Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery. (12th October 2017)

• Record Type: Journal Article
• Authors: Cunningham, Nicola A.; Abhyankar, Purva; Cowie, Julie; Galinsky, Jayne; Methven, Karen
• Is Part Of: Health expectations. Volume 21:Number 1(2018)
• Page Start: 367
• Page End: 378
• Publication Date: 2017-10-12
• Subjects: caregiver burden -- consent -- regenerative medicine -- treatment decision‐making; Medical policy -- Periodicals; Public health -- Periodicals; Health planning -- Periodicals; 362.105
• DOI: 10.1111/hex.12632
• Languages: English
• ISSNs: 1369-6513

Abstract

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.