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Current Advances in Otitis Media Bench to Bedside and Back

Current Advances in Otitis Media Bench to Bedside and Back. Joseph E. Kerschner, MD, FACS, FAAP jkerschner@mcw.edu Dean and Executive Vice President Medical College of Wisconsin Professor, Pediatric Otolaryngology Children’s Hospital of Wisconsin and Medical College of Wisconsin. Guidelines

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Current Advances in Otitis Media Bench to Bedside and Back

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  1. Current Advances in Otitis Media Bench to Bedside and Back Joseph E. Kerschner, MD, FACS, FAAP jkerschner@mcw.edu Dean and Executive Vice President Medical College of Wisconsin Professor, Pediatric Otolaryngology Children’s Hospital of Wisconsin and Medical College of Wisconsin

  2. Guidelines Antimicrobials Hearing loss and speech development Vaccines Eustachian Tube Biofilms Translational research Pathogen resistance Host-pathogen interactions Topics

  3. Knowledge Base Check • We are all at different levels • Expert • Very comfortable with all aspects of OM management • Need to learn more • Show of Hands • I have read the AAP (AAO-HNS) guidelines on acute otitis media (AOM) • There exist more than one set of guidelines • I am not interested in the publication of guidelines because they do not help with the management of individual patients

  4. Guideline Quiz • The AAO (AAP) guidelines contain 6 recommendations? True = Raise Your Hand • 2 of these 7 recommendations relate to the use of antibiotics for AOM? True = Raise Your Hand • The strongest recommendation from the guidelines relates to how practitioners should use antibiotics to treat AOM? True = Raise Your Hand

  5. http://pediatrics.aappublications.org/cgi/reprint/113/5/1451 World-wide = 15 AOM guidelines • Australia • Canada • South Africa • USA - 2004 • Europe

  6. AOM Guidelines • Diagnosis • Treatment of pain • Antimicrobial use • Observation option • First-line, second-line therapy • Failure to respond to therapy • Risk factor reduction • Alternative therapy

  7. Diagnosis • Huge problem in otitis media • Impacts treatment – When and If • Has seriously flawed research into this disease • NEJM papers in ABX section • Will be the cornerstone of new concepts in treatment • Clinical history is a poor predictor • “80% of Dx can be made by history” • Not true for OM • Huge overlap with viral URI • Need diagnostic skills

  8. Diagnosis: US vs. Dutch • Symptoms: otalgia, otorrhea, fever, or irritablity and • Signs: red, opaque or bulging tympanic membrane or • Difference in redness right and left tympanic membrane or • Acute otorrhea • Acute onset of signs and symptoms • Presence of middle ear effusion (MEE) • Signs or symptoms of middle ear inflammation • Erythema of the TM • Otalgia clearly referable to the ear • Pneumatic otoscopy • Tympanometry

  9. AOM verses OME • Major challenge • OME is more common than AOM and does not need Rx • May accompany viral URI • May be a residual of a resolved AOM • Signs and symptoms • Acute onset • Distinct erythema • Otalgia • Interfering with normal activity and/or sleep • Asymptomatic purulent otitis

  10. Pain • “The management of AOM should include an assessment of pain” • If present it should be treated • Only STRONG recommendation from panel • Present with most AOM • In past – was seen as a peripheral concern

  11. Treatment of Pain in AOM • Analgesics • Acetaminophen • Ibuprofen • Myringotomy • Topical Agents (Benzocaine) • Little additional benefit • Homeopathic treatments • No controlled studies • Narcotics • Effective • Increased risk profile

  12. Antibiotics – Why do We Treat? • “George saved his brother’s life that day. But he caught a bad cold which infected his left ear. Cost him his hearing in that ear.”

  13. Antibiotic Usage • Amoxicillin • Still best drug (?) • Efficacy • Safety • Cost • Compliance • Efficacy • 90mg/kg/day • Most effective against intermediate and highly resistant S. pneumoniae (SP)

  14. Vaccines & Antibiotic Usage • Pneumococcal Vaccine – changing story • PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, 23F) – Introduction • Decrease in SP prevalence • Increase NTHI • Subsequently • Increase in serotypes not covered • Increasing resistance in these • With over 90 serotypes we can expect this to will be played into the future • PCV13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) • Consider broader spectrum for more severe illness, recent antibiotic usage, higher NTHI percentage, daycare • High-dose amoxicillin-clavulanate has become drug of choice in these settings • Cost • Safety profile Casey, JR Ped Inf Dis J, 2010

  15. Penicillin (PCN) Allergy • Not type I hypersensitivity to PCN (urticaria/anaphylaxis) • Cefdinir – drug of choice • Cefuroxime – compliance concerns • Ceftriaxone – compliance concerns • Type I hypersensitivity to PCN • Quinolones • Clindamycin • Macrolides

  16. 2nd-Line Therapy • Of 16 FDA approved ABX for OM in children - only 5 have demonstrated much efficacy against resistant S. pneumo • High dose Amoxicillin - most effective • Cefdinir (Omnicef) • Cefuroxime (Ceftin) (compliance) • IM ceftriaxone (Rocephin) (invasive) • Clindamycin • Quinolones – not approved • Amoxicillin failure • High dose amoxicillin/clavulanate • Amoxicillin/clavulanate failure • 3-day parenteral ceftriaxone • Cefdinir • Cefuroxime • PCN allergy – very poor choices for Type I hypersensitivity • Quinolones • Clindamycin

  17. 3rd-Line Therapy • Tympanocentesis • We will see these patients ASAP • Significant past history of AOM – consider tube placement • Dutch Model • Low use of antibiotics • High rate of tympanostomy tube placement

  18. Observation Option • Treatment of OM is the most common reason for an antibiotic to be prescribed for children in the US • Began in 1989 in Netherlands • Selective antibiotic therapy • Withhold antibiotic treatment for 48 to 72 hours to allow for spontaneous resolution of OM • Rationale • Reduce antibiotic “pressure” • Reduce development of resistant organisms

  19. Observation Option • Age • <6 months • 6-23 months • >24 months • Severity • Non-severe Disease • T<102°F (39 °C) orally • Mild or no otalgia • Non-toxic appearing • Certainty of Diagnosis • Follow-up and Communication

  20. Observation Option Age Certain AOM Uncertain AOM <6 mos. Antibiotics Antibiotics 6-23 mos. Antibiotics Antibiotics if severeObserve if non-severe 24 mos. Antibiotics if severeObserve if non-severe Observe Rosenfeld R, IJPORL, 2001 This algorithm still will treat most episodes of real bacterial OM – will help limit treatment of less severe and episodes that are not “real” OM Diagnosis is key

  21. Evidence For Observation Option • Most episodes of OM will resolve without antibiotic treatment • ~80% (Rosenfeld, J Pediatr, 1994) • Between 7-20 children must be treated for each child who receives a “benefit” • Selective therapy is not equivalent to placebo trials regarding risks of complications from OM • Allows treatment in cases not spontaneously resolving • Allows treatment before complications arise • Pre-antibiotic era • Significant complications and death • Placebo studies - 17% incidence of mastoiditis (Rudberg, 1954) • AHRQ – Review and agreed that there was not an increase in suppurative complications

  22. Evidence For Observation Option • Selective therapy reduces costs, morbidity associated with antibiotic use and antimicrobial resistance • Penicillin-resistant Streptococcus pneumoniae in the Netherlands only 1.1% - (Hermans, J Infect Dis, 1997) • Prescriptions – these are in study populations – real world? • 49% reduction in antibiotic use with no increased adverse events – (Spiro DM, et al. JAMA. 2006) • Trial of initial versus deferred antibiotics: only 24% of latter group filled prescription – (Little, et al BMJ 2001)

  23. Observation OptionEvidence ?? • Hoberman A, et al NEJM 2011 • Excellent study • Examined young children < 2 years • Demonstrated that antibiotics helped regardless of severity • First study to demonstrate this – question – likely will impact new guidelines with respect to severity • Overall modest impact of antibiotics • Used stringent criteria for diagnosis • This speaks to the need for accurate diagnosis • Real world • But if we are sure about the diagnosis there is a greater positive impact on treatment

  24. Evidence Against Observation Option • Lack of rigor in studies demonstrating limited benefit from antibiotics (Wald, Ped Infect Dis J, 2003) • Complication rate increased versus universal antibiotic treatment • Mastoiditis • 3.8/100 000 per year in Netherlands • 1.2-2 /100 000 per year in higher prescribing nations (Van Zuijlen, Ped Inf Dis J, 2001)

  25. Evidence Against Observation Option • Antibiotic treatment is the current standard of care: Medical-legal issues • Delays symptomatic relief • Days 2-7 pain decreased by 41% (Del Mar, BMJ, 1997) • May place young children at added risk for serious sequelae • We should treat real infections with antibiotics and focus our antibiotic reductions in areas that we know won’t help • 21% prescription rate for “common cold”, 46% for bronchiolitis (El Sayed, Eur J Ped, 2009) • 44% - common colds, 75% bronchiolitis (Nyquist, JAMA, 1998)

  26. Follow-up and Communication • You SHOULDN’T use this option unless • Caregiver understands the risks and benefits of this treatment – specifically the need to contact PMD with progressive course • Caregiver has reliable means of communicating with PMD and vice-versa • Follow-up can be assured in the next 2-3 days • Antibiotics DO have a role in the management of AOM • Observation is more work!

  27. Individual Patient Data Meta-Analysis RCTs on AOM and Antibiotics Country year n Burke UK 1991 232 Appelman NL 1991 121 Damoiseaux NL 2000 240 Little UK 2001 315 Le Saux Canada 2005 512 McCormick USA 2005 223 Rovers et al. Lancet 2006

  28. Results for Pain and/or Fever at 3-7 days Subgroups Rate Difference (95% CI) NNT < 2 years + bilateral AOM 25% (20 - 30) 4 < 2 years + unilateral AOM 5% (2 - 8) 20 ≥ 2 years + bilateral AOM 12% (7 - 17) 9 ≥ 2 years + unilateral AOM 4% (2 - 6) 25 Otorrhea yes 36% (27 - 45) 3 no 14% (11 - 17) 8 Rovers et al. Lancet 2006

  29. Impact of AOM Guidelines • Coco A, et al Pediatrics 2010;125: 214-220. • 30 month period before and after guideline publication using ambulatory medical care survey • Antibiotics • Has made a negligible impact on the overall amount of antibiotics prescribed for AOM = 11%-16% not treated • Mild infections are being Rx’d less commonly • Absence of pain or fever • Pain • 71% increase in the use of analgesics for AOM • Increased further in patients managed with observation option

  30. Risk Factor (RF) Reduction • Modifiable • Tobacco exposure • Breast feeding • Vaccines • Influenza – Benefit unclear (Hoberman A, JAMA, 2003) • Pneumococcal – Clear but small benefit • Child care arrangements • Bottle/pacifier use • ?? – Early onset first infection • GERD • Allergy

  31. Risk Factor (RF) Reduction • Not Modifiable • Anatomic considerations • Syndromic • Craniofacial • Down • Gender • Socioeconomic status • Family History • Race – Indigenous • Immune deficiency

  32. Only 2nd large scale study looking at caregiver knowledge regarding OM RF • Significant opportunities to educate caregivers • Significant willingness to modify behaviors to lessen OM risk

  33. Viruses • Increased interest due to potential for vaccines • Major players • RSV • Influenza • Parainfluenza • Adenovirus • Rhinovirus

  34. Viral Otitis Media • Sole causative agent • 30% • “Mixed” Infections • Significant precursor to bacterial infections • RSV identified in 53% of MEE by PCR (Okamoto, J Infect Dis, 1993)

  35. Viral Effects • Eustachian Tube Dysfunction • Cytokine mediated inflammation • Immunosuppression • Increase in bacterial colonization and adherence

  36. Severity of “Mixed” Infections • Mucosal damage • Immune changes with potential for poor bacterial clearance • Changes in antibiotic pharmacokinetics • Viruses decrease amoxicillin concentration in MEE (Canafax, infect Dis J, 1998) • Changes in cytokine mediators

  37. Vaccines • Viral • Influenza A • Clinically available • Reduction in AOM by 36% in daycare setting during influenza season (Heikkinen, Am J Dis child, 1991) • RSV • Most commonly associated with OM • Invades ME readily

  38. Vaccines • Pneumococcal conjugate (7-valent) • Efficacy • Finland (2001) - 6% reduction in OM (CI -4 - 16) • California (2000) - 7% reduction in OM (CI 4-10) • Meta-analysis not possible on multiple studies • Follow-up • 6% reduction (Fireman, 2003) • Diagnosis and definitions are important • Replacement with non-covered serotypes • Overall Impact for Otitis Media – Modest • Cost – not really very cost effective for OM • NTHI – likely around the corner • Holy grail – There will be the need for antibiotics and surgeons in the future

  39. http://pediatrics.aappublications.org/cgi/reprint/113/5/1412

  40. OME - Children at Risk • At risk for speech, language , learning difficulties • Need early assessment of hearing levels, speech and language progression and need early intervention • Just finished work on recommendations for OME of short duration

  41. Children at Risk • Underlying hearing loss not associated with OME • Congenital • Anatomic – unilateral microtia • Suspected or diagnosed language delay • Cleft palate • Visual impairment • Syndromes or craniofacial disorders with cognitive, speech or language delays • Autism and other pervasive developmental disorders

  42. Watchful Waiting • 3 months from date of onset/diagnosis • Most OME is self-limited • 80% of effusions with AOM resolve by 3 months • Need to consider • Hearing levels • Recurrent infections • Development • Not mutually exclusive from RecOM • 54% of patients referred for OME • Pediatrician screening device

  43. Medications • Antihistamines • Decongestants • Corticosteroids • Antimicrobials • No evidence of benefit with OME

  44. Hearing and Language • Hearing testing • Minimum intervention after 3 months OME • Sooner with speech or other developmental delay • Primary care screening • 4 years and older • 4 frequency testing (500, 1000, 2000, 4000 Hz) • Formal audiological testing • Children younger than 4 • Older children with a failed screen

  45. Language Testing • Assessed in all children with persisting hearing loss • Language Development Survey (caregiver only) • Early Language Milestone Scale • Denver Development Screening Test II

  46. Surveillance • Most Controversial Point • When to place tympanostomy tubes (TT)? • Follow-up every 3 months until: • Fluid resolves • Significant hearing loss develops • Structural abnormalities of the ear are suspected • Tympanostomy tubes are generally mandated if patient develops • Retraction pocket • Adhesive atelectasis • Ossicular erosion

  47. “Significant” Hearing Loss • HL > 40dB = Moderate hearing loss • Tympanostomy tubes • Clear evidence of negative impact on speech language and academic performance • HL of 21 to 39dB = Mild hearing loss • Still significant • Evidence of negative impact on speech, language and school performance in children with permanent SNHL • Need to optimize listening and learning environment

  48. Get within 3 feet of the child before speaking. Turn off competing audio signals such as unnecessary music and television in the background. Face the child and speak clearly, using visual clues (hands, pictures) in addition to speech. Slow the rate, raise the level, and enunciate speech directed at the child. Read to or with the child, explaining pictures and asking questions. Repeat words, phrases, and questions when misunderstood. Assign preferential seating in the classroom near the teacher. Use a frequency-modulated personal- or sound-field-amplification system in the classroom. Optimizing Hearing and Listening TABLE 4. Strategies for Optimizing the Listening-Learning Environment for Children With OME and Hearing Loss* * Modified with permission from Roberts et al.

  49. “Significant” Hearing Loss • <20 dB hearing = Normal hearing • Assess unilaterality – even in younger children • Assess speech and language • Assess “additive” or “risk factors” • Caregiver environment • Socioeconomic environment • Assess behavioral issues • Attention • Balance • Otalgia

  50. OME/Language Studies • Some studies have questioned the impact of OME on speech/language (Paradise JL, et al. NEJM, 2007) • Significant methodolical errors • Intense screening process • Not equivalent to real world • Impact of TT is greatest on patients who are symptomatic (hearing, balance) and seek treatment • Very mild disease in treatment group • Most kids had unilateral disease • Eliminated patients most likely to benefit • Patients with speech delay, ADHD, developmental delay, other chronic illnesses, poor socioeconomic factors

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