Comparing the Components of Composite Endpoints for Healthcare Providers and Patients (REC-CHARTENDS)

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT07378137

REC-CHARTENDS

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
2. Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
3. Healthcare providers who treat patients with coronary artery disease.

Exclusion criteria

1. Aged < 18 years;
2. Inability to understand the questionnaire or presence of cognitive impairment.

Trial design

600 participants in 1 patient group

Subjects

Description:

Medical staff and patients with CAD

Treatment:

Other: Questionnaire