在线记录康复叙事在改善精神病患者生活质量方面的效果和成本效益（NEON 试验）：一项实用随机对照试验

IF 13.6 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2024-10-23 DOI:10.1016/j.lanepe.2024.101101

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引用次数: 0

摘要

背景在线叙事经历（NEON）干预提供了基于网络的自我管理心理健康康复叙事（n = 659）。我们评估了NEON干预在改善居住在英格兰、有精神健康问题和近期有精神病经历的成年人生活质量方面的有效性和成本效益。方法前瞻性注册的务实平行组随机试验控制了常规护理，从法定精神健康服务机构和通过社区参与活动招募人员，主要终点为52周（ISRCTN11152837）。所有试验程序和NEON干预措施均由一个综合网络应用程序提供。随机分配通过独立生成的名单进行（不分层）。统计人员和首席研究员对随机分配进行了保密，但未对参与者进行保密。干预组参与者可立即获得NEON干预服务。对照组参与者在完成主要终点调查问卷后接受干预。主要结果是通过曼彻斯特短期评估（MANSA）得出的生活质量。严重不良事件（SAE）通过网络安全报告表收集，并从医疗服务使用数据中识别。研究结果在 2020 年 3 月 9 日至 2021 年 3 月 1 日期间，739 名参与者被随机分配（干预组：370 人；对照组：369 人），超过 90% 的力量可检测到 MANSA 评分中 0.25 的基线调整差异。平均年龄为34.8岁（标准差（SD）12.0），561人（75.9%）为英国白人，443人（59.9%）为女性，609人（82.4%）曾接受过专科精神卫生服务，698人（94.5%）曾接受过初级精神卫生服务。对照组和干预组的基线 MANSA 平均分为 3.7（标度分别为 0.9 和 1.0）。565名（76.5%）参与者提供了主要终点MANSA数据，对照组和干预组的平均得分均为4.1（标准差为1.0）。我们发现，在主要终点时，两组患者的生活质量无明显差异（基线调整后差异为 0.07，95% CI -0.07 至 0.21，p = 0.35）。增量成本效益比（每质量调整生命年 110,501 英镑）超过了预期定义的成本效益阈值（每质量调整生命年 30,000 英镑）。158名（42.8%）对照组参与者和194名（52.4%）干预组参与者获得了NEON干预之外的叙述。没有相关的严重不良事件 (SAE)。对照组参与者报告了 116 起与此无关的 SAE，干预组参与者报告了 107 起。未来的研究应考虑 a) 对当前精神健康服务用户进行评估；b) 优化服务，使用户能够找到促进希望的叙述。

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Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with psychosis experience (NEON Trial): a pragmatic randomised controlled trial

Background

The Narrative Experiences Online (NEON) Intervention provides self-managed web-based access to mental health recovery narratives (n = 659). We evaluated effectiveness and cost-effectiveness in improving quality of life for adults resident in England with mental health problems and recent psychosis experience.

Methods

Prospectively registered pragmatic parallel-group randomised trial controlling for usual care, recruiting from statutory mental health services and through community engagement activities, with a 52-week primary endpoint (ISRCTN11152837). All trial procedures and the NEON Intervention were delivered by an integrated web-application. Randomisation was through an independently generated list (no stratification). Allocation was masked for statistical staff and the Chief Investigator but not participants. Intervention arm participants received immediate NEON Intervention access. Control arm participants received access after completing primary endpoint questionnaires. The primary outcome was quality of life through the Manchester Short Assessment (MANSA). Serious Adverse Events (SAEs) were collected through web-based safety report forms and identified from health service usage data. The primary analysis was by a prospectively described Intention To Treat principle excluding participants who had registered multiple times, with multiple imputation for missing data.

Findings

Between 9 March 2020 and 1 March 2021, 739 participants were randomised (intervention:370; control: 369), providing more than 90% power to detect a baseline-adjusted difference of 0.25 in the MANSA score. Mean age was 34.8 years (standard deviation (SD) 12.0), 561 (75.9%) were white British, 443 (59.9%) were female, 609 (82.4%) had accessed specialist care mental health services, and 698 (94.5%) had accessed primary care mental health services. Mean baseline MANSA score was 3.7 for control and intervention arms (SD 0.9 and 1.0). 565 (76.5%) participants provided primary endpoint MANSA data with a mean score of 4.1 (SD 1.0) for both arms. We found no significant difference in Quality of Life between the two arms at the primary endpoint (baseline-adjusted difference 0.07, 95% CI −0.07 to 0.21, p = 0.35). The incremental cost-effectiveness ratio (£110,501 per quality-adjusted life-year (QALY)) exceeded the prospectively defined cost-effectiveness threshold (£30,000 per QALY). 158 (42.8%) control arm and 194 (52.4%) intervention arm participants accessed narratives outside of the NEON Intervention. There were no related serious adverse events (SAEs). 116 unrelated SAEs were reported by control arm participants, and 107 by intervention arm participants.

Interpretation

Our findings do not indicate NEON Intervention access for all people with psychosis experience. Future research should consider a) evaluation with current mental health services users; b) optimisation to enable users to find hope-promoting narratives.

Funding

National Institute for Health and Care Research (NIHR).

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.