Cost-benefit of outcome adjudication in nine randomised stroke trials

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

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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.

Original languageEnglish
JournalClinical Trials
DOIs
Publication statusE-pub ahead of print - 10 Jul 2020

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    Godolphin, P. J., Bath, P. M., Algra, A., Berge, E., Chalmers, J., Eliasziw, M., Hankey, G. J., Hosomi, N., Ranta, A., Weimar, C., Woodhouse, L. J., & Montgomery, A. A. (2020). Cost-benefit of outcome adjudication in nine randomised stroke trials. Clinical Trials. https://doi.org/10.1177/1740774520939231