Open AccessAre component endpoints equal? A preference study into the practice of composite endpoints in clinical trials
Author(s) -
Vaanholt Melissa C.W.,
Kok Marlies M.,
Birgelen Clemens,
Weernink Marieke G.M.,
Til Janine A.
Publication year - 2018
Publication title -
health expectations
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.314
H-Index - 74
eISSN - 1369-7625
pISSN - 1369-6513
DOI - 10.1111/hex.12798
Subject(s) - medicine , conventional pci , stroke (engine) , angina , percutaneous coronary intervention , myocardial infarction , cardiology , revascularization , coronary artery disease , unstable angina , physical therapy , mechanical engineering , engineering
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 ( CE s): 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 ( IW s). 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 CE s and the relative values attributed to the CE s differed among subgroups based on gender, age and educational level. Conclusion Patients attribute different weight to individual CE s. This has significant implications for the interpretation of clinical trial data.