Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience.

ABSTRACT:

Objective

The purpose of this analysis was to evaluate a novel strategy for reporting adverse events in the Pediatric Heart Network's randomized surgical trial of systemic-pulmonary artery shunt versus right ventricle-pulmonary artery conduit in infants with hypoplastic left heart syndrome. The strategy was developed to align the reporting process with the needs of a surgical trial while maintaining participant safety.

Methods

Adverse event reporting was analyzed for 2 groups of study subjects: those randomized to a trial arm during a period in which a standard adverse event reporting system was used (period 1) and those randomized after institution of a system that focused serious adverse event reporting on 6 sentinel events (period 2). The analysis encompassed the period f

SUBMITTER: Virzi L 

PROVIDER: S-EPMC3144300 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature