Management of Mineral Bone Disease in Dialysis Patients

Transcription

1 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: Web Address:

2 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 Diabetes Status Transplant Status 6.2 Calcium Results for RA standard for corrected calcium Results for KDOQI standard for corrected calcium Comparison with previous audit calcium results Benchmarking local data against national data collected by the Renal Registry 6.3 Phosphate Results for RA standard for serum phosphate Evaluation of change since the previous audit 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 RA Standard for parathyroid hormone Change since last report Median/benchmarking Patients undergoing parathyroidectomy 6.6 Percentage of patients meeting all Renal Association and KDOQI targets 6.7 Phosphate Binders Change in use of binders since KDOQI Calcium load Patients with high Calcium >2.5mmol/l 6.8 Alphacalcidol 6.9 Cinacalcet th patient drug data Dialysate used 6.11 Patient contact with dietetic service 6.12 Drug data recording Discussion of Results Conclusions Recommendations 38 Appendix 1 Appendix 2 Appendix 3 Appendix 4 Glossary of Terms and Abbreviations Audit Plan Data Collection Parameters NW Region Unit Target ranges Version 1.0 February 2011 Page 1

3 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 Version 1.0 February 2011 Page 2

4 EXECUTIVE SUMMARY The total number of patients audited in 2009/2010 was 1703; this is compared to 1670 patients in 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 mmol/l and this percentage has only minimally changed since A slight decrease since 2002 is seen in all the unit results apart from MRI which has increased since 2002 (54.9%) and (6) in 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 mmol/l; this shows a slight improvement from 59.9% from All units improved their phosphate control except Salford Royal Hospital who fell from 66.8% within target in 2002 to 51.7% in 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. Version 1.0 February 2011 Page 3

5 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 There was an increase in patients achieving all 4 KDOQI targets from 1.4% in 2002 to 7% in 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 <4 on calcium free binders at RPH compared to >6 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 5 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 10 at A and COCH to 77% at SRH. Version 1.0 February 2011 Page 4

6 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 1 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 Version 1.0 February 2011 Page 5

7 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): 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): ). 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): 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: 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: 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: Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporosis Int 2005; 16: 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): Zitterman A. Vitamin D in preventive medicine: are we ignoring the evidence? Br J Nutr 2003; 89: Lips Vitamin D Deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev 2001; 22: 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: 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: 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: Version 1.0 February 2011 Page 6

8 4.0 STANDARDS Regional Association Clinical Practice Guidelines. Clinical Practice Guidelines Committee Renal Association Clinical Practice Guidelines 4th Edition 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 mmol 2 /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. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease Phosphate mmol/l Calcium mmol/l Calcium Phosphate Product CAXP should be less than 4.4 ng/l Serum parathyroid hormone ipth concentration in range ng/l Version 1.0 February 2011 Page 7

9 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. For 1 sample of dialysis population A 1 sample of dialysis population was selected by taking every 10 th 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. Version 1.0 February 2011 Page 8

10 6.0 RESULTS SUMMARY 6.1 Demographics The total number of data sets for this audit was 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 6 male to 4 female as shown in Figure 6.2. Figure 6.1: Number of patient data sets for 2002 and 2009 (individual units) A HD COCH MRI - HD MRI - HHD MRI - PD Macclesfield NMGH Tameside Wythenshawe RLH RLH PD Broad green Waterloo Warrington Whiston RPH HD RPH HHD RPH PD Accrington Blackpool Burnley Chorley Furness Kendal SRH HD SRH HHD SRH PD Bolton Rochdale Wigan A AP MRI RLH RPH SRH No. of patients (2002) No. of patients (2009) Figure 6.2: Gender split (2009) Females Males A COCH MRI RPH SRH Region Version 1.0 February 2011 Page 9

11 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) A COCH MRI RPH SRH Region White Asian Black Chinese Mixed Other Not stated Diabetic status Regionally just over 3 of dialysis patients are diabetic (Figure 6.4). There is some variation between the units with 27% at MRI and up to 4 at A and COCH (this may reflect differences in methods of recording this data). Figure 6.4: Diabetic status of patients (2009) A COCH MRI RPH SRH Region Diabetes No diabetes Unknown Version 1.0 February 2011 Page 10

12 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) 16% 14% 12% 1 8% 6% 4% 2% MRI RPH SRH Region 6.2 Serum Calcium (corrected for albumin) 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 Version 1.0 February 2011 Page 11

13 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 ( mmol/L) for regional units A COCH MRI RPH SRH Region No. of patients with calcium < 2.2 No. within guideline range of No. of patients with calcium >2.5 Figure 6.7: Graph showing percentage of patient within RA guideline range for calcium ( mmol/L) ( individual units) A COCH 130 MRI 3 Macclesfield 4 NMGH 14 Tameside Wythenshawe RPH 9 Accrington 22 Blackpool 14 Burnley 24 Chorley 0 Furness 5 Kendal 90 SRH 9 6 Bolton Rochdale 22 Wigan 433 Region E,W & NI (2008) A AP MRI RPH SRH No. of patients w ith calcium < 2.2 No. w ithin guideline range of No. of patients w ith calcium >2.5 Version 1.0 February 2011 Page 12

14 Figure 6.8: Graph showing percentage of patients within range for calcium ( mmol/L) for individual units. Chart 2 % patients within standrd for Ca A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region KDOQI standard for Calcium Regionally over 5 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 mmol/l % of patients reaching KDOQI guideline mmol/l A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region Version 1.0 February 2011 Page 13

15 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 A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region Percentage within guideline range of (2009) % of patients reaching KDOQI guideline mmol/l 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 (6) in 2009 (Figure 6.11) Regionally, the proportion of HD/HHD patients meeting the 2002 RA standard increased between 2000 (6) 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 mmol/L to mmol/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 (6), SRH (6 to 77% between 2000 and 2002 but reduced again in 2009/ %). Version 1.0 February 2011 Page 14

16 Figure 6.11: Graph showing percentage of patients meeting RA standard for corrected calcium in 2002 and MRI RPH SRH Region Figure 6.12 Percentage of patients within normal calcium range for individual units A ( ) COCH ( ) MRI ( ) RPH ( SRH ( mmol/L) Region 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 mmol/l (Figure 6.13) apart from Furness which is just over the target at 2.56 mmol/l. Version 1.0 February 2011 Page 15

17 Figure 6.13: Median corrected calcium in dialysis patients (2009) Calcium (Lowest) Calcium Highest) Median Calcium A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region 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 All PD All HD + HHD ALL REGION E,W & NI (2008) HD E,W &NI (2008) PD Calcium (Lowest) Calcium Highest) Median Calcium Version 1.0 February 2011 Page 16

18 6.3 Phosphate 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 (10) 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 A COCH MRI RPH SRH Region Figure 6.16: Percentage reaching RA standard for phosphate 1.1 to 1.8 mmol/l (individual units A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region Version 1.0 February 2011 Page 17

19 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) Aintree Arrowe MRI RPH SRH Region MRI RPH SRH Region Haemodialysis Patients Peritoneal Dialysis Patients Percentage patients to 1.8 (2000) Percentage patients to 1.8 (2002) % of patients to 1.8 (2009) 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). Version 1.0 February 2011 Page 18

20 Figure 6.18: Percentage of patients achieving target for phosphate in 2002 and A COCH MRI RPH SRH Region Percentage patients to 1.8 (2002) % of patients to 1.8 (2009) 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) A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region Version 1.0 February 2011 Page 19

21 Figure 6.20: Median phosphate for PD, HD, all NW Region (2009) compared to Renal Registry (2008) data for HD and PD patients 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 A AP MRI RPH SRH Region Percentage patients below target (4.8) Percentageof patients above 4.8 Percentage of patients below 4.2 Version 1.0 February 2011 Page 20

22 6.5 Parathyroid hormone and incidence of parathyroidectomy 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 5 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 Abbott architect Bolton Advia centaur Blackpool Beckman Immulite Roche Chester (AP) Tameside A Accrington Burnley Macclesfield Chorley Furness Kendal MRI NMGH Rochdale RPH SRH Wigan Percentage of patients 2x - 4x Wythenshawe Version 1.0 February 2011 Page 21

23 Figure 6.22 : - 9x, >9x Graph showing percentages of patients within ipth ranges <2x, 2x - 4x, 4x A COCH MRI RPH SRH Region 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) 5 45% 4 35% 3 25% 2 15% 1 5% A COCH MRI Macclesfield NMGH Tameside Wythenshawe RPH Accrington Blackpool Burnley Chorley Furness Kendal SRH Bolton Rochdale Wigan Region 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 (33%) 2002 (33%) 2009 (26.1%) Version 1.0 February 2011 Page 22

24 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 pgm/ml (pg/ml x = 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 pgm/ml (pg/ml x = pmol/l). Figure 6.24: Median PTH for NW Region Units 2009/ A COCH MRI RPH SRH Region 1st Quartile Upper Quartile ipth Median Figure 6.25: Median ipth for individual NW Region units st Quartile Upper Quartile ipth Median Version 1.0 February 2011 Page 23

25 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 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 A COCH MRI RLH RPH SRH Region % of patients with parathryoidectomy (2002) % of patients with parathryoidectomy (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 The main difference is the percentage reaching ipth targets where there has been a significant decrease since 2002 (72% to 26%). Version 1.0 February 2011 Page 24

26 Figure 6.27: Percentage of patients meeting Renal Association targets 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 Calcium Phosphate ipth Calcium Phosphate product Percentage reaching target (2002) Percentage reaching target (2009) All four 6.7 Phosphate binders Regionally the most commonly prescribed binder is sevelamer hydrochoride (33.1%); more or less equal amounts of calcium carbonate (24%), calcium acetate (2) and lanthanum carbonate (2) are prescribed and very little aluminium hydroxide (0.9%) (Figure 6.29). Version 1.0 February 2011 Page 25

27 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 Percentage of patients reaching RA Target for phosphate 67% 6 59% 67% 54% 61% A COCH MRI RPH SRH Region % 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) 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 Regionally 60.3% were prescribed binders in 2000, 61.5% in 2002 and 80.7% prescribed binders in Version 1.0 February 2011 Page 26

28 Figure 6.30: Change in use of phosphate binders (2000, 2002 and 2009) 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) 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. Version 1.0 February 2011 Page 27

29 Figure 6.32: Change in use of calcium acetate (2002 to 2009) 4 35% 3 25% 2 15% 1 5% 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 % 4 35% 3 25% 2 15% 1 5% 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 5 use of Aluminium and the drop in the regional average may be accounted by this. Version 1.0 February 2011 Page 28

30 Figure 6.34: Percentage of patients on aluminium hydroxide 2009 and % 2 15% 1 5% MRI RPH SRH Region Patients on aluminium hydroxide (2002) % Patients on aluminium hydroxide (2009) 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 A COCH MRI RPH SRH Region Patients with calcium load <1.5 Patients with calcium load >1.5 Version 1.0 February 2011 Page 29

31 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) 25% percentage on a calcium binder (calcium carbonate/calcium acetate) 2 32% 15% 1 5% 16% 46% 36% 16% 31% A COCH MRI RPH SRH Region Patients with low calcium <2.2 mmol/l Figure 6.37: Percentage of patients with low Calcium and high phosphate NOT prescribed a binder. 3 25% 2 15% 1 5% A COCH MRI RPH SRH Region Version 1.0 February 2011 Page 30

32 6.8 Alphacalcidol Figure 6.38: Patients with ipth <2x prescribed Vitamin D A COCH MRI RPH SRH Region Figure 6.39: Patients with ipth >4x prescribed Vitamin D A COCH MRI RPH SRH Region Version 1.0 February 2011 Page 31

33 6.9 Cinacalcet Figure 6.40: Percentage of patients receiving/not receiving cinacalcet (2009) 18% 16% % 12% 1 8% 6% 4% % A COCH MRI RPH SRH Region th patient data Dialysate used Figure 6.41: Percentage concentration of calcium in dialysate used for patient subset Unknown Unknown HD Patients PD Patients Calcium concentration A COCH MRI RPH SRH Version 1.0 February 2011 Page 32

34 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 10 and the lowest at SRH with 77%). There are no figures to compare with in Figure 6.42: Number of patients seen by a dietitian in past six months (2009 data) % seen in past six months (2009) % 79% 77% 81% A COCH MRI RPH SRH Region 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 A COCH MRI - HD MRI - HHD MRI - PD Macclesfield NMGH Tameside Wythenshawe RPH HD RPH PD Accringto Blackpool Burnley Chorley Kendal SRH HD SRH HHD SRH PD Bolton Rochdale Wigan Region Version 1.0 February 2011 Page 33

35 Figure 6.44: Reason for referral of 10 th patient subset to dietitian A COCH MRI RPH SRH Region 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 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 Version 1.0 February 2011 Page 34

36 Figure 6.45: Graph showing the number of prescriptions for drugs between GP and hospital records No. prescribed Alfacalcidol (H) No. prescribed Alfacalcidol GP) No. prescribed Cinacalcet (H) 7 6 No. prescribed Cinacalcet (GP) No. prescribed (H) No. prescribed (GP) No. prescribed (H) No. prescribed (GP) No. prescribed (H) No. prescribed (GP) No. prescribed (H) No. prescribed (GP) No. prescribed (H) 2 2 No. prescribed (GP) Alfacalcidol Cinacalcet Calcium Carbonate binder Calcium Acetate (Phosex) Sevelemar Hydrochloride (Renagel) Lanthanum Carbonate (Fosrenol) Alucaps Version 1.0 February 2011 Page 35

37 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 Serum calcium (corrected for albumin) Serum Phosphate KDOQI mmol/l mmol/l mmol/l mmol/l Calcium Product Phosphate < 5 CAXP should be less than 4.4 ng/l ipth 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 ng/l 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) Serum calcium (corrected for albumin) Percentage achieving Lowest performing units Best performing units target regionally RA KDOQI RA KDOQI RA KDOQI 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 Version 1.0 February 2011 Page 36

38 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 Table 4: Comparison of 2000, 2002 and 2010 data Regional HD/HHD PD Standard Calcium 2000: total calcium within the normal range. 2002: mmol/l 2010: mmol/l Phosphate 2000: < 1.8 mmol/l. 2000: PD patients mmol/l. 2002: < 1.8 mmol/l. 2010: mmol/l. ipth 2000: ipth 2 and 3 times the local normal range ( pg/ml). 2002: ipth concentration: < x4 upper limit of normal of the assay used Calcium Phosphate product 63% 68% 66.9% 6 69% 68.1% 67% 66% 60.9% 56% 59.9% 61.2% 60.7% 60.6% 26.1% 2002: Local guidelines Calcium phosphate product < % 74.1% 89.3% 84.4% 82.4% 2010: All four targets 33% 12% Table 5: Results for 2002 and 2010 related to KDOQI guidelines Regional HD/HHD PD Standard (same 2002/2010) Serum phosphate in range mmol/l 2002: Serum calcium (corrected) in range mmol/l 2002: Parathyroid hormone (ipth) ipth concentration in range ng/l 2002: Ca x PO4 should be less than 4.4 ng/l Percentage meeting all four targets 1.4% 7% 55% 53% 52.9% 51.6% 25% 52.7% 51.6% 58.1% 19% 27.8% 27.1% 31.1% 59% 77% 76.4% 75.4% 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). Version 1.0 February 2011 Page 37

39 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 5 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 Version 1.0 February 2011 Page 38

40 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 Version 1.0 February 2011 Page 39

41 GLOSSARY OF TERMS AND ABBREVIATIONS APPENDIX 1 ACE inhibitors ACR APD ARB BMI BP CABG CAPD CKD CVA CVD DM DOB egfr EPO ESA Fe Hb HD HT IHD MI NICE NSF NWRA PCR PD PTH PTH PVD RA RR Angiotensin-converting enzyme inhibitors Albumin : creatinine ratio Automated Peritoneal Dialysis Angiotensin receptor blocker (antagonist), Body Mass Index Blood Pressure Coronary Artery Bypass Grafting Continuous Ambulatory Peritoneal Dialysis Chronic Kidney Disease Cerebrovascular accident Cardiovascular Disease Diabetes Mellitus Date of Birth estimated Glomerular Filtration Rate Erythropoietin Erythropoietin stimulating agent Iron Haemoglobin Haemodialysis Hypertension Ischaemic Heart Disease Myocardial Infarction National Institute for Health and Clinical Excellence National Service Framework North West Renal Audit Protein : Creatinine ratio Peritoneal Dialysis Parathyroid Hormone Parathyroid Hormone Peripheral Vascular Disease Renal Association 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 Version 1.0 February 2011 Page 40

42 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 REASONS CHOICE Aims & objectives: FOR Regional Renal Audit Co-ordinator 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. Proposed benefits: health For 1 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 assess calcium load To compare dietetic contact between the units 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): 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): ). London GM; Guerin AP; Marchais SJ; Metivier F; Pannier B; Adda H. Arterial Version 1.0 February 2011 Page 41

43 METHODOLOGY media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant 2003 Sep; 18(9): 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: 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: 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: Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporosis Int 2005; 16: Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson- Hughes B. Fracture prevention with vitamin D supplementation: a metaanalysis of randomized controlled trials. JAMA 2005; 293(18): Zitterman A. Vitamin D in preventive medicine: are we ignoring the evidence? Br J Nutr 2003; 89: Lips Vitamin D Deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev 2001; 22: 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: 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: 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: Standards: Regional Association Clinical Practice Guidelines 1 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 mmol 2 /L 2 and ideally below 4.2 mmol 2 /L 2 Version 1.0 February 2011 Page 42