Prepared by:
Southern California Evidence-based Practice Center
Michael Marcy, M.D.
Principal Investigator
Glenn Takata, M.D., M.S.
Linda S. Chan, Ph.D.
Paul Shekelle, M.D., Ph.D.
Wilbert Mason, M.D., M.P.H.
Laura Wachsman, M.D.
Richard Ernst, Ph.D.
Joel W. Hay, Ph.D.
Pamal M. Corley, M.S.L.S.
Tricia Morphew, M.S.
Emily Ramicone, M.S.
Connie Nicholson
Investigators
File Name Description Software Version File Size __________________________________________________________________________________________________________ 01title.doc Microsoft Word® Document MS Word® 97 SR-1 39KB 8 pages Contents: Front Cover, Title Page, Preface, Structured Abstract __________________________________________________________________________________________________________ 02front.doc Microsoft Word® Document MS Word® 97 SR-1 104KB 3 pages Contents: Table of Contents __________________________________________________________________________________________________________ 03summ.doc Microsoft Word® Document MS Word® 97 SR-1 43KB 7 pages Contents: Summary: Overview; Reporting the Evidence; Methodology; Findings; Future Research __________________________________________________________________________________________________________ 04chap1.doc Microsoft Word® Document MS Word® 97 SR-1 47KB 7 pages Contents: Chapter 1. Introduction: Purpose; Scope of Work; Definition; Epidemiology; Risk Factors; Diagnosis; Alternatives for Treatment; Outcomes __________________________________________________________________________________________________________ 05chap2.doc Microsoft Word® Document MS Word® 97 SR-1 673KB 36 pages Contents: Chapter 2. Methodology: Establishment of Conceptual Framework; Nomination of Technical Experts; Topic Assessment and Refinement; Table 1. Technical expert panel; Identification of Key Questions; Table 2. Initial seven key questions for ranking by technical experts; Table 3. Rankings of initial key questions by technical experts; Table 4. Final version of the three key questions; Identification of Causal Pathways, Study Populations, Practice Settings, and Target Audience; Table 5. Causal pathways for key questions; Table 6. Preliminary literature search on seven initial key questions; Refinement of Key Questions, Definition of AOM, and Scope; Table 7. Technical expert's responses to four issues related to definition of acute otitis media January 7, 1999; Table 8. Questionnaire to poll technical experts on four unresolved issues related to definition of AOM, key questions and scope; Table 9. Technical expert's responses to four unresolved issues1 related to definition, key questions, and scope; Literature Search; Table 10. Preliminary screening results of titles and abstracts from seven databases; Table 11. Results of secondary screening of 760 articles; Table 12. Distribution of 273 non-English articles by language; Table 13. Results of reviewing 97 non-English articles; Review and Assessment of Study Quality; Data Abstraction; Procedures to Reduce Bias, Enhance Consistency, and Check Accuracy; Figure 1. Percent of titles/abstracts requiring resolution over time; Review of Results of Literature Review; Ranking of Influencing Factors; Preparation of Evidence Tables; Supplemental Analysis; Table 14. Ranking of 41 influencing factors for analysis by technical experts; Table 15. Comparisons for key question 3, antibiotics vs. no antibiotics; Table 16. Comparisons for key question 4a: amoxicillin or trimethoprim-sulfamethoxazole vs. other anitibiotics; Table 17. Comparisons for key question 4e: short-term vs. long-term antibiotic therapy; Summary of Characteristics of Articles in Evidence Report; Identification of Peer Reviewers; Peer Review Process; Table 18. Peer Review Panel; Table 19. Instructions for reviewing draft evidence report __________________________________________________________________________________________________________ 06chap3.doc Microsoft Word® Document MS Word® 97 SR-1 956KB 92 pages Contents: Chapter 3. Results: Natural History; Table 20. Key question 1: selected outcomes; Table 21. Key question 1. Terms and definitions: success and failure; Table 22. Key question 1: failure rate in the placebo or observational group; Table 23. Key question 1: presence of pain and/or fever in the placebo or observational group; Table 24. Key question 1: presence of middle ear effusion in the placebo or observational group; Table 25. Mastoiditis/suppurative complications and AOM: no antibiotic and associated antibiotic arms from cohort and randomized controlled studies; Antibiotics vs. No Antibiotics; Table 26. Summary of Del Mar, Glasziou, and Hayem (1997) meta-analysis; Table 27. Summary of Rosenfeld, Vertrees, Carr, et al. (1994) meta-analysis; Table 28. Summary of Rosenfeld (1999b) meta-analysis; Table 29. Comparison 1: Meta-Analysis 1.1-Key question 3: ampicillin/amoxicillin vs. placebo; outcome indicator: failure rate at 2-7 days of treatment; Figure 2. Shrinkage plot for outcome = failure rate at 2-7 days of treatment Comparison 1: Meta-analysis 1.1 = ampicillin/amoxicillin vs. placebo; Figure 3. Funnel plot for outcome = failure rate at 2-7 days of treatment Comparison 1: Meta-analysis 1.1 = ampicillin/amoxicillin vs. placebo; Table 30. Comparison 1: Meta-Analysis 1.2-Key question 3: ampicillin/amoxicillin vs. placebo; outcome indicator: failure rate at 2-7 days of treatment (excluded Howie studies); Table 31. Comparison 1: Meta-Analysis 1.3-Key question 3: ampicillin/amoxicillin vs. placebo; outcome indicator: failure rate at 2-7 days of treatment (excluded Howie, and Kaleida studies); Figure 4. Shrinkage plot for outcome = failure rate at 2-7 days of treatment Comparison 1: Meta-analysis 1.2 = ampicillin/amoxicillin vs. placebo (excluding Howie study); Figure 5. Shrinkage plot for outcome = failure rate at 2-7 days of treatment Comparison 1: Meta-analysis 1.3 = ampicillin/amoxicillin vs. placebo (excluding Howie and Kaleida studies); Antibiotic vs. Antibiotic; Table 32. Key Question 4a: meta-analysis comparisons (terms and definitions; success and failure); Table 33. Comparison 2: Meta-Analysis 2.1- Key question 4a: penicillin vs. ampicillin/amoxicillin; outcome indicator: failure rate at 7-14 days of treatment; Figure 6. Shrinkage plot for outcome = failure rate at 7-14 days of treatment. Comparison 2: Meta-analysis 2.1 = penicillin vs. ampicillin/amoxicillin; Table 34. Comparison 3: Meta-Analysis 3.1. Key question 4a: cefaclor vs. ampicillin/amoxicillin; outcome indicator: failure rate at 3-7 days of treatment; Figure 7. Shrinkage plot for outcome = failure rate at 3-7 days of treatment. Comparison 3: Meta-analysis 3.1 = cefaclor vs. ampicillin/amoxicillin; Figure 8. Shrinkage plot for outcome = failure rate at 5-21 days of treatment. Comparison 3: Meta-analysis 3.2 = cefaclor vs. ampicillin/amoxicillin; Figure 9. Funnel plot for outcome = failure rate at 5-21 days of treatment Comparison 3: Meta-analysis 3.2 = cefaclor vs. ampicillin/amoxicillin; Table 35. Comparison 3: Meta-Analysis 3.2. Key question 4a: cefaclor vs. ampicillin/amoxicillin; outcome indicator: failure rate at 5-21 days of treatment; Table 36. Comparison 4: Meta-Analysis 4.1. Key question 4a: cefixime vs. ampicillin/amoxicillin; outcome indicator: failure rate at 10-15 days of treatment; Figure 10. Shrinkage plot for outcome = failure rate at 10-15 days of treatment Comparison 4: Meta-analysis 4.1= cefixime vs. ampicillin/amoxicillin; Table 37. Comparison 4: Meta-Analysis 4.2. Key question 4a: cefixime vs. ampicillin/amoxicillin; outcome indicator: recurrence at 3-5 weeks of treatment; Figure 11. Shrinkage plot for outcome = recurrence at 3-5 weeks of treatment Comparison 4: Meta-analysis 4.2 = cefixime vs. ampicillin/amoxicillin; Table 38. Comparison 4: Meta-Analysis 4.3. Key question 4a: cefixime vs. ampicillin/amoxicillin; outcome indicator: diarrhea as an adverse event; Table 39. Comparison 4: Meta-Analysis 4.4. Key question 4a: cefixime vs. ampicillin/amoxicillin; outcome indicator: vomiting as an adverse event; Table 40. Comparison 4: Meta-Analysis 4.5. Key question 4a: cefixime vs. ampicillin/amoxicillin; outcome indicator: rash as an adverse event; Figure 12. Shrinkage plot for outcome = diarrhea as an adverse effect. Comparison 4: Meta-analysis 4.3 = cefixime vs. ampicillin/amoxicillin; Figure 13. Funnel plot for Outcome = diarrhea as an adverse effect. Comparison 4: Meta-analysis 4.3 = cefixime vs. ampicillin/amoxicillin; Figure 14. Shrinkage plot for outcome = vomiting as an adverse effect. Comparison 4: Meta-analysis 4.4 = cefixime vs. ampicillin/amoxicillin; Figure 15. Shrinkage plot for outcome = rash as an adverse event. Comparison 4: Meta-analysis 4.5 = cefixime vs. ampicillin/amoxicillin; Table 41. Key Question 4a. Studies not in meta-analytic comparisons: synopsis; Table 42. Summary of Kozyrskyj, Hildes-Ripstein, Longstaffe, et al. (1998) meta-analysis; Table 43. Comparison 9: Meta-Analysis 9.1. Key Question 4e: Ceftriaxone (1 dose) with amoxicillin (7-10d). outcome indicator: failure rate at 5-10 days of treatment; Figure 16. Shrinkage plot for outcome = failure rate at 5-10 days of treatment Comparison 9: Meta-analysis 9.1 = ceftriaxone (1 Dose) vs. ampicillin/amoxicillin (7-10 days); Table 44. Comparison 9: Meta-analysis 9.2. Key Question 4e: Ceftriaxone (1 dose) vs. amoxicillin (7-10d) outcome indicator: failure rate at 5-10 days of treatment (criterion of failure relaxed to include complications in Green study); Table 45. Key Question 4e. Meta-analysis comparisons: terms and definitions; success and failure; Figure 17. Shrinkage plot for outcome = failure rate at 5-10 days of treatment Comparison 9: Meta-analysis 9.2 = ceftriaxone (1 Dose) vs. ampicillin/amoxicillin (7-10 days) (criterion of failure relaxed to include complications in Green study); Table 46. Comparison 10: Meta-analysis 10.1. Key question 4e: azithromycin (<5d) vs. amoxicillin-clavulanate (7-10d) outcome indicator: failure rate at 10-14 days of treatment; Figure 18. Shrinkage plot for outcome = failure rate at 10-14 days of treatment Comparison 10: Meta-analysis 10.1 = azithromycin (<5d) vs. amoxicillin-clavulanate (7-10d); Figure 19. Funnel plot for outcome = failure rate at 10-14 days of treatment Comparison 10: Meta-analysis 10.1 = azithromycin (<5d) vs. amoxicillin-clavulanate (7-10d); Table 47. Comparison 11: Meta-Analysis 11.1. Key question 4e: azithromycin (5d) vs. amoxicillin-clavulanate (7-10d) outcome indicator: any mention of adverse events; Figure 20. Shrinkage plot for outcome = any mention of adverse events Comparison 11: Meta-analysis 11.1 = Azithromycin (5 d) vs. amoxicillin-clavulanate (7-10 d); Table 48. Comparison 11: Meta-Analysis 11.2. Key question 4e: azithromycin (5d) vs. amoxicillin-clavulanate (7-10d) outcome indicator: GI-related adverse events; Figure 21. Shrinkage plot for outcome = gastrointestinal (GI) related adverse events Comparison 11: Meta-analysis 11.2 = Azithromycin (5 d) vs. amoxicillin-clavulanate (7-10 d); Table 49. Key question 4e. Studies not in meta-analytic comparisons: synopsis __________________________________________________________________________________________________________ 07chap4.doc Microsoft Word® Document MS Word® 97 SR-1 75KB 12 pages Contents: Chapter 4. Conclusions: Natural History; Antibiotics vs. No Antibiotics; Antibiotic vs. Antibiotic; General Conclusions; Caveats; Table 50. Summary of Comparisons and Meta-Analysis Performed for Key Questions 3, 4a, and 4e __________________________________________________________________________________________________________ 08chap5.doc Microsoft Word® Document MS Word® 97 SR-1 26KB 2 pages Contents: Chapter 5. Future Research: Key Questions; Definition and Diagnostic Criteria; Quality of Studies; Study Subjects; Study Outcomes __________________________________________________________________________________________________________ 09refs.doc Microsoft Word® Document MS Word® 97 SR-1 77KB 9 pages Contents: References __________________________________________________________________________________________________________ 10abbrs.doc Microsoft Word® Document MS Word® 97 SR-1 21KB 2 pages Contents: Acronyms and Abbreviations __________________________________________________________________________________________________________ 11etbl1.doc Microsoft Word® Document MS Word® 97 SR-1 77KB 10 pages Contents: Evidence Table 1. Key question 1: Natural history of acute otitis media (in alphabetical order by first author) __________________________________________________________________________________________________________ 12etbl2.doc Microsoft Word® Document MS Word® 97 SR-1 63KB 11 pages Contents: Evidence Table 2. Key Question 3: To treat or not to treat with antibiotics (in alphabetical order by first author) __________________________________________________________________________________________________________ 13etbl3.doc Microsoft Word® Document MS Word® 97 SR-1 135KB 27 pages Contents: Evidence Table 3. Key question 4a: Other antibiotic vs. amoxicillin or trimethoprim/sulfamethoxazole (in alphabetical order by first author) __________________________________________________________________________________________________________ 14etbl4.doc Microsoft Word® Document MS Word® 97 SR-1 27KB 3 pages Contents: Evidence Table 4. Key Question 4b. Effectiveness of Oral Fluoroquinolones; Key Question 4c. High-Dose Amoxicillin Versus Standard-Dose Amoxicillin; Key Question 4d: Twice A Day High-Dose Amoxicillin Therapy Versus Three Time A Day Amoxicillin __________________________________________________________________________________________________________ 15etbl5.doc Microsoft Word® Document MS Word® 97 SR-1 155KB 34 pages Contents: Evidence Table 5. Key Question 4e: Short- Versus Long-Term Antibiotic Therapy (In Alphabetical Order by First Author) __________________________________________________________________________________________________________ 16biblio.doc Microsoft Word® Document MS Word® 97 SR-1 268KB 37 pages Contents: Bibliography __________________________________________________________________________________________________________ 17appa.doc Microsoft Word® Document MS Word® 97 SR-1 130KB 24 pages Contents: Appendix A. Economic Burden of Illness: The Societal Cost Burden of Acute Otitis Media; Table 51. Estimates of the U.S. National Cost of Otitis Media; Cost-Effectiveness Studies of Therapies for AOM; Table 52. Summary of Cost-Effectiveness Studies of Therapies for Acute Otitis Media; Attachment to Appendix A: Technical Report on the Societal Cost Burden of Acute Otitis Media; Table 53. Estimated Costs Per Episode of Acute Otitis Media; Table 54. Sensitivity analysis of estimated total annual national cost of acute otitis media in < 18-year age group: variations in total costs with respect to variations in the total annual national number of ambulatory care visits for otitis media, the percentage of episodes of otitis media that are episodes of otitis media with effusion/chronic ear infection, and the percentage of episodes of acute otitis media that progress to otitis media with effusion/chronic ear infection; Table 55. Estimated Number of Episodes of Otitis Media in the U.S., 1995, Based on Estimates of the Number of Episodes per Child in 6 Studies __________________________________________________________________________________________________________ 18appb.doc Microsoft Word® Document MS Word® 97 SR-1 60KB 4 pages Contents: Appendix B. Conceptual Framework For Management Of Acute Otitis Media __________________________________________________________________________________________________________ 19appc.doc Microsoft Word® Document MS Word® 97 SR-1 92KB 9 pages Contents: Appendix C. Key Questions __________________________________________________________________________________________________________ 20appd.doc Microsoft Word® Document MS Word® 97 SR-1 68KB 7 pages Contents: Appendix D. Definitions of Acute Otitis Media __________________________________________________________________________________________________________ 21appe.doc Microsoft Word® Document MS Word® 97 SR-1 98KB 15 pages Contents: Appendix E. Scope of the Evidence Report __________________________________________________________________________________________________________ 22appf.doc Microsoft Word® Document MS Word® 97 SR-1 48KB 3 pages Contents: Appendix F. Title and Abstract Screening Form __________________________________________________________________________________________________________ 23appg.doc Microsoft Word® Document MS Word® 97 SR-1 40KB 7 pages Contents: Appendix G. Article Quality Review Form __________________________________________________________________________________________________________ 24apph.doc Microsoft Word® Document MS Word® 97 SR-1 105KB 5 pages Contents: Appendix H. Data Abstraction Form for Article Review __________________________________________________________________________________________________________ 25appi.doc Microsoft Word® Document MS Word® 97 SR-1 21KB 1 page Contents: Appendix I. Acknowledgements __________________________________________________________________________________________________________
AHRQ Publication No. 01-E010
Current as of May 2001
Internet Citation:
Management of Acute Otitis Media. File Inventory, Evidence Report/Technology Assessment Number 15. AHRQ Publication No. 01-E010, May 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/otmedinv.htm
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