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Observational Study
. 2018 Dec;21(6):1046-1055.
doi: 10.1111/hex.12798. Epub 2018 Aug 14.

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

Melissa C W Vaanholt  1 , Marlies M Kok  2 , Clemens von Birgelen  1   2 , Marieke G M Weernink  1 , Janine A van Til  1
Affiliations
Observational Study

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

Melissa C W Vaanholt et al. Health Expect. 2018 Dec.

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.

Keywords: best-worst scaling; composite endpoints; coronary artery bypass grafting; coronary artery disease; patient preferences; percutaneous coronary intervention; revascularization; weighting procedure.

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Figures

Figure 1
Figure 1
Standardized “best‐worst” scores for the 8 potential outcomes of revascularization. A total of 147 patients participated, each of whom chose best and worst attributes from 6 sets of 4 attributes each (4248 total choices). Standardized scores range from −1.0 to 1.0, where higher (positive) values indicate that a given attribute was chosen more often as best than worst, and were more likely to be preferred relative to the other attributes. A score of “0” means that an attribute was selected as best or worst an equal number of times.15 MI, myocardial infarction; re‐CABG, redo coronary artery bypass grafting within a year post‐intervention; Re‐PCI, redo percutaneous coronary intervention within a year post‐intervention
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