Evidence Report/Technology Assessment Number 15

Management of Acute Otitis Media

File Inventory


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
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01title.doc		Microsoft Word® Document	MS Word®	97 SR-1		39KB	8 pages
Contents: Front Cover, Title Page, Preface, Structured Abstract
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02front.doc		Microsoft Word® Document	MS Word®	97 SR-1		104KB	3 pages
Contents: Table of Contents
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03summ.doc		Microsoft Word® Document	MS Word®	97 SR-1		43KB	7 pages
Contents: Summary: Overview; Reporting the Evidence; Methodology; Findings; Future Research
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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
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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
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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
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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
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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
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09refs.doc		Microsoft Word® Document	MS Word®	97 SR-1		77KB	9 pages
Contents: References
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10abbrs.doc		Microsoft Word® Document	MS Word®	97 SR-1		21KB	2 pages
Contents: Acronyms and Abbreviations
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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)
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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)
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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)
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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
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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)
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16biblio.doc		Microsoft Word® Document	MS Word®	97 SR-1		268KB	37 pages
Contents: Bibliography
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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
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18appb.doc		Microsoft Word® Document	MS Word®	97 SR-1		60KB	4 pages
Contents: Appendix B. Conceptual Framework For Management Of Acute Otitis Media
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19appc.doc		Microsoft Word® Document	MS Word®	97 SR-1		92KB	9 pages
Contents: Appendix C. Key Questions
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20appd.doc		Microsoft Word® Document	MS Word®	97 SR-1		68KB	7 pages
Contents: Appendix D. Definitions of Acute Otitis Media
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21appe.doc		Microsoft Word® Document	MS Word®	97 SR-1		98KB	15 pages
Contents: Appendix E. Scope of the Evidence Report
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22appf.doc		Microsoft Word® Document	MS Word®	97 SR-1		48KB	3 pages
Contents: Appendix F. Title and Abstract Screening Form
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23appg.doc		Microsoft Word® Document	MS Word®	97 SR-1		40KB	7 pages
Contents: Appendix G. Article Quality Review Form
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24apph.doc		Microsoft Word® Document	MS Word®	97 SR-1		105KB	5 pages
Contents: Appendix H. Data Abstraction Form for Article Review
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25appi.doc		Microsoft Word® Document	MS Word®	97 SR-1		21KB	1 page
Contents: Appendix I. Acknowledgements
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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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