Watchful Waiting for Acute Otitis Media: Are Parents and Physicians Ready?

METHODS

Physician and parent surveys were conducted in the spring of 2003 as part of a community-level randomized trial of an intervention to promote judicious antibiotic prescribing for children. The 16 communities in the trial were cities and towns in Massachusetts ranging in population from 28000 to 139000 (based on US Census data for 2000).²⁰ They were chosen as communities with defined borders and diverse demographic characteristics. In addition, analysis of health plan claims data showed that most children received primary care within the borders of their own community (and few entered from outside), suggesting that they were relatively isolated from one another. Antibiotic-use rates in these 16 communities from April 1, 2001, until March 31, 2002, ranged from 1.40 to 1.95 antibiotics dispensed per person-year (mean: 1.61) for children <6 years old, similar to rates from other regions of the United States.⁸ Microbiologic surveillance in these communities in 2001 showed that 33% of pneumococci colonizing healthy children were nonsusceptible to penicillin, with 19% resistant (minimum inhibitory concentration ≥ 2.0)²¹; these rates are consistent with national data on pneumococcal antibiotic resistance.²²

Eight study communities had received an educational intervention for both patients and physicians over the prior 3 winter seasons to combat prevalent misconceptions about antibiotic use (REACH Mass [Reducing Antibiotics for Children]). The intervention included mailed newsletters, parent-education materials in physician waiting rooms, community-wide meetings with physicians, and feedback to physicians of current prescribing practices. Although not primarily focused on otitis media, the intervention provided basic information to parents regarding otitis media and its treatment in newsletters and waiting-room materials during the first 2 years. In the final year, the intervention included information about the “observation option” without specifically endorsing it.

RESULTS

DISCUSSION

We conducted a simultaneous survey of parents and physicians in 16 Massachusetts communities to assess practices and attitudes regarding initial observation of acute otitis media before the release of recent AAP/American Academy of Family Physicians practice guidelines endorsing this strategy as an option in selected patients.⁵ A minority of parents were comfortable with this approach when posed as a hypothetical vignette. However, parents with more education, with more knowledge about antibiotics, or who feel included in medical decisions were more likely to be receptive. Although the practice of initial observation was not widespread, a majority of physicians reported using this strategy at least occasionally, with younger physicians reporting more frequent use than their older colleagues. For those physicians already using this approach, both the strength of the patient-physician relationship and the severity of the illness are important factors in choosing candidates. An intervention to promote judicious antibiotic use (including exposure to some information about the observation option for otitis) did not have a significant impact on parental views, but physicians in intervention communities were more likely to report using this option for their patients.

Rising rates of antibiotic resistance in communities²¹ and concern about high rates of antibiotic use⁷ have led US physicians to consider adopting a strategy of initial observation in selected cases of acute otitis media, which is used successfully in other countries.^14,25 Initial observation has appeal because of its potential to reduce antimicrobial use for an illness in which the benefits of immediate treatment are modest. Recent evidence-based reviews and meta-analyses suggest that 8 to 17 patients need to be treated to have a benefit (in symptoms measured at 2–7 days) in 1 patient.^10–12 Clinical trials have demonstrated reasonable acceptability and outcomes with this strategy but, given their sample sizes, cannot rule out increased risk of rare but serious infectious outcomes such as mastoiditis.¹² The potential advantages of initial observation are reflected in recent guidelines from the AAP, which endorses as an option initial observation of acute otitis media in patients ≥2 years old with nonsevere illness, in whom careful parental observation and follow-up are assured.⁵ In patients 6 months to 2 years old, observation is recommended as an option only in nonsevere cases in which the diagnosis is uncertain.

Our finding that most parents are not initially receptive to the observation option when presented as a vignette is not surprising. Most will have seen their children apparently respond to antibiotic treatment for acute otitis media, and only a small number will have ever had initial observation suggested by their child’s physician. Their level of comfort might be substantially higher if the option were explained by their own provider, or it might be lower in a real-life situation in which their child is ill. In either case, parental opinions in a community are likely to change as experience with successful treatment of acute otitis media without antibiotics becomes more common.

The data also suggest that the greatest challenge to the use of initial observation may be among less-educated or economically less-advantaged patients (for which insurance under Medicaid was a proxy in this study). Expectations for antibiotic treatment of upper respiratory illnesses have been shown to vary by patient race/ethnicity.²⁶ It is possible that patients from underserved groups, for whom the quality of care is often lower,²⁷ may be less accepting of an option that may be perceived initially to be “less” treatment. Alternatively, lower predicted acceptance may be driven by less knowledge (and therefore lower receptivity) or parental preference (even with good understanding of the pros and cons). Finally, our model suggests that parents who feel “included” in treatment decisions are more likely to be amenable to initial observation. Future work should consider whether economically disadvantaged parents or those of racial or ethnic minorities do, in fact, feel less included in decisions in the setting of acute childhood illnesses.

The 16 communities studied participated in a randomized trial to test a community-level intervention to promote judicious antibiotic prescribing for children. The intervention focused on the lack of benefit of antibiotics for colds, coughs, and flu-like illnesses and included education about otitis media. One newsletter provided information on treatment options for acute otitis media, including the observation approach, but did not advocate a particular strategy. This intervention did not seem to have an effect on parents’ receptivity to the observation option. Physicians in these communities were invited to evening educational sessions and received e-mailed “briefs” on topics related to antibiotic use and resistance. Data on observation of acute otitis media were presented, and patient-information handouts, based on a published toolkit,²⁸ were distributed. The intervention did seem to have had a small effect on the number of physicians reporting use of the observation option in their practices.

The process of dissemination and adoption of the AAP guideline supporting initial observation provides a unique window on the diffusion of an innovation in medical practice. Speed of adoption by the majority is predicted to be faster when an innovation has great advantage for its users, is compatible with existing values and beliefs, has low complexity, and is easily testable by individuals.^29,30 Even its advocates admit that the relative advantage of initial observation of ear infections is small to the individual physician and patient (although they posit longer-term community benefits of more judicious antibiotic use). Furthermore, some experts who serve as opinion leaders in the field do not believe that the evidence supports the effectiveness of watchful waiting at all.^9,31 Finally, the recommendation to “observe” is, if anything, counter to the prevailing values of our medical care system, which tends toward therapeutic intervention. Although a group of “early adopters” exists already, these data show that they are strongly influenced by the perceived desires of their patients (even if physicians’ perceptions of patient desires are often wrong³²). For all these reasons one would predict that the practice of initial observation will follow a slow adoption curve.

The opponents of the observation option criticize many of the studies on which current recommendations are based for including patients who likely had otitis media with effusion.⁹ They suggest that if stricter criteria were applied to diagnosing acute otitis media, as recommended by the AAP guidelines, antibiotic treatment would be reserved for infections more likely to be bacterial and would have greater effect. Data already exist suggesting that more severely affected children (with fever and vomiting) are more likely to benefit from early treatment.³³ Additional work identifying reliable features that would identify patients who benefit most from antibiotic treatment is needed.³⁴

Although the current data are from Massachusetts only, they represent views of patients and providers in 16 very different communities. Such data will serve as a baseline on which to judge the impact of new AAP/American Academy of Family Physicians guidelines supporting observation as an option in selected cases.⁵ As with any survey study, it is possible that the views of responders do not reflect those of the population overall. Especially because some associations were found in a secondary analysis that redefined the cutoff for physicians to be classified as “users,” these findings require replication in other populations. Specifically, the finding that family physicians were more likely to use observation conflict with prior data from a Virginia study suggesting that pediatricians prescribed antibiotics more judiciously than family physicians.³⁵ It would not be surprising if such differences varied depending on local and regional norms in training and practice. It is also possible that the relatively small number of family-physician respondents in our survey do not represent well the specialty as a whole. Finally, responses to vignettes in a survey (especially one in which a novel idea is presented) may underestimate the acceptability of the same approach were it presented by a trusted clinician with an opportunity for questions to be asked and answered.

Some have hailed release of the AAP guideline on acute otitis media as a way to further decrease unnecessary antibiotic use. Others have expressed concern about unintended consequences including increased frequency of serious bacterial infections. Ultimate adoption of initial observation will depend on additional evidence of its safety and efficacy in actual practice and clinical experience among community physicians. This study suggests that changes in practice will also depend considerably on parental knowledge and attitudes regarding the risks and benefits of antibiotics and the outcome of shared decision-making by patients and providers in the treatment of individual children.