Background
Methods
Search strategy
i. Population | People with any stage CKD including patients on dialysis (haemodialysis or peritoneal dialysis) or with a renal transplant; any gender, any location, and any severity of CKD. Populations must be representative of the CKD population (i.e., general comorbidities, reasonable age range) and be greater than 25 people in size. Subgroups of interest include (not limited to): CKD patients with albuminuria (normo-, micro-, macro-albuminuria), T2DM, glomerulonephritis, IgA nephropathy. |
ii. Interventions/comparators | All interventions and comparative data were included. Where the intervention is not relevant for the study purposes in some cases only baseline or placebo arm data is included. |
iii. Outcomes | Health state utilities from standardised generic multi-attribute utility measures such as EQ-5D, SF-6D or Health Utilities Index (HUI). HSUs for all CKD stages, dialysis modalities (haemodialysis and peritoneal dialysis), or renal transplant. Disutility associated with cardiovascular events commonly included in health economic models in CKD (acute and chronic where available): myocardial infarction, stroke, heart failure. Disutility associated with adverse events commonly included in health economic models in CKD: potassium imbalances (hypo- and hyperkalaemia), volume depletion, acute kidney injury, major hypoglycaemic events, diabetic ketoacidosis, fractures, amputations (minor/major or toe, foot, limb, etc.). Impact of comorbidities or patient characteristics on HSUs: albuminuria (normo-, micro-, macro-albuminuria), T2DM, hypertension, heart failure or cardiovascular disease, age or sex on HSUs. Impact of complications related to renal replacement therapies on HSUs: dialysis related complications (e.g. vascular access thrombosis), renal transplant failure, renal transplant surgery. |
iv. Study Designs | Interventional or non-interventional research. |
v. Other requirements | Records from January 1, 1999 to present (August, 2019) only. Abstract and full-text must be available in English text. |
Critical appraisal
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The study was conducted in a CKD population
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The study reports original empirical HSU weights
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Data were collected using a generic HRQL measure (i.e. EQ-5D, short-form 6-dimention [SF-6D] or a mappable equivalent such as short-form 36 [SF-36] or short-form 12 [SF-12]; or the Health Utility Index [HUI])
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The study sample size was at least 25 patients
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The study was conducted in a country of interest (i.e., USA, Canada, Australia, China, UK, Spain, Italy, France or Germany)
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HSU weights were presented in a comprehensive way that is useful to inform cost-effectiveness analysis (e.g. HSU weights were available by CKD stage)
1 | Study meets all HTA selection criteria and has no apparent sources of significant bias |
2 | Study meets HTA selection criteria but may be subject to bias (e.g. may need the application of a mapping algorithm to derive HSU weights or there may be study methodology bias) |
3 | Study does not meet HTA selection criteria (e.g. not a population representative of the CKD population) |
Results
Author (Year) | N Mean age (SD) | Males | Study Type | Setting and location | Population overview |
---|---|---|---|---|---|
Blakeman (2014) | 221 patients. 71.8 (9.0) years. | 41.2% | Randomised controlled trial. | General practice. Greater Manchester, UK. | Stage 3 CKD only. |
Briggs (2016) | 3547 patients. 54.3 (14.3) years. | 59.9% | Randomised controlled trial. | 500 dialysis centres. 22 countries. | Moderate to severe secondary hyperparathyroidism on HD. |
Davison (2008) | 185 patients. 63.6 (12.2) years. | 55.0% | Prospective observational study. | 10 dialysis/ renal insufficiency units. Alberta, Canada. | CKD stage 4 and 5 expected to start dialysis within 12 months. Patients currently receiving HD or PD (started in last 12 months). |
Davison (2009) | 185 patients. 63.6 (12.2) years. | 55.0% | Prospective observational study. | 10 dialysis/ renal insufficiency units. Alberta, Canada. | CKD stage 4 and 5 expected to start dialysis within 12 months. Patients currently receiving HD or PD (started in last 12 months). |
Gorodetskaya (2005) | 271 patients. 62.8 (12.7) years. | 48% | Prospective observational study. | Patients from a single nephrology and dialysis site. USA. | Two groups defined by: -GFR between 30 and 70 ml/min. -GFR < 30 ml/min. |
Jardine (2017) | 200 patients. 51.8 (12.1) years. | 69.5% | Randomised controlled trial. | 40 home and hospital dialysis centres. Australia, China, Canada, and New Zealand. | Adult patients requiring maintenance HD. |
Jesky (2016) | 745 patients. 64, 95% CI (50–76) years. | 60.8% | Prospective observational study. | Two large hospitals. Birmingham, UK. | Pre-dialysis CKD and GFR < 30 ml/min. |
Lee (2005) | 416 patients. Males: 58.2 years. Females: 55.5 years. | 58.9% | Cross-sectional study. | Renal unit departmental database. South Wales, UK. | Patients receiving HD, waiting to start HD or after receiving a renal transplant. |
Manns (2002) | 128 patients. 61.8, 95%CI (59.1, 64.6) years. | 56.3% | Cross-sectional study. | Southern Alberta Renal Program. Alberta, Canada. | All participants had received over 6 months of HD. |
Manns (2003) | 192 patients. 60.8, 95%CI (58.6, 63.0) years. | 55.7% | Cross-sectional study. | Southern Alberta Renal Program. Alberta, Canada. | All participants had received over 6 months of HD. |
Manns (2009) | 51 patients. 54.1 years. | 62.5% | Randomised controlled trial. | Southern Alberta Renal Program. Alberta, Canada. | In- or home conventional HD 3 times weekly. |
Neri (2011) | 386 patients. GFR > 90 ml/min = 48.1 (16.2) years. GFR 90–60 ml/min = 52.2 (13.4) years. GFR 59–30 ml/min = 51.5 (11.8) years. GFR 29–15 ml/min = 52.2 (12.1) years. GFR < 15 ml/min = 43.2 (14.6) years. | 61.4% | Cross-sectional study. | Two outpatient clinics. Midwest, USA. | Kidney transplant patients. |
Ortega (2007) | 307 patients. 51.6 (12) years. | 59.2% | Prospective observational study. | 16 hospitals. Spain. | Adult patients with end-stage renal disease who received a kidney transplant. |
Ortega (2009) | 162 patients. 55.8 (12.3) years. | NR | Prospective observational study. | Four hospitals. California, USA. | Pre-renal transplant and 12 months post-renal transplant. |
Ortega (2013) | 206 patients. 53.4 (12.9) years. | 61.2% | Cross-sectional study. | 39 transplantation units. Spain. | Renal transplant patients 6–24 months post-renal transplant. |
Pan (2018) | 315 patients. 57.3 (14.9) years. | 54.9% | Cross-sectional study. | First Affiliated Hospital of Soochow University. Eastern China. | Patients on HD. |
Wong (2019)a | 399 patients. 57.3 (12.7) years. | 61.9% | Cross-sectional study. | Hospital, community HD centres or home HD or PD. Hong Kong. | Patients undergoing home based nocturnal HD, PD, hospital or community HD. |
Utility Value (SD) | Sample Size (N) | Instrument | Country | Source | |
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CKD Stage 2 | |||||
0.85 (95% CI: 0.70–1) | 29 | EQ-5D-3L | UK | [16] | |
CKD Stage 3 | |||||
Stage 3a | 0.80 (95% CI: 0.69–1) | 45 | EQ-5D-3L | UK | [16] |
Stage 3b | 0.80 (95% CI: 0.68–1) | 173 | EQ-5D-3L | UK | [16] |
Stage 3 | 0.67 (0.31) | 50 | HUI3 | USA | [17] |
CKD Stage 4 | 0.74 (95% CI: 0.62–0.85) | 423 | EQ-5D-3L | USA | [16] |
0.55 (0.34) | 65 | HUI3 | USA | [17] | |
CKD Stage 5 | 0.54 (0.36) | 28 | HUI3 | USA | [17] |
0.73 (95% CI: 0.62–1) | 75 | EQ-5D-3L | UK | [16] | |
Haemodialysis | 0.75 (0.25) | 1767 | EQ-5D-3L | Various | [18] |
0.44 (0.32) | 99 | EQ-5D-3L | UK | [19] | |
0.78 (0.24) | 200 | EQ-5D-3L | Various | [20] | |
0.60 (95% CI: 0.55, 0.64) | 128 | EQ-5D-3L | Canada | [21] | |
0.69 (95% CI: 0.63,0.76) | 51 | EQ-5D-3L | Canada | [22] | |
0.54 (0.31) | 271 | HUI3 | USA | [17] | |
0.75 (0.11) | 315 | SF-6D | China | [23] | |
0.73 (0.11) | 135 | SF-6D | China | [24] | |
0.78 (0.09) | 41 | SF-6D | China | [24] | |
0.79 (0.11) | 118 | SF-6D | China | [24] | |
Peritoneal Dialysis | 0.53 (0.34) | 64 | EQ-5D-3L | UK | [19] |
0.78 (0.11) | 103 | SF-6D | China | [24] | |
Unspecified Dialysis | 0.54 (0.31) | 38 | HUI3 | USA | [17] |
0.74 (0.20) | 185 | HUI2 | Canada | [25] | |
0.58 (0.26) | 185 | HUI3 | Canada | [25] | |
0.67 (0.13) | 185 | SF-6D | Canada | [26] | |
Pre-Transplant | NR | ||||
Post-Transplant | |||||
CKD stage 1–2 | 0.79 (0.25) | 386 | HUI3 | USA | [27] |
CKD stage 3 | 0.87 (0.14) | 172 | EQ-5D-3L | USA | [27] |
CKD stage 3 | 0.75 (0.26) | 172 | HUI3 | USA | [27] |
CKD stage 4 | 0.87 (0.10) | 51 | EQ-5D-3L | USA | [27] |
CKD stage 4 | 0.74 (0.22) | 51 | HUI3 | USA | [27] |
CKD stage 5 | 0.82 (0.12) | 19 | EQ-5D-3L | USA | [27] |
CKD stage 5 | 0.67 (0.33) | 19 | HUI3 | USA | [27] |
CKD stage not reported | 0.71 (0.27) | 209 | EQ-5D-3L | UK | [19] |
CKD stage not reported | 0.77 (NR) | 126 | SF-6D | Spain | [28] |
CKD stage not reported | 0.76 (NR) | 80 | SF-6D | Spain | [28] |
Baseline | 3 Months | 6 Months | 12 months | Country | Instrument | Source | |
---|---|---|---|---|---|---|---|
CKD stage 2 | NR | ||||||
CKD stage 3 | 0.67 (0.30) | 0.67 (0.29) | UK | EQ-5D-3L | [29] | ||
CKD stage 3a | NR | ||||||
CKD stage 3b | NR | ||||||
CKD stage 4 | NR | ||||||
CKD stage 5 | NR | ||||||
Haemodialysis | 0.65 (0.027) | 0.62 (0.030) | Canada | EQ-5D-3L | [30] | ||
Peritoneal dialysis | 0.64 (0.063) | 0.67 (0.046) | Canada | EQ-5D-3L | [30] | ||
Transplant | Pre-Transplant | Post-Transplant | |||||
0.74 (0.21) | 0.81 (0.19) | 1.0 (0) | 0.82 (0.20) | Spain | EQ-5D-3L | [31] | |
0.61 (NR) | 0.74 (NR) | USA | EQ-5D-3L | [32] | |||
0.78 (NR) | 0.86 (NR) | USA | EQ-5D-3L | [32] |
Complications | EQ-5D-3L Score (95% Confidence Interval) | |
---|---|---|
Acute Effect (week 1–13) | Chronic Effect (week 14–244) | |
Myocardial Infarction | 0.52 (0.47–0.58) | 0.66 (0.57–0.76) |
Hospitalisation for unstable angina | 0.54 (0.46–0.63) | 0.60 (0.49–0.71) |
Stroke | 0.50 (0.41–0.60) | 0.49 (0.30–0.68) |
Heart Failure | 0.58 (0.54–0.63) | 0.66 (0.59–0.73) |
Bone Fracture | 0.35 (0.30–0.40) | 0.58 (0.51–0.65) |