关键词:
AHA Scientific Statements
resuscitation
HOSPITAL CARDIAC-ARREST
QUALITY-OF-LIFE
HIGH-DOSE EPINEPHRINE
IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR
FUNCTIONAL NEUROLOGICAL RECOVERY
EMERGENCY CARDIOVASCULAR CARE
TISSUE-PLASMINOGEN-ACTIVATOR
BRAIN NATRIURETIC PEPTIDE
RANDOMIZED CLINICAL-TRIAL
ACUTE CEREBRAL INFARCTION
摘要:
Background and Purpose-The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration. Methods-The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees. Results-There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physio