A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrln RCT
A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrln RCT
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DOI：
10.3310/hta23160
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发表时间：
2019-04-01
影响因子：
3.6
通讯作者：
Lincoln, Nadina B.
中科院分区：
文献类型：
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作者：
das Nair, Roshan;Bradshaw, Lucy E.;Lincoln, Nadina B.
背景：创伤性脑损伤（TBI）患者通常报告记忆障碍。这些都是持久的，衰弱和降低生活质量，但患者不定期接受记忆康复出院后从hospital.Objective：要评估的临床有效性和成本效益的一组记忆康复计划的人TBI.Design：多中心，务实，集群随机对照试验。定性和卫生经济学评价也进行了。设置：在英格兰的9个地点的社区设置。参与者：参与者年龄在18-69岁之间，在招募前经历了> 3个月的TBI，报告了记忆问题，能够前往现场参加小组会议，随机化和盲法将4 - 6名参与者随机分组至记忆康复组或按1：1的比例进行常规护理。随机化是基于计算机生成的伪随机代码，使用随机排列的大小不同的区组，按研究中心分层。参与者和治疗师都知道的治疗分配，而结果的评估是blinding.Interventions：在记忆康复手臂10个每周一次的手动记忆康复计划，除了通常的护理。参与者被教导恢复策略，以重新训练受损的记忆功能和补偿策略，使他们能够科普记忆问题。常规治疗组仅接受常规治疗。主要结果测量：随机分组后6个月和12个月评估结果。主要结局：6个月随访时患者完成的日常记忆问卷-患者版本（EMQ-p）。次要结局：Rivermead行为记忆测试-第三版（RBMT-3），一般健康问卷30项版本，欧洲脑损伤问卷，日常记忆问卷-相对版本和个人目标实现。使用服务使用问卷收集成本（基于英国NHS和个人社会服务的角度），使用EuroQol-5维度，5个级别的版本，用于获得质量调整生命年（QQs）。一个马尔可夫模型的开发，以探讨成本效益在5年和10年，3.5%的折扣applied.Results：我们随机328名参与者（记忆康复，n = 171;日常护理，n = 157），129在记忆康复臂和122在日常护理臂包括在主要分析。在6个月的随访中，我们发现两组之间的EMQ-p没有临床上重要的差异（平均评分的校正差异为-2.1，95%置信区间为-6.7至2.5; p = 0.37）。对于次要结局，在6个月随访时观察到RBMT-3和目标实现的差异有利于记忆康复组，但仅在12个月随访时保持目标实现。两组在情绪或生活质量方面没有差异。定性结果表明，积极的经验，参加试验和参加小组。参与者报告说，记忆力康复是不经常访问的日常护理。12个月时的主要健康经济学结果发现，记忆康复比常规护理便宜26.89磅，但效果较差，QALY增量损失为0.007。成本和效果的差异在统计学上并不显著，非参数自举法在这些结果中表现出相当大的不确定性。没有安全性问题，也没有死亡的报道。局限性：作为一个务实的试验，我们有广泛的纳入标准，因此，有相当大的异质性内的样本。该研究没有把握度进行进一步的亚组分析。参与者和治疗师不能盲目的治疗allocation.Conclusion：在这项试验中提供的组记忆康复是非常不可能导致临床效益或TBI的人在社区中的一个具有成本效益的治疗。未来的研究应该检查参与者的选择谁可能从记忆康复中受益最大。
Background: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital.Objective: To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI.Design: Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken.Setting: Community settings in nine sites in England.Participants: Participants were aged 18-69 years, had undergone a TBI > 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent.Randomisation and blinding Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded.Interventions: In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only.Main outcome measures: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire - patient version (EMQ-p) at 6 months' follow-up. Secondary outcomes: Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied.Results: We randomised 328 participants (memory rehabilitation, n = 171; usual care, n = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5; p = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months' follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months' follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be 26.89 pound cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported.Limitations: As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the sample. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation.Conclusion: The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation.