Composite endpoints

The promise and pitfalls of composite endpoints in sepsis and COVID-19 clinical trials

Composite endpoints reveal the tendency for statistical convention to arise locally within subfields. Composites are familiar in cardiovascular trials, yet almost unknown in sepsis. However, the VITAMINS trial in patients with septic shock adopted a …

Examining the Influence of Component Outcomes on the Composite at the Design Stage

While the literature simultaneously promotes and condemns composite endpoints, they are often used as the primary end point in clinical trials. The selection of the individual components to form the composite may be arbitrary, and the various …

Power and Sample Size Estimation for Composite Endpoints: Practical Implementation using Data Simulations

Composite endpoints are a popular outcome in controlled studies. However, the required sample size is not easily obtained due to the assortment of outcomes, correlations between them and the way in which the composite is constructed. Data simulations …

Multitype Events and the Analysis of Heart Failure Readmissions: Illustration of a New Modeling Approach and Comparison With Familiar Composite End Points

Heart failure–related hospital readmissions and mortality are often outcomes in clinical trials. Patients may experience multiple hospital readmissions over time with mortality acting as a dependent terminal event. Univariate composite end points are …

Letter Regarding Article: “Development and Evolution of a Hierarchical Clinical Composite End Point for the Evaluation of Drugs and Devices for Acute and Chronic Heart Failure: A 20-Year Perspective”

Composite End Points in Clinical Trials of Heart Failure Therapy. How Do We Measure the Effect Size?

Composite end points are popular outcomes in clinical trials of heart failure therapies. For example, a global rank composite is typically analyzed using a Mann–Whitney U test, and the results are summarized by the mean of ranks and a corresponding P …

Composite End Points in Acute Heart Failure Research: Data Simulations Illustrate the Limitations

Composite endpoints are frequently used in clinical trials of investigational treatments for acute heart failure, eg, to boost statistical power and reduce the overall sample size. By incorporating multiple and varying types of clinical outcomes they …