PEDIATRICS Vol. 121 No. 5 May 2008, pp. e1352-e1356 (doi:10.1542/10.1542/peds.2007-2278)
ARTICLE |
Comparison of Two Approaches to Observation Therapy for Acute Otitis Media in the Emergency Department
Department of Pediatrics, Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, New York
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ABSTRACT |
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 TOP ABSTRACT PATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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OBJECTIVE. This study compared parental adherence to delayed antibiotic therapy for acute otitis media with and without a written prescription in a pediatric emergency department.
PATIENTS AND METHODS. Children aged 2 to 12 years who met criteria for delayed antibiotic treatment were randomly assigned to observation therapy with or without a prescription. Patients randomly assigned to observation therapy without prescription were instructed to seek follow-up care if symptoms persisted for 2 to 3 days. Patients assigned to observation therapy with a prescription were discharged with an antibiotic prescription, and instructed to fill it if their child's symptoms persisted 2 to 3 days. A research assistant who was blinded to group assignment called parents 7 to 10 days after the visit to assess adherence to observation therapy.
RESULTS. Of 117 children assigned to the observation therapy group, 100 completed follow-up; of 115 assigned to the observation therapy with a prescription group, 106 completed follow-up. In the observation therapy group, 87 parents reported no antibiotic use within the 3-day observation period compared with 66 parents in the prescription group. During the entire study period, 81% of the observation therapy group reported no use of antibiotics compared with 53% in the prescription group. These groups did not differ in satisfaction with the visit; 91% and 95% were very or extremely satisfied, respectively. No complications were reported.
CONCLUSIONS. Observation therapy with and without a prescription were both well accepted by parents of children diagnosed with acute otitis media in an urban pediatric emergency department. Adherence to delayed antibiotic therapy was better for those not offered a prescription. These data suggest that, in the pediatric emergency department setting, observation therapy reduces antibiotic use without compromising satisfaction with the visit.
Key Words: otitis media • emergency department • adherence • delayed antibiotic use • satisfaction
Abbreviations: AOM—acute otitis media • PED—pediatric emergency department • OT—observation therapy without a prescription • OT+P—observation therapy with a prescription • OR—odds ratio • CI—confidence interval
Acute otitis media (AOM) is the most frequent diagnosis for which antibiotics are prescribed for children. In May 2004, the American Academy of Pediatrics and the American Academy of Family Practice issued guidelines to defer antibacterial therapy in selected children diagnosed with AOM and to limit management to symptomatic relief for 48 to 72 hours.1 The strategy summarized in this new guideline is often referred to as "observation therapy" to distinguish it from immediate antibiotic treatment. These guidelines are based on studies demonstrating that AOM spontaneously resolves in 80% of children and that reserving antibiotic treatment for those who remain symptomatic at 72 hours does not significantly change the disease course. It does, however, significantly decrease the number of patients exposed to antibiotics.2–5
Two approaches to observation therapy have been studied in the primary care setting with good results. In the first approach, the patient is discharged without a prescription for an antibiotic but with instructions to seek reevaluation if there is persistent otalgia or fever. McCormick et al5 found that 66% of patients offered observation therapy without a prescription in the office setting completed the 30-day study period without receiving antibiotics. Siegel et al6 studied the acceptance of observation therapy when parents were given a prescription for an antibiotic with instructions to fill it if symptoms either increased or did not resolve in 48 hours. They found that 69% of patients completed the 5- to 10-day follow-up period without filling the prescription.
In the emergency department, families frequently wait for several hours before being evaluated and receive care from a practitioner that they are likely meeting for the first time. These factors may be barriers to the acceptance of observation therapy.7,8 However, Spiro et al9 demonstrated a reduction in antibiotic use among children diagnosed with AOM in a pediatric emergency department (PED) and given a "wait-and-see prescription" to be filled only if they were not improved 48 hours after the visit. The authors found that 62% of patients in the wait-and-see group did not fill their prescriptions. These data suggest that parents may accept observation therapy in the PED with a prescription, but it is not known whether those discharged without a prescription would be more or less likely to accept observation therapy.
In this study we examined adherence to observation therapy for AOM in a PED when parents were given a prescription and advised not to fill it unless symptoms persisted 2 to 3 days or discharged without a prescription and advised to wait 2 to 3 days to see if symptoms subsided before seeking reevaluation. It also examined satisfaction with the visit and whether the physician in the PED could predict parental adherence with the recommendation for observation therapy.
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PATIENTS AND METHODS |
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TOPABSTRACTPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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A prospective, randomized trial was conducted between December 2005 and November 2006 in the PED of an urban public hospital in the Bronx, New York. This was a convenience sample of patients enrolled at all hours by 14 attendings and fellows.
Children aged 2 to 12 years were eligible if they were diagnosed with AOM. Children were excluded if they had a history of immunodeficiency or craniofacial abnormalities, were already taking antibiotics, were diagnosed with a concurrent bacterial infection requiring antibiotic treatment, did not have telephone access, had an episode of AOM within the past 30 days, had pain at the time of presentation not relieved within 30 minutes by administration of analgesics, or had a history of >48 hours of otalgia or fever.
Eligible patients were assigned to observation therapy without a prescription (OT) or observation therapy with a prescription (OT+P) using a random-number table. Parents of children randomly assigned to OT were instructed to return to the emergency department or to their child's primary care provider if the symptoms did not resolve in 2 to 3 days. Parents of children randomly assigned to the OT+P arm received a prescription for an antibiotic and instructions to fill it only if symptoms did not resolve in 2 to 3 days. Parents in both groups were given a discharge instruction sheet describing the reasons for delaying treatment of AOM, how to manage otalgia or fever during the observation period, and indications for seeking follow-up care (OT) or initiating antibiotic therapy (OT+P). As is our standard practice, parents were given complimentary bottles of ibuprofen (100 mg/5 mL) or acetaminophen (160 mg/5 mL) and/or antipyrine plus benzocaine otic drops at the discretion of the treating physician.
Once the patient was discharged, the treating physician completed a form to indicate whether the patient received a prescription for an antibiotic, the duration of the child's symptoms before the PED visit, the physician's assessment of whether the parent was likely to adhere to the plan, and whether the physician had given antipyretic or analgesic medications to the parent.
If the parent was resistant to the treatment plan, the reasons for objecting to an initial period of observation were noted. Parents of eligible children who were unwilling to accept a period of observation were given antibiotics or a prescription at the discretion of the treating physician but were not included in the final analysis and were considered to be refusals.
Seven to 10 days after the PED visit, the parent was contacted via telephone by a trained research assistant blinded to the patient's group assignment. A brief standardized structured survey, modeled on that used by McCormick et al,5 was administered to assess the child's health status, satisfaction with the visit, and interim antibiotic and other medication use, as well as any interim health care visits.
The primary outcome was adherence to the assigned treatment plan. This was defined as not filling the antibiotic prescription (OT+P) or not receiving further medical care or a prescription for antibiotics to treat AOM (OT) within 3 days after the PED visit. Secondary outcomes included use of antibiotics during the entire 7- to 10-day follow-up period, the physician's ability to predict adherence to the prescribed treatment regime, and satisfaction with the visit dichotomized as very or extremely satisfied versus not very or not at all satisfied.
Factors possibly associated with both adherence to no antibiotic use during the first 3 days and never using antibiotics during the entire 7- to 10-day follow-up period were examined using bivariate analysis. Factors associated with the dependant variable at a level of P < .1 were entered into a logistic regression model. The number of courses of antibiotics avoided was calculated by adding together all of the patients who were reported not to have used antibiotics during the 3-day study period or during the 7- to 10-day follow-up period.
Based on the results of published studies, we estimated that 70% of parents would adhere to OT and that the adherence rate to OT+P could be considered equivalent if it was 
60%. A sample of 125 subjects enrolled in each arm would provide 80% power to demonstrate this or a greater difference with an 
of .05.
Verbal consent was obtained for follow-up via telephone. The purpose of the study, to assess adherence with the prescribed treatment plan, was not described to parents. This study was approved by the institutional review board of the Albert Einstein College of Medicine and Jacobi Medical Center.
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RESULTS |
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TOPABSTRACTPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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A total of 371 children 2 to12 years old diagnosed with AOM were considered for the study. Exclusion criteria were met by 108, and 263 were approached for enrollment. Of these, 22 patients were misenrolled; 6 were either enrolled twice or had a sibling in the study, 10 were assigned to the OT+P group but left without a prescription, 6 were assigned to the OT group but left with a prescription for unclear reasons, and 9 patients refused to participate. These patients were followed but not included in the final analysis. Of the 232 subjects enrolled correctly, 206 (89%) completed telephone follow-up, 100 from the OT group and 106 from the OT+P group, and composed the sample for the remaining analyses. The characteristics of the sample are presented in Table 1.
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In the OT group, 87 parents (87%) reported that they did not give their child antibiotics or see another physician within the 3-day observation period compared with 66 parents (62%) in the OT+P group (odds ratio [OR]: 4.06; 95% confidence interval [CI]: 2.01–8.20; Table 2). During the 7- to 10-day follow-up period, 81 (81%) in the OT group reported that they did not use antibiotics compared with 57 (53%) in the OT+P group (OR: 3.67; 95% CI: 1.95–6.87). The OT group did not differ from the OT+P group in terms of satisfaction with the visit; 91% vs 95%, respectively, were very or extremely satisfied (P = .22).
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Using an intention-to-treat analysis, children lost to follow-up were assumed to not adhere. Even with this assumption, the odds were twice as great that the OT group would not use antibiotics during the 3-day observation period (OR: 2.2; 95% CI: 1.24–3.75).
Using bivariate analysis, physician prediction of adherence, group assignment, duration of fever before and after the PED visit, and height of fever were significantly associated with parental adherence to delayed therapy (Table 3). After entering these 5 variables into a logistic regression model, only days of fever after the visit and group assignment remained statistically significantly associated with adherence. After controlling for the days of fever after the visit, the odds of the OT group not using antibiotics in the first 3 days were 3.86 (95% CI: 1.86–8.03) times greater than the OT+P group.
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There were only 11 cases in which physicians felt that the parent would not adhere, and in each case they were correct. Most of the time physicians predicted that the parent would adhere, but in 42 cases (21%) they were incorrect. Thus, the physician's ability to predict adherence had a sensitivity of 21% (95% CI: 11%–45%) and a specificity of 100% (95% CI: 97%–100%).
In 26 (12%) of the 222 cases, the physician noted that the parent expressed resistance to the proposed treatment plan, although not enough to alter the plan to which they had been randomized. Twelve (46%) of these were in the OT group, and 14 (54%) were in the OT+P group. In the OT+P group, resistance was associated with an increased rate of noncompliance (OR: 4.92; 95% CI: 1.44–16.90), whereas in the OT group it was not (OR: 2.39; 95% CI: 0.57–10.08). The difference between the groups was not statistically significant.
No parent reported any adverse outcomes at the time of follow-up telephone call. Assuming that, in the absence of observation therapy, every child enrolled would have received a course of antibiotic therapy for AOM, during the 11-month study period 138 (67%) of 206 courses of antibiotic treatment were avoided, 81 in the OT group and 57 in the OT+P group.
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DISCUSSION |
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TOPABSTRACTPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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This is the first study to directly compare observation therapy among children for AOM with and without a prescription in any health care setting. Moreover, despite the fact that many children with AOM are treated in the emergency department setting, most studies of observation therapy have focused on children outside of the PED. In this PED trial, although both OT and OT+P were well accepted, there was greater adherence to delayed antibiotic therapy with OT compared with OT+P. Parents given a prescription were more likely to fill it within the first 3 days after the PED visit, contrary to the advice of the physician, and physicians were unable to predict which parents would not adhere.
Although physicians were encouraged to use American Academy of Pediatrics criteria to diagnose AOM, bacteriologic confirmation was not required. The diagnosis was left up to the clinician. This was done to replicate standard clinical practice and to improve generalizability. In addition, other studies have examined children as young as 6 months, but we chose to focus on children from 2 through 12 years of age to comply with the American Academy of Pediatrics guidelines.1 Our study was not structured to examine safety or antibiotic adverse effects.
There were several potential limitations to our study. Our results were based on parental report of antibiotic use and persistence of symptoms, as opposed to querying pharmacy databases and reevaluating patients in person. However, parents were intentionally not informed of the primary hypothesis, and questions were phrased to minimize social desirability bias. Furthermore, Spiro et al9 found that verification of parental report by the pharmacy was consistent 100% of the time when they reported not filling the prescription and 90% of the time when they reported filling it.
Our emergency department is located in an underserved urban community, and our population may have somewhat limited access to primary care. Although many children are cared for in this type of setting, our results may not be generalizable to settings where patients have better access to primary care. Patients with better access may be more likely to accept observation therapy given the perceived ease of follow-up. However, the adherence rate for the group discharged without a prescription in this study was higher than the rate reported from office settings. Barriers to accessing primary care might have contributed to this finding. Our study was not structured to evaluate the impact of access to care.
We instructed parents to wait 2 to 3 days before either seeking reevaluation or initiating antibiotic use to mirror the American Academy of Pediatrics recommendation and to accommodate the fact that patients in the emergency department are evaluated at all hours. However, we set a cutoff of 3 days after the PED visit for measuring adherence. Although this may have lead to misclassification of some patients, this error likely would have occurred equally in both groups.
Because our standard practice is to provide antipyretic and analgesic medications to patients, we cannot comment on whether this practice had any effect on acceptance of or adherence to observation therapy. We were unable to obtain detailed information regarding the specific use of antipyretics and analgesics at home, precluding the evaluation of their association with adherence. However, reported overall use of antipyretics and analgesics did not differ between the treatment groups. The presence of fever after the PED visit was associated in bivariate analysis with adherence, so addressing fever control and fever phobia and dispensing antipyretics and analgesics may contribute to increased adherence to observation therapy.
Physicians tend to overestimate and accommodate parental desire for antibiotics.10,11 In a recent study by Vernacchio et al,12 physicians reported using the observation option in 
15% of the AOM cases that they diagnose, with only a little >10% of them using it with at least half of their diagnosed AOM cases. Vernacchio et al12 also reported that the barrier physicians overwhelmingly cited was parental reluctance to accept observation therapy.
Shifting the thinking about AOM from a condition that requires antibiotic treatment to an illness that calls for symptomatic care and potential reevaluation is difficult for physicians, as well as parents. However, parents may be more willing to accept this paradigm than we expect them to be.
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CONCLUSIONS |
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TOPABSTRACTPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Our data suggest that OT and OT+P are well accepted in the PED, and neither strategy compromises satisfaction with the visit. However, when comparing the 2 approaches to observation therapy in a PED setting, OT substantially improves adherence and reduces antibiotic exposure.
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FOOTNOTES |
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Accepted Nov 8, 2007.
Address correspondence to Jennifer H. Chao, MD, 450 Clarkson Ave, Box 1228, Brooklyn, NY 11203-2098. E-mail: jenniferhchao{at}hotmail.com
The authors have indicated they have no financial relationships relevant to this article to disclose.
Dr Chao's current affiliation is Department of Emergency Medicine, SUNY Downstate Medical Center, Brooklyn, NY.
| What's Known on This Subject OT is safe and effective for the management of AOM. Observation therapy is safe and effective for the management of AOM. OT and OT+P have been studied and found to be well accepted in the private practice setting. Most physicians are not using delayed antibiotic therapy for AOM.
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| What This Study Adds OT and OT+P are well accepted by parents in an urban PED. Adherence to delayed antibiotic therapy was better for those offered OT. These data suggest that, in the PED setting, OT reduces antibiotic use without compromising satisfaction.
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REFERENCES |
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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics
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