Core Outcome Set for Clinical Trials of COVID-19 Based on Traditional Chinese and Western Medicine
Core Outcome Set for Clinical Trials of COVID-19 Based on Traditional Chinese and Western Medicine
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DOI：
10.3389/fphar.2020.00781
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发表时间：
2020-05-25
影响因子：
5.6
通讯作者：
Shang, Hongcai
中科院分区：
文献类型：
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作者：
Qiu, Ruijin;Zhao, Chen;Shang, Hongcai
背景COVID-19临床试验的核心结果集（COS）的发展是迫切的，因为大流行肆虐全球和临床试验结果的异质性。然后，进行了两轮德尔菲调查。利益相关者包括中医专家、西医专家、护士和公众。确诊COVID-19的患者也被邀请参加以可理解的语言编写的问卷调查。然后，不同的利益相关者参加了一个共识会议，通过视频会议进行表决。结果97个合格的研究方案，从160个临床试验。从中医临床试验中确定了76个结局，从西医临床试验中确定了126个结局。最后，第一轮德尔菲调查共纳入145项结果。在此基础上，开发了一个用于中西医结合临床试验的COS。COS包括临床结局（恢复/改善/进展/死亡），病因（SARS-CoV-2核酸检测、病毒载量）、炎症因子（C反应蛋白），生命体征（体温、呼吸）、血液和呼吸系统参数（淋巴细胞、病毒抗体）、呼吸结局（肺部成像、血氧饱和度、PaO 2/FiO 2比值、动脉血气分析、机械通气、氧摄入量、肺炎严重程度指数），临床疗效（预防轻中度疾病患者进展为重度疾病的患病率）和症状（临床症状评分）。根据不同的疾病类型推荐结局。结论COVID-19临床试验结果评价存在患者数量少、公众参与度低、利益相关者区域不平衡等局限性，但COVID-19临床试验结果评价体系可提高临床试验结果评价的一致性。它也应该随着研究进展而更新。
BackgroundDevelopment of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials.MethodsA preliminary list of outcomes was developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses, and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Then different stakeholders participated in a consensus meeting by video conference to vote.ResultsNinety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS included clinical outcomes (recovery/improvement/progression/death), etiology (SARS-CoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (pulmonary imaging, blood oxygen saturation, PaO2/FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), and symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instruments/definitions were also recommended.ConclusionThough there are some limitations for the research, such as insufficient patients and the public involvement, and the unbalanced stakeholders' region, the COS for COVID-19 may improve consistency of outcome reporting in clinical trials. It also should be updated with research progression.