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Management of Mineral Bone Disease in Dialysis Patients

Regional Clinical Audit Report February 2011

Authors: Dr Helen Eddington, Salford Royal Hospital Clinical Audit Lead Tracey Powell, Regional Renal Audit Coordinator, MRI Nora Kerigan, Specialist Nurse, Royal Preston Hospital Contact Address: NW Renal Audit Programme Renal Department Manchester Royal Infirmary Oxford Road Manchester M13 9WL Telephone Number: 0161 27 64224 Web Address: www.nwrenalaudit.org

NW Renal Audit Programme Management of bone mineral disease in dialysis patients

Version 1.0 February 2011 Page 1

CONTENTS

Contributors

2

Executive Summary

3

1. Introduction and Background

5

2. Aims and Objectives

5

3. Evidence Base

6

4. Standards

7

5. Methodology

8

6. Results Summary 6.1 Demographic

6.1.2 Diabetes Status 6.2.3 Transplant Status

6.2 Calcium 6.2.1 Results for RA standard for corrected calcium 6.2.2 Results for KDOQI standard for corrected calcium 6.2.3 Comparison with previous audit calcium results 6.2.4 Benchmarking local data against national data collected by the Renal

Registry 6.3 Phosphate

6.3.1 Results for RA standard for serum phosphate 6.3.2 Evaluation of change since the previous audit 6.3.3 Benchmarking local data against national data collected by the UK Renal

Registry 6.4 Calcium Phosphate Product 6.5 Parathyroid Hormone and incidence of parathyroidectomy

6.5.1 RA Standard for parathyroid hormone 6.5.2 Change since last report 6.5.3 Median/benchmarking 6.5.4 Patients undergoing parathyroidectomy

6.6 Percentage of patients meeting all Renal Association and KDOQI targets 6.7 Phosphate Binders

6.7.2 Change in use of binders since 2002 6.7.3 KDOQI Calcium load 6.7.4 Patients with high Calcium >2.5mmol/l

6.8 Alphacalcidol 6.9 Cinacalcet 6.10 10

th patient drug data 6.10.1 Dialysate used

6.11 Patient contact with dietetic service 6.12 Drug data recording

9

10 11

11 13 14

15

17 18

19 20

21 22 23 24 24 25 26 29 30 31 32

32 33 34

7. Discussion of Results 36 8. Conclusions 38 9. Recommendations 38

Appendix 1 Glossary of Terms and Abbreviations Appendix 2 Audit Plan Appendix 3 Data Collection Parameters Appendix 4 NW Region Unit Target ranges



CONTRIBUTORS

The following adult renal dialysis units took part in the bone chemistry audit:

� Aintree University Hospital

� Countess of Chester

� Manchester Royal Infirmary

o including satellite units at North Manchester General Hospital, Macclesfield ,

Prestwich, Tameside and Wythenshawe

� Royal Preston Hospital

o including satellite units - Accrington, Clifton Hospital - Blackpool, Westmoreland

Hospital - Kendal, Burnley, Chorley and Furness

� Salford Royal Hospital

o including satellite units at Bolton, Wigan and Rochdale

Data collection for the regional audits is generally undertaken within the individual units with

occasional direct assistance from NWRA audit staff. Data was collected by the following:

� Ros Adams, data collection for Salford Royal Hospital and facilitated data collection from

satellite units.

� Jovi Diaz, Rochdale Infirmary

� Christopher Goldsmith, data collection for Aintree and satellite units

� Dr Prasad Rajendran, SpR, data collection for Aintree and satellite units,

� Sak Kee Gee , North Manchester General Hospital

� Odette Holmes, Royal Bolton Hospital

� Nora Kerigan, Royal Preston Hospital and satellite units

� Michelle Marshall, Wigan

� Tracey Powell, data collection at Wythenshawe, Tameside, North Manchester General

Hospital, MRI PD, HD and HHD patients

� Diane Sanders, MRI PD patients

� Vivien Lloyd, Countess of Chester

� Abigail Price, Countess of Chester



EXECUTIVE SUMMARY

The total number of patients audited in 2009/2010 was 1703; this is compared to 1670 patients

in 2002. However we do not currently have data from Liverpool and some of its satellites

therefore this report only includes data available at time of completion of the report.

Serum Calcium:

Regionally 66.9% reached the renal association target of 2.2-2.5mmol/l and this percentage has

only minimally changed since 2002. A slight decrease since 2002 is seen in all the unit results

apart from MRI which has increased since 2002 (54.9%) and (60%) in 2009. However many

units in this region now have a laboratory lower limit of normal less than 2.2mmol/l and this may

explain the large proportion of patients with a low calcium according to targets.

The regional median for corrected calcium was below the renal registry England and Wales

median 2008 data for both haemodialysis and peritoneal dialysis patients.

Serum Phosphate:

Regionally 60.7% patients reached the target of 1.1-1.8mmol/l; this shows a slight improvement

from 59.9% from 2002. All units improved their phosphate control except Salford Royal Hospital

who fell from 66.8% within target in 2002 to 51.7% in 2009.

The regional median is comparable to the renal registry England and Wales median data from

2008, though a wide variation is seen in phosphate results.

Calcium and Phosphate product

Overall there is high achievement (84.1%) across the region of a calcium phosphate product

<4.8 with 70.7% achieving a product <4.2.

Parathyroid Hormone

Due to the differences in assay used across the region we have only analysed iPTH across the

region. As tighter guidelines were introduced between 2002 (<4x upper limit of normal) and

2009 (2-4x upper limit of normal) the percentage of patients reaching target has reduced

markedly to 35.4%. However the KDIGO guidelines have been released since this audit was

undertaken and if these were used 53.9% would reach target.

The median iPTH for the region is lower than the median iPTH for England and Wales renal

registry 2008 data; however it must be stressed that iPTH assays from different companies

cannot be compared accurately.

Parathyroidectomy

The data suggests that there has been a drop in the number of parathyroidectomies performed.

This could be due to the introduction of cinacalcet since the previous audit. It is important to

note that due to variations in recording this data is difficult to collect accurately.



Percentage reaching all 4 targets

A drop from 33% to 12% was seen in patients achieving all 4 renal association targets. This is

mainly due to the change of iPTH target between 2002 and 2009. There was an increase in

patients achieving all 4 KDOQI targets from 1.4% in 2002 to 7% in 2009.

Change in use of phosphate binders

As a region we are using much less calcium carbonate and more calcium free binders. Calcium

acetate use has increased in the region probably secondary to its lower calcium content and

price.

The use of phosphate binders varies widely across units. The 2 hubs with the best phosphate

control (A and RPH) use differing prescription strategies with <40% on calcium free binders at

RPH compared to >60% at A.

As a region 31% of patients with a serum calcium >2.5mmol/l were prescribed a calcium binder

As a region 14% of patients with a low calcium and high phosphate were not prescribed any

binder

As a region 50% of patients with an iPTH <2x upper limit of normal were prescribed vitamin D

(though this was not adjusted for previous parathyroidectomies).

Contact with Dietetic service

81% of patients within the region were seen by a dietician within the last 6 months. This varied

from 100% at A and COCH to 77% at SRH.



1.0 INTRODUCTION

Established in 1992, the North West Renal Audit Programme is a standards based programme

of continuous quality improvement through clinical audit. The programme is directed by the

North West Renal Audit Steering Group and the daily management carried out by the North

West Renal Audit Team with support from Renal Nurse Audit Facilitators.

2.0 AIMS AND OBJECTIVES

The aims and objectives for this audit include:

For whole dialysis population

� To measure achievement of the Renal Association standards and compliance with the

KDOQI guidelines for calcium, phosphate, calcium phosphate product and serum PTH.

� To assess compliance with the K/DOQI guideline for calcium load.

� To compare prescribing practice for phosphate binders and vitamin D

� To measure the incidence of parathyroidectomy

� To quantify the use of cinacalcet for the treatment of patients with secondary

hyperparathyroidism

� To compare the commercial machines and assays used by the hospital laboratories for the

measurements above.

For 10% sample of dialysis population

� To note the systems used to track drug information and assess the accuracy of these

systems.

� To quantify use of IV Vitamin D

� To compare dietetic contact between the units

Proposed Health Benefits

� To reduce the risk of renal bone disease

� To reduce the risk of hyperparathyroidism



3.0 EVIDENCE BASE

� Young EW, Albert JM, Satayathum S, Goodkin DA, Pisoni RL, Akiba T, Akizawa T,

Kurokawa K, Bommer J, Piera L, Port FK. Predictors and consequences of altered mineral

metabolism: the Dialysis Outcomes and Practice Patterns Study. Kidney Int 2005 Mar;

67(3):1179-87.

� Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral

metabolism, mortality and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004

Aug; 15(8):2208-182).

� London GM; Guerin AP; Marchais SJ; Metivier F; Pannier B; Adda H. Arterial media

calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality.

Nephrol Dial Transplant 2003 Sep; 18(9):1731-40.

� Lepage R, Roy L, Brossard J-H, Rousseau L, Dorais C, Lazue C, D’Amour P. A non-(1–84)

circulating parathyroid hormone (PTH) fragment interferes significantly with intact PTH

commercial assay measurements in uremic samples. Clinical Chemistry 1998; 44:805-

809.

� Block, GA, Hulbert-Shearon, TE, Levin, NW, Port, FK. Association of serum phosphorus

and calcium phosphate product with mortality risk in chronic hemodialysis patients: A

national study. Am J Kidney Dis 1998; 31:607.

� The importance of dietary calcium and phosphorous in the secondary hyperparathyroidism

of patients with early renal failure. Am J Kidney Dis 1997; 29:496-502.

� Foley RN, Parfrey PS, Harnett JD, Kent GM, Hu L, O'Dea R, Murray DC, Narre PE.

Hypocalcaemia, Morbidity and Mortality in End-Stage Renal Disease. Am J Nephrol 1996:

16: 386-393.

� Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of

optimal vitamin D status. Osteoporosis Int 2005; 16: 713-716.

� Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B.

Fracture prevention with vitamin D supplementation: a meta-analysis of randomized

controlled trials. JAMA 2005; 293(18): 2257-2264.

� Zitterman A. Vitamin D in preventive medicine: are we ignoring the evidence? Br J

Nutr 2003; 89: 552-572.

� Lips Vitamin D Deficiency and secondary hyperparathyroidism in the elderly:

consequences for bone loss and fractures and therapeutic implications. Endocr Rev 2001;

22: 477-501. Tsuchihashi K, Takizawa H, Torii T et al.

� Hypoparathyroidism potentiates cardiovascular complications through disturbed calcium

metabolism: possible risk of vitamin D(3) analog administration in dialysis patients with

end-stage renal disease. Nephron 2000; 84:13–20.

� Thomas MK, Lloyd-Jones DM, Thadhani RI, Shaw AC, Deraska DJ, Kitch BT, Vamvakas

EC, Dick IM, Prince RL, Finkelstein JS: Hypovitaminosis D in medical inpatients. N Engl J

Med 1998; 338:777-783.

� Bouillon RA, Auwerx JH, Lissens WD, Pelemans WK: Vitamin D status in the elderly:

Seasonal substrate deficiency causes 1,25-dihydroxycholecalciferol deficiency. Am J Clin

Nutr 1987; 45:755-763.



4.0 STANDARDS

Regional Association Clinical Practice Guidelines. Clinical Practice Guidelines

Committee Renal Association Clinical Practice Guidelines 4th Edition 2007

www.renal.org/guidelines

Phosphate Serum phosphate should be maintained between 1.1 and

1.8mmol/l

Calcium Serum calcium, adjusted for albumin concentration should

be maintained within the normal reference range for the

laboratory used and ideally between 2.2 and 2.5mmol/L

Serum calcium phosphate product The serum albumin corrected calcium phosphate product

should be kept below 4.8 mmol2/L2 and ideally below 4.2

mmol2/L2

Serum parathyroid hormone The target range for parathyroid hormone measured using

an intact PTH assay should be between 2 and 4 times the

upper limit of normal for the intact PTH assay used. The

same target range should apply when using the whole

molecule PTH assay.

K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney

Disease www.kidney.org/professionals/kdoqi/guidelines_bone/index.htm

Phosphate 1.13 – 1.78 mmol/l

Calcium 2.10 – 2.37 mmol/l

Calcium Phosphate Product CAXP should be less than 4.4 ng/l

Serum parathyroid hormone iPTH concentration in range 150 – 300 ng/l



5.0 METHODOLOGY

The patient population audited included patients in the North West Region who had been

dialysing for a least 3 months at time of data collection.

For whole dialysis population

� For HD and PD patients serum albumin corrected calcium, phosphate and iPTH was

collected from the monthly blood test that includes iPTH measurement in either November,

October or September 2009 ensuring calcium, phosphate and iPTH are taken from the

same blood test. If no iPTH was available in this time frame the most recent corrected

calcium and phosphate (HD and PD patients) was recorded.

� If iPTH was not collected with monthly bloods within the time frame above then the iPTH

result was taken from the most recent iPTH measurement taken in the past 6 months. If

the results were not available, the patient was excluded from that part of the analysis.

� Use of phosphate binders and vitamin D and the prescribed dose, and the source of this

information were recorded.

� Use of cinacalcet was recorded.

� The number of patients who had a parathyroidectomy was recorded.

� The machines and assays used by the hospital laboratories to measure the biochemical

variables were recorded.


A 10% sample of dialysis population was selected by taking every 10th patient on a list of

patients ordered by hospital number, at each unit. Additional information was collected on

these patients:

� IV Vitamin D and dialysate used recorded from the hospital drug cardex.

� The hospital systems used to track drug information was recorded and a GP record of the

patients’ drug prescription requested.

� Contact with dietitians was recorded from dietetic records.



6.0 RESULTS SUMMARY

6.1 Demographics

6.1.1 The total number of data sets for this audit was 1703. A breakdown of the numbers is

given in Figure 6.1 below (Please note there are no results for RLH for 2009). The

gender split is generally around 60% male to 40% female as shown in Figure 6.2.

Figure 6.1: Number of patient data sets for 2002 and 2009 (individual units).

0

50

100

150

200

250

300

A H

D

CO

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MR

I -

HD

MR

I -

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D

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A AP MRI RLH RPH SRH

No. of patients (2002) No. of patients (2009)

Figure 6.2: Gender split (2009)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

A COCH MRI RPH SRH Region

Females

Males



There are regional differences in the recording of ethnicity between individual units

(Figure 6.3). As a region the breakdown is white (70.5%), asian (13.4%), black (3.7%),

chinese, mixed and other (2.4%) and not stated (9.9%).

Figure 6.3: Ethnicity breakdown (2009)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


White Asian Black Chinese Mixed Other Not stated

6.1.2 Diabetic status

Regionally just over 30% of dialysis patients are diabetic (Figure 6.4). There is some

variation between the units with 27% at MRI and up to 40% at A and COCH (this may

reflect differences in methods of recording this data).

Figure 6.4: Diabetic status of patients (2009).

52 30

134 159172

547

79 45

361373

2731131

10 3 9 22

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


Diabetes No diabetes Unknown



6.1.3 Transplant Status

Transplant status data was not provided by A and COCH. The percentage of patients

who have received a transplant within the region is 9% (Figure 6.5). There is variation

regionally with the highest of 15% at MRI and the lowest of 4% at SRH (again this may

be a reflection on the way data has been collected and details are recorded at individual

units).

Figure 6.5: Percentage of patients who have received a previous kidney transplant. (2009)

0%

2%

4%

6%

8%

10%

12%

14%

16%

MRI RPH SRH Region

6.2 Serum Calcium (corrected for albumin)

6.2.1 2009 Results

Serum calcium, adjusted for albumin concentration, should be between 2.2 and

2.5mmol/l, in HD and PD patients. Regionally 66.9% of patients met the RA standard for

corrected calcium. In the hub units Aintree (77.1%) had the highest proportion of

patients meeting the standard and MRI the lowest (53.1%). In the satellite units COCH

had the highest proportion of patients meeting the standard (89.3%) and Chorley the

lowest (54.8%). Regionally, there was little difference between the number of HD/HHD

patients (61.3%) and the number of PD patients (60.9%) who met the standard.

However, if this is analysed further taking HD and Home HD patients separately there is

greater variation in the calcium control with HD patients 68%, PD patients (61%) and

HHD patients (62%).

The lower proportions of patients meeting the RA standard may be partly explained by

differing normal ranges of serum calcium in each hospital. MRI and SRFT have a lower



5 2

130

34

1423 51

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50

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25

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7

9

3 2 8 4 69

4

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120

0%

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40%

60%

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100%

A

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A AP MRI RPH SRH

No. of patients w ith calcium < 2.2 No. w ithin guideline range of 2.2 - 2.5 No. of patients w ith calcium >2.5

normal range of calcium of 2.1mmol/l and RPH of 2.15mmol/l. This may explain the

larger proportion of patients with a lower calcium (Figure 6.6) at these centres.

Figure 6.6: Graph showing percentage of patients within RA guideline range for calcium

(2.2 - 2.5mmol/L) for regional units.

5 2

173125 127 432

10167

305

370296 1139

256 27 40 31 129

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


No. of patients with calcium < 2.2 No. within guideline range of 2.2 - 2.5

No. of patients with calcium >2.5

Figure 6.7: Graph showing percentage of patient within RA guideline range for calcium

(2.2 - 2.5mmol/L) ( individual units).



Figure 6.8: Graph showing percentage of patients within range for calcium (2.2 -

2.5mmol/L) for individual units.

Chart 2 % patients within standrd for Ca

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

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6.2.2 KDOQI standard for Calcium

Regionally over 50% of patients have results within the KDOQI calcium target; with

variation between individual units with the highest of 70.2% at Wigan and the lowest of

25% at Furness (Figure 6.9).

Figure 6.9: Percentage of patients reaching KDOQI guideline calcium target of 2.1 - 2.37

mmol/L

% of patients reaching KDOQI guideline 1.1 - 2.37 mmol/L

0%

10%

20%

30%

40%

50%

60%

70%

80%

A

CO

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MR

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NM

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Bolton

Rochdale

Wig

an

Regio

n



Despite the RA targets being broader than KDOQI a few units, namely MRI, Chorley and

Wigan had a greater percentage of patients within the KDOQI target.

Figure 6.10: Comparison of patients reaching RA Standard and KDOQI guidelines.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

A

CO

CH

MR

I

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RP

H

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Burn

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Furn

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Kenda

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SR

H

Bolto

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Wig

an

Regio

n

Percentage within guideline range of 2.2 - 2.5 (2009)

% of patients reaching KDOQI guideline 2.1 - 2.37 mmol/L

6.2.3 Comparison with previous Calcium results

Regionally the proportion of patients meeting the RA standard for corrected calcium

increased between 2000 (63%) and 2002 (67.9%) and decreased slightly in 2009

(66.9%) A slight decrease since 2002 is seen in all the unit results apart from MRI which

has increased since 2002 (54.9%) and (60%) in 2009 (Figure 6.11)

Regionally, the proportion of HD/HHD patients meeting the 2002 RA standard increased

between 2000 (60%) and 2002 (69%) but reduced significantly in 2009/2010 (61.3%).

This is likely to be a reflection of a change in the standard where the guideline range has

narrowed slightly from 2.2 - 2.6mmol/L to 2.2 - 2.5mmol/L. The biochemical lower level of

normal has also changed in some hospitals to 2.1mmol/l leading to patients with a

‘normal’ calcium not reaching the renal association standards.

Regionally, there was little change in the proportion of PD patients meeting the 2002 RA

standard between 2000 (67%) and 2002 (66%); however there has been a significant

reduction meeting the standard in 2009/2010 (60.9%). However, this was not the case

separately. Between 2000 and 2002 and 2009, the proportion decreased at MRI (77%

to 56% to 52%) but the proportion increased at RPH between 2000 and 2002 (47% to

67%) but reduced in 2009/2010 (60%), SRH (60% to 77% between 2000 and 2002 but

reduced again in 2009/2019 -60.7%).



Figure 6.11: Graph showing percentage of patients meeting RA standard for corrected

calcium in 2002 and 2009.

0%

10%

20%

30%

40%

50%

60%

70%

80%

MRI RPH SRH Region

-2002 -2009

Figure 6.12 Percentage of patients within normal calcium range for individual units.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

A (2.18 -

2.62)

COCH (2.1 -

2.7)

MRI (2.1 -

2.55)

RPH (2.15 -

2.55

SRH (2.1 -

2.6mmol/L)

Region

6.2.4 Benchmarking local data against national data collected by the UK Renal Registry

There is variation between all the units; but all medians fall within the guideline range of

2.2 - 2.5 mmol/L (Figure 6.13) apart from Furness which is just over the target at 2.56

mmol/L.



Figure 6.13: Median corrected calcium in dialysis patients (2009)

1

1.5

2

2.5

3

3.5

A

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Calcium (Lowest)

Calcium Highest)

Median Calcium

The regional median for corrected calcium for HD patients was 2.31 mmol/L (Renal

Registry data for 2008 was 2.35 mmol/L); the regional median corrected calcium for PD

patients was 2.31 (Renal Registry data for PD patients in 2008 for England, Wales and

NI was 2.39) (Figure 6.14).

Figure 6.14: Median corrected calcium for North West Regional HD and PD patients (2009)

compared to Renal Registry 2008 data for HD and PD patients.

11.11.21.31.41.51.61.71.81.9

22.12.22.32.42.52.62.72.82.9

33.13.23.33.43.5

All PD All HD + HHD ALL REGION E,W & NI (2008) HD E,W &NI (2008) PD

Calcium (Lowest) Calcium Highest) Median Calcium



6.3 Phosphate

6.3.1 Results for RA standard for serum phosphate

Regionally 61.1% of patients met the RA standard for phosphate of 1.1 to 1.8 mmol/L.

In the hub units Aintree had the highest proportion of patients meeting the standard

(67.9%) and SRH the lowest (51.7%) (Figure 6.15). In the satellite units Furness (a RPH

satellite) had the highest proportion of patients meeting the standard (100%) and Bolton

(an SRH satellite) the lowest (53%) (Figure 6.16).

Figure 6.15: Percentage reaching RA standard for phosphate 1.1 to 1.8 mmol/L

0%

10%

20%

30%

40%

50%

60%

70%

80%


Figure 6.16: Percentage reaching RA standard for phosphate 1.1 to 1.8 mmol/L (individual units

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

A

CO

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I

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Tam

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Regio

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Regionally, there was little difference between the number of HD patients (60.7%) and

the number of PD patients (60.6%) who met the standard (Figure 6.16)

Figure 6.17: Percentage of HD and PD patients achieving target for phosphate (2000, 2002

and 2009).

6.3.2 Evaluation of change since the previous audit

Generally there has been an increase in patients reaching targets in all units accept for

SRH where the percentage has decreased from 66.8% in 2002 to 51.7% in 2009

Regionally the proportion of patients meeting the RA standard for phosphate has

continued to increase since 2000; 56% in 2000, 59.9% in 2002 and 60.7% in 2009

(Figure 6.16).

0%

10%

20%

30%

40%

50%

60%

70%

80%

Aintree

Arrowe MRI RPH SRH Region MRI RPH SRH Region

Percentage patients - 1.1 to 1.8 (2000) Percentage patients - 1.1 to 1.8 (2002) % of patients - 1.1 to 1.8 (2009)

Haemodialysis Patients Peritoneal Dialysis Patients



Figure 6.18: Percentage of patients achieving target for phosphate in 2002 and 2009.

0%

10%

20%

30%

40%

50%

60%

70%

80%


Percentage patients - 1.1 to 1.8 (2002)

% of patients - 1.1 to 1.8 (2009)

6.3.3 Benchmarking local data against national data collected by the UK Renal Registry

Regionally and individually all units median phosphate fall within the guidelines of the

Renal Association (1.1. to 1.8 mmol/L); there are quite large variations in the range of

figures (Figure 6.19)

Figure 6.19: Median phosphate for NW Region units (2009).

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

2.2

2.4

2.6

2.8

3

3.2

3.4

3.6

3.8

4

4.2

4.4

A

CO

CH

MR

I

Maccle

sfield

NM

GH

Tam

esid

e

Wyth

enshaw

e

RP

H

Accringto

n

Bla

ckpool

Burn

ley

Chorley

Furn

ess

Kendal

SR

H

Bolton

Rochdale

Wig

an

Regio

n



Figure 6.20: Median phosphate for PD, HD, all NW Region (2009) compared to Renal

Registry (2008) data for HD and PD patients

0.000.200.400.600.801.001.201.401.601.802.002.202.402.602.803.003.203.403.603.804.004.204.404.60

All PD All HD + HHD REGION E, W & NI (2008

data) HD

E, W & NI (2008

data) PD

Phosphate (lowest) Phosphate (highest) Median Phosphate

6.4 Calcium Phosphate product

Regionally 84.1% of dialysis patients meet the Renal Registry target of <4.8 and 70.7%

a target of <4.2 (Figure 6.21). Achievement of the <4.8 target is marginally better in HD

patients (84.4%) then PD patients (82.45); this is true for the <4.2 ng/L target also with

HD patients with 71.1% and PD patients with 68.5% meeting targets. As a region 76.2%

of patient results meet the KDOQI target of < 4.4 ng/L with HD patients again marginally

better than PD with 76.4% (HD) compared to 75.4% (PD)

Figure 6.21: Calcium Phosphate product

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

A AP MRI RPH SRH Region

Percentage patients below target (4.8) Percentageof patients above 4.8 Percentage of patients below 4.2



6.5 Parathyroid hormone and incidence of parathyroidectomy

6.5.1 RA Standard for parathyroid hormone

Units use different biochemistry laboratories and consequently different assays. To

analyse the data regionally, the RA standard was therefore interpreted on a regional

basis.

Regionally 26.1%% of patients met the regional interpretation of the RA standard for

PTH (Figure 6.22). In the hub units RPH (33%) had the highest proportion of patients

meeting the standard and both A and MRI had the lowest at 22.9%. In the satellite units

Furness (a satellite of RPH) had the highest proportion of patients meeting the standard

with 50% and Tameside (a satellite of MRI) the lowest with14.7% (Table 1, Figure 6.23).

Table 1: Assays for individual NW Region units together with the percentage of patients

reaching Renal Association target. Grouped Assay Unit Upper

Limit of

PTH assay

2x PTH

assay

4x PTH

assay

9x PTH assay Percentage

of patients 2x

- 4x

Abbott architect Bolton 70 140 280 630 31.8

Advia centaur Blackpool 73 146 292 657 22.4

Chester (AP) 66 132 264 594 34.7 Beckman

Tameside 66 132 264 594 14.7

A 65 130 260 585 22.9

Accrington 65 130 260 585 26.3

Burnley 65 130 260 585 34.2

Immulite

Macclesfield 65 130 260 585 43.5

Chorley 65 130 260 585 24.2

Furness 66 132 264 594 50.0

Kendal 66 132 264 594 30.4

MRI 60 120 240 540 22.9

NMGH 65 130 260 585 25.5

Rochdale 65 130 260 585 16.7

RPH 65 130 260 585 33.0

SRH 65 130 260 585 24.0

Wigan 65 130 260 585 29.8

Roche

Wythenshawe 65 130 260 585 23.1



Figure 6.22 : Graph showing percentages of patients within iPTH ranges <2x, 2x - 4x, 4x - 9x, >9x

49

16 95

142 130432

30

26

117

159 113445

2525

162

133 128473

26

8

111

8079

304

123 21

4 49

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


No. of patients < 2x No. of patients 2x - 4x No. of patients within 4x - 9x (KDIGO) No. of patients > 9x No. patients missing results

Figure 6.23: Patients within target (x2,x4)

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

A

CO

CH

MR

I

Maccle

sfie

ld

NM

GH

Tam

esid

e

Wyth

enshaw

e

RP

H

Accringto

n

Bla

ckpool

Burn

ley

Chorley

Furn

ess

Kendal

SR

H

Bolto

n

Rochdale

Wig

an

Regio

n

6.5.2 Change since last report

Regionally, there has been a significant decrease in the proportion of patients meeting

the audit standard for iPTH since 2002 (33% to 26.1%) though in 2002 the target was

<x4 normal range compared with the current target of 2-4x normal range.

� 2000 (33%)

� 2002 (33%)

� 2009 (26.1%)



6.5.3 Median/benchmarking

The regional median iPTH for HD patients (193.5pgm/ml) was less than the UK Renal

Registry median for HD dialysis patients in England and Wales of 244.75pgm/ml (pg/ml

x 0.105 = pmol/l). The regional median iPTH for PD patients (246 pgm/ml) was less than

the UK Renal Registry median for PD dialysis patients in England and Wales 249.52

pgm/ml (pg/ml x 0.105 = pmol/l).

Figure 6.24: Median PTH for NW Region Units 2009/2010

0

100

200

300

400

500

600


1st Quartile Upper Quartile iPTH Median

Figure 6.25: Median iPTH for individual NW Region units

0

100

200

300

400

500

600

700

800

1st Quartile Upper Quartile iPTH Median



0

5

10

15

20

25

30

A COCH MRI RLH RPH SRH Region

% of patients with parathryoidectomy (2002)

% of patients with parathryoidectomy (2009)

6.5.4 Patients undergoing parathyroidectomy

There is a significant difference in the number of patients undergoing parathyroidectomy

since 2002 (14.6%) and only 6.3% in 2009. This may be attributable to difficulties in

obtaining the data from patients’ notes and IT systems or may reflect better clinical

management of bone mineral disease.

Figure 6.26: Comparison of number of patients undergoing parathyroidectomy in 2002 and 2009.

6.6 Percentage of patients meeting all Renal Association and KDOQI targets

There has been a reduction from 33% of patients reaching all four targets in 2002 to

12% in 2009. The main difference is the percentage reaching iPTH targets where there

has been a significant decrease since 2002 (72% to 26%).



Figure 6.27: Percentage of patients meeting Renal Association targets

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Calcium Phosphate iPTH Calcium Phosphate

product

All four

Percentage reaching target (2002) Percentage reaching target (2009)

The KDOQI targets show a different story with a increase in percentage of patients

meeting all four KDOQI targets from 1.4% in 2002 to 7% in 2009 (Figure 6.28)

Figure 6.28: Percentage of patients meeting KDOQI targets

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Calcium Phosphate iPTH Calcium Phosphate

product

All four

Percentage reaching target (2002) Percentage reaching target (2009)

6.7 Phosphate binders

6.7.1 Regionally the most commonly prescribed binder is sevelamer hydrochoride (33.1%);

more or less equal amounts of calcium carbonate (24%), calcium acetate (20%) and

lanthanum carbonate (20%) are prescribed and very little aluminium hydroxide (0.9%)

(Figure 6.29).



The highest number of patients prescribed calcium carbonate binders are at MRI with

44.6% and the lowest at RPH with 12.5 patients prescribed calcium carbonate. The

highest prescribed calcium acetate is at RPH and none is prescribed at Countess of

Chester. COCH prescribed Sevelamer hydrochoride to the highest percentage of

patients (56%) and Preston the lowest percentage at 20.7%. All units prescribe

lanthanum carbonate, the highest number of patients at COCH and the lowest number at

SRH. The prescribing of aluminium hydroxide is low within the region (highest at COCH

with 5.3% and lowest at MRI with 0.2%). The prescription of the most expensive

medications does not necessarily reflect better phosphate control.

Figure 6.29: Percentage of patients on phosphate binders

6.7.2 Change in use of binders since 2002

There has been a significant increase in the number of patients prescribed phosphate

binders since the last audit data of 2002. Regionally 60.3% were prescribed binders in

2000, 61.5% in 2002 and 80.7% prescribed binders in 2009.

0%

10%

20%

30%

40%

50%

60%


% Patients on calcium carbonate (2009)

% patients on Calcium Acetate (2009)

% Patients on sevelamar (2009)

% Patients on lanthanum carbonate (Fosrenol) (2009)

% Patients on aluminium hydroxide (2009)

Percentage of patients reaching RA Target for phosphate

67% 60% 59% 67% 54% 61%



Figure 6.30: Change in use of phosphate binders (2000, 2002 and 2009)

0

10

20

30

40

50

60

70

80

90

100

MRI RPH SRH Region

No. of patients on binder (2000) No. of patients on binder (2002) % patients on binder (2009)

Figure 6.31: Change in use of calcium carbonate binder (2002 and 2009).

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

MRI RPH SRH Region

% Patients on calcium carbonate (2002) % Patients on calcium carbonate (2009)

The reduction in the prescribing of calcium carbonate binders is probably a reflection of

the combination of increasing awareness of higher oral calcium intake and its

association with calcification and other morbidity. As calcium acetate has less calcium

and yet is a similar price this may also explain its increase in use. The highest increase

in use has been seen with Sevelamer hydrochloride. This again is partly explained by

the increasing data regarding high calcium intake and hypercalcaemia. Lanthanum was

not available in 2002 so no comparison can be made.



Figure 6.32: Change in use of calcium acetate (2002 to 2009)

0%

5%

10%

15%

20%

25%

30%

35%

40%

MRI RPH SRH Region

% of patients on Calcium Acetate (2002) % patients on Calcium Acetate (2009)

Figure 6.33: Percentage of patients on Sevelamar 2009 and 2002.

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

MRI RPH SRH Region

Patients on sevelamar (2002) % Patients on sevelamar (2009)

The regional change in Aluminium use does not take into account missing 2009 data

from many hospitals in Liverpool whom in 2002 were reported to have 50% use of

Aluminium and the drop in the regional average may be accounted by this.



Figure 6.34: Percentage of patients on aluminium hydroxide 2009 and 2002.

0%

5%

10%

15%

20%

25%

MRI RPH SRH Region

Patients on aluminium hydroxide (2002) % Patients on aluminium hydroxide (2009)

6.7.3 KDOQI Calcium load

The total dose of elemental calcium provided by the calcium-based phosphate binders

should not exceed 1,500 mg/day and the total intake of elemental calcium (including

dietary calcium) should not exceed 2,000 mg/day

Figure 6.35: Calcium load for patients 2009

44

8

142

231

81

506

3

4

119

33

77

236

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


Patients with calcium load <1.5 Patients with calcium load >1.5



6.7.4 Patients with high Calcium >2.5mmol/l

Figure 6.36: Percentage of patients with high calcium (> 2.5mmol/L) and percentage of

those on a calcium binder (calcium carbonate/calcium acetate)

6.7.5 Patients with low calcium <2.2 mmol/L

Figure 6.37: Percentage of patients with low Calcium and high phosphate NOT prescribed a binder.

0%

5%

10%

15%

20%

25%


percentage on a calcium binder (calcium carbonate/calcium acetate)

32%

16%

46%

36% 16% 31%

0%

5%

10%

15%

20%

25%

30%




6.8 Alphacalcidol

Figure 6.38: Patients with iPTH <2x prescribed Vitamin D.

Figure 6.39: Patients with iPTH >4x prescribed Vitamin D.

0%

10%

20%

30%

40%

50%

60%

70%

80%


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%




6.9 Cinacalcet

Figure 6.40: Percentage of patients’ receiving/not receiving cinacalcet (2009)

6.4

4

5.65.1

16

17.6

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%


6.10 10th patient data

6.10.1 Dialysate used

Figure 6.41: Percentage concentration of calcium in dialysate used for patient subset

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 1.25 1.5 1.75 Unknown 1 1.25 1.5 1.75 Unknown

HD Patients PD Patients

Calcium concentration

A COCH MRI RPH SRH



6.11 Patient contact with dietetic service

The percentage of patients seen by a dietitian in the past six months is fairly consistent

across the units (with A and COCH the highest at 100% and the lowest at SRH with

77%). There are no figures to compare with in 2002.

Figure 6.42: Number of patients seen by a dietitian in past six months (2009 data)

% seen in past six months (2009)

81%78% 77%79%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


As might be expected, Figure 6.43 shows that the patient group least likely to have seen

a dietitian in the past six months are the Home HD and PD patients.

Figure 6.43: Percentage of patients seen by dietitian in previous six month period

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

A

CO

CH

MR

I - H

D

MR

I - H

HD

MR

I - P

D

Maccle

sfield

NM

GH

Tam

esid

e

Wyth

enshaw

e

RP

H H

D

RP

H P

D

Accringto

Bla

ckpool

Burn

ley

Chorley

Kendal

SR

H H

D

SR

H H

HD

SR

H P

D

Bolton

Rochdale

Wig

an

Regio

n



Figure 6.44: Reason for referral of 10th

patient subset to dietitian.

2 1

31

7

1253

11 6

9

35

2485

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


Routine Review All other reasons

Most dietician reviews are directed rather than routine, and this may reflect different

practices in each dietetic unit or different reporting of referral reason.

6.12 Drug data recording

Reassuringly the percentage of patients prescribed a medication by the GP corresponds

to the number of patients who are thought to be taking the medication by the hospitals.

However the dose differences were not investigated



Figure 6.45: Graph showing the number of prescriptions for drugs between GP and hospital records.

9289

7 6

33

25 26 28

4846

30 31

2 2

0

10

20

30

40

50

60

70

80

90

100

No. pre

scribed A

lfacalc

idol (H

)

No. pre

scribed A

lfacalc

idol G

P)

No. pre

scribed C

inacalc

et (H

)

No. pre

scribed C

inacalc

et (G

P)

No. pre

scribed (H

)

No. pre

scribed (G

P)

No. pre

scribed (H

)

No. pre

scribed (G

P)

No. pre

scribed (H

)

No. pre

scribed (G

P)

No. pre

scribed (H

)

No. pre

scribed (G

P)

No. pre

scribed (H

)

No. pre

scribed (G

P)

Alfacalcidol Cinacalcet Calcium

Carbonate

binder

Calcium

Acetate

(Phosex)

Sevelemar

Hydrochloride

(Renagel)

Lanthanum

Carbonate

(Fosrenol)

Alucaps



7.0 DISCUSSION OF RESULTS

7.1 The standards

Two sets of guidelines were looked at during this audit: the Renal Association Guidelines for

calcium, phosphate, calcium-phosphate product and iPTH and KDOQI guidelines for the same.

Table 2: Guidelines ranges for current audit

Renal Association KDOQI

Serum calcium

(corrected for albumin) 2.2 - 2.5 mmol/L 2.10 – 2.37 mmol/l

Serum Phosphate 1.1 - 1.8 mmol/L

1.13 – 1.78 mmol/l

Calcium Phosphate

Product < 5

CAXP should be less than 4.4

ng/l

The target range for parathyroid

hormone measured using an intact

PTH assay should be between 2 and

4 times the upper limit of normal for

the intact PTH assay used. The same

target range should apply when using

the whole molecule PTH assay.

iPTH concentration in range

150 – 300 ng/l

iPTH

to be measured at least every 6

months

The results for each of the standards have been summarised in the table below

Table 3: Summary of results for Renal Association standards (2010 data)

Percentage achieving

target regionally Lowest performing units Best performing units

RA KDOQI RA KDOQI RA KDOQI

Serum calcium

(corrected for albumin) 66.9% 26.8% MRI HD Furness COCH Wigan

Serum Phosphate 61.1% 52.7% SRH HD RPH HHD Furness Furness

Calcium Phosphate Product 89.3% 83.2% MRI HD Macclesfield Furness Furness

iPTH 26.1% 27.8% Rochdale Macclesfield Furness Furness



7.2 Comparison with previous audit data

The following table gives a breakdown of percentage reaching standards from previous audits.

It should be noted, however, that the standards have changed over this time period so direct

comparison is difficult. Data from 2000 is compared to the standards in The Renal Association.

Treatment of adult patients with renal failure. Recommended standards and audit measures.

Second Edition November 1997; and those in 2002 to The Renal Association. Treatment of

adults and children with renal failure. Standards and audit measures. Third Edition August

2002.

Table 4: Comparison of 2000, 2002 and 2010 data

Regional HD/HHD PD

Standard 2000 2002 2010 2000 2002 2010 2000 2002 2010

Calcium

2000: total calcium within the normal

range. 2002: 2.2 - 2.6 mmol/l

2010: 2.2 - 2.5 mmol/L

63% 68% 66.9% 60% 69% 68.1% 67% 66% 60.9%

Phosphate

2000: < 1.8 mmol/l. 2000: PD

patients 1.1–1.6 mmol/l. 2002: < 1.8

mmol/l. 2010: 1.1 - 1.8 mmol/L.

56% 59.9% 61.2% 60.7% 60.6%

iPTH

2000: iPTH 2 and 3 times the local

normal range (130–210 pg/ml).

2002: iPTH concentration: < x4 upper

limit of normal of the assay used

26.1%

Calcium Phosphate product

2002: Local guidelines

Calcium phosphate product < 5

2010:

67.3% 74.1% 89.3% 84.4% 82.4%

All four targets 33% 12%

Table 5: Results for 2002 and 2010 related to KDOQI guidelines

Regional HD/HHD PD

Standard (same 2002/2010) 2002 2010 2010 2010

2002 Serum phosphate in range 1.13 -

1.78 mmol/l 55% 53% 52.9% 51.6%

2002: Serum calcium (corrected) in range

2.10 - 2.37 mmol/l 25% 52.7% 51.6% 58.1%

2002: Parathyroid hormone (iPTH) iPTH

concentration in range 150 - 300 ng/l 19% 27.8% 27.1% 31.1%

2002: Ca x PO4 should be less than 4.4

ng/l 59% 77% 76.4% 75.4%

Percentage meeting all four targets 1.4% 7%

7.3 Factors influencing the data during the audit period

Data has not been submitted by Royal Liverpool Hospital for this audit period. It is our

intention to pursue data collection at RLH to ensure that we have a full dataset for

comparison when we re-audit in two years (2012).



8.0 CONCLUSIONS

This audit is a valid audit of bone chemistry metabolism. It encompassed 1703 patients across

the North West but unfortunately this report does not include data from Liverpool and its’

satellite hospitals. This audit did show wide variety of biochemical control and bone chemistry

drug usage across the region also highlighting the difficulties that all clinicians face while

treating this complex condition. The main findings are highlighted below:

• Calcium control has been maintained and is comparable to England and Wales 2008

data.

• Phosphate control is comparable to England and Wales 2008 data. All units improved

except Salford Royal Hospital

• iPTH is comparable to England and Wales 2008 data

• There has been an increase from 1.4% to 7% reaching all 4 KDOQI targets since 2002

• As a region the percentage of patients with a high serum calcium still prescribed a

calcium binder is 31%

• As a region 50% of patients with a low iPTH are prescribed vitamin D analogues.

9.0 RECOMMENDATIONS

• As a region we are comparable to England and Wales from 2008 according to Renal

registry data but there is room for improvement in both satellite units and main hubs. All

units should form, if not in place already, MDT meetings to focus on the outliers at the

minimum but also monitor for trends in biochemical values which cannot be covered in

this audit.

• Regular in-house audit should be maintained to view whether a change of practice has

led to improvement of control. Regional audit still also needs to be maintained to

highlight differences across the region and to drive improvement.

• The recording of medication in all dialysis patients can be poor. Medication and changes

of medication need to be recorded more accurately, thoroughly, and preferably

electronically to allow for easier access to all team members dealing with patients,

including GPs.

• All units need to monitor patients for increasing trends in calcium and if calcium does

become increased then the dose of vitamin D analogues or calcium binders should be

reviewed



• Though some patients who have had a parathyroidectomy require some vitamin D

analogues this does not account for the large amount of patients who have a low iPTH

according to recommended targets who are still prescribed vitamin D. In view of this all

units should monitor trends in iPTH and adjust medication accordingly to avoid low

levels.

• All units should consider the development of patient education groups with the aim to

improve patients understanding of the importance of diet, phosphate control and the

correct usage of binder therapy. This should have the aim of improving patient

compliance and concordance with drug therapies and diet.

• Future audits should consider the collection of data on 25 hydroxy-vitamin D2 and D3

levels if they have been checked and whether vitamin D2 or D3 replacement has been

prescribed and given in the previous 12 months.

• Future audits should consider collection of details regarding dialysis adequacy, dialysis

length, and more information regarding modality, e.g. haemodialfiltration or

haemodialysis, etc as if this is related to better control, as has been found in other

regions, then this could help target difficult patients for different management or with

future commissioning of services

• Future audits should consider collection of data relating to dialysate calcium as this may

have an impact on calcium control and would benefit from further analyses.

• Future audits should consider ways of collecting data on patient compliance with

medication



GLOSSARY OF TERMS AND ABBREVIATIONS APPENDIX 1

ACE inhibitors Angiotensin-converting enzyme inhibitors

ACR Albumin : creatinine ratio

APD Automated Peritoneal Dialysis

ARB Angiotensin receptor blocker (antagonist),

BMI Body Mass Index

BP Blood Pressure

CABG Coronary Artery Bypass Grafting

CAPD Continuous Ambulatory Peritoneal Dialysis

CKD Chronic Kidney Disease

CVA Cerebrovascular accident

CVD Cardiovascular Disease

DM Diabetes Mellitus

DOB Date of Birth

eGFR estimated Glomerular Filtration Rate

EPO Erythropoietin

ESA Erythropoietin stimulating agent

Fe Iron

Hb Haemoglobin

HD Haemodialysis

HT Hypertension

IHD Ischaemic Heart Disease

MI Myocardial Infarction

NICE National Institute for Health and Clinical Excellence

NSF National Service Framework

NWRA North West Renal Audit

PCR Protein : Creatinine ratio

PD Peritoneal Dialysis

PTH Parathyroid Hormone

PTH Parathyroid Hormone

PVD Peripheral Vascular Disease

RA Renal Association

RR Renal Registry

Hospital Short Codes

A University Hospital Aintree

AP Arrowe Park Hospital

MRI Manchester Royal Infirmary

RPH Royal Preston Hospital

SRH Salford Royal Hospital



PROJECT PLAN APPENDIX 2

NORTH WEST RENAL AUDIT PROGRAMME

MANAGEMENT OF MINERAL BONE DISEASE IN DIALYSIS PATIENTS

PROJECT PLANNING GUIDE

AUDIT PROJECT:

Audit leads: � Dr Helen Eddington

Specialist Registrar in Renal Medicine

Salford Royal Hospital NHS Foundation Trust

� Nora Kerigan

Specialist Nurse

Royal Preston Hospital

Audit facilitator: � Tracey Powell

Regional Renal Audit Co-ordinator

REASONS FOR

CHOICE

Aims & objectives: For whole dialysis population

� To measure achievement of the Renal Association standards and compliance

with the KDOQI guidelines for calcium, phosphate, calcium phosphate product

and serum PTH.

� To assess compliance with the K/DOQI guideline for calcium load.

� To compare prescribing practice for phosphate binders and vitamin D

� To measure the incidence of parathyroidectomy

� To quantify the use of cinacalcet for the treatment of patients with secondary

hyperparathyroidism

� To compare the commercial machines and assays used by the hospital

laboratories for the measurements above.

NB Helen Eddington plans to assess the variability of commercial intact PTH assay

measurements across the region as a separate research project.


� To note the systems used to track drug information and assess the accuracy

of these systems.

� To quantify use of IV Vitamin D

� To assess calcium load

� To compare dietetic contact between the units

Proposed health

benefits:

� To reduce the risk of renal bone disease

� To reduce the risk of hyperparathyroidism

Evidence base: � Young EW, Albert JM, Satayathum S, Goodkin DA, Pisoni RL, Akiba T,

Akizawa T, Kurokawa K, Bommer J, Piera L, Port FK. Predictors and

consequences of altered mineral metabolism: the Dialysis Outcomes and

Practice Patterns Study. Kidney Int 2005 Mar; 67(3):1179-87.

� Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM.

Mineral metabolism, mortality and morbidity in maintenance hemodialysis. J

Am Soc Nephrol 2004 Aug; 15(8):2208-182).

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PE. Hypocalcaemia, Morbidity and Mortality in End-Stage Renal Disease. Am

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Hughes B. Fracture prevention with vitamin D supplementation: a meta-

analysis of randomized controlled trials. JAMA 2005; 293(18): 2257-2264.

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84:13–20.

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deficiency. Am J Clin Nutr 1987; 45:755-763.

METHODOLOGY

Standards: � Regional Association Clinical Practice Guidelines1

Phosphate

Serum phosphate should be maintained between 1.1 and 1.8mmol/l

Calcium

Serum calcium, adjusted for albumin concentration should be maintained within the

normal reference range for the laboratory used and ideally between 2.2 and 2.5

mmol/L

Serum calcium phosphate product

The serum albumin corrected calcium phosphate product should be kept below 4.8

mmol2/L

2 and ideally below 4.2 mmol

2/L

2



Serum parathyroid hormone

The target range for parathyroid hormone measured using an intact PTH assay

should be between 2 and 4 times the upper limit of normal for the intact PTH assay

used. The same target range should apply when using the whole molecule PTH

assay.

1Clinical Practice Guidelines Committee Renal Association Clinical Practice

Guidelines 4th Edition 2007 www.renal.org/guidelines

Guidelines:

� K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in

Chronic Kidney Disease

www.kidney.org/professionals/kdoqi/guidelines_bone/index.htm

Patients: � All dialysis patients in the North West Region on 1st November 2009.

Methods: For whole dialysis population

� For HD and PD patients serum albumin corrected calcium, phosphate and

iPTH will be collected from the monthly blood test that includes iPTH

measurement in either November, October or September 2009 ensuring

calcium, phosphate and iPTH are taken from the same blood test. If no iPTH

available in this time frame record most recent corrected calcium and

phosphate (HD and PD patients).

� If iPTH has not been collected with monthly bloods within the time frame

above then the iPTH result should be taken from the most recent iPTH

measurement taken in the last 6 months. If the results are not available, the

patient will be excluded from that part of the analysis.

� Use of phosphate binders and vitamin D and the prescribed dose, and the

source of this information will be recorded.

� Use of cinacalcet will be recorded.

� The number of patients who had a parathyroidectomy will be recorded.

� The machines and assays used by the hospital laboratories to measure the

biochemical variables will be recorded.


A 10% sample of dialysis population will be selected by taking every 10th

patient on

a list of patients ordered by hospital number, at each unit. Additional information will

be collected on these patients

� IV Vitamin D and dialysate used will be recorded from the hospital drug

cardex.

� The hospital systems used to track drug information will be recorded and a GP

record of the patients’ drug prescription will be requested.

� Contact with dietitians will be recorded from dietetic records.

Health disciplines

involved:

� Dietitians Nurses

� Pharmacists Physicians

Timescale: � Start of data collection: November 2009

� Deadline for data collection: Spring 2010

ACTION

Proposed date for

audit presentation:

Presentation Meeting July 2010



DATA COLLECTION TOOL / DATA PARAMETERS APPENDIX 3

Bone Chemistry Audit Dataset

All patients

Reference number

Unit

Name

DOB

Gender (M/F)

Ethnicity

Diabetes (Y/N)

If yes, insulin (Y/N)

Phosphate

Phosphate date

Calcium

Calcium date

iPTH

iPTH date

Binder (Y/N)

Type binder

Dose of binder

Alphacalcidol (Y/N)

Oral or IV?

Alphacalcidol dose

Source of drug information (Clinic letter, dialysis

folder, IT system)

Cinacalcet (Y/N)

Dose cinacalcet

Has patient had a previous transplant (Y/N)

Parathyroidectomy (Y/N)

Date of parathyroidectomy

Comments

Every 10th patient

Reference number

IV vitamin D (Y/N)

Dose IV vitamin D

Dialysate used

Seen by dietitian (Y/N)

Date last seen by dietitian

Reason seen by dietitian

Date drug list sent

Drug 1

Drug 2

Drug 3

Drug 4

Drug 5

Drug 6

Drug 7

Drug 8

Drug 9

Drug 10



DATA TABLES APPENDIX 4

Data analysis tables are available on request from the North West Renal Audit office, telephone 0161 276

4224 or via email to [email protected] or [email protected].

Raw data for your unit can also be requested.

Both data types are available in excel spreadsheet format.

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