Underpowering in randomized trials reporting a sample size calculation.
OBJECTIVE
The objective of this study was to determine whether standard deviations (SDs) used in sample size calculations are smaller than those found in the resulting study sample, thereby leading to underpowered studies.


METHODS
The predicted SD used in the sample size calculation and the actual SD of the study sample were recorded for randomized trials recently published in one of four major journals.


RESULTS
Sample SD was greater than predicted SD for 80% of endpoints. About one quarter of trials required five times as many patients as specified in the sample size calculation.


CONCLUSIONS
Trials reporting sample size calculations for continuous endpoints published in the most reputable medical journals are often underpowered. There seems to be insufficient understanding that the SD of a sample of patients is a random variable, associated with imprecision, that cannot easily be extrapolated from one population to another.
Vickers
Andrew J
AJ
Integrative Medicine Service, Biostatistics Service, Memorial Sloan Kettering Cancer Center, Howard 1312a, 1275 York Avenue, NY 10021, USA. vickersa@mskcc.org
D003627:Data Interpretation, Statistical; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D018401:Sample Size