Distributions of baseline categorical variables were different from the expected distributions in randomized trials with integrity concerns.
Categorical variables
Data integrity
Fabricated data
P-values
Randomization
Research integrity
Statistical methods
Journal
Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383
Informations de publication
Date de publication:
02 2023
02 2023
Historique:
received:
27
10
2022
revised:
08
12
2022
accepted:
21
12
2022
pubmed:
31
12
2022
medline:
22
3
2023
entrez:
30
12
2022
Statut:
ppublish
Résumé
Comparing observed and expected distributions of baseline continuous variables in randomized controlled trials (RCTs) can be used to assess publication integrity. We explored whether baseline categorical variables could also be used. The observed and expected (binomial) distribution of all baseline categorical variables were compared in four sets of RCTs: two controls, and two with publication integrity concerns. We also compared baseline calculated and reported P-values. The observed and expected distributions of baseline categorical variables were similar in the control datasets, both for frequency counts (and percentages) and for between-group differences in frequency counts. However, in both sets of RCTs with publication integrity concerns, about twice as many variables as expected had between-group differences in frequency counts of one or 2, and far fewer variables than expected had between-group differences of >4 (P < 0.001 for both datasets). Furthermore, about one in six reported P-values for baseline categorial variables differed by > 0.1 from the calculated P-value in trials with publication integrity concerns. Comparing the observed and expected distributions and reported and calculated P-values of baseline categorical variables may help in the assessment of publication integrity of a body of RCTs.
Sections du résumé
BACKGROUND AND OBJECTIVES
Comparing observed and expected distributions of baseline continuous variables in randomized controlled trials (RCTs) can be used to assess publication integrity. We explored whether baseline categorical variables could also be used.
METHODS
The observed and expected (binomial) distribution of all baseline categorical variables were compared in four sets of RCTs: two controls, and two with publication integrity concerns. We also compared baseline calculated and reported P-values.
RESULTS
The observed and expected distributions of baseline categorical variables were similar in the control datasets, both for frequency counts (and percentages) and for between-group differences in frequency counts. However, in both sets of RCTs with publication integrity concerns, about twice as many variables as expected had between-group differences in frequency counts of one or 2, and far fewer variables than expected had between-group differences of >4 (P < 0.001 for both datasets). Furthermore, about one in six reported P-values for baseline categorial variables differed by > 0.1 from the calculated P-value in trials with publication integrity concerns.
CONCLUSION
Comparing the observed and expected distributions and reported and calculated P-values of baseline categorical variables may help in the assessment of publication integrity of a body of RCTs.
Identifiants
pubmed: 36584733
pii: S0895-4356(22)00342-0
doi: 10.1016/j.jclinepi.2022.12.018
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
117-124Subventions
Organisme : Chief Scientist Office
ID : HSRU1
Pays : United Kingdom
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.