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stat.ME2026

A tutorial on conducting sample size and power calculations for detecting treatment effect heterogeneity in cluster randomized trials with linear mixed models

Mary Ryan Baumann, Monica Taljaard, Patrick J. Heagerty +4

Cluster-randomized trials (CRTs) are a well-established class of designs for evaluating community-based interventions. An essential task in planning these trials is determining the…

stat.ME2025

On Anticipation Effect in Stepped Wedge Cluster Randomized Trials

Hao Wang, Xinyuan Chen, Katherine R. Courtright +4

In stepped wedge cluster randomized trials (SW-CRTs), the intervention is rolled out to clusters over multiple periods. A standard approach for analyzing SW-CRTs utilizes the linea…

stat.ME2025

Semiparametric principal stratification analysis beyond monotonicity

Jiaqi Tong, Brennan Kahan, Michael O. Harhay +1

Intercurrent events, common in clinical trials and observational studies, affect the existence or interpretation of final outcomes. Principal stratification addresses this challeng…

stat.ME2025

Doubly robust estimation and sensitivity analysis with outcomes truncated by death in multi-arm clinical trials

Jiaqi Tong, Chao Cheng, Guangyu Tong +2

In clinical trials, the observation of participant outcomes may frequently be hindered by death, leading to ambiguity in defining a scientifically meaningful final outcome for thos…

stat.ME2025

Analysis of cohort stepped wedge cluster-randomized trials with non-ignorable dropout via joint modeling

Alessandro Gasparini, Michael J. Crowther, Emiel O. Hoogendijk +2

Stepped wedge cluster-randomized trial (CRTs) designs randomize clusters of individuals to intervention sequences, ensuring that every cluster eventually transitions from a control…

stat.ME2024

Weighting methods for truncation by death in cluster-randomized trials

Dane Isenberg, Michael Harhay, Nandita Mitra +1

Patient-centered outcomes, such as quality of life and length of hospital stay, are the focus in a wide array of clinical studies. However, participants in randomized trials for el…