Trials using composite outcomes neglect the presence of competing risks: a methodological survey of cardiovascular studies

Hyunwoo Kim; Hamad Shahbal; Sameer Parpia; Tauben Averbuch; Harriette G C Van Spall; Lehana Thabane; Jinhui Ma

doi:10.1016/j.jclinepi.2023.05.015

Trials using composite outcomes neglect the presence of competing risks: a methodological survey of cardiovascular studies

J Clin Epidemiol. 2023 Aug:160:1-13. doi: 10.1016/j.jclinepi.2023.05.015. Epub 2023 May 27.

Authors

Hyunwoo Kim¹, Hamad Shahbal², Sameer Parpia³, Tauben Averbuch⁴, Harriette G C Van Spall⁵, Lehana Thabane⁶, Jinhui Ma⁷

Affiliations

¹ Department of Health Research Methods, Evidence, & Impact, McMaster University, Hamilton, Canada.
² Department of Biology, McMaster University, Hamilton, Canada.
³ Department of Health Research Methods, Evidence, & Impact, McMaster University, Hamilton, Canada; Department of Oncology, McMaster University, Hamilton, Canada.
⁴ Department of Cardiology, University of Calgary, Calgary, Canada.
⁵ Department of Health Research Methods, Evidence, & Impact, McMaster University, Hamilton, Canada; Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Canada; The Research Institute at St Joe's Hamilton, St Joseph's Healthcare Hamilton, Hamilton, Canada.
⁶ Department of Health Research Methods, Evidence, & Impact, McMaster University, Hamilton, Canada; The Research Institute at St Joe's Hamilton, St Joseph's Healthcare Hamilton, Hamilton, Canada; Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa. Electronic address: thabanl@mcmaster.ca.
⁷ Department of Health Research Methods, Evidence, & Impact, McMaster University, Hamilton, Canada. Electronic address: maj26@mcmaster.ca.

PMID: 37245700
DOI: 10.1016/j.jclinepi.2023.05.015

Abstract

Objective: To determine how frequently competing risks were accounted for in recently published cardiovascular disease (CVD) trials with composite end points.

Study design and setting: We conducted a methodological survey of CVD trials that used composite end points and published from January 1 to September 27, 2021. The following databases were searched: PubMed, Medline, Embase, CINAHL, and Web of Science. Eligible studies were categorized according to whether they mentioned a competing risk analysis plan. If yes, whether a competing risk analysis was proposed as the primary or sensitivity analysis.

Results: Among the 136 included studies, only 14 (10.3%) conducted a competing risk analysis and reported the corresponding results. Seven (50%) of them conducted a competing risk analysis as their primary analysis, whereas the other seven (50%) as a sensitivity analysis to assess the robustness of their findings. The most commonly used competing risk analysis methods were the subdistribution hazard model (nine studies), followed by the cause-specific hazard model (four studies) and restricted mean time lost method (one study). None of the studies accounted for competing risks in their sample size calculations.

Conclusion: Our findings underscore the pressing need for and importance of applying appropriate competing risk analysis in this field to disseminate clinically meaningful and unbiased results.

Keywords: Cardiovascular disease; Cause-specific hazard model; Competing risk; Composite outcome; Randomized controlled trial; Subdistribution hazard model.

Publication types

Review

MeSH terms

Cardiovascular Diseases* / epidemiology
Humans
Proportional Hazards Models
Risk Assessment