Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights

JR Marsal, I Urreta-Barallobre, M Ubeda-Carrillo… - Trials, 2022 - Springer
Background The real impact of the degree of association (DoA) between endpoint
components of a composite endpoint (CE) on sample size requirement (SSR) has not been …

Dealing with nonproportional hazards in coronary revascularization studies

LC Godoy, DT Ko, ME Farkouh, BR Shah… - Canadian Journal of …, 2023 - Elsevier
The Cox proportional hazards model is one of the most popular statistical tools to model time
to event outcomes without the need for specifying the hazards or survival time distributions …

Semi-competing risks data analysis: accounting for death as a competing risk when the outcome of interest is nonterminal

S Haneuse, KH Lee - Circulation: Cardiovascular Quality and …, 2016 - Am Heart Assoc
Hospital readmission is a key marker of quality of health care. Notwithstanding its
widespread use, however, it remains controversial in part because statistical methods used …

Informed choice of composite end points in cardiovascular trials

G Gomez, M Gomez-Mateu, U Dafni - … : Cardiovascular Quality and …, 2014 - Am Heart Assoc
A composite end point is often used as the primary end point to assess the efficacy of a new
treatment in randomized clinical trials. In cardiovascular trials, the often rare event of the …

Beyond composite endpoints analysis: semicompeting risks as an underutilized framework for cancer research

I Jazić, D Schrag, DJ Sargent… - JNCI: Journal of the …, 2016 - academic.oup.com
Background: Composite endpoints (CEP), such as progression-free survival, are commonly
used in cancer research. Notwithstanding their popularity, however, CEP analyses suffer …

Adaptive clinical trial designs with blinded selection of binary composite endpoints and sample size reassessment

MB Roig, GG Melis, M Posch, F Koenig - Biostatistics, 2024 - academic.oup.com
For randomized clinical trials where a single, primary, binary endpoint would require
unfeasibly large sample sizes, composite endpoints (CEs) are widely chosen as the primary …

Selection of composite binary endpoints in clinical trials

M Bofill Roig, G Gómez Melis - Biometrical Journal, 2018 - Wiley Online Library
The choice of a primary endpoint is an important issue when designing a clinical trial. It is
common to use composite endpoints as a primary endpoint because it increases the number …

Planning and evaluating clinical trials with composite time‐to‐first‐event endpoints in a competing risk framework

G Rauch, J Beyersmann - Statistics in medicine, 2013 - Wiley Online Library
Composite endpoints combine several events of interest within a single variable. These are
often time‐to‐first‐event data, which are analyzed via survival analysis techniques. To …

An optimal Wilcoxon–Mann–Whitney test of mortality and a continuous outcome

RA Matsouaka, AB Singhal… - Statistical Methods in …, 2018 - journals.sagepub.com
We consider a two-group randomized clinical trial, where mortality affects the assessment of
a follow-up continuous outcome. Using the worst-rank composite endpoint, we develop a …

An external validation of the Kidney Donor Risk Index in the UK transplant population in the presence of semi-competing events

S Riley, K Tam, WY Tse, A Connor, Y Wei - Diagnostic and Prognostic …, 2023 - Springer
Background Transplantation represents the optimal treatment for many patients with end-
stage kidney disease. When a donor kidney is available to a waitlisted patient, clinicians …