植入式神经设备试用后的使用情况:一项探索性国际调查。

IF 2.1 Q2 SURGERY BMJ Surgery Interventions Health Technologies Pub Date : 2024-04-17 eCollection Date: 2024-01-01 DOI:10.1136/bmjsit-2024-000262
Nathan Higgins, John Gardner, Anna Wexler, Philipp Kellmeyer, Kerry O'Brien, Adrian Carter
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引用次数: 0

摘要

目的:创新性神经植入物的临床试验正在迅速增加且呈现多样化趋势,但人们对参与者在试验后使用设备和持续临床护理的情况知之甚少。本探索性研究探讨了神经外科设备试验后使用的规划和协调方面的常见做法。我们还探讨了试验研究人员对试验后使用和持续护理的障碍的看法,以及与主要利益相关群体的责任有关的伦理问题:试验调查人员(66 人)完成了一项调查,内容是关于他们最近开展的手术植入神经装置调查试验的试验后使用情况。调查对象主要从事神经外科、神经内科和精神病学专业,平均拥有 14.8 年的植入式神经装置工作经验:主要研究结果包括试验期间或结束时(预随访)的装置拆卸率,以及研究方案中是否说明了试验后的使用计划。研究结果还包括研究者在为研究参与者提供试验后使用功能性植入物方面的最大 "障碍 "和 "促进因素",以及对目前主要利益相关者分担试验后责任的安排的看法:试验调查人员报告称,"所有"(64%)或 "大多数"(33%)试验参与者在试验结束后仍保留植入物,"感染 "和 "无反应 "是最常见的植入原因。当被问及促进试验后使用的主要障碍时,研究人员表示资金有限、缺乏专业知识和专业临床基础设施,以及难以维持利益相关者的关系。尽管存在这些障碍,但绝大多数研究者(95%)都认为,如果参与者在试验期间个人受益,则有道德义务提供试验后访问:结论:在试验期间或结束时,有时会对设备进行拆卸,这是出于对参与者安全和福祉的考虑。需要进一步研究试验后阶段的常见做法,这对有关利益相关者责任的伦理和务实讨论至关重要。
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Post-trial access to implantable neural devices: an exploratory international survey.

Objectives: Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups.

Design setting and participants: Trial investigators (n=66) completed a survey on post-trial access in the most recent investigational trial of a surgically implanted neural device they had conducted. Survey respondents predominantly specialized in neurosurgery, neurology and psychiatry, with a mean of 14.8 years of experience working with implantable neural devices.

Main outcome measures: Outcomes of interest included rates of device explantation during or at the conclusion of the trial (pre-follow-up) and whether plans for post-trial access were described in the study protocol. Outcomes also included investigators' greatest 'barrier' and 'facilitator' to providing research participants with post-trial access to functional implants and perspectives on current arrangements for the sharing of post-trial responsibilities among key stakeholders.

Results: Trial investigators reported either 'all' (64%) or 'most' (33%) trial participants had remained implanted after the end of the trial, with 'infection' and 'non-response' the most common reasons for explantation. When asked to describe the main barriers to facilitating post-trial access, investigators described limited funding, scarcity of expertise and specialist clinical infrastructure and difficulties maintaining stakeholder relationships. Notwithstanding these barriers, investigators overwhelmingly (95%) agreed there is an ethical obligation to provide post-trial access when participants individually benefit during the trial.

Conclusions: On occasions when devices were explanted during or at the end of the trial, this was done out of concern for the safety and well-being of participants. Further research into common practices in the post-trial phase is needed and essential to ethical and pragmatic discussions regarding stakeholder responsibilities.

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来源期刊
CiteScore
2.80
自引率
0.00%
发文量
22
审稿时长
17 weeks
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