title: Are patients with amyotrophic lateral sclerosis at risk of a therapeutic misconception?
abstract: To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a therapeutic misconception (TM) in which they misconceive research as treatment or overestimate the likelihood of its benefit.
  
  
  
  72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study ('purpose-of-research question') and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates.
  
  
  
  Although 10 of 72 (14%) subjects incorrectly said that the intervention study was 'mostly intending to help [me]' in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects' mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%-54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant 'those are the facts' or 'there is a lot of uncertainty', the estimates were much lower (12.6% and 18.5%, respectively).
  
  
  
  In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low.
authors.affiliation: Department of Bioethics, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Scott Yh
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Center for Human Experimental Therapeutics, University of Rochester, Rochester, NY, USA.
authors.forename: Renee
authors.initials: R
authors.lastname: Wilson
authors.affiliation: Department of Learning Health Sciences, University of Michigan, Ann Arbor, MI, USA Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: De Vries
authors.affiliation: Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Kerry A
authors.initials: KA
authors.lastname: Ryan
authors.affiliation: Department of Neurology, University of Rochester, Rochester, NY, USA.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Holloway
authors.affiliation: Department of Neurology, University of Rochester, Rochester, NY, USA Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA.
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
mesh_terms: D000690:Amyotrophic Lateral Sclerosis / Q000523:psychology; D002986:Clinical Trials as Topic / Q000941:ethics*; D032882:Comprehension; D003661:Decision Support Techniques; D032984:Ethics, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D008824:Michigan; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology; D055990:Therapeutic Misconception / Q000941:ethics
keywords: Clinical trials; Decision-making; Informed Consent; Research Ethics; Research on Special Populations