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Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery

Citation
Cunningham N, Abhyankar P, Cowie J, Galinsky J & Methven K (2018) Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery, Health Expectations, 21 (1), pp. 367-378.

Abstract
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.

Keywords
caregiver burden; consent; regenerative medicine; treatment decision-making

StatusPublished
AuthorsCunningham Nicola, Abhyankar Purva, Cowie Julie, Galinsky Jayne, Methven Karen
Publication date02/2018
Publication date online12/10/2017
Date accepted by journal11/09/2017
PublisherWiley-Blackwell
ISSN 1369-6513
LanguageEnglish

Journal
Health Expectations: Volume 21, Issue 1

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