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. 2019 May 28;14(5):e0217134.
doi: 10.1371/journal.pone.0217134. eCollection 2019.

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

Sébastien Kerever  1   2   3 , Alice Jacquens  4   5 , Violaine Smail-Faugeron  6   7   8 , Etienne Gayat  1   3   9 , Matthieu Resche-Rigon  2   3   10
Affiliations

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

Sébastien Kerever et al. PLoS One. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Trial registration: PROSPERO website (CRD42013005724).

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow diagram showing the selection procedure for papers.
Fig 2
Fig 2. Rate of EOL decisions observed in studies compared to the 10% expected rate (n = 33).
See this image and copyright information in PMC

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