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Cited by 27Statistical Methods in Clinical TrialsBacterial Infections and VaccinesMeta-analysis and systematic reviews

The DOI matches its Crossref record; 42 of the 42 references it cites were found in a registry or an index.

Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children

KRYSAN, DAMIAN J., KEMPER, ALEX R.·2002·The Pediatric Infectious Disease Journal
DOI 10.1097/00006454-200208000-00011
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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.

Overview

Integrity signals

Registry

Crossref · 10.1097/00006454-200208000-00011

Cites

42 of 42 references verified0 citation errors · 0 not checkable

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Citations

Cites

Research works printed but not linked: 1

  1. Kumar, 1993, Bull WHO, 71, 183

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Metadata

Authors
KRYSAN, D. J., & KEMPER, A. R.
Affiliations
University of Michigan (US)
ORCID
Venue
The Pediatric Infectious Disease Journal
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2002-08
Volume
21
Issue
8
Pages
753-757
ISSN
0891-3668 (ISSN-L)
DOI
10.1097/00006454-200208000-00011
OpenAlex
W2022080628
Cited by
27
References
42
Citations by year
2025: 1 · 2022: 1 · 2021: 1 · 2018: 2 · 2017: 1 · 2016: 1 · 2015: 1 · 2013: 4 · 2012: 3
FWCI
0.47
Type
journal article
Language
en
Open access
closed
Locations
  • The Pediatric Infectious Disease Journal (publishedVersion)
  • PubMed (publishedVersion)
Funders
University of Michigan
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
bacterial meningitis, pediatric meningitis, antimicrobial therapy, therapeutic equivalence, sample size adequacy, statistical power, case fatality, equivalence trials
MeSH terms
Anti-Bacterial Agents, Child, Data Interpretation, Statistical, Humans, Research Design, Therapeutic Equivalency, Randomized Controlled Trials as Topic, MEDLINE, Meningitis, Bacterial, Sample Size

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