Comparing the Components of Composite Endpoints for Healthcare Providers and Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Questionnaire: A questionnaire regarding the weights given by the patients with CAD and the medical staff for the individual components of the composite endpoint

Study summary

Clinical trials often employ a composite primary endpoint to increase event rates and enhance trial efficiency. However, analytic approaches to composite endpoints typically assume that the individual components are of similar importance. In practice, a treatment often has different effects on each individual endpoint, leading to uncertainty in interpreting the results of a clinical trial employing a composite primary endpoint.

Some investigators have recommended using a weighted composite endpoint to address these concerns, in which individual components are valued relative to one another. However, data to inform the weighting of individual endpoints, using opinions from both medical staff and patients, remains controversial. Furthermore, prior efforts to weigh composite endpoints have assumed that patients, physicians, and clinical trialists would assign similar values to individual events. If patients value endpoints differently from trialists, this would suggest that efforts to develop weighted composite endpoints may also need to address patient preferences.

In the current study, we aim to record the weighing of both patients and medical staff towards a composite endpoint frequently used in cardiovascular clinical trials. To better understand the value of each endpoint for patients and medical staff, we quantified the relative severity of each endpoint when compared to death and assessed for rating differences between the two groups. Additionally, we investigated whether endpoint weights varied by the demographic and clinical characteristics of patients and medical staff.

Eligibility

Primary outcome measure(s)

• Relative weight of myocardial infarction to death — Before discharge
• Relative weight of stroke to death — Before discharge
• Relative weight of cardiopulmonary resuscitation to death — Before discharge
• Relative weight of procedural complications to death — Before discharge
• Relative weight of major bleeding events to death — Before discharge
• Relative weight of acute kidney injury to death — Before discharge
• Relative weight of revascularization to death — Before discharge
• Relative weight of rehospitalization to death — Before discharge

Trial sites (1)

More Xijing Hospital trials in China

Other trials for the same condition