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. The nephrology guidance landscape was thoroughly modified with the advent of the Kidney Diseases Improving Global Outcome (KDIGO) initiative, a body that establishes global nephrology guidelines on a worldwide basis [5]. However, the number of topics and necessary updates is too large to be dealt with by KDIGO alone. KDIGO have therefore installed a coordination task force having representation from all other major guidance initiatives. It was originally thought that KDIGO would cover the whole spectrum, producing new and updated nephrology guidelines on any theme considered suitable. In 2006, the KDIGO Board of Directors decided to concentrate on selected topics only. This opened up a new opportunity for existing guidance bodies, both European and other, to take a more active role in the formulation of nephrology recommendations. The ERA–EDTA has produced nephrology guidance documents since 1999 on the treatment of renal anaemia; haemodialysis; peritoneal dialysis and transplantation (Table 1) [6]. Clinical nephrology recommendations have not yet been generated. Whereas guidance produced by other bodies (e.g. K/DOQI) has often been restrictive and focused on specific themes, the design of European guidance, in general, has been more comprehensive, at the expense of taking a position in areas where the evidence was weak. EBPG produced only one update, in 2004, on anaemia. EBPG has also collaborated with K/DOQI on bone metabolism; hypertension in CKD; cardiovascular disease in dialysis and anaemia (2006 update) and with KDIGO on hepatitis C [7]. Also to be noted is that K/DOQI invited several European experts who, in the final drafts, were referred to as ‘liaison’ members to the work groups. Several European experts are collaborating with KDIGO on the upcoming guidelines on bone and mineral metabolism and on the care of the kidney transplant recipients. Documents generated up till now by the European Best Practice Guidelines (EBPG) aNo real ‘guidelines’ but series of algorithms, generated by European experts, not under the responsibility of ERA–EDTA. bPosition statement. Documents generated up till now by the European Best Practice Guidelines (EBPG) aNo real ‘guidelines’ but series of algorithms, generated by European experts, not under the responsibility of ERA–EDTA. bPosition statement. Before starting a specific action, a think tank of 20 European experts in guidance development was appointed by the ERA–EDTA Council to develop over a ±1-year period a further plan for the future. The group was mainly composed of the physicians who are the most affected by these documents, i.e. nephrologists, including a paediatric nephrologist and renal epidemiologists. Several members had previously participated in the development of EBPG on anaemia, haemodialysis, peritoneal dialysis or transplantation; some of the participants had also been involved in the development of K/DOQI and KDIGO guidelines (Table 2), whilst others serve on the ERA–EDTA Council. During the course of its activity, the group was extended by several non-nephrologists, i.e. a clinical scientist, a renal nurse and a patient who also worked for 33 years as a general practitioner (Table 2). Members of the ERBP Advisory Board, together with their expertise, experience with other guideline bodies and nationalities TP: transplantation; Gen: general nephrology; PD: peritoneal dialysis; HD: haemodialysis. aEx officio as Secretary Treasurer of ERA–EDTA. bEx officio as President of ERA–EDTA. Members of the ERBP Advisory Board, together with their expertise, experience with other guideline bodies and nationalities TP: transplantation; Gen: general nephrology; PD: peritoneal dialysis; HD: haemodialysis. aEx officio as Secretary Treasurer of ERA–EDTA. bEx officio as President of ERA–EDTA. Although a further extension of the group by non-nephrologists (e.g. by an ethicist) was considered, this was eventually deemed unnecessary at the current time. If there is a need, ad hoc advice will be sought from specific experts. The group mentioned above will serve as Advisory Board, meeting on a regular basis several times a year to consider potential topics, the need for updates and adaptations to existing documents and their implementation. This Advisory Board should take decisions about further action based on existing and new evidence. This Board should appoint extended scientific area work groups (involving experts in a specific field) (see the ‘Composition of work group’ section). Members of this Advisory Board should be selected by the Council of ERA–EDTA based on their specific competences and CVs. The Board composition should be based on an alternating rotation system after a pre-set number of years, which should be specified in the Board's bylaws. The Board should also appoint specific watchdogs (see the ‘Literature watch’ section), who could be defined as area experts to advise the Board about new relevant data in specific fields and the need to, or possibility of, generate new recommendations. At the very beginning of the discussions of the Advisory Board, the lack of knowledge and evidence due to a shortage of randomized controlled trials (RCTs) was acknowledged [6]. Such uncertainty creates a problem for the production of new ‘guidelines’ and necessitates a search for clear definitions and alternative formats, to avoid confusing those who may otherwise consider the statements as too strong if they are based on rather weak evidence. Offering guidance should be done with sufficient transparency such that deficits, due to lack of evidence, are acknowledged. On the other hand, the need to offer guidance in areas where there is not much evidence is also recognized. ERA–EDTA has a responsibility to offer guidance from experts to clinicians especially in those areas. The latter category of guidance can be offered in a format that differs from traditional ‘guidelines’. The Advisory Board decided that the best way for this to be done was to implement ‘recommendations’ and ‘position statements’ in new formats summarizing the state of the art for a specific topic, where the available evidence and/or expertise are translated into a broad European perspective. To emphasize this change in scope, it was decided to modify the name from EBPG to ERBP (European Renal Best Practice) [6]. The structure is functioning under the ERA–EDTA, with an Advisory Board (see the ‘Outline of further action’ section) that serves as one of the Advisory Boards of ERA–EDTA. The Advisory Board decides the topics on which statements should be made, the format (i.e. recommendation, guideline, position statement or other) appointments the chairmen of the work groups that are going to address a particular topic, and reviews the final draft before its submission. In addition, the Advisory Board is in contact with other guidance bodies such as KDIGO to facilitate the harmonization of initiatives, and also, via the liaison task force of KDIGO, with K/DOQI, CARI, CSN and UKRA (Figure 1). Structure of ERBP and its Advisory Board, and their relation to ERA–EDTA and other guidance generating bodies. Structure of ERBP and its Advisory Board, and their relation to ERA–EDTA and other guidance generating bodies. There has been extensive discussion within both the ERBP Advisory Board and the KDIGO Executive Committee and Board of Directors about the terminology used in guidance documents and the methodology used to grade the quality of evidence and strength of recommendations. Tables 3 and 4 summarize the definitions and interpretations as they stood in January 2009. Worldwide the methodology is evolving, so it is possible that there will be further adaptations. Grading of quality of evidence Grading of quality of evidence Grading of strength of recommendation Grading of strength of recommendation Evidence should be graded according to the GRADE system [8]. KDIGO have decided to use A, B, C and D to describe the four grades of evidence quality, based on a GRADE document published in 2008 (Table 3) [9]. The following parameters should be considered: (1) the quality of evidence; (2) the balance of health benefits and harms; and (3) the balance of net financial benefits and costs; the latter element becomes increasingly important as resources become more and more limited. The strength of a guidance statement indicates the extent to which one can be confident that adherence to the recommendation will do more good than harm. The level of confidence depends not only on the quality of the evidence but also on the judgment of the experts in the work group [9]. Only two statement strengths have been defined by KDIGO (Table 4), with Level 1 referring to ‘strong’ recommendations. When judgment is brought in, high-quality evidence does not always lead to Level 1 guidance statements and vice versa. In situations where there is high-quality evidence that an intervention would be effective, but the intervention has frequent and/or serious side effects, the strength of the guidance statement may be moved to Level 2 (‘weak’). Lower quality evidence, based on good clinical practice or widespread experience that is unlikely to be tested by an RCT, could lead to a Level 1 guidance statement if the work group members judge the intervention to be beneficial, and if the risk involved is low enough to allow the intervention to be used unconditionally in most cases (e.g. the use of dialysis to treat end-stage or acute renal failure; the use of anticoagulants in haemodialysis). When the strength of the guidance statement and the evidence quality are combined, there are eight grades (1A to 2D). KDIGO are intending to use this system based on symbols, rather than words. The ERBP Advisory Board felt that the guidance statements should give both the overall grade and an explanation of the grade for each statement in words. For example: ‘Grade 2D (weak recommendation; low-quality evidence)’. Within the KDIGO system, it is also possible to make an ‘ungraded’ statement. The wording for these statements is likely to be ‘It would be reasonable to…’ rather than ‘We recommend/suggest…’. ERBP accepts this ninth grade as well. To avoid confusion, it is, however, recommended to only use this kind of statement exceptionally. To emphasize the difference between graded and ungraded statements, the former should be boxed, but with Level 1 statements in bold, and ungraded statements should be unboxed bullet points. Currently, KDIGO are using the word ‘guideline’ to refer to the document (the ‘book’) containing all statements, of the overall evidence is the ERBP Advisory Board to refer to the document as practice rather than practice all statements are of Level KDIGO and the ERBP Advisory are using a ‘position to describe a document that to best practice but is not based on a and a of and by the group producing the of ERBP position statements are the on renal anaemia and the of the KDIGO guideline on hepatitis The existing ‘guidelines’ should be to major new evidence. This not only the of current guidance but also the development of a to for evidence that is important enough to ad hoc changes (see the ‘Literature watch’ of guidance documents that might need are the for renal anaemia treatment where published evidence was the of a specific ERBP position statement and the of and in haemodialysis, which might need after the of the have been published For existing guidance up to the most is to this task to the group or members of the Advisory Board who have been for the guideline, at the of the ERA–EDTA Council. If considered they should work in with experts in the who are not Board The ERBP Board's be to existing ‘guidelines’ rather than new since is not for in the are as Transplantation recommendations were published by EBPG in and that much new evidence in this area has been generated. It has been into that KDIGO is transplantation ERBP to a position statement on the KDIGO document it is published and to its recommendations on topics that will not be by KDIGO, such as both of and and The Transplantation Society should also be to avoid recommendations were published by ERBP in and the might but only on selected topics such as dialysis of other topics might be new such as the for the of dialysis; the and the for cardiovascular or the for the of The on the of might be extended to cover the of care to patients with 3 and including the of available dialysis and the to patients (see the of new section). 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This is especially true for clinical nephrology topics that the area of renal the about which topics to address should be by the by the Advisory The to cover a should be after existing guidance documents from other bodies K/DOQI) to avoid and the use of harmonization with those to parallel The coordination and liaison initiative from KDIGO might be the to facilitate decisions in this However, the existing ‘guidelines’ generated in the the ‘guidelines’ or recommendations should only be considered if the for new The structure generating the documents containing the statements should of a number of work groups. work with a of should have a and of their expertise and These will in their groups. If a work group has several the should be appointed by the work group (Figure 1). The should Members might also be sought from to other areas such as the the for might be since and can from to If there are in between it is often a of lack of evidence. such should be mentioned in the the very ERA–EDTA the KDIGO to global is to the evidence and the implementation. of the members of the Advisory Board of ERBP also an active role in The with KDIGO should own European It should be noted that since the KDIGO into role is more with the coordination and of traditional guidelines and in position a for Guidelines generated by KDIGO and other bodies should be considered by ERBP and if or that to may if be hoc will be appointed to position statements, to be published in the of ERA–EDTA, the task of is for KDIGO to and for guidance bodies. of the between KDIGO and ERBP at the and the liaison task force (see the of new section). from KDIGO, other bodies are active in the of initiatives may be by ERBP ERBP initiatives may be by ERBP or published under responsibility with The Advisory Board will the to be taking into the level of evidence, the on the and patients and the available EBPG have always been based on a of The number of experts involved has been the weak and the work The following are search and evidence should be offered by an the The search should be on specific based on the system (Table system for the search randomized controlled system for the search randomized controlled The search should be in an should be to, any according to the and/or a to only might be The should be are a for evidence and may be to are only considered as of a including and quality of the under should only be used to an answer to that be are the quality of the studies and may be only best evidence a large is done The following groups could be considered to The draft can be available for the to the especially for guidance documents of a more extended format than position This will that the draft will be to all members of ERA–EDTA. It could also be available to or other guidance bodies (e.g. European Dialysis and Transplantation European Renal KDIGO, K/DOQI, These should be selected experts, and the members of the ERBP Advisory Board and the members of the ERA–EDTA as as they were not involved in the development of the document under may take in this process. 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For this to to several specific are ERA–EDTA has a experience with the of its guidance documents at its own general now each upcoming ERA–EDTA meeting will to at one on with In to the specific of guidance documents, the following messages should be (1) the important between the strength of evidence and their on the format of guidance and (2) the present of guidance development and to avoid the the general nephrologist with a of documents on the topics K/DOQI, CARI, initiatives should be considered in the following of ERBP documents at other general Society of European Society for Transplantation at specific at ERA–EDTA recommended as one of the most as this in at Such could be in with Society with to up to 20 other such might be considered each initiative will be after the of the ERBP position statement on the KDIGO hepatitis guidelines [7]. 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The to ERBP and the liaison with other guidance groups. The ERBP with its specific should offer an of clinical practice guidance on nephrology that might the current recommendations for all ERBP ERBP In the present an is on how the of European Renal Best Practice which the European Best Practice Guidelines (EBPG), are to be in The will be on the in between position statements that are not well and which of statement.
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Vanholder et al. (2009) studied this question.
Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context: