Central adjudication of serious adverse events did not affect trial's safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

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dc.contributor.authorGodolphin, Peter J.
dc.contributor.authorMontgomery, Alan A.
dc.contributor.authorWoodhouse, Lisa J.
dc.contributor.authorBereczki, Daniel
dc.contributor.authorBerge, Eivind
dc.contributor.authorCollins, Ronan
dc.contributor.authorDiez-Tejedor, Exuperio
dc.date.accessioned2020-03-26T19:53:02Z
dc.date.available2020-03-26T19:53:02Z
dc.date.issued2018
dc.departmentSelçuk Üniversitesien_US
dc.description.abstractBackground and purpose Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudication of SAEs on the safety results of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial. Methods ENOS assigned patients with acute stroke at random to receive either transdermal glyceryl trinitrate (GTN) or no GTN and to Stop or Continue previous antihypertensive treatment. SAEs were reported by local investigators who were not blinded to treatment allocation. Central adjudicators, blinded to treatment allocation, reviewed the investigators reports and used evidence available to confirm or re-categorise the classification of event, likely causality, diagnosis and expectedness of event. Results Of 4011 patients enrolled in ENOS, 1473 SAEs were reported by local investigators; this was reduced to 1444 after the review by adjudicators, with 29 re-classified as not an SAE. There was fair agreement between investigators and adjudicators regarding likely causality, with 808 agreements and 644 disagreements (56% crude agreement, weighted kappa, kappa = 0.31). Agreement increased upon dichotomisation of the causality categories, with 1432 agreements and 20 disagreements (99% crude agreement, kappa = 0.54). Repeating the main trial safety analysis with investigator reported events showed that adjudication had no effect on the main trial safety conclusions. Conclusions In a large trial, with many SAEs reported, central adjudication of these events did not affect trial conclusions. This suggests that adjudication of SAEs in a clinical trial where the intervention already has a well-established safety profile may not be necessary. Potential efficiency savings (financial, logistical) can be made through not adjudicating SAEs.en_US
dc.description.sponsorshipUK Medical Research CouncilMedical Research Council UK (MRC); Bupa Foundation; Stroke Association; National Institute for Health Research (NIHR)National Institute for Health Research (NIHR) [DRF-2016-09-057]en_US
dc.description.sponsorshipENOS was funded by the UK Medical Research Council, and Bupa Foundation, and supported by the Stroke Association. PJG was funded for this summary of independent research by the National Institute for Health Research (NIHR)'s Doctoral Research Fellowship Programme (DRF-2016-09-057). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. PMB is Stroke Association Professor of Stroke Medicine, and is a NIHR Senior Investigator. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.en_US
dc.identifier.doi10.1371/journal.pone.0208142en_US
dc.identifier.issn1932-6203en_US
dc.identifier.issue11en_US
dc.identifier.pmid30475912en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://dx.doi.org/10.1371/journal.pone.0208142
dc.identifier.urihttps://hdl.handle.net/20.500.12395/36382
dc.identifier.volume13en_US
dc.identifier.wosWOS:000451325700106en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherPUBLIC LIBRARY SCIENCEen_US
dc.relation.ispartofPLOS ONEen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.selcuk20240510_oaigen_US
dc.titleCentral adjudication of serious adverse events did not affect trial's safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trialen_US
dc.typeArticleen_US

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