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

Nicola A Cunningham, Purva Abhyankar, Julie Cowie, Jayne Galinsky, Karen Methven

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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.
Original languageEnglish
Pages (from-to)367-378
Number of pages12
JournalHealth Expectations
Volume21
Issue number1
Early online date12 Oct 2017
DOIs
Publication statusPublished - Feb 2018

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Regenerative Medicine
Neurosurgery
Caregivers
Survivors
Motivation
Stem Cells
Stroke
Placebos
Clinical Trials
Hope
Randomized Controlled Trials
Weights and Measures
Health Services Research
Cell- and Tissue-Based Therapy
Focus Groups
Decision Making
Psychology

Keywords

  • caregiver burden
  • consent
  • regenerative medicine
  • treatment decision-making

Cite this

Cunningham, Nicola A ; Abhyankar, Purva ; Cowie, Julie ; Galinsky, Jayne ; Methven, Karen. / Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery. In: Health Expectations. 2018 ; Vol. 21, No. 1. pp. 367-378.
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Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery. / Cunningham, Nicola A; Abhyankar, Purva; Cowie, Julie; Galinsky, Jayne; Methven, Karen.

In: Health Expectations, Vol. 21, No. 1, 02.2018, p. 367-378.

Research output: Contribution to journalArticle

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AU - Cowie, Julie

AU - Galinsky, Jayne

AU - Methven, Karen

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PY - 2018/2

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N2 - 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.

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