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Type: Journal article
Title: Individualizing endpoints in randomized clinical trials to better inform individual patient care: the TARGET proposal
Author: Iwashyna, T.
Deane, A.
Citation: Critical Care (UK), 2016; 20(1):218-1-218-8
Publisher: BioMed Central
Issue Date: 2016
ISSN: 1364-8535
Statement of
Theodore J. Iwashyna and Adam M. Deane
Abstract: In practice, critical care practitioners individualize treatments and goals of care for each patient in light of that patient’s acute and chronic pathophysiology, as well as their beliefs and values. Yet critical care researchers routinely measure one endpoint for all patients during randomized clinical trials (RCTs), eschewing any such individualization. More recent methodology work has explored the possibility that enrollment criteria in RCTs can be individualized, as can data analysis plans. Here we propose that the specific endpoints of a RCT can be individualized—that is, different patients within a single RCT might have different secondary endpoints measured. If done rigorously and objectively, based on pre-randomization data, such individualization of endpoints may improve the bedside usefulness of information obtained during a RCT, while perhaps also improving the power and efficiency of any RCT. We discuss the theoretical underpinnings of this proposal in light of related innovations in RCT design such as sliding dichotomies. We discuss what a full elaboration of such individualization would require, and outline a pragmatic initial step towards the use of “individualized secondary endpoints” in a large RCT evaluating optimal enteral nutrition targets in the critically ill.
Keywords: Humans
Critical Illness
Critical Care
Research Design
Patient Care Planning
Patient-Centered Care
Randomized Controlled Trials as Topic
Rights: © 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated
DOI: 10.1186/s13054-016-1388-0
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