Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.
Institute of Mental Health, Nottingham, UK.
Health Technol Assess. 2019 Apr;23(16):1-194. doi: 10.3310/hta23160.
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.
To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI.
Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken.
Community settings in nine sites in England.
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.
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.
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.
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.
We randomised 328 participants (memory rehabilitation, = 171; usual care, = 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; = 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 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.
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.
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.
Current Controlled Trials ISRCTN65792154.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 16. See the NIHR Journals Library website for further project information.
创伤性脑损伤（TBI）患者常报告存在记忆障碍。这些障碍持续存在且使人虚弱，降低了生活质量，但患者在出院后通常未接受记忆康复治疗。
评估针对 TBI 患者的团体记忆康复方案的临床效果和成本效益。
多中心、实用、集群随机对照试验。还进行了定性和健康经济学评估。
英格兰 9 个地点的社区环境。
参与者年龄在 18-69 岁之间，在招募前经历了 TBI > 3 个月，报告有记忆问题，能够前往参加团体课程的地点，能够用英语交流并同意知情同意。
将 4 至 6 名参与者的群组随机分配到记忆康复组或常规护理组，比例为 1：1。随机分配基于基于计算机生成的伪随机代码，使用随机排列的大小不等的随机块，按研究地点分层。参与者和治疗师了解治疗分配，而结果评估者则保持盲法。
在记忆康复组中，除常规护理外，还提供了 10 周的手册化记忆康复方案。向参与者教授恢复受损记忆功能的恢复策略和补偿策略，以帮助他们应对记忆问题。常规护理组仅接受常规护理。
在随机分组后 6 个月和 12 个月进行评估。主要结局：6 个月随访时患者完成的日常记忆问卷-患者版（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、欧洲脑损伤问卷、日常记忆问卷-相对版和个人目标实现。使用服务使用问卷收集成本（基于英国国民保健制度和个人社会服务视角），使用 EuroQol-5 维度，五个级别版本，得出质量调整生命年（QALY）。开发了一个马尔可夫模型来探索 5 年和 10 年的成本效益，应用 3.5%的折扣。
我们随机分配了 328 名参与者（记忆康复组，n=171；常规护理组，n=157），其中记忆康复组 129 名，常规护理组 122 名纳入主要分析。我们发现，在 6 个月随访时，两组之间在 EMQ-p 上没有临床意义上的差异（调整后的平均得分差异-2.1，95%置信区间-6.7 至 2.5；=0.37）。对于次要结局，在 6 个月随访时，记忆康复组在 RBMT-3 和目标实现方面表现出更好的结果，但在 12 个月随访时，只有目标实现方面仍存在差异。两组在情绪或生活质量方面没有差异。定性结果表明，参与者对参加试验和参加小组活动有积极的体验。参与者报告说，记忆康复在常规护理中通常不可获得。主要的健康经济学结果在 12 个月时发现，记忆康复比常规护理便宜 26.89 英镑，但效果较差，增量质量调整生命年损失 0.007。成本和效果的差异没有统计学意义，非参数自举表明这些发现存在很大的不确定性。没有安全问题，也没有报告死亡。
作为一项实用试验，我们有广泛的纳入标准，因此样本中存在相当大的异质性。该研究没有为进一步的亚组分析提供足够的效力。参与者和治疗师不能对治疗分配保持盲法。
在本试验中提供的团体记忆康复极不可能为 TBI 患者带来临床获益或具有成本效益。未来的研究应研究可能从记忆康复中获益最大的参与者的选择。
当前对照试验 ISRCTN65792154。
本项目由英国国家卫生研究院（NIHR）健康技术评估计划资助，将在；第 23 卷，第 16 期。有关该项目的更多信息，请访问 NIHR 期刊库网站。
