This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (12)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in this journal  Topic Collections  • Medical Ethics  • Movement Disorders  • Parkinson Disease/ Parkinsonian Disorders  • Surgery  • Neurosurgery  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

A Survey of Parkinson Disease Clinical Researchers

Scott Y. H. Kim, MD, PhD; Samuel Frank, MD; Robert Holloway, MD, MPH; Carol Zimmerman, RN; Renee Wilson, MA; Karl Kieburtz, MD, MPH

Arch Neurol. 2005;62:1357-1360.

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.

Design  Internet survey eliciting both quantitative and qualitative responses.

Participants  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.

Conclusion  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.

Author Affiliations: Department of Psychiatry, Bioethics Program, Center for Behavioral and Decision Sciences in Medicine, University of Michigan, Ann Arbor (Dr Kim); Department of Neurology, Boston University, Boston, Mass (Dr Frank); Department of Neurology, University of Rochester, Rochester, NY (Drs Kieburtz and Holloway, Ms Wilson, and Ms Zimmerman).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

RELATED ARTICLE

Double-Blind, Placebo-Controlled Trials for Surgical Interventions in Parkinson Disease
C. Warren Olanow
Arch Neurol. 2005;62(9):1343-1344.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Evidenced-based medicine in obstetrics: can levels B and C recommendations be elevated to level A recommendations?
For the Evidenced-Based Medicine Obstetric Group: et al.
Obstet Med 2009;2:63-66.
ABSTRACT | FULL TEXT  

The scientific and clinical basis for the treatment of Parkinson disease (2009)
Olanow et al.
Neurology 2009;72:S1-S136.
ABSTRACT | FULL TEXT  

Long-term fetal cell transplant in Huntington disease: Stayin' alive
Frank and Biglan
Neurology 2007;68:2055-2056.
FULL TEXT  

Studying neurosurgical implants for Parkinson disease: A question of design
Prehn et al.
Neurology 2006;67:1503-1505.
ABSTRACT | FULL TEXT  

A randomized trial of deep-brain stimulation for Parkinson's disease.
Deuschl et al.
NEJM 2006;355:896-908.
ABSTRACT | FULL TEXT  

What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports
Landau et al.
Neurology 2006;66:1788-1789.
FULL TEXT  

Double-Blind, Placebo-Controlled Trials for Surgical Interventions in Parkinson Disease
Olanow
Arch Neurol 2005;62:1343-1344.
FULL TEXT