Medical devices are often referred to as being invasive or non-invasive. Though invasiveness is relevant, and central, to how devices are understood and regarded in medicine and bioethics, a consensus concept or definition of invasiveness is lacking. To begin to address this problem, this essay explores four possible descriptive meanings of invasiveness: how devices are introduced to the body, where they are located in the body, whether they are foreign to the body, and how they change the body. An argument (...) is offered that invasiveness is not purely descriptive, but implicates normative concepts of danger, intrusion, and disruption. In light of this, a proposal is offered for how to understand use of the concept of invasiveness in discussions of medical devices. (shrink)

Medical interventions are usually categorized as “invasive” when they involve piercing the skin or inserting an object into the body. Beyond this standard definition, however, there is little discussion of the concept of invasiveness in the medical literature, despite evidence that the term is used in ways that do not reflect the standard definition of medical invasiveness. We interviewed psychiatrists, patients with depression, and members of the public without depression to better understand their views on the invasiveness of several psychiatric (...) electroceutical interventions (treatments that involve electrical or magnetic stimulation of the brain) for the treatment of depression. Our study shows that people recognize several kinds of invasiveness: physical, emotional, and lifestyle. In addition, several characteristics of therapies influence how invasive they are perceived to be; these include the perceived capacity of an intervention to result in harm; how localized the effects of the intervention are; the amount of control retained by the person receiving the intervention; how permanent its effects are perceived as being; and how familiar it seemed to participants. Our findings contribute to a small literature on the concept of invasiveness, which emphasizes that categorizing an intervention as invasive, or as noninvasive, evokes a variety of other normative considerations, including the potential harm it poses and how it compares to other potential therapies. It may also draw attention away from other salient features of the intervention. (shrink)

Invasive neurotechnologies are a frequent subject of discussion in neuroethics. Technologies, like deep brain stimulation and implantable brain-computer interfaces, are thought to hold significant promise for human health and well-being, but they also raise important ethical questions about autonomy, safety, stigma, privacy, and agency, among others. The terms ‘invasive’ and ‘invasiveness’ are commonly applied to these and other neurotechnologies, yet the concept of invasiveness itself is rarely defined or delimited. Some have suggested that invasiveness may have multiple meanings – physical, (...) emotional, or lifestyle – and that confusion about how people use the terms may lead to harm, especially for users of invasive devices. It is uncertain if debates in neuroethics contribute to this confusion. To investigate this, we conducted a study of how the term ‘invasiveness’ is used in neuroethics. We found that neuroethicists almost always use ‘invasiveness’ to refer to the physical features of interventions, and rarely to refer to other senses of invasiveness. We also found that referencing invasiveness does not determine which ethical issues are prioritized for a given type of neurotechnology. Overall, this study affirms the importance of understanding the meaning and use of the concept of invasiveness in ethical discussion of neurotechnology while also suggesting the need for further work in the area and consideration for rethinking what forms of technology we consider to be invasive. (shrink)

Background Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat mental disorders and may raise different ethical concerns than other therapies such as medications or talk therapy. Yet little is known about stakeholders’ perceptions of, and ethical concerns related to, these interventions. We aimed to better understand the ethical concerns of a variety of stakeholder groups (patients with depression, caregivers of patients, members of the public, and psychiatrists) regarding four PEIs: electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), (...) deep brain stimulation (DBS), and adaptive brain implants (ABI). Methods We conducted a national survey of these four stakeholder groups, using an embedded video vignette experiment depicting a patient with treatment-resistant depression and her psychiatrist discussing the possibility of treatment with one of the four PEIs. Results Participants’ ethical concerns varied by stakeholder group, by PEI, and by the interaction of the two. The three non-clinician groups tended to have similar ethical concerns, but to differ from psychiatrists. Similar concerns were raised with regard to the two implantable technologies, DBS and ABI. Overall, there was relatively little concern about the involuntary use of PEIs, though some expressed concern about the adequacy of information provided during the consent process. There was also significant concern that patients may not receive helpful therapies. Conclusions To our knowledge, this is the first national survey that includes multiple stakeholder groups and multiple PEI modalities. A better understanding of the ethical concerns of stakeholders can help to shape clinical practice and health care policy regarding PEIs. (shrink)

De Marco and colleagues claim that the standard account of invasiveness as commonly encountered ‘…does not capture all uses of the term in relation to medical interventions1 ’. This is open to challenge. Their first example is ‘non-invasive prenatal testing’. Because it involves puncturing the skin to obtain blood, De Marco et al take this as an example of how an incision or insertion is not sufficient to make an intervention invasive; here is a procedure that involves an incision, but (...) it is regarded as non-invasive. However, this ignores the context, and the term should really be understood in reference to the fetus. It is hard to believe healthcare professionals regard taking blood to measure, for example, ferritin levels as invasive but taking blood to look for fragments of fetal DNA as not. If anyone uses the term thinking it is not invasive to the mother, the solution would be to call it invasive, not redefine what is invasive. De Marco and colleagues’ second example is describing electroconvulsive therapy (ECT) as invasive. However, this is not borne out by their referenced papers. The first cited source is about non-invasive brain stimulation2 and only contains a single sentence about ECT. This sentence may suggest that their view is that ECT …. (shrink)

Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat psychiatric conditions. For depression therapy, PEIs include both approved treatment modalities, such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), and experimental neurotechnologies, such as deep brain stimulation (DBS) and adaptive brain implants (ABIs). We present results from a survey-based experiment in which members of four relevant stakeholder groups (psychiatrists, patients with depression, caregivers of adults with depression, and the general public) assessed whether treatment with one of (...) four PEIs (ECT, rTMS, DBS, or ABIs) was better or worse than living with treatment-resistant depression (TRD) and then provided a narrative explanation for their assessment. Overall, the prevalence of many narrative themes differed substantially by stakeholder group—with psychiatrists typically offering different reasons for their assessment than non-clinicians—but much less so by PEI modality. A large majority of all participants viewed their assigned PEI as better than living with TRD, with their reasons being a mix of positive views about the treatment and negative views about TRD. The minority of all participants who viewed their assigned PEI as worse than living with TRD tended to express negative affect toward it as well as emphasize its riskiness, negative side effects, and, to a lesser extent, its invasiveness. The richness of these narrative explanations enabled us to put in context and add depth to key patterns seen in recent survey-based research on PEIs. (shrink)

De Marco et al 1 argue that the standard account of medical ‘invasiveness’ (as ‘incision’ or ‘insertion’) fails to capture three aspects of its existing use, namely that invasiveness can come in degrees, often depends on features of alternative medical interventions and can be non-physical. They propose a new schematic account that suggests that medical interventions can possess ‘basic invasiveness’ (which can come in degrees and of which they suggest at least two types: physical and mental), and ‘threshold invasiveness’ which (...) can depend on the alternatives a specific intervention is being compared with. While we agree that the standard account of invasiveness fails to capture existing use and are supportive of their aim, here we express scepticism about the practical utility of De Marco et al ’s revised account. Our scepticism concerns the application of De Marco et al’s revised account in the narrow context of clinician–patient communication and deliberation about medical interventions within clinical practice, which we see as a crucial context for its use. While De Marco et al do not specify the contexts in which their revised account could be used, we assume from their discussion of treatment interventions (e.g. non-invasive prenatal testing, ventilation) and their comparison to ‘more or less invasive’ options, that at least one of the purposes in mind for …. (shrink)

In their forthcoming article, ‘What makes a medical intervention invasive?’ De Marco, Simons, and colleagues explore the meaning and usage of the term ‘invasive’ in medical contexts. They describe a ‘Standard Account’, drawn from dictionary definitions, which defines invasiveness as ‘incision of the skin or insertion of an object into the body’. They then highlight cases wherein invasiveness is employed in a manner that is inconsistent with this account (eg, in describing psychotherapy) to argue that the term invasiveness is often (...) used to explicitly or implicitly reference interventions that do not fall under the standard account. The authors offer an alternative ‘schematic’ definition of invasiveness, whereby medical interventions entail an underlying context-independent property of ‘basic invasiveness’ and may be understood both relative to each other and to a context-specific threshold of what is ‘invasive’.1 We propose that the meaning of terms such as ‘invasiveness’ is necessarily heterogeneous, and that what is implied by its usage will certainly depend on context, particularly in medical settings. Hence, the creation of a unifying definition is less critical than clarification of the implied and intended meanings of each instance of the term’s use. We further argue that interpreting the use of terms like ‘invasiveness’ in medical practice is complicated by the embedding of each use of this term in a different ‘language game’, whereby words and their meanings are understood by an in-group familiar with …. (shrink)