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statement of ERBP (Figure 1), and at explaining how it impacts on what ERBP believes that guidelines and guidance should and should not be, and what that ...
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Received for publication: 15.3.2013; Accepted in revised form: 15.3.2013

Nephrol Dial Transplant (2013) 28: 1980–1984 doi: 10.1093/ndt/gft291 Advance Access publication 29 August 2013

What guidelines should or should not be: implications for guideline production Wim Van Biesen1,2*, Sabine N. van der Veer2,3,

1

Renal Division, Ghent University Hospital, Ghent, Belgium,

2

European Renal Best Practice Methods Support Team, Ghent

University Hospital, Ghent, Belgium,

3,4

Kitty J. Jager ,

3

Denis Fouque5,

Amsterdam, the Netherlands,

Christoph Wanner

6

and Raymond Vanholder

1

4

ERA-EDTA Registry, Academic Medical Center, Amsterdam, the

Netherlands, 5

Department of Nephrology, Hôpital E. Herriot, Lyon, France and

6

Renal Division, Würzburg University Hospital, Germany

Keywords: evidence-based medicine, guideline, nephrology, shared decision making

Correspondence and offprint requests to: Wim Van Biesen; E-mail: [email protected]

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

A B S T R AC T European Renal Best Practice (ERBP) is the official guidanceproviding body of the European Renal Association—European

© The Author 2013. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Department of Medical Informatics, Academic Medical Center,

1980

‘ … through enhancing the accessibility of knowledge on patient care … ’

F I G U R E 1 : ERBP Mission Statement

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.

INTRODUCTION European Renal Best Practice (ERBP) is the official guidanceproviding body of the European Renal Association–European Dialysis and Transplant Association (ERA–EDTA). In 2008, a first paper depicted the direction ERBP would take in the future [1], which consisted of two important conceptual decisions: on the one hand, the choice for rigorous methodology, and on the other hand, the wish to provide guidance to the renal community, even when evidence was poor or lacking. The advisory board envisioned that in order to achieve these goals, it was necessary to install a Methods Support Team, with dedicated young nephrologists becoming well-trained methodologists to manage and support the guideline production process. The series in NDT Perspectives, of which this publication is the first, will shed some light on the ideas and concepts on guideline production that have emerged during discussions within this Methods Support Team. This editorial aims at providing context to the mission statement of ERBP (Figure 1), and at explaining how it impacts on what ERBP believes that guidelines and guidance should and should not be, and what that implies for the guideline production process. We will argue against seeing guidelines as ‘carved in stone’, especially when this leads to the idea that what is ‘good’, must be ‘good for all’. We rather believe that guideline-producing bodies should provide their evidence, such that they support shared decision making. However, it should be well understood that the more the effect of certain interventions is (i) consistent and accurately predictable; (ii) clinically relevant to patients rather than affecting surrogate outcomes; (iii) a priority for patients and other stakeholders [2], the more likely it is that adherence to the guideline will improve the outcome of patients [3] and the more desirable it is that the final result of the shared decision-making process is in line with the guideline [4]. This necessitates special attention to how guidance is provided and to understanding medical decision-making processes. 1981

ERBP mission and introductory

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In the past, all available medical knowledge could be assimilated in one person. The body of knowledge grew only slowly. In addition, for most of the topics covered, the relation between intervention and outcome was quite clear, for example, the use of antibiotics in infections, or sterile procedures in surgery. This made it relatively easy for physicians who treated a reasonable number of patients to comprehend what to do in which situation. Over the last three decades, the computerization of society has resulted in an exponential growth of available ‘evidence’ of varying quality, which almost everybody can now access online, resulting in an amount of information that no single individual can digest. In addition, we are now dealing with improvements and outcomes that are only observable after a long follow-up time and in larger populations (e.g. decrease of cardiovascular risk by the use of statins). All these developments created the necessity to have experts summarizing, interpreting and translating the available information. This resulted in the conception of evidence-based medicine [5, 6]. In addition, practices differed between centres, while these differences appeared to be associated with differences in outcomes [7–9]. So, as a next step, this compiled evidence was published as ‘guidelines’, to stimulate best practice and to minimize variation in practice. Much progress has already been made in the methodology of how to compile and extract evidence www.thecochranelibrary. com, webpage E. Available from: www.european-renal-bestpractice.org, starting from which ERBP has developed its own methodology standard [10]. Whereas a rigorous methodology is an indispensable step in providing high-quality guidance, the low availability of quality evidence in renal medicine remains a major hurdle, and results in remaining uncertainty about the validity of the statements in the guideline. A broad look at nephrology guidelines tells us that only few are evidence level ‘A’, some are level ‘B’ and the major bulk are evidence level ‘D’ or ‘ungraded’. In plain language, this means that, for the majority of the statements, the true effect in an individual patient may differ substantially from the effect estimated from the studies providing the basis for the statement, and can even be opposite [11]! The major reason for this discrepancy is that, we simply lack good evidence on the effectiveness of many treatments in nephrology, either because the topic has not been investigated, or available studies, be it randomized or observational, have their inherent pitfalls [12–15] or sources of bias. ERBP believes that it should be the task of a guidance body to indicate why certain evidence might be biased or not convincing. The use of objective, easy-to-read data extraction tables providing both the evidence and the quality assessment of the evidence is one promising way to achieve this goal [16]. High-quality randomized controlled trials are scant in the field of nephrology [17], and those that are available make us realise another challenge: this type of studies is expensive, and mostly performed by pharmaceutical companies [18, 19]. This results in the Catch-22 situation that evidence is mostly created, and thus only available, for (often expensive) newer drugs or interventions. Very rarely is funding available to

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investigate cheaper alternatives; so, where two sides of the coin should be evaluated, the cheaper one remains invisible. This hurdle remains one of the most delicate points in the defence of evidence-based medicine. Thus, public funding bodies should be constantly asked to support research for alternative (cheaper) treatments that will not receive support from industry, while investigators should also be open for ways to run these studies at lower costs. Here, guidance-producing bodies can be of help by building data extraction tables of systematic searches and making them publicly available. It will then become visible where evidence is lacking, or bias and confounding is apparent, and further studies are needed. This procedure will also allow us to easily update the guidelines when new evidence is available, preventing guidelines being outdated before they are published. When we opt to use dataextraction tables, we can add new evidence and see whether or not it changes the conclusions, taking into account that also the updating should be done in a transparent and rigorous manner. Providing a common template for what is required to obtain good quality data extraction will also allow us to share data-extraction tables between guideline-producing bodies, thus avoiding duplication of work and expanding the number of people willing and able to do part of the required tasks, both reducing costs and time of guideline production. Emphasizing the indispensable character of the use of rigorous methodology during guideline production creates the impression that guidelines should only be produced in areas where firm evidence is available. ERBP feels that this is unjustified. The scarcity of high-quality clinical trials, and the relatively low patient numbers in most of the nephrological conditions confront nephrologists with the absence of highquality evidence. In these circumstances, a compilation of additional expertise can help them out in daily clinical management. However, it should be made ‘transparent’ that in such cases the guidance is based on consensus rather than on evidence, and made clear that a systematic literature search has confirmed the absence of firm evidence: rigorous methodology should always be the starting point. ERBP created a special category of publications on areas where sufficient evidence is lacking, namely the ‘position statements’ [1]. Position statements include many elements of consensus and in that case the terminology should be changed from ‘guideline’ to ‘guidance’.

concerns two relationships: one between the treating physician and the patient, and a second between the guideline-producing body and its users. As a consequence, the guideline should be such that it allows us to make a decision based on the provided evidence. This is a change in paradigm from ‘we will tell you what is best’ to ‘we will provide you with the data in order to come to your own conclusion’. Certainly, and as already stated, the more convincing the evidence is, and the better the rationale of the guideline work group is, the more likely the decision maker will opt to come to the same conclusion as the guideline-producing body, an aspect that is very well captured in the GRADE system [11]. ERBP is aware that the nomenclature for rating guideline recommendations is complex, and thus, inhibits the knowledge dissemination process. The twostep rating of the GRADE system into ‘strength of recommendation’ (levels 1, 2 or not graded) and ‘quality of the supporting evidence’ (A, B, C or D) is often neglected. The implications for patients, clinicians and policy are not considered, and overall this results in a misinterpretation of the guideline. Physicians as well as patients value ‘factual’ and ‘objective’ information, but it has been well recognized that human beings do not take decisions solely on rational grounds [23]. On the contrary, emotional grounds will often play an important role in the shaping of a preference. Emotions that influence the decision-making process can be ‘immediate emotions’, i.e. be present at the moment of understanding that there is a choice to be made, resulting in heuristic decision making [24]. However, emotions can also be ‘anticipated emotions’, feelings that are not yet there, but that the physician or patient can project to be there as a consequence of a certain choice. For example, a dialysis patient could consider: if I drink this glass of beer, this is fine now, but I risk becoming fluid overloaded, and may risk pulmonary oedema, which will be unpleasant. This process can be guided by rational argumentation, be it only partly [25], as personality traits will determine which arguments will result in which emotion, and finally which decision will be made. People value much more consequences that are nearby in the future than remote ones, and they also commonly prefer ‘avoiding harm’ over ‘creating potential benefit’ [26]. Patients will, e.g. be easily compliant with their phosphate binders to avoid itching (direct harm), but it will be more difficult to convince them to take phosphate binders to avoid cardiovascular events (remote benefit) or to improve a surrogate marker such as parathyroid hormone. Similarly, also physicians are not free from ‘inborn thinking errors’: although the use of metformin has been associated with a beneficial cardiovascular outcome, even in patients with chronic kidney disease, most physicians would be reluctant to prescribe metformin out of fear for lactic acidosis (avoidance of harm), although this is a rather rare complication [27]. Providing evidence in a structured manner on the risks and benefits of alternative treatments, i.e. sulphonylureas or insulin, might convince them to take the risk of lactic acidosis, as these alternatives could just as well lead to even worse outcomes [28]. Guidelines should protect physicians and patients from ‘emotional choices’ by providing the necessary information in a way that this ‘emotional decision making’ is avoided as much as possible. At the same time, physicians should steer away from paternalistic statements claiming that

‘ … in a format that stimulates its use in clinical practice … ’ The most obvious aspect of this phrase of the mission statement regards the actual implementation process after release of the guideline [20]. ERBP believes that, in order to ensure that guidance is used in clinical practice, it is necessary to understand the most pertinent aspects of medical decision making, as much from the side of the patient as from that of the physician. These insights will impact on how the guideline is conceived and formulated. Guideline-producing bodies should aim at generating guidelines that support shared decision making. This process goes far beyond simply explaining different options to the patient [21], and is complicated by the existing uncertainty [22]. Of note, shared decision making 1982 W. Van Biesen et al.

To improve the outcome of patients with kidney disease in a sustainable way… In line with its mission statement, ERBP believes that, in this era of an overwhelming amount of available information on variable quality and relevance, there is a need for organizations that assemble and analyse the true evidence in a transparent and methodologically robust manner. This is the best guarantee for obtaining sustainable and fair health care, as guidelines can protect physicians from prescribing treatments that are ineffective, where the term ‘ineffective’ covers different meanings ranging from ‘not working at all’, to ‘not improving relevant outcomes’ or ‘achieving outcomes that are not a priority’ [29]. Guidelines can be used to steer health care policy, as is already incorporated in the GRADE system [30], and can serve to decrease the pressure of industry or public opinion to prescribe ineffective interventions. Some may argue that guidelines will be (ab) used by payers and policymakers to monitor and judge the quality of care provided by physicians. ERBP believes that this should be done with utmost care, even when using guidelines as a reference. This is especially true if it concerns indicators that not only reflect centre performance, but also individual patient preferences, e.g. the duration of dialysis sessions [3]. Instead, it is preferable to focus on developing indicators that reflect the extent to which units facilitate shared decision making in certain fields, for instance, whether the patient is offered alternative treatment options, yes or no. Also other methodological issues should be carefully considered before using guidelines to develop clinical performance indicators. First of all, the choice of which indicators one will use to monitor clinical performance may heavily affect the clinical result that clinicians will aim for in reality, as well as the actual improvement of patient outcomes [29]. If a level ‘X’ is claimed to be the best value for haemoglobin, should one then aim to have the mean of the population at ‘X’, meaning a substantial part is below ‘X’, or should one measure the percentages of patients

CONCLUSION In line with its mission statement webpage E, available from: www.european-renal-best-practice.org, ERBP believes that the best way to assure sustainable improvement in patient outcomes is to support shared decision making between physicians and patients by providing the best available and well-balanced evidence. ERBP believes that this has to be considered from the first stages of guideline conception on. C O N F L I C T O F I N T E R E S T S TAT E M E N T The concept of this paper has been approved by the advisory board of ERBP (in alphabetical order: D. Abramovic, J. Cannata, P. Cochat, A. Covic, K.-U. Eckhardt, D. Fouque, O. Heimburger, K.J. Jager, S. Jenkins, E. Lindley, F. Locatelli, G. London, A. McLeod, G. Spasovski, J. Tattersall, R. Vanholder, W. Van Biesen, C. Wanner, A. Wiecek, C. Zoccali.) during its winter meeting 2012 in Berlin. The declaration of interest forms of S.N. V., K.J.J., C.W., R.V. and W.V.B. are found on the webpage of ERBP: www.european-renal-best-practice.org

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above ‘X’, resulting in many patients far above ‘X’, which might be undesirable. A similar issue concerns protein intake in dialysis patients: should we define the minimal intake or the optimal intake? When applying indicators based on percentages of patients that achieve a given target, one should be certain that the preset percentages are achievable in clinical reality [31] without jeopardizing ‘personal choice’ [32]. In addition, aiming with the best intentions for a desirable guideline-based outcome (e.g. more fistulas) can sometimes result in unwarranted effects, as already became apparent in the ‘Fistula First’ project [33, 34]. When developing performance indicators, it seems to be logical to give priority to guideline statements for which we have a solid evidence base and which are considered a priority [35]. However, a second issue to keep in mind is that clinical performance measurement (CPM) initiatives tend to constrain the selection of their performance indicators to those whose data collection they consider feasible, implying that some ( potentially more) important aspects of care may be neglected due to the mere fact that they are supposed to be ‘unmeasurable’. For example, in the CPM project of KDOQI [36], 36 of 114 guideline recommendations were originally identified as having a high priority. However, 14 of these recommendations were not transformed into performance indicators partly because they could not be unambiguously made operational for measurement purposes.

they know what is ‘best’ for their patient. Guidelines can also be helpful in making physicians and patients aware of all available options, to avoid anchoring effects. Considering the influence of anticipated emotions in the decision-making process, physicians should rather be supported to ‘predict’ outcomes of a certain intervention, and explain the potential consequences of taking decision A versus B. In that way, the patient himself can make the decision, taking into account his own preferences. Presenting the available evidence in a format that supports the balancing of pros and cons of all potential interventions will most likely lead to outcomes that are preferred by the patient. In fact, from the very beginning, the framing of the question to the needs of the individual patient was incorporated in the early definitions of evidence-based medicine [6]. As explained in the Introduction, the more consistent the evidence is on the expected outcomes of an intervention, and the more clinically relevant the outcome is to patients, the more likely it is that shared decision making will lead to the patient opting for and adhering to the provided guidance [3], an element included in the GRADE classification.

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Received for publication: 29.4.2013; Accepted in revised form: 26.5.2013

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