Peter J Godolphin
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
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
Dr LISA WOODHOUSE L.Woodhouse@nottingham.ac.uk
Research Fellow
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.
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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