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Intensive Care Medicine
Published in: Intensive Care Medicine 9/2013

01-09-2013 | Statistical Note

How to interpret a randomized controlled study stopped early

Author: G. Leandro

Published in: Intensive Care Medicine | Issue 9/2013

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Excerpt

This issue of Intensive Care Medicine publishes data from a multicenter randomized controlled trial (RCT) by Joannes-Boyau et al. [1] on high-volume versus standard-volume hemofiltration for septic shock patients with acute kidney injury. The study was stopped early because of the authors’ inability to recruit and enroll all planned participants, therefore calling into question how to interpret lower than the expected volume of data, which is a problem that occurs frequently in RCTs [2]. …
Literature
1.
Joannes-Boyau O, Honoré P, Perez P et al (2013) High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicenter randomized controlled trial. Intens Care Med. doi:10.​1007/​s00134-013-2967-z
2.
Friedlin B, Korn EL (2009) Stopping clinical trials early for benefit: impact on estimation. Clin Trials 6:119–125CrossRef
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Sargent D (2009) Early stopping for benefit in National Cancer Institute-sponsored phase III trials: the system is working. J Clin Oncol 27(10):1543–1544PubMedCrossRef
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Korn EL, Friedlin B, Mooney M (2009) Stopping or reporting early for positive results in randomized clinical trials: the National Cancer Institute cooperative group experience from 1990 to 2005. J Clin Oncol 27(10):1712–1721PubMedCrossRef
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Montori VM, Devereaux PJ, Adhikari NKJ et al (2005) Randomized trials stopped early for benefit. A systematic review. JAMA 294(17):2203–2209PubMedCrossRef
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Berry SM, Carlin BP, Connor J (2010) Bias and trials stopped early for benefit. Letters to the Editor. JAMA 304(2):156–159
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Ware JH, Muller JE, Braunwald E (1985) The futility index. An approach to cost-effective termination of randomized clinical trials. Am J Med 78(4):635–643PubMedCrossRef
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DeMets DL (2006) Futility approaches to interim monitoring by data monitoring committees. Clin Trial 3:522–529CrossRef
Metadata
Title
How to interpret a randomized controlled study stopped early
Author
G. Leandro
Publication date
01-09-2013
Publisher
Springer Berlin Heidelberg
Published in
Intensive Care Medicine / Issue 9/2013
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-013-3000-2

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