Impute the missing data by combining retrieved dropouts and return to baseline method

Currently, various methods have been proposed to handle missing data in clinical trials. Some methods assume that the missing data are missing at random (MAR), which means that it is assumed that subjects who stopped treatment would still maintain the treatment effect. In many cases, however, researchers often assume that the missing data are missing not at random (MNAR) to conduct additional sensitivity analyses. Under the MNAR assumption, whether using some conservative imputation methods such as RTB (return to baseline) method, J2R (jump to reference) method, and CR (copy reference) method, or optimistic imputation methods like multiple imputation (MI) and its derivative RD (retrieved dropout) method, biases compared to the true treatment effect can occur in some scenarios. This paper aims to propose a method that can impute results while considering the occurrence of intercurrent events, thereby reducing the bias compared to the true treatment effect. This method combines the RD method with the RTB formula, reducing the biases and standard errors associated with using either method alone. Considering the differing treatment effects between RD subjects and non-RD subjects, our imputation results often align more closely with the true drug efficacy.

Authors

Institutions

Publication Details

Journal
PLoS ONE
Published
2025-05-29
DOI
https://doi.org/10.1371/journal.pone.0323496
Citations
3
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
7.89

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Impute the missing data by combining retrieved dropouts and return to baseline method

Xiaozhou Li, Jiaqing Liu, Zuojing Li, Zhenyu Yang et al.
3 citations
PLoS ONE
Statistical Methods in Clinical Trials
7.89
article

Impute the missing data by combining retrieved dropouts and return to baseline method

Xiaozhou Li, Jiaqing Liu, Zuojing Li, Zhenyu Yang, Chenhao Yuan
article en
3 citations

Abstract

Currently, various methods have been proposed to handle missing data in clinical trials. Some methods assume that the missing data are missing at random (MAR), which means that it is assumed that subjects who stopped treatment would still maintain the treatment effect. In many cases, however, researchers often assume that the missing data are missing not at random (MNAR) to conduct additional sensitivity analyses. Under the MNAR assumption, whether using some conservative imputation methods such as RTB (return to baseline) method, J2R (jump to reference) method, and CR (copy reference) method, or optimistic imputation methods like multiple imputation (MI) and its derivative RD (retrieved dropout) method, biases compared to the true treatment effect can occur in some scenarios. This paper aims to propose a method that can impute results while considering the occurrence of intercurrent events, thereby reducing the bias compared to the true treatment effect. This method combines the RD method with the RTB formula, reducing the biases and standard errors associated with using either method alone. Considering the differing treatment effects between RD subjects and non-RD subjects, our imputation results often align more closely with the true drug efficacy.

PLoS ONEVol. 20(5)
Shenyang Pharmaceutical University (CN), Data Management (Italy) (IT)
National Natural Science Foundation of China
Good health and well-being
Openalex Percentile: Top 3%
Statistical Methods in Clinical Trials
7.89
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.