Brain Stimulation: A Principled and Pragmatic Approach to Understanding the Ethical and Clinical Challenges of an Evolving Technology
Fig. 1
Desperation and media enthusiasm compound patient expectations—in the clinical context, hope and expectation in DBS for movement disorders challenge informed consent and can lead to a failure to meet pre-defined outcomes
1.5 The Role of Clinicians in Managing Patient Expectations
Patient outcomes in DBS are complex: Some symptoms may improve, others not. DBS can also be transformative in its effects. We have demonstrated that patient expectations of outcomes can be unrealistic, which poses a challenge for clinicians who struggle to manage patient expectations (Bell et al. 2010) (see Table 1). In the literature, measures and practices to address unfounded hope and expectations have been put forth (see Table 2). At this time, more evidence should be gathered on these recommended measures, and dialogue with other clinical areas with similar features (e.g., clinical oncology research) could help tackle these challenges and lay out more comprehensive counseling approaches.
Table 1
High patient expectations of DBS candidates (section A) and clinicians’ reactions to expectations (section B) (adapted from Bell et al. 2009)
A. High expectations of patients reported by clinicians “it will be exactly as I was when I was twenty” “I’m gonna be all better” “I’ll be really good, I’ll be really good” “it is going to fix all the problem” “I’ll be more normal” |
B. Clinician reactions to high patient expectations “you are not actually going to cure them” “this was (is) not a miracle” “it is not a quick fix” |
While the context of DBS for Parkinson’s disease can raise many challenges in the exercise of patient autonomy, it is important to note that these challenges can also provide an opportunity to enrich the exercise of patient autonomy and to enhance the patient–clinician relationship. Challenges to autonomy should encourage clinicians to engage patients in discourse about their illness, the effects of different therapies, and an evaluation of how they are making their choices (including what their goals for treatment are, how they understand and value the different effects of interventions, and what considerations inform their choices). In the age of accessible online information, patients should also be directed to reputable sources of patient-oriented information (Racine et al. 2007a). Common patient-oriented documents available online include those by the National Institute of Neurological Disorders and Stroke’s patient page on DBS for Parkinson’s disease (National Institute of Neurological Disorders and Stroke 2012), the National Parkinson Foundation (National Parkinson Foundation 2012), as well as those published by academic centers such as the Cleveland Clinic (Cleveland Clinic 2013), and the University of Florida (University of Florida Center for Movement Disorders and Neurorestoration 2013)
Principle and specification | Description of challenging aspects of context | Responsive ethical practices |
|---|---|---|
Principle of respect for autonomy | ||
Respecting the patient’s full or limited ability to engage (or assent) in decision-making. Responsibility to inform patient of risks and commitments involved in DBS. Involves a shared decision-making process where patients may need to be actively empowered to make decisions | PD can lead to cognitive deficits and compromised decision-making capacity with an impact on informed consent | Clinicians probe patient expectations and non-motor expectations; foster reasonable patient expectations |
Multidisciplinary evaluation of candidates | ||
Patients can be overly optimistic about the expected outcomes of DBS, notably because the media features enthusiastic portrayals of DBS | Social support for patients to deal with perceived failures in outcome | |
Patient vulnerability due to last resort nature of DBS can augment desperation or hope for treatment outcomes, challenging balanced understanding of information | Patients accurately communicate expectations and remain aware that chronic illness may change their perception of health information | |
Principle of justice a | ||
Principle of justice implies considerations of fair access, transparency in principles of distribution of resources, equitable distribution of resources, and technological opportunities, and assessments of global costs and burdens (including opportunity costs) | Not all DBS programs have the same capacity to perform DBS | Committing to an ideal of fairness and equity in allocating resources nationally and regionally (including human resources) and better document national and regional variations to access to DBS |
Maintaining transparency about resource allocation challenges and variations in access when dealing with health policy administrators and patients and their families | ||
Regional centers approach budgeting for DBS in different ways and are faced with varying levels of challenges related to resource constraints | Advocacy by professional associations to develop national standards of care and access to care commitment to gathering data on DBS use nationally and internationally | |
Budgets may have an impact on referrals to surgical DBS programs | Identifying strategies to balance the common use of health system resources for research and approved indications of DBS to ensure that approved indications are valued in light of research for emerging indications | |
Principle of non-maleficence | ||
Not causing or provoking harm by understanding how physical and psychosocial factors can lead to unsuspected harms; minimizing these harms | There are reports of psychosocial adjustment challenges for PD patients who have undergone DBS | A better assessment of how psychosocial factors are currently taken into account in the informed consent process |
Psychosocial challenges may impact globally the patient’s life after DBS and impact relationships to proximate and distal others | More comprehensive follow-up care to respond to psychosocial challenges | |
Different hypotheses coexist about these difficulties experienced by patients | Improve the understanding of the mechanism by which DBS exerts psychosocial effects (e.g., using patient-reported outcome measures) | |
2 The Principle of Justice and How DBS, as an Expensive Intervention, Generates Questions for Equity and Fairness
In contemporary discussions, the principle of justice is often overshadowed by considerations related to benefit, risk, and the exercise of patient autonomy where individual rights and freedom anchor the dialogue. Concerned with the social exchange of goods within a population, the principle of justice may sometimes be trumped by other considerations, or altogether overlooked, when the primary deontological obligation of clinicians is focused on the individual patient’s care (World Medical Association 1948, revised May 2006). In addition, the principle of justice is complex, notably, because it can borrow different and sometimes radically opposing meanings such as (1) to each person an equal share; (2) to each person according to need; (3) to each person according to effort; (4) to each person according to contribution; (5) to each person according to merit; or (6) to each person according to free-market exchanges (Beauchamp and Childress 2009). In spite of this complexity or the primary obligation of physicians to act in the best interests of the individual patient, clinicians have arguably broader societal responsibilities related to resource allocation, use of health services, and access to health care. For example, the code of ethics of the Canadian Medical Association states that physicians should recognize the need to “promote equitable access to healthcare resources” and “use healthcare resources prudently” (Canadian Medical Association 2004).
2.1 DBS and Issues of Justice
In the context of DBS—a high cost (estimated in one US study at $69,329 in 2006 (Lad et al. 2010)) and increasingly routine procedure for Parkinson’s disease patients—issues of distributive justice including the equitable and fair allocation of resources must be considered. Despite the high costs of the surgery, device, and battery replacement, evidence supports the medical management of Parkinson’s disease patients with DBS to improve motor function and reduce motor fluctuations and medication side effects (Grimes et al. 2012). Moreover, cost-effectiveness of research recommends funding DBS for eligible patients, where not already funded or reimbursed, because of the overall reasonable incremental cost-utility (€6,700 per quality-adjusted life year) over best medical therapy (Dams et al. 2013) (see Dams et al. 2013 also for a review of the European literature on cost-effectiveness of DBS). Other European studies have shown that the total costs of caring for a patient with Parkinson’s disease decrease after surgery (Fraix et al. 2006; Meissner et al. 2005) and that the savings allow return on the procedure investment (approximately 37,000 € when the study was conducted) over 2.2 years (Fraix et al. 2006). Therefore, based on a position where cost-effectiveness forms a basis for assessing what interventions should be available, and where access is influenced by positive assessments of cost-effectiveness, the necessary evidence and impetus are present to make DBS available to eligible patients with Parkinson’s disease. Nonetheless, the principle of justice requires broader reflection than is provided by mere estimates of cost-effectiveness, and necessitates deliberation about to whom, how, and to what extent we can afford to, provide health services.
In fact, despite evidence demonstrating improvements in quality of life and motor symptoms and relative cost-effectiveness of DBS in Parkinson’s disease, DBS represents an immediate and large investment. As such, regulators, administrators, and insurers may feel obliged to restrict the amount of DBS procedures performed, impacting access to and distribution of resources for DBS. Unfortunately, although practice guidelines support the use of DBS in Parkinson’s disease for good candidates, they do little to address issues of potential inequity in access or resource allocation that might be present. Issues of access and resource limitations are sometimes unacknowledged realities of healthcare delivery, but have important ramifications for clinicians, patients, and their families. In a study of Canadian DBS programs, we found widely discrepant approaches to resource allocation, leading to diverging scenarios for access to DBS (See Table 3), and evidence suggesting wide-ranging challenges for access to DBS (Bell et al. 2011a). We discovered that even patient selection can be impacted by the specific resource situation of a hospital. In some cases, clinicians reported that resource limitations affect how quickly patients can be screened (for instance, how quickly neuropsychological assessments can be made) or affect how many patients can even be provided with DBS in any given budgetary year. At the same time, clinicians working at health centers in other regions did not report facing challenges due to resource limitations or in meeting demand for DBS. Another center reported that despite overall limitations set on the resources that can be expended (i.e., personnel), they felt the waiting time is appropriate (see Table 3).
Table 3
Wide-ranging scenarios of access and resource allocation in Canadian DBS programs (adapted from Bell et al. 2011a)a
First scenario Clinicians facing resource allocation challenges (sites A and B) |
i.e., more patients requiring DBS than any given budgetary year will fund |
Implications of these resource limitations: |
Surgeon and operating room time are not used for DBS |
Wait times are increased and unpredictable and may cause patients to be re-evaluated before surgery |
Referrals are not proactively sought because this would overwhelm surgical capacity |
Second scenario Clinicians facing resource limits but viewing these as less problematic (site C), i.e., a short or reasonable waiting time for patients may be viewed as acceptable or even positive, allowing informed reflection of patients |
Third scenario Clinicians reporting they do not face resource challenges (sites D and E), i.e., fixed budget but clinicians not concerned about exceeding that budget |
Reasons that resource challenges are not experienced include (1) the number of potential candidates lower because of decrease in referral rate and lack of awareness of the program among referring physicians and (2) the limited number of patients because of strict screening criteria |
2.2 Access to DBS in the Canadian Context
Given that provincial healthcare systems are bound to federal obligations of access and performance through the Canadian Healthcare Act , to “protect, promote and restore the physical and mental well-being” of Canadians by ensuring “free and universal access to publicly insured health care” (Government of Canada 1984), it is striking to find that these variations can exist. We also question whether patients, families, or clinicians are truly aware of potential differences in access across the country for approved health interventions. Ultimately, the federal legislation only requires the provinces to guarantee the comprehensive coverage of insured care, to cover insurance for all residents, and to ensure equal access to insured services (Government of Canada 1984). It does not explicitly guide the provinces, who independently administer healthcare services, on how to provide access to insured services nor does it clearly mandate the level or standard of health care between provinces. Importantly, access is meant to be equitable, but the meaning of equity remains unclear. In the case of DBS, how can this resource be allocated equitably? Suggestions on how each province could be allocated DBS implantations include equally (i.e. the same share to each province), allocation based on the number of cases of Parkinson’s disease, or allocation based on the resources already available (e.g., specialized neurosurgeons). Ultimately, the current mechanism by which healthcare resources are administered in Canada may lead to a neglect of the broader national needs, allowing disparities or variation in access to persist.
Multiple factors could explain such an internally discrepant situation. Challenges in access within publically funded systems have been noted, particularly in the field of medical devices. For example, in Canada , variation in access to implantable cardioverter defibrillators (ICDs) has been shown, as some provinces (i.e., British Columbia, Saskatchewan, Manitoba, Prince Edward Island) fall well below the national average of implantation of ICDs in Canada (Canadian Heart Rhythm Task Force MEDEC 2004). In this case, different factors could explain these variations such as a culture of under-referral (e.g., physicians are hesitant to refer patients to programs that they sense are unavailable, or when they think that wait lists are too long), lack of national standards for access to ICDs, lack of a tertiary center in a province, and some clinical programs being held to fixed budgets (Simpson et al. 2005). Variations in implantation rates of ICDs have also been observed between and within some European countries (Ector et al. 2001; Boriani et al. 2010; Cunningham et al. 2005; Mond and Proclemer 2011). Widely different reasons for these variations have been proposed (McComb et al. 2009). In one Canadian province (Ontario), important inequalities in ICD implantations between those living in urban areas and rural regions have been shown (Lee et al. 2008). Similar inequalities may exist in the context of DBS implantation; however, intra-provincial regional variation in this context has been largely unexplored, likely because of the limited centers across the country providing this specialized neurosurgery (approximately one or two academic centers in every province). In light of this, it is likely that patients have to travel from remote communities to larger centers or, if no program is available, travel from one province to another to access DBS. For DBS, further investigation of how rural populations are serviced by larger academic and urban centers is warranted. Other issues impacting access to DBS could relate to manpower and specialty training in relevant fields (e.g., functional neurosurgery); complex tensions exist in Canada between recognized shortages in specialized practitioners in certain fields and a lack of jobs for many postgraduates in the same medical specialties (Woodrow et al. 2006; Vogel 2011). Moreover, a 2005 report by the Institute for Clinical Evaluative Sciences, which examined the Health Human Resources for Neurosurgical Services in Ontario, describes that one of the visible symptoms of stress in the neurosurgical service delivery system is unequal access to appropriate technology and care across the province (Tepper et al. 2005).
The challenges faced by some clinicians with regard to access and resource restrictions for DBS mean there are difficult rationing and resource allocation decisions to be made. These situations become even more challenging when clinicians are not informed about the allocation process, but are nevertheless charged with explaining to patients and their caregivers allocation decisions, the reasons for wait lists, and the variations between regions or provinces (Holloway et al. 2000). In the context of DBS, resource allocation issues can translate into a number of difficult and arguably unethical situations that require transparency when dealing with patients and families. For example, a Parkinson’s disease patient who was a good candidate can develop comorbid conditions (e.g., depression or dementia), while long wait lists may lead to necessitate re-assessments (Bell et al. 2009, 2011a). This leads to a deleterious cycle, where a long wait list necessitates frequent re-assessments, and frequent re-assessments add to the long wait list. As a result, resources must be re-allocated for the same patient and there are even more substantial personal implications for patients and families who are on waiting lists. Table 2 presents some responsive practices to respond to challenges of justice.
3 Non-maleficence and Psychosocial Aspects of DBS
The principle of “first, do no harm” captured in the Latin aphorism “primum non nocere” has been an enduring maxim of medical ethics. Although often attributed to Hippocrates who called upon physicians to abstain from doing harm, its origins are debated (Beauchamp and Childress 2009).
Modern descriptions of the principle have focused on avoidance of physical harms to patients (Beauchamp and Childress 2009). However, non-maleficence cannot be interpreted as the absolute avoidance of harm since some side effects are almost always to be expected from treatments. Hence, the principle stresses rather the avoidance of undue or unjustified harm. Accordingly, harms need to be considered in relationship to expected benefits. Further, harm can be modulated by the clinical context and social or personal circumstances in which an intervention is offered. Therefore, a contextual appreciation of what the principle means for a specific patient in a specific context needs to take place.
The historical descriptions found in the Latin formulation and related statements in Hippocratic writings also capture another aspect, that is, the fundamental or primary nature of the principle that “first” or “above all,” clinicians should not engender harm. Therefore, the principle mandates a prudential attitude calling for a circumspect and reflexive evaluation of one’s own knowledge about the beneficial effects of a treatment and that, first and foremost, the physician should avoid harming the patient. This prudential attitude is certainly relevant in the context of DBS given its rapid evolution, partial knowledge of its long-term, potential global effects on the patient, and high expectations toward DBS upheld by patients and their families.
Beyond the physical harms (and benefits) associated with DBS (discussed above), another set of harmful (or potentially beneficial) consequences (Ashkan et al. 2013; Wolz et al. 2012; Sevillano-Garcia and Manso-Calderon 2010) concern the psychosocial (or “non-motor”) effects of DBS in Parkinson’s disease. These consequences of DBS on quality of life and more comprehensive psychosocial domains are still poorly understood (Sandvik et al. 2012). A landmark qualitative study, published in two papers, showed clearly the issue at hand; contrary to studies suggesting increased independent living after surgery (Krack et al. 2003), patients faced difficulties with their familial or marital relationships after surgery and felt conflicted about returning to work (Agid et al. 2006