COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine
COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine
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DOI：
10.1016/j.jclinepi.2020.04.016
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发表时间：
2020-07-01
影响因子：
7.2
通讯作者：
Alhazzani, Waleed
中科院分区：
文献类型：
--
作者：
Alexander, Paul Elias;Debono, Victoria Borg;Alhazzani, Waleed
目的/背景和目的以往高死亡率的人类冠状病毒的流行，如2003年的急性呼吸综合征冠状病毒（SARS-CoV或SARS-1），推动了对可能对当前新出现的新型冠状病毒SARS-CoV-2 （COVID-19）有活性的化合物的表征。目前，COVID-19还没有获得批准的治疗或预防方法。我们对现有的COVID-19研究方法和已发表的报告发表评论。鉴于媒体的关注和有效性声明，我们选择氯喹和羟氯喹与阿奇霉素联合使用作为COVID-19研究的一个领域进行检查。方法/研究设计与设置检索2019年至今（2020年4月3日）的medline和EMBASE电子数据库，检索关键词为COVID-19、氯喹和羟氯喹。结果共检索到6项研究、3项随机对照试验和3项观察性研究，主要涉及氯喹和羟氯喹（与阿奇霉素联合使用）。我们审慎地评估了证据。结论氯喹/羟氯喹领域的新冠肺炎研究方法学非常薄弱。在筛选文献时，我们在COVID-19研究中观察到与潜在治疗相关的相同情况。报告非常贫乏和稀疏，而且没有报告对患者至关重要的结果，而这些结果是辨别决策优先次序所必需的。我们确实理解，在一种新型致命疾病的冲击下，在医疗保健环境中进行严格研究的障碍。然而，这种紧急大流行局势并没有将有缺陷的方法和数据转化为可信的结果。在COVID-19中，仍然缺乏最佳循证决策所需的充分有力、可比性和强有力的临床研究。
Objectives/Background and ObjectivesPrior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine.Methods/Study Design and SettingMEDLINE and EMBASE electronic databases were searched from 2019 to present (April 3rd, 2020) using a mix of keywords such as COVID-19 and chloroquine and hydroxychloroquine. We also searched the largest clinical medicine preprint repository, medRxiv.org.ResultsWe found 6 studies, 3 randomized control trials and 3 observational studies, focusing on chloroquine and hydroxychloroquine (with azithromycin). We critically appraised the evidence.ConclusionWe found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.