Imperial College London
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ProfessorVictoriaCornelius

Faculty of Medicine, School of Public Health

Professor in Medical Statistics and Trials Methodology
 
 
 
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Contact

 

+44 (0)20 7594 1218v.cornelius

 
 
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Assistant

 

Mrs Ranjit Rayat +44 (0)20 7594 3445

 
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Location

 

111Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Chis:2020:10.1016/j.jclinepi.2020.05.027,
author = {Chis, Ster AM and Cornelius, V and Cro, S},
doi = {10.1016/j.jclinepi.2020.05.027},
journal = {Journal of Clinical Epidemiology},
pages = {148--157},
title = {Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.},
url = {http://dx.doi.org/10.1016/j.jclinepi.2020.05.027},
volume = {125},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - OBJECTIVES: The objective of this study was to examine how rescue medication is defined, reported, and accounted for in randomized controlled trials (RCTs) in eczema and asthma populations. STUDY DESIGN AND SETTING: This is a systematic review of phase II/III RCTs evaluating monoclonal antibodies for treating chronic eczema or asthma. A search of EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials was conducted to identify eligible RCTs. RESULTS: Sixty published RCTs were identified, of which 60 (100%) allowed use of rescue medication but only 28 (47%) reported its use. Twenty-seven (45%) articles summarized rescue use by arm, with an average of 25% (95% CI (17%, 36%)) greater use in the placebo arm. Nine (15%) trials undertook an analysis that adjusted the primary treatment effect estimate for rescue medication use, but 8 of these used a suboptimal approach using single imputation, including 4 which used "last observation carried forward" after setting postrescue data to missing. CONCLUSION: Rescue medication use in eczema and asthma trials evaluating monoclonal antibodies is often permitted, but not routinely reported. There is evidence of imbalance in rescue use between arms, but few articles attempted to estimate a rescue-adjusted treatment effect. In trials that did, the methods used were suboptimal which could introduce bias.
AU  - Chis,Ster AM
AU  - Cornelius,V
AU  - Cro,S
DO  - 10.1016/j.jclinepi.2020.05.027
EP  - 157
PY  - 2020///
SN  - 0895-4356
SP  - 148
TI  - Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.
T2  - Journal of Clinical Epidemiology
UR  - http://dx.doi.org/10.1016/j.jclinepi.2020.05.027
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32504781
UR  - https://www.sciencedirect.com/science/article/pii/S0895435619309461?via%3Dihub
UR  - http://hdl.handle.net/10044/1/80759
VL  - 125
ER  -
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