When experimental treatments involve neurosurgery, researchers often use a placebo condition called sham surgery, which involves an invasive procedure (e.g., partial thickness burr holes). Some ethics review committees are concerned about the use of sham surgery in studies involving patients with a progressively debilitating disease such as PD because they are concerned such patients might volunteer with what ethicists call a therapeutic misconception—the subjects may believe they are being offered a "cutting edge treatment" when in fact they are being asked to serve as experimental subjects. It is important to clarify this important ethical issue since the use of sham surgery controls will likely increase with the development of new treatments for PD.
In this project, we will interview actual participants of PD clinical trials that involve sham surgery controls. Using in depth interviews, we will assess the potential for the therapeutic misconception by describing why and how PD patients make their decisions regarding participation in sham surgery controlled studies. A semi-structured interview method has been developed to provide an in depth account of the subjects’ motivations, expectations, and understanding. The interview is designed to encourage participants to tell their stories, as a chronological narrative, so that a sense of how they came to make their decisions is revealed.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Since the use of sham surgery controls will likely increase with the development of new treatments for PD, policies will need to be developed regarding the use of sham surgery controls in neurosurgical trials. These policies should be informed by the perspectives of research participants. Our hope is to better understand the decisions patients make, to inform future policy decisions. In addition, this project will provide invaluable insights for optimizing informed consent practices for future sham surgery controlled trials.
If our results indicate areas of concern, we will be able to inform policy makers of these issues and pinpoint potential solutions. If the results indicate a low incidence of misconceptions, it may allay current concerns over sham surgery, and help expedite the development of future neurosurgical trials.
As a result of our interviews, we have been able to better describe how patients make decisions whether to participate in early-phase gene transfer and cell implantation trials for PD that involve sham surgical controls. We have found that patients make careful considerations about issues such as the chance of benefit and risk involved in the trial, their personal motivations for participating and their assessment of their current functioning and PD status. We have also had the opportunity to evaluate patients’ understanding surrounding factors such as the purpose of research, the rationale for sham surgical controls and various study design elements.
The interviews we performed as part of this project have led to opportunities to interview additional subjects enrolled in some new early-phase clinical trials for PD. We were able to leverage the funding from our Rapid Response Innovation Award to obtain a R01 award from NINDS to continue this line of research. As part of this new project, we hope to interview subjects enrolling in a phase I/II gene transfer study for PD starting in 2010. In addition we recently published a paper which discusses the approach we employed in this study to examine patients’ decision making in early phase trials.