@article{f1e0a57a29e3428399f27e343845a4df,
title = "Cost-benefit of outcome adjudication in nine randomised stroke trials",
abstract = "BACKGROUND: Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process.METHODS: We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators' time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total.RESULTS: The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42).CONCLUSIONS: Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.",
keywords = "Adjudication, clinical trial, stroke",
author = "Godolphin, \{Peter J\} and Bath, \{Philip M\} and Ale Algra and Eivind Berge and John Chalmers and Misha Eliasziw and Hankey, \{Graeme J\} and Naohisa Hosomi and Annamarei Ranta and Christian Weimar and Woodhouse, \{Lisa J\} and Montgomery, \{Alan A\}",
note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: P.J.G. was funded for this summary of independent research by the National Institute for Health Research{\textquoteright}s (NIHR) Doctoral Research Fellowship Programme (DRF-2016-09-57) and also supported by the UK Medical Research Council (MC\_UU\_12023/24). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health. P.M.B. is Stroke Association Professor of Stroke Medicine and is an NIHR Senior Investigator. Funding Information: The authors would like to thank two anonymous reviewers for their useful comments and suggestions on an earlier version of this manuscript. The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: P.J.G. was funded for this summary of independent research by the National Institute for Health Research?s (NIHR) Doctoral Research Fellowship Programme (DRF-2016-09-57) and also supported by the UK Medical Research Council (MC\_UU\_12023/24). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health. P.M.B. is Stroke Association Professor of Stroke Medicine and is an NIHR Senior Investigator. Publisher Copyright: {\textcopyright} The Author(s) 2020.",
year = "2020",
month = oct,
doi = "10.1177/1740774520939231",
language = "English",
volume = "17",
pages = "576--580",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "5",
}