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Consultants' forum: should post hoc sample size calculations be done?
Author(s) -
Walters Stephen J
Publication year - 2008
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.334
Subject(s) - sample size determination , outcome (game theory) , statistical power , post hoc analysis , sample (material) , statistics , statistical significance , post hoc , research design , type i and type ii errors , computer science , psychology , econometrics , medical physics , medicine , mathematics , chemistry , mathematical economics , dentistry , chromatography
Pre‐study sample size calculations for clinical trial research protocols are now mandatory. When an investigator is designing a study to compare the outcomes of an intervention, an essential step is the calculation of sample sizes that will allow a reasonable chance (power) of detecting a pre‐determined difference (effect size) in the outcome variable, at a given level of statistical significance. Frequently studies will recruit fewer patients than the initial pre‐study sample size calculation suggested. Investigators are faced with the fact that their study may be inadequately powered to detect the pre‐specified treatment effect and the statistical analysis of the collected outcome data may or may not report a statistically significant result. If the data produces a “non‐statistically significant result” then investigators are frequently tempted to ask the question “Given the actual final study size, what is the power of the study, now, to detect a treatment effect or difference?” The aim of this article is to debate whether or not it is desirable to answer this question and to undertake a power calculation, after the data have been collected and analysed. Copyright © 2008 John Wiley & Sons, Ltd.