Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery.
BACKGROUND
Few studies explore stroke survivor views and motivations towards stem cell therapy (SCT). This qualitative study explores the views and motivations of both stroke survivors and their partners/carers towards a proposed 2-arm Phase III Randomised Controlled Trial (RCT) comparing intracerebral insertion of stem cells with placebo neurosurgery in stroke survivors with disability.


OBJECTIVE
To explore views and motivations towards a proposed 2-arm stem cell trial and identify factors that may impede and enhance participation.


DESIGN
This study adopts a naturalistic design to explore the complexity of this field, employing a participatory action-research approach comprising a specialized Conversation (World) Café form of focus group. Data were collected via 5 Conversation Cafés with stroke survivors (age 40-75) and partners/carers between June and October 2016. Of 66 participants, 53 (31 male, 22 female) were stroke survivors and 13 (6 female, 7 male) were partners/carers. Qualitative data were analysed using a thematic approach.


DISCUSSION AND CONCLUSION
Stroke survivor views and motivations reflect anticipation of the personal and future benefits of regenerative medicine. Partners/carers sought to balance the value of stroke survivor hope with carrying the weight of hope as carer, a conflict burden adding to known caregiver burden. All participants expressed the need for during and post-trial psychological support. This study provides a rare opportunity to explore the prospective views and motivations of stroke survivors and their partners/carers towards a proposed Phase III 2-arm RCT. This adds weight to qualitative evidence exploring capacity, consent, decision making, perceptions of treatment risk and supports required for clinical trial participation.
['Cunningham|Nicola A|NA|0000-0002-2699-8257', 'Abhyankar|Purva|P|0000-0002-0779-6588', 'Cowie|Julie|J|', 'Galinsky|Jayne|J|', 'Methven|Karen|K|']
D000328:Adult D000368:Aged D017028:Caregivers D055812:Community-Based Participatory Research D005260:Female D017144:Focus Groups D006801:Humans D008297:Male D008875:Middle Aged D009042:Motivation D009493:Neurosurgery D011446:Prospective Studies D044968:Regenerative Medicine D033581:Stem Cell Transplantation D020521:Stroke D000071939:Stroke Rehabilitation D017741:Survivors
regenerative medicine caregiver burden consent treatment decision-making