Stroke Research Programme, Adelaide Medical School, The University of Adelaide, South Australian Health & Medical Research Institute (SAHMRI), Adelaide, SA, Australia.
Sansom Institute for Health Research, University of South Australia, Adelaide, SA, Australia.
Health Expect. 2019 Oct;22(5):1069-1077. doi: 10.1111/hex.12932. Epub 2019 Jul 23.
Stem cell research holds the potential for a paradigm shift in the management of diseases such as stroke. Patient and public involvement in research (PPIR) can bring a focus to issues of clinical relevance and accelerate translation to real-world clinical practice.
A qualitative thematic analysis of the perspectives of stroke survivors regarding the conduct and design aspects of a proposed phase I clinical cell therapy study in stroke.
Twelve stroke survivors were purposively recruited in July 2016-August 2017 and participated in semi-structured, face-to-face interviews for input into the design of a proposed phase I clinical study of autologous dental pulp stem cells. Concurrent thematic analysis was conducted until data saturation was achieved.
Participants conveyed that the most relevant outcomes to them were regaining participation, decreased dependence on caregivers and improvement in cognition, memory, mood, pain and fatigue. The perception of risk vs. benefit was likely influenced by the time elapsed since stroke, with participants being more willing to accept a higher level of risk early in the post-stroke disease course. They believed that all stroke survivors should be given an opportunity to participate in research, irrespective of their cognitive capacity. A relatively small sample population of 12 stroke survivors was studied as thematic saturation was achieved. PERSPECTIVES study applied principles of PPIR to early-phase cell research. Incorporation of outcomes relevant to patients' need within the study design is critical to generate data that will enable personalized application of regenerative medicine in stroke.
干细胞研究有可能彻底改变中风等疾病的治疗模式。患者和公众参与研究（PPIR）可以关注具有临床相关性的问题，并加速转化为实际的临床实践。
对中风幸存者对拟议的中风 I 期临床细胞治疗研究的进行和设计方面的看法进行定性主题分析。
2016 年 7 月至 2017 年 8 月，有目的招募了 12 名中风幸存者，并对他们进行了半结构化的面对面访谈，以提供拟议的 I 期临床研究的设计意见，该研究为自体牙髓干细胞的临床研究。同时进行主题分析，直到达到数据饱和。
参与者表示，对他们最相关的结果是恢复参与、减少对照顾者的依赖以及改善认知、记忆、情绪、疼痛和疲劳。风险与收益的感知可能受中风后时间的影响，参与者在中风后疾病早期更愿意接受更高的风险水平。他们认为，所有中风幸存者都应该有机会参与研究，无论其认知能力如何。研究纳入了 12 名中风幸存者，作为主题饱和的小样本群体。PERSPECTIVES 研究将 PPIR 的原则应用于早期细胞研究。在研究设计中纳入与患者需求相关的结果对于生成数据至关重要，这些数据将使再生医学在中风中的个性化应用成为可能。
