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A word of hope for ataxia trials in COVID-19 time and beyond
Journal of Neurology ( IF 4.8 ) Pub Date : 2020-09-22 , DOI: 10.1007/s00415-020-10231-9
Roderick P P W M Maas 1 , Jordache Ramjith 2 , Thomas Klockgether 3, 4 , Kit C B Roes 2 , Bart P C van de Warrenburg 1
Affiliation  

The coronavirus disease 2019 (COVID-19) crisis confronted us, like many researchers worldwide, with an unforeseen challenge during the final stages of a randomized controlled trial involving ataxia patients. Institutional guidelines suddenly no longer allowed regular follow-up visits to take place, impeding the clinical evaluation of long-term outcomes. Here, we discuss the various scenarios that we considered in response to these imposed restrictions and share our experience of home video recording by dedicated, extensively instructed family members. Albeit somewhat unconventional at first glance, this last resort strategy enabled us to reliably assess the study’s primary endpoint at the predefined point in time and hopefully encourages researchers in other ongoing ataxia trials to continue their activities. Remote assessments of ataxia severity may serve as a reasonable substitute in interventional trials beyond the current exceptional situation generated by the COVID-19 pandemic, but will require further investigation.



中文翻译:

对 COVID-19 及以后的共济失调试验充满希望

与世界各地的许多研究人员一样,2019 年冠状病毒病 (COVID-19) 危机让我们在一项涉及共济失调患者的随机对照试验的最后阶段面临着不可预见的挑战。机构指南突然不再允许进行定期随访,从而阻碍了对长期结果的临床评估。在这里,我们讨论了我们为应对这些施加的限制而考虑的各种场景,并分享了我们由专门的、受过广泛指导的家庭成员进行家庭视频录制的经验。尽管乍一看有些不合常规,但这种最后的策略使我们能够在预定的时间点可靠地评估研究的主要终点,并希望鼓励其他正在进行的共济失调试验的研究人员继续他们的活动。

更新日期:2020-09-22
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