Grant Number: R01 HS10613
RFA/PA:
PI Name: MCCORMICK, DAVID
Project Title: OTITIS MEDIA: PARENT EDUCATION TO AVOID ANTIBIOTIC USE

Abstract:

MCCORMICK, DAVID P
UNIVERSITY OF TEXAS MED BR GALVESTON, GALVESTON, TX
OTITIS MEDIA: PARENT EDUCATION TO AVOID ANTIBIOTIC USE
R01 HS10613-01
02/01/00
DESCRIPTION: Acute Otitis Media, AOM, remains a major child health problem
around the world. The average child experiences 2.6 AOM episodes per year in
the first two years of life. In addition, the widespread use of antibiotics in
the treatment of AOM has resulted in the emergence of multi-drug resistant
pathogens. Prior research indicates that as many as 80-90% of children with
AOM will recover without antibiotics. However, there is a paucity of primary
care research to guide the provider or parent as to which child might safely
and compassionately be treated without antibiotics. This project is an
investigator-blinded randomized clinical trial to establish the safety,
efficacy, cost to parent and acceptability of an intervention consisting of
education, non-antibiotic symptomatic therapy, and careful follow up in
children with mild AOM. The diagnostic protocol combines otoscopic assessment
of the tympanic membranes with five other key clinical measures to construct a
standardized Total AOM Severity Score, differentiating mild from severe AOM.
Parents of children with mild AOM will receive information about the risks and
benefits of antibiotic treatment and subjects will be randomized to receive
symptomatic care with or without antibiotic. Outcomes include parent
satisfaction, nasopharyngeal carriage of multi-drug resistant S. pneumoniae
organisms pre- and post-treatment, symptom scores, episodes of failure/relapse,
unanticipated visits and phone calls due to AOM, untoward complications, days
absent from school or day care (parent or child), and work (parent), parent
costs, and cost-effectiveness. The goal is to establish the safety of
withholding antibiotics from children with mild AOM and change the practice of
universal antibiotic treatment for these patients. The research will result in
publication of classification criteria, standardized photosets and parent
education materials for use by clinicians. If the program is successful, the
researchers will provide educational programs for clinicians and parents who
are concerned about the excess use of antibiotics, the emergence of
drug-resistant bacteria, and the high cost of AOM.




Fiscal Year: 2000
Department: UNIVERSITY OF TEXAS MEDICAL BR GALVESTON
Project Start: 03/01/2000
Project End: 07/31/2004
IRG: ZHS1

Related Publications:

Revai K, McCormick DP, Patel J, Grady JJ, Saeed K, Chonmaitree T (2006). "Effect of pneumococcal conjugate vaccine on nasopharyngeal bacterial colonization during acute otitis media." Pediatrics, Vol. 117, pp. 1823-1829

McCormick DP, Chonmaitree T, Pittman C, Saeed K, Friedman NR, Uchida T, Baldwin CD (2005). "Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment." Pediatrics, Vol. 115, pp. 1455-1465