Dialysis versus Supportive Care

Transcription

1 Dialysis versus Supportive Care with a focus on the initial pathway in the elderly DNT Workshop. Glenelg, February 2017

2 Background: A better title would be dialysis v non-dialysis! For this discussion: It is assumed that resource limitation is not currently a factor in Australia that impacts on acceptance rates to RRT Dialysis = both HD and PD Supportive care = non-dialysis pathway Supportive care = ongoing management of the patient by renal team (with palliative care involvement at an appropriate time) with the focus on symptom minimisation, sustained wellbeing and coordinated end of life care (including hospice and full supports). Question: Why would the full gamut of supportive care not be offered to dialysis patients as well?

3 Issues to be covered: The history in Australia of acceptance to dialysis Recent trends and variation in acceptance in Australia and elsewhere Factors impacting on changing trends Imperfections of dialysis Advantages of supportive care Role of Risk Prediction Models in guiding decision making Time limited trials of dialysis The path ahead The absence of Level 1 evidence characterises this area leaving it open to opinion based medicine

4 Estimating Risk/Benefit: Facts Are a Basic Requirement There are important studies, and then there are damn important studies. (The IDEAL trial was an example) Centuries ago, before there were medical universities, the word doctor ( dottore ) denoted a learned person or teacher. Nothing has changed. The chief duty of all modern-day clinicians remains that of an expert teacher. Yet if we are to teach we must know the facts. This means knowing more than anatomy and physiology and what the guidelines say; it means knowing the actual benefits and harms of our interventions. Mandrola J, Medscape Commentary, January 23, 2017

5 Patients Expectations of the Benefits and Harms of Treatments, Screening, and Tests A Systematic Review Key Points Question: Do patients have accurate expectations of the benefits and harms of treatments, tests, and screening tests? Findings: Of the 34/54 outcomes with overestimation data available, the majority of participants overestimated benefit for 22 (65%) of them. Underestimation data were available for 15/27 outcomes available and the majority of participants underestimated harm for 10 (67%) of these. Conclusions: The majority of participants overestimated intervention benefit and underestimated harm. Hoffmann TC, PhD; Del Mar C, MD, FRACGP. JAMA Intern Med. 2015;175(2):

6 Clinicians Expectations of the Benefits and Harms of Treatments, Screening, and Tests A Systematic Review Key Points Question: Do clinicians have accurate expectations of the benefits and harms of treatments, tests, and screening tests? Findings: In this systematic review of 48 studies ( clinicians), most participants correctly estimated 13% of the 69 harm expectation outcomes and 11% of the 28 benefit expectations. The majority of participants overestimated benefit for 32% of outcomes, underestimated benefit for 9%, underestimated harm for 34%, and overestimated harm for 5% of outcomes. Conclusion: Clinicians rarely had accurate expectations of benefits or harms, with inaccuracies in both directions, but more often underestimated harms and overestimated benefits. Hoffman et al, JAMA Intern Med online Jan

7 Historical attitudes to dialysis: Dialysis No Dialysis Dialysis is what we had to offer!

8 Historical aspects to acceptance In the early years (? Up to 1990 s) no-one refused (a medical invitation) to enter dialysis Dialysis was regarded as the only hope to extend life No structured sharing of the decision, no decision aids Resources limited entry (or impacted strongly on selection) Age discrimination was rampant and absolute Nephrologists changed age limits over time in keeping with other tertiary health care areas.

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10 Incident acceptance rates (pmp) to RRT by age & by State Australia (ACT & NT excluded) yrs >85 yrs NSW VIC QLD SA WA TAS yrs NSW VIC QLD SA WA TAS NSW VIC QLD SA WA TAS ANZDATA Registry

11 500 New patients Age specific rates - Australia Age ANZDATA Annual Report, Figure 1.3

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13 Trends in adjusted* ESRD incidence rate (per million/year), by age group, in the U.S. population, Data Source: Reference Table A.2(2) and special analyses, USRDS ESRD Database. *Adjusted for sex and race. The standard population was the U.S. population in Abbreviation: ESRD, end-stage renal disease Annual Data Report, Vol 2, ESRD, Ch 1 13

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15 Approximate comparative incident rates for RRT by age >75 yrs (2014) Country Rate PMP/Yr (latest available) USA Canada UK Australia NZ ( )

16 Life on dialysis: Perceptions/Facts? Benefits Longer life (?) Fewer symptoms (?) Positive pathway (hope) Collegiality Improved QOL (?) (IDEAL, CHOICE) Improved nutrition Cognition improvement(?) Stabilise neuropathy Harms Travel Time away from home Creation of symptoms (washout) Access issues Anxiety re procedure Increased hospital time Burden on family Pruritus (80%) Increased depression

17 Life on supportive care: Perceptions/Facts? Benefits No intrusion on day by day life with dialysis demands Less travel (less family burden) No post dialysis symptoms No anxiety re procedure Symptoms can be largely managed Usually pain free Death usually a slow fade Harms Shorter life (?) More symptoms (?) Negative pathway Restricted fluids and diet Isolated at home Nutrition often problem

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19 Symptom management of the patient with CKD: Role of dialysis. Evidence based commentary. Timing of initiation to dialysis (need more evidence beyond IDEAL) Effect of dialysis on HRQOL little evidence Effect of dialysis on uremic symptoms Cabrera et al CJASN 2017: April (12) now on online Challenges: lack of strong evidence Thus the symptom burden and high level of disability are not necessarily improved by dialysis Dialysis initiation should be a shared decision making process. OK to use a Time Limited Trial of dialysis Incremental approach to dialysis treatment may increase mortality in those with comorbidities Need new approach to dialysis (in all aspects). Currently frozen in time

20 Clinical equipoise Clinical equipoise occurs "if there is genuine uncertainty within the expert medical community not necessarily on the part of the individual investigator about the preferred treatment. Clinical equipoise is distinguished from theoretical equipoise, which requires evidence on behalf of the alternative treatments to be exactly balanced. Clinical equipoise allows investigators to continue a trial until they have enough statistical evidence to convince other experts of the validity of their results, without a loss of ethical integrity on the part of the investigators Freedman, B. (1987) 'Equipoise and the ethics of clinical research'. NEJM, 317, (3):

21 Questions: Q: Are there some individuals with ESKF over the age of 75 years (e.g. those with some co-morbidities etc) in whom you have clinical equipoise about the decision to offer dialysis versus supportive care? Q. In those elderly individuals with ESKF in whom you believe there to be clinical equipoise would you be prepared to enter them in a randomised controlled trial of dialysis v supportive care?

22 Predictive Modelling : Risk calculators impacting on the choice of the initial pathway Most modelling has been done to predict risk: Of progression of CKD to RRT, Mortality for those on dialysis to assist withdrawal decision Some short term mortality models of those starting or on dialysis None on risk modelling of dialysis v non-dialysis Excellent overview in ANZSN Renal Supportive Care Guidelines (2013) by Robins & Katz. The absence of facts/evidence prevents development of a model to guide the choice of the initial pathway KPNW Prediction model of progression to RRT from CKD3/4 performs well (c stat 0.96!!) on 8 readily available predictors*. Potential for guiding practice. *Schroeder et al. CJASN 2017;12:87

23 Predicted and observed 5-year risk by quintile of predicted risk from the Kaiser Permanente Northwest prediction model. Internal development cohort n=22,500 Schroeder et al. CJASN 2017;12:87 External validation cohort n=16, by American Society of Nephrology

24 Currently available Predictor Tools for short term mortality on dialysis* 3m Survival USRDS (n=69,441) French REIN (n=28,496) 0.75 Catalan registry (n=1365) m Survival French REIN (n=4142) m Survival on HD New Eng HD clinics (n=1026) 0.80 c Statistic (2 versions) All tools use 5 or more parameters and are short on QOL indicators * Supportive Care: Time to change our prognostic tools and their use in CKD. Couchoud et al. CJASN 11:1892 (Oct 2016)

25 Do you use risk prediction to guide decision making? Q. Do you use any of the following risk prediction tools to assist in decision making for either: the initial pathway choice Or dialysis withdrawal discussions? 1. JAMA Kidney Failure risk equation 2. Modified Charlson score 3. The surprise question 4. French Rein (Couchoud) 5. Other scoring system 6. NO scoring system

26 Time limited trials of dialysis A time limited trial of dialysis should be an option: When it is not clear that a patient will have a net benefit from dialysis but when it is agreed there is reasonable chance that benefit might occur There should be clear parameters of success/failure and agreed timelines for an assessment to occur A written contract encapsulating this approach has been recommended It should be acknowledged that a period of time on dialysis may reduce kidney function and then if dialysis is withdrawn, hasten demise See US Renal Physicians Assoc. Guideline on Shared Decision making and initiation of dialysis 2010 Cabrera et al CJASN 2017: April (12) now on online

27 1. Conclusions: (based on little firm evidence) New approaches/techniques/advances in dialysis urgently needed The elements of supportive care should be applied equally to those on dialysis The decision to offer dialysis or not remains the most contentious and troublesome issue addressed by nephrologists with significant variation in acceptance rates between States and probably between Units The decision should be individualised with no specific age barrier (illegal)

28 2. Conclusions: (based on little firm evidence) The decision should: Take into account all aspects including the qualitative impact on patient and family Be a team decision involving all appropriate disciplines Be a shared decision with patient and family after appropriate education A trial of dialysis (using RPA rules ) should be one option offered when appropriate A RCT of dialysis v supportive care merits serious consideration for those in whom there is clinical equipoise about the decision

29 Suggested reading: When enough is enough: The nephrologists responsibility in ordering dialysis treatments. Germain MJ et al. AJKD 2011; 58:135 ANZSN Renal Supportive Care Guidelines Brown MA et al. Nephrology 2013; 18:401 Supportive care: Time to change our prognostic tools. Couchoud C et al. CJASN 2016; 11:1892 Supportive care: Comprehensive conservative care in ESKD. Murtagh F et al. CJASN 2016; 11:1909 Planning dialysis care: You might be surprised (Ed). Brown MA. AJKD 2016; 68:8 Comparative survival among older adults with advanced kidney disease managed conservatively versus with dialysis. Verbene WR et al. CJASN 2016; 11:633 Survival outcomes of supportive care versus dialysis therapies for elderly patients with ESKD: A systematic review and meta-analysis. Foote C et al. Nephrology 2016; 21:241 Does the evidence support conservative management as an alternative to dialysis for older patients with advanced kidney disease? (Ed.) Tam-Tham H et al. CJASN 2016; 11:552 Symptom management of the patient with CKD: The role of dialysis. Cabrera et al. CJASN 2017 :12 (online)

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31 New York Times

32 New patients by age group VIC Age ANZDATA Annual Report, Figure 1.4

33 American Journal of Kidney Diseases , DOI: ( /j.ajkd )

34 6000 Acceptance onto RRT: yrs Incidence rate (pmp) NT NSW VIC QLD SA WA TAS ACT

35 Acceptance onto RRT: yrs Incidence rate (pmp) NT NSW VIC QLD SA WA TAS ACT

36 1200 Acceptance onto RRT: >85 yrs Incidence rate (pmp) NSW 85+ VIC 85+ QLD 85+ SA 85+ WA 85+ TAS

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38 My brief from Organisers: What proportion of renal physicians have had (sic) equipoise about the benefits of dialysis and supportive care?

39 New Patients Age Specific Rates - Australia Year Total 0-19 yrs yrs yrs yrs yrs 85+ yrs

40 Canadian data on ICU admissions: Garland et al. Critical Care 2013, 17:R212

41 UK Renal Registry 2016