Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
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DOI：
10.3390/life10120350
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发表时间：
2020-12-15
期刊：
影响因子：
--
通讯作者：
Vestbo J
中科院分区：
文献类型：
--
作者：
Mathioudakis AG;Fally M;Hashad R;Kouta A;Hadi AS;Knight SB;Bakerly ND;Singh D;Williamson PR;Felton T;Vestbo J
至关重要的是，关于2019冠状病毒病（COVID-19）管理的随机对照试验（RCT）评估对患者和临床医生至关重要的结果，以促进相关性，可解释性和可比性。本方法系统性综述描述了截至2020年5月5日在ClinicalTrials.gov注册的415项关于COVID-19管理的RCT中评估的结果，以及用于测量这些结果的工具。在结局和工具的选择方面观察到显著异质性。仅分别在64.4%、48.4%和43%的纳入研究中评价了死亡率、不良事件和治疗成功或失败，而选择其他结局的频率较低。针对更严重表现（住院患者或需要重症监护）的研究最常评估死亡率（72.5%）和不良事件（55.6%），而住院（50.8%）和病毒检测/载量（55.6%）最常在社区环境中评估。结果测量工具的报告不多，而且种类繁多。在这些早期试验中，64.3%的随访时间不超过1个月，并且很少评估长期COVID-19负担。所发现的方法学问题可能会推迟在临床实践中引入可能挽救生命的治疗方法。我们的研究结果表明，需要更大的一致性，使决策者能够比较和对比研究。
It is crucial that randomized controlled trials (RCTs) on the management of coronavirus disease 2019 (COVID-19) evaluate the outcomes that are critical to patients and clinicians, to facilitate relevance, interpretability, and comparability. This methodological systematic review describes the outcomes evaluated in 415 RCTs on the management of COVID-19, that were registered with ClinicalTrials.gov, by 5 May 2020, and the instruments used to measure these outcomes. Significant heterogeneity was observed in the selection of outcomes and instruments. Mortality, adverse events and treatment success or failure are only evaluated in 64.4%, 48.4% and 43% of the included studies, respectively, while other outcomes are selected less often. Studies focusing on more severe presentations (hospitalized patients or requiring intensive care) most frequently evaluate mortality (72.5%) and adverse events (55.6%), while hospital admission (50.8%) and viral detection/load (55.6%) are most frequently assessed in the community setting. Outcome measurement instruments are poorly reported and heterogeneous. Follow-up does not exceed one month in 64.3% of these earlier trials, and long-term COVID-19 burden is rarely assessed. The methodological issues identified could delay the introduction of potentially life-saving treatments in clinical practice. Our findings demonstrate the need for greater consistency, to enable decision makers to compare and contrast studies.
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