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Otitis Media – A Primary Pediatrician’s Perspective. Dr. Zahi Grossman President Israel Ambulatory Pediatric Society. Questions Facing the Pediatrician. Does the patient have acute otitis media? Does the patient need antibiotic therapy? Which antibiotic and for how many days?.
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Otitis Media – A Primary Pediatrician’s Perspective Dr. Zahi Grossman President Israel Ambulatory Pediatric Society
Questions Facing the Pediatrician • Does the patient have acute otitis media? • Does the patient need antibiotic therapy? • Which antibiotic and for how many days?
Does the child have AOM? • Objective: to assess precision and accuracy of history taking and physical examination in diagnosing AOM • Method: systematic review of literature 1996-2002 • 397 references found • 6 (!) met inclusion criteria • Results: cloudy, bulging or immobile tympanic membrane is most helpful for detecting AOM Rothman R, JAMA 2003;290:1633-1640
Diagnosing Acute otitis Media • Diagnosis usually requires: • Presence of middle ear fluid (MEF). • Symptoms of local or systemic illness (pain, fever, irritability).
Reliance on parental symptoms report is neither sensitive nor specific Technical difficulties in the examination: Failure to remove wax Inadequate light Improper positioning of otoscope Small speculum Very short time for the examination Fighting with the child
Red membrane caused by crying Inability to differentiate AOM from effusion without performing pneumatic otoscopy
Pneumatic otoscopy • The preferred method for accurate diagnosis of middle ear effusion • Not routinely performed in Europe • Not generally performed in pediatric primary care in Israel
Overdiagnosis of OM • Incorrect diagnosis leads to overdiagnosis and overtreatment • Study evaluated pediatricians’ and otolaryngologists’ accuracy of visual diagnosis of OM • 514 pediatricians and 180 otolaryngologists • Videotaped pneumatic otoscopic examinations were evaluated by participant • Overdiagnosis of OM: 27% of pediatricians, 10% of otolaryngologists Pichichero ME,APAM2001;155:1137-1142
Acute Otitis Media Is a Self Limited Disease • 66% resolution of MEF within 1 month • 90% resolution of MEF within 3 months • Clinical spontaneous recovery occurs in 70% of cases
What Are the Goals of Therapy? • Reduce patient suffering • Return to normal function of patient and family • Preventing complications (e.g. mastoiditis)
Correlation Between Clinical Cure and Bacterial Eradication Dagan R, The Lancet Infectious Diseases, 2002;2:593-603
Treatment clinical success is not correlated with eradication of bacteria from middle ear fluid
Antibiotics Vs. Placebo:Meta - Analysis • Otitis media resolved at one week in 81% of placebo recipients • Otitis media resolved in one week in 94% of antibiotic recipients • Absolute risk reduction – 13% • NNT = 8 patients Takata G, Pediatrics 2001;108:239-247
The majority of uncomplicated cases of AOM resolve spontaneously without apparent suppurative complications. Ampicillin or Amoxicillin confers a limited therapeutic benefit. There is no evidence to support any particular antibiotic regimens as more effective at relieving symptoms (Pediatrics, 108, Aug 2001)
Antibiotics provide a small benefit for Acute otitis media in children. As most cases will resolve spontaneously , this benefit must be weighed against the possible adverse reactions. Antibiotic treatment may play an important role in reducing the risk of mastoiditis in populations where it is more common. (NNT=17)! (Glazious PP, Cochrane library ,2002:3)
Limitations of meta-analyses • Include trials with less rigid diagnostic criteria of OM • Include trials comparing suboptimal doses of antibiotic drug to placebo Wald ER, PIDJ, 2003;22:103-104
Evidence based medicine should not become Evidence b(i)ased medicine
Mastoiditis • High rate in the Netherlands :3.8/100000 py • Low in the US: 2.0/100000 py (Van Zuichlen, PIDJ,2001;20:140-144)
Mastoiditis – Israeli data • Pediatric patients admitted with acute mastoiditis between 1990-2001 • 116 cases diagnosed in 101 patients (ages 2 moths – 16 ys ) • Mastoiditis rate – 6.1/100000 py • Higher rate towards end of study period • Lower rate in infants and young children Dagan, personal communication
AAP/CDC Recommendations: • Complications (like mastoiditis) occur mainly < 2 years of age • In children > 2 years – 5-7 days of amoxicillin • In infants < 2 years – 10 days of amoxicillin
Parents’ Considerations Although some might not consider the small benefit of antibiotic therapy clinically important in view of increased antibiotic resistance, some parents may consider a 1 in 7 chance of decreasing their child’s distress to be a sufficient basis for treatment Froha j, J Pediatr 2002; 141:599-600
Delayed Prescribing - an Alternative Strategy • Delay treatment for 48-72 hours after diagnosis to determine whether there is spontaneous clinical improvement. • Used in the Netherlands. • 7 days course is begun if: • <2yrs: no improvement in 24-48 hrs. • >2yrs: no improvement in 72 hrs.
Effectiveness of Delayed Prescribing Strategy • Open randomized controlled study • General practices in northwest England • 315 children 6 mths – 10 yrs with AOM • Two strategies: • Immediate amoxicillin therapy • Delayed therapy:prescription to be collected at parents discretion after 72 hours if child is not improving
Results • Immediate antibiotic use reduced duration of symptoms by one day • Benefit occurred mainly after the first 24 hours, when symptoms diminish anyway • Only 36 of 150 parents picked up the prescriptions • 75% of parents in the delayed group satisfied with their child treatment Little P, BMJ 2001;322:336-42
Who Is Likely to Benefit From Immediate Therapy? • Secondary analysis of previous study study. • Definition: poor short term outcome = an episode of distress or night disturbance 3 days after child saw doctor. • Results: poor outcome more likely in children with high temperature or vomiting on day one. • Conclusion: in children without fever or vomiting, poor outcome is unlikely. Little P, BMJ 2002;325:22-5
Safety net antibiotic prescription • First US study on delayed prescription • 11 practices in the Cincinnati Pediatric Research Group (CPRG) • 175 children 1-12 yrs. with AOM enrolled • Parents instructed not to fill in the antibiotic prescription unless symptoms did not resolve after 48 hrs.
Results • Only 31% had filled their prescription • 78% reported pain medicine to be effective • 63% declared they would be willing to treat future AOM episodes with pain medication alone Siegel RM, Pediatrics 2003;112:527-531
שותפים לניסוח ההנחיות החדשות איגוד רופאי הילדים איגוד רופאי אף אוזן וגרון איגוד רופאי המשפחה חיפ"א חיפ"ק החוג למחלות זיהומיות בילדים נציגי קופות החולים
ועדת ההיגוי המשותפת פרופ' שי אשכנזי ד"ר זאב חורב ד"ר יצחק ברוך ד"ר הדר ירדני ד"ר מתי ברקוביץ ד"ר דני מירון ד"ר צחי גרוסמן ד"ר אלי סומך ד"ר ארי דירוא ד"ר טומי ספנסר ד"ר ישראל הדרי ד"ר מיכאל פרסיקו ד"ר אריה הררי פרופ' יונה קרוננברג ד"ר מיכאל וולף ד"ר ג'ין שלום
New Israel guidelines • Antibiotic therapy for AOM can be delayed in infants > 6 months old. • Prerequisite conditions: • Appropriate follow up by the pediatrician • Parental agreement • Adequate analgesia • Immediate antibiotic therapy should be recommended in high risk patients • No place for antihistamine, decongestants
High risk patients • Marked bulging of the eardrum • Fever > 390c • Marked restlessness • Recurrent vomiting • Facial anomalies • Immune deficiency
Recommended antibiotic therapy • First line: Amoxicillin 60-80 mg/kg/d in 2-3 divided doses, for 7 days. • Second line: amoxicillin-clavulanic acid or cefuroxime axetil • Third line: amoxicillin – clavulanic acid + amoxicillin, or ceftriaxone • New macrolides (e.g. azithromycin) are appropriate alternative drugs in beta - lactam allergic patients,and whenever therapy by amoxicillin is not possible
Acute draining ear • Local cleaning • Systemic antibiotic therapy – as in AOM (delayed approach) • No evidence for role of topical quinolones in acute draining ear • Ototopical aminoglycoside drops are not recommended due to potential ototoxicity
Myringotomy and paracentesis • Should be considered in the following cases: • Complication of AOM (e.g. mastoiditis) • Immune deficiency • Age < 2 months • Sick and suffering baby • Failure of antibiotic therapy • AOM in a child previously treated by antibiotic