Discussion Meetings

Dr. Cassandra J. Thomson presented the results of a recent qualitative study on the lived experiences of patients suffering from treatment resistant depression (TRD) and their caregivers before and after the deep brain stimulation (DBS) treatment.

This study contributed to a relatively sparse literature examining the lived experiences of DBS patients and their families and fits within an ongoing debate in neuroethics on whether and how DBS affects personality, self-perception and relationships. Qualitative studies are best able to capture complex and nuanced experiences, which are difficult to capture in quantitative studies using standardized scales.

The authors carried out semi-structured interviews with 6 DBS candidates and 5 caregivers before and after the DBS implantation and treatment and used iterative thematic analysis to analyze their data. Three primary themes were identified: 1-impact of mental illness and treatment on self-concept; 2- device acceptability and usability, and 3- relationships and connection. Details of the views expressed within these themes are available in the paper.

Dr. Thomson and colleagues concluded that patient and caregiver experiences demonstrated that the effect of DBS is gradual and involves an evolving self-concept, shifting relationship dynamics, and growing connection between body and device. For future directions and further work to do, she suggested that preparation and psycho-social rehabilitation resources need to be developed, caregivers should be educated and supported, measures should be taken to increase the patient satisfaction and user experience with rechargeable DBS devices, and that narrative accounts of patients and caregivers need to be more routinely collected.

Some of the themes emerging in the subsequent discussion involved:

• The nature of the growing connection between body and device, and whether the device ever came to be perceived as part of the body.
• The best methods for exploring user experiences of technology, comparing qualitative and quantitative methods, as well as different theoretical approaches to qualitative research.
• The adequacy of the informed  consent process for invasive brain surgery for psychiatric indications.
• The absence of statements suggesting the perception of loss of autonomy or agency as a result of the input of the devices to patients’ mental states. Rather patients attributed side effects to the devices (like medication side effects) rather than changes to the underlying self.  Furthermore, the device was perceived as restoring the real personality that had been altered by psychiatric illness.
• Extension of these studies to other groups and cultures, as well as longer-term follow-up to capture change over time.
• Post-trial continuity of care and responsibility in the context of implanted brain devices.

Professor Quigley and Dr. Downey presented their recent chapter on the legal challenges posed by integrated medical devices. The binary approach of the common law to conceptualizing person (legal subject) and device (object) results in fundamental conceptual and normative problems for emerging everyday cyborgs – people with attached and implanted medical devices.

The authors draw on Graeme Laurie’s work on the liminal analysis of law, arguing that the law should be transformed to account for the missing ‘spaces in-between’ so that it can account for the hybrid status of integrated medical devices. They use Laurie’s approach to liminal spaces to critique the manner in which medical research is regulated. This results in multiple overlapping regulatory regimes that are formed around legally constructed ‘ bounded objects’ i.e ‘tissues’, ‘data’ and ‘embryos’, that focus on objects rather than research subjects.  This results in inefficient and fragmented regulatory ‘silos.’

Quigley and Downey also point to medical device regulation – particularly regulation of integrated health devices – which treats devices narrowly as products or commodities to be regulated for safety purposes. The Cumberlege Review  (Independent Medicines and Medical Devices Safety Review), found that patient voices and experiences have been decentred and marginalized. This undermined informed choice and reporting of adverse events. They suggest that the liminal analytical approach helps to reorient regulatory attention to bring in the patient’s voice and experiences. The focus becomes the integrated person, in which device and person have a conjoined future, rather than the device or object.

The authors also address Graeme Laurie’s processual approach to regulation, which acknowledges enduring relationships between subjects and objects, acknowledges the fluidity within these categories, and recognizes the identity implications of these relationships. This too is useful in addressing the regulation of integrated medical devices in a way that captures the importance of those devices for patients and provides more room for their voices. They concluded by making concrete and much needed proposals for UK national regulations such as entrusting an independent body like a patient safety commissioner to act as a guide to healthcare system and patients, respond to crisis more swiftly and even prevent them and provide opportunity for coproduction of regulation along with enabling meaningful engagement of subjects to the process as recommended in the Cumberlege Review.

Some of the themes emerging in the subsequent discussion involved:

• The strengths and weaknesses of other approaches to addressing the regulation of integrated medical devices, including the adoption of RRI (Responsible Research and Innovation) principles.
• How the law should address the categorization challenges for integrated medical devices. Should (can) the distinction between subject and object be abandoned to create a new class of hybrids, or should the line between the two be drawn in a more refined and principled manner?  
• Should the law take into consideration the phenomenological perceptions of users?  If a device is embodied, should it be legally classified as part of the body?