A systematic review of whether COVID-19 randomized controlled trials reported on demographic and clinical characteristics.
A systematic review of whether COVID-19 randomized controlled trials reported on demographic and clinical characteristics.
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DOI：
10.1002/pds.5533
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发表时间：
2022-12
影响因子：
2.6
通讯作者：
中科院分区：
文献类型：
--
作者：
我们旨在评估COVID-19相关随机对照试验（RCT）中关键患者水平人口统计学和临床特征的报告。我们使用关键词“冠状病毒”、“covid”、“临床试验”和“随机对照试验”，从PubMed、Web of Science、clinicaltrials.gov和CDC灰色文献数据库库中检索了2020年1月至2021年6月的英文文章。通过检索，我们进行了初步审查，以排除重复条目，确定符合纳入标准的条目（即，有结果），并排除那些不符合RCT定义的。最后，我们提取了每个RCT中报告的人口统计学和临床特征。从最初的43，627篇手稿中，我们最终合格的手稿包括137篇文章中描述的149项RCT。大多数随机对照试验（113/149）研究了潜在的治疗方法，而较少研究疫苗（29），预防策略（5）和预防感染者传播的干预措施（2）。研究人群范围为10至38，206名参与者（中位数=100，IQR：60-300）。所有149项随机对照试验均报告了年龄，147项报告了性别，50项报告了种族，110项报告了至少一种合并症的患病率。没有RCT报告收入，城市与农村居住或其他社会经济地位（SES）指标。关于种族和其他SES标志物的报告有限，因此很难得出关于特定外部目标人群的结论，除非做出治疗效果同质的强有力假设。这些发现强调了对入组COVID-19相关RCT的患者的临床和人口统计学特征进行更可靠报告的必要性。
We aim to assess the reporting of key patient-level demographic and clinical characteristics among COVID-19 related randomized controlled trials (RCTs). We queried English-language articles from PubMed, Web of Science, clinicaltrials.gov, and the CDC library of gray literature databases using keywords of ‘coronavirus’, ‘covid’, ‘clinical trial’ and ‘randomized controlled trial’ from January 2020 to June 2021. From the search, we conducted an initial review to rule-out duplicate entries, identify those that met inclusion criteria (i.e., had results), and exclude those that did not meet the definition of an RCT. Lastly, we abstracted the demographic and clinical characteristics reported on within each RCT. From the initial 43,627 manuscripts, our final eligible manuscripts consisted of 149 RCTs described in 137 articles. Most of the RCTs (113/149) studied potential treatments, while fewer studied vaccines (29), prophylaxis strategies (5), and interventions to prevent transmission among those infected (2). Study populations ranged from 10 to 38,206 participants (median=100, IQR: 60-300). All 149 RCTs reported on age, 147 on sex, 50 on race, and 110 on the prevalence of at least one comorbidity. No RCTs reported on income, urban vs rural residence, or other indicators of socioeconomic status (SES). Limited reporting on race and other markers of SES make it difficult to draw conclusions about specific external target populations without making strong assumptions that treatment effects are homogenous. These findings highlight the need for more robust reporting on the clinical and demographic profiles of patients enrolled in COVID-19 related RCTs.
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影响因子：
11.1
作者：
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通讯作者：
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