CoChat
Sign Up
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
Open this paper in CoChat — free account

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

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Flagged first, then by citations

Show all 42 references

Research works printed but not linked: 1

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

Cited by

Sorted by citations

See all 27

Related

See all

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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review