Journal article
Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children
The Pediatric infectious disease journal, Vol.21(8), pp.753-757
08/2002
DOI: 10.1097/00006454-200208000-00011
PMID: 12192164
Abstract
OBJECTIVE.To evaluate claims of therapeutic equivalence in studies of the treatment of bacterial meningitis in children.
METHODS.We performed a systematic review of randomized controlled trials of antimicrobial therapy for bacterial meningitis in children indexed in MEDLINE and published after 1980 and that claimed equivalency. The sample size of each trial was compared with the minimum sample size needed to rigorously claim equivalence. The primary endpoint was case fatality.
RESULTS.Twenty-five studies were identified that met the inclusion criteria. Two of these were specifically designed to test equivalence, and the remaining based claims of equivalence on failed tests of superiority. The majority of these trials (24 of 25) that claimed equivalence had sufficient sample size to exclude a 20% difference in mortality between the tested therapies. Only 3 of the 25 trials could exclude a 10% difference in mortality.
CONCLUSION.Few of the trials in this study had sufficient sample size to claim equivalence within 10% of the expected mortality. Proving equivalency is challenging because large sample sizes are often needed to ensure adequate statistical power to rule out clinically important differences between the standard of care and new therapies.
Details
- Title: Subtitle
- Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children
- Creators
- DAMIAN KRYSAN - From the Department of Pediatrics and Communicable Diseases (DJK) and the Child Health Evaluation and Research Unit, Division of General Pediatrics (ARK), University of Michigan, Ann Arbor, MIALEX KEMPER
- Resource Type
- Journal article
- Publication Details
- The Pediatric infectious disease journal, Vol.21(8), pp.753-757
- Publisher
- Lippincott Williams & Wilkins, Inc
- DOI
- 10.1097/00006454-200208000-00011
- PMID
- 12192164
- ISSN
- 0891-3668
- eISSN
- 1532-0987
- Language
- English
- Date published
- 08/2002
- Academic Unit
- Microbiology and Immunology; Stead Family Department of Pediatrics; Infectious Disease (Pediatrics)
- Record Identifier
- 9984093497502771
Metrics
9 Record Views