Rishu Asgar H, Marinoff Nicole, Julien Lisa, Dumitrascu Mariana, Marten Nicole, Eggertson Shauna, Willems Su, Ruddell Stacy, Lane Dan, Light Bruce, Stelfox Henry T, Jouvet Philippe, Hall Richard, Reynolds Steven, Daneman Nick, Fowler Robert A
Department of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, Ontario, M4N 3M5, Canada.
Division of Critical Care Medicine, Dalhousie University and the Capital District Health Authority, Halifax, Nova Scotia, B3H 1V7, Canada.
J Crit Care. 2017 Aug;40:7-10. doi: 10.1016/j.jcrc.2017.02.009. Epub 2017 Mar 1.
Observational research focused upon emerging infectious diseases such as Ebola virus, Middle East respiratory syndrome, and Zika virus has been challenging to quickly initiate. We aimed to determine the duration of start-up procedures and barriers encountered for an observational study focused upon such infectious outbreaks.
At 1 pediatric and 5 adult intensive care units, we measured durations from protocol receipt to a variety of outbreak research milestones, including research ethics board (REB) approval, data sharing agreement (DSA) execution, and patient study screening initiation.
The median (interquartile range) time from site receipt of the protocol to REB submission was 73 (30-126) days; to REB approval, 158 (42-188) days; to DSA completion, 276 (186-312) days; and to study screening initiation, 293 (269-391) days. The median time from REB submission to REB approval was 43 (13-85) days. The median time for all start-up procedures was 335 (188-335) days.
There is a lengthy start-up period required for outbreak-focused research. Completing DSAs was the most time-consuming step. A reactive approach to newly emerging threats such as Ebola virus, Middle East respiratory syndrome, and Zika virus will likely not allow sufficient time to initiate research before most outbreaks are advanced.
针对埃博拉病毒、中东呼吸综合征和寨卡病毒等新发传染病开展观察性研究，迅速启动具有挑战性。我们旨在确定针对此类传染病暴发的观察性研究启动程序的持续时间以及遇到的障碍。
在1个儿科和5个成人重症监护病房，我们测量了从收到研究方案到达到各种疫情研究里程碑的持续时间，包括研究伦理委员会（REB）批准、数据共享协议（DSA）执行以及患者研究筛查启动。
从研究点收到研究方案到提交给REB的中位（四分位间距）时间为73（30 - 126）天；到REB批准为158（42 - 188）天；到DSA完成是276（186 - 312）天；到研究筛查启动是293（269 - 391）天。从提交给REB到REB批准的中位时间为43（13 - 85）天。所有启动程序的中位时间为335（188 - 335）天。
针对疫情的研究需要很长的启动期。完成DSA是最耗时的步骤。对于埃博拉病毒、中东呼吸综合征和寨卡病毒等新出现的威胁采取被动应对方法，很可能在大多数疫情发展到晚期之前没有足够时间启动研究。
