A short cultural history of the UK Renal Registry 1995-2020.

The Renal Association UK Renal Registry (UKRR), established in 1995, has reflected the development of Nephrology within the NHS over 25 years. It has been gradually enlarged to provide a formal agency for a range of consensus initiatives. It remains the source of the national epidemiology of renal replacement, feeding NHS infrastructures and Health Services Research. An extension into acute and chronic kidney disorders is in hand. As a template for medical audit it has contributed to a quality improvement ethos derived from several methodologies. It now offers a multifaceted virtual platform for special interest groups and patient-centricity. Its transformation demonstrates one of the compromises that have permitted specialty development within the inconstant envelope of the NHS.If not always a bellwether, the clarity, form and scale of kidney disease provision still qualifies the UKRR as a demonstrator of healthcare possibilities to Medicine, Clinical Informatics and the NHS.

Use of 12x/month haemoglobin monitoring with a computer algorithm reduces haemoglobin variability.

BACKGROUND: Haemoglobin variability may be associated with increased death. Frequent haemoglobin monitoring may allow earlier detection of trends in haemoglobin slopes, alerting staff to intercurrent events. The more frequent haemoglobin values may provide early evidence of response to erythropoietin (EPO) doses, and allow more appropriate anaemia management. Our objective is to assess whether frequent haemoglobin monitoring data (12x/month) using a computer algorithm (AMIE, Leeds, UK) will reduce haemoglobin variability compared with 1x/month monitoring. METHODS: We performed an observational case-control study of 44 unselected patients, comprising one dialysis facility measuring Crit-Line haemoglobin, lab haemoglobin, standard deviation of residuals as surrogate of haemoglobin variability and EPO dosing. RESULTS: Haemoglobin variability and 'percent in target haemoglobin range' significantly improved with 12x/month haemoglobin results using a computer algorithm. There was also a non-significant trend toward for lower EPO doses. CONCLUSION: Use of a computer algorithm to analyse 12x/month haemoglobin values provides early evidence of haemoglobin trends and allows more appropriate anaemia management, with decreased haemoglobin variability, lower EPO doses and more patients achieving target haemoglobin.

A comparison of methods for determining urea distribution volume for routine use in on-line monitoring of haemodialysis adequacy.

BACKGROUND: The availability of haemodialysis machines equipped with on-line clearance monitoring (OCM) allows frequent assessment of dialysis efficiency and adequacy without the need for blood samples. Accurate estimation of the urea distribution volume 'V' is required for Kt/V calculated from OCM to be consistent with conventional blood sample-based methods. METHODS: Ten stable HD patients were monitored monthly for 6 months. Time-averaged OCM clearance (K(OCM)) and pre- and post-dialysis blood samples were collected at each monitored session. The second generation Daugirdas formula was used to calculate the single-pool variable volume Kt/V, (Kt/V)(D). Values of V to allow comparison between OCM and blood-based Kt/V were determined from Watson's formula (V(Watson)), bioimpedance spectroscopy (V(BIS)), classical urea kinetic modelling (V(UKM_C)) and a simple computation of V (V(UKM_S)) from the blood-based Kt/V and K(OCM)t. RESULTS: Comparison of K(OCM)t/V with (Kt/V)(D) shows that using V(Watson) leads to significant systematic underestimation of dialysis dose. K(OCM)t/V(BIS) agrees with (Kt/V)(D) to within +/- 10%. K(OCM)t/V(UKM_S) is, by definition, identical to (Kt/V)(D) when initially calculated. However, if a historical value of V is used, agreement between K(OCM)t/V and (Kt/V)(D) over 6 months varies by 5% for V(BIS) and 10% for V(UKM_S). CONCLUSIONS: When investigating the effect of different treatment strategies on dialysis efficiency, any estimate of V can be used provided it is constant, as K is the relevant parameter. When frequent supervision of actual dialysis dose is required, the greatest consistency between K(OCM)t/V and the reference, Kt/V(D), over time is achieved with V(BIS).

Functional data analysis applied to a randomized controlled clinical trial in hemodialysis patients describes the variability of patient responses in the control of renal anemia.

The achievement of desirable hemoglobin levels in renal anemia that is treated with epoetins is often incomplete and subject to much variation of outcome values and applied dosage. The further development of clinical decision support for renal anemia requires the characterization of patient responses and an analysis of the dynamics of the dosage and response variables. In this methodologic article, the extended data of a randomized, controlled clinical trial comparing two epoetins were examined by the techniques of functional data analysis to establish how precisely the patterns of treatment response might be described and analyzed. The description of the trajectory of hemoglobin values in each patient as a mathematical function allowed the characterization of individual responses, with a wide variety of patterns being revealed. An analysis of the degree of system control in the management of the anemia was then possible through phase plotting. The analysis also allowed an expression of the dynamic characteristics of the entire experimental system, analyzed in summary group waveforms with standard statistical properties. In addition, a quantification of the notional instability of patient responses enabled the determination of a subset of patients for whom control might be improved in a modified management system. It is concluded that functional data analysis does provide the basis for further characterization and experimental study of the control of renal anemia.

Development and exploitation of a clinical decision support system for the management of renal anaemia.

The management of renal disease and its comorbidities lends itself to the use of computer-assisted decision support systems (CDSS); however, several issues with regard to computer-based treatment algorithms remain unresolved. This review examines the development and application of a clinical decision support system for the management of renal anaemia. Studies illustrate the dependence of outcome on prespecified haemoglobin (Hb) intervention values (thresholds) and the use of a computer program containing treatment algorithms to manage Epoetin doses and iron supplements. Early experimental studies and randomized, controlled studies are discussed that examine the use of clinical measures of haemodialysis (HD) and peritoneal dialysis (PD), including Hb, serum ferritin and red cell hypochromia or transferrin saturation. Broad flexibility of erythropoietic agent, dosing, route of administration and frequency has been built into computer programs written for clinical and experimental application. While further studies with the system are anticipated, predictability and sustainability of Hb outcomes and a capacity to manage large patient groups have been demonstrated and wider application appears promising.

Renal registries in the era of guidelines, standards and quality improvement. One view from the UK Renal Registry experience.

Over the past decade the UK Renal Registry has rehearsed the collection, analysis and presentation of a range of laboratory, as well as demographic, data from an increasing number of renal units. This has been accomplished by fully electronic means. The normalisation of disparate laboratory results to allow comparative audit remains a problem. The exercise has allowed a largely passive and intuitive exploration of the role that such data aggregation can play in a modern clinical context that is influenced by the Evidence Based Medicine movement and the development of Clinical Practice Guidelines, Standards and Clinical Performance Measures. To extend the data collection to clinical variables from these unselected patient groups, in order to explain as well as to describe clinical activity, is attractive but appears yet more challenging. These experiences can be used perhaps by the nephrological community to inform the further development of similar proposals in Europe, especially the concepts and structures required to link such information to the prospect of real clinical benefit.

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.

Patient-specific prompts in the cholesterol management of renal transplant outpatients: results and analysis of underperformance.

BACKGROUND: Renal transplant recipients have an increased risk of cardiovascular disease compared with age- and gender-matched controls. It is recommended that "high-risk" patients are treated with hydroxymethylglutaryl CoA reductase inhibitors to reduce cholesterol levels. METHOD: We evaluated the effect of a computer-based decision support algorithm in delivering patient-specific prompts to manage cholesterol in renal transplant outpatients. Data were analyzed retrospectively for a 2-year period with attention to changes in cholesterol levels, prescribing patterns of statins, and causes of underperformance. RESULTS: At baseline, 36.7% of patients achieved a total serum cholesterol level less than 5.0 mmol/L, compared with 67.2% at 2 years, with mean values of 5.6+/-0.1 mmol/L and 4.8+/-0.1 mmol/L (P<0.0001). At baseline, 24% of the patients were receiving statin therapy, increasing to 61% at 2 years. There were no significant changes in creatinine phosphokinase, trough cyclosporine levels, or total cyclosporine dose. Alkaline phosphatase levels increased (166.1+/-3.6-184.6+/-6.1 mmol/L, P=0.009), but remained within the normal clinical range; creatinine clearance increased (58.6+/-1.0-61.0+/-1.2 mL/min, P=0.05). For patients followed concurrently in two units without the algorithm, serum cholesterol measurements decreased from 5.57 mmol/L and 5.34 mmol/L to 5.31 mmol/L and 5.27 mmol/L, respectively (P=0.05), both higher than that achieved contemporaneously at St. James's. Underperformance depended less on medical noncompliance than with systematic features of the methodology and patient preference/collaboration with treatment. CONCLUSIONS: The introduction of the algorithm coincided with a significant reduction in cholesterol levels, an increase in the number of patients receiving appropriate therapy, and no serious adverse effects. Our results illustrate the positive effect of computer-generated prompts and decision support software.

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 (Spearman's 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.