cefuroxime axetil.
There are many reasons why physicians do not follow guideline recommendations. It has been suggested that the main reasons are lack of awareness, lack of agreement with guideline recommendations, or barriers to their adoption.15 A national survey of general pediatricians found that guidelines were more likely to be used if they were simple, flexible, rigorously tested, not used punitively, and motivated by desires to improve quality rather than reduce cost.16 The objective of this study was to assess compliance with the CDC’s evidence-based guidelines for the diagnosis and treatment of AOM as a first step to improving the judicious use of antimicrobials in community practice. This paper reports the baseline assessment of guideline compliance before a randomized trial of a practice-based intervention to change antimicrobial prescribing practices for children with acute upper respiratory tract illnesses.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Measurement
Compliance with diagnostic and treatment recommendations for AOM was measured by retrospective chart review. In addition, physicians completed a questionnaire to assess their self-reported usual behavior with regard to the diagnosis and antimicrobial treatment of children with AOM.
Chart Review
For each physician, a simple random sample of 
20 patient visits was reviewed to assess guideline compliance. The sample frame included all AOM visits that occurred during the winter months (October 1, 1999 to March 31, 2000). Visits were identified from billing data using the following International Classification of Diseases, Ninth Revision codes: 380.10, 381.10, 381.4, 382.0, 382.01, and 382.9. Visits were excluded if the diagnosis recorded in the chart was different from the billing diagnosis, if more than 1 diagnosis for an upper respiratory tract illness was recorded (eg, AOM and sinusitis), if the visit was for follow-up assessment and the child was improved, if the child’s chart had previously been reviewed, or if the chart was not available in the office.
Symptom duration, recorded diagnostic criteria, and antibiotic treatment and dosing schedule for the selected AOM visit were abstracted from the chart by trained reviewers and recorded on a data collection sheet. Patient demographic data, comorbidities, antibiotic allergies, weight, and any antimicrobial exposure during the past 3 months also were recorded. The number of AOM episodes during the previous 6- and 12-month periods were measured to determine if disease was recurrent. The daily dose of amoxicillin was calculated using weight, dose, and dosing schedule. Patients were considered to have penicillin allergy if penicillin or unspecified antimicrobial allergy was documented. Data were entered into an Access database for statistical analyses. A random sample of 25% of visits was double checked for errors.
Diagnosis
Compliance with recommended diagnostic criteria required documentation of:
MEE was present if the following were documented: air-fluid level or bubbles seen behind the TM, reduced TM mobility, or 2 of the following TM changes—changed position (retracted or full, blurred landmarks), changed color (blue, pink, white, or yellowish), or changed translucency (opaque or dull). Acute local ear inflammation required documentation of ear pain or a red TM. A bulging TM was considered to represent the presence of both MEE and local inflammation, and was diagnostic for AOM. New infections were those with no documented diagnosis of AOM in the previous month. Recurrent AOM was defined as 
3 episodes in 6 months or 4 episodes in 12 months. Treatment failure was defined as treatment with an antimicrobial for AOM within the past month.
Treatment
Compliance with antimicrobial treatment guidelines for drug selection occurred if:
40 kg. Infants weighing <8 kg were excluded from the analysis of subtherapeutic dosing of amoxicillin as dosing recommendations vary. The daily dose of other antimicrobials was not calculated.
Physician Questionnaire
Between June and October 2000, all physicians completed a self-administered questionnaire to assess their usual behaviors for the diagnosis and antimicrobial treatment of children with AOM. Frequency of behaviors was assessed using a 5-point scale (almost never, rarely, sometimes, often, most of the time). Self-reported compliance with diagnostic guidelines occurred if the physician required evidence of both the presence of MEE and local inflammation "most of the time" when diagnosing AOM. Self-reported compliance with treatment recommendations was assessed by the physician’s response to questions concerning their usual antimicrobial treatment for a child under 5 years of age with no known drug allergies in 2 situations: 1) a new uncomplicated infection, and 2) treatment failure. Treatment compliance was defined using the same criteria as for chart audit. Additional questions inquired about demographic information.
The physicians used 5-point categorical scales to rate the importance of various sources of information about antibiotic treatment for upper respiratory illness.
Practice Questionnaire
Between June and October 2000, the Project Director conducted a brief interview with each office manager (or the physician if there was no office manager) to obtain information about practice organization and patient demographics.
Statistical Analysis
Continuous variables are reported as mean (standard deviation) or median (range). Categorical data are reported as percentages. For comparisons among subgroups and with nonparticipants, the 
2 test or the Fisher exact test were used to compare proportions. A probability of P < .05 (2-tailed) was used to establish statistical significance. All statistical analyses were done using Stata 7.0 (Stata Corporation, College Station, TX).
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Compliance With Diagnostic Criteria
Table 2 shows compliance with diagnostic criteria. Within a large practice (3 physicians), physicians did not share a common approach to diagnosis of AOM, and compliance varied from 0% to 90% among study physicians. Of the 216 visits where the required diagnostic criteria were recorded in the chart, 48 (22%) documented evidence of both local inflammation and MEE (2 of which also had otorrhea), 143 (66%) documented a bulging TM, and 27 (13%) documented otorrhea of middle ear origin. Compliance with diagnostic criteria was 41% (138/337) in children 2 years old and 33% (78/236) in younger children and infants (P = .055).
Compliance With Treatment Recommendations
Antimicrobial treatment was prescribed at 567 visits (99%). The most commonly prescribed antimicrobials were amoxicillin (358 [63%], 95% selected in compliance with guideline recommendations), amoxicillin-clavulanate (104 [18%], 34% compliant with guidelines), cefprozil (49 [9%], 14% compliant with guidelines), and azithromycin (18 [3%], 17% compliant with guidelines).
Table 2 shows rates of compliance with treatment recommendations. Compliance varied among individual physicians from 45% to 95%, but did not vary significantly among physicians in the same practice. This variation was not explained by patient characteristics previously found to be associated with increased rates of antimicrobial prescribing.6 These included having few patients with Medicaid insurance (<10% vs 10%), and fewer black patients (<50% vs 50%).
Commonly prescribed antimicrobials for initial infections included amoxicillin (72%), amoxicillin-clavulanate (15%), cefprozil (7%), and azithromycin (2%). The drugs most frequently used for treatment failure were amoxicillin-clavulanate (53%), cefprozil (18%), and amoxicillin (15%). For recurrent disease, amoxicillin-clavulanate (45%) and amoxicillin (16%) were used most often. Eleven (58%) of 19 patients with penicillin allergy treated with an antimicrobial were treated in accordance with recommendations.
Overtreatment was the most frequent reason drug selection did not agree with CDC recommendations. To simplify the discussion, the 20 patients with penicillin allergy were excluded from further analyses of noncompliance (Table 3). Broad spectrum antimicrobials were used to treat 28% of uncomplicated new AOM infections (131/473), and no risk factor for penicillin-resistant S pneumoniae was documented in 21 of 77 (27%) patients treated with high-dose amoxicillin. Of the 243 patients treated with amoxicillin in whom treatment duration was documented (243/341, 71%), most were treated with a 10-day course (238/243, 98%). Of these, 121 (51%) were eligible for shortened treatment duration of 5 to 7 days according to the guidelines. Undertreatment also occurred. Usual-dose amoxicillin was used rather than high-dose or a second-line drug for 11 (15%) of 73 patients with treatment failure or recurrent disease (Table 3). Amoxicillin was prescribed 3 times daily for 69% of patients and twice daily for 31%.
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Compliance With Diagnostic Criteria
Twelve (41%) physicians reported compliance with diagnostic criteria for AOM (Table 2). Seven (24%) physicians used pneumatic otoscopy "rarely" or "almost never," and 16 (55%) "often" or "most of the time" to diagnose the presence of MEE in a child with an ear complaint. Objective tests to assess the presence of MEE were used infrequently. Tympanometry was used "often" or "most of the time" by only 7 (24%) physicians, and 26 (90%) physicians used acoustic reflectometry "rarely" or "almost never." Physicians who required MEE to be present "most of the time" to diagnose AOM tended to use a test to detect MEE (pneumatic otoscopy or tympanometry) more regularly than other physicians, although this failed to reach statistical significance (58% vs 29%, Fisher exact test P = .148).
Compliance With Treatment Recommendations
All physicians reported they would prescribe amoxicillin for an initial case of uncomplicated AOM (33% at high dose). Twenty-four (83%) physicians would select one of the recommended second-line drugs for treatment failure, most commonly amoxicillin-clavulanate (69% of all second-line drugs selected).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Pneumatic otoscopy is difficult to perform, especially in an uncooperative, symptomatic child.20 However, the CDC guideline emphasizes the use of pneumatic otoscopy for making the diagnosis of AOM. Twenty-five percent of study physicians reported they do not use pneumatic otoscopy to evaluate a child with an ear complaint, and in our chart review, TM mobility was rarely documented. Similar findings have been found in surveys of practicing physicians5 and residents.20,21 Objective tests to determine the presence of MEE such as tympanometry or acoustic reflectometry also were used infrequently by study physicians. Use of objective tests to detect MEE that are easier to perform than pneumatic otoscopy could increase diagnostic accuracy for AOM.22 Many other factors contribute to diagnostic inaccuracy for AOM, a condition for which there is no convenient way to identify the causative organism. These include: widespread variation in diagnostic standards,19 use of ill-fitting specula and inadequate light sources,23,24 inability to visualize the TM because of cerumen, and lack of training in visual and pneumatic otoscopy.17 Our results suggest that efforts to improve diagnostic accuracy in AOM should focus on improving knowledge about recommended diagnostic criteria, particularly the requirement for evidence of MEE and how to accurately detect it. Several training programs have recently been developed targeting community physicians.20,25
In our chart audit, amoxicillin was appropriately selected to treat new uncomplicated AOM cases in two thirds of visits reviewed. Variation from recommended treatment most often occurred because of overuse of broad-spectrum agents. These drugs offer no clinical benefit over amoxicillin for children with uncomplicated new infections.11,26 Underuse of effective treatments also occurred. In 11 (15%) visits for children with treatment failure or recurrent AOM disease, usual-dose amoxicillin rather than high-dose or a second-line antimicrobial was selected.
We were surprised to find subtherapeutic dosing in 25% of children treated with amoxicillin, although underdosing of antibiotics has been identified as a frequent problem in hospitalized adult patients.27 If antimicrobial concentrations reaching the middle ear are below the minimum inhibitory concentration (MIC90) for infecting bacteria, treatment failure, relapse, and chronic disease may ensue.28 In addition, subtherapeutic dosing provides ideal conditions for the emergence and spread of bacteria with antimicrobial resistance. For amoxicillin, maintaining the serum concentration above the MIC90 for 40% to 50% of the dosing interval is associated with bacterial cure rates of 80% to 85%.29 With the emergence of penicillin resistance, the MIC90 for amoxicillin has increased for S pneumoniae, and higher doses of amoxicillin are required for effective treatment. Undertreatment can result in unnecessary patient morbidity because of treatment failure as well as increased selection pressure for the emergence and spread of bacteria with antimicrobial resistance.1
We identified 2 problems that may contribute to underdosing of amoxicillin for children with AOM. First, the child’s weight is usually recorded in the chart in pounds rather than kilograms, so that an additional step is required to calculate the weight-based dose. Second, some frequently used texts do not clearly specify the recommended increase in usual dose from 25 to 40 mg/kg/d for treatment of any new, uncomplicated AOM infection, regardless of disease severity.30,31 These sources also recommend a range for adult daily dosing of amoxicillin from 750 to 1500 mg. A dose of 750 mg/d is equivalent to a weight-based dose of <40 mg/kg/d for a child weighing 20 kg, and <20 mg/kg/d for a child weighing 40 kg, the weight specified for switching to the adult dosing regimen.30,31
Compliance with treatment guidelines assessed by self-report was consistently higher than that measured by chart audit (Table 2). This suggests that the reasons for noncompliance are lack of agreement with treatment guidelines or problems in their implementation, rather than lack of knowledge.15 All study physicians knew that amoxicillin is the recommended first-line treatment for uncomplicated AOM, but on average, treated their patients with a broad-spectrum antimicrobial at 1 of 4 visits. Efforts to change prescribing practices need to focus on identifying and addressing barriers to judicious antimicrobial use. Previously identified barriers include parental pressure,32 the physicians’ desire to prevent a repeat visit,33 office efficiency issues, fear of litigation,32 and fear of the possible negative impact of dissatisfied patients on physician evaluation in the managed care environment.1 Reducing variation in care among physicians, particularly in the same practice, may further increase the opportunities for judicious antimicrobial use.
Physicians have not embraced the guideline recommendations to shorten treatment duration. Antimicrobial use could be reduced by limiting amoxicillin treatment duration for children over 2 years old with no risk factors for treatment failure to 5 to 7 days.34 This opportunity was missed in over half of eligible patients in our study. In our study cohort, only 6 (1%) patients were not prescribed an antimicrobial. Watchful waiting with symptomatic treatment for 24 to 48 hours before initiating antimicrobial treatment is standard practice in parts of Europe.11,35 With this treatment, symptoms spontaneously resolve without suppurative complications in the majority of cases.35,36 This approach may represent an alternative to immediate antimicrobial treatment especially in older children with uncomplicated disease. Twice daily dosing of amoxicillin and amoxicillin-clavulanate (with the appropriate increase in dose) should increase parental adherence to treatment without compromising effectiveness. Recent changes in drug formulations could facilitate this dosing regimen.
Our findings likely represent an overestimate of guideline adherence for both treatment and diagnosis for 2 reasons. First, we used liberal definitions to assess compliance. For example, documentation of any redness of the TM rather than "marked erythema" was accepted as evidence of local ear inflammation, and a bulging TM was considered diagnostic for AOM. Compliance with treatment recommendations was based mainly on antibiotic selection. We did not include subtherapeutic dosing of amoxicillin or prolonged treatment duration in our definition of noncompliance. Second, although we believe they are representative of many community pediatricians, volunteer bias for the study physicians might also lead to an overestimate of compliance. Physicians participating in this study were experienced pediatricians who volunteered knowing that the study would include observing their prescribing habits. Unfortunately, we did not have data from eligible nonparticipants to quantify this potential selection bias. Despite these concerns about overestimation, our results are consistent with those of other investigators who have used different approaches to measure diagnostic inaccuracy for otitis media. A study using video-presented ear examinations to assess diagnostic accuracy of pediatricians for otitis media found an overall correct diagnosis rate of 50% (range: 25%–73%) for AOM, otitis media with effusion, and normal TM.25 Although 73% of pediatricians correctly diagnosed the 1 example of AOM included in that study, AOM was overdiagnosed in the 8 patients with either otitis media with effusion or a normal ear from 7% to 53% of the time.25 Another study comparing the accuracy of pediatric residents’ diagnosis of AOM with that of pediatric otolaryngologists found only fair agreement for clinical findings (
= 0.3) and TM redness ( = 0.4), and poor agreement for TM position ( = 0.16).20
There are several limitations to our study. First, we chose to measure guideline compliance by chart audit, using self-report to assess measurement accuracy. Retrospective chart review is limited by incomplete data recording and variation in charting quality. We believe charting was complete for antimicrobial treatment, but less so for diagnostic criteria. Despite the inaccuracies introduced by missing data, we believe our assessment of diagnostic practices is valid as results measured by both chart audit and self-report are similar. Second, misclassification because of missing data or inappropriate study definitions may result in inaccurate estimates of compliance with guidelines. As we were unable to assess child care attendance, we may have misclassified treatment of a new infection with second-line drugs or high-dose amoxicillin in some children over 2 years of age as noncompliant. Assuming that all 26 such children were misclassified, recalculation does not significantly alter our estimate of compliance for treatment of new infection (71%, P = .096). As systemic symptoms are not specific for AOM,11 we defined the presence of signs and symptoms of systemic illness with MEE as noncompliant with recommended diagnostic criteria for AOM. Reclassifying the 19 patient visits assessed as noncompliant using this definition does not significantly alter our findings for compliance with diagnostic criteria (41%, P = .3). We believe that neither of these potential misclassification errors are a threat to the validity of our findings. Third, our sample of physicians is small and localized to 1 geographic area. It is quite possible that this sample is not representative of the population of community pediatricians in the St. Louis area. We believe that any selection bias would result in an overestimate of compliance rates. Apart from the volunteer bias already discussed, we do not believe that study physicians are systematically different from a wider population of American pediatricians. Further studies are needed to verify this hypothesis.
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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ACKNOWLEDGMENTS |
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We thank the pediatricians who participated in this study and their office staffs for their help with data collection. We also thank Wendy Sigurdsen, BSN, MHS, Project Director, Melissa Kirchoffer, MS, and Marnie Schneider, RN, BSN for their help with data collection and data management; and Benjamin Littenberg, MD, for his careful review of the manuscript.
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FOOTNOTES |
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Reprint requests to (J.M.G.) Campus Box 8005, 660 S Euclid Ave, St Louis, MO 63110. E-mail: jgarbutt{at}im.wustl.edu
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REFERENCES |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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