Jonathan Pugh is a Parfit-Radcliffe Richards Senior Research Fellow and Manager of Visitors Programmes for the Oxford Uehiro Centre, University of Oxford. He recently led a Wellcome Trust funded project entitled "The Ethics of Novel Therapeutic Applications of Deep Brain Stimulation". His research interests lie primarily in issues concerning personal autonomy in practical ethics, particularly topics pertaining to informed consent. He has also written on the ethics of human embryonic stem cell research, criminal justice, human enhancement, and gene-editing.
Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.
Humans, Placebos, Surgical Procedures, Operative, Research Design, Randomized Controlled Trials as Topic, Guidelines as Topic
No going back? Reversibility and why it matters for deep brain stimulation.
Journal of medical ethics
Deep brain stimulation (DBS) is frequently described as a 'reversible' medical treatment, and the reversibility of DBS is often cited as an important reason for preferring it to brain lesioning procedures as a last resort treatment modality for patients suffering from treatment-refractory conditions. Despite its widespread acceptance, the claim that DBS is reversible has recently come under attack. Critics have pointed out that data are beginning to suggest that there can be non-stimulation-dependent effects of DBS. Furthermore, we lack long-term data about other potential irreversible effects of neuromodulation. This has considerable normative implications for comparisons of DBS and brain lesioning procedures. Indeed, Devan Stahl and colleagues have recently argued that psychiatric DBS should be subject to the same legal safeguards as other forms of psychosurgery, supporting their position by forcibly criticising the claim that DBS is reversible. In this paper, I respond to these criticisms by first clarifying the descriptive and evaluative elements of the reversibility claim that supporters of DBS might invoke, and the different senses of 'reversibility' that we might employ in discussing the effects of medical procedures. I go on to suggest that it is possible to defend a nuanced version of the reversibility claim. To do so, I explain how DBS has some effects that are stimulation dependent in the short term, and argue that these effects can have significant normative implications for patient well-being and autonomy. I conclude that we should not abandon a nuanced version of the reversibility claim in the DBS debate.
Humans, Parkinson Disease, Iatrogenic Disease, Treatment Outcome, Deep Brain Stimulation, Personality, Differential Threshold, Personal Autonomy, Mental Disorders, Neural Inhibition