1. Otitis Media Gil C. Grimes, MD Assistant Professor Family Medicine Texas A&M HSC COM Scott and White Family Medicine Residency May 31st 2005

2. Objectives Describe criteria for diagnosing Acute Otitis Media Describe rationale for therapy for Acute Otitis Media Describe Therapy for Serous Otitis Media Describe the role of Tympanostomy Tubes

3. My Bias I am a minimalist If the evidence for intervention is not good I do nothing

4. Acute Otitis Media A diagnosis of AOM requires a history of acute onset of signs and symptoms the presence of middle ear effusion (MEE) signs and symptoms of middle-ear inflammation. Pediatrics 2004 May;113(5):1451-65 Level 1a

5. Acute Otitis Media The presence of MEE that is indicated by any of the following: Bulging of the tympanic membrane Limited or absent mobility of the tympanic membrane Air-fluid level behind the tympanic membrane Otorrhea

6. Acute Otitis Media Signs or symptoms of middle-ear inflammation as indicated by either Distinct erythema of the tympanic membrane or Distinct otalgia discomfort clearly referable to the ear(s) and interference with or precludes normal activity or sleep

7. Acute Otitis Media Otitis Media? Yes No http://www.otol.uic.edu/research/microto/Microtoscopy/Case10origweb.jpg

8. Acute Otitis Media Otitis Media? Yes No www.orldoc.ch/index

9. Acute Otitis Media Prevalence Prevalence 10% US children diagnosed by 3 months 90% by 2 years (1) Prospective cohort of children (2) 62% with AOM by 1 year 83% with AOM by 3 years 9th most common diagnosis during FM visits (3) Coded 3.2% visits (3) 1)Pediatric Infect Dis J 1989 Jan;8(1 Suppl):S9 Level 2b 2)J Infect Dis 1989 Jul;160(1):83 Level 2b 3) Ann fam Med 2004 Sep-Oct:2(5)411 Level 2c

10. Acute Otitis Media Etiology Viral pathogens found Tympanocentesis and Nasal Aspirate in AOM RSV and coronavirus RNA in 75% children 5% dual viral infections Bacterial pathogens detected 62% Viral RNA detected in 57% bacteria-negative and 45% bacteria-positive samples Pediatrics 1998 Aug;102(2):291 Level 1c

11. Acute Otitis Media Etiology Bacteria shifts Streptococcus pneumoniae S. pneumoniae is the most common bacterial organism identified non-typeable Haemophilus influenzae H. flu identified primarily in children < 5, but reduced with routine immunization Moraxella (Branhamella) catarrhalis may be changing due to heptavalent pneumococcal vaccine decrease in S. pneumoniae and increase in H. influenzae Pediatric Infectious Disease 2004 Sep;23(9):824 Level 2b

12. Acute Otitis Media Risk Factors Formula feeding incidence of otitis media is higher in formula-fed infants vs. breast-fed infants incidence of prolonged ear infections was 5x higher among formula-fed infants Duration OM episodes longer (8.8 vs. 5.9 days) J Pediatric 1995 May;126(5 Pt 1):696 Level 2b

13. Acute Otitis Media Risk Factors Day Care Attendance day care associated with increased risk of upper and lower respiratory tract illnesses in first year of life for children with familial history of atopy prospective birth cohort study of 498 children with parental history of allergy or asthma followed prospectively for first year of life Pediatrics 1999 Sep;104(3):495 Level 2b

14. Acute Otitis Media Risk Factors. Associated with 2 or more doctor-diagnosed ear infections (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.7-3.6) For children attending day care independent predictors of 2 or more doctor-diagnosed ear infections included exposure to pets in day care presence of rug or carpet in area where child slept in day care nonresidential setting for day care Pediatrics 1999 Sep;104(3):495 Level 2b

15. Acute Otitis Media Risk Factors Passive Smoking 625 Children Calgary first graders Middle ear disease 2 or more household smokers (crude odds ratio) [OR], 1.85; 95% confidence interval [CI], 1.15-2.97 10 or more cigarettes smoked by the mother per day (crude OR, 1.68; 95% CI, 1.12-2.52) 10 or more cigarettes smoked in total in the household per day (crude OR, 1.40; 95% CI, 0.98-2.00) during the first 3 years of life Arch Pediatric Adolescent Med. 1998 Feb;152(2):127 Level 2c

16. Acute Otitis Media History Poor predictive value Studies are not good Statistics LR+ greater than 5 good LR- less than 0.5 good Specificity to rule in Sensitivity to rule out Pediatric Infect Dis J 1994; 13: 765 Level 3a Reviewed in JAMA 2003 Sep 24;290(12):1633

17. Acute Otitis Media Pediatric Infect Dis J 1994; 13: 765 Level 3a Reviewed in JAMA 2003 Sep 24;290(12):1633

18. Acute Otitis Media Physical Findings Based on prospective study of 8,859 ear-related visits among children 0.5-2.5 years with acute symptoms myringotomy performed if middle ear effusion suspected on exam 51.5% had acute otitis media (i.e. middle ear effusion confirmed on myringotomy) Color not particularly helpful but cloudy membrane predictive red color was not highly predictive cloudy tympanic membrane had 80-96% positive predictive value normal color dramatically reduces likelihood of AOM (2-5% probability of middle ear effusion if normal color) Int J Pediatric Otorhinolaryngol 1989 Feb;17(1):37 Level 1b

19. Acute Otitis Media Physical Continued Position helpful if clearly bulging bulging tympanic membrane had 89-96% positive predictive value retracted tympanic membrane had 47-50% positive predictive value normal position had 22-32% probability of AOM Int J Pediatric Otorhinolaryngol 1989 Feb;17(1):37 Level 1b

20. Acute Otitis Media Mobility helpful if distinctly impaired or clearly normal distinctly impaired mobility had 78-94% positive predictive value slightly impaired mobility had 33-60% positive predictive value normal mobility dramatically reduces likelihood of AOM (2-5% probability of middle ear effusion if normal mobility)

21. Acute Otitis Media Test Name Positive Likelihood Ratio TM position: bulging51.00 TM color: cloudy34.00 TM mobility: distinctly impaired 31.00 TM color: distinctly red8.40 TM mobility: slightly impaired4.00 TM position: retracted3.50 TM color: slightly red1.40 TM position: normal0.50 TM color: normal0.20 TM mobility: normal0.20

22. Acute Otitis Media Type A pattern is normal Type B pattern is consistent with MEE Type C is seen with retracted TM

23. Acute Otitis Media Prognosis Spontaneous resolution is the norm 81% spontaneously resolve (1) 5000 children with otitis (2) >90% resolved with supportive care 2.7% had a severe course (required antibiotics or myringotomy at 5 days) 1)Pediatrics 5 May 2004 113:1452 Level 1a 2)Br Med J (Clin Res Ed). 1985 Apr 6; 290(6474):1033 Level 1b

24. Acute Otitis Media Prognosis Recurrent otitis media no long term consequences usually spontaneous recovery study of 222 children with recurrent otitis media who received no prophylaxis 4% developed chronic otitis media with effusion 12% continued having recurrent episodes most significant risk factor for continued recurrence was age < 16 months (1) 1)Pediatrics 5 May 2004 113:1452 Level 1a

25. Acute Otitis Media Prognosis Persistent effusion Watchful Waiting recommended in children without the following: Permanent hearing loss independent of OME Suspected or diagnosed speech and language delay or disorder Autism-spectrum disorder and other pervasive developmental disorders syndromes (e.g., Down) Craniofacial disorders that include cognitive, speech, and language delays Blindness or uncorrectable visual impairment Cleft palate with or without associated syndrome Developmental delay Pediatrics 5 May 2004 113:5; 1412-1429 Level 1a

26. Acute Otitis Media Prognosis Persistent effusion Change from B to non-B tympanogram favorable 25% of OME of unknown duration resolves in 3 months Warn parents of decreased hearing while effusion present Recheck every three months Pediatrics 5 May 2004 113:5; 1412-1429 Level 1a

27. Acute Otitis Media Treatment Treat Pain Acetaminophen and ibuprofen (1) 219 children treated with cefaclor evaluated pain at 2 days Ibuprofen 7% with pain NNT 5 Acetaminophen 10% with pain NNT 6 Placebo 25% 1)Fundam Clin Pharmacol. 1996;10(4):387 Level 1c

28. Acute Otitis Media Treatment Initial treatment options are observation or antibiotics for children < 6 months old, antibiotics recommended for children 6 months to 2 years old observation option recommended only if all of the following are present otherwise healthy child uncertain diagnosis non-severe illness follow-up can be ensured so antibiotics can be started if symptoms persist or worsen antibiotics recommended if certain diagnosis of AOM, severe illness, or follow-up cannot be ensured

29. Acute Otitis Media Treatment For children > 2 years old Observation option recommended only if the following are present otherwise healthy child uncertain diagnosis OR non-severe illness follow-up can be ensured so antibiotics can be started if symptoms persist or worsen Antibiotics recommended if certain diagnosis of AOM and severe illness, or follow-up cannot be ensured DynaMed Acute Otitis Media Accessed March 19 2005

30. Acute Otitis Media Treatment No improvement in 48-72 hours Confirm the diagnosis If AOM certain then begin antibiotics if not already started Change antibiotics if already started

31. Acute Otitis Media Treatment Antibiotics CDC guidelines for management and surveillance of acute otitis media in era of pneumococcal resistance You must know your community 1)Pediatrics 5 May 2004;113(5):1452 Level 1a

32. Acute Otitis Media Treatment Amoxicillin 80-90 mg/kg/day divided TID for 10 days Failure at 3 days switch to one of the following cefuroxime axetil (Ceftin) 15 mg/kg BID for 10 days amoxicillin-clavulanate (Augmentin) Augmentin 45 mg/kg/day divided BID or 40 mg/kg/day divided TID, both for 10 days ceftriaxone (Rocephin) IM 50mg/kg for 3 days 1)Pediatric Infect Dis J. 1999 Jan;18(1):1 Level 1a

33. Acute Otitis Media Treatment Penicillin Sensitive patients Not Type I reaction (no urticaria or anaphylaxis) (1) Cefdinir (Omnicef) 14 mg/kg divided once daily or BID for 5 days (BID dosing) or 10 days (once daily dosing) slightly better taste (2) Cefpodoxime (Vantin) 10 mg/kg once daily for 10 days or divided BID for 5 days Cefuroxime (Ceftin or Zinacef) 30 mg/kg divided BID for 10 days Ceftriaxone (Rocephin) 50mg/kg IM once 1)Pediatrics 5 May 2004;113(5):1452 Level 1a 2)Pediatric Infect Dis J 2000 Dec;19(12 Suppl):S181 Level 3

34. Acute Otitis Media Treatment Penicillin Sensitive Patients Type I reaction Azithromycin (Zithromax) 10 mg/kg day one then 5 mg/kg days 2-5 Clarithromycin (Biaxin) 15 mg/day divided BID for 10 days Erythromycin/sulfisoxazole (Pediazole) 50 mg/kg daily of erythromycin divided TID to QID for 10 days Sulfamethoxazole-trimethoprim (Bactrim or Septra) 6-10 mg/kg daily of trimethoprim divided BID for 10 days Pediatrics 5 May 2004;113(5):1452 Level 1a

35. Acute Otitis Media Reality Shorter therapy 5 days is likely as beneficial as longer therapy (1) Early treatment with antibiotics may lead to increased resistance (2) Side effects are as common as benefit NNT 15-17 at 1 week NNH 17 at one week Delayed antibiotics result in decreased use and decreased likelihood of asking for antibiotics in the future (3) 1)JAMA. 1998 Jun 3;279(21):1736 Level 1a 2)J Infect Dis. 2001 Mar 15;183(6):880 Level 4 3)BMJ 2001 Feb 10;322:336 Level 1c

36. Acute Otitis Media Guideline Review Pediatrics 2004 May;113(5):1451 Summary can be found in Am Fam Physician 2004 Jun 1;69(11):2713 editorial can be found in Am Fam Physician 2004 Jun 1;69(11):2537 commentary can be found in Pediatrics 2004 Sep;114(3):898 commentary can be found in Pediatrics 2005 Feb;115(2):513

37. Serous Otitis Media www.pedisurg.com/ PtEducENT/Default.htm

38. Serous Otitis Media Causes Causes Overgrowth of lymphoid tissue in the nasopharynx Chronic sinus infection Allergies of nose and nasopharynx Gastric reflux implicated Pepsin seen in MEE 45 of 54 children with SOM (1) Pepsin seen in MEE 59 of 65 children with SOM (2) 1)Lancet 2002 Feb 9;359(9305):493 Level 4 2)Laryngoscope. 2002 Nov;112(11):1930 Level 4

39. Serous Otitis Media Complications Permanent hearing loss (?) (5) Tympanosclerosis Fibrosis of middle ear space Balance problems (1) Minor language deficits (+/-) (2) No association with attention or behavior in first 6 years of life (3) Possible behavior problems in teens (4) 1)Pediatrics. 1997 Mar;99(3):334 Level 4 2)Pediatrics. 2000 May;105(5):1119 Level 2c 3)Pediatrics. 2001 May;107(5):1037 Level 1b 4) Arch Dis Child. 2001 Aug;85(2):91 Level 1b 5) Pediatrics. 2000 Sep;106(3):E42 Level 1c

40. Serous Otitis Media Physical Physical examination Pearly gray Minimal dullness Minimal retraction Presence of effusion

41. Serous Otitis Media Tests Key tests Pneumo-otoscopy with limited movement (1) Sensitivity of 94% (95% CI: 92%-96%) Specificity of 80% (95% CI: 75%-86%) Tympanogram B-curve (2) 81% sensitivity 56% specificity Audiometry Carhart Notch (2) 77% sensitivity 98% specificity 1)Pediatrics. 2003 Dec;112(6 Pt 1):1379 Level 1a 2)Clin Otolaryngol. 2003 Jun;28(3):183 Leve 1c

42. Serous Otitis Media Prognosis High rate of spontaneous resolution (1) Most resolve in 3 months Meta-analysis 11 trials (2) No significant hearing loss No speech/language delay Tubes have consequences (3) 140 children followed 8 years Sequela higher at 3-5 years 47% for retraction pocket 67% for tympanic membrane atrophy 40% for myringosclerosis 23% for hearing loss 1)Pediatrics 2004 May 5;113(5):1412 Level 1a 2)Pediatrics 2004 March; 113(3): e238 Level 1a 3)Arch Otolaryngol Head Neck Surg. 2003 May;129(5):517 level 1b

43. Serous Otitis Media Treatment Medications Antibiotics not beneficial (1) Most rigorous meta-analysis find no benefit long-term Some short-term benefit may exist Steroids Nasal steroids no evidence of benefit (2) Systemic steroids no difference long term (3) 1)J Fam Pract. 2003 Apr;52(4):321 FPIN network answer 2)Cochrane Library 2002 Issue 4:CD001935 Level 1a 3)Pediatrics. 2002 Dec;110(6):1071 Level 2b

44. Serous Otitis Media Treatment Surgery no clear evidence of benefit RCT of a birth cohort that developed MEE (1) Randomized to early tube placement or delay of 6 months (unilateral MEE) to 9 months (bilateral MEE) Delayed group had better outcomes cognition, language (not significant) at age 3 Reduced time with MEE but no change in language or hearing (2) No change in quality of life 1)N Engl J Med. 2001 Apr 19;344(16):1179 Level 1b 2)Cochrane Library 2005 Issue 1:CD001801 Level 1a

45. Serous Otitis Media Treatment Surgery no clear evidence of benefit Cohort 30,099 children born in the Netherlands Routine hearing screening at age 9 months 1,081 who failed 3 successive hearing screens were referred to ENT surgeon 386 found to have persistent bilateral otitis media with effusion for 4-6 months 187 children (mean age 19.5 months) were randomized to ventilation tubes vs. watchful waiting and followed for 1 year with language tests Ventilation tubes reduced diagnoses of bilateral otitis media with effusion at all measurements (NNT 2-4), No differences in language development Pediatrics 2000 Sep;106(3):e42 Level 1c

46. Serous Otitis Media Treatment Post-tube precautions unrandomized trial in 533 children who underwent tympanostomy tube placement parents self-selected into 1 of 3 "treatments" to prevent complications of swimming no additional precautions antibiotic drops following swimming ear molds worn during swimming control group consisted of children who never went swimming all were given precautions against deep water swimming (> 180 cm), diving and soapy water in ears during bathing no benefit was noted from antibiotic ear drops or ear plugs Arch Otolaryngol Head Neck Surg. 1996 Mar;122(3):276 Level 2b

47. Questions?