The Case Scenario
Recent clinical evidence-based guidelines suggest that a “watch and see” approach may be best in the management of pediatric acute otitis media. In this case scenario,
a team of nurses in the outpatient clinic are considering whether they should use this approach to manage AOM in the children they see. They plan to evaluate clinical studies before making their final decision. The nurses are also aware of the possibility of parental concerns concerning a change in treatment protocols. The studies are analyzed in this paper.
Cautionary use of Antibiotics in Acute Otitis Media
Acute otitis media (AOM) is the most common pediatric bacterial infection in the U.S. and the most common bacterial infection to be treated with antibiotics. However, many of the pathogens that cause AOM have developed resistance to current lines of antibiotic therapies. The Centers for Disease Control and the American Academy of Pediatrics now recommended a cautionary approach to antibiotic treatment of AOM. Several studies on clinical guidelines for AOM support their recommendations. A group of nurses in this scenario’s outpatient clinic have decided to evaluate research on the subject to determine whether this is the appropriate care for their pediatric patients.
The Block (1997) publication is a filtered source. It was published in a journal for pediatric and infectious diseases, and thus was a peer-reviewed publication. In his article, Block summarizes the most common pathogens associated with acute otitis media (AOM) and discusses which pathogens tend to infect younger and older children. The author then discusses new strains of bacteria that have become resistant to amoxicillin, the first-line antibiotic protocol used to treat AOM in younger children. He then refers to evidence provided in other studies regarding the efficacy of macrolides in eradicating bacterial strains that are resistant to amoxicillin and suggests their use as a rational alternative for the management of AOM. Although this study is relevant to the case in question, the data is 15 years old and might not reflect current best practices; thus it is recommended that the nursing team use this source with caution, perhaps only to support new evidence; like the data provided in the more recent AOM study by Leibovitz (2003).
The article by Kelly, Freidman and Johnson (2007) was published in a clinical book that provides guidelines for the diagnosis and treatment of pediatric diseases. It is not a peer-reviewed publication. Thus, the information is general and all-inclusive. However, the authors are considered authorities in the field, so it can be assumed that the information in their article is based on empirical evidence. Their guidelines are worth considering.
McCracken (1998) is a filtered source that offers evidence-based guidelines for the treatment of AOM. The McCracken publication is too old to guide the therapeutic making processes for nurse practitioners in the clinical setting; however, it may be used to support current research in the topic, like the study by Leibovitz (2003). A good argument to be made is that antibiotic resistant pathogens associated with AOM are an old issue that persists even in face of new lines of therapies. Combined with education regarding the general significance to health of antibiotic resistant pathogens, and the dangers inherent in overuse of antibiotics, the McCracken study may help support the nursing team decision for initially withholding antibiotic therapy for the treatment of pediatric OAM.
The American Academy of Pediatrics and the American Academy of Family Physicians 2004 clinical practice guidelines for the diagnosis and management of AOM are based on extensive review of evidence-based literature on the subject. The overall recommendation is cautionary use of antibiotic therapy. The first step recommended in the guidelines is to diagnose AOM as either a complicated or an uncomplicated case of AOM. If the child presents with uncomplicated AOM and the illness is not severe, and the parents assures follow-up visits, the protocol recommended is observation without the use of antibiotics. Amoxicillin (80 to 90 mg/kg per day) should be used in cases with complicated AOM or severe AOM. Therapy should be initiated in patients who failed to respond within 48-72 hours to initial management. Patients on observation should be initiated on amoxicillin, whereas patients who failed to respond to amoxicillin should be prescribed a different antibacterial agent. For all patients the reduction of risk factors is recommended. Table 1 offers a brief summary of the four studies.
However, the strongest evidence in support of adopting a wait-and-see approach would be the clinic’s own data on the clinical outcome of patients who chose “wait-and-see prescription” (WASP) versus those who chose “standard prescription” (SP), as reported by interviews of parents at the clinic. The SP group (n=217) filled their prescriptions immediately, while the WASP group (n=283) did not use antibiotics unless the condition had had failed to clear within 48 hours. The data shows that out of 283 pediatric patients in the WASP group, 72% chose not to fill the antibiotic prescription. Nevertheless, there was no statistically significant difference in the frequency of fever, otalgia, or emergency visits to the clinic between the WASP and the SP group, suggesting that in the majority of case, AOM resolved itself without resorting to antibiotic treatment. Within the WASP group, 28% reported fever and otalgia as their reason for filling their prescriptions.
Furthermore, there were seven (3.22%) cases of adverse outcomes associated with antibiotic use in the SP group, and three (1.41%) cases of adverse reactions in the WASP group. Thus, the clinical data on the use of antibiotics for the treatment of AOM in pediatric patients at this clinic strongly suggests that the high rate of success with WASP outweighs the risk of adverse reactions associated with SP. It should be stressed to the parents that nearly three quarters of the pediatric patients at this clinic were cured without antibiotics.
Based on the evidence presented in the American academies’ guidelines, and the clinic’s own clinical data, a cautionary approach to antibiotic treatment appears to be a valid management option for pediatric AOM. The disease may resolve itself without medication in children with uncomplicated AOM or with non-severe symptoms, eliminating the risk of antibiotic-related complications and the cost of therapeutic agents. If the disease does not resolve itself within a sort period of time, the child still has the option to undergo antibiotic treatment.
The Clinical Practice Guidelines are clear and easy to apply in the clinical setting. The first step towards application of these guidelines at the clinic in question is to create an easy to understand flow chart that summarizes the guidelines. The chart can be used during therapy discussions with the parents. It is clear that a short “wait and see” period of 2-3 days may be beneficial to the parent and the pediatric patient. It is also clear that initial management of the disease without resort to antibiotic treatment does not preclude their future use. More important, management through observation is to be presented as an option to the parent. The parent should make the final choice whether to initiate therapy immediately, or adopt a “wait and see” approach.
Taking all the evidence into consideration, any ethical issues that might arise in connection with the new clinical practice guidelines for the management of pediatric AOM would concern the continuation of SP rather than a change to WASP therapy. First of all, as already stated, the change in protocol does not withhold treatment for those who might need it. The vulnerable population of children diagnosed with complicated AOM or who present with severe symptoms would still undergo immediate antibiotic therapy. Only children with uncomplicated AOM, or where serious concern for adverse antibiotic effects is present, will have the option of WASP therapy. Even then, the wait is short; within 2-3 days the parent will again have the option to choose traditional antibiotic treatment. Parents will be provided with clear details regarding clinical concerns with antibiotic resistant strains of bacteria.
It must be understood that informed consent covers both options: to undergo therapy, or not to undergo therapy, whether or not the child is ultimately enrolled in a study. Furthermore, there are established clinical research protocols that protect the confidentiality of the patient, so there is no need for concern in this area either.
American Academy of Pediatrics and American Academy of Family Physicians. (2004.)
Clinical practice guideline: Diagnosis and management of acute otitis media.
Retrieved May 17, 2008, from http://aappolicy.aappublications.org/cgi/content/full/pediatrics;113/5/1451
Block, S. L. (1997). Causative pathogens, antibiotic resistance and therapeutic considerations in acute otitis media. Pediatric Infectious Disease Journal, 16, 449–456.
Kelley, P. E., Friedman, N., Johnson, C. (2007). Ear, nose, and throat. In W. W. Hay, M. J. Levin, J. M. Sondheimer, & R. R. Deterding (Eds.), Current pediatric diagnosis and treatment (18th ed., pp. 459–492). New York: Lange Medical Books/McGraw-Hill.
Leibovitz E. (2003). Acute otitis media in pediatric medicine: current issues in epidemiology, diagnosis, and management. Paediatr Durgs Suppl 1,1-12.
McCracken, G. H. (1998). Treatment of acute otitis media in an era of increasing microbial resistance. Pediatric Infectious Disease Journal, 17, 576–579