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创伤性脑损伤后记忆康复的临床和成本效益:一项实用的聚类随机对照试验。

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

机构信息

1 Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.

2 Institute of Mental Health, University of Nottingham, Nottingham, UK.

出版信息

Clin Rehabil. 2019 Jul;33(7):1171-1184. doi: 10.1177/0269215519840069. Epub 2019 Apr 12.


DOI:10.1177/0269215519840069
PMID:30977398
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6585159/
Abstract

OBJECTIVE: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING: Community. PARTICIPANTS: People with memory problems following traumatic brain injury, aged 18-69 years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS: A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES: The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12 months post randomization. RESULTS: We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5,  = 0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION: This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.

摘要

目的:评估基于团体的记忆康复方案对创伤性脑损伤患者的临床和成本效益。

设计:英格兰的多中心、实用、观察者盲法、随机对照试验。

地点:社区。

参与者:年龄在 18-69 岁之间,有创伤性脑损伤后记忆问题,能够前往团体会议,能够用英语交流并同意参与的患者。

干预措施:总共 10 周的记忆康复手册化团体课程加常规护理(干预组)与仅常规护理(对照组)。

主要观察指标:主要结果是随机分组后 6 个月时的患者报告日常记忆问卷(EMQ-p)。次要结果在 6 和 12 个月时进行评估。

结果:我们随机分配了 328 名参与者。在 6 个月随访时,两组之间主要结局无临床重要差异(干预组平均 EMQ-p 评分:38.8(26.1),对照组 44.1(24.6),调整后的平均差值:-2.1,95%置信区间(CI):-6.7 至 2.5, = 0.37)或 12 个月随访时。6 个月时,客观评估的记忆能力偏向于记忆康复组,但 12 个月时则不然。在情绪、脑损伤经历或患者日常记忆结果的亲属/朋友评估方面,两组之间没有差异,但目标达成评分在两个时间点都有利于记忆康复组。健康经济学分析表明,该干预措施不太可能具有成本效益。没有出现安全问题。

结论:对于异质创伤性脑损伤患者样本,这种记忆康复方案并没有减少日常生活中的遗忘。需要进一步研究哪些人最能从此类干预中受益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6202/6585159/15c7b29463df/10.1177_0269215519840069-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6202/6585159/531c77068c1c/10.1177_0269215519840069-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6202/6585159/15c7b29463df/10.1177_0269215519840069-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6202/6585159/531c77068c1c/10.1177_0269215519840069-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6202/6585159/15c7b29463df/10.1177_0269215519840069-fig2.jpg

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[5]
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[6]
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[7]
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[8]
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[9]
An RCT to Treat Learning Impairment in Traumatic Brain Injury: The TBI-MEM Trial.

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[10]
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