■创新神经植入物的临床试验正在迅速增加和多样化,但对参与者在试验后使用该设备和正在进行的临床护理知之甚少。这项探索性研究检查了神经外科设备试验后使用计划和协调的常见做法。我们还探讨了试验研究者对试验后访问和持续护理的障碍的观点,以及与关键利益相关者团体责任相关的道德问题。
试验研究人员(n=66)在他们进行的手术植入神经装置的最新调查试验中完成了一项关于试验后访问的调查。调查受访者主要是神经外科,神经学和精神病学,平均有14.8年的植入式神经装置工作经验。
■感兴趣的结果包括试验期间或试验结束时(随访前)的器械移植率以及研究方案中是否描述了试验后接入计划。结果还包括研究人员“最大的障碍”和“促进者”,为研究参与者提供了对功能性植入物的试验后访问权,以及对当前主要利益相关者之间共享试验后责任的安排的看法。
试验研究人员报告说,试验结束后,“所有”(64%)或“大多数”(33%)试验参与者仍在植入。以“感染”和“无反应”为最常见的外植体原因。当被要求描述促进审判后准入的主要障碍时,调查人员描述了有限的资金,缺乏专业知识和专业临床基础设施,以及维护利益相关者关系的困难。尽管有这些障碍,调查人员绝大多数(95%)认为,当参与者在试验期间单独受益时,提供试验后访问的伦理义务.
■在试验期间或试验结束时植入器械的情况下,这样做是出于对参与者安全和福祉的关注。需要对审判后阶段的共同做法进行进一步研究,这对于有关利益相关者责任的道德和务实讨论至关重要。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.