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Review
. 2019 Dec;31(6):775-782.
doi: 10.1097/MOP.0000000000000826.

Brain-related outcome measures in trials recruiting critically-ill children

Ericka L Fink  1 , Robert C Tasker  2
Affiliations
Review

Brain-related outcome measures in trials recruiting critically-ill children

Ericka L Fink et al. Curr Opin Pediatr. 2019 Dec.

Abstract

Purpose of review: Randomized controlled trials leading to innovations that improve outcomes in acute life-threatening illnesses in children are scarce. A key issue is how we refocus research on outcomes that matter and are more relevant to those making emergency decisions, and those involved with managing and living with the late-outcome. We have used information from recent trials in critically ill children - in particular those illnesses without any primary neurologic involvement - to develop an approach to brain-related outcomes that will maximize child and family benefit from research.

Recent findings: Fifteen recent pediatric critical care trials illustrate four types of brain-related outcomes assessment: death or organ-system-failures - as illustrated by studies in systemic illness; neurological and neuropsychological outcomes - as illustrated by the glycemic control studies; cognitive outcomes - as illustrated by a sedative trial; and composite outcomes - as illustrated by the therapeutic hypothermia studies.

Summary: The 15 research trials point to five areas that will need to be addressed and incorporated into future trial design, including use of: neurologic monitoring during intensive care unit admission; postdischarge outcomes assessments; strategies to improve retention in long-term follow-up; child and family-centered outcomes; and core outcomes datasets.

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Conflict of interest statement

Conflicts of interest

The authors declare no conflicts of interest in the writing of this systematic assessment of the literature. ELF receives funding from the Patient-Centered Outcomes Research Institute (PCORI) in the United States for work on an “early rehabilitation protocol in the PICU for children with acute brain injury” and is involved in the COMET (core outcome measures in effectiveness trials) initiative (see www.comet-initiative.org).

References

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