Livingston Gill, Kelly Lynsey, Lewis-Holmes Elanor, Baio Gianluca, Morris Stephen, Patel Nishma, Omar Rumana Z, Katona Cornelius, Cooper Claudia
Unit of Mental Health Sciences, University College London, London, UK.
Department of Statistical Science and PRIMENT Clinical Trials Unit, University College London, London, UK.
Health Technol Assess. 2014 Jun;18(39):1-226, v-vi. doi: 10.3310/hta18390.
Agitation is common, persistent and distressing in dementia and is linked with care breakdown. Psychotropic medication is often ineffective or harmful, but the evidence regarding non-pharmacological interventions is unclear.
We systematically reviewed and synthesised the evidence for clinical effectiveness and cost-effectiveness of non-pharmacological interventions for reducing agitation in dementia, considering dementia severity, the setting, the person with whom the intervention is implemented, whether the effects are immediate or longer term, and cost-effectiveness.
We searched twice using relevant search terms (9 August 2011 and 12 June 2012) in Web of Knowledge (incorporating MEDLINE); EMBASE; British Nursing Index; the Health Technology Assessment programme database; PsycINFO; NHS Evidence; System for Information on Grey Literature; The Stationery Office Official Documents website; The Stationery National Technical Information Service; Cumulative Index to Nursing and Allied Health Literature; and The Cochrane Library. We also searched Cochrane reviews of interventions for behaviour in dementia, included papers' references, and contacted authors about 'missed' studies. We included quantitative studies, evaluating non-pharmacological interventions for agitation in dementia, in all settings.
We rated quality, prioritising higher-quality studies. We separated results by intervention type and agitation level. As we were unable to meta-analyse results except for light therapy, we present a qualitative evidence synthesis. In addition, we calculated standardised effect sizes (SESs) with available data, to compare heterogeneous interventions. In the health economic analysis, we reviewed economic studies, calculated the cost of effective interventions from the effectiveness review, calculated the incremental cost per unit improvement in agitation, used data from a cohort study to evaluate the relationship between health and social care costs and health-related quality of life (DEMQOL-Proxy-U scores) and developed a new cost-effectiveness model.
We included 160 out of 1916 papers screened. Supervised person-centred care, communication skills (SES = -1.8 to -0.3) or modified dementia care mapping (DCM) with implementing plans (SES = -1.4 to -0.6) were all efficacious at reducing clinically significant agitation in care home residents, both immediately and up to 6 months afterwards. In care home residents, during interventions but not at follow-up, activities (SES = -0.8 to -0.6) and music therapy (SES = -0.8 to -0.5) by protocol reduced mean levels of agitation; sensory intervention (SES = -1.3 to -0.6) reduced mean and clinically significant symptoms. Advantages were not demonstrated with 'therapeutic touch' or individualised activity. Aromatherapy and light therapy did not show clinical effectiveness. Training family carers in behavioural or cognitive interventions did not decrease severe agitation. The few studies reporting activities of daily living or quality-of-life outcomes found no improvement, even when agitation had improved. We identified two health economic studies. Costs of interventions which significantly impacted on agitation were activities, £80-696; music therapy, £13-27; sensory interventions, £3-527; and training paid caregivers in person-centred care or communication skills with or without behavioural management training and DCM, £31-339. Among the 11 interventions that were evaluated using the Cohen-Mansfield Agitation Inventory (CMAI), the incremental cost per unit reduction in CMAI score ranged from £162 to £3480 for activities, £4 for music therapy, £24 to £143 for sensory interventions, and £6 to £62 for training paid caregivers in person-centred care or communication skills with or without behavioural management training and DCM. Health and social care costs ranged from around £7000 over 3 months in people without clinically significant agitation symptoms to around £15,000 at the most severe agitation levels. There is some evidence that DEMQOL-Proxy-U scores decline with Neuropsychiatric Inventory agitation scores. A multicomponent intervention in participants with mild to moderate dementia had a positive monetary net benefit and a 82.2% probability of being cost-effective at a maximum willingness to pay for a quality-adjusted life-year of £20,000 and a 83.18% probability at a value of £30,000.
Although there were some high-quality studies, there were only 33 reasonably sized (> 45 participants) randomised controlled trials, and lack of evidence means that we cannot comment on many interventions' effectiveness. There were no hospital studies and few studies in people's homes. More health economic data are needed.
Person-centred care, communication skills and DCM (all with supervision), sensory therapy activities, and structured music therapies reduce agitation in care-home dementia residents. Future interventions should change care home culture through staff training and permanently implement evidence-based treatments and evaluate health economics. There is a need for further work on interventions for agitation in people with dementia living in their own homes.
The study was registered as PROSPERO no. CRD42011001370.
The National Institute for Health Research Health Technology Assessment programme.
在痴呆症患者中，激越症状常见、持续且令人痛苦，并且与护理失败相关。精神药物治疗往往无效或有害，但关于非药物干预措施的证据尚不明确。
我们系统地回顾并综合了非药物干预措施对减少痴呆症患者激越症状的临床有效性和成本效益的证据，同时考虑了痴呆症的严重程度、干预实施的环境、实施干预的人员、效果是即时的还是长期的，以及成本效益。
我们于2011年8月9日和2012年6月12日，使用相关检索词在以下数据库进行了两次检索：《科学引文索引》（包含MEDLINE）、EMBASE、《英国护理索引》、卫生技术评估计划数据库、PsycINFO、英国国家医疗服务体系证据库、灰色文献信息系统、英国皇家文书局官方文件网站、美国国家技术信息服务局、护理学与健康相关学科累积索引以及考科蓝图书馆。我们还检索了考科蓝关于痴呆症行为干预措施的综述、纳入论文的参考文献，并就“遗漏”的研究联系了作者。我们纳入了所有环境下评估非药物干预措施对痴呆症患者激越症状影响的定量研究。
我们对研究质量进行评分，优先考虑高质量研究。我们按干预类型和激越水平对结果进行分类。由于除光疗法外我们无法进行荟萃分析，因此我们进行了定性证据综合分析。此外，我们利用可得数据计算标准化效应量（SESs），以比较不同的干预措施。在卫生经济分析中，我们回顾了经济研究，根据有效性综述计算有效干预措施的成本；计算激越症状每改善一个单位的增量成本；利用队列研究的数据评估健康和社会护理成本与健康相关生活质量（DEMQOL-Proxy-U评分）之间的关系，并建立了一个新的成本效益模型。
在筛选的1916篇论文中，我们纳入了160篇。以患者为中心的监督护理、沟通技巧（SES=-1.8至-0.3）或带有实施计划的改良痴呆症护理图谱（DCM）（SES=-1.4至-0.6）在减少养老院居民临床上显著的激越症状方面均有效，即时有效且在随后的6个月内持续有效。在养老院居民中，在干预期间而非随访期间，按方案进行的活动（SES=-0.8至-0.6）和音乐疗法（SES=-0.8至-0.5）可降低激越的平均水平；感觉干预（SES=-1.3至-0.6）可降低平均及临床上显著的症状。“治疗性触摸”或个性化活动未显示出优势。芳香疗法和光疗法未显示出临床有效性。对家庭护理人员进行行为或认知干预培训并未减少严重的激越症状。少数报告日常生活活动或生活质量结果的研究发现，即使激越症状有所改善，这些方面也没有改善。我们确定了两项卫生经济研究。对激越症状有显著影响的干预措施成本分别为：活动，80 - 696英镑；音乐疗法，13 - 27英镑；感觉干预，3 - 527英镑；以及对付费护理人员进行以患者为中心的护理或沟通技巧培训（有无行为管理培训和DCM），31 - 339英镑。在使用科恩 - 曼斯菲尔德激越量表（CMAI）评估的11项干预措施中，活动使CMAI评分每降低一个单位的增量成本为162至3480英镑，音乐疗法为4英镑，感觉干预为24至1月143英镑，对付费护理人员进行以患者为中心的护理或沟通技巧培训（有无行为管理培训和DCM）为6至62英镑。健康和社会护理成本在无临床上显著激越症状的人群中，3个月约为7000英镑，在激越症状最严重的人群中最多约为15000英镑。有证据表明，DEMQOL-Proxy-U评分随神经精神科问卷激越评分下降。对轻度至中度痴呆症患者进行的多成分干预具有正的货币净效益，在每质量调整生命年最高支付意愿为20000英镑时，具有成本效益的概率为82.2%，在价值为30000英镑时，概率为83.18%。
尽管有一些高质量研究，但仅有33项样本量合理（>45名参与者）的随机对照试验，且缺乏证据意味着我们无法对许多干预措施的有效性发表评论。没有医院研究，且在患者家中进行的研究很少。需要更多的卫生经济数据。
以患者为中心的护理、沟通技巧和DCM（均需监督）、感觉疗法活动以及结构化音乐疗法可减少养老院痴呆症患者的激越症状。未来干预措施应通过员工培训改变养老院文化，永久实施循证治疗并评估卫生经济学。对于居家痴呆症患者的激越症状干预措施，仍需进一步开展研究。
该研究在国际前瞻性系统评价注册库（PROSPERO）注册，注册号为CRD42011001370。
英国国家卫生研究院卫生技术评估计划。
