European Renal Best Practice Research Articles

Bridging the gap between what is known and what we do in renal medicine: improving implementability of the European Renal Best Practice guidelines

The increasing volume of evidence on how to treat kidney patients makes it difficult for nephrologists and renal nurses to keep up-to-date. This potentially widens the gap between what is known about best practice and how daily renal care is provided. Rigorously developed clinical practice guidelines can be important tools to bridge this gap. However, just developing and publishing guidelines does not ensure their use in actual practice. In this paper, we distinguish and illustrate three types of modifiable factors (i.e. barriers) that potentially impede renal healthcare professionals to provide care according to the guidelines: barriers related to knowledge, to attitudes and to behaviour. European Renal Best Practice (ERBP) produces guidelines for care of kidney patients in Europe and neighbouring regions. To facilitate implementation of its guidelines, ERBP aims to optimize 'guideline implementability', which regards the intrinsic characteristics of guidelines (i.e. format and content). The last section of this paper describes some of the associated ERBP activities, which are planned or pending.

A European Renal Best Practice (ERBP) position statement on the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines on Acute Kidney Injury: part 2: renal replacement therapy

This paper provides an endorsement of the KDIGO guideline on acute kidney injury; more specifically, on the part that concerns renal replacement therapy. New evidence that has emerged since the publication of the KDIGO guideline was taken into account, and the guideline is commented on from a European perspective. Advice is given on when to start and stop renal replacement therapy in acute kidney injury; which modalities should be preferentially be applied, and in which conditions; how to gain access to circulation; how to measure adequacy; and which dose can be recommended.

European Renal Best Practice (ERBP) Guideline development methodology: towards the best possible guidelines

The prime mission of European Renal Best Practice (ERBP) is to improve the outcome of patients with kidney disease in a sustainable way through enhancing the availability of the knowledge on the management of these patients in a format that stimulates its use in clinical practice in Europe. A key activity is to produce clinical practice guidelines to help clinicians make the healthcare decisions they face. To further improve the quality and validity of its clinical practice guidelines, ERBP has revised its guideline development process. The present document outlines the principles of ERBP's 10-step approach. Important features include standard procedures for selecting topics, for assembling the guideline development group, for choosing and formulating questions, for finding, appraising and summarizing the evidence, for generating recommendations, for preparing reports and organizing peer review. ERBP has adopted the Grading of Recommendations Assessment, Development and Evaluation system for rating the quality of the evidence and strength of recommendations and has addressed implementation in the development process by integrating the GuideLine Implementability Appraisal tool. Ultimately, it is anticipated that these changes will not only further improve the quality of the guideline development process, but also enhance the quality of care and improve outcomes of patients with kidney disease across Europe.

A European Renal Best Practice (ERBP) position statement on the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Blood Pressure in Non-dialysis-dependent Chronic Kidney Disease: an endorsement with some caveats for real-life application

Developing guidelines on a subject as broad as hypertension is difficult, especially when the guidance relates to hypertension in the chronic kidney disease (CKD) population. The Kidney Disease: Improving Global Outcomes Guideline Development Group has applied a rigorous methodology in reviewing all available evidence, and their recommendations are consistent with the evidence-based approach. As a result, the European Renal Best Practice endorses most of its recommendations. However, the Work Group feels that some additional advice could help clinicians in daily practice: (i) individualization of treatment should be taken into account, especially (cardiovascular) co-morbidities, age, gender and race; (ii) side-effects, such as postural dizziness should be monitored closely, particularly in elderly, diabetics and patients with arterial stiffness; (iii) the importance of salt restriction should not be neglected; (iv) although angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blocker (ARBs) remain a cornerstone in the management of hypertension, and especially cardiovascular protection, in some particular situations such as in advanced CKD and in patients without proteinuria, their role is less well defined; (v) as most CKD patients need more than one antihypertensive drug to achieve blood pressure control, the specific (renal) (dis)advantages of other classes than ACE-I or ARB should be taken into account.

Health economics and European Renal Best Practice—is it time to bring health economics into evidence-based guideline production in Europe?

Medical management of patients with kidney disease is complex and resource intensive. In times of limited health care budgets, economic evaluations have become more important over the past few years in identifying interventions with a beneficial cost-effectiveness to maximize the benefits served from the available resources. However, integrating evidence from health-economic evaluations into clinical practice guidelines remains a challenge. European Renal Best Practice (ERBP), the official guideline body of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) herewith presents some lines of thought that need consideration in the discussion on incorporating health-economic considerations into clinical guideline development.

What guidelines should or should not be: implications for guideline production

European Renal Best Practice (ERBP) is the official guidance-providing body of the European Renal Association-European Dialysis and Transplant Association. This paper introduces the mission statement of ERBP, and provides insight on what this implies for guideline production. We will discuss that improving patient outcome does not only require attention to high-quality evidence, but also understanding of the processes of medical decision making. We will advocate that rigorous methodology is the cornerstone of guideline production, but in those cases where this does not retrieve quality evidence, consensus-based guidance might be suitable. Based on its mission statement, ERBP advocates that guidelines should encourage shared decision making.

A European Renal Best Practice (ERBP) position statement on the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines on Acute Kidney Injury: Part 1: definitions, conservative management and contrast-induced nephropathy

The broad clinical syndrome of acute kidney injury (AKI) encompasses various aetiologies, including specific kidney diseases (e.g. acute interstitial nephritis), non-specific conditions (e.g. renal ischaemia) as well as extrarenal pathology (e.g. post-renal obstruction). AKI is a serious condition that affects kidney structure and function acutely, but also in the long term. Recent epidemiological evidence supports the notion that even mild, reversible AKI conveys the risk of persistent tissue damage, and severe AKI can be accompanied by an irreversible decline of kidney function and progression to end-stage kidney failure [1–3]. The Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for AKI [4] were designed to systematically compile information on this topic by experts in the field. These guidelines are based on the systematic review of relevant trials published before February 2011. Nevertheless, for many sections of the guidelines, appropriate supporting evidence is lacking in the literature. As a consequence, variations in practice will inevitably occur when clinicians take into account the needs of individual patients, available resources and limitations unique to a region, an institution or type of practice. Therefore, in line with its philosophy [5], the European Renal Best Practice (ERBP) wanted to issue a position statement on these guidelines. A working group was established to produce guidance from the European nephrology perspective, based on the compiled evidence as presented, with an update of the literature up to March 2012, following the methodology as explained in the ERBP instructions to authors [6]. The present document will deal with the diagnosis and prevention of AKI, and contrast-induced nephropathy (CIN) (Sections 1–4 of the KDIGO document), and other chapters will be discussed in a separate position statement. As a general rule, we will only mention those guideline statements of the KDIGO document that we have amended, even when the change is small. If a KDIGO recommendation is not repeated, it can be considered as endorsed by ERBP as is, unless specifically stated otherwise.

Antidepressants for depression in stage 3–5 chronic kidney disease: a systematic review of pharmacokinetics, efficacy and safety with recommendations by European Renal Best Practice (ERBP)*

The prevalence of major depression in stage 5 chronic kidney disease (CKD) varies between 14 and 30%. Patients with CKD who are depressed have a worse quality of life, are hospitalized more often and die sooner than those who are not depressed. Antidepressant drugs are effective in the general population, but whether they improve outcomes in CKD is uncertain. Drug pharmacokinetics are altered in CKD, which may necessitate dose adjustment. We aimed to systematically review available evidence of the pharmacokinetics, efficacy and safety of antidepressant drugs when used in patients with CKD3 to CKD5 (CKD3-5). This is a systematic review of randomized clinical trials and observational studies examining antidepressants in patients with CKD3-5, regardless of whether or not patients are on dialysis. Through comprehensive searches of seven databases, we identified all studies examining pharmacokinetic properties or clinical outcomes in patients with CKD3-5. One author assessed studies for eligibility and quality and extracted all data. Antidepressant drugs were the studied intervention. The main outcomes were pharmacokinetic parameters, clinical outcomes such as response to treatment, reduction in depression severity and adverse events. We identified 28 studies evaluating pharmacokinetic parameters in CKD for 24 antidepressants. Sparse and heterogeneous data precluded informative meta-analysis. Drug clearance in CKD3-5 was markedly reduced for selegiline, amitriptylinoxide, venlafaxine, desvenlafaxine, milnacipran, bupropion, reboxetine and tianeptine. We identified one randomized controlled trial (RCT) in 14 patients on haemodialysis for fluoxetine versus placebo which showed no difference for efficacy and safety measures. One other RCT of escitalopram versus placebo in 62 patients on haemodialysis provided no efficacy data. There were nine non-randomized trials, all suggesting benefit for the antidepressant under investigation. Side-effects were common, but mild in most patients. The limitations of this review include the scarcity of randomized trial data, the small size of the observational studies and possibility of publication bias. In addition, study selection and data extraction were done by one reviewer only, increasing the risk for errors made in handling of the data. Dose reduction in CKD3-5 is necessary for selegiline, amitriptylinoxide, venlafaxine, desvenlafaxine, milnacipran, bupropion, reboxetine and tianeptine. The evidence on effectiveness of antidepressants versus placebo in patients with CKD3-5, and with the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)-defined depression is insufficient, and in view of the high prevalence, a well-designed RCT is greatly needed.

The pharmacokinetics of antidepressants for depression in stage 3 to 5 chronic kidney disease: A systematic review by European Renal Best Practice (ERBP)

The pharmacokinetics of antidepressants for depression in stage 3 to 5 chronic kidney disease: A systematic review by European Renal Best Practice (ERBP)

Endorsement of the Kidney Disease Improving Global Outcomes (KDIGO) guidelines on kidney transplantation: a European Renal Best Practice (ERBP) position statement

KDIGO (Kidney Disease: Improving Global Outcomes) is an international independent body aiming to 'improve the care and outcomes of kidney disease patients worldwide, through the development and implementation of clinical practice guidelines'. Recently, the KDIGO work group has produced comprehensive clinical practice guidelines for the care of kidney transplant recipients (KTRs). The guideline makes recommendations for immunosuppression, graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy and other complications that are common in KTRs, including haematological and bone disorders. Because most guidelines were 'soft' rather than 'strong', and because global guidelines need to be adapted and implemented into the regional context where they are used, the European Renal Best Practice (ERBP) Advisory Board appointed a work group of transplant nephrologists and surgeons to review the newest KDIGO guideline and comment on its relevance and applicability for European KTRs. In this article, we concentrate only on those guidelines which we considered worth amending or adapting. All guidelines not mentioned are fully endorsed.

When to start dialysis: updated guidance following publication of the Initiating Dialysis Early and Late (IDEAL) study

This position statement is intended to be used in conjunction with the original 2002 European guideline on when to start dialysis [1]. The original guideline was based on a formal review of all evidence available at the time. The position statement considers mainly the results of the Initiating Dialysis Early and Late (IDEAL) study [2], but it also considers other relevant studies published since 2002. A formal literature review was not undertaken. The position statement has been prepared by a working group whose members were nominated by the European Renal Best Practice (ERBP) advisory board.

Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to Reduce Cardiovascular Events with Aranesp(R) Therapy (TREAT) Study

The European Renal Best Practice (ERBP), which are issued by ERA-EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations. In 2009, the Anaemia Working Group of ERBP published its first position statement about the haemoglobin target to aim for with erythropoietin-stimulating agents (ESA) and on issues that were not covered by K-DOQI in 2006-07. This second position paper of the group follows the publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Study. This multi-centre, placebo-controlled trial compared cardiovascular and renal outcomes in 4038 patients with type 2 diabetes, chronic kidney disease not on dialysis, and anaemia who were randomized to complete anaemia correction (haemoglobin target of 13 g/dL using darbepoetin alpha) or placebo (with a haemoglobin rescue value of 9 g/dL). Following the findings of the TREAT study, the Anaemia Working Group of ERBP maintains its view that 'Hb values of 11-12 g/dL should be generally sought in the CKD population without intentionally exceeding 13 g/dL' and that the doses of ESA therapy to achieve the target haemoglobin should also be considered. More caution is suggested when treating anaemia with ESA therapy in patients with type 2 diabetes not undergoing dialysis (and probably in diabetics at all CKD stages). In those with ischaemic heart disease or with a previous history of stroke, possible benefits should be weighed up against an increased risk of stroke recurrence, when deciding which Hb level to aim for. These recommendations are not intended to represent a new guideline as they are not the result of a systematic review of the evidence.

Diagnosis, prevention and treatment of haemodialysis catheter-related bloodstream infections (CRBSI): a position statement of European Renal Best Practice (ERBP).

Nephrology Section, Department of Internal Medicine, University Hospital, Gent, Belgium, Nephrology, Dialysis and Intensive Care Unit, Lapeyronie University Hospital, Montpellier, France, Department of Renal Medicine, Royal Derby Hospital, Derby, UK, Nephrology, Cliniques Universitaires Saint-Luc, Universite Catholique de Louvain, Brussels, Belgium, Nephrology Department, Consorcio Hospital General Universitario, Valencia, Spain and Vascular Surgery, Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands

Educating end-stage renal disease patients on dialysis modality selection: clinical advice from the European Renal Best Practice (ERBP) Advisory Board

Nephrology Clinic, ‘Dr. C. I. Parhon’ University Hospital, Iasi, Romania, Department of Nephrology and Renal Transplantation, University Hospitals, Leuven, Belgium, Nephrology Department, CHU Clemenceau, Caen, France, Department of Clinical Science, Karolinska Institute, Stockholm, Sweden, Renal Division, University Hospital, Ghent, Belgium and Department of Nephrology, ‘E. Herriot’ Hospital, Lyon, France

Evaluation of peritoneal membrane characteristics: clinical advice for prescription management by the ERBP working group

Peritoneal dialysis (PD) uses the peritoneal membrane as a semi-permeable membrane for solute transfer and ultrafiltration. The properties of this membrane are important determinants for selecting the optimal treatment regimen but vary among individuals as well as within the same individual over time (for review, see Coester et al. [1]). As such, evaluation of the peritoneal membrane characteristics is of importance to guide PD prescription management (Figure 1). So far, the European Best Practice Guidelines (EBPG) have not covered the evaluation of the peritoneal membrane, but other guideline bodies have done so [2–4]. The present document summarizes the point of view of the European Renal Best Practice (ERBP) advisory board on this topic. In accordance with the mission statement of ERBP [5], this position statement is not a guideline, which would necessitate a complete in-depth analysis of the literature, but reflects recommendations and/or clinical advice on how to evaluate peritoneal membrane characteristics in clinical practice and how the results should be incorporated in PD prescription. The recommendations/clinical advice are based on expert opinions, supported by evidence when available.

High-flux or low-flux dialysis: a position statement following publication of the Membrane Permeability Outcome study

The European Renal Best Practice (ERBP) Advisory Board recently decided to follow up existing guidelines, and to publish position statements when new evidence would necessitate a change in the existing guideline [1]. The purpose of this document is to provide guidance on the interpretation and relevancy of the current European Best Practice Guideline (EBPG) on dialysis strategy [2], in the light of the recently published Membrane Permeability Outcome (MPO) study [3].This position statement is intended to be considered in conjunction with the current guideline. It does not replace the guideline as we do not include a new systematic review of the literature. The MPO study specifically focused on the question whether the use of a high-, compared to a low-flux dialyser membrane, would have a measurable effect on survival.

The future of European Nephrology 'Guidelines'-a declaration of intent by European Renal Best Practice (ERBP).

The disparities of medical practice, together with a growing number of possible interventions, have increased the demand for well-conceived guidance for practitioners [1]. However, this development is hampered by the number and quality of scientific studies that test medical hypotheses, which are often unsatisfactory. This is especially true in nephrology, where well-conducted controlled trials are rare [2]. Because patients with renal failure are generally excluded from controlled studies in the general population [3], the development of sufficiently well-founded guidance in nephrology has always been difficult. With the development of European Best Practice Guidelines (EBPG), the European Renal Association–European Dialysis and Transplantation Association (ERA–EDTA) has created its own guidance-generating process. Similar initiatives have also arisen in the USA (Kidney Disease Outcome Initiative—K/DOQI), Australia (Caring for Australasians with Renal Impairment—CARI), Canada (Canadian Society of Nephrology—CSN), the UK (United Kingdom Renal Association—UKRA), as well as at several other locations around the world. These institutions have generated a plethora of often parallel recommendations on similar topics but sometimes with different messages [4]. The question can be asked: ‘Is there still a place for an institution generating European nephrology guidance?’ If there is, how should such an initiative be managed to conform with current demands? To answer these questions, the Council of ERA–EDTA set up a commission that convened three times in the course of 2008–09. The present text is a distillation of the discussions, reflections and final conclusions of this commission. It is an ad hoc document, reflecting the current status. In the future, concepts and attitudes might change, as medical thinking is influenced by changes in practice, needs, general philosophy, ethics and political/financial conditions.

European best practice quo vadis? From European best practice guidelines (EBPG) to European renal best practice (ERBP)

Although medical guidelines generally are graded according to their evidence level, low evidence 'judgement' are generally perceived as much as absolute truth by the medical community as high evidence 'guidelines' are. Being aware of this bias, a workgroup appointed by the European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA), the members of which are the authors of the current publication, decided that European nephrology guidelines issued by the Association should be published only as 'guidelines' in the case of high-level evidence; otherwise they should be named 'recommendations' or 'position statements' and be published in a different format. Acknowledging that in nephrology, high levels of evidence are often lacking, it was also decided to rename the responsible body from European Best Practice Guidelines (EBPG) to European Renal Best Practice (ERBP). The present publication reviews the arguments based on which this decision was taken.