Comparing the Components of Composite Endpoints for Healthcare Providers and Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Preference Study Comparing the Components of Composite Endpoints for Healthcare Providers and Patients With CAD
Overview
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.
Interventions
- Other Questionnaire
A questionnaire regarding the weights given by the patients with CAD and the medical staff for the individual components of the composite endpoint
Primary outcome measures
- Relative weight of myocardial infarction to death [Time frame: Before discharge]
- Relative weight of stroke to death [Time frame: Before discharge]
- Relative weight of cardiopulmonary resuscitation to death [Time frame: Before discharge]
- Relative weight of procedural complications to death [Time frame: Before discharge]
- Relative weight of major bleeding events to death [Time frame: Before discharge]
- Relative weight of acute kidney injury to death [Time frame: Before discharge]
- Relative weight of revascularization to death [Time frame: Before discharge]
- Relative weight of rehospitalization to death [Time frame: Before discharge]
Eligibility criteria
Inclusion criteria
- Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
- Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
- Healthcare providers who treat patients with coronary artery disease.
Exclusion criteria
- Aged < 18 years;
- Inability to understand the questionnaire or presence of cognitive impairment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xijing Hospital — Xi'an
Identifiers
NCT: NCT07378137 · REC-CHARTENDS