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It is common in medical studies that the outcome of interest is truncated by death, meaning that a subject has died before the outcome could be measured. In this case, restricted analysis among survivors may be subject to selection bias.…

统计方法学 · 统计学 2018-04-25 Linbo Wang , Xiao-Hua Zhou , Thomas S. Richardson

In clinical trials, principal stratification analysis is commonly employed to address the issue of truncation by death, where a subject dies before the outcome can be measured. However, in practice, many survivor outcomes may remain…

统计方法学 · 统计学 2025-07-08 Wei Li , Yuan Liu , Shanshan Luo , Zhi Geng

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 those who die. Principal stratification methods are valuable…

统计方法学 · 统计学 2025-09-01 Jiaqi Tong , Chao Cheng , Guangyu Tong , Michael O. Harhay , Fan Li

Clinical studies sometimes encounter truncation by death, rendering outcomes undefined. Statistical analysis based solely on observed survivors may give biased results because the characteristics of survivors differ between treatment…

统计方法学 · 统计学 2022-11-23 Yuhao Deng , Yingjun Chang , Xiao-Hua Zhou

We investigate the bounding problem of causal effects in experimental studies in which the outcome is truncated by death, meaning that the subject dies before the outcome can be measured. Causal effects cannot be point identified without…

统计方法学 · 统计学 2024-04-29 Aixian Chen , Xia Cui , Guangren Yang

In some randomized clinical trials, patients may die before the measurements of their outcomes. Even though randomization generates comparable treatment and control groups, the remaining survivors often differ significantly in background…

应用统计 · 统计学 2018-03-07 Fan Yang , Peng Ding

In semicompeting risks problems, nonterminal time-to-event outcomes such as time to hospital readmission are subject to truncation by death. These settings are often modeled with illness-death models for the hazards of the terminal and…

统计方法学 · 统计学 2019-02-27 Leah Comment , Fabrizia Mealli , Sebastien Haneuse , Corwin Zigler

Even in a carefully designed randomized trial, outcomes for some study participants can be missing, or more precisely, ill-defined, because participants had died prior to date of outcome collection. This problem, known as truncation by…

统计方法学 · 统计学 2022-09-27 Tamir Zehavi , Daniel Nevo

Researchers are often interested in treatment effects on outcomes that are only defined conditional on a post-treatment event status. For example, in a study of the effect of different cancer treatments on quality of life at end of…

The sufficient cause framework has been used for decades to improve our understanding of both basic and more complex causal concepts in epidemiology, such as mediation and interaction. Here, we make use of this framework to provide a…

统计方法学 · 统计学 2026-04-08 Bronner P. Gonçalves , Eiji Yamamoto , Etsuji Suzuki

Defining a causal estimand for a longitudinal outcome truncated by death is challenging, because the outcome may be undefined at the end of follow-up. Although a range of estimands and several estimators have been proposed, guidance on the…

统计方法学 · 统计学 2026-04-30 Juliette Ortholand , Young Lee , Marie-Abele C Bind

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 elderly or critically and severely ill patient populations may…

统计方法学 · 统计学 2024-04-17 Dane Isenberg , Michael Harhay , Nandita Mitra , Fan Li

Continuous outcome measurements truncated by death present a challenge for the estimation of unbiased treatment effects in randomized controlled trials (RCTs). One way to deal with such situations is to estimate the survivor average causal…

统计方法学 · 统计学 2025-12-02 Stefanie von Felten , Chiara Vanetta , Christoph M. Rüegger , Sven Wellmann , Leonhard Held

In many causal studies, outcomes are censored by death, in the sense that they are neither observed nor defined for units who die. In such studies, the focus is usually on the stratum of always survivors up to a single fixed time s.…

统计方法学 · 统计学 2024-01-02 Giulio Grossi , Marco Mariani , Alessandra Mattei , Fabrizia Mealli

In neoadjuvant trials on early-stage breast cancer, patients are usually randomized into a control group and a treatment group with an additional target therapy. Early efficacy of the new regimen is assessed via the binary pathological…

统计方法学 · 统计学 2022-04-04 Xiaoqing Tan , Judah Abberbock , Priya Rastogi , Gong Tang

Causal inference is best understood using potential outcomes. This use is particularly important in more complex settings, that is, observational studies or randomized experiments with complications such as noncompliance. The topic of this…

统计理论 · 数学 2007-06-13 Donald B. Rubin

Cluster-randomized trials (CRTs) on fragile populations frequently encounter complex attrition problems where the reasons for missing outcomes can be heterogeneous, with participants who are known alive, known to have died, or with unknown…

统计方法学 · 统计学 2025-05-06 Guangyu Tong , Chenxi Li , Eric Velazquez , Michael O. Harhay , Fan Li

In both observational studies and randomized trials, post-treatment events such as dropout, nonadherence, and truncation by death occur frequently. In some studies, conditioning on post-treatment variables is a deliberate strategy to…

统计方法学 · 统计学 2026-04-24 Marco Piccininni , Mats J. Stensrud

Death among subjects is common in observational studies evaluating the causal effects of interventions among geriatric or severely ill patients. High mortality rates complicate the comparison of the prevalence of adverse events (AEs)…

统计方法学 · 统计学 2024-10-08 Anthony Sisti , Andrew Zullo , Roee Gutman

The principal stratification has become a popular tool to address a broad class of causal inference questions, particularly in dealing with non-compliance and truncation-by-death problems. The causal effects within principal strata which…

统计方法学 · 统计学 2022-06-20 Shanshan Luo , Wei Li , Wang Miao , Yangbo He
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