针对9至17岁抽搐的在线远程行为干预:具有嵌入式过程和经济评估的ORBIT RCT。

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Health technology assessment Pub Date : 2023-10-01 DOI:10.3310/CPMS3211
Chris Hollis, Charlotte L Hall, Kareem Khan, Marie Le Novere, Louise Marston, Rebecca Jones, Rachael Hunter, Beverley J Brown, Charlotte Sanderson, Per Andrén, Sophie D Bennett, Liam R Chamberlain, E Bethan Davies, Amber Evans, Natalia Kouzoupi, Caitlin McKenzie, Isobel Heyman, Joseph Kilgariff, Cristine Glazebrook, David Mataix-Cols, Eva Serlachius, Elizabeth Murray, Tara Murphy
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引用次数: 0

摘要

背景:抽搐的行为疗法很难获得,而且在网上提供时对其有效性知之甚少。目的:研究在线提供、治疗师和家长支持的年轻抽动障碍患者治疗的临床和成本效益。设计:单盲、平行组、随机对照试验,随机分组后随访3个月(主要终点)和6个月。参与者被单独随机(1:1),使用在线系统,分组随机化,按地点分层。随机分组后12个月和18个月进行自然主义随访,参与者可以自由使用非试验干预措施。一部分参与者参与了流程评估。背景:英国的两家医院(伦敦和诺丁汉)也接受来自患者识别中心和在线自我报告的转诊。参与者:9-17岁的儿童(1)患有抽动秽语综合征或慢性抽动障碍,(2)耶鲁大学全球抽搐严重程度量表抽搐严重程度总分为15分或以上(或>10分,仅伴有运动或发声抽搐);(3)在过去12个月内未接受抽搐行为治疗或在过去2个月内开始/停止抽搐药物治疗。干预措施:10周的在线、远程治疗、治疗师支持的暴露和反应预防治疗(干预组)或在线心理教育(对照组)。结果:主要结果:随机分组后3个月,耶鲁全球抽搐严重程度量表总分;对所有有数据的随机患者进行的分析。次要结果包括情绪低落、焦虑、治疗满意度和卫生资源使用。质量调整后的生活年数来源于父母完成的生活质量测量。所有试验工作人员、统计学家和首席研究员都戴着口罩接受分组分配。结果:224名参与者被随机分为干预组(n=112)或对照组(n=12)。参与者大多为男性(n=177;79%),平均年龄为12岁。在3个月时,根据基线和部位调整的两组之间Yale Global Tic严重程度量表总Tic严重度评分的估计平均差异为-2.29分(95%置信区间-3.86至-0.71),有利于治疗(效果大小-0.31,95%置信区间-0.52至-0.10)。这种影响一直持续到18个月时的最终随访(-2.01分,95%置信区间-3.86至-0.15;效应大小-0.27,95%置信度-0.52至-0.02)。18个月时,与对照组相比,干预组每位参与者的平均增量成本为662英镑(95%置信区间-59至1384英镑),每位参与者经质量调整后的平均增量生命年为0.040(95%置信度-0.004至0.083)。每个质量调整生命年的平均增量成本为16708英镑。干预是可以接受的,并且提供了高保真度。父母的参与预测了儿童的参与和更积极的临床结果。危害:对照组发生两起严重的、无关的不良事件。局限性:我们无法将数字在线交付的效果和治疗本身分开。样本主要是白人和英国人,限制了通用性。这种设计无法与面对面的服务相比。结论:治疗师支持的年轻抽动障碍患者在线行为治疗在减少抽动方面具有临床和成本效益,其持久益处可延长至18个月。未来的工作:未来的工作应该将在线治疗与面对面治疗进行比较,并探索如何将干预嵌入临床实践。试验注册:本试验注册号为ISRCTN70758207;ClinicalTrials.gov(NCT03483493)。审判现已完成。资助:该项目由国家卫生与保健研究所(NIHR)健康与技术评估计划资助(项目编号16/19/02),并将在《健康与技术评价》上全文发表;第27卷第18期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation.

Background: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online.

Objective: To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders.

Design: Single-blind, parallel-group, randomised controlled trial, with 3-month (primary end point) and 6-month post-randomisation follow-up. Participants were individually randomised (1 : 1), using on online system, with block randomisations, stratified by site. Naturalistic follow-up was conducted at 12 and 18 months post-randomisation when participants were free to access non-trial interventions. A subset of participants participated in a process evaluation.

Setting: Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals.

Participants: Children aged 9-17 years (1) with Tourette syndrome or chronic tic disorder, (2) with a Yale Global Tic Severity Scale-total tic severity score of 15 or more (or > 10 with only motor or vocal tics) and (3) having not received behavioural therapy for tics in the past 12 months or started/stopped medication for tics within the past 2 months.

Interventions: Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control).

Outcome: Primary outcome: Yale Global Tic Severity Scale-total tic severity score 3 months post-randomisation; analysis done in all randomised patients for whom data were available. Secondary outcomes included low mood, anxiety, treatment satisfaction and health resource use. Quality-adjusted life-years are derived from parent-completed quality-of-life measures. All trial staff, statisticians and the chief investigator were masked to group allocation.

Results: Two hundred and twenty-four participants were randomised to the intervention (n = 112) or control (n = 112) group. Participants were mostly male (n = 177; 79%), with a mean age of 12 years. At 3 months the estimated mean difference in Yale Global Tic Severity Scale-total tic severity score between the groups adjusted for baseline and site was -2.29 points (95% confidence interval -3.86 to -0.71) in favour of therapy (effect size -0.31, 95% confidence interval -0.52 to -0.10). This effect was sustained throughout to the final follow-up at 18 months (-2.01 points, 95% confidence interval -3.86 to -0.15; effect size -0.27, 95% confidence interval -0.52 to -0.02). At 18 months the mean incremental cost per participant of the intervention compared to the control was £662 (95% confidence interval -£59 to £1384), with a mean incremental quality-adjusted life-year of 0.040 (95% confidence interval -0.004 to 0.083) per participant. The mean incremental cost per quality-adjusted life-year gained was £16,708. The intervention was acceptable and delivered with high fidelity. Parental engagement predicted child engagement and more positive clinical outcomes.

Harms: Two serious, unrelated adverse events occurred in the control group.

Limitations: We cannot separate the effects of digital online delivery and the therapy itself. The sample was predominately white and British, limiting generalisability. The design did not compare to face-to-face services.

Conclusion: Online, therapist-supported behavioural therapy for young people with tic disorders is clinically and cost-effective in reducing tics, with durable benefits extending up to 18 months.

Future work: Future work should compare online to face-to-face therapy and explore how to embed the intervention in clinical practice.

Trial registration: This trial is registered as ISRCTN70758207; ClinicalTrials.gov (NCT03483493). The trial is now complete.

Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Technology Assessment programme (project number 16/19/02) and will be published in full in Health and Technology Assessment; Vol. 27, No. 18. See the NIHR Journals Library website for further project information.

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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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