Studying neurosurgical implants for Parkinson disease: a question of design.
North American researchers' perspectives on designing neurosurgical implant studies for Parkinson disease (PD) challenged the custom of holding surgical trials to less stringent evidentiary standards than other clinical studies. Researchers supported placebo surgery-controlled trials. The framework they used to design and evaluate studies both of deep brain stimulation and cellular implants for PD may be applicable to a broad range of surgical implants for other disorders.
Prehn
A W
AW
Minnesota Center for Health Care Ethics, 601 25th Avenue South, Minneapolis, MN 55454, USA. prehn@stolaf.edu
Vawter
D E
DE
Gervais
K G
KG
DeVries
R G
RG
Garrett
J E
JE
Freeman
T B
TB
McIndoo
T Q
TQ
D035843:Biomedical Research; D017690:Cell Transplantation; D046690:Deep Brain Stimulation; D006801:Humans; D010300:Parkinson Disease / Q000628:therapy*; D012107:Research Design / Q000592:standards*