Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.
Yelena G Bodien, Michael McCrea, Sureyya Dikmen, Nancy Temkin, Kim Boase, Joan Machamer, Sabrina R Taylor, Mark Sherer, Harvey Levin, Joel H Kramer, John D Corrigan, Thomas W McAllister, John Whyte, Geoffrey T Manley, Joseph T Giacino
PMID 29385010WHAT IT FOUND
No patient outcomes are reported.
This methodological review offers advice for reducing measurement error in large TBI trials, not evidence that any treatment works.
What this paper is
This is a methodological review and perspective from the TRACK-TBI and TED initiatives. It describes how outcome assessment can be standardized in large multicenter TBI studies, but it reports no patient outcomes or treatment effects, so there is no finding here that therapists can act on.
The easy way to misread this
Do not treat the recommended outcome assessment steps as tested interventions. They are methodological suggestions from study design experience, not evidence that they improve patient care.