Return-to-baselineBOCFMultiple imputationDiscontinuation of assigned therapy in longitudinal clinical trials is often inevitable due to various reasons such as intolerability or lack of efficacy. When the primary outcome of interest is the mean difference between treatment groups at the end of the ...
Under this framework, we propose a novel return-to-baseline imputation method. Simulations show the completed data after the new imputation approach have the proper distribution, and the estimators based on the new imputation method outperform the traditional method in terms of both bias and variance...
6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants’ self-reported return to work/education for at least 80% of pre-injury...
The baseline characteristics of patients included in the study are presented as means with standard deviations or numbers with percentages. Among all covariates, the only category with missing data was the BMI at IHCA (13.9%, 146/1,050). To reduce bias due to missing data26, we performed fiv...
RTB assumes that any treatment effects observed prior to discontinuation are washed out, such that the mean effect at the end of the study among discontinued patients is the same as that at baseline. Multiple imputation (MI) may be used to implement this method but may overestimate the ...
multiple imputationsreference-based imputationreturn to baselineReturning to baseline (RTB) has been a practical method for handling missing data. Here we consider longitudinal clinical trials with daily patient reported outcomes (PROs), where efficacy endpoints are often defined as the average daily ...
Returning to baseline (RTB) has been a practical method for handling missing data. Here we consider longitudinal clinical trials with daily patient reported outcomes (PROs), where efficacy endpoints are often defined as the average daily values in a cycle (such as a month or a week). The con...
In this paper, we build a two-level constrained longitudinal data analysis (cLDA) model on daily values and propose two-level RTB method to impute daily values. Standard multiple imputation (MI) approach and likelihood based approach are proposed and evaluated by simulations.Man Jin...