Comparison of enrollees and decliners of Parkinson disease sham surgery trials

Authors

  • Scott Y.H. Kim MD, PhD,

    Corresponding author
    1. Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA
    2. Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, USA
    • Center for Bioethics and Social Sciences in Medicine, University of Michigan, 300 North Ingalls Street, 7C27, Ann Arbor, MI 48109, USA

    Search for more papers by this author
  • Renee M. Wilson MA,

    1. Center for Human Experimental Therapeutics, University of Rochester, Rochester, New York, USA
    Search for more papers by this author
  • H. Myra Kim ScD,

    1. Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA
    Search for more papers by this author
  • Robert G. Holloway MD, MPH,

    1. Department of Neurology, University of Rochester, Rochester, New York, USA
    2. Department of Community and Preventive Medicine, University of Rochester, Rochester, New York, USA
    Search for more papers by this author
  • Raymond G. De Vries PhD,

    1. Department of Medical Education, University of Michigan, Ann Arbor, Michigan, USA
    2. Department of Sociology, University of Michigan, Ann Arbor, Michigan, USA
    3. Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, USA
    Search for more papers by this author
  • Samuel A. Frank MD,

    1. Department of Neurology, Boston University School of Medicine, Boston, Massachusetts, USA
    Search for more papers by this author
  • Karl Kieburtz MD, MPH

    1. Department of Neurology, University of Rochester, Rochester, New York, USA
    2. Department of Environmental Medicine, University of Rochester, Rochester, New York, USA
    3. Center for Human Experimental Therapeutics, University of Rochester, Rochester, New York, USA
    Search for more papers by this author

  • Relevant conflicts of interest/financial disclosures: Nothing to report.

  • Full financial disclosures and author roles may be found in the online version of this article.

Abstract

Concerns have been raised that persons with serious illnesses participating in high-risk research, such as PD patients in sham surgery trials, have unrealistic expectations and are vulnerable to exploitation. A comparison of enrollees and decliners of such research may provide insights about the adequacy of decision making by potential subjects. We compared 61 enrollees and 10 decliners of two phase II neurosurgical intervention (i.e., cellular and gene transfer) trials for PD regarding their demographic and clinical status, perceptions and attitudes regarding research risks, potential direct benefit, and societal benefit, and perspectives on the various potential reasons for and against participation. In addition to bivariate analyses, a logistic regression model examined variables regarding risks and benefits as predictors of participation status. Enrollees perceived lower risk of harm while tolerating higher risk of harm and were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, whereas the fact that the study's purpose was not solely to benefit them was rated as “not a reason” against participation. Hope for benefit and altruism were rated higher than expectation of benefit as reasons in favor of participation for both groups. Enrollees and decliners are different in their views and attitudes toward risk. Although both are attracted to research because of hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and does not imply a failure to understand the main purpose of research. © 2012 Movement Disorder Society

Ancillary