Dissociations in the meaning of risk between health-care professionals and individuals with spinal cord injury

Abstract

Objective: Risks have been a central concern in stem cell research overall, and in clinical trials of individuals with spinal cord injury (ISCIs) in particular. We sought to elucidate how two important stakeholder groups-health-care professionals (HCPs) and ISCIs-view and value both the physical and non-physical risks of stem cell interventions. Setting: The study was conducted in Canada, and included participants from both Canada and the United States America. Study design: We used semi-structured interviews to gain perspectives on risk from HCPs and ISCIs. Methods: We applied a constant comparative analytic strategy to derive themes from the discourse collected through the interviews. Results: We identified three major themes about risk from 12 HCP and 24 ISCI participants: focus, rationale and approach. The salient components of the themes differed: HCPs focus on the physical causes of risks, and the ISCIs on their downstream consequences as well as on non-physical risks; HCPs are concerned about evidence, and ISCIs about experience; and HCPs approach risk narrowly, whereas the approach of ISCIs is more broad and contextualized. Conclusion: Although major themes were common to the two stakeholder groups, the components of the themes were dissociable and illustrate differences in what HCPs and ISCIs worry about, why they worry and how they approach their worries. We draw upon these findings to make recommendations for improving risk communication and informed consent for stem cell research for spinal cord injury.

Novel Neurotechnological Interventions for Pediatric Drug-Resistant Epilepsy: Physician Perspectives

“…21,22 The focus on the goal of seizure freedom could improve by incorporating the values of parents, who emphasize the importance of quality of life and a holistic risk-benefit trade-off on treatment, as supported in other decision-making and outcome literature. 8,19,23,24 In addition, as parents may have early preferences for the latest neurotechnologies, physicians identified the role of careful communication and guidance toward the most appropriate treatment. Communication style-for example, timing and responsiveness-is important to decision making for resective epilepsy surgery 19 and other pediatric chronic disease 25 and is critical for informed consent.…”

“…6 For various areas of biomedicine, neuroethics has been used as a lens from which to understand the decision-making values, priorities, needs, and other key factors relevant to diverse stakeholders. For example, in a series of qualitative studies on stem cells, areas of misalignment were identified between individuals with spinal cord injuries and health care providers in the target timing of clinical trials, 7 definitions of risk, 8 and trust. 9 In the realm of novel neurotechnology, results of a first-in-human brain-computer interface trial on adults with epilepsy revealed a complicated tension between the transformative sense of autonomy afforded by the device and feelings of self-estrangement.…”

Ethical Issues Surrounding a New Generation of Neuroprostheses for Patients With Spinal Cord Injuries

“…Indeed, numerous studies have shown that researchers and participants have divergent expectations and risk tolerance with regard to SCI research outcomes [11,12] and diverse functional priorities for BCI use [13]. Given these differences between participants, clinicians, and researchers regarding the purpose of such research, special protocols may be needed to ensure that expectations are discussed and disagreement is fairly adjudicated.…”

Perspectives on strategies and challenges in the conversation about stem cells for spinal cord injury

“…Using methods from past studies, we applied a thematic analysis approach to the data, involving a rigorous and an iterative process in which portions of raw data are labelled and examined for broader themes across the data set. 10 To develop the initial coding frame, two coders who were trained in qualitative research methods acted independently to examine the transcripts and came together to compare codes until a consensus was reached. These codes were continuously revisited, revised and added to as analysis went on.…”

“…Trust and effective and trusted communication in the patient-physician relationship have been linked to positive patient behaviours involving treatment decisions, compliance and information disclosure. 5 In the present study, one of a series on readiness for clinical trials, 6 decision making, 7 expectation of benefit and risk, 8 advocacy 9 and risk, 10 we sought to examine how these trusting relationships specifically are fostered and threatened in the context of the conversation about stem cell interventions for SCI.…”