在一项针对慢性疼痛青少年的跨学科随机临床试验中，快速过渡到虚拟评估和治疗：调整以及对未来试验的影响。
Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials.
机构信息
Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.
Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Sunnyvale, CA.
出版信息
Clin J Pain. 2022 Jul 1;38(7):459-469. doi: 10.1097/AJP.0000000000001040.
OBJECTIVES
COVID-19 abruptly halted in-person clinical care and research requiring a shift to virtual assessment and treatment. This unexpected transition of a 2-arm randomized controlled trial (RCT) examining interdisciplinary graded exposure treatment (GET Living) compared with multidisciplinary pain management for youth with chronic pain provided an opportunity to implement the first remotely delivered exposure treatment and remotely delivered biomechanical assessment for pediatric chronic pain. Here we describe these new approaches and provide lessons learned to inform future efforts in digital health care.
METHODS
A total of 68 youth (M=14.2 y; 80.9% female) were enrolled in the RCT (n=31 in-person, n=5 hybrid, n=32 virtual, n=9 withdrew). Of those withdrawn, n=3 withdrew due to COVID-19 related reasons. Some RCT elements required slight modification (eg, e-consent, actigraphy deployment, recruitment, and screening), while others were significantly altered (eg, session format and lab-based biomechanical assessment). Data from exit interviews were also examined to assess perspectives on the virtual format transition.
RESULTS
Results showed an increased enrollment rate when virtual care was an option (70.7%) compared with in-person (44.3%). Equivalent rates of completion for daily assessment (in-person, 72.8%; virtual, 73.3) were also observed, and participants described enhanced experience when able to complete exercises and exposures in their home environment during session (vs. a rehabilitation gym) allowing for genuine in vivo exposures (eg, household chores, riding bicycles).
DISCUSSION
Overall, our data demonstrate acceptability, feasibility, and equivalent patient engagement to virtual treatment. Novel methods implemented in this RCT can inform trial design and measures of clinical endpoints for future digital health interventions.
目的
COVID-19 突然中断了需要转为虚拟评估和治疗的面对面临床护理和研究。这一转变对一项正在进行的双臂随机对照试验（RCT）产生了影响，该试验比较了跨学科分级暴露治疗（GET Living）与多学科疼痛管理对慢性疼痛青少年的效果。这为首次远程实施暴露治疗和远程生物力学评估为儿科慢性疼痛提供了机会。在这里，我们描述了这些新方法，并提供了经验教训，为未来的数字医疗保健工作提供信息。
方法
共有 68 名青少年（M=14.2 岁；80.9%为女性）入组该 RCT（n=31 名面对面，n=5 名混合，n=32 名虚拟，n=9 名退出）。退出者中，n=3 人因 COVID-19 相关原因退出。一些 RCT 元素需要进行一些轻微的修改（例如，电子同意书、活动记录仪的部署、招募和筛选），而其他元素则发生了重大改变（例如，会议格式和实验室的生物力学评估）。还对退出访谈中的数据进行了分析，以评估参与者对虚拟格式转换的看法。
结果
当虚拟护理成为一种选择时，入组率显著增加（70.7%），而面对面护理的入组率为 44.3%。同时，也观察到每日评估的完成率相当（面对面组为 72.8%，虚拟组为 73.3%），并且参与者表示，在能够完成家庭环境中的练习和暴露时，体验得到了增强（与康复健身房相比），这使得真正的体内暴露（例如，家务、骑自行车）成为可能。
讨论
总体而言，我们的数据表明虚拟治疗是可以接受的、可行的，并且患者参与度相当。这项 RCT 中实施的新方法可以为未来的数字健康干预措施的试验设计和临床终点测量提供信息。
Zotero 插件