title: Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers.
abstract: BACKGROUND
  Sham surgery is used in neurosurgical clinical trials in Parkinson disease (PD) but remains controversial. The controversy may be compounded when gene-transfer technologies are tested in sham surgical trials.
  
  
  OBJECTIVE
  To determine the perspective of PD clinical researchers on the science and ethics of sham-surgery controls when used to test novel interventions such as gene transfer for PD.
  
  
  METHODS
  Internet survey eliciting both quantitative and qualitative responses.
  
  
  METHODS
  Investigator members of the Parkinson Study Group.
  
  
  RESULTS
  Overall response rate was 103 (61.3%) of 168 researchers. A large majority (97%) of PD clinical researchers believe sham-surgery controls are better than unblinded controls for testing the efficacy of neurosurgical interventions such as gene transfer for PD. Half of the researchers believe an unblinded control efficacy trial would be unethical because it may lead to a falsely positive result. A minority (less than 22%) believe that an invasive sham condition that involves penetration of brain tissue is justified.
  
  
  CONCLUSIONS
  It appears unlikely that the PD clinical research community will perceive future neurosurgical interventions for PD, such as gene-transfer therapies, as truly efficacious unless a sham-control condition is used to test it.
authors.affiliation: Department of Psychiatry, Bioethics Program, Center for Behavioral and Decision Sciences in Medicine, University of Michigan, Ann Arbor, 48109, USA. scottkim@umich.edu
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
authors.forename: Samuel
authors.initials: S
authors.lastname: Frank
authors.forename: Robert
authors.initials: R
authors.lastname: Holloway
authors.forename: Carol
authors.initials: C
authors.lastname: Zimmerman
authors.forename: Renee
authors.initials: R
authors.lastname: Wilson
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
mesh_terms: D000328:Adult; D003625:Data Collection; D032984:Ethics, Research; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000941:ethics / Q000379:methods / Q000706:statistics & numerical data; D010300:Parkinson Disease / Q000601:surgery*; D015990:Placebo Effect; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods / Q000706:statistics & numerical data; D012107:Research Design; D012189:Retrospective Studies; D036302:Therapeutic Human Experimentation / Q000941:ethics*