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Structured Abstract
Context:
Acute Otitis Media (AOM), a viral or bacterial infection of the ear, is the most common childhood infection for which antibiotics are prescribed in the United States. In 2001, the Southern California Evidence-based Practice Center conducted a systematic review of the evidence comparing treatments of AOM.
Objectives:
This review updates the 2001 review findings on diagnosis and treatment of uncomplicated AOM, assesses the evidence for treatment of recurrent AOM, and assesses the impact of the heptavalent pneumococcal conjugate (PCV7) vaccine on the microbiology of AOM.
Data Sources and Study Selection:
Searches of PubMed and the Cochrane databases were conducted from January 1998—July 2010 using the same search strategies used for the 2001 report, with the addition of terms not considered in the 2001 review. The Web of Science was also searched for citations of the 2001 report and its peer-reviewed publications.
Data Extraction:
After review by two investigators against pre-determined inclusion/exclusion criteria, we included existing systematic reviews and randomized controlled clinical trials for assessment of treatment efficacy and safety. Pooled analysis was performed for comparisons with three or more trials.
Results and Conclusions:
Few studies were found that examined the accuracy and precision of the diagnosis of AOM. Since PCV7’s introduction, AOM microbiology has shifted significantly, with Streptococcus pneumoniae becoming less prevalent and Haemophilus influenzae (HF) increasing in importance. For uncomplicated AOM, pooled analysis indicates that nine children (95% CI: 6, 20) would need to be treated with ampicillin or amoxicillin rather than placebo to note a difference in the rate of clinical success. However, in four studies of delayed treatment approaches for uncomplicated AOM, two had higher rates of clinical success with immediate antibiotic therapy while two did not, and in three studies, a marked decrease in antibiotic utilization was noted. We are unable to draw definitive conclusions regarding the comparative effectiveness of different antibiotics for AOM in children with recurrent otitis media (ROM). For ROM, long-term antibiotic administration will decrease AOM episodes from 3 to 1.5 for every 12 months of treatment per otitis prone child during active treatment (95% CI: 1.2, 2.1); however, potential consequences of long-term treatment need to be considered. Data were insufficient to draw conclusions about comparative effectiveness of different treatment strategies in subgroups of children with uncomplicated AOM. Adverse events were generally more frequent for amoxicillin-clavulanate than for cefdinir, ceftriaxone, or azithromycin. Higher quality studies and improved reporting of study characteristics related to quality are needed to provide definitive conclusions for AOM and ROM treatment options.
Contents
- Preface
- Acknowledgments
- Executive Summary
- 1. Introduction
- 2. Methods
- 3. Results
- Key Question I Diagnosis of AOM: What are the Operating Characteristics (Sensitivity, Specificity, and Likelihood Ratios) of Clinical Symptoms and Otoscopic Findings (Such As Bulging Tympanic Membrane) to Diagnose Uncomplicated AOM and to Distinguish It from OME?
- Key Question II What Has Been the Impact of the Pneumococcal Heptavalent Immunization (PCV7) on AOM Microbial Epidemiology (Including Acute Mastoiditis and Suppurative Complications)?
- Key Question III What is the Comparative Effectiveness of Different Treatment Options for Treating Uncomplicated Acute Otitis Media in Average Risk Children?
- Key Question IV What Is the Comparative Effectiveness of Different Management Options for Recurrent Otitis Media (Uncomplicated) and Persistent Otitis Media or Relapse of Acute Otitis Media?
- Key Question V Do Treatment Outcomes in Key Questions III and IV Differ by Characteristics of the Condition (AOM), Patient, Environment, and/or Health Care Delivery System?
- Key Question VI What Adverse Effects Have Been Observed for the Treatments Whose Outcomes Are Addressed in Key Questions 3 and 4?
- 4. Discussion
- References
- List of Acronyms/Abbreviations
- Appendixes
- Appendix A Scope, Definitions and Search Strategies
- Appendix B Sample Data Abstraction Forms
- Appendix C Evidence Tables For Randomized Controlled Trials
- Appendix D List of Excluded studies
- Appendix E List of Peer Reviewers
- Appendix F Technical Expert Panel Composition and Meeting Summaries
- Appendix G Summary Tables for Studies Included in Comparisons
- Appendix H Conceptual Framework for the Report
- Appendix I Summaries of Systematic Reviews Included in Analyses
- Appendix J Comparison of Original Research Studies Included in Systematic Reviews
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. HHSA 290-2007-10056-I. Prepared by: RAND Corporation, Santa Monica, CA.
Suggested citation:
Shekelle PG, Takata G, Newberry SJ, Coker T, Limbos M, Chan LS, Timmer M, Suttorp M, Carter J, Motala A, Valentine D, Johnsen B, Shanman R. Management of Acute Otitis Media: Update. Evidence Report/Technology Assessment No. 198. (Prepared by the RAND Evidence-Based Practice Center under Contract No. 290 2007 10056 I). Rockville, MD: Agency for Healthcare Research and Quality. November 2010.
This report is based on research conducted by the RAND Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA 290-2007-10056-I). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.
This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
- Review Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review.[JAMA. 2010]Review Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review.Coker TR, Chan LS, Newberry SJ, Limbos MA, Suttorp MJ, Shekelle PG, Takata GS. JAMA. 2010 Nov 17; 304(19):2161-9.
- Pneumococcal conjugate vaccines for preventing acute otitis media in children.[Cochrane Database Syst Rev. 2020]Pneumococcal conjugate vaccines for preventing acute otitis media in children.de Sévaux JL, Venekamp RP, Lutje V, Hak E, Schilder AG, Sanders EA, Damoiseaux RA. Cochrane Database Syst Rev. 2020 Nov 24; 11(11):CD001480. Epub 2020 Nov 24.
- New patterns in the otopathogens causing acute otitis media six to eight years after introduction of pneumococcal conjugate vaccine.[Pediatr Infect Dis J. 2010]New patterns in the otopathogens causing acute otitis media six to eight years after introduction of pneumococcal conjugate vaccine.Casey JR, Adlowitz DG, Pichichero ME. Pediatr Infect Dis J. 2010 Apr; 29(4):304-9.
- Review Pneumococcal conjugate vaccines for preventing otitis media.[Cochrane Database Syst Rev. 2014]Review Pneumococcal conjugate vaccines for preventing otitis media.Fortanier AC, Venekamp RP, Boonacker CW, Hak E, Schilder AG, Sanders EA, Damoiseaux RA. Cochrane Database Syst Rev. 2014 Apr 2; (4):CD001480. Epub 2014 Apr 2.
- Microbiology of bacteria causing recurrent acute otitis media (AOM) and AOM treatment failure in young children in Spain: shifting pathogens in the post-pneumococcal conjugate vaccination era.[Int J Pediatr Otorhinolaryngol...]Microbiology of bacteria causing recurrent acute otitis media (AOM) and AOM treatment failure in young children in Spain: shifting pathogens in the post-pneumococcal conjugate vaccination era.Pumarola F, Marès J, Losada I, Minguella I, Moraga F, Tarragó D, Aguilera U, Casanovas JM, Gadea G, Trías E, et al. Int J Pediatr Otorhinolaryngol. 2013 Aug; 77(8):1231-6. Epub 2013 Jun 6.
- Management of Acute Otitis Media: UpdateManagement of Acute Otitis Media: Update
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