Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.
File(s)
Accepted version
Author(s)
Chis Ster, Anca Maria
Cornelius, Victoria
Cro, Suzie
Type
Journal Article
Abstract
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.
Date Issued
2020-06-03
Date Acceptance
2020-05-28
Citation
Journal of Clinical Epidemiology, 2020, 125, pp.148-157
ISSN
0895-4356
Publisher
Elsevier
Start Page
148
End Page
157
Journal / Book Title
Journal of Clinical Epidemiology
Volume
125
Copyright Statement
© 2020 Elsevier Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/
Sponsor
National Institute for Health Research
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/32504781
PII: S0895-4356(19)30946-1
Grant Number
NIHR-RM-FI-2017-08-030
Subjects
Randomized controlled trials
Reporting
Rescue medication
Statistical methods
Publication Status
Published online
Coverage Spatial
United States
Date Publish Online
2020-06-03