Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst

Description

SPARE is a multi-center, international, prospective registry designed to evaluate the use of a multi-modality approach to neuroprognostication after cardiac arrest. Subjects will be evaluated with standard, accepted, and widely available assessment modalities, including clinical examination, neurophysiologic (electroencephalography and evoked potentials (per site standard of care), serum biomarkers (per site standard of care), and neuroimaging testing.

The purpose of this study is to collect data from a prospective large-scale cohort involving cardiac arrest survivors, and the clinical characteristics and prognostic features that affect their neurologic outcome. The ultimate goal is to derive a prediction model for neuroprognostication in cardiac arrest, using multiple clinical modalities that are already clinically in use, but in a standardized fashion. We hypothesize that by using a multimodal approach combining clinical assessment tools obtained at standardized time points, we will improve the accuracy of neuroprognostication in initially unconscious cardiac arrest survivors. The US and non-US populations will be compared, as the non-US population is less exposed to early WLST, thus eliminating the self-fulfilling prophecy bias that has plagued all CA studies to date.

Outcomes will be assessed at discharge, at 3 months post-arrest, 6 months, and annually up to 5 years afterwards. The primary outcome will be the proportion of subjects with good versus poor outcome, with a dichotomized approach of the modified Rankin Scale (mRS): good outcome defined as mRS scores of 0-3, and poor outcome as mRS scores of 4-6. Secondary outcome measures include overall scores on the Cerebral Performance Category Scale (CPC), Cerebral Performance Category – Extended (CPC-E), and Montreal Cognitive Assessment (MOCA) (or Telephone Montreal Cognitive Assessment (T-MOCA)).