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Evidence Report/Technology Assessment Number 198 Management of Acute Otitis Media: Update Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. HHSA 290-2007-10056-I Prepared by: RAND Corporation, Santa Monica, CA 90407 Investigators Paul G. Shekelle, M.D., Ph.D. Glenn Takata, M.D., M.S. Sydne J. Newberry, Ph.D. Tumaini Coker, M.D. Mary Ann Limbos, M.D., M.P.H. Linda S. Chan, Ph.D. Martha M. Timmer, M.S. Marika J. Suttorp, M.S. Jason Carter, B.A. Aneesa Motala, B.A. Di Valentine, J.D. Breanne Johnsen, B.A. Roberta Shanman, M.L.S. AHRQ Publication No. 11-E004 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. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. 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. 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. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. This report was requested by the American Academy of Pediatrics (AAP). The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome comments on this evidence report. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by e-mail to [email protected]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. CAPT Ernestine Murray, R.N., B.S.N., M.A.S. Director, EPC Program EPC Program Task Order Officer Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments We wish to acknowledge the invaluable guidance and expertise contributed to this project by the Technical Expert Panel members who are listed in Appendix F. We also thank CAPT Ernestine (Tina) Murray (AHRQ) for her patience, guidance, and input, and the Oregon Evidence-based Practice Center, Rose Relevo, for assistance with research on drug safety, and the administrative staff for assistance with preparation of the report. iv 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. v vi Contents Executive Summary.........................................................................................................................1 Evidence Report.............................................................................................................................19 Chapter 1. Introduction ..................................................................................................................21 Diagnostic Accuracy..............................................................................................................21 Management...........................................................................................................................21 Pneumococcal Conjugate Vaccine.........................................................................................22 Chapter 2. Methods.......................................................................................................................23 Original Proposed Key Questions.............................................................................................23 Technical Expert Panel .............................................................................................................24 Definitions of Acute Otitis Media.............................................................................................24 Literature Search.......................................................................................................................25
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