title: Ethics of sham surgery: perspective of patients.
abstract: Sham surgery is used as a control condition in neurosurgical clinical trials in Parkinson's disease (PD) but remains controversial. This study aimed to assess the perspective of patients with PD and the general public on the use of sham surgery controls. We surveyed consecutive patients from a university-based neurology outpatient clinic and a community-based general internal medicine practice. Background information was provided regarding PD and two possible methods of testing the efficacy of a novel gene transfer procedure, followed by questions that addressed participants' opinions related to the willingness to participate and permissibility of blinded and unblinded trial designs. Two hundred eighty-eight (57.6%) patients returned surveys. Patients with PD expressed less willingness to participate in the proposed gene transfer surgery trials. Unblinded studies received greater support, but a majority would still allow the use of sham surgery. Those in favor of sham surgery were more educated and more likely to use societal perspective rationales. Patients with PD are more cautious about surgical research participation than patients with non-PD. Their policy views were similar to others', with a majority supporting the use of sham controls. Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery.
authors.affiliation: Department of Neurology, Boston University School of Medicine, Boston, Massachusetts, USA. samfrank@bu.edu
authors.forename: Samuel A
authors.initials: SA
authors.lastname: Frank
authors.forename: Renee
authors.initials: R
authors.lastname: Wilson
authors.forename: Robert G
authors.initials: RG
authors.lastname: Holloway
authors.forename: Carol
authors.initials: C
authors.lastname: Zimmerman
authors.forename: Derick R
authors.initials: DR
authors.lastname: Peterson
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
mesh_terms: D000368:Aged; D003710:Demography; D026690:Ethics, Clinical; D005260:Female; D015316:Genetic Therapy / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000941:ethics*; D010300:Parkinson Disease / Q000601:surgery* / Q000628:therapy; D010919:Placebos; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
chemical_list: D010919:Placebos