Registering the importance of sharing outcomes of brain stimulation

I love it when a plan comes together (picture me here chomping on a cigar). Only on this occasion, I can’t pretend we pulled this one off through the creative repurposing of diverted rail tracks, converted freight containers and the doughty skills of B. A. Baracus.

Instead serendipitous timing meant that while the Nuffield Council on Bioethics was planning to kick-start discussions of a recommendation from our Novel Neurotechnologies report – that clinical registers should be established to record the outcomes of treatments using these technologies – the British Society for Stereotactic & Functional Neurosurgery (BSSFN) was itself working up proposals for a deep brain stimulation (DBS) registry. To capitalise on this happy coincidence we held a meeting in December for interested parties to discuss the practical and ethical priorities for a UK DBS register, and thus help to inform the BSSFN’s plans. Okay, it was a meeting that offered few opportunities for helicopter chases and lacked an iconic theme tune, but it was still pretty dynamic – and here’s why.

It swiftly became clear that many practitioners working with patients using DBS have been calling for some time for a means of capturing and sharing data on treatment outcomes. Their enthusiasm was evidenced by the attendance of many eminent names in the field, including Professor Tipu Aziz, who chaired the meeting on our behalf. However, this high level of interest was by no means limited to the clinicians present. During the course of the meeting we heard excellent presentations from Alex Green, President of the BSSFN and his colleague Alexis Johnannides about the BSSFN’s proposals; from Jonathan Howell, Consultant in Public Health, and Keith Tucker, consultant orthopaedic surgeon, about their respective experiences of working with existing registers in the UK – the Transcatheter Aortic Valve Implantation (TAVI) Registry and the National Joint Registry. Wider attendees, who contributed to a lively discussion that evidenced the timely nature of the proposals, included clinicians from the fields of neurosurgery, neurology and psychiatry, representatives from patients’ groups, NHS commissioning bodies, the National Institute for Health and Care Excellence (NICE), industry and academia.

Clearly ‘clinical register’ is not a label that conjures a single vision – there may have been as many imagined goals for a DBS register as there were people round the table. Registers can be designed to fulfil a number of distinct functions. In some cases they might primarily be intended as a means of post-market monitoring of implanted devices, enabling the identification of incident trends and a swift means of contacting those affected. In other circumstances they could chiefly be seen as a clinical audit tool, identifying performance outliers, supporting professional appraisal, or facilitating accountability and improvement amongst clinicians and centres. They can also be useful resources for research. However, their benefits can extend far beyond this monitoring and audit role, feeding a real need for high level evidence to be more widely available in this area.

In our Novel Neurotechnologies report we traced this need to features of the innovation pathways that medical devices follow. In Europe, medical devices in aren’t regulated like medicines. This might sound like the dry observation of a regulation wonk (okay, you’ve got me), but it’s one I plan to keep on making while I still find people to astonish with the fact that this means manufacturers are not required to provide evidence of a device’s efficacy to receive marketing approval, even when that device is one that is surgically implanted in the brain. Investigations of new regions of the brain in which to target stimulation, or new uses of DBS for new medical indications may also be developed through innovative approaches to treating individual patients, rather than by conducting large-scale randomised controlled trials. These combined factors clearly have important consequences in potentially limiting the quantity and public availability of accessible information about the efficacy of new devices and the outcomes of new uses of existing devices. A register, therefore, offers an important means of improving our access to and understanding of findings about the benefits, risks and emerging applications of a technology like DBS.

It became apparent thorough the presentations and discussion that the outputs of a DBS register could potentially offer significant advantages for clinical decision-making, technology assessment, post-market regulation of devices, and supporting informed consent. In particular they could be of real practical use both to NICE and to NHS specialised service commissioners by providing information on which to base their assessments of the value of particular interventions. Outputs, appropriately presented, could also be of enormous value to prospective patients and their families, particularly if they include outcomes reported by existing patients themselves.

These considerable benefits cannot however be realised without sustainable resourcing, the buy-in and trust of both clinicians and patients, and effective oversight and governance of the register to ensure the quality and completeness of the data going in and coming out. Here, it was invaluable to hear about Jonathan and Keith’s experiences of – and palpable enthusiasm for – the TAVI and joint registries. The wide-ranging discussions that followed the presentations opened the floor to those with direct experience of the practical challenges and ethical concerns that could arise in the context of a DBS register.  For example, questions were raised about managing the potentially time-consuming data-entry requirements and the possible risks associated with some surgical centres being perceived as having fewer positive outcomes than others, and compliance with data protection legislation. The interests of patients both as contributors to and users of a register were much discussed. These included the importance of securing patients’ consent to the inclusion of their personal data, and the challenges of ensuring individuals cannot be identified from the data released by the register, particularly where numbers of patients treated for a particular condition are very small. Given the range of conditions for which DBS is indicated and the complex factors contributing to both desirable and undesirable outcomes, the importance of analysing and contextualising information generated by the register so that it is genuinely useful to patients was widely emphasised.

What emerged particularly clearly from this meeting was that those planning the DBS register need not meet these challenges alone. There are rich opportunities for learning from those with direct experience of established registers and we hope we can continue to help to forge more of these important connections as the DBS register project progresses. This isn’t the end of an episode of the A-Team after all, it’s the beginning, where a crack commando unit comes together to solve a problem, and we look forward to doing all we can to support this work.

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