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; Alice Jacquens; Violaine Smail-Faugeron; Etienne Gayat; Matthieu Resche-Rigon

doi:10.1371/journal.pone.0217134

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

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

Authors

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

¹ Department of Anesthesiology and Critical Care, Lariboisière University Hospital, AP-HP, Paris, France.
² ECSTRA Team, CRESS, Epidemiology and Statistics Center, Sorbonne Paris Cité, UMR 1153, INSERM, Paris, France.
³ University Denis Diderot-Paris VII, Paris, France.
⁴ Department of Neuro-Anesthesiology and Intensive Care, Pitié-Salpêtrière University Hospital, Assistance-publique-hôpitaux de Paris, Paris, France.
⁵ Sorbonne Université, UPMC Paris 6 University, Paris, France.
⁶ Service d'Odontologie, Hôpital Bretonneau, AP-HP, Paris, France.
⁷ Unité de Recherches Biomatériaux Innovants et Interface EA4462, Montrouge, France.
⁸ Université Paris Descartes-Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Paris, France.
⁹ Biomarkers in CArdio-Neuro-VAScular diseases (BioCANVAS), UMR-S 942, Inserm, Paris, France.
¹⁰ Biostatistics and Medical Information Departments, Saint Louis University Hospital, AP-HP, Paris, France.

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).

Publication types

Research Support, Non-U.S. Gov't
Systematic Review

MeSH terms

Decision Support Techniques*
Humans
Intensive Care Units / standards*
Meta-Analysis as Topic
Periodicals as Topic*
Randomized Controlled Trials as Topic
Registries / statistics & numerical data*
Terminal Care / methods*
Terminal Care / standards*

Grants and funding

The authors would like to thank the AP-HP Assistance Publique Hôpitaux de Paris for the PhD funding allocated to SK. This research was supported through the author's (SK) involvement in the European Science Foundation Research Networking Programme “REFLECTION”-09-RNP-049. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.