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COVID-19疫苗效果和检测阴性设计
Covid-19 Vaccine Effectiveness and the Test-Negative Design


Natalie E. Dean ... 呼吸系统疾病 • 2021.10.07
相关阅读
• SARS-CoV-2变异株和疫苗

观察性研究正逐渐成为疫苗在随机试验受控环境之外所发挥效果的基本信息来源,而且正产生疫苗对试验中统计学功效不足结局(如住院或进入重症监护病房[ICU],或者患者少的亚组)的效果证据1。当大规模随机对照试验不可行时,这些研究可监测疫苗效果下降情况或测定疫苗对SARS-CoV-2变异株的效果2

Thompson等3在本期杂志中发表论文介绍了应用回顾性检测阴性设计估算COVID-19疫苗在≥50岁人群中的效果。多中心网络提供了187家医院41,552例住院及221个急诊科或急症治疗门诊21,522例就诊的数据。这些数据来自因COVID-19样疾病接受治疗并进行过SARS-CoV-2分子检测的患者。在检测阴性设计中,病例患者为SARS-CoV-2检测呈阳性的患者,对照患者为检测呈阴性的患者。通过比较病例和对照的疫苗接种概率来估算疫苗效果。表1列出了如何使用这些研究的数据计算疫苗效果。





作者信息

Natalie E. Dean, Ph.D., Joseph W. Hogan, Sc.D., and Mireille E. Schnitzer, Ph.D.
From the Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta (N.E.D.); the Department of Biostatistics, Brown University School of Public Health, Providence, RI (J.W.H.); and the Faculty of Pharmacy and the Department of Social and Preventive Medicine, University of Montreal, Montreal (M.E.S.).

 

参考文献

1. Lipsitch M, Dean NE. Understanding COVID-19 vaccine efficacy. Science 2020;370:763-765.

2. Evans SJW, Jewell NP. Vaccine effectiveness studies in the field. N Engl J Med 2021;385:650-651.

3. Thompson MG, Stenehjem E, Grannis S, et al. Effectiveness of Covid-19 vaccines in ambulatory and inpatient care settings. N Engl J Med 2021;385:1355-1371.

4. Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine 2013;31:2165-2168.

5. Chua H, Feng S, Lewnard JA, et al. The use of test-negative controls to monitor vaccine effectiveness: a systematic review of methodology. Epidemiology 2020;31:43-64.

6. Robins JM. Comment on “choice as an alternative to control in observational studies.” Stat Sci 1999;14:281-293 (https://www.jstor.org/stable/2676763).

7. Sullivan SG, Tchetgen Tchetgen EJ, Cowling BJ. Theoretical basis of the test-negative study design for Assessment of Influenza Vaccine Effectiveness. Am J Epidemiol 2016;184:345-353.

8. Lewnard JA, Patel MM, Jewell NP, et al. Theoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines. Epidemiology 2021;32:508-517.

9. Schnitzer ME, Harel D, Ho V, Koushik A, Merckx J. Identifiability and estimation under the test-negative design with population controls with the goal of identifying risk and preventive factors for SARS-CoV-2 infection. Epidemiology 2021;32:690-697.

10. Vandenbroucke JP, Pearce N. Test-negative designs: differences and commonalities with other case-control studies with “other patient” controls. Epidemiology 2019;30:838-844.

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