Combined evidence from multiple outcomes in a clinical trial

Clinical investigators are encouraged to apply recently developed statistical methodology. For each patient in a trial, favorable and unfavorable results from multiple outcomes may be summarized in a suitable summary measure. This summary measure may be used in a two-sample t-test to decide which tr...

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Bibliographic Details
Published in:Journal of clinical epidemiology 2000-11, Vol.53 (11), p.1137-1144
Main Author: Schouten, Hubert J.A
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical Trials as Topic
Computerized, statistical medical data processing and models in biomedicine
Data Interpretation, Statistical
Medical sciences
Medical statistics
Multiple comparisons
Multiple outcomes
Sample size formula
Statistical methods
Statistics as Topic
Summary measure
Treatment Outcome
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Summary:Clinical investigators are encouraged to apply recently developed statistical methodology. For each patient in a trial, favorable and unfavorable results from multiple outcomes may be summarized in a suitable summary measure. This summary measure may be used in a two-sample t-test to decide which treatment is best. An example illustrates how the evidence from the main outcome criteria may be combined. The required study size depends on the mean treatment effect on the outcomes in the summary measure. When separate outcomes are considered, there is a multiple comparisons problem, for which Hochberg offered a simple solution. Evaluation of a single-summary measure may require a larger or a smaller study size than evaluation of separate outcomes, depending on whether treatment effects are about the same or very different.
ISSN:0895-4356
1878-5921
DOI:10.1016/S0895-4356(00)00238-9