Addressing an inherent bias in neuroprognostication: a collaboration between the US and brazil to reduce the impact of self-fulfilling prophecy in cardiac arrest (spare)

Active Project Grant Awarded Last action

Award ID
R01NS128342
Recipient
Awarding agency
Obligated
$3,211,279

Award facts

Completion date 56% complete
Place of performance
Roxbury, MA 02118, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Hypoxic-ischemic brain injury in cardiac arrest survivors ranges in severity from mild cognitive impairment to per- sistent vegetative state. Precise estimation of neurologic outcome (neuroprognostication) in this setting is crucial to guide families and physicians in goals-of-care decisions and to improve allocation of critical care resources. Outcome prediction tools include neurologic examination, neuroimaging, biochemical markers, and electrophysi- ologic studies. Accurate neuroprognostication remains challenging, as previous studies assessing the prognostic accuracy of these tools have been affected by withdrawal of life support due to perceived poor neurologic prog- nosis (WLS-n), and thus subject to self-fulfilling prophecy bias. This bias, along with early pessimistic prognosti- cation, most often leads to premature death of those dependent on life support, including some with potential for good neurologic recovery. Consequently, the natural history of hypoxic-ischemic brain injury unbiased by the effect of WLS-n has not been adequately investigated. In brazil, the severity of hypoxic-ischemic brain injury is assessed by prognostic tools similar to those used in the US; however, life-sustaining therapies are maintained for prolonged periods due to cultural norms. This difference in practice, unbiased by WLS-n, allows for a unique opportunity to observe the natural history of hypoxic-ischemic brain injury, and to identify true predictors of poor outcome. The elucidation of the impact of WLS-n on the performance of neuroprognostic tools is a vital step toward more accurate outcome prediction. This will be the first study to combine the advanced expertise from leading international sites analyzing neuroimaging and electrophysiologic data applied to a population unbiased by WLS-n, and to unveil the impact of self-fulfilling prophecy bias on the natural history of hypoxic-ischemic brain injury and on the prediction performance of guideline-recommended neuroprognostic tools. We will prospectively collect data on demographics, premorbid characteristics, details of cardiac arrest and resuscitation, post-cardiac arrest care, detailed neurological examination findings, electrophysiologic studies and neuroimaging at standard- ized time points, and assess functional outcomes at discharge and at 3, 6 and 12 months. Our goals are to: 1) determine the independent effect of WLS-n on mortality and overall outcomes, and 2) demonstrate the prognostic accuracy of current guideline-recommended tools in an uncensored population. As an EX- ploratory aim, we will also develop independent, blinded multimodal neuroprognostic models for the US and brazil cohorts, and compare their performance. By completing this innovative project, we will understand the impact of WLS-n on the natural history of hypoxic-ischemic brain injury and better characterize the timing of recovery after cardiac arrest. These data will influence future neuroprognostication studies and trials of neuro- therapeutics, as well as optimize the use of critical care resources. This study is the stepping stone to strength- ening data on neuroprognostication by improving their reliability, thereby ultimately easing undue patient and family suffering from prognostic uncertainty, and directing medical resources most efficiently.

Transactions

Action Obligated Date
Amendment $25,758
Amendment $25,758
Amendment $25,758
Amendment $25,758
Amendment $478,045
Amendment $532,674
Amendment $532,674
Amendment $782,427
Original award $782,427

Subawards

Subrecipient Amount Awarded
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein The Hospital Israelita Albert Einstein will serve as a subcontract to Boston Medical Center for the proposed study entitled, “Self-fulfilling Prophecy in… $25,758
Yale Univ Yale University School of Medicine will be responsible for overseeing screening and enrollment, oversight of data collection and data entry, and coordination… $46,453
The Trustees Of The University Of Pennsylvania UPenn will 1) identify potential subjects to recruit into the study; 2) recruit and consent subjects into the trial; 3) oversight of the study; and 4)… $43,628
The Regents Of The University Of California. San Francisco The University of California, San Francisco will serve as a subcontract to Boston Medical Center for the proposed study entitled, ""Addressing an inherent… $66,071
University Of Florida As an integral member of this team science, Dr. Maciel is the site principal investigator at the University of Florida. As a site principal investigator, Dr.… $46,899
Trustees Of Boston University BUSPH will provide regular and highly accessible expertise through in-person meetings and correspondence with Dr. Patil for all aspects of the research project,… $24,728
Universidade Federal De SAO Paulo The Universidade Federal de São Paulo will serve as a subcontract to Boston Medical Center for the proposed study entitled, “Self-fulfilling Prophecy in cardiac… $25,380
Yale Univ This prospective, observational study will seek to identify the impact of withdrawal of life sustaining therapy due to perceived poor neurological prognosis… $0
Universidade Federal De SAO Paulo The Universidade Federal de São Paulo will serve as a subcontract to Boston Medical Center for the proposed study entitled, “Self-fulfilling Prophecy in cardiac… $25,380
Fund De Apoio AO Ensino Pesq E Assistencia Hcfmrpusp As a site principal investigator, Dr. Pontes-Neto will be responsible for screening and enrollment, and close oversight of data collection and input in the… $25,380
Trustees Of Boston University BUSPH will provide regular and highly accessible expertise through in-person meetings and correspondence with Dr. Patil for all aspects of the research project,… $37,551
Trustees Of Boston University $24,008
The Regents Of The University Of California. San Francisco The University of California, San Francisco will serve as a subcontract to Boston Medical Center for the proposed study entitled, ""Addressing an inherent… $66,071
Yale Univ Yale University School of Medicine will serve as a subcontract to Boston Medical Center for the proposed study entitled, ""Self-fulfilling Prophecy in cardiac… $53,394
University Of Florida As an integral member of this team science, Dr. Maciel is the site principal investigator at the University of Florida. As a site principal investigator, Dr.… $46,187
The Trustees Of The University Of Pennsylvania Improve the accuracy of neurologic prognostication in patients who have survived a sudden cardiac arrest. Dr. Fischer will identify potential subjects to… $50,147
The Regents Of The University Of California. San Francisco Addressing an inherent bias in neuroprognostication: A collaboration between the US and Brazil to reduce the impact of Self-fulfilling Prophecy in cardiac… $66,071
Fund De Apoio AO Ensino Pesq E Assistencia Hcfmrpusp $25,380
Yale Univ $53,394
The Trustees Of The University Of Pennsylvania $50,147
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Quick answers

Who received award R01NS128342?

R01NS128342 was awarded to Boston Medical Center Corporation by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on January 22, 2024.

How much is award R01NS128342 worth?

$3,211,279 has been obligated on R01NS128342.

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