Woodhouse Lisa J, Montgomery Alan A, Pocock Stuart, James Marilyn, Ranta Anna, Bath Philip M
Stroke Trials Unit, Mental Health & Clinical Neurosciences, School of Medicine, University of Nottingham, D Floor South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Nottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Derby Road, Nottingham, NG7 2UH, UK.
Contemp Clin Trials Commun. 2023 Jul 5;35:101186. doi: 10.1016/j.conctc.2023.101186. eCollection 2023 Oct.
Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its primary efficacy and safety measures and collected severity information for other vascular events.
TARDIS was an international prospective randomised open-label blinded-endpoint trial assessing one month of intensive versus guideline antiplatelet therapy in patients with acute non-cardioembolic stroke or TIA. Vascular events and their severity were recorded up to final follow-up at 90 days post randomisation. For each outcome, statistical techniques compared ordinal/continuous (10 models) and dichotomous (5 models) analyses; results were then ranked with the smallest p-value being given the smallest rank. Outcomes were also assessed within the pre-defined subgroup of participants with mild stroke (NIHSS≤3), or TIA recruited within 24 h.
Ordinal versions of vascular event outcomes were created in 3096 participants for stroke, myocardial infarction, major cardiac events, bleeding events, serious adverse events and venous thromboembolism (VTE), with 32 outcomes being created overall (29 in the subgroup population due to the absence of VTE events). Overall, the tests run on ordinal outcomes tended to rank higher than tests performed on binary outcomes. 764 (24.7%) participants were recruited within 24 h of a mild stroke/TIA; again, tests run on ordinal outcomes ranked higher.
In TARDIS, tests performed on ordinal vascular outcomes tended to attain a higher rank than those performed on binary outcomes.
ISRCTN47823388.
纳入事件严重程度的序贯血管结局比仅包含事件数量的二元结局更具信息量。TARDIS试验是首个将序贯血管结局用作主要疗效和安全性指标的血管预防研究，并收集了其他血管事件的严重程度信息。
TARDIS是一项国际前瞻性随机开放标签盲终点试验，评估急性非心源性卒中或短暂性脑缺血发作（TIA）患者接受1个月强化抗血小板治疗与指南推荐抗血小板治疗的效果。在随机分组后90天的最终随访时记录血管事件及其严重程度。对于每个结局，统计技术比较了序贯/连续（10种模型）和二分法（5种模型）分析；然后对结果进行排序，p值最小的排名最靠前。还在预先定义的轻度卒中（美国国立卫生研究院卒中量表评分≤3）或24小时内纳入的TIA参与者亚组中评估了结局。
为3096名参与者创建了卒中、心肌梗死、重大心脏事件、出血事件、严重不良事件和静脉血栓栓塞（VTE）的血管事件结局的序贯版本，总共创建了32个结局（亚组人群中为29个，因为没有VTE事件）。总体而言，对序贯结局进行的测试往往比二元结局的测试排名更高。764名（24.7%）参与者在轻度卒中/TIA发生后24小时内纳入；同样，对序贯结局进行的测试排名更高。
在TARDIS试验中，对序贯血管结局进行的测试往往比二元结局的测试排名更高。
ISRCTN47823388
