Improving Efficiency of Win Ratio Analyses Through Covariate Adjustment: A Case Study Using the EMPULSE Trial
Abstract
Heart failure is a serious condition in which the heart cannot pump blood around the body as well as it should. It affects more than 60 million people worldwide and can cause symptoms such as shortness of breath, tiredness, and difficulty carrying out everyday activities. Heart failure is also a common reason for hospital admission and can reduce life expectancy. We will conduct this research to improve the way information from clinical trials is analysed. Clinical trials are studies that test whether treatments are safe and effective. The results of these studies help doctors make decisions about patient care. It is important that all the information collected from participants is used in the best possible way so that study findings are accurate and reliable. We will use data from the EMPULSE clinical trial, which studied the medicine empagliflozin in people who had recently been admitted to hospital with heart failure. Empagliflozin (commonly known as Jardiance) is a prescription medication that lowers blood sugar by helping the kidneys remove excess glucose through urine. It is also prescribed to treat heart failure. The trial collected information about participants' health, including survival, hospital admissions, and how they felt and functioned in their daily lives. Information was collected before treatment began and during follow-up visits. Our research will not reassess whether empagliflozin is effective. Instead, we will use the EMPULSE trial as an example to…
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