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Critical Care
Published in: Critical Care 1/2017

Open Access 01-12-2017 | Letter

Understanding the null hypothesis (H0) in non-inferiority trials

Author: Jihad Mallat

Published in: Critical Care | Issue 1/2017

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Excerpt

I read with great interest the article by Zhou et al. [1] aiming to test whether a lactate-decreasing resuscitation protocol (lactate strategy), compared with central venous oxygen saturation-oriented resuscitation therapy (ScvO2 strategy), would decrease mortality among septic shock patients. …
Literature
1.
Zhou X, Liu D, Su L, Yao B, Long Y, Wang X, Chai W, Cui N, Wang H, Rui X. Use of stepwise lactate kinetics-oriented hemodynamic therapy could improve the clinical outcomes of patients with sepsis-associated hyperlactatemia. Crit Care. 2017;21(1):33.CrossRefPubMedPubMedCentral
2.
D'Agostino Sr RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues – the encounters of academic consultants in statistics. Stat Med. 2003;22(2):169–86.CrossRefPubMed
3.
Ferreira-González I. Basis for the interpretation of noninferiority studies: considering the ROCKET–AF, RE-LY, and ARISTOTLE Studies. Rev Esp Cardiol (Engl Ed). 2014;67(6):432–5.CrossRef
4.
Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA. Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate kinetics vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010;303(8):739–46.CrossRefPubMedPubMedCentral
Metadata
Title
Understanding the null hypothesis (H0) in non-inferiority trials
Author
Jihad Mallat
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2017
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-017-1685-2

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