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Acute Bacterial Sinusitis - Limitations of Test-Based Treatment

Millions of cases of upper respiratory tract infections (URTIs) occur in the US each year and are more common among children than adults. Most URTIs are viral in origin and self-limited, but up to 50% of all patient encounters for viral URTI may result in an antibiotic prescription.1 Approximately 7.5% of URTIs in children are complicated by acute bacterial sinusitis.2 A clinical practice guideline from the American Academy of Pediatrics3 recognizes acute bacterial sinusitis as a clinical diagnosis based on the duration and severity of symptoms for URTIs, with the treatment ranging from close observation to a 10-day course of antibiotics. The clinical practice guideline from the American Academy of Pediatrics has been revised only once during the past 2 decades, in part due to scant cumulative data from randomized clinical trials to inform further guidance.

Clinical guidelines for diagnosis and treatment are an important foundation for antibiotic stewardship in ambulatory pediatrics. Antibiotic stewardship is an area of increasing importance, particularly in ambulatory pediatrics because viral URTIs are common.1 Management of URTIs includes parental reassurance, clear anticipatory guidance around viral illnesses, and specific supportive care suggestions.4,5 One approach to ambulatory antibiotic stewardship is to consider the 4 moments of antibiotic decision-making.6 Does my patient have an infection that requires antibiotics? Do I need to order any diagnostic tests? If antibiotics are needed, what is the narrowest, safest, and shortest regimen I can prescribe? Does my patient understand what to expect and the follow-up plan?

In the current issue of JAMA, Shaikh et al7 randomized children aged 2 to 11 years with clinically diagnosed acute bacterial sinusitis to treatment with amoxicillin and clavulanate or matching placebo to evaluate the role of antibiotics in reducing acute bacterial sinusitis symptoms. Children were stratified according to presence or absence of colored nasal discharge. The authors compared treatment effect in a subgroup of children with the presence or absence of 3 common nasopharyngeal pathogens: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. We commend the authors for adding to the much-needed data on sinusitis diagnosis and treatment. How do these findings inform and fit into the stepwise approach to antibiotic stewardship in the ambulatory setting? Although the study by Shaikh et al7 offers interesting nuances related to 3 of the 4 moments of antibiotic decision-making,6 it does not seem to be a game changer in the understanding of acute bacterial sinusitis.

The first moment of antibiotic decision-making is “Does my patient have an infection that requires antibiotics?” Antibiotics should only be prescribed if the benefit of treatment (eg, improvement in symptoms) outweighs the risks (eg, progression of disease without treatment or adverse drug events). Several findings in this study7 reassured that most cases of acute bacterial sinusitis do not require an antibiotic. First, antibiotic treatment resulted in only modest improvement in symptom duration, with a median reduction in the duration of symptoms from 9 to 7 days. Second, the reduction in symptom burden was also modest. The authors found that the antibiotic group reported a median 2-point reduction in daily symptoms (on a 40-point scale) compared with the placebo group, but the clinical relevance of this finding is unclear. For example, a parent with a child in the antibiotic group may report their child’s daytime cough was reduced from “a lot” (4 points) to “some” (3 points) and acting more tired than usual was reduced from “a little” (2 points) to “almost none” (1 point), which together is a reduction of 2 points, but this improvement may not feel significant to families. On the other hand, when a child’s cough is reduced 2 points from “an extreme amount” to “some,” this may be more meaningful. Regardless, the 2-fold risk of diarrhea among the antibiotic group compared with the placebo group may outweigh the benefit of early symptom resolution in a young child who has already been ill for longer than 1 week. Third, most children in the placebo group improved (only 26% received another antibiotic compared with 14% in the antibiotic group), and none had serious adverse events.

The second moment of antibiotic decision-making is “Do I need to order any diagnostic tests?” Since the COVID-19 pandemic, parents have become accustomed to the possibility of nasopharyngeal testing when their child presents with symptoms for URTIs. Prior to COVID-19, pediatric clinicians diagnosed a viral illness as one of many viruses, most often without a laboratory test. Knowing the specific virus was not particularly important in most cases except for surveying the community prevalence of circulating viruses or to diagnose and treat influenza virus. After COVID-19, there is an increased desire by some parents and clinicians to name the virus causing a child’s URTI. Broad respiratory pathogen panels have filled this clinical demand, but also demonstrate the limitations of diagnostic testing, especially because a positive test result does not distinguish colonization, infection, or even residual antigenic or genetic material. The current randomized clinical trial7 does add to the discussion about the value of diagnostic tests to inform treatment of common pediatric illnesses.8 The authors found that antibiotics reduced acute bacterial sinusitis symptom duration for children who tested positive for common nasopharyngeal pathogens.7 However, nasopharyngeal testing in particular has limitations. Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis commonly colonize the respiratory epithelium, such that their presence does not always indicate infection.

Prior studies9,10 have shown that these bacterial pathogens are more abundant in children with respiratory viral infections, but their presence may poorly correlate with pathogens found in the sinuses. Furthermore, children in the current study7 met strict clinical diagnostic criteria. Widespread testing at ambulatory sites in children who do not meet strict clinical criteria could lead to unnecessary antibiotic treatment without benefit. Even if there were strong indications to initiate diagnostic testing, rapid testing for nasopharyngeal bacterial pathogens is not widely available. Larger medical practices and health care organizations may require a clear cost-benefit analysis of new rapid diagnostic tests prior to purchasing and stocking tests and other culture materials. Decisions about such purchases may be made at an administrative level and are not necessarily guided by clinical considerations alone. Adding testing and follow-up for a routine ambulatory encounter when clinics are short-staffed and clinical staff members are experiencing burnout may not be feasible, even with rapid testing.

The third and fourth moments of antibiotic decision-making are “If antibiotics are needed, what is the narrowest, safest, and shortest regimen I can prescribe?” and “Does my patient understand what to expect and the follow-up plan?” Caregiver communication and shared decision-making play key roles in maintaining parental satisfaction while reducing unnecessary antibiotic use. An important finding of the current study7 is that among children with colored nasal discharge, there was not a reduction in symptom burden in those who received antibiotic treatment vs placebo. Parents commonly perceive nasal discharge color as an indication for antibiotic treatment, so clinicians can now reassure parents that colored secretions alone are not an indication that antibiotic treatment will hasten symptom burden.

In addition, given the ubiquity of COVID-19 testing, caregivers are familiar with and often expect nasopharyngeal diagnostic tests to be performed. However, in the setting of COVID-19 testing, caregivers likely experienced or witnessed the discomfort experienced by their child during the collection of a nasopharyngeal culture. This discomfort coupled with the increased rates of diarrhea in children taking antibiotics may empower caregivers to opt out of exposing children to further discomfort if there is a possibility that good supportive care alone will lead to clinical improvement. Ultimately, the risk of causing further discomfort to an ill child may outweigh the potential benefit of a small reduction in duration and severity of symptoms among a subset of children with pathogens detected.

The current randomized clinical trial7 is an opportunity to reflect on the importance of providing clear anticipatory guidance around acute bacterial sinusitis management, such as typical symptom burden, expected duration of illness, and the insignificance of nasal secretion color. Overall, the current study7 suggests that antibiotics may provide mild relief in symptom burden in children with acute bacterial sinusitis, especially in those with common respiratory bacteria. However, given the limitations of nasopharyngeal bacterial pathogen testing, widespread adoption of a test-based treatment approach is not there yet.

Tania M. Caballero, MD, MHS1; Brandon S. A. Altillo, MD2; Aaron M. Milstone, MD, MHS3

JAMA. 2023;330(4):326-327. doi:10.1001/jama.2023.11365

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