Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
BMJ Open. 2020 Mar 19;10(3):e034354. doi: 10.1136/bmjopen-2019-034354.
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.
Semistructured interview study.
Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.
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.
Interview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.
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.
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.
早期细胞治疗试验面临许多障碍，难以成功及时完成。为了优化计划中的骨髓间充质干细胞（MSC）治疗慢性中风的临床试验的实施，我们调查了患者和医生对可能影响其参与的障碍和促进因素的看法。
半结构式访谈研究。
患者在加拿大安大略省的三家康复中心招募；医生通过滚雪球抽样在加拿大各地招募。
13 名慢性中风患者（中风至少 3 个月前发病；10 名男性，3 名女性）和 15 名医生（中风物理治疗师；9 名男性，6 名女性）参加了我们的访谈研究。进行了 13 次患者访谈和 13 次医生访谈后，达到了数据充足性。
访谈指南和定向内容分析基于理论领域框架（TDF）。对访谈进行编码，并确定了相关主题。
大多数患者对参与 MSC 治疗临床试验持乐观态度，许多患者表示有兴趣参与，即使这是一项随机对照试验，有可能被分配到安慰剂组。然而，细胞的给药方式（血管内优于脑内）和试验的目标（疗效优于安全性）可能会影响他们的参与意愿。所有医生都表示有兴趣参与该试验的筛选，但许多医生表示，他们对参与安全性试验的动力较小。医生还确定了一些与时间相关的障碍和资源需求，以确保可行性。
在进行骨髓间充质干细胞治疗中风的临床试验之前，该 TDF 的新颖应用有助于确定关键的潜在障碍和促进因素。这将用于改进我们试验的设计和实施。其他考虑早期细胞治疗试验的研究人员也可以采用类似的方法。
