... Health Professional Education and Adoption...

... A major factor in the adoption of new technologies is the “activation energy,” that is, the additional effort required to learn and put the technology in practice over and above the day-to-day work of a clinic. If the activation energy is too high, adoption is unlikely. (Hammer)...

... Adoption of a new medical technology also requires community physicians to be aware of it and its benefits and be willing to recommend and to refer their patients to the appropriate specialists. (Hammer, Miravite, Okun, Pathak)...

... Access is one barrier to new medical technologies, which can be limited by insurance companies and by the lack of qualified providers. (Miravite, Okun)...

... Educating patients and getting them involved in their own care could help push the adoption of new medical technologies. (Pathak)...

... NOTE: This list is the rapporteurs’ summary of points made by the individual speakers identified, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect ...

... Moving from practical barriers involving patients to those involving clinicians and other practitioners, the workshop addressed barriers associated with health professional education and adoption. David McMullen, the director of the ... of Neurological and Physical Medicine Devices at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, asked participants to discuss the current barriers to increasing training and engagement among health professionals on ... brain stimulation and the barriers of current practices and, second, to explore what relationships might need to be developed across different specialties and clinical practices to facilitate referrals and the ... of care. McMullen commented that he hoped the panelists would not just highlight and discuss the various barriers but would also think through some potential solutions. “What can we do as a community to come together and blaze a new ... McMullen. Clinicians will certainly be critical to greater adoption of the technologies, he added, with their roles including both patient education and patient selection....

... Lauren Hammer, a movement disorders and neuromodulation research fellow at the University of California, San Francisco, discussed some of the factors influencing whether clinicians adopt ...

... “Even if regulators approve and payers cover [the procedure],” Hammer said, “adoption requires patients and the caregivers to buy in. That requires that the clinical benefit outweighs the perceived burden on the patients.” A second factor is the so-called ... easier once the new technology has integrated, it still may require a tremendous amount of effort to reach that point, learning the new technology and modifying various established processes to adapt to it. One must ask whether that activation energy is too great to overcome. “I have a strong ... in seeing these technologies succeed,” Hammer said, “and I still found it hard to integrate some of the most recent advances like image-guided1 or physiology-guided programming.2 Physicians are busy, ...

... is the collection of images during implantable brain stimulation surgery that allow the physician to see the exact location for the device leads and stimulation. For more information, see https://www.bostonscientific.com/en-US/medical-specialties/neurological-surgery/deep-brain-stimulation-system/...

... signals (e.g., local field potentials) while delivering the stimulation treatment. Physicians can correlate the brain signals with the stimulation and the patient’s symptoms to optimize care. For more information, see https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/...

... A second factor in the adoption of new technologies is the role of doctors and other providers beyond the highly subspecialized clinicians who are most comfortable with such technologies. A recent paper reported that only about ... patients with Parkinson’s disease had seen a movement disorder specialist within the previous year, with more than 50 percent of them being managed and seen by a general neurologist (Pearson et al., 2023). “These are the partners who are going to be identifying who is appropriate for referral,” ... said. “And these are the partners who are going to be comanaging patients while stimulation is being optimized and, ideally, if we can make things simpler, even taking over stable management of these patients.” So it is vital, she said, that the subspecialists ... ways to educate these community providers and bring them into care teams. “This is going to be important if we want to expand these technologies to more people,” she said....

... Joan Miravite, a nurse practitioner, assistant professor of neurology at the Icahn School of Medicine, and director of interdisciplinary clinical care for movement disorders at Mount Sinai, described herself as having several roles: a deep ...

... She spoke briefly about barriers to care, mentioning both a lack of relevant training for clinicians and various knowledge gaps related to the procedure. A major barrier, said Miravite, is limited access to the procedure, particularly because of its ... by insurance companies. “Some insurance companies deem DBS still experimental,” she said, “and I’ve had some insurance companies deny me from programming patients because...

... I’m a nurse practitioner and not a physician.” In New York, nurse practitioners are not able to bill Medicaid for any procedures they perform in Article 28 facilities,3 ...

... situation, including creating scalable models of care; building a consensus on DBS management; collaborating with foundations, organizations, payers, and industry to educate and streamline therapy; and using advanced practice providers in specialized care. The ultimate goals, Miravite added, are to ... health equity, increase the quality of care and patient access, and improve patient outcomes....

... Martha Morrell, the chief medical officer of NeuroPace, Inc., and a clinical professor of neurology at Stanford University, began by expressing her excitement about the progress that has been made in the field and ... need to manage the expectations of their patients, she said, they need to manage their own. “Do we think we are going to develop a therapy and it is going to come out fully formed?” she asked. “Of course it’s not. It is not perfect yet.” But there has been amazing progress in a ... of devices, and that progress should only continue....

... by talking about some of the requirements that these data must fulfill in order to help improve such treatment. First, the data should be accessible and comprehensible to users, and in particular, the information derived from the large, complex datasets must be interpretable by the physician and the ... ,” Morrell said, “but only the data we have identified as important.” This should include things like biomarkers to track how somebody is doing and help predict outcomes. Third, the data should enhance the efficiency of clinical care. “We have to make everybody’s life easier,” she said. And ...

... BARRIERS TO THE ADOPTION OF DEEP BRAIN STIMULATION TECHNOLOGIES...

... Michael Okun, the executive director of the Norman Fixel Institute for Neurological Diseases at the University of Florida and the medical advisor...

... a voluntary aspect, which is equally true for the adoption of a technology. But that means it is necessary to get buy-in from the community of users, and that has not proved to be easy in this case. “We can blame health care systems, regulatory agencies, health care payers, we can blame ourselves,” ...

... want it to adopt it.” A recent discussion at the most recent Deep Brain Stimulation Think Tank4 concerned whether the technology has been branded correctly: “There was a discussion about should we be calling this brain pacemaker, which is something . . . people can understand . . . better.�...

... Third, even if people want the technology, it will be necessary that we are able to provide it to those people. “So we have a lot of people in society across the world that want therapies we may not be able to deliver,” Okun said. “We have to remember that it’s bidirectional. The ...

..., he said, but he suggested that this issue may prove not to be a major barrier. In the case of Parkinson’s disease, for instance, clinicians and nurses are sufficient. Although the initial trials may require experts, he said, it should be possible to eventually develop easier-to-use ...

... In thinking about practical barriers to further use of DBS that are related to professional education and adoption, she said she sees the issue from three perspectives. The first is awareness of the current state of technology. To illustrate the problems ... probably the most in-the-know of cutting-edge technology,” said Pathak. “They came to our booth. We were talking about deep brain stimulation, and they just looked at us like we were talking about something that was still being innovated on.” They asked when the technology would become ... for humans. “I just looked at them, and I said, ‘This has been around for over 30 years.’...

... 4 For more information on the 2023 DBS Think Tank, see https://fixel.ufhealth.org/research/deep-brain-stimulation-think-tank (accessed November 26, 2023)....

... And it was the first time that it struck me that it is not nearly as ubiquitous to everyone as it is to us.” The problem, then, is that many of the ... who are shaping decisions about whether to adopt the technology are not familiar with it and may not even know it exists. By contrast, she said, everyone knows about cardiac pacemakers. “How do we make our technology as ubiquitous as ...

... The second barrier relates to the referral pathway, she said. A patient goes to a doctor, gets referred to another doctor, and another, and eventually gets to a specialist who can recommend DBS. “By the time the patient even knows to go to a specialist, it may be too late,” Pathak ...

... Finally, Pathak emphasized the importance of educating patients and getting them involved. “Patients listen to patients,” she said. “Their stories resonate with other patients. So I think we all need to spend a ... more time understanding our patients, listening to our patients, and making sure they have enough knowledge and education to spread it around in their communities so [other] patients are more empowered to ask their doctors for the therapies that they think they ...

... To begin the discussion, McMullen asked Pathak whether the right people were at the workshop to address the DBS issue effectively. “I do think we have the right people,” she said. “I think this is a multidimensional ...

... Okun disagreed and said that it would have been valuable to get a more international perspective from organizations like the World Health Organization. “If you could [ ... Institutes of Health or whomever, then why are all these other countries having the same problem?” he said. “I think we have to stop blaming and start thinking that maybe this is a global issue.”...

... more a system problem than anything, Okun said. He explained, “We get upset at internal medicine doctors and geriatric doctors for mishandling Parkinson’s disease, though they are tasked in 30 minutes with dealing with cholesterol calculator, cardiac risk, an examination of the lungs ... their role within limited systems, limited amounts of time, limited amounts of resources. We have to figure out how to put those pieces together and incentivize them correctly so that the person gets the best possible treatment. And we don’t do that.”...

... McMullen then turned to Morrell and asked how her company, NeuroPace, had succeeded in convincing clinicians to adopt its technology. “We are all learning,” she said. “The way you ... out is figure out what you are doing well and what could be done better and just pick it off piece by piece.” One thing that the company found success with was sponsoring programs available to fellows and trainees that ... them to “come and in a nonpromotional way learn about the technology and apply it.” Those programs were met with great enthusiasm, she said, adding that the younger generation seems to be more open to learning about and ... new technologies and new treatments....

... Educating Physicians About Deep Brain Stimulation...

... Okun agreed that such educational approaches could be important, particularly in helping newer physicians become familiar with DBS and other neurotechnologies. Another approach to addressing the issues with referrals, he said, would be to expand the use of navigators, who could help ... in health care systems to access the best possible care and get them more options quickly and connected with doctors and clinicians who can best address their needs. “I very much like this model and would advocate strongly for that,” Okun said....

... Expanding Access to and Use of Deep Brain Stimulation...

... the panelists thought would work well to increase access to advanced care in community clinics, given the educational gap between academic centers and community clinics. Morrell offered an initial answer by saying that it is important to help community physicians better understand the needs of their ... and where those needs can best be met. One way would be to develop a system that takes all the information acquired by devices used in a patient’s care, ... interprets it, and comes up with a solution. “Obviously,” she said, “the holy grail would be to have a truly closed-loop device where the device is constantly ... information and then acting upon it in a dynamic way. . . . If we had something that was truly closed-loop, then it would be pretty easy for that to be implemented ...

... Okun agreed and emphasized the importance of statistics and keeping in mind how individual patients are doing relative to everyone else. For many of the devices now being used, he said, about 80–90 percent ... Conversely, it is important to identify the 10–20 percent who are not doing well. “We need to work together to identify those people,” he said, and send them to the appropriate clinicians, whether specialists or sub-sub specialists. In that way, community physicians will be able to obtain the ... they need in determining which of their patients are doing okay and which need to see a more specialized provider....

... Pathak suggested getting professional societies involved in educating their members on the benefits of implantable technologies and which patients can benefit from them. Awareness is a major problem right now, she said, but even when physicians are aware that these technologies ... , they often still prefer drugs and noninvasive therapies, even though studies have shown that as many as 70 percent of patients will benefit from DBS without complications. “I think ...

... be placed entirely on physicians. “There are enough biomarkers you can extract from the electronic medical record (EMR) which could easily come up and say, this patient meets these measures and these criteria and should be considered for brain stimulation.” The University of Pennsylvania system ... such monitoring for hypertension, postnatal care, and the initiation of diabetes care. “We did an experiment through EMR where we looked through medi-...

... The Relationship Between Physicians and Future Technologies...

... answered that it will depend in part on how well AI is integrated into the new technologies. “If you have AI or machine learning take all the data and make a suggestion to the clinician that makes sense and has some sort of biologic or medical interpretation, then the need for human data scientists ... -specific model or do specific data mining is a lot less important.” A lot of clinicians, she said, would prefer some system that processes the data and makes reasonable recommendations. “So if there is no additional effort [for the clinician] to learn and interpret, those automated systems would be ... powerful.” Still, she added, there is a great deal of work that must be done to get to that point, and in the meantime, it will be necessary to have data scientists or other specialists bridge the gap. Community providers may find it challenging to ... handle the new technologies in their current form, thus “having support from other trained professionals, like technicians focused on the neural data, ...

... Okun pointed out that if community physicians and others are going to rely on systems that interpret big data and make suggestions, they will have to be comfortable with the “black box” nature of those suggestions because there will be no indication of why ... suggestion was made. The FDA could be helpful here by reviewing and approving algorithms, signaling to doctors that they can trust the recommendations....

... Hammer commented that while the sorts of people who were attending the workshop would probably want to understand what the black box was doing, community physicians and many others may not necessarily be interested in all those details as long as the FDA signaled ...