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A word of hope for ataxia trials in COVID-19 time and beyond.
Maas, Roderick P P W M; Ramjith, Jordache; Klockgether, Thomas; Roes, Kit C B; van de Warrenburg, Bart P C.
  • Maas RPPWM; Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Center, Reinier Postlaan 4, 6525 GC, Nijmegen, The Netherlands. roderick.maas@radboudumc.nl.
  • Ramjith J; Department of Health Evidence, Section Biostatistics, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Klockgether T; Department of Neurology, University of Bonn, Bonn, Germany.
  • Roes KCB; German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
  • van de Warrenburg BPC; Department of Health Evidence, Section Biostatistics, Radboud University Medical Center, Nijmegen, The Netherlands.
J Neurol ; 268(7): 2343-2345, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-777819
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ataxia / Randomized Controlled Trials as Topic / Pandemics / COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Neurol Year: 2021 Document Type: Article Affiliation country: S00415-020-10231-9

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ataxia / Randomized Controlled Trials as Topic / Pandemics / COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Neurol Year: 2021 Document Type: Article Affiliation country: S00415-020-10231-9