Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury
Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury
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DOI：
10.1038/s41394-019-0213-9
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发表时间：
2019-07-24
影响因子：
1.2
通讯作者：
Moynahan, Megan
中科院分区：
文献类型：
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作者：
Anderson, Kim D.;Bryden, Anne M.;Moynahan, Megan
研究设计采用直接评估问题的横断面陈述偏好调查。目的确定网络神经假体（NNP）上肢配置的不同结果的相对价值，以及预期不良事件的耐受性。在美国设立学术医疗中心。方法对成人四肢瘫痪患者进行在线调查；对每个问题/陈述的同意程度使用1-7李克特量表获得。结果对手臂/手功能的潜在益处有8项陈述；对于所有的陈述，超过70%的参与者将这些功能评为“1-非常重要”。对于术后30天内可能发生的风险有不同程度的关注，对于前5年可能发生的风险的关注程度越来越高，这可能是由于该装置，基于解决该事件所需干预的侵入性程度的增加。当分析基于所有兴趣程度的结果时，超过64%的应答者对获得NNP感兴趣，成功率阈值低至50%，与损伤后时间无关。卡方分析揭示了反应与性别、损伤程度和损伤持续时间之间的一些关联；然而，在事后分析中，这些都没有统计学意义。结论：数据表明，四肢瘫痪患者对一系列手臂/手功能非常感兴趣，并且能够耐受植入神经义肢可能带来的预期风险。功能修复研究所通过分包合同从克雷格·h·尼尔森基金会的一个更大的特殊项目奖（批准号FP0020773）中资助了这个项目。
Study design A cross-sectional stated-preference survey using direct-assessment questions. Objective To determine the relative value placed on different outcomes to be used in a pivotal trial for the upper extremity configuration of the Networked Neuroprosthesis (NNP) as well as the tolerance of the expected adverse event profile. Setting Academic medical center in the United States. Methods Distribution of an online survey to adults living with tetraplegia; extent of agreement with each question/statement was obtaining using a 1-7 Likert scale. Results There were 8 statements about potential benefits in arm/hand function; for all statements, more than 70% of participants rated the functions as "1-very important" to regain. There were variable degrees of concern related to risks that could occur during the 30-day post-surgical period and increasing degrees of concern related to risks that could occur in the first 5 years, potentially due to the device, based on the increasing degree of invasiveness of the intervention required to address the event. When analysing the results based on all degrees of interest, more than 64% of responders were interested in getting the NNP with a success rate threshold as low as 50% regardless of time post-injury. Chi-squared analyses revealed some associations between responses and sex, injury level, and injury duration; however, none of these were statistically significant upon post-hoc analysis. Conclusion Data here indicate that people with tetraplegia are highly interested in a range of arm/hand functions and are tolerant of expected risks that may be associated with implanted neuroprosthetics. Sponsorship The Institute for Functional Restoration funded this project through a sub-contract to K.D. Anderson from a larger Special Projects Award (grant number FP0020773) from the Craig H. Neilsen Foundation.