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Cost-benefit of outcome adjudication in nine randomised stroke trials

Godolphin, Peter J; Bath, Philip M; Algra, Ale; Berge, Eivind; Chalmers, John; Eliasziw, Misha; Hankey, Graeme J; Hosomi, Naohisa; Ranta, Annamarei; Weimar, Christian; Woodhouse, Lisa J; Montgomery, Alan A

Authors

Peter J Godolphin

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

Ale Algra

Eivind Berge

John Chalmers

Misha Eliasziw

Graeme J Hankey

Naohisa Hosomi

Annamarei Ranta

Christian Weimar

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director, nottingham Clinical Trials Unit



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 (standard deviation: £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.

Citation

Godolphin, P. J., Bath, P. M., Algra, A., Berge, E., Chalmers, J., Eliasziw, M., …Montgomery, A. A. (2020). Cost-benefit of outcome adjudication in nine randomised stroke trials. Clinical Trials, 17(5), 576-580. https://doi.org/10.1177/1740774520939231

Journal Article Type Article
Acceptance Date May 4, 2020
Online Publication Date Jul 10, 2020
Publication Date 2020-10
Deposit Date Jun 10, 2020
Publicly Available Date Jun 10, 2020
Journal Clinical Trials
Print ISSN 1740-7745
Electronic ISSN 1740-7753
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 17
Issue 5
Pages 576-580
DOI https://doi.org/10.1177/1740774520939231
Keywords Adjudication, stroke, clinical trial
Public URL https://nottingham-repository.worktribe.com/output/4619538
Publisher URL https://journals.sagepub.com/doi/full/10.1177/1740774520939231

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