Research Article: Methodological management of end-of-life decision data in intensive care studies: A systematic review of 178 randomized control trials published in seven major journals

Date Published: May 28, 2019

Publisher: Public Library of Science

Author(s): Sébastien Kerever, Alice Jacquens, Violaine Smail-Faugeron, Etienne Gayat, Matthieu Resche-Rigon, Manuel Fernández-Alcántara.

http://doi.org/10.1371/journal.pone.0217134

Abstract

End-of-life (EOL) decisions are a serious ethical dilemma and are frequently carried out in intensive care units (ICUs). The aim of this systematic review was to investigated the different approaches used in ICUs and reported in randomized controlled trials (RCTs) to address EOL decisions and compare the impact of these different strategies regarding potential bias and mortality estimates.

We identified relevant RCTs published in the past 15 years via PubMed, EMBASE, and CINAHL. In addition, we searched The Cochrane Library and checked registries, including ClinicalTrials.gov to assess concordance between declared and published outcomes. Among the journals we screened were the 3 ICU specialty journals and the four general medicine journals with the highest impact factor. Only RCTs were selected in which in-ICU mortality was the primary or secondary outcome. The primary outcome was information regarding EOL decisions, and the secondary outcome was how EOL decisions were treated in the study analysis.

A total of 178 relevant trials were identified. The details regarding the methodological aspects resulting from EOL decisions were reported in only 62 articles (35%). The manner in which EOL decisions were considered in the study analysis was very heterogeneous, often leading to a high risk of bias.

There is a heterogeneity regarding the management of data on EOL decisions in randomized control trials with mortality endpoints. Recommendations or rules are required regarding the inclusion of patients with potential EOL decisions in RCT analyses and how to manage such decisions from a methodological point of view.

PROSPERO website (CRD42013005724).

Partial Text

End-of-life (EOL) decisions are a serious ethical dilemma in certain medical specialties, particularly for intensivists in the intensive care unit (ICU). Questions regarding the ethical dilemma of EOL decisions have been discussed in an increasing number of scientific articles over the past 10–20 years [1–3]. EOL decisions are typically classified into four categories: (i) do-not-resuscitate (DNR) orders; (ii) withholding treatment; (iii) withdrawal of treatment; and (iv) active shortening of the dying process [4]. DNR orders are instructions or decisions not to attempt cardiopulmonary resuscitation (CPR) in case of cardiac arrest during a patient’s hospital stay. Withholding treatment is the decision not to implement or increase a life-sustaining intervention. Withdrawal of treatment is the decision to actively stop a life-sustaining intervention presently being given. Active shortening of the dying process is a circumstance in which someone performs an act with the specific intention of shortening the dying process [4].

The aim of this study was to explore and identify the different ways that withholding or withdrawing life-sustaining treatment are considered in RCT studies conducted specifically in the ICU framework.

 

Source:

http://doi.org/10.1371/journal.pone.0217134

 

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