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Original research
What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for stroke? A stakeholder interview study
  1. Manoj M Lalu1,2,
  2. Madison Foster2,
  3. Justin Presseau2,3,
  4. Dar Dowlatshahi4,5,
  5. Gisell Castillo2,
  6. Analyssa Cardenas2,
  7. Whitney Tam2,
  8. Jennifer Zlepnig6,
  9. Deborah Timpson7,
  10. Yuan Yi Dong6,
  11. Pascale Juneau2,
  12. Dean A Fergusson2
  1. 1Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada
  2. 2Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  3. 3School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
  4. 4Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  5. 5Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  6. 6Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  7. 7Department of Rehabilitation, Pembroke Regional Hospital, Pembroke, Ontario, Canada
  1. Correspondence to Dr Dean A Fergusson; dafergusson{at}ohri.ca

Abstract

Objectives Early phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation.

Design Semistructured interview study.

Setting Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.

Participants Thirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews.

Methods Interview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.

Results Most patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility.

Conclusions This novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.

  • mesenchymal stem cells (MSCs)
  • stem cells
  • cellular therapy
  • chronic stroke
  • theoretical domains framework
  • clinical trials
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @manojlalu

  • MML and MF contributed equally.

  • Contributors MML and DAF: conception and design, methodology, provision of study material, manuscript writing and supervision. MF: data analysis and interpretation and manuscript writing. JP and DD: conception and design, methodology, provision of study material and manuscript writing. GC: manuscript writing. AC, JZ and YYD: collection and assembly of data, data analysis and interpretation and manuscript writing. WT: collection and assembly of data, data analysis and interpretation. DT: provision of study patients and manuscript writing. PJ: collection and assembly of data and final approval of manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethics approval was obtained from the Ottawa Health Science Network Research Ethics Board (20160708–01H) and the Pembroke Regional Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. The data that support the findings of this study are available from the corresponding author on reasonable request.

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