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.

中文翻译：

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针对慢性颈脊髓损伤的植入式电刺激装置对上肢功能的风险效益值。

研究设计 使用直接评估问题进行横断面陈述偏好调查。目的 确定网络神经假体 (NNP) 上肢配置关键试验中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 对四肢瘫痪的成年人进行在线调查；使用 1-7 李克特量表获得对每个问题/陈述的同意程度。结果 有 8 条关于手臂/手功能潜在益处的陈述；对于所有陈述，超过 70% 的参与者将重新获得的功能评为“1-非常重要”。人们对术后 30 天内可能发生的风险有不同程度的担忧，并且随着手术后 30 天内可能发生的风险（可能是由于该设备）相关的担忧程度不断增加，解决该事件所需的干预措施的侵入性。在根据所有兴趣程度分析结果时，超过 64% 的受访者对获得 NNP 感兴趣，无论受伤后的时间如何，成功率阈值低至 50%。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，根据事后分析，这些都不具有统计显着性。结论 这里的数据表明，四肢瘫痪患者对一系列手臂/手的功能高度感兴趣，并且能够容忍可能与植入神经修复术相关的预期风险。赞助 功能恢复研究所通过克雷格·尼尔森基金会 (Craig H. Neilsen Foundation) 授予的较大特别项目奖（拨款号 FP0020773）向 KD Anderson 分包合同，为该项目提供资金。