在COVID-19临床试验中使用事件前时间尺度和顺序尺度测量的风险

M.V. Yashchenko
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摘要

背景。本文显示了对新冠肺炎(COVID-19)住院患者治疗和预防的III-IV期介入临床试验终点的文献检索和分析结果。材料和方法。在发现的102项试验中,60项试验使用了顺序量表,54项试验使用了事件发生时间结果测量,49项试验使用了两种量表。时间到事件终点与住院/重症监护病房期限、停止氧疗和临床改善相关。同时,早期停止氧疗和早期出院对生物特征测量产生风险。结果和讨论。统计计算显示,在乌克兰不同地区,每天新增COVID-19住院人数与免费床位百分比相关,但不仅与一般新冠病毒感染病例数、死亡人数和每天从COVID-19中康复的人数相关。这些结果可能表明资源依赖和组织方面影响COVID-19患者的住院治疗。结论。因此,为了确保出院或停止氧疗完全是由于临床结果阳性,应收集床位数量变化、供氧情况以及与确定预期临床结果(体温、血氧饱和度、症状严重程度等)相关的数据。如果可能,建议在出院后收集生物标志物数据。
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Risks of using pre-event time scale and ordinal scale measurements in COVID-19 clinical trials
BACKGROUND. The article shows the results of literature search and analysis of endpoints of interventional clinical trials of phase III-IV of the treatment of hospitalized patients with coronavirus disease (COVID-19) and of its prevention. MATERIALS AND METHODS. Among 102 trials found, ordinal scales were used in 60 trials, time-to-event outcome measures were used in 54 trials, both scales – in 49 trials. Time-to-event endpoints were related to hospitalization/intensive care unit term, discontinuation of oxygen therapy, and clinical improvement standardized on ordinal scales. At the same time, the early discontinuation of oxygen therapy and the early discharge create risks to the biometric measurement. RESULTS AND DISCUSSION. Statistical calculations showed the association of the number of new COVID-19 hospital admissions per day with the percentage of free beds, but not only with the number of new coronavirus infection cases in general, the number of deaths and the number of people recovering from COVID-19 per day in different regions of Ukraine. These results may indicate that resource-dependence and organizational aspects affect the hospitalization of patients with COVID-19. CONCLUSIONS. Therefore, to ensure that the discharge or discontinuation of oxygen therapy was due solely to a positive clinical outcome, data on changes of number of beds, access to oxygen supplies as well as data relevant to determination of the desired clinical outcome (body temperature, oxygen saturation, severity of symptoms, etc.) should be collected. It is recommended to collect biomarker data after discharge, if possible.
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