Key result
COVID-19 trials include primary endpoint PROs ~5 times more often than AHF trials.
Why the study?
Composite endpoints are increasingly adopted in clinical trials, but trends in their use have not been compared between acute heart failure and COVID-19 trials.
COVID-19 trials have more frequently adopted patient-oriented outcomes and ordinal composite endpoints compared to acute heart failure trials, likely driven by global consensus.
May support incorporating patient-reported outcomes in heart failure trial endpoints; leaves open effects on relevance and adoption.
Composite endpoints can encode multiple pieces of information and are increasingly adopted in clinical trials. Advocacy for using composite endpoints began decades ago in cardiovascular trials, leading to incorporation of patient-oriented outcomes and consideration of a hierarchical ranking system. The use of composite endpoints in coronavirus disease (COVID-19) trials has evolved similarly. We conducted a literature review to investigate the use of composite endpoints in acute heart failure and COVID-19 clinical trials. The results showed more frequent use of patient-oriented outcomes and ordinal composite endpoints in COVID-19 trials, which might be driven by global consensus on a set of common outcome measures.
No takes yet. Share an insight, caveat, or question.
Shi et al. (2024) conducted a review in Acute heart failure and COVID-19 (n=227). COVID-19 trials vs. Acute heart failure trials was evaluated on Inclusion of patient-reported outcomes (PROs) in the primary composite endpoint (p=<0.001). COVID-19 clinical trials were significantly more likely to include patient-reported outcomes in their primary composite endpoints compared to acute heart failure trials (35.1% vs 7.0%, p<0.001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: