Shelly Benjaminy1, Cody Lo1, Judy Illes1, Anthony Traboulsee1. 1. Neuroethics Canada (SB, CL, JI) and Division of Neurology, Department of Medicine (SB, CL, JI, AT), University of British Columbia, Vancouver, Canada. SB is currently affiliated with AbilityLab, Chicago, IL.
Abstract
BACKGROUND: We sought to characterize the perspectives of participants in Canada's phase I/II chronic cerebrospinal venous insufficiency (CCSVI) clinical trial prior to and after the disclosure of trial results. METHODS: This was a researcher-administered survey of individuals who participated in Canada's CCSVI trial (Clincialtrials.gov, NCT01864941) about their (1) motivations for participating, (2) understanding of the trial process, and (3) perspectives on the social value of the trial. RESULTS: A total of 63 participants completed the survey. Participants were motivated to participate by altruism (mean score = 4.56 out of 5) and a desire to access the intervention in Canada (mean score = 3.63 out of 5). Many participants expected medical benefits, such as partial disease reversal (mean score = 3.32 out of 5). Participants felt strongly that the crossover trial design promoted fairness (mean score = 4.65 out of 5). Participants' familiarity with the CCSVI controversy increased significantly after the results were revealed (p = 0.0001). Despite negative trial results, participants still felt that the trial was an appropriate use of tax dollars (mean score = 4.68 out of 5). Many (38%) upheld the belief that further CCSVI research is necessary (responses of 4 out of 5 or higher). CONCLUSIONS: There is a strong movement in science today to ensure that research agendas reflect the perspectives of multiple stakeholders, including research participants. While previous work suggests that negative findings adversely affect trust in science, the perspectives of participants in this study demonstrate that good trial design and resilience can prevail over expected tensions.
BACKGROUND: We sought to characterize the perspectives of participants in Canada's phase I/II chronic cerebrospinal venous insufficiency (CCSVI) clinical trial prior to and after the disclosure of trial results. METHODS: This was a researcher-administered survey of individuals who participated in Canada's CCSVI trial (Clincialtrials.gov, NCT01864941) about their (1) motivations for participating, (2) understanding of the trial process, and (3) perspectives on the social value of the trial. RESULTS: A total of 63 participants completed the survey. Participants were motivated to participate by altruism (mean score = 4.56 out of 5) and a desire to access the intervention in Canada (mean score = 3.63 out of 5). Many participants expected medical benefits, such as partial disease reversal (mean score = 3.32 out of 5). Participants felt strongly that the crossover trial design promoted fairness (mean score = 4.65 out of 5). Participants' familiarity with the CCSVI controversy increased significantly after the results were revealed (p = 0.0001). Despite negative trial results, participants still felt that the trial was an appropriate use of tax dollars (mean score = 4.68 out of 5). Many (38%) upheld the belief that further CCSVI research is necessary (responses of 4 out of 5 or higher). CONCLUSIONS: There is a strong movement in science today to ensure that research agendas reflect the perspectives of multiple stakeholders, including research participants. While previous work suggests that negative findings adversely affect trust in science, the perspectives of participants in this study demonstrate that good trial design and resilience can prevail over expected tensions.
Authors: Jodie M Burton; Katayoun Alikhani; Mayank Goyal; Fiona Costello; Chris White; David Patry; Robert Bell; Michael D Hill Journal: Can J Neurol Sci Date: 2011-09 Impact factor: 2.104
Authors: Jeremy Snyder; Krystyna Adams; Valorie A Crooks; David Whitehurst; Jennifer Vallee Journal: BMC Health Serv Res Date: 2014-09-30 Impact factor: 2.655