key: cord-0697906-4megflch
authors: Martin, Dominique E.; Parsons, Jordan A.; Caskey, Fergus; Harris, David C.H.; Jha, Vivekanand
title: Ethics of kidney care in the era of COVID-19
date: 2020-10-07
journal: Kidney Int
DOI: 10.1016/j.kint.2020.09.014
sha: 402fc0f84ab390837289aabf50dc3a961b65fe16
doc_id: 697906
cord_uid: 4megflch

The COVID-19 pandemic presents significant challenges for health systems globally, including substantive ethical dilemmas that may pose specific concerns in the context of care for people with kidney disease. Ethical concerns may arise as changes to policy and practice impact on the ability of all health professionals to fulfil their ethical duties towards their patients in providing best practice care. In this paper we briefly describe such concerns and elaborate on issues of particular ethical complexity in kidney care: equitable access to dialysis during pandemic surges; balancing the risks and benefits of different kidney failure treatments, specifically with regards to suspending kidney transplantation programs and prioritizing home dialysis, and barriers to shared-decision making; and ensuring ethical practice when using unproven interventions. We present preliminary advice on how to approach these issues and recommend urgent efforts to develop resources that will support health professionals and patients in managing them.

The COVID-19 pandemic presents significant challenges for health systems globally, including substantive ethical dilemmas. The pandemic has profoundly impacted delivery of essential health services, including care for patients with or at risk of kidney disease.

Measures to reduce infection risk have changed the way care is delivered, creating potential difficulties for health professionals in fulfilling their ethical responsibilities towards individual patients, public health, and their own families (see Table 1 ). [1] [2] [3] [4] For kidney failure (KF) patients, who are dependent for survival on access to kidney replacement therapy (KRT) in the form of transplantation or dialysis, some changes have high stakes implications.

In settings where access to care was already difficult, the disruption of COVID-19 has proven catastrophic for some patients. 5 COVID-19 infection is associated with development of nephropathy and acute kidney injury (AKI), increasing demand for dialysis during surge periods. [6] [7] [8] [9] [10] Kidney transplant patients are more vulnerable to severe complications of COVID-19, 11 and transplant and dialysis patients may be at higher risk of infection. [11] [12] [13] [14] People with kidney disease and transplant recipients have a higher risk of death from Awareness of the impact of the pandemic on access to dialysis is growing, 9, 10 and professional societies have publicly called for action to address issues in kidney care during the pandemic. 16 However, despite several publications offering ethical advice during the pandemic, most focus on longstanding ethical concerns in the context of pandemics, such as obligations of healthcare workers to provide care, and the allocation of scarce resources, in particular personal protective equipment (PPE), ventilators, and anti-viral medications. 1, 2, [17] [18] [19] [20] [21] [22] [23] [24] [25] Consequently, specific considerations pertinent to KF care are neglected. In Table 1 we summarise several challenges that may arise as changes to policy and practice impact on kidney health professionals' ability to fulfil their ethical duties towards their patients in J o u r n a l P r e -p r o o f providing best practice care. These important issues deserve further elaboration, however we focus on three priority issues of particular ethical complexity: equitable access to dialysis during pandemic surges; balancing the risks and benefits of different KF treatments, specifically with regards to suspending kidney transplantation programs and prioritizing home dialysis, and barriers to shared-decision making; and ensuring ethical practice when using unproven interventions. We present preliminary advice on how to approach these issues and recommend urgent efforts to develop resources that will support health professionals and patients in managing them.

Surges in dialysis demand have been reported during the pandemic as a result of COVID-19 related AKI; there may also be difficulties in meeting regular demand for dialysis as a result of disruption to domestic and international supply chains. 5,6,26.27 For example, there may be staff shortages due to illness or isolation measures, people may be unable to travel safely to access dialysis during lockdown periods, medical products such as dialysate fluid may be unavailable due to transport delays or diversion of supplies to meet urgent needs elsewhere, and insufficient supplies of PPE may limit the ability of clinics to provide full services while meeting infection control standards. 26, 28 Home dialysis patients may face difficulties in accessing telemedicine, laboratory services, prescriptions, and delivery of dialysis supplies. 29 Although some countries, especially low-and middle-income countries (LMICs) have experience with rationing of publicly funded dialysis, 30, 31 rationing of dialysis in the context of the COVID-19 pandemic may present unfamiliar challenges for many health systems.

Notably, people with AKI requiring only temporary dialysis for survival may be unable to access this treatment if systems are overwhelmed. The pandemic may potentially exacerbate J o u r n a l P r e -p r o o f the need for rationing in any country and complicate existing ethical dilemmas regarding equity in allocation of available resources. Some dialysis centres may be able to provide dialysis to only some of those in need, leading some patients to die who would otherwise survive. Other centres may need to compromise on the quality of care provided, for example by reducing dialysis frequency or duration, or by using modalities that are not the preferred or standard treatment for particular patients. Burgner and colleagues have outlined measures that may increase efficiency in managing dialysis resources and enable more people to receive treatment or survive without dialysis during periods of peak demand. 32 Nevertheless, rationing of resources may be required for a period of weeks, and on a recurrent basis, necessitating long-term planning for equitable and efficient resource allocation.

When there are insufficient resources to meet all needs, and those resources are necessary to preserve life, several ethical principles and values are commonly used to guide allocation of resources so as to avoid or minimise unfair inequalities (inequities). 33 (See Table 2 ) In some situations several of these principles and values, taken in isolation, may produce the same conclusion. In practice, they are applied in variable combinations, informed by clinical evidence regarding the likely outcomes of particular allocation frameworks in specific populations, and, ideally, the values and preferences of those populations.

Like mechanical ventilation, dialysis is a life-sustaining treatment. Unlike ventilators, which are rarely used as long-term treatment for chronic end-stage organ failure, dialysis is used in the chronic treatment of more than two million people worldwide. 34 Dialysis machines are also routinely used to provide life-sustaining treatment to several individuals in a given time period, whereas in the same period a ventilator may be used by only one person. However, continuous kidney replacement therapy (CKRT) is often required in critically ill patients with COVID-19 related AKI, 35 making this treatment, like mechanical ventilation, a rival gooduse by one patient may exclude others who could die as a result. Ethical guidelines designed J o u r n a l P r e -p r o o f to support allocation of resources such as ventilators have received considerable attention from ethicists and politicians, 20 however they may not be well suited to allocation of dialysis resources. 36 Although some patients may be wholly excluded from dialysis as a consequence of rationing during pandemic surges in resource limited settings, rationing of dialysis that entails compromises in the quality of care provided is likely to be a more widespread challenge for healthcare providers and patients in many countries. Guidelines are thus needed to ensure that when compromises are necessary and unavoidable, they are fairly distributed and hence equitable. In the early phase of the pandemic, as resource capacities fluctuate and evidence to inform clinical decision-making slowly emerged, key strategies to optimise utility and promote equity in the allocation of limited dialysis resources include the following:

• Expand capacity and explore options to reduce demand for chronic dialysis where possible; 32

• Use alternative dialysis modalities for which capacity is more readily expanded (e.g. acute start peritoneal dialysis) when possible; 27, 35, 37 • Use transparent clinical criteria to inform decision-making based on the best available current evidence; 38 

• Engage in advance care planning with patients, exploring their preferences with regards to treatment options if they develop COVID-19 and require ICU admission and/or dialysis. 39 Determining treatment limits in advance may help to avoid futile treatment. 40 The development of guidelines to support decision-making for allocation of dialysis resources should be prioritised as part of long-term planning in response to the pandemic in all countries, 41 with consideration for the local context and respect for the values and J o u r n a l P r e -p r o o f preferences of local stakeholders. Use of well-designed guidelines and decision-making tools that are supported by stakeholders -including patients -are likely to improve impartiality in decision-making and reduce the psychological burdens of rationing on clinicians, including moral distress. 42 Procedural justice must be respected, with transparent communication of policies and guidelines, systematic monitoring and review of outcomes, and clear, accessible processes to support accountability.

Efforts to reduce demand for KRT and avoid rationing, and to protect KF patients and staff from COVID-19 infection, may influence decision-making about KF treatment modalities and potentially impact quality of patient care. The impact of COVID-19 is expected to persist for some years. Infection precautions such as use of PPE for high-risk procedures are likely to continue even if vaccines and successful treatments are developed. This will affect not only the financial cost of treatment for KF, threatening the viability of some services and increasing barriers to care for many patients, but also the risks and benefits associated with particular treatment modalities and the complexities of clinical decision-making for both patients and care providers. Ethical values and principles that are commonly used to guide decision-makers in the clinical setting such as respect for patient autonomy, nonmaleficence, beneficence, and justice still prevail, however the context in which decisions are made has changed significantly. Preparedness for managing these changes to clinical practice must include consideration of the ethical implications for decision-making, which we briefly explore below. there may be several practical barriers to SDM during the pandemic as a result of, for example, reliance on telemedicine or physical distancing measures in clinics. 43 These may raise ethical concerns about respect for patient autonomy, and complicate efforts to determine the best interests of patients who lack decision-making capacity. 44 For example, if a patient who communicates non-verbally is hospitalised and COVID-19 protections prevent the attendance of their usual carers, video calls may be ineffective in enabling carers to ascertain the views and preferences of that patient through visual cues. The additional burdens of decision-making for patients and their families as outlined below may result in increased reliance on clinicians to advise on treatment decisions. Clinicians may have less information than they ordinarily would regarding the potential risks and benefits of treatment choices, and are thus likely to experience significant ethical anxiety when implementing these decisions or supporting patients to make treatment choices. Uncertainty regarding the potential risks and benefits of options makes it difficult for clinicians to know how best to fulfil their obligations J o u r n a l P r e -p r o o f to promote patient wellbeing (beneficence) and avoid causing harm, ensuring that unavoidable harms are proportionate to the expected benefits of decisions taken (nonmaleficence). Those who feel unable to fulfil their obligations, for example as a consequence of resource constraints or policies enforcing restrictions on availability of treatments, may experience moral distress.

Fortunately, efforts to reduce risks associated with particular treatment modalities are increasingly informed by guidelines, and uncertainty may be reduced by the growing evidence base in the COVID-19 literature. 12 Use of patient and clinician decision aids, which comprise a variety of structured tools designed to support evidence-based and deliberative decision-making, may help to manage decision-making difficulties and promote the dialogue necessary for effective SDM. 43, 45, 46 Effective staff training and support for SDM, tailored to the new clinical realities of the pandemic era, will be essential to ensure that any decisionmaking aids are used effectively. Clinicians will need to cautiously and critically evaluate evidence from experiences in different countries or health system contexts for application in their local setting, and may benefit from additional training in risk communication and SDM with patients (see Table 3 ).

Kidney transplant programs were paused or activity was restricted in many countries as the pandemic developed. This was due to fears of increasing the pool of vulnerable transplant recipients who face significant risks from COVID-19 infection -in particular those admitted for surgery or receiving organs from deceased donors who might be infected -and concerns that performing surgery that might result in the need for ICU admission could use scarce resources at a time of increasing demand. [47] [48] [49] [50] [51] [52] In some contexts, insufficiency of ICU resources may have also limited deceased donation activity due to limitations in capacity to provide maintenance care of prospective deceased donors prior to retrieval of organs. In J o u r n a l P r e -p r o o f contrast to kidney transplant programs, some heart, lung, and liver transplants have been permitted on the grounds of life-saving necessity. [47] [48] [49] However for some patients, such as those in LMICs for whom ongoing dialysis may be unavailable, inaccessible, or unfeasibledue to lack of availability or financial costs -the inability to obtain a timely living donor kidney transplant may be fatal.

Decisions to institute moratoria or reduce transplant activity were made in response to a rapidly developing crisis with limited consideration of longer-term consequences and how these may be managed. The temporary suspension will exacerbate the longstanding shortage of deceased donor kidneys, place increased pressure on systems to fulfil demand once transplant activity resumes, and prevent pre-emptive transplantation, thus increasing demand for dialysis for those patients who would otherwise have received a transplant. For some, delays could eliminate the opportunity for transplantation altogether. Furthermore, continued reliance on dialysis may expose patients with KF to greater risks of COVID-19 infection over time, due to limitations on social distancing when accessing dialysis (outpatient HD) and/or obtaining dialysis resources or receiving care at home. Hence, efforts to prevent harm to some patients may create or exacerbate inequities in access to transplantation or dialysis or in exposure to the risk of COVID-19 infection.

As health systems establish some control over the spread of COVID-19 and the management of healthcare resources, transplant professionals and policy makers are now determining when and how to recommence or scale-up kidney transplantation. 50 A gradual re-opening of programs is likely to occur where non-renal surgical capacity permits, with prioritisation of low-risk cases in centres with effective systems and resources to manage infection risks.

Stakeholders will have to contend with several challenging decisions involving evaluation of risks and benefits in the context of considerable uncertainty. Determining when to proceed with donation and/or transplantation has always involved efforts to ensure expected benefits J o u r n a l P r e -p r o o f are proportionate to potential risks. In the pandemic era, customary risk-benefit analyses will be further complicated by consideration of patients' risk of contracting COVID-19 infection, and the associated risks that may be linked to specific treatment modalities. Patients', physicians', and surgeons' perceptions of risk, which may be influenced by media coverage and research reporting experiences in other countries, will also be a complicating factor in decision-making.

Kidney transplant recipients have a comparatively high risk of COVID-19 infection and mortality. 15, [53] [54] [55] Dialysis patients, particularly those attending outpatient dialysis clinics, are also at higher risk as a result of greatly increased contact with healthcare systems and hence exposure to potential infection. 13 They are also likely to be at higher risk of serious complications and death as a result of older age and comorbidities. 13 

For new KF patients, the possibility of delaying commencement of KRT may be considered in order to reduce demand and protect patients from the risks of infection associated with either transplantation or dialysis. However, rather than postponing dialysis, physicians in some countries have been urged to consider whether new incident patients might be suitable for at-home dialysis. 57 Established patients may also be encouraged to change to home HD and/or PD where this is an option, to reduce pressures on HD clinics and facilitate social distancing. The benefits of this approach must be weighed against the potential burdens and J o u r n a l P r e -p r o o f risks for patients. For example, it may not be possible to provide the customary level of support to patients commencing home HD or PD, leaving patients and their carers anxious or ill-equipped to manage, and thus at higher risk of complications. However, these concerns may be reduced by use of remote monitoring. 58 Suspension of "non-essential" surgery has also restricted options for creation of dialysis access, resulting, for example, in continued reliance on catheters rather than the safer and more reliable arterio-venous fistulae.

When evaluating the potential burdens and infection risks associated with various treatment modalities, clinicians must consider not only the patient with KF but also their personal carers. Those close to dialysis patients often play a significant role in their care, for example by providing transport to clinics or assisting in dialysis at home. 59 Dependence on carers may increase during the pandemic due to the disruption of patient transport systems or supply chains, or reduced availability of professional care. Carers may therefore be more exposed to the risk of infection.

Conservative kidney management (CKM) without dialysis should always be considered as a treatment pathway for KF. 60 Given the increased risks now associated with various forms of KRT, the balance of risks and benefits may shift in favour of CKM without dialysis for some patients whether as a temporary deferral or choice not to initiate dialysis at all. However, it is important to ensure that decisions about initiating dialysis in people approaching KF or discontinuing dialysis in those already receiving it are not unconsciously influenced by rationing considerations; for example, information about treatment options should not be withheld from patients because a clinician believes that rationing may be required. Where Respect for privacy and confidentiality: A person's right to govern access to their person and personal information, including rights to determine how information is used and by whom.

There may be an increase in health data collection and greater demand for monitoring and use of individual health data to inform practice and manage risks of infection to public health. Obtaining informed consent on collection and use of personal data from patients may be difficult due to time constraints. Tensions may arise if patients refuse collection or use of data when this is required by public health law.

Ensure public health policies are clearly communicated to patients including information about rights and responsibilities with respect to privacy of health data. Potential benefits of monitoring/data use for patients should also be communicated.

Uncertainties regarding the risks and benefits of Avoiding futility: Ensuring resources are used only where they will provide a benefit.

Maximising utility: allocating resources to produce the greatest benefits overall for a given population.

Futility estimates may determine whether to offer dialysis to patients with COVID-19 who are admitted to ICU given the high rate of mortality among COVID patients on ventilators, and whether to admit patients with existing KF to ICU if they are COVID-19 positive given their low survival rates. Futility must be defined with respect to specific goals, and often involves qualitative judgements that may be prone to bias. Decision aids should be used to promote objectivity when evaluating futility.

Utility -or benefits -is often defined by the number of lives or (quality adjusted) life years saved from an intervention, thus allocation decisions may be informed by estimates of patient survival if they receive a share of resources If applied in isolation this principle tends to disadvantage those with existing ill health and comorbidities who have poorer chances of longer-term survival (such as many KF patients), thus potentially reinforcing existing inequities.

Reciprocity and solidarity: helping those who are necessary for the provision of care and/or who contribute to the common good.

"Fair innings": Focus on allowing all people to live a "normal" life span.

Healthcare workers and others who contribute to efforts to provide care for patients with COVID-19, and/or more widespread efforts to support societal wellbeing during the pandemic, may be prioritised in the allocation of scarce resources in recognition of their contributions and because protecting these workers is beneficial for all. Reciprocity may also encourage prioritisation of care for people who have previously contributed to society in other ways. Promoting reciprocity and solidarity is often difficult when there are insufficient resources, e.g of PPE.

Prioritisation of healthcare worker safety, for example, may be in tension with professional obligations to care for patients, Often considered in the context of utilitarian analyses, the 'fair innings' approach encourages prioritisation of life-saving treatment for younger patients over those who have already enjoyed a normal, or close to normal, life span. If used in isolation, this principle thus systematically discriminates against older persons and effectively devalues the lives of older patients, who are notably more likely to have KF.

necessitating systemic interventions to ensure that workers are not forced to choose between their own safety and patient wellbeing.

Prioritarianism: Providing first for the worst off.

Equality: respecting fundamental right to health.* Often interpreted as prioritising those most likely to die without treatment, those who have already suffered significant disadvantage (such as long-standing ill health or poor quality of life), and/or those for whom death due to lack of treatment might be considered a greater harm (e.g. those who have not yet lived a full life -see 'fair innings' above). While consideration of prioritarianism may help to address existing inequities, if used in isolation it may lead to outcomes that arguably waste vital resources, for example if those prioritised have a poor prospect of survival even with treatment.

Underpins justice in resource allocation, and prohibits discrimination on irrelevant grounds such as race, religion, gender, or politics; strategies used to promote equality may include use of lottery (random chance) or a "first come, first served" approach, or the setting of common limits on care for all (e.g. limited trials of dialysis for those with COVID-19 related AKI).

• While respect for an inherent equal right to health is fundamental for any resource allocation framework, it provides limited guidance for allocation of resources when these are insufficient to meet all needs, and when needs are different within or between groups.

*notably may be interpreted as promoting equality of health outcomes, opportunities to access care, or shares of resources Engage with growing evidence in COVID-19 literature, and contribute to this by involvement in clinical trials. Evaluate evidence from different countries/health systems in context. Use guidelines and other decision-aids to avoid bias but always consider application in context of patients as individuals.

Ensure broad acceptance of any rationing decisions (including patient community where possible).

Help patients understand complex risks and benefits and address potential sources of misinformation.

Recognise the limitations of telephone discussions; invest in time if technological resources are limited. Avoid paternalism, especially when patients lack decision-making capacity. Consider increased use of key staff with best skills and experience in supporting complex decision-making but also build capacity within teams. Sharing resources across institutions may be appropriate and feasible in the context of telemedicine.

Provide PPE and take other such measures to protect staff from infection. 

Ethical considerations of the duty to care and physician safety in the COVID-19 pandemic

Ethical Rationing of Personal Protective Equipment to Minimize Moral Residue During the COVID-19 Pandemic

Mitigating risk of COVID-19 in dialysis facilities

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The Novel Coronavirus 2019 epidemic and kidneys

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Acknowledge morally complex decisions and seek support from colleagues when necessary.

J o u r n a l P r e -p r o o f

Unproven interventions should only be tried outside the confines of a formal clinical trial if conducting such a trial is unfeasible and/or the patient is unable to access such a trial 2. Absence of superior alternative There should be no superior alternative available in the form of a proven therapy, or any relevant RCTs to offer the patient

There must be sufficient reason to believe that the intervention may be beneficial in treating a particular condition. E.g. valid scientific rationale, and/or evidence of observed experience Key considerations for use of unproven and innovative treatments 8 . Limitations of use Strategies to facilitate conversion of informal trials or ad hoc innovation to formal research studies and to ensure timely communication of findings and evaluation of protocols should be implemented early

The expected risks should be significantly outweighed by any anticipated benefits 7. Outcome monitoring Robust evaluation of safety and efficacy must be undertaken as soon as possible.Outcomes must be monitored and published, and treatment ceased if the risk-benefit balance is found to be unacceptable 6. Informed consent The patient and/or their surrogate decision-maker must provide informed consent to use of an unproven intervention or innovative practice

Treatment protocols for informal trials or ad hoc use should be reviewed by independent experts, ideally by an ethics committee responsible for review of innovative treatments. This will help manage potential bias or conflicts of interest, and ensure validity of patient consent