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To evaluate the association between novel pre- and post-operative biomarker levels and 30-day unplanned readmission or mortality after paediatric congenital heart surgery.
Children aged 18 years or younger undergoing congenital heart surgery (n = 162) at Johns Hopkins Hospital from 2010 to 2014 were enrolled in the prospective cohort. Collected novel pre- and post-operative biomarkers include soluble suppression of tumorgenicity 2, galectin-3, N-terminal prohormone of brain natriuretic peptide, and glial fibrillary acidic protein. A model based on clinical variables from the Society of Thoracic Surgery database was developed and evaluated against two augmented models.
Unplanned readmission or mortality within 30 days of cardiac surgery occurred among 21 (13%) children. The clinical model augmented with pre-operative biomarkers demonstrated a statistically significant improvement over the clinical model alone with a receiver-operating characteristics curve of 0.754 (95% confidence interval: 0.65–0.86) compared to 0.617 (95% confidence interval: 0.47–0.76; p-value: 0.012). The clinical model augmented with pre- and post-operative biomarkers demonstrated a significant improvement over the clinical model alone, with a receiver-operating characteristics curve of 0.802 (95% confidence interval: 0.72–0.89; p-value: 0.003).
Novel biomarkers add significant predictive value when assessing the likelihood of unplanned readmission or mortality after paediatric congenital heart surgery. Further exploration of the utility of these novel biomarkers during the pre- or post-operative period to identify early risk of mortality or readmission will aid in determining the clinical utility and application of these biomarkers into routine risk assessment.
This chapter describes crossover trials and their applications in neurology. Crossover trials could be used to study aspects of many common neurological disorders and psychiatric disorders. To illustrate the efficiency of crossover designs, the chapter presents sample size estimates for two placebo-controlled parallel and one crossover design for a trial examining the efficiency of donepezil in treating dementia in patients with Parkinson's disease. It also describes approaches to mitigate carryover effects. Alternatives to the 2 x 2 design are used to increase efficiency, provide unbiased estimates in the presence of carryover effects, and to compare more than two treatments. This chapter reviews response adaptive designs, matching and N of 1 trial along with several recent innovations in design. Simple carryover depends only on the treatment in the period prior to when carryover occurs. Crossover trials have logistical challenges beyond the careful planning and implementation that accompanies any successful clinical trial.