Perspectives

Stroke survivors' views on the design of an early‐phase cell therapy trial for patients with chronic ischaemic stroke

Bibliographic Data

ID19505984
AuthorsAnjali Nagpal (0000-0002-2711-445X, Stroke Research Programme, Adelaide Medical School, The University of Adelaide South Australian Health & Medical Research Institute (SAHMRI) Adelaide SA Australia, corresponding author), Susan Hillier (0000-0002-6071-6137, Sansom Institute for Health Research University of South Australia Adelaide SA Australia), Austin G Milton (0000-0002-3746-4138, Stroke Research Programme, Departments of Neurology and Medicine The Queen Elizabeth Hospital, & Royal Adelaide Hospital, Central Adelaide Local Health Network (CALHN) Adelaide SA Australia), Monica Anne Hamilton‐Bruce (0000-0002-5222-620X, Royal Adelaide Hospital), Simon A Koblar (0000-0002-8667-203X, Stroke Research Programme, Adelaide Medical School, The University of Adelaide South Australian Health & Medical Research Institute (SAHMRI) Adelaide SA Australia)
Year2019
Volume22
Issue5
Pages1069-1077
Publication date2019-10-01
Open AccessYes
TypeARTICLE
VenueHealth Expectations (JOURNAL)
Journal identifiersISSN: 1369-6513 • E-ISSN: 1369-7625
PublisherWiley (PUBLISHER • GB)
DOI10.1111/hex.12932
PMID31332894
OpenAlexW2964167006
LanguageEN
Citations received1
References cited32

BACKGROUND: 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. OBJECTIVE: 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. DESIGN: 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. DISCUSSION AND CONCLUSIONS: 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

Clinical trial · Cognition · Focus group · Mood · Physical therapy · Population · Psychiatry · Qualitative research · Thematic analysis · Acute Ischemic Stroke Management · Biomedical Ethics and Regulation · Clinical Psychology · Medicine · Mesenchymal stem cell research · Psychology · Internal Medicine

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