Gonzalez Lina, Rapaport Penny, Livingston Gill, Amador Sarah, Adeleke Mariam O, Barber Julie A, Banerjee Sube, Charlesworth Georgina, Clarke Chris, Espie Colin A, Kyle Simon D, Raczek Malgorzata, Walker Zuzana, Webster Lucy, Manela Monica, Hunter Rachael Maree
Research Department of Primary Care and Population Health, University College London, London, UK.
Division of Psychiatry, University College London, London, UK; Camden and Islington NHS Foundation Trust, London, UK.
Lancet Healthy Longev. 2025 May;6(5):100708. doi: 10.1016/j.lanhl.2025.100708. Epub 2025 May 21.
People living at home with dementia frequently have disturbed sleep. The multicomponent, non-pharmacological intervention DREAMS START has shown to be effective at improving sleep in this population. We aimed to conduct a cost-utility analysis of DREAMS START compared with treatment as usual (TAU).
This economic evaluation within a single-masked, phase 3, parallel-arm, superiority randomised controlled trial involved dyads of people with dementia and sleep disturbance and their family carer. Participants were recruited from the National Health Service and the Join Dementia Research service in England. Dyads were randomly assigned (1:1) to receive the DREAMS START intervention (plus TAU) or TAU. Randomisation was blocked, with stratification by site, and a web-based system was used for allocation. Researchers collecting outcome data were masked to allocation group. The primary outcome was sleep disturbance measured by the Sleep Disorders Inventory (SDI) at 8 months. At baseline, 4 months, and 8 months, family carers completed the 5-level EuroQoL 5 dimensions (EQ-5D-5L) proxy, the Dementia Quality of Life Instrument (DEMQOL)-Proxy, and EQ-5D-5L questionnaires, and resource use for the patient and family carer was measured. We calculated the probability that the DREAMS START intervention is cost-effective from a health and personal social services perspective and from a wider societal perspective for a range of decision thresholds per quality-adjusted life-year (QALY) gained using the EQ-5D-5L scores to calculate QALYs and imputing missing data, reported with a cost-effectiveness acceptability curve. This trial was registered with ISRCTN, 13072268, and is complete.
From Feb 24, 2021, to March 5, 2023, we randomly assigned 377 dyads: 188 to the intervention group and 189 to the TAU group. The mean age of participants with dementia was 79⋅4 years (SD 9⋅0), 206 (55%) of whom were women and 171 (45%) were men. As previously reported, the mean SDI score at 8 months was lower in the intervention group than in the TAU group (adjusted difference in means -4·70 [95% CI -7·65 to -1·74], p=0·002). The mean incremental difference in health and personal social services costs was £59 less per dyad (95% CI -5168 to 5050) and, when incorporating wider societal costs, was £116 less per dyad (-5769 to 5536) for the intervention group than the TAU group, although these figures were non-significant. The mean incremental difference in QALYs per person with dementia was 0·016 more (95% CI 0·000 to 0·033) for the intervention group than for the TAU group, indicating no significant difference in quality of life. At a £20 000 per QALY gained decision threshold, there was a 78% probability that DREAMS START is cost-effective, compared with TAU.
DREAMS START is likely to be cost-effective. Given its clinical effectiveness, we recommend that this intervention forms part of routine care for people with dementia and disturbed sleep.
National Institute for Health and Care Research Health Technology Assessment.
居家患有痴呆症的患者经常存在睡眠障碍。多成分非药物干预措施“DREAMS START”已被证明能有效改善该人群的睡眠。我们旨在对“DREAMS START”与常规治疗(TAU)进行成本效用分析。
这项经济评估纳入了一项单盲、3期、平行组、优效性随机对照试验,涉及患有痴呆症和睡眠障碍的患者及其家庭护理人员。参与者从英国国家医疗服务体系和“加入痴呆症研究”服务机构招募。将患者及其护理人员配对后随机分配(1:1),分别接受“DREAMS START”干预(加常规治疗)或常规治疗。随机分组采用区组随机化,按地点分层,并使用基于网络的系统进行分配。收集结局数据的研究人员对分配组不知情。主要结局是在8个月时通过睡眠障碍量表(SDI)测量的睡眠障碍情况。在基线、4个月和8个月时,家庭护理人员完成5级欧洲五维度健康量表(EQ - 5D - 5L)代理版、痴呆症生活质量量表(DEMQOL)代理版以及EQ - 5D - 5L问卷,并测量患者和家庭护理人员的资源使用情况。我们从健康和个人社会服务角度以及更广泛的社会角度,针对每获得一个质量调整生命年(QALY)的一系列决策阈值,计算“DREAMS START”干预具有成本效益的概率,使用EQ - 5D - 5L分数计算QALY并对缺失数据进行插补,结果以成本效益可接受性曲线报告。该试验已在国际标准随机对照试验编号注册库(ISRCTN)注册,编号为13072268,现已完成。
从2021年2月24日至2023年3月5日,我们随机分配了377对患者及其护理人员:188对分配至干预组,189对分配至常规治疗组。患有痴呆症的参与者平均年龄为79.4岁(标准差9.0),其中206名(55%)为女性,171名(45%)为男性。如先前报告所述,干预组8个月时的平均SDI得分低于常规治疗组(调整后的均值差异为 - 4.70 [95%置信区间 - 7.65至 - 1.74],p = 0.002)。干预组在健康和个人社会服务成本方面的平均增量差异为每对少59英镑(95%置信区间 - 5168至5050),纳入更广泛的社会成本后,干预组每对少116英镑( - 5769至5536),但这些数字无统计学意义。干预组中患有痴呆症的患者每人的QALY平均增量比常规治疗组多0.016(95%置信区间0.000至0.033),表明生活质量无显著差异。在每获得一个QALY的决策阈值为20000英镑时,与常规治疗相比,“DREAMS START”具有成本效益的概率为78%。
“DREAMS START”可能具有成本效益。鉴于其临床有效性,我们建议该干预措施成为患有痴呆症和睡眠障碍患者常规护理的一部分。
英国国家卫生与保健研究机构卫生技术评估项目。