School of Medicine, Universidad de los Andes, Bogotá, 111711, Colombia.
Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
Syst Rev. 2021 Nov 1;10(1):289. doi: 10.1186/s13643-021-01838-8.
The coronavirus disease 19 (covid-19) pandemic has underscored the need to expedite clinical research, which may lead investigators to shift away from measuring patient-important outcomes (PIO), limiting research applicability. We aim to investigate if randomized controlled trials (RCTs) of covid-19 pharmacological therapies include PIOs.
We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confirmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identified in a living network metanalysis (NMA). The main data sources are the living WHO covid-19 database up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Two reviewers independently will review each citation, full-text article, and abstract data. To categorize the outcomes according to their importance to patients, we will adapt a previously defined hierarchy: a) mortality, b) quality of life/ functional status/symptoms, c) morbidity, and d) surrogate outcomes. Outcomes within the category a) and b) will be considered critically important to patients, and outcomes within the category c) will be regarded as important. We will use descriptive statistics to assess the proportion of studies that report each category of outcomes. We will perform univariable and multivariable analysis to explore associations between trial characteristics and the likelihood of reporting PIOs.
The findings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are effectively assessing and reporting the outcomes that are important to patients. If a deficiency in capturing PIOs is identified, this information may help inform the development of future RCTs in covid-19.
Open Science Framework registration: osf.io/6xgjz .
2019 年冠状病毒病（COVID-19）大流行凸显了加快临床研究的必要性，这可能导致研究人员不再关注患者重要结局（PIO），从而限制了研究的适用性。我们旨在调查 COVID-19 药物治疗的随机对照试验（RCT）是否包含 PIO。
我们将对纳入有 COVID-19 发病风险或疑似、可能或确诊 COVID-19 的人群的 RCT 进行一项meta 流行病学研究，研究对象为预防或治疗用的任何药物治疗或血液制品。我们将从一项正在进行的网络荟萃分析（NMA）中获得所有 RCT 的数据。主要数据源是截至 2021 年 3 月 1 日的世界卫生组织（WHO）COVID-19 数据库和截至 2021 年 2 月 20 日的六个额外的中国数据库。两名评审员将独立审查每条引文、全文文章和摘要数据。为了根据对患者的重要性对结局进行分类，我们将采用之前定义的层级：a）死亡率，b）生活质量/功能状态/症状，c）发病率，和 d）替代结局。类别 a）和 b）中的结局被认为对患者至关重要，类别 c）中的结局则被认为是重要的。我们将使用描述性统计来评估报告每个结局类别的研究比例。我们将进行单变量和多变量分析，以探讨试验特征与报告 PIO 可能性之间的关联。
这项 meta 流行病学研究的结果将帮助医疗保健专业人员和研究人员了解当前的 COVID-19 试验是否有效地评估和报告对患者重要的结局。如果发现缺乏对 PIO 的捕获，这些信息可能有助于为 COVID-19 的未来 RCT 提供信息。
开放科学框架注册：osf.io/6xgjz。
