Rounding, but not randomization method, non-normality, or correlation, affected baseline P-value distributions in randomized trials

Mark J Bolland (Corresponding Author), Greg D Gamble, Alison Avenell, Andrew Grey

Research output: Contribution to journalArticle

4 Citations (Scopus)
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Abstract

OBJECTIVE: To investigate whether comparing observed with expected p-value distributions for baseline continuous variables in randomised controlled trials (RCTs) might be limited by randomisation methods, normality and correlation of variables, or calculation of p-values from rounded summary statistics.

STUDY DESIGN AND SETTING: We assessed how each factor affects differences from expected for p-value distributions and area under the curve of the cumulative distribution function (AUC-CDF) of baseline p-values in 13 RCTs and in simulations.

RESULTS: The p-value distributions and AUC-CDF for variables with possible non-normal distribution and in simulations using eight different randomisation methods were consistent with the theoretical uniform distribution and AUC-CDF respectively, although stratification and minimisation produced smaller-than-expected proportions of p-values <0.10. 77% of 3813 pairwise correlations between baseline variables in the 13 individual RCTs were between -0.2 and 0.2. P-value distribution and AUC-CDF remained consistent with the uniform distribution in simulations with incrementally increasing correlation strength. The p-value distributions calculated from rounded summary statistics were not uniform, but expected distributions could be empirically generated.

CONCLUSIONS: Randomisation methods, non-normality and strength of correlation of baseline variables did not have important effects on baseline p-value distribution or AUC-CDF, but baseline p-values calculated from rounded summary statistics are non-uniformly distributed.

Original languageEnglish
Pages (from-to)50-62
Number of pages13
JournalJournal of Clinical Epidemiology
Volume110
Early online date8 Mar 2019
DOIs
Publication statusPublished - Jun 2019

Keywords

  • Statistical Methods
  • Research Integrity
  • P-values
  • Correlation
  • Randomisation
  • Rounding
  • Research integrity
  • Statistical methods
  • STATISTICS
  • NORMAL POSTMENOPAUSAL WOMEN
  • HEALTHY
  • DENSITY
  • CALCIUM SUPPLEMENTATION
  • ZOLEDRONATE
  • THERAPY
  • INTEGRITY
  • BONE

ASJC Scopus subject areas

  • Epidemiology

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