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Trials in adult critical care that show increased mortality of the new intervention: Inevitable or preventable mishaps?

Overview of attention for article published in Annals of Intensive Care, February 2016
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39 Mendeley
Title
Trials in adult critical care that show increased mortality of the new intervention: Inevitable or preventable mishaps?
Published in
Annals of Intensive Care, February 2016
DOI 10.1186/s13613-016-0120-1
Pubmed ID
Authors

James A. Russell, Mark D. Williams

Abstract

Several promising therapies assessed in the adult critically ill in large, multicenter randomized controlled trials (RCTs) were associated with significantly increased mortality in the intervention arms. Our hypothesis was that there would be wide ranges in sponsorship (industry or not), type(s) of intervention(s), use of DSMBs, presence of interim analyses and early stopping rules, absolute risk increase (ARI), and whether or not adequate prior proof-of-principle Phase II studies were done of RCTs that found increased mortality rates of the intervention compared to control groups. We reviewed RCTs that showed a statistically significant increased mortality rate in the intervention compared to control group(s). We recorded source of sponsorship, sample sizes, types of interventions, mortality rates, ARI (as well as odds ratios, relative risks and number needed to harm), whether there were pre-specified interim analyses and early stopping rules, and whether or not there were prior proof-of-principle (also known as Phase II) RCTs. Ten RCTs (four industry sponsored) of many interventions (high oxygen delivery, diaspirin cross-linked hemoglobin, growth hormone, methylprednisolone, hetastarch, high-frequency oscillation ventilation, intensive insulin, NOS inhibition, and beta-2 adrenergic agonist, TNF-α receptor) included 19,126 patients and were associated with wide ranges of intervention versus control group mortality rates (25.7-59 %, mean 29.9 vs 17-49 %, mean 25 %, respectively) yielding ARIs of 2.6-29 % (mean 5 %). All but two RCTs had pre-specified interim analyses, and seven RCTs were stopped early. All RCTs were preceded by published proof-of-principle RCT(s), two by the same group. Seven interventions (except diaspirin cross-linked hemoglobin and the NOS inhibitor) were available for use clinically at the time of the pivotal RCT. Common, clinically available interventions used in the critically ill were associated with increased mortality in large, pivotal RCTs even though safety was often addressed by interim analyses and early stopping rules.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 39 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 39 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 8 21%
Researcher 7 18%
Other 3 8%
Student > Doctoral Student 3 8%
Student > Ph. D. Student 3 8%
Other 7 18%
Unknown 8 21%
Readers by discipline Count As %
Medicine and Dentistry 22 56%
Nursing and Health Professions 4 10%
Arts and Humanities 1 3%
Pharmacology, Toxicology and Pharmaceutical Science 1 3%
Biochemistry, Genetics and Molecular Biology 1 3%
Other 2 5%
Unknown 8 21%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 26 February 2016.
All research outputs
#18,379,687
of 23,613,071 outputs
Outputs from Annals of Intensive Care
#909
of 1,074 outputs
Outputs of similar age
#205,311
of 300,151 outputs
Outputs of similar age from Annals of Intensive Care
#16
of 23 outputs
Altmetric has tracked 23,613,071 research outputs across all sources so far. This one is in the 19th percentile – i.e., 19% of other outputs scored the same or lower than it.
So far Altmetric has tracked 1,074 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 17.2. This one is in the 12th percentile – i.e., 12% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 300,151 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 27th percentile – i.e., 27% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 23 others from the same source and published within six weeks on either side of this one. This one is in the 30th percentile – i.e., 30% of its contemporaries scored the same or lower than it.