Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
MRC Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, London, UK.
Clin Trials. 2020 Oct;17(5):576-580. doi: 10.1177/1740774520939231. Epub 2020 Jul 10.
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.
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.
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).
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.
结局的中心裁决在随机试验中很常见，应该控制差异分类错误。然而，很少有研究估计裁决过程的成本。
我们估计了 9 项随机卒中试验（25436 名参与者）中主要结局裁决的成本。这些成本包括裁决者的时间、对裁决者的直接支付以及协调中心的费用（例如，上传头颅扫描和一般设置成本）。裁决后纠正的事件数量是我们衡量效益的指标。我们计算了每个试验和总计的每个纠正事件的成本。
这 9 项试验的主要结局均为卒中或包括卒中的复合结局。总的来说，这一主要结局的裁决过程在三分之一（3/9）的试验中花费超过 10 万英镑。经裁决纠正的每个事件的平均成本为 2295.10 英镑（SD：1482.42 英镑）。
中心裁决是一个耗时且潜在昂贵的过程。在设计试验时需要考虑这些成本，并应结合裁决带来的潜在益处进行评估，以确定它们是否超过了这一费用。
