SMIM : A unified framework of survival sensitivity analysis using multiple imputation and martingale

© 2021 The International Biometric Society..

Censored survival data are common in clinical trial studies. We propose a unified framework for sensitivity analysis to censoring at random in survival data using multiple imputation and martingale, called SMIM. The proposed framework adopts the δ-adjusted and control-based models, indexed by the sensitivity parameter, entailing censoring at random and a wide collection of censoring not at random assumptions. Also, it targets a broad class of treatment effect estimands defined as functionals of treatment-specific survival functions, taking into account missing data due to censoring. Multiple imputation facilitates the use of simple full-sample estimation; however, the standard Rubin's combining rule may overestimate the variance for inference in the sensitivity analysis framework. We decompose the multiple imputation estimator into a martingale series based on the sequential construction of the estimator and propose the wild bootstrap inference by resampling the martingale series. The new bootstrap inference has a theoretical guarantee for consistency and is computationally efficient compared to the nonparametric bootstrap counterpart. We evaluate the finite-sample performance of the proposed SMIM through simulation and an application on an HIV clinical trial.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:79

Enthalten in:

Biometrics - 79(2023), 1 vom: 27. März, Seite 230-240

Sprache:

Englisch

Beteiligte Personen:

Yang, Shu [VerfasserIn]
Zhang, Yilong [VerfasserIn]
Liu, Guanghan Frank [VerfasserIn]
Guan, Qian [VerfasserIn]

Links:

Volltext

Themen:

Delta adjustment
Journal Article
Jump-to-reference
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Restrictive mean survival time
Restrictive mean time loss
Wild-bootstrap

Anmerkungen:

Date Completed 24.03.2023

Date Revised 28.03.2023

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1111/biom.13555

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM329961357