Gong Mengchun, Liu Li, Wu Chen, Yang Yue, Shen Yang, Li Jie, Lin Kaicheng, Guo Yi, Wei Hongyun, Xu Zeyu, Zhu Hong
Institute of Health Management, Southern Medical University, Guangzhou 510515, China.
Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
Nan Fang Yi Ke Da Xue Xue Bao. 2020 Mar 30;40(3):353-357. doi: 10.12122/j.issn.1673-4254.2020.03.11.
In the setting of epidemics of communicable diseases, early initiation of epidemiological and clinical data collection and analysis and conducting relevant researches are essential to the success of epidemic containment. The coronavirus disease 2019 (COVID-19), starting initially as an epidemic in China in late 2019 and now becoming a pandemic globally, poses grave challenges to the global health care systems while also provides an opportunity for studying infectious diseases in the perspective of methodology. The authors propose the evaluation methods for case reports, randomized controlled trials (RCTs), real-world evidence studies and health economics researches during an epidemic. Case reports, which are of important value for health care workers during outbreaks of infectious diseases, should be written in standard format and style and published following a strict peer review process. RCTs provides the gold standard for evaluating the effectiveness of a given treatment for the patients from the outbreaks. We review the potential challenges faced in conducting RCTs during the outbreaks. The real-world data collected from the cases in designated hospitals allow the verification of the safety and effectiveness of the intervention measures. The data from health economics research also provide important support for optimizing communicable disease prevention and control strategies. Herein we summarize the health economics research methods, study design, and technical points during the outbreaks. We recommend that clinical research and health economics research be incorporated into the prevention and control plan and measures be taken to ensure both the standards and feasibility of these studies to improve the response capacity against outbreaks of communicable diseases.
在传染病流行的背景下，尽早启动流行病学和临床数据的收集与分析并开展相关研究对于成功控制疫情至关重要。2019年冠状病毒病（COVID-19）最初于2019年末在中国爆发，如今已成为全球大流行疾病，这给全球医疗体系带来了严峻挑战，同时也为从方法学角度研究传染病提供了契机。作者提出了疫情期间病例报告、随机对照试验（RCT）、真实世界证据研究和卫生经济学研究的评估方法。病例报告在传染病爆发期间对医护人员具有重要价值，应以标准格式和风格撰写，并经过严格的同行评审程序后发表。随机对照试验为评估针对疫情患者的特定治疗方法的有效性提供了金标准。我们回顾了疫情期间开展随机对照试验所面临的潜在挑战。从指定医院的病例中收集的真实世界数据可用于验证干预措施的安全性和有效性。卫生经济学研究的数据也为优化传染病防控策略提供了重要支持。在此我们总结了疫情期间的卫生经济学研究方法、研究设计和技术要点。我们建议将临床研究和卫生经济学研究纳入防控计划，并采取措施确保这些研究的规范性和可行性，以提高应对传染病爆发的能力。
