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远程神经认知评估的可行性:一项临床试验的大流行适应策略,即认知与帕金森病中的阻塞性睡眠呼吸暂停:正压通气治疗的影响(COPE-PAP)研究。

Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study.

机构信息

Respiratory Epidemiology and Clinical Research Unit, Research Institute of the McGill University Health Centre, Montreal, QC, Canada.

Montreal Neurological Hospital, McGill University Health Centre, Montreal, Canada.

出版信息

Trials. 2021 Dec 11;22(1):910. doi: 10.1186/s13063-021-05879-1.

Abstract

BACKGROUND

The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in patients with Parkinson's disease (PD) and obstructive sleep apnea (OSA).

METHODS

We studied PD patients with OSA and Montreal Cognitive Assessment (MoCA) score ≤ 27 participating in a RCT assessing OSA treatment impact on cognition. Trial outcomes included change in MoCA and specific cognitive domains from baseline to 3 and 6 months. With COVID19 pandemic-related restrictions, 3-month visits were converted from in-person to telephone administration with materials mailed to participants for compatible tests and retrieved by courier the same day. In exploratory analyses, we compared baseline vs. 3-month results in the control arm, which were not expected to change significantly (test-re-test), using a paired t-test and assessed agreement with the intraclass correlation coefficient (ICC).

RESULTS

Seven participants were approached and agreed to remote NCT at 3-month follow-up. Compared to the in-person NCT control arm group, they were younger (60.6 versus 70.6 years) and had a shorter disease course (3.9 versus 9.2 years). Remote NCT data were complete. The mean test-retest difference in MoCA was similar for in-person and remote NCT control-arm groups (between group difference - 0.69; 95%CI - 3.67, 2.29). Agreement was good for MOCA and varied for specific neurocognitive tests.

CONCLUSION

Telephone administration of the MoCA and a modified neurocognitive battery is feasible in patients with PD and OSA. Further validation will require a larger sample size.

摘要

背景

COVID-19 大流行给随机临床试验(RCT)的及时结果评估带来了挑战。我们的目的是描述我们对帕金森病(PD)和阻塞性睡眠呼吸暂停(OSA)患者进行的远程神经认知测试(NCT)方案,该方案通过电话进行。

方法

我们研究了患有 OSA 和蒙特利尔认知评估(MoCA)评分≤27 的 PD 患者,他们参加了一项 RCT,评估 OSA 治疗对认知的影响。试验结局包括从基线到 3 个月和 6 个月时 MoCA 及特定认知域的变化。由于 COVID19 大流行相关限制,将 3 个月的访视从面对面改为电话管理,将材料邮寄给参与者进行兼容测试,并在同一天由快递员取回。在探索性分析中,我们比较了对照组中基线与 3 个月时的结果(预计不会有明显变化,即测试-再测试),使用配对 t 检验和组内相关系数(ICC)评估一致性。

结果

有 7 名参与者在 3 个月随访时同意进行远程 NCT。与面对面 NCT 对照组相比,他们更年轻(60.6 岁对 70.6 岁),病程更短(3.9 年对 9.2 年)。远程 NCT 数据完整。面对面和远程 NCT 对照组之间 MoCA 的平均测试-再测试差异相似(组间差异-0.69;95%CI-3.67,2.29)。MoCA 的一致性良好,而特定神经认知测试的一致性各不相同。

结论

在 PD 和 OSA 患者中,通过电话进行 MoCA 和改良神经认知测试是可行的。进一步的验证需要更大的样本量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b44/8666023/1c642422a565/13063_2021_5879_Fig1_HTML.jpg

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