Part 1Relevance to Management of Acute Otitis Media Update1

Author (year)Content category by KQReview focusDatabases and included datesStudy design, inclusion criteriaTarget populationSettingOutcomesCost analsisNumber of trials, participants, and comparisonsAuthor’s highlight conclusion
Marcy (2001)2

(initial AHRQ Management of AOM systematic review)
KQ3
KQ5
KQ6
natural hx ab vs no ab ab regimenCENTRAL (TCL, through Mar 1999), MEDLINE (1966-Mar 1999), HlthSTAR (1975-Mar 1999), IPAInternational Pharmaceutical Abstracts (1970-Mar 1999), CINAHL (1982-Mar 1999), BIOSIS (1970-Mar 1999), and EMBASE (1980-Mar 1999); hand searchRCT; Cohort, for natural hxAOM 4wk–18y

exclude patients with immunodeficiencies or craniofacial deficiencies, including cleft palate
Any settingClinical failure; adverse effectsNo80 trials total: 74 addressed ab vs no ab & ab regimen

See Comparison Table for specific trial and participant numbers

7 primary comparisons & 16 analyses reported (only analyses with ≥3 trials were conducted)
Rx with amp/amox ↓ clinical failure by 12% vs no ab; ab regimen outcomes not different; cefixime & amoxillin-clavulanate ↑ adverse effects
Rosenfeld (1994)KQ3
KQ5
ab vs no ab ab regimenMEDLINE (Jan 1966–Jun 1992); Current Contents (3 months through Jun 29, 1992); hand searchRCTAOM 4wk–18y

exclude myringotomy, OM not described, mostly treatment failure or otitis prone
Not specified a prioriClinical response, MEE presenceNo33 trials total

See Comparison Table for specific trial and participant numbers

3 primary comparisons & 16 analyses reported
ab effect modest but significant; no significant difference between ab regimens studied
Damoiseaux (1998)KQ3
KQ5
ab vs no abMEDLINE (1966-Jan 1997); EMBASE (1974-Jan 1997); hand searchRCTAOM <2 years oldNot specified a prioriClinical resolution within 7dNo4 trials
416 children

1 comparison & analysis
No significant difference be-tween ab and no ab in <2y olds
Kozyrskyj (2000)KQ3
KQ5
KQ6
ab <7d vs ≥7dMEDLINE (Jan 1966–Jul 1997); EMBASE (Jan 1966– Jul 1997); Science Citation Index (Mar 1998); Current Contents (Mar 1998); hand searchRCTAOM 4wk–18y

Subgroups: ab ≤2d; oral short-acting ab; oral azithromycin; intramuscular ceftriaxone; <2 years old; perforated TM
Not specified a prioriClinical resolution 31d & 1–3m; relapse; recurrenceNo32 trials total

See Comparison Table for specific trial and participant numbers
45 primary comparisons & 54 analyses (several utilizing 1 trial)
ab 5d → effective Rx for AOM
Glasziou (2004)KQ3
KQ6
ab vs no abCENTRAL (1966-Jan 2000; TCL, issue 1, 2003); Current Contents (1966-Jan 2000); Index Medicus (1958–1965); MEDLINE (Jan 2000–Mar 2003); EMBASE (Jan 1990–Mar 2003); hand searchRCTAOM Children, age not specifiedAny settingSeverity and duration of pain; mid- to long- term hearing problems; adverse effects; recurrent attacksNo8 trials total

See Comparison Table for specific trial and participant numbers

1 comparison & 6 analyses
ab of small benefit for AOM Rx
Foxlee (2006)KQ3topical analgesiaCENTRAL (TCL, issue 2, 2006); MEDLINE (1966-May 2006); EMBASE (1990-Dec 2005); LILACS (1982-Sep 2005); hand searchRCT or quasi- RCTAOM without perforation in Adults and children

Subgroups: <24mvs≥24m–<18y vs≥18y; topical analge-sic type; concurrent ab use

exclude perforation
Primary care settingPain severity and duration; parental satisfaction; days missed from school or work; adverse eventsNo4 trials total

See Comparison Table for specific trial and participant numbers

4 comparisons & 15 analyses
evidence insufficient to make conclusions on topical analgesia effectiveness
Rovers (2006)KQ3
KQ5
KQ6
ab vs no abCENTRAL; PubMed; EMBASE (dates not specified)RCTAOM 0–12 years

Subgroups: <2y vs≥2y; bilateral AOM; otorrhoea
Not specified a prioriPain &/or fever 3–7dNo6 trials total 3, 4
(10 trials identified & 6 investigators agreed to share data)

See Comparison Table for specific trial and participant numbers

1 comparison & 21 analyses reported
ab beneficial for <2 year old with bilat AOM & AOM with otorrhea
Spurling (2007)KQ3Delayed (>48 hrs) ab vs immediate abCENTRAL (TCL, issue 1, 2004; TCL, issue 4, 2006); MEDLINE (Jan 1966–Jan 2007); EMBASE (1990-Jan 2007); Current Contents (1998-Jan 2007)RCTRespiratory tract infections All ages (For identified AOM studies 6m–12y)Not specified a prioriClinical outcomes; ab use; patient satisfaction; health-seek-ing beha-viors; alter-native thera-pies (For identified AOM studies pain, malaise, and fever)No2 trials total for AOM in children

See Comparison Table for specific trial and participant numbers

3 comparisons & 9 analyses (all utilizing 1 trial)
immediate ab→ improved pain and malaise on day 3; delayed ab → diarrhea reduced (thought not an a priori outcome of this review)
Coleman (2008)KQ3
KQ6
decongestant &/or antihistamineCENTRAL (TCL, issue 2, 2001; TCL, issue 3, 2003; TCL, issue 2, 2007); MEDLINE (Jan 1966–May 2007); EMBASE (Jan 1990–May 2007); hand searchRCT<18 years oldAny settingClinical resolution at 2wk, 1wk, 4wk; symptom resolution; medication side effects; AOM complicationsNo15 trials total

See Comparison Table for specific trial and participant numbers

5 comparisons & 52 analyses
lack of benefit for decongestant &/or antihistamine; increased risk of side effects

ab = antibiotic; amp/amox=ampicillin or amoxicillin; CENTRAL =Cochrane Central Register of Controlled Trials; CINAHL= Cumulative Index to Nursing & Allied Health Literature CI= confidence interval; Contra Otitis = contralateral otitis; HlthSTAR= Health STAR; IPA=International Pharmaceutical Abstracts; KQ=key question for Management of AOM Update; MEE= middle ear effusion; Rx=treatment; TCL=The Cochrane Library

1

For quality score of each systematic review, see next table.

2

Also, reference Takata, Chan, Shekelle, et al. (2001)

3

individual patient data meta-analyses

4

Ten trials identified; investigators of only six of the trials agreed to share their data.

From: Appendix I, Summaries of Systematic Reviews Included in Analyses

Cover of Management of Acute Otitis Media: Update
Management of Acute Otitis Media: Update.
Evidence Reports/Technology Assessments, No. 198.
Shekelle PG, Takata G, Newberry SJ, et al.

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