Donald Richardson

Structured Conversion from Thrice Weekly to Weekly Erythropoietic Regimens Using a Computerized Decision-Support System: A Randomized Clinical Study

In view of the recent interest in weekly erythropoietic regimens and the lack of studies directly comparing the available agents, the clinical effectiveness of darbepoetin-alpha (DA) and epoetin-beta (EB), when administered via the subcutaneous route on a weekly basis, after conversion from thrice-weekly subcutaneous EB, was studied. In this 9-mo, single-center, randomized study of an unselected hemodialysis population, anemia was managed with a computerized decision-support system. Per-protocol analysis of the 81 patients in each arm who completed the study showed similar hemoglobin outcomes between treatment arms, both at randomization and at the end of the study. After conversion from thrice-weekly EB to DA (at a ratio of 200 IU:1 microg, at which products are cost-neutral in the European Union), a significant fall in dose from a mean of 0.59 microg/kg per wk after randomization to 0.46 microg/kg per wk in the last month (P = 0.002) was observed; in the comparator arm, the reduction in frequency of administration of EB was associated with a significant dose increase from a mean of 107.5 to 133.2 IU/kg per wk (P = 0.002) during the same period. At hemoglobin stability, mean EB dose was found to be 44% higher than DA dose (when multiplied by 200). Similar significant dose differences were apparent in a modified intention-to-treat analysis. The study demonstrated that, under a decision-support system, both products were capable of adequately maintaining hemoglobin outcome when administered on a weekly basis but with significant dose differences at 9 mo.

A randomized, controlled study of the consequences of hemodialysis membrane composition on erythropoietic response.

BACKGROUND Membrane biocompatibility has long been thought to be relevant to hemodialysis outcomes and, possibly, renal anemia. METHODS We performed a randomized, controlled, single-center study comparing the consequences on renal anemia of 2 dialyzers of equivalent performance, but different composition, during 7 months. Two hundred eleven patients of an unselected dialysis population of 235 patients gave informed consent to undergo random assignment to either group A (SF170E; modified cellulose triacetate/midflux membrane; Nipro, Osaka, Japan) or group B (HF80LS; polysulfone/high-flux membrane; Fresenius, Bad Homburg, Germany). Anemia management was identical in both treatment groups and followed strict clinical protocols managed by computer algorithms. Dialysis adequacy, hemoglobin (Hb) level, ferritin level, percentage of red blood cell hypochromicity, C-reactive protein (CRP) level, and intravenous iron and epoetin doses were monitored monthly. RESULTS One hundred seventy-seven patients completed the 7-month study. Equilibrated Kt/V increased in both groups. Hb outcome improved overall, but did not differ between the 2 study groups. Epoetin dose was not significantly different after 7 months compared with baseline in either group. Hb level, epoetin dose, iron status, CRP level, dialysis Kt/V, and residual renal function did not differ between the 2 groups. A slight but significant negative correlation was identified between dialysis Kt/V and Hb level in the population as a whole (Spearmans correlation, -0.16; P = 0.04). CONCLUSION No significant epoetin-sparing effect was identified through the use of the high-flux polysulfone HF80LS membrane over the modified cellulose triacetate SF170E membrane. Although not a primary outcome for this study, there was a suggestion of benefit of improved Hb level, without increased need for epoetin, through increasing delivered dialysis dose.

Translating knowledge on best practice into improving quality of RRT care: a systematic review of implementation strategies

Recent studies showed wide variation in the extent to which guidelines and other types of best practice have been implemented as part of routine health care. This is also true for the delivery of renal replacement therapy (RRT) for ESRD patients. Increasing uptake of best practice within such complex care systems requires an understanding of implementation strategies and specific quality improvement (QI) techniques. Therefore, we systematically reviewed over 5000 titles published since 1990 and included papers describing planned attempts to accelerate uptake of best RRT practice into daily care. This resulted in a list of 93 QI initiatives, categorized in order to expedite shared learning. The majority of the initiatives were executed within the domains of vascular access, nutrition, and anemia management. Strategies oriented at patients were most common and many initiatives pre-defined an improvement target before starting implementation. Of the 93 initiatives, 22 were sufficiently robust methodologically to be analyzed in more detail. Our results tend to support previous findings that multifaceted strategies are more effective than single strategies. Improving our understanding of how to successfully implement best practice can inform system-level change and is the only way to close the gap between knowledge on what works and the actual care delivered to ESRD patients. Research into implementation, using specific QI techniques, should therefore be given priority in future.

Summary of the 5th Edition of the Renal Association Clinical Practice Guidelines (2009-2012)

Robert Mactier, Simon Davies, Chris Dudley, Paul Harden, Colin Jones, Suren Kanagasundaram, Andrew Lewington, Donald Richardson, Maarten Taal, Peter Andrews Richard Baker, Cormac Breen, Neill Duncan, Ken Farrington, Richard Fluck, Colin Geddes, David Goldsmith, Nic Hoenich, Stephen Holt, Alan Jardine, Sarah Jenkins, Mick Kumwenda, Elizabeth Lindley, Mark MacGregor, Ashraf Mikhail, Edward Sharples, Badi Shrestha, Rajesh Shrivastava, Simon Steddon, Graham Warwick, Martin Wilkie, Graham Woodrow, Mark Wright

UK Renal Registry 11th Annual Report (December 2008): Chapter 9 Haemoglobin, ferritin and erythropoietin amongst patients receiving dialysis in the UK in 2007: national and centre-specific analyses.

Background: The UK Renal Association (RA) and National Institute for Health and Clinical Excellence (NICE) have published Clinical Practice Guidelines which include recommendations for management of anaemia in established renal failure. Aims: To determine the extent to which the guidelines for anaemia management are met in the UK. Methods: Quarterly data (haemoglobin (Hb) and factors that influence Hb) extracts from renal centres in England, Wales and Northern Ireland (EWNI), and annual data from the Scottish Renal Registry for incident and prevalent renal replacement therapy (RRT) cohorts for 2007 were analysed by the UK Renal Registry (UKRR). Results: In the UK, in 2007 58% of patients commenced dialysis therapy with Hb ≥ 10.0 g/dl (median Hb 10.3 g/dl). Of incident patients 81% and 87% had a Hb ≥ 10.0 g/dl by 3 and 6 months of dialysis treatment respectively. The median Hb of haemodialysis (HD) patients was 11.6 g/dl with an interquartile range (IQR) of 10.6–12.6 g/dl. Of HD patients 86% had a Hb ≥ 10.0 g/dl. The median Hb of peritoneal dialysis (PD) patients in the UK was 11.9 g/dl (IQR 11.0–12.8 g/dl). 91% of UK PD patients had a Hb ≥ 10.0 g/dl. The median ferritin in HD patients in EWNI was 417 mg/L (IQR 270–598) and 95% of HD patients had a ferritin ≥ 100 mg/L. The median ferritin in PD patients was 255 mg/L (IQR 143–411) with 85% of PD patients having a ferritin ≥ 100 mg/L. In EWNI the mean ESA dose was higher for HD than PD patients (9,300 vs. 6,100 IU/week). Conclusions: This year for the first time there has been a small fall (from 85.9% in 2006 to 85.6%) in the percentage of HD patients with an Hb of ≥ 10 g/dl. This contrasts with previous annual improvements in this figure and is related to implementation of the new Hb Standard which has a target range of 10.5–12.5 g/dl.

Dialysis in Non-Renal Organ (Liver) Transplantation

The renal management of acute hepatic failure and liver transplantation requires an understanding of the features of liver failure and the causes of liver graft dysfunction. The management of any underlying pathology in addition to supportive care is fundamental to successful management and a return to independent renal function. These issues are discussed particularly in relationship to a case history involving a patient presenting with acute fulminant liver failure secondary to a paracetamol overdose who was successfully treated by liver transplantation and continuous veno-venous haemodiafiltration. The liver can be successfully transplanted but acute renal failure is a severe complication post-transplantation. Its appearance can be predicted in patients with pre-transplant renal dysfunction, severe graft dysfunction, or both. It may be avoided through careful selection of transplant recipients and correct timing of transplantation. Prevention of renal failure, appropriate patient selection for transplantation and timely procurement of a donor organ are vital for best use of limited donor resources. Treatment success depends on patient and donor selection, skilled surgeons, careful post-operative care, and successful immunosuppression.

Renal Association Clinical Practice Guideline on Anaemia of Chronic Kidney Disease

This clinical practice guideline provides recommendations on the management of anaemia of chronic kidney disease (CKD) and serves as an update of the 4th edition module published online in 2007. The recommendations in this update have been graded using the modified GRADE system to indicate both the strength of each recommendation (strong or weak) and level of evidence for the recommendation (A–D) [1, 2]. As in the previous module The Renal Association (RA) endorses the NICE Guidelines for Anaemia Management in Chronic Kidney Disease (CKD) 2006 [3]. These guidelines are an updated version of the previous ‘Complications of CKD Guidelines – Anaemia Section’. For this updated version, a systematic literature review was performed using MEDLINE & PUBMED, focusing on the topics of:

Appendix D: Methodology used for Analyses of PCT/ Local Authority Incidence and Prevalence Rates and of Standardised Ratios

The areas used were the 148 English primary care trusts (PCTs), the 4 English care trusts, the 22 Welsh local authorities, the 32 Scottish council areas and the 26 Northern Ireland district council areas – these different types of area are collectively called PCT/LAs here. In Northern Ireland, Scotland and Wales, the health authority boundaries align with the LAs and these areas have been included along with the English PCTs in the tables.

Appendix E: Additional Data Tables for 2008 new and existing patients

Abrdn 85 15 L Rfree 84 11 4 Airdrie 92 8 L St.G 62 18 20 Antrim 90 10 LWest 86 4 9 B Heart 84 14 2 Leeds 69 20 11 B QEH 73 23 4 Leic 79 10 12 Bangor 86 14 Liv Ain 98 2 Basldn 83 18 Liv RI 66 27 7 Belfast 84 12 4 M Hope 46 46 7 Bradfd 85 15 M RI 71 16 13 Brightn 66 33 1 Middlbr 80 13 8 Bristol 75 19 6 Newc 72 22 6 Camb 87 10 3 Newry 85 15 Cardff 78 15 7 Norwch 79 15 5 Carlis 74 23 3 Nottm 73 22 5 Carsh 85 14 1 Oxford 62 27 12 Chelms 73 27 Plymth 56 26 19 Clwyd 92 8 Ports 68 24 8 Colchr 100 Prestn 74 20 6 Covnt 74 19 6 Redng 70 25 5 Table E.1.2. Number of patients per treatment modality at 90 days

UK Renal Registry 11th Annual Report (December 2008): Appendix D Methodology used for analyses of PCT incidence and prevalence rates and of standardised ratios

The areas used were the 152 (English) Primary Care Trusts (PCTs), the 22 Welsh local health boards, the 32 Scottish council areas and the 26 Northern Ireland district council areas – these different types of area are collectively called PCTs here. Prior to 2007, only some of the boundaries of PCTs and Local Authorities (LAs) in England were similar. There were roughly twice as many PCTs as LAs and the registry reports published analyses by LA in the main report and prevalence rates by PCT as an appendix. In October 2006, the Office for National Statistics reduced the number of PCTs and re-aligned many of the PCT boundaries in England with those of Local Authorities. As a result, in the 2008 Report these analyses will be presented by PCT (not LA). For data for years before the boundaries changed, patients are allocated to the new PCTs as they are now. In Northern Ireland, Scotland and Wales, the Health Authority boundaries align with the LAs and these areas have been included along with the English PCTs in the tables.