Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials.

Abstract

OBJECTIVES:

To examine patients' perspectives regarding composite endpoints and the utility patients put on possible adverse outcomes of revascularization procedures.

DESIGN:

In the PRECORE study, a stated preference elicitation method Best-Worst Scaling (BWS) was used to determine patient preference for 8 component endpoints (CEs): need for redo percutaneous coronary intervention (PCI) within 1 year, minor stroke with symptoms <24 hours, minor myocardial infarction (MI) with symptoms <3 months, recurrent angina pectoris, need for redo coronary artery bypass grafting (CABG) within 1 year, major MI causing permanent disability, major stroke causing permanent disability and death within 24 hours.

SETTING:

A tertiary PCI/CABG centre.

PARTICIPANTS:

One hundred and sixty patients with coronary artery disease who underwent PCI or CABG.

MAIN OUTCOME MEASURES:

Importance weights (IWs).

RESULTS:

Patients considered need for redo PCI within 1 year (IW: 0.008), minor stroke with symptoms <24 hours (IW: 0.017), minor MI with symptoms <3 months (IW: 0.027), need for redo CABG within 1 year (IW: 0.119), recurrent angina pectoris (IW: 0.300) and major MI causing permanent disability (IW: 0.726) less severe than death within 24 hours (IW: 1.000). Major stroke causing permanent disability was considered worse than death within 24 hours (IW: 1.209). Ranking of CEs and the relative values attributed to the CEs differed among subgroups based on gender, age and educational level.

CONCLUSION:

Patients attribute different weight to individual CEs. This has significant implications for the interpretation of clinical trial data.

• Authors: Melissa C W Vaanholt, Marlies M Kok, Clemens von Birgelen, Marieke G M Weernink, Janine A van Til
• Journal: Health expectations : an international journal of public participation in health care and health policy (Health Expect) Vol. 21 Issue 6 Pg. 1046-1055 (12 2018) ISSN: 1369-7625 [Electronic] England
• PMID: 30109764 (Publication Type: Journal Article, Observational Study)
• Copyright: © 2018 The Author. Health Expectations published by John Wiley & Sons Ltd.

Topics

• Aged
• Clinical Trials as Topic
• Coronary Artery Bypass (adverse effects, methods)
• Coronary Artery Disease (surgery)
• Female
• Humans
• Male
• Myocardial Infarction
• Patient Preference
• Percutaneous Coronary Intervention (adverse effects, methods)
• Prospective Studies
• Risk Factors
• Stroke
• Treatment Outcome