Abstract #8: Parkinson's Disease Patients Willingness to Accept Risk Associated with Potentially Disease-Modifying Surgical Procedures

Exciting treatments postulated to slow the progression of Parkinson's disease (PD) include gene therapy and deep brain stimulation (DBS). These therapies also have risks of death or permanent disability. If DBS, for example, were proven to be disease modifying, standard treatment would necessitate DBS as early as the diagnosis is reasonably confirmed. Because at this stage patients have little disability, they will choose to receive the therapy only if the magnitude of disease modification is large enough to outweigh the risks. We therefore sought to concretely illuminate the amount of benefit that was perceived by patients to make the risk of DBS reasonable. With IRB exemption, a research assistant was posted in the Vanderbilt Movement Disorders Clinic and interviewed all PD patients over a four-week period. Patients were read a description of a theoretical neuroprotective neurosurgical procedure, including a 10% risk of infection and 2% risk of disabling stroke or death. Patients were then asked, if this therapy could delay the amount of time it took them to become disabled or otherwise need significant assistance by x, whether they would want the treatment. The following answer choices were inserted for x until they answered affirmatively: 6 months, 1, 2, 5, and 10 years. Overall, patients with PD wanted to receive the hypothetical therapy. Only one patient said he would not choose to receive the therapy regardless of how long it extended independence. Of the remaining patients, 50% said they would choose the therapy with five or fewer years of slowing, and 50% said they would choose the therapy with greater than five years. The median answer was 6.3 years of additional independence. PD patients would elect a neurosurgical procedure with moderate risks if it offered meaningful disease slowing. Investigators designing future trials of potentially disease-modifying therapies that carry significant risks should consider the likelihood that future patients would choose to receive the therapy, even if the results are positive.

Financial Sponsors

This research was not funded. Vanderbilt University has received income from Medtronic for research lead by Dr. Charles, and he has received income from Medtronic for speaking and consulting services.