Efficacy outcome selection in the therapeutic hypothermia after pediatric cardiac arrest trials.

ABSTRACT:

Objectives

The Therapeutic Hypothermia After Pediatric Cardiac Arrest trials will determine whether therapeutic hypothermia improves survival with good neurobehavioral outcome, as assessed by the Vineland Adaptive Behavior Scales Second Edition, in children resuscitated after cardiac arrest in the in-hospital and out-of-hospital settings. We describe the innovative efficacy outcome selection process during Therapeutic Hypothermia After Pediatric Cardiac Arrest protocol development.

Design/setting

Consensus assessment of potential outcomes and evaluation timepoints.

Interventions

None.

Measurements and main results

We evaluated practical and technical advantages of several follow-up timepoints and continuous/categorical outcome variants. Simulations estimated po

SUBMITTER: Holubkov R 

PROVIDER: S-EPMC4396179 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature