Ethics of sham surgery: Perspective of patients

Abstract

Sham surgery is used as a control condition in neurosurgical clinical trials in Parkinson's disease (PD) but remains controversial. This study aimed to assess the perspective of patients with PD and the general public on the use of sham surgery controls. We surveyed consecutive patients from a university-based neurology outpatient clinic and a community-based general internal medicine practice. Background information was provided regarding PD and two possible methods of testing the efficacy of a novel gene transfer procedure, followed by questions that addressed participants' opinions related to the willingness to participate and permissibility of blinded and unblinded trial designs. Two hundred eighty-eight (57.6%) patients returned surveys. Patients with PD expressed less willingness to participate in the proposed gene transfer surgery trials. Unblinded studies received greater support, but a majority would still allow the use of sham surgery. Those in favor of sham surgery were more educated and more likely to use societal perspective rationales. Patients with PD are more cautious about surgical research participation than patients with non-PD. Their policy views were similar to others', with a majority supporting the use of sham controls. Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery. © 2007 Movement Disorder Society Key words: sham surgery; Parkinson's disease; placebo controlled trials; gene therapy. The use of placebo or sham surgery controls in randomized trials of surgical interventions is becoming more common in Parkinson's disease (PD) research 1-5 but is not without controversy. 6 Aside from questions surrounding informed consent, the controversy over sham surgery controls involves two predominant issues. The first is whether a randomized clinical trial with sham surgery control is a scientifically superior method to test novel neurosurgical interventions for PD. PD researchers believe that a placebo surgery should be used as a control condition when testing a novel surgical intervention. 7 Second, are the risks to subjects in randomized clinical trials with sham surgery controls reasonable in relation to the potential benefit to the subjects and to society? Some of the risks associated with sham surgery in PD have been summarized, 8 but the opinion of whether the risks and burdens associated with sham surgery are too high requires input from the patients who are the potential study participants.Patients who are currently experiencing the symptoms of PD may be better able to compare the risks and benefits and best answer whether the risks to individuals is worth the benefit to science and society. Therefore, we developed a hypothetical scenario describing a gene transfer intervention with promising initial results and surveyed patients regarding their views on the use of sham surgery as the placebo in controlled surgical trials. PATIENTS AND METHODS Participants 63a neurology clinic wit...

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