Dataset Information

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.

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).

SUBMITTER: Kerever S

PROVIDER: S-EPMC6538318 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

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.

Kerever Sébastien S Jacquens Alice A Smail-Faugeron Violaine V Gayat Etienne E Resche-Rigon Matthieu M

PloS one 20190528 5

<h4>Background</h4>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.<h4>Methods</h4>We identified relevant RCTs published in the past 15 years via PubMed, EM ...[more]

PMID: 31136601

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Project description:Published negative studies should have the same rigour of methodological quality as studies with positive findings. However, the methodological quality of negative versus positive studies is not known. The objective was to assess the reported methodological quality of positive versus negative studies published in Indian medical journals.A systematic review (SR) was performed of all comparative studies published in Indian medical journals with a clinical science focus and impact factor >1 between 2011 and 2013. The methodological quality of randomised controlled trials (RCTs) was assessed using the Cochrane risk of bias tool, and the Newcastle-Ottawa scale for observational studies. The results were considered positive if the primary outcome was statistically significant and negative otherwise. When the primary outcome was not specified, we used data on the first outcome reported in the history followed by the results section. Differences in various methodological quality domains between positive versus negative studies were assessed by Fisher's exact test.Seven journals with 259 comparative studies were included in this SR. 24% (63/259) were RCTs, 24% (63/259) cohort studies, and 49% (128/259) case-control studies. 53% (137/259) of studies explicitly reported the primary outcome. Five studies did not report sufficient data to enable us to determine if results were positive or negative. Statistical significance was determined by p value in 78.3% (199/254), CI in 2.8% (7/254), both p value and CI in 11.8% (30/254), and only descriptive in 6.3% (16/254) of studies. The overall methodological quality was poor and no statistically significant differences between reporting of methodological quality were detected between studies with positive versus negative findings.There was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies (72% vs 28%) indicates a publication bias in Indian medical journals with an impact factor of >1.

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Dataset Information

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.

Background

Methods

Results

Conclusion

Trial registration

Publications

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.

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