Neurology, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
New York University, New York, NY, USA.
Curr Neurol Neurosci Rep. 2021 Oct 27;21(11):63. doi: 10.1007/s11910-021-01146-7.
Behavioral therapies are proven treatments for many neurologic conditions. However, the COVID-19 pandemic has posed significant challenges for conducting behavioral research. This article aims to (1) highlight the challenges of running behavioral clinical trials during the pandemic, (2) suggest approaches to maximize generalizability of pandemic-era studies, and (3) offer strategies for successful behavioral trials beyond the pandemic.
Thousands of clinical trials have been impacted by the COVID-19 pandemic, from undergoing protocol revisions to suspension altogether. Furthermore, for ongoing trials, recruitment of diverse populations has suffered, thereby exacerbating existing inequities in clinical research. Patient adherence and retention have been affected by a myriad of pandemic-era restraints, and medical, psychiatric, and other complications from the pandemic have the potential to have long-term effects on pandemic-era study results. In the development of post-pandemic study protocols, attention should be given to designing studies that incorporate successful aspects of pre-pandemic and pandemic-era strategies to (1) broaden recruitment using new techniques, (2) improve access for diverse populations, (3) expand protocols to include virtual and in-person participation, and (4) increase patient adherence and retention.
行为疗法已被证实可用于多种神经疾病的治疗。然而,COVID-19 大流行给行为研究的开展带来了巨大挑战。本文旨在:(1) 强调大流行期间开展行为临床试验的挑战;(2) 提出最大限度提高大流行时期研究普遍性的方法;(3) 提供大流行后成功开展行为试验的策略。
数以千计的临床试验受到 COVID-19 大流行的影响,从修改方案到完全暂停。此外,对于正在进行的试验,多样化人群的招募受到影响,从而加剧了临床研究中的现有不平等现象。由于大流行时期的各种限制,患者的依从性和保留率受到影响,而且大流行期间的医疗、精神和其他并发症有可能对大流行时期的研究结果产生长期影响。在后大流行研究方案的制定中,应注意设计将成功结合前大流行和大流行时期策略的研究:(1) 使用新技术扩大招募范围;(2) 改善多样化人群的可及性;(3) 将方案扩展到包括虚拟和现场参与;(4) 提高患者的依从性和保留率。