Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers.
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.
Kim
Scott Y H
SY
Department of Psychiatry, Bioethics Program, Center for Behavioral and Decision Sciences in Medicine, University of Michigan, Ann Arbor, 48109, USA. scottkim@umich.edu
Frank
Samuel
S
Holloway
Robert
R
Zimmerman
Carol
C
Wilson
Renee
R
Kieburtz
Karl
K
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*