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Poitras V, Wells C, Hutnik C, et al. Optimal Use of Minimally Invasive Glaucoma Surgery: A Health Technology Assessment [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jan. (CADTH Optimal Use Report, No. 8.1b.)
The Ethical Issues Analysis addressed the following research questions:
| Research Question 7: | What are the major ethical issues raised by the use of MIGS devices and procedures? |
|---|---|
| Research Question 8: | What are the broader legal, social, and cultural considerations? |
The purpose of this analysis was to identify and reflect upon key ethical concerns that should be considered when comparing the relative merits and demerits of MIGS versus pharmaceutical management or filtration surgery for the treatment of glaucoma in adults in Canada. Though other sections of this HTA implicitly touch upon broad ethical concerns, the aim of this analysis is to make such issues explicit and to identify others that may be relevant to any decisions in this regard. The issues raised in this section necessarily go beyond narrowly defined ethical concerns to encompass broader legal, social, and cultural considerations, as well. It is common in the ethics literature, across a broad range of health-related issues, to refer to ethical, legal, and social issues (ELSI) when addressing broader values related considerations. While the primary emphasis here will be on ethical considerations, social factors also figure in the discussion.
The literature search was performed by an information specialist, using a peer-reviewed search strategy.
Ethics-related information was identified by searching the following databases: MEDLINE (1946–) via Ovid, PsycINFO (1806–) via Ovid, CINAHL (1981–) via EBSCO, and PubMed. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were glaucoma, minimally invasive glaucoma surgery, and minimally invasive glaucoma surgical devices.
Methodological filters were applied to limit retrieval to studies related to ethical, legal, and social issues. Retrieval will be limited to documents added to the databases since January 1, 2000. The search was limited to English- or French-language publications.
The initial searches were completed by November 2017. Regular alerts were established to update the searches until the publication of the final report. Regular search updates were performed on databases that do not provide alert services.
Studies meeting the selection criteria of the review and identified in the alerts prior to the completion of the stakeholder feedback period were incorporated into the analysis of the final report. Studies that were identified after the stakeholder feedback period were described in the discussion, with a focus on comparing the results of these new studies with the results of the analysis conducted for this report.
Grey literature (literature that is not commercially published) was identified by searching the Grey Matters checklist (https://www.cadth.ca/grey-matters), which includes the websites of HTA agencies, clinical guideline repositories, SR repositories, and professional associations. Google and other Internet search engines were used to search for additional Web-based materials. These searches were supplemented by reviewing the bibliographies of key papers and through contacts with appropriate experts and industry.
Articles, studies, and reports were included if they explicitly and specifically raised ELSI issues related to the central question of this HTA, as well as literature which, though not explicitly about ethical issues (e.g., an empirical investigation of patient attitudes about MIGS versus pharmaceutical management of glaucoma), may point to potential ethical issues even if the participants and researchers did not formulate them as such.
The selection of relevant literature proceeded in two stages. In the first stage, the title and abstracts of citations were screened for relevance by a single reviewer. Articles were chosen to be reviewed in full-text form according to the following criteria:
In the second stage, the full-text reports were reviewed by a single reviewer. Reports meeting the previously mentioned criteria were included in the analysis, and reports that did not meet these criteria were excluded.
Because no published studies were retrieved either in the commercially published or grey literature that directly examined ELSI bearing on glaucoma or MIGS, the selection criteria was broadened to include bodies of research and commentary that dealt with issues indirectly or analogously related to potential ethical issues identified through expert recommendations in an Environmental Scan, titled Minimally Invasive Glaucoma Surgery: Implementation Considerations, which was conducted to identify and summarize information regarding the current practice and the implementation of MIGS devices and procedures in Canada.154 Further details on the Environmental Scan is described in the Implementation Issues Analysis.
The goal in a review of bioethics literature is to canvass what arises as an ethical issue from a broad range of relevant perspectives. As such, the quality of normative analysis does not figure in the article selection criteria: any identification of an issue by the public, patients, health care providers, researchers, or policy-makers is of interest whether presented through rigorous ethical argumentation or not. For example, academic ethicists may focus on certain issues because they relate to theoretical trends in their discipline, while an opinion piece by a clinical or policy leader or a patient may bring to the fore ethical questions that are neglected by academic ethicists but are highly pertinent to the assessment of the technology in the relevant context. Despite the different standards of normative argumentation for each kind of report, the importance of the issues raised cannot be assessed solely by these standards and so literature cannot be excluded based on methodological standards.
Assessment of the ethical and social considerations around the optimal use of MIGS in Canada must be grounded both in published literature and in relevant facts about the current usage of MIGS in Canada and elsewhere. Two major findings of fact bear on the ethical and social analysis that follows.
First, there is a disparity between the existing quality of evidence on the clinical effectiveness of MIGS and the belief in its value manifested in the adoption of MIGS by Canadian specialists and hospitals to date. The Clinical Review of this HTA, with the quality of evidence ranging from “very low” to “high” across outcomes, comparisons and study designs, suggests that there is largely insufficient evidence for the comparative clinical effectiveness and safety of MIGS, either alone or in combination with cataract surgery, versus other glaucoma treatment modalities. Bearing in mind that MIGS is not a single technology but a range of heterogeneous surgical procedures and devices, it is also notable that evidence is lacking both for the relative benefits of any given MIGS device or procedure over any of the others, either overall or for a subset of patients.
Despite this limited evidence, professionals who are “early adopters” of MIGS — such as those consulted for the CADTH Environmental Scan154 — believe strongly in the potential of this technology to offer a valuable new option in the pathway of glaucoma care. The availability of a new treatment modality through surgery (as opposed to medication) is particularly relevant given that a high proportion of earlier-stage patients with glaucoma are unable to take medication as prescribed. The potential of MIGS to benefit such patients by controlling their glaucoma better (and ultimately reducing health care costs) is an important part of its anticipated value. Stakeholders consulted in the Environmental Scan mentioned that other advantages of MIGS over more invasive surgeries are seen by specialists consulted as including safer surgeries, faster patient recovery, and less need for postoperative care.154
A second set of facts bearing on the ethical analysis to follow is that current usage of MIGS in Canada is based on criteria that are not strongly evidence-based, standardized, or personalized to the needs of patients. It was noted in the Environmental Scan that the availability of MIGS as part of a province or facility’s glaucoma treatment offerings is subject to funding for devices, hospital approval, training of staff, and availability of surgeons.154 Not only is MIGS unevenly available across Canada, but so too is the usage of specific MIGS devices, which tend to be used according to surgeon preference, training, experience, and comfort level.154 Moreover, the allocation of devices to patients currently proceeds without objective criteria, subject to surgeons’ discretion.154 Together, these conditions produce a situation that is notably devoid of personalized treatment for individual patients, hence, far removed from the ideal of MIGS being part of glaucoma management being tailored to the needs of individual patients. These contextual facts set the stage for the following ethical analysis.
The published literature to date contains little discussion of ethical issues relevant to MIGS. In part, this is because the use of MIGS is not seen to entail significant risks or trade-offs between benefit and harm. It is considered to be safer than more invasive glaucoma surgery, with fewer complications and faster recovery time; hence, presents no apparent harms to be weighed against their benefits to patients.154 Additionally, because MIGS devices are relatively new, there has not yet been time for ethical issues surrounding the context of their actual or potential use to emerge in practice and be analyzed by researchers.
Peer-reviewed literature about broader social and cultural considerations around the use of MIGS is also limited. As noted in the CADTH Environmental Scan, little published information exists on the geographical, epidemiological, socioeconomic and sociocultural, political, and legal dimensions of MIGS use in Canada, or on quantitative data on MIGS usage or costs.154
Drawing from information from the literature review, and the results of the clinical, economic, patients’ perspectives, and implementation analysis reports, two main categories of issues capture ethical and social concerns relevant to considering the optimal use of MIGS in Canada. They are:
The Implementation Issues Analysis and Environmental Scan reveal that specialists experienced in the use of MIGS are concerned about fair provision of MIGS surgery under conditions of scarcity and disparate health systems. Equity in access to MIGS is recognized to be a problem with current practice, given that patients in one part of a province might have no access to MIGS procedures at all while patients elsewhere in the same province might be able to choose from a range of MIGS procedures.154
Beyond systemic disparities in MIGS availability, there are economic ones, as well, due to the highly variable ways in which MIGS devices are paid for. Some patients must buy a device from a physician, health care facility, or through a pharmacy, while the device is free to other patients in the same province.154 This financial burden can be compounded by the requirement for patients in remote locations to fly to urban centres for MIGS surgery, incurring significant personal costs for travel and lodging during the preoperative and postoperative periods and for follow-up consultations.
Other ethical concerns about fairness in patient access to MIGS go beyond the systemic level down to the individual level of surgeon discretion in deciding which patients to prioritize for MIGS surgery, either government-paid or self-paid. In current practice, surgeons often have a limited number of devices to allocate and use their discretion to allocate MIGS devices as they see fit.154 This situation of personal discretion is to some extent inevitable in a content of innovation, in which the optimal use of devices is far from being clear and “early adopters” of new devices will necessarily work without formal guidance as these innovations are introduced into practice.
A more widespread use of new technology makes consistency of medical judgment important for fairness as well as quality. Many surgical specialists consulted by CADTH indicate a need for objective criteria to guide how MIGS devices are used and for which patients in which circumstances.154 Surgeons’ concerns may tend to foreground clinical criteria such as the patient’s stage of glaucoma, readiness for cataract surgery, and other medical details that might be taken to determine medical need and benefit. Yet these concerns are only part of the wider picture of equity in access to Canadian health care.
As philosopher Lynette Reid notes, the concepts of equitable access to health care is more complex than it might initially appear, given that among the many potential forms of differential or preferential access, some are justifiable (or indeed optimal) while others are not.155 Among the various forms of differential access, some are straightforwardly wrong in their principles and outcomes (such as giving preferential care on the basis of bribery or a patient’s social status) and have no particular relevance to MIGS as such. More complex issues are raised by four other forms of differential access Reid enumerates:
The first two axes of differential access have already emerged as being relevant in the view of stakeholders consulted for the Environmental Scan.154 Current practice in using MIGS takes place in a context of system-wide innovation: “early-adopter” surgeons are using various MIGS devices for patients selected for surgery according to variable medical criteria, using payment methods varying by province, institution, and patient circumstance. While such differential access is unavoidable in the early stages of innovation for a new medical device, there is currently evident discomfort with the current state of affairs among many of the stakeholders consulted in the Environmental Scan. Their expressed concerns suggest that the more widespread use of MIGS has crossed over from the early-innovation stage to one in which the lack of criteria for allocation of MIGS threatens to be arbitrary and poorly organized; thus, an unacceptable form of differential treatment.
The following sections will consider each of these four axes of differential access in turn for their bearing on the optimal use of MIGS. While conceptually distinct, these topics are substantially interwoven with respect to the current practice of MIGS use in Canada and the views of ophthalmology and glaucoma specialist physicians experienced in using MIGS, so the discussion of those issues will necessarily overlap among the sections.
Whatever policies various jurisdictions adopt with respect to public coverage of MIGS devices, it is likely that those different policies may result in some Canadians continuing to have more access than others. Questions about equity raised by disparate funding policies for medical treatment across provinces and territories in Canada are beyond the scope of this review. Equally beyond the scope of this review are ethical concerns about the legitimacy of mixed public/private-pay funding for medical procedures in the Canadian health care system.
However, some issues about payment are specific to MIGS devices and procedures and should inform thinking by health care decision-makers about their optimal use. The foremost one is clarity about whether and when the self-pay option is consistent with health act legislation. Many ophthalmology and glaucoma specialist physicians consulted by CADTH report that their institutions offer MIGS devices and procedures on a private-pay basis (either out of pocket or through patients’ third-party insurance), but at least one respondent reports that his facility decided not to have patients buy their own MIGS devices and procedures for fear that doing so could violate federal or provincial regulations.154 Clarity about the legality of private payment for MIGS must be the first order of business for any jurisdiction in order to begin discussions of equitable access.
A second issue of equity concerns whether and how MIGS devices and procedures are to be framed as either an optional upgrade within the current paradigm of medically adequate glaucoma management, as the majority of ophthalmology and glaucoma specialist physicians seem to consider it, or as a medically necessary treatment for some patients, as other ophthalmologists believe. Jurisdictions must decide what criteria define a medically necessary procedure, and when a procedure is not medically necessary but rather considered an upgrade over an existing procedure.154 Each option has its difficulties for considering equitable access.
Where MIGS is adopted into health systems as an option for patients to choose for self-payment, it may be seen as analogous to other technologies for eye care. In Manitoba, for instance, MIGS devices in some jurisdictions are offered for purchase by patients from physicians’ offices, analogously to the sale of premium lenses offered to patients as an upgrade for cataract surgeries.154
The economic calculus of choosing MIGS surgery can be difficult for patients and surgeons alike to navigate. As noted in the CADTH Environmental Scan, MIGS may give a QoL benefit to patients by reducing the burden of medication and improving vision outcomes.154 However, the cost of prescription drugs is usually covered by provincial insurance plans for patients over the age of 65 (who constitute a large proportion of patients with glaucoma), while MIGS devices and procedures usually are not, and are either bought in limited quantities by individual hospitals or are paid for by patients who can afford to do so. It is far from simple for patients or surgeons to consider the economics of either choice and balance that against QoL improvements.
Furthermore, viewing MIGS as an optional upgrade raises analogous problems to those ethicists have already identified with offering premium lenses as an upgrade for cataract surgeries. Patients with cataracts are often older, and their informed consent may be compromised by multiple factors. These include visual impairment and potential loss of independence, confusion about financial options, language or cultural barriers, and the phenomenon of “innovation bias” (or the presumption that new technology must be inherently better). As noted in a study of patients considering “premium lens” cataract surgery, “[p]atients who misunderstand the optional nature of noninsured services may make substantial sacrifices to pay for cataract surgery. Alternatively, they may decide to postpone or forgo surgery until they can afford the noninsured costs, which will leave them to suffer unnecessarily for longer with correctable impaired vision” (p. 814).157 Patients with Glaucoma considering the choice of MIGS as a self-pay upgrade may face many of these same obstacles to sound informed choice.
The difficulties these circumstances create for physicians charged with ensuring patients’ informed consent will be examined below under the discussion of professional ethics.
Looking at the issue from an equity perspective, however, recognition of these problems created by an “optional upgrade” framing of MIGS also places an onus on health systems. To the extent that health systems endorse current evidence as supporting the use of MIGS as beneficial but not essential for adequate glaucoma care, they must consider how this option can best be chosen on an informed basis given the vulnerabilities of patient populations.
The opposite pole of pursuing equity in access to MIGS might seem to be for health authorities to declare the device a medical need for certain categories of patients with glaucoma who would otherwise be taking medication. As described in the Patients’ Perspectives and Experiences Review, many patients have difficulty following a complex regime of medications. For such patients it might seem (as some specialists believe) that MIGS should be seen as a medical necessity and not a premium lifestyle choice.154
However, the concept of medical need is itself highly contextual rather than a fixed objective standard of assessment. Lynette Reid observes that in Canada the concept of medical need is bound up with many complex questions: what level and kinds of care our public health systems are intended to provide; what standard of care is affordable for all given fiscal and political constraints; and whether individual physician judgment or a holistic and standardized systems viewpoints should determine judgments of medical need.156 Two guiding maxims Reid notes are particularly relevant to thinking about MIGS as a putative medical need. First, “the judgment of what constitutes good medical care is always made in light of the opportunity costs of spending money and attention on some needs rather than others” (p.123).156 Second, within a universal health care system such as Canada’s, which upholds the principle “that people receive care based on need and not ability to pay,” it is also true that “medical need may refer to a range of acceptable solutions to prioritization problems” (p.128).156 The upshot of this is that the goal of providing equal access to MIGS — seen as a medical need rather than an optional upgrade — can be meaningfully discussed only in the context of the larger health care system. Rather than being the product of an individual surgeon’s judgment about an individual patient, it can only be assessed by a surgeon against the backdrop of a systemic consensus on what levels of care for which patients at which medical circumstances can be affordable for all under a public health care system.
The factors that must inform systemic reflection about medical need for MIGS will include relevant insights into the larger spectrum of treatment within which MIGS is situated as a new option. This includes understanding how specific groups of patients are or are not being successfully treated by the lower- and higher-intensity options bracketing MIGS (namely eye drops on one side and invasive surgery on the other). One aspect of this understanding involves considering what Reid describes as structural factors producing differential health care treatment (such as geography, racialized identities, and legacies of colonialism); these factors will be subsequently discussed.
There is also a more general characteristic of earlier-stage patients with glaucoma deeply affecting considerations of their medical need for MIGS, namely the fact that up to 80% of patients with early-stage glaucoma have difficulty taking a regimen of eye drop medication as prescribed.154 Given the potential for MIGS to benefit patients’ QoL, improve disease control, and reduce costs to individuals and the health care system when used to lessen dependence on medications, there is strong reason to consider it within the framework of publicly-insured “medical need” coverage as opposed to being a privately-funded “optional upgrade.”
Doing so would reduce the inequality created by having those patients who can afford to do so privately paying for a surgery that has significant medical and health system benefits. On the other hand, declaring MIGS a medical need for all patients taking glaucoma medication would fail to distinguish between those patients who are more or less able to use eye drops as prescribed and hence are more or less acutely in need of an alternative mode of glaucoma management. For this reason, neither the “optional upgrade” nor the “medical need” paradigm for MIGS is likely to suit all patients well.
The 1985 Canada Health Care Act declares “that the primary objective of Canadian health care policy is to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers.”158 However, the enormous scale of Canada’s geography and the distribution of its citizens across rural and remote areas, as well as more densely populated ones, means that parsing “reasonable access” and “financial or other barriers” must inevitably take geographical realities into account.
Canada’s Health Care Act makes no substantial comment on the relative quality of care that can be reasonably expected by residents of the country’s rural and remote areas as opposed to more densely populated ones.158 From a pragmatic perspective, this omission is understandable, given the extensive economic, practical, and other policy issues at stake when providing health care in remote and rural regions. However, the challenge of promoting equity in the optimal use of a medical technology such as MIGS is much complicated by the lack of principled guidance.
As noted in the Environmental Scan, most rural and remote areas of the country do not have centres that offer MIGS devices and procedures (or Trabeculectomy) as an option to patients; therefore, any patient that is a candidate for surgery will be referred to an ophthalmology and glaucoma specialist physicians, usually operating out of a larger urban centre. One surgeon who commonly operates on patients referred from the Yukon reported that not only does the territory have a high prevalence of glaucoma but the region’s lack of specialists means that patients are often referred too late in their disease progression for MIGS procedures to be a useful treatment option.154 Such patterns likely hold true as well for regions of Canada that are not remote but rural, where travel to urban centres is viable but potentially difficult and costly. A recent study of regional variations in eye disease detection and treatment in Prince Edward Island finds that that factors such as “travel times, absence from work and travel costs to the clinic”159 (p. 273) are likely responsible for geographic disparities across the province in the use of eye care and in eye disease detection and treatment. Patients living farthest from urban clinics access eye care at lower levels, leading to poorer medical outcomes.159
Such unequal patterns of eye care access, diagnosis, and treatment are particularly regrettable with respect to MIGS given its potential to be distinctively beneficial for patients in rural and remote locales. Because MIGS typically requires few or no post-operative specialist visits, its use could avoid the time, difficulty, and out-of-pocket expense that patients would otherwise incur for follow-up visits to ophthalmology and glaucoma specialist physicians after traditional invasive surgery.
This suggests that prioritizing the use of MIGS for patients living in rural and remote regions is a possible approach to seeking equity in glaucoma treatment. More standard policy responses to unequal access to care and outcomes for patients with glaucoma emphasize removing barriers to receiving care and treatment by seeking ways for patients to access care more readily. This is difficult to achieve practically and economically, however, and bringing more specialized MIGS surgeons into remote and rural areas is unlikely to happen. For this reason, identifying rural or remote residence as a preferential indication for MIGS use may also be a sound policy approach. Those responsible for formulating clinical practice guidelines or criteria for MIGS may wish to focus on geography as a criterion for optimal MIGS use.
A second important structural factor to consider with respect to equity in access to MIGS is the demographics of Canada’s population with respect to racialized and ethnic groups, their distinctive risk factors for glaucoma, and the way in which societal relationships may affect their interactions with health care systems in general and glaucoma specialists in particular.
Recent studies in the US have found that populations of African and Latino ancestry appear to have a higher risk of OAG and worse medical outcomes during the disease course, with African Americans being three to four times more likely to be diagnosed with glaucoma than white people.160,161 African Americans develop glaucoma at a younger age, suffer more rapid disease progression, and are nearly seven times likelier to go blind from glaucoma than non-Hispanic caucasians.162 The prevalence rate of glaucoma for Latinos is similar to that for African Americans.161
Importantly, the reasons for these differences are unknown, and are the subject of debate among researchers who disagree about the relevance of potential genetic factors as opposed to socioeconomic ones.163 Among African American populations in the US, research showing the prevalence of glaucoma, barriers to diagnosis and effective treatment, and worse post-surgery outcomes in black patients compared with whites have been studied mainly in socioeconomically disadvantaged urban East Coast populations such as Baltimore164 and Philadelphia.165 How much emphasis to put on racialized identities and genetic factors as opposed to social, economic, and cultural ones in understanding and countering health inequities is itself a controversial topic.
Nonetheless, continuing to target interventions and research at racialized groups seems justifiable and necessary at present. In response to identified socioeconomic factors posing barriers to access (including lack of trust for medical professionals resulting from historical legacies of injustice), ophthalmological research centres have tried public health approaches to reach populations at high risk of glaucoma in community-based settings.162 The same need to consider racial differences and disparities holds true of research on glaucoma surgeries. As Taubenslag notes:
“[U]ntil better genetic markers for surgical prognosis come along, we cannot ignore surgical outcomes disparities that fall along the lines of bio-social groups. Reviewing these disparities hopefully encourages providers to approach glaucoma surgery for their Black patients with the care, deliberation, and counseling this high-risk group deserves. There is a need for further study of racial disparities for all of the discussed procedures. This is especially true for… the new minimally invasive glaucoma surgeries (MIGS)… It is important to collect data on these ab interno procedures to determine whether they should figure more prominently in the treatment algorithm for Black patients or for other high-risk groups” (p.390).165
In order to advance such data collection and to improve the quality of care for all demographic groups of patients, in March 2018 the American Glaucoma Society awarded a research grant to “study how often minimally invasive glaucoma surgery (MIGS) devices and procedures are used in black and Latino glaucoma patients and whether these devices perform similarly across races, ethnicities, genders, ages, and regions.”166 One of the challenges this project will have to grapple with is the widespread underrepresentation of non-white groups in medical research, grounded in historical mistrust. African-American subjects studied who declined to participate in a recent Primary Open-Angle African American Glaucoma Genetics project “were primarily distinguished by their discomfort in providing DNA for research studies,” and other studies have similarly “cited mistrust in research as the most commonly identified barrier to study participation among African Americans” (p.7).98
As yet it is unknown what bearing these factors identified in US populations have for racialized populations in Canada. It is virtually certain that continuities and parallels do exist, however, and must be taken into account in considering optimal MIGS use in this country. One of the few published comments on this topic notes the need “to review and track data specific to the Canadian population toward guiding decisions regarding glaucoma screening, treatment, and public health related strategies, taking into account demographic shifts due to immigration from Asia, the Middle East, and Africa” (p.5).7
Such considerations are particularly important to adapt to the circumstances and needs of Canada’s Indigenous populations in order to honour this Call to Action by the Truth and Reconciliation Commission (2015): “In order to address the jurisdictional disputes concerning Aboriginal people who do not reside on reserves, we call upon the federal government to recognize, respect, and address the distinct health needs of the Métis, Inuit, and off-reserve Aboriginal peoples.”167 In these populations, potential genetic factors combine with common comorbidities, remote and rural residence, and histories of injustice in relationships with medical establishment to create a distinctive context for approaching glaucoma prevention, research, and treatment. Equity demands that guidelines for the optimal use of MIGS include appropriate clinical, policy, practice, and research dimensions.
In contrast to the concerns about equity in access to MIGS that are primarily the responsibility of health care systems to address, another set of ethical issues bears on the responsibilities of medical professionals (and their professional organizations). As has already been noted, MIGS devices and procedures are relatively new and now take many different forms whose comparative and collective benefits have not yet been clinically established. The practical upshot for ophthalmologists treating glaucoma, therefore, is “an abundance of available MIGS devices and procedures, with little guidance as to which patients will benefit from one device over another.”168
Many of the ethical challenges that this context poses for considering the optimal use of MIGS are framed within the existing literature on the ethics of surgical innovation. This field, part of the larger area of health care ethics, analyzes ethical hazards and responsibilities bound up with the development and use of new surgeries and medical devices. The bulk of this literature focuses on surgical innovation, but many of the concerns raised extend also to innovative medical devices. In a 2016 systematic review of published work on the ethics of surgical innovation, researchers identified four major themes: i) the need for oversight of the use of novel surgeries in order to promote patient safety and evidence-based treatment alongside innovation; ii) ensuring that patients give informed consent to treatment decisions; iii) the learning curve for surgeons devising and practising new techniques on patients; and iv) challenges of treating vulnerable patient groups.169 The following discussion will outline how these general themes in the ethics of surgical innovation bear on the optimal use of MIGS using the two broad analytic categories of “oversight” and “informed consent.”
As with any innovative procedure or device that early-adopter surgeons invest time in learning to use and build into their practice as a specialty, MIGS presents the ethical risk of personal investment inappropriately influencing clinical judgment to the detriment of patients’ welfare. The larger literature on conflicts of interest in the context of surgical innovation identifies multiple sources of conflict. At a most instrumental level, there can be reputational and financial benefits at stake in developing, testing, and using a new procedure.170 This may include relationships with a device manufacturer that might undermine objectivity in assessing the benefits of a specific innovative device (either over traditional treatments or in relation to other innovative devices) and its suitability to individual patients. The potential for such conflicts can affect not just individual clinicians but also institutions such as universities and hospitals: “institutions may depend on funding from device manufacturers and seek to cultivate a reputation for being at ‘the cutting edge,” potentially leading to “the pursuit of innovation despite risk to patients and in the absence of adequate evidence to support its use” (p.11).171
All of these potential sources add up to an overall fault in judgment by surgeons and institutions known as “optimism bias”: “a tendency to overestimate the positive effects of an innovation, which thereby contributes both to difficulties in evaluating the effectiveness of innovation and to widespread uptake of procedures with poorly understood outcomes” (p. 10).171 Put more concretely, when surgeons or institutions are professionally invested in a new procedure, they tend to want to use it and to see clinical evidence of benefit, and this motivation can lead to advocacy or recommendation of a new procedure that might not be made by specialists less invested in that option.170
The literature on innovation-related conflict of interest notes that remedies to prevent and mitigate conflicts must involve stakeholders including surgeons, regulators, hospitals, and patients. These measures include transparency by surgeons and institutions in acknowledging all potential conflicts, institutional oversight in granting privileges for innovative surgeries, and candid discussion with patients.172–174
Beyond oversight focused on conflicts of interest, another important kind of oversight relevant to the optimal use of MIGS concerns the responsibility of all stakeholders to ensure that use of an innovative device is guided by clinical evidence as extensively and as soon as possible.
Achieving this in turn requires that as an innovative device is introduced into the market and taken up by “early-adopter” surgeons, its usage and outcomes are tracked, evaluated, and reported so that its optimal usage be impartially assessed. Discussions of the ethics of surgical innovation recognize this as part of the ethical responsibility of stakeholders involved in the introduction of new devices or techniques.175,176
Following through on this commitment takes individual and organizational resources; however, and it is unclear whose responsibility it is to ensure that all uses of MIGS in Canada are tracked. Clarifying where this responsibility lies will be itself an ethical requirement for surgeons, their professional bodies, and health care institutions.
A final topic from the literature on the ethics of surgical innovation of specific relevance to the optimal use of MIGS is that of informed consent. The responsivity of surgeons to ensure that patients are fully informed of the risks and benefits — and the broader advantages and disadvantages — of a particular treatment for their disease is of course part of all clinical ethics. Given the particulars of MIGS as an innovative technology taking many forms with little clinical evidence as yet, carrying out this responsibility has distinctive challenges.
One of these challenges has to do with whether surgeons fully inform patients of the diversity of MIGS options and the paucity of clinical evidence about their effectiveness.
With respect to the first question, the ethics literature on surgical innovation takes it as axiomatic that surgeons are professionally obligated to fully disclose factors relevant to patients’ capacity for informed choice, including the uncertainties and unknowns associated with innovative procedures.176 A 2016 systematic review of this literature enumerates an interrelated list of items seen as necessary for surgeons to disclose to patients, the innovative nature of the procedure, the surgeon’s experience performing it, risks and benefits of the procedure (including possible and unknown risks or outcomes), as well as the available evidence, and alternative forms of treatment.169
In the context of MIGS usage in Canada, in which individual surgeons seem to be offering patients just one or a few in a wider and evolving terrain of MIGS devices on the market, patients should be fully informed of this scenario and of the paucity of comparative evidence. To be sure, this information is unlikely to expand meaningful choices for patients inasmuch as they lack any likelihood of or basis for “comparison shopping” among the devices or among surgeons. Nonetheless, transparency about these circumstances must be provided by surgeons to patients with glaucoma considering MIGS as a treatment option.
Another challenge — one that harkens back to previously discussed issues of equity — concerns an arguable responsibility of surgeons to take a more expansive view of what patients need for informed choice bearing on MIGS. On this more expansive view, informed choice encompasses not just clinical factors, per se, but a broader set of individual factors bearing on this choice of treatment. Such relevant information might include vulnerabilities such as old age, geographical location, and capacity to pay non-insured or out-of-pocket costs associated with choosing MIGS compared with other treatment options.
The reason why such factors may need to be simultaneously considered in the context of MIGS can be extrapolated from comments by McAlister et al. on surgeons’ responsibilities for informing patients about options for cataract surgery when self-pay options for premium lenses are available:
“Ophthalmologists providing noninsured services should consider the potential harm of financial burden on a vulnerable patient with cataracts…. [and must provide patients with] the information they need to make informed decisions about their medical care… [P]hysicians should not misrepresent medically necessary and unnecessary services when both insured and noninsured options exist. This is particularly true for patients with cataracts, given the potential added vulnerabilities of these patients” (p.814).157
Applying to the context of MIGS, these ethical principles imply that surgeons discussing this treatment option with patients must explore the financial and other personal costs associated with MIGS as opposed to other treatment options for glaucoma. For patients who live in remote or rural areas, for example, costs associated with travel for surgery and follow-up visits will have to be factored into the physician–patient discussion in order for patients to make fully informed decisions.
If the scope of physicians’ professional responsibility to enable informed consent is construed in this expansive way, the upshot is a highly complex picture of what surgeon–patient discussions must encompass. Just how broad and detailed the surgeon–patient consultation must be in order to enable informed consent will be subject to further debate—but however construed, ensuring that this responsibility is carried out well must be a concern not only for glaucoma specialists but also for their professional bodies and other health care stakeholders.
Findings about the optimal use of MIGS from an ethical, social, and cultural perspective fall within two normative categories: equity (concerning the goal of ensuring a fair societal distribution of access to MIGS) and professional conduct in the context of surgical innovation.
Within the equity category, ethically and socially relevant issues include the need for guidelines to help institutions and specialists fairly allocate MIGS under conditions of scarcity; concerns about public coverage versus private payment for MIGS; diverging views of MIGS as an “optional upgrade” or a “medical need;” concerns about equitable access to MIGS for patients living in rural and remote locations; and uncertainty about the clinical and social factors that should be brought to bear on determining the optimal use of MIGS for certain racialized groups.
With respect to the context of surgical innovation, ethical concerns include conflicts of interest arising from some institutions’ and professionals’ incentives to recommend the use of specific MIGS devices to patients; the need to have clear assignment of responsibility for tracking and reporting outcomes of MIGS usage; and challenges in conceptualizing and putting into practice the responsibility to ensure patients’ informed consent with respect to the potential use of MIGS.
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