Parametric versus non-parametric statistics in the analysis of randomized trials with non-normally distributed data Journal Article


Author: Vickers, A. J.
Article Title: Parametric versus non-parametric statistics in the analysis of randomized trials with non-normally distributed data
Abstract: Background: It has generally been argued that parametric statistics should not be applied to data with non-normal distributions. Empirical research has demonstrated that Mann-Whitney generally has greater power than the t-test unless data are sampled from the normal. In the case of randomized trials, we are typically interested in how an endpoint, such as blood pressure or pain, changes following treatment. Such trials should be analyzed using ANCOVA, rather than t-test. The objectives of this study were: a) to compare the relative power of Mann-Whitney and ANCOVA; b) to determine whether ANCOVA provides an unbiased estimate for the difference between groups; c) to investigate the distribution of change scores between repeat assessments of a nonnormally distributed variable. Methods: Polynomials were developed to simulate five archetypal non-normal distributions for baseline and post-treatment scores in a randomized trial. Simulation studies compared the power of Mann-Whitney and ANCOVA for analyzing each distribution, varying sample size, correlation and type of treatment effect (ratio or shift). Results: Change between skewed baseline and post-treatment data tended towards a normal distribution. ANCOVA was generally superior to Mann-Whitney in most situations, especially where log-transformed data were entered into the model. The estimate of the treatment effect from ANCOVA was not importantly biased. Conclusion: ANCOVA is the preferred method of analyzing randomized trials with baseline and post-treatment measures. In certain extreme cases, ANCOVA is less powerful than Mann-Whitney. Notably, in these cases, the estimate of treatment effect provided by ANCOVA is of questionable interpretability. © 2005 Vickers; licensee BioMed Central Ltd.
Keywords: clinical trial; comparative study; controlled clinical trial; randomized controlled trial; simulation; correlation analysis; statistical analysis; data analysis; scoring system; statistical model; normal distribution; rank sum test; sample size; statistical parameters; analytical parameters
Journal Title: BMC Medical Research Methodology
Volume: 5
ISSN: 1471-2288
Publisher: Biomed Central Ltd  
Date Published: 2005-11-03
Start Page: 35
Language: English
DOI: 10.1186/1471-2288-5-35
PROVIDER: scopus
PMCID: PMC1310536
PUBMED: 16269081
DOI/URL:
Notes: --- - "Cited By (since 1996): 60" - "Export Date: 24 October 2012" - "Source: Scopus"
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  1. Andrew J Vickers
    880 Vickers