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Quality of life, decision-making,
costs and the impact on carers
in people managed without dialysis:
A study protocol
Dr Helen Noble
Lecturer – Health Services Research
Queens University Belfast
Northern Ireland
MM. Yaqoob, AP. Maxwell, A. Burns, F. McCourt, A.
Agus, C. McDowell and C. Normand
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PACKS PAlliative care in Chronic Kidney Disease Study
Funding - National Institute for Health
Research
Amount - £512,000
Post Doctoral Fellowship in UK
Three years – full time
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Aim of study Measure and describe longitudinally, over 12
months, QOL, satisfaction with decision-
making, costs, cognition, frailty and
performance in patients with advanced
chronic kidney disease managed without
dialysis.
Impact on carers will also be studied.
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Background Number of people living with end-stage kidney disease
(ESKD) has increased Diabetes (Coresh et al. 2007)
Older people Increasing prevalence of co-morbidities (Ashby et al. 2005)
High mortality - median of five life years remaining for a 70-year
old (Ansell et al. 2009)
For some dialysis may be of little benefit
Provision of treatment for ESKD consumes approx 2%
of annual National Health Service budget (Steencamp et al.
2010)
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Stages of renal disease & treatment options
KDOQI CKD classification 2000
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Renal Replacement Therapy
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Travel times
PD too difficult
Transplant not possible
Arduous
Surgical procedures
Burden
Feel too old (Noble 2009)
Why opt not to dialyse
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Primary and secondary outcomes
Primary Outcome: Quality of life of patients at 3
months from baseline measured using the EQ-5D-5L
visual analogue scale.
Secondary outcomes:
Changes in QOL and symptoms (including anxiety and
depression)
Changes in cognition, frailty and performance
Understanding of the decision making process that
precedes referral to CKM
Patient satisfaction with decision-making
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Secondary outcomes (cont)
Associated health and social care costs of
patients receiving CKM
Changes in QOL for carers
Care related costs to carers of patients
Calculation of the number(%) of deaths at 3, 6,
9 and 12 months and time to death
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Recruitment & sample
Recruited from renal clinics over 7 sites
Patients – 112
Carers – up to 112
Renal physicians/CNS - 15-20
Qualitative interviews
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Inclusion criteria patients:
Stage 5 chronic kidney disease
A confirmed decision for conservative
management, i.e. management without dialysis
or other renal replacement therapy. The
decision for conservative kidney management
will be confirmed with the nephrologist
responsible for each patient.
Aged over 18 years.
Able to speak English
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Inclusion criteria carers: Primary carer for patient with stage 5
chronic kidney disease who has made a
confirmed decision for conservative kidney
management as agreed with clinicians.
Aged over 18 years.
Patient has agreed that the carer can be
approached to participate.
Able to speak English
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Inclusion criteria – renal physicians/CNS
Experience of managing clinical
consultations of patients with stage 5
chronic kidney disease who opt for
conservative kidney management
Employed in the renal specialty
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Data collection tools - Patient 3-monthly
Kidney Disease QOL-36™ Survey
EQ-5D-5L
POS-S Renal
6monthly
Decisional Conflict Scale
Ongoing
Patient Service Use Log
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Decisional Conflict Scale
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Data collection tools - Carer 3-monthly
EQ-5D-5L
EQ-5D-5L by proxy
Carer questionnaire
6monthly
Decisional Conflict Scale
Data collection tools – Renal Physician/CNS
One exploratory qualitative interview with PI
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Data collection tools –
performance, frailty, cognition
3-monthly over 12 months
Changes in cognition - 6 Item Cognitive
Impairment Test (6CIT)
Changes in frailty status - 9-point Clinical
Frailty Scale
Changes in Performance using the Palliative
Performance Scale (PPS)
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EQ-5D-5L
Standardised instrument for use as a measure of health outcome.
Valid instrument for the measurement of health status in renal
patients.
New 5 level version, EQ-5D-5L
Consists of a descriptive system and a visual analogue scale.
EQ-5D-5L will be self-completed by the patients
Completed for the patient by the carer. Inter-rater agreement can
then be assessed.
(Herdman et al 2011)
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EQ-5D-5L
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EQ-5D-5L VAS
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Development of study
Ethics application and protocol development
Working with Clinical Trials Unit
Site visits to develop protocol
Advisory Team meeting
Return next year!
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References Ansell D, Castledine C, Feehally J, Fogarty D, Ford D, Inward C, et al. The Renal Association UK Renal Registry.
The Twelfth Annual Report December 2009. Bristol: Renal Registry; 2010 2010/07.
Ashby M, op't Hoog C, Kellehear A, Kerr PG, Brooks D, Nicholls K, et al. Renal dialysis abatement: lessons from a
social study. Palliat Med 2005;19(0269-2163; 5):389-96.
Coresh J, Selvin E, Stevens L. et al. (2007) Prevalence of Chronic Kidney Disease in the United States. JAMA, 298
(17) 2038-2047
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X (2011). Development and
preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 20(10):1727-36.
Noble H, Meyer J, Kelly D et al (2009). Reasons renal patients give for deciding not to dialyse: prospective qualitative
interview study, Dialysis & Transplantation, 38 (3): 82-89.
Steencamp, R., Castledine, C., Feest, T. & Fogarty, D (2010). The Renal Association UK Renal Registry. The
Thirteenth Annual Report December 2010. Available: http://www.renalreg.com/Report-
Area/Report%202010/Chap02_Renal10_web.pdf [Accessed 3.3.14].