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Simulations for designing and interpreting intervention trials in infectious diseases.
BMC Medicine ( IF 9.3 ) Pub Date : 2017-12-31 , DOI: 10.1186/s12916-017-0985-3
M Elizabeth Halloran 1, 2 , Kari Auranen 3 , Sarah Baird 4 , Nicole E Basta 5 , Steven E Bellan 6 , Ron Brookmeyer 7 , Ben S Cooper 8 , Victor DeGruttola 9 , James P Hughes 2 , Justin Lessler 10 , Eric T Lofgren 11 , Ira M Longini 12 , Jukka-Pekka Onnela 9 , Berk Özler 13 , George R Seage 14 , Thomas A Smith 15, 16 , Alessandro Vespignani 17 , Emilia Vynnycky 18, 19 , Marc Lipsitch 14
Affiliation  

BACKGROUND Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. DISCUSSION Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. CONCLUSION Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.

中文翻译:

设计和解释传染病干预试验的模拟。

背景技术对传染病的干预既可以对接受干预的个体产生直接影响,也可以对人群产生间接影响。此外,干预组合可能在人群水平上产生复杂的相互作用,这通常很难通过标准研究设计和分析方法进行充分评估。讨论 在此,我们敦促采用一种新的范式来设计和解释传染病干预试验,特别是对于新出现的传染病,它可以更准确地反映传播过程的动态。在日益复杂的世界中,模拟可以明确地表示传输动力学,这对于正确的试验设计和解释至关重要。试验的某些道德方面也可以使用模拟来量化。此外,在进行试验后,可以使用模拟来探索对观察到的效果的可能解释。结论 通过多学科方法,在传染病动力学、流行病学、统计科学、经济学、模拟方法和临床试验的实施方面建立专家之间的合作,可以获得很多成果。
更新日期:2017-12-29
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