Effective Clinical Management of Highly Comorbid Patients with End Stage Kidney Disease
Submitting Institution
University of HertfordshireUnit of Assessment
Allied Health Professions, Dentistry, Nursing and PharmacySummary Impact Type
HealthResearch Subject Area(s)
Medical and Health Sciences: Clinical Sciences, Public Health and Health Services
Summary of the impact
Dialysis has revolutionised the management of End Stage Kidney Disease
(ESKD), but the benefits of this invasive, demanding treatment may not be
clear-cut for elderly, frail patients with other serious comorbidities.
University of Hertfordshire and East and North Hertfordshire NHS Trust
researchers have led the development of Conservative Management, an
alternative to dialysis for some patients, providing multidisciplinary
support and careful symptomatic management until death. The research shows
that quality of life is maintained, survival may not be significantly
compromised, and preferred place of death is more often achieved than for
counterparts on dialysis. Conservative Management programmes have been
adopted across the UK and elsewhere, influencing the care of many
patients.
Underpinning research
The Clinical Context
Life on dialysis can be arduous, entailing four-hourly haemodialysis
sessions thrice weekly, travel to and from dialysis centres, dietary and
fluid restrictions, and multiple medications. The impact on quality of
life for patients and carers can be huge. As many patients with End Stage
Kidney Disease (ESKD) are elderly, frail and have serious co-morbid
conditions, there are concerns about whether they necessarily benefit from
receiving dialysis, and whether other management options might not offer a
better quality of life.
The Research Programme
Research into the management of patients with advanced kidney disease has
been pursued at the university along multiple parallel research strands - clinical, psychosocial, and pharmacological - beginning in the late 1990s.
University researchers including Dr Joerg Schultz (Senior Lecturer), Dr
David Wellsted (Head, Centre for Lifespan and Chronic Illness Research),
and Professor Anwar Baydoun (Pharmacology) have worked in close
collaboration with research-active Hertfordshire NHS clinicians including
Professor Ken Farrington, Dr Shahid Chandna and Dr Maria Da Silva Gane.
Farrington, who was instrumental in setting up the university's R&D
Support Unit in 1995, attended as a visiting researcher in the early
2000s, moving to a secondment role in 2010 and a substantive contract in
2013.
Initial work by Farrington and Schultz in 1998/9, using routinely
collected data, defined a high-risk group of patients (based on age,
extra-renal comorbidity, and functional status), comprising about 10% of
incident dialysis patients. The survival of these patients was poor
(median < 3 months), raising questions about whether dialysis was the
appropriate treatment (sect. 3, Ref. 1). Local clinical practice
subsequently changed, with efforts made during patient counselling to
include prognostic information and, where appropriate, to offer
Conservative Management (CM) as a treatment option. It was though
important to emphasise that the proposed approach was rational and
appropriate rather than resource-led, because until at least the late
1980s dialysis in the UK had been underprovided and effectively rationed.
`Conservative management' traditionally connoted measures - usually
dietary - aimed at postponing the need for dialysis; CM, based on
palliative, supportive treatment and involving careful symptom control,
continued full medical treatment short of dialysis, including use of
erythropoietin to manage anaemia, and continuing multidisciplinary support
in liaison with community and hospice services.
Evaluation of this approach, based on retrospective data in collaboration
with university statisticians, demonstrated that survival in patients
undergoing CM was not significantly less than in those offered CM but
choosing to dialyse. A significantly higher proportion of patients on CM
died at home rather than in hospital (65% v 27%). Subsequent work by our
researchers and others has confirmed these findings (Ref. 2).
Further work compared quality of life in patients on dialysis and CM and
found that patients on CM tended to maintain quality of life as renal
function declined, whilst for those on dialysis, life satisfaction
deteriorated following dialysis initiation, with no recovery at least
during the following year (Ref. 3). Adjusted survival from recruitment in
late stage 4 and stage 5 CKD was 1,317 days in dialysis patients and 913
days in CM, the difference approximating the number of days on which
patients actually underwent haemodialysis sessions (mean 326 sessions per
patient).
Work has progressed in other related research strands. Psychosocial
research has included an ongoing placebo randomised control study on use
of SSRIs in treatment of depression in haemodialysis patients. Since 2008,
there has been a pharmacological collaboration between Professors
Farrington and Baydoun to investigate factors likely to predict evolution
of vascular calcification in patients with kidney failure. This attracted
funding from the pharma company Genzyme. A model was developed which has
shown differences in the potential for calcification in relation to the
severity of kidney failure. Further work is now taking place to determine
the mechanisms involved, to develop biomarker profiles, and to generate a
calcification risk score that that may be useful clinically.
References to the research
Key Publications
1. Chandna S.M., Schultz J., Lawrence C., Greenwood R.N., and
Farrington K. (1999). Is there a rationale for rationing chronic dialysis?
A hospital based cohort study of factors affecting survival and morbidity.
British Medical Journal, 318, 217-223. doi: http://dx.doi.org/10.1136/bmj.318.7178.217
2. Chandna, S.M., Da Silva-Gane, M., Marshall, C., Warwicker, P.,
Greenwood, R.N., Farrington, K. (2011). Survival of elderly
patients with stage 5 CKD: comparison of conservative management and renal
replacement therapy. Nephrology Dialysis Transplantation 26,
1608-1614. doi:10.1093/ndt/gfq630
- REF2 Output
3. Da Silva-Gane, M., Wellsted, D.M., Greenshields, H., Norton,
S., Chandna, S.M., Farrington, K. (2012). Quality of life and
survival in patients with advanced kidney failure managed conservatively
or by dialysis. Clinical Journal of the American Society of Nephrology
7(12), 2002-2009. http://dx.doi.org/10.2215/CJN.01130112
- REF2 Output
4. Patidar A., Singh D.K., Winocour P., Farrington K.,
Baydoun A. (2013). Human uraemic serum displays calcific potential in
vitro that increases with advancing chronic kidney disease. Clinical
Science, 125(5), 237-245. doi: 10.1042/cs20120638.
- REF2 Output
Selected Funding
Baydoun A., Farrington K. Calcification potential of plasma from patients
with chronic kidney disease and diabetes. Genzyme, 2010 (1 year):
£32,000.
Farrington K., Wellsted D.M., Da Silva Gane M. Facilitation of
self-management in a haemodialysis unit: An evaluation. NIHR RfPB,
PB-PG-0909-19044. July 2011: £247,164 (SELFMADE).
Farrington K., Almond M., Day C., Davenport A., Da Silva Gane M.,
Wellsted D. A pilot RCT of drug treatment for depression in patients
undergoing Haemodialysis. NIHR RfPB PB-PG-0110-21073. October 2011:
£249,317 (ASSERTID).
Details of the impact
The research relating to Conservative Management has already had a
substantial impact on care delivered to patients in the NHS and worldwide.
The associated publications have played a major role in persuading
clinicians in Renal Services across the UK that CM is a viable treatment
option for frail elderly patients with advanced kidney disease, and have
contributed to establishing CM programmes within many Renal Services
across the UK and other countries.
The initial impact occurred in local Renal Services within Hertfordshire
and Bedfordshire. The characterisation of a high-risk haemodialysis
patient group, with poor short-term survival, prompted from 2000 onwards a
reconfiguration of pre-dialysis pathways. Patients, relatives and carers
were counselled about prognosis and about CM as a treatment option. The
aims were supportive, focused on symptom control and provision of
palliative care. This approach was viewed as ground-breaking by many in
the renal community, and the team led by Farrington won the British
Journal of Renal Medicine Innovations Award in 2001. As a result the
approach became more widely known, as team members were invited to give
talks in renal units across the country. Team members also contributed to
the Kidney Alliance document (Sect. 5, Ref. 5.1), which included
putative National Service Standards for Conservative and Supportive Care.
A 2003 publication by the clinicians involved in the research (Ref. 5.2)
formally presented and disseminated the findings that survival may not be
significantly enhanced by dialysis in comparison to CM in high-risk
patients. Widely cited (Google scholar: 155 citations), it has been
effective in reaching other clinicians and NHS decision makers. It was
quoted in the National Service Framework for Renal Services (2005) (Ref.
5.3), underpinning the Quality Requirement that `people with established
renal failure receive timely evaluation of their prognosis, information
about choices available to them, and for those near end of life, a jointly
agreed palliative care plan, built around individual needs and
preferences'.
The research influenced Health Policy and Clinical Guidelines in other
ways. Farrington co-authored both the Department of Health Kidney Care
document `End of Life Care in Advanced Kidney Disease' (Ref. 5.4) and,
with the help of staff at the university's Centre for Life Span and
Chronic Illness, co-authored the UK Renal Association Guidelines on
`Planning, Initiating and Withdrawal of Renal Replacement Therapy' (Ref.
5.5). Farrington and Da Silva Gane co-authored health information
literature for Kidney Care UK (Ref. 5.6). Further dissemination came via
Farrington's invitations to speak on the topic at the World Congress of
Nephrology, Renal Association of Ireland, and Royal College of Physicians
(Edinburgh and London) between 2007 and 2012, and co-chairmanship of the
planned European Renal Best Practice (ERBP) clinical practice guideline on
the management of CKD in frail and elderly patients, reflecting growing
interest in adoption of this management approach.
The establishment of CM Programmes continues to expand in the UK and
other parts of the world. A UK Renal Registry survey (Ref. 5.7) revealed a
high prevalence of CM programmes across the UK, but with considerable
organisational variation between centres. Fifty-four centres (75%)
followed patients in a general clinic, 18 (28%) utilising a dedicated CM
clinic, and 14 (19%) employing renal palliative nurses for outreach
community care. Around 20% of patients with ESKD over 75 years old were
considered to be receiving CM. The CKMAPPS UK National Survey (2013) (Ref
5.8) found that 66 of the 67 responding renal units (from a total of 72)
had CM patients. A recent survey of European nephrologists estimated that
conservative care was provided to up to 15% of their patients (Ref. 5.9).
Similarly, in Australia around 15% of units reported having a formal CM
programme, with around 65% of ESKD patients being offered the choice of CM
and about 14% choosing this option (Ref. 5.10). This translates worldwide
into a large number of patients. There is potential for cost saving,
although this is difficult to quantify and is not the primary focus, which
is to enhance quality of life and end-of-life care.
Sources to corroborate the impact
5.1 `End Stage Renal Failure - A Framework for Planning and Service
Delivery', Kidney Alliance (2001) <www.kidneyalliance.org/docs/k_report.pdf>
5.2 Smith C, Da Silva-Gane M, Chandna S, Warwicker P, Greenwood R,
Farrington K. (2003). Choosing not to dialyse: evaluation of planned
non-dialytic management in a cohort of patients with end-stage renal
failure. Nephron Clinical Practice, 95, c40-c46.
DOI:10.1159/000073708
5.3 `National Service Framework for Renal Services, Part Two: Chronic
Kidney Disease, Acute Renal Failure and End of Life Care' (2005).
<www.gov.uk/government/uploads/system/uploads/attachment_data/file/199002/National_Service_Framework_for_Renal_Services_Part_Two_-_Chronic_Kidney_Disease__Acute_Renal_Failure_and_End_of_Life_Care.pdf>
5.4 `End of Life Care in Advanced Kidney Disease: A Framework for
Implementation', NHS Kidney Care, National End of Life Care Programme
(2009):
<www.endoflifecare.nhs.uk/search-resources/resources-search/publications/imported-publications/end-of-life-care-in-advanced-kidney-disease.aspx>
5.5 `Renal Association Guidelines: Planning, Initiating and Withdrawal of
Renal Replacement Therapy' (2009). <www.renal.org/Clinical/GuidelinesSection/RenalReplacementTherapy.aspx>
5.6 `Does everyone choose to dialyse?', Kidney Research UK web page:
<www.kidneyresearchuk.org/health/factsheets/ckd-and-issues/choosing-not-to-start-dialysis.php>
5.7 UK Renal Registry Survey (2011): Castledine C, Gilg J, Rogers C,
Ben-Shlomo Y, Caskey F. UK Renal Registry 13th Annual Report (December
2010), Chapter 15: UK renal centre survey results 2010:RRT incidence and
use of home dialysis modalities. Nephron Clinical Practice, 119,
Suppl. 2, c255-67. doi: 10.1159/000331783
5.8 CKMAPPS: Summary of UK National Survey of Conservative Kidney
Management (2013), p.1. (Unpublished report; copy available.)
5.9 van de Luijtgaarden M.W. et al. (2013). Conservative care in Europe:
Nephrologists' experience with the decision not to start renal replacement
therapy. Nephrology Dialysis Transplantation, 28(10), 2604-2612.
doi: 10.1093/ndt/gft287.
5.10 National Survey Australia (2012): Morton R.L., Turner R.M., Howard
K., Snelling P., Webster A.C. Patients who plan for conservative care
rather than dialysis: A national observational study in Australia. American
Journal of Kidney Disease 59(3), 419-427.
doi:10.1053/j.ajkd.2011.08.024