Imperial College London
Portrait Picture

Ellie Van Vogt

Faculty of Medicine, School of Public Health

NIHR Doctoral Fellow
 
 
 
//

Contact

 

e.van-vogt

 
 
//

Location

 

Stadium HouseWhite City Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Tan:2021:10.1186/s12874-021-01261-6,
author = {Tan, P-T and Cro, S and Van, Vogt E and Szigeti, M and Cornelius, V},
doi = {10.1186/s12874-021-01261-6},
journal = {BMC Medical Research Methodology},
title = {A review of the use of controlled multiple imputation in randomised controlled trials with missing outcome data},
url = {http://dx.doi.org/10.1186/s12874-021-01261-6},
volume = {21},
year = {2021}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background:Missing data are common in randomised controlled trials (RCTs) and can bias results if not handled appropriately. A statistically valid analysis under the primary missing-data assumptions should be conducted, followed by sensitivity analysis under alternative justified assumptions to assess the robustness of results. Controlled Multiple Imputation (MI) procedures, including delta-based and reference-based approaches, have been developed for analysis under missing-not-at-random assumptions. However, it is unclear how often these methods are used, how they are reported, and what their impact is on trial results. This review evaluates the current use and reporting of MI and controlled MI in RCTs.Methods:A targeted review of phase II-IV RCTs (non-cluster randomised) published in two leading general medical journals (The Lancet and New England Journal of Medicine) between January 2014 and December 2019 using MI. Data was extracted on imputation methods, analysis status, and reporting of results. Results of primary and sensitivity analyses for trials using controlled MI analyses were compared.Results:A total of 118 RCTs (9% of published RCTs) used some form of MI. MI under missing-at-random was used in 110 trials; this was for primary analysis in 43/118 (36%), and in sensitivity analysis for 70/118 (59%) (3 used in both). Sixteen studies performed controlled MI (1.3% of published RCTs), either with a delta-based (n = 9) or reference-based approach (n = 7). Controlled MI was mostly used in sensitivity analysis (n = 14/16). Two trials used controlled MI for primary analysis, including one reporting no sensitivity analysis whilst the other reported similar results without imputation. Of the 14 trials using controlled MI in sensitivity analysis, 12 yielded comparable results to the primary analysis whereas 2 demonstrated contradicting results. Only 5/110 (5%) trials using missing-at-random MI and 5/16 (31%) trials using con
AU  - Tan,P-T
AU  - Cro,S
AU  - Van,Vogt E
AU  - Szigeti,M
AU  - Cornelius,V
DO  - 10.1186/s12874-021-01261-6
PY  - 2021///
SN  - 1471-2288
TI  - A review of the use of controlled multiple imputation in randomised controlled trials with missing outcome data
T2  - BMC Medical Research Methodology
UR  - http://dx.doi.org/10.1186/s12874-021-01261-6
UR  - http://hdl.handle.net/10044/1/89181
VL  - 21
ER  -
Download