A Health Systems Ethical Framework for De-Implementation in Health Care

Abstract

Introduction

Unnecessary health care not only drive up costs, but also contribute to avoidable patient harms, underscoring an ethical obligation to eliminate practices which are harmful, lack evidence, and prevent spending on more beneficial services. To date, de-implementation ethics discussions have been limited and focused on clinical ethics principles. An analysis of de-implementation ethics in the broader context of the health care system is lacking.

Methods

To better understand the ethical considerations of de-implementation, recognizing it as a health care systems issue, we applied Krubiner and Hyder’s bioethical framework for health systems activity. We examine ethics principles relevant to de-implementation, which either call for or facilitate the reduction of low value surgery.

Results and Discussion

From 11 health systems principles proposed by Krubiner and Hyder, we identified the 5 principles most pertinent to the topic of de-implementation: evidence and effectiveness, transparency and public engagement, efficiency, responsiveness, and collaboration. An analysis of de-implementation through the lens of these principles not only supports de-implementation but proves an obligation at the health system level to eliminate low value care. Recognizing the challenge of defining “value,” the proposed framework may increase the legitimacy and objectivity of de-implementation.

Conclusions

While there is no single ideal ethical framework from which to approach de-implementation, a health systems framework allows for consideration of the systems-level factors impacting de-implementation. Framing de-implementation as a health systems issue with systems-wide ethical implications empowers providers to think about new ways to approach potential roadblocks to reducing low-value care.

Introduction

In the United States (US), low value care is a growing contributor of health care waste.(1) Unnecessary tests and treatments not only drive up costs but also contribute to avoidable patient harms. These consequences have prompted an effort to reduce ineffective, unproven, or harmful care through de-implementation. Although motivated in part by the need to cut wasteful spending, de-implementation is also necessitated by an obligation to eliminate health care that is harmful, lacks supporting evidence, or prevents directing resources to more efficacious interventions. To date, the discussion of the ethics relevant to de-implementation has been limited, and mostly focused on the clinical ethics principles of non-maleficence, beneficence, autonomy, and justice. There is a paucity of dialogue detailing the ethical considerations of de-implementation in the broader context of the health care system within which de-implementation occurs. A better understanding of de-implementation from a health systems ethical perspective would aid efforts to overcome current health systems barriers preventing the successful reduction of unnecessary or harmful care. Therefore, this paper aims to identify the health systems ethical principles pertinent to de-implementation to affirm our ethical imperative to de-implement low-value care and suggest how to carry out de-implementation within the context of a health systems ethical framework.

Defining the Harms of Low-Value Care

Unnecessary services are the largest contributor of health care waste, estimated to cost up to $100 billion in the US annually.(2) Accounting for at least 30% of total medical spending, surgery is likely a notable contributor to health care waste, but the prevalence and cost of unnecessary procedural care may be underestimated given sparse data on appropriateness. Unnecessary care, even if conventionally considered “low risk”, can also cause patient harms that physicians may not take into account (e.g. costs to patients, unemployment, or additional interventions). The risks conferred by unnecessary diagnostics or treatments depend on the disease, proposed intervention, and overuse rate, which themselves may involve a cascade of services (e.g. an unnecessary preoperative EKG for cataract surgery leading to cardiac tests, treatments, and specialty visits).(3) Similarly, overdiagnosis of some low risk cancers (e.g. breast, prostate, and thyroid) can lead to unnecessary, aggressive interventions with their own toxicities and complications.(4) In other instances, patient harms are difficult to measure, or not measured at all, given they may occur well after the service has been provided and have since become part of a long chain of cause and effect events (i.e. incisional hernia presenting several years after an unnecessary hysterectomy).

Defining De-implementation

To address the harms of unnecessary healthcare, efforts are being directed at de-implementation—the discontinuation of interventions that should no longer be provided.(5). De-implementation strategies target treatments with unproven or poor clinical effectiveness, cost-effectiveness, quality, and/or patient safety.(5) The most notable de-implementation initiative to date has been the Choosing Wisely® campaign.(6) The American Board of Internal Medicine Foundation (ABIMF) launched this campaign in 2012 to “advance a national dialogue around unnecessary medical tests and treatments.”(7) The campaign builds on the ABIMF’s belief that physicians are ethically obligated to “provide health care that is based on the wise and cost-effective management of limited clinical resources.” By partnering with over 90 professional societies, the campaign has produced nearly 600 recommendations to reduce low value care across many specialties, including 107 related to surgery.(8)

Barriers to De-implementation: Four Key Domains

Barriers to de-implementation spanning historical, economic, professional, and social domains have hindered the successful reduction of low-value services.(9) Historically, physician training and culture have instilled an inclination to “do more” for patients, exhausting all diagnostic and therapeutic options, even if the service may be only marginally beneficial, or worse, potentially net harmful. Physicians who have been inculcated to “do everything” may recommend non-beneficial services against their better judgment as a personal protective mechanism to avoid moral injury (i.e. miss a diagnosis or be in conflict with a patient’s preferences). Further, they may find convenience and comfort in habits ingrained in their practice over many years.

The prevailing fee-for-service payment structure incentivizes provision of services largely irrespective of value, especially when physicians may have a direct conflict of interest, when compensation is productivity-based, or when self-referral occurs.(10) For example, physician-owned hospitals specializing in cardiac care have significantly higher rates of coronary artery bypass graft (CABG) as compared to general hospitals without this same financial incentive for some physicians.(11) Recent changes to Medicare payment models have encouraged hospital participation in Accountable Care Organizations (ACOs); however, ACOs have mainly targeted primary care and have not been shown to reduce surgical spending, suggesting health care reform has not addressed overtreatment of surgical patients.(12) Furthermore, de-implementation strategies successful in reducing inappropriate nonprocedural care (e.g. preauthorization, restrictive ordering, and point-of-care decision support tools) have been less useful in reducing unnecessary procedures.(13)

Professional barriers to de-implementation include the proclivity of some providers to favor practices due to anecdotal personal experience as well as pressures to appease patient preferences. Furthermore, providers’ biases may result in a hesitancy to reduce specialty-specific practices. For example, although 17 surgical societies have participated in the Choosing Wisely® campaign, less than five percent of recommendations target low value surgical procedures.(8) Instead, these recommendations largely target periprocedural care primarily impacting the revenue of hospitals or other providers (i.e. laboratory or diagnostic testing). Providers are also influenced by a sense of loyalty to their patients and consequentially focus on principles of clinical ethics, believing their duty to their individual patients supersedes an obligation to society at-large. Thus, providers may feel compelled to satisfy patients by complying with their preferences, even if it means providing an intervention in the absence of proven benefit.(14) This may further be driven by a desire to avoid confrontation with patients or to ensure patients or referring providers do not perceive them to be withholding care.

Lastly, from a social standpoint, there are external sources of influence encouraging patients to seek or providers to offer low value care. Specifically, media outlets have been known to disseminate medical information from unvetted or nonmedical sources, which can influence patient preference (e.g. media coverage of celebrities’ breast cancer treatment decisions being associated with rising rates of contralateral prophylactic mastectomy (CPM)).(14) Further, direct-to-patient advertising by hospitals may highlight therapies in ways fomenting demand.(15) The group norms within a specialty can separately hinder de-implementation, as providers may feel pressured to offer low value services when other physicians offer it out of a concern that patients will seek this care from competing providers.

Clinical Ethics in De-implementation

The clinical ethics principles of non-maleficence, beneficence, and justice underpin the need for de-implementation. In cases where interventions are harmful or ineffective and/or may prevent patients from receiving a safer or more effective alternative, there is an ethical obligation for de-implementation on the basis of non-maleficence and beneficence.(5) At the same time, the reduction of unnecessary medical care facilitates justice by supporting the reallocation of resources away from cases of low value to cases of higher value (e.g. redirecting cardiac revascularization away from patient populations with overuse and towards patient populations facing underuse).(16) Despite these principles supporting de-implementation, some may counter that mandatory de-implementation is unethical given a perception that it threatens patient and provider autonomy. While patient autonomy is critical, it does not justify providing care lacking evidence of safety or efficacy. The ABIMF’s Physician Charter for Medical Professionalism clarifies this principle: “Patients’ decisions about their care must be paramount, as long as those decisions are in keeping with ethical practice and do not lead to demands for inappropriate care.”(17) Furthermore, in some clinical situations, de-implementation recommendations can actually facilitate patient autonomy. For patients who would like to forgo low value therapy, but may feel pressured to accept a treatment considered “low value”, de-implementation recommendations can validate a patient’s belief that doing less may be better than doing more.(18) In this way, recommendations to reduce low value care may empower patients to exercise more, not less, autonomy.

Moving to a Health Systems Bioethical Framework

Although clinical ethics principles frame de-implementation as an individual issue, de-implementation is just as importantly a health care systems issue with influencing factors outside of the individual patient-provider relationship.(19) Our definition of the health care system is informed by the World Health Organization (WHO) Framework for Action, which proposes a series of building blocks that comprise a ‘health system’ and includes health services, a health workforce, information system, financing, medical products, vaccines, and technologies, and leadership and governance.(20) Any of these six principles may influence de-implementation and many of the barriers to de-implementation are themselves at the level of the system, falling into the WHO Framework (i.e. poorly aligned incentive and social context, representing the principles of ‘financing’ and ‘workforce’, respectively). While there is no perfect ethical framework from which to approach de-implementation, a health systems framework featuring ethical principles, which are distinctly different from those of a traditional clinical ethics framework, allows for consideration of the systems-level factors impacting de-implementation. A unique health systems ethics approach provides a special opportunity to discuss how de-implementation broadly influences the health care system at-large and how it involves systems-wide actors, which can reframe the way we advocate for the elimination of low value care.

In their writing on ‘systems thinking,’ Krubiner and Hyder recognized the evolving complexity of health care systems and sought to develop a more holistic approach to bioethics addressing issues of system-wide functioning and population-level health outcomes as a means to “promote greater scrutiny” of structures and decisions morally relevant to health systems.(21) Through a normative ethics approach, Krubiner and Hyder worked within a large health system consortium and consulted with a number of expert individuals and groups to propose a health systems framework with 11 ethical principles drawing upon concepts from governance, human rights, and business and organizational ethics. Using a health systems definition citing the WHO Framework, they identify health systems as complex, dynamic networks with inputs from multiple actors and institutions. The health systems ethical principles proposed by Krubiner and Hyder were intended to stand alongside traditional bioethics principles pertinent to individual patient-level issues (e.g. autonomy, justice, beneficence) and public health principles targeting specific population-level issues (e.g. utility, accountability, cost/efficiency). Their proposed set of health systems ethical considerations intends to guide policies and actions targeting improvement and innovation at the highest levels of the health care system. This framework has been applied to other health systems topics as a tool to articulate and approach specific ethical concerns raised by complex health systems issues.(22)

Given the complex and dynamic nature of de-implementation and the multi-faceted, system-wide engagement required to reduce low value care, we believe that a health systems perspective is central to thinking about the ethical considerations of de-implementation. However to date, there has not been, to our knowledge, a health systems ethical framework applied to the topic of de-implementation. Therefore, we have identified five principles from Krubiner and Hyder’s broader bioethical framework reaffirming the ethical imperative to de-implement low value care (Table). Emphasizing evidence and effectiveness, transparency and public engagement, efficiency, responsiveness, and collaboration, we discuss how to effect de-implementation using these five principles as guidance.

Table.

A guide to approaching de-implementation using a health systems ethical framework

Principle	Definition	Procedural Care Example	Approach to De-Implementation
Evidence and efficacy	Using evidenced-based knowledge to support the reduction of tests and treatments not shown to be effective and/or safe. The cornerstone of de-implementation.	Re-excision of close but negative partial mastectomy margins for invasive breast cancer has been successfully de-implemented with evidence showing it does not improve survival. (14)	Incentivize comparative effectiveness and appropriateness research and post-marketing trials to inform future de-implementation decisions and value determinations.
Transparency and public engagement	Communicating reasons for de-implementing particular practices. Increasing patient understanding of “low value” designations to facilitate informed decision-making and mitigate perceived conflicts of interest.	The introduction of patient decision aids in orthopedic surgery has been associated with reductions in knee and hip replacement and surgeries for lumbar disc herniation and lumbar spinal stenosis. (39)	Facilitate multilevel dissemination of evidence and rationale for de-implementation of low value interventions through enhanced patient-provider communication and interspecialty collaboration.
Efficiency	Reducing wasteful spending on low value care to allow for increased access to more beneficial and necessary health goods or services.	Avoiding contralateral prophylactic mastectomy in average risk women with unilateral breast cancer given it does not improve overall survival yet increases cost and morbidity. (34)	Implement innovative models that financially incentivize health systems and surgeons to monitor and limit low value care, redirecting resources toward higher value services.
Responsiveness	Answering the call to eliminate wasted health care spending and avoidable patient harms associated with unnecessary health care.	Rates of inappropriate endarterectomies fell from 18% to four percent when surgeons were presented with their results from an audit on surgery appropriateness.(40)	Provide physicians and health systems with feedback (e.g. performance summaries or clinical decision support) to promote de-implementation and how to adjust practices accordingly.
Collaboration	Coordinating efforts to minimize overuse and target low value practices for de-implementation, in order to optimize patient outcomes.	The Washington State Surgical Care and Outcomes Assessment Program has identified the persistence of low value care in the high rates of inappropriate elective colon resection for acute diverticulitis.(41)	Bring together multi-level stakeholders (e.g. patients and providers), large-scale collaboratives, and health care systems to weigh-in on which practices to de-implement and develop strategies for effective low value care reduction.

6 ethical principles from Krubiner and Hyder’s Health Systems Ethics Framework were not emphasized: Holism, Sustainability, Accountability and Feedback, Equity and Empowerment, Justice and Fairness, Quality

The remaining six principles of Krubiner and Hyder’s framework (i.e. holism, sustainability, accountability and feedback, equity and empowerment, justice and fairness, and quality) are also likely relevant to de-implementation but were felt to overlap and/or rely upon the 5 principles that we felt were more essential to emphasize. For example, de-implementation aims to improve quality in health care, but should do so on the basis of evidence and effectiveness. Thus, we emphasized ‘evidence and effectiveness’ instead of ‘quality’. Similarly, principles of ‘justice and fairness’ or ‘equity and empowerment’ may be achieved with successful de-implementation of low value care, but this outcome is likely contingent upon improved efficiency allowing for reallocation of resources to enable equal access to necessary health services. As de-implementation efforts expand and low value interventions are reduced, our understanding of the interconnectedness of these principles will likely mature and expand.

Evidence and effectiveness

Evidence and effectiveness serve as the basis for de-implementation, as clinical practices are targeted for elimination if there is evidence of ineffectiveness or harm, or a lack of supporting evidence in the presence of uncertain effects.(23) Interventions with weaker evidence are more likely than those with stronger evidence to pose risks outweighing the benefits.(24) Therefore, evidence should be the cornerstone of “value”, which also ensures that practices are not arbitrarily selected for de-implementation and subject to increased bias.

Despite best intentions to determine value by objective measures (e.g. scientific evidence or clinical outcomes), an element of subjectivity remains. All too frequently, there is not enough comparative evidence to assess value and subsequently inform de-implementation recommendations.(25) For instance, in a random sample of Cochrane systematic reviews evaluating health care interventions, 49% reported insufficient evidence to either support or refute the studied intervention.(26) Value may be especially difficult to measure in surgery, where randomized comparative trials can be difficult to accrue and where a framework for evaluating surgical therapies has not been well defined.(27) A lack of randomized comparative trials in surgery creates a “grey area of clinical discretion” where surgeries are neither clearly beneficial nor contraindicated, and therefore are likely to be heavily influenced by the skills, experiences, and preferences of the surgeon.(28, 29) As a result, surgical treatments are often broadly adopted with minimal evidence of efficacy, in contrast to medical therapies, which undergo rigorous scrutiny before implementation, leading to entrenched surgical practices before evidence is available.(28). One suggestion to preventing premature widespread adoption of surgical interventions is to restrict their use until sufficient evidence supporting efficacy emerges (e.g. limiting percutaneous transluminal angioplasty and stenting for intracranial stenosis to patients within a clinical trial).(30) However this is unrealistic for a majority of therapies, especially when there is little incentive to conduct post-marketing trials examining clinically meaningful outcomes in the current health care system. (30)

In cases where evidence does exist, it is sometimes hard to determine what level of evidence is sufficient to lead to meaningful de-implementation. In some cases, evidence may consider secondary or surrogate outcomes of an intervention. If these endpoints demonstrate an effect, providers may be encouraged to hold onto a practice, in spite of a lack of improvement in the primary outcome. In other cases, surgeons may discredit evidence by overestimating their own technical skills relative to the skills of the surgeons in the trial from which the evidence is based.(13) The differential successes in de-implementing two low value breast cancer surgeries, axillary lymph node dissection (ALND) and CPM highlight that evidence alone is not enough to ensure de-implementation. While ALND was significantly and rapidly de-implemented on the basis of one trial (ACOSOG Z0011), CPM has become increasingly common despite several meta-analyses supporting de-implementation.

Transparency and public engagement

The principle of engagement and transparency means that patients and providers should be educated on which tests, treatments, and procedures are low value and why they have been targeted for de-implementation. This transparency can help reduce perceived conflicts of interest.(23) Failing to provide patients with all of the information related to a low value service, including its associated risks, low likelihood of benefit, and rationale for de-implementation, hinders patients’ ability to make fully informed decisions. The Choosing Wisely® campaign is one effort that has successfully increased direct patient education to combat misinformation and limit overtreatment. As one example, there has been a reduction in antibiotic use for acute bronchitis since providing patients with verbal advice and informational leaflets about the uncertainty of prescribing antibiotics in these circumstances.

To facilitate transparency and public engagement, providers must address patients’ concerns directly. Effective interpersonal skills are paramount to providers having straightforward, evidence-based conversations with patients about why a low value intervention is not recommended. This can help providers counter patient requests for unneeded and/or inefficacious tests or treatments in situations where they may otherwise feel obligated to cater to these preferences.(31) Furthermore, open conversation can help avoid scenarios of “preference misdiagnosis,” wherein physicians have a poor understanding of their patients’ values and inaccurately believe their patient desires an aggressive treatment.(32) Conversations about de-implementation recommendations may also give patients an opportunity to share previously unvoiced desires to forgo treatment, thereby providing an avenue for patient autonomy.

Efficiency

While in the past bioethics has focused on concerns regarding underuse and allocation of scarce resources, there has been a recent shift to emphasizing the avoidance of waste.(1) Wasteful spending on low value care crowds out financial opportunities to support other health initiatives, which can lead to worse health outcomes for the population at large, further driving an ethical imperative for de-implementation.(33) De-implementation of low value care facilitates a commitment to efficiency because it helps to limit unnecessary expenditure of resources by reducing services that do not improve individual and population health. The ABIMF’s Physician Charter notes that the physician’s “professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures” and further the provision of unnecessary services promotes disparities across the population by “[diminishing] the resources available for others.”(17) In surgery, where there is considerable overuse of many procedures (e.g. hysterectomy and carotid endarterectomy), efficient care may be particularly hard to achieve.(34) However, redirecting even a fraction of the resources wasted on low value surgery could extend useful therapies to a greater number of patients.

Although successful de-implementation supports improved stewardship of limited resources, simply reducing low value care is not sufficient to achieve optimal efficiency, particularly in such a way to simultaneously promote equity. Instead, we must be intentional about how we identify waste and redundancy in the health system so as not to inadvertently perpetuate disparity. Patient populations can be affected differentially with varying access to treatments if de-implementation does not equitably occur within and across health care systems. For example, disparate de-implementation patterns of CPM for patients with breast cancer have exacerbated a treatment disparity in which white women with higher socioeconomic status and private insurance undergo this surgery at higher rates than women of other races, socioeconomic statuses, or insurance types.(35)

Responsiveness

Just as health care systems must adapt to the constantly changing needs of their populations, practice recommendations must change based upon the most current evidence.(21) Successful de-implementation depends on the ability of a health care system to enact the changes being called for by new practice recommendations. To facilitate health care system responsiveness to a new de-implementation proposal, evidence-based information pertaining to the recommendation needs to be disseminated effectively. In addition to dissemination of recommendations, systems should support strategies that facilitate de-implementation. For example, providers are better able to respond to de-implementation recommendations when they are aware of the frequency at which they are providing an unnecessary intervention. One study demonstrated that after surgical attendings and resident physicians received weekly notifications about their patients’ phlebotomy costs, the total laboratory costs for these patients decreased.(36) Similarly, providing physicians with individualized de-implementation performance summaries relative to their peers or incorporating clinical decision support (e.g. alerts in the electronic medical record) has increased their responsiveness to various professional recommendations promoted by the Choosing Wisely® campaign.(6, 37)

Collaboration

As the Choosing Wisely® campaign points out, collaboration is critical throughout the various stages of the de-implementation process. Determining which practices to target for de-implementation can be a challenge, but one that can be addressed with fully informed patient and provider stakeholders who can help determine the value of a service with careful consideration of the risks, benefits, alternatives, and costs.(38) Furthermore, quality improvement collaboratives, like the American College of Surgeons (ACS) National Surgical Quality Improvement Program, can be leveraged to inform de-implementation initiatives. Through engagement of stakeholders at multiple levels, collaboration not only can ensure that de-implementation is done ethically, but it can also improve the likelihood of a campaign’s success.(5) For instance, the Michigan Urological Surgery Improvement Collaborative (MUSIC), funded by Blue Cross Blue Shield of Michigan, has led a quality improvement initiative that reduces the overall burden of treatment in patients with benign renal masses and others who would not benefit from intervention.(39)

In addition to multi-level collaboration, providers have a unique opportunity to coordinate their efforts in a way to promote reduction of low value care. In situations where patient preferences lead to the persistence of an inappropriate health care service, physicians can adopt a unified approach to discontinuing the intervention. The power of group norm in de-implementation is similarly realized in situations where a perceived widespread reduction of a procedure makes it “inappropriate for any provider to continue to perform his operation.”(14) In this way, providers can hold each other accountable to eliminating ineffective or harmful services in their specialty and effectively align their practices to benefit patients.

Conclusion

Despite increased de-implementation efforts over the past decade, the persistence of low value care across an array of surgical and medical specialties indicates an opportunity to do better. To understand the systems-level ethical considerations of de-implementation and demonstrate how and why we must reduce ineffective and harmful health care interventions, we analyzed de-implementation using Krubiner and Hyder’s health systems ethical framework. We identified the five principles that we felt were most relevant to de-implementation in that they either support the need to reduce low value care or help guide suggestions on how to facilitate it.(21) The inherent subjectivity of defining “value” further emphasizes the need for a de-implementation framework that considers the relevant ethics principles and provides objectivity. A heath systems ethics approach to de-implementation may increase the legitimacy of the de-implementation process by ensuring value is determined with evidence, efficiency, transparency, responsiveness, and collaboration in-mind. We believe that framing de-implementation as a health systems issue with ethical implications will empower surgeons to think about new ways to approach potential roadblocks to the reduction of low value care.