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Health Care Guideline: Diagnosis and Treatment of Otitis Media in Children Ninth Edition January 2008 I ICS I NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT The information contained in this ICSI Health Care Guideline is intended primarily for health profes- sionals and the following expert audiences: • physicians, nurses, and other health care professional and provider organizations; • health plans, health systems, health care organizations, hospitals and integrated health care delivery systems; • health care teaching institutions; • health care information technology departments; • medical specialty and professional societies; • researchers; • federal, state and local government health care policy makers and specialists; and • employee benefit managers. This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting this ICSI Health Care Guideline and applying it in your individual case. This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. An ICSI Health Care Guideline rarely will establish the only approach to a problem. Copies of this ICSI Health Care Guideline may be distributed by any organization to the organization's employees but, except as provided below, may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Improvement, Inc. If the organization is a legally constituted medical group, the ICSI Health Care Guideline may be used by the medical group in any of the following ways: • copies may be provided to anyone involved in the medical group's process for developing and implementing clinical guidelines; • the ICSI Health Care Guideline may be adopted or adapted for use within the medical group only, provided that ICSI receives appropriate attribution on all written or electronic documents; and • copies may be provided to patients and the clinicians who manage their care, if the ICSI Health Care Guideline is incorporated into the medical group's clinical guideline program. All other copyright rights in this ICSI Health Care Guideline are reserved by the Institute for Clinical Systems Improvement. The Institute for Clinical Systems Improvement assumes no liability for any adaptations or revisions or modifications made to this ICSI Health Care Guideline. 2 Symptoms Suggestive of Otitis Media Children Less Than Three Years - irritability - fever - night waking - poor feeding - running nose - conjunctivitis - balance problems - hearing loss - ear pain Children Three Years and Older - ear pain - ear drainage - hearing loss - ear popping - ear fullness - dizziness Health Care Guideline: Diagnosis and Treatment of Otitis Media in Children Ninth Edition January 2008 www.icsi.org I ICS I NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT Copyright © 2008 by Institute for Clinical Systems Improvement 1 A = Annotation 5 Diagnostic Criteria for Acute Otitis Media • Middle ear effusion (seen on exam and/or confirmed by pneumatic otoscopy) with either: - local signs of inflammation; or - ear pain, ear drainage irritability, restlessness, or poor feeding Diagnostic Criteria for Otitis Media with Effusion • Middle ear effusion (seen on exam and/or confirmed by pneumatic otoscopy) or abnormal tympanometry without signs or symptoms of acute otitis media Acute Otitis Media Caregiver or patient calls with otitis media-related symptoms or concerns 1 A Symptoms suggestive of otitis media? 2 A Triage for other illnesses and/or reassurance 3 A Schedule appointment 4 A Meets diagnostic criteria for acute otitis media? 5 A Meets diagnostic criteria for otitis media with effusion? no no no yes 13 A Discuss prevention of otitis media 6 A yes Initiate appropriate treatment 7 A History of recurrent acute otitis media? (3 episodes/6 months, 4 episodes/12 months) 8 A no yes Acute otitis media symptoms resolved? 10 A no Out of guideline 12 yes Refer to Otitis Media with Effusion algorithm (box 14) yes Schedule follow-up 11 Consider ENT referral A 9 A Diagnosis and Treatment of Otitis Media in Children Ninth Edition/January 2008 Otitis Media with Effusion Algorithm A = Annotation www.icsi.org 2 Diagnosis of otitis media with effusion 14 Is patient high risk? 15 Further assessment yes 16 Is action necessary? 17 Consider ENT referral yes 18 Discuss prevention, treatment and follow-up 19 no no Otitis media with effusion symptoms resolved? 20 Consider ENT referral no 21 Out of guideline 22 yes A A Institute for Clinical Systems Improvement www.icsi.org � Algorithms and Annotations ....................................................................................... 1-14 Algorithm (Acute Otitis Media) ......................................................................................... 1 Algorithm (Otitis Media with Effusion) ............................................................................. 2 Foreword Scope and Target Population ......................................................................................... 4 Clinical Highlights and Recommendations .................................................................. 4 Priority Aims ................................................................................................................. 4 Key Implementation Recommendations ....................................................................... 4 Related ICSI Scientific Documents .............................................................................. 4 Disclosure of Potential Conflict of Interest ................................................................... 5 Introduction to ICSI Document Development .............................................................. 5 Description of Evidence Grading.................................................................................. 6 Annotations ................................................................................................................... 7-14 Annotations (Acute Otitis Media) ............................................................................ 7-14 Annotations (Otitis Media with Effusion) ...................................................................14 Supporting Evidence.................................................................................................... 15-19 Brief Description of Evidence Grading ............................................................................ 16 References ...................................................................................................................17-19 Support for Implementation ..................................................................................... 20-25 Priority Aims and Suggested Measures ............................................................................ 21 Measurement Specifications .................................................................................. 22-23 Key Implementation Recommendations .......................................................................... 24 Knowledge Resources ...................................................................................................... 24 Resoures Available ........................................................................................................... 25 Table of Contents Diagnosis and Treatment of Otitis Media in Children Ninth Edition/January 2008 Work Group Leader Leonard Snellman, MD Pediatrics, HealthPartners Medical Group Work Group Members Allergy David Graft, MD Park Nicollet Health Services ENT William Avery, DO Sanford Health Barbara Malone, MD Midwest ENT Family Practice Jeffrey Jenkins, MD Sanford Health Heather Krueger, MD Quello Clinic, Ltd. Carolyn Sparks, MD University of MN Physicians Pharmacy Peter Marshall, PharmD HealthPartners Measurement/ Implementation Advisor Teresa Hunteman, RRT, CPHQ ICSI Facilitator Melissa Marshall, MBA ICSI Institute for Clinical Systems Improvement www.icsi.org � Foreword Scope and Target Population Children greater than 3 months to age 18. Clinical Highlights and Recommendations • A clinical examination is necessary to diagnose acute otitis media. Diagnosis should be made with pneumatic otoscopy. (Annotations #4, 5) • Educate parents on measures to prevent the occurrence of otitis media. (Annotation #6) • Children with low risk should use a wait-and-see approach to treatment. (Annotation #7) • Refer the patient to an ear, nose and throat specialist when the criteria are met. (Annotation #9) Priority Aims 1. Increase the percentage of patients with a diagnosis of acute otitis media who were advised to "wait and see." 2. Improve appropriate antibiotic usage for otitis media infections. 3. Improve caregivers' knowledge of symptoms suggestive of otitis media, appropriate indicators for a provider visit, risk factors, and outcomes of otitis media. 4. Improve the percentage of patients with otitis media who receive an appropriate referral to an ear, nose and throat specialist. Key Implementation Recommendations The following system changes were identified by the guideline work group as key strategies for health care systems to incorporate in support of the implementation of this guideline. 1. Educate caregivers regarding the risks and benefits of antibiotic treatment, management of acute otitis media symptoms and follow-up care. 2. When clinically appropriate, involve caregivers in the decision-making process by incorporating a "watchful waiting" or "wait-and-see" approach to antibiotic use. Related ICSI Scientific Documents Related Guidelines • Diagnosis and Treatment of Respiratory Illiness in Children and Adults Diagnosis and Treatment of Otitis Media in Children Ninth Edition/January 2008 Institute for Clinical Systems Improvement www.icsi.org � Disclosure of Potential Conflict of Interest ICSI has adopted a policy of transparency, disclosing potential conflict and competing interests of all indi- viduals who participate in the development, revision and approval of ICSI documents (guidelines, order sets and protocols). This applies to all work groups (guidelines, order sets and protocols) and committees (Committee on Evidence-Based Practice, Cardiovascular Steering Committee, Women's Health Steering Committee, Preventive & Health Maintenance Steering Committee, Respiratory Steering Committee and the Patient Safety & Reliability Steering Committee). Participants must disclose any potential conflict and competing interests they or their dependents (spouse, dependent children, or others claimed as dependents) may have with any organization with commercial, proprietary, or political interests relevant to the topics covered by ICSI documents. Such disclosures will be shared with all individuals who prepare, review and approve ICSI documents. David Graft receives consulting/speaker fees and conference and travel support for asthma-related proj- ects. No other work group members have potential conflicts of interest to disclose. Introduction to ICSI Document Development This document was developed and/or revised by a multidisciplinary work group utilizing a defined process for literature search and review, document development and revision, as well as obtaining and responding to ICSI members. For a description of ICSI's development and revision process, please see the Development and Revision Process for Guidelines, Order Sets and Protocols at http://www.icsi.org. Diagnosis and Treatment of Otitis Media in Children Foreword Ninth Edition/January 2008 Institute for Clinical Systems Improvement www.icsi.org � Evidence Grading System A. Primary Reports of New Data Collection: Class A: Randomized, controlled trial Class B: Cohort study Class C: Non-randomized trial with concurrent or historical controls Case-control study Study of sensitivity and specificity of a diagnostic test Population-based descriptive study Class D: Cross-sectional study Case series Case report B. Reports that Synthesize or Reflect upon Collections of Primary Reports: Class M: Meta-analysis Systematic review Decision analysis Cost-effectiveness analysis Class R: Consensus statement Consensus report Narrative review Class X: Medical opinion Citations are listed in the guideline utilizing the format of (Author, YYYY [report class]). A full explanation of ICSI's Evidence Grading System can be found at http://www.icsi.org. Diagnosis and Treatment of Otitis Media in Children Foreword Ninth Edition/January 2008 Institute for Clinical Systems Improvement www.icsi.org � Algorithm Annotations Acute Otitis Media Algorithm 1. Caregiver or Patient Calls with Otitis Media-Related Symptoms or Concerns Entrance into the guideline occurs when a caregiver or patient calls regarding an ill child /themselves whose symptoms are suggestive of otitis media, or when a provider discovers findings of otitis media on exam. 2. Symptoms Suggestive of Otitis Media? Generally Restlessness, irritability, wakefulness and poor feeding usually associated with cold symptoms and/or conjunc- tivitis (inflammation of the eye) are all general symptoms of acute otitis media (Ruuskanenen, 1994 [R]). For Children Less Than Three Years of Age Children less than three years old more often present with non-specific symptoms. Frequently, infants and toddlers with otitis media have associated upper respiratory infection symptoms (Ruuskanenen, 1994 [R]). Symptoms include irritability, fever, night waking, poor feeding, cold symptoms, conjunctivitis and occasional balance problems (Kempthrone, 1991 [R]). Ear pulling without associated symptoms is usually not a symptom of otitis media (Baker, 1992 [C]). For Children Ages Three and Older Symptoms include earache, drainage from ears, hearing loss, ear popping, ear fullness or dizziness (Kemp- throne, 1991 [R]). 3. Triage for Other Illnesses and/or Reassurance For symptoms not suggestive of otitis, reassurance and anticipatory education of the symptoms of otitis should be provided. If symptoms suggestive of another illness are described, refer to the appropriate guideline. 4. Schedule Appointment Key Points: • It is recommended that an appointment be made to accurately diagnose acute otitis media. While symptoms of acute otitis media are often dramatic, the illness is rarely an emergency. Most children can be treated symptomatically through the night unless symptoms of a more serious illness are present. Comfort measures can be discussed with parent/caretaker. Comfort measures for the child with otitis media • Hold or rock child. • Acetaminophen or ibuprofen as appropriate for age and size of child. Diagnosis and Treatment of Otitis Media in Children Ninth Edition/January 2008 Institute for Clinical Systems Improvement www.icsi.org 8 • Apply warm compresses to ear. • Elevate the head by raising the head of the crib or use pillows for an older child. • Wipe away drainage as it appears. • For pain or irritability, analgesic ear drops can be used (Auralgan, mineral oil drops, or vegetable oil drops such as olive oil). Analgesic ear drops are not to be given to a child with ventilating tubes or if drainage in the ear canal is present. Diagnosis of otitis media is made by exam. Diagnosis by phone should be avoided except in special circum- stances (children with a history of multiple sets of ventilating tubes or children in high-risk categories such as cleft palate or Down's syndrome who present with bloody or purulent drainage and who are well known to the provider, and in whom follow-up is assured) (Pantell, 1990 [R]; Shelov, 1991 [R]). 5. Meets Diagnostic Criteria for Acute Otitis Media? Key Points: • Diagnosis for acute otitis media should be made with pneumatic otoscopy. Middle-ear effusion (seen on examination and/or confirmed by pneumatic otoscopy) with: • Local signs of inflammation (redness, bulging) • Symptoms associated with acute otitis media - otalgia (ear pain) - otorrhea (ear drainage) - irritability - restlessness - poor feeding - fever Acute otitis media is characterized by middle-ear effusion with acute inflammation. (The tympanic membrane is usually full or bulging [decreased mobility by pneumatic otoscopy]. Color is usually red, yellow or cloudy.) Symptoms may include otalgia, otorrhea, irritability, restlessness, poor feeding or fever. Tympanometry is usually not necessary to establish the diagnosis of acute otitis media. Tympanocentesis, while it is the gold standard of diagnosis, is not usually indicated in the treatment of acute otitis media except for the relief of severe symptoms or when a culture is needed due to an associated, more serious infection. 6. Discuss Prevention of Otitis Media Parents/caretakers should be counseled about otitis media prevention. Elimination of controllable risk factors should be encouraged whenever possible. Otitis media prevention measures to discuss include: • Encouraging breast-feeding (Aniansson, 1994 [B]; Duncan, 1993 [B]) • Feeding child upright if bottle fed • Avoiding exposure to passive smoke (Hinton, 1988 [C]; Strachan, 1989 [D]) Diagnosis and Treatment of Otitis Media in Children Algorithm Annotations Ninth Edition/January 2008 Institute for Clinical Systems Improvement www.icsi.org � • Tobacco cessation counseling • Limiting exposure to numbers of children to the extent possible • Teaching adults and children careful hand washing technique • Limiting exposure to viral upper respiratory infections • Avoid pacifier use beyond 10 months of age (Niemelä, 1995 [B]) • Ensure immunizations are up-to-date; including influenza and 7 valent conjugated polysaccharide vaccine (PCV7) 7. Initiate Appropriate Treatment Key Point: • It is recommended that children with low risk be treated with a wait-and-see approach. • If antibiotic treatment is necessary, it is recommended that amoxicillin be the initial treatment. Treatment Options for Acute Otitis Media Watch and wait Low-risk children six months to two years without severe disease and an uncertain diagnosis should be treated with oral and topical analgesics and may be observed for 48-72 hours. If symptoms do not resolve or are worse, child should be rechecked and/or antibiotics prescribed. Parents may be provided with a prescrip- tion at the initial visit and advised to wait 48 hours, filling the prescription only if symptoms worsen or do not improve (Spiro, 2006 [A]). Clinicians must be available to communicate with parents regarding child's symptoms during the observation time. The opportunity to share decision-making for treatment can lead to higher parental satisfaction (Merenstein, 2005 [A]). Low-risk children are defined as otherwise healthy, do not attend day care and have had no prior ear infec- tions within the last month. Severe disease is defined as fever greater than or equal to 39ºC in the past 24 hours and moderate to severe otalgia. A diagnosis of acute otitis media meets any of the following criteria: sudden on