VIEWS, VISIONS AND VISTAS IN DIALYSIS

DEBATE: Should Dialysis at Home be Mandatory for All Suitable ESRD Patients? Patients Should Not Be Forced Onto Home Dialysis David C. Mendelssohn Humber River Hospital, University of Toronto, Toronto, Ontario, Canada

ABSTRACT Outcomes are similar between hospital-based hemodialysis and less expensive home-based therapies, especially home peritoneal dialysis. Because of this, some have argued that all suitable patients should be forced to these less expensive modalities. However, such an approach would violate the ethical principles of autonomy and maleficence, and would run counter to the movement toward patient-centered care. Therefore, from a North American perspective, home dialysis should be actively promoted for suitable patients, but should not be mandatory. Extending these

arguments into newer paradigms of home- and community-based dialysis, with paid assistance, will be a challenge as traditional cost effectiveness arguments may not be definitive and effective. Nephrology will need to embrace new methods for evaluation of therapies and to develop and endorse sophisticated principles of advocacy to influence health care policy and funding decision makers to maximize nonhospital-based, patient-centered care and improve outcomes in the future.

The important question about whether suitable patients should be forced onto less expensive dialysis modalities is a controversial ethical dilemma for nephrologists and will be the focus of this commentary, which updates and expands upon one published previously (1). I will assume a North American perspective, with relatively well-financed health care systems that currently allow anyone with ESRD to access treatment, and where home dialysis is not the predominant treatment strategy. Forcing unsuitable patients onto home dialysis would clearly lead to negative outcomes, would be unethical, and will not be considered further. Most discussions about dialysis modality options begin with the published literature that shows that outcomes, including survival, are similar between incenter hemodialysis (HD) and home peritoneal dialysis (PD) (2–7). While there are important methodological limitations that prevent perfect comparisons between modalities, let us set those aside as we dive deeper into the issue at hand and assume the outcome equivalence of these two traditional dialysis modalities. Similarly, let us set aside for the

moment (and return to this later) recent preliminary evidence suggesting that daily and nocturnal home hemodialysis achieves superior outcomes, compared to standard thrice weekly hemodialysis or peritoneal dialysis (8–10). Finally, let us agree with multiple published reports that home dialysis (in most but not all iterations) is less expensive than hospitalbased, three times weekly hemodialysis (11–15).

Black or White? The fundamentals of medical economics come into play in the consideration of modality options (Fig. 1). If a new modality or modality improvement allows for both (a) better or equal outcomes and (b) lower cost, then society should accept and implement the change. Clearly, both conditions seem to be satisfied in the case of home dialysis versus incenter HD. A practical and ethical nephrologist should support and promote home dialysis for many patients. It seems clear that patients approaching ESRD can be grouped into several broad categories. A minority choose conservative therapy, while another small percent are eligible for early or preemptive transplantation. Of the majority who choose to live on dialysis, there are some patients who have contraindications to PD, a few who have contraindications to HD, but the great majority can do either method. Indeed, recent studies suggest that 60–78%

Address correspondence to: David C. Mendelssohn, MD, FRCPC, Humber River Hospital, 200 Church St., Weston, Ontario, Canada M9N 1N8, Tel.: +289-772-6992, Fax: +416658-2242, or e-mail: [email protected]. Seminars in Dialysis—Vol 28, No 2 (March–April) 2015 pp. 155–158 DOI: 10.1111/sdi.12323 © 2014 Wiley Periodicals, Inc. 155

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Cost Fig. 1. Fundamentals of medical economics. * Dialysis is a costly and not completely effective therapy. A new or improved therapy that increases effectiveness and reduces cost would be implemented (orange arrow). One that increases cost with a small increase in effectiveness would be difficult to rationalize (blue arrow).

of patients (16–18) could do either PD or HD. The fundamental controversy is whether these patients should be forced to do home dialysis as it is less expensive? My opinion is clearly that they should not be. A fair percent of my academic contributions to the nephrology literature relate to issues around dialysis modality distribution. I am a strong proponent of home dialysis as a first therapy for suitable patients (19). I advocate that nephrologists should voluntarily define, and then strive to achieve, an optimal modality distribution that maximizes patient outcomes, but minimizes societal costs (20). I believe that patients should be empowered with sufficient information to make autonomous decisions, and should be given detailed education about all modality options (21). Furthermore, home dialysis should be actively promoted by nephrology teams and should not be presented as merely a neutral option to a suitable patient. However, it should not be made mandatory. Support for the approach described above was assessed in a survey of Canadian nephrologists (22) (Fig. 2). More than 80% of respondents strongly or somewhat agreed that information should be presented to patients in a way that promotes home dialysis for suitable patients. Conversely, less than 25% strongly or somewhat agreed that all suitable patients should be obligated to learn home dialysis. Indeed, just such an approach has been shown in several studies, to lead to about half of all suitable patients voluntarily choosing a home-based modality (17,18,23,24). If broadly applied, this sensible approach respects the ethical principle of autonomy (respecting patients’ right to choose among options) and would be expected to markedly increase home dialysis utilization and save money in most countries that provide dialysis therapies. This approach

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Fig. 2. What is your opinion about these aspects of CKD care in Canada? (A) I believe we should present information about center-based and home dialysis in a way that promotes home dialysis for suitable patients, but does not make it mandatory. (B) I believe that all suitable patients should be obligated to learn home dialysis (from Am J Kidney Dis 47(2):277–84, 2006).

to the active promotion of home dialysis for suitable patients (but not obliging it) has been formally endorsed by the Canadian Society of Nephrology since 1997(25). I believe similar policies should be considered and then adopted elsewhere. For a proponent of forcing suitable patients onto home dialysis, fundamental bioethical principles clash in irreconcilable conflict. The prime motivation in favor must be based on an assumption of optimizing distributive justice (saving money allows others to have treatments and maximizes outcomes for the greatest number of people). However, such a practice would violate the principles of autonomy (denying patient choice), and nonmaleficence (it may cause harm). Forcing suitable patients to home dialysis fails the test of improving patient outcomes and runs counter to the modern shift toward patient-centered care. More important, it will likely not prove to be less costly either. Especially as patient compliance and motivation are key elements of successful home dialysis, forced patients will no doubt fail frequently, with death and/or expensive and frequent hospitalization and transfers to hospital-based HD highly probable events. It is critical to understand that dialysis costs are not linear from month to month and year to year. In fact, Prichard showed 20 years ago that there is a high cost at dialysis initiation and at transition points from one modality to another, followed by a linear slope of cost if patients remained stable on any given therapy (26). Early modality failure means two sets of start-up costs, induces anxiety, and additional procedures for patients to endure. Even if one were to consider forcing all suitable patients onto home dialysis, how would one draw the line about defining suitability in a precise enough way that it can be operationalized? Is an independent, suitable patient who works at a job that precludes home dialysis expected to stop work-

HOME DIALYSIS SHOULD NOT BE MANDATORY

ing? Is a marginal patient with strong family support a candidate if it means forcing an available but unwilling family member to perform dialysis? What about a family member who works, or who babysits young children, who would no longer be able to do so? Is a family with the financial means to pay for additional support treated differently from a poor family? There is ethical quicksand at play in these considerations. Shades of Gray? As dialysis care evolves, seeking better techniques that improve upon historically dismal patient outcomes that have been difficult to overcome, shades of gray (ethically and economically speaking) arise that are worth pausing to consider. Traditionally, home dialysis has required either a patient who is capable of caring for him or herself at home, or unpaid friends or family members who will learn how to do home dialysis for the patient. Recently, many jurisdictions are interested in having fewer patients dialyze in hospital-based facilities and prefer more in home environments or in nursing homes, chronic care, or long-term care institutions. Based on quality of life and patient-centered outcomes, patients and families are likely to strongly support this. However, this model implies that older and frailer patients will prefer to dialyze in their own community. One way to support this shift in care location is to provide supplemental dialysis assistance to patients and families in the form of paid caregivers. In PD, some have advocated visiting nurses twice per day to set up and take down the automated PD circuit (assisted PD) (17,27). A similar assisted approach to home hemodialysis is possible. However, the cost of fully qualified nurses makes nurse-assisted home HD cost prohibitive, so less expensive lay persons (personal support workers) might be trained to provide HD in the home environment (28). Indeed, pilot studies are ongoing in Ontario and preliminary results are encouraging. The nephrology community will need to grapple with even more complex economic questions if these new models are to flourish. Recall the fundamental principles of medical economics discussed above. Now, we are considering new therapies that expand modality choices, enhance patient-centered care, and offer (a) some potential benefit, but (b) at much higher cost. On one hand, these models clearly promote community-based care in some circumstances where hospital-based, incenter HD would have been the default therapy offered. On the other hand, any cost advantage in favor of home and communitybased dialysis may become marginal, or be lost completely. Given that incenter, thrice weekly HD is the barometer that sets the gold standard for the highest cost per quality of life year gained that a wealthy society is willing to bear, how will the nephrology community justify the higher costs?

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Indeed, some economists insist that the costs of extending the life of a chronic dialysis patient must be considered in the quality-adjusted life year calculations. This means that any future expensive (and inexpensive) life extending modality adjustments will be judged cost ineffective. We have recently argued against this approach, which if widely endorsed, would stop innovation in dialysis care (29). Finally, there is an emerging polarization among nephrologists about whether, as individuals or as professional societies, we should prioritize cost effectiveness in clinical decisions, public policy, or in guideline development (30,31). While clearly we need to be aware of our gatekeeper role and be economically reasonable in our efforts, at the end of the day, we are in a uniquely qualified role as our patient’s advocate. Our fiduciary duty is to make the best decisions (and/or treatment recommendations) we can for each and every patient and family we treat. Based on this principle, it would be wrong for individual clinicians or for our professional societies to insist upon rigid, mandated pathways just because they are less expensive, when patients are expected to achieve more benefit through alternative therapies. Cost constraining decisions are the responsibility of payers (and the broader interests of society). Indeed, these third-party decisions may impact upon our clinical choices and for that reason, nephrologists should vigorously provide input into societal discussions about dialysis (within the broader context of consideration of limits to other expensive nonrenal therapies). However, it is better that cost-based limits be imposed upon us by others, than for us to willingly take on the role of cost constraining agent to the disadvantage of our patients. Future Directions and Challenges The nephrology community must develop logical and carefully articulated positions that confront the strictly cost-based arguments described above to allow for positive evolution of our therapies and improvement of patient outcomes. Some questions to grapple with include: Will better survival and quality of life expected with unassisted and/or assisted short daily and nocturnal hemodialysis be sufficient to compel society to bear the increased cost? Will the outcome advantages seen in the generally younger, healthier patients involved in most home HD studies to date be generalizable to the frail elderly, especially if paid dialysis assistance is required? Are there subsets of patients for whom the medical economics make sense, while in other subsets, the costs are too high? As decisions by public funders of health care and insurers become more and more based upon evidence and cost, nephrology faces a great challenge. The evidence base in nephrology is scanty compared to other disciplines (32,33). Consider the discussions above about new modalities of dialysis and/or

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forced choice. There is limited observational study data, and few randomized controlled clinical trials (RCT). Pragmatic and ethical considerations of the future make me conclude that these evaluative questions are not likely to be answered optimally through peer-reviewed funding of multiple large RCTs. New or improved treatments will almost always be more costly, with the additional burden of solid proof of concept imposed upon us. How can nephrology advance in this rigid paradigm? Conceptually, nephrology must consider embracing new and different models of establishing rigorous evaluations of new and improved therapies, such as pragmatic facility-based randomized trials and/or field evaluations (such as coverage with evidence development) after licensing. These evaluations can be designed to include safety, efficacy and cost effectiveness. We have discussed these in detail recently (34,35). Until rigorous efficacy and cost effectiveness analysis is much more widespread in nephrology, finding a pragmatic and ethical middle ground that includes consideration of all available data, that includes sensible opinion-based recommendations when evidence is lacking, that sets reasonable treatment targets for clinicians and, and that elevates patient advocacy above cost considerations, is a profound but important challenge for the nephrology community. Grappling with these polarizing imperatives will not be easy, but endorsing a mandated choice of the least expensive modality can only lead us down a very slippery slope. In North America, societal values that respect autonomy and patient preference must trump forcing undesirable modality choices onto unwilling patients and families.

References 1. Mendelssohn DC: Increasing PD utilization: should suitable patients be forced? Perit Dial Int 29:144–146, 2009 2. Fenton SSA, Schaubel D, Desmeules M, Morrison H, Mao Y, Copleston P, Jeffery J, Kjellstrand C: Hemodialysis versus Peritoneal Dialysis: a comparison of adjusted mortality rates. Am J Kidney Dis 30:334–342, 1997 3. Collins AJ, Hao W, Xia H, Ebben JP, Everson SE, Constantini EG, Ma JZ: Mortality risks of peritoneal dialysis and hemodialysis. Am J Kidney Dis 34:1065–1074, 1999 4. Yeates K, Zhu N, Vonesh E, Trpeski L, Blake P, Fenton S: Hemodialysis and peritoneal dialysis are associated with similar outcomes for end-stage renal disease treatment in Canada. Nephrol Dial Transplant 27:3568–3575, 2012 5. Bloembergen WE, Port FK, Mauger EA, Wolfe RA: A comparison of mortality between patients treated with hemodialysis and peritoneal dialysis. J Am Soc Nephrol 6:177–183, 1995 6. Vonesh EF, Snyder JJ, Foley RN, Collins AJ: Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us? Kidney Int 70:S3–S11, 2006 7. Weinhandl ED, Foley RN, Gilbertson DT, Arneson TJ, Snyder JJ, Collins AJ: Propensity-matched mortality comparison of incident hemodialysis and peritoneal dialysis patients. J Am Soc Nephrol 21: 499–506, 2010 8. Nesrallah GE, Lindsay RM, Cuerden MS, Garg AX, Port F, Austin PC, Moist LM, Pierratos A, Chan CT, Zimmerman D, Lockridge RS, Couchoud C, Chazot C, Ofsthun N, Levin A, Copland M, Courtney M, Steele A, McFarlane PA, Geary DF, Pauly RP, Komenda P, Suri RS: Intensive hemodialysis associates with improved survival compared with conventional hemodialysis. J Am Soc Nephrol 23:696–705, 2012

9. Pauly RP, Gill JS, Rose CL, Asad RA, Chery A, Pierratos A, Chan CT: Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients. Nephrol Dial Transplant 24:2915–2919, 2009 10. Weinhandl ED, Liu J, Gilbertson DT, Arneson TJ, Collins AJ: Survival in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. J Am Soc Nephrol 23:895–904, 2012 11. McFarlane PA, Pierratos A, Redelmeier DA: Cost savings of home nocturnal versus conventional in-center hemodialysis. Kidney Int 62:2216–2222, 2002 12. Klarenbach S, Tonelli M, Pauly R, Walsh M, Culleton B, So H, Hemmelgarn B, Manns B: Economic evaluation of frequent home nocturnal hemodialysis based on a randomized controlled trial. J Am Soc Nephrol 25:587–594, 2014 13. Goeree R, Manalich J, Grootendorst P, Beecroft ML, Churchill DN: Cost analysis of dialysis treatments for end-stage renal disease (ESRD). Clin Invest Med 18:455–464, 1995 14. Lee H, Manns B, Taub K, Ghali WA, Dean S, Johnson D, Donaldson C: Cost analysis of ongoing care of patients with end-stage renal disease: the impact of dialysis modality and dialysis access. Am J Kidney Dis 40:611–622, 2002 15. Golper TA: The possible impact of the US prospective payment system (“bundle”) on the growth of peritoneal dialysis. Perit Dial Int 33:596–599, 2013 16. Mendelssohn DC, Mujais S, Soroka S, Brioullette J, Tokano T, Barre P, Mittal B, Singh A, Firanek C, Story K, Finkelstein FO: A Prospective Evaluation of Renal Replacement Therapy Modality Eligibility. Nephrol Dial Transplant 24:555–561, 2009 17. Oliver MJ, Quinn RR, Richardson EP, Kiss AJ, Lamping DL, Manns BJ: Home care assistance and the utilization of peritoneal dialysis. Kidney Int 71:673–678, 2007 18. Jager KJ, Korevaar JC, Dekker FW, Krediet RT, Boeschoten EW: The effect of contraindications and patient preference on dialysis modality selection in ESRD patients in The Netherlands. Am J Kidney Dis 43:891–899, 2004 19. Mendelssohn DC, Pierratos A: Reformulating the integrated care concept for the new millennium. Perit Dial Int 22:5–8, 2002 20. Mendelssohn DC: Reflections on the optimal dialysis modality distribution: a North American perspective. Nephrol News Issues 16:26–30, 2002 21. Mendelssohn DC: Empowerment of patient preference in dialysis modality selection. Am J Kidney Dis 43:930–932, 2004 22. Mendelssohn DC, Toffelmire EB, Levin A: Attitudes of Canadian nephrologists toward multidisciplinary team-based CKD clinic care. Am J Kidney Dis 47:277–284, 2006 23. Prichard SS: Treatment modality selection in 150 consecutive patients starting ESRD therapy. Perit Dial Int 16:69–72, 1996 24. Golper TA, Vonesh EF, Wolfson M, Baudoin M, Schreiber MJ: The impact of pre-ESRD education on dialysis modality selection. J Am Soc Nephrol 11:231A, 2000 25. Mendelssohn DC; for the CSNP, Public Policy C: Principles of end stage renal disease care. Ann R Coll Physicians Surg Can 30:271–273, 1997 26. Prichard SS: The costs of dialysis in Canada. Nephrol Dial Transplant 12(S1):22–24, 1998 27. Lobbedez T, Moldovan R, Lecame M, de Ligny BH, El HW, Ryckelynck JP: Assisted peritoneal dialysis. Experience in a French renal department. Perit Dial Int 26:671–676, 2006 28. Kandasamy G, Pierratos A, Tremblay M, Rahaman N: Use of Personal Support Workers (PSW) for Home Hemodialysis (HHD): An Industry Disruptive Approach. Vancouver, BC: Canadian Society of Nephrology Annual General Meeting; P-059, 2014 29. Grima DT, Bernard LM, Dunn ES, McFarlane PA, Mendelssohn DC: Cost-effectiveness analysis of therapies for chronic kidney disease patients on dialysis: a case for excluding dialysis costs. Pharmacoeconomics 30:981–989, 2012 30. Suri RS: Musings on guidelines and evidence: an opposing view. Perit Dial Int 27:35–38; discussion 38–41, 2007 31. Mendelssohn DC: Musings on guidelines and evidence: a pragmatic and nephrocentric view. Perit Dial Int 27:31–34, 2007 32. Strippoli GF, Craig JC, Schena FP: The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol 15:411–419, 2004 33. Palmer SC, Sciancalepore M, Strippoli GFM: Trial quality in nephrology: how are we measuring up? Am J Kidney Dis 58:335–337, 2011 34. Mendelssohn DC, Manns BJ: A proposal for improving evidence generation in nephrology. Am J Kidney Dis 58:13–18, 2011 35. Mendelssohn DC, McFarlane P: Conditionally funded field evaluations-a solution to the economic barriers limiting evidence generation in dialysis? Semin Dial 24:556–559, 2011