Protocol for a cost-utility analysis of neurostimulation and intensive camp-based therapy for children with perinatal stroke and hemiparesis based on a multicentre clinical trial.
Protocol for a cost-utility analysis of neurostimulation and intensive camp-based therapy for children with perinatal stroke and hemiparesis based on a multicentre clinical trial.
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DOI：
10.1136/bmjopen-2020-041444
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发表时间：
2021-01-19
期刊：
影响因子：
2.9
通讯作者：
Zwicker JD
中科院分区：
文献类型：
--
作者：
Berrigan P;Hodge J;Kirton A;Moretti ME;Ungar WJ;Zwicker JD
围产期中风导致大脑性麻痹（CP）和终身残疾的数千名加拿大儿童。轻偏瘫是指身体一侧的功能受损，是围产期中风的常见并发症。偏瘫型CP的标准长期护理侧重于康复治疗。早期研究表明，轻偏瘫患者可能受益于连续性神经调节治疗，如经颅直流电刺激（tDCS）。tDCS使用电流非侵入性地刺激大脑的目标区域，可能增强运动学习疗法的效果。该方案描述了一项与随机对照试验（RCT）一起进行的经济学评价，以评估与单用营地治疗相比，在偏瘫CP儿童中每获得质量调整生命年（QALY），将tDCS添加到营地治疗中的增量成本。刺激围产期卒中优化恢复轨迹（SPORT）试验是一项多中心RCT，评价tDCS添加到6-18岁围产期缺血性卒中和影响上肢的致残性轻偏瘫CP儿童的2周营地治疗中。在基线、干预后1周、2个月和6个月评估结果。在基线和6个月时收集成本和生活质量数据，结果将用于进行成本效用分析（CUA）。评估将从公共医疗系统和社会的角度进行。CUA将在6个月的时间范围内进行。每个研究中心的研究伦理委员会已经批准了SPORT试验的伦理批准和相关的经济评估。经济评估的结果将提交同行评审的学术期刊发表，并提交会议介绍。 NCT 03216837;后结果。
Perinatal stroke leads to cerebral palsy (CP) and lifelong disability for thousands of Canadian children. Hemiparesis, referring to impaired functionality in one side of the body, is a common complication of perinatal stroke. Standard long-term care for hemiparetic CP focuses on rehabilitation therapies. Early research suggests that patients with hemiparesis may benefit from adjunctive neuromodulation treatments such as transcranial direct current stimulation (tDCS). tDCS uses electric current to stimulate targeted areas of the brain non-invasively, potentially enhancing the effects of motor learning therapies. This protocol describes an economic evaluation to be conducted alongside a randomised controlled trial (RCT) to assess the incremental cost of tDCS added to a camp-based therapy compared with camp-based therapy alone per quality-adjusted life year (QALY) gained in children with hemiparetic CP. The Stimulation for Perinatal Stroke Optimising Recovery Trajectories (SPORT) trial is a multicentre RCT evaluating tDCS added to a 2-week camp-based therapy for children aged 6–18 years with perinatal ischaemic stroke and disabling hemiparetic CP affecting the upper limb. Outcomes are assessed at baseline, 1 week, 2 months and 6 months following intervention. Cost and quality of life data are collected at baseline and 6 months and results will be used to conduct a cost–utility analysis (CUA). The evaluation will be conducted from the perspectives of the public healthcare system and society. The CUA will be conducted over a 6-month time horizon. Ethical approval for the SPORT trial and the associated economic evaluation has been given by the research ethics boards at each of the study sites. The findings of the economic evaluation will be submitted for publication in a peer reviewed academic journal and submitted for presentation at conference. NCT03216837; Post-results.
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影响因子：
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作者：
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