Running head: GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA

Guideline for Diagnosis and Management for Otitis Media Stacy Hernandez Methodist University

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA

Introduction There are approximately 31 million physician visits annually for acute otitis media (AOM) in the United States each year. Physicians prescribe antibiotics 802 times for every 1000 visits for complaints of AOM and are used most frequently for this diagnosis than any other diagnosis (Hansen et al., 2012). Many times AOM is misdiagnosed and antibiotics are prescribed when the diagnosis is actually otitis media with effusion (OME). The rates of antibiotic-resistance and re-occurrences have began to climb with so many children 2 months through 12 years of age taking antibiotics for AOM or misdiagnosed OME (Venekamp, Sanders, Glasziou, Del Mar, & Rovers, 2013). Studies have shown that there may be a slightly longer recovery time for children with AOM who do not take antibiotics as opposed to those who do. However, children who are prescribed antibiotics usually have side effects such as vomiting and antibiotic-induced diarrhea. The American Academy of Pediatrics (AAP) along with the American Academy of Family Physicians (AAFP) made recommendations to have a period of 48 to 72 hours of observation before prescribing antibiotics for an AOM diagnosis (Subcommittee on Management of Acute Otitis Media, 2004).

Definition of Terms Acute Otitis Media (AOM) is defined as a history of acute onset of signs and symptoms with the presence of middle ear effusion (MEE), and signs and symptoms of middle-ear inflammation (Tabers Cyclopedic Medical Dictionary Thumb-Indexed (21st ed.), 2009). Algorithm is a problem solving process that is based on guidelines that use a formula or decision tree to find the etiology of a medical problem or best treatment (Tabers Cyclopedic Medical Dictionary Thumb-Indexed (21st ed.), 2009).

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA Middle ear effusion (MEE) is defined as having evidence of air or fluid behind the tympanic membrane, bulging of tympanic membrane, and/or little or no movement of the tympanic membrane (Subcommittee on Management of Acute Otitis Media, 2004).

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Randomized Control Trail (RTC) is when individuals are randomly assigned to a control group or an experimental group of a trial. The researcher defined the protocol and method clearly (Tabers Cyclopedic Medical Dictionary Thumb-Indexed (21st ed.), 2009). Shared-Decision model (SDM) is defined as the decisions shared between the patient and the doctor that are made from the best evidence available that meet the characteristics of the patient (Venekamp et al., 2013). Systematic review is a summary of all the literature found in an extensive comprehensive search about relevant studies that deals with a specific question or topic (Tabers Cyclopedic Medical Dictionary Thumb-Indexed (21st ed.), 2009). PICO Question The question that was addressed in this clinical guideline review was: Should or should not antibiotics be prescribed to children ages 2 months through 12 years for acute otitis media? That has been a long-standing question among physicians and parents alike. Do the benefits outweigh the risks? Does the general population have enough knowledge about antibiotics use to help the physician decide if it is needed or not? Do the physicians have the knowledge and resources available to diagnose AOM correctly? These are a few questions that will be concentrated on in this paper to help answer the PICO question. The guideline selected for review that addressed the previous mentioned concerns was the Diagnosis and Management of Acute Otitis Media, which could be found at: http://www.pediatrics.aap publications.org/ content/113/5/1451.full.pdf.

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA Evidence There was an extensive literature search through many databases, published articles,

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meta-analysis, and systematic reviews to back up the recommendations from the guideline with evidence-based practice studies. Today up to 80% of 3 year old children have had at least 1 episode or more of AOM. Antibiotics were always given and therefore antibiotic-resistance for bacteria (Streptococcus pneumonia) that cause AOM has increased to >50% (Hansen et al., 2012). It was discovered in the guideline review that with the recommended (a) preventive measures, (b) correct diagnosis of acute otitis media (AOM), (c) proper pain management and (d) correct use of antibiotics, there was recorded a decrease of antibiotic resistance and a decline in re-occurrences of AOM in otherwise healthy children (Subcommittee on Management of Acute Otitis Media, 2004). Studies showed that children who did not receive antibacterial agents had a slightly longer recovery time of 1 to 3 days compared to the children who had received antibiotics. Venekamp et al. (2013) found in the 12 randomized control trials (RCT) they reviewed, that for every 14 children prescribed antibiotics for AOM, one child would have severe effects of antibiotic-induced diarrhea, vomiting or skin rash (see Appendix A). One study assessed the Shared-Decision model where parents were educated about antibiotics through the use of a clinical vignette tool. Before reading the vignettes, 93% of participants strongly agreed to the use of antibiotics for the diagnosis of AOM. After reading the vignettes, only 14% felt that the antibiotics might still be necessary. This gave the parents knowledge and let them share the decision of the route of treatment for their child that was diagnosed with AOM (Merenstein, Diener-West, Krist, Pinneger, & Cooper, 2005).

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA A randomized control trial compared two approaches to observation therapy for all children diagnosed with AOM. All children were put on observation for 3 days. One

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observational approach gave a randomized group of parents a prescription for antibiotics to fill if symptoms continued after 3 days. The second observation group was told to follow up with their doctors if symptoms persisted after the 3 days. The findings showed that parents accepted both observational methods and also found that antibiotic use had lowered (Chao, Kunkov, Reyes, Litchen, & Crain, 2008). In the systematic review by the Subcommittee on Management of Acute Otitis Media (2004), physicians were given written definition of what to look for when diagnosing AOM. They were also given an algorithm to follow for the management of AOM, which can be seen in Appendix B. With parents being educated about antibiotic use, doctors diagnosing AOM correctly, and implementing an observation period before prescribing antibiotics, this nursing student believes there will be a lower rate of adverse effects, re-occurrences, and antibiotic resistance in the future. Based on all the evidence-based studies in the literature reviews, the nursing student agrees with the recommendations of the guideline and would implement them into practice. Action Plan The first part of the implementation process for this guideline would consist of data collection on patients that presented with symptoms of AOM and a survey to find out the education level of the parent about antibiotics. At the same time, the leader will hand out a copy of the guideline and some research about it. The physicians and nurse practitioners will then have a chance to look at the information and reflect on how it could have been used in prior cases when they diagnosed children with AOM.

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA About one month later the clinic leader would perform an in-service for all physicians

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and nurse practitioners employed by the clinic. On that chosen day, the clinic will close 1 hour early. The in-service will be held out in the patients waiting room to accommodate everyone. The leader will present the guideline and recommendations to the group and will provide evidence to back them up. After the evidence has been presented, the leader will show the employees a series of pictures of either AOM or OME diagnosis. The physicians and nurse practitioners will need to be able to identify the correct diagnosis for all the pictures. The leader will then present and explain how to use the algorithm (as shown in Appendix B) for the management of AOM (Subcommittee on Management of Acute Otitis Media, 2004). The physicians and nurse practitioners will then be required to use the algorithms when patients present with complaints of AOM. Finally, the physicians and nurse practitioners will be given a pamphlet with the facts about AOM and antibiotic use to help with patient teaching and shared-decision making with the parents (Merenstein et al., 2005). The new clinic guideline will be hung on boards around the office and in a binder with all other guidelines and procedures for the clinic. Posters about antibiotic use will be posted all around the clinic to help with patient teaching. Evaluation Plan To evaluate if the implementation of the guideline worked, the clinic will keep a measurement in a database of how many patients come in with complaint of acute otitis media. There will also be a record kept of how many actual cases of AOM were diagnosed and if they were put on observation or prescribed antibiotics. The results will be compared to that of the previous set of results taken before implementation of the new guideline and recommendations.

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It will be noted how many diagnosed with AOM were re-current. Last, a second survey will be given out to parents to see how much was remembered or learned about antibiotics use. This will also help the leader to see if the physicians, nurse practitioners and nurses are performing effective patient teachings.

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA

References Chao, J. H., Kunkov, L. B., Reyes, S. L., & Crain, E. F. (2008). Comparison of two approaches to observation therapy for acute otitis media in the emergency department. Pediatrics, 121, 1352-1356. doi:10.1542/peds.2007-2278 Hansen, M. P., Jarbol, D. E., Gahrn-Hansen, B., Depont, R., Munck, A., Ryborg, C. E., & Bjerrum, L. (2012). Treatment of acute otitis media in general practice: quality variations across countries. Family Practice, 29(1), 63-68. doi:10.1093/fampr/cmr042 Merenstein, D., Diener-West, M., Krist, A., Pinneger, M., & Cooper L. A. (2005). An assessment of the Shared-Decision model in parents of children with acute otitis media. Pediatrics, 116, 1267-1275. doi:10.1542/peds.2005-0486 Subcommittee on Management of Acute Otitis Media (2004). Diagnosis and management of acute otitis media. Pediatrics, 113(5), 1451-1465. Retrieved from http://pediatrics.aap publications.org/content/113/5/1451.full.html Tabers Cyclopedic Medical Dictionary Thumb-Indexed (21st ed.). (2009). Philadelphia, PA: F. A. Davis Company Venekamp, R. P., Sanders, S., Glasziou, P. P., Del Mar, C. B., & Rovers, M. M. (2013). Antibiotics for acute otitis media in children. The Cochrane Library, 1, 1-74. Retrieved from http://www.thecochranelibrary.com

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA Appendix A Literature Reviews Author & Year Title Question/Purpose

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Design

Sample Data Collection

Findings

Limitations Level of Evidence

Chao, J. H., Kunkov, L. B., Reyes, S. L., & Crain, E. F. (2008) Comparison of two approaches to observation therapy for acute otitis media in the emergency department. Compared parental adherence to delayed antibiotic therapy for AOM with or without a prescription in a pediatric emergency room (PED). Prospective randomized trial with a convenience sample of patients from 14 different PEDs in New York City to encourage observational therapy as opposed to antibiotic therapy for AOM. A total of 232 children ages 2 through 12 from 14 different PEDs were included. Re-analysis of other studies on Antibiotic use versus observational therapy was performed. A randomized 30-day trial to test prior theories was conducted. Observation therapy was well accepted among parents whether they were given a prescription or not for AOM prior to discharge from PED. Lacks common language description. Children who did not follow up after treatment were assumed to not adhere. Level 1, Quality B

Author & Year Title Question/Purpose Design Sample Data Collection

Findings

Hansen, M. P., Jarbol, D. E., Gahrn-Hansen, B., Depont, C. R., Munck, A., Ryborg, C. E., & Bjerrum, L. D. (2012) Treatment of acute otitis media in general practice: quality variations across countries. To investigate the quality of treatment of AOM in general practice and to reduce prescribing of unnecessary antibiotics. Meta-analysis of quality of treatment of registered patients with AOM using newly developed quality indicators. 1255 patients with AOM and respiratory tract infection and 1175 patients with only AOM from 6 countries. Collection of data of registered patients with AOM from 618 general practices in 6 different countries collected over 3 week time period. Collection of data performed according to the Audit Project Odense method. General practice physicians also filled out a questionnaire on their personal prescribing methods. A 95% confidence interval was reported. Researchers used Stata version 10.0 to complete the statistical analyses. Majority of patients were treated with a variety of antibiotics. Antibiotic resistance was increased to >50% in European

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Limitations

Level of Evidence

countries. The need for a limitation in the prescriptions of antibiotics is needed to reduce antibiotic resistance. Lacking common language description. General practices (GP) participated on a voluntary basis. Data was self-reported by GPs, therefore, validity may be questioned. Level 3, Quality A

Author & Year Title Question/Purpose

Design

Sample Data Collection

Findings

Limitations Level of Evidence

Merenstein, D., Diener-West, M., Krist, A., Pinneger, M., & Cooper L. A. (2005) An assessment of the Shared-Decision model in Parents of children with acute otitis media. Objectives were to assess parental satisfaction with different doctor-parent decision-making styles and which is most effective to reduce parents tendency to choose antibiotic treatment for AOM. Cross-sectional survey that was comprised of 3 different vignettes that were developed with different questions. They were identical except with different approaches to treatment and how decisions were made. The parents read the questions and agreed or not. 466 parents of children diagnosed with AOM that were (a) 18 or older and (b) primary caregiver of child. Parents read and answered questions to 3 vignettes. Parent compliance with treatment, satisfaction, and whether or not they used shared-decision making was recorded. Before reading the vignettes, 93% of participants strongly agreed to the use of antibiotics for the diagnosis of AOM. After reading the vignettes, only 14% felt that the antibiotics might still be necessary. Education of the parent about the use of antibiotics in treating AOM and shared decision-making may reduce the antibiotic use for the treatment of AOM and higher parent satisfaction. First study known to examine parent interest in treatment therapy of AOM. Level 1, Quality B

Author & Year Title Question/Purpose Design

Subcommittee on Management of Acute Otitis Media (2004) Diagnosis and management of acute otitis media. To make a guideline to assist primary care physicians with diagnosis and management of AOM. Systematic meta-analysis of randomized control trials that identify the need for proper diagnosis of AOM using an algorithm and use of observation for management.

GUIDELINE TO DIAGNOSIS AND MANAGE OTITIS MEDIA Sample Data Collection

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Findings

Limitations Level of Evidence

74 RCTs from multiple countries. Extensive data collection of 3461original pieces of literature collected from multiple databases. Table summaries of diagnosis guidelines and data comparing different management outcomes. Antibiotics are prescribed >98% of the time in the United States for AOM as compared to the Netherlands who prescribe only 31% of the time. Studies showed that children who did not receive antibacterial agents had a slightly longer recovery time of 1 to 3 days compared to the children who had received antibiotics. The children that received the antibiotics, however, had side effects of antibiotic-induced diarrhea, vomiting or skin rash. With correct diagnosis of AOM, pain management and correct use of antibiotics, there was recorded a decrease of antibiotic resistance and lower re-occurrences of in otherwise healthy children. Exclusion of children that present with AOM and have comorbidities or reoccurring AOM. Level 1, Quality A

Author & Year Title Question/Purpose Design

Sample Data Collection Findings

Limitations Level of Evidence

Venekamp, R. P., Sanders, S., Glasziou, P. P., Del Mar, C. B., & Rovers, M. M. (2013) Antibiotics for acute otitis media in children. To assess the effects of usefulness of antibiotics for children with AOM. A systematic review of randomized control trials (RTC) that compared antimicrobial drugs with placebo and immediate antibiotic treatment with observation periods in children with AOM. 12 RTCs (3317 children and 3854 AOM episodes) from highincome countries. Two review authors independently reanalyzed previous studies. The quality data was extracted and trials assessed. Antibiotic treatment led to a reduction of pain 2 days sooner reduction of and reduction of tympanic membrane perforations. There were adverse events (vomiting and nausea) in children given antibiotics. Children without antibiotics had no adverse events and healed only a day or two later. Observational period seems justified. Antibiotic resistance was decreased All studies done were from high-income countries, therefore lacking comparison of results in low-income countries. Level 1, Quality B

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Appendix B

Figure 1. Algorithm for the management of acute otitis media adopted from Diagnosis and Management of Acute Otitis Media, by the Subcommittee on Management of Acute Otitis Media, 2004, Pediatrics 113(5), 1460.