Open AccessRegenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery
Author(s) -
Cunningham Nicola A.,
Abhyankar Purva,
Cowie Julie,
Galinsky Jayne,
Methven Karen
Publication year - 2018
Publication title -
health expectations
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.314
H-Index - 74
eISSN - 1369-7625
pISSN - 1369-6513
DOI - 10.1111/hex.12632
Subject(s) - thematic analysis , focus group , qualitative research , stroke (engine) , medicine , conversation , randomized controlled trial , psychology , physical therapy , mechanical engineering , social science , communication , marketing , sociology , engineering , business
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.